What changed in this filing

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Item 1. Financial Statements

2022-11-10 compared with 2022-08-12 · 174 added, 167 removed, 396 unchanged (46% of the section changed)

2 unchanged sentences

Balance Sheets

September 30,

Current Assets:

16 unchanged sentences

Stockholders' Equity:

Preferred stock, $ 0.001 par value, 5,000,000 shares

authorized and 0 shares issued and outstanding

Common stock, $ 0.001 par

value, 75,000,000 shares

authorized and 40,032,481

and 27,927,217 shares issued and outstanding,

Preferred stock, $ 0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding

Common stock, $ 0.001 par value, 75,000,000 shares authorized and 40,032,481 and 27,927,217 shares issued and outstanding, respectively

Additional paid-in capital

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Statements of Operations

Three Months Ended June 30, 2022

Three Months Ended June 30, 2021

Ended June 30, 2022

Ended June 30, 2021

Three Months Ended September 30, 2022

Three Months Ended September 30, 2021

Nine Months Ended September 30, 2022

Nine Months Ended September 30, 2021

Operating expenses:

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Statements of Stockholders' Equity

For the six months ended June 30, 2022 and 2021

For the nine months ended September 30, 2022 and 2021

Stockholders'

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( 41,333,212 )

Stock-based compensation

( 3,419,553 )

Balance September 30, 2022

$ ( 44,752,765 )

Balance December 31, 2020

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( 28,373,420 )

Stock-based compensation

( 3,814,348 )

Balance September 30, 2021

$ ( 32,187,768 )

See accompanying notes to the unaudited financial statements.

1 unchanged sentence

Statements of Cash Flows

Six Months Ended June 30, 2022

Six Months Ended June 30, 2021

Nine Months Ended September 30, 2022

Nine Months Ended September 30, 2021

Cash Flows from Operating Activities:

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Changes in operating assets and liabilities:

Related party receivable

Prepaid expenses

1 unchanged sentence

Accounts payable

( 1,031,937 )

Accrued expenses

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Cashless exercise of warrants

Common stock issued for subscription receivable

See accompanying notes to the unaudited financial statements.

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financial statements not misleading.

Operating results for the three and six months ended June 30, 2022 are not necessarily indicative

Operating results for the three and nine months ended September 30, 2022 are not necessarily indicative

of the final results that may be expected for the year ending December 31, 2022.

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The amount in excess of

the FDIC insurance as of June 30, 2022 was $ 8,708,880 .

the FDIC insurance as of September 30, 2022 was $ 6,777,470 .

The Company has not experienced losses on these accounts and management believes,

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period for stock options and restricted stock units.

Restricted Stock Units (“RSUs”) -

Our RSUs vest over four years from the date of grant.

The fair value of RSUs is the market price of our common stock

at the date of grant.

Performance Units (“PUs”) -

The PUs vest based on our performance against predefined share price targets and the achievement of Positive Interim, Clinical

Data as defined by the Board.

Restricted Stock Units (“RSUs”) - Our RSUs vest over

four years from the date of grant.

The fair value of RSUs is the market price of our common stock at the date of grant.

Performance Units (“PUs”) - The PUs vest based on

our performance against predefined share price targets and the achievement of Positive Interim, Clinical Data as defined by the Board.

Loss Per Common Share - Basic loss per common share is computed

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excludes common stock equivalents, because their inclusion would be anti-dilutive.

For the six months ended June 30, 2022 and 2021, the

Company’s potentially dilutive shares and options, which were not included in the calculation of net loss per share, included warrants

to purchase 16,925,504 and 5,130,240 common shares, unvested restricted stock units of 285,625 and 0 common shares, unvested performance

units of 856,875 and 0 common shares, and options for 2,864,736 and 2,811,736 common shares, respectively.

For the nine months ended September 30, 2022 and 2021,

the Company’s potentially dilutive shares and options, which were not included in the calculation of net loss per share, included

warrants to purchase 15,719,445 and 5,130,240 common shares, unvested restricted stock units of 285,625 and 0 common shares, unvested

performance units of 856,875 and 0 common shares, and options for 2,789,736 and 2,939,736 common shares, respectively.

