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])

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 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double‑stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T‑cell priming.

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!

"These new translational findings strengthen our understanding of pelareorep as a systemic immune‑priming agent that reshapes the tumor microenvironment," said Jared Kelly, Chief Executive Officer of Oncolytics. "The coordinated immune activation and tertiary lymphoid structure formation we are observing support pelareorep as a foundational backbone for combination therapy across multiple tumor types, including RAS-driven cancers. RAS mutations are especially prevalent in deadly cancers, including roughly 95% of pancreatic cancers and 45% of colorectal cancers. As we advance registrational programs in gastrointestinal cancers, we believe pelareorep will enhance immunotherapy activity and potentially help patients who did not respond initially."

Biomarker data from cohort 1 of the Phase 1/2 GOBLET trial in advanced pancreatic cancer suggest pelareorep plus atezolizumab and gemcitabine/nab-paclitaxel can shift tumors toward a more immune-active state. Patients with an immune activation signature after four weeks were more likely to achieve durable clinical benefit, supporting a potential biomarker. Pancreatic cancer continues to pose a significant unmet clinical need, with approximately 510,000 new cases reported globally each year.1

Additionally, new first-of-its-kind data from AWARE-1 show pelareorep can drive coordinated anti-tumor immune responses, including tertiary lymphoid structure ("TLS") formation, helping make immunologically cold tumors more susceptible to immunotherapy. This could include patients who have failed checkpoint inhibitors, representing a significant portion of the patient population and a meaningful unmet need in oncology.

Pelareorep has also been shown to stimulate RAS-specific T-cell clones in gastrointestinal cancers, which may enhance its ability to target RAS-mutated tumor cells. The Company will present more data on this topic at an upcoming scientific meeting.

Together, the data support pelareorep as a novel immune‑priming strategy capable of enhancing the activity of multiple therapeutic classes, including checkpoint inhibitors, targeted therapies, chemotherapy, and emerging immuno‑oncology modalities.

Abstract: Pelareorep combined with atezolizumab and chemotherapy shows immune conversion activity in advanced pancreatic cancer: Biomarker results of cohort 1 of the GOBLET trial

New biomarker data from cohort 1 of the Phase 1/2 GOBLET study demonstrated that pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel led to meaningful immune activation in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC").

An exploratory analysis integrating routine serum markers, a 172-protein circulating panel, selected T-cell receptor sequencing, and clinical outcomes found early on-treatment changes showed increases in adaptive immune and cytotoxicity-associated proteins, including interferon signaling and CD8+/NK-related markers, alongside decreases in tumor/stroma-associated proteins. A 14-protein signature linked to oncolytic activity stratified patients at Week 4 into ‘hot’ vs. ‘cold’ immune phenotypes relative to baseline. Patients demonstrating immune activation signatures experienced longer median progression-free survival (7.5 months) compared with patients who did not exhibit similar immune responses (5.6 months).

As previously reported, the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel demonstrated a 62% objective response rate in first-line mPDAC patients, more than double the response rates historically observed with chemotherapy alone.

Abstract: Imaging mass cytometry of pelareorep treated early breast cancer samples reveals developing tertiary lymphoid structures

AWARE-1 is a window-of-opportunity study evaluating the effects of pelareorep in early-stage breast cancer. In biopsies from Cohort 2 (n=8), cellular neighborhood analysis identified immune-cell clusters, including cytotoxic T cells, dendritic cells, T helper cells, activated T helper cells, B cells, differentiated B cells, and M2 macrophages. Interactions between these cells developed into TLS in select patients. TLS function as localized immune hubs that facilitate antigen presentation, T‑cell activation, and sustained anti‑tumor immune responses. Published studies link TLS formation with improved responses to immunotherapy.

These findings support pelareorep’s potential to expand cytotoxic T cells, activate dendritic cells, and promote TLS formation, helping to convert immunologically ‘cold’ tumors into immune-responsive ‘hot’ tumors.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.

(Press release, Oncolytics Biotech, MAR 19, 2026, View Source [SID1234663752])

On March 19, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the fourth quarter and year ended December 31, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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!

"We are excited to enter 2026 with significant momentum as we continue to advance the development of our ProTide pipeline with the aim to deliver significantly improved treatment outcomes for patients with cancer," said Hugh S. Griffith, NuCana’s Chief Executive Officer. "In late 2025, we presented compelling data from our Phase 2 NuTide:701 study at the annual European Society for Medical Oncology Immuno-Oncology Congress, evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant metastatic melanoma. These data demonstrated a favorable safety profile and evidence of clinical activity, including two partial responses, one of which was confirmed, and multiple cases of stable disease, including one patient whose disease converted to a complete metabolic response with no detectable active disease."

