On April 1, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.

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"We are excited to complete our PEAK NDA submission which marks a significant step toward bringing a new therapy to patients with second-line GIST," said Andrew Robbins, President and Chief Executive Officer. "Based on the strength of the PEAK data, we believe the bezuclastinib combination has the potential to meaningfully change the treatment landscape for these patients. We are grateful to the patients, investigators, and study teams who made this possible."

Pivotal data from PEAK, a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with GIST who have received prior treatment with imatinib, were reported in November 2025. As disclosed in the top-line results, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. The bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. Data for overall survival remains immature.

At the time of data cutoff, based on the number of ongoing patients receiving treatment on the bezuclastinib combination arm, the estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib. The NDA submission with bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) also remains on track for the first half of 2026.

Bezuclastinib – Expanded Access Program
Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on March 30, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of "inducement" equity awards to six new employees under the company’s 2020 Inducement Plan with a grant date of March 30, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 21,100 shares of Cogent common stock and (ii) 15,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, APR 1, 2026, View Source [SID1234664121])

On April 1, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California from April 17-22, 2026. The Company will demonstrate new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment (TME).

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 SA, a known T and NK-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the AACR (Free AACR Whitepaper) meeting will showcase RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail may overcome these historical limitations.

The Company is developing a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting the possibility of off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

"We continue to advance the RedTail platform through our lead asset, CLD-401, and now through our work with T-cell engagers," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We believe RedTail represents a major breakthrough in the ability to deliver genetic payloads in a targeted fashion to distal sites of disease through systemic administration."

"The data we will present at AACR (Free AACR Whitepaper) highlight the ability of the RedTail platform to functionally overexpress complex biologics likes cytokines and T-cell engagers and profoundly alter the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The ability of the RedTail platform to induce high levels of expression of its genetic payloads only at the tumor can potentially overcome many of the limitations currently seen with cytokine and T-cell engager therapies."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, APR 1, 2026, View Source [SID1234664120])

On April 1, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, reported financial results for the full year 2025 and provided corporate updates.

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"Our clinical data for muzastotug plus pembrolizumab consistently demonstrate potent, dose-dependent efficacy," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "The 10 mg/kg data reported at ASCO (Free ASCO Whitepaper) have now matured into the classic long survival tail of CTLA-4 inhibition. By significantly mitigating severe toxicities, patients remain on therapy longer, allowing CTLA-4-mediated intratumoral Treg depletion, alongside PD-1-mediated reinvigoration and CTLA-4-mediated priming of effector T cells, to drive durable disease control. Importantly, these data provide a clear, de-risked read-through to the 20 mg/kg dose, which already shows an encouraging 29% ORR with median duration of response not yet reached.

"Supported by Fast Track Designation and FDA alignment under Project Optimus, we are on track to finalize the optimal combination dose regimen for a potential MSS colorectal cancer registrational trial. The expanded therapeutic window also helps to establish muzastotug as a foundational combination backbone. At AACR (Free AACR Whitepaper), we will showcase this potential with data from triplet regimens—combining with fruquintinib in 3L+ MSS CRC, alongside results from the Morpheus Liver study evaluating a triplet of muzastotug, atezolizumab, and bevacizumab versus atezolizumab and bevacizumab alone in first-line HCC. These readouts underscore our ability to safely unlock deeper responses in hard-to-treat tumors."

2026 OBJECTIVES & CASH RUNWAY INTO EARLY 2028

· Data update from the ongoing Phase 1b/2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts

· Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3.

· Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.

· Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

· Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).

· Establish additional collaboration/licensing agreements.

With cash and cash equivalents of $74.5 million as of December 31, 2025, plus proceeds raised from the ATM Offering in 2026 year-to-date, Company expects a cash runway extending into early 2028.

PIPELINE HIGHLIGHTS

AMERICAN ASSOCIATION FOR CANCER RESEARCH 2026 PRESENTATIONS

The following abstracts have been selected for presentation at AACR (Free AACR Whitepaper) 2026:

1) Title: Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer

This poster will provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

2) Title: Results from the phase 1b/2 Morpheus Liver study in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC): Muzastotug (ADG126: masked anti-CTLA-4 Ab) combination arm

This poster will share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of liver cancer.

3) Title: Preclinical characterization of XB404, a masked anti-ROR1/2 antibody-drug conjugate

Partner Exelixis will present preclinical data from antibody-drug conjugate, XB404, built with Adagene’s SAFEbody masking technology and designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects.

