UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 (Exact name of Registrant as specified in its Charter) Delaware 85-1403134 (State or other jurisdiction of incorporation or organization) or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number ...

[Business Highlights and Outlook](index=1&type=section&id=Invivyd%20Reports%20Full%20Year%202023%20Financial%20Results%20and%20Recent%20Business%20Highlights) Invivyd achieved PEMGARDA's EUA for COVID-19 PrEP in 2023 and is now focused on its U.S. commercial launch [Overview](index=1&type=section&id=Overview) Invivyd secured PEMGARDA's EUA for COVID-19 PrEP in 2023, now prioritizing its U.S. commercial launch - PEMGARDA received Emergency Use Authorization (EUA) for COVID-19 pre-exposure prophylaxis in specific immunocompromised individuals[3](index=3&type=chunk)[4](index=4&type=chunk) - PEMGARDA is the first PrEP monoclonal antibody to receive EUA via rapid immunobridging and the first from the INVYMAB™ platform[3](index=3&type=chunk)[5](index=5&type=chunk) - The company is executing its U.S. commercial launch plan with a targeted field sales organization focusing on key healthcare practitioners[3](index=3&type=chunk) [Recent Program Highlights](index=1&type=section&id=Recent%20Program%20Highlights) Recent achievements include PEMGARDA's EUA, VYD2311 nomination, and a **$40.5 million** stock sale strengthening the balance sheet - PEMGARDA received EUA from the U.S. FDA on March 22, 2024, for COVID-19 pre-exposure prophylaxis in specific immunocompromised populations[4](index=4&type=chunk) - VYD2311 was nominated as the next anti-SARS-CoV-2 mAb candidate, optimized for neutralization against variants like BA.2.86 and JN.1[6](index=6&type=chunk) - The balance sheet was strengthened by selling shares totaling **$40.5 million** in gross proceeds in February 2024, ahead of PEMGARDA's launch[5](index=5&type=chunk) [Full Year 2023 Financial Results](index=2&type=section&id=Year%20End%202023%20Financial%20Results) Invivyd reported a **$198.6 million** net loss for FY2023, an improvement from 2022, with **$200.6 million** cash expected to fund operations into Q4 2024 [Financial Summary](index=2&type=section&id=Financial%20Summary) Invivyd reported a **$198.6 million** net loss for FY2023, an improvement from 2022, with **$200.6 million** in cash expected to fund operations into Q4 2024 Full Year 2023 Financial Highlights (in millions, except per share data) | Financial Metric | FY 2023 | FY 2022 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $163.6 | $183.6 | ($20.0) | | SG&A Expenses | $49.1 | $47.0 | $2.1 | | Net Loss | ($198.6) | ($241.3) | $42.7 | | Net Loss Per Share | ($1.81) | ($2.23) | $0.42 | | Cash & Cash Equivalents | $200.6 | $92.1 | $108.5 | - Cash and cash equivalents totaled **$200.6 million** as of December 31, 2023, expected to fund operations into Q4 2024, excluding PEMGARDA sales[9](index=9&type=chunk) - The decrease in R&D expenses was primarily due to lower personnel costs and adintrevimab trial wind-down, partially offset by PEMGARDA manufacturing and clinical costs[9](index=9&type=chunk) - The increase in SG&A expenses was primarily driven by higher personnel-related and commercial costs[9](index=9&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Invivyd's 2023 financial statements show total assets decreased to **$229.2 million** and a net loss of **$198.6 million** [Consolidated Balance Sheets](index=6&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) As of December 31, 2023, total assets decreased to **$229.2 million**, liabilities increased to **$51.7 million**, and stockholders' equity decreased to **$177.5 million** Consolidated Balance Sheet Summary (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $200,641 | $92,076 | | Marketable securities | $0 | $279,915 | | Total current assets | $224,881 | $376,917 | | **Total assets** | **$229,181** | **$383,167** | | **Liabilities & Equity** | | | | Total current liabilities | $50,291 | $25,031 | | **Total liabilities** | **$51,713** | **$27,197** | | **Total stockholders' equity** | **$177,468** | **$355,970** | [Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For FY2023, total operating expenses were **$212.8 million**, resulting in a net loss of **$198.6 million**, or **$1.81 per share**, an improvement from 2022 Consolidated Statement of Operations Summary (in thousands, except per share data) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $158,658 | $179,214 | | Selling, general and administrative | $49,125 | $47,044 | | Total operating expenses | $212,758 | $248,031 | | Loss from operations | ($212,758) | ($248,031) | | Other income, net | $14,115 | $6,714 | | **Net loss** | **($198,643)** | **($241,317)** | | **Net loss per share, basic and diluted** | **($1.81)** | **($2.23)** | [Company and Product Information](index=2&type=section&id=Company%20and%20Product%20Information) This section details PEMGARDA, an investigational monoclonal antibody for COVID-19 PrEP, and Invivyd's focus on antibody-based therapies [About PEMGARDA](index=2&type=section&id=About%20PEMGARDA) PEMGARDA is an investigational half-life extended monoclonal antibody targeting SARS-CoV-2, with EUA based on immunobridging and in vitro activity against variants - PEMGARDA is a half-life extended investigational monoclonal antibody engineered from adintrevimab[8](index=8&type=chunk) - It demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, by targeting the spike protein RBD[8](index=8&type=chunk) - The EUA was supported by an immunobridging approach, which has limitations due to reliance on data from different populations and non-circulating variants[11](index=11&type=chunk) - PEMGARDA is not authorized for the treatment of COVID-19 or for post-exposure prophylaxis[10](index=10&type=chunk) [About Invivyd](index=3&type=section&id=About%20Invivyd) Invivyd is a commercial-stage biopharmaceutical company focused on delivering antibody-based therapies for viral threats using its INVYMAB™ platform - Invivyd is a commercial-stage company focused on rapidly delivering antibody-based therapies for circulating viral threats[13](index=13&type=chunk) - The proprietary INVYMAB™ platform facilitates rapid, serial generation of new monoclonal antibodies to keep pace with evolving viruses[13](index=13&type=chunk) [Important Safety Information for PEMGARDA](index=7&type=section&id=IMPORTANT%20SAFETY%20INFORMATION) This section details critical safety information for PEMGARDA, including a boxed warning for anaphylaxis, contraindications, and common adverse reactions [Boxed Warning: Anaphylaxis](index=7&type=section&id=WARNING%3A%20ANAPHYLAXIS) PEMGARDA carries a boxed warning for anaphylaxis, observed in **0.6%** of participants, requiring administration in settings with immediate access to treatment and post-infusion monitoring - Anaphylaxis, observed in **0.6%** (4/623) of clinical trial participants, can be life-threatening with PEMGARDA[22](index=22&type=chunk) - PEMGARDA must be administered in settings with immediate access to anaphylaxis treatment medications[22](index=22&type=chunk) - Patients require clinical monitoring during infusion and for at least two hours post-completion[22](index=22&type=chunk) [Contraindications, Warnings, and Precautions](index=8&type=section&id=Contraindications%2C%20Warnings%2C%20and%20Precautions) PEMGARDA is contraindicated for prior severe hypersensitivity, with warnings for serious hypersensitivity, cross-hypersensitivity with COVID-19 vaccines, and potential ineffectiveness against emerging variants - Contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any PEMGARDA component[23](index=23&type=chunk) - Risk of cross-hypersensitivity with COVID-19 vaccines exists due to PEMGARDA containing polysorbate 80, similar to PEG in some vaccines[25](index=25&type=chunk) - Emerging SARS-CoV-2 viral variants may not be neutralized by PEMGARDA, rendering it ineffective against those strains[26](index=26&type=chunk) [Adverse Reactions and Use in Specific Populations](index=8&type=section&id=Adverse%20Reactions%20and%20Use%20in%20Specific%20Populations) Common adverse events (**≥2%**) include infusion reactions, respiratory infection, fatigue, headache, and nausea; data is insufficient for pregnancy/lactation, and it is not authorized for children under 12 or **40 kg** - Most common adverse events (incidence **≥2%**) include systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea[27](index=27&type=chunk) - Insufficient data exists to evaluate risks associated with use during pregnancy or lactation[28](index=28&type=chunk)[29](index=29&type=chunk) - PEMGARDA is not authorized for use in children under 12 years of age or weighing less than **40 