Portola Pharmaceuticals to Webcast Presentation at Cowen and Company’s 39th Annual Health Care Conference

On March 6, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that Scott Garland, Portola’s president and chief executive officer, will present a corporate overview at Cowen and Company’s 39th Annual Health Care Conference in Boston on Tuesday, March 12, 2019 at 8:40 a.m. ET (5:40 a.m. PT) (Press release, Portola Pharmaceuticals, MAR 6, 2019, View Source;p=RssLanding&cat=news&id=2390398 [SID1234534069]).

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Webcast Details
To access the live investor webcast on Tuesday, March 12, at 8:40 a.m. ET (5:40 a.m. PT), go to the investor section of the company’s website at View Source A replay will be available for 30 days.

Zymeworks Reports 2018 Year-End Financial Results

On March 6, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the year ended December 31, 2018 (Press release, Zymeworks, MAR 6, 2019, View Source [SID1234534014]).

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"Over the past year, we have made significant progress advancing our own pipeline while our partners continued developing their assets using our technology," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Our lead program, ZW25, continued to generate impressive clinical data and our second product candidate, ZW49, recently began a Phase 1 clinical trial. We also established our seventh and eighth pharmaceutical partnerships while our long-term partner, Eli Lilly, advanced two of their Azymetric bispecifics into the clinic."

Dr. Tehrani continued, "We entered 2019 with $200 million on our balance sheet, which will enable us to aggressively expand our clinical activities, and we look forward to providing updates throughout the year."

2018 Business Highlights and Recent Developments

ZW49 Investigational New Drug Application Accepted; Phase 1 Trial Underway
Zymeworks’ second product candidate, ZW49, a novel biparatopic HER2-targeted antibody drug conjugate (ADC), received clearance for a Phase 1 first-in-human clinical trial, which has begun enrollment in the United States.
Expanded Global Clinical Development for ZW25 and ZW49
Zymeworks expanded the ZW25 clinical trial into South Korea and also entered into a licensing agreement and collaboration with BeiGene to leverage their resources and expertise to accelerate the development of ZW25 and ZW49 in the Asia Pacific region (Zymeworks continues to own all rights in Japan).
Partner’s Programs Progress into the Clinic
Eli Lilly advanced two Azymetric immune-oncology bispecifics into the clinic triggering milestone payments to Zymeworks. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.
Financial Results for the Year Ended December 31, 2018

Revenue in 2018 was $53.0 million as compared to $51.8 million in 2017. Revenue for both years was primarily comprised of non-recurring upfront fees, expansion payments and milestone payments from the Company’s licensing and collaboration agreements. Revenue for 2018 included: recognition of $23.5 million out of the $60.0 million upfront fee from BeiGene associated with a new licensing agreement; an $18.0 million upfront fee related to a second licensing agreement with Daiichi Sankyo; a $5.0 million upfront fee related to a new licensing agreement with LEO Pharma; a $4.0 million research program expansion fee from Celgene; a $2.0 million development milestone payment from Eli Lilly, and $0.5 million in research support payments from various collaborators. Revenue for 2017 included a $50.0 million upfront fee from Janssen and a $1.0 million milestone payment from Daiichi Sankyo, as well as $0.8 million in research support payments.

For the year ended December 31, 2018, research and development expenses were $56.7 million as compared to $41.7 million in the prior year. The change was primarily due to an increase in activities related to ZW25 clinical studies and associated manufacturing costs, as well as development activities for ZW49. There were also additional research and development activities, resulting in incremental headcount-related expense and non-cash stock-based compensation expense. Research and development expenses included non-cash stock-based compensation expense of $2.2 million from equity classified equity awards and a $2.0 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

For the year ended December 31, 2018, general and administrative expenses were $29.5 million as compared to $18.6 million in the prior year. The change was primarily due to an increase in non-cash liability classified equity adjustments and stock-based compensation, as well as other increases in compensation and professional fees associated with year-on-year corporate growth. General and administrative expense included non-cash stock-based compensation expense of $3.7 million from equity classified equity awards and $5.4 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

The net loss for the year ended December 31, 2018, was $36.6 million as compared to $10.4 million in 2017, primarily due to an increase in research and development expenses associated with our lead therapeutic candidates and other programs, general and administrative expenses, and the accounting impact of an increase of $6.9 million related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

Zymeworks expects research and development expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of December 31, 2018, Zymeworks had $200.2 million in cash and cash equivalents and short-term investments.

Dynavax to Present at 39th Annual Cowen Healthcare Conference

On March 6, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that Eddie Gray, Chief Executive Officer, will present at the 39th Annual Cowen Healthcare Conference on Wednesday, March 13, at 8:40 a.m. ET (Press release, Dynavax Technologies, MAR 6, 2019, View Source [SID1234534051]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source

Supernus to Present at the 2019 Cowen Health Care Conference

On March 6, 2019 Supernus Pharmaceuticals, Inc. (NASADQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings at the 39th Annual Cowen Health Care Conference (Press release, Supernus, MAR 6, 2019, View Source [SID1234534016]).

