TAO Synergies Inc.
For the period ended Mar 31, 2025. Filed May 15, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
TAOX$2.54+8.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001410578-24-001891
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001410578-25-001327
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 92 previous paragraphs and 63 current paragraphs.
34 unchanged; 19 reworded; 9 added; 29 removed; 10 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
During the year ended December 31, 2024, we redeemed $715,000 of the Series C Preferred Stock and $86,694 of accrued dividends in cash through installment redemptions and proportionately relieved $1,592,341 of discount related to the redeemed Series C Preferred Stock. During the year ended December 31, 2024, we recognized a deemed dividend of $52,447 related to cash premiums.
Current report
Recent Developments
Current report
Exploring Strategic Alternatives
Current report
In December 2024, we announced via press release that the board of directors of the Company (the “Board “) had formed an independent special committee (the “Special Committee “) to explore strategic opportunities to create and enhance value for investors, including promising drug development platforms and/or compelling new technologies and services. Management has reviewed the Company’s financial position and has concluded that the Company’s continuing financial strength offset by anticipated future cash burn rate and publicly traded stock as currency allows the Special Committee to evaluate potential strategic opportunities.
Current report
In December 2024, the Company announced via press release the termination of its agreement with the Cleveland Clinic due to the slow pace of enrollment in the Phase 1 clinical trial. The termination of the agreement was one of various actions authorized by the Board, designed to reduce the Company’s cash burn rate.
Current report
Revenues
Current report
We did not generate any operating revenues for the three months ended March 31, 2025 and 2024.
Current report
Other Income
Current report
Net income (loss)
Removed paragraphs (29)
Previous report
On November 17, 2022, we entered into the Series B Purchase Agreement with the Series B Investors, pursuant to which we agreed to sell to the Series B Investors (i) an aggregate of 15,000 shares of Series B Preferred Stock and (ii) Series B Warrants to acquire up to an aggregate of 77,419 shares of Common Stock. We received total gross proceeds of approximately $15 million from the Series B Offering.
Previous report
The Series B Preferred Stock matured on September 9, 2024, and no shares of Series B Preferred Stock remain outstanding. The terms of the Series B Preferred Stock were as set forth in the Series B Certificate of Designations. The Series B Preferred Stock was convertible into Series B Preferred Shares at the election of the holder at any time at the Series B Conversion Price. The Series B Conversion Price was subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). We were required to redeem the Series B Preferred Stock in 15 equal monthly installments, commencing on June 1, 2023. The amortization payments due upon such redemption were payable, at our election, in cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Series B Conversion Price then in effect and (ii) the greater of (A) a 15% discount to the average of the three lowest closing prices of the Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) the lower of $31.25 and $4.30, which equals 20% of the Minimum Price (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on April 14, 2023, the date of receipt of Nasdaq Stockholder Approval; provided that if the amount set forth in clause B is the lowest effective price, we will be required to pay the amortization payment in cash. We had the ability to require holders to convert their Series B Preferred Stock into Series B Preferred Shares if the closing price of the Common Stock exceeded $290.625 per share for 20 consecutive trading days and the daily trading volume of the Common Stock exceeded 4,000 shares per day during the same period and certain equity conditions described in the Series B Certificate of Designations were satisfied.
Previous report
On March 17, 2023, the Company filed an amendment (the “First CoD Amendment”) to the Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which it amended the terms of the Series B Preferred Stock by revising the definition of “floor price” for purposes of calculating amortization payments, extending the date for the first required amortization payments, extending the deadline for stockholder approval and extending the maturity date to August 31, 2024. On May 12, 2023, the Company filed an amendment (the “Second CoD Amendment”) to the Series B Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the Company amended the terms of the Series B Preferred Stock by removing all references to the “Make-Whole Amount”. In connection with the Second CoD Amendment, on May 11, 2023, the Company entered into an amendment to the Series B Purchase Agreement pursuant to which it agreed to extend the investors’ right of participation in a subsequent financing until the one year anniversary following the later of (x) such time that no shares of Series B Preferred Stock are outstanding and (y) the maturity date of the Series B Preferred Stock. On September 22, 2023, the Company filed an amendment (the “Third CoD Amendment”) to the Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the Company amended the terms of the Series B Preferred Stock by providing that the Company and Series B Investors shall be permitted to mutually agree, in connection with any waiver of an Equity Conditions Failure (as defined in the Series B Certificate of Designations), as to (i) whether the monthly amortization payments made to the Series B Investors will be made in cash or shares of Common Stock, (ii) the methodology for calculating any applicable true-up shares required to be paid in connection with an amortization payment (including whether such true-up shares will be paid in cash or shares of Common Stock) and for calculating the conversion price in connection with any accelerated conversions, and (iii) whether any premium will apply in connection with any payment of true-up shares in cash instead of shares of Common Stock, subject to certain limitations as set forth in the Third CoD Amendment. On September 3, 2024, the Company filed an amendment to the Series B Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the Company extended the maturity date to September 9, 2024, subject to further extension pursuant to the terms of the Certificate of Designations.
