Core Insights - Invivyd, Inc. has elected two new independent directors, Dr. Srishti Gupta and Kevin F. McLaughlin, to its Board of Directors during a period of significant growth for the company [1][2] - The company is focused on commercializing its first product and utilizing its proprietary tools for variant analysis and predictive modeling to develop advanced antibody candidates [2][6] - Invivyd has received emergency use authorization (EUA) from the U.S. FDA for its first monoclonal antibody (mAb) aimed at providing protection against COVID-19 for certain immunocompromised individuals [2][6] Company Overview - Invivyd, Inc. is a biopharmaceutical company dedicated to protecting against serious viral infectious diseases, starting with SARS-CoV-2 [6] - The company's proprietary INVYMAB™ platform combines advanced viral surveillance and predictive modeling with antibody engineering to rapidly generate new mAbs [6] - The company aims to provide ongoing protection to vulnerable populations against evolving viral threats [2][6] New Board Members - Dr. Srishti Gupta brings over 20 years of healthcare experience, including 18 years at McKinsey & Company, and currently serves on the Board of Directors at Idorsia Pharmaceuticals [3] - Kevin F. McLaughlin has over 40 years of financial and operational management experience, previously serving as CFO of Acceleron Pharma, where he contributed to the company's growth into a publicly traded entity [4][5] Strategic Focus - The company is in a transformational phase as it prepares to commercialize its first product, PEMGARDA™, which has received EUA for pre-exposure prophylaxis of COVID-19 [2][6] - Invivyd's leadership emphasizes the importance of the new board members' expertise in navigating the company's growth and commercialization strategies [2]

Financial Data and Key Metrics Changes - The company ended Q1 2024 with cash and cash equivalents of $189.4 million [12] - No revenue was recorded for PEMGARDA in Q1 2024 as orders and shipments began in April [12] - The projected year-end cash position for 2024 has been improved by approximately $20 million to $25 million following a strategic review [12][40] Business Line Data and Key Metrics Changes - The company is focused on the launch of PEMGARDA, which is aimed at moderately to severely immunocompromised individuals [16] - There has been strong interest from patients and providers regarding PEMGARDA, with a high level of unsolicited inquiries received [16] - The commercial organization has been actively working on the PEMGARDA launch, with product availability achieved within a week of authorization [17] Market Data and Key Metrics Changes - The U.S. Centers for Medicare and Medicaid Services (CMS) published two healthcare common procedure coding system codes for PEMGARDA, facilitating reimbursement [18] - The company is targeting approximately 500,000 individuals in the U.S. who are the most vulnerable to COVID-19, representing a significant total addressable market [42] Company Strategy and Development Direction - The company aims to innovate and improve its products, focusing on high efficacy and safety of monoclonal antibodies against SARS-CoV-2 [7][9] - There is a commitment to filing a second EUA application for PEMGARDA, focusing on treatment for mild to moderate symptomatic COVID-19 in immunocompromised individuals [13][24] - The company is also developing VYD2311, which is expected to have an improved product profile compared to PEMGARDA [44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the near-term economic opportunity and the potential for rapid development of innovative molecules [41] - The company is encouraged by its recent progress in basic science, clinical development, and regulatory alignment, aiming to expand the population served by its products [63] - The management noted that the FDA has been highly engaged and supportive of the company's efforts, which is seen as a positive sign for future developments [112] Other Important Information - The company is in the process of searching for a permanent CEO [11] - There is a focus on building logistical support to assist immunocompromised individuals seeking PEMGARDA [47] - The company is exploring direct-to-consumer campaigns and targeted patient campaigns as part of its marketing strategy [94] Q&A Session Summary Question: Can you elaborate on your marketing strategy, including direct-to-consumer campaigns? - The early focus is on raising healthcare provider awareness, as informed providers are crucial for patient access to PEMGARDA [67] Question: How should we think about reimbursement for the other half of the target patient population? - The company is actively working on securing reimbursement for the other half of the population and is encouraged by initial engagements [109] Question: How should we think about the treatment opportunity given existing robust markets? - The company believes that immunobridging provides a rapid and efficient pathway to deliver an important COVID-19 treatment option, complementing its efforts with PrEP [80] Question: What magnitude of orders or potential orders are you seeing right now? - The company is in the early phase of the launch and is not providing incremental details on orders at this time, but expects to share more information as the launch progresses [104] Question: Can you discuss the potential approval pathway for PEMGARDA's treatment in immunocompromised individuals? - The anticipated treatment EUA submission will leverage existing data sets and is expected to be submitted imminently [71][79]

