Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vir Biotechnology Inc (VIR, Financial) presented promising Phase 2 SOLSTICE data in chronic hepatitis delta, generating significant interest from the scientific and medical community.
- The company received FDA IND clearance and fast track designation for its combination therapy for hepatitis delta.
- Vir Biotechnology Inc (VIR) entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers and the PRO-XTEN protease-cleavable masking platform.
- The company is strategically reprioritizing its pipeline to focus on high-value near-term opportunities, including hepatitis delta, hepatitis B, and the newly licensed T-cell engagers.
- The restructuring is expected to yield significant cost savings and enhance financial resilience, with a reduction of approximately $50 million annually in workforce costs and an additional $50 million in savings from phased-out programs.
Negative Points
- The company is implementing a workforce restructuring that will result in a reduction of approximately 25% of its employees.
- Vir Biotechnology Inc (VIR) is phasing out programs in influenza, COVID-19, and its T-cell-based viral vector platform, which may impact its diversification in infectious diseases.
- The upfront payment of $100 million and a near-term escrow milestone payment of $75 million to Sanofi represent significant financial commitments.
- The company reported a decline in cash, cash equivalents, and investments from $1.51 billion at the end of Q1 2024 to $1.43 billion at the end of Q2 2024.
- R&D expenses for Q2 2024 were $105.1 million, indicating high ongoing costs despite a decrease from the same period in 2023.
Q & A Highlights
Q: Are the dose escalation phases for 6309 and 6329 in unselected patient populations or specific to HER and PSMA patients?
A: For both 6309 and 6329, we are enrolling heavily pretreated tumor types. For 6309, both HER2-positive and HER2-low patients are being enrolled. For the PSMA program, there's no specific requirement for PSMA positivity, but it will be looked at. The Phase 1 studies allow for dose escalation to test the hypothesis of achieving a superior therapeutic index with better safety and efficacy than unmasked TCEs.
Q: What are the three T-cell engager programs you are most excited about, and what are your thoughts on their competitive positioning?
A: Despite the high activity around HER2, PSMA, and EGFR targets, the unmet medical need remains high. There are no T-cell engagers approved for these targets, and existing therapies often come with significant toxicities. We believe our masked T-cell engagers can offer a differentiating impact for patients.
Q: Can you share any insights regarding the safety profile of the newly in-licensed T-cell engagers, particularly concerning cytokine release syndrome?
A: Preclinical data shows a 10,000-fold reduction in potency in the masked state compared to the tumor microenvironment. We have reviewed preliminary clinical data, including safety data, which gave us confidence in the deal. We will provide more detailed information in subsequent interactions.
Q: How will you manage the clinical development of multiple T-cell engagers simultaneously?
A: Vir has demonstrated the ability to run large trials at scale. The integration of Sanofi employees will bring additional expertise, allowing us to prosecute multiple trials simultaneously. We will prioritize programs based on the most compelling clinical data as it evolves.
Q: What is the rationale behind combining 6309 with pembrolizumab in the trial design?
A: T-cell engagers require T-cells to be present and active. Combining with a PD-1 inhibitor like pembrolizumab removes a brake on T-cells, allowing them to be more active and form immune synapses with tumor cells. This combination is expected to enhance the efficacy of the T-cell engager.
Q: How do you plan to leverage the PRO-XTEN masking platform with your monoclonal antibody platform?
A: Our antibody discovery engine provides a complementary and synergistic power to develop the next stage of T-cell engagers. The PRO-XTEN platform has broad applicability, including potential use with cytokines and other protein therapeutics. We will focus on targets with biological proof-of-concept and expand from there.
Q: What was the rationale behind the decision to in-license these assets and move into oncology? Were other therapeutic areas considered?
A: We strategically evaluated opportunities that would build on our existing expertise. The in-licensed assets address high unmet needs and have strong scientific backing. The deal brings near-term catalysts and value inflection points, making it a unique fit for Vir.
Q: Will the corporate update affect the timelines or resources devoted to the HBV or HDV programs?
A: The corporate update will not impact the timelines for our hepatitis delta and hepatitis B studies. Our focus remains on clinical execution for these programs and the newly licensed T-cell engagers.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
