What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-09 compared with 2023-08-11 · 182 added, 177 removed, 592 unchanged (38% of the section changed)

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at planned levels and be forced to reduce or terminate our operations.

have generated limited revenues, have incurred significant operating losses since our inception and expect to continue to incur operating

losses for the foreseeable future.

have generated limited revenues, have incurred significant operating losses since our inception and expect to continue to incur

operating losses for the foreseeable future.

These factors raise substantial doubt about our ability to continue as a going concern.

viability is dependent on our ability to raise additional capital to finance our operations.

Without raising additional capital through

a future offering, we believe that current cash on hand is insufficient to fund operations through the end of the fourth quarter of 2023.

Our future viability is dependent on our ability to raise additional capital to finance our operations.

Without raising additional

capital through a future offering, we believe that current cash on hand is insufficient to fund operations through the end of the

first quarter of 2024.

expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our product candidates

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to commercialize our product candidates, if approved, we may require substantial additional funding in the future.

Promissory Notes

September 24, 2021, we entered into the SPA for an aggregate financing of $15.0 million with institutional investors.

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Company issued to the investors (i) senior secured convertible promissory notes in the aggregate principal amount of $5.3 million for

an aggregate purchase price of $5.0 million (collectively, the “ First Closing Notes ”) and (ii) warrants to purchase

1,507 shares of the Company’s common stock in the aggregate at a current exercise price of $3.64 per share.

At the second closing,

the Company issued to the institutional investors referenced above, (i) senior secured convertible promissory notes in the aggregate

principal amount of $10.6 million (collectively, the “ Second Closing Notes ”, together with the First Closing Notes,

the “ 2021 Notes ”) for an aggregate purchase price of $10.0 million and (ii) warrants to purchase 3,005 shares of the

Company’s common stock in the aggregate at a current exercise price of $3.64 per share.

an aggregate purchase price of $5.0 million and (ii) warrants to purchase 1,504 shares of the Company’s common stock in the aggregate

at a current exercise price of $3.64 per share.

At the second closing, the Company issued to the institutional investors referenced above,

(i) senior secured convertible promissory notes in the aggregate principal amount of $10.6 million for an aggregate purchase price of

$10.0 million and (ii) warrants to purchase 3,008 shares of the Company’s common stock in the aggregate at a current exercise price

of $3.64 per share.

The 2021 Notes were satisfied on October 10, 2022.

June 30, 2022, we entered into an $8.0 million convertible financing agreement with institutional investors (the “2022 Notes”).

The agreement provided for two closings, each for notes payable of $4.24 million (resulting in gross cash proceeds of $4.0 million).

Funds were received for the first closing on July 1, 2022 and for the second closing on August 9, 2022.

The remaining amount of principal

and interest on the 2022 Notes was repaid in the first quarter of 2023.

We were obligated under the 2022 Notes to pay additional cash

as true-up payments for interest or redemption amounts that we paid in shares of common stock that were valued below $24.07 or the lower

conversion price of $9.01 in effect between January 12, 2023 and May 12, 2023.

The true-up payments compensate the holder for the difference

between the value of a share and the conversion price in effect at the time of redemption, multiplied by the number of shares paid.

true-up payments totaling $0.6 million were paid on May 12, 2023.

June 30, 2022, we entered into an $8.0 million convertible financing agreement with institutional investors.

The agreement provided for

two closings, each for notes payable of $4.24 million (resulting in gross cash proceeds of $4.0 million).

Funds were received for the

first closing on July 1, 2022 and for the second closing on August 9, 2022.

The remaining amount of principal and interest on the 2022

Notes was repaid in the first quarter of 2023.

We were obligated under the 2022 Notes to pay additional cash as true-up payments for

interest or redemption amounts that we paid in shares of common stock that were valued below $24.07 or the lower conversion price of

$9.01 in effect between January 12, 2023 and May 12, 2023.

The true-up payments compensate the holder for the difference between the

value of a share and the conversion price in effect at the time of redemption, multiplied by the number of shares paid.

