What changed in this filing

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Item 1. Financial Statements

2022-05-16 compared with 2021-11-09 · 228 added, 293 removed, 279 unchanged (65% of the section changed)

1 unchanged sentence

Balance Sheets

September 30, 2021

December 31, 2020

and cash equivalents

transaction costs

tax receivable

current assets

Cash and cash equivalents

Deferred transaction costs

Payroll tax receivable

Prepaid assets

Total current assets

Property and equipment, net

Operating lease right-of-use assets

Liabilities and Stockholders’ Equity:

and equipment, net

lease right-of-use assets

and Stockholders’ Equity:

lease liabilities

current liabilities

Accounts payable

Finance lease liabilities

Operating lease liabilities

Accrued expenses

Total current liabilities

Finance lease liabilities

Operating lease liabilities

Note payable, non-current

Total Liabilities

Stockholders’ Equity:

Preferred stock, $ 0.001 par value:

lease liabilities

payable, non-current

Stockholders’

stock, $ 0.001 par value:

2,500,000 shares authorized;

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

Common stock, $ 0.001 par value:

0 shares issued and outstanding as of March 31, 2022 and December 31, 2021

stock, $ 0.001 par value:

25,000,000 shares authorized;

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

Accumulated deficit

14,920,302 and 14,918,887 shares issued and outstanding as of March 31, 2022

and December 31, 2021, respectively

paid-in capital

( 63,861,294 )

( 55,926,847 )

Total Stockholders’ Equity

Total Liabilities and Stockholders’ Equity

Stockholders’ Equity

Liabilities and Stockholders’ Equity

accompanying notes to the financial statements

Statements of Operations

Three Months Ended September 30,

Nine Months Ended September 30,

Months Ended March 31,

and development

and administrative

operating expenses

Research and development

General and administrative

Total operating expenses

Loss from operations

( 5,599,786 )

( 2,480,075 )

( 22,035,023 )

( 7,004,828 )

Other income (expense)

Interest expense

Interest income

Loss on sale of fixed assets

Other income (expense), net

Net loss before income taxes

( 6,027,246 )

( 2,474,298 )

from operations

( 7,507,605 )

( 2,791,770 )

Income tax benefits

income (expense)

on sale of fixed assets

income (expense), net

loss before income taxes

( 7,934,447 )

2 unchanged sentences

$ ( 2,791,668 )

Net loss per share, basic and diluted

Weighted average common shares outstanding, basic and diluted

loss per share, basic and diluted

average common shares outstanding, basic and diluted

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

$ ( 26,321,581 )

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

Issuance of common stock in an at-the-market (“ATM”) offering

Issuance costs associated with ATM offering

( 2,791,668 )

Balance at March 31, 2021 (unaudited)

$ ( 29,113,249 )

Stock-based compensation

Employee stock purchases

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

( 14,032,852 )

Months Ended March 31, 2022

at December 31, 2021

$ 124,622,405

Balance at June 30, 2021 (unaudited)

$ ( 55,926,847 )

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

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

( 7,934,447 )

Balance at September 30, 2021 (unaudited)

at March 31, 2022 (unaudited)

$ 125,386,089

2 unchanged sentences

Statements of Changes in Stockholders’ Equity

Months and Nine Months Ended September 30, 2020

Paid-In Capital

Balance at December 31, 2019

$ ( 16,847,406 )

Stock-based compensation

( 2,246,995 )

Balance at March 31, 2020 (unaudited)

( 19,094,401 )

Stock-based compensation

Employee stock purchases

Issuance of common stock in an at-the-market (“ATM”) offering

Issuance costs associated with ATM offering

( 2,201,989 )

Balance at June 30, 2020 (unaudited)

Months Ended March 31, 2021

at December 31, 2020

$ ( 26,321,581 )

Stock-based compensation

Issuance costs associated with ATM offering

of common stock warrants

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

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

of common stock in an at-the-market (“ATM”) offering

costs associated with ATM offering

( 2,791,668 )

