On August 9, 2016 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported its financial results and recent corporate highlights for the quarter ended June 30, 2016 (Press release, Fortress Biotech, AUG 8, 2016, View Source;FID=1500089727 [SID:1234514496]).

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Dr. Lindsay A. Rosenwald, Chairman, President and CEO of Fortress, said, "During the second quarter of 2016, we attained several milestones, including the commercialization of our first two products from Journey Medical Corporation’s ("Journey") dermatology
franchise: Luxamend Wound Cream and Ceracade Skin Barrier Emulsion. Our subsidiary Checkpoint Therapeutics, Inc. ("Checkpoint Therapeutics") also acquired an exclusive, worldwide license to BRD4-inhibiting (from the Bromodomain and ExtraTerminal motif ("BET") inhibitor class of anti-cancer proteins) compounds for solid tumors from Jubilant Biosys Limited ("Jubilant"). In addition, Checkpoint Therapeutics entered a sublicense agreement with TG Therapeutics, Inc., a related party ("TG
Therapeutics"), to develop and commercialize the BRD4-inhibiting compounds for hematological malignancies, while Checkpoint Therapeutics retains the right to develop and commercialize these compounds for solid tumors. We believe clinical and corporate
developments such as these will help position us to diversify our pipeline during the second half of 2016."

Financial Results:
 At June 30, 2016, Fortress’ consolidated cash and cash equivalents totaled $71.3 million compared to $81.4 million at March 31, 2016 and $98.2 million as of December 31, 2015, a decrease of $10.1 million for the quarter, of which $6.6 million relates to our subsidiaries, and $26.9 million year-to-date, of which $16.1 million relates to our subsidiaries. These totals exclude restricted cash of $14.6 million.

 Total revenue for the second quarter of 2016 was $2.2 million consisting of $1.0 million of net product revenue from our subsidiary Journey and $1.2 million of collaboration revenue from a related party, compared with no revenue reported during
last year’s second quarter. $2.9 million in total revenue was reported for the first six months of 2016 consisting of $1.4 million of net product sales from Journey and $1.5 million of collaboration revenue from a related party, compared with $0.5 million of
collaboration revenue from a related party reported for the first six months of 2015.

 Research and development expenses were $6.3 million, of which $4.0 million relates to our subsidiaries for the second quarter of 2016 and $14.1 million, of which $9.0 million relates to our subsidiaries for the first six months of 2016. This compares with $2.4 million, of which $1.1 million relates to our subsidiaries for the second quarter of 2015 and $4.1 million, of which $1.2 million relates to our subsidiaries for the first six months of 2015. Noncash stock-based compensation expense included in research and development for the second quarter of 2016 was $1.1 million, compared to $0.6 million for the second quarter of 2015, and $2.4 million for the first six months of 2016, compared with $0.9 million for the first six months of 2015.

 Research and development licenses acquired expenses were $2.0 million for the second quarter of 2016 and $2.1 million for the first six months of 2016, compared to $1.5 million for the second quarter 2015 and $9.0 million for the first six months of 2015.

 General and administrative expenses were $8.6 million, of which $3.7 million relates to our subsidiaries for the second quarter of 2016 and $16.6 million, of which $6.6 million relates to our subsidiaries for the first six months of 2016, compared to $3.8 million, of which $0.3 million relates to our subsidiaries for the second quarter of 2015 and $7.3 million, of which $1.6 million relates to our subsidiaries for the first six months of 2015. Noncash stock-based compensation expense included in general
and administrative for the second quarter of 2016 was $1.9 million, compared to $1.3 million for the second quarter of 2015, and $3.5 million for the first six months of 2016, compared with $2.5 million for the first six months of 2015.

 Net loss was $12.5 million, or $0.31 per share, for the second quarter of 2016, compared to a net loss of $6.2 million, or $0.16 per share, for the second quarter of 2015. For the first six months of 2016, net loss was $24.7 million or $0.62 per share,compared with $18.2 million or $0.47 per share in the first six months of 2015.

