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Significant YTD Progress in Neurology and Oncology Programs
New financing of $5MM closed without warrants, derivatives or other financial considerations
“Vaccinex continues to make important progress in our clinical programs to develop pepinemab, our proprietary immunotherapy product candidate, to improve patient outcomes in neurodegenerative disease and cancer,” said
Summary of
Neurodegenerative Disease:
- Huntington’s Disease Program: Submitted briefing documents along with a Type C meeting request to the FDA related to the proposed plan for a Phase 3 study of pepinemab in HD. FDA has indicated that they expect to provide a written response later this month to the questions posed in the briefing package.
- Alzheimer’s Disease Program: Enrollment completed in the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with mild dementia due to Alzheimer’s Disease (NCT04381468). The study builds on learnings from the previously completed Phase 2 SIGNAL study in HD. Topline data from this SIGNAL-AD study are expected in mid-2024, after the last enrolled patients will have received 12 months of treatment.
Oncology:
- KEYNOTE B-84: The Phase 1b/2 KEYNOTE B-84 study reached targeted enrollment of 36 patients for a pre-planned interim analysis. This open-label, Phase 1b/2 study (NCT04815720) is evaluating first line therapy of pepinemab in combination with KEYTRUDA®, Merck & Co. Inc’s (MRK) anti-PD-1 therapy, in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Vaccinex plans to complete the interim analysis in May and to publicize results in June, 2023 after meeting with Merck to discuss the next steps. - ASCO 2023 Annual Meeting: Two abstracts will be presented at the Annual Meeting of the
American College of Clinical Oncology (ASCO), being held inChicago fromJune 3-6 . The first will describe theVaccinex -sponsored Phase 1b/2 PDAC Study to evaluate pepinemab in combination with BAVENCIO®/avelumab as second line combination immunotherapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC, NCT05102721). ThisVaccinex -sponsored study will be conducted with theUniversity of Rochester Cancer Center andWilmot Cancer Institute , with grant support from a Gateway Discovery Award. Prior studies suggest that treatment with pepinemab may promote the infiltration and activation of dendritic cells and CD8+ cells into the tumor microenvironment, rendering “cold” tumors such as PDAC immunologically “hot” and leading to enhanced efficacy of immune checkpoint inhibitors (ICIs) such as avelumab. The second abstract presents rationale and update of an ongoing Phase 1/2 trial evaluating pepinemab in combination with adoptive cell therapy for breast cancer patients and will be presented by our collaborators, Dr.Hyo S. Han and Dr.Brian Czerniecki of theMoffitt Cancer Center (NCT05378464). In preclinical studies, it was shown that SEMA4D antibody blockade in combination with a dendritic cell vaccine improved trafficking of dendritic cells to tumors and stimulated adaptive tumor immunity, resulting in improved regression of both primary and distant tumors. ASCO is the largest clinical oncology meeting in US and affords an opportunity to discuss progress and strategy with partners and collaborators.
ActivMAb® Platform Technology:
- Nature Communications Paper:
Vaccinex and its collaborators published a report inNature Communications ,March 30, 2023 , “A Vaccinia-based system for directed evolution of GPCRs in mammalian cells”, describing a novel way that the ActivMAb® platform can be used for functional studies and drug discovery of the “hard to drug” class of membrane-associated G protein-coupled receptors (GPCRs) and ion channels. The publication highlights the potential for the ActivMAb® system to generate improved variants of any GPCR in a mammalian signaling system, enabling a better understanding of the functional properties of these complex receptors and the potential development of new and valuable drugs against these important targets. - First ActivMab®-based clinical program: Vaccinex’s partner, Surface Oncology, announced the initiation of a Phase 1/2 study of SRF114, a fully human monoclonal antibody targeting CCD8, for the potential treatment of solid tumors. SRF114 is the first clinical candidate to emerge from the ActivMAb® platform.
Financial Results for the Three Months Ended
Cash and
Cash and
- On
May 15, 2023 , the Company closed the private placement of approximately 7.9 million shares of its common stock for aggregate gross proceeds of$3.0 million , following the private placement that raised$2.0 million in aggregate gross proceeds onMarch 31, 2023 .FCMI Parent Co. (“FCMI”), which is controlled byAlbert D. Friedberg , the chairman of the Company’s board of directors, purchased shares in both the March andMay 2023 transactions andVaccinex (Rochester) L.L.C. , which is majority owned and controlled by Dr.Maurice Zauderer , the Company’s President, Chief Executive Officer, and a member of its board of directors, purchased shares in the March transaction. The Company intends to use the net proceeds from these private placements to fund the ongoing development and clinical trials of its lead drug candidate, pepinemab, in Alzheimer’s disease and in cancer and for working capital and general corporate purposes.
