On May 7, 2025 Experts from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center named a Top 5 "Best Hospital" in the nation for cancer care by U.S. News & World Report, reported that it will be among the specialists sharing the biggest oncology research data of the year at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3 in Chicago and online (Press release, City of Hope, MAY 7, 2025, View Source [SID1234652675]).

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This year’s ASCO (Free ASCO Whitepaper) meeting — themed "Driving Knowledge to Action. Building a Better Future" — unites nearly 45,000 oncology professionals to discuss leading-edge scientific data and attend educational sessions, empowering health care teams to deliver more effective, lifesaving cancer care to patients.

"Every year City of Hope researchers share potentially practice-changing oncology data at the ASCO (Free ASCO Whitepaper) meeting to build a better future for cancer patients and their families. We are excited to continue that tradition this year — to collaborate with and inform the best oncology experts in the world for the benefit of cancer patients everywhere," said Marcel van den Brink, M.D., Ph.D., president of City of Hope Los Angeles and National Medical Center, and chief physician executive.

Highlights of City of Hope’s ASCO (Free ASCO Whitepaper) data and educational sessions include those listed below, which focus on cancers of the breast, pancreas, colon and rectum, prostate, kidney and blood as well as supportive care, including palliative care and integrative oncology. City of Hope experts also will lead discussions on precision medicine and cancer survivorship.

ORAL ABSTRACT AND CLINICAL SCIENCE SYMPOSIUM SESSIONS

4510: Genomic characterization of baseline and post-progression tumors in IMmotion010, a randomized, Phase 3 study of adjuvant (adj) atezolizumab (atezo) vs placebo (pbo) in patients (pts) with high-risk localized renal cell carcinoma (RCC)
Session time: Saturday, May 31, from 4:54 to 5:06 p.m. CT
Session title: Biomarkers in Kidney Cancer: Are We There Yet?
Presenter: Sumanta Kumar Pal, M.D., F.A.S.C.O., City of Hope professor, Department of Medical Oncology & Therapeutics Research

Symptom Science and Palliative Care
Session time: Sunday, June 1, from 9:45 a.m. to 12:45 p.m. CT
Chair and panelist: Tanyanika Phillips, M.D., M.P.H., City of Hope assistant clinical professor, Department of Medical Oncology & Therapeutics Research

Diving Deeper to Inform Hereditary Cancer Risk and Outcomes
Session time: Monday, June 2, from 8 to 9:30 a.m. CT
Chair and panelist: Heather Hampel, M.S., C.G.C., City of Hope professor, Department of Medical Oncology & Therapeutics Research
RAPID ORAL ABSTRACT SESSIONS

1015: Treatment rechallenge after trastuzumab-deruxtecan–related interstitial lung disease: A multi-institution cohort study
Session time: Friday, May 30, from 2:57 to 3:03 p.m. CT
Session title: Breast Cancer – Metastatic
Presenter: Hope S. Rugo, M.D., F.A.S.C.O., City of Hope Women’s Cancers Program director; professor, Department of Medical Oncology & Therapeutics Research
Chair and Moderator: Jose Bazan, M.D., M.S., City of Hope associate professor, Department of Radiation Oncology

6510: MRD negativity after end of induction in the Phase 3 PhALLCON trial: A post hoc analysis
Session time: Friday, May 30, from 1:06 to 1:12 p.m. CT
Session title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Ibrahim T. Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation
DISCUSSANT FOR ORAL ABSTRACT SESSION

7504, 7505, 7506: New Roads in Myeloma
Session time: Tuesday, June 3, from 11:33 to 11:45 a.m. CT
Session title: Hematologic Malignancies — Plasma Cell Dyscrasia
Discussant: Amrita Krishnan, M.D., City of Hope professor, Department of Hematology & Hematopoietic Cell Transplantation
EDUCATION SESSIONS

An Oncologist’s Approach to Managing Endocrine Toxicities
Session time: Sunday, June 1, from 11:30 to 11:42 a.m. CT
Session title: New Drugs, New Toxicities: Side Effects of New and Emerging Breast Cancer Therapies
Chair and Presenter: Hope S. Rugo, M.D., F.A.S.C.O., City of Hope Women’s Cancers Program director; professor, Department of Medical Oncology & Therapeutics Research

Role of Personalized Interventions Among High-Risk Cancer Survivors to Reduce Morbidity
Session time: Friday, May 30, from 2:57 to 3:09 p.m. CT
Session title: Redefining Success and Survivorship in Pediatric Oncology
Chair and Presenter: Saro H. Armenian, D.O., M.P.H., City of Hope Children’s Cancer Center chair and professor

