On March 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported the launch of an expanded research initiative evaluating combinations of its clinical-stage GSK-3β inhibitor elraglusib with emerging RAS-targeted therapies.

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Despite recent advances in RAS-targeted therapies, adaptive resistance mechanisms and pathway reactivation remain some of the key barriers to achieving durable responses in patients (Dilly et al., Cancer Discov 2024).

Based on the mechanisms of action, GSK-3 inhibition may represent a critical complementary strategy capable of enhancing RAS-targeted therapies by suppressing downstream survival signaling and resistance pathways, including

NF-κB–mediated survival signaling
MYC-driven transcriptional programs
metabolic adaptation and oxidative stress buffering
tumor microenvironment immune suppression
In addition, RAS-mutant tumors — particularly pancreatic cancer — are widely considered immunologically resistant. Preclinical research suggests that GSK-3β inhibition may enhance antigen presentation, activate T cells and NK cells, and reduce exhausted T-cells. By simultaneously targeting tumor intrinsic survival pathways and modulating the tumor immune microenvironment, the combination of elraglusib and RAS inhibitors has the potential to create a multi-modal therapeutic strategy designed to overcome resistance and expand clinical benefit in RAS-driven cancers.

Expanding the Strategic Opportunity for Elraglusib

Elraglusib is a best-in-class, highly selective GSK-3β inhibitor with broad potential across multiple oncology indications, including pancreatic cancer, melanoma, colorectal cancer, and sarcoma. The investigational product has been administered to more than 500 patients and is currently being evaluated in a Phase 2 trial in metastatic pancreatic cancer (mPDAC).

The combination strategy is designed to simultaneously block proliferative signaling through RAS inhibition and disrupt tumor survival pathways via elraglusib’s GSK-3β inhibition, potentially enhancing apoptotic signaling beyond the threshold achieved with RAS inhibition alone.

The combination program is expected to include in-vitro studies of elraglusib with select RAS inhibitors using tumor models of RAS resistance, in-vivo tumor regression and survival studies, and translational biomarker analysis. Initial data from the program are expected in Q2 2026, with additional results in 2H26.

While next-generation RAS inhibitors are making meaningful progress, the emerging data suggest that combination strategies will be required to maximize clinical benefit (Long et al., Cancer Res 2026). By targeting GSK-3 – a central regulator of tumor survival – the Company believes that elraglusib has the potential to enhance depth and durability of RAS-targeted therapies. Actuate is advancing this work with leading academic collaborators and potential industry partners, further positioning elraglusib as a potential foundational component of next-generation treatment paradigms for RAS-driven cancers.

(Press release, Actuate Therapeutics, MAR 9, 2026, View Source [SID1234663390])

On March 9, 2026 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported full year 2025 financial results and provided a corporate update.

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"The pace of progress at Alpha Tau today is unlike anything we’ve ever seen before," said Alpha Tau Chief Executive Officer Uzi Sofer. "With a slew of meaningful announcements in the past few months, culminating most recently with our receipt of marketing approval in Japan, our first outside of Israel, and with multiple meaningful milestones targeted for the coming months, we remain laser focused on execution. Clinical trial progress remains our highest priority, with an astounding five clinical trials approved in parallel in the U.S. At the same time, we continue to build out our manufacturing capabilities in New Hampshire as well as our pre-commercial preparations, while entertaining multiple tracks of strategic dialogue with partners who show increasing excitement about the ever-expanding prospects for Alpha DaRT."

Recent Corporate Highlights:

● Commercial-Scale U.S. Manufacturing Milestone: In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

● FDA Approval to Start Prostate Cancer Trial: In December, Alpha Tau announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company’s Alpha DaRT technology. According to the National Cancer Institute, over 300,000 new cases of prostate cancer were expected to be diagnosed in 2025, and clinical literature indicates that up to 15% of patients treated with external beam radiation therapy can develop local recurrence within 15 years of treatment. The clinical trial is expected to enroll up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition (a rise of PSA levels by 2 ng/mL from the PSA nadir). For more information, please see here: View Source

● First Patient Treated in U.S. Brain Cancer Trial: In December, Alpha Tau treated its first patient in its pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM) using the Alpha DaRT technology. According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months, and this pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs. For more information, please see here: View Source

● First Module Submitted to FDA as Part of Application for Marketing Authorization in Skin Cancer: In January, the Company announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module with respect to non-clinical studies as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available.

● New Positive Data in Pancreatic Cancer Presented at ASCO (Free ASCO Whitepaper): In January, investigators from the Company’s first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC) were awarded two separate presentations at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium showcasing results from the trial. The results demonstrated a 22% objective response rate (ORR) and an 81% disease control rate (DCR) across all 32 patients treated in the study, or 23% ORR and 87% DCR when excluding the first two patients, who were deliberately given low dosages in order to examine feasibility and safety only. In addition, investigators presented results showing the immune-preserving profile of Alpha DaRT in PDAC, based on immune markers as well as inflammatory indices known to be negative prognostic indicators, and which typically worsen after other forms of radiation therapy.