Mr. Griffith continued, "We expect to complete enrollment in the Phase 2 NuTide:701 expansion study in the first half of 2026, with final data expected later this year. We also plan to obtain regulatory guidance from the U.S. Food and Drug Administration regarding a potential registrational pathway for NUC-7738 in melanoma. In parallel, we are evaluating additional indications and combination strategies to further explore the therapeutic potential of NUC-7738."

Mr. Griffith concluded, "Earlier this year we appointed Theresa Bruce as our Chief Operating Officer. Ms. Bruce brings over 25 years of oncology research and development experience, and her operational leadership will support the continued advancement of our pipeline. Based on our current operating plan, we expect our existing cash resources to fund operations into 2029, positioning us to execute on our key anticipated clinical and regulatory objectives."

2026 Anticipated Milestones

NUC-7738
Complete patient recruitment in the Phase 2 expansion study (NuTide:701) evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 resistant melanoma;
Announce final data from the Phase 2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 resistant melanoma;
Obtain regulatory guidance from the U.S. Food and Drug Administration regarding a potential registrational strategy for NUC-7738 in melanoma; and
Advance evaluation of additional indications and combination strategies.
NUC-3373
Evaluate optimal combinations and indications to inform potential future clinical studies of NUC-3373.

Fourth Quarter and Year-End 2025 Financial Highlights and Cash Position

As at December 31, 2025, NuCana had cash and cash equivalents of £24.3 million compared to £25.2 million at September 30, 2025 and £6.7 million at December 31, 2024.

In May 2025, NuCana completed a financing, raising £9.6 million in gross proceeds, £5.2 million upfront and £4.4 million from the exercise of warrants, before expenses and commissions.

Subsequently, in July 2025, NuCana raised, through the at-the-market program, £19.0 million in gross proceeds before expenses and commissions. On July 21, 2025, having raised the full amount of capital required, NuCana announced it had successfully canceled all remaining Series A Warrants issued in the May 2025 financing, in exchange for payments totaling $3.6 million. This initiative fully eliminated all overhanging rights from the May 2025 financing.

NuCana anticipates its cash and cash equivalents at December 31, 2025 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £2.5 million for the quarter ended December 31, 2025, as compared to a net loss of £0.7 million for the quarter ended December 31, 2024. Basic and diluted loss per ordinary share was £0.00 for the quarter ended December 31, 2025, as compared to a loss per ordinary share of £0.01 for the comparable quarter ended December 31, 2024.

NuCana reported a net loss of £29.4 million for the year ended December 31, 2025, as compared to a net loss of £19.0 million for the year ended December 31, 2024. The net loss for the year ended December 31, 2025 included the following non-cash or non-recurring items:

Finance expense of £12.6 million (2024: £nil) relating to the non-cash loss on fair value revaluation of the warrants issued in the May 2025 financing;
Professional fees of £1.4 million (2024: £nil) related to the issue of warrants; and
Share-based payment expenses of £10.0 million (2024: £1.6 million); partly offset by
Total other income of £2.7 million (2024: £nil).
Basic and diluted loss per ordinary share was £0.00 for the year ended December 31, 2025, as compared to a loss per ordinary share of £0.26 for the year ended December 31, 2024.

(Press release, Nucana, MAR 19, 2026, View Source [SID1234663751])

On March 19, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported financial results for the year ended December 31, 2025 and provided a clinical update highlighting rapid progress toward a major upcoming milestone in its pivotal MIRACLE trial of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML).

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!

"With the MIRACLE trial rapidly progressing and the first MIRACLE interim readout now clearly within reach, we believe 2026 will be a defining year for Moleculin," said Walter Klemp, Chairman and CEO of Moleculin. "The encouraging blinded efficacy data seen so far, particularly in a pretreated population that includes venetoclax failures, reinforces our belief that Annamycin has the potential to represent a significant advancement in AML therapy."

Recent Highlights

Reported (n=30) MIRACLE Trial delivered 40% preliminary blinded CRc rate;
Received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin, bringing the total number of Annamycin treated subjects reviewed by its independent expert to 90;
Entered a new Annamycin research collaboration focused on glioblastoma multiforme (GBM) with CIC biomaGUNE to evaluate intra arterial delivery of Annamycin in preclinical models;
Announced positive results from a Phase 1 clinical trial of WP1066 in pediatric recurrent malignant brain tumors, showing safety and signs of antitumor immune responses and supporting potential progression to Phase 2;
Announced a grant-funded preclinical research agreement with the University of North Carolina at Chapel Hill to evaluate Annamycin for pancreatic cancer treatment; and
Announced a targeted new investigator-initiated Phase 1B/2 study of Annamycin in third-line pancreatic cancer with Atlantic Health, based on preclinical data suggesting activity in advanced pancreatic tumors.
Clinical Development Update

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The Company is currently evaluating Annamycin in combination with cytarabine (Ara-C), collectively referred to as AnnAraC, in its pivotal Phase 3 "MIRACLE" trial for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) following induction therapy. The MIRACLE trial is a global, adaptive Phase 2B/3 clinical study being conducted across the United States, Europe, and other international sites.

