Financial Performance - The net loss for Q1 2024 was $206,699, a significant improvement of $1,505,085 or 87.9% compared to a net loss of $1,711,784 in Q1 2023[156]. - Total operating expenses decreased by approximately 42.1% to $1,691,494 for the three months ended March 31, 2024, compared to $2,921,941 for the same period in 2023[157]. - Net loss decreased to $206,699 for the three months ended March 31, 2024, compared to a loss of $1,711,784 for the same period in 2023[162]. Expenses - Research and development expenses for Q1 2024 were $609,249, a decrease of $268,468 or 30.6% compared to $877,717 in Q1 2023[156]. - General and administrative expenses for Q1 2024 were $1,082,245, down by $961,979 or 47.1% from $2,044,224 in Q1 2023[156]. - Total operating expenses decreased by approximately 42.1% to $1,691,494 for the three months ended March 31, 2024, compared to $2,921,941 for the same period in 2023[157]. - Research and development expenses decreased by approximately 30.6% to $609,249 for the three months ended March 31, 2024, compared to $877,717 for the same period in 2023[158]. - General and administrative expenses decreased by approximately 47.1% to $1,082,244 for the three months ended March 31, 2024, compared to $2,044,224 for the same period in 2023[160]. Income and Other Financial Metrics - Other income for Q1 2024 increased to $1,484,795, representing a rise of $274,638 or 22.7% compared to $1,210,157 in Q1 2023[156]. - Other income increased to $1,484,795 for the three months ended March 31, 2024, compared to $1,210,157 for the same period in 2023, primarily due to increased interest income[161]. Cash Flow and Working Capital - Working capital decreased to $22,528,628 as of March 31, 2024, from $26,256,291 as of December 31, 2023, a decrease of $3,727,663[164]. - Cash used in operating activities increased to $1,831,541 for the three months ended March 31, 2024, compared to $1,695,812 for the same period in 2023[169]. - Cash used in investing activities was $500,000 for the three months ended March 31, 2024, compared to $2,038 for the same period in 2023[170]. - Current cash and cash equivalents of approximately $25.9 million are expected to support projected operating requirements for at least the next 12 months[165]. Clinical Studies and Collaborations - The total estimated budget for the Phase 2 clinical study of Bryostatin-1 is approximately $11.0 million, with a net budgeted cost of $8.3 million after a $2.7 million NIH grant[148]. - Cumulative expenses associated with the collaboration with Cleveland Clinic for MS treatment as of March 31, 2024, amounted to approximately $375,000[155]. - The company has incurred approximately $1.6 million in cumulative expenses for the 2022 Study as of March 31, 2024[151]. - The Phase 2 study of Bryostatin-1 in moderate to severe Alzheimer's disease did not achieve statistical significance on the primary endpoint[149]. Funding and Future Requirements - Additional capital will be required to initiate and complete potential clinical trials for AD and obtain regulatory approval, with uncertainty regarding the availability of such funding[166]. - As of March 31, 2024, the company has accrued a liability for installment payments owed to investors totaling $6,015,115[147]. - The company redeemed $3,000,000 of Series B Preferred Stock during Q1 2024, issuing 106,126 shares of Common Stock[146].

