What changed in this filing

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Item 1. Financial Statements

2025-08-14 compared with 2025-05-15 · 436 added, 249 removed, 204 unchanged (77% of the section changed)

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Balance Sheets

thousands, except share and per share amounts)

thousands, except share and par value amounts)

and cash equivalents

current assets

Cash and cash

current assets

Total current assets

Property and equipment, net

Operating lease right-of-use

Liabilities and Stockholders’

and equipment, net

lease right-of-use assets

and Stockholders’ Equity:

lease liabilities

current liabilities

Accounts payable

Operating lease liabilities

Total current liabilities

Operating lease liabilities

Note payable, non-current

Commitments and Contingencies

Stockholders’ Equity:

Preferred stock, $ 0.001 par value:

lease liabilities

payable, non-current

and Contingencies (Note 5)

Stockholders’

Preferred stock,

$ 0.001 par value:

2,500,000 shares authorized;

shares issued and outstanding as of each of March 31, 2025 and December 31, 2024

Common stock, $ 0.001 par value:

213,151 and 317,577 shares issued and outstanding as of June 30, 2025 and December

31, 2024, respectively.

Common stock, $ 0.001

95,000,000 shares authorized;

and 37,143,242 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

Additional paid-in capital

Accumulated deficit

38,914,208 and 37,143,242 shares issued and outstanding as of June 30, 2025 and December

31, 2024, respectively.

paid-in capital

Stockholders’ Equity

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thousands, except share and per share amounts)

Months Ended March 31,

Operating expenses:

Months Ended June 30,

and development

and administrative

Total operating expenses

Loss from operations

Other (expense) income

Interest expense

Other (expense) income,

operating expenses

from operations

(expense) income

(expense) income, net

loss before income taxes

Income tax benefits

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 condensed financial statements.

Statements of Changes in Stockholders’ Equity

Months Ended March 31, 2025

and Six Months Ended June 30, 2025

thousands, except share amounts)

Additional Paid-In

Balance at December 31, 2024

at December 31, 2024

$ ( 271,855 )

Stock-based compensation

Exercise of common stock warrants

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

Balance at March 31, 2025

Exercise of common

stock warrants

Exercise of common

stock options, net of shares withheld for exercise price

at March 31, 2025 (unaudited)

stock purchases

of preferred stock to common stock

Exercise of common

stock options, net of shares withheld for exercise price

at June 30, 2025 (unaudited)

$ ( 354,120 )

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Statements of Changes in Stockholders’ Equity

Months Ended March 31, 2024

and Six Months Ended June 30, 2024

thousands, except share amounts)

Additional Paid-In

Balance at December 31, 2023

at December 31, 2023

$ ( 160,076 )

Exercise of common

stock warrants, net of shares withheld for exercise price

Exercise of common

stock options, net of shares withheld for exercise price

of preferred to common stock

at March 31, 2024 (unaudited)

$ ( 181,688 )

Stock-based compensation

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

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

Conversion of preferred to common stock

Balance at March 31, 2024

$ ( 181,688 )

stock purchases

of preferred stock to common stock

Exercise of common

stock warrants, net of shares withheld for exercise price

Exercise of common

stock options, net of shares withheld for exercise price

of common stock in an ATM offering

costs associated with an ATM offering

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

of common stock warrants, note payable

at June 30, 2024 (unaudited)

$ ( 205,410 )

accompanying notes to the condensed financial statements.

Statements of Cash Flows

Months Ended March 31,

Cash flows from operating

Adjustments to reconcile net loss to net cash

used for operations:

Stock-based compensation

Amortization of debt

issuance costs and discount

Payment-in-Kind interest

Non-cash operating lease,

Change in accrued interest

Changes in operating assets and liabilities:

Other current assets

Accounts payable

cash used for operating activities

Cash flows from investing

Proceeds from maturities of investments

Months Ended June 30,

flows from operating activities:

to reconcile net loss to net cash and cash equivalents used in operations:

of debt issuance costs and discount

Payment-in-Kind

operating lease expense, net

in accrued interest income

in operating assets and liabilities:

current assets

cash used in operating activities

flows from investing activities:

from maturities of investments

Purchases of investments

Purchases of property

and equipment

cash provided by investing activities

Cash flows from financing

Proceeds from exercise of common stock warrants

Proceeds from exercise of employee stock options

Payments for secondary

registration statement costs

of property and equipment

cash provided by (used in) investing activities

flows from financing activities:

from exercise of common stock warrants

from exercise of employee stock options

from employee stock purchases

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

from note payable, net of debt issuance costs and discount of $ 2,430 in 2024

from an ATM offering, net of issuance costs

for secondary registration statement costs

for debt issuance costs

cash provided by financing activities

Net change in cash and cash equivalents

Cash and cash equivalents:

