What changed in this filing

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Item 1. Financial Statements

2024-08-14 compared with 2024-05-15 · 320 added, 179 removed, 260 unchanged (66% of the section changed)

1 unchanged sentence

Balance Sheets

March 31, 2024

December 31, 2023

Current Assets:

Cash and cash equivalents

Cash and cash

Other current assets

1 unchanged sentence

Property and equipment, net

Operating lease right-of-use assets

Operating lease right-of-use

$ 292,544,985

$ 191,219,398

Liabilities and Stockholders’ Equity:

Liabilities and Stockholders’

Current Liabilities:

5 unchanged sentences

Note payable, non-current

Total Liabilities

Commitments and Contingencies (Note 5)

Commitments and Contingencies

Stockholders’ Equity:

1 unchanged sentence

2,500,000 shares authorized;

505,277 and 854,134 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

Common stock, $ 0.001 par value:

and 854,134 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

Common stock, $ 0.001

shares authorized;

30,773,895 and 25,506,012 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

and 25,506,012

shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

Additional paid-in capital

2 unchanged sentences

( 160,076,003 )

Total Stockholders’ Equity

Total Liabilities and Stockholders’ Equity

Stockholders’ Equity

Liabilities and Stockholders’ Equity

$ 292,544,985

$ 191,219,398

accompanying notes to the financial statements

accompanying notes to the Condensed financial statements

Statements of Operations

Three Months Ended March 31,

Months Ended June 30,

Operating expenses:

Research and development

General and administrative

3 unchanged sentences

( 15,055,485 )

( 46,776,921 )

( 27,603,022 )

Other income (expense)

2 unchanged sentences

( 1,314,996 )

( 3,661,295 )

( 2,557,008 )

Interest income

Other income, net

Net loss before income taxes

Other income (expense),

loss before income taxes

( 23,721,820 )

( 14,587,687 )

( 45,334,275 )

( 26,526,104 )

Income tax benefits

1 unchanged sentence

$ ( 14,587,687 )

$ ( 45,334,275 )

$ ( 26,526,104 )

Net loss per share, basic and diluted

Weighted average common shares outstanding, basic and diluted

accompanying notes to the financial statements

of Changes in Stockholders’ Equity

Months Ended March 31, 2024

at December 31, 2023

Weighted average common shares outstanding,

basic and diluted

accompanying notes to the Condensed financial statements

Statements of Changes in Stockholders’ Equity

and Six Months Ended June 30, 2024

Balance at December 31, 2023

$ 299,818,965

1 unchanged sentence

$ 139,769,322

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

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

of preferred to common stock

Stock-based compensation

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

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

Conversion of preferred to common stock

( 21,612,455 )

at March 31, 2024 (unaudited)

Balance at March 31, 2024

$ 315,393,843

1 unchanged sentence

$ 133,736,664

accompanying notes to the financial statements

of Changes in Stockholders’ Equity

Months Ended March 31, 2023

Preferred Stock

Additional Paid-In

Stock-based compensation

Employee stock purchases

Conversion of preferred to common stock

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

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

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 )

at June 30, 2024 (unaudited)

$ 382,057,737

$ ( 205,410,278 )

$ 176,684,792

accompanying notes to the Condensed financial statements

Statements of Changes in Stockholders’ Equity

and Six Months Ended June 30, 2023

Balance at December 31, 2022

2 unchanged sentences

$ 133,771,467

Stock-based compensation

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

Conversion of preferred to common stock

Issuance costs associated with private placement

( 11,938,417 )

Balance at March 31, 2023

$ 231,439,035

$ ( 108,235,304 )

$ 123,226,768

$ 231,439,035

$ ( 108,235,304 )

$ 123,226,768

Stock-based compensation

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

Employee stock purchases

Conversion of preferred to common stock

Issuance costs associated with private placement offering

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

( 14,587,687 )

Balance at March 31, 2023 (unaudited)

at June 30, 2023 (unaudited)

$ 232,932,164

4 unchanged sentences

$ 110,132,341

accompanying notes to the financial statements

accompanying notes to the Condensed financial statements

Statements of Cash Flows

Three Months Ended March 31,

Cash flows from operating activities:

Months Ended June 30,

Cash flows from operating

$ ( 45,334,275 )

$ ( 26,526,104 )

