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Vaccinex(VCNX) - 2022 Q4 - Annual Report
2023-03-31 20:01
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, 2022 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 incor ...
Vaccinex(VCNX) - 2022 Q3 - Quarterly Report
2022-11-14 13:00
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 September 30, 2022 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 incorp ...
Vaccinex(VCNX) - 2022 Q2 - Quarterly Report
2022-08-15 12:01
[PART I – FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents the company's unaudited condensed consolidated financial statements and notes for the period ended June 30, 2022 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) Condensed Consolidated Balance Sheets (in thousands): | Metric | June 30, 2022 | December 31, 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $11,400 | $8,589 | $2,811 | 32.7% | | Total current assets | $12,261 | $9,405 | $2,856 | 30.4% | | TOTAL ASSETS | $12,572 | $9,843 | $2,729 | 27.7% | | Total current liabilities | $1,491 | $2,256 | $(765) | -33.9% | | TOTAL LIABILITIES | $1,629 | $2,431 | $(802) | -33.0% | | TOTAL STOCKHOLDERS' EQUITY | $10,943 | $7,412 | $3,531 | 47.6% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data): | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $- | $- | $- | $850 | | Research and development | $3,843 | $4,064 | $6,809 | $9,577 | | General and administrative | $1,558 | $1,605 | $3,186 | $3,182 | | Total costs and expenses | $5,401 | $5,669 | $9,995 | $12,759 | | Net loss | $(5,383) | $(5,969) | $(9,978) | $(12,543) | | Net loss per share, basic and diluted | $(0.13) | $(0.21) | $(0.25) | $(0.47) | | Weighted-average shares outstanding (basic/diluted) | 42,664,051 | 28,577,779 | 40,711,167 | 26,897,283 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Unaudited)) Changes in Stockholders' Equity (in thousands): | Metric | Balance as of Jan 1, 2022 | Issuance of Common Shares | Stock-based compensation | Net loss | Balance as of June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | :--- | | Common Stock (Amount) | $3 | $1 | — | — | $4 | | Additional Paid-in Capital| $307,281 | $13,229 | $141 | — | $320,789 | | Accumulated Deficit | $(299,861) | — | — | $(9,978) | $(309,839) | | Total Stockholders' Equity| $7,412 | $13,230 | $141 | $(9,978) | $10,943 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Condensed Consolidated Statements of Cash Flows (in thousands): | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,329) | $(14,096) | | Net cash used in investing activities | $(52) | $(22) | | Net cash provided by financing activities | $13,192 | $25,907 | | NET INCREASE IN CASH AND CASH EQUIVALENTS | $2,811 | $11,789 | | CASH AND CASH EQUIVALENTS–End of period | $11,400 | $22,385 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) - The Company is a clinical-stage biotechnology company focused on discovering and developing targeted biotherapeutics for cancer, neurodegenerative diseases, and autoimmune disorders[24](index=24&type=chunk) - The Company has incurred significant losses and negative cash flows, with an **accumulated deficit of $309.8 million**, raising **substantial doubt about its ability to continue as a going concern**[27](index=27&type=chunk)[28](index=28&type=chunk) - The COVID-19 pandemic delayed the initiation of a pepinemab trial for Alzheimer's disease and impacted capital raising efforts, leading the Company to obtain a PPP Loan[31](index=31&type=chunk) Property and Equipment, Net (in thousands): | Category | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Leasehold improvements | $3,259 | $3,213 | | Research equipment | $3,505 | $3,499 | | Furniture and fixtures | $350 | $350 | | Computer equipment | $284 | $284 | | Property and equipment, gross | $7,398 | $7,346 | | Less: accumulated depreciation | $(7,144) | $(7,049) | | Property and equipment, net | $254 | $297 | Accrued Expenses (in thousands): | Category | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Accrued clinical trial cost | $619 | $468 | | Accrued payroll and related benefits | $365 | $409 | | Accrued consulting and legal | $87 | $74 | | Accrued other | $24 | $29 | | Total Accrued expenses | $1,095 | $980 | - In January 2022, the Company completed a private placement, **issuing 8,747,744 shares of common stock for approximately $9.7 million in gross proceeds**, with participation from entities affiliated with directors and officers[89](index=89&type=chunk)[90](index=90&type=chunk) Stock-based Compensation Expense (in thousands): | Category | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $55 | $45 | $97 | $73 | | General and administrative | $83 | $83 | $182 | $159 | | Total stock-based compensation expense | $138 | $128 | $279 | $232 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition, operational results, liquidity, and capital resources for the period [Cautionary Note Regarding Forward-Looking Statements](index=18&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) - Forward-looking statements involve risks including the company's ability to continue as a going concern, COVID-19 impacts, financing sufficiency, and clinical trial success[93](index=93&type=chunk)[94](index=94&type=chunk) [Company Overview](index=19&type=section&id=Company%20Overview) - Vaccinex, a clinical-stage biotech company, incurred **net losses of $5.4 million (Q2 2022)** and **$9.9 million (YTD 2022)**, holding **$11.4 million in cash** as of June 30, 2022[96](index=96&type=chunk)[98](index=98&type=chunk) - Recurring net losses and negative cash flows raise **substantial doubt about its ability to continue as a going concern**, with future operations dependent on external financing[100](index=100&type=chunk) - The COVID-19 pandemic has adversely impacted clinical trial operations and capital raising, with potential for further disruptions[101](index=101&type=chunk) [Financial Overview](index=20&type=section&id=Financial%20Overview) - The Company has not generated product revenue and does not expect to in the foreseeable future, as profitability hinges on successful commercialization of its candidates[102](index=102&type=chunk) Research and Development Expenses (in thousands): | Category | Three Months Ended June 30, 2022 | % of Total R&D | Three Months Ended June 30, 2021 | % of Total R&D | Six Months Ended June 30, 2022 | % of Total R&D | Six Months Ended June 30, 2021 | % of Total R&D | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Clinical trial costs | $2,153 | 56% | $2,215 | 54% | $3,553 | 52% | $5,905 | 62% | | Wages, benefits, and related costs | $1,129 | 29% | $1,081 | 27% | $2,155 | 32% | $2,123 | 22% | | Preclinical supplies and equipment depreciation | $419 | 11% | $498 | 12% | $814 | 12% | $1,001 | 10% | | Consulting, non-clinical trial services, and other | $142 | 4% | $270 | 7% | $287 | 4% | $548 | 6% | | Total research and development expenses | $3,843 | | $4,064 | | $6,809 | | $9,577 | | - Current R&D focuses on the clinical development of pepinemab for cancer, Alzheimer's Disease, and Huntington's Disease[106](index=106&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Revenue and Operating Expenses (in thousands): | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | % Change (QoQ) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | % Change (YoY) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | $- | $- | 0% | $- | $850 | -100% | | Research and development | $3,843 | $4,064 | -5% | $6,809 | $9,577 | -29% | | General and administrative| $1,558 | $1,605 | -3% | $3,186 | $3,182 | 0% | | Total operating expenses | $5,401 | $5,669 | -5% | $9,995 | $12,759 | -22% | | Net loss | $(5,383) | $(5,969) | -10% | $(9,978) | $(12,543) | -20% | - The decrease in R&D expenses was primarily due to the completion of prior studies, partially offset by setup costs for new clinical trials[109](index=109&type=chunk)[112](index=112&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2022, the Company's **$11.4 million in cash and cash equivalents** is insufficient to fund operations for one year, reinforcing the **'going concern' doubt**[120](index=120&type=chunk)[121](index=121&type=chunk)[114](index=114&type=chunk) - In early 2022, the Company raised **$9.7 million** from a private placement and **$3.5 million (net)** through an Open Market Sale Agreement[115](index=115&type=chunk)[116](index=116&type=chunk) - Future financing strategies may include equity or debt sales, collaborations, or licensing, and failure to secure capital could halt product development[122](index=122&type=chunk)[123](index=123&type=chunk) Cash Flows Summary (in thousands): | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Cash used in operating activities | $(10,329) | $(14,096) | | Cash used in investing activities | $(52) | $(22) | | Cash provided by financing activities | $13,192 | $25,907 | [Critical Accounting Policies and Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - There have been no material changes to the Company's critical accounting policies compared to its 2021 Annual Report on Form 10-K[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as a smaller reporting company - The Company, as a smaller reporting company, is exempt from providing quantitative and qualitative disclosures about market risk[134](index=134&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes in internal controls - The Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective as of June 30, 2022[135](index=135&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2022[136](index=136&type=chunk) [PART II – OTHER INFORMATION](index=27&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) Refers to the Annual Report on Form 10-K for risk factors, noting no material changes have occurred - Investors should carefully consider the risks outlined in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[138](index=138&type=chunk) - There have been no material changes from the risk factors disclosed in the Annual Report[138](index=138&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed with the report, including officer certifications and XBRL data - Key exhibits include CEO and CFO certifications pursuant to the Sarbanes-Oxley Act of 2002 and various Inline XBRL documents[143](index=143&type=chunk) [Signatures](index=29&type=section&id=Signatures) Contains the official signatures of the CEO and CFO, dated August 15, 2022 - The report was signed by Maurice Zauderer, Ph.D., President & Chief Executive Officer, and Scott E. Royer, CFA, MBA, Chief Financial Officer, on August 15, 2022[146](index=146&type=chunk)
Vaccinex(VCNX) - 2022 Q1 - Quarterly Report
2022-05-16 12:01
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, 2022 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 ...
