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$SRNE Announces Closing of Public Offering of Common Stock
SAN DIEGO, April 19, 2017 — Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, today announced the closing of its previously announced underwritten public offering of 23,625,084 shares of its common stock at a public offering price of $2.00 per share, before deducting underwriting discounts and commissions and estimated offering expenses payable by Sorrento. The net proceeds to Sorrento from this offering were approximately $43.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
Cantor Fitzgerald & Co. acted as the lead book-running manager for the offering. FBR Capital Markets & Co. acted as a joint book-running manager. Oppenheimer & Co. and Aegis Capital Corp. acted as co-lead managers and Joseph Gunnar & Co., Rodman & Renshaw and Roth Capital Partners acted as co-managers.
The securities described above were offered by Sorrento pursuant to a shelf registration statement on Form S-3 (File No. 333-199849) previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on December 3, 2014. A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC on April 14, 2017 and is available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by telephone at 212-829-7122, or by e-mail at prospectus@cantor.com.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for immuno-oncology, inflammation and autoimmune diseases. Sorrento’s lead product candidates include immunotherapies focused on the treatment of both solid tumors and hematological malignancies, as well as late stage pain products.
Forward-Looking Statements
This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the amount of proceeds expected from the offering and other matters that are described in Sorrento’s most recent periodic reports filed with the SEC, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2016, as amended, and the final prospectus supplement related to the offering filed with the SEC on April 14, 2017, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
All other trademarks and trade names are the property of their respective owners.
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved.
$SNGX Ricin Toxin Vaccine RiVax Program Efficacy Results to be Presented
PRINCETON, N.J., April 19, 2017 — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that results from its ricin toxin vaccine (RiVax™) development program will be presented at the 20th Annual Conference on Vaccine Research, being held April 24-26 in Bethesda, Md.
“Serum Antibody Profiling following Vaccination Reveals a Correlate of Immunity to Ricin Toxin” will be presented by Jennifer Yates, Ph.D., New York State Department of Health, Wadsworth Center and attended by Oreola Donini, Ph.D., Chief Scientific Officer of Soligenix, on April 25 at 2:15 p.m. Eastern time.
RiVax™ is the Company’s proprietary vaccine candidate for the prevention of exposure to ricin toxin that utilizes a unique antigen that is completely devoid of the toxic activity of ricin. When formulated with ThermoVax®, Soligenix’s proprietary vaccine heat stabilization technology, RiVax™ has demonstrated significantly enhanced thermostability and 100% protection in preclinical ricin aerosol challenge models.
In collaboration with the New York State Department of Health and the laboratory of Nicholas Mantis, Ph.D., Soligenix has been investigating immune correlates of protection in sera of animals vaccinated with RiVax™. The findings demonstrate that: 1) the ThermoVax® thermostabilization process significantly enhances the stability of the RiVax™ antigen; 2) degradation in the antigen can be measured with specific monoclonal antibodies; and 3) these same monoclonal antibodies can be used to probe the immune profile of vaccinated mice and primates and predict their survival to subsequent ricin exposure challenge.
These findings are expected to facilitate the potential approval of the RiVax™ product under the U.S. Food and Drug Administration (FDA) “Animal Rule” and represent a significant step forward in the understanding of ricin toxin immunology. This work was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, via Contract #HHSN272201400039C.
About the Annual Conference on Vaccine Research
In its 20th year, the Annual Conference on Vaccine Research is offered by the National Foundation of Infectious Diseases and brings together experts from around the world, including healthcare professionals, researchers, public health experts and industry. The 2017 conference includes a diverse range of topics including therapeutic vaccines and the use of novel technologies to fight emerging infectious diseases. Details regarding the annual conference can be found here.
About Ricin Toxin
Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact it is readily extracted from by-products of castor oil production. Ricin comes in many forms including powder, mist or pellet. Ricin can also be dissolved in water and other liquids. The U.S. Centers for Disease Control and Prevention (CDC) estimates the lethal dose in humans is about the size of a grain of salt. Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure. Ricin is especially toxic when inhaled. Ricin works by entering cells of the body and preventing the cells from making the proteins it needs. Without the proteins, cells die, which is eventually harmful to the entire body.
There are currently no effective treatments for ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.
About RiVax™
RiVax™ is Soligenix’s proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.
RiVax™ contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.
To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was subsequently formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine. Vaccination with the thermostabilized Alum-adjuvanted RiVax™ formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin. The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.
Heat stabilization of RiVax™ is achieved with the Company’s proprietary ThermoVax® technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines. The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. By employing ThermoVax® during the final formulation of RiVax™, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
The development of RiVax™ has been sponsored through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the FDA, which were granted to Soligenix and to the University of Texas Southwestern (UTSW) where the vaccine protein originated. To date, Soligenix, Ellen Vitetta, Ph.D. and her colleagues at UTSW have collectively received approximately $25 million in funding from NIAID for development of RiVax™ and related vaccine technologies. RiVax™ potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack. RiVax™ has received orphan drug designation from the FDA.
As a new chemical entity, an FDA approved RiVax™ vaccine has the potential to qualify for a biodefense Priority Review Voucher, which allows the holder accelerated review of a drug application. Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable and can be sold, with sales in recent years varying from between $125 million to $350 million.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the preclinical/clinical trials of RiVax™, that RiVax™ will be approved for the PRV program or the amount for which a PRV for RiVax™ can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
$NWMH Reports Full-Year 2016 Results, Triple-Digit Revenue Growth
HERNANDO, FL–(Apr 19, 2017) – National Waste Management Holdings, Inc. (OTC: NWMH) (“National Waste”) today announces financial results for the full year ended December 31, 2016, demonstrating continued revenue growth and strength in acquisition-based growth strategy.
Full-year 2016 Highlights:
- Revenues for the twelve months ended December 31, 2016, increased 161% to $6.3 million;
- Cash flows from operating activities for the twelve months ended December 31, 2016, increased to over $1.0 million;
- Acquired Northeast Data and Recycling, LLC and Sivart Services, LLC during the year ended December 31, 2016;
- Continued to see positive results from acquisitions of WRE and Gateway;
- Engaged corporate communications firm to increase shareholder dialogue and transparency;
- Appointed as CFO, Dali Kranzthor, and expanded board of directors;
- Upgraded technology to improve efficiency and reporting
Louis Paveglio, CEO of National Waste Management Holdings Inc., stated, “We executed a number of achievements throughout 2016, and are pleased to report the positive impacts of these initiatives in several respects. Our significant increase in full-year revenues was driven by the performances of companies within our growing acquisition portfolio and subsequent vertical market reach. Additionally, we enjoyed the impact of a stronger economy, an expanded customer base, and an increase in construction activity in Florida — all of which also contributed to our top-line growth.”
Revenue for the 12 months ended December 31, 2016, increased 161% to $6.3 million, as compared to revenue of $2.4 million reported for the full year ended December 31, 2015. This increase is due to a stronger national economy, better utilization of resources, the WRE and Gateway acquisitions during 2015, and the May 2016 acquisition of Sivart, which added Cooperstown, New York, to National Waste’s geographical footprint in Upstate New York.
Net loss for the twelve months ended December 31, 2016, was $(765,208), as compared to a net loss of $(132,503) for the comparable period of 2015. Depreciation and amortization expense increased to $1.0 million during 2016, as compared to $271,311 in 2015. Adjusted earnings after adding back non-cash depreciation and amortization expense and a one-time non-cash impairment charge related to intangible assets of $159,977 in 2016 were $460,912 and $138,808, an increase of $322,104, or 232%. The increased adjusted earnings is attributable to the acquisitions of WRE and Gateway in 2015, Sivart in 2016, and increased operations at the Central Florida landfill.
“We continue to see exponential growth from our aggressive acquisition strategy as we pursue a strong pattern of vertical expansion,” says National Waste CFO Dali Kranzthor. “Our commitment to increased corporate and shareholder value is evidenced through the steps we took throughout 2016 to position National Waste Management as a market leader in 2017 and beyond.”
About National Waste Management Holdings Inc.
National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.
This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.
Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact
$XOMA Presents Positive Data from PTH1R Monoclonal Antibody Program
Unmet medical needs in parathyroid hormone-related hypercalcemia contribute to potential partnering value of overall portfolio
BERKELEY, Calif., April 18, 2017 — XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and development of therapeutic antibodies, announced today the presentation of positive data from pre-clinical studies investigating the activity of its anti-PTH1R antagonist monoclonal antibody (mAb). The antibody is a potential first-in-class therapeutic agent for the treatment of hyperparathyroidism (HPT) and humoral hypercalcemia of malignancy (HHM). These presentations were made at the American Association for Cancer Research (AACR) and the Endocrine Society (ENDO) annual meetings.
The PTH1R receptor is part of the B GPCR family and is the primary receptor of two ligands, parathyroid hormone (PTH) and parathyroid related protein (PTHrP). Hypercalcemia can occur when elevated levels of PTH, as seen in primary HPT, or elevated levels of PTHrP, as seen in HHM, lead to excessive activation of the PTH1R receptor. A potent and long-acting receptor antagonist could reverse hypercalcemia in all these conditions.
“Consistent with our new strategy, we are seeking partners with a deep commitment to and an expertise in drug development who are interested in licensing this first-in-class antibody and taking it through the clinical development process,” said Jim Neal, Chief Executive Officer of XOMA. “There is a real need for better therapies that address hypercalcemia induced by hyperparathyroidism, and we are encouraged by these data, which demonstrate the efficacy of our anti-PTH1R approach as a potential treatment for patients suffering from HPT and HHM.”
Data presented at the AACR and ENDO conferences between April 1-4, 2017 showed:
- PTH1R antagonism in vitro by the anti-PTH1R mAb translated to potent in vivo activity
- XOMA’s anti-PTH1R antagonist mAb has the potential to become a first-in-class therapy for HHM, as the data demonstrated it ameliorated hypercalcemia and associated morbidities in pre-clinical models
- XOMA’s antibody libraries enabled the discovery of functional antibodies against a very complex target – i.e. the G-Protein Coupled PTH1Receptor
- A high affinity fully human mAb to PTH1R has been selected and characterized
- Proprietary antibody engineering resulted in antibodies with improved potency and manufacturing characteristics
“While hyperparathyroidism is a classic endocrine disorder, HHM spans both endocrine and oncology specialties. HHM is a life-threatening complication of many advanced cancers and is caused by tumor secretion of the PTH1R ligand, PTH-related peptide, which causes high calcium. Since current treatments often fall short of correcting hypercalcemia and many cancer patients die from such high calcium and associated metabolic complications, PTH1R antibodies could prove beneficial for the treatment of this devastating condition,” said John Wysolmerski, MD, Professor of Medicine and Associate Section Chief for Research in the Section of Endocrinology and Metabolism, Yale School of Medicine.
The complete presentations can be found online at www.xoma.com/content/pipeline/publications.htm.
About XOMA’s PTH1R Monoclonal Antibodies Program
XOMA has developed unique functional antibody antagonists targeting PTH1R, a G-protein-coupled receptor involved in the regulation of calcium metabolism. These antibodies have shown promising efficacy in in vivo studies and potentially could address high unmet medical needs, including primary hyperparathyroidism (PHPT) and humoral hypercalcemia of malignancy (HHM). Some secondary and tertiary HPT cases are additionally challenging to manage via current pharmacological approaches and may be well-addressed by XOMA’s anti-PTH1R antibody.
About XOMA Corporation
XOMA has an extensive portfolio of products, programs, and technologies that are the subject of licenses the Company has in place with other biotech and pharmaceutical companies. Many of these licenses are the result of the Company’s pioneering efforts in the discovery and development of antibody therapeutics. There are more than 20 such programs that are fully funded by partners and could produce milestone payments and royalty payments in the future. To maximize its value in a licensing transaction, XOMA continues to invest in X358, an allosteric monoclonal antibody that reduces insulin receptor activity, as the antibody could be a potential treatment for hyperinsulinism. For more information, visit www.xoma.com.
Forward-Looking Statements
Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding: the potential for XOMA’s anti-PTH1R antagonist monoclonal antibody; the potential of XOMA’s portfolio of partnered programs and licensed technologies generating milestone and royalty proceeds over time; and statements that otherwise relate to future periods. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA’s most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA’s prospects. Any forward-looking statement in this press release represents XOMA’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Investor contact: Luke Heagle Pure Communications +1 910-726-1372 lheagle@purecommunications.com Media contact: Colin Sanford Pure Communications +1 415-946-1094 csanford@purecommunications.com
$RARE Kyowa Kirin Positive 24-week Data Phase 3 Study of #Burosumab
NOVATO, California, LONDON and TOKYO, April 18, 2017 —
Study met primary endpoint of serum phosphorus response and key secondary endpoint of stiffness improvement
Ultragenyx to host conference call today at 4:30pm ET (USA) to discuss results
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) and Kyowa Kirin International PLC, a wholly owned subsidiary of Kyowa Hakko Kirin, today announced positive 24-week data from the randomised, double-blind, placebo-controlled Phase 3 study of burosumab (KRN23) in adults with X-linked hypophosphatemia (XLH). Patients treated with burosumab demonstrated a statistically significant improvement in serum phosphorus levels, with 94% of patients achieving normal levels compared to 8% on placebo (p<0.0001). Patients treated with burosumab also achieved a statistically significant improvement in stiffness and strong trends in improvements in physical function and pain. Adverse events were consistent with what has been previously observed in open label studies in adults and children. Ultragenyx is conducting the study under a collaboration and licence agreement with Kyowa Hakko Kirin. Burosumab is being developed by Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International.
“These data demonstrate a clinical improvement in patients treated with burosumab and support the potential for treatment of adults,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “When combined with a favourable safety profile and a strong serum phosphorus response, we believe these clinical data should support regulatory submissions in adults with XLH, and we look forward to discussing our filing plans with the U.S. FDA.”
“This study provides valuable additional placebo controlled data to that already obtained from the global clinical development program for pediatric and adult patients with XLH,” said Mitsuo Satoh, Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “I believe burosumab has the potential to be an effective treatment option for patients with XLH.”
“We are pleased that the data from this adult Phase 3 study supports the safety and efficacy of burosumab and look forward to progressing our discussions with the regulatory bodies in Europe and the US,” said Dr. Tom Stratford, President and CEO of KKI.
Efficacy Results
The study enrolled 134 patients, randomised 1:1 to burosumab at a dose of 1 mg/kg or placebo every four weeks for 24 weeks. The study met the primary endpoint of increasing serum phosphorus levels as 94% of patients treated with burosumab (n=68) achieved serum phosphorus levels above the lower limit of normal and maintained levels in the low normal range through 24 weeks, compared to 8% in the placebo arm (n=66; p<0.0001).
There were three pre-specified key secondary endpoints, including stiffness and physical function, both measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®), and pain measured by the Brief Pain Inventory Question 3 (BPI Q3; pain at its worst in the last 24 hours). At week 24 stiffness improved by a mean score of 7.87 points for patients treated with burosumab compared to a 0.25 point worsening among patients in the placebo group (mean difference of 8.12; p=0.0122). Physical function improved by 3.11 points for patients treated with burosumab compared to a 1.79 point worsening among patients in the placebo group (mean difference of 4.90 points; p=0.0478). Pain score improved by 0.79 for patients treated with burosumab compared to a 0.32 improvement among patients in the placebo group (mean score difference of 0.46 points; p=0.0919). Results were directionally consistent towards improvement across all three key secondary endpoints. After pre-planned multiplicity adjustment, the improvement in stiffness among patients treated with burosumab remained statistically significant at the less than the 0.0167 threshold, while physical function and pain scores demonstrated strong trends.
Safety Results
There was no difference in the overall frequency of treatment emergent adverse events, treatment related adverse events and serious adverse events between the two treatment groups. The most common (>10%) adverse events in patients treated with either burosumab or placebo were back pain (burosumab 15%, placebo 9%), nasopharyngitis (burosumab 13%, placebo 9%), tooth abscess (burosumab 13%, placebo 8%), injection site reactions (burosumab 12%, placebo 12%), headache (burosumab 12%, placebo 8%), restless legs syndrome (burosumab 12%, placebo 8%), dizziness (burosumab 10%, placebo 6%), nausea (burosumab 10%, placebo 9%), arthralgia (burosumab 9%, placebo 24%), pain in extremity (burosumab 7%, placebo 15%) and oropharyngeal pain (burosumab 2%, placebo 11%). There was no evidence of hypersensitivity reactions to injections. There were two serious adverse events in each treatment group, none of which were considered treatment-related. No differences between groups were observed in serum intact parathyroid hormone levels or ectopic mineralisation as assessed by renal ultrasounds or echocardiograms.
