On March 25, 2019 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, AmpliPhi Biosciences, MAR 25, 2019, View Source [SID1234534598]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial results release.

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"I am pleased with the strong progress AmpliPhi achieved in 2018, capped off by the announcement of the pending merger with C3J at the beginning of 2019," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "Leading up to the closing of the merger, which is expected in May 2019, we remain on track to initiate a clinical trial of AB-SA01 for the treatment of S. aureus bacteremia later in 2019. The increasing prevalence of antibiotic-resistant infections has become a global public health crisis, and we believe precisely targeted bacteriophage therapeutics, with their novel mechanism of action, could be an important therapeutic option where currently-available antibiotic treatments have become ineffective."

Recent Business Highlights

In January 2019, AmpliPhi and C3J Therapeutics, Inc., a private clinical stage biotechnology company focused on the development of novel synthetically engineered bacteriophage products, announced they had entered into a definitive agreement under which a wholly owned subsidiary of AmpliPhi will merge with C3J in an all-stock transaction, subject to shareholder approval. Certain existing C3J shareholders have agreed to purchase $10.0 million of common stock of the combined company immediately following the closing of the merger, subject to customary conditions. The financing will help fund further development of the combined company’s preclinical and clinical programs, and is expected to close immediately following the completion of the merger. Management expects the merger will close in May 2019.
Presented clinical case data from the expanded access program at the ID Week 2018 Conference in October 2018. Thirteen patients with serious and life-threatening S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney. Eighty-three percent (10 out of 12) patients in the modified intent-to-treat (mITT) population achieved treatment success at the end of therapy as reported by treating physicians. Bacteriophage treatment was well tolerated, with no adverse events attributable to the therapy.
Completed treatment of 21 patients at 7 hospitals with serious or life-threatening infections not responding to antibiotics with AmpliPhi’s bacteriophage product candidates, AB-SA01 and AB-PA01. Following administration of 1,000+ doses, a treatment success rate of 84% was observed at the end of therapy, and treatment was generally well tolerated.
Completed an underwritten public offering in October 2018 generating net proceeds of $5.8 million.
Fourth Quarter and Full Year Ended December 31, 2018 Financial Results

Research and development (R&D) expenses for the fourth quarter of 2018 were $1.4 million compared to $1.1 million for the fourth quarter of 2017. The increase of $0.3 million was primarily attributable to an increase in clinical costs and related professional services.
R&D expenses for the year ended December 31, 2018 were $4.9 million compared to $2.9 million for the year ended December 31, 2017. The increase in 2018 was impacted by a $1.2 million tax incentive payment received in 2018 from the Australian tax authority, compared to a $2.0 million tax incentive payment from the Australian tax authority received in 2017. Excluding any benefit from tax incentive payments, R&D expenses were $6.1 million and $4.9 million, respectively. The increase of $1.2 million in 2018 was primarily related to an increase in clinical activities and related professional and consulting expenses.
General and administrative (G&A) expenses were $1.5 million for the fourth quarter of 2018 compared to $1.3 million for the fourth quarter of 2017. The increase of $0.2 million was primarily due to higher legal and professional fees in the fourth quarter of 2018.
G&A expenses for the year ended December 31, 2018 were $5.7 million compared to $7.6 million for the year ended December 31, 2017. The $1.9 million decrease was primarily attributable to a decrease in severance costs, legal and professional fees and lower non-cash charges in 2018.
Operating expenses in the fourth quarter of 2018 included a non-cash charge of $1.9 million for the impairment of intangible assets for the excess of book value over the computed fair value of those assets as of December 31, 2018. The impaired assets were recorded in connection with acquisitions of a predecessor company in 2011.
Net cash used in operating activities for the year ended December 31, 2018 was $9.4 million, as compared to $9.2 million for the year ended December 31, 2017.
Cash and cash equivalents as of December 31, 2018 totaled $8.2 million.
As of March 8, 2019, there were approximately 32.3 million shares of common stock outstanding.
The audit opinion included in the company’s Annual Report on Form 10-K for the year ended December 31, 2018 contains a going concern explanatory paragraph.

On March 25, 2019 Epic Sciences, Inc. (Epic) reported that Lloyd Sanders has joined the company as president and chief executive officer (Press release, Epic Sciences, MAR 25, 2019, View Source [SID1234534614]). After serving nearly six years in the role, Murali Prahalad, Ph.D., has stepped down to pursue new opportunities and has been appointed to Epic’s board of directors.

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"Under Murali’s leadership, the Epic team has made substantial progress in advancing our proprietary Functional Cell Profiling platform and successfully launching and obtaining Medicare coverage for the world’s first predictive test for metastatic prostate cancer," said Gregory T. Lucier, chairman of Epic Sciences. "As Murali continues to advise the company in his role as a director, we welcome Lloyd to the team to capitalize on our solid foundation. The trajectory has been set for significant commercial growth through Epic’s portfolio of high-value liquid biopsy tests and expansion into breast cancer, immuno-oncology and global markets. Lloyd and the leadership team, board, investors and Epic employees are highly motivated to take Epic to the next level."

Mr. Sanders joins Epic with 20 years of diagnostics and pharmaceutical industry experience, much of it focused on oncology. Prior to Epic, he served as president of the oncology segment of the molecular diagnostics company Myriad Genetics, overseeing the oncology, urology and dermatology commercial organizations. While at Myriad, he was responsible for the sales, marketing and laboratory operations of numerous commercial products. Previously, Mr. Sanders served as chief operating officer at Dey Pharma, a division of Mylan, overseeing sales, marketing and medical affairs, including the EpiPen flagship brand. Prior to Dey Pharma, he ascended from vice president of marketing to chief operating officer of oncology biotech Genta. He also held several leadership positions and was responsible for the commercial success of several oncology products at Sanofi-Synthelabo, subsequently Sanofi-Aventis, and Pharmacia (now Pfizer).

