Healx Ltd.

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.  Editor’s note: We won’t be publishing Chutes & Ladders next week on Nov. 25 due to the Thanksgiving holiday, but will be back to our regular schedule the following week. FDA pillar Janet Woodcock set to retire in early 2024 Food and Drug Administration The FDA has long been plagued by turnover, given the lucrative industry salaries that can lure career regulators away from Washington. But Janet Woodcock, M.D., has been an outlier, a stalwart leader of the organization who’s worn almost every hat in the drug development arm of the agency. That nearly 40-year career is coming to an end, however, with Commissioner Robert Califf, M.D., confirming her plans in an all-staff email posted by the agency’s spokesperson. Califf said Woodcock will depart early next year, though an exact timeline wasn’t mentioned. His message came after reports of her retirement broke.  “While no one can fill Janet’s shoes, I’ll share news about her successor in the future,” Califf wrote.  Woodcock’s career began in 1986 as director of the Division of Biological Investigational New Drugs at the Center for Biologics Evaluation and Research (CBER) before leading the center’s Office of Therapeutics Research and Review. In 1994, Woodcock was named the director of CBER’s sibling, the Center for Drug Evaluation and Research. She also at one point served as interim commissioner of the agency, from January 2021 to February 2022. The list of her accomplishments and contributions could be kept in a scroll. Califf called her a “legend in every sense of the word.” Tweet Madrigal swiftly names new CCO with potential launch imminent Madrigal  New Madrigal CEO Bill Sibold has landed on a commercial chief, bringing on a former colleague at Sanofi who helped lead the launch of blockbuster Dupixent. Carole Huntsman has taken the gig a little more than a month after Remy Sukhija departed shortly after Sibold’s arrival. Her arrival gives Sibold a critical executive partner with the FDA set to decide on the company’s nonalcoholic steatohepatitis (NASH) drug, resmetirom, by the middle of March 2024. And Huntsman is a familiar face, having worked with Sibold at Sanofi as SVP and head of speciality care, U.S. and North America lead. She directed some 2,600 employees on the rollout of numerous drugs, including Dupixent. The unit she led was responsible for more than $10 billion in net sales in 2022, just what Madrigal wants to hear and see as it plans to debut the first approved NASH treatment. Before joining Sanofi in 2012, Huntsman was SVP of U.S. neurology and rheumatology at EMD Serono and VP of U.S. marketing for the neurology unit at Serono. Source Alkeremes cancer spinout launches with $275M and a couple seasoned development execs Mural Oncology Alkermes has formally unveiled its new cancer spinout, Mural Oncology, equipped with $275 million in committed capital and interleukin-2 (IL-2) candidate aimed at solid tumors. The move has been in the works for about a year. Leading Mural will be a couple of veteran clinical artists, with Caroline Loew, Ph.D., set to take the CEO mantle and Vicki Goodman, M.D., hired as chief medical officer. Loew was previously the CEO of Glympse Bio and before that was head of R&D strategy and planning at Bristol Myers Squibb. Goodman was the chief medical officer at Exelixis after working at Merck for almost two years. Goodman and Loew overlapped at BMS for about three years, during which Goodman was a vice president. The two’s top priority will be nemvaleukin alfa, the asset atop Mural’s pipeline. The company says registrational trials are ongoing with initial readouts slated for the first quarter of 2025. Source > Two former Amgen scientists are joining Halia Therapeutics’ leadership team, with Lisa Shamon, Ph.D., taking on the role of VP of regulatory affairs and Xianne Penny, Ph.D., as senior medical director. Before joining Halia, Shamon held various roles across Alza Corporation, Exelixis, Aeglea BioTherapeutics, FivePrime Therapeutics and Amgen, while Penny served as Amgen’s senior principal clinical immunologist for more than five years. Release > Nereid Therapeutics has named Michael Kauffman, M.D., Ph.D., to serve as president and CEO, taking the reins from Apple Tree Partners venture partner and acting CEO Spiros Liras, Ph.D. Most recently, new Nereid leader Kauffman served as longtime CEO and co-founder of