Archive for March, 2017

$ATEC Announces $18.9 Million Private Placement

Proceeds to support corporate growth strategy

CARLSBAD, Calif., March 23, 2017 — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today that it has entered into a definitive securities purchase agreement to raise approximately $18.9 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock. The private placement is being led by new healthcare dedicated institutional investors, with participation by directors and executive officers of Alphatec and other existing investors. The private placement is expected to close on or about March 28, 2017, subject to the satisfaction of customary closing conditions. Alphatec expects to use the net proceeds from the private placement for general corporate and working capital purposes.

“We appreciate the support of our new and existing investors and the confidence this conveys in our strategy to build a high-growth spine company,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “We believe the additional capital will allow us to execute on our plans to expand our surgeon customer base, drive growth through the launch of our new products—Arsenal Deformity™, Battalion™ Lateral and XYcor® Expandable Interbody—as well as support the transformation of our distribution channel.”

H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with this private placement.

Pursuant to the terms of the securities purchase agreement, Alphatec has agreed to sell 1,809,628 shares of common stock at a price of $2.00 per share.  In addition, Alphatec has agreed to sell approximately 15,245 shares of newly created Series A Convertible Preferred Stock, which shares of preferred stock are convertible into approximately 7,622,372 shares of common stock, subject to limitations on conversion until the approval by Alphatec’s stockholders as required in accordance with the NASDAQ Global Select Market rules. Purchasers will also receive warrants to purchase up to approximately 9,432,000 shares of common stock at an exercise price of $2.00 per share. The warrants will be exercisable following approval by Alphatec stockholders, and will expire 5 years from the date of such stockholder approval.

Certain directors and executive officers of Alphatec agreed to purchase an aggregate of $2.35 million of shares of Series A Convertible Preferred Stock, which shares are convertible into approximately 1,175,000 shares of common stock, and warrants to purchase up to 1,175,000 shares of common stock at a price of $2.00 per share.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Alphatec has agreed to file one or more registration statements with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series A Convertible Preferred Stock.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include statements regarding: Alphatec’s expectations on the completion, timing and size of the private placement and the anticipated use of proceeds therefrom, including such proceeds allowing Alphatec to accelerate its plans to expand its surgeon customer base, drive growth through the launch of new products and support the transformation of its distribution channel.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to, risks and uncertainties associated with: market conditions and the satisfaction of customary closing conditions related to the private placement; the uncertainty of success in launching new products; the uncertainties in Alphatec’s ability to execute upon its strategic operating plan; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community; continuation of favorable third-party payor reimbursement for procedures performed using Alphatec Spine’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec’s ability to successfully control its costs or achieve profitability; Alphatec’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement; and other risks and uncertainties inherent in Alphatec’s business, including those detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

 

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com
Friday, March 24th, 2017 Uncategorized Comments Off on $ATEC Announces $18.9 Million Private Placement

$DXCM Medicare Announces Criteria Covering Dexcom G5 Mobile CGM, Diabetes

DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for people with diabetes, is pleased to announce that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. People covered by Medicare who have either Type 1 or Type 2 diabetes and intensively manage their insulin will now be able to obtain reimbursement.

“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” said Kevin Sayer, President and Chief Executive Officer, Dexcom. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

According to CMS, therapeutic CGM may be covered by Medicare when all of the following criteria are met:

  • The beneficiary has diabetes mellitus; and,
  • The beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing; and,
  • The beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
  • The patient’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.

In order to be included in this category, the system must be defined as therapeutic CGM, meaning you can make treatment decisions using the device. Dexcom G5 Mobile is the only system approved by the FDA to meet that criteria.

See the Medicare Administrative Contractor (MAC) website for instructions for individual claim adjudication. Coverage is effective for claims with dates of service on or after January 12, 2017. A link to the article on coding and coverage can be found at: https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/coding-and-coverage-therapeutic-continuous-glucose-monitors.

To learn more about CGM, visit www.dexcom.com.

About Diabetes and Continuous Glucose Monitoring

With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.i,ii

Continuous glucose monitoring (CGM) is considered the most significant breakthrough in diabetes management in the past 40 years.iii CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high with built-in and customizable alarms. A recent study showed that after one year, patients with Type 1 diabetes who used CGM alone had significant A1C reductions regardless of the type of insulin delivery method used, including insulin pumps.iv

About DexCom, Inc.

DexCom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked DexCom highest in customer satisfaction and loyalty. For more information on the DexCom CGM, visit www.dexcom.com.

References

i Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.

ii Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.

iii Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci. 2012;(3)2:83-93.

iv J. Soupal, J. Skrha Prazny, M. Flekac, L. Petruzelkova, J. Skrha, et al. Comparison of different treatment modalities for Type 1 diabetes including Sensor-Augmented Insulin Regimens (SAIR), in 52 weeks of follow ups: A COMISAIR Study. Diabetes Technology and Therapeutics. Vol 18, No. 9, Sept. 2016.

 

DexCom, Inc.
INVESTOR CONTACT:
Steve Pacelli, 858-200-0200
or
PRESS CONTACT:
Melissa Katz, 215-514-0957

Friday, March 24th, 2017 Uncategorized Comments Off on $DXCM Medicare Announces Criteria Covering Dexcom G5 Mobile CGM, Diabetes

$RXDX Exploration of Strategic Options for Taladegib

Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that it is exploring strategic options for taladegib and has entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program. Ignyta had previously disclosed it was in discussions with Lilly regarding the optimal path forward for taladegib in the context of its pipeline priorities, which are focused substantially on molecularly targeted therapies, including its lead product candidate, entrectinib.

The agreement amends and restates the prior license, development and commercialization agreement, dated November 6, 2015, by and between Ignyta and Lilly. Taladegib is a potent, orally bioavailable small molecule hedgehog/smoothened antagonist that has achieved clinical proof-of-concept and a recommended Phase 2 dose based on results from prior clinical studies.

“Ignyta is excited to continue to develop potential combinations of taladegib with other products to address residual disease, while exploring strategic options for single agent taladegib oral and the topical formulation of taladegib by sub-licensing or selling the franchise to dermatology-focused companies who may have an interest in superficial, nodular, and advanced basal cell carcinoma (BCC). We have received inbound interest on these assets in these BCC indications, and will be weighing the merits of these potential partnerships with other opportunities to develop taladegib internally for the benefit of patients with rare cancers outside of BCC. We are pleased to have achieved an amicable resolution with Lilly to provide Ignyta with a clear path forward for pursuing these various strategic options for taladegib,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta.

About Ignyta, Inc.

Blazing a New Future for Patients with Cancer™

At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with the rarest cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class or best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.

For more information, please visit: www.ignyta.com.

Forward-Looking Statements

This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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 development of Ignyta’s product candidates and Ignyta’s efforts to explore strategic options for single agent taladegib oral and the topical formulation of taladegib. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; the potential for final results of the ongoing clinical trials of taladegib or other product candidates, or any future clinical trials of taladegib or other product candidates, to differ from preliminary or expected results; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the potential for the company to fail to maintain the CAP accreditation and CLIA certification of its diagnostic laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta 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. 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 the company files with the SEC available at www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent Quarterly Reports on Form 10-Q.

 

Ignyta, Inc.
Jacob Chacko, M.D.
CFO
858-255-5959
jc@ignyta.com

Thursday, March 23rd, 2017 Uncategorized Comments Off on $RXDX Exploration of Strategic Options for Taladegib

$IMUC and Memgen, LOI for Potential Joint Immuno-Oncology Collab.

LOS ANGELES and HOUSTON, March 23, 2017 — ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) and Memgen, LLC (“Memgen”) announce the signing of a non-binding letter of intent to exclusively negotiate the terms  to possibly establish an immuno-oncology strategic collaboration focused on conducting clinical trials combining the companies’ respective cancer immunotherapy product candidates. The discussions pertain to ImmunoCellular’s dendritic cell (DC)-based immunotherapy product candidates, ICT-107 and ICT-140, and Memgen’s ISF35, a viral cancer immunotherapy encoding an optimized version of CD40 ligand. Combining DC-based and viral oncology immunotherapeutic approaches could provide a novel way to stimulate CD40 to possibly induce a potent, specific and effective anti-tumor response. Insights from these combination trials, if successful, could also lead to later combination trials with other immune-oncology technologies, including checkpoint inhibitors.

“We are excited about the potential to work with Memgen,” said Anthony Gringeri, PhD, ImmunoCellular President and Chief Executive Officer. “Memgen’s viral cancer immunotherapy, ISF35, has the potential to enhance the activity of ImmunoCellular’s immuno-oncology product candidates, including ICT-107. The ability to stimulate CD40 with a viral vector could play an important role in increasing the efficacy of dendritic cell immunotherapies. We look forward to potentially testing these therapies in combination trials.”

“We’re very pleased to have the opportunity to work with ImmunoCellular Therapeutics and its DC product candidates, including ICT-107 in glioblastoma,” said Mark Cantwell, PhD, Memgen Chief Scientific Officer. “Preclinical research presented at the 2016 American Association of Cancer Research (AACR) Annual Meeting showed that ISF35 in combination with checkpoint inhibitors induces anti-tumor immune responses, expands tumor specific CD8 T cells, and has the potential to eradicate brain tumors. The combination of ISF35 and ICT-107 with checkpoint inhibitors may provide a multi-pronged antitumor immune response. This includes ISF35’s CD40-driven dendritic and T cell activation and expansion, ICT-107’s tumor-specific antigen presentation, and checkpoint inhibitor release of the PD-1 pathway-mediated inhibition of the antitumor immune response.”

If the parties agree upon the terms of a strategic collaboration, including financials, development, supply and control, ImmunoCellular and Memgen plan to work together to determine the best clinical strategy to leverage the collaboration.

About ICT-107 and ICT-140

ICT-107 is a dendritic cell-based immunotherapy targeting six tumor-associated antigens on glioblastoma stem cells. ICT-107 is currently being tested in a phase 3 registration trial in patients with newly diagnosed glioblastoma. The ongoing phase 3 registrational trial of ICT-107 is designed as a randomized, double-blind, placebo-controlled study of HLA-A2+ subjects, which is being conducted at about 120 sites in the US, Canada and the EU, with plans to randomize 542 patients with newly diagnosed glioblastoma. The primary endpoint in the trial is overall survival. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.

For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.

ICT-140 is a dendritic cell-based immunotherapy targeting seven tumor-associated antigens expressed on ovarian cancer cells. ImmunoCellular plans to conduct a phase 2 clinical trial in patients with ovarian cancer, pending available resources.

About ISF35

ISF35 is a viral cancer immunotherapy encoding an optimized form of CD40 ligand. Direct intratumoral delivery of ISF35, a non-replicating adenovirus encoding CD40 ligand, activates tumor-specific T cells through immunostimulation of dendritic cells. ISF35 generates an effective anti-tumor immune response and complements checkpoint inhibitors, a class of immuno-oncology (IO) drugs that removes the brakes tumors attempt to use to stop a T cell anti-tumor immune response.

Preclinical studies have shown that ISF35 in combination with checkpoint inhibitors cures 40% of mice with an aggressive B16 melanoma tumor, and eradicates melanoma brain metastases. These data add to the extensive clinical experience of ISF35 in chronic lymphocytic leukemia where safety and activity have been demonstrated. Preclinical research evaluating ISF35 in combination with PD-1, PD-L1, and CTLA-4 checkpoint inhibitors is guiding the clinical development of ISF35

About Memgen

Memgen is a clinical-stage biotech company whose mission is to substantially improve cancer patient survival with our viral cancer immunotherapies. Memgen’s lead product, ISF35, is a first-in-class, viral cancer immunotherapy encoding an optimized version of CD40 ligand. ISF35 is being combined with checkpoint inhibitors, and other drug classes, to potentially treat a broad range of cancer types, including but not limited to bladder cancer, metastatic melanoma, lymphoma, lung cancer, and hepatocellular carcinoma. Clinical trial protocols for these indications are ready for clinical collaboration. ISF35 has worldwide patent protection, qualifies for twelve years of US biologics marketing exclusivity, and has received orphan drug designation for advanced melanoma. To learn more about Memgen, please visit www.memgenbio.com.

About ImmunoCellular Therapeutics, Ltd.

ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company’s lead product candidate, ICT-107, is a patient-specific, dendritic cell-based immunotherapy targeting glioblastoma and is currently being studied in an international phase 3 trial. ImmunoCellular’s pipeline also includes: ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting CD133 found in recurrent glioblastoma; ICT-140, a patient-specific, dendritic cell-based immunotherapy targeting ovarian cancer; and the Stem-to-T-cell research program which engineers hematopoietic stem cells to generate cytotoxic T cells. To learn more about ImmunoCellular, please visit www.imuc.com.

Forward-Looking Statements for ImmunoCellular Therapeutics

This press release contains certain forward-looking statements, including statements regarding whether the parties are able to reach agreement on terms of a collaboration, the potential for success of any collaboration, the financial requirements to enable a collaboration and impact on the parties in a collaboration; the timing for collaborative development efforts, including among other things, timing for enrollment and randomization of patients, the activation of clinical sites, the receipt and announcement of clinical data; and the ability of the parties to achieve clinical, operational and financial goals from the collaboration. Forward-looking statements are not guarantees of future performance and are subject to a number of risks and uncertainties, including the availability of resources to continue to develop ImmunoCellular’s product candidates, the uncertain timing of completion and success of clinical trials, and the risk that ICT-107 can be further successfully developed or commercialized. Additional risks and uncertainties are described under the heading “Risk Factors” in ImmunoCellular’s most recently filed quarterly report on Form 10-Q for the period ended September 30, 2016. Except as required by law, ImmunoCellular undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
ImmunoCellular Therapeutics, Ltd. Memgen, LLC
Investor Relations Business Development
Jane Green bizdev@memgenbio.com
415.652.4819 mobile
jane@jmgcomm.com
Thursday, March 23rd, 2017 Uncategorized Comments Off on $IMUC and Memgen, LOI for Potential Joint Immuno-Oncology Collab.

