What changed in this filing

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Item 1. Financial Statements

2021-11-09 compared with 2021-08-11 · 364 added, 182 removed, 208 unchanged (72% of the section changed)

Financial Statements

Celcuity Inc.

Condensed Balance Sheets

June 30, 2021

Balance Sheets

September 30, 2021

December 31, 2020

2 unchanged sentences

Deferred transaction costs

Payroll tax receivable

17 unchanged sentences

2,500,000 shares authorized;

0 shares issued and outstanding as of June 30, 2021 and December 31, 2020

0 shares issued and outstanding as of September 30, 2021 and December 31, 2020

Common stock, $ 0.001 par value:

25,000,000 shares authorized;

12,654,898 and 10,299,822 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

14,905,898 and 10,299,822 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

Additional paid-in capital

4 unchanged sentences

Total Liabilities and Stockholders’ Equity

See accompanying notes to the financial statements

Celcuity Inc.

Condensed Statements of Operations

Three Months Ended June 30,

Six Months Ended June 30,

accompanying notes to the financial statements

Statements of Operations

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

24 unchanged sentences

Weighted average common shares outstanding, basic and diluted

See accompanying notes to the financial statements

Condensed Statements of Changes in Stockholders' Equity

Three Months and Six Months Ended June 30, 2021

Additional Paid-In

accompanying notes to the financial statements

Statements of Changes in Stockholders’ Equity

Months and Nine Months Ended September 30, 2021

Paid-In Capital

Balance at December 31, 2020

1 unchanged sentence

Stock-based compensation

Stock-based compensation, shares

Employee stock purchases

Employee stock purchases, shares

Exercise of common stock warrants

Exercise of common stock options, net of shares withheld for exercise price

Issuance of common stock warrants, note payable

Issuance of common stock, licensing agreement

Issuance of common stock, licensing agreement, shares

Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs

8 unchanged sentences

Exercise of common stock options, net of shares withheld for exercise price

Warrant issued - note payable

Issuance of common stock warrants, note payable

Issuance of common stock, licensing agreement

3 unchanged sentences

$ ( 43,146,101 )

See accompanying notes to the financial statements

Celcuity Inc.

Condensed Statements of Changes in Stockholders' Equity

Three Months and Six Months Ended June 30, 2020

Additional Paid-In

Stock-based compensation

Exercise of common stock options, net of shares withheld for exercise price

Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs

( 6,027,246 )

Balance at September 30, 2021 (unaudited)

$ 123,632,827

$ ( 49,173,347 )

accompanying notes to the financial statements

Statements of Changes in Stockholders’ Equity

Months and Nine Months Ended September 30, 2020

Paid-In Capital

Balance at December 31, 2019

13 unchanged sentences

( 21,296,390 )

See accompanying notes to the financial statements

Celcuity Inc.

Condensed Statements of Cash Flows

Six Months Ended June 30,

Stock-based compensation

Issuance costs associated with ATM offering

( 2,474,298 )

Balance at September 30, 2020 (unaudited)

$ ( 23,770,688 )

accompanying notes to the financial statements

Statements of Cash Flows

Nine Months Ended September 30,

Cash flows from operating activities:

7 unchanged sentences

Changes in operating assets and liabilities:

Payroll tax receivable

Prepaid assets and deposits

25 unchanged sentences

Supplemental disclosures of non-cash investing and financing activities:

Offering and registration statement costs included in accounts payable and accrued expenses

Property and equipment included in accounts payable

Issuance of common stock warrants and final fee recognized as discount to note payable

See accompanying notes to the financial statements

CELCUITY INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)

(For the Three and Six Months Ended June 30, 2021 and 2020)

Nature of Business

Celcuity Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated companion diagnostic (CDx) and therapeutic (Rx) strategy.

Our CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from targeted therapies.

accompanying notes to the financial statements

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Nine Months Ended September 30, 2021 and 2020)

Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company seeking to extend the lives of cancer

patients by pursuing an integrated companion diagnostic (CDx) and therapeutic (Rx) strategy.

Our CELsignia companion diagnostic platform

is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from targeted therapies.

This enables a CELsignia CDx to support advancement of new indications for already approved targeted therapies.

Our therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver our companion diagnostics can identify.

By pursuing an integrated companion diagnostic and therapeutic strategy, we believe we are uniquely positioned to achieve our goal of helping cancer patients receive the therapeutic best suited to treat their cancer driver.

