UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On May 9, 2024, Invivyd, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2024, and recent business highlights. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 2.02.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On May 9, 2024, the Company posted an updated corporate presentation on its website at www.invivyd.com. A copy of the presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated May 9, 2024 | |
| 99.2 | Corporate Presentation, dated May 9, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INVIVYD, INC. | ||||||
| Date: May 9, 2024 | By: | /s/ Jill Andersen | ||||
| Jill Andersen | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||
Exhibit 99.1
Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights
| • | Launched PEMGARDA™ in the U.S. for COVID-19 pre-exposure prophylaxis (PrEP) in certain adults and adolescents with moderate-to-severe immune compromise |
| • | Reported interim exploratory COVID-19 clinical event data from CANOPY Phase 3 clinical trial of VYD222 |
| • | Received product-specific reimbursement codes covering PEMGARDA from the U.S. Centers for Medicare & Medicaid Services (CMS), covering approximately half of target population |
| • | Announced plans to pursue rapid immunobridging pathway to potential EUA for COVID-19 treatment in certain immunocompromised people, based on U.S. FDA feedback |
| • | Continued to advance VYD2311, the company’s next monoclonal antibody candidate engineered with the company’s state-of-the-art technologies for variant monitoring, predictive modeling and antibody engineering |
| • | Ended Q1 2024 with cash and cash equivalents of $189.4 million |
| • | Company expects to end 2024 with at least $75 million in cash and cash equivalents, based on anticipated 2024 net product revenue of $150-$200 million and recent resource realignment |
| • | Management to host conference call today at 4:30pm ET |
WALTHAM, Mass., May 9, 2024 (GLOBE NEWSWIRE) — Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended March 31, 2024, and recent business highlights.
“The recent months have been incredibly productive for Invivyd. Moving into the commercial phase is a critical step for the company and we are executing on the PEMGARDA launch with maximum focus across the company,” said Marc Elia, Chairman of the Invivyd Board of Directors. “In addition, we look forward to sharing on today’s quarterly update call more of the scientific underpinnings of our plans going forward, including detail on the innovative engine we believe can deliver meaningful product-level advancements with associated medical and economic value creation.”
Recent Business Highlights
| • | Launched PEMGARDA, the company’s first monoclonal antibody (mAb) in a planned series of innovative antibodies, in the U.S.: On March 22, 2024, PEMGARDA (pemivibart) received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise. At the beginning |
| of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors. At the end of April, Invivyd’s market access and sales, as well as medical affairs, teams were fully operational across the U.S. The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results. |
| • | Received product-specific reimbursement codes covering PEMGARDA from the U.S. Centers for Medicare & Medicaid (CMS): In April 2024, Invivyd announced that CMS has granted a Healthcare Common Procedure Coding System (HCPCS) Q code (Q0224) covering product reimbursement and a product specific M code (M0224) covering the administration of PEMGARDA. The company estimates that CMS provides coverage for nearly half of the moderately to severely immunocompromised people at highest risk for severe COVID-19 that the company is initially targeting. |
| • | Reported interim exploratory COVID-19 clinical event data from CANOPY Phase 3 clinical trial of VYD222: In March 2024, Invivyd announced interim exploratory data from the ongoing CANOPY Phase 3 clinical trial that reflect and add further to the initial potential signal of clinical protection from symptomatic COVID-19 shared in December 2023. While not part of the primary immunobridging endpoint of the CANOPY clinical trial, the interim exploratory data may be hypothesis generating for future discovery and development work. |
Recent Pipeline Highlights
| • | Announced plans to pursue rapid immunobridging pathway to potential EUA for COVID-19 treatment in certain immunocompromised people, based on U.S. FDA feedback: In May 2024, Invivyd announced that it anticipates imminently submitting 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. This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA for COVID-19 PrEP in certain immunocompromised people and was aligned in principle with the FDA. |
