Uncategorized
$CATB #Phase1 Data on #Edasalonexent #CAT1004 in #DMD
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced the publication of Phase 1 data on edasalonexent in adult subjects. Edasalonexent is a potential disease-modifying therapy being developed for Duchenne muscular dystrophy (DMD). The Phase 1 trials demonstrated that edasalonexent (CAT-1004), an oral inhibitor of NF-kB, was safe, well tolerated, and inhibited activated NF-kB in adult subjects and the data are presented in an article titled “A Novel NF-kB Inhibitor, Edasalonexent (CAT-1004), in Development as a Disease-Modifying Treatment for Patients with Duchenne Muscular Dystrophy: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics in Adult Subjects” in the Journal of Clinical Pharmacology (J Clin Pharmacol. 2017 Jan 11. doi: 10.1002/jcph.842.)
In Duchenne muscular dystrophy (DMD), NF-kB is activated in muscle from infancy regardless of the underlying dystrophin mutation and drives inflammation and muscle degeneration while inhibiting muscle regeneration. Edasalonexent (CAT-1004) is a bifunctional orally administered small molecule that covalently links two compounds known to inhibit NF-kB, salicylic acid and docosahexaenoic acid (DHA). The three placebo-controlled trials in adult subjects assessed the safety, pharmacokinetics and pharmacodynamics of single or multiple edasalonexent doses up to 6000 mg (approximately 100 mg/kg). Seventy-nine adult subjects received edasalonexent and 25 received placebo. The NF-kB pathway and proteosome gene expression profiles in peripheral mononuclear cells were significantly decreased after 2 weeks of edasalonexent treatment. NF-kB activity was inhibited following a single dose of edasalonexent but not by equimolar doses of its component bioactives salicylic acid and DHA dosed in combination. Edasalonexent was well tolerated, and the most common adverse events were mild diarrhea and headache.
“These Phase 1 safety, tolerability and positive NF-kB biomarker results support edasalonexent development in Duchenne muscular dystrophy and potentially other diseases. The Phase 1 results in adults informed on the dose and dose schedule for the current MoveDMD trial in 4-7 year-old boys affected by Duchenne, where similar Phase 1 results were seen,” said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis. “We look forward to the results from the edasalonexent Phase 2 clinical trial in boys affected by Duchenne, which are expected in the first half of Q1 2017.”
About Edasalonexent (CAT-1004)
Edasalonexent (CAT-1004) is an oral small molecule that has the potential to be a disease-modifying therapy for all patients affected by Duchenne muscular dystrophy (DMD or Duchenne), regardless of their underlying mutation. Edasalonexent inhibits NF-kB, a protein that is activated in Duchenne and drives inflammation and fibrosis, muscle degeneration and suppresses muscle regeneration. In animal models of DMD, edasalonexent produced beneficial effects in skeletal, diaphragm and cardiac muscle and improved function. The FDA has granted orphan drug, fast track and rare pediatric disease designations and the European Commission has granted orphan medicinal product designation to edasalonexent for the treatment of DMD. We have previously reported safety, tolerability and reduction in NF-kB activity in Phase 1 trials in adults. We are currently conducting the MoveDMD® trial of edasalonexent in 4-7 year-old boys affected by Duchenne. From Part A of the MoveDMD trial, we have reported that edasalonexent was generally well tolerated with no safety signals observed and we observed NF-kB target engagement. Pharmacokinetic results demonstrated edasalonexent plasma exposure levels consistent with those previously observed in adults, at which inhibition of NF-kB was observed.
About Catabasis
At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our SMART (Safely Metabolized And Rationally Targeted) linker drug discovery platform enables us to engineer molecules that simultaneously modulate multiple targets in a disease. We are applying our SMART linker platform to build an internal pipeline of product candidates for rare diseases and plan to pursue partnerships to develop additional product candidates. For more information on the Company’s drug discovery platform and pipeline of drug candidates, please visit www.catabasis.com.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about future clinical trial plans and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company’s product candidates; and general economic and market conditions and other factors discussed in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2016, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.
Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com
$VRAY #DFG Purchases #MRIdian #Linac for University Clinic Heidelberg
Marks First Purchase of MRIdian Linac in Europe following CE Mark Approval
CLEVELAND, Jan. 19, 2017 — ViewRay, Inc. (Nasdaq: VRAY) announced today that the German Research Foundation (DFG), a federal institution supporting research in Germany, has purchased a MRIdian Linac for installation and patient treatments at the University Clinic Heidelberg as part of its initiative for MRI-based radiation therapy.
The MRIdian Linac program will be headed by Medical Director and Professor Jürgen Debus, M.D., Ph.D., who also heads radiation oncology at the German Cancer Research Center (DKFZ), the Heidelberg Heavy Ion Center (HIT) and the Marbug Heavy Ion Center (MIT). The University Clinic Heidelberg will be an important MRIdian research partner, helping to explore a wide array of topics including improved dose delivery through MRI-guidance and various clinical studies.
“We are proud to be the first to acquire MRIdian Linac within Europe and to extend the benefits of MRI-guided radiation therapy to our patients,” said Professor Debus. “The MRIdian Linac significantly improves our ability to visualize the tumor and will allow us to spare as much healthy tissue as possible while ensuring we deliver only the precise amount of radiation prescribed.”
The MRIdian Linac is the first, and currently the only, MRI-guided linear accelerator available for clinical use in Europe. DFG’s purchase of the MRIdian Linac marks the first in Europe since ViewRay received its CE Mark approval in September. The MRIdian Linac is a next-generation linear accelerator-based MRI-guided radiation therapy system. Using the MRIdian Linac system, clinicians can see soft tissue, and visualize and adjust the dose in real-time.
“MRIdian Linac is an important advance in how we plan and treat with radiation therapy, offering us the opportunity to deliver real-time adaptive therapy,” said Professor Markus Alber, Ph.D., professor for radiation physics research at the University Clinic Heidelberg. “We selected MRIdian Linac specifically for its exceptional beam quality and its fully integrated treatment planning and delivery workflow.”
“We’re pleased to see the first MRIdian Linac clinical program in Europe take shape with such a prestigious institution,” said Chris A. Raanes, president and chief executive officer of ViewRay. “We believe this is an important milestone in establishing MRIdian as a standard of care in radiation oncology and solidifies our clinical leadership role in the MRI-guided radiation therapy field.”
About ViewRay
ViewRay®, Inc. (Nasdaq: VRAY) designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track the position and shape of soft-tissue tumors during radiation. ViewRay believes this combination of enhanced visualization and accuracy will significantly improve outcomes for patients.
In the United States, ViewRay has submitted a 510(k) application for the MRIdian Linac, the company’s MR Linac technology. Therefore, the MRIdian Linac is not available for sale or distribution in the United States except for non-clinical research use. ViewRay and MRIdian are registered trademarks of ViewRay, Inc.
Forward Looking Statements:
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the head of the MRIdian Linac program at the University Clinic Heidelberg, the University Clinic Heidelberg’s research efforts using MRIdian, the demand for MRI-guided radiation therapy in Germany, the benefits of the MRIdian Linac for physicians and patients in Germany, the expected reception of the MRIdian Linac in Germany and the receipt by the University Clinic Heidelberg of its MRIdian Linac. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.
$NFEC Announces Business Cooperation with #IndianFlucon
SHENYANG, China, Jan. 19, 2017 — NF Energy Saving Corporation (NASDAQ:NFEC) (“NF Energy” or the Company), a leading energy saving service solutions provider for China’s power, petrochemical, coal, metallurgy, construction and municipal infrastructure development industries, announced that recently Mr. Shiva, as the director of Indian Flucon International Co. Ltd., has visited the Company.
Gang Li, the Chairman of the Company, who talked with Mr. Shiva said, “as one of the largest companies devoted to the manufacturing of flow control equipment, NF Energy innovated many advanced flow control equipment in recent years, which led to set up its high reputation in the domestic market. Along with rapid development in China’s economy as well as ‘one belt and one road’ as the new economic policy issued by the Chinese government, this Chinese product is more popular in the world, especially in the developing countries, such as India. Meanwhile, energy saving and emission reduction will play a key role in the global which I believe will increase product demand in the flow control equipment, so it may provide additional opportunity for us”.
Mr. Shiva also visited the workshop in the Company’s industrial park and the Company’s technicians introduced the production line to him.
After his visit, Mr. Shiva said that he is interesting in the large scale butterfly and inlet valves and believes that the two companies could cooperate each other.
About NF Energy Saving Corporation
NF Energy Saving Corporation (NASDAQ:NFEC) is a China-based provider of integrated energy conservation solutions utilizing energy-saving equipment, technical services and energy management re-engineering project operations to provide energy saving services to clients. The Company’s customers are mainly concentrated in the electrical generation (large-scale thermal power generation, hydroelectric power, and nuclear power), water supply, and heat supply industries. The majority of revenues are from energy efficient flow control solutions including equipment and energy efficiency project services. For more information, visit http://www.nfenergy.com.
Safe Harbor Statement
The statements contained herein that are not historical facts are considered “forward-looking statements.” Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In particular, statements regarding the efficacy of investment in research and development are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the effect of political, economic, and market conditions and geopolitical events; legislative and regulatory changes that affect our business; the availability of funds and working capital; the actions and initiatives of current and potential competitors; investor sentiment; and our reputation. We do not undertake any responsibility to publicly release any revisions to these forward-looking statements to take into account events or circumstances that occur after the date of this report. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events, which may cause actual results to differ from those expressed or implied by any forward-looking statements. The factors discussed herein are expressed from time to time in our filings with the Securities and Exchange Commission available at http://www.sec.gov.
For more information, please contact:
Andy Gao
Phone Number: +86-24-25609775
Email: info@nfenergy.com
$DELT #Sales Up Significantly in #Q4 2016
ZHENJIANG, China, Jan. 19, 2017 — Delta Technology Holdings Limited (NASDAQ: DELT) today provided investors unaudited sales figures of four main products for the fourth quarter (calendar quarter) of 2016, ending 31 December. Highlights include:
1. Delta Technology sold 133.30% more products in Q4 2016 than in Q4 2015.
2. The revenue of these products increased 139.55%.
3. Unit prices of these products also increased significantly in Q4 2016.
“Delta Technology is determined to provide higher quality products and to focus our priority resources on higher value-added products and clients. This policy is leading the Company to increased revenue compared to 2015, said Company CEO Mr. Xin Chao.
Mr. Xin Chao also stressed the sales of the organic compound para-chlorotoluene (PCT) have increased dramatically as the Company has executed a contract with Guangzhou Lonkey Industrial Co., Ltd., a listed company in Shenzhen Stock Exchange (stock ticker:000523).
The figures are as follows:
| Sales, tones | Revenue, USD | |||||
| Q4 2015 | Q4 2016 | Increase % | Q4 2015 | Q4 2016 | Increase % | |
| Total | 5,663 | 13,212 | 133.30% | 8,571,861.92 | 20,533,998.92 | 139.55% |
| p-Chlorotoluene | 2,262 | 9,604 | 324.58% | 2,639,214.07 | 13,909,938.39 | 427.05% |
| O-Chlorotoluene | 2,160 | 2,449 | 13.38% | 2,856,564.15 | 3,137,428.18 | 9.83% |
| p-Chlorobenzaldehyde | 301 | 499 | 65.78% | 795,954.74 | 1,683,469.34 | 111.50% |
| O-chlorobenzenecarboxyaldehyde | 940 | 660 | -29.79% | 2,280,128.96 | 1,803,163.01 | -20.92% |
Note: the currency exchange rate is calculated at USD:RMB=1:6.85, this may be various in audit.
About Delta Technology Holdings Ltd.
Founded in 2007, Delta Technology Holdings Ltd. is a leading China-based fine and specialty chemical company producing and distributing organic compound including para-chlorotoluene (“PCT”), ortho-chlorotoluene (“OCT”), PCT/OCT downstream products, unsaturated polyester resin (“UPR”), maleic acid (“MA”) and other by-product chemicals. The end application markets of the Company’s products include Automotive, Pharmaceutical, Agrochemical, Dye & Pigments, Aerospace, Ceramics, Coating-Printing, Clean Energy and Food Additives. Delta has approximately 300 employees, 25% of whom are highly-qualified experts and technical personnel. The Company serves more than 380 clients in various industries.
Safe Harbor Statement
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded or followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions or future or conditional verbs such as “will”, “should”, “would”, “may” and “could” are generally forward-looking in nature and not historical facts. Forward-looking statements in this release also include statements about business and economic trends. Investors should also consider the areas of risk described under the heading “Forward Looking Statements” and those factors captioned as “Risk Factors” in DELT’s periodic reports under the Securities Exchange Act of 1934, as amended, or in connection with any forward-looking statements that may be made by DELT.
$APDN #SupplyChain Transparency Report #ConsumerConfidence #MadeInUSA
Applied DNA Sciences cotton survey conducted by Harris Poll reveals 30% of consumers say they would stop purchasing a brand if they made a false product claim about their bedding/clothing product; three in five Americans would not purchase if child or forced laborers were involved
STONY BROOK, NY–(January 18, 2017) – Applied DNA Sciences, Inc. (NASDAQ: APDN), a provider of DNA-based supply chain, anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, announced the results of a cotton survey conducted by Harris Poll.