$SPHS Topsalysin Data from Successful Phase 2a

Poster selected as one of the best in a poster session during the 32nd Annual EAU Congress

SAN DIEGO and VANCOUVER, British Columbia, March 23, 2017  — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, today announced that data from its successful Phase 2a study of topsalysin, which evaluated the drug as a focal treatment for localized prostate cancer, will be presented as a poster on March 26, 2017 at the 32nd Annual European Association of Urology in London, UK. The poster has been selected by conference organizers as one of the best posters at the congress.

Abstract No. 758: “Intra-prostatic injection of PRX302 to focally ablate clinically significant prostate cancer: An open label, phase 2a study”
Presenting Author:  Dr. Yaalini Shanmugabavan, Division of Surgery and Interventional Sciences, University College London, London, UK
Poster Session:  Poster Session 57 – Prostate cancer: Is the future focal?
Time:  March 26, 2017 from 3:45 pm – 5:15 pm GMT

The abstract related to the poster can be accessed through the European Association of Urology Congress website at http://eau17.uroweb.org/.

About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases. Topsalysin is in Phase 2 clinical development for the focal treatment of localized prostate cancer as well as Phase 3 clinical development for the treatment of lower urinary tract symptoms of benign prostatic hyperplasia (BPH). Topsalysin is a highly potent ablative agent that is selective and targeted in that it is only activated by enzymatically active PSA which is found in high concentrations in the transition zone of the prostate and in and around prostate tumor cells.  More than 400 patients have received treatment with topsalysin, which continues to appear to be safe and well tolerated. For more information, please visit www.sophirisbio.com.

Company Contact:
Peter Slover
Chief Financial Officer
(858) 777-1760

Corporate Communications and Media Contact:
Jason Spark
Canale Communications
(619) 849-6005
jason@canalecomm.com

Thursday, March 23rd, 2017 Uncategorized Comments Off on $SPHS Topsalysin Data from Successful Phase 2a

$SNAK Announces Strategic Sale of Fresh Frozen® Foods

Strategic and Financial Review to Increase Shareholder Value Remains Ongoing

PHOENIX, March 23, 2017 — Inventure Foods, Inc. (NASDAQ:SNAK) (“Inventure Foods” or the “Company”), a leading specialty food marketer and manufacturer, announced the strategic sale of Fresh Frozen® Foods to The Pictsweet® Company, a family-owned grower and processor of frozen vegetables, in a cash transaction for approximately $23.7 million. The strategic transaction represents an important step in Inventure Foods’ ongoing strategic and financial review process to increase shareholder value.

“The sale of Fresh Frozen Foods represents a significant milestone in our efforts to enhance shareholder value,” said Terry McDaniel, Chief Executive Officer of Inventure Foods. “The proceeds from the sale of Fresh Frozen Foods will help us reduce our debt, improve our balance sheet and our overall financial flexibility. We continue to focus on delivering an improved financial performance through further execution of our strategic initiatives across the frozen and snack segments.”

Mr. McDaniel concluded, “I would like to thank the excellent Fresh Frozen associates for all of their efforts and wish them much success in the future.”

There can be no assurance that the Company’s ongoing strategic and financial review will result in any specific action, or any assurance as to its outcome or timing. The Company does not intend to comment further regarding the strategic and financial review until the Board of Directors approves a specific action or concludes its review.

About Inventure Foods

With manufacturing facilities in Arizona, Indiana, Washington and Oregon, Inventure Foods, Inc. (Nasdaq:SNAK) is a marketer and manufacturer of specialty food brands in better-for-you and indulgent categories under a variety of Company owned and licensed brand names, including Boulder Canyon Foods™, Jamba®, Seattle’s Best Coffee®, Rader Farms®, TGI Fridays™, Nathan’s Famous®, Vidalia Brands®, Poore Brothers®, Tato Skins®, Willamette Valley Fruit Company™, Bob’s Texas Style® and Sin In A Tin™. For further information about Inventure Foods, please visit www.inventurefoods.com.

About The Pictsweet® Company

The Pictsweet® Company is a full service grower, processor and marketer of frozen vegetables.  Pictsweet® was founded as a family company more than 70 years ago in Bells, Tennessee.  Today, the family company grows vegetables in 31 states with operations in Tennessee, Delaware, Texas, Utah, and California.  Pictsweet® distributes frozen vegetable products nation-wide under The Pictsweet Farms® brand.   For more information about Pictsweet®, please visit www.pictsweetfarms.com.

Note Regarding Forward-looking Statements

This press release contains forward-looking statements, including, but not limited to, the Company’s ability to improve its operational and financial performance, execute its strategic initiatives and increase shareholder value.  Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results to differ from the forward-looking statements contained in this press release and that may affect the Company’s prospects in general include, but are not limited to, general economic conditions, increases in cost or availability of ingredients, packaging, energy and employees, price competition and industry consolidation, ability to execute strategic initiatives, product recalls or safety concerns, disruptions of supply chain or information technology systems, customer acceptance of new products and changes in consumer preferences, food industry and regulatory factors, interest rate risks, dependence upon major customers, dependence upon existing and future license agreements, the possibility that the Company will need additional financing and/or to refinancing existing indebtedness due to future operating losses or in order to implement the Company’s business strategy, acquisition and divestiture-related risks, the volatility of the market price of the Company’s common stock, and such other factors as are described from time to time in the Company’s filings with the Securities and Exchange Commission.  All forward-looking statements are based on information available to the Company as of the date of this news release, and the Company assumes no obligation to update such statements.

Contact
Katie Turner, ICR (646) 277-1200
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$VBLT to Host a Key Opinion Leader Event

TEL AVIV, Israel, March 23, 2017 — VBL Therapeutics (NASDAQ:VBLT) announced today that it will be hosting a Key Opinion Leader breakfast on new targets and immunotherapeutic approaches to oncology, on April 6, 2017 in New York City.

The meeting will feature a presentation by key opinion leader Ramy Ibrahim, MD (Parker Institute), who will discuss the current treatment landscape and unmet medical need for new targets and therapeutic approaches in oncology. Dr. Ibrahim will be available to answer questions following the breakfast.

VBL Therapeutics’ management team will provide an overview of the Company’s programs in oncology, including new platform technology targeting MOSPD2 for immune/oncology applications, as well as the Company’s research and clinical development of lead candidate VB-111 in patients with recurrent glioblastoma, ovarian, and thyroid cancers.

Ramy Ibrahim, MD, currently serves as Vice President, Clinical Development at the Parker Institute for Cancer Immunotherapy, a collaboration between the country’s leading immunologists and cancer centers. He is a trained medical oncologist, who conducted bench and clinical immunotherapy research at the cancer vaccine branch of the National Cancer Institute (NCI). Dr. Ibrahim also helped develop some of the first breakthrough treatments in the field during his tenure at Bristol-Myers Squibb and MedImmune/AstraZeneca. At AstraZeneca, Dr. Ibrahim was the vice president of clinical development for Immuno-Oncology, leading the team developing multiple immunotherapies. Molecules developed under his leadership included durvalumab (anti-PDL1 antibody) and tremelimumab (anti-CTLA4 antibody) both with single drug and combination therapies with a focus on registrational studies in multiple indications including lung cancer, bladder cancer and head and neck cancer.  As a member of the Bristol-Myers Squibb Immuno-Oncology program, he served on the Yervoy (ipilimumab) clinical team supporting the program from early phase II through multiple global launches of the first FDA-approved immune checkpoint inhibitor. In addition, he played a key role in early development for nivolumab (PD-1), PDL1, and CD137 antibody.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only.  Please RSVP in advance if you plan to attend, as space is limited.  To reserve a spot, please reply to this email or contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com. A live and archived webcast of the event, with slides, will be available at http://lifesci.rampard.com/20170406/reg.jsp and on the Investors section of the Company’s website at http://www.vblrx.com.

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >200 cancer patients and we have observed its efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 pivotal trial for recurrent Glioblastoma, conducted under an FDA Special Protocol Assessment (SPA).

Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of ofranergene obadenovec (VB-111) and its therapeutic potential, clinical trials and clinical results, including the timing thereof, and our other pipeline candidates, including those targeting MOSPD2. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
Thursday, March 23rd, 2017 Uncategorized Comments Off on $VBLT to Host a Key Opinion Leader Event

$HTGM Completes Initial Technical Feasibility Testing with QIAGEN GeneReader NGS System

TUCSON, Ariz., March 23, 2017  — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (“HTG”), a provider of instruments, reagents, and services for molecular profiling applications, today announced that its HTG EdgeSeq technology has been successfully adapted for use with the QIAGEN GeneReader NGS System based on the results of initial technical feasibility tests. Results from samples tested with the HTG EdgeSeq DLBCL Cell of Origin Assay gene panel adapted for detection with the GeneReader NGS System showed strong correlation (r = 0.98) to data previously generated on the MiSeq sequencer.

“We are pleased to show the feasibility of using our HTG EdgeSeq technology with the GeneReader NGS System, which will expand the sequencing platforms available for use with our system, and, importantly, advances our precision diagnostics collaboration with QIAGEN. The HTG and QIAGEN teams have been working very closely and we are delighted with their speed and efficiency to accomplish this initial feasibility milestone,” stated TJ Johnson, Chief Executive Officer of HTG.

“Adapting our HTG EdgeSeq technology for detection on the GeneReader NGS System has been fairly straightforward to date and the initial testing results were gratifying,” said Debrah Thompson, Ph.D., HTG’s Vice President of Research. “The level of cooperation between the QIAGEN and HTG technical teams has been outstanding, and we are excited about the future of this collaboration.”

About HTG:

Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013, the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG’s original proprietary nuclease protection chemistry. Continuous improvement led to the 2014 launch of the company’s HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the results of initial feasibility testing using the GeneReader platform and our agreement and collaboration with QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN, N.V. (“QIAGEN”) and their expected benefits to us, and our business and the capabilities of our technology. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with our ability to successfully develop, market and/or commercialize new methods, technologies and/or products, including our ability to further adapt our technology to the GeneReader NGS System and expand the sequencing platforms available for use with our HTG EdgeSeq system, or successfully develop and commercialize any related products or services. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Annual Report on Form 10-K for the year ended December 31, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:
Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com
Thursday, March 23rd, 2017 Uncategorized Comments Off on $HTGM Completes Initial Technical Feasibility Testing with QIAGEN GeneReader NGS System

$GROW Continues GROW Dividends

SAN ANTONIO, TX–(March 22, 2017) – U.S. Global Investors, Inc. (NASDAQ: GROW), a boutique registered investment advisory firm with longstanding experience in global markets and specialized sectors, will continue its payment of monthly dividends in the fourth fiscal quarter of 2017.

The company’s board of directors approved payment of the $0.0025 per share per month dividend beginning in April 2017 and continuing through June 2017. The record dates are April 10, May 15 and June 12, and the payment dates will be April 24, May 29 and June 26.

At the end of this period, the company will have paid monthly dividends for more than nine years. At the March 20, 2017, closing price of $1.62, the $0.0025 monthly dividend equals a 1.85 percent yield on an annualized basis.

The continuation of future cash dividends will be determined by U.S. Global’s board of directors, at its sole discretion, after review of the company’s financial performance and other factors, and is dependent on earnings, operations, capital requirements, general financial condition of the company and general business conditions.

About U.S. Global Investors, Inc.

The story of U.S. Global Investors goes back more than 40 years when it began as an investment club. Today, U.S. Global Investors, Inc. (www.usfunds.com) is a registered investment adviser that focuses on niche markets around the world. Headquartered in San Antonio, Texas, the Company provides money management and other services to U.S. Global Investors Funds, the U.S. Global Jets ETF and other international clients.

Contact:
Lisa Aston
Marketing Leader
210.308.1222
laston@usfunds.com

Wednesday, March 22nd, 2017 Uncategorized Comments Off on $GROW Continues GROW Dividends

$XOMA Full Repayment of Hercules Technology Growth Capital Debt

Company extinguishes Hercules term loan; repayment further reduces operating expenses and strengthens XOMA’s balance sheet, reflecting its new business strategy

BERKELEY, Calif., March 22, 2017 — XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and development of therapeutic antibodies, announced today it has fully prepaid the outstanding balance of approximately $6.5 million under the Company’s term loan with Hercules Technology Growth Capital, Inc., in accordance with the terms of the loan agreement.

“This loan prepayment is another important step in our strategy to reduce debt and strengthen our balance sheet, as we continue to pursue our goal of becoming a profitable company,” said Jim Neal, Chief Executive Officer of XOMA. “We have decreased our debt by approximately $16.7 million, or 39 percent, in the past three months. We continue our focus on initiatives that enhance our financial position. Our lean cost structure gives us the opportunity to reach positive cash flow more quickly, creating value for shareholders as we realize multiple revenue streams from our portfolio of programs that are fully funded by partners across the biopharma landscape.”

XOMA funded this extinguishment using, in part, proceeds of the approximately $25 million equity offering to Biotechnology Value Fund, L.P., completed in February 2017.

About XOMA Corporation

XOMA has an extensive portfolio of products, programs, and technologies that are the subject of licenses the Company has in place with other biotech and pharmaceutical companies.  Many of these licenses are the result of the Company’s pioneering efforts in the discovery and development of antibody therapeutics.  There are more than 20 such programs that are fully funded by partners and could produce milestone payments and royalty payments in the future. In order to maximize its value in a licensing transaction, XOMA continues to invest in X358, an allosteric monoclonal antibody that reduces insulin receptor activity, as the antibody could have a major impact on the treatment of hyperinsulinism. For more information, visit www.xoma.com.

Forward-Looking Statements

Certain statements contained in this press release are forward-looking statements, including our ability to reach positive cash flow and profitability and recognize revenue from our portfolio of fully funded programs, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA’s most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA’s prospects. Any forward-looking statement in this press release represents XOMA’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Investor contact:
Luke Heagle
Pure Communications
+1 910-726-1372
lheagle@purecommunications.com

Media contact:
Colin Sanford
Pure Communications
+1 415-946-1094
csanford@purecommunications.com
Wednesday, March 22nd, 2017 Uncategorized Comments Off on $XOMA Full Repayment of Hercules Technology Growth Capital Debt

$LEXEB to Hold Annual Meeting of Stockholders

Liberty Expedia Holdings, Inc. (Nasdaq: LEXEA, LEXEB) will be holding its Annual Meeting of Stockholders on Tuesday, June 20, 2017 at approximately 8:00 a.m. M.D.T. at the corporate offices of Liberty Expedia Holdings, Inc., 12300 Liberty Boulevard, Englewood, CO 80112. The record date for the meeting is 5:00 p.m., New York City time, on April 24, 2017. The annual meeting will not be webcast.

About Liberty Expedia Holdings, Inc.

Liberty Expedia Holdings’ (Nasdaq: LEXEA, LEXEB) principal assets consist of its interest in Expedia, Inc. and its subsidiary Vitalize, LLC (formerly referred to as Bodybuilding.com). Expedia is an online travel company, empowering business and leisure travelers through technology with the tools and information they need to efficiently research, plan, book and experience travel. Vitalize is a holding company engaged in health, fitness, and media-related business segments. Vitalize currently has three wholly-owned operating subsidiaries: Bodybuilding, WeMotivate, and Verity Nutrition.

 

Liberty Expedia Holdings, Inc.
Courtnee Chun, 720-875-5420

Wednesday, March 22nd, 2017 Uncategorized Comments Off on $LEXEB to Hold Annual Meeting of Stockholders

$MBRX Receives Orphan Drug Designation for Annamycin

HOUSTON, TX–(March 22, 2017) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced its lead candidate, Annamycin (also known as “Liposomal Annamycin”), an anthracycline, has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).

Moleculin’s Chairman and CEO, Walter Klemp, commented, “We are pleased to report this key milestone and the FDA’s decision to grant Annamycin orphan drug designation. We look forward to announcing additional milestones in regard to our clinical pathway as we make further progress.”

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

About AML

Leukemia is a cancer of the white blood cells and the acute forms of leukemia can manifest quickly and leave patients with limited treatment options. AML is the most common type of acute leukemia in adults. It occurs when a clone of leukemic progenitor white blood cells proliferates in the bone marrow suppressing the production of normal blood cells. In order to qualify for a curative bone marrow transplant, patients must first undergo induction therapy. The current standard of care is the combining of 2 chemotherapeutic drugs, always including an anthracycline intended to induce a CR or complete response, which has not improved since it was first used in the 1970’s. We estimate that it has the same cure rate of about 20% as then. Currently, the only viable long term option for acute leukemia patients is a bone marrow transplant for those 20%, which is successful in a significant number of patients. For more information on AML click: http://www.moleculin.com/technology/about-acute-myeloid-leukemia/.

About Annamycin

Annamycin is an anthracycline intended for the treatment of relapsed or refractory AML. Annamycin is a unique liposome formulated anthracycline (also referred to in literature as “L-Annamycin”) that has been designed to produce little to no cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat current anthracyclines. It has been tested in 114 patients in 6 clinical trials, 3 of which focused on leukemia, with little to no cardiotoxicity and 3 of those clinical trials focused on leukemia. The Company is working with the FDA on an investigative new drug application for a Phase I/II trial for second line treatment of relapsed or refractory AML, for which no approved therapy currently exists.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 7, 2017, as amended (Registration No. 333-214898). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Wednesday, March 22nd, 2017 Uncategorized Comments Off on $MBRX Receives Orphan Drug Designation for Annamycin

$BEBE Exploring Strategic Alternatives

bebe stores, inc (Nasdaq: BEBE), announced today that its Board of Directors is exploring strategic alternatives for the company. bebe has retained B. Riley & Co. as its financial advisor and has also engaged a real estate advisor to assist with options related to its lease holdings. bebe said that there is no assurance that this process will result in any specific transaction, and it does not expect to disclose further developments during this process unless and until the Board of Directors has approved a specific transaction or otherwise determined that disclosure is appropriate.

About bebe:

Unique, sophisticated and timelessly sexy, bebe emerged as the first contemporary fashion destination in 1976. Today, bebe continues to define next-generation chic while staying true to its assertive, provocative origins. Inspired by Shakespeare’s immortal words “To be, or not to be,” the brand is, at its essence, about living, standing out and truly existing. As a global specialty retailer that designs, develops and produces a unique line of women’s apparel and accessories, bebe currently operates 134 retail stores, 34 outlet stores and www.bebe.com. In addition to its store locations in the United States, Puerto Rico and Canada, bebe also distributes and sells bebe branded product in approximately 75 doors through its licensees in more than 21 countries.

About B. Riley & Co., LLC

B. Riley & Co., LLC is a leading investment bank which provides corporate finance, research, and sales & trading to corporate, institutional and high net worth individual clients. Investment banking services include initial, secondary and follow-on offerings, institutional private placements, and merger and acquisitions advisory services. The firm is nationally recognized for its highly ranked proprietary equity research. B. Riley & Co., LLC is a member of FINRA and SIPC.

bebe stores, inc.
Walter Parks, 415-715-3900
President, Chief Operating Officer and Interim Chief Financial Officer

Wednesday, March 22nd, 2017 Uncategorized Comments Off on $BEBE Exploring Strategic Alternatives

$HTGM Obtains CE Mark for its HTG EdgeSeq ALKPlus Assay EU

TUCSON, Ariz., March 22, 2017 — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents, and services for molecular profiling applications, today announced that it has obtained CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU.

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay intended to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC). The assay may be used to aid in the identification of patients eligible for treatment with ALK-targeted therapeutics, such as crizotinib, and is automated on the HTG EdgeSeq system using a next-generation sequencer for detection.

Lung cancer is a leading cause of cancer death in men and women worldwide. In Europe, approximately 391,000 people were diagnosed with lung cancer in a single year, according to the European Society for Medical Oncology, and NSCLC accounts for 85 to 90% of all lung cancer cases. Due to the important therapeutic implications, routine testing for rearrangement in the ALK gene is now recommended for all NSCLC patients diagnosed with adenocarcinoma.

“We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our diagnostic assay menu in Europe,” stated TJ Johnson, HTG’s President and CEO. “Lung cancer is a significant global health problem and an important focus area for HTG. We plan to offer this assay to selected European early adopters as we seek additional regulatory approvals elsewhere.”

About HTG:

Headquartered in Tucson, Arizona, the mission of HTG Molecular Diagnostics, Inc. (HTG) is to empower precision medicine at the local level. In 2013, the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG’s original proprietary nuclease protection chemistry. Continuous improvement led to the 2014 launch of the company’s HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with our business and the capabilities of our technology, the benefits and uses of our HTG EdgeSeq ALKPlus Assay EU, and the European lung cancer market size and testing standards of care. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with our ability to successfully develop, market and/or commercialize new methods, technologies and/or products, including our ability to market, sell and maintain or obtain regulatory approvals for our HTG EdgeSeq ALKPlus Assay EU in Europe or other jurisdications. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the Quarter ended September 30, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:  
Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com
Wednesday, March 22nd, 2017 Uncategorized Comments Off on $HTGM Obtains CE Mark for its HTG EdgeSeq ALKPlus Assay EU

$FNJN Receives Three Decisively Favorable Final Written PTAB Decisions

Bringing the Total to Six Final Written PTAB Decisions

EAST PALO ALTO, CA–(Mar 21, 2017) – Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, and its subsidiary Finjan, Inc. (“Finjan”) announced that on March 16 and 17, 2017, the Patent Trial and Appeal Board (“PTAB”) for the United States Patent & Trademark Office (“USPTO”) ruled against Palo Alto Networks, Inc. (“PANW”) petitions for three Inter Partes Reviews (“IPRs”). Case No. IPR2015-01974 challenged Finjan’s U.S. Patent 7,647,633 and Case Nos. IPR2015-02001 and IPR2016-00157 challenged Finjan’s U.S. Patent 8,225,408. Blue Coat Systems, Inc. (“Blue Coat”) joined all three of these petitions so these PTAB decisions apply to its challenges as well.

In IPR2015-01974, the PTAB instituted a review on only two of the twelve challenged claims against the ‘633 Patent and, as a whole, found all challenged claims valid and patentable. In IPR2015-02001 and IPR2016-00157, the PTAB consolidated the petitions and instituted a review on twenty claims of the ‘408 Patent and, once again, found all challenged claims to be both valid and patentable.

Summary of IPRs Instituted

Patent and Case Number Petitioner Decision
U.S. Patent No. 8,141,154
IPR-2015-01892
PANW joined by Symantec Not unpatentable (no changes)
U.S. Patent No. 8,141,154
IPR2016-00151
PANW joined by Symantec Not unpatentable (no changes)
U.S. Patent No. 8,677,494
IPR2015-01892
Symantec joined by Blue Coat Partially Denied/Partially Granted (1 method claim unpatentable)
US Patent No. 7,647,633
IPR2015-01974
PANW joined by Blue Coat Not unpatentable (no changes)
US Patent No. 8,225,408
IPR2015-02001
PANW joined by Blue Coat Not unpatentable (no changes)
US Patent No. 8,225,408
IPR2016-00157
PANW joined by Blue Coat Not unpatentable (no changes)
US Patent No. 8,677,494
IPR2016-00159
PANW joined by Blue Coat Pending

Finjan has pending district court actions or appeals against Palo Alto Networks, Inc., Symantec Corporation, Blue Coat Systems, Inc., FireEye, Inc., Sophos, Inc., ESET and its affiliates, Cisco Systems, Inc., and Avast Software, relating to, collectively, more than 20 patents in the Finjan portfolio. The court dockets for the foregoing cases are publicly available on the Public Access to Court Electronic Records (PACER) website, www.pacer.gov, which is operated by the Administrative Office of the U.S. Courts.

ABOUT FINJAN
Established nearly 20 years ago, Finjan is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation. For more information, please visit www.finjan.com.

Follow Finjan Holdings, Inc.:
Twitter: @FinjanHoldings
LinkedIn: linkedin.com/company/finjan

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, the matters set forth herein that are forward-looking statements involve certain risks and uncertainties that could cause actual results to differ. Potential risks and uncertainties include, but are not limited to, Finjan’s expectations and beliefs regarding Finjan’s licensing program, the outcome of pending or future enforcement actions, the granting of Inter Partes Review (IPR) of our patents or an unfavorable determination pursuant to an IPR or other challenges at the USPTO of our patents, the enforceability of our patents, the cost of litigation, the unpredictability of our cash flows, our ability to expand our technology and patent portfolio, the continued use of our technologies in the market, our stock price, changes in the trading market for our securities, regulatory developments, general economic and market conditions, the market acceptance and successful business, technical and economic implementation of Finjan Holdings’ intended operational plan; and the other risk factors set forth from time to time in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2015, and the Company’s periodic filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from Finjan Holdings, Inc. All forward-looking statements herein reflect our opinions only as of the date of this release. These statements are not guarantees of future performance and actual results could differ materially from our current expectations. Finjan Holdings undertakes no obligation, and expressly disclaims any obligation, to update forward-looking statements herein in light of new information or future events.

Investor Contact:
Vanessa Winter | Finjan
Valter Pinto | KCSA Strategic Communications
(650) 282-3245
investors@finjan.com

Tuesday, March 21st, 2017 Uncategorized Comments Off on $FNJN Receives Three Decisively Favorable Final Written PTAB Decisions

$AST Update on Full Six-Patient Cohort Confirms AST-OPC1 Efficacy

-Newly reported data on sixth and final patient in cohort further confirms previously announced improvements in hand and arm function following dosing-

FREMONT, Calif., March 21, 2017 — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, reported that including the sixth and final patient in the AIS-A 10 million cell cohort in the company’s ongoing SCiStar Phase 1/2a clinical trial has further confirmed previously-announced motor function improvements at 6-months following administration of AST-OPC1.

“We are excited to see the sixth and final patient in the AIS-A 10 million cell cohort show upper extremity motor function improvement at 3 months and further improvement at 6 months, especially because this particular patient’s hand and arm function had actually been deteriorating prior to receiving treatment with AST-OPC1,” stated Dr. Edward Wirth III, Chief Medical Officer. “We are very encouraged by the meaningful improvements in the use of arms and hands seen in the SciStar study to date since such gains can increase a patient’s ability to function independently following complete cervical spinal cord injuries.”

Improvements in upper extremity motor function are being measured using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, widely used to quantify functional status of patients with spinal cord injuries.  Both subjects and physicians consistently report that improvements in upper extremity motor function are the most desirable functional improvement target in the quadriplegic population, as they can have a significant impact on functional independence, quality of life and cost of care from even relatively modest changes.   The SCiStar study is monitoring two separate ISNCSCI measurements of upper extremity motor function.  The upper extremity motor score (UEMS), is a linear scale used to quantify motor function at each of five upper extremity muscle groups driving arm and hand function; these scores are also used to calculate “motor levels”, which define the level within the cord above which a subject has a certain minimum level of function.

