Core Insights - Vaccinex has reported positive results from its SIGNAL-AD Phase 1b/2 trial of pepinemab in early stages of Alzheimer's disease, focusing on its potential to intervene early and block astrocyte activation and inflammation [2][3][7] Group 1: Clinical Findings - The study demonstrated that pepinemab treatment inhibits the increase of plasma GFAP and p-tau 217 biomarkers during Mild Cognitive Impairment (MCI), which is the earliest stage of Alzheimer's disease [3][4] - Pepinemab treatment may slow cognitive decline in patients progressing to mild dementia, as indicated by strong treatment trends across various cognitive measures [3][4] - A proteomic analysis of cerebrospinal fluid showed that several proteins associated with normal Alzheimer's progression were inhibited by pepinemab treatment, supporting its potential benefits [4] Group 2: Mechanism of Action - Pepinemab has been shown to inhibit or reverse damage caused by toxic aggregates of alpha synuclein, which are linked to various neurodegenerative diseases, including Alzheimer's [5][7] - The company plans to focus on treating patients with MCI or mild dementia due to Alzheimer's with pepinemab to slow disease progression [7] Group 3: Future Development - Vaccinex aims to continue discussions for partnerships to further develop pepinemab for Alzheimer's, Huntington's disease, and potentially other neurodegenerative diseases [7]

ROCHESTER, N.Y., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX) ("Vaccinex" or the "Company"), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease by blocking astrogliosis and neuroinflammation through the inhibition of SEMA4D, announced today the entry into definitive agreements for the immediate exercise of outstanding warrants to purchase an aggregate of 1,067,492 shares of common stock (the "Existing Warrants") at the reduce ...

ROCHESTER, N.Y., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Vaccinex (Nasdaq: VCNX) today provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer's disease. Our Company recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer's disease (AD). The purpose of this report is to share additional data related to cognitive effects that may help clarify the goals of this study, how well it succeeded, an ...

ROCHESTER, N.Y., July 31, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinicalstage biotechnology company pioneering treatment of Alzheimer's disease (AD) with anti-Semaphorin 4D (SEMA4D) antibody, today announced positive results of its early stage SIGNAL-AD clinical trial of pepinemab antibody in AD. Topline results were presented by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial, at the Alzheimer's Association International Conference in Philadelphia. Business Considerations ...

Core Insights - Pepinemab targets astrocyte reactivity and neuroinflammation, which are believed to be key drivers of neurodegeneration [1] - The SIGNAL-AD study is a Phase 1b/2 clinical trial evaluating pepinemab as a monotherapy for Alzheimer's Disease, with potential Phase 3 development in Huntington's disease [4][10] - Vaccinex, Inc. is focused on treating neurodegenerative diseases and cancer through the inhibition of Semaphorin 4D (SEMA4D) [11] Company Overview - Vaccinex, Inc. is a clinical-stage biotechnology company that has developed pepinemab, a humanized IgG4 monoclonal antibody designed to block SEMA4D [10][11] - The company has global commercial and development rights to pepinemab and is collaborating with Merck Sharp & Dohme Corp. for the KEYNOTE-B84 study [12] Clinical Study Details - The SIGNAL-AD study has been funded by the Alzheimer's Drug Discovery Foundation (ADDF) with a total of $4.75 million and an additional $0.75 million grant from the Alzheimer's Association [9] - Key outcomes of the SIGNAL-AD study will include safety, tolerability, and the impact of pepinemab on brain metabolic activity and astrocyte reactivity [6] - The study aims to evaluate biomarkers of disease progression, including plasma levels of glial fibrillary acidic protein (GFAP) and phosphorylated tau peptide (p-tau 217) [6] Market Potential - The prevalence of Alzheimer's Disease is significant, with 6 million diagnosed individuals in the US, highlighting the potential market for pepinemab if approved [6] - Current limitations of existing anti-Aβ amyloid antibodies could position pepinemab as an attractive alternative or complementary treatment [6]

ROCHESTER, N.Y., June 06, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinicalstage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that the last patient completed their last visit in its randomized, placebo-controlled double-blind study of pepinemab treatment for Alzheimer's disease. The SIGNAL-AD study was funded in part by two investments from the Alzheimer's Drug Dis ...