Beginning of period

End of period

Supplemental disclosure

of cash flow information:

Interest paid

Supplemental disclosures

of non-cash investing and financing activities:

Deferred financing costs and offering and registration

statement costs included in accounts payable

Property and equipment included in accounts

Property and equipment included in accrued

Exercise of stock options pending receipt of

cash proceeds

change in cash and cash equivalents

and cash equivalents:

disclosure of cash flow information:

disclosures of non-cash investing and financing activities:

in accounts payable attributed to offering and registration statement costs

in accounts payable attributed to property and equipment

interest receivable

stock warrants issued with note payable transaction

accompanying notes to the condensed financial statements.

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three Months Ended March 31, 2025 and 2024)

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

therapies for the treatment of multiple solid tumor indications.

The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”),

serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) pathway that

binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2.

By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib

induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”) pathway.

Gedatolisib’s

mechanism of action and pharmacokinetic properties are 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.

Site selection activities for a Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as

first-line treatment for patients with HR+/HER2- advanced breast cancer, are completed and site activities have begun.

The first patient is expected to be dosed in the

second quarter of 2025.

A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients

with metastatic castration resistant prostate cancer, is currently underway.

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

the Three and Six Months Ended June 30, 2025 and 2024)

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

targeted therapies for the treatment of multiple solid tumor indications.

The Company’s lead therapeutic candidate is

gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein

kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) pathway that binds to all Class I PI3K isoforms

and the mTOR complexes, mTORC1 and mTORC2.

By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive

inhibition of the PI3K/AKT/mTOR (“PAM”) pathway.

Gedatolisib’s mechanism of action and pharmacokinetic properties

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

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

hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast

cancer has completed enrollment of and reported topline data for cohort 1, patients with PIK3CA wild-type (“WT”)

tumors, and is continuing to enroll cohort 2, patients with PIK3CA mutant-type (“MT”) tumors.

clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor

and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer is

currently enrolling patients.

The first patient was dosed in July of 2025.

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

gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Company was co-founded in 2012 by Brian F.

Sullivan and Dr.

Laing and is based in Minnesota.

The Company has not generated any revenues to date.

The Company has not generated

any revenue to date.

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, 2024.

results for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected during the remainder of

the current year or for any other future period.

results for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected during the remainder

of the current year or for any other future period.

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

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

revenues and expenses.

revenue and expenses.

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

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

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

Company relies on third parties to conduct certain aspects of clinical studies and to formulate and manufacture our drug product.

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of third-party reports most accurately reflects expenses incurred.

With the ongoing VIKTORIA-1 Phase 3 clinical trial and the CELC-G-201

Phase 1b/2 clinical trial, and the commencement of the VIKTORIA-2 Phase 3 clinical trial, the Company’s estimated expenses in future periods and actual services performed may vary from these

estimates, and these estimates may become more significant.

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 and financial position.

With the ongoing VIKTORIA-1 and VIKTORIA-2 Phase 3 clinical trials,

and the CELC-G-201 Phase 1b/2 clinical trial, the Company’s estimated expenses in future periods and actual services performed

may vary from these estimates, and these estimates may become more significant.

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 and financial

Net Loss Per Common Share

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shares outstanding used to calculate both basic and diluted loss per common share are the same.

following table summarizes the potentially-dilutive shares excluded from the diluted weighted-average shares outstanding:

of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding

Preferred stock on an as-if-converted

to common stock basis

Options to purchase common stock

Warrants to purchase common stock

Restricted common stock

Anti-dilutive securities excluded from

diluted weighted- average shares outstanding

warrant shares of 5,747,787 are included in the computation of basic and diluted net loss per share for each of the three months ended

March 31, 2025 and 2024, as the pre-funded warrants are exercisable for nominal consideration.

following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been

anti-dilutive for the three and six-month periods presented below:

Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding

stock on an as-if-converted to common stock basis

to purchase common stock

Anti-dilutive

securities excluded from diluted weighted- average shares outstanding

warrant shares of 5,747,787 are included in the computation of basic and diluted net loss per share for each of the three and six months

ended June 30, 2025 and 2024, as the pre-funded warrants are exercisable for nominal consideration.