The Company was co-founded in 2012 by Brian F.

Our therapeutic efforts

are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver our companion diagnostics

can identify.

By pursuing an integrated companion diagnostic and therapeutic strategy, we believe we are uniquely positioned to achieve

our goal of helping cancer patients receive the therapeutic best suited to treat their cancer driver.

The Company was co-founded in 2012

Sullivan and Dr.

1 unchanged sentence

The Company has not generated any revenues to date.

Follow-on Offering

On July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 shares of common stock at a public offering price of $ 25.00 per share.

The aggregate gross proceeds from the sale of shares in the follow-on offering was approximately $ 56.3 million before deducting underwriting discounts of approximately $ 3.4 million and offering expenses of approximately $ 0.1 million.

July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 shares of common stock at a public offering price

of $ 25.00 per share.

The aggregate gross proceeds from the sale of shares in the follow-on offering was approximately $ 56.3 million before

deducting underwriting discounts of approximately $ 3.4 million and offering expenses of approximately $ 0.1 million.

February 26, 2021, the Company completed a follow-on offering whereby it sold 1,971,100 shares of common stock (including 257,100 shares

of common stock in connection with the full exercise of the underwriters’ option to purchase additional shares) at a public offering

price of $ 14.00 per share.

The aggregate gross proceeds from the sale of shares in the follow-on offering, including the sale of shares

pursuant to the full exercise of the underwriters’ option to purchase additional shares, was approximately $ 27.6 million before

deducting underwriting discounts of approximately $ 1.6 million and offering expenses of approximately $ 0.2 million.

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements

Basis of Presentation

The accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”).

Accordingly, as permitted by Article 10, the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the United States (“U.S.

The balance sheet at December 31, 2020 was derived from the audited financial statements at that date and does not include all the disclosures required by U.S.

In the opinion of management, all adjustments which are of a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements.

These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2020 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

Operating results for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period.

Accounting Estimates

Management uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S.

Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses.

of Presentation

accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10

of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”).

Accordingly, as permitted by Article 10,

the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the

United States (“U.S.

The balance sheet at December 31, 2020 was derived from the audited financial statements at

that date and does not include all the disclosures required by U.S.

In the opinion of management, all adjustments which are of

a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements.

These unaudited condensed

financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2020

and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results to be expected during the

remainder of the current year or for any future period.

uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S.

Those estimates

and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported

revenues and expenses.

Actual results could differ from those estimates and the difference could be material.

Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.

Risks and Uncertainties

The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests, the clinical and commercial success of its initial drug product, gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition.

Clinical Trial Costs

The Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers, which includes the conduct of preclinical studies and clinical trials.

These costs can be a significant component of the Company’s research and development expenses.

The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with service agreements with its third-party service providers.

The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period.

As actual costs become known, the Company adjusts its prepaid assets or accrued expenses.

Significant items subject

to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs.

and Uncertainties

Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and

commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests, the clinical and commercial

success of its initial drug product, gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of

broad adoption of its approved products, if any, by physicians and consumers, and significant competition.

Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers,

which includes the conduct of preclinical studies and clinical trials.

These costs can be a significant component of the Company’s

research and development expenses.

The Company accrues for these costs based on factors such as estimates of the work completed and in

accordance with service agreements with its third-party service providers.

The Company makes significant judgments and estimates in determining

the accrued liabilities balance in each reporting period.

As actual costs become known, the Company adjusts its prepaid assets or accrued

The Company has not experienced any material differences between accrued costs and actual costs incurred.

However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in an adjustment to expense in future periods.

Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.

Application of New or Revised Accounting Standards

Pursuant to the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), a company constituting an “emerging growth company” is, among other things, entitled to rely upon certain reduced reporting requirements.

The Company is an emerging growth company but has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards.

As a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for public companies that are not emerging growth companies.

Recently Adopted Accounting Pronouncements

In August 2020, the FASB issued ASU No.

2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ("ASU 2020-06"), which simplifies accounting for convertible instruments by removing major separation models required under current U.S.

ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for derivative scope exceptions and also simplifies the diluted earnings per share calculation in certain areas.

The standard is effective for public business entities, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years and interim periods within those fiscal years beginning after December 15, 2021.

For all other entities, the standard will be effective for fiscal years beginning after December 15, 2023.

Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and adoption must be as of the beginning of the Company’s annual fiscal year.

