What changed in this filing

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Item 1. Financial Statements

2025-05-15 compared with 2024-11-14 · 250 added, 406 removed, 203 unchanged (76% of the section changed)

1 unchanged sentence

Balance Sheets

September 30, 2024

December 31, 2023

thousands, except share and per share amounts)

Current Assets:

Cash and cash equivalents

Other current assets

Cash and cash

current assets

Total current assets

Property and equipment, net

Operating lease right-of-use assets

$ 273,036,970

$ 191,219,398

Liabilities and Stockholders’ Equity:

Operating lease right-of-use

Liabilities and Stockholders’

Current Liabilities:

1 unchanged sentence

Operating lease liabilities

Accrued expenses

Total current liabilities

1 unchanged sentence

Note payable, non-current

Total Liabilities

Commitments and Contingencies (Note 5)

Commitments and Contingencies

Stockholders’ Equity:

1 unchanged sentence

2,500,000 shares authorized;

317,577 and 854,134 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

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

Common stock, $ 0.001 par value:

95,000,000 shares authorized;

37,116,267 and 25,506,012 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

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

Additional paid-in capital

Accumulated deficit

( 235,202,067 )

( 160,076,003 )

Total Stockholders’ Equity

Total Liabilities and Stockholders’ Equity

$ 273,036,970

$ 191,219,398

Stockholders’ Equity

Liabilities and Stockholders’ Equity

accompanying notes to the condensed financial statements.

Statements of Operations

Three Months Ended September 30,

Nine Months Ended September 30,

thousands, except share and per share amounts)

Months Ended March 31,

Operating expenses:

Research and development

General and administrative

and administrative

Total operating expenses

Loss from operations

( 30,059,899 )

( 18,898,037 )

( 76,836,820 )

( 46,501,059 )

Other (expense) income

Interest expense

( 3,343,989 )

( 1,372,132 )

( 7,005,284 )

( 3,929,140 )

Interest income

Other income, net

Net loss before income taxes

( 29,791,789 )

( 18,404,540 )

( 75,126,064 )

( 44,930,644 )

Other (expense) income,

loss before income taxes

Income tax benefits

$ ( 29,791,789 )

$ ( 18,404,540 )

$ ( 75,126,064 )

$ ( 44,930,644 )

Net loss per share, basic and diluted

Weighted average common shares outstanding, basic and diluted

Weighted average common shares outstanding,

basic and diluted

accompanying notes to the condensed financial statements.

Statements of Changes in Stockholders’ Equity

and Nine Months Ended September 30, 2024

Preferred Stock

Months Ended March 31, 2025

thousands, except share amounts)

Additional Paid-In

Balance at December 31, 2024

$ ( 271,855 )

$ ( 160,076,003 )

$ 139,769,322

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 price

Conversion of preferred to common stock

( 21,612,455 )

Balance at March 31, 2024 (unaudited)

$ 315,393,843

$ ( 181,688,458 )

$ 133,736,664

Stock-based compensation

Employee stock purchases

Conversion of preferred 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

Issuance of common stock in an ATM offering

Issuance costs associated with an ATM offering

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

Issuance of common stock warrants, note payable

( 23,721,820 )

Balance at June 30, 2024 (unaudited)

$ 382,057,737

$ ( 205,410,278 )

$ 176,684,792

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 price

( 29,791,789 )

Balance at September 30, 2024 (unaudited)

$ 384,873,261

$ ( 235,202,067 )

Exercise of common stock warrants

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

Balance at March 31, 2025

$ ( 308,852 )

1 unchanged sentence

Statements of Changes in Stockholders’ Equity

and Nine Months Ended September 30, 2023

Preferred Stock

Months Ended March 31, 2024

thousands, except share amounts)

Additional Paid-In

2 unchanged sentences

$ ( 160,076 )

$ 133,771,467

Stock-based compensation

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

Conversion of preferred to common stock

Issuance costs associated with private placement offering

( 11,938,417 )

Balance at March 31, 2023 (unaudited)

