On August 8, 2016 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the second quarter ended June 30, 2016 (Filing, Q2, Fate Therapeutics, 2016, AUG 8, 2016, View Source [SID:1234514362]).

"With the opening of enrollment in our Phase 1/2 clinical trial, we believe we are well-positioned in 2016 to complete the initial safety assessment and begin evaluating the potential of ProTmune for the prevention of life-threatening immunological conditions, including acute GvHD, in cancer patients undergoing allogeneic transplant for which there is a clear unmet and urgent medical need," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Additionally, we plan to collaborate with the University of Minnesota in filing an IND later this year for our Adaptive NK Cell cancer immunotherapy, which has shown persistent and potent tumor killing independent of antigen recognition in preclinical studies. We believe our allogeneic memory-like NK cell approach is a novel and promising intervention strategy for combating both liquid and solid tumors."

Recent Highlights & Program Updates

· Opened Patient Enrollment in ProTmune Phase 1/2 Clinical Trial. Fate Therapeutics opened patient enrollment across multiple clinical sites in support of its Phase 1/2 clinical trial of ProTmune for the prevention of acute graft-versus-host disease (GvHD) and cytomegalovirus (CMV) infection. The Company expects to enroll 10 subjects in the initial Phase 1 stage of the trial, all of whom will receive ProTmune. Following an independent data monitoring committee safety review of these 10 subjects, a randomized, controlled Phase 2 stage is expected to enroll 60 subjects in a 1:1 ratio. The open-label Phase 1/2 study is designed to evaluate the safety and efficacy profile of ProTmune in adult subjects with hematologic malignancies undergoing allogeneic mobilized peripheral blood (mPB) hematopoietic cell transplantation (HCT).

· Granted Fast Track Designation by the FDA for ProTmune. In June 2016, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ProTmune for the reduction of incidence and severity of acute GvHD in patients undergoing allogeneic HCT. GvHD is a leading cause of morbidity and mortality in patients undergoing HCT, and there are currently no approved therapies for its prevention.

· Presented Preclinical Data Supporting Clinical Development of Allogeneic Memory-Like NK Cell Product Candidate. At the Innate Killer Summit in May 2016, Dr. Jeffrey Miller, M.D., Professor of Medicine and Deputy Director, University of Minnesota Cancer Center, highlighted in vitro and in vivo preclinical data demonstrating that the Company’s Adaptive NK Cell cancer immunotherapy has enhanced anti-tumor activity, including improved persistence, enhanced cytokine production and increased resistance to immunosuppressive factors in the tumor microenvironment. Additionally, the Company’s Adaptive NK Cell product candidate was shown to synergize with several different therapeutic antibodies in vivo in preclinical studies, significantly augmenting antibody-directed cellular cytotoxicity (ADCC) against solid tumors.

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· Showcased Off-the-Shelf Cancer Immunotherapy Approach Using Renewable Pluripotent Cell Lines. The Company highlighted its patent-protected platform for producing off-the-shelf NK- and T-cell immunotherapies from engineered pluripotent cell lines at the Annual Meeting of the International Society for Stem Cell Research in June 2016. Fate Therapeutics is generating precisely-engineered, highly-stable pluripotent cell lines, from which it derives monoclonal populations of effector cells with enhanced properties, such as persistence, tumor targeting, and resistance to tumor suppression. Similar to master cell lines used for the manufacture of monoclonal antibodies, engineered pluripotent cell lines have the potential to serve as a renewable cell source for the consistent manufacture of homogeneous populations of effector cells for the treatment of many thousands of patients.

· Entered into $10.3M Common Stock Purchase Agreement with Certain Institutional Investors. On August 6, 2016, Fate Therapeutics entered into a securities purchase agreement for a private placement of the Company’s common stock, under which funds managed by Franklin Advisers, Inc., together with certain other institutional investors, agreed to purchase 5.25 million shares of common stock at $1.96 per share for gross proceeds of $10.3 million. The private placement transaction is expected to close on or about August 10, 2016, subject to customary closing conditions. Proceeds from the transaction will be used primarily to advance the Company’s pipeline of programmed cellular immunotherapies and for general corporate purposes. The Company did not use a placement agent in connection with the transaction.

· Appointed Chris M. Storgard, M.D. as Chief Medical Officer. In May 2016, Dr. Chris Storgard joined the Company as Chief Medical Officer. Dr. Storgard is an experienced drug development clinician with a proven history of advancing early stage programs through clinical development and product commercialization. He is primarily responsible for leading the design and execution of the Company’s clinical trials for its product candidates.

