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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


☒	Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
	for the quarterly period ended September 30, 2024

or

☐	Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
	for the transition period from to

Commission File Number: 001-34058

CAPRICOR THERAPEUTICS, INC.

(Exact Name Of Registrant As Specified In Its Charter)


Delaware		88-0363465
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

10865 Road to the Cure, Suite 150, San Diego, California 92121

(Address of principal executive offices including zip code)

(858) 727-1755

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share	CAPR	The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

As of November 13, 2024, there were 45,469,908 shares of the registrant’s common stock, par value $0.001 per share, issued and outstanding.

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INDEX TO QUARTERLY REPORT ON FORM 10-Q


		PAGES
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements		5
Condensed Consolidated Balance Sheets at September 30, 2024 and December 31, 2023		5
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023		6
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023		7
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023		9
Notes to Unaudited Condensed Consolidated Financial Statements		10
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		29
Item 3. Quantitative and Qualitative Disclosures about Market Risk		43
Item 4. Controls and Procedures		43

PART II. OTHER INFORMATION
Item 1. Legal Proceedings		44
Item 1A. Risk Factors		44
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		44
Item 3. Defaults Upon Senior Securities		44
Item 4. Mine Safety Disclosures		44
Item 5. Other Information		44
Item 6. Exhibits		44
Signatures		46

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

●

how long we expect to maintain liquidity to fund our planned level of operations and our ability to obtain additional funds for our operations;

●

the development of our drug and vaccine candidates, including when we expect to undertake, initiate and complete clinical trials of our drug and vaccine candidates;

●

the expectation, plans, projections, initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials, compassionate uses, Investigational New Drug filings, Clinical Trial Application filings, New Drug Application filings, Biologics License Application, and other regulatory submissions;

●

regulatory developments involving products and our facilities, including the ability to obtain regulatory approvals or otherwise bring products to market;

●

the regulatory status of our drug and vaccine candidates, including our ability to obtain and maintain orphan drug, rare pediatric and Regenerative Medicine Advanced Therapy designations for our lead product candidate, deramiocel (also referred to as CAP-1002);

●

our ability to obtain approval for our products both in the United States and in countries outside the United States;

●

our use of clinical research centers, third party manufacturers and other contractors;

●

our ability to manufacture and maintain sufficient inventories of our products to meet commercial demand;

●

our ability to find collaborative partners for research, development and commercialization of potential products and retain commercial rights for our product candidates in the collaborations;

●

our ability to manufacture products for clinical and commercial use;

●

our ability to procure materials necessary for the manufacture of our product candidates;

●

our ability to protect our patents and other intellectual property;

●

our ability to raise additional financing and the terms of any additional financing;

●

our ability to market any of our products;

●

the implementation of our business model and strategic plans for our business, technologies and product candidates;

●

our estimates of our expenses, ongoing losses, future revenue, future reimbursement prices for any commercial products, and capital requirements;

●

the impact of taxes on our business;

●

our ability to compete against other companies and research institutions;

●

our ability to expand our operations internationally;

●

the effect of potential strategic transactions on our business;

●

acceptance of our products by doctors, patients or payors and the availability of reimbursement for our product candidates;

●

our ability to attract and retain key personnel; and

●

the volatility of our stock price.

We caution you that the forward-looking statements highlighted above do not encompass all of the forward-looking statements made in this Quarterly Report on Form 10 - Q.

You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections

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about future events and trends that we believe may affect our business, financial condition, results of operations and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors. Moreover, we operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. Additionally, final data may differ significantly from preliminary data reported in this document.

The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report on Form 10-Q to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make, if any.

This Quarterly Report on Form 10-Q also contains data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our internal sources. Although we believe that the third-party sources referred to in this Quarterly Report on Form 10-Q are reliable, we have not independently verified the information provided by these third parties. While we are not aware of any misstatements regarding any third-party information presented in this report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors.

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PART I — FINANCIAL INFORMATION

Item 1. Financial Statements.

