2 unchanged sentences
Balance Sheets
−Removed: September 30,
Current Assets:
3 unchanged sentences
Noncurrent Assets:
+Added: Prepaid expenses, net of current portion
Property and equipment, net
11 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, 75,000,000 shares authorized and 27,460,735 and
−Removed: 23,856,151 shares issued and outstanding, respectively
+Added: Common stock, $ 0.001 par value, 75,000,000 shares authorized and 40,032,481
+Added: and 27,927,217 shares issued and outstanding, respectively
Additional paid-in capital
4 unchanged sentences
Total Liabilities and Stockholders' Equity
−Removed: See accompanying notes to the unaudited financial statements.
+Added: See accompanying notes to the unaudited financial
CNS Pharmaceuticals, Inc.
Statements of Operations
−Removed: September 30,
−Removed: September 30,
−Removed: September 30,
−Removed: September 30,
+Added: Three Months Ended March 31, 2022
+Added: Three Months Ended March 31, 2021
Operating expenses:
5 unchanged sentences
( 3,609,657 )
−Removed: ( 11,234,378 )
−Removed: ( 6,452,966 )
Other expenses:
3 unchanged sentences
$ ( 3,613,404 )
−Removed: $ ( 11,241,425 )
−Removed: $ ( 6,452,966 )
Loss per share - basic and diluted
Weighted average shares outstanding - basic and diluted
−Removed: See accompanying notes to the unaudited financial statements.
−Removed: Pharmaceuticals, Inc.
−Removed: Statements of
−Removed: Stockholders' Equity
−Removed: For the three and nine months ended September 30, 2021 and 2020
+Added: See accompanying notes to the unaudited financial
+Added: CNS Pharmaceuticals, Inc.
+Added: Statements of Stockholders’
+Added: For the three months ended March 31, 2022 and
Stockholders'
8 unchanged sentences
$ ( 37,767,260 )
−Removed: Common stock issued for cash and subscription receivable, net
−Removed: Stock-based compensation
−Removed: ( 3,813,673 )
−Removed: ( 3,813,673 )
−Removed: Balance June 30, 2021
−Removed: ( 28,373,420 )
−Removed: Stock-based compensation
−Removed: ( 3,814,348 )
−Removed: ( 3,814,348 )
−Removed: Balance September 30, 2021
−Removed: $ ( 32,187,768 )
Balance December 31, 2020
$ ( 20,946,343 )
+Added: Common stock issued for cash, net
+Added: Exercise of warrants
Stock-based compensation
3 unchanged sentences
$ ( 24,559,747 )
−Removed: Stock-based compensation
−Removed: ( 2,473,771 )
−Removed: ( 2,473,771 )
−Removed: Balance June 30, 2020
−Removed: ( 15,930,374 )
−Removed: Common stock issued for deferred offering costs
−Removed: Stock-based compensation
−Removed: ( 2,011,064 )
−Removed: ( 2,011,064 )
−Removed: Balance September 30, 2020
−Removed: $ ( 17,941,438 )
−Removed: See accompanying notes to the unaudited
−Removed: financial statements.
+Added: See accompanying notes to the unaudited financial
CNS Pharmaceuticals, Inc.
Statements of Cash Flows
−Removed: Nine Months Ended September 30, 2021
−Removed: Nine Months Ended September 30, 2020
+Added: Three Months Ended March 31, 2022
+Added: Three Months Ended March 31, 2021
Cash Flows from Operating Activities:
4 unchanged sentences
Changes in operating assets and liabilities:
+Added: Related party receivable
Prepaid expenses
−Removed: ( 1,373,257 )
Accounts payable
−Removed: Accounts payable and accrued expenses - related party
+Added: ( 1,033,107 )
Accrued expenses
6 unchanged sentences
Cash Flows from Financing Activities:
−Removed: Payment of deferred offering cost
Payments on notes payable
Proceeds from exercise of warrants
−Removed: Proceeds from sale of common stock, net
−Removed: Net cash provided by (used in) financing activities
+Added: Proceeds from sale of common stock
+Added: Net cash provided by financing activities
Net change in cash and cash equivalents
( 2,964,293 )
−Removed: ( 5,934,190 )
Cash and cash equivalents, at beginning of period
5 unchanged sentences
Cashless exercise of warrants
−Removed: Common stock issued for deferred offering costs
−Removed: See accompanying notes to the unaudited financial statements.