Recent Corporate Highlights:
Avenue Therapeutics
 Avenue completed an End-of-Phase 2 ("EOP2") meeting with the FDA and, based on the outcome of the EOP2 meeting, Avenue anticipates that its Phase 3 program will consist of three studies: an efficacy and safety study in an orthopedic model, an
efficacy and safety study in a soft tissue model, and an open label safety study.

Checkpoint Therapeutics
 In May 2016, Jubilant and Checkpoint Therapeutics announced the signing of an exclusive, worldwide license agreement under which Jubilant out-licensed to Checkpoint Therapeutics a family of patents covering compounds that inhibit BRD4, a member of the BET domain for cancer treatment. In connection with the license agreement with Jubilant, Checkpoint Therapeutics entered into a sublicense agreement with TG Therapeutics to develop and commercialize the licensed compounds for hematological malignancies, while Checkpoint Therapeutics retains the right to develop and commercialize these compounds for solid tumors.

Journey Medical Corporation
 In June 2016, sales began for Luxamend Wound Cream and Ceracade Skin Barrier Emulsion, the first two products in Journey’s dermatology franchise. Both products were showcased at the 2016 American Academy of Dermatology (AAD)
Summer Meeting in July 2016.

 In July 2016, Journey received FDA approval for the manufacturing of a product for the treatment of acne, for which it had entered into a license and supply agreement in 2015. Journey expects sales of this product to begin in the fourth quarter of 2016.
Mustang Bio, Inc.
 In April 2016, Mustang announced that two abstracts pertaining to MB-101 (IL13Rα2‐specific CAR-T cells) for the treatment of glioblastoma were selected for presentation at the American Society of Gene and Cell Therapy’s 19th Annual Meeting ("ASGCT"). Pre-clinical and preliminary Phase I data were presented at ASGCT (Free ASGCT Whitepaper)

 In May 2016, an oral presentation related to MB-101 (IL13Rα2‐specific CAR-T cells) was presented by City of Hope investigators at the ASGCT (Free ASGCT Whitepaper) at the Marriott Wardman Park Hotel in Washington, DC.

Fortress Biotech
 On June 10, 2016, CB Pharma Acquisition Corp ("CB Pharma") held an extraordinary general meeting of its shareholders. At such meeting, the shareholders approved each of the following items: (i) an amendment to the CB Pharma’s Amended and Restated Memorandum and Articles of Association (the "Charter") to extend the date by which CB Pharma has to consummate a business combination from June 12, 2016 to December 12, 2016 (the "Extension"), (ii) an amendment to the Charter to allow the holders of the CB Pharma’s ordinary shares issued in the their initial public offering to elect to convert their shares into their pro rata portion of the funds held in trust, if the Extension is approved, and (iii) the change of CB Pharma’s name from "CB Pharma Acquisition Corp." to "Origo Acquisition Corporation" ("Origo"). In connection with the meeting, Fortress transferred 1,050,000 of its CB Pharma ordinary shares to Origo, retaining a holding of 265,000 Origo shares.

 In May 2016, positive data from the Phase 1/2 study of CNDO-109-Activated Allogeneic Natural Killer (NK) Cells in patients with acute myeloid leukemia were presented in an oral session at the Innate Killer Summit 2016 in San Diego, CA.

 In July 2016 Fortress’ stock was added to the Russell 2000 Index.

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 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 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.

On August 4, 2016 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the second quarter ended June 30, 2016 (Press release, BioCryst Pharmaceuticalsa, AUG 4, 2016, View Source [SID:1234514234]).

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"We continue to make progress, and have initiated subject screening to start the APeX-1 trial evaluating our once daily oral kallikrein inhibitor BCX7353 to prevent HAE attacks," said Jon P. Stonehouse, President & Chief Executive Officer. "Our goal remains to report out initial data by year end for this trial."

