On March 19, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported financial results for the fourth quarter and full year 2025, ending December 31, 2025 and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Lasme-cel demonstrated a potentially transformative efficacy profile in one of oncology’s most challenging settings, achieving 100% overall response rate in the target Phase 2 population. Critically, lasme-cel converted all patients in the target population into transplant-eligible candidates. The pivotal Phase 2 is now enrolling, and with a BLA submission anticipated in 2028, lasme-cel is on a clear regulatory path to potentially becoming the first off-the-shelf CAR-T therapy to address this high unmet medical need" said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. "With interim Phase 2 data for lasme-cel in r/r B-ALL, and full Phase 1 data for eti-cel in r/r NHL, both expected in Q4 2026, we are entering an important year for Cellectis, as we advance our ambition to bring life-saving off-the-shelf CAR-T therapies to patients who have run out of options".

________________________________
1 Cash, cash equivalents and fixed-term deposits include restricted cash of $4.4 million as of December 31, 2025 classified as current and non-current financial assets and fixed-term deposits of $144.8 million as of December 31, 2025, classified as current financial assets.

Allogeneic CAR-T Pipeline

Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) – BALLI-01

In October 2025, Cellectis presented full Phase 1 lasme-cel clinical data at the Cellectis’ R&D Day. The presented data position lasme-cel as a potentially game-changing therapy for patients with r/r B-ALL. Data highlighted:

Strong efficacy:

68% overall response rate (ORR) with lasme-cel Process 2, manufactured internally (n=22)
83% ORR at the recommended Phase 2 dose (RP2D) (n=12)
100% ORR in the target Phase 2 population (n=9)

In the target Phase 2 population, the complete response or complete remission with incomplete hematology recovery (CR/Cri) rate was 56%, with approximately 80% of these patients achieving minimum residual disease (MRD)-negative status

Favorable safety profile:

Low rates of ≥ grade 3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) at 2.5% and 5% respectively

Transplant eligibility in target Phase 2 population:

All patients became eligible for transplant

Strong survival benefit:

14.8 months median overall survival (OS) in patients who achieved MRD-negative CR/CRi

The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026 (n=40). Cellectis anticipates submitting a Biologics License Application (BLA) in 2028.

Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01

In December 2025, Cellectis presented encouraging Phase 1 preliminary data of eti-cel at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting. The data showcased the potential of eti-cel in r/r NHL patients who have relapsed following multiple lines of therapy including, for 93% of patients, an autologous CD19 CAR-T, with an 88% ORR and 63% CR at the current dose level (n=8).
Cellectis is initiating patient enrollment in the cohort with low dose interleukin-2 (IL-2) support to evaluate the potential to further enhance the already high response rates and durability of response in patients with r/r NHL.
Cellectis expects to present the full Phase 1 dataset in 2026, including results from the IL-2 combination.

Circular single-stranded DNA (cssDNA) as a non-viral template for gene therapy

In November 2025, Cellectis published a Nature Communications article establishing cssDNA as a highly efficient non-viral DNA donor template, for gene insertion in hematopoietic stem and progenitor cells (HSPCs).

While viral vectors such as AAV6 are commonly used for gene insertion, they raise safety and efficacy concerns. Over the past decade, non-viral DNA templates delivery has emerged as promising alternatives.

Cellectis’ research results mark a pivotal advance toward next-generation non-viral cell and gene therapies.

Key findings:

Superior efficiency: cssDNA achieved over 40% knock-in efficiency, outperforming linear DNA by 3-5 times.
Versatility: the process successfully targets multiple loci in HSPCs and primary T cells.
Better persistence: in murine models, cssDNA-edited cells showed superior engraftment and edit maintenance compared to AAV6-edited cells.

TALE base editors (TALEB) safety and precision

At ESGCT 2025, Cellectis presented a comprehensive safety study on TALE base editors (TALEB), which enable precise C-to-T DNA editing without causing double-strand breaks.

Key study highlights:

Safety assessment: researchers used advanced bioinformatics and experimental models to track potential off-target effects in the nuclear genome of primary T cells.
No bias detected: the study found no evidence of unintended editing at CTCF binding sites, which are critical for genome organization and gene expression.