Note 3 – Note Payable

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related to the note will be repaid over a 11-month period with the final payment due on September 30, 2022 .

As of June 30, 2022 and December

31, 2021, the Company’s note payable balance was $ 156,397 and $ 387,794 , respectively.

As of September 30, 2022 and

December 31, 2021, the Company’s note payable balance was $ 39,260 and $ 387,794 , respectively.

Subsequent to September 30, 2022,

the Company repaid the outstanding note balance in full.

Note 4 – Equity

Company engaged H.C.

Wainwright & Co., LLC (“Wainwright”), to act as placement agent related to the Securities Purchase

Agreement described below.

The Company agreed to pay Wainwright an aggregate fee equal to 7.0% of the gross proceeds received by the Company

from the sale of the securities in the transaction.

The Company also issued to Wainwright or its designees warrants to purchase up

to 5.0% of the aggregate number of shares of Common Stock sold in the transactions (the “Placement Agent Warrants”), or 605,263

Placement Agent Warrants.

The Placement Agent Warrants have substantially the same terms as the Common Warrants, except that the Placement

Agent Warrants have an exercise price equal to 125% of the offering price, or $1.1875 per share.

The Company also paid Wainwright $ 50,000

for non-accountable expenses and $ 10,000 for legal fees and expenses.

On January 5, 2022, the Company entered into

a Securities Purchase Agreement (the “Purchase Agreement”) with several institutional investors for the sale by the Company

of (i) 9,489,474 shares (the “Shares”) of the Company’s common stock, (ii) pre-funded warrants (the “Pre-Funded

Warrants”) to purchase up to an aggregate of 2,615,790 shares of common stock and (iii) warrants to purchase up to an aggregate

of 12,105,264 shares of common stock (the “Common Warrants” and, collectively with the Pre-Funded Warrants, the “Warrants”),

in a private placement offering.

The combined purchase price of one share of common stock (or one Pre-Funded Warrant) and the accompanying

Common Warrant is $0.95.

The Company engaged H.C.

Wainwright & Co., LLC (“Wainwright”),

to act as placement agent related to the Securities Purchase Agreement described below.

The Company agreed to pay Wainwright an aggregate

fee equal to 7.0% of the gross proceeds received by the Company from the sale of the securities in the transaction.

The Company also issued

to Wainwright or its designees warrants to purchase up to 5.0% of the aggregate number of shares of Common Stock sold in the transactions

(the “Placement Agent Warrants”), or 605,263 Placement Agent Warrants.

The Placement Agent Warrants have substantially the

same terms as the Common Warrants, except that the Placement Agent Warrants have an exercise price equal to 125% of the offering price,

or $1.1875 per share.

The Company also paid Wainwright $ 50,000 for non-accountable expenses and $ 10,000 for legal fees and expenses.

On January 5, 2022, the Company entered into a Securities Purchase

Agreement (the “Purchase Agreement”) with several institutional investors for the sale by the Company of (i) 9,489,474 shares

(the “Shares”) of the Company’s common stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase

up to an aggregate of 2,615,790 shares of common stock and (iii) warrants to purchase up to an aggregate of 12,105,264 shares of common

stock (the “Common Warrants” and, collectively with the Pre-Funded Warrants, the “Warrants”), in a private placement

The combined purchase price of one share of common stock (or one Pre-Funded Warrant) and the accompanying Common Warrant is

Subject to certain ownership limitations, the Warrants are exercisable

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purchase more than 750,000 shares of common stock) in a single year.

During the six months ended June 30, 2022 and 2021, the Company recognized

$ 605,657 and $ 875,039 of stock-based compensation, respectively, related to outstanding stock options.

At June 30, 2022, the Company had

$ 1,854,997 of unrecognized expenses related to outstanding options.

During the nine months ended September 30, 2022 and 2021, the Company

recognized $ 877,510 and $ 1,228,811 of stock-based compensation, respectively, related to outstanding stock options.

At September 30, 2022,

the Company had $ 1,583,144 of unrecognized expenses related to outstanding options.