Home goods and apparel manufacturers: Consumers are voicing their concerns. With a new president focused on protecting products born in the USA, consumers may be looking more closely at product origins, and could demand more transparency. Thirty percent of Americans said that they would completely stop purchasing a brand if they made a false product claim about a bedding/clothing product being 100% organic, 100% Pima cotton, or other claim of this type, while roughly three in five Americans (61%) say if they found a brand made their bedding/clothing products from raw cotton that was picked by child laborers /forced laborers, they would no longer purchase the brand. These statistics are part of a recent survey of over 2,000 US adults 18 and over, conducted online in December 2016 by Harris Poll on behalf of Applied DNA Sciences, that develops DNA-based technology to help justify product claims, ensure authenticity and provide an additional level of transparency across global supply chains.
Citing scientific proof of product claims as a key factor in consumer purchase decisions, the survey yielded telling insights involving product trust and how that trust influences the final decision to purchase or not:
- Over three quarters of Americans (76%) say when a product claim indicates cotton bedding/clothing is 100% organic, 100% Pima cotton, etc. they believe it is true.
- One quarter of Americans (25%) say if they discovered that a brand claimed a cotton bedding/clothing product was 100% organic, 100% Pima cotton, or other claim of this type, and it turned out not to be true, it would have a lot of negative impact on their likelihood to purchase that brand and 3 in 10 (30%) say it would completely stop them from purchasing that brand.
- 78% of Americans say if a cotton bedding/clothing product claimed to be 100% organic, 100% Pima cotton, or other claims of that type, and all else was equal, they would be likely to buy a brand that showed scientific proof of its claim over one that did not.
- Nearly one third of Americans (32%) say if they found out a brand that claimed to make their bedding/clothing products from cotton grown in the US but actually used a blend of cotton grown in the U.S. and China, they would purchase less frequently from that brand.
- Roughly three in five Americans (61%) say if they found out a brand made their bedding/clothing products from raw cotton that was picked by child laborers/forced laborers, they would no longer purchase from that brand.
“This survey reaffirms what we have known all along,” said Dr. James A. Hayward, CEO of Applied DNA Sciences. “Consumers want authentic products and want to trust in what they are buying. They have no interest in bringing a product into their home that has been born of any kind of forced labor. Our primary aim is to cleanse the cotton supply chain and by that, I mean eliminating any diversion, any mislabeling, any counterfeiting that can take place throughout the cotton supply chain. An ideal way to ascertain the true identity of a natural commodity is to use the DNA that nature gave that commodity or to mark it with a manufactured DNA. This enables the cotton to be traced to where it was picked before it went into the ginning process that cleans away seed and other debris for packaging into bails to ship around the world for spinning, dyeing and to make into clothes.”
Survey Methodology:
This survey was conducted online within the United States by Harris Poll on behalf of Applied DNA Sciences from December 27-29, 2016 among 2,015 U.S. adults ages 18 and older. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. For complete survey methodology, including weighting variables, please contact Kristen Bujold.
All sample surveys and polls, whether or not they use probability sampling, are subject to multiple sources of error which are most often not possible to quantify or estimate, including sampling error, coverage error, error associated with nonresponse, error associated with question wording and response options, and post-survey weighting and adjustments. Therefore, the words “margin of error” are avoided as they are misleading. All that can be calculated are different possible sampling errors with different probabilities for pure, unweighted, random samples with 100% response rates. These are only theoretical because no published polls come close to this ideal.
Respondents for this survey were selected from among those who have agreed to participate in our surveys. The data have been weighted to reflect the composition of the adult population. Because the sample is based on those who agreed to participate in the online panel, no estimates of theoretical sampling error can be calculated.
About The Harris Poll®
Over the last 5 decades, Harris Polls have become media staples around the world. Frequent polls tap into a representative sample of Americans of all ages, genders, income and ethnic backgrounds. From sports to health, politics to the economy, the Harris Poll reflects Americans’ opinions on a wide range of topics and are regularly published by national, local, consumer, business and trade media outlets. Harris Poll offers a diverse portfolio of proprietary client solutions to anchor and propel communications campaigns. Armed with relevant insights on public opinion, public and private sector clients harness the power of the Harris Poll to gain both credibility and coverage to drive their desired business outcomes.
About Applied DNA Sciences
We make life real and safe by providing botanical-DNA based security and authentication solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. Our patented DNA-based solutions can be used to identify, tag, track, and trace products, to help assure authenticity, traceability and quality of products. SigNature® DNA describes the platform ingredient that is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators. We are also engaged in the large-scale production of specific DNA sequences using the polymerase chain reaction.
Go to adnas.com for more information, events and to learn more about how Applied DNA Sciences makes life real and safe. Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.
Forward-Looking Statements
The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 6, 2016, which is available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor contact:
Debbie Bailey
631-240-8817
debbie.bailey@adnas.com
Media contact:
Kristen Bujold
781-639-4924
kristenb@cgprpublicrelations.com
Program contact:
MeiLin Wan
631-240-8849
meilin.wan@adnas.com
web: www.adnas.com
twitter: @APDN
$IMMU New Data for #IMMU132 in #BreastCancer at Investor R&D Day
— IMMU-132 Provides Opportunity for Significant Near-Term Value Creation —
— Submission for Accelerated Approval Application to FDA for Patients with Metastatic TNBC Remains on Track for mid-2017 —
— Company Advancing IMMU-132 in Three Additional Indications —
MORRIS PLAINS, N.J., Jan. 18, 2017 — Immunomedics, Inc. (NASDAQ:IMMU) (“Immunomedics” or “the Company”) today announced new data for sacituzumab govitecan (IMMU-132) during the Company’s Investor R&D Day. The entire presentation is available on the Company’s website, www.immunomedics.com.
IMMU-132 is Immunomedics’ proprietary solid tumor therapy candidate that is advancing through development in four indications: metastatic triple-negative breast cancer (TNBC), the lead indication and for which the Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation; urothelial cancer (UC); small-cell lung cancer (SCLC); and non-small-cell lung cancer (NSCLC). Immunomedics expects to submit a Biological License Application (BLA) to the FDA for accelerated approval of IMMU-132 in TNBC patients in mid-2017.
Cynthia L. Sullivan, President and Chief Executive Officer, said, “The data to support our BLA filing for accelerated approval for IMMU-132 in TNBC continues to improve as more confirmed results become available for the patients enrolled into our TNBC clinical trial. Additionally, with the assistance of our outside financial and strategic advisor, Greenhill & Co., LLC, we are making significant progress with multiple partnership and strategic opportunities for IMMU-132, and we are very encouraged with the interest thus far. We believe there is a limited and diminishing number of compelling oncology assets available, and we are focused on bringing IMMU-132 to late-stage cancer patients as expeditiously as possible. Furthermore, now is the right time to deliver on the potential value of IMMU-132 on behalf of our stockholders.”
New IMMU-132 Results Highlight Progress Toward Potential Accelerated Approval
Ms. Sullivan reported that IMMU-132 has been studied in over 410 diverse cancer patients, with the dose of 10 mg/kg given on days 1 and 8 of repeated 21-day cycles being the established dose regimen. According to Ms. Sullivan, some patients have been treated for more than a year.
The Company has engaged an independent third-party to review pertinent radiological scan results from the TNBC and its NSCLC indications, in a blinded fashion, as per FDA requirements.
Immunomedics disclosed results in 85 assessable TNBC patients. These results will be part of the BLA submission for the accelerated approval of IMMU-132. The Company announced last month that it had achieved the goal of enrolling 100 TNBC patients, as requested by FDA for this BLA filing. The Company reported that the objective response rate and median progression-free survival (PFS, intention-to-treat, or ITT, basis) have been maintained with these additional patient results, while the median overall survival (OS also on ITT basis) has been extended to almost 19 months. These patients experienced two complete and 23 partial responses, while an additional three patients with initial partial responses are awaiting confirmation. Overall, 81% of patients treated with IMMU-132 showed tumor shrinkage from baseline measurements. The clinical benefit rate (complete and partial remissions, and patients with stable disease) at six months or later computed to 44%. The median duration of response for those with objective responses was almost 11 months. It was emphasized that these are interim results, since 20 patients are continuing treatment; a final outcome must await analysis of all patients enrolled.
The major toxicity (grade >3) has been neutropenia (39%) in this and most cancer patient cohorts, which has been manageable by dose reduction, dose delays, or giving a hematopoietic cytokine. Diarrhea, which is the major side effect with irinotecan, the parent drug from which SN-38 is derived, has been much less, such as a grade >3 of 13%.
Dr. Linda T. Vahdat, Professor of Medicine at Weill Cornell Medical College, and Co-Leader of the Breast Cancer Program at Meyer Cancer Center, New York, who is one of the senior investigators in the IMMU-132 trial and presenter of these results, said: “These are excellent results in this very advanced and heavily-pretreated group of patients who have exhausted virtually all therapeutic options, and come with a relatively good safety profile. As the first investigator to recognize the potential role of IMMU-132 in TNBC, I am delighted with this outcome and look forward to its future use in these critical patients.”
“Further, with encouraging preclinical results of the combination of IMMU-132 with PARP inhibitors in TNBC models, we are interested in the prospect of this combination in an earlier therapy setting for these patients,” Dr. Vahdat added.
In addition to TNBC, Immunomedics is making progress with IMMU-132 across the other three advanced indications. In patients with urothelial cancer, especially metastatic urinary bladder cancer, Dr. Scott T. Tagawa, Associate Professor of Medicine and Urology, Weill Cornell Medical College, and Attending Physician, New York-Presbyterian Hospital, New York, reported on 27 assessable patients from more than 40 patients enrolled. The objective response rate was 33%, including one complete and eight partial remissions. The duration of objective response was a median of 7.5 months, with one patient with a partial response approaching 17 months. The clinical benefit rate at six months or later was 59%, but 10 patients are still under therapy. Overall, 70% of the patients showed tumor shrinkage from baseline with IMMU-132 therapy. The median PFS and OS on an ITT basis were seven and almost 16 months, respectively. The safety profile was similar to the findings in patients with TNBC.
“These patients had a median of two prior therapies and had extensive metastatic disease. While patients with metastatic urothelial cancer respond well to initial therapy with a platinum-containing regimen, few options are available after they become refractive. The recent approval of an immune checkpoint inhibitor has been an important advance, but only a fraction of patients respond. In our trial, we had two such patients who were unresponsive to this therapy but showed tumor shrinkage with IMMU-132,” Dr. Tagawa said: “I am impressed with the results we have seen in this difficult-to-treat population and we continue to enroll these advanced patients in order to better position this new agent in the management of this disease, either as a second line therapy or perhaps someday in combination with chemotherapy or an immune checkpoint inhibitor.”
Interim results in patients with lung cancers also were presented. Dr. Ronald J. Scheff, Assistant Professor of Clinical Medicine at Weill Cornell Medical College, New York, reported on over 50 patients with metastatic NSCLC being enrolled, showing about one-fifth of evaluable patients had a partial response. Overall, 64% of patients had tumor shrinkage from baseline measurements when given IMMU-132. These patients had a median of three prior therapies. Importantly, patients with either nonsquamous or squamous pathology responded, as well as patients who failed a prior immune checkpoint inhibitor treatment. The clinical benefit rate at four months or later was 43%. The median duration of response was eight months, but two patients remain under therapy and responsive for over 20 months. Median PFS and OS on an ITT basis were five and over nine months, respectively.
In patients with metastatic SCLC who had a median of two prior therapies, 16% experienced a confirmed partial response, with an additional nine patients showing tumor shrinkage >20%. Overall, 60% of patients showed tumor shrinkage from baseline. The clinical benefit rate at 4 months or later was 40%. The median duration of partial responses and stable disease was about five months (two patients extending out to 21 months), while the median PFS and OS on an ITT basis were almost four months and seven months, respectively.
“These results in advanced metastatic NSCLC and SCLC patients are very impressive. Durable responses were seen even in patients refractory to multiple prior therapeutic regimens, including immune checkpoint inhibitors,” Dr. Scheff said. “NSCLC is the most common cause of cancer death in the Western World, with very poor 5-year survival statistics. The demonstration of a median survival of over 9 months after patients had already progressed after a range of one to seven prior therapies represents a significant advance.”
Dr. Scheff added, “Although advanced metastatic SCLC commonly responds favorably to first-line chemotherapy, the disease typically subsequently recurs and is associated with a poor prognosis. An agent such as IMMU-132 that can control disease in some patients for up to almost two years is most encouraging.”
Ms. Sullivan concluded, “These updated data on our lead indications continue to be impressive, particularly because the results from the additional patients enrolled in these trials did not adversely affect the efficacy and safety outcomes. As a monotherapy in late-stage patients with these solid tumor types, it is very rewarding to have developed a product candidate that could make a positive impact and fill the high unmet medical need of such patients. Our trials continue to evaluate IMMU-132 in other cancer types, such as other metastatic breast cancers, as well as metastatic endometrial and prostate cancers. The positive results we have achieved thus far are a testament to the strength of our clinical investigators and our talented team, and we remain confident in the near-and long-term potential of IMMU-132, which could drive significant value for our stockholders.”
In his concluding remarks, Dr. Goldenberg said that the Company’s scientists are conducting studies to enhance the good clinical results with IMMU-132 even further, such as overcoming drug resistance and devising more effective drug combinations. In addition, he emphasized that clinical trials are now expanding in patients with other forms of metastatic breast cancer, as well as metastatic endometrial and prostate cancers, since they have high expression of Trop-2.
Value Realization Process for IMMU-132
In addition to the new clinical data, Immunomedics announced a series of updates related to other aspects of the IMMU-132 program.