Of the 134 patients enrolled in the study, one patient in the burosumab arm discontinued treatment during the 24-week double-blind treatment period due to consent withdrawal. There have been no deaths in the study.
About the Phase 3 Adult XLH Program
This Phase 3 study is a randomised, double-blind, placebo-controlled clinical study designed to assess the efficacy and safety of burosumab administered every four weeks in 134 adult XLH patients in the US, EU, Canada, Japan, and Korea. The primary endpoint of the study is the percentage of patients who achieved average serum phosphorus levels in the normal range over 24 weeks. The three key secondary endpoints are pain measured by BPI Q3, stiffness and physical function, both measured by WOMAC®. After 24 weeks, all patients receive burosumab through the extension period of the study.
Ultragenyx is conducting a second, fully-enrolled open-label bone quality Phase 3 study in 14 adult XLH patients evaluating the improvement in osteomalacia, the underlying bone pathology of XLH, via bone biopsy. The bone quality study complements the phosphate and patient symptom data from the larger Phase 3 XLH study by evaluating the effect of burosumab more directly on the bone.
About Burosumab (KRN23)
Burosumab is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23). FGF23 is a hormone that reduces serum levels of phosphorus and active vitamin D by regulating phosphate excretion and active vitamin D production by the kidney. Burosumab is being developed by Ultragenyx and Kyowa Hakko Kirin to treat XLH and tumor-induced osteomalacia (TIO), diseases characterized by excess levels of FGF23. Phosphate wasting in XLH and TIO is caused by excessive levels and activity of FGF23. Burosumab is designed to bind to and thereby inhibit the biological activity of FGF23. By blocking excess FGF23 in patients with XLH and TIO, burosumab is intended to increase phosphate reabsorption from the kidney and increase the production of vitamin D, which enhances intestinal absorption of phosphate and calcium.
A clinical program studying burosumab in adults and pediatric patients with XLH is ongoing. Burosumab is also being developed for TIO, a disease characterized by typically benign tumors that produce excess levels of FGF23, which can lead to severe osteomalacia, fractures, bone and muscle pain, and muscle weakness.
Details of Ultragenyx Conference Call
Ultragenyx will host a conference call today, Tuesday, April 18, 2017 at 4:30pm ET (USA), during which Dr. Kakkis will discuss the topline data. The live and replayed webcast of the call will be available through the company’s website at http://ir.ultragenyx.com/events.cfm. To participate in the live call by phone, dial 855-797-6910 (USA) or 262-912-6260 (international) and enter the passcode 10146009. The replay of the call will be available for one year.
About Ultragenyx
Ultragenyx is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The company is led by a management team experienced in the development and commercialisation of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company’s website at http://www.ultragenyx.com.
About Kyowa Kirin
Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world.
Kyowa Kirin International PLC (KKI) is a wholly owned subsidiary of Kyowa Hakko Kirin and is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in Europe and the United States. KKI is headquartered in Scotland.
You can learn more about the business at: http://www.kyowa-kirin.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Ultragenyx’s expectations regarding ongoing or additional studies for its product candidates and timing regarding these studies, potential indications for its product candidates, discussions with the FDA and sufficiency for, and timing of, regulatory submissions, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of our regulatory filings and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of our drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Ultragenyx’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 17, 2017, and its subsequent periodic reports filed with the Securities and Exchange Commission.
$MTFB Announces Positive Results for Iclaprim, in the REVIVE-1 Phase 3 Study
- Iclaprim met the primary endpoint
- Iclaprim was well tolerated in the study
- Data from the second Phase 3 ABSSSI Trial, REVIVE-2, expected in the second half of 2017
- NDA submission expected in the first half of 2018
- Company to host conference call today at 8:00 am EDT, 1:00 pm BST
NEW YORK, April 18, 2017 — Motif Bio plc (Motif) (NASDAQ:MTFB), (NASDAQ:MTFBW), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced positive topline results from REVIVE-1, a global Phase 3 clinical trial of its investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
Iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure (TOC) endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.
| Time point | Endpoint | Iclaprim N=298 |
Vancomycin N=300 |
% Difference (95% CI) |
||||||||||
| ETP | Early Clinical Response (ECR)* | 241 (80.9%) | 243 (81.0%) | -0.13 (-6.42, 6.17) |
||||||||||
| TOC | Clinical cure | 251 (84.2%) | 261 (87.0%) | -2.77 (-8.39, 2.85) |
||||||||||
*≥20% reduction of lesion area at 48-72 hours
In an analysis of a pre-specified secondary endpoint, 60.4% of patients receiving iclaprim demonstrated resolution or near resolution at end of therapy (EOT), compared to 58.3% of patients receiving vancomycin (treatment difference: 2.07%, 95% CI: -5.80% to 9.94%). In another pre-specified secondary endpoint analysis, using a modified clinical cure TOC endpoint defined by a ≥90% reduction in lesion size at TOC, no increase in lesion size since ETP and no requirement for additional antibiotics, clinical cure was seen in 68.5% of patients receiving iclaprim and 73.0% of patients receiving vancomycin (treatment difference: -4.54%, 95% CI: -11.83% to 2.74%).
Graham Lumsden, Chief Executive Officer of Motif Bio commented, “The successful completion of REVIVE-1 is a significant achievement for Motif Bio. I would like to thank the patients and physicians that participated in this important study. We believe that iclaprim, if approved, could be an important option for patients with ABSSSI, especially for patients with severe infections who may also have kidney disease with or without diabetes. Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in renally impaired patients. It is estimated that up to 26% of the 3.6 million ABSSSI patients hospitalized annually in the U.S. have kidney disease.”
William D. O’Riordan M.D., FACEP, Chief Medical Officer, eStudySite commented, “Following the positive outcome in this clinical trial, the differentiated mechanism, potency, spectrum, safety and efficacy of iclaprim, if approved, could provide a valuable new antibiotic treatment option that is urgently needed to offset the rising problem of bacterial resistance.”
Data from REVIVE-2, the second Phase 3 trial, which uses an identical protocol to REVIVE-1 but has different trial centers, are expected in the second half of 2017 and submission of a New Drug Application (NDA) for iclaprim for the treatment of ABSSSI is anticipated in the first half of 2018.
Iclaprim has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of ABSSSI and hospital acquired bacterial pneumonia (HABP), which enables Priority Review following submission of a NDA. If approved, it is anticipated that iclaprim will be eligible to receive 10 years of market exclusivity in the U.S. from the date of approval. The FDA has also granted Fast Track designation for iclaprim.
REVIVE-1 Overview and Adverse Event (AE) Summary
REVIVE-1 is a 600-patient double-blinded, active-controlled, global, multicenter trial, in patients with ABSSSI that compares the safety and efficacy of an 80mg intravenous dose of iclaprim with a 15mg/kg intravenous dose of vancomycin. Treatments were administered every 12 hours for 5 to 14 days.
Iclaprim was well tolerated in the study, with most adverse events categorized as mild.
| Iclaprim N=293 |
Vancomycin N=297 |
||||||
| TEAEs (Treatment Emergent Adverse Events) | 151 (51.5%) | 128 (43.1%) | |||||
| Study drug related TEAEs | 57 (19.5%) | 53 (17.8%) | |||||
| TEAEs leading to discontinuation of study drug | 8 (2.7%) | 13 (4.4%) | |||||
| TEAE-related SAEs (Serious AEs) | 8 (2.7%) | 12 (4.0%) | |||||
| Deaths | 0 (0.0%) | 1 (0.3%) |
Motif Bio plans to present the full data from this study at an upcoming scientific forum.
Conference call details
Motif Bio management will host a conference call regarding this announcement at 8:00 am EDT, 1:00 pm BST, on Tuesday, April 18, 2017. The call may be accessed by dialing (866) 219-5264 for callers in the U.S., +1-703-736-7410 for callers outside the U.S., using the conference ID number 6665100. A live webcast of the call will be available from the investor relations section of the company’s website at www.motifbio.com, and will be archived there for 30 days.
About iclaprim
Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC90 of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 900 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients.
About Motif Bio plc www.motifbio.com
Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017.
Forward-Looking Statements
This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, and (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates. More detailed information about the risks and uncertainties affecting Motif Bio plc is contained under the heading “Risk Factors” in Motif Bio plc’s registration statement on Form F-1 filed with the SEC, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.
For further information please contact: Motif Bio plc Contact: Graham Lumsden Chief Executive Officer ir@motifbio.com Investor Contact: Patricia L. Bank Westwicke Partners 415-513-1284 patti.bank@westwicke.com
$NVLS and Alpine Immune Sciences, Inc. Agree to Combine
– Plan to Accelerate Development of Novel Immunotherapies Focused on Inflammation and Immuno-Oncology –
– Combined Company Well Capitalized with $90 Million in Funding to Advance Discovery and Development –
– Existing Investors OrbiMed Advisors, Frazier Healthcare Partners and Alpine BioVentures Will Invest $17 Million Immediately Prior to The Closing –
– Conference Call on April 18, 2017 at 4:30 pm ET –
Nivalis Therapeutics, Inc. (NASDAQ: NVLS) and Alpine Immune Sciences, Inc., a privately-held biotechnology company developing novel therapies using its next-generation immune system modulation platform, today jointly announced they have entered into a definitive merger agreement under which Alpine will merge with a wholly-owned subsidiary of Nivalis in an all-stock transaction. The merger will result in a combined company with a novel protein-based discovery platform focused on inflammation and immuno-oncology.
Alpine is focused on developing novel protein-based therapies using its variant immunoglobulin domain (vIgD™) platform technology. The vIgD platform is designed to create novel therapeutics that modulate multiple therapeutic targets, including many present in the immune synapse. Alpine’s vIgDs are developed via a unique process known as directed evolution which can produce proteins capable of either enhancing or diminishing an immune response, creating a platform applicable to both oncology and inflammatory diseases. Alpine plans to initiate a Phase 1 clinical trial with its first compound, a dual ICOS/CD28 antagonist engineered for use in autoimmune and inflammatory diseases, in the second half of 2018.
“We believe this transaction with Alpine is an exciting path forward to advance important new therapies for patients and to create significant value for shareholders,” said Howard Furst, Chairman of the Board of Nivalis. “Alpine, which has discovered novel ways to target the immune synapse, is led by a solid and experienced management team that has successfully brought immunotherapies to market.”
“This merger provides a unique opportunity to accelerate the development of our novel immunotherapy platform focused on both inflammation and immuno-oncology,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine Immune Sciences. “We look forward to building on our early success by taking multiple novel programs into the clinic to help patients with significant medical needs.”
Nivalis’ financial advisor for the transaction is Ladenburg Thalmann & Co. Inc., and Nivalis’ legal advisors are Latham & Watkins LLP and Ballard Spahr LLP. Alpine’s legal advisors are Sidley Austin LLP and Ascent Law Partners LLP.
About the Proposed Transaction
On January 3, 2017, Nivalis announced the initiation of a process to explore and review a range of strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources. As part of that process, bids were solicited from interested parties and over eighty interested parties submitted a proposal to enter into a strategic transaction with Nivalis. After a thorough review of each alternative and extensive negotiation with Alpine Immune Sciences, Nivalis’ board of directors unanimously decided to approve and enter into a definitive merger agreement with Alpine.
Frazier Healthcare Partners, Alpine BioVentures, and OrbiMed Advisors will invest a combined additional $17 million into Alpine Immune Sciences prior to the close of the transaction based on a valuation of Alpine which is consistent with that used to calculate the exchange ratio under the merger agreement. Following the merger, current Alpine shareholders will own approximately 74 percent of the combined company and current Nivalis shareholders will own approximately 26 percent of the combined company. The exchange ratio is based on a valuation of Nivalis equal to $50 million, which includes approximately $44 million in cash expected to be held by Nivalis at the time of closing. The combined company is expected to have approximately $90 million in cash and cash equivalents at the closing of the transaction.
The transaction has been approved by the board of directors of both companies. The merger is expected to close in the third quarter of 2017, subject to the approval of the stockholders of each company and the satisfaction or waiver of other customary conditions.
Management and Organization
Mitchell H. Gold, M.D., Alpine’s Executive Chairman and Chief Executive Officer, will become the Chairman and Chief Executive Officer of the combined company. Following the merger, the board of directors of the combined company will expand to seven seats with two representatives from Nivalis.
Upon closing of the transaction, the name of the combined company will become Alpine Immune Sciences, Inc. and shares of the combined company’s common stock will trade on the NASDAQ Global Market.
Conference Call and Webcast
Dr. Gold and R. Michael Carruthers, interim president and chief financial officer of Nivalis, will host a conference call and simultaneous webcast to discuss the proposed transaction on April 18, 2017, at 4:30 p.m. Eastern Time. The webcast can be accessed by visiting the Investors section of Nivalis’ website at ir.nivalis.com. Alternatively, please call 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). The conference ID number is 13660534. The webcast will be archived on Nivalis’ website for at least 30 days.
About Nivalis Therapeutics, Inc.
Nivalis Therapeutics, Inc. (http://www.nivalis.com) is a pharmaceutical company that has historically been focused on the discovery and development of product candidates for patients with cystic fibrosis, or CF. The Company’s development candidates selectively target an enzyme known as S-nitrosoglutathione reductase (GSNOR). GSNOR regulates levels of an endogenous protein known as S-nitrosoglutathione, or GSNO. Depleted levels of GSNO have been associated with CF, asthma, inflammatory bowel diseases and certain cardiovascular diseases. Following recent disappointing results of a Phase 2 clinical trial of its lead product candidate, cavosonstat, in CF, Nivalis determined to not pursue the development of this compound in CF and to wind down its research and development activities while devoting its efforts to investigating and evaluating strategic alternatives.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. was founded in 2015 and is focused on developing novel protein-based immunotherapies using its proprietary variant immunoglobulin domain (vIgD™) platform technology. The vIgD platform is designed to interact with multiple targets, including many present in the immune synapse. Alpine’s vIgDs are developed using a unique process known as directed evolution, which can produce proteins capable of either enhancing or diminishing an immune response and thereby may apply therapeutically to both oncology and inflammatory diseases. Alpine has also developed its transmembrane immunomodulatory protein (TIP™) technology, based on the vIgD platform, to enhance engineered cellular therapies. In October 2015, Alpine signed a worldwide research and license agreement with Kite Pharma, Inc. (NASDAQ:KITE) for up to $535 million in up front and potential milestone payments and in addition, royalties on resulting sales. The agreement allows Kite access to certain targets developed using Alpine’s TIP™ platform. For more information, visit www.alpineimmunesciences.com/.
Forward-Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning Nivalis, Alpine, the proposed transaction and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Nivalis, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the conditions to the closing of the transaction are not satisfied, including the failure to timely or at all obtain stockholder approval for the transaction; uncertainties as to the timing of the consummation of the transaction and the ability of each of Nivalis and Alpine to consummate the transaction; risks related to Nivalis’ ability to correctly estimate its operating expenses and its expenses associated with the transaction; risks related to the market price of Nivalis’ common stock relative to the exchange ratio; the ability of Nivalis or Alpine to protect their respective intellectual property rights; competitive responses to the transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Nivalis’ most recent Annual Report on Form 10-K, and Nivalis’ recent Quarterly Report on Form 10-Q and Current Reports on Form 8-K filed with the SEC. Nivalis can give no assurance that the conditions to the transaction will be satisfied. Except as required by applicable law, Nivalis undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
No Offer or Solicitation
This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the United States Securities Act of 1933, as amended. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.
Participants in the Solicitation
Nivalis and Alpine, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Nivalis’ directors and executive officers is included in Nivalis’ Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on February 13, 2017, and the proxy statement for Nivalis’ 2017 annual meeting of stockholders, filed with the SEC on April 6, 2017. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement relating to the transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated below.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transaction between Nivalis and Alpine, Nivalis intends to file relevant materials with the SEC, including a registration statement that will contain a proxy statement and prospectus. NIVALIS URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT NIVALIS, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Nivalis with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Nivalis with the SEC by contacting Investor Relations by mail at Attn: Investor Relations, 3122 Sterling Circle, Boulder, Colorado, 80301. Investors and stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.
For Alpine Immune Sciences, Inc.