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

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for credit losses recorded for these securities.

following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of March 31, 2025 and December

of Investment

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of June 30, 2025 and December

Schedule of Investment

Cost, as Adjusted

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Unrealized Holding Losses

(in thousands)

Cost, as Adjusted

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Unrealized Holding Losses

Treasury Bills

Cost, as Adjusted

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Unrealized Holding Losses

(in thousands)

Cost, as Adjusted

1 unchanged sentence

Unrealized Holding Losses

Treasury Bills

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

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

As of March 31, 2025, the Company had six

As of June 30, 2025, the Company had three

material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 3.6 million.

Stockholders’ Equity

December 31, 2024, the Company’s authorized capital stock consisted of 95,000,000 shares

of common stock, of which 37,143,242 shares

were outstanding, and 2,500,000 shares

of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 317,577 shares

were outstanding.

December 31, 2024, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 37,143,242 shares

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

317,577 shares were outstanding.

March 2025, an investor exercised 695,650 warrants at an exercise price of $ 8.05 , which generated approximately $ 5.6 million in cash.

The warrants were issued pursuant to a private placement that closed on December 9, 2022.

March 31, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 37,839,392 shares

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

June 2025, 104,426 shares of preferred stock were converted into 1,044,260 shares of common stock.

June 30, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 38,914,208 shares

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

213,151 shares were outstanding.

As of March 31, 2025, no dividends have been declared on the Company’s capital stock.

As of June 30, 2025, no dividends have been declared on the Company’s capital stock.

Stock-Based Compensation

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

Company recognized total stock-based compensation expense as follows for the three and six months ended June 30, 2025 and 2024:

Schedule of Stock-based Compensation Expenses

compensation expense in operating expenses:

and development

and administrative

compensation expense

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 371,432 and

255,060 shares on January 1, 2025 and 2024, respectively ,

and will increase

automatically on January 1 of each year 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.

However, the Company’s board may reduce the amount

of the increase in any particular year.

the Annual Meeting held on May 13, 2025, the stockholders approved a 3,000,000

share increase to the number of shares reserved for issuance under the 2017 Plan.

The total remaining shares available for grant

under the Company’s 2017 Plan as of June 30, 2025 was 3,775,453 .

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

Schedule of Stock Options Activity

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Exercise Price

Options outstanding at beginning

Balance at March 31

Options exercisable

Weighted 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, 2025.

The stock-based

compensation expense disclosed in the following paragraphs is shown in thousands.

of Stock Options Outstanding and Exercisable

outstanding at beginning of year

exercisable at June 30:

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

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

following table summarizes additional information about stock options outstanding and exercisable at June 30, 2025.

The stock-based compensation

expense disclosed in the following paragraphs is shown in thousands.

Schedule of Stock Options Outstanding and Exercisable

Exercise Price

Company recognized stock-based compensation expense for stock options of $ 2,376

for the three months ended March 31, 2025 and 2024, respectively.

In January 2025, May 2022, December 2021 and May 2020, the Company modified previously granted stock option awards to certain employees.

The total incremental compensation expense recognized as a result of the modifications was $ 141 and $ 45 for the three months ended March 31, 2025 and 2024, respectively.

The effect of these modifications on stock-based compensation over the remaining service periods will be $ 416 .

for the three months ended June 30, 2025 and 2024, respectively, and $ 4,636

for the six months ended June 30, 2025 and 2024, respectively.

In January 2025, May 2022, December 2021 and May 2020, the Company

modified previously granted stock option awards to certain employees.

The total incremental compensation expense recognized as a

result of the modifications was $ 70

for the three months ended June 30, 2025 and 2024, respectively, and $ 211

for the six months ended June 30, 2025 and 2024, respectively.

The effect of these modifications on stock-based compensation over

the remaining service periods will be $ 346 .

During the three and six months ended June 30, 2025, options in the amount of 2,561

shares were exercised, respectively, with an intrinsic value of $ 16

respectively.

During the three and six months ended June 30, 2024, options in the amount of 16,197

were exercised, respectively, with an intrinsic value of $ 170

respectively.

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

for the three months ended March 31:

of Assumptions for Fair Value of Equity-based Awards

Risk-free interest rate

Expected volatility

Expected life (years)

Expected dividend yield

for the six months ended June 30:

Schedule 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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The expected life is

based on the simplified method for the time-based awards, in accordance

with 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

for the time-based awards.

based on the simplified method for the time-based awards in accordance with SEC Staff Accounting Bulletin Nos.

