Invivyd (IVVD) Company Report

Invivyd, Inc. priced an underwritten public offering of 44,000,000 shares of common stock at $2.50 per share and 6,000,000 pre-funded warrants at $2.4999 per pre-funded warrant.
The offering is expected to generate approximately $125.0 million in gross proceeds, with approximately $117.2 million in net proceeds after deducting underwriting discounts and offering expenses.
The net proceeds will be used for commercial preparedness for the potential launch of VYD2311, continued research and development for pipeline programs such as respiratory syncytial virus (RSV) and measles, advancement of the Spike Protein Elimination and Recovery (SPEAR) Study Group efforts, and for working capital and other general corporate purposes.
The offering closed on November 19, 2025.

3 days ago

8-K

Invivyd Announces Pricing of Public Offering

IVVD

New Projects/Investments

Invivyd, Inc. announced the pricing of an underwritten public offering on November 17, 2025, for 44,000,000 shares of its common stock at $2.50 per share and pre-funded warrants to purchase 6,000,000 shares at $2.4999 per pre-funded warrant.
The offering is expected to generate approximately $125.0 million in gross proceeds and is anticipated to close on or about November 19, 2025.
Invivyd intends to use the net proceeds for commercial preparedness for the potential launch of VYD2311, continued research and development for pipeline programs (such as RSV and measles), advancement of the SPEAR Study Group efforts, and for working capital and other general corporate purposes.
The company also granted the underwriters an option to purchase up to an additional 7,500,000 shares of common stock for a period of 30 days.

5 days ago

Press Release

Invivyd Reports Q3 2025 Financial Results and Commercial Progress

IVVD

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

Invivyd reported Q3 2025 PEMGARDA net product revenue of $13.1 million, representing 41% growth over Q3 2024 and 11% growth over Q2 2025.
The company's cash and cash equivalents totaled $85.0 million at the end of Q3 2025, which increased to over $100 million by October 2025 after a public offering and at-the-market (ATM) facility usage.
Invivyd has established a commercial foundation for PEMGARDA, with 811 accounts having infusion experience and 76% reordering accounts, and plans to scale this infrastructure for its VYD2311 candidate.
The company is strategically positioning VYD2311 as a potential blockbuster monoclonal antibody, aiming to provide a non-vaccine alternative for COVID protection with anticipated high efficacy and long duration.

Nov 6, 2025, 1:30 PM

Presentation

Invivyd Reports Q3 2025 Results, Secures Funding, and Advances VYD2311 Program

IVVD

Earnings

New Projects/Investments

Revenue Acceleration/Inflection

Invivyd announced Q3 2025 financial results, with Pemgarda revenues growing 11% quarter-on-quarter and 41% year-over-year.
The company received U.S. FDA feedback for its VYD2311 antibody, with pivotal clinical studies on track to initiate around year-end and deliver top-line data in mid-2026.
Invivyd raised approximately $87 million in capital in Q3 2025 and shortly thereafter, making it well-capitalized through anticipated pivotal data for VYD2311 in mid-2026.
The company stated it has no plans to actively sunset Pemgarda even after the potential approval of VYD2311.

Nov 6, 2025, 1:30 PM

Transcript

Invivyd Reports Q3 2025 Results and VYD2311 Clinical Program Update

IVVD

Earnings

New Projects/Investments

Guidance Update

Invivyd reported Q3 2025 PEMGARDA revenues that increased 11% quarter-on-quarter and 41% year-over-year.
The company successfully raised approximately $87 million in capital during Q3 2025 and shortly thereafter, ensuring it is well-capitalized through anticipated pivotal data for VYD2311 in mid-2026.
Following FDA feedback, Invivyd is on track to initiate pivotal clinical studies for its VYD2311 antibody around year-end, with top-line data expected in mid-2026.
Invivyd is expanding its commercial organization in preparation for the VYD2311 launch, while continuing to grow its PEMGARDA commercial franchise.

Nov 6, 2025, 1:30 PM

Transcript

Invivyd Announces Q3 2025 Financial Results and VYD2311 Clinical Progress

IVVD

Earnings

New Projects/Investments

Revenue Acceleration/Inflection

Invivyd reported strong Q3 2025 financial results, with Pemgarda revenues increasing 11% quarter-on-quarter and 41% year-over-year.
The company successfully raised approximately $87 million in capital, securing funding through anticipated pivotal data for VYD2311 in mid-2026.
The pivotal clinical program for VYD2311 is on track to initiate around year-end, with top-line data expected in mid-2026, targeting a potential blockbuster market.
Invivyd is expanding its commercial organization in preparation for the VYD2311 launch and is also pursuing early-stage discovery programs in RSV and measles, with an update expected before year-end.

