On March 9, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that the first patient has been enrolled in its Phase 1 clinical trial evaluating IDE892, an investigational MTA-cooperative PRMT5 inhibitor being developed for patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE892 as a monotherapy agent and in combination with IDE397, IDEAYA’s MAT2A inhibitor, in mid-2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.

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"We are excited to have enrolled the first patient in our Phase 1 clinical trial evaluating IDE892 in patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. We designed IDE892 with potential best-in-class properties, including specific biophysical and pharmacokinetic properties that we believe will maximize its therapeutic window and clinical efficacy, both as a monotherapy agent and as a combination partner with our MAT2A inhibitor, IDE397. Next, we look forward to advancing our first-in-class CDKN2A-defiency program to progress our broader corporate strategy of enabling wholly owned rational combinations targeting MTAP-deletion," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE892 was designed to be a potential best-in-class PRMT5 inhibitor, with ~1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes and observed single-digit nano-molar potency in endogenous MTAP-deleted cell lines, and greater than 50-fold potency differential in MTAP-deleted versus MTAP wild type HCT116 isogenic cell lines. In addition, IDE892 inhibited the arginine dimethylation of a key PRMT5 substrate involved in mRNA splicing, spliceosome protein SmB (SmB-SDMA), with pico-molar potency in MTAP-deleted cell lines with greater than 100-fold potency differential versus an MTAP wild type cell line. IDE892 has demonstrated monotherapy regressions in MTAP-deleted preclinical models, and durable complete responses in combination with IDE397.

Loss of MTAP leads to the accumulation of methylthioadenosine (MTA) and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397. In preclinical studies, dual inhibition of PRMT5 and MAT2A with the combination of IDE892 and IDE397 resulted in potent anti-tumor activity in MTAP-deleted tumor models, including complete and durable responses at well-tolerated doses below those required for monotherapy activity.

IDEAYA has also advanced its CDKN2A-deficiency program and is on track to select a potential first-in-class development candidate in H2 2026 with a target IND in H1 2027. IDEAYA has demonstrated robust monotherapy efficacy with its CDKN2A lead in multiple preclinical models, including in a KRAS mutation pancreatic model. IDEAYA plans to evaluate its CDKN2A-deficiency program preclinically as a monotherapy agent, and in combination with assets in its MTAP-deletion portfolio and potentially other RAS and KRAS targeted assets. CDKN2A-defiency is common in cancer, with a prevalence of over 80% in pancreatic cancer (M. Schutte, et al., Cancer Research, 1997; IDEAYA analysis, TCGA) and is typically co-deleted in MTAP-deletion solid tumors and a common co-alteration with KRAS mutations, particularly in pancreatic cancer, creating rational combination opportunities with MTAP-deletion and KRAS targeted therapies, respectively.

As part of IDEAYA’s strategic prioritization of its proprietary MTAP-deleted pipeline, including IDE397 and IDE892, and the advancement of its CDKN2A-deficiency program, the company has deprioritized its clinical combination activities with Trodelvy and will be concluding enrollment in the ongoing Phase 1/2 trials with Gilead. Based on preliminary data from these trials supporting the mechanistic rationale for the combination in MTAP-deleted cancers, IDEAYA may evaluate additional combinations between IDE397 and other TOP1 payload ADCs in this setting, including IDE034, its B7H3/PTK7 bispecific TOP1 ADC.

MTAP deletion is estimated to occur in 15–20% of non-small cell lung cancer, up to 40% of pancreatic cancer, and approximately 15% of all solid tumors, and is commonly co-deleted with CDKN2A due to the proximity of the two genes on chromosome 9p21. There are no approved therapies for patients with MTAP deletion, highlighting the significant unmet need and important new opportunities for precision therapies.

(Press release, Ideaya Biosciences, MAR 9, 2026, View Source [SID1234663379])

On March 9, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for oral presentation in the Practice-changing, Paradigm-shifting Clinical Trials in Urology session, as part of the American Urological Association (AUA) 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. The presentation will feature new data from the Company’s phase 3 clinical trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in patients with intermediate- to high-risk localized prostate cancer.

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Presentation Details:

Aglatimagene – Localized Prostate Cancer

Abstract Title: Extended follow-up shows accumulating benefit for patients treated with CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) in men with localized prostate cancer: update from PrTK03 randomized phase 3 clinical trial
Presentation Type: Plenary
Presenter: Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine, Oregon Health & Science University, Chief, Urology Section, Portland VA Medical Center
Session Title: P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology
Session Date/Time: Friday, May 15, 2026; 11:30 AM – 11:40 AM ET
Location: Hall D, Walter E. Washington Convention Center, Washington, D.C.
Full abstracts will be released by AUA on date and time of presentation. Details from the presentation will be available following the event on the Candel website at View Source

(Press release, Candel Therapeutics, MAR 9, 2026, View Source [SID1234663378])

On March 9, 2026 Xilio therapeutics presented its corporate presentation.

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(Presentation, Xilio Therapeutics, MAR 9, 2026, View Source [SID1234663375])

On March 9, 2026 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) ("we", the "Company" or "Cartesian"), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, reported financial results for the year ended December 31, 2025, and outlined recent business updates.

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"Building on a productive year, we look forward to a potentially transformative 2026 as we advance Descartes-08 across several autoimmune indications," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. "Our top priority remains delivering on our Phase 3 AURORA trial in myasthenia gravis (MG), for which we are on track to enroll approximately 100 patients. This trial represents a crucial opportunity to demonstrate the potential of Descartes-08 to improve patient outcomes and redefine the standard-of-care for MG. Descartes-08’s ease of use, including, flexible, convenient outpatient administration with no preconditioning chemotherapy, combined with deep and durable responses observed through 12 months following a single course of treatment, and a favorable safety profile, underscore our belief that Descartes-08 holds significant promise to deliver meaningful benefit to patients."

