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Seres Therapeutics Reports Fourth Quarter and Full Year Financial Results and Provides Operational Updates

On March 6, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported fourth quarter and full year 2018 financial results and provided an operational update (Press release, Seres Therapeutics, MAR 6, 2019, View Source [SID1234534032]).

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"This has been a highly eventful period where we advanced our microbiome clinical programs and implemented a more focused R&D strategy. During the last several months, we initiated two clinical studies and implemented corporate changes to concentrate resources on the highest priority programs," said Eric Shaff, President and Chief Executive Officer of Seres Therapeutics. "Seres is working to expeditiously progress our ongoing clinical studies to data read outs while also advancing our next generation, rationally-designed, fermented microbiome drug discovery capabilities centered on SER-301 for ulcerative colitis. We expect to complete SER-287 Phase 2b study enrollment by mid-2020 and obtain SER-401 Phase 1b study results in 2020. We continue to evaluate design options around our SER-109 Phase 3 study in order to expedite trial results."

Seres also announced today the initiation of a SER-401 Phase 1b study in patients with metastatic melanoma. SER-401 is an oral microbiome therapeutic candidate sourced from healthy individuals identified to have a microbiome bacterial signature similar to that observed in immunotherapy responders. The Phase 1b study, conducted in collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, will evaluate the potential for SER-401 to augment response to anti-PD-1 checkpoint inhibitor therapy. The study is designed to enroll 30 patients, who will receive the FDA-approved anti-PD-1 inhibitor nivolumab and will be randomized 2:1 to receive either SER-401 or placebo. The study will evaluate safety, impact on the gastrointestinal microbiome and various clinical and immunological outcome measures.

Recent Highlights and Events

SER-109 Phase 3 study progress: Seres continues to recruit patients into the SER-109 Phase 3 study for recurrent C. difficile infection. The widespread use of fecal microbiota transplantation, an unapproved and uncontrolled practice, has impacted the enrollment rate of this placebo-controlled clinical trial. Seres is evaluating modification of the study design to expedite clinical results.
Corporate changes to focus on highest priority programs and appointment of Chief Scientific Officer (January 2019): The Company has concentrated resources on completing the SER-287 Phase 2b study in mild-to-moderate ulcerative colitis, the SER-109 Phase 3 study for recurrent C. difficile infection and the SER-401 Phase 1b study in metastatic melanoma. In addition, Seres will continue to advance its next generation, rationally-designed, fermented drug discovery capabilities, with a focus on SER-301 for ulcerative colitis. Seres made changes to its executive team and reduced its full-time workforce by approximately 30%. Matthew Henn, Ph.D., previously Executive Vice President and Head of Discovery and Microbiome R&D, was appointed Chief Scientific Officer.
Chief Executive Officer appointed (January 2019): Seres announced the appointment of Eric D. Shaff as President and Chief Executive Officer. Mr. Shaff, who was Chief Operating and Financial Officer, succeeded Roger J. Pomerantz, M.D., who continues as Chair of Seres’ Board of Directors.
SER-287 Phase 2b study initiated in ulcerative colitis (January 2019): Seres announced the start of a Phase 2b trial, ECO-RESET, evaluating SER-287 in patients with active mild-to-moderate ulcerative colitis. Seres received $40 million in milestone payments associated with this study start from Nestlé Health Science. The Company obtained feedback from the FDA indicating that results from this study, in conjunction with data from a second pivotal study, could enable a Biologics License Application. The Company expects to complete trial enrollment by mid-2020.
Chief Medical Officer appointed (October 2018): Seres appointed Kevin Horgan, M.D., as Executive Vice President and Chief Medical Officer. Dr. Horgan will lead Seres’ clinical development, clinical operations, regulatory affairs and medical affairs functions.
Financial Results

Seres reported a net loss of $98.9 million for the full year 2018, as compared to a net loss of $89.4 million for the prior year. Seres reported a net loss of $21.3 million for the fourth quarter of 2018, as compared to a net loss of $29.0 million for the same period in 2017. The fourth quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company’s microbiome therapeutics platform. The fourth quarter net loss figure was inclusive of $10.6 million in recognized revenue associated primarily with the Company’s collaboration with Nestlé Health Science.

Research and development expenses for the fourth quarter 2018 were $24.8 million, as compared to $24.0 million for the same period in 2017. The research and development expense was primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as well as the Company’s immuno-oncology efforts.

General and administrative expenses for the fourth quarter were $7.5 million, as compared to $8.8 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees and facility costs.

The increase in the Company’s cash, cash equivalents and investments balance during the quarter was $12.9 million. Seres ended the fourth quarter with approximately $85.8 million in cash, cash equivalents and investments. The increase in cash in Q4 was inclusive of $40.0 million in milestones received under the Company’s collaboration with Nestlé Health Science. Based on the Company’s current operating plan, cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential incoming milestone payments, into the fourth quarter of this year.

Conference Call Information

Seres’ management will host a conference call today, March 6, 2019, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 6566237. To join the live webcast, please visit the "Investors and Media" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

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]).

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.

Savara To Report Q4/Year-End 2018 Financial Results And Business Update On March 13, 2019

On March 6, 2019 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported it will release its fourth quarter and year-end 2018 financial results on Wednesday, March 13, 2019 (Press release, Savara, MAR 6, 2019, View Source [SID1234534029]). Savara management will also host a conference call for investors at 5:30 p.m. ET/2:30 p.m. PT on Wednesday, March 13, 2019 to discuss its fourth quarter and year-end 2018 financial results and provide a business update.

Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through March 20, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10128884.

CymaBay Announces Pricing of Public Offering of Common Stock

On March 6, 2019 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported the pricing of its previously announced underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $12.50 per share, before underwriting discounts and commissions (Press release, CymaBay Therapeutics, MAR 6, 2019, View Source [SID1234534028]). All of the shares of common stock are being offered by CymaBay. In addition, CymaBay has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock at the public offering price less underwriting discounts and commissions. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

The offering is expected to close on March 8, 2019, subject to the satisfaction of customary closing conditions.

Citigroup, Evercore ISI and Cantor Fitzgerald & Co. are acting as the joint book-running managers for the offering. Oppenheimer & Co. Inc. and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and the accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected].

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

CRISPR Therapeutics to Participate in Upcoming Investor Conferences

On March 6, 2019 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to make the following presentations later this month (Press release, CRISPR Therapeutics, MAR 6, 2019, View Source [SID1234534027]):

Barclays Global Healthcare Conference
Date: Wednesday, March 13, 2019
Presentation: 10:15 a.m. ET
Location: Miami, FL

Oppenheimer’s 29th Annual Healthcare Conference
Date: Wednesday, March 20, 2019
Presentation: 1:35 p.m. ET
Location: New York, NY

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following each presentation.