Vaccinex(VCNX) - 2021 Q4 - Annual Report
2022-03-31 13:00
[Part I](index=4&type=section&id=PART%20I) [Business](index=4&type=section&id=Item%201.%20Business) Vaccinex is a clinical-stage biotechnology company developing biotherapeutics for cancer and neurodegenerative/autoimmune diseases, leveraging its SEMA4D and ActivMAb® platforms - Vaccinex is a clinical-stage biotechnology company focused on discovering and developing biotherapeutics for cancer, neurodegenerative diseases, and autoimmune disorders[17](index=17&type=chunk) - The company's lead product candidate is pepinemab, a SEMA4D-targeting antibody for HNSCC, Huntington's disease, and Alzheimer's disease[17](index=17&type=chunk) - Vaccinex utilizes two primary proprietary platform technologies: the SEMA4D antibody platform and the ActivMAb® antibody discovery platform[18](index=18&type=chunk)[19](index=19&type=chunk) - As of December 31, 2021, the company had **39 full-time and two part-time employees**[237](index=237&type=chunk) [Product Pipeline](index=5&type=section&id=Product%20Pipeline) - Pepinemab, a humanized monoclonal antibody blocking SEMA4D signaling, has treated or enrolled **528 patients** across ten clinical trials as of December 31, 2021[22](index=22&type=chunk) - In 2021, the company initiated the KEYNOTE-B84 trial, a Phase 1b/2 study of pepinemab with Keytruda® for front-line recurrent or metastatic head and neck cancer (R/M HNSCC)[21](index=21&type=chunk)[26](index=26&type=chunk) - The SIGNAL-AD trial, a Phase 1b study of pepinemab in Alzheimer's disease, initiated in late 2020, is supported by grants from the Alzheimer's Association and the Alzheimer's Drug Discovery Foundation[28](index=28&type=chunk) - VX5, a human antibody to CXCL13 discovered via the ActivMAb platform, is in preclinical development for Multiple Sclerosis (MS) and other autoimmune disorders[29](index=29&type=chunk) [Our Strategy](index=6&type=section&id=Our%20Strategy) - Develop pepinemab in combination with checkpoint inhibitors for cancer, with an ongoing study in HNSCC in collaboration with Merck[32](index=32&type=chunk) - Develop pepinemab as a therapy for Huntington's disease, with plans for a potential pivotal Phase 3 study, possibly with a partner[33](index=33&type=chunk) - Develop pepinemab for Alzheimer's disease, with the SIGNAL-AD trial initiated in 2021 and topline data expected in 2023[33](index=33&type=chunk) - Leverage the ActivMAb® platform to identify human antibodies for internal pipeline development and strategic collaborations, particularly against difficult multi-pass membrane targets[33](index=33&type=chunk) [Manufacturing and Commercialization](index=30&type=section&id=Manufacturing%20and%20Commercialization) - The company relies on third-party contract manufacturing organizations (CMOs) like Catalent for pepinemab production, as it does not own manufacturing facilities[156](index=156&type=chunk) - The company plans to commercialize pepinemab for Huntington's Disease in the U.S. itself if approved, but will seek partners for other indications and international markets, lacking established sales operations[158](index=158&type=chunk) [Intellectual Property](index=31&type=section&id=Intellectual%20Property) - The SEMA4D antibody platform and pepinemab patent portfolio includes issued and pending patents in the U.S. and foreign countries, expiring between **2030 and 2038**[169](index=169&type=chunk)[170](index=170&type=chunk) - The ActivMAb platform is protected by wholly-owned and exclusively licensed patents from the University of Rochester, expiring between **2025 and 2041**[176](index=176&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) - The VX5 patent portfolio includes a family licensed from the University of Rochester and three wholly-owned families, expiring between **2025 and 2034**[181](index=181&type=chunk)[182](index=182&type=chunk) [Government Regulation](index=34&type=section&id=Government%20Regulation) - Product candidates are regulated as biologics by the FDA, requiring rigorous preclinical testing, IND effectiveness, and adequate clinical trials before BLA submission and approval[187](index=187&type=chunk)[192](index=192&type=chunk) - The FDA offers expedited programs like Priority Review, Fast Track, Breakthrough Therapy, and Accelerated Approval for serious conditions, potentially applicable to the company's product candidates[203](index=203&type=chunk) - Post-approval, products are subject to ongoing regulation, including cGMP for manufacturing, postmarketing commitments, and advertising and promotion rules[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk) - Sales