The true-up payments

totaling $0.6 million were paid on May 12, 2023.

connection with each of the first and second closings of the 2022 Notes we also issued warrants to purchase 38,894 shares of the Company’s

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The warrants have a current exercise price of $3.64 and are exercisable for five years following issuance of the 2022 Notes.

Underwriting Agreement

December 7, 2022, we entered into an underwriting agreement (the “ Underwriting Agreement ”) with Lake Street Capital

Management, LLC (the “ Underwriter ”), pursuant to which we agreed to issue and sell (i) 190,000 shares (the “ Firm

Shares ”) of the Company’s common stock, par value $0.0001 per share (the “ Common Stock ”), (ii) pre-funded

warrants (the “ Pre-Funded Warrants ”) to purchase 51,666 shares of Common Stock and (iii) warrants to purchase 483,333

shares of Common Stock (the “ Common Warrants ” and, collectively with the Pre-Funded Warrants, the “ Warrants ”)

to the Underwriter in a public offering (the “ Offering ”).

In addition, under the terms of the Underwriting Agreement,

the Company granted the Underwriter the option, for 45 days from the closing of the Offering, to purchase up to 28,500 additional shares

of Common Stock and Common Warrants to purchase up to an additional 72,500 shares of Common Stock (the “ Option Shares ”

and, together with the Firm Shares, the “ Shares ”).

December Offering

December 7, 2022, we entered into an underwriting agreement with Lake Street Capital Management, LLC (the “ Underwriter ”),

pursuant to which we agreed to issue and sell (i) 190,000 shares of the Company’s common stock, par value $0.0001 per share, (ii)

pre-funded warrants to purchase 51,666 shares of common stock and (iii) warrants to purchase 483,333 shares of common stock to the Underwriter

in a public offering.

In addition, the Company granted the Underwriter the option, for 45 days from the closing of the offering, to purchase

up to 28,500 additional shares of common stock and common warrants to purchase up to an additional 72,500 shares of common stock.

Underwriter agreed to purchase the shares from the Company pursuant to at a price of $15.62 per share.

lieu of a purchase of common stock that would otherwise result in an investor’s beneficial ownership exceeding 4.99% (or, at the

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to purchase one share of common stock at an exercise price of $0.0001.

Each Pre-Funded Warrant will be exercisable upon issuance and

will expire when exercised in full (all Pre-Funded Warrants were exercised immediately upon issuance).

Each Pre-Funded Warrant is being

sold with a Common Warrant to purchase two shares of Common Stock.

The public purchase price of one share of Common Stock and accompanying

Common Warrant to purchase two shares of Common Stock is $16.80 and the combined purchase price of one Pre-Funded Warrant and accompanying

Common Warrant to purchase two shares of Common Stock is $16.80.

The Underwriter agreed to purchase the Firm Shares from the Company

pursuant to the Underwriting Agreement at a price of $15.62 per share.

Each pre-funded warrant was exercisable upon issuance and will

expire when exercised in full (all pre-funded warrants were exercised immediately upon issuance).

Each pre-funded warrant was sold with

a common warrant to purchase two shares of common stock.

The public purchase price of one share of common stock and accompanying common

warrant to purchase two shares of Common Stock is $16.80 and the combined purchase price of one pre-funded warrant and accompanying common

warrant to purchase two shares of common stock is $16.80.

common warrant is exercisable immediately at an exercise price of $16.80 per share and will expire five years following the date of issuance.

The offering closed on December 9, 2022 and we received aggregate gross proceeds of approximately $4.1 million from the Offering.

Offering was made under a registration statement on Form S-1 filed with the Securities and Exchange Commission (Registration No.

connection with the Offering, the Company’s directors and executive officers signed lock-up agreements by which they agreed not

to sell or transfer any Common Stock without first obtaining the written consent of the Underwriter, subject to certain exceptions, for

a period of 90 days after the date of the final prospectus relating to the Offering.

