KCC2

Stelios Papadopolous, Ph.D., a pioneering leader in biotech, appointed to Board of Directors; two industry veterans joined management team as Ovid prepares to take OV329 into patient trials and move its first KCC2 direct activator into the clinic Topline results from Phase 1 study of OV329 expected in Q3 2025, which will include biomarkers that measure clinical effect and target engagement, safety, and tolerability OV350, Ovid’s first program in its KCC2 direct activator library, initiated a first-in-human study in Q1 2025 Cash, cash equivalents and marketable securities of $53.1 million as of December 31, 2024, are expected to support operations and development programs into the second half of 2026 NEW YORK, March 11, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today reported business updates and financial results for the fourth quarter and year ended December 31, 2024. “Ovid is at an exciting inflection point. Our pipeline programs are moving into the next stage of clinical development and I believe our team is the strongest that it has been since the founding of the Company,” said Dr. Jeremy Levin, D.Phil., MB BChir., Chairman and CEO of Ovid Therapeutics. “To support us in capturing the substantial potential therapeutic and financial value associated with OV329, our program for treatment-resistant epilepsies, and our portfolio of first-in-class KCC2 activators, Dr. Stelios Papadopoulos has joined our Board and two industry leaders, Dr. Manal Morsy and Victoria “Tori” Fort joined our management team. Stelios’s extensive industry expertise and strategic vision will be invaluable to Ovid through our next stage of growth. Manal and Tori will support our regulatory and investor strategy and engagement,” stated Levin. Business Strategy & Updates Ovid expects its cash runway to support operations and clinical development programs into the second half of 2026, during which time multiple pipeline and regulatory milestones are anticipated. These anticipated milestones include: results for OV329 biomarker and safety data (Q3 2025); initiation of a Phase 2a patient study for OV329 in drug resistant epilepsies (Q1 2026); results from a first-in-human safety and exploratory biomarker study with OV350, our first KCC2 direct activator (Q4 2025); and initiation of human trials for the first oral KCC2 direct activator, OV4071 (Q2 2026). In the event the Company is unable to raise capital or enter into partnerships or co-development opportunities as and when needed, it will be required to delay, reduce the scope of or prioritize various research and development activities. The Company will continue to manage its clinical development programs, operations and cash expenditures with fiscal discipline to support the potential achievement of key value-creating clinical milestones. Given the breadth and depth of its pipeline, and the broad therapeutic opportunity it may yield, Ovid will continue to explore partnerships and co-development opportunities for select programs and regions to accelerate development and offset costs. Additional pipeline updates follow below. Organizational Updates Ovid has strengthened its Board of Directors and leadership team with key appointments intended to support the Company’s pipeline, business development and financial strategies. These include: Appointed Stelios Papadopolous, Ph.D., to serve on Board of Directors. Dr. Papadopolous is a scientist, investor and entrepreneur who has played a pivotal role in shaping the biotechnology industry for the last 30 years through bridging scientific discovery with financial strategy. His leadership, deal-making creativity, and ability to catalyze growth will be instrumental to Ovid as it seeks to capture the full potential value of its pipeline programs. Dr. Papadopoulos has served in roles including: the Vice Chairman of Cowen & Co., LLC; a leader in investment banking at PaineWebber, Chairman of PaineWebber Development Corp., a subsidiary focusing on biotechnology; and Vice President in the Equity Research Department of Drexel Burnham Lambert, covering the biotechnology industry. Dr. Papadopolous will serve on the Audit and Compensation Committees of Ovid’s Board of Directors. Leadership appointments. In February 2025, Manal Morsy, M.D., Ph.D., MBA and Victoria Fort joined Ovid as Chief Regulatory Officer and Head of Corporate Affairs & Corporate Strategy, respectively. Dr. Morsy brings deep expertise from successful global regulatory strategies and submissions spanning three decades, including adult and pediatric development drug candidates at J&J, Merck, PTC, and Athersys. She is a trained scientist, clinician and geneticist whose work has been published in many leading scientific and medical journals. Ms. Fort joins Ovid from Frontier Medicines, where she led corporate strategy, guided the company’s transition to a clinical-stage organization and helped secure critical financing. Pipeline Strategy & Updates Ovid is advancing a differentiated pipeline of potential first-in-class and best-in-class small molecule