2 unchanged sentences
Balance Sheets
+Added: September 30,
Current Assets:
16 unchanged sentences
Preferred stock, $ 0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding
−Removed: Common stock, $ 0.001 par value, 300,000,000 shares authorized and 1,443,274 and
−Removed: 124,306 shares issued and outstanding, respectively
+Added: Common stock, $ 0.001 par value, 300,000,000 shares authorized and 33,446,403 and 124,306 shares issued and outstanding, respectively
Additional paid-in capital
4 unchanged sentences
( 4,432,115 )
−Removed: ( 4,432,115 )
Total Liabilities and Stockholders' Equity (Deficit)
−Removed: See accompanying notes to
−Removed: the unaudited financial statements.
+Added: See accompanying notes to the unaudited financial statements.
CNS Pharmaceuticals, Inc.
Statements of Operations
−Removed: June 30, 2024
−Removed: June 30, 2023
−Removed: June 30, 2024
−Removed: June 30, 2023
+Added: Three Months Ended
+Added: Three Months Ended
+Added: Nine Months Ended
+Added: Nine Months Ended
+Added: September 30, 2024
+Added: September 30, 2023
+Added: September 30, 2024
+Added: September 30, 2023
Operating expenses:
19 unchanged sentences
Weighted average shares outstanding - diluted
−Removed: See accompanying notes to the unaudited financial
+Added: See accompanying notes to the unaudited financial statements.
Pharmaceuticals, Inc.
1 unchanged sentence
Stockholders' Equity (Deficit)
−Removed: For the six months
−Removed: ended June 30, 2024 and 2023
+Added: For the nine months ended September 30, 2024 and 2023
Stockholders'
20 unchanged sentences
( 4,293,601 )
+Added: Common stock issued for cash and warrants, net
+Added: Stock-based compensation
+Added: Common stock issued for license agreement
+Added: ( 5,605,934 )
+Added: ( 5,605,934 )
+Added: Balance, September 30, 2024
+Added: $ ( 81,248,338 )
Balance December 31, 2022
13 unchanged sentences
( 59,668,858 )
+Added: Common stock issued for cash, net
+Added: Stock-based compensation
+Added: ( 4,522,795 )
+Added: ( 4,522,795 )
+Added: Balance, September 30, 2023
+Added: $ ( 64,191,653 )
+Added: $ ( 1,740,752 )
See accompanying notes to the unaudited financial statements.
1 unchanged sentence
Statements of Cash Flows
−Removed: Six Months Ended
−Removed: Six Months Ended
−Removed: June 30, 2024
−Removed: June 30, 2023
+Added: Nine Months Ended
+Added: Nine Months Ended
+Added: September 30, 2024
+Added: September 30, 2023
Cash Flows from Operating Activities:
3 unchanged sentences
Stock-based compensation
−Removed: Gain on disposal of fixed assets
+Added: Common stock issued for license agreement
+Added: (Gain) loss on disposal of fixed assets
Changes in operating assets and liabilities:
1 unchanged sentence
Accounts payable and accrued expenses
+Added: ( 1,806,420 )
Net cash used in operating activities
1 unchanged sentence
( 11,603,678 )
+Added: Cash Flows from Investing Activities:
+Added: Purchase of property and equipment
+Added: Net cash used in investing activities
Cash Flows from Financing Activities:
13 unchanged sentences
Reclassification of deferred offering costs to equity
−Removed: See accompanying notes to the unaudited financial
+Added: See accompanying notes to the unaudited financial statements.
CNS Pharmaceuticals, Inc.
20 unchanged sentences
Note 2 – Summary of Significant Accounting
−Removed: of Presentation - The accompanying unaudited financial statements of the Company have been prepared in accordance with
−Removed: accounting principles generally accepted in the United Stated of America (“U.S.
−Removed: GAAP”) for interim unaudited financial
−Removed: Accordingly, they do not include all of the information and footnotes required by generally accepted accounting
−Removed: principles for complete financial statements.
−Removed: The unaudited financial statements include all adjustments (consisting of normal
−Removed: recurring adjustments) which are, in the opinion of management, necessary in order to make the condensed financial statements not
−Removed: Operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the final results
−Removed: that may be expected for the year ending December 31, 2024.
−Removed: For more complete financial information, these unaudited financial
−Removed: statements should be read in conjunction with the audited financial statements for the period ended December 31, 2023 included in
−Removed: our Form 10-K filed with the SEC on April 1, 2024 (“Form 10-K”).
−Removed: Notes to the financial statements which would
−Removed: substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal period, as reported
−Removed: in the Form 10-K, have been omitted.
