Core Viewpoint - TAO Synergies Inc. has rebranded from Synaptogenix, Inc. and will begin trading under the new ticker symbol "TAOX" on July 1, 2025, reflecting its strategic focus on the synergies between cryptocurrency and artificial intelligence [1][3] Group 1: Company Overview - TAO Synergies Inc. is the first pure-play public company dedicated to the convergence of cryptocurrency and AI, with a treasury strategy centered on acquiring TAO, the native cryptocurrency of Bittensor [4] - The company aims to stake TAO to generate revenue and capital appreciation, emphasizing its mission to create significant value for shareholders [4] Group 2: Strategic Focus - The company has begun staking TAO to capitalize on both staking yield and the growth of the token, positioning itself to leverage the leading AI token by market capitalization and adoption [2] - Executive Chairman Joshua Silverman highlighted that the rebranding and focus on TAO represents a pivotal moment in the company's commitment to digital assets and long-term shareholder value [3]

Core Insights - Synaptogenix has initiated its cryptocurrency treasury strategy by purchasing TAO, a leading AI-focused crypto token, with the aim of generating token-based yield and capital appreciation [1][2] - The company has partnered with BitGo for custody, trading, and staking services, leveraging BitGo's expertise to enhance its treasury strategy [1][2] - The initial acquisition of TAO was funded through the company's significant cash reserves, indicating a well-capitalized balance sheet [2] Company Strategy - The cryptocurrency treasury strategy is focused exclusively on artificial intelligence and machine learning, reflecting the company's commitment to innovation in these sectors [1][2] - The partnership with BitGo emphasizes the company's long-term conviction in TAO and its goal of creating significant value for shareholders [2] BitGo's Role - BitGo will provide secure custody for Synaptogenix's digital assets in regulated, insured cold storage, ensuring high standards of security and regulatory compliance [2] - BitGo's infrastructure will facilitate Synaptogenix's planned acquisitions of TAO and enable staking directly from qualified custody, allowing for revenue generation [2][3] - BitGo is recognized as the largest independent digital asset custodian and staking provider globally, serving thousands of institutions and millions of retail investors [3]

Singular focus on Bittensor (TAO), the leading AI token byadoption and market capitalization James Altucher to lead TAO token strategy initiatives Planned initial acquisition of $10 million in TAO equates to over two times the Company's current market capitalization; total acquisition target of $100 millionNEW YORK, June 9, 2025 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company") today announced its launch of a differentiated cryptocurrency treasury strategy focused exclusive ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-40458 SYNAPTOGENIX, INC. (Exact name of registrant as specified in its charter) (S ...