medicines that are intended to bring hyperexcited neurons back to homeostasis. The Company seeks to become a leader in neurotherapeutics by addressing intractable brain disorders with significant unmet need. This includes treating conditions and symptoms that manifest from excessive neural excitation such as seizures and psychosis. Central to the Company’s strategy is identifying and developing differentiated mechanisms of action to interdict unaddressed biological targets in the central nervous system (CNS) that are fundamental to disease pathology. This strategy includes developing a potential best-in-class, next-generation GABA aminotransferase (GABA-AT) inhibitor; translating the direct activation of the potassium chloride co-transporter 2 (KCC2) for a broad range of neurological and psychiatric conditions; and pioneering Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibition for neurovascular and neuro-inflammatory conditions. OV329 A next-generation GABA-AT inhibitor: Ovid is developing OV329 as a next-generation GABA-AT inhibitor for the potential treatment of drug-resistant epilepsies (DREs) in adult and pediatric patients. OV329 seeks to endogenously deliver optimal levels of GABA to reduce seizures and provide a preferable safety and tolerability profile relative to the first-generation, GABA-AT inhibitor, vigabatrin. Ovid’s preclinical characterization suggests that OV329 is 100-fold more potent than vigabatrin in animals, delivers synaptic and extra-synaptic inhibition, and has a lasting pharmacodynamic effect despite rapid tissue clearance. In animal models, OV329 has been shown to have a therapeutic index and does not appear to induce sedation at therapeutic doses, whereas vigabatrin has no therapeutic window. A therapeutic dose of vigabatrin has been shown by independent researchers, and by Ovid, to preferentially accumulate in the retina. Human safety & tolerability: Ovid is completing a Phase 1 single- ascending dose (SAD) and multiple ascending dose (MAD) study evaluating OV329’s safety, tolerability, pharmacokinetics (PK) and biomarkers that may serve as a measure of clinical effect and target engagement. In the cohorts completed to-date, there have been no serious adverse events and no adverse events reported have been associated with OV329. Topline biomarker & safety data expected Q3 2025: Ovid added a higher dose cohort to its Phase 1 study, to increase dosing opportunities for future Phase 2 programs. Topline results from this cohort is expected in Q3 2025, and will include findings regarding how OV329 performed in specific parameters of transcranial magnetic stimulation (TMS) and magnetic resonance spectroscopy (MRS). Collectively, Ovid believes TMS and MRS have the potential to detect GABAergic activity, target engagement and clinical effect. TMS is a proven protocol for focal non-invasive electrical cortical stimulation that can safely and non-invasively measure target engagement. TMS has been previously used to correlate anti-seizure activity with vigabatrin and other anti-seizure medications (“ASMs”). Ovid is utilizing a range of TMS parameters for OV329, which can measure cortical excitation, including GABA-ergic, GABA (A) and GABA (B) receptor activity1. MRS technology has been utilized with other ASMs, including vigabatrin, as a way to measure GABA levels in selected regions of the brain. Utilizing MRS, Ovid will be able to evaluate and quantify the change in GABA levels in the medial parietal lobe relative to an untreated baseline. Ocular safety profile: To evaluate OV329’s safety compared to vigabatrin, Ovid has conducted additional animal experiments to evaluate the risk of drug accumulating in the eye and causing retinal cell dysregulation. At the 2024 American Epilepsy Society meeting in December, Ovid presented the full results from an animal study, which demonstrated that OV329 did not accumulate in animal eyes, in contrast to vigabatrin, which was found to accumulate in less than 48 hours. OV329 was present in the brain and plasma of mice, then rapidly cleared the tissue and remained undetectable in the retina, eye, and brain. In contrast, vigabatrin was demonstrated to preferentially accumulate in the eye, retina and brain, which is consistent with previously published independent research. TMS is a proven protocol for focal non-invasive electrical cortical stimulation that can safely and non-invasively measure target engagement. TMS has been previously used to correlate anti-seizure activity with vigabatrin and other anti-seizure medications (“ASMs”). Ovid is utilizing a range of TMS parameters for OV329, which can measure cortical excitation, including GABA-ergic, GABA (A) and GABA (B) receptor activity1. MRS technology has been utilized with other ASMs, including vigabatrin, as a way to measure GABA levels in selected regions of the brain. Utilizing MRS, Ovid will be able to evaluate and quantify the change in GABA levels in the medial parietal lobe relative to an untreated baseline. OV350 and KCC2 library Initiated a Phase 1, first-in-human