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Last patient last visit in randomized, double-blind, SIGNAL-AD Phase 2a study of pepinemab treatment for Alzheimer’s Disease is scheduled for early
Treatment with pepinemab believed to halt or slow progression of neurodegenerative disease:
Of interest to investors:
- Vaccinex’s lead product, pepinemab, is designed to block astrocyte activation that is otherwise triggered by SEMA4D upregulation on stressed or damaged neurons in the brain during progression of Alzheimer’s Disease (AD) and Huntington’s Disease (HD).
- Astrocytes, which are key brain cells that support the health and function of neurons, express high affinity receptors for SEMA4D and undergo substantial changes in morphology and gene expression when SEMA4D binds to these receptors. As a result, they switch from normal supportive functions to neurotoxic inflammatory activity that is believed to accelerate and aggravate progression of neurodegenerative diseases.
- The Company’s hypothesis, which is being tested in the SIGNAL-AD study, is that treating with pepinemab antibody can block signaling by SEMA4D and prevent some or all damaging consequences of astrocyte activation.
- The Company has previously reported that antibody blockade of SEMA4D appears to protect and restore healthy astrocyte functions and, by some measures, also appears to slow or prevent cognitive decline in Huntington’s disease.
- The Company believes that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of treatment with anti-Aβ amyloid antibodies could make pepinemab, if approved, attractive as a potential alternative treatment or possibly for use in combination with anti-Aβ to enhance the benefit to patients. Pepinemab has, to date, been well-tolerated in clinical trials that enrolled a total of more than 600 patients, with no evidence of amyloid-related imaging abnormalities (ARIA).
Of further interest to the medical and research communities:
- Deposition of Aβ amyloid in the brain is recognized as the earliest event in the pathologic cascade for AD. However, the observation that many elderly, cognitively normal subjects also evidence deposition of Aβ amyloid in their brains suggests that this is not of itself sufficient for disease progression and that a sequence of subsequent events, including astrocyte activation and formation of toxic tau tangles in neurons, is required. Others have recently shown that Aβ deposition in combination with astrocyte activation is associated with increased plasma levels of phosphorylated tau peptide (p-tau 217).
- Key outcomes of the SIGNAL-AD study will include impact of pepinemab treatment on brain metabolic activity, an important biomarker of clinical progression in AD, together with other biomarkers of disease progression including plasma levels of glial fibrillary acidic protein (GFAP) released by reactive astrocytes, and phosphorylated tau peptide. Exploratory evaluation of treatment effects on cognitive decline will employ several validated cognitive scales. Topline data will be presented at a major Alzheimer’s medical conference.
- The SIGNAL-AD study was funded in part by two investments from the Alzheimer’s
Drug Discovery Foundation (ADDF) for a total of$4.75 million , and by an$0.75 million grant from the Alzheimer’s Association.
Financial Results for the Quarter Ended
Cash and
On
Research and Development Expenses. Research and development expenses for the quarter ended
General and Administrative Expenses. General and administrative expenses for the quarter ended
Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended
Total Stockholders’ Equity. Stockholders’ Equity as of
Financial tables are included below. The Company effected a 1-for-14 reverse stock split on
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and other glial cells in the brain and dendritic cells in immune tissue. Over 600 patients have been treated or enrolled in clinical trials of pepinemab in different indications and pepinemab appears to be well-tolerated with a favorable safety profile.
About Vaccinex Inc.
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
Forward Looking Statements
To the extent that statements contained in this press release 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 expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial; expectations with respect to compliance with Nasdaq listing standards; our plans, expectations and objectives with respect to the results and timing of the KEYNOTE-B84 clinical trial; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®; expectations with respect to the collaboration of Merck, the potential to initiate a Phase 3 trial in Huntington’s disease; and other statements identified by words such as “anticipate,” “believe,” “schedule,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “suggest”, 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 possible delisting of our common stock from Nasdaq if the Company is 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, the Company assumes 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 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
Chief Operating Officer,
(585) 271-2700
eevans@vaccinex.com
Condensed Balance Sheets (Unaudited)
(in thousands, except share and per share data)
| As of |
As of |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,972 | $ | 1,535 | ||||
| Accounts receivable | 2,775 | 961 | ||||||
| Prepaid expenses and other current assets | 1,312 | 853 | ||||||
| Derivative asset | 95 | - | ||||||
| Total current assets | 7,154 | 3,349 | ||||||
| Property and equipment, net | 110 | 136 | ||||||
| Operating lease right-of-use asset | 103 | 146 | ||||||
| TOTAL ASSETS | $ | 7,367 | $ | 3,631 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,329 | $ | 2,039 | ||||
| Accrued expenses | 1,880 | 1,242 | ||||||
| Deferred revenue | 59 | 63 | ||||||
| Current portion of long-term debt | 76 | 75 | ||||||
| Operating lease liability | 103 | 146 | ||||||
| Warrant liability | 259 | 2,351 | ||||||
| Total current liabilities | 4,706 | 5,916 | ||||||
| Long-term debt | 6 | 26 | ||||||
| TOTAL LIABILITIES | 4,712 | 5,942 | ||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Convertible preferred stock (Series A), par value of |
1,236 | - | ||||||
| Common stock, par value of as of shares issued as of 1,584,300 and 892,617 shares outstanding as of and |
1 | - | ||||||
| Additional paid-in capital | 345,253 | 337,627 | ||||||
| (11 | ) | (11 | ) | |||||
| Accumulated deficit | (343,824 | ) | (339,927 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY/(DEFICIT) | 2,655 | (2,311 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 7,367 | $ | 3,631 | ||||
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands, except share and per share data)
| Three Months Ended |
||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 104 | $ | 550 | ||||
| Costs and expenses: | ||||||||
| Research and development | 3,383 | 3,812 | ||||||
| General and administrative | 1,795 | 1,724 | ||||||
| Total costs and expenses | 5,178 | 5,536 | ||||||
| Loss from operations | (5,074 | ) | (4,986 | ) | ||||
| Financing costs - warrant liabilities | (28 | ) | - | |||||
| Change in fair value of warrant liabilities | 1,206 | - | ||||||
| Other income (expense), net | (1 | ) | 24 | |||||
| Loss before provision for income taxes | (3,897 | ) | (4,962 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss attributable to |
$ | (3,897 | ) | $ | (4,962 | ) | ||
| Comprehensive loss | $ | (3,897 | ) | $ | (4,962 | ) | ||
| Net loss per share attributable to stockholders, basic and diluted |
$ | (2.94 | ) | $ | (20.89 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to diluted |
1,327,257 | 237,527 | ||||||
Source: Vaccinex, Inc.