+Added: See accompanying notes to the unaudited financial
CNS Pharmaceuticals, Inc.
5 unchanged sentences
of anti-cancer drug candidates.
−Removed: Note 2 – Summary of Significant Accounting Policies
+Added: Note 2 – Summary of Significant Accounting
Basis of Presentation - The accompanying unaudited financial
6 unchanged sentences
financial statements not misleading.
−Removed: Operating results for the nine months ended September 30, 2021 are not necessarily indicative of
−Removed: the final results that may be expected for the year ending December 31, 2021.
−Removed: For more complete financial information, these unaudited
−Removed: financial statements should be read in conjunction with the audited financial statements for the period ended December 31, 2020 included
−Removed: in our Form 10-K filed with the SEC on February 12, 2021 (“Form 10-K”).
−Removed: Notes to the financial statements which would substantially
−Removed: duplicate the disclosures contained in the audited financial statements for the most recent fiscal period, as reported in the Form 10-K,
−Removed: have been omitted.
+Added: Operating results for the three months ended March 31, 2022 are not necessarily indicative of the
+Added: final results that may be expected for the year ending December 31, 2022.
+Added: For more complete financial information, these unaudited financial
+Added: statements should be read in conjunction with the audited financial statements for the period ended December 31, 2021 included in our
+Added: Form 10-K filed with the SEC on March 3, 2022 (“Form 10-K”).
+Added: Notes to the financial statements which would substantially duplicate
+Added: the disclosures contained in the audited financial statements for the most recent fiscal period, as reported in the Form 10-K, have been
Liquidity and Going Concern - These financial statements have
19 unchanged sentences
The amount in excess
−Removed: of the FDIC insurance as of September 30, 2021 was $ 8,076,223 .
−Removed: The Company has not experienced losses on these accounts and management
−Removed: believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
+Added: of the FDIC insurance as of March 31, 2022 was $ 12,190,498 .
+Added: The Company has not experienced losses on these accounts and management believes,
+Added: based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
Loss Per Common Share - Basic loss per common share is computed
4 unchanged sentences
excludes common stock equivalents, because their inclusion would be anti-dilutive.
−Removed: For the nine months ended September 30, 2021, the Company’s
−Removed: potentially dilutive shares and options, which were not included in the calculation of net loss per share, included warrants to purchase
−Removed: 5,130,240 common shares, and options for 2,939,736 common shares.
−Removed: For the nine months ended September 30, 2020, the Company’s potentially
−Removed: dilutive shares and options, which were not included in the calculation of net loss per share warrants to purchase 3,986,630 common shares,
−Removed: and options for 2,220,736 common shares.
+Added: For the three months ended March 31, 2022 and 2021,
+Added: the Company’s potentially dilutive shares and options, which were not included in the calculation of net loss per share, included
+Added: warrants to purchase 16,925,504 and 5,130,240 common shares, and options for 2,864,736 and 2,736,736 common shares, respectively.
+Added: Note 3 – Note Payable
+Added: 8, 2021, the Company entered into a short-term note payable for an aggregate of $ 425,990 , bearing interest at 3.3 % per year to finance
+Added: certain insurance policies.
+Added: Principal and interest payments related to the note will be repaid over a 11-month period with the final
+Added: payment due on September 30, 2022 .
+Added: As of March 31, 2022 and December 31, 2021, the Company’s note payable balance was $ 272,572
+Added: and $ 387,794 , respectively.
Note 4 – Equity
−Removed: In January 2021, the Company entered into a twelve-month agreement with
−Removed: an investor relations firm that includes the issuance of 25,000 restricted shares of common stock.
−Removed: Upon signing the agreement, 6,250 shares
−Removed: vested immediately, and the remaining 18,750 shares will vest quarterly over the remainder of the agreement.
−Removed: The Company may terminate
−Removed: the agreement at any time during the twelve-month period with a fifteen-day notice.