study for a KCC2 direct activator, OV350: In Q4 2024, Ovid successfully submitted a regulatory application for a Phase 1 trial of OV350 and initiated a first-in-human study for this class of molecule in Q1 2025. OV350 is the first of multiple anticipated programs from Ovid’s library of KCC2 direct activators. The Phase 1 trial intends to evaluate the safety, tolerability and pharmacokinetic parameters of an intravenous formulation of OV350 in healthy human volunteers. It will also include an exploratory biomarker using quantitative EEG. In preclinical and animal disease models, OV350 has demonstrated antipsychotic and anticonvulsant effects, indicating that it may have broad therapeutic utility. The initial indication intended for OV350, and the oral program to follow, is psychosis associated with neuronal-synuclein diseases (NSD), including Parkinson’s disease, and Lewy body dementia (LBD). These conditions have similar underlying biology, significant unmet need and an established regulatory pathway. KCC2 direct activator library. Ovid has made significant progress with its KCC2 direct activator library and is progressing four programs toward clinical development, which are expected to yield successive regulatory submissions annually for the next three to four years. These programs are unique structures with discreet pharmacology and differentiated therapeutic attributes as characterized in phenotypic and disease biology models. Ovid believes these molecules may have relevance across a range of conditions that have symptoms driven by neural hyperexcitability such as seizures and psychoses. Based upon the bioavailability and potency characteristics, Ovid believes different programs in the library have amenability for oral and intramuscular or subcutaneous formulations to address clinical indications across the care continuum. OV4071, the first oral KCC2 direct activator: Ovid has initiated IND-enabling studies of OV4071, the first oral direct activator of the biological target, KCC2. It anticipates initiating human studies with OV4071 in Q2 2026, with both healthy volunteer and patient cohorts. This oral program behaves similarly to OV350 in phenotypic and disease model screens and is similarly intended for the potential treatment of psychoses in NSD and LBD. OV888/GV101 & ROCK2 inhibitor programs OV888/GV101 Capsule for CCM: In the third quarter of 2024, Ovid and Graviton Bioscience announced the decision to pause the initiation of the Phase 2 proof-of-concept study of OV888/ GV101 capsule, following the recent completion of long-duration competitor and academic trials in CCM, and after discussions with key stakeholders. Ovid and Graviton Bioscience are evaluating clinical design learnings and regulatory feedback from recently completed competitor Phase 2 programs. Ovid and Graviton Bioscience are confident of the potential therapeutic effects of ROCK2 inhibition for CCM and will seek to optimize future development approaches with the benefit of further insights on study duration, enrichment strategies, endpoints, and time-to-event measurements. Fourth Quarter and Annual 2024 Financial Results Cash, cash equivalents and marketable securities as of December 31, 2024 totaled $53.1 million. Revenues from royalty agreements were $566,000 for the year ended December 31, 2024, as compared to $392,000 for the same period in 2023. Research and development expenses were $5.9 million and $36.8 million for the three months and full year ended December 31, 2024, compared to $10.6 million and $28.6 million for the same periods in 2023. The overall increase is related to the advancement of Ovid’s clinical and preclinical pipeline programs as described above. The decrease between the three-month periods is the result of the organizational restructuring in the second quarter of 2024, which re-prioritized development programs. General and administrative expenses were $4.9 million and $25.7 million for the three months and full year ended December 31, 2024, as compared to $7.7 million and $31.1 million for the same periods in 2023. The decrease was driven by the previous organizational restructuring and related cost-reduction efforts. Total operating expenses were $10.8 million and $62.5 million for the three months and full year ended December 31, 2024, as compared to $18.3 million and $59.7 million for the same periods in 2023. Ovid reported a net loss of $9.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.13 for the three months ended December 31, 2024, as compared to a net loss of $15.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.21 for the same period in 2023. Ovid reported a net loss of $26.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.37 for the year ended December 31, 2024, as compared to a net loss of $52.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.73 for the same period in 2023. 1 Tsuboyama M, Lee Kaye H, Rotenberg A. Biomarkers Obtained by Transcranial Magnetic Stimulation of the Motor Cortex in Epilepsy. Front Integr Neurosci. 