February Offering

February 2, 2023, we entered into a definitive Securities Purchase Agreement (the “ Purchase Agreement ”) with

certain institutional investors (the “ Purchasers ”), pursuant to which the Company agreed to issue and sell in a

registered direct offering (the “ Offering ”), priced “at-the-market” under the rules of The Nasdaq

Stock Market, an aggregate of 297,619 shares (the “ Shares ”) of common stock of the Company, par value $0.0001 per

share (the “ Common Stock ”), at an offering price of $10.08 per share, for gross proceeds of approximately $3.0

million before the deduction of placement agent fees and related costs of $0.3 million.

The closing of the Offering occurred on

February 6, 2023.

The Shares were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No.

333-269157), which was initially filed with the Securities and Exchange Commission (the “ Commission ”) on January

9, 2023 and was declared effective by the Commission on January 17, 2023 (the “Registration Statement”), and a related

a concurrent private placement (the “ Private Placement ”), the Company issued to the Purchasers, for each share of

Common Stock purchased in the Offering, a common warrant to purchase one share of Common Stock (the “ Common Warrants ”).

The Common Warrants are exercisable immediately upon issuance and terminate five and one-half years following issuance.

The Common Warrants

have an exercise price of $8.58 per share and are exercisable to purchase an aggregate of up to 297,619 shares of Common Stock and expire

on August 7, 2028.

A holder of a Common Warrant will not have the right to exercise any portion of its warrants if the holder, together

with its affiliates, would beneficially own in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance)

of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the “ Beneficial Ownership

Limitation ”);

February 2, 2023, we entered into a definitive Securities Purchase Agreement with certain institutional investors , pursuant to which

the Company agreed to issue and sell in a registered direct offering, priced “at-the-market” under the rules of The Nasdaq

Stock Market, an aggregate of 297,619 shares of common stock of the Company, par value $0.0001 per share, at an offering price of $10.08

per share, for gross proceeds of approximately $3.0 million before the deduction of placement agent fees and related costs of $0.3 million.

The closing of the Offering occurred on February 6, 2023.

a concurrent private placement, the Company issued to the institutional investors, for each share of common stock purchased in the offering,

a common warrant to purchase one share of common stock.

The common warrants are exercisable immediately upon issuance and terminate five

and one-half years following issuance.

The common warrants have an exercise price of $8.58 per share and are exercisable to purchase

an aggregate of up to 297,619 shares of Common Stock and expire on August 7, 2028.

A holder of a common warrant will not have the right

to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or 9.99%

at the election of the holder prior to the date of issuance) of the number of shares of common stock outstanding immediately after giving

effect to such exercise;

provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease

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acted as the exclusive placement agent (the “ Placement Agent ”) for the offering.

We issued warrants

(the “ Placement Agent Warrants ”) to purchase up to 20,833 shares of Common Stock to the Placement Agent (including

its designees).

These warrants have an exercise price equal to $12.60 per share and are exercisable for five years from the commencement

of sales in the Offering.

The Common Warrants and Placement Agent Warrants and the shares of our Common Stock issuable upon the exercise

of the Common Warrants and Placement Agent Warrants are not being registered under the Securities Act of 1933, as amended (the “ Securities

Act ”), are not being offered pursuant to the Registration Statement, and are being offered pursuant to the exemption provided

in Section 4(a)(2) under the Securities Act and Rule 506(b).

the Purchase Agreement, we agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any

shares of Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock for a period of 30 days following

the closing of the Offering.

Our officers and directors agreed, subject to limited exceptions, for a period of 90 days after the closing

of the Offering, to not offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of, directly or indirectly, or establish

or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Securities

Exchange Act of 1934, as amended, with respect to, any shares of Common Stock or securities convertible, exchangeable or exercisable

into, shares of Common Stock beneficially owned, held or thereafter acquired by them.

closing of the Offering and the Private Placement was subject to satisfaction of customary closing conditions set forth in the Purchase

The representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the

parties to the Purchase Agreement.

In addition, such representations, warranties and covenants (i) are intended as a way of allocating

the risk between the parties to the Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in

a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company.

Accordingly, the

Purchase Agreement is filed with this report only to provide investors with information regarding the terms of transaction, and not to

provide investors with any other factual information regarding the Company.

Moreover, information concerning the subject matter of the

representations and warranties may change after the date of the Purchase Agreement, which subsequent information may or may not be fully

reflected in public disclosures.

