Advancing VYD222 into medical growth primarily based on in vitro information demonstrating neutralizing exercise in opposition to a number of vital variants of concern, together with XBB.1.5

Anticipate near-term designation of a further monoclonal antibody in opposition to SARS-CoV-2 with complementary binding properties to VYD222 for growth

Properly capitalized with $372 million in money, money equivalents and marketable securities anticipated to help working runway into second half of 2024

Convention name scheduled for Thursday, March 23^rd at 4:30 p.m. ET

WALTHAM, Mass., March 23, 2023 (GLOBE NEWSWIRE) — Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical firm on a mission to guard the weak from severe viral infectious ailments, as we speak introduced monetary outcomes for the yr ended December 31, 2022, and up to date enterprise highlights.

“2022 was a transformational yr for Invivyd as we reformed our technique and are actually squarely centered on leveraging our built-in discovery platform to advance a stream of SARS-CoV-2 monoclonal antibody (mAb) candidates. There continues to be an pressing, unmet medical want for weak populations given no antibodies are at the moment approved,” mentioned Dave Hering, CEO of Invivyd. “We’re happy to have just lately introduced plans to advance VYD222 into medical growth as a novel mAb therapeutic possibility for COVID-19. We imagine VYD222 is a extremely engaging candidate that would doubtlessly leverage adintrevimab’s robust medical information package deal to help potential accelerated growth. Importantly, in vitro information on VYD222 has proven neutralizing exercise in opposition to a number of at the moment circulating variants of concern, together with people who led to the obsolescence of merchandise beforehand approved within the U.S. We proceed to plan for a Part 1 medical trial begin in Q1 2023. Assuming constructive Part 1 information, we anticipate quickly initiating Part 3 pivotal trials that would help regulatory filings globally.”

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Latest Enterprise Highlights

• Earlier in March 2023, the corporate introduced plans to advance VYD222 into the clinic as a mAb therapeutic possibility for COVID-19 with a deal with serving weak populations. VYD222 is likely one of the two mAb parts of NVD200, a mixture mAb product candidate that Invivyd had beforehand chosen for development previous to evolution within the present world COVID-19 regulatory paradigm. The corporate is prioritizing the medical growth of VYD222 as a substitute of NVD200 with the purpose of offering sufferers with a therapeutic possibility for COVID-19 as rapidly and effectively as attainable. VYD222 was engineered from adintrevimab, Invivyd’s investigational mAb that has a strong security information package deal and demonstrated clinically significant ends in world Part 3 medical trials for each the prevention and remedy of COVID-19. The adintrevimab medical information package deal has the potential to help accelerated growth of VYD222. 

• In March 2023, the corporate and collaborators revealed an article within the journal Science Translational Medication titled, “Antibody-mediated safety in opposition to symptomatic COVID-19 will be achieved at low serum neutralizing titers.” The work builds on vaccine research demonstrating neutralizing antibody titers as correlates of safety in opposition to illness and will inform the evolution of regulatory frameworks for therapeutic antibodies.

• The corporate continues to leverage its built-in discovery platform, mapping frequent mutational escape routes to foretell potential merchandise to deal with future variants of the SARS-CoV-2 virus. Past VYD222, the corporate is constantly monitoring evolving variants and engineering to optimize pipeline candidates and has initiated a brand new mAb marketing campaign that targets re-engineering and affinity maturations of present molecules in opposition to the latest variants of concern, equivalent to XBB.1.5. The corporate is at the moment evaluating a number of of those candidates in preclinical research to help nomination of extra candidates for IND-enabling and medical growth.

• In December 2022, the corporate was invited to take part in a U.S. Meals and Drug Administration-European Medicines Company workshop to discover expedited growth pathways for mAbs. The assembly featured displays by scientists, clinicians, regulators, and business representatives to debate various methods to help the expedited availability of novel monoclonal antibody therapies. The corporate goals to leverage evolving COVID-19 regulatory paradigms to ship this much-needed product for immunocompromised people and different weak populations.

• The corporate has introduced key management positions that broaden the corporate’s business experience in help of its growth and industrial planning.

  • Appointed Jeremy Gowler as chief working officer and industrial officer. Mr. Gowler brings 20 years of expertise throughout a number of key commercialization features all through the product lifecycle.

