Cornerstone Pharmaceuticals, Inc.

Rafael Holdings will provide Cylo Therapeutics' shareholders with shares of its class B common stock based on valuing Cylo’s shares at 95 cents apiece. With just weeks to go before the FDA decides whether to approve the first treatment for a rare genetic condition, Rafael Holdings is merging with Cyclo Therapeutics to try to push their own candidate over the line.Cyclo’s lead asset is Trappsol Cyclo, a formulation of hydroxypropyl beta cyclodextrin that is being evaluated in a phase 3 trial in Niemann-Pick disease type C1 (NPC). The rare, genetic lysosomal storage disease prevents the body from moving and using cholesterol and other lipids in cells. This leads to a buildup of cholesterol and other lipids in the liver, spleen or lungs.After the deal closes, which is expected in late 2024, Rafael said it will continue to fund the phase 3 trial of Trappsol Cyclo through to its 48-week interim analysis. Enrollment in the study was completed in May, and Cyclo has previously said the top-line readout is likely in the first half of 2025.The expectation among Cyclo’s leadership is that this phase 3 data will be the evidence needed to get Trappsol Cyclo approved as “a much-needed treatment option for the treatment of NPC1,” they said in a second-quarter update last week. Rafael’s interest in Cyclo dates back to March 2023, when the holding company made its first investment in the biotech. Since then, Rafael scooped up $5 million worth of Cyclo’s stock in June 2023 and contributed to a $2.4 million raise via a private offering of Cyclo’s stock in October of that year.Now, the companies have announced a merger where Rafael will provide Cylo’s shareholders with shares of its class B common stock based on valuing the biotech's shares at 95 cents apiece. Cyclo's shares closed at $1.26 yesterday and were trading down about 17% before the market open Thursday in the wake of the news “The proposed merger with Cyclo Therapeutics is a major step forward in our strategy to invest in, develop and commercialize clinical stage assets in areas of high unmet medical need,” Rafael’s CEO Bill Conkling said in the Aug. 22 release.In this morning’s release, Cyclo’s CEO N. Scott Fine said the biotech’s partnership with Rafael over the last year and a half has “enabled Cyclo to get to where we are today.”“We are extremely pleased to announce our merger agreement with Rafael Holdings and believe that the strength of Rafael’s balance sheet and its strong management team will solidify our commitment to deliver the results of the TransportNPC trial for our shareholders and patients.” Beyond Cyclo, Rafael’s interests include a majority investment in cancer-metabolism-focused Cornerstone Pharmaceuticals and a majority equity interest in LipoMedix Pharmaceuticals, which is working on liposome-delivered oncology therapies.There are currently no FDA-approved therapies for NPC, although Johnson & Johnson’s Zavesca is approved in Europe, Japan and certain other countries. But the race has heated up this month after an FDA advisory committee gave its backing to Zevra Therapeutics’ arimoclomol ahead of a regulatory decision next month.Arimoclomol was originally submitted to the FDA in July 2020 but was rejected almost a year later because the agency questioned aspects of the single clinical trial used to support the application. Zevra returned to the FDA in December 2023 with a rescored scale and more results from the study, including data from an open-label expansion phase. 

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.   Scorpion’s CEO, CMO out the door Scorpion Therapeutics It’s a new year and change is afoot at Scorpion Therapeutics, with both former CEO Axel Hoos, M.D., Ph.D., and CMO Michael Streit, M.D., hitting the exits.  Industry veteran Hoos has led the oncology company since July 2021, when he left GSK for Scorpion. At the time, Hoos had taken the reins from interim CEO Adam Friedman, M.D., Ph.D., who will now take back the top title, this time without the temporary designation. Friedman is part of Scorpion’s founding team and most recently served as the biotech’s president of corporate strategy and business development.    The Boston biotech is also replacing Streit, who was the first to fill the company’s chief medical officer position. Streit joined in 2022 from Sanofi, where he had most recently served as vice president and senior project head.  Now, Mark Chao, M.D., Ph.D., will take over as CMO. He joins Scorpion from TenSixteen Bio, where he served as co-founder and CEO.  But the changes don’t stop there. Scorpion has also promoted Erica Jackson, Ph.D., to chief discovery officer. She previously served as the company’s executive vice president of biology. Fierce Biotech  CRISPR hunts for new CMO  CRISPR Therapeutics CRISPR Therapeutics Chief Medical Officer Phuong Khanh Morrow, M.D., is resigning—a decision that was announced six days after the company secured FDA approval for its Vertex-partnered gene therapy Casgevy. The biotech has already kicked off the search for a new CMO, a spokesperson told Fierce Biotech. “CRISPR Therapeutics has a seasoned leadership team with extensive experience managing clinical development for CRISPR’s programs and is well positioned to successfully manage the transition,” a spokesperson said via email. Morrow, who has been with the company since May 2022, will officially depart Jan. 26. Her resignation was not the result of any disagreement with the gene-editing company, according to CRISPR Tx. Before joining the Swiss-American biotech, Morrow spent more than 10 years in various leadership roles at Amgen. Fierce Biotech  Long-time Evotec CEO steps down Evotec Evotec’s CEO Werner Lanthaler has resigned from his role before his expected end of term, which was set for March 2026, citing personal reasons.  