The Company’s early adoption of this accounting standard on April 8, 2021, in conjunction with the closing of a loan agreement, did not have an impact on the Company’s financial statements and related disclosures.

However, the status

and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s

estimates, resulting in an adjustment to expense in future periods.

Changes in these estimates that result in material changes to the

Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.

of New or Revised Accounting Standards

to the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), a company constituting an “emerging growth company”

is, among other things, entitled to rely upon certain reduced reporting requirements.

The Company is an emerging growth company but has

irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or

revised accounting standards.

As a result, the Company will comply with new or revised accounting standards on the relevant dates on

which adoption of such standards is required for public companies that are not emerging growth companies.

Adopted Accounting Pronouncements

August 2020, the FASB issued ASU No.

2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging

- Contracts in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s

Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required

under current U.S.

ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for derivative

scope exceptions and also simplifies the diluted earnings per share calculation in certain areas.

The standard is effective for public

business entities, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years and interim

periods within those fiscal years beginning after December 15, 2021.

For all other entities, the standard will be effective for fiscal

years beginning after December 15, 2023.

Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020,

and adoption must be as of the beginning of the Company’s annual fiscal year.

The Company’s early adoption of this accounting

standard on April 8, 2021, in conjunction with the closing of a loan agreement, did not have an impact on the Company’s financial

statements and related disclosures.

Net Loss Per Common Share

Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period.

For all periods presented, the common shares underlying the options and warrants have been excluded from the calculation because their effect would be anti-dilutive.

Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same.

For the three and six months ended June 30, 2021 and 2020, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were options to purchase 1,023,513 and 723,194 shares of common stock, respectively, warrants to purchase 378,442 and 353,585 shares of common stock, respectively, and 2,964 and 15,686 shares of restricted common stock, respectively.

Operating and Finance Leases

The Company leases its corporate space in Minneapolis, Minnesota.

In September 2017, the Company entered into a non-cancelable operating lease agreement for building space.

The new lease commenced, and the Company moved to the facility in May 2018, in conjunction with the termination of its then existing lease.

and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average

common shares outstanding during the period.

For all periods presented, the common shares underlying the options and warrants have been

excluded from the calculation because their effect would be anti-dilutive.

Therefore, the weighted-average shares outstanding used to

calculate both basic and diluted loss per common share are the same.

the three and nine months ended September 30, 2021 and 2020, potentially dilutive securities excluded from the computations of diluted

weighted-average shares outstanding were options to purchase 1,184,721 and 810,725 shares of common stock, respectively, warrants to

purchase 378,442 and 353,585 shares of common stock, respectively, and 2,964 and 15,686 shares of restricted common stock, respectively.

and Finance Leases

Company leases its corporate space in Minneapolis, Minnesota.

In September 2017, the Company entered into a non-cancelable operating

lease agreement for building space.

The new lease commenced, and the Company moved to the facility in May 2018, in conjunction with the

termination of its then existing lease.

Rent expense is recorded on a straight-line basis over the lease term.

In July 2020 the Company signed an amendment to extend this lease through April 30, 2022.

The lease amendment provides for monthly rent, real estate taxes and operating expenses.

As a result of the lease amendment, the Company recorded an incremental $ 197,211 in the operating right-of-use (“ROU”) asset and lease liability.

The lease agreement, as amended, includes the option to extend the term for one additional year.

The option to extend is at the Company’s discretion and because the Company has not determined if the option to extend will be exercised, the extended lease term is not included in the ROU assets and lease liabilities.

The Company regularly evaluates the renewal options and when it is reasonably certain of exercise, the Company will include the renewal period in its lease term.

In May 2018, the Company entered into a non-cancelable finance lease agreement for office equipment with a five-year term.

The underlying assets are included in furniture and equipment.

In July 2020 the Company

signed an amendment to extend this lease through April 30, 2022.

The lease amendment provides for monthly rent, real estate taxes and

operating expenses.

As a result of the lease amendment, the Company recorded an incremental $ 197,211 in the operating right-of-use (“ROU”)

asset and lease liability.

In July 2021, the Company signed the second amendment to extend this lease through April 30, 2023.

This amendment

provides for monthly rent, real estate taxes and operating expenses.

The Company recorded an incremental $ 193,517 in the operating right-of-use

(“ROU”) asset and lease liability pertaining to this amendment.

The second amendment also includes the option to extend the

term for one additional year.

