On February 26, 2025 Eikon Therapeutics, Inc., a pivotal-stage biotechnology company that integrates advanced engineering with cutting-edge molecular and cell biology to accelerate drug discovery and development, reported the initial closing of a $350.7 million Series D financing. Since its founding in 2019, Eikon Therapeutics has privately raised in excess of $1.1 billion to support its mission of developing new medicines to address grievous illnesses (Press release, Eikon Therapeutics, FEB 26, 2025, View Source [SID1234650654]).

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The financing round was led by Eikon’s existing investors, with participation from new investors. The investment syndicate is composed of top mutual funds, sovereign wealth funds, and healthcare and technology-focused venture firms including Lux Capital, Alexandria Venture Investments, AME Cloud Ventures, The Column Group, E15 VC, Foresite Capital, General Catalyst, Soros Capital, StepStone Group, funds and accounts advised by T. Rowe Price Associates, Inc., and UC Investments (Office of the Chief Investment Officer of the Regents of the University of California), among others.

"Eikon has made remarkable progress in advancing a pivotal-stage clinical pipeline and early-stage development program powered by our single-molecule tracking technology and the deep expertise of our multidisciplinary team. With clinical studies now operating in 28 countries, across 5 continents, we are accelerating the development of much-needed therapies while continuing to expand our research and development capabilities," said Roger M. Perlmutter, M.D., Ph.D., CEO and Board Chair of Eikon Therapeutics. "This financing provides the resources necessary to build a fully-integrated, 21st-century biotechnology company that leverages advanced computing, data sciences, and decades of experience in bringing innovative medicines to patients. The continued support of our world-class syndicate of investors is a testament both to the progress we have already made, and to the confidence of investors in our ability to deliver important new medicines for the world."

Eikon’s clinical portfolio is anchored by its lead program, EIK1001, a systemically administered co-agonist of toll-like receptors 7 and 8 now in a Phase III trial for advanced melanoma. EIK1001 has demonstrated both single-agent efficacy and promising in-combination activity with anti-PD-(L)1 agents across multiple tumor types. In parallel, the company is advancing EIK1003, a highly selective PARP1 inhibitor currently undergoing Phase 1 evaluation in patients with breast, ovarian, prostate, or pancreatic cancers, and EIK1004, a central nervous system-penetrant PARP1-selective inhibitor poised to initiate Phase 1 studies targeting brain cancers.

Eikon’s early-stage pipeline features, among other undisclosed candidates, two androgen receptor antagonists and an internally derived WRN inhibitor (EIK1005) that is being studied for its potential as a therapy for patients with MSI-high and other DNA repair–deficient cancers.

"Eikon has engineered a next-generation drug discovery engine that seamlessly integrates automation, high-performance computing, and advanced data science to transform how new medicines are developed," said Lux Capital Co-founder and Managing Partner Josh Wolfe. "By harnessing its proprietary single molecule tracking technology, Eikon is uncovering biological processes in living cells with an unprecedented level of precision, generating insights at a pace that was previously out of reach. With a skilled leadership team that is deeply experienced in bringing groundbreaking therapies to patients, Eikon is setting a new standard for innovation in biotechnology."

Eikon Therapeutics will participate in the upcoming TD Cowen Healthcare Conference in Boston, March 3-5, 2025.

On February 26, 2025 Tyercan reported that its independently developed first-in-class drug, Tye1001, reported clinical trial approval from China’s NMPA, following its approval by the US FDA on July 12, 2024 (Press release, Shanghai Medicilon, FEB 26, 2025, View Source [SID1234651889]). This marks a significant milestone of dual approval in both China and the US.

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As Tyercan’s partner, Medicilon delivered comprehensive GLP-compliant preclinical services, including pharmacodynamics, pharmacokinetics, and safety assessment, accelerating the R&D process.