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

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with the agreements would also be cancelled.

Company had 1,079 and 1,958 shares of restricted stock outstanding as of March 31, 2025 and 2024, respectively, and no shares of restricted

stock vested during the three months ended March 31, 2025 and 2024.

The Company recognized stock-based compensation expense for restricted

stock of $ 4 and $ 5 for the three months ended March 31, 2025 and 2024, 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 371,432 and

255,060 shares

on January 1, 2025 and 2024, respectively, and will increase

automatically on January 1 of each year 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.

However, the Company’s board may reduce the amount

of the increase in any particular year.

each of the Annual Meetings held on May 12, 2021 and May 12, 2022, the stockholders approved a 500,000

share increase each year to the number of shares reserved for issuance under the 2017 Plan.

At each of the Annual Meetings held on

May 11, 2023 and May 9, 2024, the stockholders approved a 1,500,000

share increase each year to the number of shares reserved for issuance under the 2017 Plan.

The total remaining shares available for

grant under the Company’s 2017 Plan as of March 31, 2025 was 1,007,905 .

unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized at March 31, 2025:

of Unrecognized Compensation Cost

(in thousands)

stock awards (“RSAs”) granted to members of the Company’s board during the three and six months ended June 30,

2025 and 2024 were 1,029

shares and 1,429

shares, respectively.

During the three and six months ended June 30, 2025 and 2024, RSAs vested in the amount of 1,079

shares and 2,308

shares, respectively.

The Company recognized stock-based compensation expense for RSAs of $ 2

for the three months ended June 30, 2025 and 2024, respectively, and $ 6

for the six months ended June 30, 2025 and 2024, respectively.

RSAs outstanding as of June 30, 2025 and June 30, 2024 were 1,029

shares and 1,079

shares, respectively.

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

unrecognized compensation cost related to stock options and RSAs that is estimated to be recognized at June 30,

2025 is as follows:

Schedule of Unrecognized Compensation Cost

estimated compensation cost to be recognized

Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 180 and

the three months ended March 31, 2025 and 2024, 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 185,716 and

127,530 shares

on January 1, 2025 and 2024, respectively, and will increase automatically on each subsequent January 1 by the number

Stock Purchase Plan

Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 326

for the three months ended June 30, 2025 and 2024, respectively, and $ 506

for the six months ended June 30, 2025 and 2024, respectively.

The number of shares reserved for issuance was automatically

increased by 185,716

on January 1, 2025, and will increase automatically on January 1 of each year through 2027 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

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

total remaining shares available for issuance under the employee stock purchase plan as of March 31, 2025 was 546,666 .

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

of Stock-based Compensation Expenses

(in thousands)

Stock-based compensation expense in operating

Research and development

General and administrative

The total remaining

shares available for issuance under the employee stock purchase plan as of June 30, 2025 was 519,700 .

May 30, 2024, the Company entered into an Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”)

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April 8, 2021, as amended, between the Company and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan

of the first $ 100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the

“Term A Loan”) and $ 21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under

the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”).

The Company will be eligible to draw on a fourth tranche of $ 30 million (the “Term D Loan”) and fifth tranche of $ 50 million

(the “Term E Loan”), in each case upon achievement of certain clinical trial milestones and satisfaction of certain financial

covenants determined on a pro forma as-funded basis.

The Lenders may, in their sole discretion upon the Company’s request, make

additional term loans to the Company of $ 45 million (the “Term F Loan”).

Funding of these additional tranches is also subject

to other customary conditions and limits on when the Company can request funding for such tranches.

Costs associated with the new borrowings

were approximately $ 2.4 million.

to the A&R Loan Agreement, 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 May 1, 2029 and will bear interest at a rate equal to the sum of (a) the

greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest

will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal

balance on a monthly basis through May 31, 2027.

of the first $ 100

million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8

million (the “Term A Loan”) and $ 21.5

million (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus

accrued payment-in-kind interest, in addition to $ 61.7

million of new borrowings (the “Term C Loan”).

The Company became eligible to draw on a fourth tranche of $ 30

million (the “Term D Loan”) as of July 28, 2025 and will become eligible to draw on a fifth tranche of $ 50

million (the “Term E Loan”) upon achievement of certain clinical trial milestones and satisfaction of

certain financial covenants.

The Lenders may, in their sole discretion upon the

Company’s request, make additional term loans to the Company of $ 45

million (the “Term F Loan”).

Funding of these additional tranches is also subject to other customary conditions and

limits on when the Company can request funding for such tranches.

