Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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


☐	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:

001-37348

Corbus Pharmaceuticals Holdings, Inc.

(Exact name of registrant as specified in its charter)

    Delaware

    46-4348039

    (State or other jurisdiction of
incorporation or organization)

    (I.R.S. Employer
Identification Number)

    500 River Ridge Drive
Norwood, MA

    02062

    (Address of principal executive offices)

    (Zip code)

(617) 963-0100

(Registrant’s telephone number, including area code)

(Former Name, Former Address and Former Fiscal Year if Changed Since Last Report): N/A

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


Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share	CRBP	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 4, 2024, 12,179,482 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.

CORBUS PHARMACEUTICALS HOLDINGS, INC.

Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2024

TABLE OF CONTENTS


		Page
	PART I

	FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (unaudited)	3
	Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	3
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023	4
	Condensed Consolidated Statement of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023	5
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	26
Item 4.	Controls and Procedures	26

	PART II

	OTHER INFORMATION

Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	31
	Signatures	32

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PART I — FINANCIAL INFORMATION

Item 1. Financial Statements.

Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)


	September 30, 2024			December 31, 2023

ASSETS
Current assets:
Cash and cash equivalents	$	19,423		$	13,724
Investments		139,939			7,182
Restricted cash		285			192
Prepaid expenses and other current assets		1,243			2,448
Total current assets		160,890			23,546
Restricted cash		385			478
Property and equipment, net		519			973
Operating lease right-of-use assets		2,377			3,063
Other assets		—			212
Total assets	$	164,171		$	28,272
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Notes payable	$	—		$	301
Accounts payable		2,887			3,179
Accrued expenses		7,176			11,030
Derivative liability		—			39
Operating lease liabilities, current		1,562			1,437
Loan payable		—			15,908
Total current liabilities		11,625			31,894
Other long-term liabilities		—			44
Operating lease liabilities, noncurrent		2,048			3,239
Total liabilities		13,673			35,177
Stockholders’ equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2024 and December 31, 2023.		—			—
Common stock, $0.0001 par value; 300,000,000 shares authorized, 12,179,482 and 4,423,683 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		1			—
Additional paid-in capital		617,653			429,780
Accumulated deficit		(467,363	)		(436,684	)
Accumulated other comprehensive gain (loss)		207			(1	)
Total stockholders’ equity (deficit)		150,498			(6,905	)
Total liabilities and stockholders’ equity	$	164,171		$	28,272

See notes to the unaudited condensed consolidated financial statements.

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Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)


	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2024			2023			2024			2023
Operating expenses:
Research and development	$	10,808		$	6,551		$	23,435		$	24,188
General and administrative		4,697			2,937			12,681			10,786
Total operating expenses		15,505			9,488			36,116			34,974
Operating loss		(15,505	)		(9,488	)		(36,116	)		(34,974	)
Other income (expense), net:
Other income, net		713			218			4,317			630
Interest income		1,189			217			2,757			711
Interest expense		(381	)		(980	)		(1,872	)		(2,928	)
Change in fair value of derivative liability		—			—			39			—
Foreign currency transaction gain (loss), net		201			(20	)		196			(21	)
Other income (expense), net		1,722			(565	)		5,437			(1,608	)
Net loss	$	(13,783	)	$	(10,053	)	$	(30,679	)	$	(36,582	)
Net loss per share, basic and diluted	$	(1.15	)	$	(2.27	)	$	(2.92	)	$	(8.52	)
Weighted average number of common shares outstanding, basic and diluted		12,014,700			4,423,617			10,490,981			4,295,178

Comprehensive loss:
Net loss	$	(13,783	)	$	(10,053	)	$	(30,679	)	$	(36,582	)
Other comprehensive (loss) income:
Change in unrealized gain on marketable debt securities		595			16			208			119
Total other comprehensive income		595			16			208			119
Total comprehensive loss	$	(13,188	)	$	(10,037	)	$	(30,471	)	$	(36,463	)

See notes to the unaudited condensed consolidated financial statements.

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Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)


	For the Three Months Ended September 30, 2024
	Common Stock				Additional Paid-in		Accumulated			Accumulated Other Comprehensive			Total Stockholders’
	Shares		Amount		Capital		Deficit			Loss			Equity
Balance at June 30, 2024		11,498,917	$	1	$	579,510	$	(453,580	)	$	(388	)	$	125,543
Issuance of common stock, net of issuance costs		668,379		—		35,842		—			—			35,842
Issuance of common stock upon cashless exercise of warrants		6,087		—		—		—			—			—
Issuance of common stock upon exercise of stock options		2,588		—		58		—			—			58
Issuance of common stock upon vesting of restricted stock		3,511		—		—		—			—			—
Stock-based compensation expense		—		—		2,243		—			—			2,243
Change in unrealized gain (loss) on marketable debt securities		—		—		—		—			595			595
Net loss		—		—		—		(13,783	)		—			(13,783	)
Balance at September 30, 2024		12,179,482	$	1	$	617,653	$	(467,363	)	$	207		$	150,498


	For the Three Months Ended September 30, 2023
	Common Stock				Additional Paid-in		Accumulated			Accumulated Other Comprehensive			Total Stockholders’
	Shares		Amount		Capital		Deficit			Loss			Equity
Balance at June 30, 2023		4,422,741	$	—	$	428,153	$	(418,609	)	$	(23	)	$	9,521
Issuance of common stock, net of issuance costs		942		—		7		—			—			7
Issuance of common stock upon conversion of K2 Loan and Security Agreement		—		—		—		—			—			—
Stock-based compensation expense		—		—		821		—			—			821
Change in unrealized gain (loss) on marketable debt securities		—		—		—		—			16			16
Net loss		—		—		—		(10,053	)		—			(10,053	)
Balance at September 30, 2023		4,423,683	$	—	$	428,981	$	(428,662	)	$	(7	)	$	312

See notes to the unaudited condensed consolidated financial statements.