ONGOING COLLABORATIONS

· Sanofi: Invested up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with Sanofi’s SAR445877 (PD-1 x IL-15 fusion protein) in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody discovery program.

· Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody into next-generation T cell therapies.

· Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.

· ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.

· Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC).

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$74.5 million as of December 31, 2025, compared to US$85.2 million as of December 31, 2024. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$6.1 million as of December 31, 2025 from US$ 18.2 million as of December 31, 2024. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.

Net Revenue:

Net revenue was US$7.7 million for the year ended December 31, 2025, compared to US$0.1 million in 2024. The increase of approximately 7,333% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi, ConjugateBio and Third Arc Bio, respectively.

Research and Development (R&D) Expenses:

R&D expenses were US$22.0 million for the year ended December 31, 2025, compared to US$28.8 million in 2024. The decrease of approximately 23% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$7.1 million for the year ended December 31, 2025, compared to US$7.3 million in 2024. The decrease was mainly a result of cost-control measures.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$17.6 million for the year ended December 31, 2025, compared to US$33.4 million in 2024.

Ordinary Shares Outstanding:

As of December 31, 2025, there were 59,231,993 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

ADG126- Phase 1b/2 data:

· As presented at ASCO (Free ASCO Whitepaper) 2025, muzastotug showed 29% (6/21) confirmed overall response rate (ORR) in the combined 20 mg/kg dose cohorts.

· Among 41 patients in the combined 10mg/kg dose cohorts, median overall survival (mOS) was 19.4 months with a 17.8-month median follow-up, which compares favorably to 11-12 month mOS from fruquintinib Phase 3 trials in the same population1

· Across 67 patients in all cohorts, a low 4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts and 27% in the 20 mg/kg cohorts, which were generally transient and manageable.

· Updated data demonstrate the durability of response and further support the optimized therapeutic index profile of muzastotug, which overcomes well-known dose-limiting toxicities of other CTLA-4 inhibitors at 10-20-fold higher doses2, to provide potentially improved efficacy.

· Randomized Phase 2 trial enrollment ongoing, with results expected in 1H 2027; registration trial expected to begin once optimal dose regimen has been established

(Press release, Adagene, APR 1, 2026, View Source [SID1234664119])

On March 31, 2026 AAVivo, a Delaware-registered biotechnology company focused on next-generation AAV-based gene therapies and supported by Virovek, reported that it will host a sponsored symposium at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11–15, 2026, in Boston, Massachusetts.

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The symposium, titled "Breaking Barriers in In Vivo CAR-T Therapy: CD3scFv-Engineered AAV Capsids Drive Superior CAR-T Cell Generation and Complete Tumor Eradication," will showcase compelling new preclinical data from AAVivo’s proprietary AAVTCeT platform.

During the session, the company will present evidence demonstrating how its CD3scFv-engineered AAV capsids enable highly efficient in vivo CAR-T cell generation, resulting in complete tumor eradication in preclinical models. This innovative approach addresses major limitations of traditional ex vivo CAR-T therapies, including complex and costly manufacturing processes, limited patient accessibility, and scalability challenges.

"Presenting at ASGCT (Free ASGCT Whitepaper) 2026 provides an important platform to share our progress toward transforming CAR-T therapy," said Haifeng Chen, PhD, CEO of AAVivo. "Our AAVTCeT platform has the potential to deliver an off-the-shelf, in vivo solution that could significantly improve patient outcomes and broaden access to life-changing cell therapies. We look forward to engaging with the gene and cell therapy community and potential partners in Boston."

Symposium Details

Title: Breaking Barriers in In Vivo CAR-T Therapy: CD3scFv-Engineered AAV Capsids Drive Superior CAR-T Cell Generation and Complete Tumor Eradication
Date & Time: Friday, May 15, 2026 | 10:15 – 10:45 AM
Location: Room 109AB, Thomas M. Menino Convention & Exhibition Center, Boston, MA
Format: Sponsored Symposium (open to ASGCT (Free ASGCT Whitepaper) 2026 registered attendees; also livestreamed via the ASGCT (Free ASGCT Whitepaper) Events App)
The presentation will include an overview of the AAVTCeT platform technology, key preclinical efficacy and safety data, and the company’s development roadmap for clinical translation.

AAVivo is advancing its platform with the support of Virovek’s established AAV expertise to develop more accessible and cost-effective genetic medicines.