These research results provide a strong framework for the safe development of TALEB in therapeutic cell engineering, supporting their potential for future nuclear and mitochondrial applications.

Partnerships

AstraZeneca – Joint Research and Collaboration Agreement

Activities are progressing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.

Servier (through its sublicensee Allogene) – Anti-CD19 CAR-T

Under the Servier Agreement, Cellectis is eligible to up to $340 million in development and sales milestones as well as low double-digit royalties on sales.

In December 2025, an arbitral tribunal has issued its decision in the arbitration proceedings against Les Laboratoires Servier and Institut de Recherches Internationales Servier IRIS SARL ("Servier"), relating to the License, Development and Commercialization Agreement entered into between Servier and Cellectis on March 6, 2019, as amended (the "Servier Agreement"). The Tribunal ruled on a partial termination of the License Agreement with respect to product UCART19 V1 (also referred to as "ALLO-501" by Allogene) and provided that Cellectis shall, at Allogene’s request, engage in good-faith discussions regarding the granting of a direct license to product UCART19 V1. All other claims brought by the parties were dismissed.

Allogene – Anti-CD70 CAR-T

According to Allogene, the TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, and Allogene is currently exploring partnering opportunities to advance the asset.

Iovance

According to Iovance, new data across several pipeline programs is anticipated throughout 2026, including a Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC.

Corporate

Annual Shareholders Meeting

On June 26, 2025, Cellectis held a Shareholders General Meeting. At the meeting, during which approximately 57% of voting rights were exercised, resolutions 1 through 23 and resolutions 25 and 26 were adopted, while resolution 24 was rejected, consistent with the recommendations of the Board of Directors. The detailed results of the vote and the resolutions are available on Cellectis’ website: View Source

Board composition

The Cellectis Shareholders’ Meeting appointed Mr. André Muller as a director of the Company’s Board of Directors. At the close of this meeting, the term of Mr. Axel-Sven Malkomes expired, and the previously announced resignation of Mr. Pierre Bastid became effective. In connection with these changes to the Board of Directors, the Board of Directors appointed Mr. André Muller, Dr. Donald Bergstrom, and Dr. Rainer Boehm as the members of the Company’s Audit Committee.

2025 Financial Results

Cash: As of December 31, 2025, Cellectis had $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets. The Company believes its cash, cash equivalents, and fixed-term deposits will be sufficient to fund its operations into H2 2027.

This compares to $264 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets as of December 31, 2024. This $53 million change includes $36.9 million of cash-in from our revenue, $8.4 million of interest received from our financial and cash-equivalent investments, $2.2 million cash-in from R&D tax credit, $3.2 million cash-in from VAT credit payments, and a $4.8 million foreign currency translation impact offset by cash payments from Cellectis to suppliers of $50.5 million, Cellectis’ wages, bonuses and social expenses paid of $40.0 million, the payments of lease debts of $10.8 million, the repayment of the Prêt Garanti par l’Etat (PGE) loan for $5.4 million and the payments of capital expenditures for $3.5 million.

We currently foresee focusing our cash spending at Cellectis in supporting the development of our pipeline of product candidates, including the manufacturing and clinical development expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina).

Revenues and Other Income: Consolidated revenues and other income were $79.6 million for the year ended December 31, 2025 compared to $49.2 million for the year ended December 31, 2024. This $30.4 million increase between the years ended December 31, 2024 and 2025 is mainly driven by the evolution of activities performed in connection with the research plans and fulfillment of our performance obligations under the Joint Research and Collaboration Agreement signed with AstraZeneca. Revenues as recorded in the year ended December 31, 2024 included a $5.4 million development milestone under the License Agreement signed with Servier.

