On March 23, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of non-cereblon/non-VHL Targeted Glue degraders, reported three upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual meeting being held in San Diego on 17-22 April, including an invited presentation on the discovery of AMX-883, Amphista’s BRD9 clinical candidate, at the New Drugs on the Horizon: Part 3 session.

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Oral presentation details:

Title: Discovery of AMX-883: an orally bioavailable, novel degrader of BRD9 as a karyotype-independent pro-differentiation agent for the potential treatment of AML

Session: New Drugs on the Horizon: Part 3

Date: Monday 20 April | 10:15-11:45 AM PST

Presenter: Martin Pass, Chief Development Officer, Amphista Therapeutics

Poster presentations details:

Title: Rational development of novel DCAF16-mediated SMARCA2 selective Targeted Glues for the treatment of SMARCA4 deficient tumors

Session: Proximity-Induced Drug Discovery 1

Date: Tuesday 21 April | 9:00 AM – 12:00 PM PST

Presenter: James Lynch, Senior Director Bioscience, Amphista Therapeutics

Abstract:

SMARCA2 and SMARCA4 are mutually exclusive catalytic subunits of the SWI/SNF chromatin remodelling complex. In non-small cell lung cancer (NSCLC), SMARCA4 mutations are observed in >5% patients and are associated with poor prognosis and advanced disease. Selective degradation of SMARCA2 exploits paralogue dependency in SMARCA4-deficient tumors to impact disease burden with minimal toxicity in normal tissues.
Here, we report the rational design and optimisation of a novel class of SMARCA2 degraders that exploit a Targeted Glue mechanism to induce DCAF16-dependent proteasomal degradation. Amphista’s degraders potently drive >95% SMARCA2 degradation within 4 hours, resulting in deep suppression of biomarkers KRT80 and PLAU in vitro. Further, we observe exceptional degradation specificity for SMARCA2, as revealed by global proteomics and, critical for a best-in-class molecule, achieve near complete selectivity over SMARCA4 in a SMARCA4 WT model.

Comprehensive mode of action studies, including E3-ligase knock-out and cysteine mutant rescue experiments demonstrate that our SMARCA2 Targeted Glues induce degradation via selective recruitment of DCAF16 and covalent interaction with a single DCAF16 cysteine residue. Structural studies, including generation of multiple high resolution (sub-3Å) cryo-EM ternary complex structures have enabled informed structure-activity relationship optimisations of degradation potency, kinetics and selectivity. Consequently, optimised compounds can deliver fast, deep degradation of SMARCA2 as demonstrated in-vivo in a disease-relevant SMARCA4 mutant model.

We have achieved compound profiles that uniquely position Amphista to deliver class-leading SMARCA2 degraders for the treatment of SMARCA4-mutant NSCLC.

Title: Rational development of novel FBXO22-mediated TEAD Targeted Glues for Mesothelioma and NSCLC Treatment

Session: Targeted Protein Degradation and Induced Proximity

Date: Tuesday 21 April | 9:00 AM – 12:00 PM PST

Presenter: Marta Carrara, Associate Director Bioscience, Amphista Therapeutics

Abstract:

TEAD transcription factors are emerging oncology targets due to their function as key effectors of the Hippo signalling pathway, which is frequently dysregulated in cancer. Here, we report the discovery and development of potent, deep, and rapid-acting TEAD Targeted Glue degraders that leverage an aldehyde-mediated degron mechanism. Our compounds demonstrate exceptional on-pathway selectivity profiles and exhibit the expected Hippo signalling modulation.

Mechanistically, we demonstrate that amine-based TEAD degrader amine scaffolds undergo extracellular conversion to reactive aldehyde species, which mediate covalent engagement of FBXO22 C326, triggering TEAD proteasomal degradation. The degraders identified were able to be rationally and systematically optimised for both degradation potency and kinetics, achieving enhanced degradation profiles compared to previously reported FBXO22-targeting approaches, establishing design principles for this degrader class.

Our findings highlight aldehyde-mediated degrons as a viable strategy for targeted protein degradation, enabling rational design of degraders that hijack endogenous protein quality control machinery for precision medicine applications.

(Press release, Amphista Therapeutics, MAR 23, 2026, View Source [SID1234663819])

On March 23, 2026 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC).

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The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival (OS), progression free survival (PFS) and Duration of Response (DoR) compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes. .

