1. Phase 1b segment evaluated safety and tolerability of the combination

    Paves the way to expand and accelerate enrollment in the Phase 2 segment of the study

    ROCHESTER, N.Y., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX, Vaccinex, the Company))), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today reported positive interim safety data in the Phase Ib "safety run-in" segment of the KEYNOTE B84 combination study of Keytruda® ((Merck, NYSE:MRK, known as MSD outside of the United States and Canada)) and pepinemab (Vaccinex) in patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma…

    Phase 1b segment evaluated safety and tolerability of the combination

    Paves the way to expand and accelerate enrollment in the Phase 2 segment of the study

    ROCHESTER, N.Y., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX, Vaccinex, the Company))), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today reported positive interim safety data in the Phase Ib "safety run-in" segment of the KEYNOTE B84 combination study of Keytruda® ((Merck, NYSE:MRK, known as MSD outside of the United States and Canada)) and pepinemab (Vaccinex) in patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The Phase 2 segment of the study is now expected to begin enrollment and is expected to accelerate patient accrual.

    The Phase Ib "safety run-in" segment of the trial (NCT04815720) was intended to evaluate the safety and tolerability of pepinemab (20 mg/kg) in combination with Keytruda (Merck's anti-PD-1 therapy, pembrolizumab, 200 mg Q3W/every three weeks) to determine a recommended Phase 2 dose (RP2D) for the dose expansion phase of the study enrolling patients with R/M HNSCC. The interim safety analysis was completed by the Data Safety Monitoring Board and signals initiation of the Phase 2 expansion segment.

    "We are very pleased that the interim KEYNOTE B84 safety data indicated that the combination of pepinemab and Keytruda appears to be well tolerated," stated Maurice Zauderer, Ph.D., President and Chief Executive Officer. "Vaccinex hopes that the combination of pepinemab and an anti-PD-1 therapy for the treatment of advanced R/M HSNCC may result in improved patient benefits. There is strong rationale for development in HNSCC because these tumors express very high levels of SEMA4D and we believe that preclinical data indicated that this contributes to disease pathology. We look forward to progressing with the recruitment of the Phase 2 segment of the trial."

    About the KEYNOTE B84 Study:

    The KEYNOTE B84 combination study of Keytruda® (Merck's anti-PD-1 therapy, pembrolizumab) and pepinemab (Vaccinex's monoclonal antibody inhibitor of SEMA4D) is being conducted for first line treatment of patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study has two segments:

    • Segment 1: The completed Phase 1b "safety run-in" segment assessed the safety and tolerability of the combination and defined a Recommended Phase 2 Dose (RP2D) in 3-6 subjects. After enrolling the first three subjects, the Data Safety Monitoring Board determined that the RP2D dose of pepinemab (20 mg/kg) and Keytruda (200 mg Q3W) was safe and well tolerated.
    • Segment 2: The Phase 2 "expansion" segment is now expected to proceed to enroll up to 62 subjects across 19 U.S. trial sites. The primary objective of this segment is to evaluate Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of the combination in immunotherapy naïve patients with advanced R/M HNSCC.

    Secondary objectives of the study are to evaluate Progression-Free Survival (PFS) by RECIST 1.1, Overall Survival (OS), and Duration of Response (DOR).

    The study is also expected to evaluate a number of exploratory measures including the pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of the combination and a number of biomarkers and genomic tumor signatures.

    Additional information about the study is available at: the KEYNOTE B84 clinicaltrials.gov link. Vaccinex anticipates interim results for the primary efficacy endpoint, ORR, in the second half of 2022.

    Vaccinex will sponsor the study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc.

    Vaccinex has global commercial and development rights to pepinemab.

    Keytruda® is a trademark of Merck.

    About Pepinemab

    Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates chronic inflammation in the tumor microenvironment. Preclinical/clinical data show that pepinemab promotes infiltration/activation of dendritic cells/ CD8+ T-cells and reverses immunosuppression within the tumor.

    Results of a Phase 1b/2 study to evaluate the combination of pepinemab with checkpoint inhibitor, BAVENCIO®, (with Merck KGaA) were presented by Dr. Shafique, MD, Assistant Professor Thoracic Oncology, Moffitt Cancer Center, in an oral poster and discussion section at ASCO 2020 and were highlighted in the July 2021 publication of Clinical Cancer Research. Vaccinex reported that results of the Phase 1b/2 CLASSICAL-Lung trial showed a 25-33% Overall Response Rate (ORR) for patients with difficult to treat PD-L1 low/negative tumors treated with the combination, while reported ORR for similar patients treated with anti-PD-L1 monotherapy is ~10-15%. The study report also indicated that pepinemab did not increase immune-related toxicities of BAVENCIO but increased penetration of cytotoxic T cells. The publication is available electronically at: Clinical Cancer Research.        

    About Vaccinex, Inc.

    Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The Company's lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes prevents immune infiltration into tumors and triggers chronic inflammation in the brain. The Company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels.

    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. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington's and Alzheimer's disease and other indications, and other statements identified by words such as "may," "will," "appears," "expect," "hope", "planned," "anticipate," "estimate," "intend," "hypothesis," "potential," "suggest", "advance," and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Securities and Exchange Commission ("SEC") and the other risks and uncertainties described in the Company's most recent annual year end Annual Report on Form 10-K and subsequent filings with the SEC.                                

    Investor Contact                                        

    John Mullaly                                        

    LifeSci Advisors, LLC                                

    617-429-3548                                        

            



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  2. ROCHESTER, N.Y., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced that Dr. Elizabeth Evans, PhD, Chief Operating Officer and SVP, Discovery and Translational Medicine, will present Poster #434, Phase 1/2 study to evaluate pepinemab in combination with pembrolizumab in advanced, recurrent or metastatic head and neck cancer (KEYNOTE B84), at the Society for Immunology of Cancer's (SITC) 36th Annual Meeting being held from November 12th - 14th in Washington D.C. Please see Presentation details below:

    SITC Conference Information

    Date: November 12-14, 2021

    ROCHESTER, N.Y., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced that Dr. Elizabeth Evans, PhD, Chief Operating Officer and SVP, Discovery and Translational Medicine, will present Poster #434, Phase 1/2 study to evaluate pepinemab in combination with pembrolizumab in advanced, recurrent or metastatic head and neck cancer (KEYNOTE B84), at the Society for Immunology of Cancer's (SITC) 36th Annual Meeting being held from November 12th - 14th in Washington D.C. Please see Presentation details below:

    SITC Conference Information

    Date: November 12-14, 2021
    Session Title:Clinical Trials in Progress, Poster Session
    Poster #: TitlePoster #434: Phase 1/2 study to evaluate pepinemab in combination with pembrolizumab in advanced, recurrent or metastatic head and neck cancer (KEYNOTE B84)
    Add to calendar:https://ir.vaccinex.com/node/8411/ics
    Program Link:https://sitc.sitcancer.org/2021/abstracts/titles/index.php?filter=Keynote+B84
    Access:The Poster will be presented in-person 12:30 -2 and 7 - 8:30 p.m. ET on Saturday, November 13, and on the SITC 2021 virtual meeting platform from 7 a.m. ET on Friday, November 12, 2021, until the virtual meeting platform is closed on January 9, 2022. The Poster will also be available on Vaccinex's website starting on November 12, 2021, at: https://ir.vaccinex.com/presentations

    For more information about the SITC Annual Meeting please refer to the conference website. The in-person program in Washington D.C. will be streamed live on the digital platform.

    About Vaccinex, Inc.

    Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The company's lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that prevents immune infiltration into tumors and triggers chronic inflammation in the brain, is currently being evaluated in the clinic as a treatment for head & neck cancer and Alzheimer's disease, with ongoing exploration of potential phase 3 development in Huntington's disease. The company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels.

    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. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington's and Alzheimer's disease and other indications, and other statements identified by words such as "may," "will," "appears," "expect," "planned," "anticipate," "estimate," "intend," "hypothesis," "potential," "suggest", "advance," and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Securities and Exchange Commission ("SEC") and the other risks and uncertainties described in the Company's Form 10-K for year-end December 31, 2020, and subsequent filings with the SEC.

    Investor Contact                                        

    John Mullaly                                        

    LifeSci Advisors, LLC                                

    617-429-3548                                        

                             



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  3. ROCHESTER, N.Y., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced that Terrence Fisher, Ph.D., Vice President, Clinical Science, is scheduled to present at the Clinical Trials on Alzheimer's Disease Meeting in Boston, Massachusetts on Thursday, November 11, 2021. Please see Presentation details below:

    CTAD Conference

    Date:     November 11, 2021
    Time: 2:40 pm. ET: Oral Communications (OC) Section
    Session Title: OC #24: SEMA4D blocking antibody, pepinemab, is a novel potential treatment for neurodegenerative disease: clinical proof of concept in Huntington's

    ROCHESTER, N.Y., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced that Terrence Fisher, Ph.D., Vice President, Clinical Science, is scheduled to present at the Clinical Trials on Alzheimer's Disease Meeting in Boston, Massachusetts on Thursday, November 11, 2021. Please see Presentation details below:

    CTAD Conference

    Date:     November 11, 2021
    Time: 2:40 pm. ET: Oral Communications (OC) Section
    Session Title: OC #24: SEMA4D blocking antibody, pepinemab, is a novel potential treatment for neurodegenerative disease: clinical proof of concept in Huntington's Disease (HD) supports clinical development in Alzheimer's Disease (AD)
    Presenter: Terrence Fisher, Ph.D., Vice-President, Clinical Science
    Add to calendar: https://ir.vaccinex.com/node/8406/ics
    Program Link: https://www.ctad-alzheimer.com/program-0
    Replay: The slide presentation will be available on Vaccinex's website 48 hours after the event at: https://ir.vaccinex.com/presentations
       

    For more information about the CTAD, please refer to the conference website. The in-person program in Boston will be streamed live on the digital platform and become available on demand after 48 hours to registered participants.

    About Vaccinex, Inc.

    Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The company's lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that prevents immune infiltration into tumors and triggers chronic inflammation in the brain, and is currently being evaluated in the clinic as a treatment for head & neck cancer and Alzheimer's disease with ongoing exploration of potential phase 3 development in Huntington's disease. The company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels.

    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. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington's and Alzheimer's disease and other indications, and other statements identified by words such as "may," "will," "appears," "expect," "planned," "anticipate," "estimate," "intend," "hypothesis," "potential," "suggest", "advance," and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Securities and Exchange Commission ("SEC") and the other risks and uncertainties described in the Company's Form 10-K for year-end December 31, 2020, and subsequent filings with the SEC.

    Investor Contact

    John Mullaly

    LifeSci Advisors, LLC

    617-429-3548



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  4. Enrollment underway in combination Phase 1b/2 study of pepinemab with KEYTRUDA® in Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

    Patient screening and enrollment underway in Phase 1/2a study of pepinemab in Alzheimer's disease

    Engaged in partnering discussions for a randomized Phase 3 trial in Huntington's disease

    ROCHESTER, N.Y., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "We made steady progress on our pepinemab clinical programs since…

    Enrollment underway in combination Phase 1b/2 study of pepinemab with KEYTRUDA® in Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

    Patient screening and enrollment underway in Phase 1/2a study of pepinemab in Alzheimer's disease

    Engaged in partnering discussions for a randomized Phase 3 trial in Huntington's disease

    ROCHESTER, N.Y., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "We made steady progress on our pepinemab clinical programs since our last quarterly update. Enrollment is now underway in the Phase 1b/2 head and neck cancer trial and the Phase 1/2a Alzheimer's disease trial, two of the serious indications in which SEMA4D is overexpressed and is believed to contribute to disease pathology," stated Maurice Zauderer, Ph.D., President and Chief Executive Officer.

    "As presented at the September European Huntington's Disease Network meeting, we believe post-hoc analysis of the Phase 2, SIGNAL trial of pepinemab in patients with early manifest Huntington's disease (HD) supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild advanced disease. We are engaged in discussions with potential partners for the advancement of this important program."

    Pepinemab Clinical Updates:

    Head and Neck Cancer. Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in advanced recurrent or metastatic head and neck cancer.

    The study will enroll up to 65 subjects across 18 U.S. trial sites and will assess whether combination therapy can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival. Vaccinex anticipates data from this study in the second half of 2022.  

    Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication.

    • Alzheimer's Disease. Patient screening and enrollment have been initiated in the Phase 1/2a clinical trial of pepinemab in Alzheimer's disease. The Alzheimer's trial is being funded in part by the Alzheimer's Drug Discovery Foundation by the Alzheimer's Association under the 2020 Part the Cloud Program.



      The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 14 U.S. trial sites. Vaccinex anticipates topline data from this study in late 2022 or early 2023.

    • Huntington's disease. We believe that post-hoc analysis of the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington's disease (HD) supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild cognitive deficits.
      • Highly significant improvement (p=0.007) in the (Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite score, a widely employed measure comprised of 6 different cognitive assessments.
      • Significant benefit in reducing apathy severity (p=0.017, 1-sided), a problem behavior that has previously been correlated with cognition in both HD and AD.
      • Striking increase in brain metabolic activity as measured by FDG-PET in most brain regions. Decline in FDG-PET signal has been reported to correlate with cognitive decline in several studies of AD.

       The company continues to actively explore advancing pepinemab into a Phase 3 HD trial in collaboration with a biopharmaceutical partner; discussions are ongoing.

    • Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" studies in head and neck cancer and melanoma.

    Upcoming Anticipated Milestones:

    • H2:2022– Meaningful data from open label head and neck cancer trial
    • Late 2022/Early 2023 – Topline data from randomized Alzheimer's trial

    ActivMAb® Updates:

    As previously announced, we have entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb® antibody discovery platform to address difficult to drug G-protein Coupled Receptors (GPCRs) known to be strongly associated with diseases. "We believe this enabling technology will allow us and our collaborators to address significant market opportunities," said Ernest S. Smith, Ph.D., Chief Scientific Officer.

    Financial Results for the Three Months Ended September 30, 2021:

    Research and Development Expenses. Research and development expenses for the three months ended September 30, 2021 were $3.6 million as compared to $7.3 million for the comparable period in 2020.

    General and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2021 were $1.5 million as compared to $1.9 million for the comparable period in 2020.

    Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on September 30, 2021 were $13.8 million, as compared to $10.6 million as of December 31, 2020.

    About Vaccinex, Inc.

    Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The company's lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that prevents immune infiltration into tumors and triggers chronic inflammation in the brain. The company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels.

    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. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington's and Alzheimer's disease and other indications, and other statements identified by words such as "may," "will," "appears," "expect," "planned," "anticipate," "estimate," "intend," "hypothesis," "potential," "suggest", "advance," and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Securities and Exchange Commission ("SEC") and the other risks and uncertainties described in the Company's Form 10-K for year end December 31, 2021 and subsequent filings with the SEC.                                

    Investor Contact                                        

    John Mullaly                                        

    LifeSci Advisors, LLC                                

    617-429-3548                                        

            

     

    VACCINEX, INC.

    Condensed Consolidated Balance Sheets (Unaudited)

    (in thousands, except share and per share data)

      As of

    September 30, 2021
      As of

    December 31, 2020
     
    ASSETS        
    Current assets:        
    Cash and cash equivalents $13,741  $10,596 
    Accounts receivable  50   157 
    Prepaid expenses and other current assets  1,071   533 
    Total current assets  14,862   11,286 
    Property and equipment, net  327   416 
    TOTAL ASSETS $15,189  $11,702 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
    Accounts payable $957  $3,169 
    Accrued expenses  1,208   1,937 
    Senior secured convertible debt, net  -   8,074 
    Total current liabilities  2,165   13,180 
    Long-term debt  1,134   1,134 
    TOTAL LIABILITIES  3,299   14,314 
    Commitments and contingencies (Note 7)        
    Stockholders' equity (deficit):        
    Common stock, par value of $0.0001 per share; 100,000,000 shares authorized

    as of September 30, 2021, and December 31, 2020; 30,801,962 and 22,388,027

    shares issued as of September 30, 2021 and December 31, 2020, respectively;

    30,801,110 and 22,387,175 shares outstanding as of September 30, 2021

    and December 31, 2020, respectively
      3   3 
    Additional paid-in capital  307,128   250,914 
    Treasury stock, at cost; 852 shares of common stock as of September 30, 2021 and