R&D Expenses: Consolidated R&D expenses were $93.5 million for the year ended December 31, 2025, compared to $90.5 million for the year ended December 31, 2024. This $3.0 million increase is mainly due to (i) a $4.2 million increase in personnel expenses driven by an evolution of our R&D headcount consistent with our roadmap, higher fair market value of stock-based compensation instruments due to underlying stock dynamics, and foreign exchange effects; (ii) a $0.3 million increase in depreciation and amortization; compensated by (iii) a $1.5 million decrease in purchases and external expenses.

SG&A Expenses: Consolidated SG&A expenses were $19.8 million for the year ended December 31, 2025 compared to $19.1 million for the year ended December 31, 2024. The $0.7 million change is mainly due to a $0.6 million increase in purchases and external expenses.

Other operating income and expenses: Other operating income and expenses decreased slightly by $0.2 million between the years ended December 31, 2024 and 2025, from $0.8 million in 2024 to $0.6 million in 2025.

Net financial gain (loss): Net financial loss was $34.9 million for the year ended December 31, 2025, compared to a $22.8 million net financial gain for the year ended December 31, 2024. This $57.7 million difference reflects mainly a $28.3 million decrease in financial income and a $29.5 million increase in financial expenses between the years ended December 31, 2024 and 2025.

The decrease in financial income is mainly attributable to (i) a $14.3 million gain in change in fair value of the derivative instrument component of the SIA, which was recorded last year before derecognition of the derivative in May 2024; (ii) a $7.2 million decrease in foreign exchange gains; (iii) a $1.8 million decrease in income from cash, cash equivalents and financial assets in line with the evolution of interest rates in 2025, (iv) a $ 5.7 million gain recognized in the year ended December 31, 2024 on the fair value measurement of the Tranches A, B and C warrants issued to the European Investment Bank ("EIB"), partially offset by (v) a $0.8 million increase in FX derivatives fair value gains.

The increase in financial expenses is mainly attributable to a (i) $22.2 million increase in foreign exchange loss over the period due to the devaluation of the USD against the Euro, (ii) a $14.7 million loss on the fair value measurement of the Tranches A, B and C warrants issued to the EIB, (iii) a $0.7 million increase in interest on our financial and lease liabilities, partially offset by (iv) a $7.8 million decrease in the loss on fair value measurement of our investment in shares of Cibus which was entirely sold in Q1 2025.

Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $67.6 million (or a $0.67 loss per share) for the year ended December 31, 2025, compared to a $36.8 million loss (or a $0.41 loss per share) for the year ended December 31, 2024. The $30.8 million change in net loss was primarily driven by (i) a $30.4 million increase in revenues and other income, offset by (ii) a $3.9 million increase in operating expenses and other operating income and (iii) a $57.7 million change from a net financial gain of $22.8 million as of December 31, 2024 to a net financial loss of $34.9 million as of December 31, 2025.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $61.5 million (or a $0.61 loss per share) for the year ended December 31, 2025, compared to a net loss of $33.6 million (or a $0.37 loss per share) for the year ended December 31, 2024.

The year-end consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board ("IFRS").

Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

(Press release, Cellectis, MAR 19, 2026, View Source [SID1234663770])

On March 19, 2026 Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2025 financial results and business updates.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Looking ahead in 2026, Genelux is entering a pivotal period of key clinical readouts for Olvi-Vec and defining milestones for the Company. With the Phase 3 OnPrime/GOG-3076 registrational trial expected to yield topline data in the second half of the year, we are focused on continued disciplined execution. Our productive interactions with the FDA, most recently in January 2026, have informed our next steps and strengthen our conviction in the development of Olvi-Vec for cancer patients with limited alternatives," said Thomas Zindrick, President, CEO and Chairman of Genelux. "Encouraging interim data reported in January 2026 from our systemic lung cancer programs provided additional insight into the potential of Olvi-Vec. In platinum-relapsed or refractory advanced SCLC, systemically delivered Olvi‑Vec demonstrated partial responses, and in advanced or metastatic recurrent NSCLC, early signals of anti-tumor activity were observed. Collectively, these findings further support our strategy of developing Olvi-Vec as a potential platinum resensitizing agent across multiple platinum-treated solid tumors."

