US-based biopharmaceutical company Vaccinex is set to delist from the Nasdaq stock exchange despite reporting positive Phase II results for its lead candidate pepinemab in Alzheimer's disease last year. The company plans to submit a Form 25 to the Securities and Exchange Commission around March 17, with the delisting becoming effective 10 days after filing.
The decision follows a suspension of Vaccinex's common stock trading in December 2024 after a Nasdaq hearings panel determined the company had failed to meet equity requirements for continued listing. Currently trading under the ticker VCNX, Vaccinex's market capitalization has dwindled to just under $2.5 million.
Financial Challenges Despite Clinical Promise
Vaccinex went public in 2018 with an initial public offering (IPO) priced at $12 per share, raising approximately $40 million to advance its neurodegenerative disease pipeline. However, share prices have since collapsed to $3.82 by early December 2024, reflecting investor concerns about the company's financial stability.
Like many early-stage biopharmaceutical companies, Vaccinex directed most of its resources toward developing its lead candidate. As research and development expenses for pepinemab increased, the company's financial position deteriorated. According to its most recent quarterly results ending September 2024, Vaccinex had only $2.9 million in cash remaining.
Despite these financial challenges, the company has affirmed its commitment to continue developing pepinemab for both Alzheimer's disease and cancer indications "through partnerships, grants and other financing avenues."
Promising Clinical Data for Pepinemab
Pepinemab, an antibody previously known as pepinemabin, has shown encouraging results in clinical trials. In July 2024, Vaccinex reported positive topline results from a Phase Ib/II trial (NCT04381468) in Alzheimer's disease patients. The drug, administered as a monotherapy, demonstrated a statistically significant increase in FDG-PET signal in brain regions typically affected by early disease progression.
The company has also evaluated pepinemab in Huntington's disease, where it showed a similar Phase II safety profile and effects on brain metabolic activity.
Competitive Pressures in the Alzheimer's Market
The lack of investor enthusiasm for Vaccinex appears partly due to intense competition in the Alzheimer's disease market. Established treatments from larger pharmaceutical companies have dominated the landscape, including Eisai and Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab), which received US approvals in 2023 and 2024 respectively.
These competitors have substantial market projections, with Leqembi forecast to generate $5.3 billion in global revenues by 2030 and Kisunla expected to reach $1.7 billion in the same timeframe, according to GlobalData's Pharma Intelligence Centre.
Oncology Partnerships Continue
Despite the upcoming delisting, Vaccinex remains committed to developing pepinemab for oncology indications through strategic partnerships. The company is currently evaluating the antibody in combination with MSD's Keytruda in the Phase Ib/II KEYNOTE-B84 study (NCT04815720) for recurrent or metastatic head and neck cancer (HNSCC).
Additionally, Vaccinex has partnered with Merck KGaA to test pepinemab in combination with Bavencio (avelumab) in a Phase Ib/II study targeting patients with metastatic pancreatic adenocarcinoma (PDAC).
Future Outlook
While Vaccinex will no longer be publicly traded, the company's continued focus on clinical development through partnerships suggests a strategic pivot rather than a complete cessation of operations. The positive clinical data for pepinemab in both neurodegenerative and oncological indications may still provide opportunities for the company to secure additional funding or potential acquisition interest from larger pharmaceutical companies seeking to expand their pipelines in these therapeutic areas.