−Removed: During the nine months ended September 30, 2021,
−Removed: the Company issued 18,750 common shares and recognized $ 37,875 of stock-based compensation related to the agreement and will issue the
−Removed: remaining shares over the service period.
−Removed: During the nine months ended September 30, 2021, the Company issued
−Removed: 75,000 shares of common stock and recognized $ 140,250 of expense for investor relations services for a four month period ending September
−Removed: On February 12, 2021, the Company entered into a Capital on Demand™
−Removed: Sales Agreement (the “Agreement”) with JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of
−Removed: Arcadia Securities, LLC (collectively, the “Agent”).
−Removed: Pursuant to the terms of the Agreement, the Company may sell from time
−Removed: to time, through the Agent, shares of the Company’s common stock with an aggregate sales price of up to $20.0 million.
−Removed: During the nine months ended September 30, 2021, the Company sold 2,063,059
−Removed: shares of common stock to the Agent for net proceeds of $ 4,653,821 .
+Added: Company engaged H.C.
+Added: Wainwright & Co., LLC (“Wainwright”), to act as placement agent related to the Securities
+Added: Purchase Agreement described below.
+Added: The Company agreed to pay Wainwright an aggregate fee equal to 7.0% of the gross proceeds
+Added: received by the Company from the sale of the securities in the transaction.
+Added: The Company will also issue to Wainwright or its
+Added: designees warrants to purchase up to 5.0% of the aggregate number of shares of Common Stock sold in the transactions (the
+Added: “Placement Agent Warrants”), or 605,263
+Added: Placement Agent Warrants.
+Added: The Placement Agent Warrants have substantially the same terms as the Common Warrants, except that the
+Added: Placement Agent Warrants have an exercise price equal to 125% of the offering price, or $1.1875 per share.
+Added: The Company also paid
+Added: Wainwright $ 50,000 for non-accountable
+Added: expenses and $ 10,000 for
+Added: legal fees and expenses.
+Added: On January 5, 2022, the Company entered
+Added: into a Securities Purchase Agreement (the “Purchase Agreement”) with several institutional investors for the sale by the
+Added: Company of (i) 9,489,474 shares (the “Shares”) of the Company’s common stock, (ii) pre-funded warrants (the
+Added: “Pre-Funded Warrants”) to purchase up to an aggregate of 2,615,790 shares of common stock and (iii) warrants to
+Added: purchase up to an aggregate of 12,105,264 shares of common stock (the “Common Warrants” and, collectively with the
+Added: Pre-Funded Warrants, the “Warrants”), in a private placement offering.
+Added: The combined purchase price of one share of
+Added: common stock (or one Pre-Funded Warrant) and the accompanying Common Warrant is $0.95.
+Added: Subject to certain ownership limitations, the Warrants are exercisable
+Added: upon issuance.
+Added: Each Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $ 0.001 (as adjusted from
+Added: time to time in accordance with the terms thereof).
+Added: Each Common Warrant is exercisable into one share of common stock at a price per share
+Added: of $ 0.82 (as adjusted from time to time in accordance with the terms thereof) and will expire on the fifth anniversary of the date of
+Added: The gross proceeds from the Purchase Agreement were $ 11,497,385 resulting in net proceeds, after payment of commissions and
+Added: expenses, received by the Company of $ 10,625,786 .
Stock Options
11 unchanged sentences
purchase more than 750,000 shares of common stock) in a single year.
−Removed: the nine months ended September 30, 2021, the Board of Directors approved grants of 739,000
−Removed: options to officers, employees, board of directors and a consultant.
−Removed: The exercise price of the options ranges from $ 1.80
−Removed: and the options expire ten-years following issuance.
−Removed: fair value of these option grants at issuance was $ 1,969,712 .
−Removed: Of the 739,000 options issued, 128,000
−Removed: options vest on the first anniversary date of issuance, 75,000
−Removed: options have a vesting term of 25% vest upon issuance, 50% vest upon Board approving a business development acquisition and 25% vest
−Removed: over a three year period in equal installments on each of the succeeding three anniversary dates.
−Removed: The remaining options issued vest in
−Removed: four equal annual installments beginning on the first anniversary following issuance.