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

Adjustments to reconcile net loss to net cash

and cash equivalents used for operations:

Stock-based compensation

Amortization of debt issuance costs and discount

Non-cash operating lease, net

Change in accrued interest income

( 1,697,811 )

Payment-in-Kind interest

Non-cash operating lease expense, net

Change in accrued

interest income

Changes in operating assets and liabilities:

2 unchanged sentences

Accrued expenses

( 1,020,102 )

Net cash used for operating activities

1 unchanged sentence

( 22,529,890 )

Cash flows from investing activities:

Cash flows from investing

Proceeds from maturities of investments

Purchases of investments

1 unchanged sentence

( 113,903,646 )

Proceeds from maturities of investments

Purchases of property and equipment

Net cash provided by investing activities

Cash flows from financing activities:

Purchases of property

and equipment

Net cash (used for)

provided by investing activities

( 102,531,391 )

Cash flows from financing

Proceeds from exercise of common stock warrants

Proceeds from exercise of employee stock options

Payments for secondary registration statement costs

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 $ 2,429,917

Proceeds from an ATM offering, net of issuance

Payments for secondary registration statement

Payments for debt issuance costs

Payments for finance leases

Payments for finance

Net cash provided by financing activities

3 unchanged sentences

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

Property and equipment included in accrued expenses

Exercise of stock options pending receipt of cash proceeds

accompanying notes to the financial statements

Supplemental disclosures

of non-cash investing and financing activities:

Offering and registration statement costs included

in accounts payable

Property and equipment included in accounts

Non-cash interest receivable

Common stock warrants issued with note payable

accompanying notes to the Condensed financial statements

TO CONDENSED FINANCIAL STATEMENTS (unaudited)

the Three Months Ended March 31, 2024 and 2023)

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

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

Its mechanism of action and pharmacokinetic

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

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

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

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

in combination with darolutamide in patients with metastatic castration resistant prostate cancer, was initiated in the first quarter

of 2024 and is currently enrolling patients.

The Company’s CELsignia companion diagnostic platform is uniquely able to analyze

live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.

was co-founded in 2012 by Brian F.

the Three and Six Months Ended June 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 patients.

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

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 F.

Sullivan and Dr.

Laing and is based in Minnesota.

The Company has not generated any revenues

The Company has not

generated any revenues to date.

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

12 unchanged sentences

and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected during the remainder of

the current year or for any future period.

results for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected during the remainder

of the current year or for any future period.

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

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

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

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

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

1 unchanged sentence

Restricted common stock

warrant shares of 5,747,787 and zero are included in the computation of basic and diluted net loss per share for the periods ended March

31, 2024, and March 31, 2023, respectively, as the pre-funded warrants are exercisable for nominal consideration.

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

ended June 30, 2024, and June 30, 2023, respectively, 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 March 31, 2024 and December

Schedule of Investment

March 31, 2024

Amortized Cost,

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

of Investment

Holding Gains

Holding Losses

Treasury Bills

$ 252,609,622

2 unchanged sentences

$ 252,614,893

December 31, 2023

Amortized Cost,

Holding Gains

Holding Losses

Treasury Bills

$ 149,919,974

12 unchanged sentences

parties that include, among others, arrangements with vendors, consultants, CMO’s, and CRO’s.

The Company currently has three

The Company currently has two

Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests.

15 unchanged sentences

executed by the parties.

As of March 31, 2024, the Company had two material non-cancelable contractual commitments with respect to these

As of June 30, 2024, the Company had two material non-cancelable contractual commitments with respect to these

arrangements, which totaled approximately $ 1.8 million.

Stockholders’

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

8 unchanged sentences

the shares transferred is $ 5.75 per share.

March 15, 2024, one of the Company’s investors exercised 1,739,080

of common stock warrants at an exercise price of $ 8.05 ,

which generated approximately $ 14

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.

Additional common stock warrants of 3,683

from several investors were exercised, which generated approximately $ 9,000 in

cash in the first quarter of 2024.

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

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

generated approximately $ 14 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.

Additional common stock warrants of 3,683 from several investors were exercised, which

generated approximately $ 9,000 in cash in the first quarter of 2024.

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

6 unchanged sentences

the shares transferred is $ 5.75 per share.

March 31, 2024, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 30,773,895 shares

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.

