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SAN FRANCISCO - Vir Biotechnology, Inc. (NASDAQ:VIR), currently trading at $5.85 and according to InvestingPro analysis showing potential upside based on its Fair Value, has dosed the first patient in its Phase 1 clinical trial evaluating VIR-5525, a dual-masked T-cell engager targeting epidermal growth factor receptor (EGFR) for solid tumors, the company announced Thursday.
The open-label, non-randomized trial will assess the safety, pharmacokinetics, and preliminary anti-tumor activity of VIR-5525 as both a monotherapy and in combination with pembrolizumab in patients with EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and cutaneous squamous cell carcinoma.
VIR-5525 represents the company’s third dual-masked T-cell engager in clinical trials. The therapy incorporates Vir’s PRO-XTEN masking technology, designed to selectively activate in the tumor microenvironment while minimizing damage to healthy tissues.
"EGFR has been well characterized as a key oncogenic driver and a marker of poor prognosis in cancer," said Mark Eisner, Chief Medical Officer at Vir Biotechnology, in a statement based on the press release.
The first patient dosing triggers a $75 million milestone payment under Vir’s 2024 license agreement with Sanofi for the PRO-XTEN platform and clinical-stage T-cell engagers. This anticipated payment had been held as restricted cash since the transaction closing. InvestingPro data shows the company maintains a healthy current ratio of 6.79, with more cash than debt on its balance sheet, though analysts note the company is quickly burning through its cash reserves.
Vir continues dose escalation for its other dual-masked T-cell engagers: VIR-5818, targeting HER2-expressing solid tumors, and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer. Initial Phase 1 data presented in January showed early clinical response signals and promising safety profiles for both candidates in heavily pretreated patients.
The company is also advancing multiple preclinical dual-masked T-cell engagers against clinically validated targets for various solid tumors with high unmet needs. While the company reported revenue of $20.86 million in the last twelve months, InvestingPro analysis reveals that 5 analysts have revised their earnings upwards for the upcoming period, suggesting potential optimism about the company’s pipeline developments. For deeper insights into Vir’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
In other recent news, Vir Biotechnology reported its first-quarter 2025 financial results, which showed a slight miss in earnings per share (EPS) and a significant shortfall in revenue. The company posted an EPS of -$0.88, compared to the forecasted -$0.87, and reported revenue of $3.03 million, which was well below the expected $13.65 million. Additionally, H.C. Wainwright adjusted its price target for Vir Biotechnology shares, reducing it to $15 from the previous $110, while maintaining a Buy rating. This adjustment followed the release of data from the Phase 2 MARCH study on chronic hepatitis B virus treatment, which did not meet the necessary functional cure thresholds. Despite this, the analyst remains optimistic about Vir’s potential, focusing on the company’s ongoing work in other areas. The chronic hepatitis delta virus treatment is now considered the main value driver, with the ECLIPSE 1 Phase 3 trial currently enrolling participants and the ECLIPSE 2 trial expected to commence soon. These developments highlight the company’s current challenges and ongoing efforts in advancing its treatment pipeline.
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