CAPRICOR THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS



ASSETS

	September 30, 2024
	(unaudited)		December 31, 2023

CURRENT ASSETS
Cash and cash equivalents	$	68,377,402	$	14,694,857
Marketable securities		16,651,222		24,792,846
Receivables		409,682		10,371,993
Prepaid expenses and other current assets		385,065		995,776

TOTAL CURRENT ASSETS		85,823,371		50,855,472

PROPERTY AND EQUIPMENT, net		5,315,385		5,560,641

OTHER ASSETS
Lease right-of-use assets, net		1,493,611		2,050,042
Other assets		319,246		268,172

TOTAL ASSETS	$	92,951,613	$	58,734,327

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES
Accounts payable and accrued expenses	$	6,531,363	$	6,250,241
Lease liabilities, current		813,634		749,112
Deferred revenue, current		13,130,509		24,270,465

TOTAL CURRENT LIABILITIES		20,475,506		31,269,818

LONG-TERM LIABILITIES
CIRM liability		3,376,259		3,376,259
Lease liabilities, net of current		834,889		1,486,783

TOTAL LONG-TERM LIABILITIES		4,211,148		4,863,042

TOTAL LIABILITIES		24,686,654		36,132,860

COMMITMENTS AND CONTINGENCIES (NOTE 6)

STOCKHOLDERS’ EQUITY
Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding		—		—
Common stock, $0.001 par value, 100,000,000 and 50,000,000 shares authorized, 40,332,392 and 31,148,320 shares issued and outstanding, respectively		40,332		31,148
Additional paid-in capital		260,846,342		181,701,859
Accumulated other comprehensive income		96,221		235,813
Accumulated deficit		(192,717,936)		(159,367,353)

TOTAL STOCKHOLDERS’ EQUITY		68,264,959		22,601,467

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	92,951,613	$	58,734,327

See accompanying notes to the unaudited condensed consolidated financial statements.

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CAPRICOR THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023

REVENUE
Revenue	$	2,261,642	$	6,185,814	$	11,139,956	$	13,089,977

TOTAL REVENUE		2,261,642		6,185,814		11,139,956		13,089,977

OPERATING EXPENSES
Research and development		11,807,867		10,028,964		35,413,649		26,507,872
General and administrative		3,463,655		3,021,450		10,593,308		9,378,672

TOTAL OPERATING EXPENSES		15,271,522		13,050,414		46,006,957		35,886,544

LOSS FROM OPERATIONS		(13,009,880)		(6,864,600)		(34,867,001)		(22,796,567)

OTHER INCOME (EXPENSE)
Investment income		453,152		479,380		1,516,418		1,276,502
Loss on disposal of fixed assets		—		(5,388)		—		(5,388)

TOTAL OTHER INCOME (EXPENSE)		453,152		473,992		1,516,418		1,271,114

NET LOSS		(12,556,728)		(6,390,608)		(33,350,583)		(21,525,453)

OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain (loss) on marketable securities		(58,766)		(66,485)		(139,592)		7,964

COMPREHENSIVE LOSS	$	(12,615,494)	$	(6,457,093)	$	(33,490,175)	$	(21,517,489)

Net loss per share, basic and diluted	$	(0.38)	$	(0.25)	$	(1.04)	$	(0.85)
Weighted average number of shares, basic and diluted		33,090,063		25,817,676		32,099,181		25,468,880

See accompanying notes to the unaudited condensed consolidated financial statements.

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CAPRICOR THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)


						OTHER				TOTAL
	COMMON STOCK			ADDITIONAL PAID-		COMPREHENSIVE		ACCUMULATED		STOCKHOLDERS'
	SHARES	AMOUNT		IN CAPITAL		INCOME		DEFICIT		EQUITY

Balance at December 31, 2023	31,148,320	$	31,148	$	181,701,859	$	235,813	$	(159,367,353)	$	22,601,467

Issuance of common stock, net of fees	447,221		447		2,289,797		—		—		2,290,244

Stock-based compensation	—		—		3,265,412		—		—		3,265,412

Stock options exercised	4,642		5		(5)		—		—		—

Unrealized gain on marketable securities	—		—		—		71,888		—		71,888

Net loss	—		—		—		—		(9,794,073)		(9,794,073)

Balance at March 31, 2024	31,600,183	$	31,600	$	187,257,063	$	307,701	$	(169,161,426)	$	18,434,938

Issuance of common stock, net of fees	330,458		331		1,985,518		—		—		1,985,849

Stock-based compensation	—		—		2,152,793		—		—		2,152,793

Stock options exercised	53,286		53		81,169		—		—		81,222

Unrealized loss on marketable securities	—		—		—		(152,714)		—		(152,714)

Net loss	—		—		—		—		(10,999,782)		(10,999,782)

Balance at June 30, 2024	31,983,927	$	31,984	$	191,476,543	$	154,987	$	(180,161,208)	$	11,502,306