The following table summarizes the stock option

activity for the six months ended June 30, 2022:

activity for the nine months ended September 30, 2022:

Schedule of Stock Option Activity

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Outstanding, December 31, 2021

Outstanding, June 30, 2022

Exercisable, June 30, 2022

As of June 30, 2022, the outstanding stock options have a

weighted average remaining term of 7.27 years and the aggregate intrinsic value of options vested and outstanding were $ 81,400 .

of June 30, 2022, there were no awards remaining to be issued under the 2017 Plan and 992,764 awards remaining to be issued

under the 2020 Plan.

Outstanding, September 30, 2022

Exercisable, September 30, 2022

As of September 30, 2022, the outstanding stock options have a weighted

average remaining term of 6.98 years and the aggregate intrinsic value of options vested and outstanding were $ 36,850 .

As of September

30, 2022, there were no awards remaining to be issued under the 2017 Plan and 1,067,764 awards remaining to be issued under the 2020 Plan.

Stock Warrants

During the six months ended June 30, 2022, the Company received $ 2,616

During the nine months ended September 30, 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 .

The following table summarizes the stock warrant

activity for the six months ended June 30, 2022:

activity for the nine months ended September 30, 2022:

Schedule of warrants activity

1 unchanged sentence

Outstanding, December 31, 2021

Outstanding, June 30, 2022

Exercisable, June 30, 2022

As of June 30, 2022, the outstanding and exercisable warrants have

a weighted average remaining term of 4.01 years and have no aggregate intrinsic value.

( 2,615,790 )

( 1,206,059 )

Outstanding, September 30, 2022

Exercisable, September 30, 2022

As of September 30, 2022, the outstanding and exercisable warrants

have a weighted average remaining term of 4.06 years and have no aggregate intrinsic value.

Restricted Stock Units

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The Company valued the RSUs based on the stock price at grant which total $ 95,399 .

During the six months ended June 30, 2022, the Company recognized $ 5,962

During the nine months ended September 30, 2022, the Company recognized

$ 11,925 of stock-based compensation, related to outstanding stock RSUs.

At June 30, 2022, the Company had $ 89,437 of unrecognized expenses

related to outstanding RSUs.

At September 30, 2022, the Company had $ 83,474 of unrecognized

expenses related to outstanding RSUs.

The following table summarizes the RSUs activity

for the six months ended June 30, 2022:

for the nine months ended September 30, 2022:

Schedule of restricted stock units activity

1 unchanged sentence

Non-vested, December 31, 2021

Non-vested, June 30, 2022

Non-vested, September 30, 2022

Performance Units

On April 28, 2022, the Compensation Committee

approved, the officers and employees were awarded a total of

On April 28, 2022, the Compensation Committee approved, the officers

and employees were awarded a total of 856,875 PUs.

For awards granted in 2022, they vest as follows:

(i) 285,625 of the PU grant will vest if within 24 months from

issuance the average the closing price of the Company’s common stock over a ten trading day period exceeds $2.00 (subject to

pro rata adjustment for stock splits or similar events), (ii) 285,625 of the PU grant will vest if within 36 months from issuance

the average the closing price of the Company’s common stock over a ten trading day period exceeds $4.00 (subject to pro rata

adjustment for stock splits or similar events) and (iii) 285,625 of the PU grant will vest if within 24 months from issuance the

Company achieves “Positive Interim, Clinical Data” as defined by the Board of Directors.

(i) 285,625 of the PU grant will

vest if within 24 months from issuance the average the closing price of the Company’s common stock over a ten trading day period

exceeds $2.00 (subject to pro rata adjustment for stock splits or similar events), (ii) 285,625 of the PU grant will vest if within 36

months from issuance the average the closing price of the Company’s common stock over a ten trading day period exceeds $4.00 (subject

to pro rata adjustment for stock splits or similar events) and (iii) 285,625 of the PU grant will vest if within 24 months from issuance

the Company achieves “Positive Interim, Clinical Data” as defined by the Board of Directors.

To the extent that the market

and/or “Positive Interim Clinical Data” conditions are not met, the applicable portions of the PUs will not vest and

will be cancelled.

and/or “Positive Interim Clinical Data” conditions are not met, the applicable portions of the PUs will not vest and will

be cancelled.