Consistent with scientific advice previously received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the FDA advised that a potential biologics licensing application (BLA) for VCN-01 in metastatic PDAC could be supported by Theriva’s proposed Phase 3 clinical trial (if successful) comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated "macrocycles" (enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial), the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints (including progression free survival), and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.

"We are very pleased to align with the FDA on the key elements of our proposed pivotal Phase 3 trial evaluating VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Data from our VIRAGE Phase 2b study demonstrated improved outcomes in PDAC patients treated with 2 doses of VCN-01 and we believe that administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel that may further improve patient outcomes. The combined feedback from the FDA and the EMA now enables us to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding and/or partnerships, which, if successful, may deliver a novel and effective treatment option for patients with this difficult to treat solid tumor cancer."

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

(Press release, , MAR 23, 2026, View Source [SID1234663838])

On March 23, 2026 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported fourth quarter and year end 2025 financial results and provided a corporate update.

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"We delivered another strong quarter, maintaining a disciplined approach to capital allocation and a continued focus on maximizing our cash runway," said Lindsay Androski, President and CEO of Arbutus. "I am thrilled to announce that two additional patients from our Phase 2a trials of imdusiran have achieved functional cure in chronic hepatitis B ("cHBV"), and am pleased with our team’s continuing progress on our cHBV programs."

LNP Litigation

On March 3, 2026, Arbutus, along with its exclusive licensee, Genevant Sciences ("Genevant"), entered into a settlement agreement to resolve all global patent infringement litigation and patent revocation proceedings involving Moderna. As part of the settlement, Moderna will pay Arbutus and Genevant $950 million upfront in July 2026 ("Noncontingent Settlement Payment") and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. §1498 ("Section 1498") does not bar Arbutus’ and Genevant’s claims against Moderna for patent infringement, except as to doses characterized by the district court as having gone to U.S. government employees. In asserting that defense, Moderna argued that Section 1498 applies such that U.S. taxpayers should assume liability for its infringement of Arbutus’ and Genevant’s patents for sales made under one of its government contracts. Moderna has also consented to entry of a judgment of infringement and of no invalidity of four Arbutus/Genevant patents. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Annual Report on Form 10-K filed with the SEC on March 20, 2026. Under the Company’s license with Genevant, the Company is entitled to receive, after deduction of litigation costs, 20% of the Noncontingent Settlement Payment. In addition, the Company owns approximately 16% of the outstanding common equity of Genevant.
Arbutus continues to consult closely with and support Genevant to protect and defend Arbutus’ intellectual property, which is the subject of an on-going lawsuit against Pfizer/BioNTech. The Company, together with Genevant, is seeking fair compensation for use of Arbutus’ patented lipid nanoparticle ("LNP") technology that was developed with great effort and at a great expense, and without which Pfizer/BioNTech’s COVID-19 vaccines would not have been successful. The claim construction hearing for the lawsuit against Pfizer/BioNTech occurred in December 2024, and the court issued a claim construction ruling in September 2025, which construed the disputed claim terms in a manner the Company generally considers to be favorable. The parties are awaiting further scheduling in the litigation.
Corporate Updates

Two additional patients from the Company’s Phase 2a clinical trials of imdusiran achieved functional cure, making a total of 10 patients to date that have achieved functional cure during Phase 2a clinical trials and long-term follow-up. Two of these functionally cured patients seroreverted during long-term follow-up, but remain virally suppressed and off nucleos(t)ide analogue ("NA") therapy.
In December 2025, the Company recognized revenue of $0.5 million following the achievement of a contractual milestone related to Alnylam’s use of the Company’s proprietary LNP technology in an additional product candidate to treat hepatocellular carcinoma (HCC), underscoring the important role the Company’s LNP technology plays in the delivery of nucleic acids to the body. Payment was received in January 2026.
In connection with payments the Company expects to receive under the Moderna settlement, the Company is currently evaluating a return of capital to its shareholders in the third quarter of calendar year 2026, following the receipt of its portion of the noncontingent lump sum payment from Moderna.
Financial Results

Cash, Cash Equivalents and Investments

As of December 31, 2025, the Company had cash, cash equivalents and investments in marketable securities of $91.5 million compared to $122.6 million as of December 31, 2024. During the year ended December 31, 2025, the Company used $39.6 million in operating activities, which included one-time payments related to its restructuring efforts. This was partially offset by $5.5 million of proceeds from the exercise of stock options.