2019 Oct 30;13:57. doi: 10.3389/fnint.2019.00057. PMID: 31736722; PMCID: PMC6837164. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need. The Company is advancing a pipeline of novel, highly specific, small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; OV350, and a library of compounds that directly activate the KCC2 transporter, for multiple neurological and psychiatric conditions; and OV888/GV101, a highly selective ROCK2 inhibitor for undisclosed neurovascular and neuro-inflammatory conditions. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation: statements regarding the expected timing of initiation, completion, and results and data of Ovid’s clinical studies; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; Ovid’s ability to achieve expected benefits of cost-savings efforts; Ovid’s ability to secure additional sources of funding; Ovid’s potential future business development opportunities; the potential use and development of OV329, OV350 and other compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101; the potential therapeutic opportunity of OV329, OV350 and other compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101; Ovid’s evaluation of the results of recently completed competitor trials to OV888/GV101 for CCM; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” 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, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, 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 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 most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and 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. Contacts Investor Relations & Media Victoria Fort VFort@ovidrx.com

NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small-molecule medicines for brain conditions with significant unmet need, today announced the appointment of Stelios Papadopoulos, Ph.D. to its Board of Directors. “Stelios is a pioneering force in biotechnology. His vision and strategic acumen have shaped the landscape of our industry—building companies, financing breakthroughs, and enabling transformative medicines. We are honored to welcome him to our Board at a defining moment for Ovid,” said Jeremy Levin, D.Phil, MB BChir, Chairman and CEO of Ovid Therapeutics. “With our advancing pipeline, including our novel KCC2 direct activators and OV329 epilepsy program, Ovid stands on the cusp of delivering real change for neurological and psychiatric diseases. Stelios’s leadership, deal-making creativity, and ability to catalyze growth will be instrumental in propelling Ovid forward.” “Ovid’s unique research and development programs and talented team stand out in the field of CNS therapeutics, which will continue to be an area of significant interest and activity in the biopharmaceutical sector,” said Dr. Papadopoulos. “Novel and precise, small-molecule medicines for major disorders of the brain will continue to be deeply needed. I look forward to serving on the Board and working with the management team as they pioneer a class of neurotherapeutics and pursue broad scientific and business opportunities associated with restoring neural homeostasis.” Dr. Papadopoulos is a scientist, investor and entrepreneur who has played a pivotal role in shaping the biotechnology industry by bridging scientific discovery with financial strategy. Dr. Papadopoulos has helped build and guide numerous biotech companies through critical phases of growth. He has deep expertise from a career spanning more than four decades in biotechnology. This includes serving as an investment banker at Cowen & Co., LLC and PaineWebber, Incorporated and, prior to that, in equity research at Drexel Burnham Lambert and Donaldson, Lufkin and Jenrette. Before coming to Wall Street in 1985, Dr. Papadopoulos was on the faculty of the Department of Cell Biology at New York University Medical Center. He has served on many boards, including as the recent past Chairman of the Board for Biogen. Dr. Papadopoulos is currently the Chairman of Exelixis, Inc., which he co-founded, and Regulus Therapeutics Inc. He is a co-founder and chairman of Fondation Santé, a nonprofit organization dedicated to advancing biomedical research. Dr. Papadopoulos has earned an MS in physics, a PhD in biophysics and an MBA in finance, all from New York University. Dr. Papadopoulos will be a member of Ovid’s Audit and Compensation Committees. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing novel medicines for brain conditions with significant unmet need. The Company is advancing a pipeline of novel, targeted small molecule candidates that have the potential to modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; OV350, and a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders; and OV888/GV101, a highly selective ROCK2 inhibitor, for undisclosed neurovascular and neuro-inflammatory conditions. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements,” including, without limitation, statements regarding the potential use and development of OV329, OV350 and compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101. You can identify forward-looking statements because they contain words such as “advances,” “anticipates,” “believes,” “could,” “intends,” “may,” “potential,” “progress,” 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. 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 on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 12, 2024, 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. Contact: Victoria Fort vfort@ovidrx.com

