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.

On March 6, 2019 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has decided to terminate its collaboration with its Chinese partner BioChain for the licensing of the Septin9 marker and the exclusive distribution rights in China for Epi proColon, a blood test for colorectal cancer detection, with immediate effect (Press release, Epigenomics, MAR 6, 2019, View Source [SID1234534055]). The company makes use of its contractual right to terminate the agreement when BioChain did not pay Epigenomics more than the contractually agreed minimum royalties over a period of three years. Epigenomics AG will evaluate all options for the distribution of Septin9 in China to maximize the full potential of the test in this key market.

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Taking also into account the termination of the license agreement with Biochain, the Company has today determined its outlook for the financial year 2019. Epigenomics AG expects revenues to be in a range of EUR 3.0 to 6.0 million (compared to EUR 1.5 million for the financial year 2018 based on preliminary, unaudited numbers). This represents an estimated increase in revenues of between 100% and 300% which is expected to be essentially driven by the new reimbursement rate published by Medicare of $192 per Epi proColon test. Adjusted EBITDA (EBITDA before share-based payment expenses) is expected to be in the range of EUR -11.5 to -14.0 million (compared to EUR -11.4 million for the financial year 2018 based on preliminary, unaudited numbers). Given the termination of the license agreement with Biochain, future licensing revenue on the Chinese market is not included in the outlook for 2019.

Explanatory notes regarding the term "EBITDA before share-based payment expenses" can be found in section 7.3 (pages 131-132) of the prospectus published by the Company on October 8, 2018. The prospectus is available on the internet at: www.epigenomics.com/news-investors/capital-increase.

On March 6, 2019 Ipsen (Euronext: IPN; ADR: IPSEY) reported the EU launch of a new pre-filled syringe for Somatuline Autogel (lanreotide) for patients with neuroendocrine tumors (NETs), acromegaly or symptoms associated with carcinoid syndrome, and released findings from the human factor studies that underpinned its development as a poster presentation (Abstract #H14) at ENETS 2019.1,2 As of April 2019, patients in Ireland will be the first to benefit from the new ready-to-use, pre-filled syringe (Press release, Ipsen, MAR 6, 2019, View Source [SID1234534071]). Ipsen has confirmed they are committed to making this new pre-filled syringe available to patients and healthcare professionals throughout Europe, the U.S., Canada, Australia and New Zealand during 2019 following necessary regulatory approvals.

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The new pre-filled syringe for Somatuline Autogel was the result of several studies, involving patients, their caregivers, nurses and other healthcare professionals, to inform and test enhancements to the existing pre-filled syringe.1 Notable new features are modified ergonomics and handling, a needle shield removal system, an injection process with plunger support and heightened ease of use.1 The automatic, built-in safety system, which helps to prevent needle stick injury by locking in place following the administration, has not been changed.

"Today’s announcement around the EU launch of a new pre-filled syringe for Somatuline Autogel is not only an important new option for patients living with acromegaly and NETs but represents a significant milestone in our commitment to patient-centric innovation," said Bartek Bednarz, Senior Vice President, Global Oncology Franchise at Ipsen. "We are also proud to be sharing as a poster presentation at ENETS 2019 the results of several studies, where we tested, evolved and validated changes for every stage of the Somatuline Autogel injection experience", added Sotirios Stergiopoulos, Chief Medical Officer at Ipsen.

"NETs and acromegaly can be associated with a number of uncomfortable and unpleasant symptoms, so any innovation that eases the physical challenges of treatment for the patient and their healthcare team is a step forward," said Daphne T Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, U.S. and one of the authors of the study.

On March 6, 2019 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the year ended December 31, 2018 (Press release, Lipocine, MAR 6, 2019, View Source [SID1234534017]).

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Fourth Quarter 2019 and Recent Corporate Highlights

·Currently conducting an ABPM clinical study to assess TLANDO’s effect on blood pressure, if any. The study has enrolled 138 subjects and results are currently expected before the end of the first quarter of 2019.
·The Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("PTO") granted Lipocine’s Priority Motion in the interference case with Clarus Therapeutics, and entered adverse judgment against Clarus. The PTAB ruling cancels all claims of the Clarus 8,828,428 patent. Clarus has filed an appeal of the PTAB judgement to the Court of Appeals for the Federal Circuit.
·Successfully completed a definitive phlebotomy study which supports the reliability of TLANDO clinical measurements conducted in the Phase 3 trials.
·Data from clinical trials of LPCN 1144 in potential non-alcoholic fatty liver disease ("NAFLD") patients were presented at the NASH-TAG Conference, January 2019, in Park City, UT.
·Data highlighting the association of hypogonadism and NAFLD and interim liver fat reductions with LPCN 1144 treatment were presented at the Keystone Symposia on Integrated Pathways of Disease in non-alchoholic steatohepatitis ("NASH") and NAFLD, January 2019 in Santa Fe, NM.
·Interim results from an ongoing sixteen-week Liver Fat Imaging study demonstrated meaningful liver fat reduction in patients treated with LPCN 1144. Liver fat changes were assessed using magnetic resonance imaging, proton density fat fraction ("MRI-PDFF") technique, a non-invasive quantitative biomarker of liver fat content.
oTreatment results showed post-treatment absolute and relative mean reductions in liver fat of 7.6% and 38%, respectively, from baseline levels.
oSixteen-week results from the study are currently expected before the end of the first quarter of 2019.
·Received clearance by U.S. Food and Drug Administration ("FDA") for an Investigational New Drug ("IND") application to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH.

Year Ended December 31, 2018 Financial Results

Lipocine reported a net loss of $11.7 million, or ($0.55) per diluted share, for the year ended December 31, 2018, compared with a net loss of $21.0 million, or ($1.05) per diluted share, in the year ended December 31, 2017.

Research and development expenses were $6.5 million for the year ended December 31, 2018, compared with $11.0 million for the year ended December 31, 2017. The decrease in research and development expenses year over year was primarily due to reduced costs associated with TLANDO which include decreased contract research organization expenses, decreased contract manufacturing expenses and decreased outside services and consulting costs. Additionally, there were significant decreases in contract manufacturing expenses associated with LPCN 1107.

General and administrative expenses were $5.3 million for the year ended December 31, 2018, compared with $10.2 million for the year ended December 31, 2017. The decrease in general and administrative expenses year over year was primarily due to decreased personnel costs related to an overall reduction in headcount resulting in lower stock compensation expense, bonus expense, and salary and related benefit costs in 2018. Additionally, expenses for pre-commercialization marketing and sales activities related to TLANDO decreased significantly.

As of December 31, 2018, the Company had unrestricted cash, cash equivalents and marketable securities aggregating $15.3 million, compared to $21.4 million at December 31, 2017.

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.