| • | Continued to advance VYD2311, the company’s next anticipated mAb candidate: In March 2024, Invivyd announced that it expects that VYD2311 will be the next anti-SARS-CoV-2 mAb candidate that it advances into clinical development. VYD2311 is optimized for neutralization potency against recent SARS-CoV-2 lineages such as BA.2.86 and JN.1. The design of VYD2311 leverages Invivyd’s state-of-the-art technologies for variant surveillance, predictive modeling, and antibody engineering. |
First Quarter 2024 Financial Results:
| • | Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024. |
| • | Projected 2024 Year-End Cash Position: Based on current operating plans, 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. Invivyd is maintaining its existing guidance, although the previously issued guidance was based on PEMGARDA being authorized for PrEP of COVID-19 in certain immunocompromised people and did not contemplate any potential sales for COVID-19 treatment, if authorized, or inventory build that may be required to deliver medicine timely to patients in need. |
| • | Research & Development (R&D) Expenses (including In-Process R&D): R&D expenses were $31.2 million for the quarter ended March 31, 2024, compared to $28.0 million for the comparable period of 2023. This increase is primarily attributable to an increase in commercial manufacturing costs of PEMGARDA and an increase in clinical trial costs related to the ongoing monitoring of our CANOPY Phase 3 clinical trial. |
| • | Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $14.9 million for the quarter ended March 31, 2024, compared to $11.0 million for the comparable period of 2023. This increase is primarily attributable to an increase in personnel-related costs and commercial costs driven by the preparation for launch of PEMGARDA. |
| • | Net Loss and Net Loss per Share: Net loss was $43.5 million for the quarter ended March 31, 2024, compared to $35.3 million for the comparable period in 2023. Basic and diluted net loss per share was $0.38 for the quarter ended March 31, 2024, compared to $0.32 for the comparable period in 2023. |
Conference Call & Webcast
Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity in pseudotyped virus-like particle and authentic virus neutralization assays against major SARS-CoV-2 variants, including JN.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents
(12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse events (all grades, incidence ≥2%) observed in participants who have moderate-to-severe immune compromise treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Additionally, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, PEMGARDA as a mAb for COVID-19 PrEP in certain adults and adolescents with moderate-to-severe immune compromise; the company’s plans and expectations related to the commercialization of PEMGARDA; the company’s intention to pursue a rapid immunobridging pathway to potential EUA for COVID-19 treatment in certain immunocompromised people; the company’s anticipated submission of a COVID-19 treatment EUA request to the FDA for pemivibart, and the timing thereof; the company’s research and clinical development efforts, and the timing thereof; the potential of VYD222 for clinical protection from symptomatic COVID-19 based on interim exploratory data from the CANOPY Phase 3 clinical trial; the company’s expectation that PEMGARDA is the first mAb in a planned series of innovative antibody candidates and VYD2311 will be the next mAb candidate to advance into clinical development; the future of the COVID-19 landscape; the company’s belief that its innovative engine can deliver meaningful product-level advancements with associated medical and economic value creation; the company’s anticipated 2024 net product revenue and projected 2024 year-end cash position; the company’s commitment to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; the design of the company’s INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: how long the EUA granted by the FDA for PEMGARDA for COVID-19 PrEP in certain adults and adolescents with moderate-to-severe immune compromise will remain in effect and whether such EUA is revoked or revised by the FDA; the company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; the company’s ability to effectively utilize an immunobridging pathway to potential EUA for pemivibart for COVID-19 treatment in certain immunocompromised people; whether the company is able to successfully submit a COVID-19 treatment EUA request to the FDA, and the timing, scope and outcome of any such EUA request; uncertainties related to the regulatory authorization or approval process; changes in the regulatory environment; the timing and progress of the company’s discovery, preclinical and clinical development activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of PEMGARDA or any other product candidate following regulatory authorization or approval; the predictability of clinical success of the company’s product candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical
trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether PEMGARDA or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the complexities of manufacturing mAb therapies; the company’s dependence on third parties to manufacture, label, package, store and distribute clinical and commercial supplies of its product candidates; whether the company is able to provide sufficient commercial supply of PEMGARDA to meet market demand; whether the company can obtain and maintain third-party coverage and adequate reimbursement for PEMGARDA or any other product candidate; the company’s ability to deliver meaningful product-level advancements with associated medical and economic value creation; the company’s ability to leverage its INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; any litigation and other proceedings or government investigations relating to the company; the company’s ability to continue as a going concern; the company’s ability to optimize operating expenses; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Contacts:
Media Relations
(781) 208-0160
media@invivyd.com
Investor Relations
(781) 208-0160
investors@invivyd.com
INVIVYD, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)
| March 31, 2024 |
December 31, 2023 |
|||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 189,388 | $ | 200,641 | ||||
| Inventory |
109 | — | ||||||
| Prepaid expenses and other current assets |
20,386 | 24,240 | ||||||
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|
|
|
|
|||||
| Total current assets |
209,883 | 224,881 | ||||||
| Property and equipment, net |
1,901 | 1,896 | ||||||
| Operating lease right-of-use assets |
1,827 | 2,229 | ||||||
| Other non-current assets |
1,857 | 175 | ||||||
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|
|
|
|
|||||
| Total assets |
$ | 215,468 | $ | 229,181 | ||||
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| Liabilities, Preferred Stock and Stockholders’ Equity |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 1,168 | $ | 7,953 | ||||
| Accrued expenses |
34,003 | 40,860 | ||||||
| Operating lease liabilities, current |
1,134 | 1,443 | ||||||
| Other current liability |
40 | 35 | ||||||
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|
|
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| Total current liabilities |
36,345 | 50,291 | ||||||
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|
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| Operating lease liabilities, non-current |
625 | 722 | ||||||
| Other non-current liability |
— | 700 | ||||||
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|
|
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| Total liabilities |
36,970 | 51,713 | ||||||
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| Commitments and contingencies |
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| Stockholders’ equity (deficit): |
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| Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at March 31, 2024 and December 31, 2023 |
— | — | ||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 119,221,230 shares issued and outstanding at March 31, 2024; 110,160,684 shares issued and outstanding at December 31, 2023 |
12 | 11 | ||||||
| Additional paid-in capital |
954,063 | 909,539 | ||||||
| Accumulated other comprehensive loss |
(12 | ) | (13 | ) | ||||
| Accumulated deficit |
(775,565 | ) | (732,069 | ) | ||||
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|
|
|
|
|||||
| Total stockholders’ equity |
178,498 | 177,468 | ||||||
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| Total liabilities, preferred stock and stockholders’ equity |
$ | 215,468 | $ | 229,181 | ||||
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INVIVYD, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)
| Three Months Ended March 31, 2024 |
Three Months Ended March 31, 2023 |
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| Operating expenses: |
||||||||
| Research and development(1) |
$ | 31,160 | $ | 27,201 | ||||
| Acquired in-process research and development(2) |
— | 825 | ||||||
| Selling, general and administrative |
14,929 | 11,045 | ||||||
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|
|
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| Total operating expenses |
46,089 | 39,071 | ||||||
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|
|
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| Loss from operations |
(46,089 | ) | (39,071 | ) | ||||
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| Other income: |
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| Other income, net |
2,593 | 3,750 | ||||||
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| Total other income, net |
2,593 | 3,750 | ||||||