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Date: Wednesday, March 13, 2019

Time: 9:20 a.m. ET

Place: The Boston Marriott Copley Place, Boston, Mass.

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website after the conference.

Flex Pharma Reports Fourth Quarter and Fiscal 2018 Financial Results

On March 6, 2019 Flex Pharma, Inc. (NASDAQ: FLKS), reported its financial results for the three months and fiscal year ended December 31, 2018 (Press release, Flex Pharma, MAR 6, 2019, View Source [SID1234534031]).

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On January 3, 2019, Flex Pharma (the "Company") and Salarius Pharmaceuticals, LLC ("Salarius") entered into an Agreement and Plan of Merger (the "Merger Agreement") pursuant to which, among other things, Falcon Acquisition Sub, LLC, a wholly owned subsidiary of the Company, will merge with and into Salarius, with Salarius continuing as a wholly owned subsidiary of the Company and the surviving company. On February 14, 2019, the Company filed a registration statement on Form S-4 with the Securities and Exchange Commission that provides additional information related to the merger. The merger is expected to close in the first half of 2019. The Company continues to sell HOTSHOT, its consumer product that helps to prevent and treat exercise associated muscle cramps.

The Merger Agreement (i) values Flex Pharma at $10.5 million, subject to adjustment, on a dollar-for-dollar basis, based on Flex Pharma’s net cash balance at the closing of the merger compared to a target net cash of $3.3 million, and (ii) values Salarius at $36.6 million, subject to adjustment, on a dollar-for-dollar basis, based on the sale of Series A Preferred Units pursuant to subscription agreements that Salarius entered into prior to the Merger Agreement compared to the target sale of $7.0 million of Series A Preferred Units.

Under the Merger Agreement, immediately following the effective time of the merger, Flex Pharma’s current stockholders will own approximately 19.9% of the combined company, on a partially-diluted basis, and Salarius’ current members will own approximately 80.1% of the combined company, on a partially-diluted basis.

In addition, at or prior to the closing of the merger, Flex Pharma will pay a dividend of or distribute one right per share of the Company’s common stock to its stockholders of record as of a date and time determined by the Company’s board of directors. Each right will entitle such stockholders to receive a warrant to purchase shares of Flex Pharma’s common stock ("Warrant") six months and one day following the closing date of the merger.

The aggregate value of all of the Warrants to be issued to Flex Pharma’s stockholders generally represents the difference between (i) Flex Pharma’s value and (ii) the value of Flex Pharma’s common stock that Flex Pharma’s current stockholders will have in the combined company.

"We continue to make progress towards completing the merger with Salarius with the recent filing of our Registration Statement on Form S-4," stated William McVicar, Ph.D., Flex Pharma’s President and Chief Executive Officer. "We continue to believe that a merger with Salarius is the best opportunity for significant near- and long-term value creation for Flex stockholders. Salarius’ lead compound, Seclidemstat, is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study in Ewing sarcoma and Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers. We believe that Salarius could be poised to address significant unmet needs in oncology and we look forward to completing the merger with Salarius."

Fourth Quarter & Full Year 2018 Financial Results

Cash Position: As of December 31, 2018, Flex Pharma had cash and cash equivalents of $9.8 million. The Company held no marketable securities at December 31, 2018. During the three months ended December 31, 2018, cash and cash equivalents decreased by $3.1 million.
Total Revenue: Total revenue for the three months ended December 31, 2018 was approximately $163,000. Total revenue for the year ended December 31, 2018 was approximately $0.8 million, including approximately approximately $11,000 of other revenue.
Cost of Product Revenue: Cost of product revenue for the three months ended December 31, 2018 was approximately $75,000. There were no inventory write-offs during the three months ended December 31, 2018. Cost of product for the twelve months ended December 31, 2018 was approximately $431,000 and included inventory write offs of approximately $85,000.
R&D Expense: Research and development expense for the three months ended December 31, 2018 was $0.2 million and $11.9 million for the year ended December 31, 2018. Research and development expense for these time periods primarily included costs associated with the Company’s clinical operations and wind-down of FLX-787 Phase 2 clinical studies, personnel costs (including salaries, termination-related costs, retention-related costs and stock-based compensation costs) and external consultant costs.
SG&A Expense: Selling, general and administrative expense for the three months ended December 31, 2018 was $1.9 million and $10.6 million for the year ended December 31, 2018. Selling, general and administrative expense for this period primarily included personnel costs (including salaries, retention-related costs and stock-based compensation costs), fulfillment costs related to HOTSHOT, legal and professional costs, and external consultant costs.
Net Loss and Cash Flow: Net loss for the three months ended December 31, 2018 was ($2.0) million, or ($0.11) per share and included $0.2 million of stock-based compensation expense. For the year ended December 31, 2018, net loss was ($21.9) million, or ($1.22) per share and included $1.9 million of stock-based compensation expense. As of December 31, 2018, Flex Pharma had 18,067,392 shares of common stock outstanding. The net loss for the fourth quarter of 2018, as well as for the year ended December 31, 2018, was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with HOTSHOT, and general and administrative costs.