Integrative Oncology: Defining the Evidence
Session time: Sunday, June 1, from 4:30 to 4:42 p.m. CT
Session title: Real-world Implementation of ASCO (Free ASCO Whitepaper) SIO Guidelines: Pain, Fatigue, Depression
Presenter: Krisstina Gowin, D.O., City of Hope associate professor, Medical Oncology and Therapeutics Research, Department of Supportive Care Medicine
POSTER SESSIONS

1070 / Poster Board 49: Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a Phase (Ph) 1b/2, open-label, umbrella study
Session time: Monday, June 2, from 9 a.m. to noon CT
Session title: Breast Cancer — Metastatic
Presenter: Hope S. Rugo, M.D., F.A.S.C.O., City of Hope Women’s Cancers Program director; professor, Department of Medical Oncology & Therapeutics Research

LBA 4175 / Poster Board 465: NAPOLI 3, a Phase 3 study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final overall survival (OS) analysis and characteristics of the long-term survivors
Session time: Saturday, May 31, from 9 a.m. to noon CT
Session title: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary
Presenter: Vincent Chung, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

3553 / Poster Board 222: Vilastobart (XTX101), a tumor-activated, Fc-enhanced anti–CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with MSS CRC
Session time: Saturday, May 31, from 9 a.m. to noon CT
Session title: Gastrointestinal Cancer — Colorectal and Anal
Presenter: Marwan Fakih, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

5041 / Poster Board 240: Cardiovascular (CV) event risk in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide (ENZA) or abiraterone acetate (AA) in the United States (US)
Session time: Monday, June 2, from 9 a.m. to noon CT
Session title: Genitourinary Cancer — Prostate, Testicular, and Penile
Presenter: Alan H. Bryce, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

4540 / Poster Board 340: Efficacy of second line (2L) treatment with tivozanib (Tivo) as monotherapy or with nivolumab (Nivo) in patients (pts) with metastatic renal cell carcinoma (mRCC) previously treated with an immune checkpoint inhibitor (ICI) combination of ipilimumab (Ipi)/Nivo or vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI)/ICI in the Phase 3 TiNivo-2 study
Session time: Monday, June 2, from 9 a.m. to noon CT
Session title: Genitourinary Cancer — Kidney and Bladder
Presenter: Alexander Chehrazi-Raffle, M.D., City of Hope assistant professor, Department of Medical Oncology & Therapeutics Research

4550 / Poster Board 350: Long-term clinical outcomes with nivolumab/ipilimumab with or without Clostridium butyricum MIYAIRI588 in metastatic renal cell carcinoma (mRCC): A randomized Phase Ib clinical trial
Session time: Monday, June 2, from 9 a.m. to noon CT
Session title: Genitourinary Cancer — Kidney and Bladder
Presenter: Miguel Zugman, M.D., City of Hope postdoctoral medical oncology research fellow
RECOGNITION

Both Lorna Rodriguez-Rodriguez, M.D., Ph.D., City of Hope professor, Division of Gynecologic Oncology, Department of Surgery, and Stacy W. Gray, M.D., A.M., City of Hope professor, Medical Oncology & Therapeutics Research, Population Sciences, were inducted as fellows of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (FASCO), a distinction that honors people who have encouraged others to conquer cancer through research, education and promotion of the highest-quality patient care.

On May 7, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Nuvation Bio, MAY 7, 2025, View Source [SID1234652674]).

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"Nuvation Bio continued to execute with focus in the first quarter as we prepare for the potential U.S. approval and launch of taletrectinib for advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Data recently published in the Journal of Clinical Oncology and presented at the European Lung Cancer Congress and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting further reinforce taletrectinib’s potential to deliver a differentiated profile with strong efficacy, high central nervous system activity, and favorable tolerability. We also continue to advance our broader pipeline, including safusidenib and NUV-1511, for which we plan to provide program updates later this year. With a team that has successfully brought numerous oncology therapies to market and a strong balance sheet, we are well-positioned to enter our next chapter as a commercial-stage company."

