ROCHESTER, N.Y. – Vaccinex, Inc. (NASDAQ:) has shared new clinical findings from its SIGNAL-AD Phase 1b/2 trial, indicating progress in the treatment of Alzheimer’s disease (AD) with its lead product, pepinemab. The recent data focuses on the early stages of AD, starting with Mild Cognitive Impairment (MCI) through to mild dementia, and suggests that pepinemab may slow disease progression.
The company reports that the treatment with pepinemab has shown to inhibit the increase of plasma GFAP and p-tau 217 biomarkers, which are typically associated with the progression from MCI to AD. GFAP is a marker of astrocyte reactivity, and p-tau 217 is a fragment of toxic tau protein tangles found in neurons as the disease progresses. The study also observed that pepinemab may slow cognitive decline, as indicated by trends in various cognitive measures.
In addition to cognitive effects, proteomic analysis of Cerebrospinal Fluid (CSF) from patients treated with pepinemab revealed the inhibition of several proteins that usually increase during AD progression. This finding supports the potential benefit of the treatment.
Vaccinex also highlighted a new discovery that pepinemab could inhibit or reverse damage caused by alpha synuclein, a protein linked to several neurodegenerative diseases, including Dementia with Lewy Bodies and Parkinson’s disease. This suggests a broader application of the drug beyond AD.
The company has not observed adverse effects related to vascular integrity of the brain tissue, which is a concern with some AD treatments. In a human Brain-Chip model, pepinemab was shown to inhibit or reverse damage caused by toxic alpha synuclein aggregates.
Building on prior success in a Phase 2 study of Huntington’s disease (HD), Vaccinex believes that treating patients with MCI or mild dementia due to AD with pepinemab could be a productive path forward. The company is planning to continue discussions for partnerships to further develop pepinemab for AD, HD, and potentially other neurodegenerative diseases.
The information is based on a press release statement from Vaccinex, and it should be noted that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected. Vaccinex has not made any claims regarding the commercial availability of pepinemab for Alzheimer’s disease at this time.
In other recent news, Vaccinex, Inc., a biotechnology company, faces potential delisting from the Nasdaq Capital Market due to an equity shortfall. The company has failed to meet the Nasdaq’s Equity Standard or its Alternative Standards. Vaccinex plans to appeal the decision to a Nasdaq Hearings Panel to potentially prevent delisting.
Simultaneously, Vaccinex has secured approximately $6.2 million in funding through agreements allowing the exercise of existing warrants at a reduced price and the issuance of new warrants. The company has also made significant progress in its SIGNAL-AD clinical trial for Alzheimer’s disease treatment with the investigational drug, pepinemab. The trial results indicate a significant effect in slowing cognitive decline in patients with Mild Cognitive Impairment due to Alzheimer’s disease.
Furthermore, Vaccinex has exercised its right to call for the cancellation of several series of warrants issued between October 2023 and March 2024, following the positive development in the clinical trial. Entities controlled by significant figures within Vaccinex, including Albert D. Friedberg, chair of the Board, and Maurice Zauderer, Ph.D., president, CEO, and board member, were among the warrant holders. Lastly, Vaccinex is considering partnerships for further development of pepinemab, which could potentially reduce the company’s operating expenses.
InvestingPro Insights
As Vaccinex (NASDAQ:VCNX) reports promising clinical findings for its Alzheimer’s disease treatment, pepinemab, it’s crucial to consider the company’s financial position and market performance. According to InvestingPro data, Vaccinex has a market capitalization of $9.23 million USD, reflecting its current market valuation.
InvestingPro Tips highlight that analysts anticipate sales growth for Vaccinex in the current year, which aligns with the potential progress of pepinemab in clinical trials. This positive outlook is further supported by the expectation that net income will grow this year, and analysts predict the company will be profitable this year. These projections could be linked to the promising results from the SIGNAL-AD Phase 1b/2 trial and the potential broader applications of pepinemab in neurodegenerative diseases.
However, it’s important to note that Vaccinex is currently not profitable over the last twelve months, with a revenue of just $0.36 million USD in the last twelve months as of Q2 2024. The company’s gross profit margin stands at a concerning -4101.97%, indicating significant challenges in its cost structure.
Despite these financial hurdles, Vaccinex has shown a significant return over the last week (18.88%) and a strong return over the last month (18.53%), possibly reflecting market optimism about the recent clinical findings. However, the company’s stock price has fallen significantly over the last year (-70.05%), suggesting ongoing investor concerns about its long-term prospects.
For investors interested in a deeper analysis, InvestingPro offers 16 additional tips for Vaccinex, providing a more comprehensive view of the company’s financial health and market position.
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