depend on coverage and reimbursement from third-party payors like Medicare and Medicaid, requiring participation in government programs for federal funding[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, and third-party dependence risks, including recurring losses, clinical trial uncertainties, and reliance on external manufacturing and intellectual property protection - The company has a history of net losses, with **$22.4 million in 2021** and **$28.9 million in 2020**, and an accumulated deficit of **$299.9 million** as of December 31, 2021, with no product revenue to date[252](index=252&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, requiring additional capital that may not be available on acceptable terms[257](index=257&type=chunk) - The business heavily depends on the success of its lead product candidate, pepinemab, with the Phase 2 SIGNAL trial for Huntington's Disease not meeting its primary endpoints, creating uncertainty[272](index=272&type=chunk)[278](index=278&type=chunk) - The COVID-19 pandemic has adversely impacted the business, causing delays in clinical trial enrollment and affecting capital raising ability[269](index=269&type=chunk) - The company relies on third parties like Catalent for manufacturing and CROs for clinical trials, making it vulnerable to delays and performance issues[331](index=331&type=chunk)[332](index=332&type=chunk)[333](index=333&type=chunk) - As of December 31, 2021, executive officers, directors, and their affiliates beneficially owned approximately **44.7%** of the company's common stock, allowing significant control[369](index=369&type=chunk) [Unresolved Staff Comments](index=71&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - None[380](index=380&type=chunk) [Properties](index=71&type=section&id=Item%202.%20Properties) The company's principal executive office is approximately **31,180 square feet** of leased office and laboratory space in Rochester, New York - The company leases approximately **31,180 square feet** of office and laboratory space in Rochester, New York[381](index=381&type=chunk) [Legal Proceedings](index=71&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would adversely affect its business, financial condition, or operations - The company is not presently a party to any material legal proceedings[382](index=382&type=chunk) [Mine Safety Disclosures](index=71&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[383](index=383&type=chunk) [Part II](index=72&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=72&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Capital Market under 'VCNX', with **143 holders of record** as of March 25, 2022, and no repurchases in Q4 2021 - Common stock trades on the Nasdaq Capital Market under the symbol 'VCNX'[386](index=386&type=chunk) - As of March 25, 2022, there were **143 holders of record** of the company's common stock[386](index=386&type=chunk) - No shares were repurchased during the fourth quarter of the year ended December 31, 2021[387](index=387&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=73&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Vaccinex reported a net loss of **$22.4 million** in 2021, a decrease from **$28.9 million** in 2020, driven by reduced R&D and G&A expenses, but faces substantial doubt about its going concern ability with **$8.6 million** cash at year-end 2021 Results of Operations (in thousands) | | Year Ended December 31, | | | :--- | :--- | :--- | | | **2021** | **2020** | | Revenue | $ 900 | $ 625 | | Research and development | 17,160 | 21,549 | | General and administrative | 6,230 | 7,405 | | **Loss from operations** | **(22,490)** | **(28,331)** | | **Net loss** | **(22,380)** | **(28,851)** | | Net loss per share | (0.78) | (1.54) | - Research and development expenses decreased by **$4.4 million (20%)** in 2021 compared to 2020, mainly due to the completion of major clinical trials[410](index=410&type=chunk) - General and administrative expenses decreased by **$1.2 million (16%)** in 2021 compared to 2020, due to planned cost control measures[411](index=411&type=chunk) - The company's recurring net losses and negative cash flows raise substantial doubt about its ability to continue as a going concern, with cash and cash equivalents at **$8.6 million** as of December 31, 2021[395](index=395&type=chunk)[420](index=420&type=chunk) Cash Flows (in thousands) | | Year Ended December 31, | | | :--- | :--- | :--- | | | **2021** | **2020** | | Cash used in operating activities | $ (25,298) | $ (28,647) | | Cash used in investing activities | (32) | (290) | | Cash