kg**[30](index=30&type=chunk) [Emergency Use Authorization (EUA) Details](index=9&type=section&id=EMERGENCY%20USE%20AUTHORIZATION%20%28EUA%29%20FOR%20PEMGARDA) PEMGARDA's EUA is for COVID-19 pre-exposure prophylaxis in specific immunocompromised adults and adolescents, not for treatment or post-exposure, and requires mandatory adverse event reporting - Authorized for COVID-19 pre-exposure prophylaxis in adults and adolescents (**≥12 years**, **≥40 kg**) with moderate-to-severe immune compromise unlikely to mount an adequate vaccine response[31](index=31&type=chunk)[35](index=35&type=chunk) - PEMGARDA is not authorized for COVID-19 treatment or post-exposure prophylaxis[35](index=35&type=chunk) - Healthcare providers are responsible for mandatory reporting of all serious adverse events and medication errors to the FDA MedWatch program[36](index=36&type=chunk)[37](index=37&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward%20Looking%20Statements) This section contains forward-looking statements about PEMGARDA's potential, commercialization, and financial outlook, subject to significant risks and uncertainties detailed in SEC filings [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward%20Looking%20Statements) This section contains forward-looking statements about PEMGARDA's potential, commercialization, and financial outlook, subject to significant risks and uncertainties detailed in SEC filings - The press release includes forward-looking statements regarding PEMGARDA's potential, commercialization, INVYMAB platform, R&D, and cash runway[14](index=14&type=chunk) - These statements involve risks and uncertainties, including EUA duration, commercialization success, regulatory changes, manufacturing complexities, and market competition[14](index=14&type=chunk)[15](index=15&type=chunk) - Investors are advised against undue reliance on these statements and directed to the 'Risk Factors' section in SEC filings for potential risks[15](index=15&type=chunk)

Financial Data and Key Metrics Changes - Invivyd ended Q3 2023 with approximately $265 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into Q4 2024 without any revenue from VYD222 [53] Business Line Data and Key Metrics Changes - The CANOPY trial for VYD222 has completed enrollment with approximately 750 participants, including around 300 immunocompromised individuals, indicating strong progress in clinical development [6][12] - Cohort B of the CANOPY trial enrolled approximately 450 individuals at risk for exposure to SARS-CoV-2, with a focus on building a safety database for VYD222 [34] Market Data and Key Metrics Changes - There are over 9 million immunocompromised individuals at risk for severe COVID-19 in the U.S., with a targeted initial launch focus on approximately 485,000 individuals at the highest risk [37][62] - Market research indicates that 76% of U.S. physicians would be likely to use Evusheld for their immunocompromised patients if it were available, highlighting ongoing market opportunities [40] Company Strategy and Development Direction - The company is strategically positioned to address the evolving COVID-19 landscape through its proprietary INVYMAB platform, which combines viral surveillance and advanced antibody engineering [7][14] - Invivyd aims to apply for Emergency Use Authorization (EUA) for VYD222 as soon as possible, with initial primary endpoint data expected in late 2023 or early Q1 2024 [28][29] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgent need for new monoclonal antibodies for immunocompromised individuals, who remain at high risk for COVID-19 despite vaccination efforts [8][14] - The company is optimistic about the potential for VYD222 to meet significant unmet medical needs and is preparing for a commercial launch in 2024 [44][85] Other Important Information - The company has begun manufacturing commercial inventory of VYD222 in anticipation of a potential EUA submission [42] - The management team includes experienced leaders with a strong track record in launching products in the biotechnology sector [43] Q&A Session Summary Question: Enrollment completion in the CANOPY Phase 3 trial - Management confirmed that the primary endpoint at Day 28 is the immunobridging endpoint or serum neutralizing titers compared to historical data from the adintrevimab trial [56] Question: Gating factors for submission - Management stated that the gating components include collecting preliminary primary endpoint data and combining it with the rest of the data package for the EUA submission [66] Question: Expected launch trajectory and manufacturing scale - Management indicated that the initial focus for the launch will be on the highest risk groups, including stem cell transplant recipients and solid organ transplant recipients [62] Question: Size of the sales force needed for targeted population - Management noted that a relatively small commercial footprint would be needed to capitalize on the concentrated market of immunocompromised individuals [76] Question: Updates on in vitro neutralization assay - Management confirmed that updates to the neutralization assay are made in real-time as new data becomes available, and they are pursuing the PrEP indication only [73]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-40703 INVIVYD, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 8 ...

Invivyd, Inc. (NASDAQ:IVVD) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Gabriella Linville-Engler - Investor Relations Dave Hering - Chief Financial Officer Pete Schmidt - Chief Medical Officer Conference Call Participants Maxwell Skor - Morgan Stanley Evan Wang - Guggenheim Patrick Trucchio - H.C. Wainwright Operator Welcome to the Invivyd Second Quarter 2023 Business and Financial Results Update Call. I will now turn the call over to Gabriella Linville-Engler, Directo ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Invivyd, Inc. as of June 30, 2023, show a net loss of $50.2 million for the second quarter and $85.5 million for the first six months of the year, with total assets of $315.4 million primarily in cash and marketable securities [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $315.4 million from $383.2 million at year-end 2022, driven by a reduction in marketable securities, while liabilities increased and equity decreased reflecting the net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,947 | $92,076 | | Marketable securities | $176,483 | $279,915 | | Total current assets | $309,986 | $376,917 | | **Total assets** | **$315,414** | **$383,167** | | **Liabilities & Equity** | | | | Total current liabilities | $32,505 | $25,031 | | Total liabilities | $33,851 | $27,197 | | Total stockholders' equity | $281,563 | $355,970 | | **Total liabilities and stockholders' equity** | **$315,414** | **$383,167** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2023, the net loss was $50.2 million, comparable to Q2 2022, while the six-month net loss improved significantly to $85.5 million from $151.7 million due to decreased research and development expenses, with no revenue generated Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | Six Months 2023 | Six Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $43,618 | $37,129 | $70,819 | $129,164 | | Selling, general and administrative | $10,107 | $14,620 | $21,152 | $23,324 | | Total operating expenses | $53,875 | $51,749 | $92,946 | $152,488 | | Loss from operations | $(53,875) | $(51,749) | $(92,946) | $(152,488) | | Net loss | $(50,228) | $(50,990) | $(85,549) | $(151,656) | | Net loss per share, basic and diluted | $(0.46) | $(0.47) | $(0.78) | $(1.40) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Total stockholders' equity decreased from $356.0 million at year-end 2022 to $281.6 million at June 30, 2023, primarily due to the $85.5 million net loss, partially offset by stock-based compensation and option exercises - The accumulated deficit grew from **$533.4 million** at the end of 2022 to **$619.0 million** as of June 30, 2023, reflecting the ongoing net losses[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities was $78.6 million, offset by $107.6 million from investing activities and $0.8 million from financing activities, resulting in a net increase of $29.9 million in cash and cash equivalents Six-Month Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(78,572) | $(116,441) | | Net cash provided by investing activities | $107,631 | $48,983 | | Net cash provided by financing activities | $812 | $119 | | **Net increase (decrease) in cash** | **$29,871** | **$(67,339)** | | Cash and cash equivalents at end of period | $121,947 | $474,885 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on antibody-based