Previous report
The holders of the Series B Preferred Stock were entitled to dividends of 7% per annum, compounded monthly, which were payable in cash or shares of Common Stock at our option, in accordance with the terms of the Certificate of Designations. Upon the occurrence and during the continuance of a Triggering Event (as defined in the Series B Certificate of Designations), the Series B Preferred Stock would have accrued dividends at the rate of 15% per annum. The holders of Series B Preferred Stock had no voting rights on account of the Series B Preferred Stock, other than with respect to certain matters affecting the rights of the Series B Preferred Stock.
Previous report
Further, the Series B Certificate of Designations contained a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of, or as part of any amortization payment under, the Series B Certificate of Designations or Series B Warrants.
Previous report
The Series B Warrants are exercisable for Series B Warrant Shares at an initial exercise price of $$2.8586 per share (as adjusted from time to time pursuant to the terms of the Series B Warrants, the “Series B Exercise Price”) and expire five years from the date of issuance. The Series B Exercise Price was reduced based upon the Reverse Stock Split and the Series C Private Placement (see below). The Series B Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Series B Exercise Price (subject to certain exceptions). There is no established public trading market for the Series B Warrants and the Company does not intend to list the Series B Warrants on any national securities exchange or nationally recognized trading system.
Previous report
The Company effected the Reverse Stock Split on April 4, 2024. Pursuant to the terms of the Series B Certificate of Designations and the Series B Warrants, the Series B Conversion Price and the Series B Exercise Price were adjusted accordingly.
Previous report
September 2024 Private Placement
Previous report
Notwithstanding the foregoing, our ability to settle conversions is subject to certain limitations set forth in the Certificate of Designations, including a limit on the number of shares that may be issued until the time, if any, that we receives Nasdaq Stockholder Approval. We have agreed to seek Nasdaq Stockholder Approval of these matters at a meeting to be held no later than December 31, 2024. Further, the Series C Certificate of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of the Series C Certificate of Designations or Series C Warrants.
Previous report
Results of Most Recent Extended Confirmatory Phase 2 Clinical Trial
Previous report
On July 23, 2020, we entered into the 2020 Services Agreement with WCT. The 2020 Services Agreement relates to services for our 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. On January 22, 2022, we executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million. The updated total estimated budget for the services, including pass-through costs, is approximately $11.0 million. As previously disclosed, on January 22, 2020, we were granted a $2.7 million award from the NIH, which award is being used to support the 2020 Study, resulting in a current estimated net budgeted cost of the 2020 Study to us of $8.3 million. Of the $2.7 million grant, virtually all has been received as of February 22, 2022. The 2020 Study was completed in December 2023.
Previous report
On December 16, 2022, we issued a press release announcing that an 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 SIB total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial). On March 7, 2023, we announced results of our analysis of secondary endpoints and post hoc analysis from our Phase 2 study of Bryostatin-1. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB (Severe Impairment Battery) 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. However, 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.
Previous report
Open Label Dose Ranging Clinical Trial
Previous report
On May 12, 2022, we entered into a services agreement with WCT (the “2022 Services Agreement”). The 2022 Services Agreement relates to services for 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”).