provided by financing activities | 23,323 | 36,757 | [Quantitative and Qualitative Disclosures About Market Risk](index=79&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on cash and equivalents, with immaterial impact due to short-term nature, and minor unhedged foreign currency exposure - Primary market risk is interest rate sensitivity on cash and cash equivalents (**$8.6 million** as of December 31, 2021), with an immaterial expected impact due to the portfolio's short-term nature[435](index=435&type=chunk) - The company has some foreign currency risk from payments to certain suppliers and service providers, but resulting gains and losses have not been significant to date[436](index=436&type=chunk)[437](index=437&type=chunk) [Financial Statements and Supplementary Data](index=80&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements are included, with the auditor's report from Deloitte & Touche LLP highlighting a 'Going Concern' paragraph due to recurring losses and negative cash flows - The auditor's report includes a paragraph expressing substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows from operations[529](index=529&type=chunk) Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$9,843** | **$11,702** | | Cash and cash equivalents | $8,589 | $10,596 | | Total current assets | $9,405 | $11,286 | | **Total Liabilities** | **$2,431** | **$14,314** | | Total current liabilities | $2,256 | $13,180 | | **Total Stockholders' Equity (Deficit)** | **$7,412** | **$(2,612)** | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | $900 | $625 | | R&D Expenses | $17,160 | $21,549 | | G&A Expenses | $6,230 | $7,405 | | **Net Loss** | **$(22,380)** | **$(28,851)** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=80&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[439](index=439&type=chunk) [Controls and Procedures](index=80&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2021, with no material changes reported in Q4 2021 - Management concluded that as of December 31, 2021, the company's disclosure controls and procedures were effective[444](index=444&type=chunk) - Based on an assessment using the COSO framework (2013), management concluded that internal control over financial reporting was effective as of December 31, 2021[441](index=441&type=chunk)[442](index=442&type=chunk) - As an emerging growth company, this report does not include an attestation report from the independent registered public accounting firm regarding internal control over financial reporting[443](index=443&type=chunk) [Part III](index=81&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=81&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details biographical information for directors and executive officers, including key figures, the independent audit committee, and the adopted code of business conduct and ethics - The board of directors includes Chairman Albert D. Friedberg and President/CEO Maurice Zauderer, Ph.D[449](index=449&type=chunk)[456](index=456&type=chunk) - The Audit Committee members are Gerald E. Van Strydonck (Chair), Jacob B. Frieberg, and Dr. Bala S. Manian, all independent directors[465](index=465&type=chunk) - The board has determined that Mr. Van Strydonck qualifies as an 'audit committee financial expert'[465](index=465&type=chunk) [Executive Compensation](index=83&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2021 included base salaries and stock option awards for named officers, with a severance plan for change in control and annual cash retainers and stock options for non-employee directors 2021 Summary Compensation Table | Name and Principal Position | Salary ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | Maurice Zauderer, President and CEO | 374,901 | 26,600 | 401,501 | | Ernest S. Smith, SVP, Research and CSO | 264,739 | 19,000 | 283,789 | | Scott E. Royer, CFO | 242,151 | 11,400 | 253,551 | - In April 2021, the named executive officers received incentive stock option grants under the 2018 Omnibus Incentive Plan[471](index=471&type=chunk) - The company has a Severance Pay Plan providing a lump sum cash payment (six months' salary for executive officers) for involuntary severance following a change in control[484](index=484&type=chunk) - Non-employee directors receive a **$35,000** annual cash retainer, additional retainers for committee chair positions, and annual stock option awards valued at approximately **$40,000**[489](index=489&type=chunk)[490](index=490&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=88&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 25, 2022, directors and executive