therapies for viral threats, particularly SARS-CoV-2 with lead candidate VYD222, and outline significant accounting policies, collaboration agreements, commitments, and the expectation that current cash will fund operations for at least the next 12 months despite ongoing losses - The company's mission is to deliver antibody-based therapies for viral threats, starting with SARS-CoV-2, with its lead candidate, VYD222, in development for preventing symptomatic COVID-19 in vulnerable populations[27](index=27&type=chunk)[28](index=28&type=chunk) - The company has not generated any revenue since inception and has an accumulated deficit of **$619.0 million** as of June 30, 2023, but management expects existing cash, cash equivalents, and marketable securities to fund operations for at least 12 months from the report's issuance date[34](index=34&type=chunk)[36](index=36&type=chunk) - The company has multiple agreements with Adimab for antibody discovery, development, and platform technology, involving potential milestone payments up to **$24.6 million** under the Assignment Agreement and up to **$18.0 million** per product under the Collaboration Agreement, plus royalties[62](index=62&type=chunk)[65](index=65&type=chunk)[73](index=73&type=chunk) - As of June 30, 2023, the company had noncancelable purchase obligations of **$10.4 million** for resin and less than **$0.1 million** for VYD222 drug substance batches with WuXi Biologics, with an additional **$4.3 million** commitment for materials made in July 2023[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing antibody therapies for viral threats, led by its COVID-19 candidate, VYD222, for which positive initial Phase 1 data were announced and a potential EUA pathway aligned with the FDA, with the financial analysis showing a reduced net loss of $85.5 million for the first six months of 2023 due to strategic shifts in R&D spending, and existing cash of $298.4 million expected to fund operations into Q4 2024 [Overview](index=29&type=section&id=Overview) The company focuses on developing antibody-based therapies for viral threats, with lead candidate VYD222 showing positive initial Phase 1 data against Omicron XBB.1.5, aligning with the FDA on a potential EUA pathway, and planning a pivotal CANOPY trial with initial data expected by year-end 2023, employing a "serial monotherapy" strategy - Positive initial data from the Phase 1 trial of VYD222 showed it was generally well-tolerated and demonstrated robust neutralization activity against Omicron XBB.1.5[173](index=173&type=chunk) - The company has reached general alignment with the FDA on a pathway to a potential Emergency Use Authorization (EUA) for VYD222, utilizing an immunobridging approach based on serum neutralizing titers[174](index=174&type=chunk) - A pivotal clinical trial for VYD222, named CANOPY, is planned to initiate, with initial primary endpoint data expected by the end of 2023[175](index=175&type=chunk)[176](index=176&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) For Q2 2023, the net loss was $50.2 million, with R&D expenses increasing to $43.6 million due to the VYD222 program, while the six-month net loss decreased to $85.5 million from $151.7 million year-over-year, primarily due to a $58.4 million reduction in R&D expenses as spending shifted from the adintrevimab to the VYD222 program Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $43,618 | $37,129 | $6,489 | | Selling, general and administrative | $10,107 | $14,620 | $(4,513) | | **Total operating expenses** | **$53,875** | **$51,749** | **$2,126** | | **Net loss** | **$(50,228)** | **$(50,990)** | **$762** | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $70,819 | $129,164 | $(58,345) | | Selling, general and administrative | $21,152 | $23,324 | $(2,172) | | **Total operating expenses** | **$92,946** | **$152,488** | **$(59,542)** | | **Net loss** | **$(85,549)** | **$(151,656)** | **$66,107** | - The primary driver for the change in R&D expenses was the shift in focus from the adintrevimab program, which saw expenses decrease by **$97.6 million** in the first half of 2023, to the VYD222 program, which incurred **$40.4 million** in costs during the same period[209](index=209&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held $298.4 million in cash, cash equivalents, and marketable securities, with net cash used in operations of $78.6 million for the first six months, and believes its current capital is sufficient to fund operations into Q4 2024, though substantial additional funding will be required for long-term operations and commercialization - The company had cash, cash equivalents, and marketable securities totaling **$298.4 million** as of June 30, 2023[215](index=215&type=chunk) - Management believes that existing cash resources are sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2024[186](index=186&type=chunk)[222](index=222&type=chunk) Six-Month Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(78,572) | $(116,441) | | Net cash provided by investing activities | $107,631 | $48,983 | | Net cash provided by financing activities | $812 | $119 | | **Net increase (decrease) in cash** | **$29,871** | **$(67,339)** | [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, Invivyd, Inc. is not required to provide quantitative and qualitative disclosures about market risk[231](index=231&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer, evaluated the company's disclosure controls and procedures as of June 30, 2023, concluding they were effective at a reasonable assurance level, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2023, the Chief Executive Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[232](index=232&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[233](index=233&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is facing a securities class action lawsuit filed on January 31, 2023, alleging false and misleading statements about ADG20's effectiveness against the Omicron variant, which the company intends to defend vigorously, while an SEC investigation into similar matters concluded on August 9, 2023, with no recommended action - A securities class action lawsuit was filed against the company and former officers concerning statements about ADG20's effectiveness against the Omicron variant, and the company plans to defend itself vigorously[236](index=236&type=chunk)[237](index=237&type=chunk) - On August 9, 2023, the SEC concluded its investigation regarding the company's statements on ADG20's efficacy against Omicron and notified the company that it does not intend to recommend any enforcement action[238](index=238&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 - No material changes have occurred to the risk factors disclosed in the company's 2022 Form 10-K[239](index=239&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not issue any unregistered equity securities during the three months ended June 30, 2023, but repurchased 46,600 shares of common stock in May 2023 at an average price of $0.002 per share related to employee cessation of service - No unregistered equity securities were issued during the second quarter of 2023[240](index=240&type=chunk) - In May 2023, the company repurchased **46,600 shares** of common stock at an average price of **$0.002 per share** from former employees[241](index=241&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) On August 8, 2023, the Board of Directors designated David Hering, the company's Chief Executive Officer, to also serve as the company's principal financial officer, effective immediately, with no changes to his compensation arrangement - Effective August 8, 2023, CEO David Hering was also designated as the company's principal financial officer[242](index=242&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, certifications, and XBRL data files