● Received Marketing Approval in Japan for Head and Neck Cancer: In February, Alpha Tau announced the receipt of Japanese marketing approval for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer, marking the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients in total at five selected leading clinical centers in Japan, and the Company’s immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease.

Expected Upcoming Milestone Targets:

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma at the end of Q1 2026. For more information, please see here: View Source

● Completion of patient recruitment in pancreatic cancer pilot study in the U.S. in Q2 2026. For more information, please see here: View Source

● Initial safety readout from the first three patients in the recurrent GBM trial in Q2 2026, and completion of patient recruitment in the second half of 2026. For more information, please see here: View Source

Financial results for year ended December 31, 2025

R&D expenses for the year ended December 31, 2025 were $32.1 million, compared to $27.0 million for the same period in 2024, due to increased employee compensation and benefits, increased costs of raw materials, and increased third-party contractor expenses (including clinical trial sites).

Marketing expenses for the year ended December 31, 2025 were $1.9 million, compared to $2.3 million for the same period in 2024, due to decreased compensation expenses and travel abroad.

G&A expenses for the year ended December 31, 2025 were $8.4 million, compared to $6.7 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal and IR expenses).

Financial expense, net, for the year ended December 31, 2025 was $0.2 million, compared to $4.3 million financial income, net, for the same period in 2024, due to a decrease in income from remeasurement of warrants and in interest from bank deposits as well as increased expense from changes in foreign exchange rates.

For the year ended December 31, 2025, the Company had a net loss of $42.6 million, or $0.53 per share, compared to a net loss of $31.8 million, or $0.45 per share, in the year ending December 31, 2024.

Balance Sheet Highlights

As of December 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $76.9 million, compared to $62.9 million at December 31, 2024.

Annual Report Availability

Alpha Tau’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025, has been filed today with the Securities and Exchange Commission. The Annual Report on Form 20-F can be accessed on the Investor Relations section of Alpha Tau’s website at View Source and on the SEC’s website at www.sec.gov.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAR 9, 2026, View Source [SID1234663356])

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 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).

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The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-µg treatment cohort at Day 57, representing the strongest treatment response observed in the study.

We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.

Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point.

The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.

The Company believes the dataset represents decision-grade evidence supporting advancement of the SkinJect program toward regulatory discussions and potential strategic partnerships.

Interpreting Clinical and Histological Endpoints

The SKNJCT-003 study evaluated two complementary efficacy endpoints:

• Clinical clearance — visual disappearance of the treated lesion
• Histological clearance — absence of tumor cells on excisional biopsy

The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving 73% clinical clearance and 40% histological clearance at Day 57. Taken together, the results suggest that a meaningful proportion of treated lesions achieved both visual and histological clearance, supporting the therapeutic potential of the SkinJect platform.

Interpreting Biological Activity in the Placebo Active Arm (P-MNA) Cohort:

The biological activity observed in the P-MNA is consistent with mechanisms well recognized in intratumoral device therapies and microneedle-based delivery systems, and is consistent with what the company had observed in the SKNJCT-001 Phase 1 safety and tolerability study in March of 2021, and the positively trending interim analysis of SKNJCT-003 in March of 2023 which demonstrated more than sixty (60) percent of clinical clearance.

Microneedle insertion into tumor tissue produces localized micro-injury that can trigger and amplify several biological processes, including:

• mechanical disruption of tumor architecture
• activation of wound-healing pathways
• localized immune signaling

Basal cell carcinoma is known to be a highly immunogenic tumor, and these localized biological responses can contribute to tumor regression even in the absence of an active therapeutic agent.

These mechanisms have been described in dermatologic oncology literature and reflect the inherent biological activity of microneedle-based delivery platforms.

Microneedle-based tumor disruption is increasingly recognized as a biologically active delivery platform, and the therapeutic contribution of the active drug should be interpreted on top of this device-mediated biological effect.

Importantly, the study demonstrated clear separation between the P-MNA cohort and the 200-µg treatment cohort at Day 57, where the active treatment group achieved 73% clinical clearance compared with 38% in P-MNA, supporting the additional therapeutic contribution of the drug delivered through the SkinJect microneedle system.

The Company believes that the dataset should be interpreted in the context of both:

Biologic activity from the microneedle delivery platform
Additional drug-related therapeutic effect
Potential Clinical Impact

Basal cell carcinoma is the most common cancer worldwide, with millions of lesions treated each year.

The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.

In clinical practice, lesions that achieve visual clearance are often monitored through routine dermatologic follow-up, reserving surgical procedures for lesions that recur or persist.

If confirmed in future studies, this approach could provide dermatologists with a minimally invasive treatment option that may reduce the need for Mohs surgery, the current surgical standard for many basal cell carcinomas.

The treatment approach may be particularly relevant for patients with Gorlin Syndrome, a rare genetic condition in which individuals may develop dozens or hundreds of basal cell carcinomas throughout their lifetime. For these patients, repeated surgical procedures can be extremely burdensome, impractical and potentially disfiguring; a non-invasive treatment could be transformative.

Dataset Supports Next Development Milestones

Based on the available data, the Company considers the current dataset to be decision-grade and supportive of the next phase of development. The Company intends to use these results to advance regulatory discussions with the Food and Drug Administration (the "FDA") and to accelerate partnering discussions, as further elaborated on below.