Revenue

Total revenue was $14.1 million for the year ended December 31, 2025, compared to $6.2 million for the same period in 2024. The increase of $7.9 million was due to the recognition of all previously-deferred revenue as a result of the conclusion of the Company’s strategic partnership with Qilu Pharmaceutical, partially offset by a decrease in license royalty revenues due to a decline in Alnylam’s sales of ONPATTRO.

Operating Expenses

Research and development expenses were $25.2 million for the year ended December 31, 2025, compared to $54.0 million for the same period in 2024. The decrease of $28.8 million was due primarily to cost savings from the Company’s decisions to streamline the organization to focus its efforts on advancing the clinical development of imdusiran and AB-101, which included ceasing all discovery efforts, discontinuing its IM-PROVE III clinical trial, and right-sizing the Company’s workforce.

General and administrative expenses were $15.9 million for the year ended December 31, 2025, compared to $22.1 million for the same period in 2024. This decrease was due primarily to cost-cutting efforts by the Company, which drove reductions in employee compensation-related expenses and legal fees.

Restructuring costs for the year ended December 31, 2025 were $12.9 million, and all remaining restructuring-related payments are expected to be made by the first quarter of 2026.

Net Loss

For the year ended December 31, 2025, the Company’s net loss was $33.5 million, or a loss of $0.17 per basic and diluted common share, as compared to a net loss of $69.9 million, or a loss of $0.38 per basic and diluted common share, for the quarter ended December 31, 2024.

Outstanding Shares

As of December 31, 2025, the Company had 192.5 million common shares issued and outstanding, as well as 14.0 million stock options and unvested restricted stock units outstanding.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND LOSS
(in thousands, except share and per share data)

Year ended December 31,
2025 2024
Revenue
Collaborations and licenses $ 12,601 $ 3,919
Non-cash royalty revenue 1,482 2,252
Total revenue 14,083 6,171
Operating expenses
Research and development 25,241 54,037
General and administrative 15,893 22,108
Change in fair value of contingent consideration (1,830 ) 2,625
Restructuring costs 12,939 3,720
Total operating expenses 52,243 82,490
Loss from operations (38,160 ) (76,319 )
Other income
Interest income 4,068 6,585
Gain on sale of property and equipment 674 —
Interest expense (97 ) (137 )
Foreign exchange gain / (loss) 14 (49 )
Total other income 4,659 6,399
Net loss $ (33,501 ) $ (69,920 )
Net loss per common share
Basic and diluted $ (0.17 ) $ (0.38 )
Weighted average number of common shares
Basic and diluted 191,599,600 185,608,874

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

December 31, 2025 December 31, 2024
Cash, cash equivalents and marketable securities, current $ 91,471 $ 122,623
Accounts receivable and other current assets 2,985 4,693
Total current assets 94,456 127,316
Property and equipment, net of accumulated depreciation and impairment 32 3,309
Right of use asset — 1,048
Other non-current assets 130 34
Total assets $ 94,618 $ 131,707

Accounts payable and accrued liabilities $ 5,459 $ 7,564
Deferred license revenue, current — 7,571
Lease liability, current 547 483
Total current liabilities 6,006 15,618
Liability related to sale of future royalties 3,442 4,829
Deferred license revenue, non-current — 2,863
Contingent consideration 8,395 10,225
Lease liability, non-current 199 806
Total stockholders’ equity 76,576 97,366
Total liabilities and stockholders’ equity $ 94,618 $ 131,707

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Year ended December 31,
2025 2024
Net loss $ (33,501 ) $ (69,920 )
Non-cash items 3,887 7,899
Change in deferred license revenue (10,434 ) (1,357 )
Other changes in working capital 411 (1,472 )
Net cash used in operating activities (39,637 ) (64,850 )
Net cash provided by investing activities 15,580 22,948
Issuance of common shares pursuant to the Open Market Sale Agreement — 44,123
Cash provided by other financing activities 5,721 7,873
Net cash provided by financing activities 5,721 51,996
Effect of foreign exchange rate changes on cash and cash equivalents 14 (49 )
(Decrease) / increase in cash and cash equivalents (18,322 ) 10,045
Cash and cash equivalents, beginning of period 36,330 26,285
Cash and cash equivalents, end of period 18,008 36,330
Investments in marketable securities 73,463 86,293
Cash, cash equivalents and investments, end of period $ 91,471 $ 122,623