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

The Priority Review of the Company’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) is progressing on time with all planned inspections now completed. The PDUFA goal date of June 23, 2025, positions Nuvation Bio to commercialize taletrectinib in the U.S., if approved, in mid-2025.
In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for adult patients with locally advanced or metastatic ROS1+ NSCLC. As part of an exclusive license agreement, Innovent Biologics is commercializing taletrectinib in Greater China.
In February 2025, Nuvation Bio launched an Expanded Access Program in the U.S., enabling eligible patients with advanced ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal TRUST-II study.
In March 2025, Nippon Kayaku completed submission of a Marketing Authorization Application for taletrectinib for advanced ROS1+ NSCLC to Japan’s Pharmaceuticals and Medical Devices Agency. As part of an exclusive license agreement, Nippon Kayaku will commercialize taletrectinib in Japan.
In March 2025, new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus crizotinib in advanced ROS1+ NSCLC were presented at the European Lung Cancer Congress.
In April 2025, results from the pivotal Phase 2 TRUST-I and TRUST-II studies were published in Journal of Clinical Oncology.
In April 2025, new nonclinical data for taletrectinib in ROS1+ NSCLC were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

The Company expects to provide an update on the pivotal study design for the safusidenib program in the second half of 2025.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 in the second half of 2025.
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

As previously announced, the Company is evaluating next steps for the NUV-868 program, including external partnership opportunities or further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.
Corporate Updates:

In March 2025, Nuvation Bio secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners. The Company will receive $150 million in royalty interest financing and $50 million in debt upon U.S. FDA approval of taletrectinib by September 30, 2025, with access to an additional $50 million in debt at the Company’s option until June 30, 2026, as long as the Company has achieved first U.S. commercial sale. The royalty interest financing is expected to fully fund the U.S. commercial launch of taletrectinib; the pro forma cash balance is expected to fully fund development of the Company’s clinical-stage pipeline and create a path to potential profitability without a need for additional fundraising.
In March 2025, Nuvation Bio appointed Stephen Dang, Ph.D., as Senior Vice President, General Counsel. Dr. Dang brings over 17 years of experience in the biopharmaceutical industry across all stages of the drug product life cycle.
First Quarter 2025 Financial Results

As of March 31, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $461.7 million.

For the three months ended March 31, 2025, research and development expenses were $24.6 million, compared to $12.8 million for the three months ended March 31, 2024. The increase was primarily due to a $6.2 million increase in personnel-related costs driven by the acquisition of AnHeart as well as stock-based compensation and other benefits and $0.2 million increase in amortization of assembled workforce and $5.4 million increase in third-party costs related to clinical trial expense for taletrectinib.

For the three months ended March 31, 2025, selling, general, and administrative expenses were $35.4 million, compared to $7.4 million for the three months ended March 31, 2024. The increase was due to a $10.7 million increase in personnel-related costs as a result of the acquisition of AnHeart, $12.2 million increase in sales and marketing expenses, $1.4 million increase in professional fees, $0.5 million increase in occupancy expenses, $1.1 million increase in legal fees, $0.2 million increase in foreign currency impact and $2.0 million increase in other expenses as a result of the integration of AnHeart offset by $0.1 million decrease in taxes.

For the three months ended March 31, 2025, Nuvation Bio reported a net loss of $53.2 million, or $(0.16) per share. This compares to a net loss of $14.8 million, or $(0.07) per share, for the comparable period in 2024.

Conference Call and Webcast

Nuvation Bio will host a conference call on Wednesday, May 7, 2025, at 4:30 p.m. ET, during which Company executives will provide an overview of its programs, summarize the commercial strategy for taletrectinib, and review financial results for the first quarter of 2025.

Investors and the general public are invited to listen to the live webcast and can register on the Nuvation Bio website at View Source Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access code 341248.

A replay of the webcast will be available on the Company’s website shortly after the conference call concludes.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

On May 7, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the first quarter ended March 31, 2025 (Press release, Vir Biotechnology, MAY 7, 2025, View Source [SID1234652673]).

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"The first quarter of 2025 marked significant progress in our mission of powering the immune system to transform lives," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "We successfully dosed the first patient in our ECLIPSE Phase 3 registrational program for hepatitis delta, a devastating disease with no FDA-approved treatment in the U.S. In our oncology portfolio, we are continuing dose escalation in our VIR-5818 HER2-targeting and VIR-5500 PSMA-targeting T-cell engager programs and preparing to initiate a Phase 1 study of our EGFR-targeting T-cell engager, VIR-5525, this quarter. We remain confident in our ability to deliver potentially transformative medicines for patients with significant unmet needs."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