Invivyd (NASDAQ:IVVD) just reported results for the first quarter of 2024.Invivyd reported earnings per share of -38 cents. This met the analyst estimate for EPS of -38 cents.The company did not report any revenue for the quarter.InvestorPlace Earnings is a project that leverages data from TradeSmith to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These article ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Invivyd, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Invivyd, Inc., including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity (deficit), and statements of cash flows, along with detailed notes explaining the company's business, accounting policies, and financial activities [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's financial position at specific points in time, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $189,388 | $200,641 | | Total current assets | $209,883 | $224,881 | | Total assets | $215,468 | $229,181 | | Total current liabilities | $36,345 | $50,291 | | Total liabilities | $36,970 | $51,713 | | Total stockholders' equity | $178,498 | $177,468 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement outlines the company's financial performance over specific periods, reporting revenues, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $31,160 | $27,201 | | Acquired in-process research and development | $0 | $825 | | Selling, general and administrative | $14,929 | $11,045 | | Total operating expenses | $46,089 | $39,071 | | Loss from operations | $(46,089) | $(39,071) | | Other income, net | $2,593 | $3,750 | | Net loss | $(43,496) | $(35,321) | | Net loss per share (basic and diluted) | $(0.38) | $(0.32) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) This statement details changes in the company's equity accounts over time, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (Deficit) (in thousands) | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Common stock | $12 | $11 | | Additional paid-in capital | $954,063 | $909,539 | | Accumulated deficit | $(775,565) | $(732,069) | | Total stockholders' equity | $178,498 | $177,468 | - Issuance of **9,000,000 shares of common stock**, net of issuance costs, contributed **$39,057 thousand** to additional paid-in capital during the three months ended March 31, 2024[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement reports the cash generated and used by the company during specific periods, categorized into operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(50,214) | $(41,181) | | Net cash (used in) provided by investing activities | $(140) | $75,036 | | Net cash provided by financing activities | $39,101 | $542 | | Net (decrease) increase in cash and cash equivalents | $(11,253) | $34,397 | | Cash and cash equivalents at end of period | $189,388 | $126,473 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide additional information and explanations to the financial statements, detailing accounting policies, business activities, and financial disclosures [Note 1. Nature of the Business and Basis of Presentation](index=8&type=section&id=Note%201.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) This note describes the company's core business, recent developments, and the foundational principles used in preparing the financial statements - Received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents on **March 22, 2024**[25](index=25&type=chunk)[155](index=155&type=chunk) - Intends to submit an EUA application for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people in **May 2024**[26](index=26&type=chunk)[156](index=156&type=chunk) - Nominated VYD2311, a mAb optimized for neutralization potency against recent SARS-CoV-2 lineages (BA.2.86 and JN.1), as a drug candidate in **January 2024**, expected to be the next pipeline program[27](index=27&type=chunk)[157](index=157&type=chunk) - Incurred a **net loss of $43.5 million** for the three months ended March 31, 2024, with an **accumulated deficit of $775.6 million**[32](index=32&type=chunk)[164](index=164&type=chunk) - Concluded there is **substantial doubt about its ability to continue as a going concern** beyond one year from the issuance of these financial statements without additional funding[33](index=33&type=chunk)[168](index=168&type=chunk)[198](index=198&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods applied in the preparation of the financial statements, including inventory valuation - Changed inventory accounting policy: PEMGARDA™ inventory costs are now capitalized after receiving EUA in March 2024, as probable future economic benefit was determined; previously, manufacturing costs were expensed as R&D[39](index=39&type=chunk) - Inventory is stated at the lower of cost or estimated net realizable value with cost determined on a first-in, first-out basis[40](index=40&type=chunk) [Note 3. Fair Value Measurements](index=12&type=section&id=Note%203.%20Fair%20Value%20Measurements) This note provides information on how the company measures the fair value of its financial assets and liabilities, categorized by valuation inputs Fair Value Measurements (in thousands) | Asset (in thousands) | March 31, 2024 (Level 1) | December 31, 2023 (Level 1) | | :------------------- | :----------------------- | :-------------------------- | | Money market funds | $187,690 | $198,193 | [Note 4. Prepaid Expenses and Other Current Assets](index=14&type=section&id=Note%204.