Commercial
Immunomedics unveiled a summary of the commercial assessment conducted by Health Advances LLC, an independent third-party consulting firm focused exclusively on the healthcare industry, retained to conduct a full commercial assessment of the U.S. and European market opportunities for IMMU-132. The Health Advances study determined that if the current IMMU-132 clinical data are supported by confirmatory/pivotal studies, the U.S. and European market opportunity for IMMU-132 as a third-line monotherapy in TNBC, UC, NSCLC, and SCLC could exceed $3 billion by 2025. Combination and early-line approaches may increase the opportunity to over $7 billion. “IMMU-132’s initial clinical data are very exciting to top oncology key opinion leaders, who see it as a compelling agent with significant potential to address major unmet needs,” said Andrew Funderburk, Partner, Health Advances.
Regulatory
Regulatory developments for the IMMU-132 program in TNBC also were presented. The development timeline includes commencement of the Phase 3 confirmatory trial having a Special Protocol Assessment (SPA) in with FDA, in the next few months. Immunomedics plans to file the results with the 100-patient study required by FDA in the accelerated approval application in mid-2017.
Chemistry, Manufacturing, and Controls (CMC)
The Company has added significant value to the IMMU-132 program in preparation of the BLA filing for accelerated approval in TNBC, including the scaled-up manufacturing of the ADC for Phase 3/commercial launch materials, extensive comparability testing of Phase 2 vs. Phase 3/commercial product, stability assessments of Phase 3/commercial lots, and full characterization and other analyses required in the CMC portion of the BLA. Additionally, an independent audit of commercial manufacturing facilities, processes, and other relevant CMC matters is underway, all in preparation for the timely BLA filing.
Intellectual Property
IMMU-132 has an exceptionally strong patent portfolio. Including the proprietary linker and the use of this ADC in patient therapy, IMMU-132 has been patented in the United States and abroad. IMMU-132, as a biotechnology product, could gain regulatory exclusivity in the United States for 12 years and for 10 years in Europe. Currently, 32 patents on IMMU-132 have been issued in the United States alone, with a patent life extending to 2033; 16 foreign patents also exist.
Vinson & Elkins L.L.P. and DLA Piper LLP (US) are serving as legal advisors, and Greenhill & Co., LLC, is serving as financial advisor to Immunomedics.
About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of eight clinical-stage product candidates. Immunomedics’ portfolio of investigational products includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 306 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release.
Important Additional Information
Immunomedics, Inc. (the “Company”), its directors and certain of its executive officers are deemed to be participants in the solicitation of proxies from Company stockholders in connection with the matters to be considered at the Company’s 2016 Annual Meeting. The Company has filed a definitive proxy statement and form of WHITE proxy card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with any such solicitation of proxies from Company stockholders. COMPANY STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE ACCOMPANYING WHITE PROXY CARD AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY FILES WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Information regarding the identity of the participants, and their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement and other materials filed by the Company with the SEC. Stockholders will be able to obtain the proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at www.immunomedics.com, by writing to Immunomedics, Inc. at 300 The American Road, Morris Plains, New Jersey 07950, by calling the Company’s proxy solicitor, MacKenzie Partners, Inc. at (212) 929-5500, or by calling Dr. Chau Cheng, Senior Director, Investor Relations & Corporate Secretary, (973) 605-8200, extension 123.
Forward-Looking Statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Corporate Secretary (973) 605-8200, extension 123 ccheng@immunomedics.com Media Dan Katcher / Ed Trissel / Nick Lamplough Joele Frank, Wilkinson Brimmer Katcher (212) 355-4449 Investors Dan Burch/Bob Marese MacKenzie Partners, Inc. (212) 929-5500
$UNXL #MOU w/ #GIS, $3M Preferred #EquityFinancing
General Interface Solutions, a subsidiary of Foxconn, and UniPixel execute MOU to enter into a strategic partnership
SANTA CLARA, Calif., Jan. 18, 2017 — UniPixel, Inc. (NASDAQ: UNXL), a provider of Performance Engineered Films™ to the touchscreen and flexible electronics markets, today announced a Memorandum of Understanding (“MOU”) to enter into a strategic partnership with General Interface Solution, Limited (“GIS”), a Taiwan-based, subsidiary of Foxconn, and a billion-dollar provider of integrated touch display solutions in the mobile phone, Notebook PC, 2-in-1 laptop and tablet markets to global customers including major PC and smart phone brands.
Under the memorandum the parties will form a strategic manufacturing project that will initially extend over three years and which may be renewed by mutual agreement. A definitive agreement is expected to be executed in the coming weeks. The parties also contemplate entering into a separate development project for foldable/flexible displays.
Jeff Hawthorne, president and chief executive officer of UniPixel, commented, “We are very pleased to enter into this MOU with GIS. They are a highly respected, leading-edge provider of integrated touch display solutions. UniPixel will benefit from the manufacturing expertise and scale of GIS to address the volume production requirements of our multiple design wins. An additional benefit is a potential path to Asia-based manufacturing in parallel with our Colorado Springs production. Both companies will also explore advanced development opportunities to utilize UniPixel’s unique metal mesh technology to co-develop integrated touch displays for bendable and foldable applications in the coming years.”
UniPixel today filed Form 8-K with the Securities and Exchange Commission regarding this Memorandum of Understanding.
also…
UniPixel Announced Preferred Equity Financing for $3 Million
Preferred Shares Priced at $1.50
SANTA CLARA, Calif., Jan. 18, 2017 — UniPixel, Inc. (NASDAQ: UNXL), a provider of Performance Engineered Films™ to the touchscreen and flexible electronics markets, today announced that it has entered into a financing agreement for $3 million of convertible, redeemable Preferred shares. The fixed conversion price of the Preferred shares is set at $1.50, subject to potential adjustments which primarily do not arise until after 90 days. The financing agreement also includes 2,500,000 warrants priced at $1.50 which will have a single price-only reset feature after six months which will reset the warrant price to 93% of the lowest conversion price during the six-month period but will only reset if the price is below $1.50. All of the Preferred shares must be fully converted or redeemed within twelve months from closing. UniPixel has the right to convert any portion of the Preferred shares to the investor by the issuance of common stock so long as the company’s stock price is at least $1.50, or, at any time, to redeem in cash equal to 125% of the financing. After the first 90 days, the investor will be permitted to convert the Preferred shares into shares of common stock at the investor’s choice, at a price equal to 93% of the common share value on the day preceding any conversion.
This press release shall 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 jurisdiction in which the offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
The Benchmark Company acted as the sole placement agent for the transaction.
The offering of the common stock and warrants will be made under UniPixel’s effective shelf registration statement (File No. 333-203691) declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 10, 2015. UniPixel will file a prospectus supplement with the SEC for the offering to which this communication relates. When available, the prospectus supplement and accompanying base prospectus, meeting the requirements of Section 10 of the Securities Act of 1933, as amended, may be obtained from The Benchmark Company at 150 East 58th Street, 17th Floor, New York, NY 10155 or by calling (212) 312-6700 or e-mail at bcarlsson@benchmarkcompany.com, or by visiting the EDGAR database on the SEC’s website located at http://www.sec.gov.
About UniPixel
UniPixel, Inc. (NASDAQ: UNXL) develops and markets Performance Engineered Films for the touchscreen and flexible electronics markets. The Company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For further information, visit www.unipixel.com.
Forward-looking Statements
All statements in this news release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including the statement regarding the completion of the offering and conversion or redemption of the Preferred shares. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology. These statements are based on management’s current expectations. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. These risks, uncertainties, and other factors include, but are not limited to, the satisfaction of the conditions of the closing of the offering, market conditions and other risks related to UniPixel’s business and operations as are discussed under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to UniPixel as of the date hereof, and UniPixel assumes no obligation to update any forward-looking statement.
Trademarks in this release are the property of their respective owners.
Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com
$LIFE #FDA #FastTrack for #Resolaris in Limb Girdle #MuscularDystrophy
– First Reported Fast Track Designation for LGMD2B Treatment –
SAN DIEGO, Jan. 18, 2017 — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris™ was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), making it the first known therapeutic candidate for the treatment of LGMD2B to receive the designation. In addition, the FDA removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials.
“This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical needs, represents another step forward for our first product candidate based on the Physiocrine pathway,” said John Mendlein, PhD, CEO of aTyr Pharma. “Combined with our Phase1b/2 data in LGMD2B, adult facioscapulohumeral muscular dystrophy (FSHD) and early onset FSHD patients, we believe we are building a clinical and regulatory foundation for future development of Resolaris to treat patients across multiple rare genetic myopathies with an immune component.”
aTyr previously announced results from a completed Phase 1b/2 open-label, intra-patient dose escalation trial testing doses of Resolaris up to 3.0 mg/kg biweekly in patients with LGMD2B. Based on the clinical trials completed to date, Resolaris has demonstrated a favorable safety profile without signs of immuno-suppression of circulating immune cells. 78% of the LGMD2B patients in the trial (7 of 9) recorded increases in their muscle function at 14 weeks as measured by manual muscle test (MMT), a validated assessment tool. Overall, the LGMD2B patients had a mean increase of MMT scores from baseline of 6.2%.
“We appreciate the FDA’s responsiveness to our request to remove the partial clinical hold that provides dosing flexibility based on our data for Resolaris,” commented Sanjay Shukla, MD, MS, Chief Medical Officer of aTyr Pharma. “We also believe that during our safety and dose ranging Phase 1b/2 clinical trials we have potentially identified a dose for the next phase of clinical development with a favorable safety profile and potential clinical activity across different rare muscle indications.”
About Resolaris™
aTyr Pharma is developing Resolaris as a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr believes Resolaris has the potential to provide therapeutic benefit to patients with rare myopathies with an immune component characterized by excessive immune cell involvement.
About LGMD2B
Limb girdle muscular dystrophy (LGMD) refers to a group of rare genetic myopathies, of which there are more than 20 different subtypes, none with approved therapies. LGMD affects an estimated 16,000 patients in the U.S., approximately 3,000 of whom have LGMD2B. LGMD2B is a recessive genetic disease caused by a toxic loss of function in the dysferlin gene. Patients experience progressive debilitating muscle weakness and atrophy as well as immune cell invasion in the skeletal muscle. To learn more about LGMD2B please visit www.jain-foundation.org.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. The Company’s lead candidate, Resolaris™, is a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 80 issued or allowed patents and over 230 pending patent applications that are owned or exclusively licensed by aTyr, including over 300 potential Physiocrine-based protein compositions. aTyr’s key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options. For more information, please visit http://www.atyrpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential of Resolaris, the ability of the Company to undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals, and the timing of initiation of additional clinical trials and of reporting results from our clinical trials reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our Physiocrine-based product candidates, as well as those set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2015 and in our subsequent SEC filings including our most recent Quarterly Report for the quarter ended September 30, 2016. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
| Contact: | |
| Mark Johnson | |
| Sr. Director, Investor Relations | |
| mjohnson@atyrpharma.com | |
| 858-223-1163 |
$CLCD to be #Acquired by $LLY Bolstering #PainManagement, #Migraine Portfolio
$960 million deal will enhance Lilly’s existing pain management portfolio for migraine; adds potential near-term launch to its late-stage pipeline
INDIANAPOLIS and CAMBRIDGE, Mass., Jan. 18, 2017 — Eli Lilly and Company (NYSE: LLY) and CoLucid Pharmaceuticals, Inc. (NASD: CLCD) today announced an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million. This all-cash transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.
CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.
More than 36 million people suffer from migraine in the United States alone. Lasmiditan, if approved, would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.
Lasmiditan is an important addition to Lilly’s emerging pain management pipeline, which includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache. In addition, tanezumab is being studied, in collaboration with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.
“Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine,” said David A. Ricks, Lilly’s president and chief executive officer. “This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine.”
Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. Over the past 12 years, CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan as evident by the first positive Phase 3 trial. At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly. Lilly has since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.
“We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization,” said Thomas P. Mathers, CoLucid’s chief executive officer. “We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients.”
Under the terms of the agreement, Lilly will acquire all shares of CoLucid Pharmaceuticals for a purchase price of $46.50 per share or approximately $960 million. The transaction is expected to close by the end of the first quarter of 2017, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
While the financial charge will not be finalized until after completion of the acquisition, Lilly is expecting to recognize a financial charge of approximately $850 million (no tax benefit), or approximately $0.80 per share, as an acquired in-process research and development charge to earnings in the first quarter of 2017. The company’s reported earnings per share guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company’s non-GAAP earnings per share guidance as a result of this transaction.
Goldman, Sachs & Co. is acting as the exclusive financial advisor, and Weil, Gotshal & Manges LLP is acting as legal advisor to Lilly in this transaction. MTS Health Partners is acting as the exclusive financial advisor, and Faegre Baker Daniels LLP is acting as legal advisor to CoLucid.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.
About CoLucid Pharmaceuticals, Inc.
CoLucid was founded in 2005 and is developing lasmiditan oral tablets for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of Lilly’s acquisition of CoLucid Pharmaceuticals. It reflects Lilly‘s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in implementing the transaction and in drug development. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the transaction, that the molecules will be approved on the anticipated timeline or at all, or that the potential products will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly‘s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Additional Information about the Acquisition and Where to Find It
The tender offer for the outstanding shares of CoLucid Pharmaceuticals, Inc. (“CoLucid”) referenced in this communication has not yet commenced. This announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of CoLucid, nor is it a substitute for the tender offer materials that Lilly and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (the “SEC”) upon commencement of the tender offer. At the time the tender offer is commenced, Lilly and its acquisition subsidiary will file tender offer materials on Schedule TO, and CoLucid will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important information. Holders of shares of CoLucid are urged to read these documents when they become available because they will contain important information that holders of CoLucid securities should consider before making any decision regarding tendering their securities. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of CoLucid at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Lilly and CoLucid file annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Lilly or CoLucid at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Lilly’s and CoLucid’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.