Issuance of common stock, net of fees	8,272,427		8,272		67,197,597		—		—		67,205,869

Exercise of common warrants	38,000		38		58,151		—		—		58,189

Stock-based compensation	—		—		2,051,283		—		—		2,051,283

Stock options exercised	38,038		38		62,768		—		—		62,806

Unrealized loss on marketable securities	—		—		—		(58,766)		—		(58,766)

Net loss	—		—		—		—		(12,556,728)		(12,556,728)

Balance at September 30, 2024	40,332,392	$	40,332	$	260,846,342	$	96,221	$	(192,717,936)	$	68,264,959

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						OTHER				TOTAL
	COMMON STOCK			ADDITIONAL PAID-		COMPREHENSIVE		ACCUMULATED		STOCKHOLDERS'
	SHARES	AMOUNT		IN CAPITAL		INCOME		DEFICIT		EQUITY

Balance at December 31, 2022	25,241,402	$	25,241	$	148,735,420	$	105,244	$	(137,079,811)	$	11,786,094

Stock-based compensation	—		—		2,194,784		—		—		2,194,784

Stock options exercised	13,752		14		3,881		—		—		3,895

Unrealized loss on marketable securities	—		—		—		(10,258)		—		(10,258)

Net loss	—		—		—		—		(7,768,266)		(7,768,266)

Balance at March 31, 2023	25,255,154	$	25,255	$	150,934,085	$	94,986	$	(144,848,077)	$	6,206,249

Issuance of common stock, net of fees	452,385		452		2,129,943		—		—		2,130,395

Stock-based compensation	—		—		1,618,712		—		—		1,618,712

Stock options exercised	56,773		57		57,622		—		—		57,679

Unrealized gain on marketable securities	—		—		—		84,707		—		84,707

Net loss	—		—		—		—		(7,366,579)		(7,366,579)

Balance at June 30, 2023	25,764,312	$	25,764	$	154,740,362	$	179,693	$	(152,214,656)	$	2,731,163

Issuance of common stock, net of fees	69,985		70		221,011		—		—		221,081

Stock-based compensation	—		—		1,717,193		—		—		1,717,193

Stock options exercised	20,773		21		(21)		—		—		—

Unrealized loss on marketable securities	—		—		—		(66,485)		—		(66,485)

Net loss	—		—		—		—		(6,390,608)		(6,390,608)

Balance at September 30, 2023	25,855,070	$	25,855	$	156,678,545	$	113,208	$	(158,605,264)	$	(1,787,656)

See accompanying notes to the unaudited condensed consolidated financial statements.

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CAPRICOR THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)


	Nine months ended September 30,
	2024		2023
Cash flows from operating activities:
Net loss	$	(33,350,583)	$	(21,525,453)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of fixed assets		—		5,388
Depreciation and amortization		1,049,509		761,274
Stock-based compensation		7,469,488		5,530,689
Changes in lease liabilities		(30,941)		(13,921)
Changes in operating assets and liabilities:
Receivables		9,962,311		—
Prepaid expenses and other current assets		610,711		461,475
Other assets		(51,074)		—
Accounts payable and accrued expenses		281,122		1,868,032
Deferred revenue		(11,139,956)		(1,089,977)
Net cash used in operating activities		(25,199,413)		(14,002,493)

Cash flows from investing activities:
Purchase of marketable securities		(69,077,305)		(72,665,821)
Proceeds from sales and maturities of marketable securities		77,079,337		84,955,000
Purchases of property and equipment		(678,073)		(753,056)
Payments for leasehold improvements		(126,180)		(565,255)
Net cash provided by investing activities		7,197,779		10,970,868

Cash flows from financing activities:
Net proceeds from sale of common stock		71,481,962		2,351,476
Proceeds from exercise of stock awards and warrants		202,217		61,574
Net cash provided by financing activities		71,684,179		2,413,050

Net increase (decrease) in cash and cash equivalents		53,682,545		(618,575)

Cash and cash equivalents balance at beginning of period		14,694,857		9,603,242

Cash and cash equivalents balance at end of period	$	68,377,402	$	8,984,667

Supplemental disclosures of cash flow information:
Interest paid in cash	$	—	$	—
Income taxes paid in cash	$	—	$	—

See accompanying notes to the unaudited condensed consolidated financial statements.