Previous report
Pursuant to the terms of the 2022 Services Agreement, WCT provided services to enroll approximately 12 2022 Study subjects. The first 2022 Study site was initiated during the third quarter of 2022. As of September 30, 2024, we incurred approximately $1.6 million of cumulative expenses associated with the 2022 Study. We terminated the 2022 Services Agreement in December 2022. Of the total $1.6 million incurred for the trial as of September 30, 2024, $0 and approximately $14,000 is reflected in the statement of comprehensive loss for the three months ended September 30, 2024 and 2023, respectively and $0 and approximately $131,000 is reflected in the statement of comprehensive loss for the nine months ended September 30, 2024 and 2023, respectively.
Previous report
LSU Health
Previous report
Effective June 20, 2024, the Company signed a collaboration agreement with LSU Health to pursue pre-clinical testing of the Company’s polyunsaturated fatty acid (“PUFA”) analogs as a treatment for spinal cord injury (“SCI”). The Company also announced that the US Patent and Trademark Office (USPTO) recently issued US Patent No. 12,016,837 titled*‘Halogenated Esters of Cyclopropanated Unsaturated Fatty Acids for Use in the Treatment of Neurodegenerative Diseases,’* covering its family of analogs. Synaptogenix holds exclusive rights to its PUFA analogs pursuant to a licensing agreement with CRE, formerly known as the Blanchette Rockefeller Neurosciences Institute. The studies will compare the analogs with Bryostatin in SCI. The total estimated costs associated with this collaboration are approximately $200,000. As of September 30, 2024, the Company has paid amounts owed to LSU Health and its affiliates of $50,000 of which $0 was expensed during the three months ended September 30, 2024.
Previous report
Total operating expenses for the three months ended September 30, 2024 were $1,359,669 as compared to $1,429,792 for the three months ended September 30, 2023, a decrease of approximately 4.9%. The decrease in total operating expenses is due to the decrease in general and administrative expenses partially offset by an increase in research and development expenses.
Previous report
Other Income / Expense
Previous report
Net loss
Previous report
We recognized losses of $5,742,013 and income of $763,203 for the three months ended September 30, 2024 and 2023, respectively. The increased loss was primarily attributable to the increase in research and development expenses and the increase in other loss partially offset by a decrease in general and administrative expenses.
Previous report
Comparison of the nine months ended September 30, 2024 and 2023
Previous report
Operating Expenses
Previous report
Overview
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income / Expense
Previous report
Net loss
Previous report
Net Cash Used in / Provided by Financing Activities
Reworded paragraphs (19)
Previous wording
The unaudited financial statements for the nine months ended September 30, 2024 and 2023 include a summary of our significant accounting policies and should be read in conjunction with the discussion below and our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in the financial statements. All such adjustments are of a normal recurring nature.
Current wording
The unaudited financial statements for the three months ended March 31, 2025 and 2024 include a summary of our significant accounting policies and should be read in conjunction with the discussion below and our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in the financial statements. All such adjustments are of a normal recurring nature.
Previous wording
Notwithstanding the foregoing, the Company’s ability to settle conversions and make amortization payments using shares of Common Stock was subject to certain limitations set forth in the Series B Certificate of Designations, including a limit on the number of shares that may be issued until the Nasdaq Stockholder Approval. The Company received Nasdaq Stockholder Approval at the Company’s special meeting of stockholders held on April 14, 2023. Further, the Series B Certificate of Designations contained a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of, or as part of any amortization payment under, the Series B Certificate of Designations or Series B Warrants.
Current wording
The Company received Nasdaq Stockholder Approval at the Company’s special meeting of stockholders held on December 6, 2024.
Previous wording
and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Series C Exercise Price (subject to certain exceptions). There is no established public trading market for the Series C Warrants and we do not intend to list the Series C Warrants on any national securities exchange or nationally recognized trading system.
Current wording
The Series C Warrants are exercisable immediately at the Series C Exercise Price and expire five years from the date of issuance. The Series C Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Series C Exercise Price (subject to certain exceptions). There is no established public trading market for the Series C Warrants and we do not intend to list the Series C Warrants on any national securities exchange or nationally recognized trading system.