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the composition of the company's prepaid expenses and other current assets, including external research and development costs Prepaid Expenses and Other Current Assets (in thousands) | Category (in thousands) | March 31, 2024 | December 31, 2023 | | :---------------------- | :------------- | :---------------- | | Prepaid external research, development and manufacturing costs | $15,582 | $19,962 | | Total prepaid expenses and other current assets | $20,386 | $24,240 | [Note 5. Accrued Expenses](index=15&type=section&id=Note%205.%20Accrued%20Expenses) This note provides a breakdown of the company's accrued liabilities, including external research, development, manufacturing costs, and employee compensation Accrued Expenses (in thousands) | Category (in thousands) | March 31, 2024 | December 31, 2023 | | :---------------------- | :------------- | :---------------- | | Accrued external research, development and manufacturing costs | $29,139 | $28,151 | | Accrued employee compensation | $1,689 | $10,752 | | Total accrued expenses | $34,003 | $40,860 | [Note 6. License and Collaboration Agreements](index=15&type=section&id=Note%206.%20License%20and%20Collaboration%20Agreements) This note describes the company's various agreements with third parties for licensing and collaboration, including milestone payments and fees - Under the Adimab Assignment Agreement, total milestone payments achieved and paid as of March 31, 2024, are **$11.1 million** out of a maximum aggregate of **$24.6 million**[59](index=59&type=chunk) - No IPR&D expense was recognized for the Adimab Assignment Agreement in Q1 2024, compared to **$0.4 million** in Q1 2023[61](index=61&type=chunk)[140](index=140&type=chunk) - The quarterly fee under the Adimab Collaboration Agreement decreased from **$1.3 million to $0.6 million** effective January 2024, due to a reduced scope of Adimab's exclusivity obligations[67](index=67&type=chunk)[142](index=142&type=chunk) - A portion of the first annual fee under the Adimab Platform Transfer Agreement was recognized as research and development expense in Q1 2024[75](index=75&type=chunk)[144](index=144&type=chunk) - No IPR&D expense was recognized under the WuXi Biologics Cell Line License Agreement in Q1 2024, compared to **$0.4 million** in Q1 2023[86](index=86&type=chunk) [Note 7. Population Health Partners, L.P.](index=21&type=section&id=Note%207.%20Population%20Health%20Partners,%20L.P.) This note details the company's past advisory services agreement and warrant issuance with Population Health Partners, L.P. - The PHP Work Order for advisory services terminated in **May 2023**[87](index=87&type=chunk)[101](index=101&type=chunk) - Recognized **$1.5 million** in R&D expense in Q1 2023 related to cash compensation to PHP; no expense in Q1 2024[89](index=89&type=chunk)[148](index=148&type=chunk) - Issued a warrant to PHP in **November 2022**, exercisable for up to **6,824,712 shares of common stock** at **$3.48 per share**, vesting upon market capitalization targets or fundamental transactions[90](index=90&type=chunk)[96](index=96&type=chunk)[132](index=132&type=chunk) [Note 8. Commitments and Contingencies](index=23&type=section&id=Note%208.%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, purchase commitments, and potential legal liabilities, including a securities class action lawsuit Operating Lease Commitments (in thousands) | Year Ending December 31, | Operating Lease (in thousands) | | :----------------------- | :----------------------------- | | 2024 (excluding Q1 2024) | $1,087 | | 2025 | $430 | | 2026 | $328 | | Total lease payments | $1,845 | - Total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics: **$69.3 million**, expected to be paid in **2024 and 2025**[103](index=103&type=chunk) - Noncancelable purchase obligations for materials for future manufacturing: **$24.7 million**, expected to be paid in **2024**[105](index=105&type=chunk) - A securities class action lawsuit was filed on **January 31, 2023**, alleging violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 concerning ADG20's effectiveness against the Omicron variant; the company intends to vigorously defend the action[109](index=109&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) [Note 9. Common Stock](index=29&type=section&id=Note%209.%20Common%20Stock) This note provides information on the company's common stock, including shares reserved for equity plans and recent stock issuances - Reserved **46,292,290 shares of common stock** for equity incentive plans as of March 31, 2024[113](index=113&type=chunk) - Sold **9,000,000 shares of common stock** under the Sales Agreement (ATM facility) in **February 2024** at an average price of **$4.50 per share**, generating **$39.3 million** in net proceeds[116](index=116&type=chunk)[189](index=189&type=chunk) - **$34.5 million** remained available for sale under the Sales Agreement as of March 31, 2024[116](index=116&type=chunk)[189](index=189&type=chunk) [Note 10. Stock-Based Compensation](index=29&type=section&id=Note%2010.