Synaptogenix, Inc. is an emerging biopharmaceutical company dedicated to developing innovative therapeutics for the treatment of neurodegenerative disorders. With a focus on Alzheimer's disease (AD) and other cognitive dysfunctions, the company has built a robust pipeline of product candidates leveraging its exclusive license to key patents and technologies.
Company Background
Founded in October 2012 as Neurotrope Bioscience, Inc., Synaptogenix was initially established to commercialize technologies developed by the Blanchette Rockefeller Neurosciences Institute (BRNI) for therapeutic applications in Alzheimer's disease and other cognitive dysfunctions. These technologies had been under development at BRNI since 1999, supported by various non-investor sources including not-for-profit foundations, the NIH, and individual philanthropists.
In March 2013, the company, then known as Neurotrope Bioscience, Inc., began funding the development of the licensed technology in collaboration with BRNI. A significant milestone was reached on May 17, 2020, when Neurotrope, Inc. announced plans for the complete legal and structural separation of its wholly owned subsidiary, Neurotrope Bioscience, Inc. This process culminated on December 7, 2020, when the company officially became an independent entity, Synaptogenix, Inc., incorporated in Delaware.
Research Focus
Throughout its history, Synaptogenix has maintained a primary focus on developing a product platform based on Bryostatin-1 for the treatment of Alzheimer's disease. The company has also explored the potential of Bryostatin-1 in other neurodegenerative or cognitive diseases, including Fragile X syndrome, Multiple Sclerosis, and Niemann-Pick Type C disease, which have undergone pre-clinical testing.
Recent Developments
A significant development in the company's journey occurred in November 2022 when Synaptogenix secured a $15 million private placement for the sale of Series B convertible preferred stock and warrants. These funds were earmarked for the continued development of Bryostatin-1, including an extended confirmatory Phase 2 clinical trial for the treatment of Alzheimer's disease.
Financials
Synaptogenix's financial standing has seen its fair share of ups and downs over the years. In 2020, the company reported a net loss of $12.70 million, with a net cash position of $5.80 million at the end of the year. This was followed by a net loss of $5.57 million in 2021 and a net loss of $6.04 million in 2022, accompanied by growing cash reserves of $34.21 million and $37.48 million, respectively.
For the most recent fiscal year (2023), Synaptogenix reported a net loss of $6,038,504. The company did not generate any revenue, as it is a pre-revenue biopharmaceutical company focused on developing therapeutic products.
In the most recent quarter (Q3 2024), the company reported a net income of $6,048,738. This positive net income was primarily due to changes in the fair value of financial instruments. However, the company's operating cash flow (OCF) and free cash flow (FCF) for the quarter were both negative at -$1,031,048, reflecting ongoing research and development expenses.
Liquidity
The company's cash position received a significant boost in 2022, when it raised $13.93 million through the issuance of common stock. This provided the necessary funding to advance its clinical development programs, including a Phase 2 study assessing the safety, tolerability, and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD patients.
As of September 30, 2024, Synaptogenix had approximately $19.63 million in cash and cash equivalents, compared to $28.7 million at December 31, 2023. The company expects its current cash and cash equivalents will be sufficient to support its projected operating requirements and financial commitments for at least the next 12 months from the date of the 10-Q.
Synaptogenix maintains a strong liquidity position with no debt, resulting in a debt-to-equity ratio of 0. The company's current ratio and quick ratio are both 65.36, indicating a robust ability to meet short-term obligations. The company does not have any disclosed available credit lines.
Clinical Trials
The results of the extended confirmatory Phase 2 study, announced in December 2022, were not as positive as the company had hoped. While the study did not achieve statistical significance on the primary endpoint, Synaptogenix's management remained optimistic, highlighting the positive results observed in a subgroup of patients with more advanced AD. The company's analysis of secondary endpoints and post hoc analysis showed statistical significance in the most advanced and severe AD patient population with baseline MMSE-2 scores of 10-14. Following these results, the company terminated a Phase 2 open label, dose ranging study for Bryostatin-1 in December 2022.
Expanding Research
Undeterred by this setback, Synaptogenix continued to explore the potential of Bryostatin-1, announcing a collaboration with Cleveland Clinic in 2022 to pursue possible treatments for multiple sclerosis (MS). This partnership marked an important diversification of the company's pipeline, as it sought to expand its reach beyond AD and into other neurodegenerative indications.
In addition to AD and MS, Synaptogenix is evaluating the potential of Bryostatin-1 for the treatment of other neurodegenerative or cognitive diseases and dysfunctions, such as Fragile X syndrome. The company has collaborations with Nemours A.I. DuPont Hospital to initiate a clinical trial using Bryostatin-1 to treat Fragile X syndrome and with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS.
Recent Financing
In September 2024, Synaptogenix announced a $5.0 million financing, which included the sale of 5,000 shares of its newly issued Series C convertible preferred stock. This strategic move not only provided the company with additional capital to fuel its ongoing R&D efforts but also demonstrated the continued confidence of its existing investors in the company's long-term prospects.
Operating Expenses
During the three months ended September 30, 2024, the company incurred $222,900 in research and development expenses and $1.14 million in general and administrative expenses. For the nine months ended September 30, 2024, the company incurred $1.17 million in research and development expenses and $3.46 million in general and administrative expenses.
Geographic Markets
Synaptogenix primarily operates in the United States and does not disclose any financial information by geographic region.
Conclusion
Despite the challenges it has faced, Synaptogenix remains committed to its mission of developing innovative therapies for neurodegenerative disorders. With a talented team of researchers and a growing pipeline of product candidates, the company is well-positioned to navigate the complexities of this field and make a meaningful impact on the lives of patients suffering from these debilitating conditions.
As Synaptogenix continues to forge ahead, investors and industry observers will be closely monitoring the company's progress, eagerly awaiting the results of its future clinical trials and the potential breakthroughs that may emerge from its research. With a steadfast focus on innovation and a determination to overcome the obstacles that have confronted it, Synaptogenix is poised to play a vital role in the ongoing battle against neurodegenerative diseases.