What changed in this filing

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Item 1. Financial Statements

2023-11-13 compared with 2023-08-11 · 169 added, 121 removed, 340 unchanged (46% of the section changed)

1 unchanged sentence

Balance Sheets

June 30, 2023

September 30, 2023

December 31, 2022

1 unchanged sentence

Cash and cash equivalents

Deferred transaction costs

Payroll tax receivable

Prepaid assets

Other current assets

Total current assets

13 unchanged sentences

Total Liabilities

and Contingencies (Note 5)

Commitments and Contingencies (Note 5)

Stockholders’ Equity:

1 unchanged sentence

2,500,000 shares authorized;

1,085,873 and 1,120,873 shares issued and outstanding as of June 30, 2023 and December 31, 2022

1,060,873 and 1,120,873 shares issued and outstanding as of September 30, 2023 and December 31, 2022

Common stock, $ 0.001 par value:

65,000,000 shares authorized as of June 30, 2023 and December 31, 2022, respectively;

22,081,893 and 21,667,250 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

65,000,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively;

22,369,393 and 21,667,250 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

Additional paid-in capital

8 unchanged sentences

Statements of Operations

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

11 unchanged sentences

( 3,929,140 )

( 1,428,108 )

Interest income

Other income (expense), net

( 1,036,807 )

Net loss before income taxes

9 unchanged sentences

Net loss per share, basic and diluted

Net loss per share, basic

Weighted average common shares outstanding, basic and diluted

Weighted average common shares outstanding, basic

accompanying notes to the financial statements

Statements of Changes in Stockholders’ Equity

and Six Months Ended June 30, 2023

and Nine Months Ended September 30, 2023

Preferred Stock

20 unchanged sentences

( 14,587,687 )

Balance at June 30, 2023 (unaudited)

Balance at June 30, 2023

$ 232,932,164

1 unchanged sentence

$ 110,132,341

Stock-based compensation

Conversion of preferred to common stock

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

( 18,404,540 )

at September 30, 2023 (unaudited)

$ 234,100,541

$ ( 141,227,531 )

accompanying notes to the financial statements

Statements of Changes in Stockholders’ Equity

and Six Months Ended June 30, 2022

and Nine Months Ended September 30, 2022

Additional Paid-In

6 unchanged sentences

( 7,934,447 )

Balance at March 31, 2022 (unaudited)

Balance at March 31, 2022

$ 125,386,089

5 unchanged sentences

( 9,960,526 )

Balance at June 30, 2022 (unaudited)

Balance at June 30, 2022

$ 126,995,610

$ ( 73,821,820 )

Stock-based compensation

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

( 10,893,721 )

at September 30, 2022 (unaudited)

$ 128,225,939

$ ( 84,715,541 )

accompanying notes to the financial statements

Statements of Cash Flows

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

8 unchanged sentences

Changes in operating assets and liabilities:

Payroll tax receivable

Prepaid assets and deposits

Other current assets

( 1,065,732 )

( 5,817,737 )

Accounts payable

25 unchanged sentences

Offering and registration statement costs included in accounts payable

Offering and registration statement costs included in accrued expenses

Deferred financing costs and offering and registration statement costs included in accrued expenses

Property and equipment included in accounts payable

1 unchanged sentence

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2023 and 2022)

Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on development of targeted

therapies for multiple solid tumor indications.

The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and

mTOR inhibitor.

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.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with

fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients.

Its 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.

the Three and Nine Months Ended September 30, 2023 and 2022)

Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company pursuing development for oncology.

The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor.

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.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients

with HR+/HER2- advanced breast cancer is currently enrolling patients.

A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib

in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is expected to be initiated in the

first quarter of 2024.

The company’s 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

Sullivan and Dr.

is based in Minnesota.

Laing and is based in Minnesota.

The Company has not generated any revenues to date.

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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, 2022.

results for the three and six months ended June 30, 2023 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 and nine months ended September 30, 2023 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.

7 unchanged sentences

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

commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests and initial drug product, gedatolisib,

the clinical and commercial success of 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.