officers as a group beneficially owned **47.6%** of common stock, with Albert D. Friedberg as the largest individual owner, and the company maintains the 2018 Omnibus Incentive Plan Security Ownership of Major Holders (as of March 25, 2022) | Name of Beneficial Owner | Percentage of Shares Beneficially Owned | | :--- | :--- | | Albert D. Friedberg (Chairman) | 36.5% | | FCMI Parent Co., et al | 27.1% | | Maurice Zauderer (CEO) | 8.4% | | Friedberg Global-Macro Hedge Fund Ltd. | 8.2% | | Vaccinex (Rochester), L.L.C. | 6.8% | | All directors and executive officers as a group (12 persons) | 47.6% | Equity Compensation Plan Information (as of December 31, 2021) | | Number of securities to be issued upon exercise of outstanding options | Weighted-average exercise price of outstanding options | Number of securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | **Total** | **1,154,563** | **$5.55** | **396,324** | [Certain Relationships and Related Transactions, and Director Independence](index=90&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company discloses related-party transactions, including headquarters lease from an affiliate of Chairman Friedberg and a research collaboration with Surface Oncology, Inc., while five directors are deemed independent - The company leases its headquarters from 1895 Management, Ltd., an indirect subsidiary of FCMI Parent, affiliated with Chairman Albert D. Friedberg, with rent expense of **$174,000** in 2021[505](index=505&type=chunk) - A research collaboration and license agreement with Surface Oncology, Inc., where director J. Jeffrey Goater is CEO, generated **$850,000** for a product license and **$50,000** in maintenance fees for Vaccinex in 2021[506](index=506&type=chunk)[611](index=611&type=chunk) - The Board of Directors has determined that Messrs. Frieberg and Van Strydonck, Dr. Manian, and Mses. Yanni and Bedrij Stecyk are independent directors[508](index=508&type=chunk) [Principal Accounting Fees and Services](index=91&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) The company paid Deloitte & Touche LLP **$290,000** in 2021 and **$565,500** in 2020 for pre-approved audit services, including annual financial statements and quarterly report reviews Fees Paid to Deloitte & Touche LLP | | Fiscal Year 2021 | Fiscal Year 2020 | | :--- | :--- | :--- | | Audit Fees | $ 290,000 | $ 565,500 | | Audit-Related Fees | $ — | $ — | | Tax Fees | $ — | $ — | | All Other Fees | $ — | $ — | | **Total** | **$ 290,000** | **$ 565,500** | - The audit committee pre-approved all audit and non-audit services provided by Deloitte & Touche LLP[512](index=512&type=chunk) [Part IV](index=93&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=93&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists consolidated financial statements and all exhibits filed with or incorporated by reference into the Form 10-K, including corporate documents and material contracts - This item contains the index to the consolidated financial statements and a list of all exhibits filed with the report[516](index=516&type=chunk) [Form 10-K Summary](index=95&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no Form 10-K summary - None[518](index=518&type=chunk)
Vaccinex(VCNX) - 2021 Q3 - Quarterly Report
2021-11-08 13:00
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 September 30, 2021 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 incorp ...
Vaccinex(VCNX) - 2021 Q2 - Quarterly Report
2021-08-16 12:01
Commission File Number: 001-38624 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 June 30, 2021 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 incorporati ...
Vaccinex (VCNX) Presents At 2021 Global Healthcare Virtual Conference - Slideshow
2021-06-03 20:29
Treatment for Cancer and Neurodegenerative Disease Unique Targets Novel Mechanisms New Medicines VX15 (pepinemab) Antibody Forward Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. ("Vaccinex," "we," "us," or "our"), they are forward-looking statements reflecting management's current beliefs and expectations. Words such as "may," "will," "expect," "anticipate," "estimate," "intend" and similar expressions or thei ...
Vaccinex(VCNX) - 2021 Q1 - Quarterly Report
2021-05-17 12:00
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, 2021 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 ...
Vaccinex(VCNX) - 2020 Q4 - Annual Report
2021-03-31 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 1895 Mount Hope Avenue Rochester, NY 14620 (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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO ...