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Company Has Reassured Nasdaq of Actions It Plans to Take to Meet Minimum Bid Price Requirement
Randomized Phase 2 Study in Alzheimer’s Disease on Schedule to Complete Treatment in
Investors will recall that
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and other glial cells in the brain and of innate immune cells that regulate immune responses. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.
About Vaccinex Inc.
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA and Pfizer.
Forward Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about our ability to regain compliance with the minimum bid price standard, the continued listing of our common stock on the Nasdaq Capital Market, our plans, expectations and objectives with respect to the results and timing of the KEYNOTE-B84 clinical trial, planned interim analysis, the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications, the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®, expectations with respect to the collaboration of Merck, expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial, the potential to initiate a Phase 3 trial in HD and any impact from ongoing FDA discussions, the expected timeline for disclosure of trial results at scientific conferences or through publications, and other statements identified by words such as “believes,” “being,” “may,” “will,” “appears,” “expect,” “continue,” “estimate,” “ongoing,” “potential,” “prevents,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, our ability to regain compliance with the minimum bid price standard, the possible delisting of our common stock from Nasdaq if we are unable to comply with Nasdaq listing standards, whether Nasdaq will confirm that we have regained compliance with the minimum bid price standard or otherwise grant further relief from delisting, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC.
Chief Operating Officer,
Source: Vaccinex, Inc.