"In parallel, we are advancing our manufacturing and operational capabilities to support the long-term development of Olvi-Vec and lay the groundwork for potential commercial readiness following successful registration, if obtained. These efforts are intended to ensure appropriate supply, quality systems, and organizational infrastructure as we advance our registration-directed programs," concluded Mr. Zindrick.

Clinical Program Highlights

Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer:
Genelux continues to advance Olvi-Vec toward potential registration in platinum-resistant/refractory ovarian cancer (PRROC). Intraperitoneal administration of Olvi-Vec enables high and condensed dosing in PRROC, where patients need options that can deliver anti-tumor activity and effectively reverse platinum resistance:

The ongoing Phase 3 OnPrime/GOG-3076 registrational trial (NCT05281471) of Olvi-Vec in platinum-resistant/refractory ovarian cancer is being conducted at sites across the United States, with topline data anticipated in the second half of 2026.
The OnPrime/GOG-3076 study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec in combination platinum-doublet chemotherapy and bevacizumab compared to the active comparator arm with physician’s choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer).
As of its most recent assessment in February 2026, the Independent Data Monitoring Committee recommended study continuation without modification.
Olvi-Vec in Lung Cancer:
Genelux is advancing two ongoing trials of systemically delivered Olvi-Vec in lung cancer. These trials are designed to demonstrate that Olvi-Vec’s oncolytic immunotherapy mechanism can extend beyond intraperitoneal delivery into a systemic setting across multiple solid tumor types and showcase Olvi-Vec’s potential to resensitize tumors to platinum-based chemotherapy:

The Phase 1b/2 study (OLVI-VEC-SCLC-202) in SCLC (NCT07136285) is evaluating Olvi-Vec in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-resistant or relapsed disease after failing previous treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China. Data from the dose escalation cohorts are expected to support determination of a systemic dose for Phase 2. The following preliminary findings were reported in January 2026:
Partial responses in 3 of 9 SCLC patients (33%), including two responses in the highest dose cohort with ~55% and ~85% tumor shrinkage from baseline.
The disease control rate was 67% (6/9 patients), with tumor shrinkage ranging from 24–85% from baseline among patients achieving disease control.
Durability signals were observed, including one patient with ongoing progression‑free survival (PFS) of 12.1 months and another patient with PFS of 7.7 months, the latter exceeding their prior line of therapy by 5.8 months (PFS of 7.7 months vs. 1.9 months).
The Phase 2 VIRO-25 study (NCT06463665) is assessing Olvi-Vec in combination with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent NSCLC who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States.
In preliminary findings reported in January 2026, Olvi‑Vec demonstrated a 60% disease control rate (3/5 evaluable patients), with tumor size changes of 8.9%, -18.9%, and -22.7% respectively, as compared to baseline.
Olvi‑Vec was generally well tolerated across the SCLC and NSCLC studies as of their data review cutoff dates of December 23, 2025 and December 31, 2025, respectively.
Additional dose‑finding updates from both the SCLC Phase 1b/2 and NSCLC Phase 2 VIRO‑25 trials are expected throughout 2026, aligning with the Company’s strategy to optimize a systemic dosing regimen to inform future registrational development.

Business Updates

Chief Medical Officer

Jason Litten, M.D., joined the Company as Chief Medical Officer in January 2026. Dr. Litten brings more than 20 years of experience across academia, large pharmaceutical organizations, and innovative biotechnology companies. He has led the design, execution, and interpretation of Phase 1-4 clinical trials in both liquid and solid tumors, with expertise across biologics, small molecules, and cellular therapies, and will oversee Genelux’s clinical development strategy.

Underwritten Public Offering of Common Stock

In January 2026, the Company closed an underwritten follow-on public offering of 6,666,667 shares of common stock at a price of $3.00 per share, generating net proceeds of $18.5 million, after deducting underwriting discounts, commissions and offering expenses. Net proceeds are expected to be used for general corporate purposes, which may include research and development expenses, clinical trial expenses, capital expenditures, and working capital.