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Invivyd, Inc.'s unaudited condensed consolidated financial statements for Q1 2023, including balance sheets, statements of operations, equity, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from $383.2 million to $350.6 million, driven by reduced marketable securities, while total liabilities and stockholders' equity also decreased | Metric (in thousands) | March 31, 2023 | December 31, 2022 | Change | | :-------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $126,473 | $92,076 | +$34,397 | | Marketable securities | $206,955 | $279,915 | -$72,960 | | Total current assets | $344,623 | $376,917 | -$32,294 | | Total assets | $350,564 | $383,167 | -$32,603 | | Total current liabilities | $22,057 | $25,031 | -$2,974 | | Total liabilities | $23,815 | $27,197 | -$3,382 | | Total stockholders' equity | $326,749 | $355,970 | -$29,221 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $35.3 million for Q1 2023, a significant improvement from $100.7 million in Q1 2022, primarily due to reduced R&D expenses | Metric (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :-------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $27,201 | $92,035 | -$64,834 | | Acquired in-process R&D | $825 | $0 | +$825 | | Selling, general and administrative | $11,045 | $8,704 | +$2,341 | | Total operating expenses | $39,071 | $100,739 | -$61,668 | | Loss from operations | $(39,071) | $(100,739) | +$61,668 | | Other income | $3,750 | $73 | +$3,677 | | Net loss | $(35,321) | $(100,666) | +$65,345 | | Net loss per share (basic & diluted) | $(0.32) | $(0.93) | +$0.61 | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Total stockholders' equity decreased from $356.0 million to $326.7 million, mainly due to the net loss, partially offset by stock-based compensation and option exercises | Metric (in thousands) | December 31, 2022 | March 31, 2023 | Change | | :-------------------- | :---------------- | :------------- | :----- | | Common stock | $11 | $11 | $0 | | Additional paid-in capital | $889,657 | $895,600 | +$5,943 | | Accumulated other comprehensive loss | $(272) | $(115) | +$157 | | Accumulated deficit | $(533,426) | $(568,747) | -$35,321 | | Total stockholders' equity | $355,970 | $326,749 | -$29,221 | - Key activities impacting equity included **$5.4 million** in stock-based compensation expense, **$459 thousand** from stock option exercises, and a net loss of **$35.3 million**[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by $34.4 million in Q1 2023, a significant improvement from a $10.0 million decrease in Q1 2022, driven by reduced operating cash use and increased investing cash | Metric (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :-------------------- | :-------------------------------- | :-------------------------------- | :----- | | Net cash used in operating activities | $(41,181) | $(59,049) | +$17,868 | | Net cash provided by investing activities | $75,036 | $49,000 | +$26,036 | | Net cash provided by financing activities | $542 | $45 | +$497 | | Net increase (decrease) in cash and cash equivalents | $34,397 | $(10,004) | +$44,401 | | Cash and cash equivalents at end of period | $126,473 | $532,220 | -$405,747 | - The decrease in cash used in operating activities was primarily due to a lower net loss and changes in operating assets and liabilities, including an increase in prepaid expenses and a decrease in accrued expenses[21](index=21&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and disclosures for the unaudited condensed consolidated financial statements, covering business, accounting policies, and various agreements [Note 1. Nature of the Business and Basis of Presentation](index=7&type=section&id=Note%201.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) Invivyd is a biopharmaceutical company developing antibody-based therapies for viral threats, with a Phase 1 clinical trial for VYD222 initiated in March 2023 - Invivyd is a biopharmaceutical company developing antibody-based therapies for viral threats, initially SARS-CoV-2, with plans to expand into influenza and other high-need indications[25](index=25&type=chunk) - In March 2023, the company began a Phase 1 clinical trial for VYD222, a monoclonal antibody candidate for COVID-19 prevention, and received FDA IND clearance in April 2023[26](index=26&type=chunk) - The company has not generated revenue since inception, incurred a net loss of **$35.3 million** for Q1 2023, and has an accumulated deficit of **$568.7 million** as of March 31, 2023[32](index=32&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=8&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) The company's financial statements are prepared in accordance with U.S. GAAP, with ASU 2016-13 adopted in January 2023, having an immaterial impact - The company adopted ASU 2016-13, "Financial Instruments-Credit Losses," on January 1, 2023, with an immaterial impact on its financial statements[40](index=40&type=chunk) - The condensed consolidated financial statements are unaudited and prepared in conformity with U.S. GAAP, with certain disclosures condensed or omitted per SEC rules for interim reporting[41](index=41&type=chunk)[42](index=42&type=chunk) [Note 3. Marketable Securities](index=9&type=section&id=Note%203.%20Marketable%20Securities) Marketable securities, classified as available-for-sale debt securities, decreased to $207.0 million at March 31, 2023, from $279.9 million at December 31, 2022 | Marketable Securities (in thousands) | March 31, 2023 Fair Value | December 31, 2022 Fair Value | Change | | :--------------------------------- | :------------------------ | :--------------------------- | :----- | | U.S. Treasury securities | $90,935 | $107,871 | -$16,936 | | Federal agency securities | $116,020 | $172,044 | -$56,024 | | Total financial assets | $206,955 | $279,915 | -$72,960 | - No available-for-sale marketable securities held as of March 31, 2023, or December 31, 2022, had remaining maturities greater than twelve months[50](index=50&type=chunk) [Note 4. Fair Value Measurements](index=10&type=section&id=Note%204.%20Fair%20Value%20Measurements) Financial assets and liabilities are classified into a three-level hierarchy, with cash equivalents and U.S. Treasury securities as Level 1, and federal agency securities as Level 2 | Fair Value Measurements (in thousands) | Level 1 (March 31, 2023) | Level 2 (March 31, 2023) | Total (March 31, 2023) | Level 1 (December 31, 2022) | Level 2 (December 31, 2022) | Total (December 31, 2022) | | :----------------------------------- | :----------------------- | :----------------------- | :--------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Money market funds | $124,198 | $0 | $124,198 | $91,050 | $0 | $91,050 | | U.S. Treasury securities | $90,935 | $0 | $90,935 | $107,871 | $0 | $107,871 | | Federal agency securities | $0 | $116,020 | $116,020 | $0 | $172,044 | $172,044 | | Total | $215,133 | $116,020 | $331,153 | $198,921 | $172,044 | $370,965 | - Money market funds and U.S. Treasury securities are valued using Level 1 inputs (quoted market prices), while federal agency securities are valued using Level 2 inputs (quoted prices for similar securities or observable market data)[52](index=52&type=chunk)[53](index=53&type=chunk) [Note 5. Prepaid Expenses and Other Current Assets](index=11&type=section&id=Note%205.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets increased significantly to $11.2 million at March 31, 2023, from $4.9 million at December 31, 2022, primarily due to higher prepaid R&D and manufacturing costs | Prepaid Expenses (in thousands) | March 31, 2023 | December 31, 2022 | Change | | :------------------------------ | :------------- | :---------------- | :----- | | Prepaid external R&D and manufacturing costs | $7,145 | $843 | +$6,302 | | Prepaid insurance | $1,968 | $2,392 | -$424 | | Prepaid compensation and other | $1,549 | $1,314 | +$235 | | Interest receivable | $533 | $377 | +$156 | | Total | $11,195 | $4,926 | +$6,269 | [Note 6. Accrued Expenses](index=11&type=section&id=Note%206.%20Accrued%20Expenses) Accrued expenses decreased to $14.5 million at March 31, 2023, from $21.9 million at December 31, 2022, mainly due to reductions in accrued external R&D, manufacturing, and employee compensation costs | Accrued Expenses (in thousands) | March 31, 2023 | December 31, 2022 | Change | | :------------------------------ | :------------- | :---------------- | :----- | | Accrued external R&D and manufacturing costs | $10,992 | $13,955 | -$2,963 | | Accrued professional and consultant fees | $1,940 | $1,153 | +$787 | | Accrued employee compensation | $1,428 | $5,985 | -$4,557 | | Other | $141 | $818 | -$677 | | Total | $14,501 | $21,911 | -$7,410 | [Note 7. License and Collaboration Agreements](index=11&type=section&id=Note%207.