The UEMS improvement at 6-months for the final patient was 9 points and in line with the median and average 6-month UEMS improvement for all six patients in this cohort (9.7 average; 9 median). In all six patients, administration of AST-OPC1 was followed by early improvements in UEMS at 3-months that were sustained or further increased through their most recent follow-up assessment.

In addition to the motor score gains, the final patient in the AIS-A 10 million cell cohort has so far achieved a one motor level improvement over baseline on both sides of his body.   All six patients in this cohort have now achieved at least a one motor level improvement over baseline on at least one side.

“These results are quite encouraging, and suggest that there are meaningful improvements in the recovery of functional ability in patients treated with the 10 million cell dose of AST-OPC1 versus spontaneous recovery rates observed in a closely matched untreated patient population,” said Steve Cartt, Chief Executive Officer of Asterias. “We look forward to reporting additional efficacy and safety data for this cohort, as well as for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, later this year.”

The trial results to date continue to indicate a positive safety profile for AST-OPC1. There have been no serious adverse events related to AST-OPC1 and data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.

Each year in the U.S. more than 17,000 people suffer a severe, debilitating spinal cord injury. These injuries can be devastating to quality of life and ability to function independently. Lifetime healthcare costs for these patients can often approach $5 million. Improvements in arm, hand and finger functional capabilities in these patients can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites that have enrolled and dosed patients in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) in Los Angeles, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with complete cervical spine injuries, which represents the first targeted population for registration trials.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

Tuesday, March 21st, 2017 Uncategorized Comments Off on $AST Update on Full Six-Patient Cohort Confirms AST-OPC1 Efficacy

$FCEL and Korean-based POSCO Energy Announce Strategic Agreement

  • FuelCell Energy to commence market activities for Asian market development offering entire portfolio of SureSource solutions
  • POSCO Energy to support existing South Korean fuel cell installations and operate local manufacturing facility
  • Parties expect to finalize detailed definitive agreements by fall 2017

DANBURY, Conn., March 21, 2017 — FuelCell Energy, Inc.  (Nasdaq:FCEL), a global leader in delivering clean, innovative and affordable fuel cell solutions for the supply, recovery and storage of energy, today announced a memorandum of understanding with partner POSCO Energy to use an existing FuelCell Energy subsidiary to directly develop the Asian fuel cell business for the purpose of expanding Asian market opportunities.  Under this agreement, FuelCell Energy will immediately commence marketing the entire suite of SureSource solutions in Korea as well as the broader Asian markets for the supply, recovery and storage of energy.  POSCO Energy will continue to service the existing installed base of fuel cell plants in South Korea and will commit to a specified level of module purchases from FuelCell Energy to supplement its own local manufacturing for servicing their existing fleet.  Definitive agreements are expected to be finalized by fall 2017 subject to completion of due diligence, regulatory approvals, and customary closing conditions.

“Offering our entire portfolio of solutions throughout Asia aligns well with our growing list of global customers as well as sizeable projects with existing customers of POSCO Energy,” said Chip Bottone, President and Chief Executive Officer FuelCell Energy.  “This revised relationship is structured to rapidly grow market opportunities and enable project-level investment by third parties while leveraging the deep relationships of POSCO Energy.”

“We believe FuelCell Energy will be successful in the significant Asian utility-scale stationary fuel cell market by now directly marketing its high quality products,” said Dong Jun Yoon, President and Chief Executive Officer, POSCO Energy.

The installed fleet in South Korea consists of 18 sites, totaling more than 170 megawatts with a customer base that includes 15 of Korea’s largest utilities and independent power producers.  The backlog for the underlying service agreements for these installations includes over 300 megawatts of future fuel cell module production under existing service agreements.

“We have the capabilities in place for the development, construction, operation and maintenance of fuel cell projects in Korea as we leverage our decade-plus working relationship with POSCO Energy; utilize our global monitoring and control center to remotely operate and monitor plants worldwide; continue to manage the joint purchasing from our shared global supply chain; and we helped design the production process and procured manufacturing equipment on behalf of POSCO Energy for the fuel cell manufacturing facility in South Korea,” commented Tony Rauseo, Chief Operating Officer, FuelCell Energy.  “We see this as a natural evolution for growing the Asian market.”

Fuel cells are well suited for addressing the energy, environmental and economic goals of the Korean government.  High population density, limited land, and scarce natural resources that lead to the importation of more than 90 percent of the fuel needed to generate power and heat requires highly efficient and affordable power that can be located near where the power is used.  The virtual lack of criteria pollutants and low carbon footprint of fuel cells combined with affordable economics and minimal space needs have led to significant fuel cell adoption by Korean utilities and independent power producers. With high availability and capacity factors, fuel cell power plants make meaningful contributions to Renewable Portfolio Standard targets.

Cautionary Language Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements with respect to the Company’s plans and expectations regarding the memorandum of understanding. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause such a difference include, without limitation, changes to projected deliveries and order flow, changes to production rate and product costs, general risks associated with product development, manufacturing, changes in the regulatory environment, customer strategies, unanticipated manufacturing issues that impact power plant performance, changes in critical accounting policies, potential volatility of energy prices, rapid technological change, competition, and the Company’s ability to achieve its sales plans and cost reduction targets, as well as other risks set forth in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements contained herein speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statement to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.

About FuelCell Energy
FuelCell Energy (NASDAQ:FCEL) delivers efficient, affordable and clean solutions for the supply, recovery and storage of energy.  We design, manufacture, undertake project development, install, operate and maintain megawatt-scale fuel cell systems, serving utilities, industrial and large municipal power users with solutions that include both utility-scale and on-site power generation, carbon capture, local hydrogen production for transportation and industry, and long duration energy storage.  With SureSource™ installations on three continents and millions of megawatt hours of ultra-clean power produced, FuelCell Energy is a global leader with environmentally responsible power solutions.  Visit us online at www.fuelcellenergy.com and follow us on Twitter.

SureSource, SureSource 1500, SureSource 3000, SureSource 4000, SureSource Recovery, SureSource Capture, SureSource Hydrogen, SureSource Storage, SureSource Service, SureSource Capital, FuelCell Energy, and FuelCell Energy logo are all trademarks of FuelCell Energy, Inc.

Contact:

FuelCell Energy, Inc.
Kurt Goddard, Vice President Investor Relations
(+1) 203-830-7494
ir@fce.com

Tuesday, March 21st, 2017 Uncategorized Comments Off on $FCEL and Korean-based POSCO Energy Announce Strategic Agreement

$GEMP to Present Phase 2 Clinical Gemcabene Data on Insulin Sensitization

Gemcabene Demonstrated a Doubling of the Glucose Disposal Rate and 40% LDL-C Reduction

LIVONIA, Mich., March 21, 2017 — Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, announced today the results of a Phase 2 trial that investigated insulin sensitization and LDL-C lowering by gemcabene in non-diabetic, obese patients. The results were featured in a poster presentation at the recent American College of Cardiology (ACC) 66th Annual Scientific Session in Washington, D.C.

“We are very encouraged by the meaningful effects on both the glucose disposal rate and LDL-C reduction in this study showcasing the differentiated cardiometabolic effects of gemcabene,” said Mina Sooch, CEO of Gemphire.  “As we progress the clinical development of gemcabene to include a Phase 2 trial (AZURE-1) in patients with NASH, the ability for gemcabene to impact severe glucose metabolism abnormalities could be another potential benefit in these patients who often have increased insulin resistance.   Also, the 40% reductions in LDL-C continue to support the potential for gemcabene to impact this important cardiovascular risk factor in ASCVD patients (which we are studying in the ROYAL-1 trial) particularly those with metabolic syndrome or type 2 diabetes.  We look forward to a transformational year in 2017 with data readouts expected from all three of our Phase 2b trials in dyslipidemia patients.”

Rebecca Bakker-Arkema, Gemphire’s Vice President of Drug & Clinical Development, presented the results of the double-blind, randomized, placebo controlled, Phase 2 trial (1027-014).  Fifty-three subjects, ranging in age from 26 to 63 years, BMI 30 to 40kg/m2, and fasting glucose <126mg/dL, entered the study.  Following a 2-week screening phase, subjects were randomized to receive either 900 mg gemcabene or placebo on Day 2 through Week 4.  A euglycemic hyperinsulinemic clamp study quantified glucose disposal rate (GDR), a measure of how well insulin is able to remove glucose from the circulation, before administration of study drug on Day 1 and again 1 hour following the last dose of gemcabene at the end of the fourth week of treatment.

The primary efficacy endpoint was insulin sensitivity as defined by average GDR (mg/kg per min) during the last 30 minutes of the 3-hour euglycemic hyperinsulinemic clamp study.  An increase in the GDR suggests an improvement in insulin function. The percentage change from baseline in the GDR was compared for the placebo and 900 mg gemcabene group using a 2-sample t-test.  Additionally, a post-hoc analysis was performed on mean percent change in LDL-C, total cholesterol (TC), TGs and GDR using a paired t-test.

Gemcabene was associated with a doubling of 13% mean increase in GDR compared to a 6.8% increase for placebo.  Although statistical significance was not observed in the pre-specified analysis, a post-hoc analysis more applicable to the size of this study showed a statistically significant change from baseline to Day 29 in GDR for gemcabene 900 mg (p<0.0178) versus a non-significant effect for placebo.

In addition, gemcabene 900 mg lowered LDL-C by 40% (p<0.0001) and TC by 27% (p<0.0001) consistent with past results in hypercholesterolemic subjects.  Gemcabene was generally well-tolerated.  There were no deaths, serious adverse events, or withdrawals due to adverse events during the study.

“The current clinical study was conducted in response to preclinical studies that showed increased insulin sensitivity in mouse 3T3 L1 adipocytes and obese diabetic rats by gemcabene,” said Charles Bisgaier, Ph.D., Chief Scientific Officer and Co-founder of Gemphire.  “The results from this clinical study support the evaluation of gemcabene on glycemic control measures and dyslipidemia in diabetic subjects expected to enroll across our planned clinical programs.”

To view the poster, please refer to the “Publications and Presentations” section of the company’s website at www.gemphire.com.

About Gemcabene
Gemphire’s product candidate, gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins.  Gemcabene’s mechanism of action is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibit the production of cholesterol and triglycerides in the liver.  The combined effect for these mechanisms has been clinically observed to result in a reduction of plasma VLDL-C, LDL-C, and triglycerides.  In addition, gemcabene has been shown to markedly lower C-reactive protein.  Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels.  Gemcabene also reduces acetyl-CoA carboxylase (ACC) and CCR2/CCR5 receptor mRNA levels, which may have applications in non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD).  Gemcabene has demonstrated proof of concept efficacy in the STAMTM model for NASH developed at SMC Laboratories in Tokyo, Japan.  Gemcabene has been tested as monotherapy and in combination with statins and other drugs in 895 subjects across 18 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.

About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH.  We are focused on providing new treatment options for cardiometabolic diseases through our complementary, convenient, cost-effective product candidate gemcabene as add-on to the standard of care especially statins that will benefit patients, physicians, and payors.  Gemphire has initiated 3 clinical trials for homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic cardiovascular disease (ASCVD), and severe hypertriglyceridemia (SHTG) under NCT02722408, NCT02634151, and NCT02944383, respectively with a fourth planned trial in NASH.  Please visit www.gemphire.com for more information.

Forward Looking Statements
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials and future expectations and plans and prospects for Gemphire, expectations regarding operating expenses and cash used in operations, and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” “scheduled” 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: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory requirements or developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the “Risk Factors” section of Gemphire’s Annual Report on Form 10-K for the period ended December 31, 2016, and in other filings Gemphire makes with the SEC from time to time.  In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof.  Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change.  However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.

Contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
(646) 597-6987

Jeff Mathiesen, CFO
Gemphire Therapeutics Inc.
(734)-245-1700
Tuesday, March 21st, 2017 Uncategorized Comments Off on $GEMP to Present Phase 2 Clinical Gemcabene Data on Insulin Sensitization

$SILC $17m Orders in Hand, $30m Projected Annual

Differentiated Cloud Products Pushing Silicom To A New Level

KFAR SAVA, Israel, March 21, 2017  — Silicom Ltd. (NASDAQ: SILC) today announced that it has achieved the most significant design win in its history. This design win, from a top-10 Cloud player, is for a highly customized version of Silicom’s 100-Gigabit high bandwidth switch fabric on a NIC cloud solution.

Based on this design win, Silicom has received initial purchase orders (POs) in the aggregate amount of $17 million to cover a small-volume Alpha phase, an intensive Beta program and the product’s first commercial deployment. Having completed deliveries for the Alpha phase, Silicom is now in the process of delivering the Beta-program products while completing two additional activities: 1) finalizing the product configuration and validating the solution’s performance within the servers in which the Silicom products will be deployed, in cooperation with a Tier-1 server manufacturer; and 2) ramping up product manufacturing to a full mass-production level. Based on the customer’s guidance, Silicom forecasts that revenues related to the design win will build to more than $30 million per year.

“We are very excited to have received what we believe will become the largest Design Win in our history – an achievement with the potential of being a game-changer for Silicom once development and ramp-up are finalized. While, due to the complexity of the product and its cutting edge technology, there remain challenges that we must overcome before large-scale data center commercial deployment can be assured, we believe we are on the right track for a successful conclusion. We are proud that our customer shares this view, as demonstrated by these sizeable initial purchase orders and its close, enthusiastic cooperation in the project,” commented Shaike Orbach, Silicom’s President & CEO.