Standard treatment for many autoimmune diseases includes drugs that suppress the immune system. Even when this approach works (and it doesn’t work for everyone), chronic immunosuppression puts patients at risk of infections among other complications. Nuvig Therapeutics is developing a first-in-class drug that could offer an alternative treatment for autoimmune diseases and the startup now has $161 million to advance clinical development of its lead program. Nuvig aims to treat autoimmune disease by tapping into a built-in mechanism of the body that tamps down inflammatory pathways. The Menlo Park, California-based company’s drugs are proteins engineered to bind to type II Fc receptors, a class of receptors that regulate immune responses. The company says the binding of its drug to these receptors leads to the expansion of regulatory T cells, or Tregs, a type of immune cell that suppresses immune responses. This approach also downregulates numerous inflammatory pathways . Lead Nuvig program NVG-2089 has Phase 1 results showing it was safe and well tolerated. Also important, the results showed the drug engaged its target. In Phase 2, Nuvig will test NVG-2089 as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare disorder in which the immune system attacks myelin, the protective sheath covering nerve fibers. This disease leads to nerve and motor problems as well as progressively worsening muscle function. Consumer / Employer Health Executives on Digital Transformation in Healthcare Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. By MedCity News Standard CIDP treatment includes intravenous immunoglobulin (IVIg), an infusion of antibodies sourced from healthy donors. This treatment provides a patient with antibodies that block the inflammatory processes that damage myelin. Immunosuppressants are another CIDP treatment option. Not all patients respond to these therapies, but there’s already a new alternative. This past June, the FDA expanded the approval of Argenx drug Vyvgart Hytrulo to include CIDP. This injectable drug, which was initially approved to treat generalized myasthenia gravis, is an antibody fragment designed to bind to and block the neonatal Fc receptor (FcRn). Consequently, disease-driving autoantibodies go to a cellular system that degrades proteins. Through the first three quarters of 2024, Argenx reported more than $1.4 billion in product sales, a 77.5% increase over the same period in 2023. These figures includes Vyvgart, the original intravenously infused formulation of the FcRn inhibitor. Argenx has touted its drug’s potential uses in a wide range of autoimmune indications and the company is in various stages of clinical development testing its FcRn-blocker in multiple diseases. Similarly, Nuvig says its drug has the potential to address many autoimmune indications. But first, the company will see how its drug works in CIDP. Nuvig chose CIDP because it is an indication where IVIg is the standard of care and there is still unmet need for a better-tolerated therapy that is not immunosuppressive, co-founder and Chief Scientific Officer Pamela Conley said in an email. She added that her company’s approach is distinct from that of the Argenx drug and other FcRn inhibitors. Most autoimmune diseases, including CIDP, are not entirely mediated by the presence of autoantibodies, she explained. Rather, most of the damage in CIDP is mediated by immune cells that infiltrate the myelin that protect nerve cells. An FcRn blocker like Argenx’s drug does nothing to reduce the infiltration of immune cells into myelin, Conley said. Furthermore, blocking FcRn leads to an up to 80% reduction in overall circulating antibodies. Chronic maintenance of these low antibody levels is immunosuppressive, putting patients at risk of infection. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Rather than being immunosuppressive, Nuvig’s drug is immunomodulatory, Conley said. The drug offers a broader approach by down regulating the response of immune cells that drive inflammation while also expanding and activating Tregs, which is similar to what happens with IVIg. Conley added that clinical tests of the Argenx drug showed the overall response of CIDP patients was less than what has been observed in CIDP studies with IVIg. “We believe that the [mechanism of action] of NVG-2089 will lead to greater efficacy in CIDP than what was observed with Vyvgart,” Conley said. Nuvig, which is based on research from The Rockefeller University, emerged from stealth in 2022 backed by a $47 million Series A round. The new Series B round