%20License%20and%20Collaboration%20Agreements) Invivyd has key agreements with Adimab and WuXi Biologics for antibody discovery, development, and manufacturing, involving milestone payments, royalties, and service fees [Adimab Assignment Agreement](index=11&type=section&id=Adimab%20Assignment%20Agreement) Invivyd is obligated to pay Adimab up to $24.6 million in development and regulatory milestones, with $0.4 million incurred in Q1 2023 for VYD222's Phase 1 trial - Invivyd is obligated to pay Adimab up to **$24.6 million** in development and regulatory milestones for products, with **$7.5 million** paid by December 31, 2022[61](index=61&type=chunk) - In March 2023, a **$0.4 million** milestone payment was incurred and recognized as acquired IPR&D expense upon dosing the first subject in the VYD222 Phase 1 clinical trial[62](index=62&type=chunk) - The company recognized no R&D expense for Adimab services under this agreement in Q1 2023, compared to **$0.3 million** in Q1 2022[60](index=60&type=chunk) [Adimab Collaboration Agreement](index=12&type=section&id=Adimab%20Collaboration%20Agreement) Invivyd pays Adimab a quarterly fee of $1.3 million for exclusivity and services, with R&D expenses of $0.2 million in Q1 2023, and potential milestones up to $18.0 million per product - Invivyd pays Adimab a quarterly fee of **$1.3 million** for exclusivity and services, recognized as R&D expense in both Q1 2023 and Q1 2022[67](index=67&type=chunk) - R&D expense for Adimab services under this agreement was **$0.2 million** in Q1 2023, a decrease from **$0.4 million** in Q1 2022[68](index=68&type=chunk) - The company is obligated to pay up to **$18.0 million** in development and regulatory milestones for each product and mid-single-digit royalties on net sales[69](index=69&type=chunk) [Adimab Platform Transfer Agreement](index=13&type=section&id=Adimab%20Platform%20Transfer%20Agreement) This agreement grants Invivyd rights to Adimab's platform technology, with an upfront fee of $3.0 million recognized in September 2022, and no expense recognized in Q1 2023 - The company recognized **$3.0 million** as IPR&D expense in September 2022 for upfront consideration under this agreement[73](index=73&type=chunk) - Invivyd is obligated to pay annual fees for platform improvements and up to **$9.5 million** in development and regulatory milestones per product, plus low single-digit royalties on net sales[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - No expense was recognized in Q1 2023 under this agreement, as it was not effective in Q1 2022[149](index=149&type=chunk) [WuXi Biologics Cell Line License Agreement](index=14&type=section&id=WuXi%20Biologics%20Cell%20Line%20License%20Agreement) Invivyd recognized $0.4 million in license fees as IPR&D expense in February 2023 for additional Licensed Cell Lines, with royalties of less than 1.0% due on net sales - In February 2023, Invivyd recognized **$0.4 million** in license fees as IPR&D expense for additional Licensed Cell Lines[80](index=80&type=chunk)[83](index=83&type=chunk) - Royalties of less than **1.0%** are payable on net sales of Licensed Products, unless WuXi Biologics manufactures all commercial supplies[81](index=81&type=chunk) [Research Collaboration and License Agreement with The Scripps Research Institute](index=14&type=section&id=Research%20Collaboration%20and%20License%20Agreement%20with%20The%20Scripps%20Research%20Institute) This agreement for influenza and beta coronavirus vaccine candidates was terminated in April 2022, resulting in no R&D expense recognized in Q1 2023 - The Research Agreement with TSRI was terminated in April 2022[85](index=85&type=chunk) - No R&D expense was recognized in Q1 2023, compared to **$0.9 million** in Q1 2022, due to the termination of the agreement[86](index=86&type=chunk) [Note 8. Population Health Partners, L.P.](index=15&type=section&id=Note%208.%20Population%20Health%20Partners,%20L.P.) Invivyd recognized $1.5 million in R&D expense for advisory services from PHP in Q1 2023 and issued a warrant for 6,824,712 common shares to PHP - Invivyd recognized **$1.5 million** in R&D expense for Q1 2023 related to advisory services from PHP, with a monthly cash fee of **$0.5 million**[89](index=89&type=chunk)[154](index=154&type=chunk) - A warrant to purchase **6,824,712** shares of common stock was issued to PHP in November 2022, vesting upon achievement of market capitalization targets or a change of control[90](index=90&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) [Note 9. Commitments and Contingencies](index=16&type=section&id=Note%209.%20Commitments%20and%20Contingencies) Invivyd has operating lease commitments totaling $3.6 million, $15.1 million in contractual obligations for VYD222 drug substance, and is involved in a securities class action lawsuit and SEC inquiry [Operating Lease Commitments](index=16&type=section&id=Operating%20Lease%20Commitments) Invivyd has noncancelable operating leases for office and laboratory space, with total lease cost of $0.442 million for Q1 2023 and future minimum payments of $3.578 million | Lease Cost (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Operating lease cost | $430 | $105 | | Variable lease cost | $12 | $8 | | Total lease cost | $442 | $113 | | Year Ending December 31, | Operating Lease Payments (in thousands) | | :----------------------- | :-------------------------------------- | | 2023 (remaining) | $1,299 | | 2024 | $1,521 | | 2025 | $430 | | 2026 | $328 | | Total lease payments | $3,578 | | Present value adjustment | $(235) | | Present value of operating lease liability | $3,343 | [Clinical and Manufacturing Agreements](index=17&type=section&id=Clinical%20and%20Manufacturing%20Agreements) Contractually binding VYD222 drug substance batches total $15.1 million, expected to be incurred and paid in 2023, with a low eight-figure credit applied from WuXi Biologics - The total remaining cost of contractually binding VYD222 drug substance batches to be manufactured under the Clinical Master Services Agreement is **$15.1 million**, expected to be incurred and paid in 2023[108](index=108&type=chunk) - A low eight-figure credit from WuXi Biologics was applied as a reduction of R&D expenses and accounts payable during Q1 2023[108](index=108&type=chunk) [Legal Proceedings](index=18&type=section&id=Legal%20Proceedings) Invivyd faces a securities class action lawsuit alleging misleading statements about ADG20's effectiveness and is cooperating with an SEC inquiry regarding ADG20's efficacy - A securities class action lawsuit was filed on January 31, 2023, alleging violations of securities laws due to purportedly false and misleading statements regarding ADG20's effectiveness against the Omicron variant[113](index=113&type=chunk) - The SEC requested documents and information concerning ADG20's efficacy testing and public statements, to which the company intends to cooperate fully[115](index=115&type=chunk) [Note 10. Common Stock](index=18&type=section&id=Note%2010.%20Common%20Stock) As of March 31, 2023, 43,892,474 shares of common stock were reserved for future issuance, and 206,802 unvested restricted shares were repurchased and retired in March 2023 - As of March 31, 2023, **43,892,474** shares of common stock were reserved for future issuance under equity incentive plans[117](index=117&type=chunk) - In March 2023, the company repurchased and retired **206,802** shares of unvested restricted common stock due to an employee's termination of service[121](index=121&type=chunk) [Note 11. Stock-Based Compensation](index=19&type=section&id=Note%2011.%20Stock-Based%20Compensation) Stock-based compensation expense for Q1 2023 was $5.4 million, with $53.8 million in unrecognized expense remaining, and the PHP Warrant had a grant date fair value of $17.4 million [Stock Option Activity](index=20&type=section&id=Stock%20Option%20Activity) As of March 31, 2023, 23,883,782 stock options were outstanding with a weighted-average exercise price of $6.28, and the grant date fair value of options granted in Q1 2023 was $1.34 | Stock Option Activity | Outstanding at Dec 31, 2022 | Granted (Q1 2023) | Exercised (Q1 2023) | Forfeited (Q1 2023) | Outstanding at Mar 31, 2023 | | :-------------------- | :-------------------------- | :---------------- | :------------------ | :------------------ | :-------------------------- | | Number of Shares | 23,239,391 | 3,064,800 | (423,203) | (1,997,206) | 23,883,782 | | Weighted Average Exercise Price | $7.01 | $2.11 | $0.78 | $9.49 | $6.28 | - The weighted-average grant date fair value of stock options granted was **$1.34** per share for Q1 2023, compared to **$4.23** per share for Q1 2022[129](index=129&type=chunk) [Stock-Based Compensation Expense](index=21&type=section&id=Stock-Based%20Compensation%20Expense) Total stock-based compensation expense for Q1 2023 was $5.4 million, an increase from $2.0 million in Q1 2022, with most allocated to SG&A expenses | Expense Category (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :------------------------------ | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $2,263 | $3,153 | -$890 | | Selling, general and administrative | $3,137 | $(1,170) | +$4,307 | | Total | $5,400 | $1,983 | +$3,417 | - As of March 31, 2023, total unrecognized stock-based compensation expense was **$53.8 million**, expected to be recognized over a weighted-average period of **2.7 years**[133](index=133&type=chunk) [Warrant Expense](index=22&type=section&id=Warrant%20Expense) The PHP Warrant, issued in November 2022, had an aggregate grant date fair value of $17.4 million, recognized as warrant expense on the grant date - The aggregate grant date fair value of the PHP Warrant was **$17.4 million**, recognized as warrant expense in November 2022[137](index=137&type=chunk) - As of March 31, 2023, **6,824,712** warrants were outstanding with a weighted-average exercise price of **$3.48** and a remaining contractual term of **9.64 years**[137](index=137&type=chunk) [Note 12. Income Taxes](index=22&type=section&id=Note%2012.