$ 231,439,035

$ ( 108,235,304 )

$ 123,226,768

Stock-based compensation

Employee stock purchases

Conversion of preferred to common stock

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

( 14,587,687 )

Balance at June 30, 2023 (unaudited)

$ 232,932,164

$ ( 122,822,991 )

$ 110,132,341

$ 232,932,164

$ ( 122,822,991 )

$ 110,132,341

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

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

( 18,404,540 )

Balance at September 30, 2023 (unaudited)

$ 234,100,541

$ ( 141,227,531 )

Balance at March 31, 2024

$ ( 181,688 )

2 unchanged sentences

Statements of Cash Flows

Nine Months Ended September 30,

Cash flows from operating activities:

$ ( 75,126,064 )

$ ( 44,930,644 )

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

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

Amortization of debt

issuance costs and discount

Payment-in-Kind interest

Non-cash operating lease, net

Change in accrued interest income

( 1,112,420 )

Non-cash operating lease,

Change in accrued interest

Changes in operating assets and liabilities:

Other current assets

( 1,065,732 )

Accounts payable

Accrued expenses

Net cash used for operating activities

( 55,696,760 )

( 35,276,332 )

Cash flows from investing activities:

cash used for operating activities

Cash flows from investing

Proceeds from maturities of investments

Purchases of investments

( 515,557,800 )

( 184,779,534 )

Purchases of property and equipment

Net cash (used for) provided by investing activities

( 100,627,800 )

Cash flows from financing activities:

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

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 $ 2,437,644

Proceeds from an ATM offering, net of issuance costs

Payments for secondary registration statement costs

Payments for debt issuance costs

Payments for finance leases

Net cash provided by financing activities

Payments for secondary

registration statement costs

cash provided by financing activities

Net change in cash and cash equivalents

( 18,059,485 )

Cash and cash equivalents:

1 unchanged sentence

End of period

Supplemental disclosure of cash flow information:

Supplemental disclosure

of cash flow information:

Interest paid

Supplemental disclosures of non-cash investing and financing activities:

Offering and registration statement costs included in accounts payable

Property and equipment included in accounts payable

Common stock warrants issued with note payable transaction

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

accompanying notes to the condensed financial statements

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three and Nine Months Ended September 30, 2024 and 2023)

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

therapies for treatment of 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

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

castration resistant prostate cancer, was initiated in the first quarter of 2024 and is currently enrolling patients.

A Phase 3 clinical

trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2-

advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025.

The Company was co-founded in 2012 by Brian

Sullivan and Dr.

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.

Laing and is based in Minnesota.

14 unchanged sentences

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 and nine months ended September 30, 2024 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 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.

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

9 unchanged sentences

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

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

providers, which includes the conduct of preclinical studies and clinical trials.

These costs can be a significant component of the

Company’s research and development expenses.

The Company primarily relies on a compilation of progress reports from

third-party service providers, including the respective invoicing, to record actual expenses, along with determining changes to

prepaid assets and accrued liabilities.

To date, the Company believes utilization of third-party reports most accurately reflects

expenses incurred.

As the current VIKTORIA-1 Phase 3, the CELC-G-201 Phase 1b/2 and the VIKTORIA-2 Phase 3 clinical trials ramp up

site activation and patient enrollment, 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.

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

there are alternative vendors that can perform these functions, any disruption or delay by the Company’s current third parties

in carrying out their contractual duties could delay the clinical trials.

The Company records prepaid assets or accrued expenses for

prepaid or estimated clinical trial costs conducted by third-party service providers, which includes the conduct of preclinical studies

and clinical trials.

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

primarily relies on a compilation of progress reports from third-party service providers, including the respective invoicing, to record

actual expenses, along with determining changes to prepaid assets and accrued liabilities.

To date, the Company believes utilization

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.

Net Loss Per Common Share

7 unchanged sentences

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

September 30,

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

Preferred stock on an as-if-converted

to common stock basis

Options to purchase common stock

1 unchanged sentence

Restricted common stock

Antidilutive securities excluded from computation of earnings per share, amount

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

September 30, 2024, as the pre-funded warrants are exercisable for nominal consideration.