Lanthaler, who has led the German biotech since 2009, will serve as a strategic advisor to Evotec’s board, which has launched a search for a permanent CEO.  Until a successor is chosen, board member Mario Polywka will take on the role of interim CEO. Ploywka had served as Evotec’s chief operating officer from 2006 to 2018. Release  > LianBio CEO Yizhe Wang, Ph.D., is headed for the exits in pursuit of new opportunities. Chief Investment Officer Adam Stone will be the interim chief while the search for a permanent replacement begins. Release > Ex-Biogen CEO Michel Vounatsos has joined the board of Quris-AI. Former Merck regional president Yossi Ben Amram was also named president of the company. Release > Vicore Pharma has hired Bertil Lindmark, Ph.D., M.D., to serve as chief medical officer, taking the reins from Rohit Batta. Lindmark joins from Galecto, where he also held the CMO role, and has previous experience as AstraZeneca’s global vice president of clinical development for respiratory and inflammation. Release > Applied Therapeutics has named Constantine Chinoporos as its new chief operating officer and chief business officer. He’s been a strategic advisor for Apollo Therapeutics since February 2023 after past c-suite roles at other biotechs. Disclosure > Innate Pharma CEO Mondher Mahjoubi has resigned to pursue a new gig at a larger pharmaceutical company, the European biotech announced. Chairman and co-founder Hervé Brailly will be the interim leader while the search for a replacement gets underway. Release > SpliceBio will bring on Aniz Girach, M.D., as chief medical officer. Girach was previously CMO of fellow gene editing biotech ProQR until March 2023. Release > New year, new gig for Nathan Dowden, who’s been promoted at Entrada from chief operating officer to president and COO. He’s been with the company since 2019 after working at Rubius. Release > Relmada CMO Cedric O’Gorman, M.D., is leaving the company after one year. He previously was the chief medical officer at Alpha Cognition. Release > After Zevra’s recent acquisition of Acer, Adrian Quartel, M.D., will become the new chief medical officer. He was the CMO of Acer and was the chief medical officer of Adamis before that. Release > ARIAD Pharmaceuticals founder Harvey Berger, M.D., has been hired as the new CEO of Kojin Therapeutics. Kojin is backed by the likes of Leaps By Bayer and AbbVie’s venture arm. Release > Included in Radionetics Oncology’s latest financing announcement was news that the biotech has brought on Paul Grayson as CEO. He was most recently president and CEO of fellow oncology company Tentarix Biotherapeutics. Release  > Mineralys Therapeutics has tapped Minji Kim, Ph.D., to serve as chief business officer. Before Mineralys, she held the same role at Affamed Therapeutics and has past experience at Jounce Therapeutics, Curis and Hoffmann-La Roche. Release > ProMIS Neurosciences is bringing on Neil Warma as interim CEO to replace Gail Farfel, Ph.D. Warma has been a director on the company’s board since 2022. Release > Brii is bringing aboard former HemoShear CSO Brian Alvin Johns, Ph.D., for the same role. Before HemoShear, he was VP of discovery at Viiv and GSK. Release > Heike Keilhack, Ph.D., is joining ROME Therapeutics as chief scientific officer. She previously was CSO and oversaw R&D of two now-clinical-stage PARP inhibitors at Ribon Therapeutics. Release > Diagnostics vet Brian Kim is the new CEO of genomics company Mission Bio, the company announced. He previously was CEO of Fortis Life Science and held other leadership roles at Biosearch Technologies and PerkinElmer. Release > SV Health Investors has appointed Nikola Trbovic as managing partner and Jamil Beg as partner. The two will help steer the firm’s biotech portfolio, which includes companies like Bicycle and Nimbus. Release > CymaBay Therapeutics and former Chief Commercial Officer Lewis Stuart mutually agreed that Stuart would leave the company on Dec. 29. CymaBay’s VP Liver Franchise Lead Ben Kozub will assume leadership of commercial organization. Release > Alaunos Therapeutics has tapped Dale Curtis Hogue, Jr., to serve as director of the immuno-oncology company. Hogue most recently founded Dune Lake Capital and previously worked as a senior analyst at Discovery Capital Management. Release > Viatris has chosen Philippe Martin to lead the company’s research and development as chief R&D officer. Martin has clocked in past experience at Celgene and Schering-Plough (acquired by Merck). Release > Noriyuki Kasahara, M.D., Ph.D., is moving from 4DMT’s board to its C-suite, being named chief scientific officer. Kasahara is a brain surgeon who previously worked at UCSF. Release > Scribe Therapeutics’ next chief scientific officer and head of research and development will be Aarif Khakoo, M.D., who joins the CRISPR genetic medicines company from Calico Life Sciences. Also joining the biotech is Maria Mirotsou, Ph.D., as vice president of discovery biology. Release > Eterna Therapeutics has picked Sanjeev Luther as its next CEO, as of Jan. 1. He succeeds Matt Angel, Ph.D. Luther has spent the past 30 years at various roles across biopharma, most recently as CEO at Cornerstone Pharmaceuticals. Release > Henrik Luessen is the new chief business officer for German biotech Eleva, which