C-LLY
| Refer to: | Lauren Zierke; lauren_zierke@lilly.com; (317) 277-6524 (Media) |
| Phil Johnson; johnson_philip_l@lilly.com; (317) 655-6874 (Investors) |
$APRI Announces #Mexico Approval of #Vitaros for #ErectileDysfunction #ED
Ferring Plans to Launch in Mexico and Argentina During the Second Quarter 2017
SAN DIEGO, Jan. 18, 2017 — Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Mexico has granted Apricus’ commercialization partner, Ferring Pharmaceuticals, market approval for Vitaros®, an on-demand topical cream indicated for the treatment of patients with erectile dysfunction.
This is the twenty-sixth country in which the product has been approved, including Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
“We are very pleased that Ferring has received its second approval for Vitaros in Latin America,” said Richard Pascoe, Chief Executive Officer of Apricus. “Moreover, we look forward to Ferring’s launches of Vitaros in Latin America throughout the year, in addition to the portfolio of countries across the EU they have the rights to as well. Again, congratulations to the Ferring team for their continued commitment to building the Vitaros global brand.”
Last year, the Company expanded its exclusive Vitaros distribution agreement with Ferring in Latin America to include Germany, Austria, Belgium, Denmark, Finland, Iceland, Luxembourg, Norway, the Netherlands, Sweden, Switzerland and certain countries in Asia (previously Sandoz’s territories), the United Kingdom (previously Takeda’s territory) and Korea. Under the terms of the agreement, Apricus has received a total of $4.5 million in upfront payments from Ferring, in addition to a regulatory milestone payment of $1.6 million. Apricus is eligible to receive up to an additional $28 million in regulatory, launch and sales milestones, plus royalties on future net sales.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ commercial product, Vitaros®*, for the treatment of erectile dysfunction, is approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in certain countries in Europe and the Middle East. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Recordati Ireland Ltd. (Recordati), Ferring International Center S.A. (Ferring Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has one active product candidate, RayVa(TM), its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon.
For further information on Apricus, visit http://www.apricusbio.com.
*Vitaros® is a registered trademark of NexMed International Limited. Such trademark is registered in certain countries throughout the world and pending registration in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to potential Vitaros approvals and product launches by Apricus’ commercial partners in additional countries and the timing thereof; and the potential for Apricus to receive future milestone and royalty revenue. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus’ control, including, but not limited to: Apricus’ ability to have its product Vitaros be approved by relevant regulatory authorities in additional countries; Apricus’ dependence on its commercial partners to carry out the commercial launch of Vitaros in Mexico and other territories and the potential for delays in the timing of commercial launch; Apricus’ ability to obtain and maintain intellectual property protection for the product; Apricus’ ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; competition in the ED market and other markets in which Apricus and its partners operate; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus’ most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC’s website at www.sec.gov or without charge from Apricus.
CONTACT:
Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933
$DXTR #CABG MicroCutter 5/80 Enabled Procedure at @STS_CTsurgery #STS2017 @GRBCC
— Less Invasive Uniportal Lobectomy Highlighted —
Dextera Surgical Inc. (Nasdaq: DXTR), manufacturer of the smallest-profile and most maneuverable articulating surgical stapling platform on the market for minimally invasive surgery, today announced that the company’s MicroCutter 5/80 will be featured in a presentation highlighting Uniportal Lobectomy performed through a single incision in the subxiphoid or subcostal space, at The Society of Thoracic Surgeons and American Association for Thoracic Surgery’s Tech Conference (TechCon) in Houston, Texas.
This less invasive approach to the lobectomy procedure using Dextera Surgical’s MicroCutter 5/80 surgical stapling technology will be presented by Joel Dunning, M.D., cardiothoracic surgeon at James Cook University Hospital, Department of Cardiothoracic Surgery in Middlesbrough, U.K. Dr. Dunning’s presentation, entitled “Subxiphoid and Subcostal Uniportal Lobectomy” will take place Saturday, January 21 at 11:37 a.m. CST, in the General Thoracic Track II: Advanced Thoracic Surgery, room 310ABC.
MicroCutter Indication Information
The MicroCutter 5/80 Stapler is manufactured and cleared for use in the United States for transection and resection in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures, as well as application for transection, resection and/or creation of anastomoses in the small and large intestine, and the transection of the appendix. The MicroCutter 5/80 may be used with both MicroCutter 30 White Reloads in vascular/thin tissue and MicroCutter 30 Blue Reloads for medium tissue.
About Dextera Surgical
Dextera Surgical (Nasdaq:DXTR) designs and manufactures proprietary stapling devices for minimally invasive surgical procedures. In the U.S., surgical staplers are routinely used in more than one million minimally invasive laparoscopic, video-assisted or robotic-assisted surgical procedures annually.
Dextera Surgical also markets the only automated anastomosis devices for coronary artery bypass graft (CABG) surgery on the market today: the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System. These products, sold by Dextera Surgical under the Cardica brand name, have demonstrated long-term reliable clinical performance for more than a decade.
Dextera Surgical Inc.
Investors:
Bob Newell, 650-331-7133
Vice President, Finance and Chief Financial Officer
investors@dexterasurgical.com
or
Media:
Jessica Volchok, 310-849-7985
jessica@nicoleosmer.com
$TRCH to Participate at the #NobleFinancial 13th Annual Investor Conference #NobleCON13
PLANO, TX–(January 17, 2017) – Torchlight Energy Resources, Inc. (NASDAQ: TRCH) (“Torchlight” or “the Company”), today announced that management will present at the NobleCON13 Annual Small Cap & Emerging Growth Investor Conference on January 31, 2017.
NobleCON13 Annual Small Cap & Emerging Growth Investor Conference
Date: January 31, 2017
Presentation Time: 1:00 p.m. ET
Location: Boca Raton Resort & Club (501 E Camino Real)
Boca Raton, FL
Webcast: http://noble.mediasite.com/mediasite/Play/a2a94ecd48ca4a058ec909a5731fdb5c1d
Conference participation is by invitation only and registration is mandatory. For more information on the conferences or to schedule a one-on-one meeting, please contact the respective conference coordinators.
Please view Torchlight’s website, www.torchlightenergy.com for additional information and available webcast of presentations.
About NobleCon13
NobleCON13 annual small cap and emerging growth investor conference is an initiative of NOBLE Capital Markets and dedicated to providing a forum where private and publicly traded emerging growth companies with less than $2 billion in market capitalization can network with the investment community, fund managers and high net worth investors who focus on small cap equities. The 2017 Conference will be held over two days and will include feature presentations by CEOs and CFOs from several principal industry sectors, expert panels moderated by industry leaders, and the opportunity for investors to meet and network with management of presenting companies on a one-on-one basis. Additionally, NobleCon13 will provide ample networking opportunities through social mixers and special events.
About Torchlight Energy
Torchlight Energy Resources, Inc. (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.
Contact:
Derek Gradwell
MZ Group
SVP Natural Resources
Phone: 512-270-6990
Email: dgradwell@mzgroup.us
Web: www.mzgroup.us
$BNTC Receives #OrphanDrug Designation for #ddRNA Therapeutic #BB301 in #OPMD
SYDNEY, Jan. 17, 2017 — Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is pleased to announce that the European Commission, based on a favourable recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted Orphan Drug Designation to BB-301 as an orphan medicinal product for the treatment of patients with oculopharyngeal muscular dystrophy (OPMD).
Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralised authorisation procedure.
OPMD is a rare inherited myopathy characterised by dysphagia (difficulty in swallowing), the loss of muscle strength, and weakness in multiple parts of the body. Patients typically suffer from severe dysphagia, ptosis (eye lid drooping), tongue atrophy, proximal lower limb weakness, dysphonia (altered and weak voice), limitation in looking upward, as well as facial muscle and proximal upper limb weakness. Progressing throughout that patient’s life, OPMD is not typically diagnosed until the individuals reach their 50’s or 60’s. As the dysphagia becomes more severe, patients become malnourished, lose significant weight, become dehydrated and suffer from repeated incidents of aspiration pneumonia. The latter two ailments often result in death.
Currently, therapeutic strategies employ repetitive surgical interventions that have limited efficacy.
“We are very excited that BB-301 has received Orphan Drug Designation in Europe from the EMA COMP. This is a key program in our pipeline and we are happy to see the EMA recognising the urgent and unmet medical need for a safe and effective treatment for OPMD patients. We believe that our innovative approach may offer new treatment options for patients who might not otherwise be able to receive benefit in treating their disease. Having European Orphan Drug Designation will allow us to optimise steps to further advance BB-301 towards regulatory approval,” said David Suhy, Chief Scientific Officer.
BB-301 is a ddRNAi therapeutic for the treatment of OPMD comprised of a single expression construct for the ‘knockdown and replace strategy’ of mutant PABPN1, the principle cellular component that leads to the diseased condition in humans. BB-301 is currently in preclinical development and Benitec plans to initiate IND-enabling studies later this year. Entry into the clinic with a Phase I/II study in OPMD patients is anticipated in 2018, subject to toxicity results and future regulatory review.
For further information regarding Benitec and its activities, please contact the persons below, or visit the Benitec website at www.benitec.com
| Australia Investor Relations | United States Investor Relations |
| Market EyeOrla Keegan
Director Tel: +61 (2) 8097 1201 Email: orla.keegan@marketeye.com.au |
M Group Strategic CommunicationsJay Morakis
Managing Director Tel: +1 212.266.0190 Email: jmorakis@MGroupSC.com |
About Benitec Biopharma Limited:
Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is a biotechnology company developing innovative therapeutics based on its patented gene-silencing technology called ddRNAi or ‘expressed RNAi’. Based in Sydney, Australia with laboratories in Hayward, California (USA), and collaborators and licensees around the world, the company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including hepatitis B, wet age-related macular degeneration and OPMD. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington’s Disease, chronic neuropathic pain, cancer immunotherapy and retinitis pigmentosa.
Safe Harbor Statement:
This press release contains “forward-looking statements” within the meaning of section 27A of the US Securities Act of 1933 and section 21E of the US Securities Exchange Act of 1934. Any forward-looking statements that may be in the press release are subject to risks and uncertainties relating to the difficulties in Benitec’s plans to develop and commercialise its product candidates, the timing of the initiation and completion of preclinical and clinical trials, the timing of patient enrolment and dosing in clinical trials, the timing of expected regulatory filings, the clinical utility and potential attributes and benefits of ddRNAi and Benitec’s product candidates, potential future out-licenses and collaborations, the intellectual property position and the ability to procure additional sources of financing. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
$CIDM #DoveChannel Available Now on $AAPL #AppleTV
Cinedigm Corp’s (NASDAQ: CIDM) Dove Channel today announced the service is now available on Apple TV to kick off the New Year. Dove Channel app is optimized for tvOS, with a new fresh design featuring an improved user interface. Additionally, the app update allows subscribers to synch their account and stream movies across connected devices including iPhone, iPad and other platforms.
Dove Channel serves the faith and family audience, offering a wide variety of content from meaningful mainstream movies, independent films, and documentaries, to heartwarming TV series and children’s programs. The specialized streaming service offers families a safe entertainment choice utilizing The Dove Foundation™ rating system, which ranks programs in six key areas: sexuality, language, violence, drug and alcohol use, nudity, and other, to ensure appropriate programming for families.
Dove Channel’s subscription-based offering is $4.99 per month, and viewers can subscribe within the app on Apple TV. The Dove Channel app can be found and downloaded on the App Store for Apple TV, which lives on the home screen of the new Apple TV.
All Dove Channel content is sortable and searchable, and homeschoolers will soon be able to easily create customized, password-protected “shelves” where exclusive videos and curriculum can be stored for a personalized homeschool network. Dove Channel currently offers over 300 homeschooling titles, and shelving curriculum categories include Bible studies, science, literature, and history — all organized by age, offering engaging video content in accordance with the Dove Faith & Family Seal of Approval. The proprietary rating system and family filter tool also allows parents to customize viewing preferences for their families.
For more information on Dove Channel, please visit www.dovechannel.com.
ABOUT DOVE CHANNEL:
Dove Channel was developed in response to caring consumers who want to make informed choices when selecting entertainment. New streaming technologies make it challenging to locate films that do not offend your sensitivities or violate your values. Dove Channel provides a safe walled garden with hundreds of movies and TV series that reflect the time-honored standards of The Dove Foundation™, known for its trusted Faith & Family Dove Seals of Approval. As a member, consumers take advantage of our unique Customization Tool which gives you complete control by selecting the type of entertainment that exactly fits your tastes and personal preferences. www.DoveChannel.com
ABOUT CINEDIGM:
Cinedigm is a leading independent content distributor in the United States, with direct relationships with thousands of digital platforms and retail storefronts, including iTunes, Netflix, Amazon, Wal-Mart and Target, as well as the national Video on Demand platform on cable television. Cinedigm has a distribution library of over 60,000 film and TV episodes.