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|
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| Net loss |
(43,496 | ) | (35,321 | ) | ||||
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| Other comprehensive income (loss) |
||||||||
| Unrealized gain on available-for-sale securities, net of tax |
1 | 157 | ||||||
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|
|
|
|
|||||
| Comprehensive loss |
$ | (43,495 | ) | $ | (35,164 | ) | ||
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|
|
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|
|||||
| Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.38 | ) | $ | (0.32 | ) | ||
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|
|||||
| Weighted-average common shares outstanding, basic and diluted |
115,618,209 | 108,785,519 | ||||||
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|
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| (1) | Includes related-party amounts of $1,135 and $2,960 for the three months ended March 31, 2024 and 2023, respectively. |
| (2) | Includes related-party amounts of $0 and $375 for the three months ended March 31, 2024 and 2023, respectively. |
Exhibit 99.2 INVIVYD Q1 2024 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 9, 2024 © 2024 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “seek,” “could,” “intend,” “target,” “aim,” “project,” “designed to,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning, among other things, PEMGARDA as a monoclonal antibody (mAb) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise; our plans, strategy and expectations related to the launch and commercialization of PEMGARDA; our intention to pursue a rapid immunobridging pathway to potential Emergency Use Authorization (EUA) for COVID-19 treatment in certain immunocompromised people; our anticipated submission of a COVID-19 treatment EUA request to the U.S. Food and Drug Administration (FDA) for pemivibart, and the timing thereof; our belief that pemivibart has the potential to offer Invivyd’s first, one-time, outpatient, long-acting COVID-19 treatment, if authorized; the potential of VYD222 for clinical protection from symptomatic COVID-19 based on interim exploratory data from the CANOPY Phase 3 clinical trial; the future of the COVID-19 landscape; our expectations about the size of target patient populations and the potential market opportunity for our product candidates, as well as our market position; our research and clinical development efforts, including statements regarding initiation or completion of studies or trials, the time-frame during which results may become available, and the potential utility of generated data; potential alignment of our strategy and the evolving U.S. regulatory landscape; our expectation regarding a repeatable, low-cost pathway for novel molecules with anticipated improved profiles over pemivibart; the potential of our SARS-CoV-2 variant tracking and analysis capabilities; our expectations regarding advancement of our pipeline and anticipated improved pharmaceutical profiles; the company’s anticipated 2024 net product revenue and projected 2024 year-end cash position; our business strategies and objectives, and ability to execute on them; our future prospects; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: how long the EUA granted by the FDA for PEMGARDA for COVID-19 PrEP in certain adults and adolescents with moderate-to-severe immune compromise will remain in effect and whether such EUA is revoked or revised by the FDA; our ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; our ability to effectively utilize an immunobridging pathway to potential EUA for pemivibart for COVID-19 treatment in certain immunocompromised people; whether we are able to successfully submit a COVID-19 treatment EUA request to the FDA, and the timing, scope and outcome of any such EUA request; uncertainties related to the regulatory authorization or approval process; changes in the regulatory environment; the timing, progress and results of our discovery, preclinical and clinical development activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of PEMGARDA or any other product candidate following regulatory authorization or approval; the predictability of clinical success of our product candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; our reliance on third parties with respect to virus assay creation and product candidate testing and with respect to our clinical trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether PEMGARDA or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the complexities of manufacturing mAb therapies; our dependence on third parties to manufacture, label, package, store and distribute clinical and commercial supplies of our product candidates; whether we are able to provide sufficient commercial supply of PEMGARDA to meet market demand; whether