8-K: Invivyd's PEMGARDA Receives FDA Emergency Use Authorization for COVID-19 Prevention in Immunocompromised Individuals

Invivyd, Inc. announced that its monoclonal antibody PEMGARDA has received emergency use authorization from the FDA for the prevention of COVID-19 in certain immunocompromised individuals, marking a significant milestone in the company's efforts to address the evolving virus.

Summary

• Invivyd, Inc. reported financial results for the full year ended December 31, 2023, and highlighted recent business developments.
• The company received emergency use authorization (EUA) from the U.S. FDA for PEMGARDA (pemivibart), a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise.
• PEMGARDA is the first authorized monoclonal antibody from Invivyd's INVYMAB platform, designed to address the challenge of rapid viral evolution.
• The company reported cash and cash equivalents of $200.6 million as of December 31, 2023.
• In February 2024, Invivyd sold shares totaling $40.5 million in gross proceeds under its At-the-Market facility.
• Research and development expenses for 2023 were $163.6 million, down from $183.6 million in 2022.
• Selling, general, and administrative expenses for 2023 were $49.1 million, up from $47 million in 2022.
• Net loss for 2023 was $198.6 million, compared to $241.3 million in 2022.
• The company is preparing for the full commercial launch of PEMGARDA, with product availability expected imminently.
• Invivyd also announced the development of VYD2311, its next anticipated anti-SARS-CoV-2 monoclonal antibody candidate.

Sentiment

Score: 8

Explanation: The document reflects a highly positive sentiment due to the successful EUA of PEMGARDA, the company's strong cash position, and the potential of its INVYMAB platform. However, the inherent risks and uncertainties in the biopharmaceutical industry, along with the company's net loss, temper the sentiment slightly.

Positives

• The emergency use authorization of PEMGARDA is a significant achievement for Invivyd.
• PEMGARDA is the first pre-exposure prophylaxis monoclonal antibody to receive an EUA using a rapid immunobridging trial design.
• The INVYMAB platform approach demonstrates potential for rapid development of monoclonal antibodies against evolving viral threats.
• The company has a strong cash position to support the commercial launch of PEMGARDA.
• Invivyd is actively developing a pipeline of monoclonal antibody candidates, including VYD2311, to address emerging SARS-CoV-2 variants.

Negatives

• The company reported a net loss of $198.6 million for the year ended December 31, 2023.
• Research and development expenses remain high at $163.6 million for 2023.
• There are limitations to the data supporting the benefits of PEMGARDA.
• Certain SARS-CoV-2 viral variants may emerge that are not neutralized by monoclonal antibodies such as PEMGARDA.

Risks

• The EUA for PEMGARDA may be revoked or revised by the FDA.
• The company may face challenges in building and maintaining sales, marketing, and distribution capabilities for PEMGARDA.
• Changes in the regulatory environment could impact the development and approval of product candidates.
• Unexpected safety or efficacy data in clinical trials could hinder product development.
• The company relies on third parties for various aspects of development and manufacturing.
• There is a risk that PEMGARDA may not be effective against all SARS-CoV-2 variants.
• The company may face difficulties in obtaining third-party coverage and adequate reimbursement for PEMGARDA.
• The company's ability to continue as a going concern and meet future funding needs is uncertain.

Future Outlook

Invivyd expects its existing cash and cash equivalents to fund operating expenses and capital expenditure requirements into the fourth quarter of 2024, excluding anticipated cash collections from PEMGARDA sales. The company is focused on the commercial launch of PEMGARDA and advancing its pipeline of monoclonal antibody candidates.

Management Comments

• 'We made remarkable progress throughout 2023 and in recent months. Roughly one year ago we were initiating the Phase 1 clinical trial of VYD222, and today we are incredibly proud to have received emergency use authorization (EUA) of PEMGARDA for PrEP of COVID-19 in certain adults and adolescents (aged 12 or older weighing at least 40kg) in the U.S. with moderate-to-severe immune compromise who are unlikely to mount an adequate response to COVID-19 vaccination,' said Dave Hering, Chief Executive Officer of Invivyd.
• 'PEMGARDA is the first PrEP mAb to receive an EUA using a rapid immunobridging trial design leveraging a biomarker as a surrogate of clinical efficacy and the first authorized mAb from our novel platform approach designed to rapidly and serially engineer durable mAbs targeting conserved viral epitopes. This exciting milestone is a testament to our teams incredible dedication, skill, and ability to execute to plan.'
• 'With PEMGARDA now authorized and anticipated to be available for order in the U.S. imminently, we are laser-focused on executing our commercial launch plan and look forward to providing insights on key launch metrics as time progresses. With a relatively compact field sales organization, we believe that we can efficiently reach key healthcare practitioners and institutions who care for the highest risk moderately to severely immunocompromised adults and adolescents, with the opportunity to potentially expand our efforts and footprint over time within our authorized population.'

Industry Context

The EUA for PEMGARDA positions Invivyd as a key player in the evolving landscape of COVID-19 prevention, particularly for immunocompromised individuals who may not adequately respond to vaccination. The company's INVYMAB platform approach aligns with the industry's focus on developing therapies that can keep pace with viral evolution.

Comparison to Industry Standards

• PEMGARDA's EUA is based on an immunobridging approach, similar to that used for other neutralizing monoclonal antibodies against SARS-CoV-2, such as adintrevimab (the parent monoclonal antibody of pemivibart) and other monoclonal antibodies that were previously authorized for EUA.
• However, the clinical efficacy data for these other monoclonal antibodies were based on different populations and SARS-CoV-2 variants that are no longer circulating.
• The company's INVYMAB platform is designed for rapid, serial generation of new monoclonal antibodies, which is a similar approach to that used by Vir Biotechnology for their sotrovimab product, although sotrovimab is no longer authorized in the US due to reduced efficacy against circulating variants.
• Regeneron's REGEN-COV (casirivimab and imdevimab) was also previously authorized for EUA but is no longer authorized due to reduced efficacy against circulating variants.
• AstraZeneca's Evusheld (tixagevimab and cilgavimab) was also previously authorized for EUA but is no longer authorized due to reduced efficacy against circulating variants.

Stakeholder Impact

• Shareholders: Potential positive impact due to the EUA and commercial launch of PEMGARDA, but also risks associated with the company's net loss and reliance on third parties.
• Employees: Potential positive impact due to the company's growth and focus on developing innovative therapies.
• Customers: PEMGARDA provides a new option for COVID-19 prevention in immunocompromised individuals.
• Suppliers: Potential positive impact due to increased demand for manufacturing and related services.
• Creditors: The company's strong cash position reduces the risk for creditors in the near term.

Next Steps

• Prepare for the full commercial launch of PEMGARDA in the U.S.
• Provide insights on key PEMGARDA launch metrics.
• Advance VYD2311 into clinical development.
• Engage with the FDA to establish a streamlined development pathway for future monoclonal antibody candidates.

Key Dates

Keywords

PEMGARDA, pemivibart, COVID-19, monoclonal antibody, mAb, pre-exposure prophylaxis, PrEP, immunocompromised, emergency use authorization, EUA, FDA, INVYMAB, SARS-CoV-2, biopharmaceutical, Invivyd, VYD2311, viral evolution