Additionally, given Cinedigm’s infrastructure, technology, content and distribution expertise, the Company has rapidly become a leader in the quickly evolving over-the-top digital network business. Cinedigm’s first channel, DOCURAMA, launched in May 2014, and is currently available on iOS, Roku, Xbox and Samsung, with additional platforms currently being rolled out. Cinedigm launched CONtv, a Comic Con branded channel, on March 3, 2015. The Company’s third OTT channel, DOVE CHANNEL, launched on September 15, 2015 and is a digital streaming subscription service targeted to families and kids seeking high quality and family friendly content approved by Dove Foundation. Combined, the three streaming channels currently provide more than 5,500 hours of content to viewers across more than 3.2 million app downloads.
Cinedigm™ and Cinedigm Digital Cinema Corp™ are trademarks of Cinedigm Corp. www.cinedigm.com. [CIDM-G]
Cinedigm
Jill Newhouse Calcaterra
310-466-5135
jcalcaterra@cinedigm.com
$PULM #PUR1900 Receives #QIDP Designation from #FDA
The FDA designation adds five years of market exclusivity for Pulmatrix’ inhaled product for treating fungal infections in the lungs of CF patients
LEXINGTON, Mass., Jan. 17, 2017 — Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food & Drug Administration.
Under the QIDP program, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix will receive five years of additional market exclusivity for PUR1900.
In its letter to Pulmatrix, the FDA wrote: “We have reviewed your request and conclude that it meets the criteria for QIDP. Therefore we are designating your Itraconazole Inhalation Powder (PUR1900) product for inhalation use as a QIDP for….treatment of pulmonary Aspergillus infections in patients with cystic fibrosis.”
“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis (CF) patients suffering from fungal lung infections,” said Pulmatrix CEO Robert Clarke, PhD. “It will give us the benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity.”
Currently, many CF patients experience allergic reactions when their lungs become infected with a fungus called Aspergillus. Doctors now try to treat those infections with oral drugs such as itraconazole. Oral antifungals require very high doses to get enough of the drug to the lungs through the bloodstream to fight the fungus, causing severe side effects, and oral antifungals are not always effective.
Pulmatrix’s goal is to solve this problem by combining itraconazole with its innovative dry powder iSPERSE™ technology. The combination of iSPERSE™ and itraconazole makes it possible for patients to inhale the drug into their lungs, to the site of infection, where it’s needed.
“By delivering the drug directly to the lungs, we should be able to fight the infection far more effectively than the oral drug can, with far fewer side effects,” explained Pulmatrix’s Chief Scientific Officer, David L. Hava, PhD. “That should bring great benefits to patients.”
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for lung diseases, including opportunities in major pulmonary diseases through collaborations, like PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients with rare disease like cystic fibrosis. Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact
Robert Clarke, CEO
(781) 357-2333
rclarke@pulmatrix.com
William Duke, CFO
(781) 357-2333
wduke@pulmatrix.com
$SHLO Hosts #ConferenceCall to Present #Q4 & #FY16 Financials
VALLEY CITY, Ohio, Jan. 13, 2017 — Shiloh Industries, Inc. (NASDAQ:SHLO), a leading global supplier providing lightweighting, noise and vibration solutions to the automotive, commercial vehicle and other industrial markets, today announced that the Company will release its fourth-quarter and full-year fiscal 2016 results on Tuesday, January 17, 2017 after the market closes. The Company will host a conference call the same day at 5:00 p.m. (ET).
The conference call can be accessed by dialing 1-877-407-0784, or for international callers, 1-201-689-8560. Please dial-in approximately five minutes in advance and request the Shiloh Industries fourth-quarter conference call. A replay will be available after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the replay is 13652133. The replay will be available until January 31, 2017.
Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of the Company’s website at www.shiloh.com. The on-line replay will be available for a limited time shortly after the call.
About Shiloh Industries, Inc.
Shiloh Industries, Inc. is a leading global supplier of lightweighting, noise and vibration solutions to the automotive, commercial vehicle and industrial markets, capable of delivering solutions in aluminum, magnesium, steel and high-strength steel alloys to original equipment manufacturers and suppliers. The company offers the broadest portfolio of lightweighting solutions in the industry through their BlankLight®, CastLight™ and StampLight™ brands. Shiloh designs and manufactures components in body, chassis and powertrain systems with expertise in precision blanks, ShilohCore™ acoustic laminates, aluminum and steel laser welded blanks, complex stampings, modular assemblies, aluminum and magnesium die casting, as well as precision machined components. Shiloh has over 3,100 dedicated employees with operations, sales and technical centers throughout Asia, Europe and North America.
CONTACT: Thomas M. Dugan Vice President of Finance and Treasurer Shiloh Industries, Inc. +1 (330) 558-2600
$ENT #Acquires #SatelliteCommunication Payload
LOS ANGELES, Jan. 13, 2017 — Global Eagle Entertainment Inc. (GEE) (NASDAQ:ENT) has acquired Ku-band payload on an SES communication satellite in a move to boost capacity for its customers in North America, the Gulf of Mexico and the Caribbean. GEE will rebrand the satellite as Eagle-1.
“Eagle-1 is a key element in the strategic expansion of our global satellite network to optimize quality of experience (QoE) for our rapidly growing user base,” said Abel Avellan, president of GEE. “Our vision is to reach hundreds of millions of people on the move around the world with a reasonably priced high-speed Wi-Fi experience that is equivalent to what they get at their homes or offices. To that end, GEE is increasing satellite capacity and upgrading our robust ground infrastructure of owned teleports. We are also bringing to market a portfolio of exclusive solutions, such as our patented SpeedNet™ high-speed browsing technology. For users, that means the best value and experience for entertainment and internet services wherever they travel – in the air, at sea or on land.”
“Our strategic plan calls for us to own critical elements of our infrastructure, especially in areas where we have the greatest density of users. It enables us to deliver bandwidth where it is needed at the most competitive price,” said Dave Davis, chief executive officer of GEE. “This may involve selectively deploying additional Eagle-series payloads over locations where it makes good sense in the future.”
Eagle-1 will be integrated seamlessly into GEE’s global network as the company continues to innovate with its own infrastructure and patented technologies to take advantage of the most efficient, cost-competitive global mobility network that combines wideband, high-throughput and ultra-high-throughput satellite components in a frequency-agnostic way.
About Global Eagle Entertainment (GEE)
Global Eagle Entertainment Inc. (NASDAQ:ENT) is a leading provider of satellite-based connectivity and media to fast-growing, global mobility markets across air, land and sea. Supported by proprietary and best-in-class technologies, GEE offers a fully integrated suite of rich media content and seamless connectivity solutions that cover the globe. With approximately 1,500 employees and 50 offices on six continents, GEE delivers exceptional service and rapid support to a diverse base of customers around the world. Find out more at: www.geemedia.com.
Forward-Looking Statements
We make forward-looking statements in this press release within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts for future events, including, without limitation, our strategies and pricing with respect to global Wi-Fi deployment and future expansion of our satellite network and capacity, the potential benefits that may bring to our content and media products and our potential acquisition of additional satellite interests in the future. These statements may be preceded by, followed by or include the words “may,” “might,” “will,” “will likely result,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or similar expressions. As a result of a number of risks and uncertainties, our forward-looking statements may turn out to be wrong, and our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. A discussion of risks and uncertainties related to GEE’s business in the section entitled “Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K and our subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and GEE undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contacts: Kevin Trosian Senior Vice President, Corporate Development and Investor Relations +1 310-740-8624 investor.relations@geemedia.com (Investor queries) Jim Rhodes Rhodes Communications, Inc. +1 757-451-0602 jrhodes@rhodescomm.com (Press queries)
$NAKD and #BendonLimited Announce #LOI to #Merge
Transformative Merger Expected to Create a Powerful Portfolio of Innerwear, Sleepwear & Swimwear Brands
Naked Brand Group Inc. (NASDAQ:NAKD) (“Naked” or the “Company”), an innovative innerwear fashion and lifestyle brand, and Bendon Limited (“Bendon”), a global leader in intimate apparel and swimwear renowned for best in category technology and design throughout its 70 year history, announced today that they have entered into a Letter of Intent (the “LOI”) for a proposed merger of the companies (the “Merger”). Expected benefits of this proposed merger include:
- Bendon would gain immediate access to the U.S. capital markets enabling it to further grow the business globally, both organically and through future strategic acquisitions;
- The Naked brand would be able to leverage Bendon’s well-established global wholesale and retail distribution channels;
- The combined entity would capitalize on the industry-leading expertise of Carole Hochman, Naked’s Chief Executive Officer, to strengthen its global intimate apparel and sleepwear brand portfolio; and
- Operating synergies through integrated supply chain management and administrative functions.
Bendon’s brands include Heidi Klum Intimates and Swimwear, Stella McCartney Lingerie and Swimwear, Bendon, Bendon Man, Davenport, Evollove, Fayreform, Hickory, Lovable (in Australia and New Zealand) and Pleasure State. Bendon’s brands are distributed globally through over 4,000 doors across 34 countries, as well as through a growing network of 60 company-owned Bendon retail and outlet stores in Australia, New Zealand and Ireland. Bendon is headquartered in Auckland, and maintains additional offices in Sydney, New York, London and Hong Kong. For the fiscal year ended 2016, Bendon generated approximately NZ $144 million (US $100 million) in net sales.
Ms. Hochman stated, “We are extremely excited about the potential of this proposed merger, and look forward to capitalizing on Bendon’s scale and expertise to further expand the Naked brands. The Bendon team has built a phenomenal business, and by leveraging their infrastructure, product and geographic knowledge, and talent, we believe that we can accelerate our growth in the innerwear fashion and lifestyle market.”
Justin Davis-Rice, Executive Chairman of Bendon, commented, “This is a transformative merger that will create a powerful creative, marketing, operational and capital markets platform. As a publicly traded company in the U.S., we expect to have an opportunity to accelerate our growth and strengthen our position as a global leader in intimate apparel, swimwear, innerwear fashion and lifestyle brands through both organic growth and strategic acquisitions. We are also delighted to partner with industry pioneer, Carole Hochman, who brings unrivalled experience to our company and whose expertise is expected to not only strengthen our existing brands but to provide us with an unprecedented opportunity to develop our sleepwear business, a product category that represents a significant growth opportunity.”
Eric Watson, Executive Chairman of Cullen Investments, Bendon’s majority shareholder, added, “This is an incredible opportunity for Bendon to strengthen its leadership in the industry and drive the continued growth of the business as a consolidator of globally recognized brands.”
Carole Hochman, who will become Chief Creative Officer of the merged company, is considered one of the single most influential women in the intimate apparel and sleepwear business in the United States with experience that extends more than 30 years. She was the driving force behind the Carole Hochman Design Group, for which she served as Chief Creative Officer until her departure in 2013 and for which she was previously CEO until its acquisition by Komar in 2010. Under Carole’s leadership, Carole Hochman Design Group manufactured the Carole Hochman brand of sleepwear, loungewear and daywear, in addition to numerous other sleepwear collections including Christian Dior, Oscar de la Renta, Ralph Lauren, Jockey, Donna Karan, Tommy Bahama and Betsey Johnson.
As stated in the LOI, Mr. Davis-Rice will join Naked’s board of directors, effective immediately. Concurrent with the completion of the proposed Merger, Ms. Hochman would retain a seat on the board of the combined company.
Terms of Letter of Intent
The LOI with Bendon provides that the Company would issue the holders of ordinary shares of Bendon an aggregate of 118,812,163 shares of common stock of the Company, subject to adjustment, representing approximately 93.6% of the combined company. Completion of the Merger is subject to the negotiation of a definitive merger agreement (the “Merger Agreement”), satisfaction of the conditions negotiated therein and approval of the Merger by the Company’s stockholders. Accordingly, there can be no assurance that a Merger Agreement will be entered into or that the proposed Merger will be consummated. Further, readers are cautioned that those portions of the LOI that describe the proposed Merger, including the consideration to be issued therein, are non-binding.
Pursuant to the terms of the LOI, the Company’s management as well as certain insiders will agree to sign voting agreements pursuant to which each such person will grant a proxy and/or agree to vote for the Merger at any meeting of stockholders. In addition, key employees of Bendon will be offered employment with the Company, to be effective upon completion of the Merger. Upon completion of the Merger, the Board of the Company would be comprised of Ms. Hochman, Mr. Davis-Rice and several additional members to be identified and nominated by Bendon.
Pursuant to the terms of the LOI, the Company has agreed to adhere to a no-shop provision until the earlier of the date the Merger Agreement is executed or the LOI is terminated. If the Merger Agreement is not executed by February 10, 2017, or the Merger is not consummated within six months thereafter (each a “Merger Milestone”), the Company will be required to issue to Bendon 2.5 million shares of common stock; provided, however, that the Company shall not be required to issue Bendon such shares if Bendon’s action(s) or lack thereof has been the principal cause of or resulted in the failure of the parties to achieve a Merger Milestone.
Assuming Naked and Bendon enter into the Merger Agreement, the parties will look to seek shareholder approval from Naked’s shareholders in the first quarter of 2017, subject to SEC review of the proxy statement to be filed by the parties for the proposed transaction.