Tye1001: Redefining Targeted Tumor Therapy
Tye1001 is a novel anti-tumor protein drug for advanced solid tumors and lymphomas. It consists of a highly potent and toxic small-molecule toxin conjugated to a specific drug carrier. The drug primarily targets solid tumors through the EPR effect in tumor vasculature and specific receptors on cell surfaces. It enters tumor cells via endocytosis, degrades in lysosomes, and releases the toxin small-molecule, which targets cell microtubules to inhibit tumor growth.

Preclinical data shows that Tye1001 has broad anti-tumor activity, with significant efficacy in various mouse models of gastric cancer, lymphoma, nasopharyngeal cancer, and others. Its high safety profile offers a promising new treatment option for patients and strong scientific support for future clinical development.

The dual approval of Tye1001 in China and the US not only highlights Tyercan ‘s R&D strength but also demonstrates its innovation in the PDC field and leadership in tumor-targeted therapy.

Medicilon’s XDC R&D Platform: Accelerating Preclinical R&D and Dual Submissions
Medicilon’s close collaboration with Tyercan played a key role in Tye1001’s success. Tye1001 is a coupling drug based on the presence of corresponding endogenous protein, with high potential interference and high bioanalytical challenges, Medicilon’s analytical scientists overcame complex bioanalytical challenges through innovative tool antibody development and validation strategies.

It is also worth mentioning that Medicilon’s solid and comprehensive preclinical research capabilities, which have successfully helped 28 ADC drugs to be approved in the clinic, have laid a solid foundation for Tye1001’s dual reporting and approval in China and the US.

As one of China’s earliest CROs to offer full-service preclinical research compliant with both Chinese GLP and U.S. GLP standards, Medicilon has contributed to approximately 520 IND approvals, including 86 U.S. FDA approvals and 60 dual submissions (data as of the end of 2024).

Medicilon congratulates Tailikon on Tye1001’s dual IND approvals and looks forward to its continued success in clinical trials. Medicilon will continue to enhance its integrated preclinical R&D platform, empowering pharmaceutical companies to overcome drug R&D challenges.

On February 26, 2025 Boston Scientific Corporation (the "Company") (NYSE: BSX) reported that American Medical Systems Europe B.V. ("AMS Europe"), its wholly owned finance subsidiary, has completed a public offering of €850,000,000 aggregate principal amount of 3.000% notes due 2031 and €650,000,000 aggregate principal amount of 3.250% notes due 2034 (collectively, the "Notes") (Press release, Boston Scientific, FEB 26, 2025, View Source [SID1234650623]). The Notes are fully and unconditionally guaranteed by the Company. Application has been made for the Notes to be admitted to the Official List of the Irish Stock Exchange plc trading as Euronext Dublin and to trading on the Global Exchange Market thereof.

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The Company intends to use the net proceeds from the offering, together with cash on hand, to fund the repayment at maturity of AMS Europe’s 0.750% senior notes due March 8, 2025 and to pay accrued and unpaid interest with respect to such notes, and for general corporate purposes, which may include, among other things, short term investments, reduction of short term debt, funding of working capital and potential future acquisitions.

On February 26, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter and full year ended December 31, 2024, and provided an update on corporate progress (Press release, Revolution Medicines, FEB 26, 2025, View Source [SID1234650639]).

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The company’s mission is to revolutionize treatment for patients with RAS-addicted cancers through the discovery, development and delivery of innovative, targeted medicines across lines of therapy and tumor types. Its deep pipeline of clinical-stage RAS(ON) inhibitors includes daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor.

"In 2024 we built on our record of execution by advancing our highly differentiated portfolio of RAS-focused investigational drugs, making significant progress in building the organizational capabilities needed to drive the next stage of our strategy, and ending the year in an exceptionally strong financial position," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "In 2025 we aim to increase impact for patients with RAS-addicted tumors, including pancreatic cancer and lung cancer, by enrolling the ongoing registrational trials and opening additional pivotal trials in earlier lines of therapy."

