Vaccinex Announces Q1 2024 Financial Results and Corporate Update

Vaccinex Inc., a clinical-stage biotechnology company, announced several important updates and financial results for the first quarter ending March 31, 2024. The company, listed on Nasdaq under the ticker VCNX, is advancing a unique approach to treating neurodegenerative diseases and cancer by inhibiting Semaphorin 4D (SEMA4D). The update included significant progress in their Alzheimer's disease treatment program with the experimental drug pepinemab.

Pepinemab, an anti-SEMA4D antibody, is the focus of the SIGNAL-AD Phase 2a trial targeting mild Alzheimer’s Disease (AD). Vaccinex aims to complete the 12-month treatment of the last patient in early June 2024, with the database lock expected by early July for final analysis. The drug is designed to prevent astrocyte activation, which is commonly triggered by SEMA4D upregulation in stressed or damaged neurons, contributing to neurodegenerative disease progression. By blocking this activation, pepinemab aims to maintain healthy astrocyte functions and potentially slow cognitive decline.

Alzheimer’s Disease, affecting approximately 6 million people in the U.S., has been challenging to treat effectively. Current treatments often focus on anti-amyloid beta (Aβ) antibodies, which have limitations. Vaccinex's approach with pepinemab is seen as a potential alternative or adjunctive treatment to enhance patient outcomes. Notably, pepinemab has shown to be well-tolerated in clinical trials involving over 600 patients, without evidence of amyloid-related imaging abnormalities (ARIA).

The company’s research highlights the role of astrocyte activation and subsequent formation of toxic tau tangles in neurons as key factors in AD progression, beyond just Aβ amyloid deposition. The SIGNAL-AD study will also examine the impact of pepinemab on brain metabolic activity and other biomarkers like glial fibrillary acidic protein (GFAP) and phosphorylated tau peptide (p-tau 217). Results will be presented at an upcoming major Alzheimer’s medical conference. This study has received significant financial backing, including $4.75 million from the Alzheimer’s Drug Discovery Foundation (ADDF) and a $0.75 million grant from the Alzheimer’s Association.

Financially, Vaccinex reported cash, cash equivalents, and marketable securities totaling $3.0 million as of March 31, 2024, up from $1.5 million at the end of 2023. The company raised substantial funds through private placements and public offerings in early 2024, amassing gross proceeds of $4.94 million from common stock transactions and an additional $1.50 million through a public offering. Furthermore, ADDF invested $1.75 million in a private placement of preferred stock and common warrants.

Research and development expenses were $3.4 million for Q1 2024, slightly down from $3.8 million in Q1 2023. General and administrative expenses were $1.8 million, up from $1.7 million in the previous year’s comparable period. The comprehensive loss for Q1 2024 was $3.9 million, reducing from $5.0 million in Q1 2023. This translated to a net loss per share of $(2.94), compared to $(20.89) the previous year.

Vaccinex’s stockholders’ equity improved to $2.7 million by March 31, 2024, from a deficit of $(2.3) million at the end of 2023. This improvement followed warrant modifications that allowed classification as equity, addressing a previous issue that had impacted compliance with Nasdaq’s listing requirements. Despite receiving a notice from Nasdaq about failing to meet the minimum $2.5 million stockholders’ equity requirement, the company has submitted a compliance plan, awaiting approval.

Pepinemab, a humanized IgG4 monoclonal antibody, has shown promise in blocking SEMA4D, which disrupts the functions of astrocytes and glial cells in the brain. This potentially mitigates harmful inflammation in chronic brain diseases and enhances immune responses to tumors.

Vaccinex continues to explore pepinemab’s use in oncology, including combination studies with KEYTRUDA® and BAVENCIO® for various cancers, demonstrating broad potential beyond neurodegenerative diseases.

As of now, Vaccinex holds global rights to pepinemab and is actively pursuing further clinical developments, particularly in collaboration with established pharmaceutical companies like Merck Sharp & Dohme Corp. The company remains optimistic about its innovative treatments and the potential impacts on both Alzheimer’s and cancer therapies.