    December 31, 2020, respectively
      (11)  (11)
    Accumulated deficit  (295,230)  (277,481)
    Total Vaccinex, Inc. stockholders' equity (deficit)  11,890   (26,575)
    Noncontrolling interests  -   23,963 
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT)  11,890   (2,612)
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $15,189  $11,702 

    VACCINEX, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

    (in thousands, except share and per share data)

      Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
      2021 2020 2021 2020
    Revenue $50  $625  $900  $625 
    Costs and expenses:                
    Cost of revenue  -   2   -   2 
    Research and development  3,629   7,334   13,206   17,300 
    General and administrative  1,484   1,872   4,666   5,565 
    Total costs and expenses  5,113   9,208   17,872   22,867 
    Loss from operations  (5,063)  (8,583)  (16,972)  (22,242)
    Interest expense  (142)  (148)  (825)  (150)
    Other income (expense), net  (1)  (23)  48   (14)
    Loss before provision for income taxes  (5,206)  (8,754)  (17,749)  (22,406)
    Provision for income taxes  -   -   -   - 
    Net loss  (5,206)  (8,754)  (17,749)  (22,406)
    Net loss attributable to noncontrolling interests  -   -   -   - 
    Net loss attributable to Vaccinex, Inc. common stockholders $(5,206) $(8,754) $(17,749) $(22,406)
    Comprehensive loss $(5,206) $(8,754) $(17,749) $(22,406)
    Net loss per share attributable to Vaccinex, Inc. common stockholders, basic and diluted $(0.17) $(0.44) $(0.63) $(1.27)
    Weighted-average shares used in computing net loss per share attributable to

    Vaccinex, Inc. common stockholders, basic and diluted
      30,801,110   20,074,726   28,198,559   17,587,219 


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  5. Virtual Dates: November 18th – 19th, 2021

    ROCHESTER, N.Y., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced that Maurice Zauderer, Ph.D., President and Chief Executive Officer, is scheduled to present virtually at the 12th Annual Jefferies London Healthcare Conference and invites investors to participate in virtual one-on-one meetings on Thursday and Friday, November 18th and 19th. Please see Presentation details below:

    12th Annual Jefferies London Healthcare Conference
    Date:November 18th to 19th, 2021
    Time:Virtual presentation available Thursday, November

    Virtual Dates: November 18th – 19th, 2021

    ROCHESTER, N.Y., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced that Maurice Zauderer, Ph.D., President and Chief Executive Officer, is scheduled to present virtually at the 12th Annual Jefferies London Healthcare Conference and invites investors to participate in virtual one-on-one meetings on Thursday and Friday, November 18th and 19th. Please see Presentation details below:

    12th Annual Jefferies London Healthcare Conference
    Date:November 18th to 19th, 2021
    Time:Virtual presentation available Thursday, November 18 at 8:00am GMT/3:00am ET through Friday, November 19 at 5:00pm GMT / 12:00pm ET
    Presenter:Maurice Zauderer, Ph.D., President and Chief Executive Officer
    Webcast Link:https://wsw.meetmax.com/admin/presenterlinks/?432681186&group=TbkBHEif
    Replay:The presentation and a replay of the webcast will be available on Vaccinex's website shortly after the event at: https://ir.vaccinex.com/presentations

    Please contact your Jefferies representative or Vaccinex if you would like to participate in a virtual one-on-one meeting during the conference.

    For more information about the Jefferies London Healthcare Conference, please refer to the Jefferies conference website. Vaccinex's presentation will also be available on the Jefferies website for 30 days after the conference.

    About Vaccinex, Inc.

    Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The company's lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that prevents immune infiltration into tumors and triggers chronic inflammation in the brain, and is currently being evaluated in the clinic as a treatment for head & neck cancer and Alzheimer's disease with ongoing exploration of further phase 3 development in Huntington's disease. The company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels.

    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. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington's and Alzheimer's disease and other indications, and other statements identified by words such as "may," "will," "appears," "expect," "planned," "anticipate," "estimate," "intend," "hypothesis," "potential," "suggest", "advance," and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Securities and Exchange Commission ("SEC") and the other risks and uncertainties described in the Company's Form 10-K for year-end December 31, 2021, and subsequent filings with the SEC.

    Investor Contact                                        

    John Mullaly                                        

    LifeSci Advisors, LLC                                

    617-429-3548                                        

                            



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