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CAPRICOR THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Description of Business

Capricor Therapeutics, Inc., a Delaware corporation (together with its wholly-owned subsidiary, referred to herein as “Capricor Therapeutics,” the “Company,” “we,” “us” or “our”), is a clinical-stage biotechnology company focused on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”), a rare form of muscular dystrophy which results in muscle degeneration and premature death, and other diseases with high unmet medical needs. Capricor, Inc. (“Capricor”), a wholly-owned subsidiary of Capricor Therapeutics, was founded in 2005 as a Delaware corporation. Capricor became public after the completion of a merger between Capricor and a subsidiary of Nile Therapeutics, Inc., a Delaware corporation (“Nile”), in 2013, where Capricor became a wholly-owned subsidiary of Nile and Nile formally changed its name to Capricor Therapeutics, Inc. Capricor Therapeutics was listed on the Nasdaq Capital Market shortly thereafter. Capricor Therapeutics, together with its subsidiary, Capricor, has multiple therapeutic drug candidates in various stages of development.

Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements for Capricor Therapeutics and its wholly-owned subsidiary have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and with the instructions to Form 10-Q and, therefore, do not include all disclosures necessary for a complete presentation of financial position, results of operations and cash flows in conformity with U.S. GAAP. In the Company’s opinion, all adjustments, consisting of normal and recurring adjustments, considered necessary for a fair presentation have been included. The accompanying financial information should be read in conjunction with the financial statements and the notes thereto in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2024, from which the December 31, 2023 consolidated balance sheet was derived. Interim results are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.

Basis of Consolidation

Our condensed consolidated financial statements include the accounts of the Company and our wholly-owned subsidiary. All intercompany transactions have been eliminated in consolidation.

Reclassification

Certain reclassification of prior period amounts has been made to conform to the current year presentation.

Liquidity and Capital Resources

The Company has an accumulated deficit of approximately $192.7 million and cash, cash equivalents and marketable securities of approximately $85.0 million as of September 30, 2024. The Company has historically financed its research and development activities as well as operational expenses primarily from equity financings, government grants, and payments from distribution agreements and collaboration partners. The Company’s principal uses of cash are for research and development expenses, expenses in development of manufacturing capabilities, general and administrative expenses, capital expenditures and other working capital requirements.

On June 21, 2021, the Company established an “at-the-market” program (the “ATM Program”) with an aggregate offering price of up to $75.0 million, pursuant to a Common Stock Sales Agreement with Wainwright. From June 21, 2021 through October 1, 2024, the Company sold an aggregate of 9,228,383 shares of common stock under the ATM Program at an average price of approximately $8.13 per share for gross proceeds of approximately $75.0 million which represents

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all amounts that were available to be sold under the ATM Program (see Note 2 - "Stockholder’s Equity"). Effective October 1, 2024, the ATM Program has been closed and terminated.

In the first quarter of 2024, the Company received our first milestone payment of $10.0 million from Nippon Shinyaku Co., Ltd. (“Nippon Shinyaku”), which was triggered upon completion of the interim futility analysis of the HOPE-3 trial whereby the outcome was determined to be not futile.

In September 2024, the Company completed a private placement with Nippon Shinyaku whereby we issued and sold an aggregate of 2,798,507 shares of common stock at a price per share of $5.36 for an aggregate purchase price of $15.0 million (see Note 2 – “Stockholder’s Equity”).

Subsequent to September 30, 2024, the Company completed an underwritten public offering, pursuant to which the Company issued and sold an aggregate of 5,073,800 shares of common stock at a public offering price of $17.00 per share for gross proceeds of approximately $86.3 million (see Note 9 - “Subsequent Events”).

The Company’s future expenditures and capital requirements may be substantial and will depend on many factors, including, but not limited to, the following:

●

the timing and costs associated with our research and development activities, clinical trials and preclinical studies, including the enrollment and progress of our ongoing HOPE-3 Phase 3 clinical trial of deramiocel (also referred to as CAP-1002) in DMD;

●

the timing and costs associated with the manufacturing of our product candidates, including the expansion of our manufacturing capacity to support the potential commercialization of deramiocel for DMD;

●

the timing and costs associated with potential commercialization of our product candidates;

●

the number and scope of our research programs, including the expansion of our exosomes program;

●

the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

●

the costs associated with pursuing marketing approval and potential commercialization of deramiocel in countries outside the United States.