Karyopharm. Release > Wendye Robbins, M.D., will be taking the top spot at Incendia Therapeutics. With more than 20 years of industry experience under her belt, Robbins continues to also serve as an independent director for Rapt Therapeutics. Release > Memo Therapeutics has tapped Erik van den Berg to helm the antibody-focused biotech. Van den Berg joins from AM-Pharma, where he was CEO for 12 years, and succeeds Karsten Fischer, who led Memo for five years. Release > Nucleome Therapeutics has nabbed Stephen Harrison, Ph.D., to serve as chief scientific officer. Before joining Nucleome, Harrison held executive leadership positions at Engine Biosciences, Relypsa (divested to Galencia), Nektar Therapeutics and KAI Pharmaceuticals (acquired by Amgen). Release > Theseus Pharmaceuticals is shrinking its head count by 72%, including R&D head William Shakespeare, Ph.D., although he will continue to support the biotech in a consulting role until the end of June 2024. Fierce Biotech > Melissa Faris has departed GSK to take up a spot as OMass Therapeutics’ chief business officer. Faris spent years with the Big Pharma, most recently serving as VP and head of immunology business development. Release > 1910 Genetics has promoted SVP and Head of Chemistry Bridget Cole, Ph.D., to chief scientific officer. Before 1910, she served as Nocion Therapeutics’ SVP of drug discovery, and has held past roles at Axial Biotherapeutics, Flatley Discovery Lab, Surface Logix and Pfizer. Release > Noema Pharma has chosen Robert Lasser, M.D., to serve as the company’s chief medical officer. Most recently, Lasser served as an executive leader for Sage Therapeutics and has held past leadership roles across Medday Pharmaceuticals, Roche, Shire Pharmaceuticals (acquired by Takeda), Johnson & Johnson and Novartis. Release > IMIDomics is building out its leadership team, tapping Eric Perakslis, Ph.D., to serve as SVP and chief technology officer, and Ramon Felciano, Ph.D., to serve as strategic adviser in biomedical artificial intelligence and data science. Perakslis has held leadership roles at the FDA, Datavant, Takeda and Johnson & Johnson, while Felciano is the founder and CEO of Digital Alchemy. Release > Affini-T Therapeutics, an immunotherapy company planning an IPO in 2024, has appointed Kathy Bergsteinsson as chief financial officer. Bergsteinsson most recently served as managing director and head of healthcare equity capital markets for Morgan Stanley. Release > Attorney Graham Owens has been tapped to serve as executive director of the Rare Disease Company Coalition. Owens also serves as regulatory and oversight counsel for the Senate Small Business Committee. LinkedIn > Former venture partner at Versant Ventures and CEO of Inception Therapeutics Jeremy Caldwell, Ph.D., has joined Red Tree Venture Capital as a partner. Release > Ori Biotech is preparing for the commercial launch of its cell therapy manufacturing platform, tapping Gillian Bonthron to be chief financial officer and John Machulski to be chief operating officer as well as promoting Thomas Heathman, Ph.D., from VP of commercial operations to chief commercial officer. Bonthron joins with experience at Healx and Perspectum under her belt, while Machulski joins from Catalent and has past experience at Lonza, GE Life Sciences (now Cytiva), Sanofi, Pfizer and Johnson & Johnson. Release > Sofinnova Partners is bolstering its medtech leadership team, bringing on Mano Iyer as a partner and promoting Cécile Dupont to partner. Iyer is the founder of ReCor Medical, and Dupont has been with Sofinnova since 2019. Release 

OV329 Phase 1 trial is progressing on trackAn IV formulation candidate suitable for future clinical trials has been achieved for OV350, one of several compounds from the Company’s KCC2 activator portfolioTakeda's guidance on soticlestat remains unchanged; anticipates regulatory filings in its FY 2024Current cash runway expected to fund operations into the first half of 2025 NEW YORK, March 13, 2023 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with epilepsies and seizure-related disorders, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2022. “Ovid has significant momentum entering 2023. OV329, our next generation GABA-aminotransferase inhibitor program, is being actively studied in healthy volunteers. In the first half of 2024, we anticipate data characterizing OV329’s potential efficacy using a biomarker as well as its initial safety profile. In addition, Takeda is progressing the study of soticlestat in two, pivotal Phase 3 trials of patients with Dravet and Lennox-Gastaut syndromes,” said Jeremy Levin, D.Phil, MB BChir., Chairman and CEO of Ovid Therapeutics. "We continue to refine our development pipeline of differentiated anti-seizure medicines while maintaining fiscal and strategic focus to drive long-term shareholder value,” remarked Dr. Levin. 