%20Income%20Taxes) The company recorded no income tax benefits for net operating losses or R&D tax credits in Q1 2023 and Q1 2022 due to uncertainty of realizing a benefit - No income tax benefits were recorded for net operating losses or R&D tax credits in Q1 2023 and Q1 2022 due to uncertainty of realization[138](index=138&type=chunk) [Note 13. Defined Contribution Plan](index=22&type=section&id=Note%2013.%20Defined%20Contribution%20Plan) Invivyd contributed $0.2 million to its 401(k) Plan in both Q1 2023 and Q1 2022, representing 3% of eligible participants' compensation - The company contributed **$0.2 million** to its 401(k) Plan in both Q1 2023 and Q1 2022, representing **3%** of eligible participants' compensation[139](index=139&type=chunk) [Note 14. Net Loss per Share](index=22&type=section&id=Note%2014.%20Net%20Loss%20per%20Share) Basic and diluted net loss per share for Q1 2023 was $(0.32), a significant improvement from $(0.93) in Q1 2022, with potential dilutive securities excluded | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :----- | :-------------------------------- | :-------------------------------- | :----- | | Net loss attributable to common stockholders | $(35,321) | $(100,666) | +$65,345 | | Weighted-average common shares outstanding | 108,785,519 | 107,869,570 | +915,949 | | Net loss per share (basic and diluted) | $(0.32) | $(0.93) | +$0.61 | - Potential dilutive securities, including stock options and warrants, were excluded from diluted EPS calculation as their effect was anti-dilutive[141](index=141&type=chunk)[142](index=142&type=chunk) [Note 15. Related Party Transactions](index=23&type=section&id=Note%2015.%20Related%20Party%20Transactions) Invivyd has ongoing related party transactions primarily with Adimab and Population Health Partners, L.P., involving milestone payments, R&D service fees, and cash compensation [Adimab Assignment Agreement](index=23&type=section&id=Adimab%20Assignment%20Agreement) In Q1 2023, Invivyd recognized $0.4 million as IPR&D expense for a milestone payment to Adimab, with no R&D expense for Adimab services - In Q1 2023, Invivyd recognized **$0.4 million** as IPR&D expense for a milestone payment to Adimab, compared to **$0** in Q1 2022[145](index=145&type=chunk) - No R&D expense was recognized for Adimab services in Q1 2023, down from **$0.3 million** in Q1 2022[146](index=146&type=chunk) [Adimab Collaboration Agreement](index=23&type=section&id=Adimab%20Collaboration%20Agreement) Invivyd recognized $1.3 million in R&D expense for the quarterly fee to Adimab in both Q1 2023 and Q1 2022, with R&D expense for services at $0.2 million in Q1 2023 - Invivyd recognized **$1.3 million** in R&D expense for the quarterly fee to Adimab in both Q1 2023 and Q1 2022[147](index=147&type=chunk) - R&D expense for Adimab services was **$0.2 million** in Q1 2023, down from **$0.4 million** in Q1 2022[148](index=148&type=chunk) [Adimab Platform Transfer Agreement](index=23&type=section&id=Adimab%20Platform%20Transfer%20Agreement) No expense was recognized in Q1 2023 under this agreement, as it was not effective in Q1 2022 - No expense was recognized in Q1 2023 under this agreement, as it was not effective in Q1 2022[149](index=149&type=chunk) [Population Health Partners, L.P.](index=24&type=section&id=Population%20Health%20Partners,%20L.P.) Invivyd recognized $1.5 million in R&D expense for services from PHP in Q1 2023, with $0.8 million due to PHP as of March 31, 2023 - Invivyd recognized **$1.5 million** in R&D expense for services from PHP in Q1 2023; these agreements were not effective in Q1 2022[154](index=154&type=chunk) - As of March 31, 2023, **$0.8 million** was due to PHP by the company[154](index=154&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Invivyd's financial condition and operational results for Q1 2023, highlighting R&D expenses, ongoing losses, and liquidity [Cautionary Note Regarding Forward-Looking Statements](index=25&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section advises readers that the report contains forward-looking statements regarding future events, financial trends, and business prospects, subject to risks and uncertainties [Overview](index=26&type=section&id=Overview) Invivyd is a biopharmaceutical company focused on developing antibody therapies for viral threats, particularly VYD222 for COVID-19, and discusses significant R&D expenses, ongoing losses, and liquidity - Invivyd is a biopharmaceutical company developing antibody-based therapies for viral threats, starting with SARS-CoV-2, and is generating a pipeline for COVID-19, influenza, and other high-need indications[161](index=161&type=chunk) - In March 2023, the company initiated a Phase 1 clinical trial for VYD222, a COVID-19 prevention mAb candidate, with initial data anticipated in Q2 2023, and received FDA IND clearance in April 2023[162](index=162&type=chunk) - The company incurred a net loss of **$35.3 million** for Q1 2023 and has an accumulated deficit of **$568.7 million** as of March 31, 2023, expecting continued significant expenses and losses[169](index=169&type=chunk) [Impact of COVID-19 on Our Operations](index=28&type=section&id=Impact%20of%20COVID-19%20on%20Our%20Operations) The COVID-19 pandemic continues to impact Invivyd's operations, affecting VYD222's commercial prospects, clinical trial design, and supply chains, with the ultimate extent remaining uncertain - The COVID-19 pandemic continues to impact the potential commercial prospects of VYD222 and other product candidates, affecting clinical trial design, enrollment, and regulatory approval[174](index=174&type=chunk) - The company has experienced delays and disruptions in development activities due to the pandemic, with ongoing uncertainty regarding its ultimate impact on business, financial condition, and product development timelines[175](index=175&type=chunk) [Components of Our Results of Operations](index=28&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section details Invivyd's revenue, R&D, IPR&D, SG&A expenses, other income, and income tax components, noting no revenue to date and expensing R&D as incurred [Revenue](index=28&type=section&id=Revenue) The company has not generated any revenue from product sales or other sources since its inception - The company has not generated any revenue from product sales or other sources since its inception[176](index=176&type=chunk) [Research and Development Expenses](index=28&type=section&id=Research%20and%20Development%20Expenses) R&D expenses include costs for non-clinical and preclinical development, product candidate procurement, global clinical development, personnel, third-party services, laboratory expenses, and licensing payments, expected to increase substantially - R&D expenses include costs for non-clinical and preclinical development, product candidate procurement, global clinical development, personnel, third-party services (CROs, CDMOs, consultants), laboratory expenses, and licensing payments[177](index=177&type=chunk)[178](index=178&type=chunk)[181](index=181&type=chunk) - R&D costs are expensed as incurred, and non-refundable advance payments are recorded as prepaid expenses and expensed as goods are delivered or services performed[178](index=178&type=chunk) - The company expects R&D expenses to increase substantially as VYD222 advances through clinical development, new product candidates are pursued, and additional personnel are hired[180](index=180&type=chunk) [Acquired In-Process Research and Development ("IPR&D") Expenses](index=30&type=section&id=Acquired%20In-Process%20Research%20and%20Development%20(%22IPR%26D%22)%20Expenses) IPR&D expenses primarily consist of costs for contingent milestone payments to acquire rights to Adimab's antibodies and platform technology, expensed due to no alternative future use - IPR&D expenses primarily consist of costs for contingent milestone payments to acquire rights to Adimab's antibodies and platform technology, expensed because they had no alternative future use[185](index=185&type=chunk) [Selling, General and Administrative