Alzheimer's Disease Research and Development - Synaptogenix is focused on developing Bryostatin-1 for Alzheimer's disease, with ongoing clinical trials and pre-clinical evaluations for other neurodegenerative diseases[13] - A Phase 2 exploratory trial enrolled 147 patients, showing a net improvement of 2.6 points in the SIB score for the 20 µg dose compared to placebo in the Completer population[15][17] - The 20 µg dose demonstrated a sustained improvement in cognition, with a significant increase of 3.59 points in the mITT population at week 15 compared to controls[24] - The confirmatory Phase 2 trial did not achieve statistical significance on the primary endpoint, with an average increase of 1.3 points for the Bryostatin-1 group at week 13[32][33] - The Phase 2 trial results indicated that Bryostatin-1 could potentially treat Alzheimer's disease and help reduce its progression[22] - Neurotrope announced a statistically significant improvement of 4.8 points in the mean SIB at week 13 for the Bryostatin-1 treatment group, with a p-value of < 0.0076[35] - The extended confirmatory Phase 2 study of Bryostatin-1 did not achieve statistical significance on the primary endpoint, with an average increase in SIB total score of 1.4 points for the Bryostatin-1 group[38] - Statistical significance was achieved in nearly all pre-specified secondary endpoints for the most advanced and severe AD patient population (MMSE: 10-14) with a p-value of < 0.05[38] - The activation of the PKC ε – BDNF pathway in central nervous system neurons may improve neuronal vitality and function, potentially enhancing memory and cognition in AD patients[58] - Treatment with Bryostatin-1 for 12 weeks in genetically modified rodents demonstrated promotion of new synapse growth and preservation of existing synapses, reversing the decrease of PKC ε[67] Financial Overview and Funding - The total estimated budget for the confirmatory trial was approximately $7.8 million, with total expenses incurred of about $7.6 million[31] - A $2.7 million award from the National Institutes of Health was granted to support an additional Phase 2 clinical study focused on the moderate stratum showing improvement in the 203 study[36] - The total estimated budget for the current Phase 2 trial services is approximately $11.0 million, with an estimated net cost to Neurotrope of $9.3 million after NIH funding[37] - The company incurred approximately $11.2 million in cumulative expenses for the Phase 2 clinical trial of Bryostatin-1 as of December 31, 2023, with an estimated net budgeted cost of $8.6 million after a $2.7 million NIH grant[96] - The company has incurred approximately $1.6 million in cumulative expenses for the 2022 Study as of December 31, 2023[99] - The total estimated budget for the 2022 Study services was approximately $2.0 million, but the agreement was terminated in December 2022[98] Collaborations and Licensing - Synaptogenix has entered into licensing agreements with Stanford University for the use of synthetic bryostatin in neurodegenerative disease therapeutics[14] - The company has licensed technology from Stanford for the use of bryostatin derivatives in treating central nervous system disorders, with obligations including a $10,000 annual maintenance fee and royalties of 3% on net sales[78] - The company maintains an exclusive, non-transferable, royalty-bearing right to develop certain products for therapeutic applications for Alzheimer's disease and other cognitive dysfunctions under the CRE License[101] - The company has licensed an extensive intellectual property portfolio from CRE, including issued patents and pending applications for key pharmaceutical markets[108] Regulatory Environment - The FDA has placed the development of the IND for Fragile X on clinical hold pending further analytics[41] - The FDA's approval process for new drugs includes rigorous preclinical testing and clinical trials to demonstrate safety and efficacy[117] - The FDA charges an annual program fee exceeding $415,000 per product for approved NDAs[128] - The FDA's internal review goals are six months for priority NDAs and ten months for regular NDAs from the filing date[129] - The FDA may grant accelerated approval based on a surrogate endpoint that predicts clinical benefit for serious conditions[141] - The FDA may issue a complete response letter outlining deficiencies in an NDA submission, requiring additional testing or information[145] Market Potential and Competitive Landscape - Over 50 million people worldwide are estimated to have AD or other forms of dementia in 2023, indicating significant commercial potential for effective therapies[51] - The global sales of major prescription drug therapies for Alzheimer's Disease (AD) were approximately $2.8 billion in 2022, with a projected growth to approximately $6.8 billion by 2032, reflecting a compounded annual growth rate (CAGR) of 9.3%[55] - The markets for drugs to treat AD are primarily in developed regions, including North America, Europe, and Japan[54] - The company is pursuing a unique mechanism involving PKC ε activation to treat Alzheimer's disease, with no direct competitors currently in this field[206] Corporate Structure and Governance - The company has five full-time personnel, including three executive officers, and maintains good relations with employees and consultants[207] - The corporate headquarters is located in New York, with a lease expiring on June 30, 2024, at a cost of approximately $5,900 per month[209] - The company has no ongoing legal proceedings against it[210] - The company was incorporated in Delaware in 2012 and underwent a structural separation from Neurotrope in December 2020[211]