Recent Clinical Highlights

Pancreatic Ductal Adenocarcinoma (PDAC)

The company currently has two RAS(ON) inhibitors being developed for patients with PDAC, daraxonrasib and zoldonrasib. The company is evaluating these compounds as monotherapy and in combination regimens.

Daraxonrasib in PDAC

On December 2, 2024, the company reported a new analysis of safety and activity data from its ongoing monotherapy trial of daraxonrasib in patients with previously treated PDAC harboring a RAS mutation. As of the July 23, 2024 data cutoff date, at the 300 mg once daily (QD) dose, the same dose used in the ongoing RASolute 302 Phase 3 PDAC trial, patients with PDAC harboring a KRAS G12X mutation achieved a median progression-free survival (PFS) of 8.8 months (95% confidence interval (CI), 8.5 – not estimable (NE)), while the median overall survival (OS) was not estimable (95% CI, NE – NE), and patients with PDAC harboring any RAS mutation achieved a median PFS of 8.5 months (95% CI, 5.9 – NE), while the median OS was not estimable (95% CI, 8.5 – NE).

These data are consistent with the initial dataset from the same July 23, 2024 data cutoff date presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (Triple) meeting in October 2024, which demonstrated that, at a dose range of 160 to 300 mg QD, patients with PDAC harboring a KRAS G12X mutation achieved a median PFS of 8.5 months (95% CI, 5.3 – 11.7) and a median OS of 14.5 months (95% CI, 8.8 – NE), while patients with PDAC harboring any RAS mutation achieved a median PFS of 7.6 months (95% CI, 5.9 – 11.1) and a median OS of 14.5 months (95% CI, 8.8 – NE).

Daraxonrasib exhibited a manageable safety and tolerability profile in both datasets and no new safety signals were observed. The most common treatment-related adverse events (TRAEs) were rash and gastrointestinal-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 10% of patients and there were no treatment discontinuations due to TRAEs.

On January 24, 2025, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), the company presented data showing that treatment with daraxonrasib induced early and deep reduction of RAS mutant circulating tumor DNA (ctDNA) in patients with previously treated PDAC, indicating inhibition of all major forms of oncogenic RAS. These results further support the ongoing RASolute 302 trial.

Zoldonrasib in PDAC

On October 25, 2024, the company reported first-in-human clinical results for zoldonrasib at the Triple meeting. Zoldonrasib demonstrated encouraging safety and antitumor activity in patients with RAS G12D PDAC.

Non-Small Cell Lung Cancer (NSCLC)

The company is also developing its RAS(ON) inhibitors for patients with advanced NSCLC.

Daraxonrasib in NSCLC

On December 2, 2024, the company reported updated results in patients with previously treated RAS mutant NSCLC who received daraxonrasib. Daraxonrasib was generally well tolerated and demonstrated favorable dose intensity and compelling PFS and OS.

Supported by these data, and having finalized the study design disclosed on December 2, 2024, the company has initiated a global, randomized Phase 3 trial (RASolve 301) of daraxonrasib versus docetaxel in patients with previously treated, locally advanced or metastatic NSCLC.

RAS(ON) Inhibitor Combination Trials

The company has ongoing efforts to identify and advance rational combination strategies with its RAS(ON) inhibitors, using a data-driven approach to prioritize among multiple options for advancing into early lines of therapy.

Daraxonrasib with Pembrolizumab

On December 2, 2024, the company reported data showing that the combination of daraxonrasib with pembrolizumab in NSCLC was generally well tolerated, and the safety profile was consistent with previously reported results for the individual agents.

Elironrasib with Daraxonrasib

On December 2, 2024, the company reported initial clinical safety, tolerability and activity for the first-of-its-kind RAS inhibitor doublet with the combination of elironrasib with daraxonrasib, which showed the combination was generally well tolerated and provided initial proof-of-mechanism in patients with colorectal cancer who were previously treated with a KRAS(OFF) G12C inhibitor. The company believes these preliminary observations support continued development of this RAS(ON) inhibitor doublet in a broad range of G12C-mutant tumor types and earlier lines of therapy.