Fourth Quarter and 2025 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $14.6 million as of December 31, 2025. Subsequently, on January 8, 2026, the Company raised an additional $18.5 million in net proceeds through an underwritten offering of common stock, resulting in a pro forma balance of $33.1 million as of December 31, 2025. Based on its current operating plan, the Company expects the combined cash, cash equivalents, marketable securities and restricted cash will fund operations into the first quarter of 2027.

Research and development (R&D) expenses were $19.9 million and $19.0 million for the years ended December 31, 2025 and 2024, respectively, an increase of $0.9 million. The increase was primarily driven by increased clinical trial costs associated with the Company’s Phase 3 On Prime/GOG-3076 registrational trial in 2025.

General and administrative (G&A) expenses were $13.4 million and $12.7 million for the years ended December 31, 2025 and 2024, respectively, an increase of $0.7 million. The increase was primarily driven by an increase in employee compensation due to the combination of annual salary increases and changes to headcount required to support the Company’s operations, as partially offset by a decrease in consulting services.

Net loss was $32.1 million or $0.86 per share for the year ending December 31, 2025, as compared to $29.9 million or $0.95 for the year ended December 31, 2024.

(Press release, Genelux, MAR 19, 2026, View Source [SID1234663771])

On March 19, 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 audited financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update highlighting significant progress across its pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This has truly been a transformational year for Relmada, marked by significant progress with our lead program NDV-01," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "Our recently reported 12-month data for NDV-01 demonstrated durable complete responses with a favorable safety profile, reinforcing the program’s potential to become a best-in-class therapy for patients with non-muscle invasive bladder cancer. With a successful $160 million PIPE financing and regulatory alignment with the FDA on two registrational pathways, we believe that we are well positioned to advance NDV-01 into the Phase 3 RESCUE program in mid-2026. Our team is now focused on executing this plan and initiating the RESCUE registrational program as we work to bring NDV-01 to patients as efficiently as possible."

"NDV-01’s compelling efficacy, durability, and favorable safety profile, combined with operational ease-of-use are the cornerstone of its differentiated product profile and best-in-class potential," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "We continue to be encouraged by the high response rates and durable clinical benefit observed through 12 months, including in the BCG-unresponsive population, alongside a favorable safety profile with no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations. Our clinical program builds on the urologic oncology community’s comfort with conventional Gem/Doce’s efficacy and safety profile with a sustained release product that could provide physicians and patients with a streamlined, less than 5-minute in-office procedure. These results reinforce our confidence as we advance NDV-01 into the Phase 3 RESCUE registrational program in mid-2026."

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

In the 12-month follow-up of the Phase 2a study (March 9, 2026 Company press release) treatment with NDV-01 produced:

Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC
BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time
No patient had progression to muscle-invasive disease, and no patient underwent a radical cystectomy
Favorable overall tolerability – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations or dose interruptions.
Phase 3 RESCUE Registrational Pathways:

As previously disclosed in the Company’s January 12, 2026 regulatory update, Relmada has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations and primary endpoints.

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 affect ~75,000 patients/year in the U.S. The primary endpoint of the study is disease free survival (DFS).

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 U.S., have few, if any, effective treatment alternatives to radical cystectomy. The primary endpoint of the study is complete response (CR) rate at any time.

Expected Upcoming Relmada Milestones:

NDV-01 United States IND clearance – Mid-2026
NDV-01 Phase 3 RESCUE Program initiation – Mid-2026
Sepranolone Phase 2 initiation in Prader-Willi syndrome – Mid-2026
Initial 3-month NDV-01 data from Phase 3 2L BCG-unresponsive study expected by YE 2026
Financial Results

Fourth Quarter 2025 Financial Results

Research and development expense for the three months ended December 31, 2025, totaled $8.1 million, compared to $11.0 million for the three months ended December 31, 2024, a decrease of $2.9 million. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials for REL-1017, partially offset by increased costs related to the start-up the Phase 3 NDV-01 trials and Phase 2b sepranolone study and additional R&D personnel.
General and administrative expense for the three months ended December 31, 2025, totaled $12.3 million compared to $8.1 million for the three months ended December 31, 2024, an increase of approximately $4.2 million. The increase was primarily driven by an increase in compensation costs partially offset by a decrease in stock based compensation costs.
Net cash used in operating activities for the three months ended December 31, 2025, totaled $14.6 million compared to $8.8 million for the three months ended December 31, 2024.
The net loss for the three months ended December 31, 2025, was $19.9 million, or $0.27 per basic and diluted share, compared with a net loss of $18.6 million, or $0.62 per basic and diluted share, for the three months ended December 31, 2024.
Twelve Month Ended December 31, 2025 Financial Results