2022 Business Strategy & Update R&D strategy: Ovid is advancing a differentiated pipeline of programs that use potential first-in-class and best-in-class mechanisms of action to act upon under-addressed biological targets implicated in causing seizures. This pipeline has produced two clinical development programs, soticlestat (which was repurchased by Takeda) and OV329, which are being studied in Phase 3 and Phase 1 trials, respectively. In addition, the Company continues to advance several research-stage, small molecule anti-seizure programs.Financial strategy: The Company is directing its capital to programs that it believes represent value-creating opportunities for shareholders, and anticipates its cash runway should fund operations into the first half of 2025. To support this strategy, Ovid instituted cost-cutting measures that began in 2022 and continue into this year. In addition, Ovid is eligible to receive non-dilutive capital from Takeda, if and when soticlestat is successfully approved and marketed.Business development strategy: Ovid intends to conduct disciplined business development activities with a focus on clinical stage assets and enabling technologies to complement its portfolio of anti-seizure medicines. Activities focus on in-licensing assets that can increase opportunities to create shareholder value and mitigate risk to shareholders associated with any one program. Updates in 2022 include: Healx: Healx has been progressing development efforts for gaboxadol (OV101) as part of the agreement that Ovid entered in February 2022, under which Healx secured an exclusive option right to develop and commercialize the compound. Healx stated that it intends to initiate a clinical trial of gaboxadol in combination with another molecule for people living with Fragile X syndrome in 2023.Gensaic: In August 2022, Ovid entered into a research agreement with Gensaic to harness its novel phage-derived particle (PDP) gene delivery platform for the development of genetic medicines for central nervous system indications. Relative to genetic medicines using viral vectors, Ovid believes PDPs may be optimal for crossing the blood-brain barrier and potentially more cost effective to manufacture. Infrastructure & human capital updates: Ovid intends to maintain a concentrated workforce with experts dedicated to anti-seizure medicines development. The Company expanded its bench of leaders in Q1 2023, with the addition of Manoj Malhotra, M.D. and Toshiya Nishi, D.V.M. Dr. Malhotra is a recognized board-certified epileptologist who joined Ovid from past leadership roles at the Cleveland Clinic, Eisai, Novartis and Takeda. Dr. Nishi is the co-inventor of soticlestat and a skilled translational scientist. Pipeline Update & Anticipated Milestones OV329, a potential next generation GABA-aminotransferase (GABA-AT) inhibitor, is advancing on track in a Phase 1 trial of healthy volunteers. Ovid believes OV329 is more potent than prior GABA-AT inhibitors, and therefore may potentially provide: significant seizure reduction efficacy, an improved safety profile, and preferable (lower) dosing. Ovid anticipates full Phase 1 findings in H1 2024, including biomarker data that may serve as a validated proxy for seizure reduction efficacy.OV350, one of several compounds in Ovid’s KCC2 portfolio, has been successfully formulated for potential clinical study as an IV formulation. Ovid is evaluating this formulation in several preclinical seizure models and anticipates a possible IND filing in 2024. In addition, development efforts will continue to characterize other compounds in the KCC2 library with a focus on achieving an oral formulation and exploring applications in epilepsies and other brain disorders.Takeda is executing two pivotal Phase 3 trials studying soticlestat for Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). It previously disclosed that it anticipates regulatory filings in its fiscal year 2024 and confirmed during regularly scheduled communications on March 