was co-led by Sanofi Ventures, Blue Owl Healthcare Opportunities (formerly Cowen Healthcare Investments), and Norwest Venture Partners. Other participants include new investors B Capital, Leaps by Bayer, Global BioAccess Fund, LOTTE Holdings, Alexandria Venture Investments, and funds managed by abrdn Inc., as well as earlier investors Novo Holdings, Platanus, Bristol Myers Squibb, Digitalis Ventures, and Mission BioCapital. Here’s a recap of other recent biotech financing news: —Metabolic medications biotech Antag Therapeutics raised €80 million (about $80.6 million) to enter the clinic with obesity drug candidate AT-7687, a peptide designed to block the GIP receptor. The drug is based on an endogenous GIP receptor antagonist. The drug is intended to be dosed alongside current or future obesity drugs, including those that block the GLP-1 receptor. Compared to other drugs being developed to block GIP, Antag says its approach offers flexibility in dosing that could improve both efficacy and tolerability. The drug could also be used by itself as a maintenance treatment. In tests in monkeys, Antag said AT-7687 dosed with a GLP-1 drug produced “best-in-industry weight loss” along with improved glycemic control and lipid profiles that were independent of weight changes. Antag added that these benefits were achieved without gastrointestinal side effects. The biotech’s pipeline includes drug combinations for other targets and a follow-on molecule that could offer monthly dosing. Versant Ventures led Antag’s Series A financing. —Maze Therapeutics raised $115 million to advance clinical development of its two lead programs. MZE829, an oral drug designed to block a protein called APOL1, is on track to Phase 2 testing in the rare kidney disease focal segmental glomerulosclerosis. MZE782, an oral inhibitor of SCL6A19, is on in Phase 1 testing; South San Francisco-based Maze plans to evaluate it in chronic kidney disease and phenylketonuria. Maze’s Series D round was co-led by Frazier Life Sciences and Deep Track Capital. —Adcendo, a developer of antibody drug conjugates for cancer, recently received FDA clearance to begin a Phase 1/2 test of ADCE-D01 in patients with advanced soft tissue sarcoma. Now it has $135 million to fund the clinical research. ADCE-D01 is designed to target uPARAP, a receptor that’s overexpressed in mesenchymal cancers, including subtypes of soft tissue sarcoma. Copenhagen-based Adcendo earlier this year expanded its Series A round of funding to €98 million (about $102.5 million). The new round, a Series B financing, was led by TCGX. —Kanglin Biotechnology unveiled $20 million in Series A financing to advance to clinical development with lead program, KL003, a gene therapy for the rare blood diseases beta thalassemia and sickle cell disease. Those diseases are already addressed by FDA-approved gene therapies from Vertex Pharmaceuticals and Bluebird Bio. Hangzhou, China-based Kanglin claims its lentiviral vector-based therapy can be best in class with shorter time to transfusion independence and engraftment of the genetically modified cells. No investor details were disclosed. —35Pharma raised $53 million to support clinical development of HS135 for pulmonary hypertension and HS235 for cardiometabolic disease and obesity. Both drugs are fusion proteins designed to block activins and growth differentiation factors (GDFs), proteins associated with many diseases. Frazier Life Sciences led the Series C round for Montreal-based 35Pharma. —Startup Valora Therapeutics emerged with $30 million to advance the development of a new class of drugs it calls antibody lectin chimera, or AbLecs. These engineered antibodies target the glycol-immune checkpoint, blocking glycans, sugar molecules on the surface of cells, from interacting with lectins. This approach has potential applications to cancer and autoimmune disease. Avalon BioVentures co-led the seed round of San Diego-based Valora. —Enveda raised $130 million to support its pipeline of 10 programs and multiple discovery candidates, all from an AI technology platform that applies machine learning techniques to metabolomics data. In October, the Boulder, Colorado-based company began a Phase 1 study of ENV-294, a potential oral anti-inflammatory drug for atopic dermatitis and other inflammatory disorders. Kinnevik and FPV led the Series C round, which brings the company’s funding total to $360 million. —TRexBio closed $84 million to advance its lead internal program, TRB-061, through early clinical development. The drug is an agonist of the TNFR2 receptor, which is abundant on regulatory T cells in the skin and gut. TRB-061 is a potential treatment for atopic dermatitis and ulcerative colitis; a Phase 1 study is on track to begin in the first half of 2025. Delos Capital led TRexBio’s Series B financing. —Wellington Management and Venrock led the $215 million financing of Metsera, a clinical-stage developer of metabolic disorder drugs. The Series B round comes seven months after Metsera launched backed by $290 million. The most advanced