Balance at September 30, 2020 (unaudited)

at March 31, 2021 (unaudited)

$ ( 29,113,249 )

1 unchanged sentence

Statements of Cash Flows

Nine Months Ended September 30,

Cash flows from operating activities:

Months Ended March 31,

flows from operating activities:

$ ( 7,934,447 )

$ ( 2,791,668 )

Adjustments to reconcile net loss to net cash used for operations:

Stock-based compensation

Issuance of common stock, licensing agreement

Amortization of debt issuance costs and discount

Loss on sale of fixed assets

Changes in operating assets and liabilities:

Payroll tax receivable

Prepaid assets and deposits

Accounts payable

Accrued expenses

Non-cash operating lease, net

Net cash used for operating activities

to reconcile net loss to net cash used for operations:

of debt issuance costs and discount

on sale of fixed assets

in operating assets and liabilities:

tax receivable

assets and deposits

operating lease, net

cash used for operating activities

( 5,933,032 )

( 2,521,505 )

Cash flows from investing activities:

Purchases of property and equipment

Proceeds from sale of property and equipment

Net cash used for investing activities

Cash flows from financing activities:

Proceeds from exercise of common stock warrants

Proceeds from exercise of employee stock options

Proceeds from employee stock purchases

Proceeds from follow-on offering, net of underwriting discounts and offering costs

Proceeds from note payable, net of debt issuance costs and discount of $ 652,061

Gross proceeds from an ATM offering

Payments for secondary registration statement costs

Payments for finance leases

Net cash provided by financing activities

Net change in cash and cash equivalents

flows from investing activities:

of property and equipment

from sale of property and equipment

cash used for investing activities

flows from financing activities:

from exercise of common stock warrants

from exercise of employee stock options

from follow-on offering, net of underwriting discounts and offering costs

proceeds from an ATM offering

for secondary registration statement costs

for finance leases

cash (used for) provided by financing activities

change in cash and cash equivalents

( 5,990,955 )

Cash and cash equivalents:

Beginning of period

End of period

Supplemental disclosures of non-cash investing and financing activities:

Property and equipment included in accounts payable

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

and cash equivalents:

disclosure of cash flow information:

disclosures of non-cash investing and financing activities:

and registration statement costs included in accounts payable

and equipment included in accounts payable

accompanying notes to the financial statements

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

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

the Three Months Ended March 31, 2022 and 2021)

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

patients by pursuing an integrated therapeutic and companion diagnostic strategy.

The company’s lead therapeutic candidate is gedatolisib,

a potent, reversible dual inhibitor that selectively targets all Class I isoforms of PI3K and mTOR.

Its mechanism of action and pharmacokinetic

properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.

The company expects to initiate a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022.

CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients

likely to benefit from already approved targeted therapies.

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

Sullivan and Dr.

1 unchanged sentence

The Company has not generated any revenues to date.

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

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and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

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.

results for the three months ended March 31, 2022 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.

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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.

the three months ended March 31, 2022 and 2021, potentially dilutive securities excluded from the computations of diluted weighted-average

shares outstanding were options to purchase 1,353,406 and 855,072 shares of common stock, respectively, warrants to purchase 377,652

and 352,400 shares of common stock, respectively, and 2,964 and 15,686 shares of restricted common stock, respectively.

and Finance Leases

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date in determining the present value of the lease payments.