24 unchanged sentences

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 is the same.

the three and six months ended June 30, 2023 and 2022, potentially dilutive securities excluded from the computations of diluted weighted-average

shares outstanding were preferred stock on an as-if-converted to common stock basis of 10,858,730 and zero shares of common stock, respectively,

options to purchase 2,185,567 and 1,782,782 shares of common stock, respectively, warrants to purchase 7,266,102 and 377,652 shares of

common stock, respectively, and 1,958 and 3,273 shares of restricted common stock, respectively.

For all periods presented, the common shares underlying the preferred stock, options, warrants,

and restricted stock 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 is the same.

the three and nine months ended September 30, 2023 and 2022, potentially dilutive securities excluded from the computations of diluted

weighted-average shares outstanding were preferred stock on an as-if-converted to common stock basis of 10,608,730 and zero shares of

common stock, respectively, options to purchase 2,702,629 and 1,919,114 shares of common stock, respectively, warrants to purchase 7,266,102

and 309,652 shares of common stock, respectively, and 1,958 and 3,273 shares of restricted common stock, respectively.

securities for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported

2 unchanged sentences

the establishment of an allowance for credit losses.

All of the Company’s held-to-maturity investment securities are U.S.

and agencies securities that are guaranteed or otherwise supported by the United States government and have no history of credit losses.

Accordingly, the Company does not expect to incur any credit losses on held-to-maturity investment securities and has no allowance for

credit losses recorded for these securities.

following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of June 30, 2023 and December

All of the Company’s held-to-maturity

investment securities are U.S.

Treasury and agencies securities that are guaranteed or otherwise

supported by the United States government and have no history of credit losses.

Accordingly, the Company does not expect to incur any

credit losses on held-to-maturity investment securities and has no allowance

for credit losses recorded for these securities.

following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2023 and

December 31, 2022:

Schedule of Investment

3 unchanged sentences

Estimated Fair Value

June 30, 2023

September 30, 2023

Amortized Cost, as Adjusted

20 unchanged sentences

$ 144,087,110

fair value of the Company’s held-to-maturity debt securities is determined based upon inputs, other than the quoted prices in

active markets, that are observable either directly or indirectly and are classified as level 2 fair value instruments.

fair value of the Company’s held-to-maturity debt securities is determined based upon inputs, other than the quoted prices in active

markets, that are observable either directly or indirectly and are classified as level 2 fair value instruments.

Company leases its corporate space in Minneapolis, Minnesota, with an operating lease in place through April 30, 2026.

21 unchanged sentences

Contracts related to the Expanded Access study, are generally based on time and material.

In addition, contracts related to the Company’s Phase 3 clinical study (VIKTORIA-1) are generally cancelable with reasonable notice

within 120 days and the Company’s obligations under these contracts are primarily based on services performed through termination

dates plus certain cancelation charges, if any, as defined in each of the respective agreements.

In addition, these agreements may, from

time to time, be subjected to amendments as a result of any change orders executed by the parties.

As of June 30, 2023, the Company had

only one material non-cancelable contractual commitment with respect to these arrangements, which totaled approximately $ 2.0 million.

Stockholders’

In addition, contracts related to the Company’s Phase 3 (VIKTORIA-1) and Phase 1b/2 (CELC-G-201) clinical trials are generally

cancelable with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services

performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements.

these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties.

As of September

30, 2023, the Company had two material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately

$ 2.3 million.

Stockholders’ Equity

December 31, 2022, the Company’s authorized capital stock consisted of 65,000,000 shares of $ .001 par value common stock, of which

8 unchanged sentences

shares transferred is $ 5.75 per share.

June 30, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 22,081,893 shares

were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which

1,085,873 shares were outstanding.

As of June 30, 2023, no dividends have been declared on the Company’s capital stock.

September 21, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred

Stock into 250,0000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis of

the shares transferred is $ 5.75 per share.

September 30, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 22,369,393

shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock,

of which 1,060,873 shares were outstanding.