Advance regulatory discussions with the FDA

The Company plans to proceed toward an End-of-Phase-2 meeting with the FDA to determine the optimal registrational development pathway, where the clinical development strategy may include:

• continued evaluation of the 200-µg dose
• potential optimization of patch application duration
• evaluation of additional treatment sessions
• potential refinement of treatment intervals

Accelerate partnering discussions

The dataset also provides a foundation for ongoing discussions with potential strategic partners, particularly companies active in dermatology and oncology.

Management Commentary

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, commented:

"We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma. The separation observed in the 200-µg treatment cohort, combined with the known biological activity of microneedle-based delivery systems, provides a strong foundation for advancing the program toward regulatory discussions and potential strategic partnerships.

The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention."

Strategic Focus on Phase 2 De-Risking and Partnering

Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.

The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.

(Press release, Skinject, MAR 9, 2026, View Source [SID1234663391])

On March 9, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage company focused on promising new therapies in oncology and obesity, reported a corporate update and announced financial results for the fourth quarter and year ended December 31, 2025.

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"Our encouraging data readouts for CRB-701 and CRB-913 in the fourth quarter of 2025 set the stage for a potentially transformative 2026. This summer we anticipate key data readouts for both programs that we expect will elucidate their differentiated efficacy and safety profiles, as well as potential clinical utility and commercial opportunities," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "The clinical responses we are generating in HNSCC and cervical cancer patients with CRB-701, a highly stable Nectin-4 ADC, highlight its potential in treating these challenging tumor types. In parallel, the rapid weight loss and favorable GI tolerability we’ve seen with CRB-913 suggest it could provide a novel long-term weight management solution for people struggling with chronic obesity."

Key Corporate and Program Updates

CRB-701 is a next-generation, highly stable Nectin-4 targeting ADC being developed to treat HNSCC and cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CRB-701 for the treatment of both cancer types. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

Encouraging CRB-701 Phase 1/2 data in Q4 2025. Corbus presented dose optimization data at the 2025 European Society for Medical Oncology Congress (ESMO 2025). Highlights included:
Unconfirmed Objective Response Rate with CRB-701 at the 3.6 mg/kg dose: HNSCC – 47.6%, Cervical cancer – 37.5%, and Bladder – 55.6%.
Favorable safety and tolerability with no grade 4 or 5 treatment-related adverse events.
Markedly low levels of peripheral neuropathy and skin toxicity.
Link here for CRB-701 ESMO (Free ESMO Whitepaper) data press release and here for archived KOL event discussing the findings.

Anticipated catalysts for CRB-701 in 2026:
Provide update in Q1 2026 from discussions with FDA regarding registrational study protocols for HNSCC and cervical cancer.
Report monotherapy data in mid-2026 with a key focus being durability data and patient stratification.
Generate CRB-701 + Keytruda combination data in first line ("1L") HNSCC patients in Q4 2026.
CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.

Encouraging CRB-913 data in Q4 2025. Corbus completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study in December 2025. SAD portion: n=64 across 8 cohorts; MAD portion: n=48 across 4 cohorts. Highest SAD dose tested was 600 mg/day and highest MAD dose tested was 150 mg/day. Highlights include:
Weight loss of 2.9% (placebo adjusted) at 14-days in dedicated 150 mg/day obesity cohort (n=12). Weight loss started early and deepened with time. Safe and well-tolerated across all cohorts and all doses studied.
Very favorable GI profile with no reports of vomiting, constipation or nausea.
Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative.
Link here for Phase 1a study data press release and here for archived KOL event discussing the findings.

Anticipated catalyst for CRB-913 in 2026:
CANYON-1 Phase 1b dose-ranging 12-week study (n=240) expected to be completed in summer 2026.
CRB-601 is an anti-αvβ8 integrin monoclonal antibody (mAB) designed to block the activation of latent TGFβ in the tumor micro-environment to treat solid tumors.

Phase 1 dose escalation trial of CRB-601 completed in Q4 2025.
Preliminary monotherapy data were presented in November 2025 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025.
Corbus has deprioritized this program and does not plan to enroll additional patients.
Financial Results for the Quarter and Year Ended December 31, 2025

The Company reported a net loss of approximately $20.6 million, or a net loss per basic and diluted share of $1.25, for the three months ended December 31, 2025, compared to a net loss of $9.5 million, or a net loss per basic and diluted share of $0.78, for the three months ended December 31, 2024.

Operating expenses increased by $9.4 million to approximately $22.0 million for the three months ended December 31, 2025, compared to approximately $12.6 million for the three months ended December 31, 2024. The increase was primarily attributable to an increase in clinical development expenses.

The Company had $163.3 million of cash, cash equivalents, and investment on hand at December 31, 2025, which is expected to fund operations into 2028 based on planned expenditures. In the fourth quarter of 2025, the Company completed a public offering that raised a total of $75 million in gross proceeds.

(Press release, Corbus Pharmaceuticals, MAR 9, 2026, View Source [SID1234663414])