Jennifer Paganelli, 347-658-8290
jpaganelli@w2ogroup.com
$IDXG Coverage of ThyraMIR® with UnitedHealthcare
PARSIPPANY, N.J., April 18, 2017 — Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (the “Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services, today announced that UnitedHealthcare, the largest health plan in the United States, has agreed to cover Interpace’s ThyraMIR® test used in assessing indeterminate thyroid nodule fine needle aspirate (FNA) biopsies. The coverage is now in effect and is subject to members’ specific benefit plan design. The UnitedHealthcare policy decision is consistent with the National Comprehensive Cancer Network (NCCN) Thyroid Carcinoma Guidelines, which recommend that clinicians consider the use of molecular testing to identify patients with indeterminate cytopathology results whose nodules are actually benign and can thus avoid surgery. Interpace is not currently a contracted, in-network lab provider with UnitedHealthcare. Interpace’s ThyGenX® and ThyraMIR assays are now covered for approximately 250 million patients nationwide, including through Medicare, National, and Regional health plans. Medicare approved coverage for ThyraMIR in January 2016 (LCD L35396).
ThyGenX – ThyraMIR represents the only test in the market that combines the rule-in properties of next-generation sequencing of a patient’s DNA and RNA, with rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, over 80% of the Company’s total cases are reflexed to ThyraMIR for additional assessment. The Company first launched ThyraMIR on April 15, 2015 making it available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 5,000 ThyraMir tests for nearly 400 physicians and hospitals.
According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign. Molecular testing using ThyGenX – ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests: PancraGEN®, for the evaluation of pancreatic cysts and assessment of risk of concomitant or subsequent cancer; ThyGenX®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; and ThyraMIR®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace’s mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science. For more information, please visit Interpace Diagnostics’ website at www.interpacediagnostics.com.
About Thyroid Nodules, ThyGenX and ThyraMIR Testing
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
Forward Looking Information
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company’s future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the Company’s ability to adequately finance the business, its ability to restructure its debt and other obligations, the market’s acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and its ability to maintain its NASDAQ listing. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company’s filings with the SEC, including without limitation, the Annual Report on Form 10-K filed with the SEC on March 31, 2017. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
CONTACTS:
Interpace Diagnostics
Investor Relations:
Paul Kuntz
Redchip
Paul@Redchip.com
$TRCH Announces Private Placement of $8 Million in Unsecured Promissory Notes
PLANO, TX–(April 17, 2017) – Torchlight Energy Resources, Inc. (TRCH) (“Torchlight” or the “Company”), today announced the closing of $8 million in unsecured 12% promissory notes through a private placement. The promissory notes bear interest at the rate of 12% per annum and mature on April 10, 2020, with interest payable monthly and a lump sum payment of outstanding principal due on maturity. The notes were issued at a purchase price of 94.25% of the principal amount, resulting in net proceeds of $7.54 million. In addition to the 12% cash interest, the notes will earn a common stock PIK at the rate of 2.5% annually.
The proceeds from the notes will be used to redeem the $3.6 million of subordinated notes outstanding and to finance two horizontal wells in the Company’s Hazel Project located in the Midland Basin, as well as for general corporate purposes.
“We are pleased to obtain this debt financing which should address our capital needs all the way into 2018,” stated John Brda, Torchlight Energy’s CEO. “We believe the terms of this debt are favorable to the Company, and will allow us to retire existing debt and add significant production in our Hazel Project through two new horizontal wells.”
About Torchlight Energy
Torchlight Energy Resources, Inc. (NASDAQ: TRCH), based in Plano, Texas, is a high growth oil and gas Exploration and Production (E&P) company with a primary focus on acquisition and development of highly profitable domestic oil fields. The company has assets focused in West and Central Texas where their targets are established plays such as the Permian Basin. For additional information on the Company, please visit www.torchlightenergy.com.
Forward Looking Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements involve risks and uncertainties that could cause actual results to differ materially from those described in such statements. Such forward-looking statements involve known and unknown risks and uncertainties, including risks associated with the Company’s ability to obtain additional capital in the future to fund planned expansion, the demand for oil and natural gas, general economic factors, competition in the industry and other factors that could cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. The Company is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Investor Relations Contact
Derek Gradwell
MZ Group
SVP Natural Resources
Phone: 512-270-6990
Email: dgradwell@mzgroup.us
Web: www.mzgroup.us
$RPRX New U.S. Patent for Treatment Using Off Drug Intervals
THE WOODLANDS, Texas, April 17, 2017 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the issuance of a new patent, U.S. Patent number 9,616,074 (the ‘074 patent), that bolsters the Company’s intellectual property relating to Proellex® (telapristone acetate). The ‘074 patent, which expires in 2027, relates to the use of Selective Progesterone Receptor Modulators (SPRM), in particular Telapristone Acetate (Proellex®) or Ulipristal Acetate, with an Off Drug Interval (ODI) for the treatment of estrogen-dependent hyperproliferative uterine conditions, such as uterine fibroids and endometriosis. Under the terms of the patent, ODI is defined as daily administration of the SPRM for a period of time, followed by an ODI sufficient for the patient to menstruate and then by another period of administration of the SPRM.
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to the Company’s pipeline and plans for growth, and are subject to such risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company’s website at http://www.reprosrx.com.
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
$WPRT to Sell its APU Assets for USD$70 million, Definitive
~Sale in-line with previously announced portfolio review~
VANCOUVER, April 17, 2017 – Westport Fuel Systems Inc. (“Westport Fuel Systems“) (TSX:WPRT / Nasdaq:WPRT) today announced that it has entered into a definitive agreement to sell the assets of its Auxiliary Power Unit (“APU“) business for $70 million United States dollars, subject to certain customary adjustments. The transaction is expected to close within a few weeks. The divestiture is consistent with Westport’s strategy to streamline its business and product lines and focus on alternative fuel solutions for the transportation and automotive industries.
“We are pleased to have completed this transaction as part of our portfolio review that began with the closing of the merger with Fuel Systems in June of 2016” stated Nancy Gougarty, CEO of Westport Fuel Systems. “After a careful assessment of the APU product line and its fit with the other Westport Fuel Systems businesses, we decided it made the most sense for our shareholders to pursue this sale.”
J.P. Morgan acted as financial advisor for Westport Fuel Systems on the transaction.
About Westport Fuel Systems
At Westport Fuel Systems, we are driving innovation to power a cleaner tomorrow. We are inventors, engineers, manufacturers and suppliers of advanced clean-burning fuel systems and components that can change the way the world moves. Our technology delivers performance, fuel efficiency and environmental benefits to address the challenges of global climate change and urban air quality. Headquartered in Vancouver, Canada, we serve our customers in more than 70 countries with leading global transportation and industrial application brands. At Westport Fuel Systems, we think ahead. For more information, visit www.wfsinc.com.
$MOCO to be Acquired by $AME
BERWYN, Pa. and MINNEAPOLIS, April 17, 2017 — AMETEK, Inc. (NYSE:AME) and MOCON, Inc. (NASDAQ:MOCO) announced that they have entered into a definitive merger agreement under which AMETEK will acquire all of the outstanding shares of common stock of MOCON at a price of $30 per share in cash, which represents a premium of 39% to MOCON’s closing share price on April 13, 2017. The aggregate enterprise value of the transaction is approximately $182 million, taking into account MOCON’s outstanding equity awards and net cash to be acquired in the transaction. The transaction was unanimously approved by the Board of Directors of MOCON.
Founded in 1963 and headquartered in Minneapolis, MN, MOCON is a leading provider of laboratory and field gas analysis instrumentation to research laboratories, production facilities and quality control departments in food and beverage, pharmaceutical, and industrial applications. For the calendar year ending December 31, 2016, MOCON had sales of approximately $63 million.
“MOCON is an excellent company that has tremendous synergy with AMETEK,” comments David A. Zapico, AMETEK Chief Executive Officer. “They are the global leader in gas analysis instrumentation for package and permeation testing. Its products and technologies nicely complement our existing gas analysis instrumentation business and provides us with opportunities to expand into the growing food and pharmaceutical package testing market.”
“We believe this transaction creates significant value for our shareholders and provides long-term benefits for our customers and employees,” said Robert L. Demorest, MOCON President and Chief Executive Officer. “By joining a larger global enterprise, MOCON will have the resources to expand our market leading gas analysis products and technologies. We look forward to joining the outstanding team at AMETEK.”
The closing of the transaction is subject to customary closing conditions, including the approval of MOCON’s shareholders and applicable regulatory approvals. The transaction is expected to be completed in the late second quarter or third quarter of calendar year 2017.
About AMETEK
AMETEK is a leading global manufacturer of electronic instruments and electro-mechanical devices with annual sales of approximately $4.0 billion. AMETEK’s Corporate Growth Plan is based on Four Key Strategies: Operational Excellence, Strategic Acquisitions, Global & Market Expansion and New Products. AMETEK’s objective is double-digit percentage growth in earnings per share over the business cycle and a superior return on total capital. The common stock of AMETEK is a component of the S&P 500 Index.
About MOCON
MOCON is a leading provider of detectors, instruments, systems and consulting services to research laboratories, production facilities, and quality control and safety departments in the medical, pharmaceutical, food and beverage, packaging, environmental, oil and gas and other industries worldwide.
Additional Information and Where to Find It
This document may be deemed to be solicitation materials in respect of the proposed acquisition of MOCON by AMETEK. In connection with the proposed merger, MOCON will file with the SEC and furnish to MOCON’s shareholders a proxy statement and other relevant documents. This filing does not constitute a solicitation of any vote or approval. MOCON SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER.
Investors will be able to obtain a free copy of documents filed with the SEC at the SEC’s website at www.sec.gov. In addition, investors may obtain a free copy of MOCON’s filings with the SEC from MOCON’s website at www.mocon.com or by directing a request to: MOCON, Inc., 7500 Mendelssohn Avenue North, Minneapolis, MN; Attention: Elissa Lindsoe, Chief Financial Officer.
Participants in the Solicitation
MOCON and its directors, executive officers and certain other members of management and employees of MOCON may be deemed “participants” in the solicitation of proxies from shareholders of MOCON in favor of the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered participants in the solicitation of the shareholders of MOCON in connection with the proposed merger will be set forth in the proxy statement and the other relevant documents to be filed with the SEC. You can find information about MOCON’s executive officers and directors in its Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed with the SEC on March 9, 2017, and in its definitive proxy statement filed with the SEC on Schedule 14A on April 13, 2016.
Forward-looking Information
Statements in this news release relating to future events are “forward-looking statements.” Forward-looking statements are subject to various factors and uncertainties that may cause actual results to differ significantly from expectations. Forward-looking statements in this news release include, but are not limited to, statements about the benefits of the merger; potential synergies and the timing thereof; the expected timing of the completion of the merger; and the combined company’s plans, objectives, expectations and intentions with respect to future operations, products and services. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, but are not limited to, the following: (1) MOCON may be unable to obtain shareholder approval as required for the merger; (2) conditions to the closing of the merger, including the obtaining of required regulatory approvals, may not be satisfied; (3) the merger may involve unexpected costs, liabilities or delays; (4) the business of MOCON may suffer as a result of uncertainty surrounding the merger; (5) the outcome of any legal proceedings related to the merger; (6) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (7) the ability to recognize benefits of the merger; (8) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (9) other risks to consummation of the merger, including the risk that the merger will not be consummated within the expected time period or at all; (10) general industry and economic conditions; and (11) the risks described from time to time in AMETEK’s and MOCON’s filings with the U.S. Securities and Exchange Commission, including their most recent reports on Form 10-K, 10-Q and 8-K. You are encouraged to read AMETEK’s and MOCON’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. AMETEK and MOCON disclaim any intention or obligation to update or revise any forward-looking statements.
CONTACT: MOCON, Inc. Investor Contact: Elissa Lindsoe, 763-493-6370 CFO www.mocon.com or Three Part Advisors, LLC Steven Hooser, 214-872-2710 Investor Relations shooser@threepa.com
$CBLI Announces Commencement of In Vivo Biocomparability Study
BUFFALO, NY–(Apr 17, 2017) – Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of a side-by-side analytical comparison of two formulations of entolimod. The FDA agreed with CBLI that these data indicate the in vitro analytical comparability of the formulations. Based on the outcome of its review, the FDA has provided CBLI with its consent for initiation of an in vivo biocomparability study of these formulations in non-human primates (NHP).
The objective of the in vivo biocomparability study is to compare the historical drug formulation used in prior nonclinical and clinical studies versus the to-be-marketed drug formulation of entolimod submitted for approval under CBLI’s application for pre-Emergency Use Authorization (pre-EUA). Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.
“We are excited to have received agreement from the FDA to commence the in vivo biocomparability study,” continued Yakov Kogan, PhD, MBA, Chief Executive Officer. “Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier.”
The planned biocomparability study is funded in part by the Department of Defense (DoD) Joint Warfighter Medical Research Program (JWMRP) contract award number W81XWH-15-C-0101 to CBLI. The DoD JWMRP contract is valued at up to $9.2 million and supports further development of entolimod as a medical radiation countermeasure.
Disclaimer
The mention of any specific companies, commercial products, processes, or services by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government. The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company’s proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, immuno-oncology, and vaccines. The company’s most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome, an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the company’s website at http://www.cbiolabs.com.
This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that do not relate strictly to historical or current facts. Words and phrases such as “potential,” “may,” “future,” “will,” “plan,” “anticipate,” “believe,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the company’s future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, research and clinical analyses and trials, regulatory approvals or the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
Factors that could contribute to such differences include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the company’s plans and expectations with respect to future clinical trials and commercial scale-up activities; the company’s ability to attract collaborators with development, regulatory and commercialization expertise and the financial risks related to those relationships; the company’s ability to comply with its obligations under license agreements; the company’s inability to obtain regulatory approval in a timely manner or at all; the commercialization of the company’s product candidates, if approved; the company’s plans to research, develop and commercialize its product candidates; future agreements with third parties in connection with the commercialization of any approved product; the size and growth potential of the markets for the company’s product candidates, and its ability to serve those markets; the rate and degree of market acceptance of the company’s product candidates; the company’s history of operating losses and the potential for future losses, which may lead the company to not be able to continue as a going concern; regulatory developments in the United States and foreign countries; the performance of the company’s third-party suppliers and manufacturers; and the success of competing therapies that are or may become available. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. Any forward-looking statements speak only as of the date on which such statements are made, and the company undertakes no obligation to update any forward-looking statement to reflect events or circumstances occurring or arising after the date on which such statement is made, except as may be required by law. See also the “Risk Factors” and “Forward-Looking Statements” described in the company’s periodic filings with the Securities and Exchange Commission.
Contacts:
Cleveland BioLabs, Inc.
C. Neil Lyons
Chief Financial Officer
T: 301-675-4570
E: nlyons@cbiolabs.com
$EXPI Supports Accelerated Growth with the Addition of Four Industry Veterans to Management
Former DocuSign, Zillow executives among those bringing expertise to eXp’s rapidly expanding cloud-based brokerage
BELLINGHAM, WA–(April 17, 2017) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, today announced the addition of industry veterans Kee Wah Chung, Kathy Gordon, Scott Petronis and Mitch Robinson to its management team.
“Our daily objective is to be the most agent-centric brokerage firm in the world,” said Russ Cofano, President and General Counsel of eXp World Holdings. “Adding Kee Wah, Kathy, Scott and Mitch to our stellar team will allow us to provide new and exciting services for both current and future agents on the eXp platform. Our ability to attract top talent is further enabled by our accelerating growth, as evidenced by our year-over-year agent growth of over 200 percent when we surpassed the 3,000 agent mark in mid-March.”
The four industry veterans joining eXp Realty’s management team include:
KEE WAH CHUNG
Kee Wah Chung joins eXp Realty as Vice President of Agent Experience. Kee Wah will lead the continued buildout of an exceptional end-to-end Agent Experience though a robust service-delivery model for onboarding new agents, providing transaction management services, and supporting agents via eXp tools and systems. Kee Wah previously worked as Director of the Real Estate Customer Success Program for DocuSign. There, he created the first real estate-focused team to drive a world-class customer experience for onboarding brokers, agents, and staff.
KATHY GORDON
Kathy Gordon, who has nearly two decades of experience in the industry, joins eXp Realty as Vice President, Brokerage Operations. In this position, she will deliver value to eXp agents through the support of eXp’s state administrative brokers, the administration of eXp’s brokerage policies and procedures, and license law and regulatory compliance. She also will serve as liaison with eXp’s legal resources and risk management programs. Kathy previously was Broker of Record at one of Keller Williams’ largest firms, with nearly 3000 agents. She also served as the Director of Compliance and Risk Mitigation for her region, while coaching/consulting multiple offices in areas of compliance, risk mitigation, operations, and leadership.