−Removed: the nine months ended September 30, 2021 and 2020, the Company recognized $ 1,228,811 and $ 930,443 of stock-based compensation,
−Removed: respectively, related to outstanding stock options.
−Removed: At September 30, 2021, the Company had $ 2,999,404 of unrecognized expenses
−Removed: related to outstanding options.
−Removed: The following table summarizes the stock option activity for the nine
−Removed: months ended September 30, 2021:
+Added: During the three months ended March 31, 2022 and 2021, the Company
+Added: recognized $ 336,685 and $ 418,053 of stock-based compensation, respectively, related to outstanding stock options.
+Added: At March 31, 2022, the
+Added: Company had $ 2,222,762 of unrecognized expenses related to outstanding options.
+Added: The following table summarizes the stock option
+Added: activity for the three months ended March 31, 2022:
Schedule of Stock Option Activity
1 unchanged sentence
Outstanding, December 31, 2021
−Removed: Outstanding, September 30, 2021
−Removed: Exercisable, September 30, 2021
−Removed: of September 30, 2021, the outstanding stock options have a weighted average remaining term of 8.04 years
−Removed: and the aggregate intrinsic value of options vested and outstanding were $ 370,281 and
−Removed: $ 397,375 respectively.
−Removed: As of September 30, 2021, there are no awards
+Added: Outstanding, March 31, 2022
+Added: Exercisable, March 31, 2022
+Added: As of March 31, 2022, the outstanding stock options have a
+Added: weighted average remaining term of 7.52 years
+Added: and the aggregate intrinsic value of options vested and outstanding were $ 81,400 .
+Added: As of March 31, 2022, there were 60,500 awards
remaining to be issued under the 2017 Plan and 2,074,764 awards
1 unchanged sentence
Stock Warrants
−Removed: During the nine months ended September 30, 2021, the Company received
+Added: During the three months ended March 31, 2022, the Company received
$ 2,616 in cash proceeds from the exercise of 2,615,790 warrants previously issued at an exercise price of $ 0.001 .
−Removed: In addition, the Company
−Removed: received notices to exercise 1,580,140 warrants on a cashless basis resulting in issuance of 1,296,075 shares of common stock.
−Removed: The following table summarizes the stock warrant activity for the nine
−Removed: months ended September 30, 2021:
+Added: following table summarizes the stock warrant activity for the three months ended March 31, 2022 :
Schedule of warrants activity
1 unchanged sentence
Outstanding, December 31, 2021
−Removed: ( 1,731,390 )
−Removed: Outstanding, September 30, 2021
−Removed: Exercisable, September 30, 2021
−Removed: As of September 30, 2021 the outstanding and exercisable warrants have
−Removed: a weighted average remaining term of 3.02 years and have an aggregate intrinsic value of $ 738,793 .
+Added: Outstanding, March 31, 2022
+Added: Exercisable, March 31, 2022
+Added: As of March 31, 2022, the outstanding and exercisable warrants have
+Added: a weighted average remaining term of 4.26 years and have no aggregate intrinsic value.
Note 5 – Commitments and Contingencies
45 unchanged sentences
Downs’ 2021 annual base salary
+Added: to $ 340,000 .
Scientific Advisory Board
−Removed: July 15, 2021, our compensation committee recommended to our Board and our Board approved the following policy for the Scientific Advisory
−Removed: Board members.
+Added: 2021, our compensation committee recommended to our Board and our Board approved the following policy for the Scientific Advisory Board
The Scientific Advisory board consists of Dr.
−Removed: Priebe, a significant shareholder and related party, and Dr.
−Removed: Each scientific advisory board member shall receive annual
−Removed: cash compensation of $68,600.
−Removed: As of September 30, 2021, the Company has accrued $ 28,767
+Added: Waldemar Priebe, a significant shareholder and related party, and Dr.
+Added: Each scientific advisory board member shall receive annual cash compensation of $68,600.
+Added: During the three month months ended March 31,
+Added: 2022, the Company paid $ 48,684 related to the Scientific Advisory Board compensation.
+Added: As of March 31, 2022, the Company has accrued $ 48,684
related to the Scientific Advisory Board compensation.
13 unchanged sentences
Waldemar Priebe, our founder
−Removed: and largest shareholder.
−Removed: Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound commonly
−Removed: known as WP744.
+Added: and significant shareholder.
+Added: Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound
+Added: commonly known as WP744.
In exchange for these rights, the Company agreed to pay consideration to HPI as follows:
−Removed: (i) a royalty of 2% of net sales
−Removed: of any product utilizing WP744 for a period of ten years after the first commercial sale of such;
−Removed: and (ii) $100,000 upon beginning Phase
−Removed: II clinical trials;
−Removed: and (iii) $200,000 upon the approval by the FDA of a New Drug Application for any product utilizing WP744;
−Removed: a series of quarterly development payments totaling $750,000 beginning immediately after the Company’s raise of $7,000,000 of investment
−Removed: In addition, the Company issued 200,000 shares of the Company’s common stock valued at $0.045 per share to HPI upon execution
−Removed: of the agreement.
−Removed: Our rights pursuant to the HPI License are contingent on us raising at least $7.0 million within 12 months from the
−Removed: effective date of the HPI License, a date which was extended by an additional 12 months by the payment of $40,000.
−Removed: On November 13, 2019,
−Removed: the Company closed its IPO and as a result completed the acquisition of the intellectual property discussed in the HPI agreement.
−Removed: to this agreement, the Company purchased $385,000 of pharmaceutical products from HPI for the manufacturing of Berubicin API in a related
−Removed: party transaction reviewed and approved by the Company’s audit committee.
−Removed: During the nine months ended September 30, 2021 and
−Removed: 2020, the Company recognized $ 262,500 and $ 150,000 , respectively related to this agreement.
−Removed: As of September 30, 2021, the Company accrued
−Removed: $ 100,000 related to the beginning of Phase II clinical trials.
−Removed: Subsequent to September 30, 2021, the Company committed to purchase additional
−Removed: materials to be used in future drug manufacturing from HPI with an estimated cost of $85,000.
−Removed: 30, 2018, we entered into a sublicense agreement with WPD Pharmaceuticals, Inc.
−Removed: Pursuant to the agreement, the Company
−Removed: granted WPD an exclusive sublicense, even as to us, for the patent rights we licensed pursuant to the HPI License within the following
−Removed: Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova, Romania, Bulgaria, Serbia, Macedonia, Albania, Armenia, Azerbaijan,
−Removed: Georgia, Montenegro, Bosnia, Croatia, Slovenia, Slovakia, Czech Republic, Hungary, Chechnya, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan,
−Removed: Turkmenistan, Greece, Austria, and Russia.
−Removed: The sublicense agreement provides that WPD must use commercially reasonable development efforts
−Removed: to attempt to develop and commercialize licensed products in the above mentioned territories, which means the expenditure of at least
−Removed: $2.0 million on the development, testing, regulatory approval or commercialization of the licensed products during the three year period
−Removed: immediately following the date of the sublicense agreement.
−Removed: In the event that WPD fails to use commercially reasonable development efforts
−Removed: by the foregoing three-year deadline, we have the right to terminate this sublicense agreement.
−Removed: The Company is currently validating WPD
−Removed: expenditures related to this agreement.
−Removed: In consideration for the rights granted under the sublicense agreement, to the extent we are
−Removed: required to make any payments to HPI pursuant to the HPI License as a result of this sublicense agreement, WPD agreed to advance us such
−Removed: payments, and to pay us a royalty equal to 1% of such payments.
−Removed: WPD is a Polish corporation that is majority-owned by an entity controlled
+Added: (i) a royalty of 2%
+Added: of net sales of any product utilizing WP744 for a period of ten years after the first commercial sale of such;
+Added: and (ii) $100,000 upon
+Added: beginning Phase II clinical trials (paid in 2021);
+Added: and (iii) $200,000 upon the approval by the FDA of a New Drug Application for any
+Added: product utilizing WP744;
+Added: and (iv) a series of quarterly development payments totaling $750,000 beginning immediately after the Company’s
+Added: raise of $7,000,000 of investment capital.
+Added: In addition, the Company issued 200,000 shares of the Company’s common stock valued
+Added: at $0.045 per share to HPI upon execution of the agreement.
+Added: On November 13, 2019, the Company closed its IPO, thereby fulfilling all
+Added: conditions precedent and completing the acquisition of the intellectual property discussed in the HPI agreement.
+Added: During the three months
+Added: ended March 31, 2022 and 2021, the Company recognized $ 87,500
+Added: related to this agreement.
+Added: Unrelated to this agreement, from time to time, the Company purchases pharmaceutical products from
+Added: HPI which are necessary for the manufacturing of Berubicin API and drug product in related party transactions which are reviewed and
+Added: approved by the Company’s audit committee based upon the standards of providing superior pricing and time to delivery than that
+Added: available from unrelated third parties.
+Added: During the three months ended March 31, 2022 and 2021, the Company expensed $ 41,075
+Added: and $ 385,000
+Added: respectively related to the purchase of pharmaceutical products from HPI.
+Added: On August 30, 2018, we entered into a sublicense agreement with WPD
+Added: Pharmaceuticals, Inc.
+Added: Pursuant to the agreement, the Company granted WPD an exclusive sublicense, even as to us,
+Added: for the patent rights we licensed pursuant to the HPI License within the following countries:
+Added: Poland, Estonia, Latvia, Lithuania, Belarus,
+Added: Ukraine, Moldova, Romania, Bulgaria, Serbia, Macedonia, Albania, Armenia, Azerbaijan, Georgia, Montenegro, Bosnia, Croatia, Slovenia,
+Added: Slovakia, Czech Republic, Hungary, Chechnya, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Greece, Austria, and Russia.
+Added: The sublicense agreement provides that WPD must use commercially reasonable development efforts to attempt to develop and commercialize
+Added: licensed products in the above-mentioned territories, which means the expenditure of at least $2.0 million on the development, testing,
+Added: regulatory approval or commercialization of the licensed products during the three year period immediately following the date of the sublicense
+Added: In the event that WPD fails to use commercially reasonable development efforts by the foregoing three-year deadline, we have
+Added: the right to terminate this sublicense agreement.
+Added: The Company is currently validating WPD expenditures related to this agreement.
+Added: In consideration
+Added: for the rights granted under the sublicense agreement, to the extent we are required to make any payments to HPI pursuant to the HPI License
+Added: as a result of this sublicense agreement, WPD agreed to advance us such payments, and to pay us a royalty equal to 1% of such payments.
+Added: WPD is a Polish corporation that is majority-owned by an entity controlled by Dr.
Priebe, our founder and largest shareholder.
−Removed: February 19, 2021, CNS entered into an Investigational Medicinal Product Supply Agreement with WPD, a related party.
−Removed: CNS agreed to
−Removed: sell the Berubicin drug product to WPD at historical cost of manufacturing without markup so that WPD may conduct the clinical
−Removed: trials contemplated by the sublicense agreement.
−Removed: WPD agreed to pay CNS the following payments:
−Removed: (i) an upfront payment of $ 131,073 upon
−Removed: execution of the agreement, (ii), a payment of $ 262,145 upon
−Removed: final batch release and certification performed by WPD's subcontractor, and (iii) a final payment of $262,145 upon Clinical Trial
−Removed: Application acceptance by the relevant regulatory authority.
−Removed: All three milestones have been met as of September 30, 2021.
−Removed: addition, as of September 30, 2021, the drug product with a cost of approximately $ 655,000 has
−Removed: been delivered to WPD and is being held at a third party depot.
−Removed: As such, the full amount of approximately $655,000 is now due from
−Removed: As of September 30, 2021, CNS has invoiced the first of the three amounts plus pass through cost for a total of $132,648.
−Removed: However, WPD has not remitted payment for that invoice and, as such we have not recorded a receivable for the second and third
−Removed: milestones due to the collectability issues, and we have recorded a reserve against the related receivable resulting in an
−Removed: increase to our research and development expense.
−Removed: The Company is working with WPD to resolve this situation.
+Added: On February 19, 2021, CNS entered into an Investigational Medicinal
+Added: Product Supply Agreement with WPD, a related party.
+Added: CNS agreed to sell the Berubicin drug product to WPD at historical cost of manufacturing
+Added: without markup so that WPD may conduct the clinical trials contemplated by the sublicense agreement.
+Added: WPD agreed to pay CNS the following
+Added: (i) an upfront payment of $ 131,073 upon execution of the agreement, (ii), a payment of $ 262,145 upon final batch release
+Added: and certification performed by WPD's subcontractor, and (iii) a final payment of $262,145 upon Clinical Trial Application acceptance
+Added: by the relevant regulatory authority.
+Added: All three milestones have been met as of December 31, 2021.
+Added: In addition, as of December 31, 2021,
+Added: the drug product with a cost of approximately $ 655,000 has been delivered to WPD and is being held at a third party depot.
+Added: full amount of approximately $655,000 is now due from WPD.
+Added: As of December 31, 2021, CNS has invoiced the three amounts plus pass
+Added: through cost for a total of $656,938.
+Added: As of March 31, 2022, the Company has received payments for the first and second amounts due for
+Added: a total of $ 393,182 .
+Added: However, as of March 31, 2022, WPD has not remitted payment for the final invoice and, as such, we have not recorded
+Added: a receivable due to the collectability issues.
+Added: The Company is continuing to work with WPD to resolve this situation.
On August 31, 2018, the Company entered into a sublicense agreement
9 unchanged sentences
the founder and a shareholder of ALI, holds 38% of the membership interests of ALI.
+Added: On June 10, 2020, the FDA granted Orphan Drug Designation (“ODD”)
+Added: for Berubicin for the treatment of malignant gliomas.
+Added: ODD from the FDA is available for drugs targeting diseases with less than 200,000
+Added: cases per year.
+Added: ODD may enable market exclusivity of 7 years from the date of approval of a New Drug Application (“NDA) in the United
+Added: During that period the FDA generally could not approve another product containing the same drug for the same designated indication.
+Added: Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the
+Added: same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy
+Added: or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market
+Added: The ODD now constitutes our primary intellectual property protections although the Company is exploring if there are other patents
+Added: that could be filed related to Berubicin to extend additional protections.
+Added: On July 24, 2021, the Company received Fast Track Designation from
+Added: the FDA for Berubicin.
+Added: Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat
+Added: serious conditions and fill an unmet medical need.
WP1244 Portfolio
18 unchanged sentences
following the Effective Date and (iii) Commencement of Phase I Study within the five (5) year period following the Effective Date.
−Removed: the nine months ended September 30, 2021, the Company paid $ 22,902 and accrued $ 25,766 to UTMDACC related to this agreement.
−Removed: 2020, pursuant to the WP1244 Portfolio license agreement described above, the Company entered into a Sponsored Research Agreement with
−Removed: UTMDACC to perform research relating to novel anticancer agents targeting CNS malignancies.
−Removed: The Company agreed to fund approximately $1,134,000
−Removed: over a two-year period.
−Removed: The Company recorded $ 734,000 in 2020 related to this agreement in research and development expenses in the Company’s
−Removed: Consolidated Statements of Operations.
−Removed: The remainder will be paid and recorded in 2021.
−Removed: The principal investigator for this agreement
−Removed: Waldemar Priebe, who controls a majority of the Company’s share.
−Removed: During the nine months ended September 30, 2021, the Company
−Removed: paid $ 200,000 and accrued an additional $400,000 to UTMDACC
−Removed: related to this agreement.
−Removed: As of September 30, 2021, the Company has accrued $ 600,000 in research and development expenses to UTMDACC.
+Added: the three months ended March 31, 2022 and 2021, the Company paid $ 44,424 and $ 22,902 to UTMDACC related to this agreement, respectively.
+Added: 7, 2020, pursuant to the WP1244 Portfolio license agreement described above, the Company entered into a Sponsored Research Agreement
+Added: with UTMDACC to perform research relating to novel anticancer agents targeting CNS malignancies.
+Added: The Company agreed to fund
+Added: approximately $1,134,000 over a two-year period.