The option to extend is at the Company’s discretion and because the Company has not determined if

the option to extend will be exercised, the extended lease term is not included in the ROU assets and lease liabilities.

regularly evaluates the renewal options and when it is reasonably certain of exercise, the Company will include the renewal period in

its lease term.

May 2018, the Company entered into a non-cancelable finance lease agreement for office equipment with a five-year term.

The underlying

assets are included in furniture and equipment.

The lease contains a bargain purchase option at the end of the lease.

When an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments.

Supplemental balance sheet information consisted of the following at June 30, 2021:

an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement

date in determining the present value of the lease payments.

balance sheet information consisted of the following at September 30, 2021:

of Supplemental Balance Sheet Information Related to Leases

Operating Lease

10 unchanged sentences

Long term portion

Maturity analysis under lease agreements consisted of the following as of June 30, 2021:

analysis under lease agreements consisted of the following as of September 30, 2021:

of Maturity Analysis Under Lease Agreements

Operating Leases

2 unchanged sentences

Present value discount

Less amount representing services

Amount representing services

Present value of net minimum lease payments

Weighted Average

Remaining Lease Term

Discount Rate

Weighted Average

Operating lease

Finance lease

Lease costs for the period ended June 30, 2021:

Lease costs for the period ended September 30, 2021:

Schedule of Lease Costs

Three-month Period

Six-month Period

Nine-month Period

Operating lease cost

1 unchanged sentence

Variable lease cost

Supplemental cash flow information related to leases for the period ended June 30, 2021:

Total lease cost

cash flow information related to leases for the period ended September 30, 2021:

of Supplemental Cash Flow Information Related to Leases

Three-month Period

Six-month Period

Nine-month Period

Cash paid for amounts included in operating and finance leases:

2 unchanged sentences

Financing cash outflow from finance leases

Clinical Research Studies

The Company enters into contracts in the normal course of business for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes.

The Company currently has five Phase II clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests.

The Company also has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib.

Timing of milestone payments are uncertain and the contracts generally provide for termination following a certain period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material.

Total cash paid for amounts

included in operating and finance leases

Research Studies

Company enters into contracts in the normal course of business for clinical trials, preclinical studies, manufacturing and other services

and products for operating purposes.

The Company currently has six Phase II clinical trial agreements in place to evaluate targeted therapies

selected with one of our CELsignia tests.

The Company also has a license agreement in place with Pfizer to research, develop, manufacture

and commercialize gedatolisib.

In conjunction with the license agreement, the Company is continuing a Phase I study – B2151009

related to gedatolisib.

Timing of milestone payments are uncertain and the contracts generally provide for termination following a certain

period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material.

Stockholders’ Equity

On February 26, 2021, the Company completed a follow-on offering whereby it sold 1,971,100 shares of common stock (including 257,100 shares of common stock in connection with the full exercise of the underwriters’ option to purchase additional shares) at a public offering price of $ 14.00 per share.

The aggregate gross proceeds from the sale of shares in the follow-on offering, including the sale of shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, was approximately $ 27.6 million before deducting underwriting discounts of approximately $ 1.6 million and offering expenses of approximately $ 0.2 million.

On June 5, 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B.

July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 shares of common stock at a public offering price

of $ 25.00 per share.

The offering generated approximately $ 56.3 million before deducting underwriting discounts of approximately $ 3.4

million and offering expenses of approximately $ 0.1 million.

February 26, 2021, the Company completed a follow-on offering whereby it sold 1,971,100 shares of common stock (including 257,100 shares

of common stock in connection with the full exercise of the underwriters’ option to purchase additional shares) at a public offering

price of $ 14.00 per share.

The aggregate gross proceeds from the sale of shares in the follow-on offering, including the sale of shares

pursuant to the full exercise of the underwriters’ option to purchase additional shares, was approximately $ 27.6 million before

deducting underwriting discounts of approximately $ 1.6 million and offering expenses of approximately $ 0.2 million.

June 5, 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B.

Riley FBR, Inc.

(the “Agent”).

Pursuant to the ATM Agreement, the Company was able to offer and sell from time to time, at its option, shares of common stock having an aggregate offering price of up to $ 10,000,000 , par value $0.001 per share (the “Placement Shares”), through the Agent.

The Placement Shares were registered under the Securities Act of 1933, as amended, pursuant to the Registration Statement on Form S-3 (File No.

333-227466), which was originally filed with the SEC on September 21, 2018 and declared effective by the SEC on October 4, 2018, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed on June 5, 2020.