SCOTT PETRONIS
As eXp Realty’s new Chief Product and Technology Officer, Scott Petronis will lead the delivery of strategic agent-centric solutions that power the business and its rapidly growing agent base. Scott has more than 20 years of experience in delivering software and SaaS products for businesses and consumers. Most recently, Scott headed up products and technology for Onboard Informatics, a leading provider of data and technology solutions to U.S. real estate brokerage firms. For the past five years, Scott has been a fixture in industry technology initiatives through his work with the Real Estate Standards Organization (RESO), including leading the Web API initiative as the Chair of the Transport Workgroup. In that role, he drove agreement on a new standard that allows companies to more rapidly innovate solutions for the real estate industry.
MITCH ROBINSON
In his new role as Senior Vice President, Marketing and Communications for eXp Realty, Mitch Robinson is responsible for branding, external and internal communications, digital and social media, events (both live and within eXp World, the company’s fully immersive 3D Cloud Campus). Robinson was an early employee at Expedia before joining the online real estate marketplace Zillow. As the leader of Zillow’s trade marketing team, Mitch spearheaded marketing initiatives working with real estate agents, brokers, MLSs, rental professionals, and builders. In this role, he blended technology innovation with a deep appreciation for the ways in which agents can be successful in an industry ripe for disruption.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) is the holding company for eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an attractive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers real estate professionals within its ranks opportunities to earn company stock for production and contributions to overall company growth.
For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpRealty.com.
Safe Harbor Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Mitch Robinson
SVP, Marketing and Communications
Email contact
$PME Declares Quarterly Cash Dividend For the Second Quarter 2017
FUZHOU, China, April 13, 2017 — Pingtan Marine Enterprise Ltd. (Nasdaq: PME), (“Pingtan,” or the “Company”) a global fishing company based in the People’s Republic of China (PRC), today announced that the Company has declared a quarterly cash dividend of $0.01 per share of common stock outstanding, payable in cash on or about May 15, 2017 to shareholders of record on April 30, 2017. This marks the tenth consecutive quarterly dividend paid by Pingtan. The Company intends to continue paying a cash dividend on a quarterly basis, and expects to adjust its quarterly dividend rate in accordance with its earnings performance.
About Pingtan
Pingtan is a global fishing company engaging in ocean fishing through its subsidiary, Fujian Provincial Pingtan County Ocean Fishing Group Co., Ltd., or Pingtan Fishing.
Business Risks and Forward-Looking Statements
This press release contains forward-looking statements that are subject to the safe harbors created under the Securities Act of 1933 and the Securities Exchange Act of 1934, including statements about the Company’s expectation that it currently intends to continue paying dividends on a quarterly basis. Although forward-looking statements reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Risks include anticipated growth and growth strategies; need for additional capital and the availability of financing; our ability to successfully manage relationships with customers, distributors and other important relationships; technological changes; competition; demand for our products and services; the deterioration of general economic conditions, whether internationally, nationally or in the local markets in which we operate; operational, mechanical, climatic or other unanticipated issues that adversely affect the production capacity of the Company’s fishing vessels and their ability to generate expected annual revenue and net income; legislative or regulatory changes that may adversely affect our business; and other risk factors contained in Pingtan’s SEC filings available at www.sec.gov, including Pingtan’s most recent Annual Report on Form10-K and Quarterly Reports on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. Pingtan undertakes no obligation to update or revise any forward-looking statements for any reason.
CONTACT:
Roy Yu
Chief Financial Officer
Pingtan Marine Enterprise Ltd.
Tel: +86 591 87271753
ryu@ptmarine.net
INVESTOR RELATIONS:
The Equity Group Inc.
Adam Prior, Senior Vice President
Tel: (212) 836-9606
aprior@equityny.com
In China
Katherine Yao, Senior Associate
Tel: +86 10 6587 6435
kyao@equityny.com
$EYES Argus II Retinal Prosthesis Implanted in First Patient in Asia
-Underscores Second Sight’s Commitment to Expansion in Asia–
Second Sight Medical Products, Inc. (NASDAQ:EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to provide some useful vision to blind patients, today announced that the Argus® II Retinal Prosthesis System (“Argus II”) has been implanted in the first patient in Asia through an exclusive distribution partnership with Orient Europharma Co., Ltd. (OEP) and with charitable support from the Hong-Lu Foundation in Taiwan. The Argus II was provided under special import permits authorized by the Taiwan Food and Drug Administration (TFDA).
The surgical procedure was performed by Dr. Yih-Shiou Hwang and his team at Chang Gung Memorial Hospital (CGMH), in Linkou, Taiwan in a 40-year-old patient who suffers from blindness caused by retinal degeneration. Dr. Paulo Stanga, Consultant, Ophthalmologist & Vitreoretinal Surgeon at the Manchester Royal Eye Hospital, UK supervised the implantation.
“We are very pleased to expand the availability of the Argus II to Asia as we continue to offer our technology to patients with Retinitis Pigmentosa (RP), providing them with the potential opportunity to lead more independent lives,” said Will McGuire, President and CEO of Second Sight. “We look forward to supporting broader access to the Argus II to patients with RP throughout Asia and the other regions we serve.”
About the Argus II Retinal Prosthesis System
Second Sight’s Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina’s remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread approval, and is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, United Kingdom, and the U.S.
About Second Sight
Second Sight’s mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed and manufactures the Argus® II Retinal Prosthesis System. Second Sight is currently conducting a trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. Second Sight is also developing the Orion™ I Visual Cortical Prosthesis that is intended to restore some vision to individuals who are blind due to many causes other than preventable or treatable conditions. U.S. Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com.
About Orient Europharma (OEP)
Orient Europharma. Co., Ltd. (4120.TT) Headquartered in Taipei, Taiwan, is a specialty pharmaceutical company focused on the manufacturing, marketing and distribution of both ethical and OTC products. OEP stands among top 30 pharmaceutical companies in both Taiwan and the Philippines based on IMS surveys, with an annual turnover of $150 million U.S. dollars. With subsidiaries across Asia and a strong sales network of 360 dedicated and experienced sales representatives covering CNS, CV, oncology, ophthalmology, respiratory and women’s health, OEP has the ability and expertise to commercialize products throughout the region. The key to OEP’s success lies in the enthusiasm and professionalism of its employees, who take pride in their in day-to-day work knowing their contributions make a difference to patients.
Safe Harbor
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, which are intended to be covered by the “safe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements.” These statements may be identified by words such as “estimates,” “anticipates,” “projects,” “plans,” or “planned,” “seeks,” “may,” “will,” “expects,” “intends,” “believes,” “should” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Second Sight expects or anticipates will occur in the future are forward-looking statements. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K as filed on March 16, 2017, and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Investor Relations:
Institutional Investors
In-Site Communications, Inc.
Lisa Wilson, 212-452-2793
President
lwilson@insitecony.com
or
Individual Investors
MZ North America
Greg Falesnik, 949-385-6449
Managing Director
greg.falesnik@mzgroup.us
or
Media:
Pascale Communications, LLC
Allison Howell, 412-228-1678
Senior Account Director
allison@pascalecommunications.com
$FCSC to Present at 7th Annual World Orphan Drug Congress USA 2017
EXTON, Pa., April 13, 2017 — Fibrocell Science, Inc. (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that John Maslowski, Chief Executive Officer, will present at the 7th Annual World Orphan Drug Congress USA on Friday, April 21 at 2:30 pm EDT in Washington, D.C., and the Alliance for Regenerative Medicine’s (ARM) 5th Annual Cell & Gene Therapy Investor Day on Thursday, April 27 at 4:15 pm EDT in Boston, Massachusetts.
A live webcast of Fibrocell’s presentation at ARM’s Cell & Gene Therapy Investor Day will be available under the investor relations section of the Company’s website at www.fibrocell.com/investors/events and archived for 30 days. Please visit Fibrocell’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Fibrocell
Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue. Fibrocell’s most advanced product candidate, FCX-007, has begun a Phase I/II trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its product candidate for the treatment of linear scleroderma. In addition, Fibrocell has a third program in the research phase for the treatment of arthritis and related conditions. Fibrocell’s gene therapy portfolio is being developed in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology. For more information, visit http://www.fibrocell.com or follow Fibrocell on Twitter at @Fibrocell.
Trademarks
Fibrocell, the Fibrocell logo and Fibrocell Science are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners.
Investor & Media Relations Contact: Karen Casey 484.713.6133 kcasey@fibrocell.com
$MICT and India’s Cyient Team Up
The two will jointly bid on Aerospace and Defense contracts under Indo-Israeli Aerospace and Defense procurement agreement
MONTVALE, N.J., April 13, 2017 — Micronet Enertec Technologies, Inc. (NASDAQCM: MICT), announced today that its wholly-owned subsidiary, Enertec Systems 2001 Ltd. (Enertec), entered into a Teaming Agreement with Cyient DLM Private Limited (NSE: CYIENT.NS) based in India to jointly pursue contracts with Israeli Aerospace and Defense companies that have offset obligations in India. These obligations are based on an ongoing Aerospace and Defense trade agreement between the governments of India and Israel.
India and Israel have strong trade ties, with the value of Aerospace and Defense contracts between the countries totaling over $9 billion between 1999 and 2009. India is the largest purchaser of Israeli Aerospace and Defense equipment, currently estimated at a rate of over $2 billion per year. Israel is India’s second largest Aerospace and Defense supplier. Per the inter-governmental trade agreement between the two countries, and in accordance with India’s Aerospace and Defense Procurement Procedures (DPP), any Indian purchase of foreign military equipment over a certain amount necessitates an offset procurement of 30% of its value by the Israeli government.
Cyient is an Indian Aerospace and Defense company focused on engineering, networks and operations, established in 1991. It has over 12,000 employees across 38 global locations and was featured among the top 30 outsourcing companies in the world during 2014.
Based on the Teaming Agreement, Enertec and Cyient will jointly bid on Aerospace and Defense contracts that are part of any required offset pursuant to the DPP. Enertec will lead planning and design, while Cyient will lead procurements and production in India, thereby meeting offset requirements.
“One of Enertec’s largest Aerospace and Defense customers just received a $1.1 billion contract approved by the Indian government. This substantial contract is one part of a $3 billion agreement between India and Israel’s top Aerospace and Defense contractors. Trade contracts of this magnitude increases the need for more offset transactions, whereby Israel is obligated to purchase Aerospace and Defense services from India. By teaming up with India-based Cyient, Enertec is well positioned to potentially benefit from this trade opportunity, while having the ability to tackle larger scale projects,” stated David Lucatz, CEO and Chairman of Micronet Enertec Technologies Inc.
About Micronet Enertec Technologies, Inc.
Micronet Enertec Technologies, Inc. (NASDAQCM: MICT) provides high tech solutions for severe environments and the battlefield, including missile defense technologies for Aerospace & Aerospace and Defense and rugged mobile devices for the growing commercial Mobile Resource Management (MRM) market. MICT designs, develops, manufactures and supplies customized Aerospace and Defense computer-based systems, simulators, automatic test equipment and electronic instruments, addressing the Aerospace and Defense industry. Solutions and systems are integrated into critical systems such as command and control, missile fire control, maintenance of Aerospace and Defense aircraft and missiles for the Israeli Air Force, Israeli Navy and by foreign Aerospace and Defense entities. MICT’s MRM division develops, manufactures and provides mobile computing platforms for the mobile logistics management market in the U.S., Europe and Israel. American-manufactured systems are designed for outdoor and challenging work environments in trucking, distribution, logistics, public safety and construction.
Forward-looking Statements
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. These forward-looking statements include, but are not limited to, those statements regarding Enertec’s plan to pursue contracts with Israeli defense companies that have offset obligations in India pursuant to its Teaming Agreement with Cyient and Enertec’s position to potentially benefit and tackle larger scale projects. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. The forward-looking statements contained in this press release are subject to other risks and uncertainties, including those discussed in the “Risk Factors” section and elsewhere in the Company’s annual report on Form 10-K for the year ended December 31, 2016 and in subsequent filings with the Securities and Exchange Commission. Except as otherwise required by law, the Company is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
$TROV Announces the Addition of Dr. Sandra Silberman to its Clinical Advisory Board
SAN DIEGO, April 13, 2017 — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, announced today that Dr. Sandra Silberman, a leading clinical researcher in hematology/oncology, has joined Dr. Jorge Cortes, Dr. Philip Janku and Dr. David Berz, as a member of Trovagene’s Clinical Advisory Board (CAB). Dr. Silberman has extensive experience in the development of novel therapies for the treatment of hematologic cancers and will work with Trovagene through the clinical development process for PCM-075, an oral and highly selective polo-like kinase 1 (PLK1) inhibitor for the treatment of acute myeloid leukemia (AML).
“We are thrilled to have Dr. Silberman join our Clinical Advisory Board,” said Bill Welch, Chief Executive Officer of Trovagene. “We are fortunate to have access to these industry leading physicians for guidance and collaboration as we work to achieve our goal to transform oncology with the development of precision cancer therapeutics.”
Trovagene recently gained exclusive global development and commercialization rights for PCM-075 from Nerviano Medical Sciences, S.r.l., a major European oncology research and development company. A Phase 1 safety study of PCM-075 has already been successfully completed in patients with advanced metastatic cancers with data indicating an acceptable safety profile as well as antitumor activity. Trovagene believes that PCM-075 has pharmacokinetic and pharmacodynamic properties that provide advantages and may show improvement in clinical benefits over an earlier PLK1 inhibitor, for the treatment of patients with AML.
Trovagene plans to submit an investigational new drug (IND) application to the FDA in the second quarter of 2017. This submission will include a Phase 1/2 clinical protocol that will identify the safety of PCM-075 in AML patients, provide a preliminary assessment of response, study the effect of different clinical dosing regimens, as well as explore the potential of correlative biomarker analyses to select patients more likely to respond.
“I am excited to join Trovagene’s Clinical Advisory Board,” said Dr. Silberman. “I look forward to contributing my experience gained from leading the clinical development of imatinib (Gleevec®), the first targeted therapy for chronic myelogenous leukemia, to the development process for PCM-075.”
Background on Clinical Advisory Board Members
Jorge Eduardo Cortes, MD
Dr. Cortes is a Deputy Chair and Professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston Texas where he directs the CML Program. He is chief editor of Hematological Malignancies Reports and Clinical Leukemia and serves in the Editorial Board of the Journal of Clinical Oncology, Leukemia, Clinical Cancer Research, Leukemia and Lymphoma and the American Journal of Hematology. Over the course of his 25-year career specializing in leukemia research, Dr. Cortes served several prestigious academic appointments at the University of Texas, including associate professor in the Department of Leukemia at the Graduate School of Biomedical Sciences and Chair of the CML section at the MD Anderson Cancer Center. He has received numerous awards including the Faculty Scholar Award from MD Anderson Cancer Center in 2003, the Annual Celgene Young Investigator Achievement Award for Clinical Research in Hematology in 2005, The Dr. John J. Kenny Award from The Leukemia & Lymphoma Society in 2006, the Service to Mankind Award from The Leukemia & Lymphoma Society in 2007 and the Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical Research from MD Anderson Cancer Center in 2007.
Filip Janku, MD, PhD
Dr. Janku serves as an Assistant Professor in the Department of Investigational Cancer Therapeutics (Phase I Program) at MD Anderson Cancer Center. Dr. Janku’s research focuses on proof-of-concept clinical trials that possess a pivotal correlative component especially those involving liquid biopsies, molecular profiling of cell-free DNA, the PI3K/AKT/mTOR pathway and therapeutic use of oncolytic bacteria. Dr. Janku received multiple awards for his research efforts, including Sidney Kimmel Scholar award, several ASCO Merit Awards as well as an American Association for Cancer Research Scholar-in-Training Award.
Sandra L. Silberman, MD, PhD
Dr. Silberman is an independent industry consultant, who has advised many major companies, including Bristol-Myers Squibb, AstraZeneca, Imclone, and Roche, in their various oncology programs. She began her career in clinical development at Pfizer, Inc., where she initiated the company’s first program in clinical oncology and oversaw the introduction of erlotinib (Tarceva®) into clinical trials. She led the global development of Gleevec®, an innovative drug and the first targeted therapy for chronic myelogenous leukemia (CML), while she was at Novartis Clinical Research. Dr. Silberman was Vice President, Global Head of Translational Medicine and Innovation at Quintiles Transnational, a premier clinical research organization. She was also the Vice President and Global Head of Oncology at Eisai Medical Research, and at present consults for a number of other oncology biotechnology companies. She is currently an attending physician in the Duke Hematology/Oncology Fellowship program at the VAMC in Durham, NC.