Second Quarter Financial Results
For the three months ended June 30, 2016, revenues decreased to $4.8 million from $25.8 million in the second quarter of 2015. The decrease was primarily due to the one time, partial recognition of a large upfront payment from Seqirus UK Limited (Seqirus) associated with the licensing of RAPIVAB (peramivir injection) in the second quarter of 2015, as well as lower collaborative revenue associated with BCX4430 development in the second quarter of 2016.

Research and Development (R&D) expenses for the second quarter of 2016 decreased to $14 .2 million from $16.5 million in the second quarter of 2015. This decrease was primarily due to lower development costs associated with the Company’s BCX4430 program.

General and administrative (G&A) expenses for the second quarter of 2016 decreased to $2.7 million compared to $3.5 million for the second quarter of 2015, due to a general reduction of administrative expenses throughout the Company during the second quarter of 2016, as compared to the second quarter of 2015.

Interest expense, which is primarily related to Company’s non-recourse notes payable, was $1.4 million in the second quarter of 2016 and $1.3 million in the second quarter of 2015. In addition, a $3.7 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the second quarter of 2016, as compared to a $796,000 mark-to-market loss in the second quarter of 2015. These gains and losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement. During the second quarters of 2016 and 2015, we also realized currency gains of $811,000 and $1.5 million, respectively, from the exercise of a U.S. Dollar/Japanese yen currency option within our foreign currency hedge.

The net loss for the second quarter of 2016 was $16.3 million, or a $0.22 net loss per share, compared to net income of $4.9 million, or $0.06 net income per fully diluted share, for the second quarter 2015.

Cash, cash equivalents and investments decreased to $64.3 million at June 30, 2016, as compared to $100.9 million at December 31, 2015. Net operating cash use for the second quarter of 2016 was $15.4 million, as compared to $12.0 million for the second quarter of 2015.

Year to Date Financial Results
For the six months ended June 30, 2016, total revenues decreased to $9.6 million from $32.7 million in the first half of 2015. The decrease in revenue resulted from the recognition of approximately $21.7 million of collaborative revenue in the second quarter of 2015 associated with the RAPIVAB out-licensing transaction with Seqirus in June 2015.

R&D expenses increased to $34.7 million in the first half of 2016 from $33.6 million in the first half of 2015. The increase in 2016 R&D expense, as compared to 2015, reflects increased spending in our RAPIVAB program, somewhat offset by decreased development activity in our BCX4430 program. The majority of R&D spending was associated with the Company’s HAE development program.

G&A expenses decreased to $5.9 million for the six months ended June 30, 2016 from $7.6 million for the six months ended June 30, 2015, due primarily to lower unrestricted grants awarded to HAE patient advocacy groups, as well as a general reduction of administrative expenses in the first half of 2016.

In the first half of 2016 and 2015, interest expense was $2.9 million and $2.6 million, respectively, and was primarily related to the Company’s non-recourse notes payable. A mark-to-market loss on our foreign currency hedge of $6.4 million was recognized in the first half of 2016, compared to a mark-to-market loss of $332,000 in the first half of 2015. These gains and losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement. As noted above, we also realized currency gains of $811,000 and $1.5 million from the exercise of U.S. dollar/Japanese yen currency options during the first half of 2016 and 2015, respectively.

The net loss for the six months ended June 30, 2016 increased to $39.1 million, or $0.53 per share, from $10.3 million, or $0.14 per share for the same period last year.

Corporate Update & Outlook
The APeX-1 clinical trial of BCX7353 for prophylaxis of angioedema attacks in patients with HAE has received regulatory approval in Canada and several European countries, and patient screening has commenced. We expect initial data from APeX-1 to be available by year end 2016.

A clinical pharmacology study of several dosage formulations of avoralstat is nearing completion. Cohorts of healthy volunteers have received single doses ranging from 200 mg to 2000 mg of avoralstat in tablet or suspension formulations, with no clinically significant adverse events reported. While these dosing formulations have improved total avoralstat exposure (AUC) up to approximately five-fold compared to a 500 mg dose given as soft gel capsules, the plasma concentration-time profile has not met our objectives of twice-daily dosing with drug levels at or above the target range. For that reason, we have decided to stop further development of avoralstat.