Previous wording
During the three and nine months ended September 30, 2024, the Company redeemed $0 and $6,000,000, respectively, of the Series B Preferred Stock and $274,140 and $396,640, respectively of accrued dividends by issuing 100,000 and 374,219 shares, respectively, of Common Stock through installment conversions and proportionately relieved $0 and $4,911,312 of discount, respectively, related to the redeemed Series B Preferred Stock. During the three and nine months ended September 30, 2024, the Company recognized a deemed dividend of $19,392 and $271,086, respectively, related to cash premiums.
Current wording
During the three months ended March 31, 2025, we redeemed $715,000 of the Series C Preferred Stock and $53,563 of accrued dividends in cash through installment redemptions and relieved $1,086,984 of discount related to the redeemed Series C Preferred Stock. During the three months ended March 31, 2025, we recognized a deemed dividend of $53,799 related to cash premiums.
Previous wording
As of September 30, 2024 and December 31, 2023, the Company has accrued a liability for installment payments owed to investors in either cash or shares of $0 and $3,395,945, respectively. The Company paid approximately $8.8 million to fully satisfy its obligations to the Series B preferred stockholders. Subsequent to September 30, 2024, and as of November 12, 2024, the Company has issued 0 shares of Common Stock in partial satisfaction of the accrued preferred redemption liability.
Current wording
As of March 31, 2025, we have accrued a liability for installment payments owed to investors in either cash or shares of $0.
Previous wording
On September 5, 2018, we announced a collaboration with Nemours, a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, we announced our memorandum of understanding with Nemours A.I. DuPont Hospital (“Nemours”) to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. We intend to provide the Bryostatin-1 drug product candidate and obtain the IND and Nemours intends to provide the clinical site and attendant support for the trial. We and Nemours, jointly, will develop the trial protocol. We currently estimate our total trial and IND cost to be approximately $2 million. As of September 30, 2024, we have incurred cumulative expenses associated with this agreement of approximately $100,000.
Current wording
On September 5, 2018, we announced a collaboration with Nemours, a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, we announced our memorandum of understanding with Nemours A.I. DuPont Hospital (“Nemours”) to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. We intend to provide the Bryostatin-1 drug product candidate and obtain the IND and Nemours intends to provide the clinical site and attendant support for the trial. We and Nemours, jointly, will develop the trial protocol. We currently estimate our total trial and IND cost to be approximately $2 million. As of the end of the period covered by this quarterly report, we have incurred cumulative expenses associated with this agreement of approximately $100,000.
Previous wording
On February 23, 2022, we announced our collaboration with Cleveland Clinic to pursue possible treatments for MS, and on July 19, 2023, we announced that we had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. Cleveland Clinic will manage the clinical trial’s implementation, including an IND submission to the FDA and patient enrollment. Cleveland Clinic has enrolled three subjects and has dosed two to - date, with the total planned enrollment in the MS Trial of 20 subjects. The total estimated costs associated with this collaboration are approximately $2.0 million. As of September 30, 2024, we have incurred expenses due to Cleveland Clinic approximately $590,000 of which $0 was expensed during the three months ended September 30, 2024.
Current wording
On February 23, 2022, we announced our collaboration with Cleveland Clinic to pursue possible treatments for MS, and on July 19, 2023, we announced that we had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. Cleveland Clinic will manage the clinical trial’s implementation, including an IND submission to the FDA and patient enrollment. Cleveland Clinic has enrolled three subjects and has dosed two to - date, with the total planned enrollment in the MS Trial of 20 subjects. The total estimated costs associated with this collaboration are approximately $2.0 million. As of March 31, 2025, we have incurred expenses due to Cleveland Clinic approximately $743,000 of which $215,459 was expensed during the three months ended March 31, 2025.
Previous wording
Total operating expenses for the nine months ended September 30, 2024 were $4,632,130 as compared to $6,181,446 for the nine months ended September 30, 2023, a decrease of approximately 25.1%. The decrease in total operating expenses is due to the decrease in research and development and general and administrative expenses.
Current wording
Total operating expenses for the three months ended March 31, 2025 were $1,069,165 as compared to $1,691,494 for the three months ended March 31, 2024, a decrease of approximately 36.8%. The decrease in total operating expenses is due to the decrease in both research and development and general and administrative expenses.