The fair value at grant date of these performance units was $ 169,663 .

Compensation expense is recognized ratably during the period the PUs are expected to vest or when “Positive Interim

Clinical Data” is achieved.

The fair value of each performance unit with market

conditions (vesting terms (i) and (ii)) is estimated at the date of grant using a Monte Carlo simulation with the following assumptions:

underlying stock price $ 0.33 , hurdle prices ranging from $ 2.00 -$ 4.00 , expected terms ranging from 2 - 3 years, cost of equity 18.7 % and

risk-free rate of 2.8 %.

During the six months ended June 30, 2022, the Company recognized $ 7,309

Compensation expense is recognized ratably during

the period the PUs are expected to vest or when “Positive Interim Clinical Data” is achieved.

The fair value of each performance unit with market conditions (vesting

terms (i) and (ii)) is estimated at the date of grant using a Monte Carlo simulation with the following assumptions:

underlying stock

price $ 0.33 , hurdle prices ranging from $ 2.00 -$ 4.00 , expected terms ranging from 2 - 3 years, cost of equity 18.7 % and risk-free rate of

During the nine months ended September 30, 2022, the Company recognized

$ 14,619 for vesting term (i), $ 9,193 for vesting term (ii) and $ 0 for vesting term (iii), related to outstanding stock PUs.

At June 30, 2022,

30, 2022, the Company had $ 145,853 of unrecognized expenses related to PUs.

The following table summarizes the PUs activity

for the six months ended June 30, 2022:

for the nine months ended September 30, 2022:

Schedule of performance units activity

1 unchanged sentence

Non-vested, December 31, 2021

Non-vested, June 30, 2022

Non-vested, September 30, 2022

Note 5 – Commitments and Contingencies

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On February 6, 2021, the compensation committee of the board of directors set Mr.

Climaco’s 2021 annual

base salary to $ 525,000 .

Climaco’s 2021 annual base salary

to $ 525,000 .

On June 28, 2019, we entered into employment letters with Drs.

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for the Scientific Advisory Board members.

The Scientific Advisory board consists of Dr.

The Scientific Advisory board consisted of Dr.

Waldemar Priebe, a significant shareholder and

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Each scientific advisory board member shall receive annual cash compensation of $68,600.

six month months ended June 30, 2022, the Company paid $ 65,834 related to the Scientific Advisory Board compensation.

June 30, 2022, the Company has accrued $ 65,834 related to the Scientific Advisory Board compensation.

nine month months ended September 30, 2022, the Company paid $ 76,087 related to the Scientific Advisory Board compensation.

25, 2022, Dr.

Waldemar Priebe is no longer a member of the Scientific Advisory Board.

As of September 30, 2022, the Company has accrued

$ 82,984 related to Mr.

Hsu’s Scientific Advisory Board compensation.

WP744 Portfolio (Berubicin)

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precedent and completing the acquisition of the intellectual property discussed in the HPI agreement.

During the six months ended June

During the nine months ended September

30, 2022 and 2021, the Company recognized $ 262,500 related to this agreement.

Unrelated to this agreement, from time to time,

the Company purchases pharmaceutical products from HPI which are necessary for the manufacturing of Berubicin API and drug product in

related party transactions 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 available from unrelated third parties.

During the six months ended June 30, 2022 and

2021, the Company expensed $ 41,075 and $ 385,000 respectively related to the purchase of pharmaceutical products from HPI.

Unrelated to this agreement, from time to time, the Company

purchases pharmaceutical products from HPI which are necessary for the manufacturing of Berubicin API and drug product in related party

transactions 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 available from unrelated third parties.

During the nine months ended September 30, 2022 and 2021, the Company

expensed $ 41,075 and $ 385,000 respectively related to the purchase of pharmaceutical products from HPI.

On August 30, 2018, we entered into a sublicense agreement with WPD

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regulatory approval or commercialization of the licensed products during the three year period immediately following the date of the sublicense

In consideration

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

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.

In consideration 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 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.

WPD is a Polish corporation that is majority-owned by an entity controlled by Dr.

Priebe, our founder and largest shareholder.