About Naked:
Naked was founded on one basic desire – to create a new standard for how products worn close to the skin fit, feel, and function. Naked’s women’s and men’s collections are available at www.wearnaked.com, and Naked has a growing retail footprint for its innovative and luxurious innerwear products in some of the leading online and department stores in North America including Nordstrom, Bloomingdale’s, Dillard’s, Soma, Saks Fifth Avenue, Amazon.com, BareNecessities.com, and more. In 2014, renowned designer and sleepwear pioneer Carole Hochman joined Naked as Chief Executive Officer, Chief Creative Officer, and Chairwoman with the goal of growing Naked into a global lifestyle brand. In June 2015, Naked announced a strategic partnership with NBA Miami HEAT (now Chicago Bulls) star Dwyane Wade. The 3-time NBA Champion, 11-time All Star, and Olympic Gold Medalist joined the Company’s Advisory Board, and is the Creative Director for a signature collection of men’s innerwear launching 2016. Naked is now headquartered in New York City and plans to expand in the future into other apparel and product categories that can exemplify the mission of the brand, such as activewear, swimwear, sportswear and more. http://www.nakedbrands.com/
About Bendon:
Bendon is a global leader in intimate apparel and swimwear renowned for its best in category innovation in design, and technology and unwavering commitment to premium quality products throughout its 70-year history. Bendon has a portfolio of 10 highly productive brands, including owned brands Bendon, Bendon Man, Davenport, Evollove, Fayreform, Hickory, Lovable (in Australia and New Zealand) and Pleasure State, as well as licensed brands Heidi Klum Intimates and Swimwear and Stella McCartney Lingerie and Swimwear.
In October 2014 Bendon announced supermodel and television host Heidi Klum as the Creative Director and face of Bendon’s flagship Intimates collection, succeeding Elle Macpherson after 25 years with the brand. Bendon products are distributed through over 4,000 doors across 34 countries as well as through a growing network of 60 company-owned Bendon retail and outlet stores in Australia, New Zealand and Ireland. Bendon’s global supply chain is one of its strongest assets, controlling sourcing, manufacturing and production at over 30 partner facilities across Asia. The company has more than 700 staff at offices and stores in Auckland, Sydney, New York, London and Hong Kong and is poised for continued meaningful growth as it opens additional retail stores and expands its current portfolio of products. http://www.bendongroup.com/
Additional Information about the Proposed Merger and Where to Find It
In connection with the proposed Merger, Naked intends to file relevant materials with the Securities and Exchange Commission, or the SEC, including a proxy statement. Investors and security holders of Naked are urged to read these materials when they become available because they will contain important information about Naked, Bendon and the proposed Merger. The proxy statement and other relevant materials (when they become available), and any other documents filed by Naked with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and securityholders may obtain free copies of the documents filed with the SEC by Naked by directing a written request to: Naked Brand Group Inc., 95 Madison Avenue, 10th Floor, New York, New York 10016, Attention: Investor Relations. Investors and securityholders are urged to read the proxy statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed Merger.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities
Participants in the Solicitation
Naked and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Naked in connection with the proposed Merger. Information regarding the special interests of these directors and executive officers in the proposed Merger will be included in the proxy statement referred to above. Additional information regarding the directors and executive officers of Naked is also included in Naked’s Annual Report on Form 10-K for the year ended January 31, 2016 and the proxy statement for Naked’s 2016 Annual Meeting of Stockholders. These documents are available free of charge at the SEC’s web site (www.sec.gov) and from Investor Relations at Naked at the address described above.
Forward-Looking Statements 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 Act of 1934, as amended. These forward-looking statements involve a number of risks and uncertainties related to operating performance and outlook of Naked and the combined businesses of Naked and Bendon following the Merger, as well as other future events and their potential effects on Naked and the combined company that are subject to risks and uncertainties. The following factors, among others, in the future could cause Naked’s or Bendon’s actual results, performance, achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These factors include, but are not limited to, statements relating to the possibility that Naked and Bendon are able to execute the Merger Agreement when expected or at all; the structure, timing and completion of the proposed Merger; Naked’s continued listing on the NASDAQ Capital Market until closing of the proposed Merger; the combined company’s listing on the NASDAQ Capital Market after closing of the proposed Merger; the benefits of the Merger, including future financial and operating results of the combined company, Naked and Bendon’s plans, objectives, expectations and intentions, and the ability to realize the expected synergies or savings from the proposed Merger in the amounts or in the timeframe anticipated; the risk that competing offers or acquisition proposals will be made; the ability to integrate Naked’s and Bendon’s businesses in a timely and cost-efficient manner; the inherent uncertainty associated with financial projections; the potential impact of the announcement or closing of the proposed Merger on customer, supplier, employee and other relationships. In addition, these forward-looking statements necessarily depend upon assumptions, estimates and dates that may be incorrect or imprecise and involve known and unknown risks, uncertainties and other factors. Accordingly, any forward-looking statements included in this announcement do not purport to be predictions of future events or circumstances and may not be realized. Forward-looking statements can be identified by, among other things, the use of forward- looking terms such as “believes,” “expects,” “may,” “will,” “should,” “seeks,” “anticipates,” “intends,” “continues,” “could,” “estimates,” “plans,” “potential,” “predicts,” “goal,” “objective,” or the negative of any of these terms, or comparable terminology, or by discussions of our outlook, plans, goals, strategy or intentions. Forward-looking statements speak only as of the date made. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we assume no obligation to update any of these forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting these forward-looking statements.
Investors:
ICR
Jean Fontana/Megan Crudele, 203-682-8200
jean.fontana@icrinc.com
or
Media:
ICR
Alecia Pulman/Brittany Fraser, 203-682-8200
NakedBrandsPR@icrinc.com
$GLBS Announces Update Regarding #PrivatePlacement
ATHENS, GREECE– (Jan 13, 2017) – Globus Maritime Limited (“Globus,” or the “Company”), (NASDAQ: GLBS), a dry bulk shipping company, announced today that its previously disclosed private placement and conversion of debt will not occur as planned. The transaction was previously described in the Company’s press release issued on November 28, 2016 and Current Report on Form 6-K filed with the Securities and Exchange Commission on November 29, 2016. These transactions with multiple parties had to all close simultaneously, but one party has not agreed to consummate the transaction.
This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities offered have not been registered under the U.S. Securities Act of 1933, as amended, or any other securities laws and may not be offered or sold in the United States or to a U.S. person absent registration or an applicable exemption from registration requirements.
About Globus Maritime Limited
Globus is an integrated dry bulk shipping company that provides marine transportation services worldwide and presently owns, operates and manages a fleet of dry bulk vessels that transport iron ore, coal, grain, steel products, cement, alumina and other dry bulk cargoes internationally. Globus’ subsidiaries own and operate five vessels with a total carrying capacity of 300,571 DWT and a weighted average age of 8.8 years as of December 31, 2016.
Safe Harbor Statement
This communication contains “forward-looking statements” (as defined in Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements provide the Company’s current expectations or forecasts of future events. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts or that are not present facts or conditions. Words or phrases such as “anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “will” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The Company’s actual results could differ materially from those anticipated in forward-looking statements for many reasons specifically as described in the Company’s filings with the Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements, which speak only as of the date of this communication. Globus undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this communication or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks Globus describes in the reports it will file from time to time with the Securities and Exchange Commission after the date of this communication.
For further information please contact:
Globus Maritime Limited
Athanasios Feidakis
CEO, CFO
+30 210 960 8300
a.g.feidakis@globusmaritime.gr
Capital Link – New York
Nicolas Bornozis
+1 212 661 7566
globus@capitallink.com
$BVXV #Universal #Flu #Vaccine Candidate Efficacy Highlighted In Recent Study
NESS ZIONA, Israel, January 12, 2017 —
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of the Universal Flu Vaccine candidate M-001, reports the publication this week of an article titled, “Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain” in the prestigious peer-reviewed scientific journal Vaccine.
The Vaccine article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax’s BVX-005 clinical trial in the elderly) showed significantly increased protective antibodies against the new epidemic 2014/15 flu strain (A/Swiss) – a strain which did not exist when M-001 was administered to the BVX-005 participants.
Despite the $4.3 billion market[1], current flu vaccines have many shortcomings including that they are specific to just 3 or 4 existing flu strains, and must be reformulated each year. Furthermore, seasonal flu vaccine effectiveness is only about 40% on average[2], and as low as 9% in the elderly[3] who are the most at risk group. Conversely, as a universal flu vaccine candidate, M-001 is designed to provide improved and broad protection against all current and future seasonal and pandemic flu strains.
The study reported in Vaccine offers evidence of the broadening protective effects offered by M-001, a significant advantage over current flu vaccines.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist and co-inventor of M-001, commented, “We consider this study to provide validation of M-001’s potential. It is a promising indication that our vaccine may provide improved protection against future flu strains, including potentially pandemic strains that don’t yet exist!”
The article also discusses M-001’s mechanism of action. It is available online at http://www.sciencedirect.com/science/article/pii/S0264410X1631297X.
About BiondVax Pharmaceuticals Ltd
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, general business conditions in the industry, changes in regulatory and legal compliance environments in which BiondVax engages, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
1. EvaluatePharma: Quoted by Edison Research http://www.edisoninvestmentresearch.com/research/report/biondvax-pharmaceuticals/preview/ [accessed 12 January 2017].
2. CDC: Seasonal influenza vaccine effectiveness, 2005-2016. https://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm [accessed 11 January 2017].
3. CDC: Interim adjusted estimates of seasonal influenza vaccine effectiveness – United States, February 2013. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a2.htm [accessed 11 January 2017].
BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com.
For further information, please contact:
Joshua E Phillipson
Business Development
+972-8-930-2529 x5105
j.phillipson@biondvax.com
Kenny Green
Investor Relations
+1-646-201-9246
kenny@biondvax.com
$STRP #Settles With the #FCC
Straight Path Remains the Largest Holder of 39 GHz Spectrum and Significant Holder of 28 GHz, Continuing Its Leadership in Developing 5G Wireless Technology
Straight Path Communications Inc. (NYSE MKT:STRP), one of the largest holders of flexible mobile and fixed-use wireless millimeter wave spectrum, today announced a comprehensive settlement with the Federal Communications Commission (FCC) related to the company’s wireless spectrum licenses. As part of the agreement, the FCC has terminated its investigation of Straight Path, and Straight Path can now move forward with the vast majority of its nationwide 39 GHz spectrum fully intact, and its 28 GHz spectrum unchanged. Both of these spectrum bands, 28 and 39 GHz, were the recent beneficiaries of a dramatic rule change instituted in July 2016 by the FCC’s Spectrum Frontiers Report & Order. The change allows these bands to be used for mobile wireless and is central to the industry-wide push to 5G, in order to provide higher speeds to hundreds of millions of consumers and businesses throughout the U.S.
Straight Path Communications CEO Davidi Jonas commented on the FCC settlement:
“We are pleased that we were able to achieve a comprehensive settlement with the FCC, which allows us to move forward as the largest holder of 39 GHz spectrum, with about 95 percent of the total licenses commercially available at this time, as well as a significant holder of 28 GHz in major markets, including New York and San Francisco. These licenses allow us to continue as a leader in the next frontier of telecommunications.
“Straight Path Communications’ spectrum is part of the bedrock for 5G and will play an important role in the development of this next-generation ecosystem, underscored by activities already underway by leading wireless carriers and equipment manufacturers in the U.S.
“Post-settlement, Straight Path Communications holds an average of 620 MHz in the top 30 U.S. markets and covers the entire nation with 39 GHz spectrum. Additionally, the Company has retained all of its 28 GHz spectrum licenses.
“With this settlement, we have cleared the way for a review of strategic alternatives to maximize shareholder value. To represent us in our endeavors, we have retained Evercore, a premier independent investment banking advisory firm.
“We look forward to continuing our role in the important development and deployment of 5G technology. This includes accelerating the innovative hardware and software we are developing for Fixed 5G® in our Gigabit Mobility Lab in Plano, Texas, under the guidance of our CTO, Jerry Pi, a renowned pioneer in millimeter wave 5G.”
At 8AM ET TODAY (Thursday, January 12) Straight Path Communications will host a media call to discuss this announcement. For dial-in information please email: pmb@skdknick.com
Settlement terms
Straight Path will move forward with a full national network of 735 licenses, including deep coverage in major markets, totaling more than 175 billion MHz-PoPs in 39 GHz spectrum, while agreeing to return 93 of its 828 39 GHz spectrum licenses to the FCC. Straight Path will also move forward with all of its 28 GHz spectrum, totaling approximately 39 billion MHz-PoPs, covering many key markets. Straight Path agreed to pay $15 million in installments over a nine-month period. The company also agreed to proceed with its plan to market its spectrum assets to maximize shareholder value. Straight Path agreed to pay the FCC 20 percent of the value received from a sale of its spectrum assets. If Straight Path does not announce a transaction within 12 months, it will pay another $85 million to the FCC (or return its spectrum licenses to the FCC).
About 5G and Frequency Bands 28 GHz and 39 GHz
5G is the next chapter of wireless innovation. As outgoing FCC Chairman Tom Wheeler stated: “If the United States is going to continue to be a world leader in wireless, we need to speed the deployment of 5G, here, on our shores.”
Unlike 4G, 5G technology relies on uncongested spectrum bands such as 28 GHz and 39 GHz that are free of interference. Compared to today’s 4G networks, 5G could allow wireless carriers to deliver data to users at speeds 10 times as fast, and with only 1 millisecond of delay. Straight Path Communications has been a leader in championing the use of these bands to unlock the potential of 5G technology. The company is a contributing member of ATIS 3GPP, the leading standard-setting body for 5G, and worked closely with the FCC to help adopt “Spectrum Frontiers” rules that open up new spectrum bands, including 28 GHz and 39 GHz, for flexible mobile and fixed-use wireless broadband.
About Straight Path Communications Inc.
Straight Path (NYSE MKT: STRP) holds an extensive portfolio of 39 GHz and 28 GHz wireless spectrum licenses. Straight Path is developing next generation wireless technology through its Straight Path Ventures subsidiary. Straight Path holds licenses and conducts other business related to certain patents through its Straight Path IP Group subsidiary. Additional information is available on Straight Path’s websites.