Elironrasib with Pembrolizumab

On December 2, 2024, the company reported initial safety and tolerability data on the combination of elironrasib with pembrolizumab in patients with RAS G12C-mutant NSCLC, which support combinability with a safety profile consistent with previously reported results for the individual agents.

The company believes the three pairwise combinations of elironrasib with daraxonrasib, daraxonrasib with pembrolizumab, and elironrasib with pembrolizumab justify investigation of the triplet combination of elironrasib and daraxonrasib with pembrolizumab as a potential chemotherapy-sparing, first-line option for patients with NSCLC.

Zoldonrasib with Daraxonrasib

The company has completed dose escalation for a second RAS(ON) inhibitor doublet – zoldonrasib combined with daraxonrasib – and is currently in an expansion phase across a range of solid tumors at the anticipated single agent recommended Phase 2 doses for both agents.

Strategic Priorities and Markers of Progress

The company has five strategic priorities for this year to maximize the potential impact for patients with RAS-addicted cancers:

Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic PDAC and NSCLC.

The company anticipates substantially completing enrollment in RASolute 302, the company’s randomized Phase 3 trial comparing daraxonrasib to standard of care chemotherapy in 2L patients with metastatic PDAC, in 2025 to enable an expected data readout in 2026.

Having finalized the study design disclosed on December 2, 2024, the company is now activating investigational sites for RASolve 301, its global randomized Phase 3 trial comparing daraxonrasib to docetaxel in patients with previously treated, locally advanced or metastatic RAS mutant NSCLC.

Advance daraxonrasib into earlier-line randomized pivotal trials in patients with PDAC.

The company anticipates initiating two pivotal trials in earlier lines of treatment for PDAC in the second half of 2025:

• A global, randomized Phase 3 trial in first-line patients with metastatic PDAC. The trial is expected to compare a reference arm of patients treated with chemotherapy to two investigational arms, one with patients treated with daraxonrasib monotherapy and one with patients treated with daraxonrasib plus chemotherapy.

• A global, randomized Phase 3 trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC.

Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination.

The company expects to share additional clinical safety and antitumor activity on zoldonrasib in the second quarter of 2025.

The company currently expects to initiate one or more pivotal combination trials in 2026 that incorporate either elironrasib or zoldonrasib and expects to share clinical data supporting these plans in the second or third quarter of 2025.

Progress earlier-stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization.

The company expects to advance RMC-5127, a RAS(ON) G12V-selective inhibitor, to a clinic-ready stage in 2025 to enable the expected initiation of a first-in-human dose escalation Phase 1 clinical trial in 2026.

Grow commercial and operational capabilities and increase pre-commercial activities in support of a potential launch.

The company continues to expand key aspects of its organization to support a potential launch by continuing to add top talent, including U.S. field teams. The company plans to retain control of U.S. commercial rights as a core element of the current strategy and is also exploring strategies for serving patients outside the U.S., potentially including partnership opportunities.
Corporate and Financial Highlights

Financing

In December 2024, the company completed an upsized public equity offering, raising $823 million in net proceeds. This included the exercise in full by the underwriters of their option to purchase additional shares of common stock. These funds will be used to strengthen the company’s balance sheet and overall financial position to support the continued development and expansion of its product pipeline and preparation for the potential commercial launch of daraxonrasib, subject to FDA approval.

Fourth Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $2.3 billion as of December 31, 2024, compared to $1.9 billion as of December 31, 2023. The increase was primarily attributable to the company’s public equity offering in December 2024.