Alzheimer's Disease Development - Synaptogenix is focused on developing Bryostatin-1 for Alzheimer's disease, with ongoing clinical trials and pre-clinical evaluations for other neurodegenerative diseases[15] - The Phase 2 clinical trial enrolled 147 patients, with the 20 µg dose showing a net improvement of 2.6 points on the SIB scale compared to placebo in the Completer population[21] - The confirmatory Phase 2 trial was initiated with 100 patients, focusing on the 20 µg dose for advanced Alzheimer's patients not on memantine, with a total budget of approximately $7.8 million[33] - The Phase 2 trial results indicated sustained cognitive improvement in patients receiving the 20 µg dose, suggesting potential for treating Alzheimer's disease progression[26] - The confirmatory Phase 2 study of Bryostatin-1 showed a statistically significant improvement of 4.8 points in the mean SIB score at week 13 for the treatment group compared to baseline (p < 0.0076) with 32 patients[37] - The extended confirmatory Phase 2 clinical trial received a $2.7 million award from the National Institutes of Health to support further studies focused on the moderate stratum[38] - The extended confirmatory Phase 2 study did not achieve statistical significance on the primary endpoint, with an average increase of 1.4 points for the Bryostatin-1 group and 0.6 points for the placebo group at week 28[41] - Statistical significance was achieved in nearly all pre-specified secondary endpoints for the most advanced and severe AD patient population (MMSE: 10-14) with p < 0.05[41] - The company is evaluating data from the Phase 2 study to determine next steps for Bryostatin-1 development for AD and other potential indications[41] Financial and Strategic Considerations - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, leading to a reverse stock split on April 4, 2024[18] - The Special Committee was formed to explore strategic opportunities for enhancing value, considering the company's financial strength and anticipated cash burn[17] - The total estimated budget for the current trial services is approximately $11.0 million, with a net cost of $9.3 million after NIH funding[40] - The company has incurred approximately $11.2 million in cumulative expenses for the Phase 2 clinical trial of Bryostatin-1 as of December 31, 2023[109] - The Company received a $2.7 million grant from the NIH to support the Phase 2 Study, resulting in a net budgeted cost of $8.3 million for the study[109] Licensing and Collaboration - Synaptogenix has exclusive licensing agreements with Stanford University for synthetic bryostatin and is evaluating other compounds with similar therapeutic properties[16] - The company is obligated to pay Stanford a 3% royalty on net sales of licensed products and milestone payments of up to $3.7 million based on product development stages[86] - The company has entered into multiple licensing agreements with Stanford for the use of bryostatin derivatives in treating central nervous system disorders[86][87] - The CRE License allows the Company to develop products for therapeutic applications for Alzheimer's Disease and other cognitive dysfunctions, with certain restrictions on sublicensing[111] - The CRE License requires the company to pay a fixed research fee of $1 million for each of the five calendar years following a Series B Preferred Stock financing that generates at least $25 million[117] - The company has paid approximately $348,000 to CRE as an advance royalty payment, which will offset future royalty obligations until fully accounted[118] - The company has licensed an extensive intellectual property portfolio from CRE, including issued patents and pending applications related to key pharmaceutical markets[119] Regulatory and Approval Processes - The FDA's approval process for new drugs includes rigorous preclinical testing and clinical trials to demonstrate safety and efficacy[129] - Human clinical trials are conducted in four phases, with Phase 3 focusing on generating sufficient data to evaluate the drug's efficacy and safety[135] - The FDA requires sponsors of Phase 3 clinical trials to submit a diversity action plan, which includes enrollment diversity goals and a rationale for these goals[138] - The FDA aims to complete its substantive review of priority NDAs within six months and regular NDAs within ten months from the filing date[142][143] - The FDA may grant fast track designation for products addressing unmet medical needs, allowing for greater interaction with the agency during the review process[152] - The FDA may issue an approval letter or a complete response letter based on the evaluation of an NDA, with resubmissions reviewed in two to six months[161] - An approval letter allows for commercial marketing of the drug, but may include limitations on indications and require post-approval studies[162] - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of a product outweigh its risks, which can significantly impact market potential[164] Market Potential and Competitive Landscape - The global market for Alzheimer's disease (AD) therapies is projected to grow from approximately $2.8 billion in 2022 to about $6.8 billion by 2032, reflecting a compounded annual growth rate (CAGR) of 9.3%[62] - There are over 30 million people worldwide estimated to have had AD in 2024, indicating significant commercial potential for effective new therapies[60] - Current major drug therapies for AD have a collective worldwide sales CAGR of 6.5% from 2017 to 2021, despite their limited efficacy in treating disease progression[62] - Recent therapeutic trials with monoclonal antibodies have shown a decline rate reduction of 24% to 27% in patients with mild cognitive impairment after 18 months of treatment[65] - The company has developed drug prototypes that activate the PKC ε pathway, which may improve neuronal vitality and function in areas of the brain affected by AD[64] Challenges and Risks - The company faces significant uncertainty regarding the coverage and reimbursement status of its products approved by the FDA, which may adversely affect sales and financial condition[206] - In Europe and other countries, pricing and reimbursement schemes vary widely, with some requiring additional studies for cost-effectiveness before marketing approval[207] - Cost containment measures by government authorities and third-party payors may limit coverage and reimbursement for medical products, impacting future sales[210] - The Inflation Reduction Act of 2022 introduces provisions for drug price negotiations starting in 2026, which could decrease revenue for selected drugs[216] - Legislative proposals at various levels may broaden healthcare access while containing costs, potentially impacting the company's ability to generate revenue and achieve profitability[219] Research and Development Initiatives - The establishment of a Scientific Advisory Board with experts in Alzheimer's disease aims to enhance the company's research and development efforts in neurological diseases[220]