"Epic has established an impressive position in the prostate cancer liquid biopsy market and I am eager to work with the team to advance the mission of providing very powerful predictive, actionable information to physicians and patients that can extend lives," said Mr. Sanders. "By expanding the breadth and depth of Epic’s portfolio of reimbursed products, and building our thriving biopharma solutions business that supports our pharmaceutical partners’ development of next-generation immunotherapies and targeted cancer agents, we can play an important role in changing cancer from a lethal to a chronic, manageable disease."

On March 25, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into an agreement with funds managed by Oberland Capital Management, LLC ("Oberland Capital") for up to $135.7 million in exchange for selling rights to a portion of royalty revenues on worldwide net sales of Erivedge (Press release, Curis, MAR 25, 2019, View Source [SID1234534632]).

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Under the terms of the agreement, Curis received $65.0 million in an upfront cash payment, plus Curis is entitled to receive up to an additional $70.7 million in milestone payments if future net royalties exceed pre-defined annual and cumulative thresholds. Oberland Capital will receive 100% of the first $13.2 million and 35% thereafter of annual net royalties due to Curis from worldwide net sales of Erivedge, excluding a portion of non-US royalties retained by Curis. At the closing of the transaction, Curis used a portion of the sale proceeds to retire existing debt, with remaining proceeds of approximately $30 million, excluding closing costs and related transaction fees, to be used to fund its operations.

James Dentzer, President & CEO of Curis, commented, "We are pleased to announce this agreement with Oberland Capital. We believe this structure provides Curis with substantial non-dilutive capital today, while retaining significant participation in the future upside potential of Erivedge. The proceeds of this transaction further strengthen our cash position as we fund our three lead therapeutic candidates to reach their near term development catalysts and beyond."

"Erivedge is an attractive asset commercialized by a world-class marketer and we are pleased to partner with Curis as it advances its clinical pipeline" said Andrew Rubinstein, Managing Partner of Oberland Capital. "Acquiring a participation in Erivedge royalties reflects our strategy of investing in commercial stage or near-commercial stage biopharmaceutical products that address serious diseases or areas of high unmet medical need."

About Erivedge
Erivedge (vismodegib) is a first-in-class orally-administered small molecule which is designed to selectively inhibit the Hedgehog signaling pathway by targeting a protein called Smoothened. Genetic mutations that lead to unregulated activation of Hedgehog signaling are found in basal cell carcinoma (BCC) and medulloblastomas. Aberrant signaling in the Hedgehog pathway is implicated in over 90% of BCC cases. Erivedge is being developed and commercialized by Roche and Genentech under a 2003 collaboration agreement between Curis and Genentech whereby Genentech obtained an exclusive, global, royalty-bearing license with the right to sublicense, to make, use, sell and import small molecule and antibody Hedgehog pathway inhibitors for human therapeutic applications, including cancer therapy. Erivedge is approved for use in patients with advanced basal cell carcinoma in the U.S. and over 60 foreign countries. It is also under regulatory review for commercialization in a number of additional territories.

On March 25, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, reported that details on the presentation of data from five studies supporting the company’s lead drug candidate, AsiDNA, in poster sessions at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held March 29 – April 3, 2019, in Atlanta, GA, USA (Press release, Onxeo, MAR 25, 2019, View Source [SID1234534652]).

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Françoise Bono, PhD, Chief Scientific Officer, commented: "We are very pleased to have five studies accepted and presented at the prominent AACR (Free AACR Whitepaper) meeting as it reflects the interest, the quality and the diversity of our current translational research on AsiDNA. Through these data, we further demonstrate the uniqueness of our lead compound in terms of mechanism of action and its related unique properties, especially on preventing the occurrence of resistance to treatment, one of the major issues in oncology today. All these data complement and reinforce our rationale for the continued clinical development of AsiDNA expected to start in the coming weeks, now that we have identified the active doses that trigger target engagement and confirmed the favorable safety profile in our phase I DRIIV study. We look forward to presenting and discussing our very exciting findings during the conference."

On March 25, 2019 PharmaMar (PHM:MSE) reported that its Phase II trial of lurbinectedin as a single agent for the treatment of relapsed small cell lung cancer (SCLC) has achieved its primary endpoint, by both investigator review and IRC (Independent Review Committee) (Press release, PharmaMar, MAR 25, 2019, View Source [SID1234534599]).

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The primary endpoint of this trial was to measure the Overall Response Rate (ORR), with other secondary endpoints such as Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS) and safety.

This multicenter, single arm, phase II clinical trial, involving 105 patients from 38 centers in nine different countries in Europe and the US, assessed the safety and efficacy of lurbinectedin in patients with relapsed SCLC.

The results will be submitted for presentation at a major medical meeting.

Around 15% to 20% of lung cancers are small cell, and it is one of the cancer types with the worst prognosis. The treatment of relapsed SCLC has not changed substantially in more than two decades. The last FDA approved new chemical entity in second line small cell lung cancer was topotecan, in 1996.

In the lurbinectedin clinical program, the SCLC indication is currently PharmaMar’s first priority. PharmaMar completed the recruitment in July 2018 of its Phase III ATLANTIS study for the treatment of relapsed SCLC. The Company is awaiting results.

Lurbinectedin was designated an Orphan Drug by the FDA in August 2018, and a positive opinion for Orphan Drug Designation by EMA was received in January 2019 for the treatment of SCLC.

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