On February 19, 2021, CNS entered into an

Investigational Medicinal Product Supply Agreement with WPD, a related party.

CNS agreed to sell the Berubicin drug product to WPD

at historical cost of manufacturing without markup so that WPD may conduct the clinical trials contemplated by the sublicense

WPD agreed to pay CNS the following payments:

(i) an upfront payment of $ 131,073 upon

execution of the agreement, (ii) a payment of $ 262,145 upon

final batch release and certification performed by WPD's subcontractor, and (iii) a final payment of $262,145 upon Clinical

Trial Application acceptance by the relevant regulatory authority.

Priebe, our founder and

largest shareholder.

On February 19, 2021, CNS entered into an Investigational Medicinal

Product Supply Agreement with WPD, a related party.

CNS agreed to sell the Berubicin drug product to WPD at historical cost of manufacturing

without markup so that WPD may conduct the clinical trials contemplated by the sublicense agreement.

WPD agreed to pay CNS the following

(i) an upfront payment of $ 131,073 upon execution of the agreement, (ii) a payment of $ 262,145 upon final batch release

and certification performed by WPD's subcontractor, and (iii) a final payment of $262,145 upon Clinical Trial Application acceptance

by the relevant regulatory authority.

All three milestones have been met as of December 31, 2021.

addition, as of December 31, 2021, the drug product with a cost of approximately $ 655,000

has been delivered to WPD and is being held at a third party depot.

As such, the full amount of approximately $655,000 is now

due from WPD.

As of December 31, 2021, CNS has invoiced the three amounts plus pass through cost for a total of $656,938.

30, 2022, the Company has received payments for the first and second amounts due for a total of $ 393,182 .

However, as of June 30, 2022, WPD has not remitted payment for the final invoice and, as such, we have not recorded a receivable due

to the collectability issues.

The Company is continuing to work with WPD to resolve this situation.

In addition, as of December 31, 2021,

the drug product with a cost of approximately $ 655,000 has been delivered to WPD and is being held at a third party depot.

full amount of approximately $655,000 is due from WPD.

As of December 31, 2021, CNS has invoiced the three amounts plus pass through cost

for a total of $656,938.

As of September 30, 2022, the Company has received payments for the first and second amounts due for a total

of $ 393,182 and has entered into a settlement agreement whereby WPD agreed to return 168 vials (approximately 40% of the total) to us

in settlement of the final amount owed.

On October 24, 2022, the Company received confirmation from our third party depot service provider

that the vials had been transferred into our inventory.

As such, this matter is now fully resolved.

On August 31, 2018, the Company entered into a sublicense agreement

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or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market

The ODD now constitutes our primary intellectual property protections although the Company is exploring if there are other patents

The ODD constitutes our primary intellectual property protections although the Company is exploring if there are other patents

that could be filed related to Berubicin to extend additional protections.

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following the Effective Date and (iii) Commencement of Phase I Study within the five (5) year period following the Effective Date.

the six months ended June 30, 2022 and 2021, the Company paid $ 44,424 and $ 22,902 to UTMDACC related to this agreement, respectively.

On May 7, 2020, pursuant to the WP1244 Portfolio license agreement

described above, the Company entered into a Sponsored Research Agreement with UTMDACC to perform research relating to novel anticancer

agents targeting CNS malignancies.

The Company agreed to fund approximately $1,134,000 over a two-year period.

the nine months ended September 30, 2022 and 2021, the Company paid $ 49,607 and $ 22,902 , respectively.

2020, pursuant to the WP1244 Portfolio license agreement described above, the Company entered into a Sponsored Research Agreement with

UTMDACC to perform research relating to novel anticancer agents targeting CNS malignancies.

The Company agreed to fund approximately $1,134,000

over a two-year period.

During the year ended December 31, 2020, the Company paid $ 334,000 and accrued $ 400,000 related to this agreement

in research and development expenses in the Company’s Consolidated Statements of Operations.

During the year ended December 31,

31, 2020, the Company paid $ 334,000 and accrued $ 400,000 related to this agreement in research and development expenses in the Company’s

Consolidated Statements of Operations.

During the year ended December 31, 2021, the Company paid $ 800,000 to UTMDACC related to this

The Company has no further payment obligations as of June 30, 2022.