+Added: Basis of Presentation - The accompanying unaudited financial
+Added: statements of the Company have been prepared in accordance with accounting principles generally accepted in the United Stated of America
+Added: GAAP”) for interim unaudited financial information.
+Added: Accordingly, they do not include all of the information and footnotes
+Added: required by generally accepted accounting principles for complete financial statements.
+Added: The unaudited financial statements include all
+Added: adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary in order to make the condensed
+Added: financial statements not misleading.
+Added: Operating results for the three and nine months ended September 30, 2024 are not necessarily indicative
+Added: of the final results that may be expected for the year ending December 31, 2024.
+Added: For more complete financial information, these unaudited
+Added: financial statements should be read in conjunction with the audited financial statements for the period ended December 31, 2023 included
+Added: in our Form 10-K filed with the SEC on April 1, 2024 (“Form 10-K”).
+Added: Notes to the financial statements which would substantially
+Added: duplicate the disclosures contained in the audited financial statements for the most recent fiscal period, as reported in the Form 10-K,
+Added: have been omitted.
Liquidity and Going Concern - These financial statements have
19 unchanged sentences
The amount in excess of
−Removed: the FDIC insurance as of June 30, 2024 was $ 1,241,559 .
+Added: the FDIC insurance as of September 30, 2024 was $ 6,723,124 .
The Company has not experienced losses on these accounts and management believes,
based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
−Removed: Compensation - Employee and non-employee share-based compensation is measured at the grant date, based on the fair value
−Removed: of the award, and is recognized as an expense over the requisite service period for stock options and restricted stock units.
+Added: Stock-based Compensation - Employee and non-employee share-based
+Added: compensation is measured at the grant date, based on the fair value of the award, and is recognized as an expense over the requisite service
+Added: period for stock options and restricted stock units.
Restricted Stock Units (“RSUs”) - Our RSUs vest over
3 unchanged sentences
our performance against predefined share price targets and the achievement of Positive Interim, Clinical Data as defined by the Board.
−Removed: Loss Per Common Share - Basic loss per common share is computed
−Removed: by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period.
−Removed: loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the
−Removed: dilutive effect of common stock equivalents.
−Removed: In periods when losses are reported, the weighted-average number of common shares outstanding
−Removed: excludes common stock equivalents, because their inclusion would be anti-dilutive.
−Removed: As of June 30, 2024, the Company’s potentially
−Removed: dilutive shares and options, which were not included in the calculation of net loss per share, included warrants to purchase 1,551,422
−Removed: common shares, unvested restricted stock units of 5,475 common shares, unvested performance units of 577 and options for 12,177 common
−Removed: shares, respectively.
−Removed: As of June 30, 2023, the Company’s potentially dilutive shares and options, which were not included in the
−Removed: calculation of net loss per share, included warrants to purchase 45,399 common shares, unvested restricted stock units of 193 common shares,
−Removed: unvested performance units of 577 and options for 2,591 common shares, respectively.
+Added: Per Common Share - Basic loss per common share is computed by dividing net loss available to common shareholders by the
+Added: weighted-average number of common shares outstanding during the period.
+Added: Diluted loss per common share is determined using the
+Added: weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock
+Added: In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock
+Added: equivalents, because their inclusion would be anti-dilutive.
+Added: As of September 30, 2024, the Company’s potentially dilutive
+Added: shares and options, which were not included in the calculation of net loss per share, included warrants to purchase 2,976,422
+Added: common shares, unvested restricted stock units of 5,475
+Added: common shares, unvested performance units of 192
+Added: and options for 12,177
+Added: common shares, respectively.
+Added: As of September 30, 2023, the Company’s potentially dilutive shares and options, which were not
+Added: included in the calculation of net loss per share, included warrants to purchase 45,399
+Added: common shares, unvested restricted stock units of 193
+Added: common shares, unvested performance units of 577
+Added: and options for 6,598
+Added: common shares, respectively.
Note 3 – Note Payable
3 unchanged sentences
related to the note will be repaid over an 11-month period with the final payment due on October 8, 2024 .
−Removed: As of June 30, 2024 the Company’s
−Removed: note payable balance was $ 123,248 .
+Added: As of September 30, 2024 the
+Added: Company’s note payable balance was $ 31,187 .
Note 4 – Equity
34 unchanged sentences
with A.G.P./Alliance Global Partners (“AGP”) and Maxim Group LLC (“Maxim” and collectively with AGP, the “Placement
−Removed: Agents”) (the “Placement Agreement”) for the public offering by the Company of (i) 44,314
−Removed: shares (the “Shares”) of the Company’s common stock, par value $ 0.001
−Removed: per share (the “Common Stock”) (ii) pre-funded warrants to purchase 222,354
+Added: Agents”) (the “Placement Agreement”) for the public offering by the Company of (i) 44,314 shares (the “Shares”)
+Added: of the Company’s common stock, par value $0.001 per share (the “Common Stock”) (ii) pre-funded warrants to purchase
222,354 shares of Common Stock (the “Pre-Funded Warrants”);
3 unchanged sentences
shares of Common Stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants)).
−Removed: The Common Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”).
−Removed: The combined purchase
−Removed: price of one share of Common Stock and accompanying Common Warrants was $ 15.00
−Removed: and the combined purchase price of one Pre-Funded Warrant and accompanying Common Warrants was $ 14.95 .
−Removed: In connection with the offering, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with
−Removed: certain institutional investors that participated in the offering.
+Added: Common Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”).
+Added: The combined purchase price
+Added: of one share of Common Stock and accompanying Common Warrants was $15.00 and the combined purchase price of one Pre-Funded Warrant and
+Added: accompanying Common Warrants was $14.95.
+Added: In connection with the offering, the Company entered into a Securities Purchase Agreement (the
+Added: “Purchase Agreement”) with certain institutional investors that participated in the offering.
As of April 1, 2024, 44,094
1 unchanged sentence
The closing of the sales of these securities occurred on February 1, 2024.
−Removed: net proceeds to the Company from the offering were $ 3,331,000 ,
−Removed: after deducting the placement agents’ fees and other offering expenses.
+Added: The net proceeds
+Added: to the Company from the offering were $ 3,331,000 , after deducting the placement agents’ fees and other offering expenses.
On June 14, 2024, the Company entered into securities purchase agreements
−Removed: with institutional investors for the sale by the Company of 336,000
−Removed: shares of the Company’s common stock and pre-funded warrants to purchase 30,000
−Removed: shares of common stock in lieu thereof (the “June 14 Pre-Funded Warrants”) in a registered direct offering.
−Removed: In a concurrent
−Removed: private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 366,000
+Added: with institutional investors for the sale by the Company of 336,000 shares of the Company’s common stock and pre-funded warrants
+Added: to purchase 30,000 shares of common stock in lieu thereof (the “June 14 Pre-Funded Warrants”) in a registered direct offering.
+Added: In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 366,000
shares of common stock (the “June 14 Common Warrants”).
−Removed: The combined purchase price of one share of common stock (or
−Removed: pre-funded warrant in lieu thereof) and accompanying June 14 Common Warrant was $ 3.75 .
−Removed: The closing of this offering and private placement occurred on June 17, 2024.
+Added: The combined purchase price of one share of common stock (or pre-funded
+Added: warrant in lieu thereof) and accompanying June 14 Common Warrant was $3.75.
+Added: The closing of this offering and private placement occurred
+Added: on June 17, 2024.
Subject to certain ownership limitations, each of the June 14 Common
Warrants is immediately exercisable, has an exercise price of $3.62 per share, and expire five years from the date of issuance.
−Removed: Subject to certain ownership limitations, each June 14 Pre-Funded
−Removed: Warrant is exercisable into one share of common stock at a price per share of $ 0.001
−Removed: (as adjusted from time to time in accordance with the terms thereof).
−Removed: The gross proceeds to the Company from the offering was
−Removed: approximately $ 1.37
−Removed: million, resulting in net proceeds, after payment of commissions and expenses, received by the Company of $ 1,203,259 .
+Added: Subject to certain ownership limitations, each June 14 Pre-Funded Warrant
+Added: is exercisable into one share of common stock at a price per share of $0.001 (as adjusted from time to time in accordance with the terms
+Added: The gross proceeds to the Company from the offering was approximately $ 1.37 million , resulting in net proceeds, after payment
+Added: of commissions and expenses, received by the Company of $ 1,203,259 .
On June 26, 2024, the Company entered into securities purchase agreements
12 unchanged sentences
by the Company of $ 1,221,154 .
+Added: On July 3, 2024, the Company entered into securities purchase agreements
+Added: with institutional investors for the sale by the Company of 1,425,000 shares of the Company’s common stock in a registered direct
+Added: In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate
+Added: of 1,425,000 shares of common stock (the “July 3 Common Warrants”).
+Added: The combined purchase price of one share of common stock
+Added: and accompanying July 3 Common Warrant is $1.39.
+Added: The closing of this offering and private placement occurred on July 5, 2024.
+Added: Subject to certain ownership limitations, each of the July 3 Common
+Added: Warrants is immediately exercisable, has an exercise price of $1.26 per share, and expire five years from the date of issuance.
+Added: proceeds to the Company from the offering were approximately $ 1.98 million , before deducting the financial advisor fees and other estimated
+Added: offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Warrants.
+Added: On July 26, 2024, the Company entered into a Sales Agreement (the “AGP
+Added: ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”).
+Added: Pursuant to the terms of the AGP ATM Sales Agreement,
+Added: the Company originally was permitted to sell from time to time through AGP, as sales agent or principal, shares of the Company’s
+Added: common stock, par value $0.001 per share with initial aggregate sales price of up to $5.2 million.
+Added: On July 30, 2024, the Company increased
+Added: the aggregate sales price of common shares that may be sold under the AGP ATM Sales Agreement to $25.0 million (not including the original
+Added: $5.2 million).
+Added: As of September 30, 2024, the Company has sold 30,004,761 Shares pursuant to the Agreement for net proceeds of approximately
+Added: $ 10.6 million .
+Added: Common share issued for license agreement
+Added: On July 29, 2024, the Company entered into an Exclusive License Agreement
+Added: and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice Biosciences, Inc.
+Added: pursuant to which Cortice granted the Company an exclusive license to the intellectual property rights related to certain patents around
+Added: the compound TPI 287 in the United States, Canada, Mexico and Japan.
+Added: The term of the license will expire, other than due to a breach of
+Added: the Cortice Agreements, at the end of the royalty term with respect to any licensed product in any of the included territories, which
+Added: begins upon the first commercial sale in such territory and ends on the latest of (i) ten years after such sale, (ii) the expiration of
+Added: regulatory or marketing exclusivity for such licensed product in such country, or (c) the expiration of the last to expire valid patent
+Added: claim in such country covering such licensed product.
+Added: Pursuant to the Cortice Agreements, the Company agreed to issue
+Added: Cortice 573,368
+Added: shares of the Company’s common stock upon the closing of the transaction, which occurred on July 29, 2024, and 43,330
+Added: shares of Company common stock upon the receipt of shareholder approval of such issuance as required by the rules of the Nasdaq
+Added: Stock Market.
+Added: The Company also agreed to make milestone payments to Cortice in either cash or shares of Company common stock (at
+Added: Cortice’s option) upon:
+Added: (i) meeting the primary endpoint a pivotal trial for a licensed product – either $15.0 million
+Added: or 411,132 shares of Company common stock;
+Added: (ii) FDA acceptance of an New Drug Application for a licensed product – either
+Added: $30.0 million or 822,264 shares of Company common stock;
+Added: (iii) the first commercial sale in the United States of a licensed product
+Added: – either $45.0 million or 1,233,395 shares of Company common stock;
+Added: and (iv) the first commercial sale in Japan of a licensed
+Added: product – either $10.0 million or 205,566 shares of Company common stock.
+Added: The Company’s obligation to pay the above
+Added: milestones in Company common stock is subject to the receipt of shareholder approval as required by the rules of the Nasdaq Stock
+Added: The Company also agreed to pay Cortice royalties on sales of licensed products of between 3.0%-7.5%.
+Added: Finally, to the extent
+Added: Cortice is required to pay any milestone payments to the original holder of the intellectual property rights licensed, the Company
+Added: has agreed to make such payments to Cortice.
+Added: As of September 30, 2024, there were no accruals related to the milestone payments and
+Added: the Company issued 573,368
+Added: Shares with a fair value of $ 596,302
+Added: pursuant to the Cortice Agreement.
Stock Options
21 unchanged sentences
Of the 5,330 options
−Removed: issued, 1,750 options vest on the first anniversary or at the time of the 2025 shareholder meeting, whichever occurs first and 3,580 options
−Removed: vest in 36 equal monthly installments over 3 years .
+Added: issued, 1,750 options vest on the first anniversary or at the time of the 2025 shareholder meeting, whichever occurs first and 3,580 options vest in 36 equal monthly installments over 3 years.
The total fair value of these option grants at issuance was $ 58,335 .
−Removed: During the six months ended June 30, 2024 and 2023, the Company
−Removed: recognized $ 412,749 and $ 544,248 of stock-based compensation, respectively, related to outstanding stock options.
−Removed: At June 30, 2024, the
−Removed: Company had $ 366,400 of unrecognized expenses related to outstanding options.
+Added: During the nine months ended September 30, 2024 and 2023, the
+Added: Company recognized $ 571,705
+Added: and $ 727,864
+Added: of stock-based compensation, respectively, related to outstanding stock options.
+Added: At September 30, 2024, the Company had $ 207,444
+Added: of unrecognized expenses related to outstanding options.
The following table summarizes
−Removed: the stock option activity for the six months ended June 30, 2024:
+Added: the stock option activity for the nine months ended September 30, 2024:
Schedule of stock option activity
1 unchanged sentence
Outstanding, December 31, 2023
−Removed: Outstanding, June 30, 2024
−Removed: Exercisable, June 30, 2024
−Removed: The aggregate fair value of the options measured during the six months
−Removed: ended June 30, 2024 were calculated using the Black-Scholes option pricing model based on the following assumptions:
−Removed: Schedule of assumptions
−Removed: Six Months Ended
−Removed: June 30, 2024
+Added: Outstanding, September 30, 2024
+Added: Exercisable, September 30, 2024
+Added: The aggregate fair value of the options measured during the nine months
+Added: ended September 30, 2024 were calculated using the Black-Scholes option pricing model based on the following assumptions:
+Added: Schedule of black-ccholes option assumptions
+Added: Nine Months Ended
+Added: September 30, 2024
Fair value of common stock on measurement date
10 unchanged sentences
The Company does not expect to pay a dividend in the foreseeable future.
−Removed: As of June 30, 2024, the outstanding stock options have a weighted
+Added: As of September 30, 2024, the outstanding stock options have a weighted
average remaining term of 8.58 years and no aggregate intrinsic value.
−Removed: As of June 30, 2024, there were no awards remaining to be issued
−Removed: under the 2017 Plan and 69,973 awards remaining to be issued under the 2020 Plan.
+Added: As of September 30, 2024, there were no awards remaining to be
+Added: issued under the 2017 Plan and 69,973 awards remaining to be issued under the 2020 Plan.
Stock Warrants
4 unchanged sentences
per share and a new termination date of February 1, 2029.
−Removed: During the six months ended June 30, 2024, the Company received $ 21,326
+Added: During the nine months ended September 30, 2024, the Company received
$ 21,326 in cash proceeds from the exercise of 253,034 warrants previously issued at an exercise price range of $0.001 to $15.00.
The following table summarizes the stock warrant
−Removed: activity for the six months ended June 30, 2024:
+Added: activity for the nine months ended September 30, 2024:
Schedule of stock warrant
1 unchanged sentence
Outstanding, December 31, 2023
−Removed: Outstanding, June 30, 2024
−Removed: Exercisable, June 30, 2024
−Removed: As of June 30, 2024, the outstanding and exercisable warrants have
−Removed: a weighted average remaining term of 4.22 years and had no aggregate intrinsic value.
+Added: Outstanding, September 30, 2024
+Added: Exercisable, September 30, 2024
+Added: As of September 30, 2024, the outstanding and exercisable
+Added: warrants have a weighted average remaining term of 4.35
+Added: years and had no aggregate intrinsic value.
Restricted Stock Units
9 unchanged sentences
the RSUs based on the stock price at grant which total $ 69,027 .
−Removed: During the six months ended June 30, 2024,
+Added: During the nine months ended September 30,
2024, the Company recognized $ 36,990 of stock-based compensation, related to outstanding stock RSUs.
−Removed: At June 30, 2024, the Company had $ 103,123
−Removed: of unrecognized expenses related to outstanding RSUs.
+Added: At September 30, 2024, the Company
+Added: had $ 85,699 of unrecognized expenses related to outstanding RSUs.
The following table summarizes
−Removed: the RSUs activity for the six months ended June 30, 2024:
+Added: the RSUs activity for the nine months ended September 30, 2024:
Schedule of RSUs activity
1 unchanged sentence
Non-vested, December 31, 2023
−Removed: Non-vested, June 30, 2024
+Added: Non-vested, September 30, 2024
Performance Units
18 unchanged sentences
price $501, hurdle prices ranging from $3,000 -$6,000, expected terms ranging from 2-3 years, cost of equity 18.7% and risk-free rate
−Removed: During the six months ended June 30, 2024,
+Added: During the nine months ended September 30,
2024, the Company recognized $ 100,362 related to outstanding stock PUs.
−Removed: At June 30, 2024, the Company had $ 95,399 of unrecognized expenses
−Removed: related to PUs.
+Added: At September 30, 2024, the Company had $ 0 of unrecognized
+Added: expenses related to PUs.
The following table summarizes
−Removed: the PUs activity for the six months ended June 30, 2024:
+Added: the PUs activity for the nine months ended September 30, 2024:
Schedule of PUs activity
1 unchanged sentence
Non-vested, December 31, 2023
−Removed: Non-vested, June 30, 2024
+Added: Non-vested, September 30, 2024
Note 5 – Commitments and Contingencies
43 unchanged sentences
the cash compensation program for the Scientific Advisory Board.
−Removed: As of June 30, 2024, the Company has accrued $ 177,309 related to
+Added: As of September 30, 2024, the Company has accrued $ 177,309 related
Hsu’s Scientific Advisory Board compensation.
25 unchanged sentences
of the intellectual property discussed in the HPI agreement.
−Removed: During the six months ended June 30, 2024 and 2023, the Company recognized
+Added: During the nine months ended September 30, 2024 and 2023, the Company recognized
$ 37,500 and $ 37,500 related to this agreement.
Unrelated to this agreement, from time to time, the Company purchases pharmaceutical products
−Removed: from HPI which are necessary for the manufacturing of Berubicin API and drug product in related party transactions which are reviewed
+Added: from HPI which are necessary for the manufacturing of Berubicin API and drug product which are reviewed
and approved by the Company’s audit committee based upon the standards of providing superior pricing and time to delivery than that
25 unchanged sentences
On August 31, 2018, the Company entered into a sublicense agreement
−Removed: with Animal Life Sciences, LLC (“ALI”), a related party, pursuant to which we granted ALI an exclusive sublicense, even as
+Added: with Animal Life Sciences, LLC (“ALI”), pursuant to which we granted ALI an exclusive sublicense, even as
to us, for the patent rights we licensed pursuant to the HPI License solely for the treatment of cancer in non-human animals through any
5 unchanged sentences
such payments, and to pay us a royalty equal to 1% of such payments.
−Removed: Waldemar Priebe, our founder, is also the founder and a shareholder
+Added: Waldemar Priebe, our founder, is also the founder of ALI.
On June 10, 2020, the FDA granted Orphan Drug Designation (“ODD”)
17 unchanged sentences
WP1244 Portfolio
−Removed: On January 10, 2020, Company entered into a Patent
−Removed: and Technology License Agreement (the “WP1244 Agreement”) with The Board of Regents of The University of Texas System, an
−Removed: agency of the State of Texas, on behalf of The University of Texas M.
+Added: On January 10, 2020, Company entered into a Patent and Technology License
+Added: Agreement (the “WP1244 Agreement”) with The Board of Regents of The University of Texas System, an agency of the State of
+Added: Texas, on behalf of The University of Texas M.
Anderson Cancer Center (“UTMDACC”).
−Removed: Pursuant to the
−Removed: WP1244 Agreement, the Company obtained a royalty-bearing, worldwide, exclusive license to certain intellectual property rights, including
−Removed: patent rights, related to the Company’s recently announced WP1244 drug technology.
−Removed: In consideration, the Company must make payments
−Removed: to UTMDACC including an up-front license fee, annual maintenance fee, milestone payments and royalty payments (including minimum annual
−Removed: royalties) on sales of licensed products developed under the WP1244 Agreement.
−Removed: The term of the WP1244 Agreement expires on the last to
−Removed: (a) the expiration of all patents subject to the WP1244 Agreement, or (b) fifteen years after execution;
−Removed: provided that UTMDACC
−Removed: has the right to terminate this WP1244 Agreement in the event that the Company fails to meet certain commercial diligence milestones.
−Removed: The commercial diligence milestones are as follows (i) initiated PC toxicology to support filing of Investigational New Drug Application
−Removed: (“IND”) or New Drug Application (“NDA”) for the Licensed Product within the eighteen (18) month period following
−Removed: the Effective Date (ii) file and IND for the Licensed Product within three (3) year period following the Effective Date and (iii) Commencement
−Removed: of Phase I Study within the five (5) year period following the Effective Date.
−Removed: The Company has not met the commercial diligence milestones
−Removed: and has not paid the annual maintenance fee required as of the date hereof.
−Removed: On April 25, 2024, UTMDACC provided notice to the Company
−Removed: of its intent to terminate the WP1244 Agreement if the Company fails to pay the annual maintenance fee of $50,000, as well as $1,300 in
−Removed: On May 25, 2024 the WP1244 Agreement was terminated.
+Added: Pursuant to the WP1244 Agreement, the
+Added: Company obtained a royalty-bearing, worldwide, exclusive license to certain intellectual property rights, including patent rights, related
+Added: to the Company’s recently announced WP1244 drug technology.
+Added: In consideration, the Company must make payments to UTMDACC including
+Added: an up-front license fee, annual maintenance fee, milestone payments and royalty payments (including minimum annual royalties) on sales
+Added: of licensed products developed under the WP1244 Agreement.
+Added: The term of the WP1244 Agreement expires on the last to occur of:
+Added: (a) the expiration
+Added: of all patents subject to the WP1244 Agreement, or (b) fifteen years after execution;
+Added: provided that UTMDACC has the right to terminate
+Added: this WP1244 Agreement in the event that the Company fails to meet certain commercial diligence milestones.
+Added: The commercial diligence milestones
+Added: are as follows (i) initiated PC toxicology to support filing of Investigational New Drug Application (“IND”) or New Drug Application
+Added: (“NDA”) for the Licensed Product within the eighteen (18) month period following the Effective Date (ii) file and IND for
+Added: the Licensed Product within three (3) year period following the Effective Date and (iii) Commencement of Phase I Study within the five
+Added: (5) year period following the Effective Date.
+Added: The Company has not met the commercial diligence milestones and has not paid the annual
+Added: maintenance fee required as of the date hereof.
+Added: On April 25, 2024, UTMDACC provided notice to the Company of its intent to terminate the
+Added: WP1244 Agreement if the Company fails to pay the annual maintenance fee of $50,000, as well as $1,300 in expenses.
+Added: On May 25, 2024 the
+Added: WP1244 Agreement was terminated.
There are no termination penalty provisions in the Agreement.
−Removed: six months ended June 30, 2024 and 2023, the Company paid $ 1,994 and $ 27,341 , respectively.
+Added: During the nine months ended September
+Added: 30, 2024 and 2023, the Company paid $52,537 and $45,092, respectively.
Nasdaq Capital Markets Listing Qualifications
−Removed: On August 17, 2023, the Company was notified by the Listing Qualifications
−Removed: Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) that the Company was not in compliance with the
−Removed: minimum $ 2,500,000 stockholders’ equity requirement for continued listing set forth in Listing Rule 5550(b).
−Removed: On February 27, 2024,
−Removed: the Staff notified the Company that it did not comply with the $1.00 minimum bid price requirement set forth under Listing Rule 5550(a)(2).
−Removed: On February 14, 2024, the Company was notified that because it had not regained compliance with the Nasdaq equity requirement, its securities
−Removed: would be delisted unless it requested a hearing.
−Removed: On February 21, 2024, the Company requested a hearing, which was held on April 18, 2024.
−Removed: On May 6, 2024, the Company received notification from the Nasdaq Hearings
−Removed: Panel (“Panel”) that it had granted an extension until July 15, 2024, which was extended until August 12, 2024 to demonstrate
−Removed: compliance with Listing Rules 5550(a)(2) and 5550(b).
−Removed: On July 5, 2024, the Company received a letter from the Nasdaq Staff
−Removed: notifying the Company that it had regained compliance with Bid Price Rule as a result of the closing bid price of the Company’s
−Removed: common stock being at $ 1.00 per share or greater for the 20 consecutive business days from June 5, 2024, through July 3, 2024.
−Removed: the Company is in compliance with the Bid Price Rule.
−Removed: On August 7, 2024, the Company filed Form 8-K with the SEC indicating
−Removed: that as of that date, the Company’s shareholders’ equity was above the $ 2.5 million continued listing equity requirement as
−Removed: set forth in Listing Rule 5550(b)(1).
+Added: On September 12, 2024, the Company received a letter from the Staff
+Added: of Nasdaq notifying the Company that for the previous 30 consecutive business days the Company’s common stock had not maintained
+Added: a closing bid price of $1.00 per share (the “Minimum Bid Price Requirement”) required for continued listing on The Nasdaq
+Added: Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2).
+Added: Normally, a company would be afforded a 180-calendar day period to demonstrate
+Added: compliance with the Minimum Bid Price Requirement.
+Added: However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible
+Added: for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected one or more reverse stock splits over the prior
+Added: two-year period with a cumulative ratio of 250 shares or more to one.
+Added: The Company requested a hearing before a Hearings Panel (the “Panel”),
+Added: but prior to such hearing, on October 30, 2024 the Panel provided the Company a temporary exception to regain compliance with the Minimum
+Added: Bid Price Requirement until March 11, 2025.
+Added: The Panel noted that it reserves the right to reconsider the terms of this exception based
+Added: on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the
+Added: Company’s securities on Nasdaq inadvisable or unwarranted.
+Added: The Panel notification advised the Company that the Nasdaq Listing and
+Added: Hearing Review Council may, on its own motion, determine to review any Panel decision within 45 calendar days after issuance of the written
+Added: If the Listing Council determines to review the Panel’s decision in the Company’s matter, it may affirm, modify,
+Added: reverse, dismiss or remand the decision to the Panel.
Note 6 – Subsequent Events
−Removed: On July 3, 2024, the Company entered into securities purchase agreements
−Removed: with institutional investors for the sale by the Company of 1,425,000 shares of the Company’s common stock in a registered direct
−Removed: In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate
−Removed: of 1,425,000 shares of common stock (the “July 3 Common Warrants”).
−Removed: The combined purchase price of one share of common stock
−Removed: and accompanying July 3 Common Warrant is $1.39.
−Removed: The closing of this offering and private placement occurred on July 5, 2024.
−Removed: Subject to certain ownership limitations, each of the July 3 Common
−Removed: Warrants is immediately exercisable, has an exercise price of $1.26 per share, and expire five years from the date of issuance.
−Removed: proceeds to the Company from the offering were approximately $1.98 million, before deducting the financial advisor fees and other estimated
−Removed: offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Warrants.
−Removed: 2024, the Company entered into a Sales Agreement (the “AGP ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”).
−Removed: Pursuant to the terms of the AGP ATM Sales Agreement, the Company originally was permitted to sell from time to time through AGP, as
−Removed: sales agent or principal, shares of the Company’s common stock, par value $0.001 per share with initial aggregate sales price of
−Removed: up to $5.2 million.
−Removed: On July 30, 2024, the Company increased the aggregate sales price of common shares that may be sold under the AGP
−Removed: ATM Sales Agreement to $25.0 million (not including the original $5.2 million).
−Removed: As of August 14, 2024, the Company has sold 28,704,761 Shares
−Removed: pursuant to the Agreement for net proceeds of approximately $10.5 million.
−Removed: On July 29, 2024, the Company entered into an Exclusive License Agreement
−Removed: and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice Biosciences, Inc.
−Removed: pursuant to which Cortice granted the Company an exclusive license to the intellectual property rights related to certain patents around
−Removed: the compound TPI 287 in the United States, Canada, Mexico and Japan.
−Removed: The term of the license will expire, other than due to a breach of
−Removed: the Cortice Agreements, at the end of the royalty term with respect to any licensed product in any of the included territories, which
−Removed: begins upon the first commercial sale in such territory and ends on the latest of (i) ten years after such sale, (ii) the expiration of
−Removed: regulatory or marketing exclusivity for such licensed product in such country, or (c) the expiration of the last to expire valid patent
−Removed: claim in such country covering such licensed product.
−Removed: Pursuant to the Cortice Agreements, the Company agreed to issue Cortice
−Removed: 573,368 shares of the Company’s common stock upon the closing of the transaction, which occurred on July 29, 2024, and 43,330 shares
−Removed: of Company common stock upon the receipt of shareholder approval of such issuance as required by the rules of the Nasdaq Stock Market.
−Removed: The Company also agreed to make milestone payments to Cortice in either cash or shares of Company common stock (at Cortice’s option)
−Removed: (i) meeting the primary endpoint a pivotal trial for a licensed product – either $15.0 million or 411,132 shares of Company
−Removed: common stock;
−Removed: (ii) FDA acceptance of an New Drug Application for a licensed product – either $30.0 million or 822,264 shares of
−Removed: Company common stock;
−Removed: (iii) the first commercial sale in the United States of a licensed product – either $45.0 million or 1,233,395
−Removed: shares of Company common stock;
−Removed: and (iv) the first commercial sale in Japan of a licensed product – either $10.0 million or 205,566
−Removed: shares of Company common stock.
−Removed: The Company’s obligation to pay the above milestones in Company common stock is subject to the receipt
−Removed: of shareholder approval as required by the rules of the Nasdaq Stock Market.
−Removed: The Company also agreed to pay Cortice royalties on sales
−Removed: of licensed products of between 3.0%-7.5%.
−Removed: Finally, to the extent Cortice is required to pay any milestone payments to the original holder
−Removed: of the intellectual property rights licensed, the Company has agreed to make such payments to Cortice.
+Added: On October 23, 2024, the Company entered into a placement agency agreement
+Added: (the “Placement Agency Agreement”) with A.G.P./Alliance Global Partners (the “Placement Agent”) in connection
+Added: with the sale by the Company of:
+Added: (i) 3,700,000 shares (the “Shares”) of the Company’s common stock, and (ii) pre-funded
+Added: warrants to purchase 13,947,060 shares of common stock (the “Pre-Funded Warrants”), in a registered direct offering (the “Offering”).
+Added: The per share purchase price of each share of common stock was $0.17 per share and the purchase price for each Pre-Funded Warrant was
+Added: $0.169 per Pre-Funded Warrant.
+Added: In connection with the Offering, the Company entered into a Securities Purchase Agreement with certain institutional
+Added: investors that participated in the Offering.
+Added: The gross proceeds to the Company from the Offering were approximately $3.0 million, before
+Added: deducting the Placement Agent fees and other estimated offering expenses payable by the Company.
+Added: Pursuant to the terms of the AGP ATM Sales Agreement, the Company originally
+Added: was permitted to sell from time to time through AGP, as sales agent or principal, shares of the Company’s common stock, par value
+Added: $0.001 per share with initial aggregate sales price of up to $5.2 million.
+Added: Subsequent to September 30, 2024, the Company has sold 6,393,243
+Added: Shares pursuant to the Agreement for net proceeds of approximately $1.6 million.
+Added: Subsequent to September 30, 2024, a total of 13,947,060 Warrants (exercisable
+Added: into one share of common stock at a price per share of $0.001) were exercised by investors.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.