we can obtain and maintain third-party coverage and adequate reimbursement for PEMGARDA or any other product candidate; the ability of our SARS-CoV-2 variant tracking and analysis capabilities to effectively enable epitope surveillance and intelligent mAb selection in addition to surveillance of emergent SARS-CoV-2 lineages; whether we are able to achieve high potency and/or variation resistance with our future product pipeline; any litigation and other proceedings or government investigations relating to the company; our ability to continue as a going concern; our ability to optimize operating expenses; and whether we have adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this presentation are described under the heading “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC), and in our other filings with the SEC, and in our future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this presentation are made as of this date, and we undertake no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. 2
AGENDA • Introduction/Overview • Financials • PEMGARDA EUA & Commercial Launch • CANOPY Clinical Data • Pathway to Potential Treatment EUA • Variant Monitoring & Predictive Modeling • Product Pipeline • Q&A 3
INVIVYD HAS ENTERED A TRANSFORMATIONAL PERIOD OF GROWTH • Invivyd has been built to address the unique challenges presented by SARS-CoV-2, and potentially other viruses in the future • We are pioneering a still brand-new approach to antibody therapeutics and prophylactics, starting with SARS-CoV-2 • Our strategy is to combine the potential for high efficacy and attractive safety of monoclonal antibodies (mAbs) targeting the SARS-CoV-2 spike protein with the opportunity for product evolution commonly seen in the vaccine space • The U.S. FDA’s recent emergency use authorization (EUA) of PEMGARDA for pre- exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and our opportunity to pursue a rapid immunobridging pathway to a potential EUA for treatment of mild-to-moderate COVID-19 in certain immunocompromised people, represent growing alignment between our strategy and the evolving U.S. regulatory landscape 4
FINANCIALS Cash and cash equivalents were $189.4 million as of March 31, 2024 Invivyd is maintaining its existing guidance of $150-$200 million in anticipated 2024 PEMGARDA net product revenue and year-end cash guidance of at least $75 million in cash and cash equivalents – Previously issued guidance was based on PEMGARDA being authorized for PrEP of COVID-19 in certain immunocompromised people and did not contemplate any potential sales for COVID-19 treatment, if authorized, or inventory build that may be required to deliver medicine timely to patients in need 5
PEMGARDA EUA MAKES AN IMPORTANT THERAPY AVAILABLE TO CERTAIN PATIENTS & PROVIDES PROOF-OF-CONCEPT FOR PLATFORM PEMGARDA has not been approved, but has been authorized for emergency use by FDA under an emergency use authorization (EUA), for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning. 6
INVIVYD IS RAPIDLY EXECUTING ON ITS COMMERCIAL STRATEGY Product Securing Full Commercial Availability Reimbursement Implementation & Access Deploy national account managers Fully deploy contracted Key Publish WAC in pricing compendia √ √ √ focused on payor engagement Account Managers (KAMs) Make product available for order Activate targeted awareness Obtain HCPCS code from CMS √ √ √ through major distributors campaigns and associated coverage Secure inclusion in institutional Account reordering √ Receive and ship first order √ IP formularies, as needed Obtain coverage from Expand utilization within IP major commercial payors authorized population WAC: Wholesale acquisition cost; HCPCS: Healthcare Common Procedure Coding System; CMS: U.S. Centers for Medicare & Medicaid Services; IP: In process 7
THE PEMGARDA EUA FOR PRE-EXPOSURE PROPHYLAXIS IS BASED ON AN IMMUNOBRIDGING CLINICAL TRIAL (CANOPY) CANOPY CLINICAL TRIAL OVERVIEW VYD222 4500 mg IV (n≈300) COHORT A Open Label Moderate-to-severe immune // compromise (N≈300) Day 1 Month 3 Month 12 (Dosing) (Redosing) (Last visit) Primary endpoints: • Safety/tolerability • Day 28 serum virus neutralizing antibody (sVNA) titers (calculated from the pharmacokinetic concentrations of VYD222 and the EC value for 50 VYD222 against relevant SARS-CoV-2 variants) VYD222 4500 mg IV (n≈300) COHORT B At risk of SARS-CoV-2 exposure 2:1 Randomization due to regular unmasked indoor // Month 12 Day 1 Month 3 interactions (N≈450) (Last visit) (Dosing) (Redosing) Primary endpoint: Placebo IV (n≈150) • Safety/tolerability 8 Source: F: NCT06039449; IV, intravenous; SAEs, serious adverse events; AEs, adverse events
