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])

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 disorders, reported 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

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The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC.

"These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026."

"I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies," said Max Kates, MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.

Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:

Clinical Results (Response Data)
Complete Response
Anytime 95% (36/38)
3 month 87% (33/38)
6 month 86% (25/29)
9 month 85% (22/26)
12 month 76% (19/25)
12-month KM analysis 83%
N=48 patients dosed in overall population; KM: Kaplan-Meier analysis

Efficacy in BCG-Unresponsive Subpopulation**:

Clinical Results (Response Data)
Complete Response
Anytime 94% (16/17)
3 month 82% (14/17)
6 month 86% (12/14)
9 month 91% (10/11)
12 month 80% (8/10)
12-month KM analysis 84%
N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis
No patient had progression to muscle-invasive disease
No patient underwent a radical cystectomy
No patients had a ≥ Grade 3 treatment related adverse event (TRAE)
No patients discontinued treatment due to AEs
Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE).
Among treatment-related AEs,
54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1)
8% had an asymptomatic positive urine culture
8% had hematuria
Phase 3 RESCUE Registrational Pathways:

Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects ~75,000 patients/year in the US.

Primary endpoint: Disease Free Survival (DFS)
Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS), quality of life (QOL) metrics
Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy.

Primary endpoint: Complete response (CR) rate at any time
Key secondary endpoint: Duration of response (DOR), progression free survival (PFS), recurrence free survival (RFS) amongst responders
Expected Upcoming NDV-01 Milestones:

NDV-01 United States IND clearance – Mid-2026
Phase 3 RESCUE Program Initiation – Mid-2026
Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026
About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in approximately 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663371])

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 disorders, reported that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in the Leerink Partners Global Healthcare Conference being held in Miami, Florida, from March 8-11, 2026.

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Leerink Partners Global Healthcare Conference Details
Format: Fireside Chat
Date Tuesday, March 10, 2026
Time: 8:40 AM ET
Webcast: Click Here

Management will also be available for one-one-one investor meetings during the conference. Please contact your Leerink Partners representative to schedule a meeting.

The webcast can also be accessed on the Events page the Investors section of the Relmada website at View Source An archived replay will be available for 90 days following the conclusion of the event.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663370])