Previous wording
For the three months ended September 30, 2024, we incurred $222,897 in research and development expenses as compared to $212,103 for the three months ended September 30, 2023, an increase of approximately 5.1%. These expenses were incurred primarily in connection with developing the potential AD therapeutic product and the initiation of the MS trial with Cleveland Clinic. Of these expenses, for the three months ended September 30, 2024, $31,630 was incurred principally relating to our current MS clinical trial and our storage of drug product, $173,797 for clinical consulting services, $7,534 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $9,936 for development of alternative drug supply with Stanford University; comparatively, for the three months ended September 30, 2023, $95,248 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $96,883 for clinical consulting services, $5,041 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, and $14,931 for development of alternative drug supply with Stanford University.
Current wording
For the three months ended March 31, 2025, we incurred $60,816 in research and development expenses as compared to $609,249 for the three months ended March 31, 2024, a decrease of approximately 90.0%. These expenses were incurred primarily in connection with developing the potential AD therapeutic product and the MS trial with Cleveland Clinic during the three months ended March 31, 2024. Of these expenses, for the year ended three months ended March 31, 2025, $19,839 was incurred principally relating to our storage of drug product, $19,177 for clinical consulting services, $7,425 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, and $14,375 for development of alternative drug supply with Stanford University; comparatively, for the three months ended March 31, 2024, $421,823 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $170,444 for clinical consulting services, $7,104 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, and $9,878 for development of alternative drug supply with Stanford University.
Previous wording
Our research and development expenses have decreased as our current Phase 2 clinical trial for AD was concluded by the end of 2023 and our Phase 2 dose ranging study was discontinued while we initiated our MS clinical trial. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1.
Current wording
Our research and development expenses have decreased as our Phase 2 clinical trial for AD was concluded by the end of 2023 and our Phase 2 dose ranging study and our MS clinical trial were discontinued. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1.
Previous wording
We incurred $1,136,772 and $1,217,689 of general and administrative expenses for the three months ended September 30, 2024 and 2023, respectively, a decrease of approximately 6.6%. During the three months ended September 30, 2024, $315,830 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $300,598 for the three months ended September 30, 2023; $113,173 was incurred for legal expenses versus $180,566 for the 2023 comparable period. The higher legal fees for 2023 is based upon the prior year’s increased fees for special stockholder vote requirements and for regulatory compliance; $258,990 was incurred for outside operations consulting services during the three months ended September 30, 2024, versus $247,344 for the comparable period in 2023; $26,226 was incurred for travel expenses during the three months ended September 30, 2024, versus $48,148 for the comparable period in 2023 as Company officers and directors conducted overseas due diligence for strategic investments; $95,314 was incurred for investor relations services during the three months ended September 30, 2024, versus $62,643 for the comparable period in 2023; $58,995 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the three months ended September 30, 2024, versus $59,812 for the comparable period in 2023; $161,467 was incurred for insurance during the three months ended September 30, 2024, versus $190,786 for the comparable period in 2023. The decrease is attributable to lower premiums; $102,986 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the three months ended September 30, 2024, versus $112,728 for the comparable period in 2023; and $3,791 was recorded as non-cash stock options compensation expense during the three months ended September 30, 2024, versus $15,064 for the comparable period in 2023, as options granted during the 2023 period partially vested upon issuance.
Current wording
We incurred $1,008,349 and $1,082,245 of general and administrative expenses for the three months ended March 31, 2025 and 2024, respectively, a decrease of approximately 6.8%. During the three months ended March 31, 2025, $237,242 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $342,659 for the three months ended March 31, 2024, the decrease resulted primarily from compensation reductions for our President and our Chief Executive Officer; $78,447 was incurred for legal expenses versus $113,656 for the 2024 comparable period. The higher legal fees for 2024 is based upon the prior year’s increased fees for special stockholder meeting requirements and for regulatory compliance; $194,358 was incurred for outside operations consulting services during the three months ended March 31, 2025, versus $262,002 for the comparable period in 2024, as the lower amount for the 2025 period reflects the decrease in regulatory and compliance work; $15,959 was incurred for travel expenses during the three months ended March 31, 2025, versus $34,881 for the comparable period in 2024 as Company officers and directors conducted overseas due diligence for strategic investments in 2024; $149,961 was incurred for investor relations services during the three months ended March 31, 2025, versus $164,732 for the comparable period in 2024; $89,746 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the three months ended March 31, 2025, versus $20,713 for the comparable period in 2024, the increase was attributable to year end 2024 audit services paid during the current 2025 quarter; $130,204 was incurred for insurance during the three months ended March 31, 2025, versus $154,965 for the comparable period in 2024. The decrease is attributable to lower premiums; $108,724 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the three months ended March 31, 2025, versus $(25,771) for the comparable period in 2024. The increase is attributable to credits for lower franchise taxes paid during the 2024 period credited to 2024; and $3,709 was recorded as non-cash stock options compensation expense during the three months ended March 31, 2025, versus $14,407 for the comparable period in 2024.