%20Stock-Based%20Compensation) This note details the company's stock-based compensation expense, unrecognized compensation, and stock option grants Stock-Based Compensation Expense (in thousands) | Category (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :---------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,677 | $2,263 | | Selling, general and administrative | $3,702 | $3,137 | | Total stock-based compensation expense | $5,379 | $5,400 | - Total unrecognized stock-based compensation expense was **$40.2 million** as of March 31, 2024, expected to be recognized over a weighted-average period of **2.4 years**[130](index=130&type=chunk) - Granted **3,647,000 stock options** with a weighted-average grant date fair value of **$2.53 per share** during the three months ended March 31, 2024[128](index=128&type=chunk) [Note 11. Income Taxes](index=34&type=section&id=Note%2011.%20Income%20Taxes) This note discusses the company's income tax position, including the lack of recorded tax benefits and monitoring of global minimum tax frameworks - No income tax benefits were recorded for net operating losses or research and development tax credits due to uncertainty of realizing a benefit from those items[134](index=134&type=chunk)[180](index=180&type=chunk) - Monitoring the impact of the Pillar Two global corporate minimum tax framework, not expecting a material impact on the effective tax rate[181](index=181&type=chunk) [Note 12. Defined Contribution Plan](index=34&type=section&id=Note%2012.%20Defined%20Contribution%20Plan) This note reports the company's contributions to its 401(k) defined contribution plan for employees - Contributed **$0.2 million** to the 401(k) Plan for both the three months ended March 31, 2024, and 2023[135](index=135&type=chunk) [Note 13. Net Loss per Share](index=34&type=section&id=Note%2013.%20Net%20Loss%20per%20Share) This note presents the calculation of basic and diluted net loss per share, including the impact of potential common shares Net Loss per Share | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :----- | :-------------------------------- | :-------------------------------- | | Net loss attributable to common stockholders | $(43,496) | $(35,321) | | Weighted-average common shares outstanding | 115,618,209 | 108,785,519 | | Net loss per share, basic and diluted | $(0.38) | $(0.32) | - Excluded **33,188,745 potential common shares** (stock options and warrants) from diluted EPS calculation in Q1 2024 due to anti-dilutive effect[137](index=137&type=chunk) [Note 14. Related Party Transactions](index=34&type=section&id=Note%2014.%20Related%20Party%20Transactions) This note discloses transactions and agreements with related parties, including Adimab and Population Health Partners - Adimab, a principal stockholder, is entitled to receive milestone and royalty payments and receives payments for ongoing services under various agreements[139](index=139&type=chunk) - No IPR&D expense was recognized for the Adimab Assignment Agreement in Q1 2024, compared to **$0.4 million** in Q1 2023[140](index=140&type=chunk) - Research and development expense related to the quarterly fee under the Adimab Collaboration Agreement was **$0.6 million** in Q1 2024, down from **$1.3 million** in Q1 2023[142](index=142&type=chunk) - A portion of the first annual fee under the Adimab Platform Transfer Agreement was recognized as research and development expense in Q1 2024, with no expense in Q1 2023[144](index=144&type=chunk) - Research and development expense for services performed by Population Health Partners (PHP) was **$1.5 million** in Q1 2023, with no expense in Q1 2024 as the work order terminated in **May 2023**[148](index=148&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting the increased net loss, the receipt of EUA for PEMGARDA™, plans for future product candidates, and the ongoing need for additional funding due to substantial doubt about its ability to continue as a going concern [Cautionary Note Regarding Forward-Looking Statements](index=37&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This note advises readers that the report contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially - The report contains forward-looking statements regarding commercialization of PEMGARDA, leveraging the INVYMAB™ platform, clinical trial timing, regulatory submissions, market acceptance, manufacturing, funding needs, and competitive position[151](index=151&type=chunk) - Actual results may differ materially from forward-looking statements due to known and unknown risks and uncertainties, as detailed in the "Risk Factors" section of the 2023 Form 10-K[152](index=152&type=chunk)[153](index=153&type=chunk) [Overview](index=39&type=section&id=Overview) This section provides a high-level summary of the company's recent strategic developments, financial performance, and going concern considerations - Received Emergency Use Authorization (EUA) from the FDA for PEMGARDA™ (pemivibart) for COVID-19 pre-exposure prophylaxis on **March 22, 2024**[155](index=155&type=chunk) - Plans to submit an EUA application for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people[156](index=156&type=chunk) - VYD2311, a mAb optimized for recent SARS-CoV-2 lineages, is expected to be the next pipeline program to advance into clinical development[157](index=157&type=chunk) - Incurred a **net loss of $43.5 million** for Q1 2024, with an **accumulated deficit of $775.6 million** as of March 31, 2024[164](index=164&type=chunk) - **Substantial doubt exists about the company's ability to continue as a going concern** beyond one year without additional funding[168](index=168&type=chunk) [Components of Our Results of Operations](index=43&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section explains the key elements contributing to the company's financial