Synaptogenix, Inc. (NASDAQ:SNPX) is a biopharmaceutical company focused on developing innovative treatments for neurodegenerative and cognitive disorders. The company's lead product candidate, Bryostatin-1, is currently in clinical trials for the treatment of Alzheimer's disease (AD) and other neurological conditions.
Business Overview
Synaptogenix was formed in 2012 with the primary purpose of commercializing technologies initially developed by the Blanchette Rockefeller Neurosciences Institute (BRNI) for therapeutic applications in AD and other cognitive dysfunctions. The company has an exclusive license to certain patents and technologies from BRNI, now known as Cognitive Research Enterprises, Inc. (CRE).
Bryostatin-1, Synaptogenix's lead drug candidate, is a natural product derived from a marine bryozoan that has shown promise in activating Protein Kinase C Epsilon (PKCĪµ), a key regulator of synaptic function and neuronal plasticity. The company is evaluating Bryostatin-1 for the treatment of AD, as well as other neurodegenerative and cognitive disorders such as Fragile X syndrome, Multiple Sclerosis, and Niemann-Pick Type C disease.
Financials
For the fiscal year ended December 31, 2023, Synaptogenix reported an annual net loss of $6,038,504, with no revenue generated. The company's annual operating cash flow was -$5,173,209, and its annual free cash flow was -$5,175,916.
In the first quarter of 2024, Synaptogenix reported a net loss of $206,699, with no revenue generated. The company's operating cash flow for the quarter was -$1,831,541, and its free cash flow was -$2,331,541.
Liquidity
As of March 31, 2024, Synaptogenix had $26.3 million in cash and cash equivalents, compared to $28.7 million as of December 31, 2023. The company expects its current cash and cash equivalents, approximately $25.9 million as of the date of this report, to be sufficient to support its projected operating requirements and financial commitments for at least the next 12 months.
Synaptogenix will likely need additional capital to initiate and pursue potential additional development projects, including the continuing development of Bryostatin-1 beyond the ongoing Phase 2 trial. The company may seek to access capital through equity or debt financing, collaborative or licensing arrangements, or other sources. However, there is no assurance that the company will be able to obtain such additional funding on favorable terms, or at all, which could have a material adverse effect on its business and financial condition.
Clinical Development Update
Synaptogenix's lead product candidate, Bryostatin-1, is currently in clinical development for the treatment of Alzheimer's disease.
Extended Confirmatory Phase 2 Clinical Trial
In July 2020, the company initiated a Phase 2 clinical study assessing the safety, tolerability, and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment. This study, known as the "2020 Study," was completed in December 2023.
On December 16, 2022, Synaptogenix announced that the extended confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD (Study #204) did not achieve statistical significance on the primary endpoint, which was change from baseline to Week 13 in the Severe Impairment Battery (SIB) total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial).
However, on March 7, 2023, the company announced results of its analysis of secondary endpoints and post hoc analysis from the Phase 2 study. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints were met with statistical significance in the low-to-moderately severe AD patient stratum. Importantly, nearly all pre-specified secondary endpoints in the most advanced and severe AD (MMSE: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = <0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive.
Open Label Dose Ranging Clinical Trial
In May 2022, Synaptogenix initiated a Phase 2 "open label," dose ranging study, clinical trial assessing the safety, tolerability, and efficacy of Bryostatin-1 administered via infusion in the treatment of moderately severe to severe AD subjects not receiving memantine treatment (the "2022 Study"). However, the company terminated the 2022 Services Agreement in December 2022.
Other Development Projects
Synaptogenix is also evaluating the potential of Bryostatin-1 for the treatment of other neurological disorders, such as Fragile X syndrome and Multiple Sclerosis (MS).
In September 2018, the company announced a collaboration with Nemours, a premier U.S. children's hospital, to initiate a clinical trial in children with Fragile X syndrome. The company estimates the total trial and IND cost for this program to be approximately $2 million. As of March 31, 2024, Synaptogenix has incurred cumulative expenses of approximately $100,000 associated with this agreement. The FDA has placed the development of the IND on clinical hold pending completion of further analytics relating to drug pharmacokinetics and pharmacodynamics.
On February 23, 2022, Synaptogenix announced its collaboration with Cleveland Clinic to pursue possible treatments for MS, and on July 19, 2023, the company announced that it had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. The total estimated costs associated with this collaboration are approximately $2.0 million. As of March 31, 2024, Synaptogenix has paid Cleveland Clinic approximately $375,000, which was expensed during the current quarter.
Risks and Challenges
Synaptogenix operates in a highly competitive and regulated industry, which exposes the company to various risks and uncertainties. These include, but are not limited to, the significant length of time associated with drug development and related insufficient cash flows, the company's limited patent portfolio, the ability to expand its business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of raw materials, existing or increased competition, stock volatility and illiquidity, and the company's ability to implement its business plans or strategies.
Additionally, the company's ability to access capital when needed is not assured and, if not achieved on a timely basis, will likely have a materially adverse effect on its business, financial condition, and results of operations.
Conclusion
Synaptogenix is a biopharmaceutical company focused on developing innovative treatments for neurodegenerative and cognitive disorders, with a particular emphasis on Bryostatin-1 for the treatment of Alzheimer's disease. While the company's lead product candidate did not meet the primary endpoint in a recent extended confirmatory Phase 2 clinical trial, the positive results observed in the most advanced and severe AD patient population provide encouragement for the continued development of Bryostatin-1.
As Synaptogenix navigates the challenges of the pharmaceutical industry, its ability to secure additional funding will be crucial in determining the pace and scope of its future development efforts. Investors will want to closely monitor the company's progress in its ongoing and planned clinical trials, as well as its efforts to strengthen its financial position and manage the risks inherent to its business.