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As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors set forth in the 2023 Form 10-K, other than as described below.
+Added: Risks Related to the Commercialization of Our Product Candidates
+Added: Our commercial prospects may be harmed if academic or other third-party labs unrelated to Invivyd generate virologic activity data that creates doubt regarding the neutralization activity of pemivibart or any other of Invivyd’s product candidates, even if such data is ultimately shown to be inconsistent with neutralization data generated through Invivyd’s industrial-grade virology efforts.
+Added: From time to time, academic or other third-party labs unrelated to Invivyd may produce and run tests on their own molecules meant to resemble Invivyd molecules, such as pemivibart, or run tests on Invivyd molecules utilizing differing assays, and put neutralization findings of unknown quality into the public domain.
+Added: In connection with the emergency use authorization (“EUA”) for PEMGARDA (pemivibart), the U.S.
+Added: Food and Drug Administration (“FDA”) has acknowledged that neutralization findings from sources other than Invivyd’s independent, contracted vendor may differ due to, among other reasons, assay differences or because the molecule tested by other labs differs from pemivibart in sequence.
+Added: Nevertheless, publicly available neutralization data against emerging SARS-CoV-2 variants are reviewed by the FDA and may be factored into the totality of evidence when considering the potential for adequate neutralization activity of PEMGARDA to support continued emergency use authorization.
+Added: To the extent that virologic activity data in the public domain generated by academic or other third-party labs unrelated to Invivyd creates doubt regarding the neutralization activity of pemivibart or other Invivyd product candidates, it could adversely impact our regulatory authorization and market acceptance by healthcare providers (“HCPs”) or patients, particularly if such publicly available neutralization findings are referenced by the FDA in relation to the regulatory authorization of any Invivyd product candidate, which would adversely affect our commercial prospects and ability to generate revenues, even if such data is preliminary, non-peer-reviewed, and/or generated with molecules that are not authentic Invivyd molecules, and even if such data is ultimately shown to be inconsistent with neutralization data generated through Invivyd’s industrial-grade virology efforts.
+Added: For example, in October 2024, Invivyd withdrew formal revenue guidance for FY2024 following growth headwinds after the FDA updated the PEMGARDA Fact Sheet for HCPs (“Fact Sheet”) in August 2024 to include a link to contested, non-peer-reviewed neutralization data of a non-pemivibart antibody generated by an academic lab, which indicated that PEMGARDA may have reduced susceptibility to certain SARS-CoV-2 variants, including KP.3.1.1.
+Added: In September 2024, we announced that pseudovirus in vitro neutralization data generated by Invivyd’s independent, contracted vendor as part of our industrial-grade virology efforts showed continued neutralizing activity of PEMGARDA against KP.3.1.1 and other SARS-CoV-2 variants tested, and later that month, the FDA re-issued an updated PEMGARDA Fact Sheet to provide accurate in vitro neutralization activity of PEMGARDA against dominant circulating variants, including KP.3.1.1.
+Added: However, this series of events resulted in confusion in the HCP and vulnerable population communities about PEMGARDA and negatively impacted our net product revenue growth.
+Added: If academic or other third-party labs unrelated to Invivyd generate virologic activity data that creates doubt regarding the neutralization activity of pemivibart or any other of Invivyd’s product candidates, our regulatory authorization and our commercial
+Added: prospects may be harmed, even if such data is ultimately shown to be inconsistent with neutralization data generated through Invivyd’s industrial-grade virology efforts.
Risks Related to Our Dependence on Third Parties
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In addition, any third parties conducting our nonclinical activities or our clinical trials, or monitoring and managing our data, will not be our employees, and except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our programs.
−Removed: If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the quality or accuracy of the nonclinical, clinical or other data they generate or otherwise obtain is compromised or not timely made available to us or regulatory authorities, due to the failure to adhere to applicable protocols, regulatory requirements, contractual obligations or for other reasons, our preclinical studies or clinical trials may be extended, delayed or terminated, the strength and reliability of our data may be adversely impacted, which may impact our ability to obtain or maintain regulatory authorization or approval, or result in modification to the regulatory authorization or approval documents (e.g., Emergency Use Authorization (“EUA”) fact sheet, letter of authorization or prescribing information), and may impact our ability to successfully commercialize our product candidates.