Previous wording
We recognized total other loss of $4,382,344 for the three months ended September 30, 2024 as compared to total other income of $2,192,995 for the three months ended September 30, 2023, which consisted, for 2024 and 2023, of interest income on funds deposited in interest bearing money market accounts and investments in short-term US treasury bills and changes in fair value of warrant and derivative liabilities and offering costs. The decrease in interest income and unrealized gains on treasury bills totaling $249,314 for the three months ended September 30, 2024 is primarily attributable to the decrease in cash balances over the period and lower interest rates. The total increased loss is primarily attributable to the increase in change in fair value of derivative liability of $892,000 and the increase in fair value of warrant liability of $991,000, loss on issuance of Series C Preferred Stock of approximately $3.8 million, warrant issuance costs of $618,375 and share of loss in equity investment of $12,025.
Current wording
We recognized total other income of $1,454,334 for the three months ended March 31, 2025 as compared to total other income of $1,484,795 for the three months ended March 31, 2025, which consisted, for 2025 and 2024, of interest income on funds deposited in interest-bearing money market accounts and investments in short-term U.S. treasury bills and changes in fair value of warrant and derivative liabilities and offering costs. The decrease in interest income and unrealized gains on treasury bills totaling $281,061 for the three months ended March 31, 2025 is primarily attributable to the decrease in cash balances over the period and lower interest rates. The total decrease in other income is primarily attributable to the decrease in interest income as noted above, in and the decrease in change in fair value of derivative liability of $1,051,000, partially offset by the change in fair value of derivative liability of $1,293,000 and the decrease in net loss in equity investment of $8,600.
Previous wording
We recognized losses of $7,222,021 and $5,042,535 for the nine months ended September 30, 2024 and 2023, respectively. The increased loss was primarily attributable to the increase in other loss partially offset by the decrease in research and development and general and administrative expenses.
Current wording
We recognized income of $385,169 versus a loss of ($206,699) for the three months ended March 31, 2025 and 2024, respectively. The increased income was primarily attributable to the decrease in research and development and general and administrative expenses partially offset by the decrease in other income.
Previous wording
Since inception, we have incurred negative cash flows from operations. As of September 30, 2024, we had working capital of $21,939,418 as compared to working capital of $26,256,291 as of December 31, 2023. The $4,316,873 decrease in working capital was primarily attributable to approximately $4.6 million of operating expenses and redemptions of Series B preferred stock of approximately $8.8 million, partially offset by the dncrease in preferred stock liabilities of approximately $3.4 million, net proceeds from Series C preferred stock offering of approximately $4.5 million, non-cash expenses of approximately $0.1 million and interest income of approximately $1.1 million.
Current wording
Since inception, we have incurred negative cash flows from operations. As of March 31, 2025, we had working capital of $15,106,751 as compared to working capital of $16,706,587 as of December 31, 2024. The $1,599,836 decrease in working capital was primarily attributable to approximately $1.0 million of operating expenses, redemption of Series C Preferred Stock of approximately $800,000 partially offset by and interest income of approximately $0.2 million.
Previous wording
We expect that our current cash and cash equivalents of approximately $18.3 million will be sufficient to support our projected operating requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q, which would include the continuing development of Bryostatin-1, our novel drug candidate targeting the activation of PKCε, our initiation and possible development of a therapeutic for MS and other possible therapeutics.
Current wording
We expect that our current cash and cash equivalents of approximately $13.8 million will be sufficient to support our projected operating requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q, which may include the continuing development of Bryostatin-1 for neurodegenerative diseases.