results, including revenue, research and development, and administrative expenses - No revenue generated through March 31, 2024; expects to generate revenue from sales of PEMGARDA starting with Q2 2024 financial results[169](index=169&type=chunk)[163](index=163&type=chunk) - Research and development expenses are expensed as incurred, covering nonclinical/preclinical development, product candidate procurement, global clinical development, personnel, third-party agreements, and laboratory costs[170](index=170&type=chunk) - Acquired in-process research and development (IPR&D) expenses consist of contingent milestone payments for acquiring rights to Adimab's antibodies and platform technology, expensed due to no alternative future use[175](index=175&type=chunk) - Selling, general and administrative expenses include personnel, professional/consultant fees, and other administrative costs, expected to increase with business expansion and commercialization of PEMGARDA[176](index=176&type=chunk)[177](index=177&type=chunk) - Other income, net, primarily consists of interest income earned from cash, cash equivalents, and marketable securities[179](index=179&type=chunk) - No income tax expense or benefits recorded due to uncertainty of realizing benefits from net operating losses and R&D tax credits[180](index=180&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) This section details the company's financial performance for the reported periods, analyzing changes in operating expenses, other income, and net loss Results of Operations (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Total operating expenses | $46,089 | $39,071 | | Other income, net | $2,593 | $3,750 | | Net loss | $(43,496) | $(35,321) | - Research and development expenses increased by **$4.0 million** to **$31.2 million** in Q1 2024, primarily due to a **$6.9 million increase** in contract manufacturing costs and a **$3.1 million increase** in contract research costs for the VYD222 program, and **$1.9 million** for the newly nominated VYD2311 program[183](index=183&type=chunk)[184](index=184&type=chunk) - No acquired in-process research and development (IPR&D) expense was recognized in Q1 2024, compared to **$0.8 million** in Q1 2023[185](index=185&type=chunk) - Selling, general and administrative expenses increased by **$3.9 million** to **$14.9 million** in Q1 2024, mainly due to a **$1.1 million increase** in headcount-related costs and a **$2.9 million increase** in professional and consultant fees for commercialization[186](index=186&type=chunk)[191](index=191&type=chunk) - Other income decreased to **$2.6 million** in Q1 2024 from **$3.8 million** in Q1 2023, primarily due to lower interest earned on invested cash balances and the absence of net accretion of discounts on marketable securities[187](index=187&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, sources and uses of cash, and its ability to meet short-term and long-term financial obligations - Cash and cash equivalents totaled **$189.4 million** as of March 31, 2024[190](index=190&type=chunk) - Generated **$39.3 million** in net proceeds from selling **9 million common shares** through an 'at the market' (ATM) facility in Q1 2024; **$34.5 million** remains available under the facility[189](index=189&type=chunk) - Net cash used in operating activities was **$(50.2) million** in Q1 2024, compared to **$(41.2) million** in Q1 2023[191](index=191&type=chunk) - Net cash used in investing activities was **$(0.1) million** in Q1 2024, a significant change from **$75.0 million provided** in Q1 2023 (primarily from marketable securities maturities)[194](index=194&type=chunk) - Net cash provided by financing activities was **$39.1 million** in Q1 2024, primarily from common stock issuance, compared to **$0.5 million** in Q1 2023[195](index=195&type=chunk) - Concluded there is **substantial doubt about its ability to continue as a going concern** beyond one year from the issuance date of the financial statements, based on current operating plans and excluding revenues or external financing[198](index=198&type=chunk) - Remaining noncancelable purchase obligations for commercial drug substance and product manufacturing with WuXi Biologics total **$69.3 million** (due 2024-2025), plus **$24.7 million** for materials (due 2024)[200](index=200&type=chunk) - As an "emerging growth company," the company intends to rely on exemptions from certain disclosure requirements and an extended transition period for new accounting standards[204](index=204&type=chunk)[205](index=205&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=56&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 - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[207](index=207&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Interim Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of the company's disclosure controls and procedures as of March 31, 2024, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were **effective** at the reasonable assurance level as of March 31, 2024[208](index=208&type=chunk) - No material changes in internal control over financial reporting occurred during the period covered by this Quarterly Report on Form 10-Q[209](index=209&type=chunk) [PART II. OTHER INFORMATION](index=57&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional legal, equity, and administrative information not covered in the financial statements [Item 1. Legal Proceedings](index=57&type=section&id=Item%201.