Sales of the Company’s common stock, if any, under this prospectus supplement were able to be made by any method deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

During the six months ended June 30, 2021, the Company sold 3,082 shares of common stock pursuant to the ATM Agreement, at an average selling price of $ 12.64 per share.

On February 23, 2021, in conjunction with the Company’s follow-on offering, the ATM Agreement was terminated.

Pursuant to the ATM Agreement, the Company was able to offer and sell from time to time, at its option, shares

of common stock having an aggregate offering price of up to $ 10,000,000 , par value $ 0.001 per share (the “Placement Shares”),

through the Agent.

Placement Shares were registered under the Securities Act of 1933, as amended, pursuant to the Registration Statement on Form S-3 (File

333-227466), which was originally filed with the SEC on September 21, 2018 and declared effective by the SEC on October 4, 2018,

the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed on June 5, 2020.

the Company’s common stock, if any, under this prospectus supplement were able to be made by any method deemed to be an “at

the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

of the nine months ended September 30, 2021, the Company sold 3,082 shares of common stock pursuant to the ATM Agreement, at an average

selling price of $ 12.64 per share.

February 23, 2021, in conjunction with the Company’s follow-on offering, the ATM Agreement was terminated.

Stock-Based Compensation

The following table summarizes the activity for all stock options outstanding for the six months ended June 30:

following table summarizes the activity for all stock options outstanding for the nine months ended September 30:

of Stock Options Exercised

Weighted Average Exercise Price

1 unchanged sentence

Options outstanding at beginning of year

Balance at June 30

Options exercisable at June 30:

Balance at September 30

Options exercisable at September 30:

Weighted Average Grant Date Fair Value for options granted during the period:

The following table summarizes additional information about stock options outstanding and exercisable at June 30, 2021:

Options Outstanding

Options Exercisable

following table summarizes additional information about stock options outstanding and exercisable at September 30, 2021:

of Stock Options Outstanding and Exercisable

Options Outstanding Options Exercisable

Options Outstanding

5 unchanged sentences

Aggregate Intrinsic Value

The Company recognized stock-based compensation expense for stock options of $ 520,361 and $ 414,272 for the three months ended June 30, 2021 and 2020, respectively and $ 938,553 and $ 864,937 for the six months ended June 30, 2021 and 2020, respectively.

In May 2020, the Company modified the exercise price on 203,750 stock option awards to $5.10, the closing market price on the Nasdaq Capital Market on May 14, 2020.

Company recognized stock-based compensation expense for stock options of $ 673,022 and $ 410,544 for the three months ended September 30,

2021 and 2020, respectively and $ 1,611,575 and $ 1,275,481 for the nine months ended September 30, 2021 and 2020, respectively.

2020, the Company modified the exercise price on 203,750 stock option awards to $ 5.10 , the closing market price on the Nasdaq Capital

Market on May 14, 2020.

No director or officer awards were modified.

The effect on stock-based compensation was $ 12,790 and $ 51,000 for the three months ended June 30, 2021 and 2020, respectively and $ 26,239 and $ 51,000 for the six months ended June 30, 2021 and 2020.

The effect on stock-based compensation was $ 12,602 and $ 19,000 for

the three months ended September 30, 2021 and 2020, respectively and $ 34,396 and $ 70,000 for the nine months ended September 30, 2021

The effect on stock-based compensation over the remaining service period will be approximately $ 97,000 .

The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions for the six months ended June 30:

Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions

for the nine months ended September 30:

of Fair Value of Equity-based Awards

Risk-free interest rate

0.63 % - 1.14 %

0.35 % - 1.66 %

Expected volatility

76.6 % - 76.9 %

73.3 % - 74.4 %

Expected life (years)

Expected dividend yield

The inputs for the Black-Scholes valuation model require management’s significant assumptions.

Prior to the Company’s initial public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings.

Subsequent to the initial public offering, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date.

inputs for the Black-Scholes valuation model require management’s significant assumptions.

Prior to the Company’s initial

public offering, the price per share of common stock was determined by the Company’s board based on recent prices of common stock

sold in private offerings.

Subsequent to the initial public offering, the price per share of common stock is determined by using the

closing market price on the Nasdaq Capital Market on the grant date.

The risk-free interest rates are based on the rate for U.S.

Treasury securities at the date of grant with maturity dates approximately equal to the expected life at the grant date.