Financial Performance - The company reported a net loss of $3.9 million for the three months ended March 31, 2024, compared to a net loss of $5.0 million for the same period in 2023[124]. - The net loss attributable to the Company was $3,897,000 for the three months ended March 31, 2024, compared to a net loss of $4,962,000 for the same period in 2023[143]. - For the three months ended March 31, 2024, the company incurred a net loss of $3.9 million, compared to a net loss of $5.0 million for the same period in 2023, indicating a 22% improvement[158]. - The company has incurred losses since inception, raising substantial doubt about its ability to continue as a going concern[126]. - The company anticipates continued losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern within one year after the issuance of its financial statements[160]. Cash and Liquidity - As of March 31, 2024, the company had cash and cash equivalents of $3.0 million, which is insufficient to fund planned operations for the next year[130]. - As of March 31, 2024, the company reported cash and cash equivalents of $3.0 million, up from $1.5 million as of December 31, 2023[157]. - Cash used in operating activities for the three months ended March 31, 2024, was $4.6 million, a decrease from $5.0 million in the same period of 2023[162]. - The company had an accumulated deficit of $343.8 million as of March 31, 2024, compared to $339.9 million as of December 31, 2023[158]. - The company plans to finance operations through public or private equity sales, debt financing, or other capital sources, but there are no assurances that additional capital will be available[161]. Revenue Generation - The company has not generated any revenue from product sales to date, relying instead on limited service revenue from collaboration agreements[124]. - The Company has not generated any revenue from product sales and does not expect to do so in the foreseeable future as it continues to seek regulatory approvals for its product candidates[138]. - The Company recorded service revenue of $104,000 for the three months ended March 31, 2024, compared to $50,000 for the same period in 2023, and $500,000 from a collaboration agreement with Surface Oncology in Q1 2023[137][144]. Operating Expenses - Research and development expenses decreased by $429,000, or 11%, to $3,383,000 for the three months ended March 31, 2024, compared to $3,812,000 for the same period in 2023[145]. - General and administrative expenses increased by $71,000, or 4%, to $1,795,000 for the three months ended March 31, 2024, compared to $1,724,000 for the same period in 2023[146]. - Total operating expenses decreased by $358,000, or 6%, to $5,178,000 for the three months ended March 31, 2024, compared to $5,536,000 for the same period in 2023[145]. Clinical Development - The company initiated a phase 1/2a clinical study of pepinemab for Alzheimer's disease, with topline data expected in Q3 2024[134]. - The company is focused on developing pepinemab for multiple indications, including Alzheimer's disease and various cancers[122]. - The company is conducting a Phase 1b/2 study evaluating pepinemab in combination with BAVENCIO® for patients with metastatic pancreatic ductal adenocarcinoma, expected to enroll 40 subjects[136]. Stockholder Equity and Financing - The company received a Nasdaq deficiency notice on April 11, 2024, indicating it no longer meets the requirement of maintaining a minimum of $2.5 million in stockholders' equity[131]. - The company’s stockholders' equity was reported at $2.7 million as of March 31, 2024, which exceeds the minimum required under Nasdaq's Equity Standard[132]. - The Company sold 208 shares of common stock at a weighted average price of $10.30, generating net proceeds of $2,077,000 during the three months ended March 31, 2024[148]. - The Company received approximately $6.1 million in gross proceeds from private placements and a public offering during the three months ended March 31, 2024[149]. - The Series A Preferred Stock has a liquidation preference of $175,000 per share, subject to adjustments, and carries a 5% cumulative dividend, increasing by 2% each year[152][153]. Investment Activities - The investing activities during the three months ended March 31, 2024, were primarily due to purchases of property and equipment[164]. - Financing activities provided $6.1 million during the three months ended March 31, 2024, compared to $2.0 million in the same period of 2023, reflecting a 205% increase[165]. Technology and Pipeline - The company has multiple platform technologies, including the SEMA4D antibody platform, to support pipeline expansion and partnership opportunities[123].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38624 Vaccinex, Inc. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organiza ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited financial statements for the nine months ended September 30, 2023, show a significant deterioration in its financial position [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) The balance sheet reflects a critical decline in liquidity and a shift from stockholders' equity to a significant deficit as of September 30, 2023 Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $127 | $6,391 | | Total current assets | $2,206 | $7,478 | | TOTAL ASSETS | $2,558 | $7,977 | | **Liabilities & Equity** | | | | Accounts payable | $4,225 | $1,518 | | Total current liabilities | $6,362 | $2,537 | | TOTAL LIABILITIES | $6,427 | $2,784 | | TOTAL STOCKHOLDERS' EQUITY/(DEFICIT) | $(3,869) | $5,193 | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported wider net losses for the three and nine-month periods ending September 30, 2023, driven by increased research and development expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | 9 Months 2023 | 9 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $20 | $50 | $570 | $50 | | Research and development | $4,355 | $3,429 | $13,217 | $10,238 | | General and administrative | $1,499 | $1,413 | $5,250 | $4,599 | | Loss from operations | $(5,834) | $(4,792) | $(17,897) | $(14,787) | | Net loss | $(4,912) | $(4,759) | $(16,934) | $(14,737) | | Net loss per share | $(1.09) | $(1.67) | $(4.28) | $(5.34) | [Condensed Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) The company's equity position reversed from a surplus to a deficit in the first nine months of 2023, primarily due to substantial net losses - Total stockholders' equity shifted from **$5.19 million** at the beginning of 2023 to a deficit of **$(3.87) million** as of September 30, 2023[20](index=20&type=chunk) - The primary drivers of the change were the **net loss of $16.9 million** for the nine-month period, partially offset by proceeds from the issuance of common shares[20](index=20&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Despite