%20Legal%20Proceedings) A securities class action lawsuit was filed against the company on January 31, 2023, alleging misleading statements regarding ADG20's effectiveness against the Omicron variant of COVID-19. The company is vigorously defending the action, which is in its early stages, and the outcome's materiality cannot yet be assessed - A securities class action lawsuit, Brill v. Invivyd, Inc., et. al., was filed on **January 31, 2023**, alleging violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5[212](index=212&type=chunk) - The complaint alleges purportedly materially false and misleading statements and omissions concerning ADG20's effectiveness against the Omicron variant of COVID-19[212](index=212&type=chunk) - The company believes it has strong defenses and intends to vigorously defend against this action; the lawsuit is in early stages, and its likely outcome or materiality cannot yet be assessed[213](index=213&type=chunk) [Item 1A. Risk Factors](index=57&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's 2023 Form 10-K - There have been no material changes from the risk factors set forth in the 2023 Form 10-K[214](index=214&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not issue any unregistered equity securities or purchase any of its own equity securities during the three months ended March 31, 2024 - No unregistered equity securities were issued during the three months ended March 31, 2024[215](index=215&type=chunk) - The company did not purchase any equity securities during the three months ended March 31, 2024[216](index=216&type=chunk) [Item 5. Other Information](index=57&type=section&id=Item%205.%20Other%20Information) No director or officer of the company adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended March 31, 2024 - No director or officer adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the three months ended March 31, 2024[217](index=217&type=chunk) [Item 6. Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate organizational documents, amendments to agreements, and certifications required by the Sarbanes-Oxley Act - Includes Amended and Restated Certificate of Incorporation, Bylaws, and amendments[219](index=219&type=chunk) - Lists Amendment No. 2 to the Cell Line License Agreement by and between the Registrant and WuXi Biologics (Hong Kong) Limited[219](index=219&type=chunk) - Includes certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[219](index=219&type=chunk) [Signatures](index=59&type=section&id=Signatures) The report is officially signed by Jeremy Gowler, Interim Chief Executive Officer, Chief Operating Officer and Chief Commercial Officer, and William Duke, Jr., Chief Financial Officer, on May 9, 2024 - The report was signed by Jeremy Gowler (Interim Chief Executive Officer, Chief Operating Officer and Chief Commercial Officer) and William Duke, Jr. (Chief Financial Officer) on **May 9, 2024**[223](index=223&type=chunk)

[Introduction and Company Overview](index=1&type=section&id=Introduction) Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, with **PEMGARDA** as its first commercial product - Invivyd, Inc. (Nasdaq: **IVVD**) is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases[2](index=2&type=chunk) - The company is currently executing on the commercial launch of **PEMGARDA**, its first monoclonal antibody (mAb) product[3](index=3&type=chunk) [Recent Business and Pipeline Highlights](index=1&type=section&id=Recent%20Business%20and%20Pipeline%20Highlights) Invivyd launched PEMGARDA commercially, reported positive clinical data for VYD222, and advanced VYD2311 as its next mAb candidate [PEMGARDA Commercialization & Reimbursement](index=1&type=section&id=PEMGARDA%20Commercialization%20%26%20Reimbursement) Invivyd successfully launched **PEMGARDA** in the U.S. after EUA for COVID-19 PrEP, securing CMS reimbursement codes for the target population - **PEMGARDA** (pemivibart) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on **March 22, 2024**, for COVID-19 pre-exposure prophylaxis (PrEP) in immunocompromised individuals[4](index=4&type=chunk)[5](index=5&type=chunk) - **PEMGARDA** was launched in the U.S. and became available for purchase through authorized specialty distributors at the beginning of **April**, with market access and sales teams fully operational by the **end of April**[4](index=4&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The U.S. Centers for Medicare & Medicaid Services (CMS) granted product-specific reimbursement codes (**HCPCS Q code Q0224** and **M code M0224**) for **PEMGARDA** in **April 2024**, covering an estimated **half of the target immunocompromised population**[5](index=5&type=chunk)[9](index=9&type=chunk) [Clinical Development & Pipeline Advancement](index=1&type=section&id=Clinical%20Development%20%26%20Pipeline%20Advancement) Invivyd reported positive VYD222 Phase 3 data, plans a rapid EUA for PEMGARDA treatment, and is advancing VYD2311 for new variants - Interim exploratory COVID-19 clinical event data from the **CANOPY Phase 3 clinical trial** of **VYD222** were reported in **March 2024**, reflecting a potential signal of clinical protection from symptomatic COVID-19[5](index=5&type=chunk)[9](index=9&type=chunk) - Invivyd plans to imminently submit an EUA application to the FDA for **pemivibart** for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people, utilizing a rapid immunobridging pathway aligned with FDA feedback[5](index=5&type=chunk)[9](index=9&type=chunk) - **VYD2311** is