R&D Expenses: Research and development expenses were $188.1 million for the quarter ended December 31, 2024, compared to $148.5 million for the quarter ended December 31, 2023. The increase was primarily due to an increase in clinical trial expenses for daraxonrasib, elironrasib, and zoldonrasib, and an increase in personnel-related expenses related to additional headcount. Research and development expenses for the quarter ended December 31, 2023, included $13.1 million of expenses related to the wind-down of EQRx, Inc. (EQRx), which primarily consisted of non-recurring employee-related termination expenses and stock-based compensation expense related to the acceleration of EQRx equity awards in conjunction with the closing of the transaction.

G&A Expenses: General and administrative expenses were $28.2 million for the quarter ended December 31, 2024, compared to $32.2 million for the quarter ended December 31, 2023. The decrease was primarily due to $13.8 million of expenses related to the wind-down of EQRx, which primarily consisted of non-recurring employee-related termination expenses and stock-based compensation expense related to the acceleration of EQRx equity awards in conjunction with the closing of the EQRx transaction that were included in the quarter ended December 31, 2023, offset by an increase in commercial preparation activities and an increase in personnel-related expenses related to additional headcount.

Net Loss: Net loss was $194.6 million for the quarter ended December 31, 2024, compared to net loss of $161.5 million for the quarter ended December 31, 2023. Net loss for the quarter ended December 31, 2023, included $26.9 million of operating expenses related to the wind-down of EQRx.

Full Year 2024 Financial Highlights

Revenue: Total revenue was zero for the year ended December 31, 2024, compared to $11.6 million for the year ended December 31, 2023. The decrease in revenue was due to the termination of the company’s collaboration agreement with Sanofi in 2023.

R&D Expenses: Research and development expenses were $592.2 million for the year ended December 31, 2024, compared to $423.1 million for the year ended December 31, 2023. The increase was primarily due to an increase in clinical trial expenses for daraxonrasib, elironrasib and zoldonrasib, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation. Research and development expenses for the year ended December 31, 2023, included $13.1 million of expenses related to the wind-down of EQRx.

G&A Expenses: General and administrative expenses were $97.3 million for the year ended December 31, 2024, compared to $75.6 million for the year ended December 31, 2023. The increase was primarily due to an increase in commercial preparation activities and an increase in personnel-related expenses related to additional headcount. General and administrative expenses for the year ended December 31, 2023, included $13.8 million of expenses related to the wind-down of EQRx.

Net Loss: Net loss was $600.1 million for the year ended December 31, 2024, compared to net loss of $436.4 million for the year ended December 31, 2023.

2025 Financial Guidance
Revolution Medicines expects full year 2025 GAAP net loss to be between $840 million and $900 million, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million. Based on the company’s current operating plan, the company projects that current cash, cash equivalents and marketable securities can fund planned operations into the second half of 2027.

Webcast
Revolution Medicines will host a webcast this afternoon, February 26, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On February 26, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Vir Biotechnology, FEB 26, 2025, View Source [SID1234650655]).

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"2024 was a year of transformation for Vir Biotechnology as we successfully defined and executed on our renewed strategic direction, focusing our resources on our most promising programs in infectious diseases and oncology," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "As we enter 2025, we are poised for significant advancement with the initiation of our Phase 3 registrational program in chronic hepatitis delta and further clinical progression of our dual-masked T-cell engagers in solid tumors. Our disciplined capital deployment and strategic approach to partnerships enable us to maximize value creation from our pipeline and deliver transformative therapies to patients."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

ECLIPSE Phase 3 registrational clinical program in chronic hepatitis delta is advancing with the first patient in (FPI) expected during the first half of 2025.
Positive data from the SOLSTICE Phase 2 clinical trial were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in November 2024. This data demonstrated the potential of the first-of-its-kind investigational combination to address a critical unmet need in CHD, showing rapid and sustained virologic suppression, using the most stringent measure of zero detectable hepatitis delta RNA in the blood or target not detected, (TND defined as HDV RNA < 0 IU/mL), and no treatment-related serious adverse events (SAEs).
Tobevibart and elebsiran combination therapy has received multiple regulatory designations potentially supporting an expedited development and review process and recognizing the significant unmet need in CHD: U.S. FDA Breakthrough Therapy designation, U.S. FDA Fast Track designation, European Priority Medicines (PRIME) designation and European Orphan Drug designation.
Solid Tumors