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.

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

9 unchanged sentences

for credit losses recorded for these securities.

following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2024 and

December 31, 2023:

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

of Investment

September 30, 2024

Treasury Bills

$ 251,455,468

$ 251,652,388

$ 251,455,468

$ 251,652,388

December 31, 2023

Treasury Bills

$ 149,919,974

$ 149,950,969

$ 149,919,974

$ 149,950,969

Cost, as Adjusted

Unrealized Holding Gains

Unrealized Holding Losses

(in thousands)

Cost, as Adjusted

Unrealized Holding Gains

Unrealized Holding Losses

Cost, as Adjusted

Unrealized Holding Gains

Unrealized Holding Losses

(in thousands)

Cost, as Adjusted

Unrealized Holding Gains

Unrealized Holding Losses

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

7 unchanged sentences

Company enters into contracts in the normal course of business to conduct research and development programs internally and through third

parties that include, among others, arrangements with vendors, consultants, contract manufacturing organizations (“CMOs”)

and contract research organizations (“CROs”).

The Company currently has two Phase 2 clinical trial agreements in place to

evaluate targeted therapies selected with one of our CELsignia tests.

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.

The Company also has a license agreement in place with Pfizer

to research, develop, manufacture and commercialize gedatolisib.

In conjunction with the license agreement, the Company continued a Phase

1b study – B2151009 related to gedatolisib.

parties that include, among others, arrangements with vendors, consultants, contract manufacturing organizations, and contract research

organizations.

The Company has a license agreement in place with Pfizer Inc.

(“Pfizer”) to research, develop, manufacture

and commercialize gedatolisib.

In conjunction with the license agreement, the Company completed a Phase 1b clinical trial – B2151009

related to gedatolisib.

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

Contracts related to the Phase 1B and the Expanded Access studies are generally based on time and material.

In addition, contracts related

to the Company’s Phase 3 clinical study (VIKTORIA-1) and Phase 1b/2 clinical study (CELC-G-201) 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 September 30, 2024, the Company

had two material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 1.6 million.

August 2024, the Company entered into two software license agreements.

These agreements will expire in August 2026.

As of September

30, 2024, the Company had non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 0.2 million.

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

studies (VIKTORIA-1 and VIKTORIA-2) and the Phase 1b/2 clinical trial (CELC-G-201) 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 subject to amendments as a result of any change orders executed by the parties.

As of March 31, 2025, the Company had six

material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 6.9 million.

Stockholders’ Equity

December 31, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of $ .001 par value common stock, of which

25,506,012 shares were outstanding, and 2,500,000 shares of $ .001 par value preferred stock, of which 854,134 shares were outstanding.

January 15, 2024, one of the Company’s preferred shareholders elected to convert 224,244 shares of Series A Convertible Preferred

Stock into 2,242,440 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.

March 14, 2024, one of the Company’s preferred shareholders elected to convert 50,000 shares of Series A Convertible Preferred

Stock into 500,000 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.

March 15, 2024, one of the Company’s investors exercised 1,739,080 common stock warrants at an exercise price of $ 8.05 per share,

which generated approximately $ 14.0 million in cash.

The warrants were issued pursuant to the Securities Purchase Agreement dated May

15, 2022, that closed and was funded on December 9, 2022.

common stock warrants of 3,683 from several investors were exercised, which generated approximately $ 9,000 in cash in the first quarter

The 3,683 common stock warrants were net of shares withheld for exercise price.

March 19, 2024, one of the Company’s preferred shareholders elected to convert 43,913 shares of Series A Convertible Preferred

Stock into 439,130 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.

March 26, 2024, one of the Company’s preferred shareholders elected to convert 30,700 shares of Series A Convertible Preferred

Stock into 307,000 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.

May 31, 2024, one of the Company’s preferred shareholders elected to convert 100,000 shares of Series A Convertible Preferred Stock

into 1,000,000 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.