“This groundbreaking design win is a clear demonstration of the success of our Cloud strategy, the cornerstone of our approach to appropriately address the industry’s transition to Cloud-based solutions. Our success demonstrates the power and urgency of the Cloud transformation, together with the superb fit of our unique connectivity products for the industry’s needs. The combination of strong market needs and our demonstrated competitive edge gives us confidence about our future prospects,” concluded Mr. Orbach.

About Silicom

Silicom Ltd. is an industry-leading provider of high-performance networking and data infrastructure solutions. Designed primarily to increase data center efficiency, Silicom’s solutions dramatically improve the performance and availability of networking appliances and other server-based systems.

Silicom’s products are used by a large and growing base of OEM customers, many of whom are market leaders, as performance-boosting solutions for their offerings in the Cyber Security, Network Monitoring and Analytics, Traffic Management, Application Delivery, WAN Optimization, High Frequency Trading and other mission-critical segments within the fast-growing data center, enterprise networking, virtualization, cloud computing and big data markets. Silicom’s product portfolio includes multi-port 1/10/25/40/100 Gigabit Ethernet server adapters, Intelligent Bypass solutions, Encryption accelerators, Ultra Low Latency solutions, Time Stamping and other innovative Smart adapters. These products are available for incorporation directly into our OEM customers’ systems, or provided as part of Silicom’s patented SETAC (Server To Appliance Converter), a unique approach to the provision of high quality standard platforms with modular front connectivity.

For more information, please visit: www.silicom.co.il

Statements in this press release which are not historical data are forward-looking statements which involve known and unknown risks, uncertainties, or other factors not under the company’s control, which may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not limited to, difficulty in commercializing and marketing of Silicom’s products and services, maintaining and protecting brand recognition, protection of intellectual property, competition and other factors detailed in the company’s periodic filings with the Securities and Exchange Commission. These forward-looking statements can generally be identified as such because the context of the statement will include words, such as “expects,” “should,” “believes,” “anticipates” or words of similar import. Similarly, statements that describe future plans, objectives or goals are also forward-looking statements. In light of significant risks and uncertainties inherent in forward-looking statements, the inclusion of such statements should not be regarded as a representation by the company that it will achieve such forward-looking statements. The company disclaims any duty to update such statements, whether as a result of new information, future events, or otherwise.

Company Contact:
Eran Gilad, CFO
Silicom Ltd.
Tel: +972-9-764-4555
E-mail: erang@silicom.co.il

Investor relations contact:
Ehud Helft
GK Investor Relations
Tel: +1-646-201-9246
E-mail : silicom@gkir.com

Tuesday, March 21st, 2017 Uncategorized Comments Off on $SILC $17m Orders in Hand, $30m Projected Annual

$PULM Receives European Patent for its iSPERSE Inhaled Drug Delivery Technology

The patent extends Pulmatrix’s broad protection for its innovative technology to Europe

LEXINGTON, Mass., March 21, 2017  — Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has received a key patent from the European Union.

“This new patent shows our continued ability to obtain patents that protect our unique iSPERSE inhaled drug technology—and that also reflect the advances we are making in drug delivery,” said Robert W. Clarke, Ph.D., Chief Executive Officer for Pulmatrix. “It gives us a strong intellectual property protection position in Europe as we move forward with our drug candidates for COPD, fungal infections, and other diseases.”

The new EU patent (EP 2410981 B1) follows on similar patents that Pulmatrix has been granted in the United States and Japan. The most important of those patents is US 9,433,576, which gives broad protection to Pulmatrix’s innovative drug delivery technology—and to its use to treat a wide variety of diseases.

These patents explain that delivering drugs directly to the lungs offers numerous advantages. But the full potential can’t be realized unless most of the drug actually gets to the lungs, rather than being stuck in the throat or mouth, causing side effects. Pulmatrix’s technology uses dry powders that ‘fly’ easily into the lungs, making the delivery much more efficient. In addition, the technology can deliver much larger doses of drugs—and many more different types of drugs—than existing methods can.

“This new patent means that we are now protected from competitors copying our advances in Europe, as well as in the United States,” added Dr. Clarke.

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. Such forward-looking statements include, but are not limited to, statements concerning the amount and use of proceeds the Company expects to receive from the sale of the shares of common stock in the registered direct offering, the closing of the transaction described in this press release, which is subject to customary conditions, and other statements that are not statements of historical fact, and may be identified by words such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that”, “may,” “plans,” “seeks,” “projects,” “targets,” and “would,” and their opposites and similar expressions are intended to identify forward-looking statements. 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, market and other conditions, the satisfaction of customary closing conditions related to the registered direct offering of common stock, 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 filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2017, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. 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

Tuesday, March 21st, 2017 Uncategorized Comments Off on $PULM Receives European Patent for its iSPERSE Inhaled Drug Delivery Technology

$KERX Announces the Largest Medicare Part D Plan Sponsor Added Auryxia

Additional formularies expand unrestricted access to Auryxia to approximately 85 percent of phosphate binder patients across Medicare Part D and commercial insurance providers

BOSTON, March 20, 2017 — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that the nation’s largest Medicare Part D plan sponsor has added Auryxia® (ferric citrate) to its Medicare Part D plan formularies, effective immediately. Auryxia is currently indicated in the U.S. for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis. Addition to these Part D plan formularies significantly increases unrestricted access to Auryxia for people on dialysis and their caregivers.

“We are pleased that another large insurance provider has recognized the value that Auryxia can bring to patients,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “The addition to these formularies, which covers both the remainder of 2017 and the full year 2018, will support continuing growth of Auryxia in dialysis as well as ensuring that we can provide broad access to Auryxia for people with iron deficiency anemia (IDA) and non-dialysis dependent (NDD) CKD, pending approval of this indication later this year.”

It is estimated that there are approximately 450,000 people in the U.S. who have End Stage Renal Disease (ESRD) and who require dialysis treatment. The majority of ESRD patients require chronic treatment with phosphate-binding medicines to lower and maintain serum phosphorus at acceptable levels. Medicare Part D and commercial insurance companies cover most of the prescription costs for people with ESRD, including the vast majority of phosphate binder prescriptions.

Keryx is seeking a label expansion for ferric citrate to include the treatment of iron deficiency anemia in adults with non-dialysis dependent CKD. A supplemental new drug application is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 6, 2017 for completion.

About Auryxia®

Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with CKD on dialysis. The U.S. approval of Auryxia was based on data from the company’s Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the established guidelines range of 3.5 to 5.5 mg/dL.

Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.

Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)

Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®.

Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.

Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.

Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.

Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.

Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.

For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/

Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, the expected impact of the new formulary coverage for Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: whether we can increase adoption of Auryxia in patients with CKD on dialysis; the risk that expanded formulary access to Auryxia may not lead to increased adoption or sales; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate), an iron-based phosphate binder, in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis depended chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.

 

KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Senior Vice President, Corporate Affairs
T: 617.466.3519 
amy.sullivan@keryx.com

Lora Pike
Senior Director, Investor Relations
T: 617.466.3511
lora.pike@keryx.com
Monday, March 20th, 2017 Uncategorized Comments Off on $KERX Announces the Largest Medicare Part D Plan Sponsor Added Auryxia

$HAWK and JANA Partners Announce Addition of Two New Independent Directors to Board

JANA Partners Agrees to Support All Nominees at 2017 Annual Meeting

PLEASANTON, Calif., March 20, 2017 — Blackhawk Network Holdings, Inc. (NASDAQ:HAWK) and JANA Partners LLC today announced that the Company will add two new independent directors to its Board of Directors, effective no later than April 24, 2017.  These two directors will be on Blackhawk’s slate of directors nominated for election to the Board of Directors at the Company’s 2017 Annual Meeting, along with eleven incumbents, pursuant to an agreement with JANA Partners LLC.  The two new directors will be Robert Henske and Jeffrey H. Fox.  Biographical information on the new directors is provided below.  The Board will increase to thirteen members from the current eleven.

Under the agreement with JANA, Blackhawk will also form a Cost Savings Committee of the Board that will evaluate all options for increasing cost savings, including by, if the Cost Savings Committee so determines, engaging a cost consultant.  The Committee will be comprised of four members, two of whom will be the new directors.

In addition, Jerry Ulrich, the Company’s Chief Financial Officer, announced that he plans to retire by the end of this year after 11 years with the Company. The Company has initiated a search to identify a replacement for Ulrich, with assistance from Mr. Henske and other Board members.  The Company also reaffirmed all previous 2017 guidance.  “We’re very grateful to Jerry for his significant contributions to the success of Blackhawk,” said Talbott Roche, Chief Executive Officer of Blackhawk.  “Jerry has been a great leader, colleague and friend, and I appreciate his strong commitment to the Company.”

Mr. Ulrich added, “I’ve been honored to be part of a great team at Blackhawk and look forward to assisting the Company with the search and transition process.”

As previously disclosed, the Blackhawk Board has also been engaged in succession planning for Bill Tauscher’s responsibilities as Head of International leading the Company’s international business and its corporate development strategy and execution.  Mr. Tauscher anticipates stepping down from his international responsibilities in 2017 as a search and transition is completed.  In addition, a similar transition is planned for Mr. Tauscher’s corporate development responsibilities following the transition of his international responsibilities.  Mr. Tauscher intends to continue serving as Chairman of the Blackhawk Board.  Roche said, “Bill’s service to the Company has been integral to our success. I look forward to his continued support as Chairman of the Board.”

Blackhawk also announced that it intends to restructure equity compensation for the Company’s named executive officers beginning in 2018 to enhance alignment with stockholder value creation.  In addition, the Company has made certain changes to its compensation practices that will result in a lower dilution rate for 2017.

Barry Rosenstein, Managing Partner of JANA Partners, said, “We have appreciated our constructive dialogue with Bill Tauscher, Talbott Roche and their team.  We believe that all Blackhawk stockholders will benefit from Jeff’s and Robert’s experience as the Company enhances its operational efficiency, including through the creation of the Cost Savings Committee, and makes the other value-creating enhancements announced today.”  JANA Partners currently owns approximately 4.7 percent of the Company’s outstanding common stock.

The director nominations will be included in the Company’s 2017 proxy statement and submitted for stockholder approval at the Company’s 2017 Annual Meeting, to be held on June 9, 2017.  The Company expects to file its proxy materials for the 2017 Annual Meeting in the near future and encourages stockholders to review the proxy materials when they become available.

In connection with the appointments, Blackhawk and JANA have entered into a cooperation agreement.  Under the agreement, Blackhawk has agreed to nominate Mr. Henske and Mr. Fox for election to the Board at the Company’s 2017 Annual Meeting and JANA has agreed to customary standstill and voting commitments.  The cooperation agreement will be filed with the Securities and Exchange Commission.

Biographical Information on New Director Nominees
Jeffrey H. Fox is a principal of The Circumference Group LLC, an investment and advisory firm which he founded in 2009. Mr. Fox was President and Chief Executive Officer of Convergys Corporation from 2010 to November 2012, and then Executive Chairman until April 2013. Previously, Mr. Fox worked for Alltel Corporation as Chief Operating Officer from 2007 through 2008, and as a Group President from 1996 until 2007. Prior to joining Alltel, Mr. Fox worked in investment banking for ten years with Stephens Inc., preceded by two years with Merrill Lynch, specializing in mergers and acquisitions advisory services. Mr. Fox also currently serves as non-executive Chairman of the Board of Convergys Corporation (NYSE:CVG) and as a member of the Board of Avis Budget Group, Inc. (NASDAQ:CAR).

Robert B. Henske served as a Managing Director at Hellman & Friedman LLC from July 2007 through 2014, and as a Senior Advisor from 2014 to 2016. From May 2005 until July 2007, he served as Senior Vice President and General Manager of the Consumer Tax Group of Intuit Inc. He was Intuit’s CFO from January 2003 to September 2005. Prior to joining Intuit, he served as Senior Vice President and CFO of Synopsys, Inc., a supplier of electronic design automation software, from May 2000 until January 2003. From January 1997 to May 2000, Mr. Henske was a partner at Oak Hill Capital Management, a Robert M. Bass Group private equity investment firm. Prior to that he was a Partner at Bain & Company.  Mr. Henske has served as a director of VeriFone Systems, Inc. (NYSE:PAY) since January 2005.

About Blackhawk Network Holdings, Inc.
Blackhawk Network Holdings, Inc. (NASDAQ:HAWK) is a leading global stored value and payments provider, which supports the program management and distribution of gift cards, telecom products, and financial services products in retail, digital and incentive channels. Blackhawk’s digital platform enables the management of stored value products, promotions, and loyalty programs across a network of digital distribution partners including retailers, financial service providers, and mobile wallets. For more information, please visit www.blackhawknetwork.com or product websites Cardpool, Gift Card Lab, Gift Card Mall, GiftCards.com and OmniCard.