We issued placement

agent warrants to purchase up to 20,832 shares of common stock to the Placement Agent (including its designees).

These warrants have

an exercise price equal to $12.60 per share and are exercisable for five years from the commencement of sales in the offering.

warrants and placement agent warrants and the shares of our common stock issuable upon the exercise of the common warrants and placement

agent warrants are not being registered under the Securities Act of 1933, as amended, are not being offered pursuant to the Registration

Statement, and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act of 1933 and Rule 506(b).

the Securities Purchase Agreement, we agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance

of any shares of common stock or any securities convertible into or exercisable or exchangeable for Common Stock for a period of 30 days

following the closing of the offering.

Our officers and directors agreed, subject to limited exceptions, for a period of 90 days after

the closing of the offering, to not offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of, directly or indirectly,

or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section

16 of the Securities Exchange Act of 1934, as amended, with respect to, any shares of common stock or securities convertible, exchangeable

or exercisable into, shares of common stock beneficially owned, held or thereafter acquired by them.

May 12, 2023, the Company completed a public offering of an aggregate of 1,800,876 shares of its common stock at par value $0.0001 per

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its affiliates, would beneficially own in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance) of the

number of shares of Common Stock outstanding immediately after giving effect to such exercise (the “ Beneficial Ownership Limitation ”);

provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership

Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%.

Gross proceeds from this offering

are approximately $7.0 million before the deduction of placement agent fees and related costs of $0.7 million.

number of shares of Common Stock outstanding immediately after giving effect to such exercise ;

provided, however, that upon 61 days’

prior notice to the Company, the holder may increase or decrease the beneficial ownership limitation, provided that in no event shall

the beneficial ownership limitation exceed 9.99%.

Gross proceeds from this offering are approximately $7.0 million before the

deduction of placement agent fees and related costs of $0.7 million.

Wainwright & Co.

acted as the exclusive placement agent for the offering.

The shares and related warrants were offered by the Company

pursuant to a registration statement on Form S-1 (File No.

333-271480), which was initially filed with the Commission on April 28, 2023

and was declared effective by the Commission on May 9, 2023 (the “Registration Statement”), and a related prospectus.

Registration Statement also registered warrants issued to the placement agent to purchase 126,061 shares of Common Stock at a per share

exercise price of $4.8588, which is 125% of the price of the Shares in the offering.

connection with the offering, the Company also agreed to amend certain existing warrants to purchase up to an aggregate of 210,085 shares

The Company also registered warrants issued to the placement

agent to purchase 126,061 shares of common stock at a per share exercise price of $4.8588, which is 125% of the price of the shares in

the offering.

connection with the offering, the Company amended certain existing warrants to purchase up to an aggregate of 210,085 shares

of the Company’s common stock that were previously issued in September 2021 through December 2022 to purchasers in the offering

at exercise prices ranging from $16.80 to $187.20 per share, such that effective upon the closing of the offering the amended warrants

will have a reduced exercise price of $3.64 per share, at an additional offering price of $0.125 per amended warrant.

at exercise prices ranging from $16.80 to $187.20 per share, such that the amended warrants

have a reduced exercise price of $3.64 per share, at an additional offering price of $0.125 per amended warrant.

October Notes

October 23, 2023, the Company entered into a Securities Purchase Agreement (the “SPA”) for an aggregate financing of $1.7

million with investors.

At the first closing under the SPA, which occurred on October 25, 2023, the Company issued to the investors (i) senior secured convertible promissory notes in the aggregate principal amount of $612,000 for an aggregate

purchase price of $566,667 and (ii) warrants to purchase 1,255,697 shares of the Company’s common stock in the aggregate.

At the second closing under the SPA, which will occur upon certain conditions being satisfied, the Company will

issue to the investors referenced above, (i) additional notes in the aggregate principal amount of $1,224,000 for an aggregate purchase

price of $1,133,333 and (i) additional warrants to purchase 2,511,394 shares of the common stock in the aggregate.