David Berz, MD, PhD, MPH
Dr. David Berz is triple Board Certified in Internal Medicine, Hematology and Oncology. Dr. Berz has many years of extensive experience in the field of oncology, including private practice and clinical research, and is currently a scientist at City of Hope. Dr. Berz specializes in thoracic/lung malignancies, melanoma, and cancer immune-therapy. He is a member of the Melanoma Research Society and the Multidisciplinary Malignant Melanoma Committee at City of Hope. Dr. Berz is also a member of the American Society of Clinical Oncology and the American Society of Hematology.
About Trovagene, Inc.
Trovagene is a biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit www.trovagene.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Trovagene Contact
Vicki Kelemen
Sr. Director, Communications
858-952-7652
vkelemen@trovagene.com
$NVET to Acquire $ZTS
- Purchase price of US$6.72 per share, or approximately US$85 million in aggregate
- Acquisition to strengthen Zoetis’ pipeline in companion animal therapeutics for chronic pain, a global area estimated at US$400 million annually1
Zoetis Inc. (NYSE:ZTS) and Nexvet Biopharma plc (Nasdaq:NVET) today announced an agreement in which Zoetis, through a wholly owned subsidiary (“Zoetis Bidco”), will purchase Nexvet, an innovator in monoclonal antibody therapies for companion animals, for a purchase price of US$6.72 per share, representing an aggregate equity valuation of approximately US$85 million. The acquisition will strengthen Zoetis’ pipeline of solutions for chronic pain management in dogs and cats, which represents an area of high-need in companion animal health.
This per share consideration represents a 66% premium over Nexvet’s closing price on April 12, 2017.
The board of directors of Nexvet has unanimously approved the acquisition, which is being implemented by means of a scheme of arrangement, a statutory procedure under Irish law. The acquisition is subject to approval by Nexvet’s shareholders and the Irish High Court and other customary conditions, and it is currently expected to be completed during the second half of 2017.
Nexvet, founded in 2010 and headquartered in Tullamore, Ireland, is a biologic therapeutics company with a pipeline of monoclonal antibody (mAb) therapies being developed for companion animals in pain and other therapeutic areas. The company has research and development operations in Melbourne, Australia, a manufacturing facility in Tullamore, and a U.S. office in San Francisco.
Acquisition Is a Strategic Fit
“This acquisition is a strategic fit that brings to Zoetis an R&D organization that shares our commitment to industry-leading innovation,” said Dr. Alejandro Bernal, Executive Vice President and Group President, Strategy, Commercial and Business Development at Zoetis. “It will strengthen our R&D pipeline in monoclonal antibodies and help sustain our category leadership in chronic pain management for companion animals, which is an area poised for innovation with new mAb therapies. The transaction demonstrates how we continue to invest to drive innovation and future growth.”
“We are certain that Zoetis, with its leadership in R&D, high quality manufacturing, marketing excellence, global scale and strong customer relationships, is the ideal company to guide our monoclonal antibody candidates through development into commercialization,” said Dr. George Gunn, Chairman of the Board of Nexvet. “We see the integration with Zoetis as the logical next step to realize our ambition to bring groundbreaking antibody therapeutics to market.”
A Promising Pipeline of First-In-Class Antibody Therapies for Pain
Therapies to treat chronic pain in companion animals represent a global area valued at an estimated US$400 million a year1. Nexvet’s pipeline product ranevetmab, a mAb targeting nerve-growth factor (NGF) for treatment of chronic pain associated with osteoarthritis in dogs, would, upon approval, be the companion animal industry’s first monoclonal antibody therapy administered monthly by injection for chronic pain. Ranevetmab would enable Zoetis to expand its portfolio of solutions for chronic pain in dogs.
Nexvet is also developing frunevetmab, a monoclonal antibody targeting NGF to treat chronic pain associated with osteoarthritis in cats. Feline treatments for pain are limited, and frunevetmab could open up a new opportunity in feline pain that is underserved today.
Zoetis has been a leader in the treatment of osteoarthritis pain and inflammation in dogs for two decades with the company’s Rimadyl® (carprofen), the first non-steroidal anti-inflammatory drug (NSAID) product approved for use in dogs. Zoetis also developed and markets the NSAID product Trocoxil (mavacoxib), a COX-2 inhibitor approved in the European Union and other international markets to treat arthritis pain and inflammation in dogs.
Zoetis has earned a reputation as a pioneer in bringing veterinarians first-in-class antibody therapy solutions for areas of high unmet need in animal health. The company’s mAb therapy Cytopoint™ was licensed in the U.S. in December 2016 to control the clinical signs such as itching associated with atopic dermatitis in dogs. Zoetis anticipates its approval in the European Union this year.
“We recognize the significant achievements of the Nexvet R&D team,” said Dr. Catherine Knupp, Executive Vice President and President, Research and Development at Zoetis. “The research programs initiated by Nexvet will be integrated into our operation to leverage the scale and experience of Zoetis’ existing global R&D expertise.”
Terms of the Transaction
Under the terms of the proposed acquisition, Nexvet shareholders will receive US$6.72 in cash per ordinary share. The cash consideration payable by Zoetis under the terms of the proposed acquisition will be funded by cash on hand. It is intended that the acquisition will be implemented by means of a scheme of arrangement (“Scheme Document”) under Chapter 1 of Part 9 of the Irish Companies Act 2014. It is intended that the Scheme Document, which will form part of the Proxy Statement filed by Nexvet with the United States Securities and Exchange Commission (the “SEC”) containing the full terms and conditions of the acquisition (including notices of the shareholder and scheme meetings), and the balance of the Proxy Statement will be mailed as soon as practicable after the date of this announcement to Nexvet shareholders, and, for information only, to holders of Nexvet’s warrants, options and restricted share units. The Nexvet Proxy Statement, including the Scheme Document, will be made available by Nexvet at www.nexvet.com.
About Zoetis
Zoetis (NYSE: ZTS) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2016, the company generated annual revenue of US$4.9 billion with approximately 9,000 employees. For more information, visit www.Zoetis.com.
About Nexvet (www.nexvet.com)
Nexvet is a veterinary biologic therapeutics company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s PETization™ platform is designed to rapidly create monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates are designed to build upon the safety and efficacy data from clinically tested human therapies, which is intended to reduce clinical risk and development cost.
Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and conducts manufacturing in Ireland.
1 Zoetis research on file, 2017
General
The announcement required under the Irish Takeover Rules (a Rule 2.5 announcement) has been made, dated April 13, 2017, and is available at www.zoetis.com and www.nexvet.com.
This announcement should be read in conjunction with, and is subject to, the full text of the Rule 2.5 announcement (including its appendices). The acquisition is subject to the conditions set out in Schedule 1 to the Rule 2.5 announcement and the further terms to be set out in the Scheme Document. The sources and bases of information contained in this announcement are set out in Schedule 2 of the Rule 2.5 announcement. Certain definitions and expressions used in this announcement are set out in Schedule 3 of the Rule 2.5 announcement. Finally, a copy of the transaction agreement entered into between Nexvet, Zoetis and Zoetis Bidco, which relates to, among other things, the implementation of the acquisition, is set out in Schedule 4 of the Rule 2.5 announcement.
The release, publication or distribution of this announcement in or into certain jurisdictions may be restricted by the laws of those jurisdictions (“Restricted Jurisdiction”). Accordingly, copies of this announcement and all other documents relating to the acquisition are not being, and must not be, released, published, mailed or otherwise forwarded, distributed or sent in, into or from any Restricted Jurisdiction. Persons receiving such documents (including, without limitation, nominees, trustees and custodians) should observe these restrictions. Failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, the companies involved in the proposed acquisition disclaim any responsibility or liability for the violations of any such restrictions by any person.
Any response in relation to the acquisition should be made only on the basis of the information contained in the Proxy Statement relating to the acquisition, which will include the Scheme Document as required by Irish law and other documents by which the acquisition and the Scheme are made. Nexvet shareholders are advised to read carefully the formal documentation in relation to the proposed transaction once the Proxy Statement has been dispatched.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.
Participants in the Solicitation
Nexvet and its directors and executive officers and employees may be considered participants in the solicitation of proxies from the shareholders of Nexvet with respect to the transactions contemplated by the Scheme Document/Proxy Statement. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders of Nexvet in connection with the proposed transactions, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Proxy Statement when it is filed with the SEC. Information regarding Nexvet’s directors and executive officers is contained in Nexvet’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016 which is filed with the SEC. Information concerning the interests of Nexvet’s participants in the solicitation, which may, in some cases, be different than those of Nexvet’s shareholders generally will be set forth in the Proxy Statement relating to the transaction when it becomes available.
No Offer or Solicitation
This announcement is for information purposes only and is not intended to and does not constitute an offer to purchase, sell, subscribe for or exchange, or the solicitation of an offer to purchase, sell, subscribe for or exchange or an invitation to purchase, sell, subscribe for or exchange any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer Document), which will contain the full terms and conditions of the acquisition, including details of how to vote with respect to the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document (of, if applicable, the Takeover Offer Document). No offer of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the United States Securities Act of 1933.
DISCLOSURE NOTICES
Forward-Looking Statements:
Zoetis and Zoetis Bidco: This press release contains forward-looking statements, which reflect the current views of Zoetis and Zoetis Bidco and with respect to business plans or prospects, expectations regarding products, and other future events. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Each of Zoetis and Zoetis Bidco expressly disclaim any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. With respect to Zoetis and Zoetis Bidco, a further list and description of risks, uncertainties and other matters can be found in Zoetis’ Annual Report on Form 10-K for the fiscal year ended December 31, 2016, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in Zoetis’ Quarterly Reports on Form 10-Q and in Zoetis’ Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.
Nexvet: This press release contains forward-looking statements including those regarding its future results of operations and financial position, ability to access financing on acceptable terms or at all, results of any current or future pivotal study, future expenditures relating to lead product candidates, time for completion of any of studies or facilities upgrades, ability to develop its pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture its own product candidates, ability to meet conditions for the receipt of government grants, time for regulatory submissions, ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products. They also reflect uncertainties as to whether the Company’s shareholders will approve the acquisition, the possibility that competing offers may be made, or other factors that could cause the acquisition not to occur. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Nexvet expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Additional information regarding factors that could cause actual results to differ materially from our expectations expressed in this release include those summarized under Risk Factors in its reports on Forms 10-Q and 10-K and the other documents filed from time to time with the SEC.
Statement Required by the Irish Takeover Rules (as defined below)
The directors of Zoetis and the directors of Zoetis Bidco accept responsibility for the information contained in this announcement other than information relating to Nexvet, and the directors of Nexvet and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the directors of Zoetis and the directors of Zoetis Bidco (who have taken reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.
The directors of Nexvet accept responsibility for the information contained in this announcement relating to Nexvet and the directors of Nexvet and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the directors of Nexvet (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.
Evercore Partners International LLP (“Evercore”), which is authorized and regulated in the United Kingdom by the Financial Conduct Authority, is acting as Financial Adviser exclusively for Nexvet and no one else in connection with the acquisition and the other matters referred to in this announcement, and will not regard any other person as its client in relation to the acquisition and the other matters referred to in this announcement and will not be responsible to anyone other than Nexvet for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the acquisition or the other matters referred to in this announcement. Neither Evercore nor any of its subsidiaries, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Evercore in connection with this announcement, any statement contained herein or otherwise.
Cowen and Company, LLC, which is a securities broker-dealer registered with the SEC and subject to regulation by the SEC and the Financial Industry Regulatory Authority, is acting as financial adviser for Nexvet and for no one else in connection with the acquisition and the other matters referred to in this announcement, and will not be responsible to anyone other than Nexvet for providing the protections afforded to clients of Cowen or for providing advice in relation to the acquisition and the other matters referred to in this announcement.
Goldman Sachs, which is authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority in the United Kingdom, is acting as financial adviser exclusively for Zoetis and Zoetis Bidco and no one else in connection with the acquisition and the other matters referred to in this announcement, and will not regard any other person as its client in relation to the acquisition and the other matters referred to in this announcement and will not be responsible to anyone other than Zoetis and Zoetis Bidco for providing the protections afforded to clients of Goldman Sachs, nor for providing advice in relation to the acquisition or the other matters referred to in this announcement.
Dealing Disclosure Requirements
Under the provisions of Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013 (the “Irish Takeover Rules”), if any person is, or becomes, ‘interested’ (directly or indirectly) in, 1% or more of any class of ‘relevant securities’ of Nexvet, all ‘dealings’ in any ‘relevant securities’ of Nexvet (including by means of an option in respect of, or a derivative referenced to, any such ‘relevant securities’) must be publicly disclosed by not later than 3:30 pm (New York time) on the ‘business’ day following the date of the relevant transaction. This requirement will continue until the date on which the ‘offer period’ ends. If two or more persons co-operate on the basis of any agreement, either express or tacit, either oral or written, to acquire an ‘interest’ in ‘relevant securities’ of Nexvet, they will be deemed to be a single person for the purpose of Rule 8.3 of the Irish Takeover Rules.
Under the provisions of Rule 8.1 of the Irish Takeover Rules, all ‘dealings’ in ‘relevant securities’ of Nexvet by Zoetis or Zoetis Bidco or by any party acting in concert with Zoetis must also be disclosed by no later than 12 noon (New York time) on the ‘business’ day following the date of the relevant transaction.
A disclosure table, giving details of the companies in whose ‘relevant securities’ ‘dealings’ should be disclosed, can be found on the Irish Takeover Panel’s website at www.irishtakeoverpanel.ie.
Interests in securities arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an ‘interest’ by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities.
Terms in quotation marks are defined in the Irish Takeover Rules, which can also be found on the Irish Takeover Panel’s website. If you are in any doubt as to whether or not you are required to disclose a dealing under Rule 8, please consult the Irish Takeover Panel’s website at www.irishtakeoverpanel.ie or contact the Irish Takeover Panel on telephone number +353 1 678 9020 or fax number +353 1 678 9289.
No Profit Forecast / Asset Valuation
No statement in this announcement is intended to constitute a profit forecast for any period, nor should any statements be interpreted to mean that earnings, earnings per share, losses or losses per share will necessarily be greater or lesser than those for the relevant preceding financial periods for any of Nexvet or Zoetis or Zoetis Bidco as appropriate. No statement in this announcement constitutes an asset valuation.
Zoetis Media:
Elinore White, 1-973-443-2835 (o)
elinore.y.white@zoetis.com
or
Bill Price, 1-973-443-2742 (o)
william.price@zoetis.com
or
Zoetis Investors:
Steve Frank, 1-973-822-7141 (o)
steve.frank@zoetis.com
or
Nexvet Investors:
Candice Knoll, 1-415-375-3340 ext. 4
or
Nexvet Media:
Mark Heffernan, +1-415-602-5587
$TNXP Results FDA Initial Cross-Disciplinary, TNX-102 SL in PTSD
Registration of TNX-102 SL Could be Solely Supported by the Phase 3 HONOR Study if Topline Data are Statistically Persuasive
NEW YORK, April 11, 2017 — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced today the receipt of official minutes from its Initial Cross-Disciplinary Breakthrough Meeting held with the U.S. Food and Drug Administration (FDA) on March 9, 2017. Upon being awarded Breakthrough Therapy designation in December 2016, Tonix was invited to meet with the FDA to evaluate the feasibility of accelerating the development and registration of TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).
Seth Lederman, M.D., president and chief executive officer of Tonix, stated, “The FDA’s consideration of a single-study New Drug Application (NDA) and continued support of the Phase 3 HONOR study are critical to accelerating the availability of a potentially improved treatment option for PTSD patients, especially those patients with military-related PTSD. The FDA’s standard of evidence for drug approval typically requires two positive Phase 3 trials; however, following our Initial Cross-Disciplinary Breakthrough Meeting in March, the FDA confirmed a single-study NDA approval could be possible based on statistically persuasive topline data from the ongoing HONOR study. Additionally, due to the lack of evidence of potential abuse in clinical studies of TNX-102 SL, the FDA agreed that studies in assessing abuse potential of TNX-102 SL are not required to support the TNX-102 SL NDA.”