Previous wording
We expect to require additional capital in order to initiate, pursue and complete all potential AD clinical trials and obtain regulatory approval of one or more therapeutic candidates. However, additional future funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to initiate, pursue and complete all planned clinical trials or continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and operations. Any additional equity financing, if available, may not be available on favorable terms, would most likely be significantly dilutive to our current stockholders and debt financing, if available, and may involve restrictive covenants. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would likely materially harm our business and financial condition.
Current wording
We expect to require additional capital in order to initiate, pursue and complete all potential clinical trials and obtain regulatory approval of one or more therapeutic candidates. However, additional future funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to initiate, pursue and complete all planned clinical trials or continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and operations. Any additional equity financing, if available, may not be available on favorable terms, would most likely be significantly dilutive to our current stockholders and debt financing, if available, and may involve restrictive covenants. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would likely materially harm our business and financial condition.
Previous wording
Cash used in operating activities was $3,716,123 for the nine months ended September 30, 2024, compared to $4,107,209 for the nine months ended September 30, 2023. The $391,086 decrease primarily resulted from the and increase in accounts payable and accrued expenses of approximately $0.4 million and the increase in offering costs of approximately $4.6 million, partially offset by the increased net loss of approximately $2.2 million, increase in prepaid expenses of approximately $0.2 million, the changes in fair value of non-cash warrant and derivative liabilities totaling approximately $1.0 million and the decrease in non-cash stock-based compensation and consulting fees of approximately $1.0 million.
Current wording
Cash used in operating activities was $2,000,596 for the three months ended March 31, 2025, compared to $1,831,541 for the three months ended March 31, 2024. The $169,055 increase primarily resulted from the increase in non-cash expenses and change in fair value of liabilities of approximately $0.3 million, the decrease in prepaid expenses of approximately $0.3 million and the decrease in accounts payable and accrued expenses of totaling approximately $0.2 million partially offset by the increase in net income of approximately $0.6 million.
Previous wording
Net cash used in investing activities was $1.0 million for the nine months ended September 30, 2024 compared to $2,707 for the nine months ended September 30, 2023. The cash used in investing activities for the nine months ended September 30, 2024 was for the purchase of available for sale debt securities versus capital expenditures for nine months ended September 30, 2023.
Current wording
Net cash used in investing activities was $0 for the three months ended March 31, 2025 compared to $500,000 for the three months ended March 31, 2024. The cash used in investing activities for the three months ended March 31, 2024 was for the purchase of available for sale debt securities.
Previous wording
Net cash used in financing activities was $4,319,595 for the nine months ended September 30, 2024 compared to $1,641,015 for the nine months ended September 30, 2023 which consists of redemptions of amounts due to preferred stock investors.
Current wording
Net cash used in financing activities was $822,362 for the three months ended March 31, 2025 compared to $0 for the three months ended March 31, 2024. The cash used in financing activities for the three months ended March 31, 2025 consisted of redemptions and dividends of amounts due to preferred stock investors.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Net Cash Used in Financing Activities
Rearranged previous paragraphs (10)
Previous report — wording carried elsewhere
The Series B Certificate of Designations included certain Triggering Events (as defined in the Series B Certificate of Designations), including, among other things, the failure to file and maintain an effective registration statement covering the sale of the holder’s securities registrable pursuant to the Series B Registration Rights Agreement (defined below) and our failure to pay any amounts due to the holders of the Series B Preferred Stock when due. In connection with a Triggering Event, each holder of Series B Preferred Stock will be able to require us to redeem in cash any or all of the holder’s Series B Preferred Stock at a premium set forth in the Series B Certificate of Designations.
Previous report — wording carried elsewhere
We are subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Series B Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters.
Previous report — wording carried elsewhere
In connection with the Series B Purchase Agreement, we and the Series B Investors entered into a Registration Rights Agreement (the “Series B Registration Rights Agreement”) on November 17, 2022. Under the terms of the Series B Registration Rights Agreement, we agreed to register 200% of the Series B Preferred Shares, the Series B Warrant Shares and the shares of Common Stock issuable as amortization payments as well as any shares of Common Stock paid as dividends. We filed a registration statement for the resale of such securities on December 16, 2022. We also agreed to other customary obligations regarding registration, including indemnification and maintenance of the effectiveness of the registration statement.