Financial Performance - The net loss for the nine months ended September 30, 2023, was $5,042,535, a reduction of 49.9% from $10,056,302 in the same period of 2022[175]. - The company reported a net income of $763,203 for the three months ended September 30, 2023, compared to a net loss of $3,026,476 in the prior year[183]. - Total operating expenses for the nine months ended September 30, 2023, were $6,181,446, a decrease of approximately 39.7% compared to $10,246,129 for the same period in 2022[170]. - General and administrative expenses decreased by approximately 10.3% to $4,784,415 for the nine months ended September 30, 2023, compared to $5,334,260 in 2022[173]. - Research and development expenses for the nine months ended September 30, 2023, were $1,397,031, down 71.6% from $4,911,869 in the prior year, primarily due to reduced activities related to the Phase 2 clinical trial for Alzheimer's Disease (AD)[171]. Cash Flow and Liquidity - Cash used in operating activities was $4,107,209 for the nine months ended September 30, 2023, a decrease of approximately 51.3% compared to $8,427,727 for the same period in 2022[189]. - The net cash used in investing activities was $2,707 for the nine months ended September 30, 2023, down from $5,275 in the prior year, indicating a reduction in capital expenditures[191]. - Net cash used in financing activities was $1,641,015 for the nine months ended September 30, 2023, compared to cash provided by financing activities of $553,150 for the same period in 2022, reflecting a shift towards paying dividends and redeeming investments[192]. - As of September 30, 2023, the company had working capital of $30,522,980, a decrease of $6,749,871 from $37,272,851 as of December 31, 2022, primarily due to operating expenses and preferred stock dividends[185]. - The decrease in cash used in operating activities was primarily due to a reduction in net loss of approximately $5.0 million[190]. Clinical Study and Research Development - The Phase 2 study of Bryostatin-1 did not achieve statistical significance on the primary endpoint, but secondary endpoints showed statistical significance in the most advanced and severe Alzheimer's disease patient population[159]. - The total estimated budget for the Phase 2 clinical study assessing Bryostatin-1 is approximately $11 million, with a net budgeted cost to the company of $8.3 million after NIH grant support[157]. - As of September 30, 2023, the company incurred cumulative expenses of approximately $10.6 million associated with services provided for the Phase 2 clinical study of Bryostatin-1, offset by NIH reimbursements of $2.7 million[158]. - The company incurred approximately $1.5 million of cumulative expenses associated with the 2022 Study as of September 30, 2023[163]. - The company anticipates ongoing research and development expenditures as part of its product development strategy[188]. Funding and Financial Challenges - Additional capital will be required to initiate and complete potential AD clinical trials and obtain regulatory approval for therapeutic candidates[187]. - The company may face challenges in accessing additional funding on favorable terms, which could materially harm its business and financial condition[187]. - The company expects to incur losses and negative cash flows from operations over at least the next several years as it continues to develop AD and other therapeutic products[188]. Preferred Stock and Dividends - The Series B Preferred Stock carries a dividend rate of 7% per annum, compounded monthly, which increases to 15% per annum upon the occurrence of a Triggering Event[146]. - During the three months ended September 30, 2023, the company redeemed $3 million of the Series B Preferred Stock and $192,500 of accrued dividends, issuing 8,086,785 shares of Common Stock through installment conversions[154]. - For the nine months ended September 30, 2023, the company redeemed $6 million of the Series B Preferred Stock and $882,149 of accrued dividends, also issuing 8,086,785 shares of Common Stock through installment conversions[155]. - The company recognized a deemed dividend of $932,128 related to true-up conversion shares in excess of pre-amortization installment amounts during the three months ended September 30, 2023[154]. - As of September 30, 2023, the company has accrued a liability for installment payments owed to investors of $1,527,001[156]. Other Income and Expenses - Other income increased significantly to $1,138,911 for the nine months ended September 30, 2023, from $189,827 in the prior year, driven by higher interest income and changes in fair value of liabilities[174]. - Other income for the three months ended September 30, 2023, surged to $2,192,995 from $140,730 in the same period of 2022, reflecting increased interest income and favorable changes in liability valuations[182]. - For the three months ended September 30, 2023, research and development expenses were $212,103, a decrease of 85.7% from $1,484,694 in the prior year[179]. - General and administrative expenses for the three months ended September 30, 2023, were $1,217,689, down 27.6% from $1,682,512 in 2022[181].

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 June 30, 2023 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) Del ...

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, 2023 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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2022 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: 333-249434 SYNAPTOGENIX, INC. (Exact name of registrant as specified in its charter) Delaware 46-1585656 (State or ...

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 September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ (Former name, former address and former fiscal year, if changed since last report) Securities registered p ...

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 June 30, 2022 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) Del ...

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, 2022 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) De ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Registrant's Telephone Number, including area code) Securities registered pursuant to Section 12(b) of the Act: | Name of each exchange on which | | | | --- | --- | --- | | Title of each ...