In connection with

the financing, the Company issued a $0.2 million senior secured convertible promissory note to a board member.

combined notes are subject to an original issue discount of 8%, have a term of six months from their respective date of issuance and

accrue interest at the rate of 6.0% per annum.

The notes are convertible into common stock, at a per share conversion price equal to

Beginning ninety days following issuance of the notes at the first closing and second closing, respectively, the Company is obligated to redeem monthly one third of the

original principal amount under the applicable note, plus accrued but unpaid interest, liquidated damages and any other amounts then

owing to the holder of such note.

The Company is required to pay the redemption amount in cash with a premium of 10% or, at the

election of the investor at any time, some or all of the principal amount and interest may be paid by conversion of shares under

the note into common stock based on a conversion price equal to $1.5675.

warrants have an exercise price of $1.5675 and are exercisable for five years following issuance on each of the first and second closing dates under the SPA.

of Our Operating Results

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costs for convertible notes

issuance costs for convertible notes represent the original issue discount (expensed immediately due to the initial recognition at

fair value of the 2022 Notes noted above), and legal and accounting fees incurred in connection with the issuance of the 2022

issuance costs for convertible notes represent the original issue discount (expensed immediately due to the initial recognition at fair

value of the 2022 Notes noted above), and legal and accounting fees incurred in connection with the issuance of the 2022 Notes.

in fair value of convertible notes

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available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

As of June 30, 2023

As of September 30,

2023 and December 31, 2022, we continue to maintain a full valuation allowance against all of our deferred tax assets based on our evaluation

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of Operations

of the three months ended June 30, 2023 and 2022:

Three Months Ended June 30,

of the three months ended September 30, 2023 and 2022:

Three Months Ended September 30,

Federal grants

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Other income (expense):

Issuance costs for convertible notes

Loss on issuance of convertible notes

Change in fair value of convertible notes

Issuance of liability classified warrants

Change in fair value of liability classified warrants

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Interest expense

Other income, net

Other income and expense, net

Total other income (expenses), net

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grant funding

from federal grants for the three months ended June 30, 2023 and 2022 totaled $0.5 million and $0.2 million, respectively.

from federal grants for the three months ended September 30, 2023 and 2022 totaled $0.4 million and $0.3 million, respectively.

The difference

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and development expenses

and development expenses for the three months ended June 30, 2023 and 2022 were $1.6 million and $5.3 million, respectively, representing

and development expenses for the three months ended September 30, 2023 and 2022 were $1.9 million and $4.8 million, respectively, representing

a decrease of $2.9 million.

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We do not currently track expenses on a program-by-program basis.

expect future research and development expenses to approximate current levels.

expect future research and development expenses to fluctuate based on timing of projects and clinical trials.

and administrative expenses

and administrative expenses for the three months ended June 30, 2023 and 2022 were $1.1 million and $1.9 million, respectively, representing

a decrease of $0.8 million.

The decrease was primarily a result of reduced stock-based compensation, reduced costs associated with liability

insurance and no current employee bonus expenses in the 2023 period.

We expect future general and administrative expenses to approximate

current levels.

and administrative expenses for the three months ended September 30, 2023 and 2022 were $1.2 million and $1.7 million, respectively,

representing a decrease of $0.5 million.

The decrease was primarily a result of reduced stock-based compensation, reduced costs associated

with liability insurance, legal, and consulting fees, and no current employee bonus expenses in the 2023 period.

We expect future general

and administrative expenses to approximate current levels.

income and expense

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The change in

fair value of liability classified warrants for the three months ended June 30, 2023 are primarily the result of the warrants outstanding

fair value of liability classified warrants for the three months ended September 30, 2023 are primarily the result of the warrants outstanding

for both the 2021 Notes and 2022 Notes compared to only changes related to the warrants associated with the 2021 Notes in the prior period,

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corresponding activity in the 2023 period associated with the 2021 Notes due to the settlement of the 2021 Notes during the previous

of the six months ended June 30, 2023 and 2022:

Six Months Ended June 30

of the nine months ended September 30, 2023 and 2022:

Nine Months Ended September 30

Federal grants

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Other income (expense):

Issuance costs for convertible notes

Loss on issuance of convertible notes

Change in fair value of convertible notes

Issuance of liability classified warrants

Change in fair value of liability classified warrants

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Interest expense

Other income, net

Total other income, net

Other income and expense, net

Total other income (expense), net

(18,729,609 )

Net loss attributable to noncontrolling interests

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grant funding

from federal grants for the six months ended June 30, 2023 and 2022 totaled $1.3 million and $0.8 million, respectively.