+Added: During the year ended December 31, 2020, the Company paid $ 334,000 and
+Added: accrued $ 400,000
+Added: related to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations.
+Added: the year ended December 31, 2021, the Company paid $ 800,000 to
+Added: UTMDACC related to this agreement.
+Added: The Company has no further payment obligations as of March 31, 2022.
+Added: The principal investigator
+Added: for this agreement is Dr.
+Added: Waldemar Priebe, a significant shareholder.
Anti-Viral Portfolio
9 unchanged sentences
Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland.
−Removed: Pursuant to the Agreement, the Company agreed to pay WPD the following
−Removed: (i) an upfront payment of $ 225,000 to WPD (paid in April 2020);
−Removed: and (ii) within thirty days of the verified achievement of the
−Removed: Phase II Milestone, (such verification shall be conducted by an independent third party mutually acceptable to the parties hereto), the
−Removed: Company will make a payment of $775,000 to WPD.
−Removed: WPD agreed to pay the Company a development fee of 50% of the net sales for any products
−Removed: in the above territories;
−Removed: provided that Poland shall not be included as a territory after WPD receives marketing approval for a product
−Removed: in one-half of the countries included in the agreed upon territories or upon the payment by WPD to the Company of development fees of
−Removed: $1.0 million.
+Added: Pursuant to the Agreement, the Company agreed to pay WPD the
+Added: following payments:
+Added: (i) an upfront payment of $ 225,000 to
+Added: WPD (paid in April 2020);
+Added: and (ii) within thirty days of the verified achievement of the Phase II Milestone, (such verification
+Added: shall be conducted by an independent third party mutually acceptable to the parties hereto), the Company will make a payment of
+Added: WPD agreed to pay the Company a development fee of 50% of the net sales for any products in the above territories;
+Added: that Poland shall not be included as a territory after WPD receives marketing approval for a product in one-half of the countries
+Added: included in the agreed upon territories or upon the payment by WPD to the Company of development fees of $ 1.0
The term of the Agreement will expire on the expiration of the sublicense pursuant to which WPD has originally sublicensed
the products.
−Removed: During the nine months ended September 30, 2020, the Company paid $225,000 related to this agreement.
−Removed: 2021, the Company received Fast Track Designation from the FDA for Berubicin.
−Removed: Fast Track Designation is designed to facilitate the
−Removed: development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
−Removed: – Subsequent Events
−Removed: Subsequent to September 30, 2021, the Company
−Removed: received a notice to exercise 915,263 warrants on a cashless basis resulting in issuance of 460,232 shares of common stock.
+Added: During the year ended December 31, 2020, the Company paid $ 225,000
+Added: related to this agreement.
+Added: Nasdaq Capital Markets Listing Qualifications
+Added: On February 18, 2022, the Company received
+Added: a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company
+Added: that for the last 30 consecutive business days the bid price for the Company’s common stock had closed below the minimum $1.00 per
+Added: share requirement for continued inclusion in Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
+Added: The deficiency letter does not result in the immediate delisting of the Company’s common stock from Nasdaq.
+Added: The Company has been provided an initial period
+Added: of 180 calendar days, or until August 17, 2022, to regain compliance with the Bid Price Rule.
+Added: If the Company is not in compliance
+Added: with the Bid Price Rule by August 17, 2022, the Company may be afforded a second 180 calendar day period to regain compliance.
+Added: the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial
+Added: listing standards required by Nasdaq, except for the minimum bid price requirement.
+Added: The Company intends to monitor the closing
+Added: bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Bid Price Rule, which
+Added: could include effecting a reverse stock split.
+Added: However, there can be no assurance that the Company will be able to regain compliance with
+Added: the Bid Price Rule.
+Added: Note 6 – Subsequent Events
+Added: On April 28, 2022, the Compensation Committee approved cash bonuses
+Added: totaling $213,000 to the officers of the Company.
+Added: In addition, the officers and employees were awarded a total of 1,142,500 Restricted
+Added: Stock Units that partially vest over 4 years, partially vest upon the Company’s common stock price exceeding various closing prices
+Added: ranging from $2.00 - $4.00 per share and partially upon the completion of milestones established by the Board.
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.