A phase 1 first-in-human study of the broad-spectrum antiviral drug BCX4430 has been completed. Study drug was administered by i.m. injection to healthy volunteers. Single doses of BCX4430 ranging from 0.3 to 10 mg/kg were administered, and daily doses of 2.5 mg/kg to 10 mg/kg were administered for 7 days. Exposure to BCX4430 was dose-proportional. BCX4430 dosing was generally safe and well-tolerated, and there were no grade 3 or 4 adverse events.

On July 5, 2016, BioCryst announced that the National Institute of Allergy and Infectious Diseases (NIAID) has provided additional funding for efficacy studies of BCX4430 in non-human primates to further assess effective dose regimens. This funding represents an increase of $5.5 million for the development of BCX4430 as a treatment for hemorrhagic fever viruses. The NIAID contract value now totals $39.5 million, if all contract options are exercised. To date, approximately $35.4 million of funding has been awarded under the contract.

About APeX-1
APeX-1 is a two part, Phase 2, randomized, double-blind, placebo-controlled proof of concept and dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of BCX7353 as a preventative treatment to eliminate or reduce the frequency of angioedema attacks in HAE patients. Up to a total of approximately 50 eligible subjects with HAE will be enrolled in the trial.

In part 1 of APeX-1, up to 36 subjects with HAE will be randomized in a 1:1 ratio to receive an oral dose of either 350 mg of BCX7353 once daily or placebo once daily for four weeks. An interim analysis will be conducted after the first 24 subjects have completed treatment through study day 28. If a robust treatment effect is observed at the interim analysis, Part 2 of the study will be initiated. In the event the treatment effect is not well characterized with 24 subjects, a total of up to approximately 36 subjects will be enrolled in part 1. The sample size in Part 1 was kept flexible to cover a range of response options that would achieve 90% power with an alpha of 0.05, based on reduction of attack rate of at least 70% on BCX7353, placebo response rate of approximately 30%, and standard deviation of approximately 0.45 attacks per week.

To characterize dose-response in part 2 of APeX-1, 14 additional subjects with HAE will be randomized to 250mg of BCX7353 once daily (n=6), 125mg of BCX7353 once daily (n=6) or placebo (n=2).

The primary efficacy endpoint of APeX-1 is the number of angioedema attacks; attack rate per week, counts of attacks, proportion of subjects with no attacks, and number of attack-free days will be analyzed. Efficacy analyses will be conducted for HAE attacks reported over the entire dosing interval (Days 1 through 28) and during the dosing period in which plasma concentrations of BCX7353 should be at steady-state conditions (Days 8 through 28). Secondary efficacy endpoints include severity and duration of angioedema attacks, and measures of health-related quality of life. Safety will be characterized through evaluation of adverse events and laboratory testing. Pharmacokinetics and pharmacodynamic effects will be assessed through measurement of plasma drug levels and kallikrein inhibition.

About BCX7353
Discovered by BioCryst, BCX7353 is a novel, once-daily, selective inhibitor of plasma kallikrein in development for the prevention of angioedema attacks in patients diagnosed with HAE. By inhibiting plasma kallikrein, BCX7353 suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks in HAE patients. BCX7353 has been generally safe and well tolerated in clinical pharmacology studies that have enrolled 117 healthy volunteers, 46 receiving single doses of up to 1000 mg, and 71 receiving once-daily doses of up to 500 mg for 7 days and 350 mg for 14 days. In the second week of study, approximately 4-5% of healthy volunteers administered daily doses of ‘7353 for at least 7 days developed a drug-related skin rash that resolved within a few days.

Financial Outlook for 2016
Based upon development plans and our awarded government contracts, BioCryst expects its 2016 net operating cash use to be in the range of $55 to $75 million, and its 2016 operating expenses to be in the range of $78 to $98 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.