June 26, 2024, one of the Company’s preferred shareholders elected to convert 87,700 shares of Series A Convertible Preferred Stock

into 877,000 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.

stock warrants of 19,390 from several investors were exercised, which generated approximately $ 173,000 in cash in the second quarter

The 19,390 common stock warrants were net of shares withheld for exercise price.

stock warrants of 65,204 from several investors were exercised, which generated approximately $ 554,000 in cash in the third quarter of

The 65,204 common stock warrants were net of shares withheld for exercise price.

September 30, 2024, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 37,116,267

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.

As of September 30, 2024, no dividends have been declared on the Company’s capital stock.

and Issuance of Stock

April 22, 2024, pursuant to an Open Market Sale Agreement SM with Jefferies LLC, as agent, the Company sold 285,714 shares

of common stock in a single transaction at a price of $ 17.50 per share, generating gross proceeds of $ 5.0 million.

May 8, 2024, pursuant to an Open Market Sale Agreement with Jefferies LLC, as agent, the Company sold 149,700 shares of common stock

in a single transaction at a price of $ 17.65 per share, generating gross proceeds of $ 2.6 million.

and other offering expenses related to the Open Market Sale Agreement transactions in April and May 2024 were $ 0.3 million.

May 30, 2024, the Company entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus

& Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of Common

Stock, at a price to the public of $ 15.50 , generating gross proceeds of approximately $ 60.0 million.

The offering closed on May 31, 2024

and resulted in net proceeds to the Company of approximately $ 56.3 million after deducting underwriting discounts and other offering

expenses payable by the Company.

The Company intends to use the net proceeds from the offering for working capital and general corporate

purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, expansion of business

development activities and other general corporate purposes.

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

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.

As of March 31, 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 nine months ended September 30:

of Stock Options Activity

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

Schedule of Stock Options Activity

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, 2024:

of Stock Options Outstanding and Exercisable

Options Outstanding

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

Exercise Price

Company recognized stock-based compensation expense for stock options of $ 1,843,424 and $ 1,065,567 for the three months ended September

30, 2024 and 2023, respectively and $ 4,463,423 and $ 3,516,180 for the nine months ended September 30, 2024 and 2023, 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 $ 26,652 and $ 30,188 for the three months ended

September 30, 2024 and 2023, respectively, and $ 80,063 and $ 107,490 for the nine months ended September 30, 2024 and 2023, respectively.

The effect of this modification on stock-based compensation over the remaining service period will be approximately $ 83,000 .

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 $ 15,773 and $ 15,773 for the three months ended September 30, 2024 and 2023, respectively and $ 47,300 and $ 49,617 for the nine months

ended September 30, 2024 and 2023, respectively.

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

period will be approximately $ 51,000 .

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 $ 0 and $ 3,041 for the three months ended September 30, 2024 and 2023, respectively and $ 696 and $ 16,975

for the nine months ended September 30, 2024 and 2023, respectively.

The effect of this modification on stock-based compensation over

the remaining service period will be $ 0 .

Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards and the Monte Carlo simulation model was

used to estimate the fair value of the performance-based awards, with the following weighted-average assumptions for the nine months

ended September 30:

Company recognized stock-based compensation expense for stock options of $ 2,260

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 .

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

3.48 % - 4.71 %

3.41 % - 4.61 %

Expected volatility

71.2 to 76.10 %

78.0 to 79.8 %

Expected life (years)

5.25 to 10.00

Expected dividend yield

inputs for the Black-Scholes valuation model and the Monte Carlo simulation model require management’s significant assumptions.

Prior to the Company’s initial public offering, the price per share of common stock was determined by the Company’s board

based on recent prices of common stock sold in private offerings.

Subsequent to the initial public offering, the price per share of common

stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date.

The risk-free interest rates are

based on the rate for U.S.

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

The expected life is based on the simplified method for the time-based awards and the life of the option for the performance-based

awards, in accordance with the SEC Staff Accounting Bulletin Nos.

The expected volatility is estimated based on historical

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

being publicly traded for the time-based awards.

