Vir Biotechnology, Inc. Stock Price, News & Analysis

Vir Biotechnology (Nasdaq: VIR) has appointed Jason O'Byrne as Executive Vice President and Chief Financial Officer, effective October 2, 2024. O'Byrne brings over 20 years of experience in finance and operations to Vir. He joins from Caribou Biosciences, where he served as CFO, and previously held senior roles at Audentes Therapeutics and Genentech. O'Byrne's expertise spans capital allocation, corporate strategy, and operational execution.

CEO Marianne De Backer praised O'Byrne's exceptional leadership and proven track record in financial strategy across public companies. O'Byrne expressed excitement about joining Vir as it expands into oncology and continues work in infectious diseases. His appointment aims to support Vir's mission of advancing innovative antibody therapeutics.

Vir Biotechnology (Nasdaq: VIR) has closed its exclusive worldwide license agreement with Sanofi, initially announced on August 1, 2024. This strategic deal grants Vir exclusive rights to three clinical-stage masked T-cell engagers (TCEs) and the PRO-XTEN masking platform for oncology and infectious disease applications. The agreement includes:

1. SAR446309: A dual-masked HER2-targeted TCE in phase 1 for metastatic HER2+ tumors.
2. SAR446329: A dual-masked PSMA-targeted TCE in phase 1 for metastatic castration-resistant prostate cancer.
3. SAR446368: A dual-masked EGFR-targeted TCE with an active IND, phase 1 study expected to begin in Q1 2025.

Key Sanofi employees with TCE expertise will join Vir. The company plans to provide further details at its upcoming R&D Day in November.

Vir Biotechnology (NASDAQ: VIR) has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The company's CEO, Marianne De Backer, M.Sc., Ph.D., MBA, is scheduled to take part in a fireside chat on Thursday, September 5, at 1:50 p.m. PT / 4:50 p.m. ET in New York City.

Investors and interested parties can access a live webcast of the fireside chat through the Events & Presentations section of Vir Biotechnology's website at www.vir.bio. The webcast will remain archived on the site for 30 days following the event, allowing those unable to attend the live session to catch up on the discussion.

Vir Biotechnology (Nasdaq: VIR) reported Q2 2024 financial results and announced a strategic restructuring. Key highlights include:

1. Positive preliminary Phase 2 data for chronic hepatitis delta treatment

2. FDA IND clearance and Fast Track Designation for tobevibart and elebsiran

3. Exclusive license agreement with Sanofi

4. Strategic workforce restructuring, reducing headcount by 25%

5. $1.43 billion in cash and investments as of June 30, 2024

6. Q2 2024 revenues of $3.1 million, down from $3.8 million in Q2 2023

7. Net loss of $(138.4) million, or $(1.02) per share

8. Lowered full-year 2024 operating expense guidance to $580-$610 million

Vir Biotechnology (Nasdaq: VIR) has entered an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases. The deal includes SAR446309 (HER2-targeted), SAR446329 (PSMA-targeted), and SAR446368 (EGFR-targeted) TCEs. This strategic move aligns with Vir's mission of powering the immune system and aims to address treatment-associated toxicity in cancer therapeutics.

The proprietary masking platform potentially increases the therapeutic index and mitigates toxicities associated with systemic immune activation. Key employees with expertise in TCEs will join Vir upon regulatory clearance. Vir will make an upfront payment to Sanofi, which is also eligible for future milestone payments and tiered royalties on worldwide net sales.

Vir Biotechnology (Nasdaq: VIR) has announced that it will release its second quarter 2024 financial results on August 1, 2024. The company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on the same day to discuss the results. Investors can access the financial results via a press release that will be available on the company's website after market close. The conference call can be accessed through a webcast on Vir's website or by dialing in using the provided toll-free numbers. A recorded version of the call will be available on the website approximately two hours after the event and will be archived for 30 days.

Vir Biotechnology (Nasdaq: VIR) has received FDA clearance for its IND application and Fast Track designation for its combination treatment of tobevibart and elebsiran aimed at chronic hepatitis delta infection. The IND clearance follows positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024. The Phase 2 SOLSTICE trial data showed high rates of virologic response and ALT normalization at 12 and 24 weeks, with complete 24-week data expected in Q4. This Fast Track designation will facilitate the expedited review and development of this promising treatment. Hepatitis delta, considered the most severe form of chronic viral hepatitis by the WHO, affects over 12 million people globally. Vir plans to initiate its ECLIPSE trial soon, which will support potential registration of the treatment.

Vir Biotechnology announced promising preliminary phase 2 data from its SOLSTICE trial for hepatitis delta treatment. The study evaluates tobevibart, a monoclonal antibody, and elebsiran, a small interfering RNA, as monotherapy and combination therapy.

Key findings include high virologic response rates and ALT normalization at 12 and 24 weeks. Combination therapy showed 100% virologic response at both 12 and 24 weeks, while tobevibart monotherapy had 73% and 55% at these intervals. Most adverse events were mild and transient without serious occurrences.

Further data will be presented at the EASL Congress 2024, with a conference call scheduled for June 5, 2024.

Vir Biotechnology (Nasdaq: VIR) announced CEO Marianne De Backer will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference. The event is scheduled for June 12 at 11:00 a.m. PT / 2:00 p.m. ET at the Loews Miami Beach Hotel. The discussion will be webcast live and archived for 30 days on the Vir website.