About the HONOR Study
HONOR is a 12-week Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) versus placebo, in participants with military-related PTSD. The two-arm, adaptive design trial will enroll up to 550 participants across approximately 35 U.S. sites. The study will have one unblinded interim analysis (IA) by an independent data monitoring committee when the study has results from approximately 50% of efficacy-evaluable participants, or approximately 275 participants, which is projected to occur in the first half of 2018. If the IA results require continued enrollment, topline results from the 550-participants trial are expected to be available in the second half of 2018. Additional details of the HONOR study are available at www.thehonorstudy.com, or http://bit.ly/2lrMZ1H.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to address public health challenges. TNX-102 SL is in Phase 3 development and has been granted Breakthrough Therapy designation by the FDA for the treatment of PTSD. PTSD is a serious condition characterized by chronic disability, inadequate treatment options especially for military-related PTSD, and an overall high utilization of healthcare services that contributes to significant economic burdens. The Protectic™ protective eutectic and Angstro-Technology™ formulation are essential elements of the proprietary TNX-102 SL composition for which a Notice of Allowance has been issued by the U.S. Patent and Trademark Office. Other development efforts include TNX-601 (tianeptine oxalate), a clinical candidate at Pre-IND (Investigational New Drug) application stage, designed for daytime use for the treatment of PTSD, and TNX-801, a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2016, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.
Contacts Jessica Smiley Investor Relations investor.relations@tonixpharma.com (212) 980-9155 x185 Edison Advisors (investors) Tirth Patel tpatel@edisongroup.com (646) 653-7035 Russo Partners (media) Rich Allan rich.allan@russopartnersllc.com (646) 942-5588
$DTRM Selected by $ORNAV $ORNBV for Global Source-to-Contract
CARMEL, IN–(Apr 11, 2017) – Determine, Inc. (NASDAQ: DTRM), the pioneering leader in global Source-to-Pay and Enterprise Contract Lifecycle Management (ECLM) Cloud Platform solutions, announced today that Orion Corporation (NASDAQ OMX Helsinki: ORNAV and ORNBV), the leading Finnish global pharmaceutical and diagnostics company, selected Determine to optimize its source-to-contract effectiveness on the Determine Cloud Platform.
After conducting a thorough assessment of the marketplace, Orion, headquartered in Espoo, Finland, selected the Determine Cloud Platform as its provider of choice to meet its global Contract Management, Sourcing and Supplier Management requirements. The Determine Cloud Platform, which features a single point of entry and single source of data truth integrated through all its modular solutions, provides the flexibility and configurability required by global organizations like Orion to manage their complex Source-to-Contract needs.
“Our expectations for the chosen solution are for it to provide enhanced visibility and support following of the commonly agreed processes. In Orion there are a lot of people in different organizations taking part in Supplier Relationship Management, Contract Lifecycle Management and Sourcing projects. Determine Cloud Platform will be a daily tool for many, thus it played a big role in our selection decision, that we felt the system was easy to use.”
— Irina Tornikoski, Head of Indirect Procurement, Orion Corporation
To effectively serve users across multiple Source-to-Contract needs, the Determine Cloud Platform provides the highest level of workflow integration. The platform has a unique ability to connect users and processes through a single master database on a common platform, enabling Orion to manage wider business processes across the enterprise, empowering collaboration to achieve their business goals.
“Orion is one of the most innovative pharmaceutical and diagnostics organizations in world today, and the entire Determine team is both proud and excited to be serving their complex needs. The fact that Orion is choosing to translate the Determine Cloud Platform’s innovative technology into improved compliance and risk management, optimized workflow and bottom-line impact for their advanced source-to-contract needs is a testament to the possibilities our proprietary platform provides.”
— Jeffrey Grosman, COO, Determine, Inc.
Based on leading material design concepts, the Determine Cloud Platform user interfaces and user experience (UI/UX) also provides ease-of-use with minimal training, and configurability for all user levels, enabling strong and rapid adoption across numerous cross-functional Orion teams.
“Orion was searching for one comprehensive tool that would allow them to more effectively manage their suppliers, sourcing and contracts — the entire source-to-contract process — and provide the visibility and control to achieve greater efficiency, cost savings and risk control. We look forward to exceeding their expectations by providing them with the highest levels of Platformance.”
— Steve Potts, CRO, Determine, Inc.
About Orion
Orion is a globally operating Finnish developer of pharmaceuticals and diagnostic tests — a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. It is continuously developing new drugs and treatment methods. The core therapy areas of Orion’s pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion’s net sales in 2016 amounted to EUR 1,074 million and the company had approximately 3,500 employees. Orion’s A and B shares are listed on Nasdaq Helsinki. Founded in 1917, Orion celebrates its centennial anniversary in 2017.
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About Determine, Inc.
Determine, Inc. (NASDAQ: DTRM) is a leading global provider of SaaS Source-to-Pay and Enterprise Contract Lifecycle Management (ECLM) solutions. The Determine Cloud Platform provides procurement, legal and finance professionals analytics of their supplier, contract and financial performance. Our technologies empower customers to drive new revenue, identify savings, improve compliance and mitigate risk.
The Determine Cloud Platform seamlessly integrates with major ERP or third-party systems such as SAP, Oracle, Sage, QAD and Microsoft. Modular solutions can be configured to add more as needed to provide additional value beyond spend management. Our unified master database and business process approach empower users at every level to make more informed and smarter decisions.
For more information, please visit: www.determine.com.
Contact
Media Relations:
Rose Lee
Determine Inc.
+1.650.532.1590
pr@determine.com
$CNXR and Healthx Agreement to Provide Benefits Shopping, Engagement Solutions
BROOKFIELD, Wis. and INDIANAPOLIS, April 11, 2017 — Connecture, Inc. (NASDAQ:CNXR), a provider of web-based information systems used to create health insurance marketplaces, and Healthx, Inc., the leader in cloud-based digital engagement solutions for healthcare payers and other stakeholders, announced today they are collaborating to integrate Connecture’s smart shopping, enrollment and engagement solutions with Healthx’s portal technology.
The collaboration between Connecture and Healthx offers payer customers, such as commercial health plans and third party administrators (TPAs), a comprehensive set of benefits tools that they can choose from based on their customers’ needs. Connecture’s health insurance shopping, enrollment and administration technology will integrate with the Healthx member, employer and broker portals. This solution, along with Healthx’s self-service tools, will further empower members to better manage their health.
“Connecture is laser-focused on providing the best end-to-end user experience for our customers and their members and employees,” said Jeff Surges, president and CEO of Connecture. “By incorporating Connecture’s smart technology into Healthx’s sophisticated member portals, we are ensuring that users have a simple way to shop for and enroll in medical and ancillary benefits, while also staying well connected and informed about their care, long after the point of plan enrollment.”
“Healthx has always been committed to enhancing member engagement to improve health outcomes while increasing administrative efficiency, and this relationship works to support that objective,” said Sean Downs, CEO for Healthx. “We are excited to work with Connecture, a fellow industry-leading partner, to provide a complementary technology that puts the member at the center of everything they do relative to their health. Through integration with Healthx, payers can now optimize digital engagement with their members throughout the entire member lifecycle, whether during enrollment, when members are well or need access to care, or when they are managing their healthcare finances and during benefit renewal.”
Helping Provider-Sponsored Health Plans and ACOs Provide a Holistic Experience for Member-Patients
According to Surges, the collaboration with Healthx also offers hospitals and health systems administering their own health plans and ACOs with a unique opportunity to provide their member-patients with powerful tools. This will help members better manage the cost of care and obtain important information about their health. Additionally, members can shop for and enroll in the medical and ancillary coverage that best meets their needs.
“Health insurance is ever-changing and complicated for most people,” added Surges. “For hospitals transitioning to a provider-sponsored health plan model, administering health insurance effectively and early-on in the patient-member healthcare journey, and supplementing that with streamlined benefits administration support, is key to member enrollment, engagement, satisfaction and renewal.”
Connecture and Healthx said the new integrated offering is now available for all types of health insurance carriers and provider organizations.
About Connecture
Connecture (NASDAQ:CNXR) is a leading web-based consumer shopping, enrollment and retention platform for health insurance distribution. Connecture offers a personalized health insurance shopping experience that recommends the best fit insurance plan based on an individual’s preferences, health status, preferred providers, medications and expected out-of-pocket costs. Connecture’s customers are health insurance marketplace operators, such as health plans, brokers and exchange operators, who must distribute health insurance in a cost-effective manner to a growing number of insured consumers. Connecture’s solutions automate key functions in the health insurance distribution process, allowing its customers to price and present plan options accurately to consumers and efficiently enroll, renew and manage plan members.
About Healthx
Healthx provides the healthcare industry’s leading digital engagement platform connecting our payer customers to their consumer, provider, employer and broker constituents. As an innovator in cloud-based technology, Healthx supports over 180 payers representing 24 million members and 700,000 providers. Our engagement expertise enables us to guide customers to achieve their business objectives by driving online portal and mobile app utilization and producing measurable ROI. The platform can integrate with over 150 third party applications, customized into a seamless user experience across the consumer engagement ecosystem including shop and enroll, managing benefits, cost transparency, payment processing, wellness, health education and other specialty content. Healthx is a proven and trusted partner, led by healthcare and technology experts passionate about delivering engagement solutions that drive outcomes. For more information, visit www.healthx.com. Follow Healthx on Twitter, LinkedIn and Facebook.
Media Contacts: Jeff Hyman Channel Marketing Director for Connecture (818) 415-2569 jhyman@connecture.com Ron Wozny Vice President of Marketing for Healthx 317-550-3244 rwozny@healthx.com
$WINT Successful Completion of Second and Final AEROSURF Phase 2b
DSMB Recommends Continued Enrollment in AEROSURF Phase 2b Clinical Trial Without Modifications- -Company Remains on Track to Release Phase 2b Results Mid-Year 2017
WARRINGTON, Pa., April 11, 2017 — Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that the AEROSURF® (lucinactant for inhalation) phase 2b independent Data Safety Monitoring Board (DSMB) has completed its second and final interim safety review and has recommended continuing the trial without modification. The final DSMB interim review was convened following achievement in mid-March 2017 of a pre-specified patient enrollment milestone. In addition, the Company reaffirms its plan to announce top-line results from the AEROSURF phase 2b clinical trial in mid-year 2017.
“We are very encouraged by the AEROSURF safety and tolerability profile to date and by the progress we have made with patient enrollment in this trial,” said Steve Simonson, M.D., Senior Vice President and Chief Development Officer of Windtree Therapeutics. “We believe that AEROSURF, if successful, has the potential to transform the treatment of RDS in premature infants. We look forward to completing this clinical trial and sharing top-line results in mid-2017.”
AEROSURF is a novel, investigational drug/device combination product that combines the Company’s proprietary KL4 surfactant and aerosolization technologies. AEROSURF is being developed to potentially reduce the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). The AEROSURF phase 2b clinical trial is a multicenter, randomized, controlled study with masked treatment assignment in up to 240 premature infants receiving nasal continuous positive airway pressure (nCPAP) for RDS, and is designed to evaluate aerosolized KL4 surfactant administered to premature infants 28 to 32 week gestational age in two dose groups (25 and 50 minutes), with up to two potential repeat doses, compared to infants receiving nCPAP alone. The key objectives of this trial are to:
- evaluate efficacy by: (i) incidence of nCPAP failure, (ii) time to nCPAP failure (defined as the need for intubation and delayed surfactant therapy), and (iii) physiological parameters indicating the effectiveness of lung function;
- define the dose regimen(s) for the planned phase 3 clinical program
- provide an estimation of the expected efficacy margin of AEROSURF treatment; and
- further characterize the AEROSURF safety profile
The trial is being conducted in approximately 50 clinical sites in North America, Europe and Latin America.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree’s proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.
For more information, please visit the Company’s website at www.windtreetx.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties include: the risk that the Company is a development company with limited resources and no operating revenues and its ability to continue as a going concern in the near term is highly dependent upon obtaining results from the AEROSURF phase 2b clinical trial in mid-2017 that are sufficient to support a strategic or financing transaction; risks affecting the Company’s ability to raise capital, including pursuant to its universal shelf registration statement, which permits only limited primary offerings and expires in June 2017, a pending delisting notice from The Nasdaq Market, a potential shortage of available shares of common stock, and a complex capital structure; risks affecting the timing of the Company’s planned clinical trials, which may involve time-consuming and expensive clinical trials and be subject to potentially significant delays or regulatory holds, or fail, and its ability successfully to complete its development programs, secure regulatory approval of its product candidates in the U.S. and in markets outside the U.S.; risks related to development of the aerosol delivery systems (ADS) and related components; risks related to the manufacture of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements of the U.S. Food and Drug Administration or other regulatory authorities that may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree’s products; and other risks and uncertainties described in Windtree’s filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
$AIQ Enters into Definitive Going Private Merger Agreement
Alliance HealthCare Services, Inc. (NASDAQ: AIQ) (the “Company,” “Alliance,” “we” or “our”), a leading national provider of outsourced radiology, oncology and interventional services, announced today that it has signed a definitive merger agreement with Tahoe Investment Group Co., Ltd. (“Tahoe”), formerly known as Fujian Thai Hot Investment Co., Ltd., THAIHOT Investment Company Limited (“THAIHOT”), THAIHOT Investment Company US Limited and Alliance HealthCare Services Merger Sub Limited (each an indirect wholly owned subsidiary of Tahoe, and, together with Tahoe, the “Tahoe Group”), pursuant to which the Tahoe Group will acquire all of the outstanding common stock of Alliance that is not beneficially owned by the Tahoe Group or owned by Alliance as treasury stock, for US $13.25 per share in cash, or a total payment of approximately US $75 million to equity holders of Alliance other than the Tahoe Group.
The US $13.25 per share price represents a premium of 67% over the Company’s closing trading price on December 9, 2016, the last trading day prior to Tahoe’s initial proposal was publicly disclosed, and a premium of 38% over the US $9.60 purchase price per share initially offered by Tahoe.
As previously disclosed on March 29, 2016, Tahoe, through THAIHOT, completed the purchase of a majority interest in Alliance and THAIHOT currently owns approximately 51% of the outstanding common stock of Alliance.
The Company’s Board of Directors, acting on the unanimous recommendation of the special committee formed by the Board of Directors (the “Special Committee”), approved the merger agreement and the transactions contemplated by the merger agreement and resolved to recommend that the Company’s stockholders adopt the merger agreement and the transactions contemplated by the merger agreement. The Special Committee, which is comprised solely of independent and disinterested directors of the Company who are unaffiliated with the Tahoe Group or management of the Company, exclusively negotiated the terms of the merger agreement with the Tahoe Group, with the assistance of its independent financial and legal advisors.
Neil Dimick, Chairman of the Special Committee, said, “We are confident that we have negotiated a fair price and that this merger is in the best interest of our minority stockholders. The price of US $13.25 is a 67% premium over the last trading day prior to the offer and a 38% premium over the initial offer by Tahoe in December.”
“We continue to be supportive of Alliance’s strategy in the United States and China,” says Qisen Huang, Chairman and Founder of Tahoe. Huang continued, “Healthcare has been a major focus for Tahoe in the last two years and we expect to continue to expand our healthcare business lines globally to benefit the health of those we serve.”
“I am pleased to see that the Special Committee and Tahoe have finished their work and have come to an agreement enabling the Company to move forward,” says Tom Tomlinson, CEO of Alliance HealthCare Services. Tomlinson continued, “Tahoe has been a very supportive majority stockholder and we look forward to continued collaboration as we use our position as an industry leader in outsourced medical services to increase the quality of care delivered in the United States as well as expand healthcare services in China.”
Upon closing of the merger, Alliance will become an indirect wholly owned subsidiary of Tahoe. Alliance is expected to remain headquartered in Southern California. Alliance’s executive management team is expected to remain in place. All of Alliance’s divisions within the United States are expected to continue unaffected.
The merger is subject to approval by Alliance’s stockholders, including a non-waivable condition requiring approval by the holders of a majority of the outstanding shares of Alliance common stock that are not beneficially owned by the members of the Tahoe Group or certain senior executive officers of the Company, as well as certain other customary closing conditions. The merger is not subject to a financing condition. The Company will call a meeting of stockholders for the purpose of voting on the adoption of the merger agreement in due course. If completed, the merger will result in the Company becoming a privately held company and Alliance’s common stock would no longer be listed on NASDAQ.
Lazard is serving as sole financial advisor to the Special Committee, O’Melveny & Myers LLP is serving as legal counsel to the Special Committee, and Richards, Layton & Finger P.A. is serving as Delaware legal counsel to the Special Committee. Latham & Watkins LLP is serving as legal counsel to the Company. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to the Tahoe Group.
About Tahoe
Tahoe is an investment holding company based in Fuzhou, China, holding a diversified portfolio of assets in various industries including real estate development, securities, hospitality, biomedicine and healthcare. Tahoe was founded in 1996 and as of September 30, 2016, the total assets of Tahoe Investment Group Co. Ltd exceeded US $18.9 billion. Tahoe’s diversified portfolio includes controlling ownership in Thai Hot Group, one of the leading real-estate developers in China listed on the Shenzhen Stock Exchange (SZSE:000732). Tahoe is also the third largest shareholder of the Shanghai Stock Exchange listed Dongxing Securities (SHSE:601198). Tahoe expanded its business landscape to include biomedicine and healthcare industry by acquiring a large-scale pharmaceutical company. In early 2015, Tahoe made healthcare and medical services one of its top priorities, including radiology and oncology, and it intends to expand healthcare services in mainland China to an underserved healthcare marketplace. Qisen Huang is the Founder and Chairman of Tahoe.