10, 2023. Takeda repurchased Ovid's interest in soticlestat in 2021, and Ovid is subsequently eligible to receive regulatory and commercial milestone payments of up to $660 million, as well as royalties up to 20% on global sales, if regulatory approval is received and soticlestat is commercialized. Ovid has no ongoing obligations or costs associated with the development of soticlestat.Genetic medicines for neurodevelopmental conditions. Ovid is evaluating business development opportunities associated with its non-core nucleic acid programs. Fourth Quarter and Year-End Financial Results 2022 Cash, cash equivalents and marketable securities as of December 31, 2022 totaled $129.0 million.Revenue was $46,280 for the fourth quarter and $1.5 million for the year ended December 31, 2022, as compared to zero and $208.4 million for the same periods in 2021. The annual decrease was due to the receipt of a one-time upfront payment of $196.0 million from Takeda pursuant to the Royalty, License and Termination Agreement associated with soticlestat in 2021. Revenue in 2022 was generated from licensing and other agreements.Research and development expenses were $5.5 million and $24.6 million for the fourth quarter and for the year ended December 31, 2022, respectively, as compared to $18.1 million and $46.9 million for the same periods in 2021. The annual reduction in expenditures was largely due to cessation of clinical development programs related to gaboxadol and soticlestat, offset by clinical development costs for OV329.General and administrative expenses were $6.7 million and $32.4 million for the fourth quarter and year ended December 31, 2022, as compared to $8.3 million and $37.2 million for the same period in 2021. The annual decrease of $4.8 million was attributed to personnel cost reductions following corporate cost-cutting efforts and headcount reduction conducted in March 2022.Total operating expenses were respectively $12.2 million and $57.1 million in the fourth quarter and year ended December 31, 2022, which were a reduction from $26.4 million and $84.2 million during the same periods last year. The annual decrease was a result of the above mentioned cost cutting and personnel reduction efforts undertaken in 2022.Ovid reported a net loss of $11.5 million, or basic and diluted net loss per share attributable to common stockholders of $0.16 for the fourth quarter of 2022, as compared to a net loss of $26.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.38, for the same period in 2021. The Company reported net loss of $54.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.77 for the year ended December 31, 2022, compared to a net income of $122.8 million, or basic and diluted net income per share attributable to common stockholders of $1.78 and $1.76, respectively, for the year ended December 31, 2021. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science. Ovid’s pipeline of small molecule and genetic medicines candidates seek to meaningfully improve the lives of people and families affected by epilepsies and seizure-related disorders. Ovid is developing OV329, a GABA-aminotransferase inhibitor, for treatment-resistant seizures, and OV350, a direct activator of the KCC2 transporter, for potential treatment of epilepsies. In addition, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24-hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation: statements regarding the Phase 1 study in healthy volunteers for OV329; the potential use of OV329 to treat rare and treatment-resistant forms of epilepsy and seizures; the clinical and regulatory development of OV329, including the anticipated timing of clinical data; the likelihood that data for OV329 will support future development and therapeutic potential; the potential development of OV350 and other KCC2 compounds in Ovid’s library; the suitability of Ovid’s library of novel, direct KCC2 transporter activators for a range of formulations and administrations; the timing for filing of Ovid’s IND applications; the potential benefits of Gensaic’s proprietary phage-derived platform; the timing for the completion of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for Dravet syndrome and Lennox-Gastaut syndrome; and the duration of Ovid’s expectations regarding its cash runway and the expectation that it will support the advancement of Ovid’s pipeline. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expected,” “intends,” “may,” “plan,” “potentially,” “seek,” “strive” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its technology or its business strategy, or risks related to Ovid’s ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 8, 2022, and in future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Condensed Consolidated Statements of OperationsUnaudited For The Three MonthsEnded December 31, 2022 For The Three MonthsEnded December 31, 2021 For The Year EndedDecember 31, 2022 For The Year EndedDecember 31, 2021Revenue: License and other revenue$46,280 $— $1,502,748 $12,382,779 License revenue - related party — — — 196,000,000 Total revenue 46,280 — 1,502,748 208,382,779 Operating expenses: Research and development 5,545,269 18,089,614 24,618,399 46,939,583 General and administrative 6,673,710 8,264,050 32,432,510 37,234,104 Total operating expenses 12,218,979 26,353,664 57,050,909 84,173,687 (Loss) income from operations (12,172,699) (26,353,664) (55,548,161) 124,209,092 Other income (expense), net 668,124 3,901 1,379,132 (45,690)Loss before provision for income taxes (11,504,576) (26,349,763) (54,169,029) 124,163,402 Provision for income taxes — (349,714) — 1,328,818 Net (loss) income$(11,504,576) $(26,000,049) $(54,169,029) $122,834,584 Net (loss) income per share, basic$(0.16) $(0.38) $(0.77) $1.78 Net (loss) income per share, diluted$(0.16) $(0.38) $(0.77) $1.76 Weighted-average common shares outstanding, basic 70,472,598 68,159,651 70,424,819 67,479,403 Weighted-average common shares outstanding, diluted 70,472,598 68,159,651 70,424,819 68,067,992 Select Condensed Balance Sheet DataUnaudited December 31, 2022 December 31, 2021Cash, cash equivalents and marketable securities$129,001,411 $187,797,532Working capital(1) 124,389,166 175,680,808Total assets 155,265,814 194,544,757Total stockholder's equity 132,272,564 179,746,436(1)Working capital defined as current assets less current liabilities Contacts Investors and Media:Ovid Therapeutics Inc.Meg Alexander917-943-6681malexander@ovidrx.com OR Investors:Argot PartnersMaeve Conneighton212-596-7231ovid@argotpartners.com

Israel-based AION Labs, an AI-enabled drug discovery partnership between global pharma and tech companies, announced the launch of its second startup, DenovAI. DenovAI will develop an AI-enabled computational biophysics platform that can discover potential antibodies directed toward specific epitopes (the part of an antigen molecule recognized by the immune system to which an antibody attaches itself). The company said the platform will design antibodies from scratch, then suggest which candidates will likely make effective drugs. AION Labs was built under a government tender and includes pharma giants AstraZeneca, Merck, Pfizer and Teva, alongside venture capital firm Israel Biotech Fund, strategic partner Amazon Web Services and German independent research institute Bio Med X. Funding and pharmaceutical data for machine learning development and model training will be provided to DenovAI by AION Labs. "We have seen major advances in the field of therapeutic antibodies, but the process of developing new drugs is incredibly slow, vastly expensive and inefficient. With the support of AION Labs and its partners, we hope to develop a cutting-edge solution that will disrupt the whole field, cutting discovery timelines from months to days. And which could dramatically broaden the scope of antibody therapy to many more diseases," Dr. Kashif Sadiq, founder and CEO of DenovAI, said in a statement. THE LARGER TREND AION Labs announced its first startup last year, dubbed OMEC.AI, which aims to build an AI-enabled computational platform to help researchers assess the clinical trial readiness of a drug candidate, identify hidden safety liabilities and suggest experiments to close any identified gaps. "What we're trying to achieve at AION Labs in general … is creating great independent-growth AI-based startups for the biotech field so we can help scientists and researchers — not to replace them, but to really empower them by bringing new technological capability so that they can optimize the whole process of drug discovery and development," Mati Gil, CEO of AION Labs, told MobiHealthNews in September. Other companies utilizing AI tools for drug discovery include drug research platform Insilico Medicine and UK-based health tech firm Healx, which uses AI to accelerate drug discovery and treatments for rare diseases.