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.

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.