Expenses](index=30&type=section&id=Selling,%20General%20and%20Administrative%20Expenses) SG&A expenses include personnel-related costs, professional and consultant fees, insurance, and market research, expected to increase with business expansion and public company operations - SG&A expenses include personnel-related costs (salaries, bonuses, benefits, stock-based compensation), professional and consultant fees (legal, accounting, administrative), insurance, and market research[186](index=186&type=chunk) - SG&A expenses are expected to increase with business expansion, headcount growth, and costs associated with operating as a public company and potential commercialization efforts[187](index=187&type=chunk) [Other Income (Expense), Net](index=31&type=section&id=Other%20Income%20(Expense),%20Net) Other income primarily consists of interest earned from cash, cash equivalents, and marketable securities, and net amortization or accretion of premiums and discounts - Other income primarily consists of interest earned from cash, cash equivalents, and marketable securities, and net amortization/accretion of premiums/discounts on marketable securities[189](index=189&type=chunk) [Income Taxes](index=31&type=section&id=Income%20Taxes) The company has not recorded any income tax expense or benefits for net operating losses or R&D tax credits due to the uncertainty of realizing a benefit - The company has not recorded income tax expense or benefits for net losses or R&D tax credits due to uncertainty of realizing a benefit[190](index=190&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section compares Invivyd's financial performance for Q1 2023 versus Q1 2022, detailing changes in R&D, IPR&D, SG&A, and other income [Comparison of the three months ended March 31, 2023 and 2022](index=31&type=section&id=Comparison%20of%20the%20three%20months%20ended%20March%2031,%202023%20and%202022) Invivyd's net loss significantly decreased to $35.3 million in Q1 2023 from $100.7 million in Q1 2022, driven by reduced R&D expenses and increased other income | Metric (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :-------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $27,201 | $92,035 | -$64,834 | | Acquired in-process research and development | $825 | $0 | +$825 | | Selling, general and administrative | $11,045 | $8,704 | +$2,341 | | Total operating expenses | $39,071 | $100,739 | -$61,668 | | Loss from operations | $(39,071) | $(100,739) | +$61,668 | | Other income | $3,750 | $73 | +$3,677 | | Net loss | $(35,321) | $(100,666) | +$65,345 | [Research and Development Expenses](index=31&type=section&id=Research%20and%20Development%20Expenses) R&D expenses decreased by $64.8 million to $27.2 million in Q1 2023, primarily due to reduced adintrevimab program costs, partially offset by increased VYD222 and external discovery costs | R&D Expense (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Adintrevimab | $2,537 | $77,583 | -$75,046 | | VYD222 | $8,915 | $0 | +$8,915 | | Personnel-related costs | $7,296 | $9,512 | -$2,216 | | External discovery-related and other costs | $8,453 | $4,940 | +$3,513 | | Total R&D expenses | $27,201 | $92,035 | -$64,834 | - The **$75.0 million** decrease in adintrevimab program costs was due to reduced contract manufacturing (**$53.1 million**) and contract research expenses (**$19.7 million**) following clinical trial pauses and closures[192](index=192&type=chunk) - VYD222 program costs increased by **$8.9 million** due to IND-enabling activities and contract manufacturing for clinical trials[197](index=197&type=chunk) [Acquired In-Process Research and Development ("IPR&D") Expenses](index=32&type=section&id=Acquired%20In-Process%20Research%20and%20Development%20(%22IPR%26D%22)%20Expenses) IPR&D expenses were $0.8 million in Q1 2023, including milestone payments to Adimab and license fees to WuXi Biologics, with no IPR&D expense in Q1 2022 - IPR&D expenses were **$0.8 million** in Q1 2023, comprising a **$0.4 million** milestone payment to Adimab for VYD222 and **$0.4 million** in license fees to WuXi Biologics[193](index=193&type=chunk) - No IPR&D expense was recognized during Q1 2022[194](index=194&type=chunk) [Selling, General and Administrative Expenses](index=32&type=section&id=Selling,%20General%20and%20Administrative%20Expenses) SG&A expenses increased by $2.3 million to $11.0 million in Q1 2023, mainly due to higher personnel-related costs, partially offset by lower professional and consultant fees | SG&A Expense (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Personnel-related costs | $6,267 | $1,643 | +$4,624 | | Professional and consultant fees | $4,103 | $6,661 | -$2,558 | | Other | $675 | $400 | +$275 | | Total SG&A expenses | $11,045 | $8,704 | +$2,341 | - The **$4.6 million** increase in personnel-related costs was primarily due to the non-recurring reversal of stock-based compensation expense in Q1 2022 related to a former CEO's resignation[198](index=198&type=chunk) [Other Income](index=32&type=section&id=Other%20Income) Other income significantly increased to $3.8 million in Q1 2023, primarily from interest income and net accretion of discounts on marketable securities, up from less than $0.1 million in Q1 2022 - Other income increased to **$3.8 million** in Q1 2023, primarily from **$1.1 million** in interest income and **$2.7 million** in net accretion of discounts on marketable securities[196](index=196&type=chunk) - Other income was less than **$0.1 million** in Q1 2022[196](index=196&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) Invivyd has incurred significant operating losses and expects its $333.4 million in cash, equivalents, and marketable securities to fund operations into H2 2024, with future funding sought externally [Sources of Liquidity](index=32&type=section&id=Sources%20of%20Liquidity) Since inception, Invivyd has financed operations with $464.7 million from preferred stock sales and $327.5 million from its IPO, holding $333.4 million in cash, equivalents, and marketable securities - Since inception, Invivyd has financed operations with **$464.7 million** from preferred stock sales and **$327.5 million** from its IPO[199](index=199&type=chunk) - As of March 31, 2023, the company had **$333.4 million** in cash, cash equivalents, and marketable securities[199](index=199&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) In Q1 2023, net cash used in operating activities decreased to $41.2 million, while net cash provided by investing activities increased to $75.0 million, and financing activities provided $0.5 million | Cash Flow (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :----------------------- | :-------------------------------- | :-------------------------------- | :----- | | Net cash used in operating activities | $(41,181) | $(59,049) | +$17,868 | | Net cash provided by investing activities | $75,036 | $49,000 | +$26,036 | | Net cash provided by financing activities | $542 | $45 | +$497 | | Net increase (decrease) in cash and cash equivalents | $34,397 | $(10,004) | +$44,401 | [Funding Requirements](index=33&type=section&id=Funding%20Requirements) The company expects its $333.4 million in cash, equivalents, and marketable securities to fund operations into H2 2024, with future funding through equity, debt, collaborations, or grants - The company expects its **$333.4 million** in cash, cash equivalents, and marketable securities to fund operating expenses and capital expenditures into the second half of 2024[206](index=206&type=chunk) - Future funding will be sought through equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements, which may dilute ownership or impose restrictions[207](index=207&type=chunk) [Contractual Obligations and Commitments](index=34&type=section&id=Contractual%20Obligations%20and%20Commitments) No material changes to contractual obligations occurred during Q1 2023 from those described in the 2022 Form 10-K - No material changes to contractual obligations occurred during Q1 2023 from those described in the 2022 Form 10-K[208](index=208&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The company's financial statements are prepared under U.S. GAAP, requiring management estimates, with no significant changes to critical accounting policies reported from the 2022 Form 10-K - No significant changes to critical accounting policies and estimates were reported from those described in the 2022 Form 10-K[210](index=210&type=chunk) [Recently Issued Accounting Pronouncements](index=35&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) A description of recently issued accounting pronouncements that may impact the company's financial position, results, and cash flows is provided in Note 2 - A description