As of September 30, 2023, no dividends have been declared on the Company’s capital

Stock-Based Compensation

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

of Stock Options Activity

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

Schedule of Stock Options Activity

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:

following table summarizes additional information about stock options outstanding and exercisable at June 30, 2023:

of Stock Options Outstanding and Exercisable

following table summarizes additional information about stock options outstanding and exercisable at September 30, 2023:

Schedule of Stock Options Outstanding and Exercisable

Options Outstanding

7 unchanged sentences

Aggregate Intrinsic Value

Company recognized stock-based compensation expense for stock options of $ 1,228,284 and $ 1,460,031 for the three months ended June 30,

2023 and 2022, respectively, and $ 2,450,612 and $ 2,169,540 for the six months ended June 30, 2023 and 2022, respectively.

the Company modified the exercise price on 776,324 stock option awards to $ 5.50 , the closing market price on the Nasdaq Capital Market

on May 17, 2022.

The effect of this modification on stock-based compensation was $ 37,690 and $ 428,343 for the three months ending June

30, 2023 and 2022, respectively, and $ 77,302 and $ 428,343 for the six months ending June 30, 2023 and 2022, respectively.

The effect of

this modification on stock-based compensation over the remaining service period will be approximately $ 228,000 .

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 of this modification on stock-based compensation was $ 16,920

and $ 25,755 for the three months ended June 30, 2023 and 2022, respectively, and $ 33,844 and $ 53,784 for the six months ended June 30,

2023 and 2022, respectively.

Company recognized stock-based compensation expense for stock options of $ 1,065,568 and $ 1,162,751 for the three months ended September

30, 2023 and 2022, respectively, and $ 3,516,180 and $ 3,329,969 for the nine months ended September 30, 2023 and 2022, respectively.

May 2022, the Company modified the exercise price on 776,324 stock option awards to $ 5.50 , the closing market price on the Nasdaq Capital

Market on May 17, 2022.

The effect of this modification on stock-based compensation was $ 30,188 and $ 49,088 for the three months ending

September 30, 2023 and 2022, respectively, and $ 107,490 and $ 477,431 for the nine months ending September 30, 2023 and 2022, respectively.

The effect of this modification on stock-based compensation over the remaining service period will be approximately $ 190,000 .

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.

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 of this modification on stock-based compensation

was $ 6,826 and $ 11,601 for the three months ended June 30, 2023 and 2022, respectively, and $ 13,934 and $ 23,216 for the six months ended

June 30, 2023 and 2022.

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

was $ 15,773 and $ 21,778 for the three months ended September 30, 2023 and 2022, respectively, and $ 49,617 and $ 75,562 for the nine months

ended September 30, 2023 and 2022, respectively.

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

period will be approximately $ 114,000 .

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 $ 3,041 and $ 7,681 for the three months ended September 30, 2023 and 2022, respectively,

and $ 16,975 and $ 30,897 for the nine months ended September 30, 2023 and 2022.

The effect of this modification on stock-based compensation

over the remaining service period will be approximately $ 3,000 .

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

for the six months ended June 30:

of Assumptions for Fair Value of Equity-based Awards

for the nine months ended September 30:

Schedule of Assumptions for Fair Value of Equity-based Awards

Risk-free interest rate

2 unchanged sentences

Expected volatility

78.0 to 79.8 %

76.2 % - 79.6 %

18 unchanged sentences

with the agreements would also be cancelled.

stock awards were granted to members of the Company’s board during the three months ended June 30, 2023 and 2022.

The Company had

1,958 and 3,273 shares of restricted stock outstanding as of June 30, 2023 and 2022, respectively, and 3,273 and 2,964 shares of restricted

stock vested during the three months ended June 30, 2023 and 2022, respectively.

The Company recognized stock-based compensation expense

for restricted stock of $ 4,052 and $ 6,775 for the three months ended June 30, 2023 and 2022, respectively, and $ 8,694 and $ 27,119 for

the six months ended June 30, 2023 and 2022, respectively.

Company had 1,958 and 3,273 shares of restricted stock outstanding as of September 30, 2023 and 2022, respectively, and 0 and 250 shares

of restricted stock vested during the three months ended September 30, 2023 and 2022, respectively.