Second Quarter 2016 Financial Results

· Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of June 30, 2016 were $45.9 million compared to $64.8 million as of December 31, 2015. The decrease is primarily driven by the Company’s use of cash to fund operating activities and to service principal and interest obligations under its loan agreement with Silicon Valley Bank. This balance as of June 30, 2016 did not include $10.3 million in proceeds which the Company expects to receive upon the closing of the private placement transaction.

· Total Revenue: Revenue was $1.0 million for the second quarter of 2016 compared to $0.3 million for the comparable period in 2015. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.

· Total Operating Expenses: Total operating expenses were $9.0 million for the second quarter of 2016 compared to $7.5 million for the comparable period in 2015. Operating expenses for the second quarter of 2016 included $0.8 million of stock compensation expense, compared to $0.7 million for the second quarter of 2015.

· R&D Expenses: Research and development expenses were $6.8 million for the second quarter of 2016 compared to $4.9 million for the comparable period in 2015. The increase in R&D expenses is primarily related to an increase in third-party service provider fees to support the Company’s clinical development of ProTmune and preclinical development of its Adaptive NK Cell product candidate in collaboration with the University of Minnesota, and an increase in personnel expenses resulting from the hiring of additional employees to support the conduct of its research activities, including activities under its collaboration with Juno.

· G&A Expenses: General and administrative expenses were $2.2 million for the second quarter of 2016 compared to $2.7 million for the comparable period in 2015. The decrease in G&A expenses is primarily related to a decrease in intellectual property-related expenses.

· Common Shares Outstanding: Common shares outstanding as of June 30, 2016 were 28.9 million compared to 28.7 million as of December 31, 2015. Common shares outstanding increased primarily as a result of the issuance of shares under the Company’s equity incentive plan. Common shares outstanding as of June 30, 2016 did not include 5.25 million shares which the Company expects to issue upon the closing of the private placement transaction.

On August 5, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the second quarter and six months ended June 30, 2016 (Press release, Dynavax Technologies, AUG 5, 2016, View Source [SID:1234514334]).

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The Company had $139.0 million in cash, cash equivalents and marketable securities as of June 30, 2016, compared to $196.1 million at December 31, 2015. The net loss for the second quarter of 2016 was $29.0 million, or $0.75 per basic and diluted share, compared to $23.6 million, or $0.80 per basic and diluted share, for the second quarter of 2015.

Recent Progress

During the quarter, the U.S. Food and Drug Administration (FDA) established December 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date for its review of the Biologics License Application (BLA) for HEPLISAV-B, the company’s investigational vaccine for immunization against hepatitis B infection in adults 18 years of age and older. In August, the FDA informed the Company that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV-B at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date.

Preparations for launch of HEPLISAV-B are continuing, including pre-commercial activities, manufacturing of launch inventory and continued infrastructure spending related to implementation of commercial development and information technology systems and capabilities and related increases in headcount.

In June, we reported additional details from the HBV-23 pivotal Phase 3 HEPLISAV-B trial at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA).

We presented encouraging additional data from Part 1 of the Phase 1/2 study evaluating our lead immunotherapy product candidate, SD-101, in lymphoma patients in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Recently our collaborator, Merck, initiated a Phase 1 study of SD-101 in combination with its immunomodulator MK-1966 in cancer patients.

Financials

Total revenues for the second quarter of 2016 were $2.6 million compared to $1.6 million for the same period in 2015. Revenue primarily reflects research and development revenues from our collaboration with AstraZeneca.

Research and development expenses for the second quarter of 2016 were $22.8 million compared to $19.7 for the same period in 2015. This $3.1 million increase was primarily due to an increase in employee headcount and regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B, partially offset by a reduction in outside services expense associated with the completion of HBV-23 in the fourth quarter of 2015.

General and administrative expenses for the second quarter of 2016 were $9.2 million compared to $5.1 for the same period in 2015. This $4.1 million increase reflects expenses related to preparation for the commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development.

The net loss for the second quarter of 2016 was $29.0 million, or $0.75 per basic and diluted share, compared to $23.6 million, or $0.80 per basic and diluted share, for the same period in 2015.