For the performance-based awards, the Company’s full historical volatility was

used to value the options.

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

Prior to the Company’s initial

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

sold in private offerings.

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

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

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

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

The expected life is

based on the simplified method 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.

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

2 unchanged sentences

with the agreements would also be cancelled.

Company had 1,079 and 1,958 shares of restricted stock outstanding as of September 30, 2024 and 2023, respectively, and no shares of

restricted stock vested during the three months ended September 30, 2024 and 2023.

The Company recognized stock-based compensation expense

for restricted stock of $ 4,448 and $ 4,903 for the three months ended September 30, 2024 and 2023, respectively and $ 17,773 and $ 13,597

for the nine months ended September 30, 2024 and 2023, 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 102,998 , 149,189 , 216,673 ,

and 255,060 shares on January 1, 2021, 2022, 2023, and 2024, respectively, and will increase automatically on January 1 of each year

from 2025 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

the Annual Meetings held on May 12, 2021 and May 12, 2022, the stockholders approved one-time, 500,000 increases each year for a total

increase of 1,000,000 , to the number of shares reserved for issuance under the 2017 Plan.

At the Annual Meetings held on May 11, 2023

and May 9, 2024, the stockholders approved one-time, 1,500,000 increases each year for a total increase of 3,000,000 , 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 September 30, 2024 was 1,286,511 .

unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized at September 30, 2024:

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

Total estimated compensation cost to be recognized

Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 83,329 and $ 38,167 for the three

months ended September 30, 2024 and 2023, respectively and $ 191,863 and $ 129,125 for the nine months ended September 30, 2024 and 2023,

respectively.

The Company initially reserved a total of 100,000 shares for issuance under the employee stock purchase plan.

of shares reserved for issuance was automatically increased by 51,499 , 74,594 , 108,337 , and 127,530 shares on January 1, 2021, 2022,

2023, and 2024, 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, 2024 was 373,739 .

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

(in thousands)

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

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

Three Months Ended

Nine Months Ended

Stock-based compensation expense in operating expenses:

(in thousands)

Stock-based compensation expense in operating

Research and development

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The A&R Loan Agreement amends and restates, in its entirety, that certain Loan and Security Agreement, dated

April 8, 2021, as amended, between the Company and Innovatus, as collateral agent, and the Lenders named therein.

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

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Costs associated with the new borrowings

was approximately $ 2.4 million.

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.

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.

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 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 (the “Conversion

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 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.

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

5 unchanged sentences

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 $ 900,000 , 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.

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.

If the Company achieves the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during

1 unchanged sentence

achievement of the Term E Milestone, of the Company’s intent not to draw the full amount of the Term E Loan, a non-utilization

fee of $ 1,500,000 , with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E

Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans.

fee of $ 1.5 million, with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term

E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans.

the 18-month anniversary of the Effective Date, the Company shall have the option to prepay all, but not less than all, of the Term Loans

24 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.

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 September 30, 2024 and December 31, 2023:

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

of Long-term Debt

September 30,

$ 100,000,000

PIK interest (added to principal)

unamortized debt issuance costs

( 1,856,880 )

(in thousands)

PIK interest (added

to principal)

unamortized debt

issuance costs

unamortized debt discount

( 6,059,370 )

Total long-term debt

1 unchanged sentence

of Long Term Debt Future Principal Payments

$ 104,840,164

Subsequent Event

October 7, 2024, the Company held a Special Meeting of Stockholders at which the Company’s stockholders approved an amendment to

the Company’s Certificate of Incorporation to increase the authorized number of shares of the Company’s Common Stock from

65,000,000 to 95,000,000 (the “Authorized Share Increase”).

The Authorized Share Increase had previously been approved, subject

to stockholder approval, by the Company’s Board of Directors.

On October 7, 2024, the Company filed a certificate of amendment

to the Certificate of Incorporation with the Delaware Secretary of State to effect the Authorized Share Increase, which became effective

immediately upon its filing.

(in thousands)

Ending December 31,

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