(Press release, AAVivo, MAR 31, 2026, View Source [SID1234664118])

On March 31, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ, BCTXL) (TSX: BCT) ("BriaCell"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, and its majority-owned subsidiary, BriaPro Therapeutics Corp. ("BriaPro"), reported the completion of the previously announced asset purchase transaction (the "Transaction") pursuant to a definitive purchase agreement dated February 4, 2026 (the "Purchase Agreement"), under which BriaPro acquired BriaCell’s exclusive license to develop and commercialize Soluble CD80 ("sCD80") as a biologic agent for the treatment of cancer and other associated assets.

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Background

BriaCell originally secured the exclusive license from the University of Maryland, Baltimore County ("UMBC") on August 2, 2022. The novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s scientific advisory board, is titled "Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients" and is covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2. In animal models, sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al. and Samuel T Haile et al. in collaboration with Dr. Ostrand-Rosenberg). Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn, et al.). Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune system to recognize and destroy tumor cells.

The Transaction

Under the terms of the Purchase Agreement, BriaPro gained the worldwide rights to develop and commercialize sCD80 as a therapeutic agent for the treatment of cancer, while UMBC holds all rights, title and interest in the inventions and the patent, except for certain rights retained by the United States Government. BriaPro will pay 2% royalties to UMBC upon the commercialization of the product plus other development costs.

As part of the Transaction, BriaCell has made available to BriaPro up to $3 million to fund research and development efforts (the "Credit Facility"). Each drawdown under the Credit Facility will be subject to BriaCell’s approval regarding the use of funds.

As consideration for the transfer of the exclusive license and the Credit Facility, BriaPro issued to BriaCell 23,972,589 Common Shares at an aggregate value of approximately C$1.18M, increasing BriaCell’s interest in BriaPro to approximately 78% post-transaction.

Appointment of Jamieson Bondarenko as BriaPro Board Chair

Upon closing of the Transaction, Mr. Jamieson Bondarenko was appointed to the BriaPro board as Chairman. Mr. Bondarenko has served as Chairman of BriaCell since 2019. He provides strategic capital markets & corporate development advice to early-stage life sciences companies through his merchant capital company, JGRNT Capital Corp. Previously, he held a number of senior investment banking roles, including as Managing Director at Eight Capital and at Dundee Securities. Mr. Bondarenko is expected to play a significant role in BriaPro’s pursuit of capital markets and other strategic opportunities as the company advances its expanding IP portfolio.

Shareholder Approval

The Transaction was approved by 99.81% of the votes cast by the disinterested shareholders of BriaPro in accordance with Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions. As a 10% shareholder with an interest in the Transaction, BriaCell’s shareholdings in BriaPro were excluded from voting.

Formal Valuation Requirements

In respect of the formal valuation requirement of MI 61-101, BriaPro relied on the specified markets exemptions set forth in subsection 5.5(b) of MI 61-101, as none of its securities are listed or quoted on a specified senior exchange, and BriaCell relied on the exemption set forth in subsection 5.5(a) of MI 61‑101, as the fair market value of the Transaction did not exceed 25% of BriaCell’s market capitalization.

Though a formal valuation is not required under applicable securities laws, as a matter of good governance and best corporate practice, BriaCell obtained a fairness opinion confirming, subject to certain customary assumptions and qualifications, that the consideration received by BriaCell in the Transaction was fair to BriaCell shareholders.

"Our mission has been to develop safe and effective treatments for cancer patients who do not respond to existing treatments, and a transformational anti-cancer agent such as sCD80 may provide us with such an additional opportunity," stated Dr. Bill Williams, BriaCell and BriaPro’s President and CEO. "Based on the promising data in animal studies, we plan to explore the potential use of sCD80 technology as a therapeutic agent in combination with our other immunotherapies or on its own. We look forward to accelerating the development of this novel anti-cancer agent to bring hope to patients who need it the most."

Early Warning

Immediately prior to the closing of the Transaction, BriaCell owned and controlled an aggregate of 31,963,452 Common Shares, representing approximately 66.7% of the issued and outstanding Common Shares of BriaPro. Immediately following the closing of the Transaction, BriaCell owns and controls an aggregate of 55,936,041 Common Shares representing approximately 78% of the issued and outstanding Common Shares of BriaPro.

BriaCell acquired the Common Shares for investment purposes and may make further acquisitions or dispositions of securities of BriaPro depending on market conditions and other relevant factors.

This press release is issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues. A copy of the related early warning report will be filed with the applicable securities commissions and be available under BriaPro’s profile on SEDAR at www.sedarplus.ca.

(Press release, BriaCell Therapeutics, MAR 31, 2026, View Source [SID1234664109])