ECLIPSE 1, the first Phase 3 trial of the Company’s registrational program in CHD, enrolled its first patient in March 2025 and is progressing as planned. The clinical trial will assess the efficacy and safety of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or other regions where its access is limited.
The Company is advancing plans for the initiation of ECLIPSE 2, a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy.
The Company plans to share Phase 2 SOLSTICE subgroup analysis data in CHD in a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025. The poster was selected by EASL to be highlighted during the poster tour on May 8, 2025.
Tobevibart and elebsiran combination therapy is supported by multiple U.S. and EU regulatory designations, including U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation, U.S. FDA Fast Track designation, European Priority Medicines (PRIME) designation and European Orphan Drug designation, signifying the significant unmet need in CHD.
Solid Tumors

VIR-5818, the only dual-masked HER2-targeting T-cell engager (TCE) in clinical trials, continues to advance through dose escalation as a monotherapy, and in combination with pembrolizumab, in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer.
In early Phase 1 data reported in January 2025, VIR-5818 showed tumor shrinkage across various tumor types in 50% (10/20) of participants receiving doses ≥400 µg/kg, with confirmed partial responses in 33% (2/6) of participants with HER2-positive colorectal cancer (CRC).
VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation aiming to further optimize dosing and efficacy.
In early Phase 1 data reported in January 2025, VIR-5500 showed PSA reductions in 100% (12/12) of metastatic castration resistant prostate cancer (mCRPC) patients after an initial dose ≥120 µg/kg. PSA50 response was confirmed in 58% (7/12) of participants.
Early Phase 1 data for VIR-5818 and VIR-5500 reported in January 2025 showed promising safety profiles for both clinical candidates, with maximum tolerated dose (MTD) not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported.
Initial clinical data demonstrate the PRO-XTEN masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.
The Company plans to initiate a Phase 1 study of VIR-5525, its PRO-XTEN dual-masked EGFR-targeting TCE, in the second quarter of 2025, to evaluate its potential across a number of solid tumor indications.
Chronic Hepatitis B (CHB)

The Company will present functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, alone, or in combination with pegylated interferon alfa (PEG-IFNα) at the EASL Congress 2025 on May 9, 2025.
Future advancement in CHB by the Company will be contingent on securing a worldwide development and commercialization partner1.
1 Outside China Territory (People’s Republic of China, Hong Kong, Taiwan, and Macau)

Preclinical Pipeline Candidates

The Company continues to progress multiple undisclosed PRO-XTEN dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors. These preclinical candidates integrate the PRO-XTEN masking technology with novel TCEs discovered and engineered using Vir Biotechnology’s antibody discovery platform and the Company’s proprietary dAIsY (data AI structure and antibody) AI engine.
The Company has advanced a broadly neutralizing antibody to development candidate status in its HIV cure program in collaboration with the Gates Foundation.
Corporate Update

In January 2025, the Company announced positive initial Phase 1 dose escalation data for two of its PRO-XTEN dual-masked TCEs.
During the quarter, Vir Biotechnology and Alnylam Pharmaceuticals (Alnylam) amended and restated their collaboration agreement, with Alnylam electing not to opt-in to its profit-sharing option for elebsiran in CHB and CHD indications. The amended agreement provides the Company with the flexibility to pursue commercialization partners in markets outside the U.S.
First Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2025, the Company had approximately $1.02 billion in cash, cash equivalents and investments, representing a decrease of approximately $75.6 million during the first quarter of 2025.

Revenues: Total revenues for the first quarter of 2025 were $3.0 million compared to $56.4 million for the same period in 2024. The decrease was primarily due to $51.7 million of deferred revenue recognized during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024.

Cost of Revenue: The change in cost of revenue for the first quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the first quarter of 2025 were $118.6 million, which included $7.0 million of non-cash stock-based compensation expense, compared to $100.1 million for the same period in 2024, which included $13.6 million of non-cash stock-based compensation expense. The increase was primarily driven by a $30.0 million expense to Alnylam and initiation of the ECLIPSE Phase 3 registrational program, partially offset by lower headcount, deprioritized programs and the closing of the Company’s St. Louis, Missouri and Portland, Oregon sites.