Dr. Brunn continued, "Beyond MG, we are working to activate sites for our Phase 2 TRITON trial of Descartes-08 in myositis, which we plan to initiate in the first half of 2026. In parallel, we are also excited to explore potentially enhanced cell therapy delivery options of existing product candidates and next generation agents in development through in-vivo platforms with multiple feasibility studies underway. With an upcoming year of focused clinical execution, we believe we are well-positioned to fill the significant unmet need that remains within the autoimmune treatment landscape."

Pipeline Progress and Anticipated Milestones

Enrollment Continues to Progress in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian’s autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. In December 2025, the AURORA trial was named to Nature Medicine’s "Eleven clinical trials that will shape medicine in 2026" list.
Phase 2 TRITON Trial Initiation in Myositis Anticipated in 1H26. In January 2026, Cartesian announced that the U.S. Food and Drug Administration (FDA) accepted the investigational new drug (IND) application for its planned Phase 2 TRITON trial in myositis. The randomized, double-blind, placebo-controlled Phase 2 trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in up to 50 patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24. The Company currently intends to conduct a blinded interim analysis through the Data Safety Monitoring Board (DSMB) after ten patients reach the primary endpoint, at which point Cartesian may revise sample size assumptions to what could be necessary to support the trial becoming pivotal, pending FDA review.
Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Juvenile Dermatomyositis (JDM) Remains Ongoing. In January 2026, Cartesian announced the initiation of its Phase 1/2 (HELIOS) pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including JDM. JDM is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM.
Descartes-08’s Mechanism of Action and Phase 2b 12-Month Data in MG Highlighted in Nature Medicine. In January 2026, Cartesian announced the publication of two peer reviewed journal articles in Nature Medicine detailing the mechanism of action of Descartes-08 and outlining deep and durable response data observed throughout 12 months after a single course of therapy in the Phase 2b trial of Descartes-08, consistent with previously announced 12-month data.
Continuing Evaluation of the Potential for Enhanced Delivery Platforms for Cell Therapies. The Company continues to evaluate the potential for enhanced delivery platforms for its cell therapies with multiple agreements in place to explore optimizing in-vivo delivery of Descartes-08 and next generation agents currently in development.

Corporate Updates

Adrian Bot Appointed to Cartesian’s Board of Directors. Adrian Bot, M.D., Ph.D., was appointed to the Company’s Board of Directors in December 2025. Dr. Bot is a biopharma executive with three decades of experience in research and development with a focus on immune, cell, gene therapy and nanomedicines. His appointment to the Board of Directors supports the Company’s strategic expansion to explore potential enhanced delivery platforms for cell therapies.
Carsten Brunn Named Cartesian’s Chairman of the Board of Directors. Dr. Brunn was appointed Cartesian’s Chairman of the Board of Directors in October 2025 following the departure of Carrie S. Cox who stepped down to focus on other responsibilities, including her recent appointment as Executive Chair of another publicly-traded company. In connection with Dr. Brunn’s assumption of the role of Chairman of the Board, Patrick Zenner, M.B.A., was named as Lead Independent Director of the Board of Directors.

Full Year 2025 Financial Results

Cash, cash equivalents and restricted cash as of December 31, 2025 was $126.9 million and is expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial and initiation of its Phase 2 TRITON trial in myositis, into mid-2027.
Research and development expenses were $58.0 million for the year ended December 31, 2025, compared to $45.1 million for the year ended December 31, 2024. The increase in expenses was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial coupled with an increase in employee expenses as a result of headcount growth.
General and administrative expenses were $31.5 million for the year ended December 31, 2025, compared to $30.1 million for the year ended December 31, 2024. The increase in expenses was primarily the result of increased facilities and stock-based compensation expenses.
Net loss was $130.3 million, or $5.02 net loss per share allocable to common stockholders (basic), for the year ended December 31, 2025, compared to net loss of $77.4 million, or $4.48 net loss per share allocable to common stockholders (basic), for the year ended December 31, 2024.

About Descartes-08

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.

(Press release, Selecta Biosciences, MAR 9, 2026, View Source [SID1234663373])

On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $160.0 million to the Company, before placement agent fees and offering expenses. The PIPE financing included participation from Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, RA Capital Management, Balyasny Asset Management, OrbiMed, Spruce Street Capital, Squadron Capital Management, Columbia Threadneedle Investments, Adage Capital Management, Marshall Wace, Braidwell LP, Great Point Partners, LLC and Eventide Asset Management.

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Pursuant to the terms of the securities purchase agreement, Relmada is selling an aggregate of (i) 29,474,569 shares of its common stock ("Common Stock") at a purchase price of $4.75 per share and (ii) pre-funded warrants to purchase 4,210,527 shares of Common Stock at a purchase price of $4.749 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.001 per share. The PIPE financing is expected to close on or about March 11, 2026, subject to satisfaction of customary closing conditions.

Relmada intends to use the net proceeds from the PIPE financing, together with existing cash, cash equivalents, and short-term investments, for working capital and general corporate purposes, which includes the advancement of research and development of its product candidates.

Jefferies, Leerink Partners, Piper Sandler and Mizuho are acting as placement agents for the PIPE financing.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, Relmada and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of Common Stock and the Common Stock issuable upon exercise of the pre-funded warrants, in each case sold in the PIPE financing.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663372])