expected to be the next anti-SARS-CoV-2 mAb candidate to advance into clinical development, optimized for neutralization potency against recent lineages like **BA.2.86** and **JN.1** using Invivyd's state-of-the-art technologies[5](index=5&type=chunk)[9](index=9&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) Invivyd reported its Q1 **2024** financial results, including cash position, operating expenses, and net loss, reflecting **PEMGARDA** launch activities [Cash Position and Outlook](index=2&type=section&id=Cash%20Position%20and%20Outlook) Invivyd ended Q1 **2024** with **$189.4 million** in cash, projecting at least **$75 million** by year-end based on **PEMGARDA** revenue Cash and Cash Equivalents | Metric | March 31, 2024 (in millions) | December 31, 2023 (in millions) | | :----- | :--------------------------- | :------------------------------ | | Cash and cash equivalents | $189.4 | $200.6 | - Invivyd expects to end **2024** with at least **$75 million** in cash and cash equivalents, based on anticipated **2024** net product revenue of **$150 million to $200 million** and recent resource realignment[5](index=5&type=chunk)[12](index=12&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) R&D and SG&A expenses increased in Q1 **2024**, driven by **PEMGARDA** commercial manufacturing, clinical trials, and launch-related personnel costs Operating Expenses (Q1 2024 vs. Q1 2023) | Expense Category | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY, in thousands) | Primary Driver | | :--------------- | :--------------------- | :--------------------- | :------------------------- | :------------- | | Research & Development | $31,160 | $27,201 | +$3,959 | Commercial manufacturing of PEMGARDA, CANOPY Phase 3 clinical trial monitoring | | Selling, General & Administrative | $14,929 | $11,045 | +$3,884 | Personnel-related costs, commercial costs for PEMGARDA launch | [Net Loss and Net Loss per Share](index=3&type=section&id=Net%20Loss%20and%20Net%20Loss%20per%20Share) Invivyd reported an increased net loss of **$43.5 million** and a net loss per share of **$0.38** for Q1 **2024** compared to the prior year Net Loss and EPS (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net Loss (in millions) | $(43.5) | $(35.3) | $(8.2) | | Net Loss per Share (Basic & Diluted) | $(0.38) | $(0.32) | $(0.06) | [Condensed Consolidated Balance Sheets](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Invivyd's total assets were **$215.5 million** as of March 31, **2024**, with a decrease in cash and current liabilities from year-end **2023** Key Balance Sheet Data (March 31, 2024 vs. December 31, 2023) | Metric (in thousands) | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :-------------------- | :---------------------------- | :------------------------------- | | Total Assets | $215,468 | $229,181 | | Total Liabilities | $36,970 | $51,713 | | Total Stockholders' Equity | $178,498 | $177,468 | | Cash and cash equivalents | $189,388 | $200,641 | | Total current assets | $209,883 | $224,881 | | Total current liabilities | $36,345 | $50,291 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) Invivyd reported total operating expenses of **$46.1 million** and a net loss of **$43.5 million** for Q1 **2024** Key Income Statement Data (Three Months Ended March 31, 2024 vs. 2023) | Metric (in thousands) | March 31, 2024 (in thousands) | March 31, 2023 (in thousands) | | :-------------------- | :---------------------------- | :---------------------------- | | Total operating expenses | $46,089 | $39,071 | | Loss from operations | $(46,089) | $(39,071) | | Other income, net | $2,593 | $3,750 | | Net loss | $(43,496) | $(35,321) | | Comprehensive loss | $(43,495) | $(35,164) | [About PEMGARDA](index=3&type=section&id=About%20PEMGARDA) This section details **PEMGARDA's** product description, authorized use, safety information, and the immunobridging approach supporting its EUA [Product Description and Mechanism](index=3&type=section&id=Product%20Description%20and%20Mechanism) **PEMGARDA** is a half-life extended investigational mAb targeting the SARS-CoV-2 spike protein RBD, demonstrating in vitro neutralizing activity against variants like **JN.1** - **PEMGARDA** (pemivibart) is a half-life extended investigational monoclonal antibody (mAb) engineered from **adintrevimab**[11](index=11&type=chunk) - It targets the **SARS-CoV-2 spike protein receptor binding domain (RBD)**, inhibiting virus attachment to **human ACE2 receptors**, and has demonstrated in vitro neutralizing activity against major variants, including **JN.1**[11](index=11&type=chunk) [Authorized Use and Safety Information](index=3&type=section&id=Authorized%20Use%20and%20Safety%20Information) **PEMGARDA** is authorized under EUA for COVID-19 pre-exposure prophylaxis in specific immunocompromised individuals, with a boxed warning for **anaphylaxis** - **PEMGARDA** is authorized for emergency use for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (**12 years and older weighing at least 40 kg**) with moderate-to-severe immune compromise[12](index=12&type=chunk)[13](index=13&type=chunk) - It is not authorized for use for the treatment of COVID-19 or post-exposure prophylaxis of COVID-19[13](index=13&type=chunk) - Anaphylaxis has been observed with **PEMGARDA**, and the **PEMGARDA Fact Sheet for Healthcare Providers** includes a boxed warning for **anaphylaxis**[13](index=13&type=chunk) [Immunobridging Approach and Data