of recently issued accounting pronouncements is provided in Note 2 of the condensed consolidated financial statements[211](index=211&type=chunk) [Emerging Growth Company Status](index=35&type=section&id=Emerging%20Growth%20Company%20Status) Invivyd is an "emerging growth company" under the JOBS Act, relying on exemptions from certain disclosure requirements and an extended transition period for new accounting standards - Invivyd is an "emerging growth company" and intends to rely on exemptions from certain disclosure requirements and an extended transition period for new accounting standards[212](index=212&type=chunk)[213](index=213&type=chunk)[214](index=214&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Invivyd is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Invivyd is exempt from providing quantitative and qualitative disclosures about market risk[215](index=215&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that Invivyd's disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=36&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, with the CEO and Interim CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023 - Management, with the CEO and Interim CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023[216](index=216&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No changes in internal control over financial reporting occurred during the period that materially affected, or are reasonably likely to materially affect, internal control over financial reporting - No changes in internal control over financial reporting occurred during the period that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[217](index=217&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) Invivyd is involved in a securities class action lawsuit alleging misleading statements about ADG20's effectiveness and is cooperating with an SEC inquiry regarding ADG20's efficacy - A securities class action lawsuit was filed on January 31, 2023, alleging violations of securities laws regarding ADG20's effectiveness against the Omicron variant[220](index=220&type=chunk) - The SEC requested documents concerning ADG20's efficacy and public statements, and the company intends to cooperate fully[222](index=222&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's 2022 Form 10-K have occurred - No material changes to the risk factors set forth in the 2022 Form 10-K have occurred[223](index=223&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Invivyd did not issue any unregistered equity securities during Q1 2023 but repurchased and retired 206,802 shares of unvested restricted common stock due to employee termination [Recent Sales of Unregistered Securities; Use of Proceeds](index=37&type=section&id=Recent%20Sales%20of%20Unregistered%20Securities;%20Use%20of%20Proceeds) The company did not issue any unregistered equity securities during the three months ended March 31, 2023 - No unregistered equity securities were issued during the three months ended March 31, 2023[224](index=224&type=chunk) [Purchases of Equity Securities by the Issuer](index=37&type=section&id=Purchases%20of%20Equity%20Securities%20by%20the%20Issuer) In March 2023, Invivyd repurchased and retired 206,802 shares of common stock at an average price of $0.002 per share, which were unvested restricted stock from early-exercised options | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :----- | :------------------------------- | :--------------------------- | | March 1, 2023 to March 31, 2023 | 206,802 | $0.002 | | Total | 206,802 | $0.002 | - The repurchased shares were unvested restricted common stock from early-exercised employee stock options, due to termination of service[225](index=225&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) Frederick W. Driscoll, Interim Chief Financial Officer, provided notice of his planned retirement effective May 31, 2023 - Frederick W. Driscoll, Interim Chief Financial Officer, announced his planned retirement effective May 31, 2023[226](index=226&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including amendments to corporate documents, consulting agreements, compensation policies, and certifications - The exhibits include the Amended and Restated Certificate of Incorporation, Bylaws, an amendment to the Cell Line License Agreement, a Consulting Services Agreement, and certifications from executive officers[227](index=227&type=chunk) [Signatures](index=39&type=section&id=Signatures) The report is signed by David Hering, M.B.A., Chief Executive Officer and Director, and Frederick W. Driscoll, Interim Chief Financial Officer, on May 11, 2023 - The report was signed by David Hering, CEO, and Frederick W. Driscoll, Interim CFO, on May 11, 2023[231](index=231&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40703 INVIVYD, INC. (Exact name of Registrant as specified in its Charter) Delaware 85-1403134 (State or other jurisdiction of Indica ...

FORWARD LOOKING STATEMENTS All trademarks in this presentation are the property of their respective owners. 2 2 INVIVYD No vaccine alternatives for prevention • 116 million adults in U.S. with comorbidities7 VYD222 is an investigational product candidate not approved for use in any country. The safety and efficacy of VYD222 have not been established. VYD INVIVYD Continuous monitoring of viral evolution coupled with rapid antibody discovery and engineering to address the evolving SARS-CoV-2 threat Monitor va ...

Financial Data and Key Metrics Changes - Operating expenses for Q3 2022 were $34.1 million, down from $49.4 million in Q3 2021, attributed to the wind down of clinical trials and manufacturing activities [35] - SG&A expenses increased to $13.2 million in Q3 2022 from $11.1 million in Q3 2021, due to higher public company costs and professional services [37] - The net loss for Q3 2022 was $45.1 million, compared to $60.4 million in Q3 2021, with a basic and diluted net loss per share of $0.42 versus $0.98 in the prior year [37] - The company ended Q3 2022 with cash, cash equivalents, and marketable securities totaling $419 million, expected to fund operations into Q2 2024 [38] Business Line Data and Key Metrics Changes - The company is advancing its proprietary combination anti-SARS-CoV-2 receptor binding domain (RBM) candidate, NVD 200, into clinical development [16] - NVD 200 is a reengineered version of Adintrevimab, demonstrating retained in vitro activity against current and emerging variants [16][49] Market Data and Key Metrics Changes - The annual market for COVID-19 prevention and treatment is estimated to be between $80 billion and $100 billion, with the company aiming to capture a portion of this revenue [33] Company Strategy and Development Direction - The company focuses on continuous innovation and the development of a suite of antibody therapies to address ongoing viral evolution [12][22] - The integrated discovery platform is seen as a competitive advantage, allowing for rapid engineering of antibodies to meet emerging viral threats [23] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing need for effective COVID-19 treatments, particularly for vulnerable populations such as the immunocompromised [32] - The company is committed to addressing the continuous health toll of COVID-19 and sees significant opportunities for shareholder value creation through innovation [32] Other Important Information - The company plans to update its cash runway guidance after completing its 2023 budget [38] - Management highlighted the importance of speed in developing new candidates in response to rapidly evolving variants [52] Q&A Session Summary Question: Clinical trial design for NVD 200 - Management acknowledged the dynamic nature of the clinical landscape and indicated that NVD 200 will enter the clinic in Q1 2023, with ongoing data expected throughout the year [42][43] Question: Neutralization activity of NVD 200 against emerging variants - Management confirmed that in vitro testing shows NVD 200 retains activity against current and emerging variants, validating the company's approach [49][50] Question: Speed of developing new candidates - Management stated that the company has demonstrated the ability to rapidly generate clinical data and is focused on staying ahead of viral evolution [52][53] Question: Conversations with regulators regarding surrogate markers - Management indicated that while specific conversations with regulators are not disclosed, there is a recognized need for increased speed in product development [57][58] Question: Prioritization of prevention versus treatment - Management emphasized that prevention is the highest priority, especially for underserved populations like the immunocompromised [60]