About Imdusiran (AB-729)  

Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens, including hepatitis B surface antigen ("HBsAg"), which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine ("GalNAc") delivery technology enabling subcutaneous delivery. In Arbutus’ Phase 2a clinical trials, eight patients with cHBV achieved functional cure following treatment with imdusiran and NA therapy in combination with either pegylated interferon alfa-2a or low dose nivolumab plus an immunotherapeutic, with six out of the eight patients continuing to sustain functional cure for over two years. An additional 41 patients across the Company’s Phase 2a clinical trials were able to remain off NA therapy for at least 48 weeks during their Phase 2a clinical trials following treatment with imdusiran. Two additional patients who discontinued NA therapy in their Phase 2a clinical trials have now achieved functional cure during their participation in long-term follow-up. Functional cure is defined as sustained HBsAg seroclearance and hepatitis B virus deoxyribonucleic acid ("HBV DNA") less than the lower limit of quantification after 24 weeks off treatment, with or without anti-hepatitis B surface antibodies. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and HBV DNA.

About HBV  

Hepatitis B is a potentially life-threatening liver infection caused by hepatitis B virus ("HBV"). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options.

(Press release, Arbutus Biopharma, MAR 23, 2026, View Source [SID1234663820])

On March 23, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) announced today it has entered into a definitive agreement to acquire Ouro Medicines, a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

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The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio. OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027.

"This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases," said Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead. "BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care."

BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ‑level disease, and, in some cases, enable an immune reset marked by durable, drug‑free remission without ongoing immunosuppression. T cell engagers represent an important modality for patients alongside Gilead’s portfolio of CAR-T assets.

"From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases," said Jaideep Dudani, PhD, CoFounder and Chief Executive Officer of Ouro Medicines. "Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging a proven track record in late stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences."

Terms of the Transaction

Under the terms of the agreement Gilead will acquire all of the outstanding equity of Ouro Medicines for a total of $1,675 million in upfront cash consideration, subject to customary adjustments, which is payable at closing, and up to $500 million in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.

Strategic Collaboration with Galapagos

Gilead is currently in advanced discussions with Galapagos with respect to a potential research and development collaboration on the acquired Ouro Medicines assets. The arrangement between Gilead and Galapagos is contemplated to include the following key terms:

Galapagos would pay 50% of the upfront consideration and 50% of any contingent milestone payments payable to Ouro Medicines’ shareholders.
Galapagos would absorb substantially all of Ouro Medicines’ operating assets and retain its employees.
Gilead and Galapagos would collaborate on the development of OM336, with Galapagos responsible for development costs through initiation of registrational studies. Registrational study costs would be shared equally between the parties.
Gilead would retain sole worldwide commercialization rights (other than in Greater China where Keymed Biosciences has existing commercialization rights) and Gilead would pay Galapagos royalties of 20%-23% of net sales.
Amended legacy Galapagos Option License and Collaboration Agreement ("OLCA") to allow for up to $500 million of Galapagos’ current cash to be used freely by Galapagos, including up to $150 million for potential share repurchases.
Centerview Partners LLC and TD Cowen are acting as financial advisors to Gilead. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Ouro Medicines. Morgan Stanley & Co., LLC is acting as financial advisor to Galapagos. Covington & Burling LLP, Mayer Brown LLP, and Arnold & Porter Kaye Scholer LLP are serving as legal counsel to Gilead. Goodwin Procter LLP is serving as legal counsel to Ouro Medicines. Paul Weiss LLP and Linklaters LLP are serving as legal counsel to Galapagos.

About OM336

OM336 is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. OM336 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for certain autoimmune diseases. OM336 is under an open IND in the U.S. and is expected to enter registrational studies in 2027. OM336 is in-licensed by Ouro Medicines from Keymed Biosciences, which owns the rights to develop the program in Greater China.

On March 23, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its audited financial results for the year ended December 31, 2025, and provided a corporate update.

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"Since our last quarterly update, we have been working diligently to move forward with a Phase 1/2a first-in-human clinical trial of GLIX1 in glioblastoma, and I am pleased to report that we expect to initiate the study by the end of this month, with the commencement of patient enrollment shortly thereafter," stated Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1, the lead asset that we acquired through our collaboration with Hemispherian, is a unique molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models, excellent blood-brain-barrier penetration and a favorable safety profile in toxicology studies. We are eager to establish the safety, recommended dose and proof-of-concept in order to advance this promising candidate through an efficient development pathway.