SVNA TITERS & EXPLORATORY EFFICACY DATA FROM IMMUNOCOMPROMISED COHORT IN CANOPY CLINICAL TRIAL Cohort A - Calculated VYD222 sVNA titers against JN.1 based on observed PK concentration by timepoints Additional exploratory COVID-19 clinical event data anticipated mid-year 2024 Proportion of participants with confirmed symptomatic COVID-19 While the PEMGARDA EUA was based on through Day 90 (exploratory data): immunobridging data from Cohort A, the 1% (3/298) exploratory event data are expected to be hypothesis generating for future studies in terms of dose and titers Notes: The interim exploratory COVID-19 clinical event data shown were not used for the basis of the EUA nor referenced in the PEMGARDA Fact Sheet. Beyond this interim update, additional cases of confirmed symptomatic COVID-19 have occurred in Cohort A post Day 90. 9
INTERIM EXPLORATORY DATA FROM CANOPY CLINICAL TRIAL While not part of the primary immunobridging endpoint of the CANOPY clinical trial, interim exploratory data may be hypothesis generating for future Invivyd discovery and development work Cohort B (Randomized, placebo-controlled cohort without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19: As of Dec 1, 2023 Through Day 90 (median 67 days follow-up) Pemivibart 0% (0/322) 0.3% (1/314) Placebo 3% (5/162) 5% (8/159) Relative Risk Reduction 100% 94% Cohort A (Open-label cohort with moderate-to-severe immune compromise) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19: As of Dec 1, 2023 Through Day 90 (median 35 days follow-up) Pemivibart 0% (0/306) 1% (3/298) Notes: These are exploratory endpoints; these data were not used for the basis of the EUA nor referenced in the PEMGARDA Fact Sheet. Beyond this interim update, additional cases of confirmed symptomatic COVID-19 have occurred in Cohort A and Cohort B post Day 90. These data will be analyzed and presented at a later timepoint. 10
RAPID REGULATORY PATHWAY TO A POTENTIAL COVID-19 TREATMENT EUA REFLECTS THE DEMONSTRATED UTILITY OF MONOCLONAL ANTIBODIES Old therapy vs old variants New therapy vs new variants Immunobridging approach (known clinical efficacy) (Unknown clinical efficacy) STAMP clinical trial of PEMGARDA (pemivibart) adintrevimab • Invivyd anticipates submitting a treatment EUA application for PEMGARDA (pemivibart) imminently • 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 adintrevimab • COVID-19 treatment EUA pathway offers a novel, rapid pathway to potential second EUA for pemivibart Repeatable, low-cost pathway could also be used for possible follow-on novel molecules with anticipated improved profiles over pemivibart RBD: Receptor binding domain 11
DESPITE VACCINATION, IMMUNOCOMPROMISED PEOPLE ARE DISPROPORTIONALLY IMPACTED BY SEVERE COVID-19 OUTCOMES 1 The recent INFORM study, conducted during the Omicron period, found that in a sample of nearly 12 million people: Immunocompromised (IC) people represented only IC individuals accounted for IC individuals accounted for 3.9% of the study population… 22% of COVID-19 hospitalizations 24% of COVID-19 deaths IC IC IC YET Immunocompetent Immunocompetent Immunocompetent Immunocompetent Even though >80% of the IC population had received ≥3 COVID-19 vaccines References: 1. Evans Lancet Reg 2023 12
NO ONE-TIME OUTPATIENT COVID-19 TREATMENT CURRENTLY EXISTS BUT MAY BE AN IMPORTANT THERAPEUTIC OPTION Indication or Authorized Use Treatment Dosing Select Limitations for Treatment (Abbreviated) Setting Mild-to-moderate COVID-19 in adults and Oral dose twice daily Studied in non- Significant drug-drug PAXLOVID pediatrics at high risk for progression to severe 1-2 (nirmatrelvir/ritonavir) for 5 days hospitalized interactions COVID-19 Adults with mild-to-moderate COVID-19 at high- Oral dose twice daily risk for progression to severe COVID-19 and for Low efficacy reported LAGEVRIO Non-hospitalized 3 4 (molnupiravir) for 5 days whom alternative treatment options are not from MOVE-OUT (31%) accessible or clinically appropriate Adults and pediatric patients who are IV infusions for 3 Requires 3 consecutive VEKLURY® hospitalized or not hospitalized and have mild-to- Non-hospitalized or consecutive days (for days of IV infusions (for 5 (remdesivir) moderate COVID-19 and are at high risk for hospitalized non-hospitalized patients) non-hospitalized patients) progression to severe COVID-19 Pemivibart has the potential to offer Invivyd’s first, one-time, outpatient, long-acting COVID-19 treatment, if authorized See the following materials for additional information: 1. PAXLOVID Full Prescribing Information (Revised 5/2023); 2. Paxlovid Fact Sheet for Healthcare Providers (Revised 4/2024); 3. LAGEVRIO Fact Sheet for Healthcare Providers (Revised 10/2023); 4. Bernal N Engl J Med 2022; 5. VELKURY Prescribing Information (Revised 2/204) No head-to-head clinical trials have been conducted between PEMGARDA (pemivibart) and any other COVID-19 treatment. Comparative conclusions regarding the safety and efficacy of 13 PEMGARDA (pemivibart) relative to other COVID-19 treatment therapies cannot be made. All trademarks are the property of their respective owners.