Costs associated with the new borrowings were approximately $ 2.4

to the A&R Loan Agreement, 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 May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate

(as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable

in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a

monthly basis through May 31, 2027.

The A&R Loan Agreement is secured by all assets of the Company.

Proceeds will be

used for working capital purposes and to fund the Company’s general business requirements, including the Phase 3 VIKTORIA-2 clinical

The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and

includes financial covenants related to liquidity and other financial measures.

Innovatus has the right, at its election and until August

9, 2025, to convert up to 20 % of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price

per share of $ 10.00 .

Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior

Loan Agreement to purchase 26,042 shares of common stock at a price per share of $ 14.40 through April 8, 2031.

Proceeds will be used

for working capital purposes and to fund the Company’s general business requirements, including the ongoing Phase 3 VIKTORIA-1

clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial.

The A&R Loan Agreement

contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants

related to liquidity and other financial measures.

Innovatus has the right, at its election and until August 9, 2025, to

convert up to 20 %

of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 .

Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to

purchase 26,042

shares of common stock at a price per share of $ 14.40

through April 8, 2031.

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

A&R Loan Agreement contains a Final Fee, which is equal to 4.5 % of the initial funding of the agreement and is due on the earliest

2 unchanged sentences

non-utilization fee for both the Term D and Term E Loans.

If the Company achieves the Term D Milestone and (i) fails to draw the full

Because the Company achieved the Term D Milestone on July 28, 2025, if the Company (i) fails to draw the full

amount of the Term D Loan during the Term D Draw Period and (ii) fails to notify Collateral Agent, at any time before the date that is

four weeks after the Company’s achievement of the Term D Milestone, of the Company’s intent not to draw the full amount of

the Term D Loan, a non-utilization fee of $ 0.9 million, with respect to the Term D Loan shall become due and payable on the earliest of

(i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment

the Term D Loan, a non-utilization fee of $ 0.9 million with respect to the Term D Loan shall become due and payable on the earliest

of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment

in whole of the Term Loans.

30 unchanged sentences

price are subject to certain proportional adjustments as set forth in such Warrant.

On May 13, 2025, the Company entered into the First Amendment (the “First

Amendment”) to the A&R Loan Agreement, pursuant to which the Company agreed to (i) pay Oxford an amendment fee of $40,000 on

the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to

20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00, (iii)

extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of

Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as

defined in the First Amendment) to 50% if the Company fails to achieve the Term D Milestone prior to June 1, 2025 and to decrease the

Minimum Liquidity Percentage back to 30% if the Company subsequently achieves the Term D Milestone prior to the end of the Term D Draw

Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the

First Amendment and related documentation.

May 13, 2025, the Company entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant

to which the Company agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to

March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into

shares of the Company’s common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period

to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv)

update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if the Company

fails to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if the Company

subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from

any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.

Company evaluated the change of terms under ASC 470-50, “Debt – Modification and Extinguishment”, and concluded the

1 unchanged sentence

modification of the debt and not an extinguishment of the debt.

debt consisted of the following at March 31, 2025 and December 31, 2024:

of Long-term Debt

(in thousands)

PIK interest (added

to principal)

unamortized debt

issuance costs

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

debt consisted of the following at June 30, 2025 and December 31, 2024:

Schedule of Long-term Debt

PIK interest (added to principal)

unamortized debt issuance costs

unamortized debt discount

Total long-term debt

long-term debt

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

of Long Term Debt Future Principal Payments

(in thousands)

Schedule of Long Term Debt Future Principal Payments

Ending December 31,

License Agreement

April 8, 2021, the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib,

a potent, investigational, multi-target PAM inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2

to induce comprehensive blockade of the PAM pathway.

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.

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.

One of these milestone events requires a $ 5.0 million payment within 60 days following the

Food and Drug Administration (“FDA”) regulatory filing of a New Drug Application (“NDA”) for gedatolisib.

The Company has determined the NDA filing with the

FDA is now probable and has recorded this as a research and development expense during the three and six months ended June 30,

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 patent 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.

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

Amendment to Amended and Restated Loan and Security Agreement

July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement,

pursuant to which the A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the

Notes (as defined below) and certain transactions in connection therewith, including the conversion thereof settled solely in common

stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in

connection with the pricing of the Notes, (iii) require an amendment fee payable by the Company to Oxford in the amount of $ 25,000 ,

which was paid upon execution of the Second Amendment, and (iv) extend to May

9, 2026 the expiration date of Innovatus’ right to convert up to 20 %

of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 .