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

balance sheet information consisted of the following at March 31, 2022:

of Supplemental Balance Sheet Information Related to Leases

Operating Lease

Right-of-use assets

Operating lease liability

lease liability

short term portion

Long term portion

Finance Lease

Furniture and equipment

and equipment

Accumulated depreciation

Net book value of property and equipment under finance lease

Finance lease liability

book value of property and equipment under finance lease

lease liability

short term portion

Long term portion

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

analysis under lease agreements consisted of the following as of March 31, 2022:

of Maturity Analysis Under Lease Agreements

3 unchanged sentences

Present value discount

Amount representing services

Less amount representing services

Present value of net minimum lease payments

Remaining Lease Term

Discount Rate

2 unchanged sentences

Finance lease

Lease costs for the period ended September 30, 2021:

costs for the period ended March 31, 2022:

Schedule of Lease Costs

Three-month Period

Nine-month Period

Operating lease cost

Finance lease cost:

Variable lease cost

Total lease cost

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

cash flow information related to leases period ended March 31, 2022:

of Supplemental Cash Flow Information Related to Leases

Three-month Period

Nine-month Period

Cash paid for amounts included in operating and finance leases:

Operating cash outflow from operating leases

Operating cash outflow from finance leases

Financing cash outflow from finance leases

paid for amounts included in operating and finance leases:

cash outflow from operating leases

cash outflow from finance leases

Total cash paid for amounts

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and products for operating purposes.

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

The Company currently has five Phase 2 clinical trial agreements in place to evaluate targeted therapies

selected with one of our CELsignia tests.

1 unchanged sentence

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.

In conjunction with the license agreement, the Company continued a Phase 1b study – B2151009 related

to gedatolisib.

These patients subsequently transitioned to an Expanded Access study – CELC-G-001.

Timing of milestone payments

related to the Phase 2 clinical trials 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.

Contracts related to the

Phase 1b study, the Expanded Access study, and the Phase 3 clinical study to date, are generally based on time and material.

Stockholders’ Equity

February 4, 2022, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC, as agent (“Jefferies”),

pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering

price of up to $ 50,000,000 .

We will pay Jefferies a commission equal to 3.0 % of the aggregate gross proceeds from each sale of such shares.

To date, we have not yet made any sales under this arrangement.

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

17 unchanged sentences

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.

the Company’s common stock 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.

the three months ended March 31, 2022 and 2021, the Company sold 0 and 3,082 shares, respectively, 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

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

Options outstanding at beginning of year

Balance at September 30

Options exercisable at September 30:

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

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

following table summarizes the activity for all stock options outstanding for the three months ended March 31:

of Stock Options Activity

Average Exercise Price

outstanding at beginning of year

exercisable at March 31:

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

following table summarizes additional information about stock options outstanding and exercisable at March 31, 2022:

of Stock Options Outstanding and Exercisable

Options Outstanding Options Exercisable

Options Outstanding

Weighted Average Remaining Contractual Life

Weighted Average Exercise Price

Aggregate Intrinsic Value

Options Exercisable

Weighted Average Exercise Price

Aggregate Intrinsic Value

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.

Average Remaining Contractual Life

Average Exercise Price

Intrinsic Value

Average Exercise Price

Intrinsic Value

Company recognized stock-based compensation expense for stock options of $ 709,509 and $ 418,192 for the three months ended March 31, 2022

and 2021, respectively.

In December 2021, the Company modified the exercise price on 311,000 stock option awards to $ 13.44 , the closing

market price on the Nasdaq Capital Market on December 15, 2021.

No director or officer awards were modified.

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 effect of this modification

on stock-based compensation was $ 28,029 and $ 0 for the three months ended March 31, 2022 and 2021, respectively.

The effect of this modification

on stock-based compensation over the remaining service period will be approximately $ 316,000 .

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.

No director or

officer awards were modified.

The effect of this modification on stock-based compensation was $ 11,614 and $ 13,449 for the three months

ended March 31, 2022 and 2021, respectively.

The effect of this modification on stock-based compensation over the remaining service period

will be approximately $ 73,000 .

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

Expected volatility

Expected life (years)

Expected dividend yield

for the three months ended March 31:

of Assumptions for Fair Value of Equity-based Awards

interest rate

dividend yield

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

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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.

restricted stock awards were granted during the three months ended March 31, 2022 and 2021.