The expected life is based on the simplified method in accordance with the SEC Staff Accounting Bulletin Nos.

The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated volatility since being publicly traded.

All assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for options granted to employees.

In the event the Company terminates any of its consulting agreements, the unvested options issued in connection with the agreements would also be cancelled.

Restricted stock awards were granted to two members of the Company’s board during the three months ended June 30, 2021 and 2020.

The Company had 2,964 and 15,686 shares of restricted stock outstanding as of June 30, 2021 and 2020, respectively, and 15,686 and 0 shares of restricted stock vested during the three months ended June 30, 2021 and 2020.

The Company recognized stock-based compensation expense for restricted stock of $ 18,112 and $ 10,912 for the three months ended June 30, 2021 and 2020, respectively and $ 38,567 and $ 10,912 for the six months ended June 30, 2021 and 2020.

The Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”).

The number of shares reserved for issuance was automatically increased by 102,540 shares on January 1, 2020 and by 102,998 shares on January 1, 2021 and will increase automatically on January 1 of each of 2022 through 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December 31.

At the Annual Meeting held on May 12, 2021, the stockholders approved a one-time, 500,000 increase to the number of shares reserved for issuance under the 2017 Plan.

securities at the date of grant with maturity dates approximately equal to the expected life at the grant date.

The expected life is

based on the simplified method in accordance with the SEC Staff Accounting Bulletin Nos.

The expected volatility is estimated

based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated

volatility since being publicly traded.

assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for

options granted to employees.

In the event the Company terminates any of its consulting agreements, the unvested options issued in connection

with the agreements would also be cancelled.

Company had 2,964

shares of restricted stock outstanding as of

September 30, 2021 and 2020, respectively, and 0

shares of restricted stock vested during the

three months ended September 30, 2021 and 2020.

The Company recognized stock-based compensation expense for restricted stock of $ 20,792

for the three months ended September 30, 2021

and 2020, respectively and $ 59,359

for the nine months ended September 30, 2021

and 2020, respectively.

Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive

Plan (the “2017 Plan”).

The number of shares reserved for issuance was automatically increased by 102,540 shares on January

1, 2020 and by 102,998 shares on January 1, 2021 and will increase automatically on January 1 of each of 2022 through 2027 by the number

of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December

At the Annual Meeting held on May 12, 2021, the stockholders approved a one-time, 500,000 increase to the number of shares reserved

for issuance under the 2017 Plan.

However, the Company’s board may reduce the amount of the increase in any particular year.

The total remaining shares available for grant under the Company’s 2017 Plan as of June 30, 2021 was 585,772 .

Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:

total remaining shares available for grant under the Company’s 2017 Plan as of September 30, 2021 was 423,564 .

unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:

of Unrecognized Compensation Cost

Total estimated compensation cost to be recognized

The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 1,844 and ($ 1,991 ) for the three months ended June 30, 2021 and 2020, respectively and $ 12,295 and $ 11,993 for the six months ended June 30, 2021 and 2020, respectively.

The Company initially reserved a total of 100,000 shares for issuance under the employee stock purchase plan.The number of shares reserved for issuance was automatically increased by 51,270 shares on January 1, 2020 and 51,499 shares on January 1, 2021 and will increase automatically on each subsequent January 1 by the number of shares equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31.

However, the Company’s board may reduce the amount of the increase in any particular year.

The total remaining shares available for issuance under the employee stock purchase plan as of June 30,2021 was 158,214 .

The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30:

Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 6,102

for the three months ended September 30, 2021

and 2020, respectively and $ 18,397

for the nine months ended September 30, 2021

and 2020, respectively.

The Company initially reserved a total of 100,000

shares for issuance under the employee stock

purchase plan.

The number of shares reserved for issuance was automatically increased by 51,270

shares on January 1, 2020 and 51,499

shares on January 1, 2021 and will increase automatically

on each subsequent January 1 by the number

of shares equal to 0.5% of the total outstanding number of shares of

Company common stock as of the immediately preceding December 31.

However, the Company’s board may reduce the amount of the increase

in any particular year.

The total remaining shares available for issuance under the employee stock purchase plan as of September 30,

2021 was 158,214 .

Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30:

of Stock-based Compensation Expense

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Stock-based compensation expense in operating expenses:

1 unchanged sentence

General and administrative

On April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender.The Lender agreed to loan up to $ 25 million in three tranches consisting of (i) a $ 15.0 million non-contingent term A loan that was funded on April 8, 2021, (ii) a $ 5 million term B loan to be funded upon request of the Company no later than March 31, 2022, and (iii) a $ 5 million term C loan to be funded upon request of the Company no later than March 31, 2023 (collectively the “Term Loans”).

