Vaccinex(VCNX) - 2023 Q2 - Quarterly Report

Financial Performance - The company reported a net loss of $7.1 million for Q2 2023, compared to a net loss of $5.4 million for Q2 2022, and a net loss of $12.0 million for the first half of 2023, compared to $10.0 million for the same period in 2022[83]. - The company reported a net loss attributable to Vaccinex, Inc. of $7.06 million for the three months ended June 30, 2023, compared to a net loss of $5.38 million for the same period in 2022[102]. - For the six months ended June 30, 2023, the company reported a net loss of $12.0 million, compared to a net loss of $10.0 million for the same period in 2022, indicating an increase in losses[118]. - The company anticipates continued net losses as it develops and seeks regulatory approvals for its product candidates, with an accumulated deficit of $331.7 million as of June 30, 2023[118]. Cash and Liquidity - As of June 30, 2023, the company had cash and cash equivalents of $1.9 million, down from $6.4 million as of December 31, 2022[83]. - Cash used in operating activities for the six months ended June 30, 2023, was $10.5 million, slightly higher than $10.3 million for the same period in 2022[122]. - Financing activities provided a net of $6.1 million during the six months ended June 30, 2023, compared to $13.2 million in the same period of 2022[125]. - The remaining principal balance of the PPP Loan as of June 30, 2023, is approximately $138,000, with a maturity date of May 8, 2025[116]. - The company plans to finance operations through equity sales, debt financing, and other capital sources until sufficient revenue is generated from product commercialization[119]. Revenue Generation - The company has not generated any revenue from product sales to date and continues to incur significant development expenses, raising doubts about its ability to continue as a going concern[83]. - The company generated $500,000 from a collaboration agreement with Surface Oncology and $50,000 in service revenue during the six months ended June 30, 2023, totaling $550,000 in revenue, compared to no revenue in the same period of 2022[97][108]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future as it continues to seek regulatory approvals for its product candidates[98][111]. Research and Development - The company is developing pepinemab for multiple indications, including Alzheimer's disease and various cancers, leveraging its SEMA4D antibody platform[81]. - The company reported an objective response rate (ORR) of 21.1% in patients with PD-L1-low tumors in a Phase 2 study, nearly double the historical response rate of 11.9% for ICI monotherapy[94]. - The median progression-free survival (PFS) for the CPS<20 population was 5.79 months, compared to 2.2 months for historical ICI monotherapy[94]. - The company is conducting a Phase 1b/2 study evaluating pepinemab in combination with BAVENCIO® for metastatic pancreatic ductal adenocarcinoma, expected to enroll 40 subjects[95]. - The company has reached its enrollment target of 40 participants for the Phase 1b/2 SIGNAL-AD study evaluating pepinemab for mild dementia due to Alzheimer's disease, with topline data expected in mid-2024[105]. - The company entered into a collaboration with Merck for the first-line treatment of recurrent or metastatic head and neck cancer, showing an approximately 2X increase in objective response rate compared to historical data[105]. Compliance and Regulatory Matters - The company received a letter from Nasdaq on October 10, 2022, regarding non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance period until October 9, 2023[87]. - The company has submitted a compliance plan to Nasdaq to regain compliance with the stockholders' equity requirement of $2.5 million[88]. - The company is seeking stockholder approval for a proposed reverse stock split to address non-compliance with Nasdaq's minimum bid price requirement[89]. - The company will no longer be classified as an "emerging growth company" after December 30, 2023, losing certain exemptions from public company requirements[127]. Expenses - Research and development expenses for the three months ended June 30, 2023, increased by $1.2 million, or 31%, to $5.05 million, compared to $3.84 million in the same period of 2022[106]. - Total operating expenses for the six months ended June 30, 2023, were $12.61 million, a 26% increase from $9.99 million in the same period of 2022[109]. - The company has incurred significant negative cash flows from operations since its inception in 2001, primarily due to research and development expenses[118].