2021, the Company paid $ 800,000 to UTMDACC related to this agreement.

The Company has no further payment obligations as of September

The principal investigator for this agreement is Dr.

Priebe, a significant shareholder.

Waldemar Priebe, a significant shareholder.

Anti-Viral Portfolio

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the products.

During the year ended December 31, 2020, the Company paid $ 225,000 related to this agreement.

Nasdaq Capital Markets Listing Qualifications

On February 18, 2022, the Company received

a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company

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

share requirement for continued inclusion in Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).

The deficiency letter does not result in the immediate delisting of the Company’s common stock from Nasdaq.

The Company has been provided an initial period

of 180 calendar days, or until August 17, 2022, to regain compliance with the Bid Price Rule.

If the Company is not in compliance

with the Bid Price Rule by August 17, 2022, the Company may be afforded a second 180 calendar day period to regain compliance.

the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial

listing standards required by Nasdaq, except for the minimum bid price requirement.

The Company believes it meets the foregoing requirements and has requested an additional 180 day period.

On July 7, 2022, the Company filed a

Definitive Proxy Statement on Form DEF 14A for its Annual Meeting of Stockholders to be held on July 27, 2022.

The Annual Meeting of Stockholders was adjourned on

July 27, 2022 until August 3, 2022, and then adjourned again until August 16, 2022.

In this Definitive Proxy

Statement, the Company included a proposal to authorize an amendment to the Company’s amended and restated articles of incorporation

to empower the Board of Directors to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a

split ratio of between 1-for-2 and 1-for-30 as determined by the Board of Directors in its sole discretion, prior to the one-year anniversary

of this Annual Meeting.

Assuming this proposal is approved by the Company’s stockholders, the Company intends to monitor the closing

bid price of its common stock and may, if appropriate, effect a reverse stock split of the Company’s common stock, to regain compliance

with the Bid Price Rule in order to avoid being delisted from Nasdaq as well as to provide for additional shares available for issuance

to continue to fund the Company’s clinical research programs.

Notwithstanding the foregoing, there can be no assurance that the

stockholders of the Company will authorize a reverse stock split, nor that the Company will be able to regain compliance with the Bid

Price Rule if a reverse stock split is authorized.

On February 18, 2022, the Company received a deficiency letter from

the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company 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 share requirement for continued

inclusion in Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).

The deficiency letter

does not result in the immediate delisting of the Company’s common stock from Nasdaq.

The Company was initially provided an initial period of 180 calendar

days, or until August 17, 2022, to regain compliance with the Bid Price Rule.

The Company was granted a second 180 calendar day

period, or until February 13, 2023, to regain compliance since it met the continued listing requirement for market value of publicly held

shares and all other initial listing standards required by Nasdaq, except for the minimum bid price requirement.

On July 7, 2022, the Company filed a Definitive Proxy Statement on

Form DEF 14A for its Annual Meeting of Stockholders to be held on July 27, 2022.

The Annual Meeting of Stockholders was

adjourned on July 27, 2022 until August 3, 2022, then adjourned again until August 16, 2022, and then adjourned again until August 25,

In this Definitive Proxy Statement, the Company included a proposal to authorize an amendment to the Company’s amended and

restated articles of incorporation to empower the Board of Directors to effect a reverse stock split of the outstanding shares of the

Company’s common stock, at a split ratio of between 1-for-2 and 1-for-30 as determined by the Board of Directors in its sole discretion,

prior to the one-year anniversary of this Annual Meeting.

This proposal was approved by the Company’s stockholders when the Annual

Meeting of Stockholders was reconvened on August 25, 2022.

The Company intends to monitor the closing bid price of its common stock and,

if appropriate, effect a reverse stock split of the Company’s common stock, to regain compliance with the Bid Price Rule in order

to avoid being delisted from Nasdaq as well as to provide for additional shares available for issuance to continue to fund the Company’s

clinical research programs.

Notwithstanding the foregoing, there can be no assurance that the Company will be able to regain and maintain

compliance with the Bid Price Rule if a reverse stock split is effected.

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.

What changed 10-Q

Item 1. Financial Statements