Corporate: www.straightpath.com
Spectrum: www.straightpath39.com
Safe Harbor
In this press release, all statements that are not purely about historical facts, including, but not limited to, those in which we use the words “believe,” “anticipate,” “expect,” “plan,” “intend,” “estimate, “target” and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors, including, but not limited to, those described in our Annual Report on Form 10-K for the fiscal year ended July 31, 2016 and our other periodic filings with the SEC (under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”). We are under no obligation, and expressly disclaim any obligation, to update the forward-looking statements in this press release, whether as a result of new information, future events or otherwise.
Straight Path Communications Inc.
Yonatan Cantor, 804-433-1523
yonatan.cantor@straightpath.com
$APOP Receives #Patent Notice of Allowance from #USPTO
Method of treatment patent provides important protection in type I diabetes, inflammatory bowel disease, graft versus host disease and transplant rejection
TEL AVIV, Israel, Jan. 12, 2017 — Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cells isolation technology, announces today that it has received a formal notice of allowance around a key method of treatment patent (Application No. 13/811,374) from the United States Patent & Trademark Office. The allowed claims relate to the engineering of regulatory immune cells with enhanced apoptotic activity to be used for immunomodulation for treating or preventing immune related disorders.
The patent that we expect to be granted based on the allowed claims will protect Cellect’s technology and method when used for treating multiple medical conditions with significant unmet needs, such as type I diabetes, inflammatory bowel disease, graft versus host disease, and transplant rejection.
Shai Yarkoni, CEO, commented that: “This is a key milestone for us and an important initial accomplishment for our business in the US. Cellect has seven families of patents and patent applications to protect its core assets for enabling stem cell regenerative medicine.”
About Cellect Biotechnology Ltd.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP), (NASDAQ:APOPW), (TASE:APOP). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue, a technology that aims to improve a variety of stem cells applications.
The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stems cell related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.
Forward Looking Statements
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss our expectation that a patent will be issued based on the allowed patent, the potential of our technology and its proposed uses. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. and in the Company’s period filings with the SEC and the Tel-Aviv Stock Exchange.
Contact Cellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officer www.cellectbio.com + 972-9-974-1444 LifeSci Advisors Bob Yedid, Managing Director 646-597-6989 bob@lifesciadvisors.com
$TBIO Announces: #LifeLabs Selects #ICE #COLDPCR
Three-Year Renewable Agreement Also Includes Non-Exclusive License to ICP in Canada
New Patent Has Issued Covering ICE COLD-PCR Technology in Canada
Transgenomic, Inc. (TBIO) (NASDAQ: TBIO), today announced a licensing agreement with leading Canadian laboratory services provider LifeLabs, which has selected Transgenomic’s ICE COLD-PCR (ICP) technology as its mutation enrichment platform for cancer testing. The three-year, renewable agreement includes a non-exclusive license to the ICP technology in Canada. Separately, Transgenomic also announced issuance of a new Canadian patent for ICP.
“LifeLabs is among the largest laboratory service providers in North America, and we view their adoption of ICE COLD-PCR as a key validation of both the technology and our commercial model that focuses on licensing to a wide variety of molecular diagnostics partners worldwide,” commented Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We believe that this sizable commercial licensing agreement is indicative of the growing traction in the marketplace we have been anticipating, and we believe that it will be followed by additional significant ICP agreements going forward.”
LifeLabs intends to use ICE COLD-PCR with tissue samples and is receiving a non-exclusive license to the ICP technology in Canada. The three-year renewable agreement also allows LifeLabs to benefit from technology improvements and additional product launches during its term.
“As the largest laboratory service provider in Canada, LifeLabs is committed to offering our customers access to advanced clinical genomic analyses made possible by major new technologies such as ICE COLD-PCR,” said Joby McKenzie, Senior Vice President, Business Development of LifeLabs. “We anticipate that this flexible, versatile mutation enrichment technology will be applied to other molecular testing applications as adoption of genomic and precision medicine expands.”
Recently-issued Canadian Patent No. 2792433, Full Cold-PCR Enrichment with Reference Blocking Sequence, covers the use of the ICE COLD-PCR method that enriches mutated DNA sequences in a background of normal DNA through to 2030. This method can be applied to the analysis of very low quantities of circulating tumor DNA found in a patient’s blood.
Transgenomic’s ICE COLD-PCR technology delivers up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations that allow accurate patient monitoring as well as stratification of cancer sub-populations. ICP works well with most patient samples, including tissue, blood, plasma, urine and other biofluids and it is compatible with most of the downstream genomic analytic platforms commonly available in laboratories today.
ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed worldwide rights to the technology to Transgenomic.
About LifeLabs
LifeLabs is a Canadian-owned company with over 50 years of experience providing laboratory testing services to help health care providers diagnose, treat, monitor and prevent disease in patients. In communities across British Columbia and Ontario, LifeLabs delivers cost-effective, convenient access to laboratory testing services essential for optimal outcomes in health care. LifeLabs employs over 5,000 professionally trained staff and delivers over 100 million laboratory tests, supporting over 19 million patient visits annually. In 2013, LifeLabs acquired BC Biomedical in British Columbia and CML HealthCare in Ontario, making LifeLabs the largest community laboratory in Canada. LifeLabs is indirectly owned by OMERS Administration Corporation, whose interest is managed by Borealis Infrastructure.
About Transgenomic
Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in oncology and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR, which enables use of liquid biopsies for mutation detection. The company also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management’s current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets, expectations regarding new clients, projects and prospects, and MX-ICP’s ability to accelerate the Company’s growth and generate revenue. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
Media:
BLL Partners
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investors:
Transgenomic Investor Relations
investor.relations@transgenomic.com
$NETE #PayOnline New Client a Top #Russia C2C Accommodation Rental Service
Sutochno.ru receives over 700,000 online booking requests annually
MIAMI, FL–(Jan 12, 2017) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today announces that Sutochno.ru, the leading C2C short-term accommodation booking service in Russia, is now a client of PayOnline.
Sutochno.ru features over 70,000 property listings, which last year attracted more than 700,000 guests who used the platform to book short-term accommodations throughout Russia. Sutochno.ru differentiates itself from Airbnb by being more country specific and offering a more attractive pricing model for guests. Additionally, while Airbnb takes commissions from the guests, Sutochno.ru only charges the hosts a commission and an optional fee to have a priority position in the list of available properties.
“We are excited to partner with PayOnline for our payment processing needs. PayOnline provides us with a complete solution for all of our payment needs such as pre-authorization, escrowing and payment processing via all types of cards,” commented Yuri Kuznetsov, founder of Sutochno.ru. “Together with PayOnline we are developing innovative mechanisms specific to our business that will add convenience, security and enhance the user experience.”
“We are honored to see Sutochno.ru amongst our merchants; PayOnline has invested heavily in product development, and it is rewarding to see how merchants can utilize the capabilities of our platform to meet their business needs and provide an excellent experience to the end consumer,” commented Marat Abasaliev, CEO of PayOnline.
About Sutochno.ru
Sutochno.ru is a Russian based peer-to-peer marketplace allowing consumers to list their residential properties for other consumers to book on a short-term basis. The company was launched 5 years ago, currently serves over 700,000 guests on an annual basis and has over 70,000 active listings. Further information is available at www.sutochno.ru.
About Net Element
Net Element, Inc. (NASDAQ: NETE ) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.com.
Forward-Looking Statements
Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to whether the relationship with Sutochno.ru will positively impact the Company. Additional examples of such risks and uncertainties are : (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Net Element
+1 (786) 923-0502
media@netelement.com
$HTM Announces Substantial Increase in the #SanEmidioII #Reservoir Capacity
BOISE, IDAHO–(Marketwired – Jan. 11, 2017) – U.S. Geothermal Inc. (the “Company”) (NYSE MKT:HTM), a leading and profitable renewable energy company focused on the development, production, and sale of electricity from geothermal energy, announced today that the estimate of the geothermal reservoir capacity associated with its San Emidio II project has increased from the earlier estimate of 10 net megawatts, to an estimated generation capacity of up to 47 net megawatts. This increased capacity is in addition to the current 10 megawatts being produced by the existing San Emidio I plant.
In early 2016, five 1,000 foot temperature gradient wells were drilled in the Southwest Zone and later in the year, two of those wells were deepened. Both wells intersected a high permeability, high temperature geothermal reservoir. Data from flow tests that took place in late 2016 on the two deepened wells were incorporated into a Probabilistic Power Density model developed by Geothermal Science Inc., an independent geothermal reservoir engineering company. Based on the flow rate and temperature produced by the two wells, and by measurement of pressure response across the wellfield, the model estimates that the area encompassed by the five wells drilled in 2016 (.18 square miles) has a 90% probability of 18.8 net megawatts of generation capacity as the Minimum. A larger area (1.4 square miles), defined by additional temperature gradient wells and geophysics, has a 50% probability of 47 net megawatts of generation capacity and was rated as the Most Likely outcome.
“This large increase in the size of the San Emidio II reservoir is an exceptional result from our development program,” said Dennis Gilles, Chief Executive Officer. “Having the ability to add a larger power plant to our San Emidio complex will help reduce capital and operating costs, and give us a very cost competitive project. Additionally, it will allow us to deploy two, or possibly three, of the previously acquired power plants whose acquisition we had announced in early 2016.”
The three remaining 1,000-foot-deep temperature gradient wells all have high temperature gradients and bottomhole temperatures indicating that an active geothermal resource exists below them. Permits to deepen these three remaining wells down into the production reservoir were received from the Bureau of Land Management and State of Nevada in late December. Subject to weather conditions, drilling to deepen those wells is planned for the first quarter of 2017. If the three wells intersect geothermal resource with similar permeability and temperature, the extent of the resource may be expanded and its power generation estimate increased. Additional permitting that will allow for more drilling to further expand the resource and to prepare for site development and construction activities is also underway.
About U.S. Geothermal Inc.:
U.S. Geothermal Inc. is a leading and profitable renewable energy company focused on the development, production and sale of electricity from geothermal energy. The company is currently operating geothermal power projects at Neal Hot Springs, Oregon, San Emidio, Nevada and Raft River, Idaho for a total power generation of approximately 45 MWs. The company is also developing an additional 90 MWs of projects at: the Geysers, California; a second phase project at San Emidio, Nevada; at Crescent Valley, Nevada; and the El Ceibillo project located near Guatemala City, Guatemala. U.S. Geothermal’s growth strategy is to reach 200 MWs of generation by 2021 through a combination of internal development and strategic acquisitions.
For more information, please visit our website at: http://www.usgeothermal.com
The information provided in this news release may contain forward-looking statements within the definition of the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995. Readers are cautioned to review the risk factors identified by the company in its filings with US and Canadian securities agencies. All statements, other than statements of historical fact, included herein, without limitation, statements relating to the future operating or financial performance, development schedules or estimated resources of U.S. Geothermal, are forward-looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. These forward-looking statements may include statements regarding perceived merit of properties; interpretation of the results of well tests; project development; resource megawatt capacity; capital expenditures; timelines; strategic plans; or other statements that are not statements of fact. Forward-looking statements involve various risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from U.S. Geothermal’s expectations include the uncertainties involving the availability of financing in the debt and capital markets; uncertainties involved in the interpretation of results of well tests; the need for cooperation of government agencies in the development and operation of properties; the need to obtain permits and governmental approvals; risks of construction; unexpected cost increases, which could include significant increases in estimated capital and operating costs; and other risks and uncertainties disclosed in U.S. Geothermal’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the United States Securities and Exchange Commission and Canadian securities regulatory authorities and in other U.S. Geothermal reports and documents filed with applicable securities regulatory authorities from time to time. Forward-looking statements are based on management’s expectations, beliefs and opinions on the date the statements are made. U.S. Geothermal Inc. assumes no obligation to update forward-looking statements if management’s expectations, beliefs, or opinions, or other factors, should change.
The NYSE MKT does not accept responsibility for the adequacy of this release.
Scott Anderson
Director of Investor Relations and Corporate Communications
U.S. Geothermal Inc.
208-424-1030
208-424-1027
sanderson@usgeothermal.com
$LTRX Preliminary Q2 Data Ahead of 19th Annual #NeedhamGrowthConference
Company Will Report Results for Second Quarter of Fiscal 2017 on Thursday, January 26, 2017
IRVINE, Calif., Jan. 11, 2017 — Lantronix, Inc. (the “Company”) (NASDAQ:LTRX), a global provider of secure data access and management solutions for Internet of Things (IoT) and information technology (IT) assets, today announced preliminary net revenue for its second fiscal quarter ended December 31, 2016.
The Company estimates net revenue for the second quarter of fiscal 2017 to be in the range of $10.9 -$11.1 million, representing year-over-year revenue growth in the range of 14-16%, compared with net revenue of $9.5 million for the second quarter of fiscal 2016.
“We experienced continued momentum with preliminary results showing year-over-year growth in sales in both our IoT and IT management product lines in the December quarter,” said Lantronix CEO Jeff Benck. “I’m grateful to our team for finishing the calendar year strong and demonstrating continued operational execution.”
Lantronix management will be presenting this week at the 19th Annual Needham Growth Conference in New York City. A webcast of the Company’s presentation will be available live on Thursday, January 12, 2017 at 9:20 a.m. Eastern Standard Time (6:20AM Pacific Standard Time) in the investor relations section of the Company’s website at www.lantronix.com.