Research and development (R&D) expense for the 12 months ended December 31, 2025, totaled $26.9 million, compared to $46.2 million for the 12 months ended December 31, 2024, a decrease of $19.3 million. The decrease was primarily driven by a decrease in study costs associated with completion and conclusion of two Phase 3 trials for REL-1017, partially offset by increased costs related to the acquisition of NDV-01 and sepranolone, as well as the start-up of the Phase 3 NDV-01 trials and Phase 2b sepranolone study.
General and administrative (G&A) expense for the 12 months ended December 31, 2025, totaled $32.2 million compared to $37.7 million for the 12 months ended December 31, 2024, a decrease of approximately $5.5 million. The decrease was primarily driven by a decrease in stock-based compensation expense and lower professional fees, partially offset by an increase in personnel-related costs.
Net cash used in operating activities for the 12 months ended December 31, 2025, totaled $45.8 million compared to $51.8 million for the 12 months ended December 31, 2024.
The net loss for the 12 months ended December 31, 2025, was $57.4 million, or $1.45 per basic and diluted share, compared with a net loss of $80.0 million, or $2.65 per basic and diluted share, for the 12 months ended December 31, 2024.
The Company’s cash balance of $93.0 million in cash, cash equivalents, and short-term investments, includes net proceeds of approximately $94 million from an underwritten stock offering announced November 5, 2025. This compares to cash, cash equivalents, and short-term investments of approximately $44.9 million at December 31, 2024.
On March 9, 2026, the Company announced a private financing with gross proceeds of $160 million. This financing, along with the cash, cash equivalents, and short-term investments as of December 31, 2025, is expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program.
The Company had 104,890,223 shares outstanding, as of March 16, 2026
Conference Call and Webcast Information:
Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.

Conference Call and Webcast Information:

Date: Thursday, March 19, 2026 at 4:30 PM ET
Participant Dial-in (US): 1-877-407-0792
Participant Dial-in (International): 1-201-689-8263
Webcast Access: Click Here
A replay of the webcast will be available in the Investors section of the Relmada website at View Source

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 less than 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 high-grade non-muscle invasive bladder cancer (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.

About Sepranolone and GABA Modulation

Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile.

About Prader-Willi Syndrome (PWS)

PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.

(Press release, Relmada Therapeutics, MAR 19, 2026, View Source [SID1234663754])

On March 19, 2026 Damora Therapeutics, Inc. (formerly Galecto, Inc.) ("Damora" or the "Company") (NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care for patients with blood disorders, reported its operating and financial results for the year ended December 31, 2025, and recent corporate highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At Damora Therapeutics, we strive to rapidly bring forward best-in-class medicines to dramatically improve the lives of patients with blood disorders. Today, we are well on the path to achieving our goal based on recent progress, including the acquisition of three highly innovative mutant calreticulin (mutCALR) targeted therapies and two oversubscribed financings extending our cash runway into Phase 3 development," said Sherwin Sattarzadeh, Chief Operating Officer of Damora Therapeutics. "With this strong foundation in place, we are on track to submit an IND or CTA for our lead program DMR-001 in mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF) by mid-2026 and subsequently deliver important clinical datasets next year."

Corporate Highlights

Completed the acquisition of Damora Therapeutics in November 2025, adding a pipeline of differentiated therapeutics targeting mutCALR-driven MPNs, including lead candidate DMR-001, and additional programs DMR-002 and DMR-003, supported by gross proceeds of approximately $285 million concurrent private financing.