Limitations](index=4&type=section&id=Immunobridging%20Approach%20and%20Data%20Limitations) **PEMGARDA's** EUA relies on an immunobridging approach, with data limitations including reliance on older variant efficacy and variability in **EC50** determinations - The EUA for **PEMGARDA** was supported by an immunobridging approach, which determines effectiveness based on serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2[14](index=14&type=chunk) - Limitations of the data include that evidence of clinical efficacy for other mAbs was based on different populations and SARS-CoV-2 variants no longer circulating, and variability in cell-based **EC50 value determinations**[14](index=14&type=chunk) - The emergency use authorization for **PEMGARDA** is only valid for the duration of the COVID-19 pandemic declaration, unless terminated or revoked sooner[15](index=15&type=chunk) [About Invivyd](index=4&type=section&id=About%20Invivyd) Invivyd is a biopharmaceutical company focused on viral infectious diseases, leveraging its **INVYMAB™ platform** to develop new monoclonal antibodies against evolving threats - Invivyd, Inc. is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with **SARS-CoV-2**[16](index=16&type=chunk) - The company's proprietary **INVYMAB™ platform** combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats[16](index=16&type=chunk) - **PEMGARDA** is Invivyd's first mAb authorized under EUA, representing the initial product in a planned series of innovative antibody candidates[16](index=16&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Note%20Regarding%20Forward%20Looking%20Statements) This section warns that forward-looking statements are subject to risks and uncertainties, and Invivyd disclaims any obligation to update them - The press release contains forward-looking statements, identified by terms like '**anticipates,**' '**expects,**' and '**potential,**' covering topics such as **PEMGARDA** commercialization, pipeline development, and financial projections[17](index=17&type=chunk) - These statements involve risks and uncertainties, including regulatory changes, competition, manufacturing complexities, and funding adequacy, which could cause actual results to differ materially[17](index=17&type=chunk)[18](index=18&type=chunk) - Invivyd undertakes no duty to update such information, except as required by applicable law, and advises readers to consult the company's **SEC filings** for a comprehensive list of risk factors[18](index=18&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides details on the conference call and webcast for Q1 **2024** financial results, along with contact information [Conference Call & Webcast](index=3&type=section&id=Conference%20Call%20%26%20Webcast) Invivyd hosted a conference call and webcast on **May 9, 2024**, to discuss Q1 **2024** results, with a replay available on its investor website - Invivyd management hosted a conference call and webcast on **May 9, 2024**, at **4:30 PM ET** to provide a quarterly update[5](index=5&type=chunk)[10](index=10&type=chunk) - A replay of the webcast is available via the company's investor website approximately **two hours** after the call's conclusion[10](index=10&type=chunk) [Contacts](index=6&type=section&id=Contacts) Contact information for media and investor relations is provided for inquiries - Media Relations and Investor Relations can be contacted at **(781) 208-0160** or via email at **media@invivyd.com** and **investors@invivyd.com**, respectively[20](index=20&type=chunk)

Pathway leverages immunobridging approach via serum virus neutralizing antibody (sVNA) titers enabled by prior successful COVID-19 treatment clinical trial "STAMP" conducted with prototype antibody adintrevimabCompany anticipates submitting a COVID-19 treatment EUA application for PEMGARDA™ (pemivibart) imminentlyCOVID-19 treatment EUA pathway offers a novel, rapid pathway to potential second EUA for pemivibartInvivyd leaves 2024 net product revenue and year-end cash guidance unchanged although potential ne ...

WALTHAM, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 9, 2024, at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 31, 2024, and recent business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should us ...

Improvements realized through comprehensive resource realignment ensuring robust investment in the commercial launch of PEMGARDATM and the discovery of novel monoclonal antibodiesCompany now expects to end 2024 with at least $75 million in cash and cash equivalents, an update to previously issued financial guidance WALTHAM, Mass., April 30, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to protection from serious viral infectious diseases, today announced that foll ...

Product-specific Q Code (Q0224) facilitates product reimbursement for PEMGARDA; corresponding M Code (M0224) defines reimbursement for product administrationReimbursement through Medicare/Medicaid represents approximately 50% of covered lives in target population WALTHAM, Mass., April 15, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the U.S. Centers for Medicare & Medicaid ...

WALTHAM, Mass., April 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the company's Board of Directors has appointed Jeremy Gowler as Interim Chief Executive Officer (CEO), effective immediately, while the Board institutes a search for a permanent CEO. Mr. Gowler succeeds Dave Hering. "The Invivyd Board of Directors is positioning the company for its next phase of growth, ...