+Added: If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the quality or accuracy of the nonclinical, clinical or other data they generate or otherwise obtain is compromised or not timely made available to us or regulatory authorities, due to the failure to adhere to applicable protocols, regulatory requirements, contractual obligations or for other reasons, our preclinical studies or clinical trials may be extended, delayed or terminated, the strength and reliability of our data may be adversely impacted, which may impact our ability to obtain or maintain regulatory authorization or approval, or result in modification to the regulatory authorization or approval documents (e.g., EUA fact sheet, letter of authorization or prescribing information), and may impact our ability to successfully commercialize our product candidates.
Consequently, our results of operations and the commercial prospects for our product candidates may be harmed, our costs could increase substantially and our ability to generate revenue could be impaired significantly.
−Removed: For example, following receipt of EUA from the U.S.
−Removed: Food and Drug Administration (“FDA”) in March 2024 for PEMGARDA (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg), we were informed in mid-July 2024 by our third-party authentic virus neutralization assay (“AVNA”) vendor that a possible contamination event may have impacted the AVNA potency value generated by such vendor for pemivibart against JN.1, which was the dominant circulating SARS-CoV-2 variant in the United States between January 2024 and
−Removed: Along with the pseudotyped neutralization assay (“PVNA”) potency value for pemivibart against JN.1, the PEMGARDA Fact Sheet reflects the AVNA potency value for pemivibart against JN.1.
−Removed: In light of this potential contamination event, the FDA has indicated that revisions will likely be made to the PEMGARDA Fact Sheet are under consideration.
−Removed: We are pursuing additional AVNA assay work with multiple third-party AVNA vendors to reassess the AVNA potency value for pemivibart against JN.1, while also working with our third-party PVNA vendor to continue to generate and provide the FDA with PVNA potency data against SARS-CoV-2 variants, as required by the PEMGARDA EUA.
−Removed: The timeline for completing this additional AVNA assay work remains uncertain and the ultimate outcome of such work and its impact on the PEMGARDA EUA remains uncertain at this time.
+Added: For example, following receipt of EUA from the FDA in March 2024 for PEMGARDA (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg), we were informed in mid-July 2024 by our third-party authentic virus neutralization assay (“AVNA”) vendor that a possible contamination event may have impacted the AVNA potency value generated by such vendor for pemivibart against JN.1, which was the dominant circulating SARS-CoV-2 variant in the United States between January 2024 and April 2024.
+Added: Along with the pseudotyped viral neutralization assay (“PVNA”) potency value for pemivibart against JN.1, the original PEMGARDA Fact Sheet reflected the AVNA potency value for pemivibart against JN.1.We have been pursuing additional AVNA assay work with multiple third-party AVNA vendors to reassess the AVNA potency value for pemivibart against JN.1, while also working with our third-party PVNA vendor to continue to generate and provide the FDA with PVNA potency data against SARS-CoV-2 variants, as required by the PEMGARDA EUA.
+Added: As a result of the possible contamination event at our third-party AVNA vendor that may have impacted the AVNA potency value for pemivibart against JN.1, the FDA made modifications to the PEMGARDA Fact Sheet, including, among other changes, removal of the AVNA potency value for pemivibart against JN.1 and incorporation of certain other available information for HCPs to consider when determining whether to prescribe PEMGARDA.
Our reliance on CROs and other third parties reduces our control over our nonclinical activities and clinical trials, but does not relieve us of our regulatory responsibilities.
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Use of Proceeds
−Removed: We did not issue any unregistered equity securities during the three months ended June 30, 2024.
+Added: We did not issue any unregistered equity securities during the three months ended September 30, 2024.
Purchases of Equity Securities by the Issuer
−Removed: We did not purchase any of our equity securities during the three months ended June 30, 2024.
+Added: We did not purchase any of our equity securities during the three months ended September 30, 2024.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.