Core Insights - Synaptogenix, Inc. has formed an independent Special Committee to explore strategic opportunities aimed at enhancing value for investors [1] - The company has a strong financial position with $19.6 million in cash as of September 30, 2024, and approximately 1.3 million common shares outstanding [1][9] Company Overview - Synaptogenix is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases, particularly its lead candidate Bryostatin-1 for Alzheimer's disease [2] - Bryostatin-1 has received Orphan Drug Designation from the U.S. FDA for treating Fragile X syndrome and has been tested in over 1,500 individuals in cancer studies, providing a substantial safety database [2] Strategic Initiatives - The company is considering collaborations with third-party strategic and non-dilutive investment partners for the development of Bryostatin-1 [10] - Synaptogenix has submitted a grant proposal to the National Institutes of Health (NIH) for the development of Bryostatin-1 [10] - The CEO of Synaptogenix indicated expectations of a significant reduction in the cash burn rate while maintaining financial strength [3]

Core Viewpoint - Synaptogenix, Inc. has announced a $5.0 million financing through the sale of 5,000 shares of Series C convertible preferred stock, aimed at enhancing its strategic capabilities for potential acquisitions and research funding [1][2]. Financing Details - The financing involves the sale of Series C convertible preferred stock with a stated value of $1,000 per share, convertible into common stock [1]. - The initial conversion price for the preferred stock is set at $4.00 per share, with a quarterly dividend of 5.0% payable in cash [2]. - The offering includes a concurrent private placement of additional shares and unregistered common stock purchase warrants, expected to close around September 12, 2024 [1][2]. Regulatory Information - The securities in the Registered Offering are offered under an effective shelf registration statement declared by the SEC on April 27, 2022 [3]. - The Private Placement transactions are exempt from registration requirements under the Securities Act, relying on specific exemptions [4]. Company Background - Synaptogenix is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases, with its lead candidate, Bryostatin-1, undergoing clinical studies for Alzheimer's disease and other conditions [6]. - Bryostatin-1 has received Orphan Drug Designation from the FDA for treating Fragile X syndrome and has been tested in over 1,500 individuals in cancer studies, providing a substantial safety data base [6].

Financial Performance - The company reported total gross proceeds of approximately $15 million from the November Private Placement, which included the sale of 15,000 shares of Series B Preferred Stock and warrants to acquire up to 77,419 shares of Common Stock [125]. - The net loss for the three months ended June 30, 2024 was $1,273,309, a reduction of 68.9% compared to a loss of $4,093,954 in 2023 [148]. - Total operating expenses for the three months ended June 30, 2024 were $1,580,967, a decrease of approximately 13.6% compared to $1,829,713 for the same period in 2023 [143]. - Total operating expenses for the six months ended June 30, 2024 were $3,272,461, a decrease of approximately 31.1% from $4,751,654 in 2023 [149]. - Other income for the three months ended June 30, 2024 was $307,658, a significant improvement from a loss of $2,264,241 in the same period of 2023 [146]. Research and Development - The company incurred approximately $1.6 million of cumulative expenses associated with the Phase 2 "open label" dose-ranging study of Bryostatin-1 as of June 30, 2024 [136]. - The total estimated budget for the Phase 2 clinical study assessing Bryostatin-1 in the treatment of moderately severe Alzheimer's disease is approximately $11 million, with a net budgeted cost of $8.3 million after a $2.7 million NIH grant [133]. - The company has incurred cumulative expenses of approximately $590,000 related to the collaboration with Cleveland Clinic for a Phase 1 trial of Bryostatin-1 in Multiple Sclerosis as of June 30, 2024 [139]. - The company announced that the extended confirmatory Phase 2 study of Bryostatin-1 did not achieve statistical significance on the primary endpoint, but showed significant results in certain secondary endpoints for advanced Alzheimer's patients [134]. - The company is evaluating plans to advance development for Fragile X syndrome after filing for an IND with the FDA, which is currently on clinical hold [139]. Expenses and Liabilities - The company has accrued a liability for installment payments owed to investors of $8,829,761 as of June 30, 2024 [132]. - Research and development expenses increased to $342,068 for the three months ended June 30, 2024, up 11.3% from $307,211 in 2023, primarily related to the MS clinical trial [144]. - General and administrative expenses decreased by approximately 18.6% to $1,238,899 for the three months ended June 30, 2024, down from $1,522,502 in 2023 [145]. - Research and development expenses for the six months ended June 30, 2024 were $951,317, down 19.7% from $1,184,928 in 2023 [150]. - General and administrative expenses for the six months ended June 30, 2024 were $2,321,144, a decrease of approximately 34.9% from $3,566,726 in 2023 [154]. Cash Flow and Capital - The company had working capital of $18,472,861 as of June 30, 2024, down from $26,256,291 as of December 31, 2023, reflecting a decrease of $7,783,430 [157]. - The company expects its current cash and cash equivalents of approximately $24.4 million to support projected operating requirements for at least the next 12 months [158]. - Cash used in operating activities decreased by $250,224 to $2,685,075 for the six months ended June 30, 2024, compared to $2,935,299 for the same period in 2023 [164]. - Net cash used in investing activities was $1,000,000 for the six months ended June 30, 2024, a significant increase from $2,707 in the same period of 2023 [165]. - Net cash used in financing activities was $0 for the six months ended June 30, 2024, compared to $1,641,064 for the same period in 2023 [166]. Stock and Dividends - The Series B Preferred Stock holders are entitled to dividends of 7% per annum, compounded monthly, which can be paid in cash or shares of Common Stock at the company's option [127]. - There were no redemptions of amounts due to preferred stock investors in the first half of 2024, contrasting with the previous year [166].