program of the New York-based company is a long-acting GLP-1 drug administered once-monthly — a key dosing edge over currently available GLP-1 drugs that patients must inject once weekly. Metsera expects to report preliminary Phase 2 data in the first half of 2025. —Alentis Therapeutics raised $181.4 million for clinical development of two antibody drug conjugates. ALE.P02 is on track to begin Phase 1/2 testing in advanced CLDN1-positive squamous solid tumors. ALE.P03 is being readied to enter the clinic in patients with CLDN-positive tumors. Alentis last raised money in 2023, a $103 million Series C round. Orbimed led the latest round, a Series D financing, along with co-leads Novo Holdings and Jeito Capital. —Arda Therapeutics raised $43 million to take a new approach to treating chronic disease. Rather than modulating the activity of proteins produced by cells that drive disease, San Francisco-based Arda is developing targeted biologic drugs that deplete those cells. Andreessen Horowitz led Arda’s Series A financing. —Evommune raised $115 million as the biotech prepares for upcoming data readouts for two skin disease drugs. Lead program EVO756 is on expected to report data in the first half of 2025 from a Phase 2 test in chronic inducible urticaria. Phase 2 tests are also planned for EVO756 in chronic spontaneous urticaria and for EVO301 in atopic dermatitis. Data from these tests are expected in 2026. RA Capital Management and Sectoral Asset Management led the Palo Alto-based biotech’s Series C financing. —Trace Neuroscience launched with $101 million and a lead program in development for amyotrophic lateral sclerosis (ALS). The South San Francisco-based biotech says its antisense oligonucleotide drug restore a protein called UNC13A, which in turn reestablishes healthy communication between nerves and muscle cells that are affected by neurodegenerative disorders. Third Rock Ventures led Trace’s Series A financing. —Axonis Therapeutics has $115 million to support a lead program in development for treating epilepsy and pain. The Boston-based company’s drug candidate, AXN-027, targets KCC2, a chloride transporter in the central nervous system that is essential for inhibitory neurotransmission. It’s the same target being pursued by Ovid Therapeutics, which acquired its KCC2-targeting molecules from AstraZeneca. Cormorant Asset Management and venBio Partners co-led Axonis’s Series A financing. —Blue Earth Therapeutics announced its presence in the growing radiopharmaceuticals sector with a $76.5 million Series A round. The Oxford, U.K.-based company will apply the proceeds toward Phase 2 tests of its radioligand therapies that target PSMA, the same protein hit by Novartis radiopharmaceutical Pluvicto. Soleus Capital led the round, which was co-led by Sands Capital Management. —Archon Biosciences, a Seattle startup from the University of Washington lab of Nobel Prize-winning scientist David Baker, emerged with $20 million and a platform technology that designs antibodies in a way that controls their structure. These antibody cages, or AbCs, can control how a drug distributes in the body to potentially offer advantages in safety and potency. Madrona Ventures led Archon’s seed financing. —Kivu Bioscience launched with $92 million, revealing antibody drug conjugates and technology licensed from Lonza subsidiary Synaffix. The startup, named for Lake Kivu in Africa, isn’t disclosing its cancer targets, but it plans to advance its lead program into Phase 1 testing in 2025. Novo Holdings led Kivu’s Series A financing. —Agomab raised $89 million to support ongoing clinical testing of AGMB-129, which is in development as a potential treatment for fibrostenosing Crohn’s disease. In this complication of the inflammatory gut disorder, scar tissue (fibrosis) and inflammation lead to thickening of the bowel. The Antwerp, Belgium-based biotech’s drug is a small molecule designed to block ALK5, a protein involved in a signaling pathway associated with fibrosis. Agomab’s Series D round added new investors Sanofi and Invus. —Pathos AI raised $62 million as it plans to advance to mid-stage clinical development. P-500, one of two clinical-stage assets the biotech acquired in the past year, is a brain-penetrating small molecule inhibitor of a target called PRMT5. The Chicago-based company says it will use its AI-powered technology to make patient selection and clinical trial design decisions. New Enterprise Associates led Pathos AI’s Series C round. —With a lead drug candidate in Phase 1/2 testing and a new program on its heels, B-cell therapies developer Be Biopharma raised $82 million in Series C financing. The Cambridge-based biotech’s technology engineers B cells to produce therapeutic proteins. Its most advanced program, BE-101, is in development for treating hemophilia B. The next program is BE-102, a potential treatment for hypophosphatasia, a rare inherited disorder that leads to weak bones and teeth. Be Bio last raised money in 2022, a $130 million Series B round. Picture: Feodora Chiosea, Getty Images