In January 2025, the Company presented encouraging preliminary safety and efficacy data in ongoing Phase 1 dose escalation trials for its dual-masked T-cell engager (TCE) programs.
VIR-5818, the only dual-masked HER2-targeting TCE in clinical trials, 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, 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.
Both clinical candidates have shown promising safety profiles, with maximum tolerated dose (MTD) not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2.
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 is advancing VIR-5818 and VIR-5500 through ongoing Phase 1 dose escalation studies, aiming to further optimize dosing and efficacy. Additionally, the Company plans to initiate a Phase 1 study of VIR-5525, its dual-masked EGFR-targeting TCE, in the first half of 2025, evaluating its potential across a number of solid tumor indications.
Chronic Hepatitis B (CHB)

The Company anticipates functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 trial in the second quarter of 2025.
Positive end-of-treatment results of the MARCH Part B Phase 2 trial evaluating tobevibart and elebsiran in combination with PEG-IFNα or tobevibart and elebsiran alone were presented at AASLD The Liver Meeting in November 2024. The data demonstrated compelling hepatitis B surface antigen (HBsAg) loss and anti–hepatitis B surface antibody (anti-HBs) development at the end of treatment.
Future advancement in CHB by the Company will be contingent on securing a worldwide development and commercialization partner outside of China Territory (People’s Republic of China, Hong Kong, Taiwan and Macau) to best enable further development in this area of high unmet need.
Preclinical Pipeline Candidates

The Company is advancing multiple undisclosed dual-masked TCEs against clinically validated targets with potential applications across a variety of solid tumors. These preclinical candidates leverage 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 continues to advance its HIV broadly neutralizing antibody program for HIV cure in collaboration with the Gates Foundation.
Corporate Update

In November 2024, the Company hosted an investor event highlighting positive data from its SOLSTICE Phase 2 trial in hepatitis delta and its MARCH Part B Phase 2 trial in hepatitis B presented at AASLD.
In January 2025, the Company announced positive initial Phase 1 dose escalation data for two of its PRO-XTEN masked TCEs through an investor event.
The Company announced Maninder Hora, Ph.D. will assume the role of Executive Vice President, Chief Technical Operations Officer in February 2025, following the departure of the current Chief Technology Officer, Aine Hanley, Ph.D.
Fourth Quarter and Full Year 2024 Financial Results

"Our focus on operational efficiency and program prioritization achieved a 28% year-over-year reduction in operating expense, excluding the upfront expense related to the Sanofi licensing agreement," said Jason O’Byrne, MBA, Executive Vice President and Chief Financial Officer, Vir Biotechnology. "We enter 2025 with a robust financial position to support our key strategic priorities, including $1.10 billion in cash, cash equivalents and investments and a cash runway into mid-2027."

Cash, Cash Equivalents and Investments: As of December 31, 2024, the Company had approximately $1.10 billion in cash, cash equivalents and investments, representing a decline of approximately $90.6 million during the fourth quarter of 2024. For the full year of 2024, cash, cash equivalents and investments declined approximately $532.3 million. The 2024 full year decrease includes a $103.7 million upfront payment made to Sanofi upon the closing of the Sanofi license agreement and $75.0 million that was reclassified to restricted cash in the third quarter of 2024 and subject to VIR-5525 achieving "first in human dosing" by 2026.