Core Insights - Synaptogenix, Inc. has announced a collaboration with LSU Health New Orleans for preclinical testing of its polyunsaturated fatty acid (PUFA) analogs as a treatment for spinal cord injury (SCI) [3] - The company has received a new patent for its PUFA analogs, which are aimed at treating neurodegenerative diseases [3][8] - The PUFA analogs are designed to activate the enzyme PKC epsilon (PKC ε), which has shown potential in preclinical models for addressing various neurodegenerative diseases [5] Company Overview - Synaptogenix is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative disorders, including Alzheimer's disease and Fragile X syndrome [10] - The company holds exclusive rights to its PUFA analogs through a licensing agreement with Cognitive Research Enterprises, Inc. [4] - Bryostatin-1, another therapeutic candidate from Synaptogenix, has undergone testing in over 1,500 individuals in cancer studies, providing a substantial safety database [10] Research and Development - The collaboration with LSU Health New Orleans aims to compare the efficacy of PUFA analogs with Bryostatin in treating spinal cord injury [3] - Previous preclinical testing indicated that PUFA analogs could slow or reverse neurodegenerative processes in Alzheimer's disease and promote synaptogenesis [9] - The company is developing and patenting this class of compounds as next-generation treatments for neurodegenerative diseases [9]

Core Viewpoint - Synaptogenix, Inc. has received FDA authorization for an Investigational New Drug application for Bryostatin-1, aimed at treating multiple sclerosis (MS) [1][3]. Group 1: Clinical Trial Details - A fully-funded, open-label clinical trial will be conducted at the Cleveland Clinic Neurological Institute's Mellen Center for MS, utilizing advanced 7-tesla MRI technology to assess biomarkers related to Bryostatin-1's effects on the brain [2]. - The trial will incorporate behavioral and cognitive measures to evaluate the treatment's efficacy [3]. Group 2: Mechanism and Potential Benefits - Bryostatin-1 activates protein kinase C (PKC) enzymes, which are essential for synapse health and cognitive functions, potentially enhancing anti-inflammatory effects to protect nerve fibers [3][4]. - Preclinical studies indicate that Bryostatin-1 may prevent synapse loss, neuronal death, and reduce neurological deficits, suggesting its promise as a therapeutic agent for MS, particularly progressive forms [4]. Group 3: Financial Position - As of March 31, 2024, Synaptogenix has approximately $26.3 million in cash, ensuring full funding for the Phase 1 MS trial and supporting ongoing development of Bryostatin-1 and other innovative assets [4].