On-track to report topline data from CLASSICAL-Lung and SIGNAL clinical trials this year

Announces expansion of pepinemab development program into Alzheimer’s disease

Completes private placement of common stock, raising gross proceeds of $7.5 million

ROCHESTER, N.Y., March 09, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and Huntington’s disease, today announced financial results for the fourth quarter ended December 31, 2019 and provided a corporate update.

Fourth Quarter and Recent Accomplishments:

• Expansion of the pepinemab development program to include Alzheimer’s disease based on findings from Cohort A of the company’s ongoing SIGNAL Huntington’s disease study was announced. This research will be funded in part by awards of up to $3,750,000, expected to be received during 2020 from the Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Association “Part the Cloud” Program.
• Company scientists and collaborators made three oral presentations highlighting Semaphorin 4D (SEMA4D) as an emerging and important cancer target at the ASCO-SITC Clinical Immuno-Oncology Symposium. The company’s lead therapeutic candidate, pepinemab (VX15), is a monoclonal antibody that targets SEMA4D.
• Presented updated interim data from a Phase 1b/2 study of pepinemab in combination with avelumab (BAVENCIO®) in non-small cell lung cancer at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
• Raised gross proceeds of approximately $7.5 million through a private placement of 1,468,563 shares of the company’s common stock in January 2020.

Pepinemab Clinical Updates:

• Non-Small Cell Lung Cancer (NSCLC). CLASSICAL-Lung clinical trial. Near topline data in the first half of 2020.
• Huntington’s Disease. The company’s SIGNAL trial evaluating pepinemab for the treatment of Huntington’s disease is ongoing, with topline data from Cohort B expected in October.
• In addition, the company’s lead drug candidate, pepinemab is being evaluated in multiple investigator-sponsored trials (ISTs) in additional indications:
  • Melanoma - The UCLA School of Medicine, in collaboration with Bristol-Myers Squibb, is evaluating pepinemab in combination with the checkpoint inhibitors nivolumab and ipilimumab in a small cohort of patients with advanced melanoma whose tumors progressed during or following initial treatment with immunotherapy.
  • Osteosarcoma - The National Cancer Institute’s Children’s Oncology Group is evaluating pepinemab for the treatment of osteosarcoma.
  • Other Cancers - Multiple “window of opportunity” trials are being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.

“During the fourth quarter, we achieved a very significant milestone for our company with the presentation of updated interim data from our ongoing CLASSICAL-Lung Phase 1b/2 study of pepinemab in combination with the anti-PD-L1 checkpoint inhibitor, BAVENCIO® (avelumab), in non-small cell lung cancer,” stated Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. “The data showed that 17 of 29 study subjects who had failed prior single agent checkpoint inhibitor therapy appeared to benefit from the combination of pepinemab and avelumab. Notably, two of these subjects were partial responders with tumor reductions of 63% and 52%, and 15 subjects experienced stable disease. We are very pleased with these very compelling interim data and look forward to near topline data by mid-year as we continue to efficiently advance the promising combination of pepinemab and a checkpoint inhibitor through clinical development.      

“At the same time, our SIGNAL clinical trial of pepinemab in Huntington’s disease, our most advanced study, is ongoing and we look forward to topline data from Cohort B later this year.

“We believe these trials, together with ongoing investigator sponsored trials in other cancer indications, and our recent announcement that we are planning to initiate a study in Alzheimer’s disease later this year, offer multiple opportunities to demonstrate the broad potential of pepinemab in treating serious diseases,” Dr. Zauderer concluded.

Upcoming Expected Milestones:

• First half 2020 – Near topline data from the CLASSICAL-Lung non-small cell lung cancer study anticipated.
• May/June 2020 (ASCO) - Interim analysis of combination Window-of-Opportunity studies at Emory University (melanoma, head and neck squamous cell carcinoma, colorectal and pancreatic cancer) expected.
• Second half 2020 – Anticipated publication of data from Cohort A of the SIGNAL Huntington’s disease trial.
• Mid-2020 - Anticipated enrollment of first patient in Alzheimer’s disease Phase 1 study
• October 2020 – Topline data from Cohort B of SIGNAL Huntington’s disease study expected.

Financial Results for the Three and Twelve Months Ended December 31, 2019:

Revenue. Revenue for the year ended December 31, 2019 was $523,000 as compared to $724,000 for the year ended December 31, 2018. The company’s revenues were generated primarily from collaboration arrangements with Surface Oncology, Merck KGaA and Heptares Therapeutics.

Research and Development Expenses. Research and development expenses for the three months ended December 31, 2019 were $4.4 million as compared to $7.1 million for the comparable period in 2018. This decrease was attributable to fewer subjects enrolled in active clinical trials during the three months ended December 31, 2019. For the full year 2019, research and development expenses were $25.7 million as compared to $22.4 million for the full year 2018. This increase was attributable to more subjects enrolled in active clinical trials during the first half of 2019.  During the course of 2019, clinical trial expenses decreased as subjects completed their participation in our clinical trials.

General and Administrative Expenses. General and administrative expenses for the three months ended December 31, 2019 were $1.9 million as compared to $1.4 million for the comparable period in 2018. For the full year 2019, general and administrative expenses were $6.7 million as compared to $4.6 million for the full year 2018 driven primarily by increased insurance premiums and costs associated with being a public company.  

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on December 31, 2019 were $2.8 million, as compared to $19.7 million on December 31, 2018. In January 2020, the company raised gross proceeds of approximately $7.5 million through a private placement of 1,468,563 shares of its common stock.

About Vaccinex, Inc.

Vaccinex, Inc. is a clinical-stage immunotherapy company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including cancer, neurodegenerative diseases, and autoimmune disorders, with currently active clinical trials in Non-Small Cell Lung Cancer and Huntington’s disease. Vaccinex is based in Rochester, New York.

Forward Looking Statements

To the extent that statements contained in this press release 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. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “potential,” “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements in this press release include, among others, statements about the expected timing and results of our ongoing clinical trials and our expectations regarding the potential benefits, activity and effectiveness of our product candidates. Forward-looking statements may involve substantial risks and uncertainties that could cause 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, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, our history of operating losses and need to raise additional capital to continue as a going concern, 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 our Form 10-K filed with the SEC on March 13, 2019 and subsequent periodic reports.

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com

Source: Vaccinex, Inc.