Strengthened the leadership team in January 2026 with the appointments of Sherwin Sattarzadeh as Chief Operating Officer and Becker Hewes, M.D. as Chief Medical Officer, adding deep hematology/oncology drug development experience.

Strengthened the balance sheet with gross proceeds of approximately $316 million from a public offering completed in February 2026.

Announced the Company’s name change to Damora Therapeutics, Inc., with its common stock beginning to trade on Nasdaq under the ticker symbol "DMRA" in March 2026.

Anticipated Milestones

Damora anticipates the following upcoming milestones across its mutCALR programs:

DMR-001: IND or CTA submission expected in mid-2026
DMR-002: IND or CTA submission expected in the second half of 2026
DMR-003: IND or CTA submission expected in 2027
Two clinical proof-of-concept datasets for DMR-001 anticipated beginning mid-2027

Full-Year 2025 Financial Results

Cash Position: Cash and cash equivalents were approximately $257.6 million as of December 31, 2025. Including the proceeds from the public offering completed in February 2026, the Company had approximately $535 million in cash and cash equivalents as of February 28, 2026, and anticipates that its cash and cash equivalents will be sufficient to fund operations into Phase 3 development of DMR-001.

R&D Expenses: Research and development expenses were $26.9 million for the year ended December 31, 2025, compared to $6.4 million for the year ended December 31, 2024. The increase was primarily related to costs associated with warrants granted pursuant to the Company’s antibody discovery and option agreement, increased preclinical study and clinical trial-related expenses, increased chemistry, manufacturing and control (CMC) activities, and other research and development costs.

G&A Expenses: General and administrative expenses were $9.7 million for the year ended December 31, 2025, compared to $10.5 million for the year ended December 31, 2024. The decrease was primarily related to decreased stock-based compensation costs.

Net Loss: Net loss for the year ended December 31, 2025, was $209.8 million, compared to $21.4 million for the year ended December 31, 2024. The increase in net loss was primarily related to the recognition of acquired in-process research and development costs of $174.3 million from the acquisition of Damora Therapeutics, which was accounted for as an asset acquisition.

(Press release, Damora Therapeutics, MAR 19, 2026, View Source [SID1234663772])

On March 19, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the full year ended December 31, 2025, and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Based upon continued progress in our GPS and SLS009 clinical programs in AML, we believe 2026 is shaping up to be a pivotal year for SELLAS," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are advancing toward the final analysis of our Phase 3 REGAL trial evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Once we reach the required pre-specified 80th event, which will be announced, we will proceed with the necessary procedures towards database lock completion, statistical analysis, unblinding, and disclosure of topline results. If positive, REGAL could position GPS as a first- and best-in-class immunotherapeutic option in this AML population and serve as a significant value-inflection point for SELLAS."

Dr. Stergiou continued, "We also continue to make significant progress in our SLS009 clinical program for AML. Following the positive Phase 2 results of SLS009 in r/r AML presented at ASH (Free ASH Whitepaper), particularly in high-risk molecular subtypes, we have now dosed the first patient in the expansion cohort, which is evaluating SLS009 in newly diagnosed, first-line AML patients. Additionally, our preclinical data presented at ESMO (Free ESMO Whitepaper) in T-PLL demonstrated a statistically significant survival benefit of SLS009 both as monotherapy and in combination with venetoclax in a patient-derived xenograft model, further supporting the breadth of the CKD9 inhibition strategy. With a catalyst rich outlook, continued clinical execution, our strongest financial position in history and expansion into earlier treatment settings, we look forward to an important year ahead."

Recent Corporate Highlights:

European Collaboration to Advance SLS009 Clinical Program: In January 2026, SELLAS entered into a strategic collaboration with IMPACT-AML to expand SLS009 clinical program in Europe. Under the agreement, IMPACT-AML’s STREAM clinical network will conduct a study of SLS009 in combination with AZA/VEN in newly diagnosed AML patients. The enrollment of approximately 40 patients in Europe is anticipated in Q2 2026.