  • Promoted Pete Schmidt, M.D. to chief medical officer. Dr. Schmidt had served as Invivyd’s vice chairman of medical analysis for the previous two years, and is now liable for overseeing all medical, medical growth and regulatory actions at Invivyd.

12 months Finish 2022 Monetary Outcomes

• Money Place: Money, money equivalents and marketable securities have been $372 million as of December 31, 2022.

• Money Runway: Based mostly on present working plans, Invivyd expects its present complete money, money equivalents and marketable securities will allow the corporate to fund its working bills into the second half of 2024.

• Analysis & Growth (R&D) Bills (together with In-process Analysis & Growth): R&D bills have been $183.6 million for the yr ended December 31, 2022, in comparison with $190.4 million for the comparable interval of 2021. This lower is attributable to wind-down of adintrevimab medical trials, partially offset by a rise in contract manufacturing and personnel-related bills, together with a rise of $6.2 million of stock-based compensation expense.

• Promoting, Basic & Administrative (SG&A) Bills: SG&A bills have been $47.0 million for the yr ended December 31, 2022, in comparison with $36.5 million for the comparable interval of 2021. This improve is attributable to greater public firm prices and personnel-related bills.

• Warrant Expense: Warrant expense was $17.4 million for the yr ended December 31, 2022, in comparison with $0 for the comparable interval of 2021. This improve is attributable to a one-time cost related to warrants issued to Inhabitants Well being Companions, L.P. (PHP) as compensation for consulting providers to be offered by PHP to the corporate beneath the settlement entered into within the fourth quarter of 2022.

• Web Loss and Web Loss per Share: Web loss was $241.3 million for the yr ended December 31, 2022, in comparison with $226.8 million for the comparable interval in 2021. Primary and diluted internet loss per share was $2.23 for the yr ended December 31, 2022, in comparison with $5.32 for the comparable interval in 2021.

Convention Name
In reference to this announcement, Invivyd will host a convention name and webcast as we speak at 4:30 p.m. ET. A dwell audio webcast might be accessible at invivyd.com/buyers. events can also register for the webcast through this hyperlink. Analysts wishing to take part within the query and reply session ought to use this hyperlink. A replay of the webcast might be accessible through the corporate’s investor web site roughly two hours after the decision’s conclusion. Those that plan on collaborating are suggested to hitch quarter-hour previous to the beginning time.

About Invivyd
(Nasdaq: IVVD)
Invivyd, Inc., is a biopharmaceutical firm on a mission to quickly and perpetually ship antibody-based therapies that shield weak folks from the devastating penalties of circulating viral threats, starting with SARS-CoV-2. ​​Invivyd’s know-how works on the intersection of evolutionary virology, predictive modeling, and antibody engineering, and is designed to establish high-quality, long-lasting antibodies with a excessive barrier to viral escape. The corporate is producing a strong pipeline of product candidates which might be utilized in prevention or remedy of great viral ailments, beginning with COVID-19 and increasing into influenza and different high-need indications. Go to https://invivyd.com/ to study extra.