The Company also announced that it will report its financial results for the fiscal year 2017 second quarter ended December 31, 2016 on January 26, 2017 after the close of the market. Management will host an investor conference call and audio webcast at 5:00 p.m. Eastern Standard Time (2:00 p.m. Pacific Standard Time) on Thursday, January 26, 2017 to discuss the Company’s fiscal year 2017 second quarter results.
To access the live conference call, investors should dial 1-844-802-2442 (US) or 1-412-317-5135 (international) and indicate that they are participating in the Lantronix Q2 FY 2017 call. The webcast will be available simultaneously via the investor relations section of the Company’s website at www.lantronix.com.
Investors can access a replay of the conference call starting at approximately 5:00 p.m. Pacific Standard Time on Thursday, January 26, 2017 at www.lantronix.com. A telephonic replay will also be available through February 2, 2017 by dialing 1-877-344-7529 (US) or 1-412-317-0088 (international) and entering passcode 10099548.
About Lantronix
Lantronix, Inc. is a global provider of secure data access and management solutions for Internet of Things (IoT) and information technology (IT) assets. Our mission is to be the leading supplier of IoT gateways that enable companies to dramatically simplify the creation, deployment, and management of IoT projects while providing secure access to data for applications and people.
With more than two decades of experience in creating robust machine to machine (M2M) technologies, Lantronix is an innovator in enabling our customers to build new business models and realize the possibilities of the Internet of Things. Our connectivity solutions are deployed inside millions of machines serving a wide range of industries, including data center, medical, security, industrial, transportation, retail, financial, environmental and government.
Lantronix is headquartered in Irvine, California, with offices in Europe and Asia. For more information, visit www.lantronix.com.
Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.
Forward-Looking Statements
This news release contains forward-looking statements, including statements concerning our projected operating and financial performance. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our results or experiences, or future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this news release. Some of the risks and uncertainties that may cause actual results to differ from those expressed or implied in the forward-looking statements are described in “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, as well as in our other filings with the SEC. In addition, actual results may differ as a result of additional risks and uncertainties of which we are currently unaware or which we do not currently view as material to our business. For these reasons, investors are cautioned not to place undue reliance on any forward-looking statements. The forward-looking statements we make speak only as of the date on which they are made. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations, except as required by applicable law or the rules of the NASDAQ Stock Market, LLC. If we do update or correct any forward-looking statements, investors should not conclude that we will make additional updates or corrections.
© 2017 Lantronix, Inc. All rights reserved.
Lantronix Contact: E.E. Wang Director, Corporate Marketing and Investor Relations investors@lantronix.com ee.wang@lantronix.com 949-614-5879 Jeremy Whitaker Chief Financial Officer investors@lantronix.com
$KRNT Signs #Agreement with $AMZN
Kornit’s Digital Printing Technology Helps Amazon Expand Its On-Demand Production for Personalized Garment Decoration
ROSH-HA`AYIN, Israel, Jan. 11, 2017 — Kornit Digital (NASDAQ:KRNT), a worldwide market leader in digital textile printing technology, announced today that following previous purchases by Amazon, it has been selected to deliver a large number of on-demand textile production systems to Amazon in support of the company’s Merch by Amazon program.
U.S. online apparel sales in 2015 amounted to $90 billion, according to the Internet Retailer publication, representing 20% year over year growth. As the apparel market transitions to short cycle on demand customized garments, Kornit is focused on providing a fully personalized garment decoration solution with ultra-fast turnaround times.
“We are excited to have been selected as a garment printing solution provider for Amazon, and look forward to the business potential this relationship represents,” said Gabi Seligsohn, CEO of Kornit. “Kornit Digital is at the forefront of the digital direct-to-garment market, and we believe that Amazon’s decision is great testament to that. We are deeply committed to the success of our business with Amazon and reiterate our commitment to all of our customers to stay at the forefront of the DTG market and continue to provide them with the most advanced, cost effective production solutions.”
Through this agreement, Kornit will deliver the company’s flagship high-productivity system, the Avalanche 1000, to support Amazon’s expansion of production capacity for the company’s Merch by Amazon service. A self-service program for developers, Merch by Amazon is the simple way for content creators to increase revenue through the sale of t-shirts.
“Customer demand for graphic t-shirts offered through Merch by Amazon continues to grow rapidly, and more developers and content creators join the service every day,” said Miguel Roque, Director, Merch by Amazon. “Kornit’s ability to deliver solutions and support that meet our high quality and high volume manufacturing requirements will help us to continue expanding program capacity to meet customer requests.”
In conjunction with the commercial agreements, Kornit Digital has agreed to grant Amazon warrants to acquire over a five-year period up to 2,932,176 of Kornit Digital’s common shares at $13.03 per share, based on the volume weighted average closing prices of Kornit Digital common shares for the thirty trading days prior to January 10, 2017. Vesting is tied to payments made by Amazon in connection with the purchase of goods and services from Kornit Digital, the extent of which is more broadly described in a report on Form 6-K filed by Kornit with the SEC earlier today.
About Kornit Digital
Kornit Digital (NASDAQ:KRNT) develops, manufactures and markets industrial digital printing technologies for the garment, apparel and textile industries. Kornit delivers complete solutions, including digital printing systems, inks, consumables, software and after-sales support. Leading the digital direct-to-garment printing market with its exclusive eco-friendly NeoPigment printing process, Kornit caters directly to the changing needs of the textile printing value chain. Kornit’s technology enables innovative business models based on web-to-print, on-demand and mass customization concepts. With its immense experience in the direct-to-garment market, Kornit also offers a revolutionary approach to the roll-to-roll textile printing industry: Digitally printing with a single ink set onto multiple types of fabric with no additional finishing processes. Founded in 2003, Kornit Digital is a global company, headquartered in Israel with offices in the USA, Europe and Asia Pacific, and serves customers in more than 100 countries worldwide. For more information, visit Kornit Digital at www.kornit.com.
Investor contact: Michael Callahan, ICR (203) 682-8311 Michael.Callahan@icrinc.com
$DSCI #Acquires #MEDIHONEY Brand From Long-Term Partner
Secures 10-year Supply Source
Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration company focused on advanced wound and burn care, today announced that it has purchased the MEDIHONEY® brand and related intellectual property and goodwill from its long-term partner, New Zealand-based Comvita Limited. Consideration is an upfront payment of $13.25 million in cash, with an additional $5.0 million potentially payable in the form of an earn-out upon achievement of future annual sales milestones. Prior to the acquisition, Derma Sciences held the exclusive global license for the Comvita-owned MEDIHONEY brand and patents for the medical and professional market segments. The purchase eliminates Derma Sciences’ obligation of royalty payments to Comvita on the sale of MEDIHONEY products, which royalties amounted to $1.6 million in 2016.
Additional agreements entered into at the time of the acquisition include an exclusive medical honey supply agreement from Comvita to Derma Sciences for 10 years with fixed pricing terms for two years, a worldwide licensing agreement from Derma Sciences to Comvita to use the purchased intellectual property in the over-the-counter (OTC) market, and the continued manufacture of honey-based products by Derma Sciences for Comvita for OTC consumer product sales.
“Under Derma’s leadership, the MEDIHONEY brand has grown to be the largest line of medical-grade honey products for advanced wound care use in the world, totaling global sales of approximately $20.0 million in 2016,” said Stephen T. Wills, Executive Chairman of Derma Sciences. “What is important to Derma Sciences and to the healthcare professionals and patients who benefit from these important products, is security of supply. Under the terms of the deal, we have a new 10-year medical honey supply agreement with Comvita, which gives Derma Sciences cost certainty for the first two years and priority of medical honey supply with respect to its needs. Comvita has supplied us for more than a decade, and having the backing of Comvita, its supply chain, and related partnerships gives us the confidence to continue to invest in the growth of our MEDIHONEY business.”
About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It is engaged in the development and commercialization of novel proprietary regenerative products derived from placental/birth tissues for use in a broad range of clinical applications including the treatment of complex chronic wounds, acute wounds and localized areas of injury or inflammation, in addition to filling soft tissue defects or voids. The Company also markets TCC-EZ®, a gold-standard total contact casting system for diabetic foot ulcers. Derma Sciences’ MEDIHONEY® product line is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. The Company also offers a full product line of traditional dressings. For more information, please visit www.dermasciences.com.
Forward-Looking Statements
Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company’s results include, but are not limited to product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company’s actual results and forward-looking statements include but are not limited to, those discussed in the Company’s filings with the U.S. Securities and Exchange Commission.
Derma Sciences, Inc.
John Yetter, 609-514-4744
Chief Financial Officer
jyetter@dermasciences.com
or
Investors
LHA
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
$EXPI Nearly Triples #RealEstate #Agent Count in 2016
Over 1,500 Real Estate Professionals Joined eXp Realty in 2016 for a Total of 2,401
BELLINGHAM, WA–(January 11, 2017) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, announced today the Company ended 2016 with 2,401 real estate brokers and agents on its platform, representing an increase 1,537, or 178%, when compared to 864 at the end of 2015.
eXp Realty has now grown its family of agents and brokers across 42 states and D.C. in the U.S., as well as Alberta, Canada. The Company continues to attract top talent with its unique agent-centric model that allows agents and brokers to build their own businesses, while establishing a direct ownership interest the Company as a shareholder and partner.
“Our rapid growth in 2016 not only exceeded our goal of 2,200 agents by year-end, but also established us as one of the fastest growing brokerages in North America,” said Glenn Sanford, Founder, CEO and Chairman of eXp World Holdings, Inc. “Our model has resonated with quality real estate professionals, allowing us to attract some of the top producing agents as well as some of the highest ranking teams throughout the U.S. and Canada. These entrepreneurial, high-achieving professionals recognize agent ownership as a fundamental shift in the relationship between the agent and the brokerage firm. Looking ahead to 2017, we expect to continue our accelerated growth rate in both agent count and revenues as a result of our unique commitment to agent ownership, support and engagement.”
About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage®. As a full-service real estate brokerage, eXp Realty LLC provides 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 aggressive 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 equity awards for production and contributions to overall company growth.
For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpWorldHoldings.com. For eXp Realty please 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.
Investor Relations Contact:
Greg Falesnik
Managing Director
MZ Group – MZ North America
949-385-6449
Email contact
www.mzgroup.us
Media Contact:
Russ Cofano
President
eXp World Holdings, Inc.
573-825-0780
Email contact
Trade Contact:
Jason Gesing
CEO
eXp Realty, LLC
617-970-8518
Email contact
$SRPT #LicenseAgreement with Nationwide Children’s Hospital, #Galgt2 #GeneTherapy
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial stage developer of innovative RNA-targeted therapeutics, today announced it has entered an exclusive license agreement with Nationwide Children’s Hospital, for their Galgt2 gene therapy program developed by researcher Dr. Paul Martin, Ph.D.
“We are taking a multi-front approach in the battle against Duchenne muscular dystrophy,” said Edward Kaye, Sarepta’s chief executive officer. “We find this therapeutic approach to be of particular interest as it has the potential to treat all patients suffering from the disease regardless their mutation.”
The experimental program explores the potential surrogate gene therapy approach to Duchenne muscular dystrophy. As a “surrogate gene therapy approach”, the gene therapy looks to induce genes that make proteins that can perform a similar function as dystrophin, with the goal of producing a muscle cell that can function normally even when dystrophin is absent. It has the potential to be used broadly in several muscular dystrophies.
“We are pleased to have this opportunity to help advance our Galgt2 gene therapy program,” said Dr. Kevin Flanigan, the Principal Investigator leading the clinical trial. “Our goal is to have this program in the clinic during 2017 and begin to evaluate a therapy that has the potential to treat patients of all ages and disease severity.”
About Sarepta Therapeutics
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.
About The Research Institute at Nationwide Children’s Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2016-17 list of “America’s Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric healthcare systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the U.S., supporting basic, clinical, translational and health services research at Nationwide Children’s. The Research Institute encompasses three research facilities totaling 525,000 square feet dedicated to research. More information is available at NationwideChildrens.org/Research.
Forward-Looking Statements
This press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the exclusive license agreement Sarepta has entered into with Nationwide Children’s Hospital for their Galgt2 gene therapy program, the potential for this therapeutic approach to treat all patients suffering from DMD regardless of their mutation, age and disease severity, the expected clinical progress of the program in 2017, the potential for the gene therapy to be used in several muscular dystrophies, the gene therapy’s mechanism of action and potential efficacy and Sarepta taking a multi-front approach in the battle against DMD.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the expected benefits and opportunities related to the exclusive license agreement and related agreements between the parties may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development; the partnership between Sarepta and Nationwide Children’s hospital may not result in any viable treatments suitable for clinical research or commercialization due to a variety of reasons including that the results of additional research may not be consistent with past results or may not be positive or may otherwise fail to meet regulatory approval requirements for the safety and efficacy of product candidates or may never become commercialized products due to other various reasons including any potential future inability of the parties to fulfill their commitments and obligations under the agreements; and even if the agreements result in commercialized products, the parties may not achieve any significant revenues from the sale of such products.
Any of the foregoing risks could adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review Sarepta’s 2015 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Internet Posting of Information
We routinely post information that may be important to investors in the ‘For Investors’ section of our web site at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com
TraderPower Featured Companies
Top Small Cap Market News
- $SOBR InvestorNewsBreaks – SOBR Safe Inc. (NASDAQ: SOBR) Closes on $8.2M Private Placement
- $CLNN InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Two Upcoming Investor Conferences
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
Recent Posts
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
Recent Comments
Archives
- October 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009