has a moss-based platform that develops complex proteins for treatment of diseases. Release > Ashvattha Therapeutics has named Mehdi Paborji, Ph.D., as senior vice president of technical operations to oversee CMC and manufacturing for the biotech’s nanomedicines. Release  > Deka Biosciences has tapped Stanley Frankel, M.D., to serve as senior clinical advisor, interim chief medical officer and scientific advisory board member. The hematologist-oncologist joins Deka with past experience as SVP, global drug development for cell therapy for BMS following the 2019 acquisition of Celgene. Release > HERVOLUTION Therapeutics has chosen J. Robert Coleman, Ph.D., to lead the biotech as CEO. Before joining HERVOLUTION, Coleman co-founded Codagenix and served as the company’s CEO for 12 years. Release > ImPact Biotech has appointed clinical radiologist Eyal Morag, M.D., to be the company’s chief medical officer. Morag joins from Microbot Medical, where he was also CMO, and currently serves in scientific and medical advisory roles at Aidoc Medical, Vortex Imaging and HighRad. Release

CAMBRIDGE, Mass., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Eterna Therapeutics Inc. (Nasdaq: ERNA) (“Eterna” or the “Company”), a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines, has appointed Sanjeev Luther as President and Chief Executive Officer and a member of the company's Board of Directors, effective January 1, 2024. Mr. Luther will replace Matt Angel, Ph.D., the current President and Chief Executive Officer. James Bristol, Ph.D., Chairman of Eterna’s Board of Directors, said, “We are excited to have Sanjeev take on the role of President and CEO of Eterna as we continue our work to support the development of next-generation therapies using mRNA cell engineering. Sanjeev has an impressive track record in leadership, strategic planning, and business development across various global organizations in the pharmaceutical and healthcare sectors. The Board looks forward to working with Sanjeev as Eterna continues to capitalize on its in-licensed portfolio of patented mRNA cell engineering technologies.” Mr. Luther stated, “It’s an honor to join Eterna’s team at this exciting time. I look forward to working closely with Eterna's scientists, management team, and Board to deliver sustained value to our shareholders and to further the reach and promise of mRNA cell engineering.” Mr. Luther is a seasoned pharmaceutical executive having spent over 30 years in leadership roles across public and private biotechnology and global pharmaceutical companies. Most recently, he served as President, CEO, and Board Member of Cornerstone Pharmaceuticals, where he oversaw the evolution of the company’s pipeline for rare cancers and secured strategic partnership, in-licensing, and out-licensing agreements. At Cornerstone, he also held the roles of Chief Operations Officer and Chief Business Officer. Prior to Cornerstone, Mr. Luther led business-building and fundraising strategies for Fortune 500 corporations and start-ups in pharmaceuticals, biotech, medical devices, and diagnostics, including Bristol-Myers Squibb, Novartis, Bausch and Lomb, and GE Healthcare. He has experience across a range of therapeutic areas and stages, from R&D through commercialization. Mr. Luther holds an MBA in Marketing and a B.S. in Marketing/Business Administration from the State University of New York at Buffalo. About Eterna Therapeutics Inc.Eterna Therapeutics is a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines. Eterna has in-licensed a portfolio of over 130 patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the NoveSlice™ and UltraSlice™ gene-editing proteins, and the ToRNAdo™ mRNA delivery system from Factor Bioscience. NoveSlice™, UltraSlice™, and ToRNAdo™ are trademarks of Factor Bioscience. For more information, please visit www.eternatx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as “believe,” “could,” “estimate,” “anticipate,” “expect,” “plan,” “possible,” “potential,” “project,” “will” or other similar words and the negatives of such words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those stated or implied in any forward-looking statement as a result of various factors, including, but not limited to, uncertainties related to: (i) the evolution of Eterna’s business model into a platform company focused on mRNA, induced pluripotent stem (iPS) cell and gene editing technologies; (ii) Eterna’s ability to successfully, cost-effectively and efficiently develop its technology and products; (iii) Eterna’s ability to successfully commence clinical trials of any products on a timely basis or at all; (iv) Eterna’s ability to successfully fund and manage the growth of its development activities; and (v) Eterna’s ability to obtain regulatory approvals of its products for commercialization. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this communication speak only as of the date on which they were made, and Eterna does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law. Factors that may cause Eterna’s actual results to differ from those expressed or implied in forward-looking statements contained in this press release are more fully disclosed in Eterna’s periodic public filings with the U.S. Securities and Exchange Commission, particularly under the heading “Risk Factors” in Eterna’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as under similar headings in Eterna’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Investor Relations Contact:investors@eternatx.com Media Contact:EternaPR@westwicke.com