Forward-Looking Statements
This press 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. Forward-looking statements are indicated by words or phrases such as “guidance,” “believes,” “expects,” “forecasts,” “projects,” “outlook,” “anticipates,” “estimates,” “plans,” “continuing,” “ongoing,” and similar words or phrases and the negative of such words and phrases. Forward-looking statements are based on our current plans and expectations and involve risks and uncertainties which are, in many instances, beyond Blackhawk’s control, and which could cause actual results to differ materially from those included in or contemplated or implied by the forward-looking statements. Such risks and uncertainties include the following:  Blackhawk’s ability to grow adjusted operating revenues and adjusted net income as anticipated; Blackhawk’s ability to grow at historic rates or at all; the consequences should Blackhawk lose one or more of its top distribution partners or fail to attract new distribution partners to its network or if the financial performance of Blackhawk’s distribution partners’ businesses decline; Blackhawk’s reliance on its content providers; the demand for their products and Blackhawk’s exclusivity arrangements with them; Blackhawk’s reliance on relationships with card issuing banks; the consequences to Blackhawk’s future growth if its distribution partners fail to actively and effectively promote its products and services; the timing and manner that Blackhawk’s distribution partners restore the full offering of Blackhawk’s products after they achieve EMV compliance; changes in consumer behavior away from Blackhawk’s distribution partners or our products resulting from limits or controls implemented by Blackhawk’s distribution partners during their transition to EMV compliance; the consequences if consumers do not return to purchase Blackhawk’s products at distribution partner stores; the requirement that Blackhawk comply with applicable laws and regulations, including increasingly stringent money-laundering rules and regulations; and other risks and uncertainties described in Blackhawk’s reports and filings with the Securities and Exchange Commission (the “SEC”), including the risks and uncertainties set forth in Item 1A under the heading Risk Factors in Blackhawk’s Annual Report Form 10-K for the year ended January 2, 2016 which was filed on March 2, 2016, in Blackhawk’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 10, 2016 which was filed on October 19, 2016 and in Blackhawk’s Form 10-K for the year ended December 31, 2016 which was filed on February 27, 2017, and other subsequent periodic reports Blackhawk files with the Securities and Exchange Commission.  Blackhawk undertakes no obligation to update forward-looking statements to reflect developments or information obtained after the date hereof and disclaims any obligation to do so other than as may be required by law.

INVESTORS/ANALYSTS:
Patrick Cronin
(925) 226-9973
investor.relations@bhnetwork.com

MEDIA:
Abernathy MacGregor
Pat Tucker, PCT@abmac.com, 212-371-5999
Jim Lucas, JBL@abmac.com, 213-630-6550
Monday, March 20th, 2017 Uncategorized Comments Off on $HAWK and JANA Partners Announce Addition of Two New Independent Directors to Board

$ALSK Announces Tender Offer for Outstanding 6.25% Convertible Notes Due 2018

Alaska Communications Systems Group, Inc. (NASDAQ: ALSK) (the “Company”) today announced a tender offer (the “Tender Offer”) to purchase any and all of its outstanding 6.25% Convertible Notes due 2018 (the “Notes”). As of March 17, 2017, there were $94.0 million aggregate principal amount of the Notes outstanding.

Upon the terms and subject to the conditions set forth in the Company’s Offer to Purchase, dated March 17, 2017 (the “Offer to Purchase”), and the related Letter of Transmittal, the Company is offering to pay, for cash, an amount equal to $1,025 per $1,000 principal amount of Notes purchased. The Tender Offer will expire at 12:00 midnight, New York City time, on April 14, 2017 (one minute after 11:59 p.m., New York City time, on April 13, 2017), or any other date and time to which the Company extends such Tender Offer (such date and time, as it may be extended, the “Expiration Date”), unless earlier terminated.

The Tender Offer is subject to the satisfaction or waiver of certain conditions, as described in the Offer to Purchase. The Tender Offer is not conditioned upon a minimum amount of Notes being tendered.

For Notes that have been validly tendered at or prior to the Expiration Date and that are accepted for purchase pursuant to the Tender Offer, settlement will occur within three business days following the Expiration Date, assuming the conditions to the Tender Offer have been either satisfied or waived by the Company (including a financing condition) at or prior to the Expiration Date as further described in the Offer to Purchase. Accrued and unpaid interest on the Notes, if any, up to, but not including, the settlement date, will also be paid in cash on all Notes purchased in the Tender Offer.

The complete terms and conditions of the Tender Offer are set forth in the Offer to Purchase and related Letter of Transmittal that are being sent to holders of the Notes. Copies of the Offer to Purchase and Letter of Transmittal may be obtained from the Information Agent for the Tender Offer, Global Bondholder Services Corporation, at (866) 470-4200 (US toll-free) or (212) 430-3774 (collect).

Odeon Capital Group LLC is acting as the Dealer Manager for the Tender Offer. Questions regarding the Tender Offer may be directed to Odeon Capital Group LLC at (212) 257-6164 (collect).

Forward-Looking Statements

This press release includes certain “forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s beliefs as well as on a number of assumptions concerning future events made using information currently available to management. Readers are cautioned not to put undue reliance on such forward-looking statements, which are not a guarantee of performance and are subject to a number of uncertainties and other factors, many of which are outside the Company’s control. Such factors include, without limitation, Federal and Alaska Universal Service Fund changes, the Company’s ability to meet the terms and conditions of its new credit facility, draw down funds under the facility and continue to meet its requirements, the Company’s ability to meet the conditions of and complete the Tender Offer, adverse economic conditions, the effects of competition in the Company’s markets, its relatively small size compared with its competitors, its ability to compete, manage, integrate, market, maintain, and attract sufficient customers for its products and services, adverse changes in labor matters, including workforce levels, the Company’s ability to service its debt (including pursuant to refinanced credit arrangements) and refinance as required, labor negotiations, including renegotiating the collective bargaining agreement, employee benefit costs, the Company’s ability to control other operating costs, disruption of suppliers’ provisioning of critical products or services, the impact of natural or man-made disasters, changes in the Company’s relationships with large customers, unforeseen changes in public policies, regulatory changes, changes in technology and standards, its internal control over financial reporting, and changes in accounting standards or policies, which could affect reported financial results. For further information regarding risks and uncertainties associated with the Company’s business, please refer to its SEC filings, including, but not limited to, the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in its most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. Copies of the Company’s SEC filings may be obtained by contacting its investor relations department at (907) 564-7556 or by visiting its investor relations website at www.alsk.com or at the SEC’s website, www.sec.gov.

Important Information Regarding the Tender Offer

This press release is for informational purposes only and is neither an offer to buy nor the solicitation of an offer to sell any and all of the Company’s outstanding 6.25% Convertible Notes due 2018. The Tender Offer will be made solely by the Offer to Purchase, the Letter of Transmittal and related materials, as they may be amended or supplemented. Holders should read the Company’s commencement Tender Offer statement on Schedule TO filed with the SEC in connection with the Tender Offer, which will include as exhibits the Offer to Purchase, the Letter of Transmittal and related materials, as well as any amendments or supplements to the Schedule TO when they become available, because they will contain important information. Each of these documents will be filed with the SEC, and, when available, holders may obtain them for free from the SEC at its website (www.sec.gov) or from the Company’s information agent in connection with the Tender Offer.

About Alaska Communications

Alaska Communications (NASDAQ: ALSK) is the leading provider of advanced broadband and managed IT services for businesses and consumers in Alaska. The company operates a highly reliable, advanced statewide data network with the latest technology and the most diverse undersea fiber optic system connecting Alaska to the contiguous U.S. For more information, visit www.alaskacommunications.com or www.alsk.com.

 

Alaska Communications
Media Contact:
Heather Cavanaugh, 907-564-7722
or
Investor Contact:
Tiffany Smith, 907-564-7556
investors@acsalaska.com

Monday, March 20th, 2017 Uncategorized Comments Off on $ALSK Announces Tender Offer for Outstanding 6.25% Convertible Notes Due 2018

$NKTR NKTR-181 Meets Primary and Secondary Endpoints in Phase 3

NKTR-181 Significantly Reduced Pain in Patients with Moderate to Severe Chronic Low Back Pain Primary Efficacy Endpoint Achieved (p=0.0019) Analyst Conference Call and Webcast Today at 5:45 a.m. PDT/8:45 a.m. EDT

SAN FRANCISCO, March 20, 2017 — Nektar Therapeutics (Nasdaq: NKTR) today announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic.  NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.1  The U.S. Food and Drug Administration (FDA) has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

“The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study,” said clinical investigator Martin Hale, M.D., medical director of Gold Coast Research. “While standard opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction.  The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions.”

The SUMMIT-07 study compared twice-daily dosing of NKTR-181 tablets to placebo in the treatment of over 600 patients with moderate to severe chronic low back pain who were new to opioid therapy (opioid-naïve). The clinical trial met the primary efficacy endpoint of the study in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study were also met with high statistical significance.

Pain is one of the most common reasons people seek medical treatment.2 Low back pain is the second most common cause of disability for adults in the U.S. 3 Approximately 149 million work days are lost every year because of low back pain, with total costs estimated to be $100 to 200 billion a year (of which two-thirds is due to lost wages and lower productivity).4 A study published in the American Pain Society’s The Journal of Pain in October 2014 estimated that 19 percent of the U.S. population, or 39 million people, suffer from some type of persistent pain.5

The Phase 3 SUMMIT-07 study used an enriched-enrollment randomized withdrawal (EERW) trial design in patients with moderate to severe chronic low back pain. The trial included an open-label titration period in which patients were titrated to a tolerated, effective dose of NKTR-181 (100 mg to 400 mg twice-daily). Following this open-label titration period, patients entered a double-blind, placebo-controlled treatment period in which they were randomized 1:1 to either continue to receive the tolerated, effective dose of NKTR-181 or to receive matching placebo (i.e. active drug was withdrawn) for a period of 12 weeks.

During the open-label titration period of the trial in which patients were titrated to a tolerated, effective dose of NKTR-181, average pain scores dropped by 65% (from 6.73 at screening to 2.32 at randomization, n=610).

The primary endpoint of the study was mean change in the weekly average pain score in the double-blind randomized treatment period from baseline (end of open-label titration period) to week 12 (end of double-blind randomized treatment period).

Primary and key sensitivity analyses:

  • During the double-blind randomized treatment period of the trial, average pain scores increased more in the placebo arm versus NKTR-181 at week 12 from randomization baseline (1.46, placebo versus 0.92, NKTR-181, p=0.0019, n=610).
  • 83% of patients completed the 12-week double-blind randomized treatment period and for these study completers, average pain scores increased more in the placebo arm versus NKTR-181 at week 12 from baseline (1.25, placebo versus 0.56, NKTR-181, p<0.0001, n=504).

Key secondary endpoints:

  • A statistically significant proportion of patients on NKTR-181 experienced pain reductions greater than 30% compared to placebo (71.2% versus 57.1%; p=0.0003).
  • A statistically significant proportion of patients on NKTR-181 experienced pain reductions greater than 50% compared to placebo (51.1% versus 37.9%; p=0.001).
  • A statistically significant proportion of patients on NKTR-181 reported their general overall status and quality of life as “improved” or “very much improved” compared to placebo as assessed by the Patient’s Global Impression of Change (PGIC) of pain medication questionnaire (51.5% versus 33.2%; p<0.0001).

The study also demonstrated that NKTR-181 had a favorable safety profile and was well tolerated. During the double-blind randomized treatment period, the most commonly reported adverse events for patients (>5%) were nausea (10.4%) and constipation (8.7%) in the NKTR-181 arm as compared to nausea (6.0%) and constipation (3.0%) in the placebo arm.

Patients randomized to NKTR-181 as compared to placebo reported more favorable sleep outcomes as measured by the validated Medical Outcomes Study (MOS) Sleep Scale, which captures debilitating aspects of sleep most strongly associated with chronic pain.  Patients reported better overall quality of sleep with less sleep problems on NKTR-181 versus placebo. There were no differences in daytime sleepiness on NKTR-181 versus placebo.

Full data from the SUMMIT-07 study will be presented at a medical meeting in the second half of 2017.

“As a new molecule, NKTR-181 has a highly differentiated profile with the potential to be one of the most important advancements in pain medicine,” said Howard W. Robin, President and CEO of Nektar Therapeutics. “Given the seriousness of the current opioid epidemic in the U.S. and the significant number of people battling chronic pain, we are committed to bringing this new molecule to patients and physicians as quickly as possible.”

In March 2017, results from a separate human abuse potential trial of NKTR-181 were published in the American Academy of Pain Medicine’s journal of Pain Medicine. The human abuse potential study assessed the relative abuse potential of a range of therapeutic doses of NKTR-181 (100 mg to 400 mg), the same dose range evaluated in the Phase 3 SUMMIT-07 efficacy trial.  All doses of NKTR-181 tested for abuse potential were rated similarly to placebo in “drug liking” and “feeling high” scores and had highly statistically significant lower “drug liking” scores and reduced “feeling high” scores as compared to 40 mg oxycodone (p < 0.0001).  In addition, all doses of NKTR-181 also scored lower on sleepiness when compared to 40 mg oxycodone (p < 0.0001).

“It is clear that there is a pressing societal need for better and safer analgesics,” said Dr. Jack Henningfield, Ph.D., Adjunct Professor of Behavioral Biology in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine and Head of Health Policy and Abuse Liability at Pinney & Associates in Bethesda, MD. “In the human abuse potential study, even the highest analgesic dose of NKTR-181 was barely distinguishable from placebo with respect to both drug-liking and feeling high and these effects were modest compared to those produced by oxycodone.  Drug-liking and feeling high are two of the most important metrics that help us understand the abuse potential of a medicine.  Importantly, as NKTR-181 is a new chemical entity, the properties of NKTR-181 are inherent to its molecular structure and independent of any abuse-deterrent formulation.  Today’s reported efficacy and safety results, along with the human abuse potential data published this past week in Pain Medicine, suggest NKTR-181 may be a major advance towards safer opioid therapy for the treatment of moderate to severe chronic pain.”

Conference Call and Webcast Information
Nektar will host a conference call and webcast presentation today, March 20, 2017, at 8:45 a.m. Eastern Daylight Time to discuss the study results. The call can be accessed by dialing (877) 881-2183 (U.S.) or (970) 315-0453 (international), and entering passcode 89288091. To access the live webcast, or the subsequent archived recording, visit the Investors section of the Nektar website at www.nektar.com. The webcast will be available for replay on Nektar’s website for two weeks following the call.

