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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Vaccinex, Inc. (Exact name of registrant as specified in its charter) Delaware 16-1603202 (State or other jurisdiction of incorporation or organization) 1895 Mount Ho ...

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)

WASHINGTON, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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) Delaware 16-1603202 (State or other jurisdiction of incorporati ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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) Delaware 16-1603202 (State or other jurisdiction of incorporat ...