The Company’s options for raising additional capital include potentially seeking additional financing primarily from, but not limited to, the sale and issuance of equity or debt securities, the licensing or sale of its technology and other assets, potential distribution and other partnering opportunities, and from government grants. The Company has incurred significant operating losses and negative cash flows from operations. The Company’s plan to address its financial position may include potentially seeking additional financing primarily from, but not limited to, the sale and issuance of equity or debt securities, the licensing or sale of its technology and from government grants.

The Company will require substantial additional capital to fund its operations. The Company cannot provide assurances that financing will be available when and as needed or that, if available, financing will be available on favorable or acceptable terms. If the Company is unable to obtain additional financing when and if required, it would have a material adverse effect on the Company’s business and results of operations. The Company would likely need to delay, curtail or terminate portions of its clinical trials and research and development programs. To the extent the Company issues additional equity securities, its existing stockholders would experience substantial dilution.

Business Uncertainty Related to the Coronavirus

In light of past uncertainties due to COVID-19 and its economic and other impacts and to uncertainties around the timing and availability of grant disbursements, the loss of revenue from the REGRESS and ALPHA trials as well as any potential equity and debt financings, the Company submitted for the Employee Retention Credit (“ERC”), a credit against certain payroll taxes allowed to an eligible employer for qualifying wages, which was established by the CARES Act. The Company has submitted $738,778 in ERC for applicable 2020 and 2021 periods, receiving $191,199 in 2021 and $191,463 in 2023. As of September 30, 2024, the Company has recorded a receivable for $366,551 for the remainder of funds for which we are still awaiting receipt.

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Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period. Management uses its historical records and knowledge of its business in making these estimates. Accordingly, actual results may differ from these estimates.

Cash and Cash Equivalents

The Company considers all highly liquid investments with a maturity of less than 30 days at the date of purchase to be cash equivalents.

Marketable Securities

The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company’s marketable securities are considered as available-for-sale and carried at estimated fair values. Realized gains and losses on the sale of debt and equity securities are determined using the specific identification method. Unrealized gains and losses on available-for-sale securities are presented as accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. As of September 30, 2024, marketable securities consist primarily of short-term United States treasuries.

Property and Equipment

Property and equipment are stated at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation is computed using the straight-line method over the related estimated useful life of the asset, which such estimated useful lives range from five to seven years. Leasehold improvements are depreciated on a straight-line basis over the shorter of the useful life of the asset or the lease term. Depreciation was $361,167 and $276,471 for the three months ended September 30, 2024 and 2023, respectively, and $1,049,509 and $761,274 for the nine months ended September 30, 2024 and 2023, respectively.

Property and equipment, net consisted of the following:


	September 30,		December 31,
	2024		2023
Furniture and fixtures	$	197,141	$	187,997
Laboratory equipment		6,102,784		5,449,597
Leasehold improvements		2,255,283		2,129,102
		8,555,208		7,766,696
Less accumulated depreciation		(3,239,823)		(2,206,055)
Property and equipment, net	$	5,315,385	$	5,560,641

Leases

ASC Topic 842, Leases (“ASC 842”), requires lessees to recognize most leases on the balance sheet with a corresponding right-to-use (“ROU”) asset. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance.

Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them.

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The Company leases office and laboratory space, all of which are operating leases (see Note 6 - “Commitments and Contingencies”). Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. In addition, the Company’s lease agreements generally do not contain any residual value guarantees or restrictive covenants.

The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment.

For real estate leases, the Company has elected the practical expedient under ASC 842 to account for the lease and non-lease components together for existing classes of underlying assets and allocates the contract consideration to the lease component only. This practical expedient is not elected for manufacturing facilities and equipment embedded in product supply arrangements.

Revenue Recognition

The Company adopted ASU 606, Revenue for Contracts from Customers, (“ASU 606”), which amended revenue recognition principles under U.S. GAAP and provides a single, comprehensive set of criteria for revenue recognition within and across all industries (see Note 7 – “License and Distribution Agreements”).

The revenue standard provides a five-step framework for recognizing revenue as control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that it determines are within the scope of the revenue standard, the Company performs the following five steps: (i) identify the contract; (ii) identify the performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. At contract inception, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation, or whether they are not distinct and are combined with other goods and services until a distinct bundle is identified. The Company then determines the transaction price, which typically includes upfront payments and any variable consideration that the Company determines is probable to not cause a significant reversal in the amount of cumulative revenue recognized when the uncertainty associated with the variable consideration is resolved. The Company then allocates the transaction price to each performance obligation and recognizes the associated revenue when, or as, each performance obligation is satisfied.