About NKTR-181
NKTR-181 is the first long-acting, selective mu-opioid agonist designed to provide potent pain relief without the inherent high levels of euphoria which lead to abuse and addiction with standard opioids.  The novel molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier in order to slow its rate of entry into the brain and attenuate the dopamine release that underlies euphoria.  NKTR-181 is the first opioid molecule to exhibit reduction in specific CNS-mediated side effects, like euphoria, through the strategic alteration of brain-entry kinetics.  NKTR-181 is an investigational product and has not been approved by the FDA or any other regulatory agencies.

Current strategies of abuse deterrence to address the addictive qualities of standard opioids rely on formulations alone.  All abuse-deterrent formulations are limited in that once the opioid within the formulation is liberated through tampering, it can rapidly enter the brain and is highly euphorigenic.  Preclinical data show that the inherent properties of NKTR-181 reduce its rate of entry into the brain compared to standard mu opioids, regardless of route of administration.12

About the SUMMIT-07 Study Design
SUMMIT-07 used an enriched-enrollment, randomized withdrawal (EERW) design and enrolled opioid-naïve patients ages 18 to 75 years who had moderate to severe non-neuropathic chronic low back pain for at least six months. The study included an open-label, dose-titration period followed by a randomized, double-blind, placebo-controlled 12-week treatment period.

During the open-label titration phase, study participants with pain scores of between 5 and 9 were titrated on NKTR-181 tablets administered orally twice daily until they experienced an adequate and sustained pain response (a drop of at least 2 points and a pain score below 4 on the numeric rating scale (NRS) of 0-10).

Patients who achieved this were then randomized on a 1:1 basis to either continue receiving their analgesic dose of NKTR-181 or to receive placebo (i.e. the active drug was withdrawn) during the double-blind 12-week treatment period. A total of 610 patients were randomized into the double-blind treatment period.  The primary outcome was based on assessing worsening of pain in the placebo arm relative to the active arm for patients who achieved substantial analgesic responses with NKTR-181.  The primary efficacy endpoint was a change in pain as measured by the change in a patient’s weekly pain score from baseline to week 12 of the randomized, double-blind, treatment period.

About Opioids and Abuse
Pain is one of the most common reasons people seek medical treatment.2 A study published in the American Pain Society’s The Journal of Pain in October 2014 estimated that 19 percent of the U.S. population, or 39 million people, suffer from persistent pain.5

Opioids are considered the most effective therapeutic option for pain. In 2016, 230 million opioid prescriptions were written in the U.S.However, these painkillers can cause serious side effects such as respiratory depression and sedation, and they have the potential for addiction, abuse and misuse.In 2014, nearly 2 million Americans either abused or were dependent on prescription opioid pain relievers.One in five Americans say they have a family member who has been addicted to prescription painkillers.In 2015, there were nearly 22,000 deaths involving prescription opioids in the U.S.10

According to a 2011 Institute of Medicine Report, pain is a significant public health problem that costs society at least $560 to 635 billion annually.2 In the U.S., prescription opioid abuse costs were about $78.5 billion in 2013.11

About Nektar Therapeutics
Nektar Therapeutics is a research-based biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: “plan,” “expect,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential therapeutic benefit of NKTR-181 for treating patients with pain, the potential importance of NKTR-181’s development in the area of new pain medicines, the risks of opioid abuse resulting from new and existing pain medicines, future development plans for NKTR-181 (including, but not limited to, future clinical development plans and future regulatory filings seeking regulatory approval for NKTR-181), the potential timeframe for commercial availability of NKTR-181, and certain other statements regarding the prospects and potential of NKTR-181 specifically, and Nektar’s business and technology platform generally.  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) challenges and uncertainties inherent in pharmaceutical research and development, including the uncertainty of future clinical and regulatory success, where the risk of failure remains high and failure can unexpectedly occur at any stage prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors; (ii) the regulatory pathway to review and approve NKTR-181 for use in patients, even with a Fast Track designation by the FDA, is subject to substantial uncertainty; (iii) regulations concerning and controlling the access to opioid-based pharmaceuticals are strict and there is no guarantee which scheduling category will apply to NKTR-181 if regulatory approval is achieved; (iv) the partnering process for NKTR-181 is at a very early stage and there is therefore substantial uncertainty as to the timing and terms of a potential partnership, or the success of our partnering efforts; (v) drug manufacturing challenges which can delay or render unavailable sufficient supplies of NKTR-181; (vi) changing standards of care and new regulations (including, but not limited to, standards and regulations related to health care cost containment) can affect the use NKTR-181 and commercial success following a regulatory approval; (vii) Nektar’s patent applications for NKTR-181 may not issue in one or more jurisdictions, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required in the future; (viii) the outcome of any existing or future intellectual property or other litigation related to Nektar’s proprietary product candidates, including, without limitation, NKTR-181, is unpredictable and could have a material adverse effect on our business; and (ix) certain other important risks and uncertainties set forth in Nektar’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission on March 1, 2017. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585

Jodi Sievers of Nektar Therapeutics
415-482-5593

For Media:
Dan Budwick of Pure Communications
973-271-6085
dan@purecommunications.com

  1. Hyman, Steven E., Harvard Review of Psychiatry. 2(1):43-46, May/June 1994.
  2. 2011 National Academy of Sciences. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research, 2010 Decision Resources, and Harstall, C. How prevalent is chronic pain? Pain Clinical Updates X, 1-4 (2003).
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  9. The Washington Post/Kaiser Family Foundation Survey of Long-Term Prescription Painkiller Users and Their Household Members: http://kff.org/other/report/the-washington-post-kaiser-family-foundation-survey-of-long-term-prescription-painkiller-users-and-their-household-members.
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  12. 2010 Society of Neuroscience Annual Meeting (Nov 13-17, #HHH11).
Monday, March 20th, 2017 Uncategorized Comments Off on $NKTR NKTR-181 Meets Primary and Secondary Endpoints in Phase 3

$ESPR FDA Confirmation Pathway to Approval for an LDL-C

– Global Pivotal Phase 3 Program Design Can Support Approval for an LDL-C Lowering Indication –
– Proposed LDL-C Lowering Indication Will Include Patients with High CVD Risk, Specifically Those with ASCVD and/or HeFH –
– On Track to Submit NDA for an LDL-C Lowering Indication by 1H 2019 –
– Conference Call and Webcast on Monday, March 20, 2017 at 8:00 a.m. Eastern Time –

ANN ARBOR, Mich., March 20, 2017 — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.

Esperion plans to submit a new drug application (NDA) by 1H 2019 for an LDL-C lowering indication based on the successful completion of the global pivotal Phase 3 program. The proposed product label would include specific language for use of bempedoic acid as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia, specifically those at high cardiovascular disease (CVD) risk with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) who require additional LDL-C lowering.

“We are very pleased to have achieved clarity from FDA regarding Esperion’s LDL-C lowering development program,” said Tim M. Mayleben, president and chief executive officer of Esperion. “Our experienced lipid management team has worked closely with regulatory authorities and our key advisors to achieve this encouraging outcome. We continue to believe that bempedoic acid has the potential to provide physicians with a complementary and convenient oral treatment option that’s cost-effective for their patients with hypercholesterolemia who require additional LDL-C lowering. We remain focused on completing the global pivotal Phase 3 program for bempedoic acid and reporting top-line results from our long-term safety and tolerability study by Q2 2018 and top-line results from our ongoing Phase 3 LDL-C lowering efficacy studies by mid-2018.”

Interactions with FDA also addressed the ongoing cardiovascular outcomes trial (CVOT), Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen (CLEAR) Outcomes for bempedoic acid in patients with or at high risk for CVD who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered statin intolerant. For purposes of the CVOT, agreement has been reached with FDA that the following definition of statin intolerance is acceptable for the CVOT: “the inability to tolerate two or more statins, one at the lowest approved daily starting dose, due to an adverse effect,” as defined in CLEAR Outcomes. The lowest approved daily starting statin doses include an average daily dose of <5 mg rosuvastatin, <10 mg of atorvastatin, <10 mg simvastatin, <20 mg lovastatin, <40 mg pravastatin, <40 mg fluvastatin and <2 mg of pitavastatin. In CLEAR Outcomes, patients and investigators will provide written confirmation that the patient is statin intolerant and that the patient is aware of the benefits of statins in reducing the risk of cardiovascular events and death. The Company expects to submit an NDA for a cardiovascular disease risk reduction indication to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) by 2022, upon successful completion of CLEAR Outcomes.

Global Pivotal Phase 3 Program

The Phase 3 clinical development program initiated in January 2016 with a global pivotal 52-week long-term safety and tolerability study (Study 1) in patients with hypercholesterolemia (with ASCVD and/or HeFH) at high CVD risk and whose LDL-C is not adequately controlled with current lipid-modifying therapies. Patient enrollment of more than 2,200 patients was completed in January 2017 and top-line results from this study are expected by Q2 2018. An open-label extension study (1002-050) of Study 1 was initiated in February 2017 to collect additional patient safety data.

Three additional global pivotal Phase 3 LDL-C lowering efficacy studies initiated in December 2016 and are currently enrolling patients at high CVD risk with hypercholesterolemia who are inadequately treated with current lipid-modifying therapies and require additional LDL-C lowering:

  • Study 2: patients with ASCVD and/or HeFH who have LDL-C levels of ≥100 mg/dL;
  • Study 3: patients who are only able to tolerate less than the lowest approved daily starting dose of their statin and considered “statin intolerant” who have LDL-C levels of ≥100 mg/dL;
  • Study 4: patients on low dose or less than low dose of their statin who are taking ezetimibe who have LDL-C levels of ≥100 mg/dL.

The overall global pivotal Phase 3 program is expected to enroll approximately 3,200 patients at high CVD risk with hypercholesterolemia on optimized background lipid-modifying therapy. Top-line results from our long-term safety and tolerability study are expected by Q2 2018 with top-line results from the three LDL-C lowering efficacy studies expected by mid-2018. Submissions of an NDA to the FDA and a MAA to the EMA for an LDL-C lowering indication are expected by 1H 2019.

CLEAR Outcomes CVOT

The CLEAR Outcomes CVOT, initiated in the fourth quarter of 2016, is expected to enroll approximately 12,600 patients with hypercholesterolemia and high CVD risk at more than 600 sites in approximately 30 countries. Patients enrolling in the study will be required to have a history of, or be at high-risk for, CVD with LDL-C levels between 100 mg/dL and 190 mg/dL despite background lipid-lowering therapy, resulting in an expected average baseline LDL-C level in all patients of approximately 135 mg/dL. The CVOT is currently enrolling patients, expected to enroll over a 30-month period and on track to be well-underway by 1H 2019, when we expect to submit our LDL-C lowering indication global regulatory submissions.

The Company expects to submit an NDA for cardiovascular disease risk reduction to the FDA and a MAA to EMA by 2022, upon the successful completion of CLEAR Outcomes.

Conference Call and Webcast Information

Esperion’s lipid management team will host a conference call to discuss these updates. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 81741000. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at investor.esperion.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the Company’s website for approximately 90 days.

About Bempedoic Acid

With a targeted mechanism of action, bempedoic acid is a first-in-class, orally available, once-daily ACL inhibitor that has been shown to reduce cholesterol biosynthesis and lower elevated levels of LDL-C by up-regulating the LDL receptor, but may potentially reduce the occurrence of muscle-related side effects. Completed Phase 1 and 2 studies in more than 800 patients treated with bempedoic acid have produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy, approximately 50 percent in combination with ezetimibe, and an incremental 20+ percent when added to stable statin therapy.

Esperion’s Commitment to Patients with Hypercholesterolemia

In the United States, 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in Europe and 30 million people in Japan also live with elevated LDL-C. Esperion’s mission as the lipid management company is to provide patients and physicians with convenient, complementary, cost-effective, once-daily, oral therapies to significantly reduce elevated levels of LDL-C in patients inadequately treated with current lipid-modifying therapies. It is estimated that 40 million patients in the U.S. are taking statins with approximately 5-20 percent of these patients only able to tolerate less than the lowest approved daily starting dose of their statin and considered “statin intolerant.” Esperion-discovered and developed, bempedoic acid is a targeted LDL-C lowering therapy in Phase 3 development. The Company has two Phase 3 products in development: 1) bempedoic acid (monotherapy) an oral, once-daily pill, and 2) an oral, once-daily fixed dose combination pill of bempedoic acid and ezetimibe (BA+EZ).

The Lipid Management Company

Esperion Therapeutics, Inc. is the lipid management company passionately committed to developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated LDL-C. Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced lipid management team at Esperion is committed to developing new LDL-C lowering therapies that will make a substantial impact on reducing global CVD; the leading cause of death around the world. Bempedoic acid, the Company’s lead product candidate, is a targeted therapy that has been shown to significantly reduce elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the regulatory approval pathway for bempedoic acid, the therapeutic potential of, and clinical development plan for, bempedoic acid, including the Company’s timing, designs, plans, and announcement of results regarding its global Phase 3 long-term safety and tolerability program for bempedoic acid. Any express or implied statements contained in this press release that are not statements of historical fact, including interpretation of guidance given by the FDA, may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, changes in the FDA guidance for regulatory approval, delays or failures in the Company’s studies, including risks regarding the FDA’s interpretation of the Company’s clinical trial results, the risk that U.S. Food and Drug Administration may require additional studies or data, that Esperion may need to change the design of its Phase 3 program, that positive results from a clinical study of bempedoic acid may not be sufficient for FDA approval or necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, that existing cash resources may be used more quickly than anticipated, that Esperion’s global Phase 3 long-term safety and tolerability program for bempedoic acid may not produce sufficient safety or tolerability results or show meaningful change in LDL-C or other key lipid measures of patients, if approved that Esperion’s product could have labeling restrictions that impact its marketing and adoption, or the risk that other unanticipated developments or data could interfere with the scope of development and commercialization of bempedoic acid, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. The FDA guidance described in this release was given as of a specific date and the FDA could change its position on the clinical endpoints or other standards for review/approval. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Actual results could differ from those described therein. Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

Media Contact:
Elliot Fox
W2O Group 
212.257.6724
efox@w2ogroup.com

Investor Contact: 
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
Monday, March 20th, 2017 Uncategorized Comments Off on $ESPR FDA Confirmation Pathway to Approval for an LDL-C

$SBBP Announces New Employment Inducement Awards

DUBLIN, Ireland and TREVOSE, Pa., March 17, 2017 — Strongbridge Biopharma plc, (Nasdaq:SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it has approved inducement equity awards to 17 individuals who have recently become, or are expected to become, non-executive employees of the Company.