Phase 3 REGAL Trial of GPS: On December 29, 2025, the Company provided an update on the pivotal Phase 3 REGAL trial, announcing that a total of 72 events had been recorded as of December 26, 2025, with the study remaining fully blinded. After reaching the required pre-specified 80th event, customary database lock and blinded data review procedures must be completed before statistical analysis, unblinding, and disclosure of topline results. Because the final analysis is event-driven, the timing of studies with overall survival as an endpoint can vary; SELLAS will announce the 80th event when it occurs.

Phase 2 SLS009 in r/r AML: On December 7, 2025, the Company announced that clinical data from its ongoing Phase 2 study of SLS009, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025. SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR/Cri/MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring ASXL1 or TP53 mutations achieved response rates of 48% and 57%, respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.

Expansion of SLS009 into Earlier-Line AML Treatment: Following the encouraging Phase 2 results of SLS009 in r/r AML particularly in patients with high-risk molecular subtypes, the Company has expanded the development program into earlier lines of therapy. After receiving constructive feedback from the FDA, SELLAS dosed the first patient in an 80-patient trial in newly diagnosed AML patients as well as those who become refractory early to AZA/VEN treatment which we established through our extensive transcriptomics, genomics, and proteomics models.

Preclinical Data on SLS009 in AML at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper): The data shows that SLS009 induces apoptosis in AML cell lines, including those harboring high-risk ASXL1 and TP53 mutations. Pharmacodynamic changes were observed as early as 8 hours after treatment and became more pronounced over time, with reductions in MCL-1 and survivin, correlating with increased apoptosis. The poster, entitled, "Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines" will be presented on April 21, 2026.

Preclinical Data on SLS009 in T-PLL Presented at ESMO (Free ESMO Whitepaper) 2025: In October 2025, preclinical data demonstrating statistically significant survival benefit of SLS009 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany. The results showed that SLS009, as a monotherapy and in combination with VEN, significantly prolonged survival compared to VEN alone in an in vivo patient-derived xenograft model of T-cell prolymphocytic leukemia (T-PLL). These findings further support the therapeutic potential of SLS009 to improve outcomes across multiple hematologic malignancies.

Virtual R&D Day on Advancing Novel Therapies in AML: On October 29, 2025, SELLAS hosted a virtual R&D Day on "Advancing Novel Therapies in Acute Myeloid Leukemia (AML)" featuring key opinion leaders and Company management. The event provided a detailed review of the Company’s ongoing Phase 3 REGAL trial of GPS and the SLS009 program, underscoring each therapy’s potential to address multiple stages of disease progression along the AML treatment continuum. To access a replay of the R&D Day, please click here.

Received $67.2 Million in Gross Proceeds from Warrant Exercises in 2025: In September and October 2025, SELLAS received a total of approximately $54.6 million in gross proceeds from the immediate exercise of existing warrants, including $23.6 million from warrants issued in January 2025 and $31.0 million from warrants issued in March and August 2024. An additional $12.6 million in proceeds was received during 2025 from the exercise of other previously outstanding warrants.

Received Additional $42.6 Million in Proceeds from Warrant Exercises in Q1 2026: Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants. These additional proceeds bolster the reported $71.8 million cash and cash equivalents as of December 31, 2025, and provide the Company with the strongest financial position in its history.

Financial Results for the Full Year 2025:

Research and Development Expenses: Research and development expenses for the year ended December 31, 2025, were $16.0 million, compared to $19.1 million for the year ended December 31, 2024. The decrease was primarily due to decreases in clinical trial expenses and clinical and regulatory consulting costs, which were primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024.

General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2025, were $12.3 million, as compared to $12.4 million for the year ended December 31, 2024. The decrease was primarily attributable to a decrease in personnel related expenses.

Net Loss: The net loss was $26.9 million for the year ended December 31, 2025, or a basic and diluted loss per share of $0.25, as compared to a net loss of $30.9 million for the year ended December 31, 2024, or a basic and diluted loss per share of $0.50.

Cash Position: As of December 31, 2025, cash and cash equivalents totaled approximately $71.8 million. Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants.

(Press release, Sellas Life Sciences, MAR 19, 2026, View Source [SID1234663755])