About Alliance HealthCare Services
Alliance HealthCare Services (NASDAQ: AIQ) is a leading national provider of outsourced medical services including radiology, oncology and interventional. We partner with healthcare providers and hospitals to provide a full continuum of services from mobile to fixed-site to comprehensive service line management and joint venture partnerships. We also operate freestanding clinics and Ambulatory Surgical Centers that are not owned by hospitals or providers.
As of December 31, 2016, Alliance operated 625 diagnostic radiology and radiation therapy systems, including 113 fixed-site radiology centers across the country, and 33 radiation therapy centers and SRS facilities. With a strategy of partnering with hospitals, health systems and physician practices, Alliance provides quality clinical services for over 1,100 hospitals and other healthcare partners in 46 states, where approximately 2,450 Alliance Team Members are committed to providing exceptional patient care and exceeding customer expectations. For more information, visit www.alliancehealthcareservices-us.com.
Additional Information and Where to Find It
This communication may be deemed to be solicitation material in respect of the proposed acquisition of Alliance by the Tahoe Group and their respective affiliates. In connection with the proposed merger, Alliance will file with the SEC and furnish to Alliance’s stockholders a proxy statement and other relevant documents. This filing does not constitute a solicitation of any vote or approval. BEFORE MAKING ANY VOTING DECISION, ALLIANCE’S STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER.
Investors will be able to obtain a free copy of the proxy statement, when available, and other relevant documents filed by Alliance with the SEC at the SEC’s website at www.sec.gov. In addition, investors may obtain a free copy of the proxy statement, when available, and other relevant documents from Alliance’s website at www.alliancehealthcareservices-us.com/proxy or by directing a request to Alliance HealthCare Services, Inc., Attn: Rhonda Longmore-Grund, CFO, 100 Bayview Circle, Suite 400, Newport Beach, California 92660 or calling 949.242.5300.
Participants in the Solicitation
Alliance and its directors, executive officers and certain other members of management and employees of Alliance may be deemed to be “participants” in the solicitation of proxies from the stockholders of Alliance in connection with the proposed Merger. Information regarding the interests of the persons who may, under the rules of the SEC, be considered participants in the solicitation of the stockholders of Alliance in connection with the proposed Merger, which may be different than those of Alliance’s stockholders generally, will be set forth in the proxy statement and the other relevant documents to be filed with the SEC. Stockholders can find information about Alliance and its directors and executive officers and their ownership of Alliance’s Common Stock in Alliance’s definitive proxy statement for its most recent annual meeting of stockholders, filed with the SEC on April 29, 2016, and additional information about the ownership of Alliance’s Common Stock by Alliance’s directors and executive officers is included in their Forms 3, 4 and 5 filed with the SEC.
Forward-Looking Statements
This communication contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. This communication contains forward-looking statements related to Alliance, the Tahoe Group and the proposed acquisition of Alliance by the Tahoe Group and their respective affiliates. Actual results and events in future periods may differ materially from those expressed or implied by these forward-looking statements because of a number of risks, uncertainties and other factors. All statements other than statements of historical fact, including statements containing the words “aim,” “anticipate,” “are confident,” “estimate,” “expect,” “will be,” “will continue,” “will likely result,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning, or the negative of these terms, are statements that could be deemed forward-looking statements. Risks, uncertainties and other factors include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (ii) the inability to complete the proposed merger due to the failure to obtain stockholder approval for the proposed merger or the failure to satisfy other conditions to completion of the proposed merger; (iii) the failure of the proposed merger to close for any other reason; (iv) risks related to disruption of management’s attention from Alliance’s ongoing business operations due to the transaction; (v) the outcome of any legal proceedings, regulatory proceedings or enforcement matters that may be instituted against Alliance and others relating to the merger agreement; (vi) the risk that the pendency of the proposed merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the pendency of the proposed merger; (vii) the effect of the announcement of the proposed merger on Alliance’s relationships with its customers, operating results and business generally; and (viii) the amount of the costs, fees, expenses and charges related to the proposed merger. Consider these factors carefully in evaluating the forward-looking statements. Additional factors that may cause results to differ materially from those described in the forward-looking statements are set forth in Alliance’s Annual Report on Form 10–K for the fiscal year ended December 31, 2016, filed with the SEC on March 10, 2017, under the heading “Item 1A. Risk Factors,” and in subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The forward-looking statements represent Alliance’s views as of the date on which such statements were made and Alliance undertakes no obligation to publicly update such forward-looking statements.
Alliance HealthCare Services, Inc.
Rhonda Longmore-Grund, 949-242-5300
Executive Vice President
Chief Financial Officer
$DRYS Announces 2nd Consecutive Common Stock Dividend
ATHENS, GREECE–(Apr 11, 2017) – DryShips Inc. (NASDAQ: DRYS) (the “Company” or “DryShips”), a diversified owner of ocean going cargo vessels, announced today that its Board of Directors has declared a quarterly cash dividend with respect to the quarter ended March 31, 2017, under the previously announced new dividend policy. Under this policy, the Company will pay a regular fixed quarterly dividend of $2.5 million to the holders of common stock.
With respect to the quarter ended March 31, 2017, the Board of Directors declared a dividend of $2.5 million to the common shareholders of record as of May 1, 2017 and payable on or about May 15, 2017. The dividend per share amount to be paid by the Company will be determined based on the number of shares outstanding on the record date.
Updated Key Information as of April 11, 2017:
- Cash and cash equivalents about $422.0 million, (or $8.98 per share)
- Book value of vessels, including deposits about $194.3 million, (or $4.13 per share)
- 3rd Party Loans about $16.5 million
- Sifnos Loan Facility balance about $200.0 million
- Number of Shares Outstanding about 47,010,986
About DryShips
The Company is a diversified owner of ocean going cargo vessels that operate worldwide. The Company owns a fleet of (i) 13 Panamax drybulk vessels; (ii) four Newcastlemax drybulk vessels, which are expected to be delivered in the second quarter of 2017; (iii) three Kamsarmax drybulk vessels, two second-hand vessels expected to be delivered in the second quarter of 2017 and one newbuilding expected to be delivered in the third quarter of 2017; (iv) one very large crude carrier, which is expected to be delivered in the second quarter of 2017; (v) one Aframax tanker newbuilding and one Aframax second-hand tanker, both of which are expected to be delivered in the second quarter of 2017; (vi) four VLGC newbuildings, two of which are expected to be delivered in June and September 2017 and the other two before the end of 2017; and (vii) six offshore support vessels, comprising two platform supply and four oil spill recovery vessels.
DryShips’ common stock is listed on the NASDAQ Capital Market where it trades under the symbol “DRYS.”
Visit the Company’s website at www.dryships.com. The information contained on the Company’s website does not constitute a part of this press release.
Forward-Looking Statements
Matters discussed in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with such safe harbor legislation.
Forward-looking statements reflect our current views with respect to future events and financial performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.
The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although the Company believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, the Company cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.
Important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include the factors related to the strength of world economies and currencies, general market conditions, including changes in charter rates and vessel values, failure of a seller or shipyard to deliver one or more vessels, failure of a buyer to accept delivery of a vessel, our inability to procure acquisition financing, default by one or more charterers of our ships, changes in demand for drybulk or LPG commodities, changes in demand that may affect attitudes of time charterers, scheduled and unscheduled drydocking, changes in our voyage and operating expenses, including bunker prices, dry-docking and insurance costs, changes in governmental rules and regulations, changes in our relationships with the lenders under our debt agreements, potential liability from pending or future litigation, domestic and international political conditions, potential disruption of shipping routes due to accidents, international hostilities and political events or acts by terrorists.
Risks and uncertainties are further described in reports filed by DryShips Inc. with the Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 20-F.
Investor Relations / Media:
Nicolas Bornozis
Capital Link, Inc. (New York)
Tel. 212-661-7566
E-mail: dryships@capitallink.com
$SPWR Installation Underway at New Toyota Headquarters
Expected to Be Largest Behind-the-Meter Solar Power System in Texas upon Completion
SAN JOSE, Calif., April 10, 2017 — SunPower (NASDAQ:SPWR) today announced that construction has begun on an 8.79-megawatt SunPower® solar system at Toyota Motor North America’s new headquarters in Plano, Texas, which the auto maker plans to occupy this year. Close to one megawatt larger than originally planned, it is expected to be the Lone Star State’s largest corporate office on-site solar installation among non-utility companies.
About 50 certified workers are now installing high-efficiency SunPower solar panels on steel carport structures across the top of four parking garages. When complete, more than 20,000 solar panels will cover the area equal to 10 football fields, offering shade and protection to vehicles underneath. The system is expected to generate enough clean energy to offset approximately 33 percent of the headquarters’ energy needs, reducing Toyota’s reliance on traditional electricity from the grid.
“We are excited to see this solar power project start to really take shape on our new headquarters campus,” said Kevin Butt, regional director, North American Environmental Division, Toyota. “As a long-standing solar advisor, SunPower is helping us realize Toyota’s 2050 global environmental challenge to eliminate carbon emissions in all operations.”
Toyota is integrating a range of energy efficient technologies and sustainable materials into the design of its state-of-the-art campus, with the intention of achieving LEED® Platinum certification by the U.S. Green Building Council (USGBC). SunPower’s 20 percent efficient E-Series solar panels selected for this project are Cradle to Cradle Certified™ Silver, which may provide Toyota a significant advantage toward reaching that goal. SunPower is the only solar panel manufacturer in the world to achieve this certification, which demonstrates a product’s quality based on rankings in five categories: material health, material reutilization, renewable energy use, water stewardship, and social fairness.
“We’re proud to partner with Toyota on this innovative solar project as the company works to achieve its ambitious sustainability goals,” said Nam Nguyen, SunPower senior vice president. “The unique long-span carport design will feature SunPower’s high reliability solar panels that deliver 30 percent more electricity than conventional solar, optimizing Toyota’s renewable energy investment.”
As a result of 14 years of partnership, SunPower solar power systems are currently operating at a number of Toyota facilities in the U.S.:
- Since 2009, a 1.5-megawatt SunPower solar power system has been operating at Toyota’s facility in West Caldwell, New Jersey.
- In 2008, at the Toyota North American parts center in Ontario, California, SunPower installed a 2.3-megawatt system that produces more than 3.7 million kilowatt hours per year, providing up to 58 percent of the electricity needed at the facility. At the time of completion, it was the second largest single-rooftop solar array in North America.
- Toyota’s South Campus headquarters building in Torrance, California, was one of the largest privately funded systems of its kind when it opened in 2003. Also built by SunPower, the system covers 53,000 square feet of rooftop.
Toyota is financing the SunPower solar project installed at its Plano, Texas, location through a power purchase agreement (PPA) arranged by SunPower, which allows Toyota to buy power at competitive rates – acting as a hedge against future utility rate increases – with no upfront capital cost. Toyota will own the renewable energy credits associated with the system.
About SunPower
With more than 30 years of proven experience, SunPower is a global leader in solar innovation and sustainability. Our unique approach emphasizes the seamless integration of advanced SunPower technologies, delivering The Power of One® complete solar solutions and lasting customer value. SunPower provides outstanding service and impressive electricity cost savings for residential, commercial and power plant customers. At SunPower, we are passionately committed to changing the way our world is powered. And as we continue shaping the future of Smart Energy, we are guided by our legacy of innovation, optimism, perseverance and integrity. Headquartered in Silicon Valley, SunPower has dedicated, customer-focused employees in Africa, Asia, Australia, Europe, North America and South America. Since 2011, we’ve been majority-owned by Total, the fourth largest publicly-listed energy company in the world. For more information, visit www.sunpower.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding timeline and projected energy output. These forward-looking statements are based on our current assumptions, expectations, and beliefs and involve substantial risks and uncertainties that may cause results, performance, or achievement to materially differ from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: regulatory changes and the availability of economic incentives promoting use of solar energy, challenges inherent in constructing and maintaining certain of our large projects, and fluctuations or declines in the performance of our solar panels and other products and solutions. A detailed discussion of these factors and other risks that affect our business is included in filings we make with the Securities and Exchange Commission (SEC) from time to time, including our most recent report on Form 10-K, particularly under the heading “Risk Factors.” Copies of these filings are available online from the SEC or on the SEC Filings section of our Investor Relations website at investors.sunpowercorp.com. All forward-looking statements in this press release are based on information currently available to us, and we assume no obligation to update these forward-looking statements in light of new information or future events.
©2017 SunPower Corporation. All Rights Reserved. SUNPOWER and the SUNPOWER logo are registered trademarks of SunPower Corporation in the U.S. and other countries as well. Cradle to Cradle Certified™ is a certification mark licensed by the Cradle to Cradle Products Innovation Institute. LEED is a trademark owned by the U.S. Green Building Council. All other trademarks are properties of their respective owners.
$GERN Janssen Wraps 2nd Internal Data Review for Imetelstat Trials
Both IMerge and IMbark Continue in Lower Risk Myelodysplastic Syndromes and Relapsed or Refractory Myelofibrosis
Conference Call Scheduled for 8:00 a.m. EDT Today, April 10
MENLO PARK, Calif., April 10, 2017 — Geron Corporation (Nasdaq:GERN) today announced that Janssen Research & Development, LLC has completed the second internal data reviews of IMerge and IMbark, the clinical trials of the telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively. For IMerge, the benefit/risk profile of imetelstat in the treated patients supports continued development in lower risk myelodysplastic syndromes. A data package and proposed trial design refinements are planned to be provided to the FDA. For IMbark, the current results suggest clinical benefit and a potential overall survival benefit associated with imetelstat treatment in relapsed or refractory myelofibrosis; the trial will continue unchanged to evaluate maturing efficacy and safety data, including an assessment of overall survival.
IMerge
IMerge (NCT02598661) is a Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The clinical trial is in two parts: Part 1 is a Phase 2, open-label, single-arm design in approximately 30 patients and Part 2 is designed to be a Phase 3, randomized, controlled trial in approximately 170 patients. The primary efficacy endpoint is the rate of red blood cell transfusion independence lasting at least 8 weeks. Key secondary endpoints include the rates of red blood cell transfusion independence lasting at least 24 weeks and hematologic improvement. Part 1 of the trial is fully enrolled.
The second internal review of IMerge included data from the approximately 30 patients enrolled in Part 1. Based on this second internal review, the Collaboration’s Joint Steering Committee has determined the following:
- The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified.
- The benefit/risk profile of imetelstat, including assessments of 8-week and 24-week transfusion independence and hematologic improvement by erythroid (HI-E) response, across multiple MDS sub-types, supports continued development in lower risk MDS.
- Part 1 of the trial will continue unmodified, and patients remaining in the treatment phase may continue to receive imetelstat.
- A data package, as well as proposed refinements to the trial design for Part 2 of IMerge, is planned to be provided to the FDA.
- Data from Part 1 are expected to be submitted for consideration for presentation at a medical conference in the future.
Geron expects that FDA feedback and the totality of imetelstat program information, including an assessment of the evolving treatment landscape in MDS and the potential application of imetelstat in multiple hematologic malignancies, will inform Janssen’s decision to initiate Part 2 of IMerge. If Part 2 of IMerge is initiated, Geron expects this Phase 3 stage of IMerge to be opened for patient enrollment in the fourth quarter of 2017.
IMbark
IMbark (NCT02426086) was originally designed as a Phase 2 clinical trial to evaluate two dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered every three weeks) in approximately 200 patients with Intermediate-2 or High risk MF who have relapsed after or are refractory to prior treatment with a JAK inhibitor. The co-primary efficacy endpoints for the trial are spleen response rate (≥35% reduction of spleen volume assessed by imaging) and symptom response rate (³50% reduction in Total Symptom Score) at 24 weeks.
The second internal review of IMbark included data from the approximately 100 patients who were enrolled in the trial, with each dosing arm analyzed separately. Based on this second internal review, the Collaboration’s Joint Steering Committee has determined the following:
- The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified.
- The data support 9.4 mg/kg as an appropriate starting dose for the relapsed or refractory MF patient population.