"In parallel, we continue to conduct pre-clinical activities in support of further development of GLIX1 in additional cancer indications with high unmet needs, and, separately, we are also conducting studies to further investigate and affirm the potential synergistic effect of GLIX1 in combination with PARP inhibitors, as we work to maximize the value of the GLIX1 opportunity.

"In metastatic pancreatic cancer, enrollment has accelerated in the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide, which is being led by Columbia University and supported by both Regeneron and BioLineRx, and we continue to anticipate that a prespecified interim/futility analysis will read out in 2026. We believe PDAC represents another opportunity to introduce a much-needed new treatment option to patients suffering from a very challenging tumor type, while creating sustained value for our company," Mr. Serlin concluded.

Corporate Updates

Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers.
Patent preserves BioLineRx’s ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types.
Patent further broadens and strengthens GLIX1’s patent protection until 2040, with a possible patent-term extension of up to five years.
Financial Updates

With $20.9 million on its balance sheet as of December 31, 2025, BioLineRx is maintaining its cash runway guidance into the first half of 2027.
Clinical Updates
GLIX1

On track to initiate a Phase 1/2a clinical trial of GLIX1 in glioblastoma by the end of the month.
Three renowned academic centers are planned to participate in this clinical trial: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, NYU Langone Health, led by Dr. Alexandra M. Miller and Moffit Cancer Center, led by Dr. Patrick Grogan.
The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027.
The Phase 2a expansion part of the trial is planned to include various population cohorts, including GBM (newly diagnosed and/or recurrent), as well as additional cancers with/without standard of care (e.g., PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for rapid and effective advanced clinical development.
Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications are ongoing.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)

Enrollment has accelerated in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026.
Sickle Cell Disease (SCD) & Gene Therapy

Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December.

A second SCD study, sponsored by St. Jude Children’s Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs for gene therapies for patients with SCD (NCT06442761).
APHEXDA Performance Update

For the full-year 2025, APHEXDA sales were $6.7 million, which provided royalty revenue to the Company of $1.2 million.
Financial Results for the Year ended December 31, 2025

Revenues for the year ended December 31, 2025 were $1.2 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the up-front payment received by the Company under the Gloria License Agreement and a milestone payment achieved under the Gloria License Agreement, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid License Agreement and $6.0 million of net revenues from product sales of APHEXDA in the United States.

Cost of revenues for the year ended December 31, 2025 were $0.2 million, compared to cost of revenues of $9.3 million for the year ended December 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects the amortization of intangible assets, sub-license fees on the up-front payment received for the Ayrmid License Agreement, sub-license fees accrued on a milestone payment recorded under the Gloria License Agreement, as well as royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales.

Research and development expenses for the year ended December 31, 2025 were $8.1 million, a decrease of $1.1 million, or 11.5%, compared to $9.2 million for the year ended December 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, offset by expenses related to initiation of the GLIX1 project.

There were no sales and marketing expenses for the year ended December 31, 2025, compared to $23.6 million for the year ended December 31, 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license agreement.

General and administrative expenses for the year ended December 31, 2025 were $3.1 million, a decrease of $3.2 million, or 50.3%, compared to $6.3 million for the year ended December 31, 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, and a decrease in a number of general and administrative expenses.

Non-operating income (expenses) for the years ended December 31, 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, as a result of changes in its share price, offset by warrant offering expenses.

Net financial income for the year ended December 31, 2025 was $0.2 million, compared to net financial expenses of $7.3 million for the year ended December 31, 2024. Net financial income for 2025 relates to investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the appreciation of the NIS against the U.S. dollar during the period, partially offset by interest paid on loans. Net financial expenses for 2024 primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to loan agreement with BlackRock, partially offset by investment income earned on bank deposits.

Net loss for the year ended December 31, 2025 was $2.0 million, compared to $9.2 million for the year ended December 31, 2024.

As of December 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $20.9 million, sufficient to fund operations, as currently planned, into the first half of 2027.
A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected].

Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 25, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

(Press release, BioLineRx, MAR 23, 2026, View Source [SID1234663821])