April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences

Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender.

Lender agreed to loan up to $ 25 million in three tranches consisting of (i) a $ 15.0 million non-contingent term A loan that was funded

on April 8, 2021, (ii) a $ 5 million term B loan to be funded upon request of the Company no later than March 31, 2022, and (iii) a $ 5

million term C loan to be funded upon request of the Company no later than March 31, 2023 (collectively the “Term Loans”).

Funding of the term B and C loan is subject to the Company’s ability to achieve certain milestones.

The Innovatus Loan Agreement is secured by a lien covering substantially all assets of the Company.

The loan agreement also contains certain events of default, warranties and covenants of the Company.

In connection with each funding of the Term Loans, the Company is required to issue Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s stock equal to 2.5% of the principal amount of the relevant Term Loan funded divided by the exercise price, which will be based on the lower of (i) $ 14.40 per share or (ii) the volume weighted price per share of the Company’s stock for the five-trading day period ending on the last trading day immediately preceding the funding date of the Term B or Term C Loan, as applicable.

The warrants may be exercised on a cashless basis and are immediately exercisable through the tenth anniversary of the applicable funding date.

In connection with the first tranche of the Term Loans, the Company issued a warrant to Innovatus to purchase 26,042 shares of the Company’s common stock at an exercise price of $14.40 per share.

The Company evaluated the warrant under ASC470, debt, and recognized an additional debt discount of approximately $ 0.3 million based on the relative fair value of the base instruments and warrants.

The Company calculated the fair value of the warrant using the Black-Scholes model.

The Company is also required to maintain a minimum cash balance in agreement with the term loans’ default terms.

The Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met.

The Term Loans will mature on the fifth anniversary of the initial funding date and will bear interest at a rate equal to sum of (a) the greater of (i)Prime Rate (as defined in the loan agreement) or (ii) 3.25%, plus (b) 5.70%.

The Innovatus Loan Agreement

is secured by a lien covering substantially all assets of the Company.

Loan Agreement also contains certain events of default, warranties and covenants of the Company.

In connection with each funding of the

Term Loans, the Company is required to issue Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s

stock equal to 2.5% of the principal amount of the relevant Term Loan funded divided by the exercise price, which will be based on the

lower of (i) $14.40 per share or (ii) the volume weighted price per share of the Company’s stock for the five-trading day period

ending on the last trading day immediately preceding the funding date of the Term B or Term C Loan, as applicable.

The warrants may be

exercised on a cashless basis and are immediately exercisable through the tenth anniversary of the applicable funding date.

In connection

with the first tranche of the Term Loans, the Company issued a warrant to Innovatus to purchase 26,042 shares of the Company’s

common stock at an exercise price of $ 14.40 per share.

The Company evaluated the warrant under ASC 470, debt, and recognized an additional

debt discount of approximately $ 0.3 million based on the relative fair value of the base instruments and warrants.

The Company calculated

the fair value of the warrant using the Black-Scholes model.

The Company is also required to maintain a minimum cash balance in agreement

with the term loans’ default terms.

Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met.

The Term Loans will mature on the fifth anniversary of the initial funding date and will bear interest at a rate equal to sum of (a)

the greater of (i) Prime Rate (as defined in the Loan Agreement) or (ii) 3.25%, plus (b) 5.70%.

The effective interest rate is 11.36 %.

Additionally, the Company elected to make 2.7 % of the interest rate as payable in kind, which shall accrue as principal monthly.

The Company is obligated to pay the Lender (i) a non-refundable facility fee in the amount of 1.00% of each term loan that is funded (the “Facility Fee”), and (ii) a final fee equal to 4.50% of the aggregate amount of the term loans funded (the “Final Fee”).

In connection with the funding of the first tranche of the Term Loans, a final fee of approximately $ 0.7 million was recorded as additional principal and as a debt discount, and a facility fee of approximately $ 0.1 million was recorded as additional debt discount.

The Company has the option to prepay the loan at any time following the first anniversary of the loan closing, with tiered prepayment fees ranging from 0 – 2% based on when the prepayment would occur.