Revenue: Revenue for the quarter ended December 31, 2024 was $12.4 million compared to $16.8 million for the same period in 2023. Revenue for the full year of 2024 was $74.2 million compared to $86.2 million in 2023. The decreases in the fourth quarter and full year were primarily driven by grant revenue, where lower revenue was recognized in accordance with our agreement with BARDA and the Gates Foundation. In addition, the decrease in the full year 2024 was attributable to lower revenues from the release of profit-sharing amount previously constrained under the 2020 GSK Agreement, partially offset by the recognition of deferred revenue related to the expiry of GSK’s rights to select up to two additional non-influenza target pathogens during the first quarter of 2024.

Cost of Revenue: Cost of revenue for the fourth quarter of 2024 was $0.7 million compared to $0.8 million for the same period in 2023. Cost of revenue for the full year of 2024 was $0.8 million compared to $2.8 million in 2023. The decreases were due to lower third-party royalties owed based on the lower collaboration revenue under the 2020 GSK Agreement.

Research and Development Expenses (R&D): R&D expenses for the fourth quarter of 2024 were $106.1 million, which included $8.3 million of non-cash stock-based compensation expense, compared to $109.1 million for the same period in 2023, which included $16.5 million of non-cash stock-based compensation expense. R&D expenses for the full year of 2024 were $506.5 million, which included $43.9 million of non-cash stock-based compensation expense, compared to $579.7 million in 2023, which included $62.7 million of non-cash stock-based compensation expense. The decrease of the fourth quarter R&D expense was primarily due to lower expenses for personnel and de-prioritized programs, partially offset by non-cash in-process R&D assets impairment charges and contingent consideration liability revaluation. The decrease of the full year R&D expense was primarily due to lower clinical costs and contract manufacturing costs associated with the Company’s discontinued flu asset, VIR-2482, lower contract manufacturing costs associated with elebsiran used in the Company’s CHD and CHB clinical trials and lower personnel costs, partially offset by the $102.8 million of the Sanofi upfront payment being recognized as in-process R&D expense.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the fourth quarter of 2024 were $26.7 million, which included $7.5 million of non-cash stock-based compensation expense, compared to $41.2 million for the same period in 2023, which included $11.8 million of non-cash stock-based compensation expense. SG&A expenses for the full year of 2024 were $119.0 million, which included $34.5 million of non-cash stock-based compensation expense, compared to $174.4 million in 2023, which included $48.6 million of non-cash stock-based compensation expense. The decrease in both the fourth quarter and the full year was primarily related to lower personnel and other expenses associated with previously announced cost-saving initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges: Restructuring, long-lived assets impairment and related charges for the fourth quarter of 2024 were $(3.9) million compared to $4.7 million for the same period in 2023. The $(3.9) million in the fourth quarter of 2024 was primarily related to a gain from terminating our lease in St. Louis, Missouri. The $4.7 million in the fourth quarter of 2023 was primarily related to the severance expenses.

Other Income: Other income for the fourth quarter of 2024 was $12.5 million compared to $18.3 million for the same period in 2023. The decrease was primarily due to lower interest income. Other income for the full year of 2024 was $64.1 million compared to $56.1 million in 2023. The increase was primarily due to lower unrealized loss from the Company’s equity investment and lower foreign exchange loss, partially offset by lower interest income.

Benefit from Income Taxes: Benefit from income taxes for the fourth quarter and the full year of 2024 was nominal. Benefit from income taxes for the fourth quarter and the full year of 2023 was $4.8 million and $13.1 million, respectively, primarily due to a pre-tax loss and the Company’s ability to carry back the research and development credit to 2022.

Net Loss: Net loss attributable to Vir Biotechnology for the fourth quarter of 2024 was $(104.6) million, or $(0.76) per share, basic and diluted, compared to a net loss of $(116.0) million, or $(0.86) per share, basic and diluted, for the same period in 2023. Net loss attributable to Vir Biotechnology for the year of 2024 was $(522.0) million, or $(3.83) per share, basic and diluted, compared to a net loss of $(615.1) million, or $(4.59) per share, basic and diluted, in 2023.

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 fourth quarter and full year 2024 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, 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.