The difference

is due to the timing of research activities eligible for funding.

We expect funding from federal grants to fluctuate in the future due

to the timing of preclinical and clinical development activities under the grants.

from federal grants for the nine months ended September 30, 2023 and 2022 totaled $1.7 million

and $1.1 million, respectively.

The difference is due to the timing of research activities eligible for funding.

We expect funding

from federal grants to fluctuate in the future due to the timing of preclinical and clinical development activities under the grants.

and development expenses

and development expenses for the six months ended June 30, 2023 and 2022 were $3.4 million and $8.4 million, respectively, representing

and development expenses for the nine months ended September 30, 2023 and 2022 were $5.4 million and $13.4 million, respectively, representing

a decrease of $8.0 million.

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We do not currently track expenses on a program-by-program basis.

expect future research and development expenses to approximate current levels.

expect future research and development expenses to fluctuate based on timing of projects and clinical trials.

and administrative expenses

and administrative expenses for the six months ended June 30, 2023 and 2022 were $2.7 million and $4.2 million, respectively, representing

and administrative expenses for the nine months ended September 30, 2023 and 2022 were $3.9 million and $5.7 million, respectively, representing

a decrease of $1.8 million.

The decrease was primarily a result of reduced stock-based compensation, reduced liability insurance and

no current employee bonus expenses in the 2023 period.

We expect future general and administrative expenses to approximate current levels.

The decrease was primarily a result of reduced stock-based compensation, reduced liability insurance legal,

and consulting fees and no current employee bonus expenses in the 2023 period.

We expect future general and administrative expenses to

approximate current levels.

income and expense

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The change in

fair value of liability classified warrants for the six months ended June 30, 2023 are primarily the result of the warrants outstanding

fair value of liability classified warrants for the nine months ended September 30, 2023 are primarily the result of the warrants outstanding

for both the 2021 Notes and 2022 Notes compared to only changes related to the warrants associated with the 2021 Notes in the prior period,

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of liquidity and capital

of June 30 2023, we had $3.8 million of cash and cash equivalents.

On May 12, 2023, we completed a public offering with gross

proceeds of $7.0 million, before deducting placement agent fees and related costs of $0.7 million, for the sale of an aggregate of

1.8 million shares of common stock (or pre-funded warrants in lieu thereof) at a combined offering price of $3.887 per share,

including warrants to purchase up to 3.6 million shares at an exercise price of $3.64 per share.

Since inception, we have generated

limited revenues and have incurred significant operating losses and negative cash flows from our operations, and we anticipate that

we will continue to incur losses for the foreseeable future.

We have not yet commercialized any of our product candidates and we do

not expect to generate revenue from sales of any product candidates for several years, if at all.

of September 30, 2023, we had $1.5 million of cash and cash equivalents.

On October 23, 2023, we entered into a SPA for an aggregate

financing of $1.7 million with investors to issue at the first closing, (i) senior secured convertible promissory notes in the

aggregate principal amount of $612,000 for an aggregate purchase price of $566,667 and (ii) warrants to purchase 1,255,697 shares of

the Company’s common stock, par value $0.0001 per share in the aggregate.

Upon certain conditions being satisfied, at the

second closing, we will issue to the investors referenced above, (i) additional notes in the aggregate principal amount of

$1,224,000 for an aggregate purchase price of $1,133,333 and (i) additional warrants to purchase 2,511,394 shares of the common

stock in the aggregate.

Since inception, we have generated limited revenues and have incurred significant operating losses and

negative cash flows from our operations, and we anticipate that we will continue to incur losses for the foreseeable future.

not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates

for several years, if at all.

have funded our operations to date primarily with proceeds from the sale of common equity, funding under federal research grants and

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that anticipated additional financing will be available to us on favorable terms, if at all, or that we will enter into any collaborations.

funding under two approved federal research grants totaled $3.2 million at June 30, 2023 and is expected to be utilized by August 2024.