The Company is solely responsible for the development, manufacturing and commercialization activities associated with elebsiran after the amendment and restatement of the Company’s agreement with Alnylam.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the first quarter of 2025 were $23.9 million, which included $7.1 million of non-cash stock-based compensation expense, compared to $36.3 million for the same period in 2024, which included $10.2 million of non-cash stock-based compensation expense. The decrease was largely due to ongoing cost saving realized through headcount reductions and other initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: The change in restructuring, long-lived assets impairment and related charges, net for the first quarter of 2025 compared to the same period in 2024 was nominal. Our restructuring plans implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the first quarter of 2025 was $18.6 million compared to $15.1 million for the same period in 2024. The increase was primarily driven by an unrealized gain on our equity investments, partially offset by lower interest income.

Provision for Income Taxes: The change in provision for income taxes for the first quarter of 2025 compared to the same period in 2024 was nominal.

Net Loss: Net loss for the first quarter of 2025 was $121.0 million, or $(0.88) per share, basic and diluted, compared to a net loss of $65.3 million, or $(0.48) per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund its operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the first quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

About VIR-5818, VIR-5500, VIR-5525

VIR-5818, VIR-5500 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B.

On May 7, 2025 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys") and Sona Nanotech Inc. (CSE: SONA) (OTC: SNANF) ("Sona") reported that they have entered into a Research Agreement ("Agreement") to collaborate on the development of new cancer therapeutics based on BioVaxys’ DPX Immune Educating Platform ("DPX") in combination with Sona’s Targeted Hyperthermia Therapy ("THT"), a photothermal cancer therapy that uses highly targeted infrared light to treat solid tumors (Press release, BioVaxys Technology, MAY 7, 2025, View Source [SID1234652672]). The heat for THT is delivered to tumors using infrared light that is absorbed by Sona’s proprietary biocompatible Gold Nanorod ("GNR") technology which elicits a strong immune response.

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Carman Giacomantonio, MD, Chief Medical Officer ("CMO") for Sona Nanotech Inc., commented, "Looking beyond our approaching first-in-human Early Feasibility Study clinical trial for our THT cancer therapy, Sona continues to conduct research to build our pipeline of programs to fully exploit the potential of our GNR technology platform. To that end, we’re pleased to enter this research collaboration with BioVaxys whose DPX technology provides a unique delivery system that better presents antigens to the immune system. We believe that DPX, with its immune stimulating properties and antigen presentation capabilities, could be an ideal carrier for the neo-antigens that Sona’s THT enables, thereby accelerating THT’s efficacy and so we look forward to working with the BioVaxys team to quickly assess the potential for technology synergies."

"We are very pleased to have the opportunity to evaluate synergies between our DPX platform and Sona’s THT and GNR technologies, as our collaboration is ideal for advancing the highly promising applications of our respective technologies," says Kenneth Kovan, President and Chief Operating Officer at BioVaxys. "With Sona’s exciting study data and the clinical trial data we have with DPX it’s conceivable that our collaboration could lead to a new and even better treatment for immunotherapy-resistant solid tumors."

The collaboration between BioVaxys and Sona will evaluate the immune stimulatory properties of DPX (without an antigen cargo) administered together with THT, as a characteristic of DPX is that it helps prime the innate immune system which in turn can activate and strengthen the adaptive immune response. The collaboration will also evaluate the combination use of THT together with a DPX formulation as a carrier for novel neoantigens expressed on the surface of tumor cells following immunotherapy, such as with THT. Neoantigens are unique proteins that are not present in healthy tissues that arise from changes in cancer cells and play a crucial role in stimulating anti-tumor immune response. Immunotherapy such as THT can trigger these tumor cell changes and the expression of neoantigens, so packaging a tumor neoantigen in DPX for presentation to the immune system is anticipated to accelerate THT’s efficacy.

The research studies based on the BioVaxys and Sona technologies will be conducted at Dalhousie University, Halifax, Nova Scotia, under the direction of Sona’s CMO, Carman Giacomantonio, MD MSc FRCSC, Division of General and Gastrointestinal Surgery, Department of Pathology, Dalhousie University, and Barry Kennedy, PhD, of the Giacomantonio Immuno-Oncology Research Group at Dalhousie University (the "Principal Investigators").

Each company will contribute their respective technologies for the study with the research costs covered by the Giacomantonio Immuno-Oncology Research Group. Any novel candidate therapeutic developed in this program will be co-owned and co-prosecuted by BioVaxys and Sona, with the parties planning to enter into a commercialization agreement for a vaccine clinical candidate prior to the initiation of any Phase 1 study.

