Alpine Immune Sciences Provides Corporate Update and Reports First Quarter 2018 Financial Results

On May 14, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer, autoimmune/inflammatory, and other diseases, reported financial results for the first quarter ended March 31, 2018 (Press release, Alpine Immune Sciences, MAY 14, 2018, View Source [SID1234526574]).

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"We are increasingly encouraged by our promising preclinical results, which demonstrate the potential of our platform to change the way we approach and treat both cancer and autoimmune/inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We continue to make progress on our lead programs and remain on track to file INDs for ALPN-101, a dual ICOS/CD28 antagonist for the treatment of autoimmune/inflammatory diseases in the fourth quarter of this year, and ALPN-202, our lead oncology program, in 2019."

Corporate and Scientific Development Highlights

Presentation of ALPN-202 immuno-oncology program data: Alpine’s poster at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting debuted preclinical data for the ALPN-202 program, representing a potentially novel immuno-oncology approach to the treatment of cancer. Results demonstrated molecules in the ALPN-202 program are able to antagonize PD-L1 and CTLA-4 while providing a CD28 costimulatory signal, resulting in the elimination of tumors, complete resistance to tumor rechallenge, and superiority to an approved anti PD-L1 therapeutic in a murine cancer model. The potentially unique mechanism of ALPN-202 seeks to address the lack of costimulatory activity in many current immuno-oncology therapies and may improve the immune system’s response to cancer. With preclinical results demonstrating both checkpoint blockade and immune system costimulation, Alpine’s ALPN-202 program could potentially be a more potent and broadly applicable therapeutic for the treatment of cancer.

Chris Peetz appointed to Board of Directors: On April 24, 2018, Alpine announced the appointment of Chris Peetz to its Board of Directors. Currently serving as Chief Executive Officer of Flashlight Therapeutics, Mr. Peetz is an experienced life sciences executive. He previously served as Chief Financial Officer and Head of Corporate Development at Tobira Therapeutics (acquired by Allergan in November 2016) and, prior to that, held senior management roles at Jennerex Biotherapeutics and Onyx Pharmaceuticals (now Amgen). Earlier, he was at LaSalle Corporate Finance, Abgenix, and Solazyme.

First Quarter 2018 Financial Results

Alpine ended the first quarter of 2018 with $76.7 million in cash, cash equivalents, and short-term investments compared to $81.2 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $4.4 million.
Revenue for the first quarter of 2018 was $0.3 million compared to $0.7 million in the first quarter of 2017. The decrease was primarily attributable to the timing of revenue recognized under Alpine’s collaboration agreement with Kite Pharma, a Gilead (NASDAQ:GILD) company. As previously announced, under the terms of the research collaboration and license agreement with Kite, which was extended on October 30, 2017, Alpine received upfront payments of $5.5 million, which were initially recorded as deferred revenue and expensed over the period of the research term.
Research and development expenses for the first quarter of 2018 were $3.8 million compared to $1.9 million for the same period in 2017. The $1.9 million increase was primarily attributable to increased activity in preclinical studies and the addition of operational and research personnel related to expanding research and discovery programs.
General and administrative expenses for the first quarter of 2018 were $2.1 million compared to $0.9 million for the same period in 2017. The $1.2 million increase was primarily attributable to higher professional and legal service fees and increased headcount to support our operations as a public company.
Cash Guidance

The company expects to have cash to fund operations into 2020, including the clinical advancement of ALPN-101 for the treatment of autoimmune/inflammatory diseases and ALPN-202 for the treatment of cancer.

BMG Pharma: GelX® Approved in Europe for Prevention of Oral Mucositis in Cancer Patients

On May 14, 2018 BMG Pharma S.r.l., an innovative specialty pharmaceutical company, reported the European regulatory approval for its GelX product to be used for the prevention of oral mucositis (Press release, BMG PHARMA, MAY 14, 2018, View Source [SID1234526593]).

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This new regulatory approval for GelX is the first for a medical product to be used for both the treatment and prevention of oral mucositis in cancer patients.

The approval is based on clinical data, (conducted under Good Clinical Practice(GCP) principles) from 149 adult and paediatric patients showing unique results with 99,3% of patients experiencing prevention or remission of oral mucositis during cancer therapy.

This new approval will allow patients to receive cancer treatment with a significantly reduced chance of developing oral mucositis during that treatment and to reduce the grade of oral mucositis, allowing the opportunity for normal eating and drinking.

Marco Mastrodonato, Founder and CEO of BMG Pharma S.r.l. commented– "We achieved a unique milestones by giving the opportunity to cancer patients to prevent Oral Mucositis in both adults and children which will allow them to continue with a complete nutritional program while under cancer treatment. GelX will be available through its partners to over 1.1m patients in the 7 major markets, suffering from oral mucositis as a side-effect of cancer and transplants treatment.’’

GelX Oral Gel and GelX Oral Spray are proprietary products of BMG Pharma Srl, which thanks to their innovative formula alleviate pain in cancer patients, offering unique solutions for chemotherapy & radiation induced oral mucositis.

Immatics Appoints Stephen Eck as Chief Medical Officer US

On May 14, 2018 Immatics, a leading company in the field of cancer immunotherapy, reported the appointment of Stephen Eck, M.D., Ph.D. as Chief Medical Officer (CMO) at Immatics US, Inc. (Houston, Texas), effective immediately (Press release, Immatics Biotechnologies, MAY 14, 2018, View Source [SID1234569553]).

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Stephen Eck is a hematologist and oncologist with more than 25 years experience in academia and industry. He began his professional career at the University of Pennsylvania where he was Director of the Gene Therapy Program, and has since held a number of leaderships roles in oncology drug and biomarker development at prominent pharmaceutical companies. Prior to joining Immatics, Stephen Eck served as Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma, and previously held senior roles at Pfizer and Eli Lilly.

Dr. Harpreet Singh, CEO and President of Immatics US, said: "Stephen’s appointment will further strengthen our cell therapy programs and global development capabilities. He brings significant experience in both early and late-stage development, as well as new drug approvals, in oncology and cancer immunotherapies, which will be invaluable to us as we progress our clinical and pre-clinical programs."

Dr. Stephen Eck, Chief Medical Officer of Immatics US, said: "Immatics has truly impressed me as having one of the most innovative approaches in immuno-oncology. I am thrilled to be joining the Company at this very exciting time in its history, and as T-cell therapies move to become more widely used in cancer therapeutics. Immatics’ unique approach gets at the root cause of prior failures in the treatment of solid cancers by addressing novel, highly-specific cancer targets and mobilizing billions of activated T cells against these."

Whilst at Astellas Pharma, Stephen Eck worked closely with The University of Texas MD Anderson Cancer Center, a key collaborator of Immatics, on a number of clinical trials, joint collaborations and external advisory committees. Notably, he is a member of MD Anderson’s Moon Shots Program advisory board. Additionally, he is a Fellow of the American Association for the Advancement of Science, and is Chairman of the Board of Directors of the Personalized Medicine Coalition. Stephen Eck has a Ph.D. in Chemistry from Harvard University and an M.D. degree from the University of Mississippi School of Medicine."

10-Q – Quarterly report [Sections 13 or 15(d)]

BioXcel Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioXcel Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527534]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Mersana Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mersana Therapeutics, 2018, MAY 14, 2018, View Source [SID1234527574]).

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