Previous report — wording carried elsewhere
In connection with the Series B Offering, pursuant to an Engagement Letter, between the Company and Katalyst Securities LLC (the “Series B Placement Agent”), we paid the Series B Placement Agent (i) a cash fee equal to 7% of the gross proceeds from any sale of securities in the Series B Offering and (ii) warrants to purchase shares of Common Stock equal to 3% of the number of shares of Common Stock that the Series B Preferred Shares are initially convertible into, with an exercise price of $2.8586 per share, pursuant to the above, and a five-year term.
Previous report — wording carried elsewhere
The Series C Warrants are exercisable immediately at the Series C Exercise Price and expire five years from the date of issuance. The Series C Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like,
Previous report — wording carried elsewhere
Our research and development expenses have increased slightly as we initiated our MS clinical trial while our current Phase 2 clinical trial for AD was concluded by the end of 2023 and our Phase 2 dose ranging study was discontinued. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1.
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
For the nine months ended September 30, 2024, we incurred $1,174,214 in research and development expenses as compared to $1,397,031 for the nine months ended September 30, 2023, a decrease of approximately 15.9%. These expenses were incurred primarily in connection with developing the potential AD therapeutic product and the initiation of the MS trial with Cleveland Clinic. Of these expenses, for the nine months ended September 30, 2024, $697,899 was incurred principally relating to our current MS clinical trial and our storage of drug product, $426,523 for clinical consulting services, $22,107 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $27,685 for development of alternative drug supply with Stanford University; comparatively, for the nine months ended September 30, 2023, $938,003 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $252,752 for clinical consulting services, $15,288 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $41,399 for development of alternative drug supply with Stanford University and $149,589 of non-cash stock options compensation expense.
Previous report — wording carried elsewhere
We incurred $3,457,916 and $4,784,415 of general and administrative expenses for the nine months ended September 30, 2024 and 2023, respectively, a decrease of approximately 27.7%. During the nine months ended September 30, 2024, $986,382 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $948,689 for the nine months ended September 30, 2023; $397,123 was incurred for legal expenses versus $673,882 for the 2023 comparable period. The higher legal fees for 2023 is based upon the prior year’s increased fees for special stockholder vote requirements and for regulatory compliance; $751,761 was incurred for outside operations consulting services during the nine months ended September 30, 2024, versus $720,159 for the comparable period in 2023; $83,412 was incurred for travel expenses during the nine months ended September 30, 2024, versus $122,196 for the comparable period in 2023 as Company officers and directors conducted overseas due diligence for strategic investments; $316,249 was incurred for investor relations services during the nine months ended September 30, 2024, versus $303,271 for the comparable period in 2023; $214,192 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the nine months ended September 30, 2024, versus $245,021 for the comparable period in 2023; $470,695 was incurred for insurance during the nine months ended September 30, 2024, versus $577,950 for the comparable period in 2023. The decrease is attributable to lower premiums; $216,433 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the nine months ended September 30, 2024, versus $348,575 for the comparable period in 2023. The decrease is attributable to credits for franchise taxes paid during the 2023 period credited to 2024; and $21,618 was recorded as non-cash stock options compensation expense during the nine months ended September 30, 2024, versus $844,672 for the comparable period in 2023, as options granted during the 2023 period partially vested upon issuance.
Previous report — wording carried elsewhere
We recognized total other loss of $2,589,891 for the nine months ended September 30, 2024 as compared to total other income of $1,138,911 for the nine months ended September 30, 2023, which consisted, for 2024 and 2023, of interest income on funds deposited in interest bearing money market accounts and investments in short-term US treasury bills and changes in fair value of warrant and derivative liabilities and offering costs. The decrease in interest income and unrealized gains on treasury bills totaling $278,927 for the nine months ended September 30, 2024 is primarily attributable to the decrease in cash balances over the period and lower interest rates. The total decreased income is primarily attributable to the increase in change in fair value of warrant liability of $314,000, loss on issuance of Series C Preferred Stock of approximately $3.8 million, warrant issuance costs of $618,375 and share of loss in equity investment of $30,475 partially offset by the change in fair value of deriviate liability of 1,091,000.