June 30, 2024, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 37,014,751 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, 2024, no dividends have been declared on the Company’s capital stock.

As of June 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

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 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 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.

Stock-Based Compensation

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

Schedule of Stock Options Activity

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

of Stock Options Activity

Exercise Price

Options outstanding at beginning of year

Balance at March 31

Options exercisable at March 31:

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, 2024:

Schedule of Stock Options Outstanding and Exercisable

Options Outstanding

Options outstanding at beginning

Balance at June 30

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 June 30, 2024:

of Stock Options Outstanding and Exercisable

Exercise Price

Company recognized stock-based compensation expense for stock options of $ 1,290,193 and $ 1,222,328 for the three months ended March 31,

2024 and 2023, respectively.

In 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 $ 26,719 and

$ 39,612 for the three months ending March 31, 2024 and 2023, respectively.

The effect of this modification on stock-based compensation

over the remaining service period will be approximately $ 137,000 .

In December 2021, the Company modified the exercise price on 311,000

stock option awards to $ 13.44 , the closing market price on the Nasdaq Capital Market on December 15, 2021.

No director or officer awards

were modified.

The effect of this modification on stock-based compensation was $ 15,764 and $ 16,924 for the three months ended March 31,

Company recognized stock-based compensation expense for stock options of $ 1,329,807 and $ 1,228,284 for the three months ended June 30,

2024 and 2023, respectively and $ 2,619,999 and $ 2,450,612 for the six months ended June 30, 2024 and 2023, respectively.

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

on May 17, 2022.

The effect of this modification on stock-based compensation was $ 26,692 and $ 37,690 for the three months ending June

30, 2024 and 2023, respectively and $ 53,411 and $ 77,302 for the six months ending June 30, 2024 and 2023, respectively.

The effect of

this modification on stock-based compensation over the remaining service period will be approximately $ 110,000 .

In December 2021, the

Company modified the exercise price on 311,000 stock option awards to $ 13.44 , the closing market price on the Nasdaq Capital Market on

December 15, 2021.

No director or officer awards were modified.

The effect of this modification on stock-based compensation was $ 15,763

and $ 16,920 for the three months ended June 30, 2024 and 2023, respectively and $ 31,527 and $ 33,844 for the six months ending June 30,

2024 and 2023, respectively.

4 unchanged sentences

The effect of this modification on stock-based compensation

was $ 696 and $ 7,108 for the three months ended March 31, 2024 and 2023, respectively.

The effect of this modification on stock-based

compensation over the remaining service period will be $ 0 .

was $ 0 and $ 6,826 for the three months ended June 30, 2024 and 2023, respectively and $ 696 and $ 13,934 for the six months ending June

30, 2024 and 2023, respectively.

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

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:

Schedule of Assumptions for Fair Value of Equity-based Awards

for the six months ended June 30:

of Assumptions for Fair Value of Equity-based Awards

Risk-free interest rate

3.94 % - 4.33 %

3.64 % - 4.14 %

Expected volatility

Expected life (years)

Expected dividend yield

dividend yield

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

15 unchanged sentences

with the agreements would also be cancelled.

restricted stock awards were granted during the three months ended March 31, 2024 and 2023.

The Company had 1,958 and 3,273 shares of

restricted stock outstanding as of March 31, 2024 and 2023, respectively, and 0 shares of restricted stock vested during the three months

ended March 31, 2024 and 2023.

The Company recognized stock-based compensation expense for restricted stock of $ 4,849 and $ 4,642 for

the three months ended March 31, 2024 and 2023, respectively.

stock awards were granted to members of the Company’s board during the three months ended June 30, 2024 and 2023.

The Company had

1,079 and 1,958 shares of restricted stock outstanding as of June 30, 2024 and 2023, respectively, and 1,958 and 3,273 shares of restricted

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

The Company recognized stock-based compensation expense for restricted

stock of $ 8,475 and $ 4,052 for the three months ended June 30, 2024 and 2023, respectively and $ 13,325 and $ 8,694 for the six months

ended June 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

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At the Annual Meeting held on May 11, 2023

the stockholders approved a one-time, 1,500,000 increase to the number of shares reserved for issuance under the 2017 Plan.

remaining shares available for grant under the Company’s 2017 Plan as of March 31, 2024 was 1,003,414 .

unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized at March 31, 2024:

Schedule of Unrecognized Compensation Cost

Total estimated compensation cost to be recognized

and May 9, 2024, the stockholders approved a one-time, 1,500,000 increase each year for a total of 3,000,000 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, 2024 was 2,267,956 .