Cautionary Be aware Concerning Ahead Wanting Statements
This press launch incorporates forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995. Phrases equivalent to “anticipates,” “believes,” “might,” “expects,” “intends,” “potential,” “tasks,” and “future” or comparable expressions (in addition to different phrases or expressions referencing future occasions, circumstances or circumstances) are meant to establish forward-looking statements. Ahead-looking statements embody statements regarding, amongst different issues, the power for Invivyd, different firms or mixture of firms and business representatives to affect regulators to vary or undertake new growth pathways or timelines; the power of Invivyd to speed up growth timelines for the unmet want for remedy of COVID-19; the curiosity or acceptance by regulatory authorities of regulatory and medical methods to help doubtlessly expedited growth of novel monoclonal antibody therapies; the potential for achievement and or expedited discovery, growth, or commercialization of antibody therapies for COVID-19; the continued unmet want for prevention and remedy of COVID-19, significantly for immunocompromised and different weak populations; the viability and acceptability of latest regulatory technique, coverage or strategy to drug growth and the potential of the identical to keep up tempo with altering COVID-19 variants; the way forward for the COVID-19 panorama together with the expectation of continued evolution and emergence of latest variants and subvariants; our ongoing analysis and medical growth plans and the timing thereof; our plans to advance VYD222 or different early stage candidates as a possible prophylaxis and remedy possibility for COVID-19, together with illness attributable to most variants, as both a single or mixture agent; the potential for VYD222 or different product candidates to show exercise in opposition to predominant SARS-CoV-2 variant(s) within the U.S. and globally; the potential for the medical information package deal ensuing from medical trials of adintrevimab to help accelerated VYD222 monotherapy growth; our plans to advance VYD222 into the clinic; our expectations that we will obtain regulatory alignment and advance pivotal research with VYD222; our expectations relating to the anticipated timeline of our money runway; anticipated advantages to the corporate of current government officer appointments and promotions; our plans, know-how and assets to develop therapeutic or preventative choices for different infectious ailments, equivalent to extra coronaviruses and seasonal influenza, within the U.S. and globally; and different statements that aren’t historic reality. We could not truly obtain the plans, intentions or expectations disclosed in our forward-looking statements and you shouldn’t place undue reliance on our forward-looking statements. These forward-looking statements contain dangers and uncertainties that would trigger our precise outcomes to vary materially from the outcomes described in or implied by the forward-looking statements, together with, with out limitation: the power to realize alignment with the relevant regulatory authorities on the medical growth pathway for VYD222 and the timing thereof; the power for Invivyd and/or different firms, scientists, clinicians or business representatives to influence the technique, coverage or strategy to drug growth drafted or utilized by regulatory authorities, together with the FDA and EMA; the influence of any such change on the velocity or success of growth and commercialization of antibodies for the prevention and/or remedy of COVID-19; the power of the corporate to generate and make the most of instruments to find and develop antibodies to deal with present and potential future variants; the impacts of the COVID-19 pandemic on our enterprise and people of our collaborators, our medical trials and our monetary place; surprising security or efficacy information noticed throughout preclinical research or medical trials; the predictability of medical success of VYD222 or different pipeline candidates or mixture of candidates primarily based on neutralizing exercise in pre-clinical research; variability of ends in fashions used to foretell exercise in opposition to SARS-CoV-2 variants of concern; medical trial web site activation or enrollment charges which might be decrease than anticipated; adjustments in anticipated or present competitors; adjustments within the regulatory atmosphere; the uncertainties and timing of the regulatory approval course of, together with the end result of our discussions with regulatory authorities regarding our medical trials; whether or not VYD222 or every other pipeline candidate or mixture of candidates is ready to show exercise in opposition to predominant SARS-CoV-2 variant(s) within the U.S. and globally; whether or not we’re in a position to efficiently submit an emergency use authorization sooner or later, and the end result of any such emergency use authorization submission; whether or not analysis and growth efforts will enhance efficacy of adintrevimab in opposition to predominant variants or establish extra monoclonal antibodies or mixture of antibodies for the prevention and remedy of COVID-19 and different infectious ailments; whether or not analysis and growth efforts will establish and lead to protected and efficient therapeutic or preventative choices for different infectious ailments within the U.S. or globally and whether or not now we have ample funding to fulfill future working bills and capital expenditure necessities. Different elements that will trigger our precise outcomes to vary materially from these expressed or implied within the forward-looking statements on this press launch are described beneath the heading “Threat Elements” in our Quarterly Report on Kind 10-Q for the quarter ended September 30, 2022 filed with the Securities and Change Fee (the “SEC”), and in our different filings with the SEC, and in Invivyd’s future experiences to be filed with the SEC and accessible at www.sec.gov. Such dangers could also be amplified by the impacts of the COVID-19 pandemic. Ahead-looking statements contained on this press launch are made as of this date, and Invivyd undertakes no responsibility to replace such info whether or not because of new info, future occasions or in any other case, besides as required beneath relevant legislation.

This press launch incorporates hyperlinks to info that isn’t deemed to be included by reference on this press launch.

Contacts
Media Contact:
Kate Burdick, Evoke Canale
860-462-1569
[email protected]

Investor Contact:
Chris Brinzey, ICR Westwicke
339-970-2843
[email protected]

INVIVYD, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In 1000’s, besides share and per share quantities)

INVIVYD, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In 1000’s, besides share and per share quantities)

^{(1) Consists of related-party quantities of $8,154 and $4,150 for the years ended December 31, 2022 and 2021, respectively.
(2) Consists of related-party quantities of $4,400 and $7,500 for the years ended December 31, 2022 and 2021, respectively.
(3) Consists of related-party quantities of $17,373 and $0 for the years ended December 31, 2022 and 2021, respectively.}