The study’s adaptive design will integrate data from the ongoing Phase 2B portion (i.e., Part A) with the eventual Phase 3 portion (i.e., Part B). In Part A, approximately 75 to 90 subjects are randomized in a 1:1:1 ratio to receive high-dose cytarabine (HiDAC) combined with either placebo, 190 mg/m² Annamycin, or 230 mg/m² Annamycin. These Annamycin doses were selected based on recommendations from the FDA during the Company’s End-of-Phase 2 meeting. The protocol allows for early unblinding of data at 45 subjects, enabling an initial readout of approximately 30 subjects treated with Annamycin plus cytarabine and 15 subjects in the control arm receiving cytarabine plus placebo. This initial unblinding is expected in mid-2026, following completion of treatment for the first 45 patients.

In February 2026, Moleculin reported a blinded preliminary composite complete remission (CRc) rate of 40% in the MIRACLE trial’s first 30 subjects treated and with blinded, preliminary efficacy data. This CRc rate is comprised of a complete remission (CR) rate of 30% and complete remission with partial hematological recovery (CRh) of 10%. MIRACLE is randomizing 1:1:1 of the three different arms described above. This includes the control arm of cytarabine plus placebo. Even with the control arm included, these preliminary, blinded results substantially outperform historical outcomes for CR with cytarabine alone in the treatment of R/R AML. Of particular note is that roughly 35% of the subjects treated to date are relapsed or refractory (R/R) from a venetoclax regimen, a subject population that is generally considered among the most challenging to address with 2nd line therapies. The subjects treated to date presented with a high degree of genetic markers that are considered predictive of poor treatment response. These efficacy rates were observed across six different countries.

For Part B of the trial, 222 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative. Data from the control arm and the optimum dose of Annamycin chosen in the Phase 2B portion of the trial will be combined with the data for the Phase 3 portion of the trial in determining efficacy and safety for the trial.

For additional information, the MIRACLE trial is registered on ClinicalTrials.gov under identifier NCT06788756.

Expected Milestones for Annamycin AML Development Program

Q1 2026: MIRACLE – 45th subject treated with unblinding of data for 45 subjects expected in mid-2026
Q3 2026: MIRACLE – 90 subjects treated and unblinding thereafter
2H 2026: MIRACLE – Start of Part B
2H 2026: Atlantic Health pancreatic cancer clinical trial begins
2027: Begin recruitment of 3rd line AML subjects
2027: Begin pediatric AML clinical study
2028: End recruitment of Part B
2028: Primary efficacy data for MIRACLE 2nd line subjects
2028: Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
Soft Tissue Sarcoma (STS Lung Metastases) Program

Moleculin’s Phase 1B/2 trial of Annamycin for soft tissue sarcoma lung metastases demonstrated:

Median overall survival of 13.5 months
Achieved in a median seventh-line therapy population
These results compare favorably with historical outcomes in earlier-line therapies.
Pancreatic Cancer Program

An investigator-initiated Phase 1B/2 study evaluating Annamycin for third-line pancreatic cancer is expected to begin in 2026.

Preclinical research suggests Annamycin may have particular activity in pancreatic tumors due to its ability to concentrate in pancreatic tissue.

WP1066 Program

The Company’s STAT3-inhibiting immunomodulator WP1066 continues to advance through investigator-initiated clinical studies targeting glioblastoma and pediatric brain tumors.

Moleculin expects several important milestones in the coming months.

Summary of Financial Results for the Full Year 2025

Research and development (R&D) expense was $15.9 million and $17.7 million for the years ended December 31, 2025 and 2024, respectively. The decrease in R&D of $1.8 million is primarily attributable to a reduction in sponsored research activities during the current year compared to the prior year.

General and administrative (G&A) expenses and depreciation and amortization expenses were $9.2 million and $8.9 million for the years ended December 31, 2025 and 2024, respectively. The increase in G&A of $0.3 million was primarily attributable to higher regulatory and legal services, as well as increased consulting and investor relations expenses.

As of December 31, 2025, the Company had cash and cash equivalents of $8.9 million and prepaid expenses and other current assets of $0.8 million. The Company also had $3.5 million of accounts payable and $3.3 million of accrued expenses and other current liabilities. A significant portion of the accounts payable and accrued expenses were due to work performed in relation to our preclinical activities and our clinical trials. Management believes that cash resources as of December 31, 2025, along with $8.3 million in gross proceeds received via financing activities in the first quarter of 2026 will be sufficient to fund the Company’s planned operations into the third quarter of 2026.

(Press release, Moleculin, MAR 19, 2026, View Source [SID1234663750])