Nov 6, 2025, 1:30 PM

Transcript

Invivyd Reports Q3 2025 Financial Results and VYD2311 Clinical Progress

IVVD

Earnings

Product Launch

New Projects/Investments

Invivyd reported PEMGARDA net product revenue of $13.1 million for Q3 2025, marking 41% growth year-over-year and 11% growth quarter-over-quarter.
The company's cash and cash equivalents stood at $85.0 million as of September 30, 2025, with October 2025 ending cash exceeding $100 million following a $57.5 million public offering in August 2025 and an additional $29.8 million from an at-the-market offering in October 2025.
Invivyd announced U.S. IND clearance and FDA alignment for VYD2311, a vaccine-alternative antibody for COVID, with its REVOLUTION pivotal clinical program expected to commence around year-end 2025 and top-line data anticipated mid-2026.
Net loss for Q3 2025 significantly decreased to $10.5 million, compared to $60.7 million in Q3 2024, resulting in a basic and diluted net loss per share of $0.06.

Nov 6, 2025, 12:10 PM

8-K

Invivyd, Inc. Posts Investor Presentation Highlighting Antibody Pipeline and Clinical Progress

IVVD

Product Launch

New Projects/Investments

Invivyd, Inc. filed an 8-K on October 30, 2025, announcing the posting of an investor presentation detailing its pipeline and clinical programs.
The company is committed to developing best-in-class antibody protection and treatment for viral threats, including COVID (PEMGARDA® and VYD2311), Long COVID, RSV, and Measles.
The VYD2311/REVOLUTION Clinical Program is advancing, with Phase 1/2 data demonstrating attractive safety for VYD2311 at high doses. The pivotal 'DECLARATION' study aims for a 70%-90% reduction in symptomatic COVID with a single 250 mg IM dose, leveraging VYD2311's 76-day half-life for potential long-term protection.
Invivyd is undertaking launch preparations for its product candidates, including PEMGARDA® and VYD2311, pending regulatory approvals, and notes broad recognition for antibodies in COVID from various medical societies and guidelines.

Oct 30, 2025, 8:07 PM

8-K

Invivyd Provides Update on COVID Monoclonal Antibody Programs and Clinical Trials

IVVD

Product Launch

New Projects/Investments

Study Update

Invivyd is advancing its REVOLUTION clinical program for the COVID-19 monoclonal antibody (mAb) candidate VYD2311, which includes the DECLARATION Phase 3 trial to prevent symptomatic COVID and the LIBERTY Phase 3 trial for safety/tolerability and co-administration with mRNA vaccines.
The DECLARATION trial aims for a 70%-90% reduction in symptomatic COVID over three months with a single 250 mg intramuscular dose of VYD2311, which has demonstrated a long half-life of 76 days.
Initial Phase 1/2 study data for VYD2311 showed attractive safety at high doses, with no deaths, serious adverse events (SAEs), or severe treatment-emergent adverse events (TEAEs) reported.
The company highlights the ability of mAbs like VYD2311 and PEMGARDA (pemivibart) to be engineered for consistent high activity against SARS-CoV-2 variants, contrasting with the perceived limitations of COVID vaccines. PEMGARDA is also undergoing launch preparation for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients.

Oct 30, 2025, 12:30 PM

Presentation

Invivyd Provides Update on VYD2311 Clinical Program

IVVD

New Projects/Investments

Product Launch

Invivyd provided an update on its Revolution Clinical Program for VYD2311, an antibody being developed as an alternative to COVID vaccination, highlighting its potential to offer better, safer protection from infectious diseases.
The Phase 1/2 study for VYD2311 was completed, demonstrating that the drug was generally safe and well-tolerated even at extremely high doses.
The pivotal Declaration study (Phase 3) is a randomized, placebo-controlled trial designed to assess VYD2311's ability to reduce the risk of symptomatic COVID-19, with an expected 70% to 90% reduction over a 90-day period for a single 250 mg intramuscular dose. The study is also designed to show greater than 50% protection out to one year.
Invivyd is also planning the Liberty study to compare the safety and tolerability of VYD2311 against mRNA vaccines and to assess the impact of combining them.
The company sees an enormous commercial opportunity for VYD2311, citing U.S. COVID vaccine sales of $3.8 billion in 2024, and expects VYD2311 to be reimbursed by Medicare Part B and D.

Oct 30, 2025, 12:30 PM

Transcript

Filings & Transcripts

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