Sona’s current focus for advanced biomedical applications using its biocompatible GNR platform technology with its THT therapy aims to shrink cancerous tumors for certain solid cancers and in so doing trigger a systematic immune response to eliminate both treated and distant, untreated metastases. Sona’s GNRs are uniquely manufactured without the use of CTAB (cetyltrimethylammonium bromide), eliminating the toxicity risks associated with the use of other GNR technologies in medical applications.

In a preclinical study presented at the 19th International Canadian Melanoma Conference in Vancouver this past February, Sona’s research team confirmed that its GNR-based THT causes cancer-specific cell death that activates a strong immune response by the body’s immune system. Of critical importance is evidence that the immunity generated by Sona’s THT is observed in cancers that are known to be resistant to modern immunotherapies. Using an industry standard, immunotherapy resistant, CT-26 colon cancer model, Sona’s THT -activated systemic immunity that, when followed by previously ineffective PD-1 inhibition, demonstrated a 100% response rate in these previously resistant tumors. These findings were published in Frontiers in Immunology and repeated in industry standard preclinical breast cancer and melanoma models.

BioVaxys’ DPX technology is a patented delivery platform that can incorporate a range of bioactive molecules, such as mRNA/polynucleotides, peptides/proteins, virus-like particles, and small molecules, to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform, which is non-aqueous and non-systemic, facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. The DPX platform has been proven in multiple Phase 1 and Phase 2 clinical studies across a range of different antigens in oncology and infectious disease applications, and has demonstrated excellent safety and tolerability.

A study conducted by Hakimeh Ebrahimi-Nik, DVM, PhD, of The Ohio State University Comprehensive Cancer Center and Pelotonia Institute for Immuno-Oncology, and presented December by BioVaxys at the Personalized Cancer Vaccine Summit in Boston, compared the immune-stimulating properties of the most commonly used vaccine adjuvants that are frequently given together with cancer immunotherapies to boost their efficacy, against DPX antigen formulations as well as DPX administered just on its own. The DPX formulations were shown to be more effective than any of the popular adjuvants, as effective as the gold standard—bone marrow-derived dendritic cells—and DPX on its own appeared to have meaningful immune stimulating properties.

On May 7, 2025 Hanx Biopharmaceuticals Ltd. (HanxBio), a clinical-stage biotechnology company pioneering next-generation immunotherapies, reported its expanding oncology and autoimmune disease pipeline with five research poster presentations at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago (April 25–30) (Press release, HanX Biopharmaceuticals, MAY 7, 2025, View Source [SID1234652671]). The presentations spotlighted novel bispecific antibodies and a CSF-1R inhibitor, underscoring the company’s leadership in innovative cancer treatment strategies.

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Key Highlights from HanxBio’s AACR (Free AACR Whitepaper) Presentations

1. HX044: A first-in-class (FIC) CTLA-4xSIRPα is a bispecific antibody fusion protein designed to enhance safety and amplify anti-tumor immunity. HX044 targets PD-1-resistant solid tumors (e.g., non-small cell lung cancer, melanoma, renal cell carcinoma). Currently in Phase I trials, it represents a breakthrough in overcoming resistance to existing immunotherapies.

2. HX035: A preclinical OX40-targeting bispecific antibody engineered to address inflammatory and autoimmune diseases. By binding two distinct OX40 epitopes, HX035 aims to achieve best-in-class (BIC) precision in modulating immune responses.

3. HX016-7 & HX016-9: Two preclinical bispecific antibodies targeting PD-L1xVEGF and PD-1xVEGF, respectively. These dual-target therapies aim to disrupt both tumor immune evasion and blood vessel growth (angiogenesis), offering a novel approach to treating solid tumors.

4. HX301 (Narazaciclib): A CSF-1R inhibitor co-developed with Traws Pharma, Inc., now in Phase II trials for glioblastoma. HX301 is being evaluated in combination with temozolomide (TMZ), a standard chemotherapy, to enhance anti-tumor efficacy.

Dr. Henry Li, CEO and CSO of HanxBio, attended and presented posters at the AACR (Free AACR Whitepaper) Annual Conference and he emphasized the company’s progress: "Our AACR (Free AACR Whitepaper) presentations reflect HanxBio’s commitment to redefining cancer and autoimmune disease treatment through cutting-edge bispecific antibody platforms. With HX044 advancing in clinical trials and a robust preclinical pipeline, we are poised to deliver transformative therapies that address critical unmet needs for patients globally." He added, "By targeting multiple pathways simultaneously or by exploring coordinated binding (cis-bindings)—we aim to overcome enhanced activity and safety, thus improving outcomes for hard-to-treat cancers."