The Company recognized stock-based

compensation expense for restricted stock of $ 4,903 and $ 7,245 for the three months ended September 30, 2023 and 2022, respectively,

and $ 13,597 and $ 36,686 for the nine months ended September 30, 2023 and 2022, respectively.

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

10 unchanged sentences

The total remaining shares available

for grant under the Company’s 2017 Plan as of June 30, 2023 was 1,702,461 .

for grant under the Company’s 2017 Plan as of September 30, 2023 was 1,147,899 .

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

of Unrecognized Compensation Cost

Schedule 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 $ 38,167 and $ 53,058 for the three

months ended June 30, 2023 and 2022, respectively, and $ 90,958 and $ 79,071 for the six months ended June 30, 2023 and 2022, respectively.

months ended September 30, 2023 and 2022, respectively and $ 129,125 and $ 132,129 for the nine months ended September 30, 2023 and 2022,

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 51,499 , 74,594 and 108,337 shares on January 1, 2021, 2022 and 2023, 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 June 30, 2023

was 283,008 .

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

of Stock-based Compensation Expense

of shares reserved for issuance was automatically increased by 51,499 , 74,594 and 108,337 shares on January 1, 2021, 2022 and 2023, 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

September 30, 2023 was 283,008 .

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

Schedule of Stock-based Compensation Expense

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Stock-based compensation expense in operating expenses:

6 unchanged sentences

to $ 75 million, a $ 50 million increase from the original Loan Amount.

As of June 30, 2023, term loans totaling $ 35 million are outstanding

As of September 30, 2023, term loans totaling $ 35 million are outstanding

under the Loan Agreement, including the initial Term A loan of $ 15 million which was funded on April 8, 2021, and a $ 20 million Term

B loan which was funded on December 22, 2022.

debt consisted of the following at June 30, 2023 and December 31, 2022:

of Long-term Debt

June 30, 2023

debt consisted of the following at September 30, 2023 and December 31, 2022:

Schedule of Long-term Debt

September 30, 2023

December 31, 2022

4 unchanged sentences

principal payments, including the incurred PIK interest, are as follows:

of Long Term Debt Future Principal Payments

Schedule of Long Term Debt Future Principal Payments

Subsequent Events

October 18, 2023, the Company entered into a securities purchase agreement with certain investors (the “Investors”) pursuant

to which the Company agreed to sell to the Investors in a private placement (the “Private Placement”) pre-funded warrants

(the “Warrants”) to purchase up to 5,747,787 shares of the Company’s common stock, par value $ 0.001 per share (the

“Common Stock”).

Each Warrant is immediately exercisable and will not expire.

Each warrant to purchase one share has a purchase

price of $ 8.699 per share, and an exercise price of $ 0.001 per share for the Common Stock issuable upon exercise of the Warrant.

closing of the Private Placement occurred on October 20, 2023 and resulted in gross proceeds to the Company of approximately $ 50 million,

before deducting offering expenses payable by the Company.

connection with the Private Placement, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”)

with the Investors, pursuant to which the Company has agreed to file, no later than 30 days following the Closing Date of the Private

Placement, a registration statement covering the resale by the Investors of the shares issued or issuable upon exercise or exchange of

the Warrants (as defined more specifically in the Registration Rights Agreement, the “Registrable Securities”).

the event that a registration statement covering the Registrable Securities is not filed with the SEC on or prior to the filing deadline

as set forth in the Registration Rights Agreement, or is not declared effective within the timeframe provided therein, or if certain

other circumstances occur, as described in the Registration Rights Agreement, that prevent the Investors from selling securities pursuant

to the registration statement, the Company has agreed to make pro rata payments to each holder as liquidated damages in an amount equal

to 1.0 % of the aggregate amount paid pursuant to the Securities Purchase Agreement by such Investor for each 30-day period or pro rata

for any portion thereof for each such month during which such event continues, provided that the maximum aggregate amounts payable as

liquidated damages shall not exceed 6.0 % of the aggregate amount invested by each such holder in the Registrable Securities then held

by the holder.

October 13, 2023, one of the Company’s preferred shareholders elected to convert 181,739 shares of Series A Convertible Preferred

Stock into 1,817,390 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis

of the shares transferred is $ 5.75 per share.

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