COVID-19 TREATMENT REPRESENTS A LARGE OPPORTUNITY 1 Paxlovid script data reflects ongoing need for COVID-19 treatments Recent reporting underscores the compelling potential opportunity in COVID-19 treatment: • Pfizer reported $2 billion in Paxlovid revenues for 1Q 2024, with $1.8 billion from the U.S.; Pfizer anticipates $3 billion 2 in Paxlovid full year 2024 revenue • Gilead reported $555 million in Veklury 3 sales for 1Q 2024 Reference: 1. Jefferies Equity Research Report: Pfizer (May 1, 2024); 2. Pfizer First-Quarter 2024 Results; 3. Gilead First Quarter 2024 Financial Results 14
INVIVYD’S SARS-COV-2 VARIANT INSIGHTS ARE POWERED BY VIVYDTOOLS ANALYTICS VivydTools SARS-CoV-2 Variant Dashboard • Variant tracking and analysis is automated using proprietary bioinformatics • Clinical sequence data is supplemented with wastewater data • Internal analysis provides a detailed view of SARS-CoV-2 evolution across the U.S. SARS-CoV-2 Lineages in Wastewater • VivydTools enable epitope surveillance and intelligent mAb selection in addition to surveillance of emergent SARS-CoV-2 lineages 15
EPITOPIC ANALYSIS IS BUILT FROM INDIVIDUAL RESIDUE ANALYSIS SARS-CoV-2 spike protein evolution is Individual residue analysis yields two observations tracked at the residue (amino acid) level 1. Observed mutational potential at individual amino acid positions or for a complete epitope are increasingly informative of future divergence 2. To date, the VYD222 epitope (area of RBD outlined in blue below) has been stable Lower polymorphic plasticity Higher polymorphic plasticity Each graph represents the frequency of different substitutions observed at one specific amino acid position in the receptor binding domain (RBD) of the spike Aug Sep Oct Nov Dec Jan Feb Mar 2023 | 2024 Note: Epitope is defined as all residues within 5 angstroms of VYD222 binding interface determined via co-crystal analysis. 16
VIRAL ANALYSIS ENABLES SYNTHETIC ANTIGEN DESIGN AND INCREASINGLY INTELLIGENT ANTIBODIES Analysis of convergent evolution yields patterns of prediction regarding spike / RBD mutations Predictive data is computationally combined with deep mutational scanning data specific for our mAbs to inform synthetic antigen design (spike antigen variations that may dominate the viral landscape in the future) Synthetic antigens screened via Invivyd technology using unique Boolean antibody optimization process Synthetic antigen 17 SARS-CoV-2 Phylogeny: Cov2tree.org, DMS data: Tyler Starr
INVIVYD DISCOVERY PROCESS NOW INCORPORATES SYNTHETIC EVOLUTIONARY INTELLIGENCE Circulating Ags Synthetic Ags EVOLUTIONARY INTELLIGENCE BOOLEAN MAB Proprietary incorporation DISCOVERY SCREENS of probabilistic future evolution into today’s mAb discovery and qualification PREDICTIVE VARIANT NEUTRALIZATION INTELLIGENT MAB SELECTION 18 18 Ags: Antigen
INVIVYD’S PIPELINE IS RAPIDLY ADVANCING TOWARD HIGHER INTELLIGENCE AND ANTICIPATED IMPROVED PHARMACEUTICAL PROFILES • First generation, mined from SARS-CoV-1 survivor serum and optimized against Wuhan Adintrevimab • Optimized on one dimension (ACE2:RBD affinity) (ADG20) • 2nd generation, engineered from ADG20 to recover activity against BA.2 PEMGARDA • Engineered for single dimension (ACE2:RBD breadth), constraining potency (pemivibart) • 3rd generation, optimized for post-Omicron two-dimensional problem (ACE2:RBD, immune evasion) VYD2311 • Highly potent and demonstrated post-Omicron variant resistance • Leverages evolutionary intelligence from VivydTools analysis and predictive synthetic antigens VYDXXXX • Expected high potency and designed for high variation resistance 19
SUMMARY: KEY ELEMENTS OF STRATEGY Variant Monitoring Pipeline Development & Commercial Opportunity • Virus is in constant motion • Pemivibart reflects Invivyd’s first generation technology • Individual residue mutations and combinations are • Invivyd now almost two years into analytics and technology under constant analysis and direct observation; data development and corresponding discovery strategies are routinely shared with the US FDA • More evasion resistant, more potent antibodies can enable • Invivyd monitors, analyzes, and tests constantly, but will more elegant ROAs and doses that improve access and the not update except through the PEMGARDA Fact Sheet medical value associated with protection and treatment • Neutralization assays exhibit wide variances by system • Rapid, highly efficient development pathways could unlock and laboratory, but have questionable meaning in the rapid profile improvements context of ongoing pharmaceutical activity Overall aim is to maximize the medical value of high-quality protection from symptomatic disease (PrEP) and adverse outcomes (treatment) in the broadest possible populations over time ROA: routes of administration 20
Q&A 21
