Core Insights - Invivyd, Inc. announced the publication of results from its CANOPY Phase 3 clinical trial of pemivibart, demonstrating its safety and efficacy for the prevention of symptomatic COVID-19 in a contemporary U.S. population facing immune-evasive Omicron variants [1][4][6] Group 1: Clinical Trial Overview - The CANOPY Phase 3 clinical trial randomized 788 adult participants across 18 sites, focusing on immunocompromised individuals and those at risk due to regular face-to-face interactions [2][8] - The trial met all primary and exploratory endpoints during a significant COVID-19 transmission period in the U.S. from September 2023 to September 2024 [2][8] - Pemivibart showed an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months [4][6] Group 2: Safety and Tolerability - Pemivibart was generally well-tolerated, with most adverse events classified as mild to moderate [3][6] - The most common treatment-emergent adverse events included infusion-related reactions, with a low incidence of anaphylactic reactions (0.6%) [3][12] - The safety profile aligns with previous clinical trials for COVID-19 monoclonal antibodies [3][6] Group 3: Regulatory and Future Implications - The trial's results support the emergency use authorization (EUA) of PEMGARDA (pemivibart) for pre-exposure prophylaxis in certain immunocompromised patients [2][10] - The publication aims to educate clinicians on the potential of monoclonal antibodies in combating COVID-19, particularly for immunocompromised individuals [5][7] - Invivyd plans to leverage data from the CANOPY trial to expedite the approval of novel antibodies like VYD2311 [7][18]

WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) in moderately to seve ...

FDA acknowledges that the benefit of repeat doses of COVID-19 vaccine boosters for Americans is uncertain; the updated regulatory framework for COVID-19 vaccines articulated by the Agency generally aligns with recent Invivyd Citizen Petition requestsIn contrast to vaccine boosters, monoclonal antibody (mAb) therapies, including pemivibart, underwent contemporary randomized, placebo-controlled trials to evaluate safety, immunogenicity, and exploratory efficacy in relevant, modern Americans, against relevant, ...

Invivyd (IVVD) FY 2025 Conference May 20, 2025 11:00 AM ET Speaker0 Not ready. Okay. Hello, everyone, and welcome to the third annual, HC Wainwright BioConnect Conference. I'm Patrick Trucchio, a senior health parent at HC Wainwright. It's my pleasure to, introduce you to the management of InVivid. I'm Katie Falzoni, senior vice president of finance and Robert Allen, CSO. So first, I think it'd be good to start out with, some background on Invivid platform and on the validation of this antibody platform. Sp ...

Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants Katie Falzone - SVP - FinanceMarc Elia - Chairperson of the BoardTimothy Lee - Chief Commercial OfficerRobert Allen - Chief Scientific OfficerMark Wingertzahn - Senior Vice President of Clinical Development & Medical AffairsWilliam Duke - Chief Financial OfficerKyle Yang - Senior AssociateLuis Santos - Senior Equity Research Associate, Healthcare & Biotechnology Operator Thank you for standing by, and welcome to Nvivit's Firs ...

Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Speaker0 Thank you for standing by, and welcome to Nvivit's First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again. I would now like to hand the call over to Katie Bozzon ...

Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -250%. A quarter ago, it was expected that this company would post a loss of $0.25 per share when it actually produced a loss of $0.15, delivering a surprise of 40%.Over the last four quarters, the company has surpassed cons ...

Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents [156]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024 [181]. Financial Performance - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, with an accumulated deficit of $918.3 million as of the same date [165]. - Product revenue, net was $11.3 million for the three months ended March 31, 2025, compared to $0 for the same period in 2024, reflecting sales from the launch of PEMGARDA [191]. - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, a decrease from a net loss of $43.5 million in the same period of 2024 [206][207]. - Other income decreased to $0.6 million for the three months ended March 31, 2025, from $2.6 million in 2024, primarily due to interest earned on invested cash balances [197]. - The company incurred a net cash used in operating activities of $21.1 million for the three months ended March 31, 2025, compared to $50.2 million for the same period in 2024, indicating a 58.1% improvement [205][207]. - The company reported a net decrease in cash and cash equivalents of $21.3 million for the three months ended March 31, 2025, compared to a decrease of $11.3 million in the same period of 2024 [205]. Research and Development - The ongoing Phase 1 clinical trial of VYD2311 is evaluating safety, tolerability, pharmacokinetics, and immunogenicity, with positive clinical data reported for both safety and pharmacokinetics [157]. - The company aims to develop monoclonal antibodies (mAbs) for serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications [158]. - The company expects research and development expenses to increase as it advances VYD2311 through clinical development and seeks regulatory approval for its product candidates [177]. - Research and development expenses decreased by $20.5 million to $10.6 million for the three months ended March 31, 2025, from $31.2 million in 2024 [196]. - Acquired in-process research and development expenses consist primarily of costs related to acquiring rights to Adimab's antibodies for COVID-19 and SARS [182]. Commercialization and Expenses - Invivyd, Inc. has incurred significant commercialization expenses related to product manufacturing, marketing, sales, and distribution of PEMGARDA [166]. - The company anticipates ongoing expenses related to the commercialization of PEMGARDA and the development of other product candidates, which may lead to continued operating losses [198]. - Selling, general and administrative expenses increased by $1.8 million to $16.8 million for the three months ended March 31, 2025, compared to $14.9 million in 2024 [196]. - Cost of product revenue was $0.8 million for the three months ended March 31, 2025, with no cost recorded for the same period in 2024 [192]. - The company has committed to noncancelable purchase obligations of $27.4 million related to commercial drug substance and drug product manufacturing, expected to be paid in 2025 [214]. Funding and Liquidity - Invivyd, Inc. has financed operations primarily with net proceeds of $464.7 million from preferred stock sales and $327.5 million from its IPO [164]. - The company expects to require additional funding to support ongoing operations and growth strategy, with substantial doubt about its ability to continue as a going concern without securing additional funds [169]. - The company entered into a Loan Agreement providing for a senior secured term loan facility of up to $30 million, with terms including a repayment period starting March 1, 2029 [203][204]. - The company raised $39.3 million from the sale of 9,000,000 shares of common stock at an average price of $4.50 per share under a Sales Agreement in February 2024 [202]. - The company expects to finance operations through a combination of revenue contributions, equity offerings, and debt financing, indicating a focus on maintaining liquidity [213]. - The company has substantial doubt about its ability to continue as a going concern, as it may not have sufficient cash to fund operations beyond one year from the issuance of its financial statements [212]. Inventory and Manufacturing - The company has capitalized inventory costs since March 2024, which would have resulted in reported margins approaching 80% if pre-EUA manufacturing costs had been capitalized [193]. - The company is actively monitoring SARS-CoV-2 variants and reported continued neutralizing activity of PEMGARDA against variants KP.3.1.1 and LB.1 [161]. - The company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles [162]. Accounting and Compliance - The JOBS Act allows emerging growth companies to delay the adoption of new accounting standards until they apply to private companies [220]. - Companies are exempt from compliance with the auditor attestation requirement for internal control over financial reporting [221]. - Reduced disclosure obligations regarding executive compensation are available for smaller reporting companies [221]. - Exemptions from non-binding advisory votes on executive compensation and stockholder approval of golden parachute payments are provided [221]. - Companies are not required to disclose quantitative and qualitative information about market risk as they qualify as smaller reporting companies [222].

INVIVYD Q1 2025 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 15, 2025 © 2025 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are ...

Exhibit 99.1 Invivyd Reports First Quarter 2025 Financial Results and Recent Business Highlights WALTHAM, Mass., May 15, 2025 – Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended March 31, 2025, and provided recent business highlights. "To drive long-term topline growth, we made a strategic decision to internalize our sales force at the beginning of 2025," said Bill Duke, Chief Financial Officer of Invivyd. "Although this shift created a short-term headwind, we're now seein ...