Pursuant to the terms and conditions of the two grants, we are required to submit progress reports to NIDA on an annual basis and a final

research performance progress report within 120 days of the performance period end date.

Additionally, the grants limit the use of funds

to activities that are clearly severable and independent from activities that involve human subjects until the receipt by NIDA of (i)

Institutional Review Board (“ IRB ”) approval, (ii) federal-wide assurance from the Office for Human Research Protections,

(iii) a Data and Safety Monitoring Plan, (iv) certification that all key personnel have completed education on the protection of human

subjects and (v) a Clinical Trials Dissemination Plan.

We must also comply with the data sharing policies of NIDA and the NIH Public

Access Policy, that require submission of final peer-reviewed journal manuscripts that arise from the use of grants to PubMed Central

immediately upon acceptance for publication.

funding under two approved federal research grants totaled $2.7 million at September 30, 2023 and is expected to be utilized by August

Pursuant to the terms and conditions of the two grants, we are required to submit progress reports to NIDA on an annual basis and

a final research performance progress report within 120 days of the performance period end date.

Additionally, the grants limit the use

of funds to activities that are clearly severable and independent from activities that involve human subjects until the receipt by NIDA

of (i) Institutional Review Board (“ IRB ”) approval, (ii) federal-wide assurance from the Office for Human Research

Protections, (iii) a Data and Safety Monitoring Plan, (iv) certification that all key personnel have completed education on the protection

of human subjects and (v) a Clinical Trials Dissemination Plan.

We must also comply with the data sharing policies of NIDA and the NIH

Public Access Policy, that require submission of final peer-reviewed journal manuscripts that arise from the use of grants to PubMed

Central immediately upon acceptance for publication.

grant must be repaid.

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following table summarizes our cash flows for each of the periods presented:

Six Months Ended June 30,

Nine Months Ended September 30,

Net cash used in operating activities

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Net cash provided by investing activities

Net cash provided by (used in) financing activities

Net increase (decrease) in cash and cash equivalents

Net cash provided by financing activities

Net decrease in cash and cash equivalents

$ (1,683,321 )

the six months ended June 30, 2023 and 2022, we used cash in operating activities of $6.7 million and $7.9 million, respectively.

decrease primarily resulted from the timing of vendor invoicing and payments.

the six months ended June 30, 2023, there were no investing activities.

the six months ended June 30, 2023, net cash provided by financing activities was $7.4 million, primarily consisting of proceeds from

2023 February and 2023 May offerings, net of transaction costs and the repayment of financed insurance premiums and cash payment of 2022

During the six months ended June 30, 2022, net cash used in financing activities was $0.7 million, primarily consisting of repayment

of financed insurance premiums and cash redemption payment of convertible notes.

$ (7,761,655 )

the nine months ended September 30, 2023 and 2022, we used cash in operating activities of $9.0 million and $14.6 million, respectively.

The decrease primarily resulted from the timing of vendor invoicing and payments.

the nine months ended September 30, 2023, there were no investing activities.

the nine months ended September 30, 2023, net cash provided by financing activities was $7.3 million, primarily consisting of proceeds

from 2023 February and 2023 May offerings of $9.1 million, net of transaction costs of $0.4 million and the repayment of financed insurance

premiums of $0.3 million and cash payment of 2022 Notes of $1.0 million.

During the nine months ended September 30, 2022, net cash provided

by financing activities was $6.8 million, primarily consisting of proceeds from the issuance of the 2022 Notes, net repayment of financed

insurance premiums and cash payment of convertible notes.

primary use of cash is to fund operating expenses, primarily related to our research and development activities.

20 unchanged sentences

have generated limited revenues and have incurred significant operating losses since our inception.

As of June 30, 2023, had an accumulated

deficit of $115.4 million.

As of September 30, 2023, had an

accumulated deficit of $118.0 million.

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

128 unchanged sentences

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 2. Management’s Discussion and Analysis