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

in connection with the release of the topline data from the wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, the Company achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore is eligible to draw an additional $ 30.0

million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement).

The Company intends to draw down such $ 30.0 million in

late August 2025 prior to the expiration of the Term D Draw Period (as defined in the A&R Loan Agreement) on August 31, 2025.

2025 Equity Offering

July 30, 2025, the Company entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies

LLC, TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several

underwriters named therein (collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and

sell in a public offering (i) 1,836,842

shares (the “Shares”) of the Company’s common stock, at a price to the public of $ 38.00

per Share and (b) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000

shares of common stock (the “Pre-Funded Warrants”), at a price to the public of $ 37.999

per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $ 0.001

per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”).

In addition, pursuant to the Equity

Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional 335,526

shares of common stock (the “Option Shares”), less underwriting discounts and commissions.

The Underwriters exercised

their option to purchase the Option Shares in full on July 30, 2025.

The Equity Offering was completed on July 31, 2025.

net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were

approximately $ 91.6

million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares.

Company may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $ 0.001 per share, or alternatively, at the election

of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined

according to the formula set forth in each Pre-Funded Warrant.

The Pre-Funded Warrants are exercisable at any time after the date of

issuance until all of the Pre-Funded Warrants

are exercised.

A holder (together with its “attribution parties,” as defined in the Pre-Funded Warrant) may not exercise

any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together with its attribution parties), would beneficially

own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise.

a holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, which increase or decrease shall not

become effective until 61 days after notice from the holder to the Company.

2025 Convertible Notes Offering

July 30, 2025, the Company also entered into an underwriting agreement (the “Note Underwriting Agreement”) with the

Underwriters, subject to customary conditions, to issue and sell in a public offering $ 175,000,000

aggregate principal amount of the Company’s 2.750 %

Convertible Senior Notes due 2031 (the “Notes”) to the Underwriters (the “Note Offering”).

pursuant to the Note Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional $ 26,250,000

aggregate principal amount of Notes solely to cover over-allotments.

On July 30, 2025, the Underwriters exercised such option to

purchase an additional $ 26,250,000

aggregate principal amount of Notes.

The issuance of $ 201,250,000

aggregate principal amount of Notes was completed on August 1, 2025.

The Notes were issued

pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between the Company

Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first supplemental

indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the

“Indenture”), dated as of August 1, 2025, between the Company and the Trustee.

The net proceeds from the Note Offering,

after deducting underwriting discounts and commissions and offering expenses, were approximately $ 194.9

million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full.

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Six Months Ended June 30, 2025 and 2024)

Notes are general, unsecured, senior obligations of the Company.

The Notes will accrue interest payable semi-annually in arrears on February

1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750 % per year.

In addition, special interest will accrue

on the Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided

in the Indenture and as described below.

The Notes also have customary provisions relating to the occurrence of “Events of Default”

(as defined in the Indenture) with certain interest penalty provisions.

The Notes will mature on August 1, 2031 , unless earlier converted,

redeemed or repurchased by the Company.

may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding

the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $ 1,000 principal amount of the Notes, which

is equivalent to an initial conversion price of approximately $ 51.30 per share of common stock.

The conversion rate is subject to customary

adjustments upon the occurrence of certain events as described in the Indenture.

In addition, if certain corporate events that constitute

a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances,

be increased for a specified period of time.

Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any

time, and from time to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately

before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid

interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds

130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days

ending on, and including, the trading day immediately before the date the Company sends the related redemption notice;

and (ii) the trading

day immediately before the date the Company sends such notice.

However, the Company may not redeem less than all of the outstanding Notes

unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time the Company

sends the related redemption notice.

In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with

respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances

if it is converted after it is called for redemption.

a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth

in the Indenture, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount

of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and

certain de-listing events with respect to the common stock.

the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert

all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect

to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder

or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding

immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes;

provided, that such

4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder;

provided further, that such limitation

in no event can exceed 19.99%.

Warrants Exercised

In July 2025, an investor exercised

1,286,960 warrants at an exercise price of $ 8.05 , which generated approximately $ 10.4 million in cash.

The warrants were issued pursuant

to a private placement that closed on December 9, 2022.

2025, investors exercised 200,000 warrants at an exercise price of $ 8.05 , which generated approximately $ 1.6 million in cash.

were issued pursuant to a private placement that closed on December 9, 2022.

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