The inducement awards are being made in the form of non-qualified stock options to purchase an aggregate of 326,000 ordinary shares of the Company, and are being made as a material inducement to these individuals to enter into employment with the Company pursuant to NASDAQ Listing Rule 5635(c)(4).

The exercise price of the options will be equal to the closing price of the Company’s ordinary shares on the grant date and will be exercisable in 16 equal quarterly installments following the grant date, subject to the employee’s continuous employment with the Company.  The options will have a ten-year term and will be subject to the terms and conditions of the Company’s 2017 Inducement Plan, pursuant to which the options have been, or will be, granted.

About Strongbridge Biopharma
Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s first commercial product is KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022. In addition to establishing this neuromuscular disease franchise, the Company has a clinical-stage pipeline of therapies for rare endocrine diseases. Strongbridge’s lead compounds include COR-003 (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing’s syndrome, and COR-005, a next-generation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional applications in Cushing’s syndrome and neuroendocrine tumors. Both COR-003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties.  All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge’s strategy, plans, and objectives of management for future operations. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

Contacts:

Corporate and Media Relations
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
lrocco@elixirhealthpr.com

Investor Relations
The Trout Group
Marcy Nanus
+1 646-378-2927
mnanus@troutgroup.com

USA
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Tel. +1 610-254-9200
Fax. +1 215-355-7389
Friday, March 17th, 2017 Uncategorized Comments Off on $SBBP Announces New Employment Inducement Awards

$ATRA Interim Results Phase 1 Trial of Autologous #ATA188 in #MS

Presentation Selected for the Emerging Science Program at the American Academy of Neurology (AAN) Annual Meeting 2017

SOUTH SAN FRANCISCO, Calif., March 17, 2017 — Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, today announced that interim Phase 1 trial results from autologous, targeted Epstein-Barr Virus (EBV) Specific Cytotoxic T Lymphocytes (CTL), or the autologous version of ATA188, will be presented by its collaborating investigators at the QIMR Berghofer Medical Research Institute and The University of Queensland during the 69th American Academy of Neurology (AAN) Annual Meeting. The meeting will take place in Boston, Massachusetts from April 22-28, 2017.

Abstract Title:  Symptomatic and objective clinical improvement in progressive multiple sclerosis patients treated with autologous Epstein–Barr virus-specific T cell therapy: Interim results of a phase I trial

The emerging science program emphasizes ongoing neurosciences research of an extraordinary nature, which warrants expedited presentation. Emerging science abstracts have key aspects of the research conducted after the original abstract submission deadline.

About ATA188

EBV is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis.  T-cells are a critical component of the body’s immune system and can be harnessed to counteract viral infections, cancers, and certain autoimmune disorders. By focusing the T-cells on specific proteins involved in the disease, the power of the immune system can be employed to combat the condition.  ATA188 utilizes a technology in which T-cells are educated to recognize specific antigens of EBV that are implicated in MS. In the context of MS, ATA188 finds the EBV-infected B cells in the central nervous system that may catalyze autoimmune response and MS pathophysiology. The autologous version of ATA188 is currently being studied in an ongoing Phase 1 clinical trial in patients with primary and secondary progressive MS. Atara Bio plans to initiate a Phase 1 trial of allogeneic ATA188 in patients with MS in the second half of 2017.

About Atara Biotherapeutics’ Allogeneic Cellular Therapy Platform

Atara Bio’s cellular therapy platform provides healthy immune capability to a patient and arms the immune system to precisely target and combat disease. Cells derived from healthy donors are manufactured in advance and stored as inventory so that a customized unit of cells can be chosen for each patient. The cells are ready to infuse in approximately 3 to 5 days. Once administered, the cells home to their target, expand in-vivo to eliminate diseased cells, and eventually recede. This versatile platform can be directed towards a broad array of disease causing targets and has demonstrated clinical proof of concept across both viral and non-viral targets in conditions ranging from liquid and solid tumors to infectious and autoimmune diseases. The Company has pursued prospective feedback from health authorities on both manufacturing and clinical trial design. Atara Bio’s lead product candidate has the potential to be the first commercial allogeneic T-cell therapy for a viral target implicated in cancer.

About Atara Biotherapeutics, Inc.

Atara Biotherapeutics, Inc. is a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, with an initial focus on allogeneic T-cell therapies for cancer, autoimmune, and infectious disease. Atara Bio’s T-cell product candidates harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The Company’s initial clinical stage T-cell product candidates include Epstein-Barr virus targeted Cytotoxic T-cells (EBV-CTL), or ATA129, Cytomegalovirus targeted Cytotoxic T-cells (CMV-CTL), or ATA230, and Wilms Tumor 1 targeted Cytotoxic T-cells (WT1-CTL), or ATA520. These product candidates have demonstrated the potential to have therapeutic benefit in a number of clinical indications including hematologic malignancies, solid tumors, and refractory viral infections. The Company is also developing a next generation of allogeneic T-cell product candidates utilizing a technology to selectively enhance a T-cell’s ability to target specific viral proteins implicated in disease. Initial clinical investigations employing this approach will focus on multiple sclerosis and other virally mediated cancers and infections.

INVESTOR & MEDIA CONTACTS:

Investors:
Steve Klass, Burns McClellan on behalf of Atara Bio
212-213-0006 x331
sklass@burnsmc.com

Media:
Justin Jackson, Burns McClellan
212-213-0006 x327
jjackson@burnsmc.com
Friday, March 17th, 2017 Uncategorized Comments Off on $ATRA Interim Results Phase 1 Trial of Autologous #ATA188 in #MS

$AKTX Announces R&D Day on April 24, 2017

Presentation to Include New Coversin Phase II Data in PNH and Latest Data on Pipeline

NEW YORK and LONDON, March 17, 2017  — Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced today that it will hold a Research and Development Day on April 24, 2017 in New York. The event will be hosted by members of Akari’s executive leadership team and will feature presentations from investigators and independent scientific advisors. The meeting will cover three main areas:

  • Interim results from the ongoing phase 2 trial in paroxysmal nocturnal hemoglobinuria (PNH) will be presented by Dr Anita Hill, the lead investigator in the study.  Dr Hill is a Consultant Haematologist and Honorary Clinical Associate Professor at Leeds Teaching Hospital, which is one of the world’s largest treatment centers for PNH patients.
  • Results from the pre-clinical development program targeting new disease opportunities for our lead compound Coversin, focusing on its unique dual leukotriene B4 (LTB4)/C5 activity will be presented by Dr Robert Snelgrove, National Heart and Lung Institute, Imperial College London whose particular expertise lies in LTB4 and lung inflammation.
  • New data on the pre-clinical pipeline, including the once-weekly subcutaneous formulation of Coversin, will be presented by Professor Arne Skerra, Professor of Biological Chemistry at the University of Munich and Chairman of XL-protein GmbH.

The presentation will be webcast simultaneously. Details of how to access the presentation and simultaneous webcast will be posted on the calendar section of the Company’s website (www.akaritx.com) a week before R&D Day.

About Akari Therapeutics Plc

Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements 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. Such risks and uncertainties for our company include, but are not limited to: an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K filed on March 23, 2016. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Contact: 

Investor Contact:
The Trout Group
Lee Stern		
lstern@troutgroup.com	
646–378–2922 

Media Contact:
Susan Forman / Laura Radocaj
Dian Griesel Int'l.
(212) 825-3210
Friday, March 17th, 2017 Uncategorized Comments Off on $AKTX Announces R&D Day on April 24, 2017

$NSAT Announces Receipt of New Indication of Interest

VANCOUVER, March 17, 2017  – Norsat International Inc. (“Norsat” or the “Company”) (TSX: NII and NYSE MKT: NSAT), a provider of unique and customized communication solutions for remote and challenging applications, today announced that further to its news release of September 19, 2016, it has recently received a new indication of interest from Privet Fund Management LLP (“Privet”).  Privet has provided a non-binding letter of interest to acquire the Company for cash consideration of US$10.25 per share subject to due diligence, financing, the completion of a definitive agreement and other conditions.

The Board, together with the Company’s financial advisors and legal counsel, has been reviewing various strategic alternatives and opportunities to maximize value for shareholders. The Board will consider and evaluate the non-binding indication of interest from Privet as part of this ongoing process.

There can be no assurance that a transaction will be completed. The Company does not intend to make any further announcements regarding a potential sale unless and until the Board has approved a specific transaction or other course of action requiring disclosure.

About Norsat International Inc.
Founded in 1977, Norsat International Inc. is a leading provider of innovative communication solutions that enable the transmission of data, audio and video for remote and challenging applications. Norsat’s products and services include leading-edge product design and development, production, distribution and infield support and service of fly-away satellite terminals, microwave components, antennas, Radio Frequency (RF) conditioning products, maritime based satellite terminals and remote network connectivity solutions. More information is available at www.norsat.com, via email at investor@norsat.com or by phone at 1-604-821-2800.

Forward Looking Statements
The discussion and analysis of this news release contains forward-looking statements concerning anticipated developments in Norsat’s operations in future periods, the adequacy of its financial resources and other events or conditions that may occur in the future. Forward-looking statements are frequently, but not always, identified by words such as “expects,” “anticipates,” “believes,” “intends,” “estimates,”, “predicts,” “potential,” “targeted,” “plans,” “possible” and similar expressions, or statements that events, conditions or results “will,” “may,” “could” or “should” occur or be achieved. In addition to statements about the expression of interest from Privet and a possible sale, these forward-looking statements include, without limitation, statements about Norsat’s market opportunities, strategies, competition, expected activities and expenditures as it pursues its business plan, the adequacy of available cash resources and other statements about future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and actual achievements of the Company or other future events or conditions may differ materially from those reflected in the forward-looking statements due to a variety of risks, uncertainties and other factors, such as business and economic risks and uncertainties. The forward-looking statements are based on the beliefs, expectations and opinions of management on the date the statements are made. Consequently, all forward-looking statements made in this news release are qualified by this cautionary statement and there can be no assurance that actual results or anticipated developments will be realized. For the reasons set forth above, investors should not place undue reliance on forward-looking statements. These forward-looking statements are made as of the date of this news release and Norsat assumes no obligation to update or revise them to reflect new events or circumstances, other than as required by law.

Friday, March 17th, 2017 Uncategorized Comments Off on $NSAT Announces Receipt of New Indication of Interest

$VIVE Announces Pricing of #PublicOffering of Shares of Common Stock

SUNNYVALE, CA–(March 17, 2017) – Viveve Medical, Inc. (“Viveve”) (NASDAQ: VIVE), a medical technology company focused on women’s health, today announced the pricing of an underwritten public offering of 7,500,000 shares of its common stock at a public offering price of $4.00 per share, before underwriting discounts and commissions. In addition, Viveve has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

Cowen and Company, LLC and Raymond James & Associates, Inc. are acting as joint book-running managers of the offering. Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc., is acting as co-manager. The offering is expected to close on or about March 22, 2017, subject to the satisfaction of customary closing conditions.

This announcement shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any offer or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The securities described above are being offered by Viveve pursuant to a registration statement on Form S-1 declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on March 16, 2017. The offering will be made only by means of a prospectus. Copies of the final prospectus filed with the SEC can be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806 or by fax at (631) 254-7140; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716, or by telephone at (800) 248-8863, or by e-mail at prospectus@raymondjames.com; or by accessing the SEC’s website, www.sec.gov.

About Viveve

Viveve Medical, Inc. is a women’s health and wellness company passionately committed to advancing new solutions to improve women’s overall well-being and quality of life. The company’s internationally patented Viveve® System, that delivers the GENEVEVE™ treatment, incorporates clinically-proven, cryogen-cooled, monopolar radiofrequency (CMRF) to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in one 30-minute in-office session. In the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis. Consistent with approvals in many countries internationally, Viveve is currently seeking regulatory approval in the United States for improvement in sexual function in women. For more information visit Viveve’s website at www.viveve.com.

Safe Harbor Statement

All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. 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, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, future expectations, plans and prospects for us, and the timing of these events, along with those set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, the preliminary prospectus related to the public offering, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission, which are available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Viveve is a registered trademark of Viveve, Inc.

GENEVEVE is a trademark of Viveve, Inc.

Contact Information

Contact:
Investor Relations
Amato and Partners, LLC
90 Park Avenue. 17th Floor
New York, NY 10016
admin@amatoandpartners.com

Media contact:
Sara Zelkovic
Berry & Company Public Relations
212 253 8881
szelkovic@berrypr.com

Friday, March 17th, 2017 Uncategorized Comments Off on $VIVE Announces Pricing of #PublicOffering of Shares of Common Stock