The Company’s distribution agreements may entitle it to additional payments upon the achievement of milestones or shares of product revenue on sales. The milestones are generally categorized into three types: development milestones, regulatory milestones and sales-based milestones. The Company evaluates whether it is probable that the consideration associated with each milestone or shared revenue payments will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are excluded from the transaction price until they meet this threshold. At the end of each subsequent reporting period, the Company re-evaluates the probability of a significant reversal of the cumulative revenue recognized for its milestones and royalties, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and net income (loss) in the Company’s condensed consolidated statements of operation and comprehensive loss. Typically, milestone payments and shared revenue payments are achieved after the Company’s performance obligations associated with the distribution agreements have been completed and after the customer has assumed responsibility for the commercialization program. Milestones or shared revenue payments achieved after the Company’s performance obligations have been completed are recognized as revenue in the period the milestone or shared revenue payments were achieved. If a milestone payment is achieved during the performance period, the milestone payment would be recognized as revenue to the extent performance had been completed at that point, and the remaining balance would be recorded as deferred revenue.

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The revenue standard requires the Company to assess whether a significant financing component exists in determining the transaction price. The Company performs this assessment at the onset of its distribution agreements. Typically, a significant financing component does not exist because the customer is paying for services in advance with an upfront payment. Additionally, future shared revenue payments are not substantially within the control of the Company or the customer.

Whenever the Company determines that goods or services promised in a contract should be accounted for as a combined performance obligation over time, the Company determines the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using either the proportional performance method or on a straight-line basis if efforts will be expended evenly over time. Percentage of completion of patient visits in clinical trials are used as the measure of performance. The Company feels this method of measurement to be the best depiction of the transfer of services and recognition of revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations. If the Company determines that the performance obligation is satisfied over time, any upfront payment received is initially recorded as deferred revenue on its condensed consolidated balance sheets.

Certain judgments affect the application of the Company’s revenue recognition policy. For example, the Company records short-term (less than one year) and long-term (over one year) deferred revenue based on its best estimate of when such revenue will be recognized. This estimate is based on the Company’s current operating plan, and the Company may recognize a different amount of deferred revenue over the next 12-month period if its plan changes in the future.

Under the U.S. Commercialization and Distribution Agreement (the “U.S. Distribution Agreement”) with Nippon Shinyaku, the transaction price consists of variable shared revenue payments and fixed components in the form of an upfront payment and milestones. The timing of the fixed component of the transaction price is upfront, however, the performance obligation is satisfied over a period of time, which is the estimated duration of the HOPE-3 clinical trial, Cohort A arm. Therefore, upon receipt of the upfront payment and achievement of milestones, a contract liability is recorded which represents deferred revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition.

Grant Income

Generally, government research grants that provide funding for research and development activities are recognized as income when the related expenses are incurred, as applicable. Because the terms of the grant award (the “CIRM Award”) from the California Institute for Regenerative Medicine (“CIRM”) allow Capricor to elect to convert the grant into a loan after the end of the project period, the CIRM Award is being classified as a liability rather than income (see Note 5 - “Government Grant Awards”). Grant income is due upon submission of a reimbursement request. The transaction price varies for grant income based on the expenses incurred under the awards. No grant income was recognized for the three and nine months ended September 30, 2024 and 2023.

Research and Development

Costs relating to the design and development of new products are expensed as research and development as incurred in accordance with Financial Accounting Standards Board (“FASB”) ASC 730-10, Research and Development. Research and development costs amounted to approximately $11.8 million and $10.0 million for the three months ended September 30, 2024 and 2023, respectively, and approximately $35.4 million and $26.5 million for the nine months ended September 30, 2024 and 2023, respectively.

Comprehensive Income (Loss)

Comprehensive income (loss) generally represents all changes in stockholders’ equity during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $12.6 million and $6.5 million for the three months ended September 30, 2024 and 2023, respectively, and approximately $33.5 million and $21.5 million for the nine months ended September 30, 2024 and 2023, respectively. The

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Company’s other comprehensive income (loss) is related to a net unrealized gain (loss) on marketable securities. The Company’s other comprehensive income (loss) was $(58,766) and $(66,485) for the three months ended September 30, 2024 and 2023, respectively, and $(139,592) and $7,964 for the nine months ended September 30, 2024 and 2023, respectively.

Clinical Trial Expense

As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants, contract research organizations (“CROs”), and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contra