On August 5, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported that it has completed the settlement of its recommended public offer to the shareholders of Meda Aktiebolag (publ.) to tender all their shares in Meda to Mylan (the "Offer") (Press release, Mylan, AUG 5, 2016, View Source [SID:1234514657]). As previously announced, the Offer was accepted by shareholders holding approximately 94% of the total number of outstanding shares and votes in Meda, as of July 29, 2016. Upon the completion and settlement of the Offer, Mylan acquired each of these shares in accordance with the terms of the Offer. The Offer was initially announced on Feb. 10, 2016 and it was declared unconditional on Aug. 2, 2016. The acceptance period expired on July 29, 2016 and will not be extended.

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Mylan Chairman Robert Coury commented, "We are very pleased to have received the overwhelming shareholder support required to complete our acquisition of Meda. Mylan continues to differentiate itself among the world’s pharmaceutical companies in terms of our unique profile and growth trajectory. The addition of Meda will only further add to our existing leadership position within our space and continue to create significant value for our shareholders and other stakeholders. On behalf of Mylan’s entire board of directors, we welcome our new Mylan shareholders and look forward to them sharing in the anticipated future success of our combined company."

Mylan CEO Heather Bresch continued, "The addition of Meda builds on everything we have put in place around the world, creating even greater scale, breadth and diversity across products, geographies and sales channels. As a result, our R&D and manufacturing platform is unmatched, and we now have a more powerful global commercial infrastructure across developed and emerging markets and branded, generic and over-the-counter products. This transaction also is extremely compelling financially, providing significant accretion to Mylan’s adjusted earnings per share, the opportunity for substantial synergies and further acceleration of our growth. Importantly, I would like to welcome Meda’s talented and dedicated workforce to the Mylan family, and I look forward to their contributions as we strive to deliver better health for a better world."

Mylan President Rajiv Malik added, "With the addition of Meda, Mylan now has six $1 billion therapeutic franchises, and through our enhanced scale and expanded commercial capabilities, we see significant opportunities to further distinguish Mylan among our customers and patients. Allergy/respiratory, pain/CNS and dermatology – recently bolstered by our acquisition of the Renaissance topicals business – represent just a few of the exciting areas where we expect to create additional value from our combined portfolio, pipeline and capabilities. Meda also opens up a number of new opportunities for us, such as significantly expanding our over-the-counter presence into a $1 billion business. Additionally, Meda accelerates our expansion in attractive emerging markets, such as China, Southeast Asia, Russia and the Middle East, and provides us opportunities to maximize our efficient, high quality operating platform and broad product portfolio. I too would like to extend a warm welcome to the Meda team and am excited to begin integrating our businesses and bringing together the best from both of our organizations."

Meda is now a controlled subsidiary of Mylan. Mylan intends to initiate compulsory acquisition proceedings for the remaining shares in Meda in accordance with the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)) and has acted to have the Meda shares delisted from Nasdaq Stockholm.

Mylan discloses the information provided herein pursuant to Nasdaq Stockholm’s Takeover Rules (the "Takeover Rules"). The information was submitted for publication on Aug. 5, 2016, 15:00 CET.

On August 5, 2016 Lantern Pharma, Inc. (Dallas, TX, US) and BioNumerik Pharmaceuticals, Inc. of San Antonio, Texas reported that they have entered into an exclusive agreement for Lantern Pharma to evaluate BioNumerik’s Tavocept for human therapeutic indications using Lantern’s 5-M theranostic platform (Press release, Lantern Pharma, AUG 5, 2016, View Source [SID1234564256]). Tavocept is an investigational new drug candidate from BioNumerik’s portfolio that has shown potential for both oncology and non-oncology indications. Lantern Pharma is a Precision Oncology Medicine company focused on using its proprietary 5-M platform to identify specific drug sensitivity signatures for patient tumor types. The Tavocept transaction demonstrates Lantern’s commitment to the development of precision cancer drugs by employing its cutting-edge companion 5-M theranostics platform with the objective of providing more precise and therefore more effective treatments to patients sooner.

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Dr. Arun Asaithambi of Lantern Pharma, commented: "We believe Lantern Pharma’s approach can be successfully applied to identify new value opportunities for drug candidates with promising potential that have encountered development challenges. We are excited about Tavocept and the potential to enhance its therapeutic potency through the application of our 5-M approach."

"We believe Tavocept has important potential to be of benefit to patients, and we are excited to be working with Lantern Pharma to examine possible ways to realize and expand that potential," said Thomas W. Lyles, Jr., President of BioNumerik Pharmaceuticals, Inc.

AVEO has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AVEO, AUG 4, 2016, View Source [SID1234514232]).

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