The Company had 2,964 and 15,686 shares of

restricted stock outstanding as of March 31, 2022 and 2021, respectively, and 0 shares of restricted stock vested during the three months

ended March 31, 2022 and 2021.

The Company recognized stock-based compensation expense for restricted stock of $ 20,344 and $ 20,456 for

the three months ended March 31, 2022 and 2021, 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.

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

The number of shares reserved for issuance was automatically increased by 102,540 , 102,998 and 149,189

shares on January 1, 2020, 2021 and 2022, respectively, and will increase automatically on January 1 of each of 2023 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.

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

The total remaining shares available for grant under the Company’s 2017 Plan as of March 31, 2022 was 398,445 .

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

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:

estimated compensation cost to be recognized

Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 26,148 and $ 10,450 for the three

months ended March 31, 2022 and 2021, 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 , 51,499 and 74,594 shares on January

1, 2020, 2021 and 2022, respectively, 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 March 31, 2022 was 224,817 .

Company recognized total stock-based compensation expense as follows for the three months ended March 31:

of Stock-based Compensation Expense

Three Months Ended

Nine Months Ended

September 30,

Stock-based compensation expense in operating expenses:

Research and development

General and administrative

compensation expense in operating expenses:

and development

and administrative

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

4 unchanged sentences

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 Company is no longer eligible

to draw on the term B loan.

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.

2 unchanged sentences

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.

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.

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.

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method over the life of the Term Loans.

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

The carrying value of the debt approximates fair value as of March 31, 2022.

debt consisted of the following:

Schedule of Long-term Debt

September 30, 2021

PIK interest (added to principal)

1 unchanged sentence

unamortized debt discount

( 1,016,662 )

Total long-term debt

long-term debt

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

Schedule of Future Principal Payments

Years Ending December 31,

of Long Term Debt Future Principal Payments

License Agreement

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

April 8, 2021, 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.

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

Subsequent Events

May 15, 2022, the Company entered into a securities purchase agreement with certain institutional and other accredited

investors for the sale of Company common stock, preferred stock that may be convertible into common stock and warrants

initially exercisable for preferred stock for $ 100

million in the aggregate, before deducting

placement agent fees and other offering expenses.

Pursuant to the securities purchase agreement, investors will purchase shares of common

stock and preferred stock at a price per share of $ 5.75 (on an as converted to common stock basis).

For each share of common stock

and each 1/10 of a share of preferred stock purchased, investors will receive a warrant initially exercisable for preferred stock equivalent

to 0.40 shares of common stock on an as converted basis.

The exercise price of the warrants will be at a 40 % premium to the price

paid by investors for the initial shares of common stock purchased in the private placement.

The preferred stock will be convertible

into common stock at the holder’s election, subject to certain limitations such as beneficial ownership and the approval by the

Company’s stockholders to increase the number of authorized shares of common stock sufficient to cover the shares of common stock

issuable upon conversion of (i) the preferred stock purchased in the private placement and (ii) the shares of preferred stock that may

be issued upon exercise of warrants purchased in the private placement.

The warrants are initially exercisable for preferred stock and

will convert into warrants to purchase common stock if the proposed increase in the Company’s authorized common stock is approved

by stockholders.

The closing of the private placement is conditioned on, among other customary items, the first patient enrolled

in the Company’s forthcoming Phase 3 clinical study (VIKTORIA-1) having received their first dose of treatment at

a clinical site located in the United States, provided that such date must occur on or before December 31, 2022.

The Company also

entered into a customary registration rights agreement with the investors pursuant to which it agreed to file a registration statement

with the SEC registering the resale of (i) the shares of common stock to be issued and sold in the private placement,

(ii) the shares of common stock issuable upon conversion of the preferred stock purchased in the private placement and

(iii) the shares of common stock issuable upon conversion of the shares of preferred stock that may be issued upon

exercise of warrants purchased in the private placement.

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