Research and Development Expenses. Research and development expenses for the quarter ended
The increase in research and development expenses is primarily attributable to increased patient enrollment in the SIGNAL-AD study and the Phase 1b/2 KEYNOTE B84 study in R/M HNSCC.
General and Administrative Expenses. General and administrative expenses for the quarter ended
Essentially flat level of general and administrative expenses reflects careful cost control measures.
Revenue.
Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended
Full financial tables are included below. For further details on Vaccinex’s financials, please refer to its Form 10Q filed
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
BAVENCIO®/avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt,
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in inflammatory reactions in the brain as well as in tumor immune evasion. Data show that by preventing deleterious inflammatory gliosis during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the function and health of neurons in the brain. Additional clinical data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in neurodegenerative disease and oncology. Pepinemab has been administered to more than 400 patients and appears to have a favorable safety and tolerability profile.
About ActivMAb®
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique capabilities for multi-pass membrane targets such as G-protein-coupled receptors (GPCRs) and ion channels. The ActivMAb® technology has five main applications: complex membrane antigen presentation, antibody or antigen discovery, directed evolution, and protein optimization. The first clinical candidate selected through use of this technology (SRF114, a fully human monoclonal antibody targeting CCR8 for the potential treatment of solid tumors), recently entered development in a Phase 1/2 study sponsored by our licensee, Surface Oncology. Vaccinex has entered into multiple antibody discovery collaborations with leading biopharmaceutical companies.
About Vaccinex Inc.
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 the KEYNOTE-B84 clinical trial, planned interim analysis, the use and potential benefits of pepinemab in R/M HNSCC, metastatic pancreatic adenocarcinoma (PDAC) and other indications, the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®, the expected timeline for publication and disclosure of trial results, the expected timeline of a response from the FDA on the proposed Phase 3 HD trial, the use of proceeds from our private placements, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “planned,” “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 studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later 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, the possible delisting of our common stock from NASDAQ if we are unable to regain compliance with the NASDAQ listing standards, 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 annual year-end Form 10-K and subsequent filings with the SEC.
Investor Contact
John Mullaly
617-429-3548
jmullaly@lifesciadvisors.com
Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share data) |
||||||||
| As of |
As of |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,323 | $ | 6,391 | ||||
| Accounts receivable | - | 175 | ||||||
| Prepaid expenses and other current assets | 1,095 | 912 | ||||||
| Total current assets | 4,418 | 7,478 | ||||||
| Property and equipment, net | 207 | 189 | ||||||
| Operating lease right-of-use asset | 270 | 310 | ||||||
| TOTAL ASSETS | $ | 4,895 | $ | 7,977 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,093 | $ | 1,518 | ||||
| Accrued expenses | 975 | 781 | ||||||
| Current portion of long-term debt | 75 | 74 | ||||||
| Operating lease liability | 167 | 164 | ||||||
| Total current liabilities | 2,310 | 2,537 | ||||||
| Long-term debt | 82 | 101 | ||||||
| Operating lease liability, net of current portion | 103 | 146 | ||||||
| TOTAL LIABILITIES | 2,495 | 2,784 | ||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, par value of 100,000,000 shares authorized as of 54,857,221 and 49,881,613 shares issued as of 54,856,369 and 49,880,761 shares outstanding as of March 31, 2023 and |
5 | 5 | ||||||
| Additional paid-in capital | 327,044 | 324,875 | ||||||
| (11 | ) | (11 | ) | |||||
| Accumulated deficit | (324,638 | ) | (319,676 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 2,400 | 5,193 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 4,895 | $ | 7,977 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share data) |
||||||||
| Three Months Ended |
||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 550 | $ | - | ||||
| Costs and expenses: | ||||||||
| Research and development | 3,812 | 2,966 | ||||||
| General and administrative | 1,724 | 1,628 | ||||||
| Total costs and expenses | 5,536 | 4,594 | ||||||
| Loss from operations | (4,986 | ) | (4,594 | ) | ||||
| Interest expense | (0 | ) | (1 | ) | ||||
| Other income (expense), net | 24 | - | ||||||
| Loss before provision for income taxes | (4,962 | ) | (4,595 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Comprehensive loss | $ | (4,962 | ) | $ | (4,595 | ) | ||
| Net loss per share attributable to |
$ | (0.10 | ) | $ | (0.12 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to |
49,880,761 | 38,758,283 | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
Source: Vaccinex, Inc.