raising capital from financing activities, the company experienced a significant net decrease in cash, leaving a minimal balance at the end of the period Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,642) | $(14,475) | | Net cash used in investing activities | $(67) | $(101) | | Net cash provided by financing activities | $7,445 | $13,173 | | **Net (decrease)/increase in cash** | **$(6,264)** | **$(1,403)** | | **Cash at end of period** | **$127** | **$7,186** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Key notes highlight substantial doubt about the company's ability to continue as a going concern, a reverse stock split, and Nasdaq compliance issues - The company's financial condition, including a negative cash flow from operations of **$13.6 million** and an accumulated deficit of **$336.6 million**, raises substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk) - A **1-for-15 reverse stock split** of common stock was effected on September 25, 2023, with all share and per-share amounts retroactively adjusted[34](index=34&type=chunk) - The company received Nasdaq deficiency notices for failing to meet minimum bid price and stockholders' equity requirements, though it later regained equity compliance[49](index=49&type=chunk)[50](index=50&type=chunk)[52](index=52&type=chunk) - Subsequent to the quarter end, the company raised aggregate gross proceeds of **$9.6 million** in a public offering on October 3, 2023[79](index=79&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage focus, going concern risks, recent financing activities, and rising R&D expenses for key clinical trials [Company Overview and Going Concern](index=18&type=section&id=Company%20Overview%20and%20Going%20Concern) The company is a clinical-stage biotech whose significant historical losses and low cash balance raise substantial doubt about its ability to continue operations - The company is a clinical-stage biotechnology company focused on SEMA4D biology to develop its lead product candidate, pepinemab, for neurodegenerative diseases and cancer[87](index=87&type=chunk) - Recurring net losses and negative cash flows have raised **substantial doubt** about the company's ability to continue as a going concern[91](index=91&type=chunk) - As of September 30, 2023, cash and cash equivalents were **$0.1 million**, which is insufficient to fund planned operations for the next year[92](index=92&type=chunk) [Corporate and Clinical Updates](index=20&type=section&id=Corporate%20and%20Clinical%20Updates) The company executed a reverse stock split and a public offering while pausing certain programs to focus resources on its Alzheimer's research - A **1-for-15 reverse stock split** was completed on September 25, 2023, and a public offering raised **$9.6 million** in gross proceeds on October 3, 2023[98](index=98&type=chunk)[100](index=100&type=chunk) - Interim data from the KEYNOTE B-84 study showed pepinemab plus KEYTRUDA **doubled objective response rates (21.1%)** and median progression-free survival in hard-to-treat patients[103](index=103&type=chunk) - The company has **paused development for Huntington's Disease and Cancer research** to focus on Alzheimer's research, with topline data for the SIGNAL-AD study expected in H2 2024[109](index=109&type=chunk)[110](index=110&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating results for the nine months ended September 30, 2023, show increased R&D and G&A expenses, partially offset by a milestone payment and an employee retention credit Operating Expenses Comparison (Nine Months Ended Sep 30, in thousands) | Expense Category | 2023 | 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $13,217 | $10,238 | $2,979 | 29% | | General and administrative | $5,250 | $4,599 | $651 | 14% | | **Total operating expenses** | **$18,467** | **$14,837** | **$3,630** | **24%** | - The increase in R&D expenses was primarily due to increased patient enrollment in the **SIGNAL-AD (Alzheimer's)** and head and neck clinical trials[118](index=118&type=chunk) - Other income for the nine months of 2023 was **$0.96 million**, a significant increase from $52,000 in 2022, mainly due to the recognition of a **$0.92 million employee retention credit**[120](index=120&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company's critically low liquidity has been managed through a series of equity sales, but it will require additional capital to sustain future operations - The company has relied on numerous private and public sales of equity to fund operations, including raising **$2.04M** in March 2023, **$2.96M** in May 2023, and **$0.58M** in September 2023[125](index=125&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - Post-quarter financing includes a **$9.6 million public offering** in October 2023 and a **$70,000 warrant offering** in November 2023[123](index=123&type=chunk)[124](index=124&type=chunk) - Net cash used in operating activities for the first nine months of 2023 was **$13.6 million**, and the company expects to continue generating losses[134](index=134&type=chunk)[135](index=135&type=chunk)[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this disclosure is not required - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[149](index=149&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's principal officers concluded that disclosure controls and procedures were effective as of the end of the reporting period - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of September 30, 2023[150](index=150&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the quarter ended September 30, 2023[151](index=151&type=chunk) PART II – OTHER INFORMATION [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces a significant risk of delisting from Nasdaq due to non-compliance with the minimum bid price requirement - The company is not in compliance with Nasdaq's **minimum bid price requirement** and has until March 4, 2024, to regain compliance to avoid delisting[155](index=155&type=chunk)[156](index=156&type=chunk) - The company previously failed to meet the minimum stockholders' equity requirement but **regained compliance** following a $9.6 million public offering on October 3, 2023[157](index=157&type=chunk)[158](index=158&type=chunk) - A potential delisting from Nasdaq would negatively affect the stock price and **materially harm** the company's ability to raise capital[160](index=160&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including documents related to the reverse stock split and recent financing activities - Key exhibits filed include the Certificate of Amendment for the reverse stock split, forms of warrants, and stock purchase agreements from recent financing activities[167](index=167&type=chunk)

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].