Innovatus also has the right, at its election, after June 1, 2021 and until the third anniversary of the Loan Agreement, to convert up to 20% of the outstanding principal amount of all Terms Loans made under the Loan Agreement into shares of the Company’s common stock at a price per share equal to the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the execution of the Loan Agreement (the “Conversion Right”).

In connection with the loan agreement and the funding of the first tranche of the Term Loans, the Company incurred debt issuance costs of approximately $ 0.5 million.

The debt issuance costs, and the debt discount are amortized to interest expense using the effective interest method over the life of the Term Loans.

The carrying value of the debt approximates fair value as of June 30, 2021.

Long-term debt consisted of the following:

June 30, 2021

Company is obligated to pay the Lenders (i) a non-refundable facility fee in the amount of 1.00 % of each term loan that is funded (the

“Facility Fee”), and (ii) a final fee equal to 4.50 % of the aggregate amount of the term loans funded (the “Final Fee”).

In connection with the funding of the first tranche of the Term Loans, a final fee of approximately $ 0.7 million was recorded as additional

principal and as a debt discount, and a facility fee of approximately $ 0.1 million was recorded as additional debt discount.

has the option to prepay the loan at any time following the first anniversary of the loan closing, with tiered prepayment fees ranging

from 0 – 2% based on when the prepayment would occur.

also has the right, at its election, after June 1, 2021 and until the third anniversary of the Loan Agreement, to convert up to 20 % of

the outstanding principal amount of all Terms Loans made under the Loan Agreement into shares of the Company’s common stock at

a price per share equal to the volume weighted average closing price of the Company’s stock for the 5-trading day period ending

on the last trading day immediately preceding the execution of the Loan Agreement (the “Conversion Right”).

connection with the Loan Agreement and the funding of the first tranche of the Term Loans, the Company incurred debt issuance costs of

approximately $ 0.5 million.

The debt issuance costs, and the debt discount are amortized to interest expense using the effective interest

method over the life of the Term Loans.

The carrying value of the debt approximates fair value as of September 30, 2021.

debt consisted of the following:

Schedule of Long-term Debt

September 30, 2021

PIK interest (added to principal)

3 unchanged sentences

Total long-term debt

Future principal payments, including the final fee, are as follows:

principal payments, including the final fee, are as follows:

Schedule of Future Principal Payments

Years Ending December 31,

License Agreement

On April 8 th , the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, a potent, well-tolerated, reversible dual inhibitor that targets PI3K and mTOR, for the treatment, diagnosis and prevention of all diseases.

The Company paid Pfizer $ 5.0 million in upfront fees and issued to Pfizer $ 5.0 million of shares of the Company’s common stock pursuant to an Equity Grant Agreement.

The upfront payment and the issuance of shares were expensed to research & development in full for the three months ending June 30, 2021.

The Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $ 335.0 million.

Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition.

April 8 th , the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib,

a potent, well-tolerated, reversible dual inhibitor that targets PI3K and mTOR, for the treatment, diagnosis and prevention of all diseases.

The Company paid Pfizer $ 5.0 million in upfront fees and issued to Pfizer $ 5.0 million of shares of the Company’s common stock

pursuant to an Equity Grant Agreement.

The upfront payment and the issuance of shares were expensed to research & development in

full for the three months ending June 30, 2021.

Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events,

up to an aggregate of $ 335.0 million.

Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages

ranging from the low to mid-teens, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses

and generic competition.

Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations.

The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the License Agreement, a valid claim of a licensed patent right.

The Company has the right to terminate the License Agreement for convenience upon 90 days’ prior written notice.

Pfizer may not terminate the agreement for convenience.

Either the Company or Pfizer may terminate the License Agreement if the other party is in material breach and such breach is not cured within the specified cure period.

In addition, either the Company or Pfizer may terminate the License Agreement in the event of specified insolvency events involving the other party.

Subsequent Events

As noted in footnote 2, on July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 shares of common stock at a public offering price of $ 25.00 per share.

On July 19, 2021, the Company signed an amendment to exercise the option to extend the lease for a period of one year.

The commencement of the extended period is May 1, 2022 and will terminate on April 30, 2023.

The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale

of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product or (c) the

date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but

for the license granted in the license agreement, a valid claim of a licensed patent right.

Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice.

Pfizer may not terminate

the agreement for convenience.

Either the Company or Pfizer may terminate the license agreement if the other party is in material breach

and such breach is not cured within the specified cure period.

In addition, either the Company or Pfizer may terminate the license agreement

in the event of specified insolvency events involving the other party.

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