- In these relapsed or refractory MF patients treated in the 9.4 mg/kg dosing arm, the spleen volume response rate observed to date was less than that reported in front-line MF patients treated in trials with other drugs. However, activity within multiple outcome measures was observed with imetelstat treatment, which suggests clinical benefit in this relapsed or refractory MF patient population. These outcome measures included a range of spleen volume reductions, decreases in Total Symptoms Score, and improvements in hematologic parameters, such as anemia and peripheral blood counts. In addition, the data suggest a potential overall survival benefit associated with imetelstat treatment in these patients.
- The trial will continue without any modifications, including conduct of all safety and efficacy assessments as planned in the protocol, including overall survival. Patients remaining in the treatment phase may continue to receive imetelstat.
- Enrollment of new patients to the trial will remain suspended because the total number of patients enrolled to date is adequate to assess longer-term outcome measures when the data are fully matured.
During the next year, Geron expects Janssen to evaluate maturing efficacy and safety data from the trial, including an assessment of overall survival. Geron expects the longer-term data from the trial, potential health authority feedback, and the totality of imetelstat program information, including an assessment of the evolving treatment landscape in MF and the potential application of imetelstat in multiple hematologic malignancies, including MDS, will inform Janssen’s decision whether to continue development of imetelstat in relapsed or refractory MF.
Conference Call
At 8:00 a.m. EDT on April 10, 2017, Geron’s management will host a conference call to review outcomes from the second internal data reviews of IMbark and IMerge. Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID number is 6116409. A live audio-only webcast is also available through the company’s website at www.geron.com in the Investors section under Events and at http://edge.media-server.com/m/p/w5mtfw9k. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through May 11, 2017.
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities. The joint governance structure includes a Joint Steering Committee with equal membership from both companies.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) continued development of imetelstat by Janssen for MDS in Part 2 and continued conduct by Janssen of IMbark and/or IMerge; (ii) data that suggest clinical benefit and potential overall survival benefit of imetelstat in MF; (iii) a planned data package will be provided to the FDA for IMerge; (iv) that Janssen will conduct any additional data reviews for IMbark during the next year; (v) potential outcomes of any data reviews conducted by Janssen for IMbark; (vi) any future presentation of data from current clinical trials of imetelstat by Janssen at a medical conference; (vii) the safety and efficacy of imetelstat; (viii) that if Janssen decides to proceed with Part 2 of IMerge, the clinical trial will be opened for patient enrollment in the fourth quarter of 2017; (ix) potential receipt by Geron of additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, and royalties from sales of imetelstat; and (x) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) whether Janssen decides to initiate Part 2 of IMerge and to continue to conduct IMerge and/or IMbark; (ii) whether imetelstat is safe and efficacious and will succeed in IMbark and/or IMerge by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (iii) whether health authorities permit IMbark and/or IMerge to continue to proceed under the existing protocols or any amendments thereto; (iv) Janssen’s ability to collect additional and more mature data from current clinical trials of imetelstat; (v) Geron’s dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (vi) any future efficacy or safety results from any clinical trial of imetelstat may cause the benefit/risk profile of imetelstat to become unacceptable; and (vii) patent coverage of imetelstat enables Janssen to successfully commercialize imetelstat. Additional information on the above-stated risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s annual report on Form 10-K for the year ended December 31, 2016. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com
$MXWL Announces Agreement with Viex Capital Advisors
SAN DIEGO, April 10, 2017 — Maxwell Technologies, Inc. (NASDAQ: MXWL) (“Maxwell” or the “Company”), a leading developer and manufacturer of capacitor energy storage and power delivery solutions, announced today that it entered into a cooperation agreement with Viex Capital Advisors, LLC and its affiliates (“Viex”) under which the Maxwell Board has agreed to appoint Mr. John Mutch as an independent director and to nominate Mr. Mutch for election at the 2017 Annual Meeting of Stockholders as a Class III director of the Company for a term expiring in 2020. Mr. Mutch was selected by Viex but is not an affiliate or associate of Viex. Additionally, the Company and Viex have agreed that, following the 2017 Annual Meeting, the Board will reduce its size to eight, including the Viex nominee.
“We are pleased to strengthen our Board with the addition of a new, highly qualified, independent director nominee, who will add valuable experience and fresh perspective to the Maxwell Board,” said Dave Schlotterbeck, Maxwell’s Chairman of the Board. “The entire Maxwell team is unified in its focus on maximizing stockholder value and looks forward to working collaboratively with our directors to generate enhanced returns for the Company’s stockholders.”
“We believe Maxwell is an excellent company, with solid fundamentals and a strong market position in the energy storage space,” said Eric Singer, Founder and Managing Member of Viex. “We appreciate the constructive working relationship we have built with Franz and the team at Maxwell over the last year and are pleased to have reached this agreement. We believe that strengthening the Board with highly experienced and independent directors will support the Company in executing on its plans to drive sales growth and profitability for the benefit of all shareholders. We are excited to work collaboratively to realize the Company’s full potential for value creation.”
As part of the agreement, Viex has agreed to abide by certain customary standstill and voting provisions and has agreed to vote in favor of the Company’s slate of director nominees at the 2017 Annual Meeting and certain other matters.
The complete agreement between Maxwell and Viex will be included as an exhibit to a Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission.
Barclays is serving as financial advisors to Maxwell and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel.
About Maxwell
Maxwell is a global leader in the development and manufacture of innovative, cost-effective energy storage and power delivery solutions. Our ultracapacitor products provide safe and reliable power solutions for applications in consumer and industrial electronics, transportation, renewable energy and information technology. Our CONDIS® high-voltage grading and coupling capacitors help to ensure the safety and reliability of electric utility infrastructure and other applications involving transport, distribution and measurement of high-voltage electrical energy. For more information, visit www.maxwell.com.
Forward-Looking Statements
Statements in this news release that are “forward-looking statements” are based on current expectations and assumptions that are subject to risks and uncertainties and are subject to the Safe Harbor provisions created by the Private Securities Litigation Reform Act of 1995. Such risks, uncertainties and contingencies include, but are not limited to, the following:
- Dependence upon the sale of products to a small number of customers and vertical markets, some of which are heavily dependent on government funding or government subsidy programs which could be reduced, modified or discontinued in the future;
- Uncertainties related to the global geopolitical landscape and the recent elections in the United States;
- Risks related to acquisitions and potential for unsuccessful integration of acquisitions;
- Risk that our restructuring efforts may not be successful and that we may not be able to realize the anticipated cost savings and other benefits;
- Our ability to obtain sufficient capital to meet our operating or other needs;
- Downward pressures on product pricing from increased competition and shifts in sales mix with respect to low margin and high margin business;
- Our ability to manage and minimize the impact of unfavorable legal proceedings;
- Risk that activist stockholders attempt to effect changes to our company which could adversely affect our corporate governance;
- Risks related to our international operations including, but not limited to, our ability to adequately comply with the changing rules and regulations in countries where our business is conducted, our ability to oversee and control our foreign subsidiaries and their operations, our ability to effectively manage foreign currency exchange rate fluctuations arising from our international operations, and our ability to continue to comply with the U.S. Foreign Corrupt Practices Act as well as the anti-bribery laws of foreign jurisdictions;
- Dependence upon the sale of products into Asia and Europe, where macroeconomic factors outside our control may adversely affect our sales;
- Our ability to remain competitive and stimulate customer demand through successful introduction of new products, and to educate our prospective customers on the products we offer;
- Successful acquisition, development and retention of key personnel;
- Our ability to effectively manage our reliance upon certain suppliers of key component parts, specialty equipment and logistical services;
- Our ability to manage product quality problems;
- Our ability to protect our intellectual property rights and to defend claims against us;
- Our ability to effectively identify, enter into, manage and benefit from strategic alliances;
- Occurrence of a catastrophic event at any of our facilities;
- Occurrence of a technology systems failure, network disruption, or breach in data security; and
- Our ability to match production volume to actual customer demand.
For further information regarding risks and uncertainties associated with Maxwell’s business, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections of our SEC filings, including, but not limited to, our annual report on Form 10-K and quarterly reports on Form 10-Q. Copies of these documents may be obtained by contacting Maxwell’s investor relations department at (858) 503-3368, or at our investor relations website: www.investors.maxwell.com.
Investor Contact: Soohwan Kim, CFA, The Blueshirt Group, +1 (858) 503-3368, ir@maxwell.com
Media Contact: Sylvie Tse, Metis Communications, +1 (617) 236-0500, maxwell@metiscomm.com
$SALE to Be Acquired by Harland Clarke, $11.60 per share in Cash
Transaction Dramatically Expands HCH and Valassis’ Digital Scale, Advances RetailMeNot’s Goal in Becoming a Leading Savings Destination
SAN ANTONIO and AUSTIN, Texas, April 10, 2017 — Harland Clarke Holdings Corp. (“HCH”), a provider of best-in-class integrated payment solutions and marketing services, today announced it has reached a definitive agreement to acquire RetailMeNot, Inc. (NASDAQ:SALE), a leading savings destination connecting consumers with retailers, restaurants and brands, both online and in-store. Under the agreement, Harland Clarke Holdings, a wholly owned subsidiary of MacAndrews & Forbes Incorporated and owner of Valassis, a leader in intelligent media delivery, providing unparalleled consumer targeting insights on a large scale, will acquire all of the outstanding shares of RetailMeNot Series 1 common stock for $11.60 per share in cash.
By bringing together Valassis’ unmatched quantity of genuine valuable offers from its large, diversified client base with RetailMeNot’s premier digital audience distribution and brand, the companies’ combined offerings will become the consumer savings destination of choice. This transaction significantly advances RetailMeNot’s goal of becoming a leading savings destination, and is a natural step forward in the growth trajectory of the company.
The combined companies will create an omni-channel media network with tens of thousands of advertisers reaching hundreds of millions of consumers around the world.
The purchase price represents a premium of approximately 50% over the closing share price of RetailMeNot’s common stock on April 7, 2017 and a premium of approximately 36% over the average closing share price for the 60 calendar days ended April 7, 2017. The transaction, which has been unanimously approved by RetailMeNot’s Board of Directors, has an equity value of approximately $630 million.
“RetailMeNot provides a new global digital channel to distribute our clients’ offers that perfectly complements Valassis’ current digital, mobile, mail and other print networks. RetailMeNot’s capabilities span multiple platforms and channels including web, mobile and app, delivering online coupons and sales, discounted gift cards, and cash back offers, along with food, dining and travel offers. The addition of RetailMeNot brings Valassis’ clients a new, vast and active consumer base explicitly seeking deals, offers and savings. We are thrilled that we will be working with RetailMeNot’s outstanding Austin based team and look forward to continuing to grow our business together,” said Victor Nichols, CEO of HCH.
“This is an exciting and important milestone for RetailMeNot,” said Cotter Cunningham, CEO & founder, RetailMeNot. “Not only are we delivering an immediate and significant cash premium to our stockholders, but we are also meaningfully advancing our goal of becoming a leading savings destination for consumers. This acquisition is a testament to the unwavering commitment and hard work of our 500 plus dedicated employees. Having founded RetailMeNot over seven years ago, I firmly believe that Valassis not only shares our commitment to consumers and merchant partners, but supports continued innovation in driving new solutions for retailers and brands. I am confident in the future of RetailMeNot in its partnership with Valassis and look forward to working closely with the combined team to ensure together we become the premier savings destination.”
The transaction will be effected through a tender offer by a wholly-owned subsidiary of HCH for all of the outstanding shares of Series 1 common stock of RetailMeNot. Following the successful completion of the tender offer, HCH will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price per share. The transaction is subject to customary closing conditions, including receipt of certain regulatory approvals and receipt of a majority of RetailMeNot’s issued and outstanding shares of Series 1 common stock in the tender offer. The transaction is expected to close in the second quarter of 2017. Upon completion of the transaction, RetailMeNot will become a privately held company and RetailMeNot’s Series 1 common shares will no longer be listed on any public market. In light of the transition, RetailMeNot will not provide earnings guidance going forward.
LionTree Advisors is serving as lead financial advisor to Harland Clarke Holdings, with Moelis & Company also serving as financial advisor to Harland Clarke Holdings. Wachtell, Lipton, Rosen & Katz is serving as legal advisor to Harland Clarke Holdings. Cleary Gottlieb Steen & Hamilton LLP is serving as legal advisor to Harland Clarke Holdings for financing matters.
Qatalyst Partners is serving as financial advisor and DLA Piper LLP (US) is serving as legal advisor to RetailMeNot in connection with the transaction.
About RetailMeNot, Inc.
RetailMeNot, Inc. (http://www.retailmenot.com/corp/) is a leading savings destination connecting consumers with retailers, restaurants and brands, both online and in-store. The company enables consumers across the globe to find hundreds of thousands of digital offers to save money while they shop or dine out. During the 12 months ended December 31, 2016, RetailMeNot, Inc. experienced over 650 million visits to its websites. It also averaged 23.1 million mobile unique visitors per month during the three months ended December 31, 2016. RetailMeNot, Inc. estimates that approximately $4.4 billion in retailer sales were attributable to consumer transactions from paid digital offers in its marketplace in 2016, more than $600 million of which were attributable to its in-store solution. The RetailMeNot, Inc. portfolio of websites and mobile applications includes RetailMeNot.com in the United States; RetailMeNot.ca in Canada; VoucherCodes.co.uk in the United Kingdom; ma-reduc.com and Poulpeo.com in France; and GiftCardZen.com and Deals2Buy.com in North America. RetailMeNot, Inc. is listed on the NASDAQ stock exchange under the ticker symbol “SALE.”
About Harland Clarke Holdings
HCH is comprised of companies focused on optimizing client relationships through multiple channels by enabling them to acquire, retain and grow their customer base. Its major business units, Valassis, Harland Clarke and Scantron are recognized as leading providers of marketing services, transaction solutions, education services and intelligent media delivery that create millions of customer touch points annually for their clients. Harland Clarke Holdings is a wholly owned subsidiary of MacAndrews & Forbes Incorporated.
About Valassis
Valassis is a leader in intelligent media delivery, providing over 58,000 clients with innovative media solutions to influence consumers wherever they plan, shop, buy and share. By integrating online and offline data combined with powerful insights, Valassis precisely targets its clients’ most valuable shoppers, offering unparalleled reach and scale. NCH Marketing Services, Inc. and Clipper Magazine are Valassis subsidiaries, and RedPlum® is its consumer brand. Its signature Have You Seen Me?® program delivers hope to missing children and their families. Valassis is a wholly owned subsidiary of HCH.
About MacAndrews & Forbes Incorporated
MacAndrews & Forbes Incorporated owns and operates a diverse array of businesses, tapping into the broad expertise of its management team to support the delivery of best in class products and services to end users and consumers all over the world. MacAndrews & Forbes’ businesses span a wide range of industries, from global leaders in consumer marketing and payment systems, cosmetics and digital entertainment, to biotechnology and military equipment.
Contact Information
For RetailMeNot, Inc.:
Investor Contacts
J. Scott Di Valerio
sdivalerio@rmn.com
(206) 919-0825
Anne Bawden
abawden@rmn.com
(415) 200-8654
Media Contact
Michelle Skupin
mskupin@rmn.com
(808) 224-3215
For MacAndrews & Forbes Incorporated:
Media Contact
Josh Vlasto
jvlasto@mafgrp.com
212-572-5969
For Harland Clarke Holdings:
Media Contact
Debbie Serot
Debbie.serot@harlandclarke.com
(210) 697-6239
Forward-looking Statements
Statements in this document that are not strictly historical, including statements regarding the proposed acquisition, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined businesses and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be “forward-looking” statements within the meaning of the federal securities laws, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: general economic conditions and conditions affecting the industries in which Harland Clarke, Valassis and RetailMeNot operate; the uncertainty of regulatory approvals; the parties’ ability to satisfy the tender offer and merger agreement conditions and consummate the transaction; the availability of financing on attractive terms or at all; the ability to realize anticipated growth; and RetailMeNot’s performance and maintenance of important business relationships. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in RetailMeNot’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2016. The forward-looking statements made herein speak only as of the date hereof and none of Harland Clarke, Valassis or RetailMeNot, or any of their respective affiliates, assumes any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Additional Information and Notice to Investors
This announcement is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the outstanding shares of RetailMeNot Series 1 common stock described in this press release has not yet commenced. At the time the planned offer is commenced a wholly-owned subsidiary of Harland Clarke will file a tender offer statement on Schedule TO with the Securities and Exchange Commission and RetailMeNot will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the planned offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Those materials will be made available to RetailMeNot security holders at no expense to them. In addition, all of those materials (and all other offer documents filed with the SEC) will be available at no charge on the SEC’s website: www.sec.gov.
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