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

of Unrecognized Compensation Cost

estimated compensation cost to be recognized

Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 72,230 and $ 44,646 for the three

months ended March 31, 2024 and 2023, respectively.

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

stock purchase plan.

The number of shares reserved for issuance was automatically increased by 51,499 , 74,594 , 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.

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

The total remaining shares available for issuance

under the employee stock purchase plan as of March 31, 2024 was 394,165 .

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

Schedule of Stock-based Compensation Expense

Three Months Ended

Stock-based compensation expense in operating expenses:

Research and development

General and administrative

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

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

August 9, 2022, the Company amended the Loan Agreement.

Under the amended Loan Agreement, Innovatus, as Lender, has agreed to loan up

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

As of March 31, 2024, term loans totaling $ 35 million are outstanding

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

B loan which was funded on December 22, 2022.

March 29, 2024, the Company entered into a second amendment to its existing Loan Agreement to extend the date through which the Company

may draw on the Term C Loan from April 1, 2024 to June 1, 2024.

Other than as set forth in the second amendment, the amended Loan Agreement

shall continue in full force and effect without alteration or amendment.

debt consisted of the following at March 31, 2024 and December 31, 2023:

Schedule of Long-term Debt

PIK interest (added to principal)

unamortized debt issuance costs

unamortized debt discount

months ended June 30, 2024 and 2023, respectively and $ 108,534 and $ 90,958 for the six months ended June 30, 2024 and 2023, respectively.

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

The number of shares reserved

for issuance was automatically increased by 51,499 , 74,594 , 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

June 30, 2024 was 373,739 .

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

of Stock-based Compensation Expenses

Stock-based compensation expense in operating

and administrative

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

with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral agent, and the

Lenders including Innovatus in its capacity as a Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and

Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount

of up to $ 180 million.

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.

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

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.

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 Right”).

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 to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans.

is also a contingent 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 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 $ 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.

If the Company

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

After 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

advanced by the Lenders under the A&R Loan Agreement, provided the Company (i) provides written notice to Collateral Agent of

its election to prepay the Term Loans at least seven Business Days prior to such prepayment, and (ii) pays to Lenders on the date of

such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all

outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C)

the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation,

Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.

At May 30, 2024, the Company

recognized the Final Fee of $ 4.5

million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan.

connection with the funding of each of the Term C Loan, the Term D Loan, the Term E Loan and the Term F Loan, the Company agreed to issue

to Innovatus and Oxford warrants to purchase that number of shares of the Company’s common stock equal to 2.5 % of the principal

amount of the applicable Term Loan divided by the exercise price, which shall, with respect to the Term C Loan, be equal to the lower

of (i) the volume weighted average closing price of the Company’s common stock for the five-trading day period ending on the last

trading day immediately preceding the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately

preceding the execution of the A&R Loan Agreement.

Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise

price of $ 14.84 per share.

The relative fair value of the warrants was approximately $ 1.2 million.

For the additional Term Loans, the

exercise price will be based on the lower of (i) the exercise price for the Warrants issued pursuant to the Term C Loan or (ii) the volume

weighted average closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately

preceding the applicable Term Loan funding.

The Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary

of the applicable funding date.

The number of shares of common stock for which each Warrant is exercisable and the associated exercise

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

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

change in terms did not result in significant and consequential changes to the economic substance of the debt and thus resulted in a

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

debt consisted of the following at June 30, 2024 and December 31, 2023:

of Long-term Debt

$ 100,000,000

PIK interest (added

to principal)

unamortized debt

issuance costs

( 2,089,840 )

unamortized debt

( 6,304,664 )

Total long-term debt

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

Schedule of Long Term Debt Future Principal Payments

Subsequent Event

Subsequent to March 31, 2024, pursuant

to an Open Market Sale Agreement SM with Jefferies LLC, as agent, the Company sold 435,414 shares of common stock at an average

selling price of $ 17.55 per share, generating gross proceeds of $ 7.6 million before deducting commissions and other offering expenses

of $ 0.2 million.

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

of Long Term Debt Future Principal Payments

Ending December 31,

$ 104,587,676

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