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Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)


	For the Nine Months Ended September 30, 2024
	Common Stock				Additional Paid-in		Accumulated			Accumulated Other Comprehensive			Total Stockholders’
	Shares		Amount		Capital		Deficit			Loss			Equity
Balance at December 31, 2023		4,423,683	$	—	$	429,780	$	(436,684	)	$	(1	)	$	(6,905	)
Issuance of common stock, net of issuance costs		7,462,916		1		180,236		—			—			180,237
Issuance of common stock upon cashless exercise of warrants		6,087		—		—		—			—			—
Issuance of common stock upon conversion of K2 Loan and Security Agreement		142,857		—		1,125		—			—			1,125
Issuance of common stock upon exercise of stock options		136,664		—		1,999		—			—			1,999
Issuance of common stock upon vesting of restricted stock		7,275		—		—		—			—			—
Stock-based compensation expense		—		—		4,513		—			—			4,513
Change in unrealized gain (loss) on marketable debt securities		—		—		—		—			208			208
Net loss		—		—		—		(30,679	)		—			(30,679	)
Balance at September 30, 2024		12,179,482	$	1	$	617,653	$	(467,363	)	$	207		$	150,498


	For the Nine Months Ended September 30, 2023
	Common Stock				Additional Paid-in		Accumulated			Accumulated Other Comprehensive			Total Stockholders’
	Shares		Amount		Capital		Deficit			Loss			Equity
Balance at December 31, 2022		4,171,297	$	—	$	425,196	$	(392,080	)	$	(126	)	$	32,990
Issuance of common stock, net of issuance costs		14,106		—		109		—			—			109
Issuance of common stock upon conversion of K2 Loan and Security Agreement		194,444		—		875		—			—			875
Issuance of common stock upon exercise of stock options		43,836		—		130		—			—			130
Stock-based compensation expense		—		—		2,671		—			—			2,671
Change in unrealized gain (loss) on marketable debt securities		—		—		—		—			119			119
Net loss		—		—		—		(36,582	)		—			(36,582	)
Balance at September 30, 2023		4,423,683	$	—	$	428,981	$	(428,662	)	$	(7	)	$	312

See notes to the unaudited condensed consolidated financial statements.

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Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)


	Nine Months Ended September 30,
	2024			2023
Cash flows from operating activities:
Net loss	$	(30,679	)	$	(36,582	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		4,513			2,671
Depreciation expense		454			493
Net amortization on discount of investments		(2,500	)		(426	)
Amortization of debt discount		396			634
Other		(10	)		13
Changes in operating assets and liabilities:
Decrease (increase) in prepaid expenses and other current assets		1,129			(1,377	)
Decrease (increase) in other assets		212			(46	)
Decrease in operating lease right-of-use asset		686			606
(Decrease) increase in other long-term liabilities		(44	)		797
(Decrease) increase in accounts payable		(75	)		2,527
(Decrease) increase in accrued expenses		(3,868	)		1,547
Decrease in operating lease liabilities		(1,066	)		(949	)
Net cash used in operating activities		(30,852	)		(30,092	)
Cash flows from investing activities:
Purchases of investments		(169,563	)		(30,556	)
Proceeds from sales and maturities of investments		39,523			55,810
Net cash (used in) provided by investing activities		(130,040	)		25,254
Cash flows from financing activities:
Proceeds from issuance of common stock, net		182,071			127
Repayment of notes payable		(301	)		(353	)
Repayment of long-term borrowings		(15,179	)		(690	)
Net cash provided by (used in) financing activities		166,591			(916	)
Net increase (decrease) in cash, cash equivalents, and restricted cash		5,699			(5,754	)
Cash, cash equivalents, and restricted cash at beginning of the period		14,394			17,673
Cash, cash equivalents, and restricted cash at end of the period	$	20,093		$	11,919
Supplemental disclosure of cash flow information and non-cash transactions:
Cash paid during the period for interest	$	2,818		$	1,986
Write off of fully depreciated property and equipment	$	—		$	178
Common stock issuance costs not yet paid	$	75		$	—
Issuance of common stock for conversion of convertible debt	$	1,125		$	875

See notes to the unaudited condensed consolidated financial statements.

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Corbus Pharmaceuticals Holdings, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

September 30, 2024

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

Nature of Business

Corbus Pharmaceuticals Holdings, Inc. (the "Company" or "Corbus") is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. The Company’s business is subject to significant risks and uncertainties and the Company will be dependent on raising substantial additional capital before it becomes profitable, and it may never achieve profitability.

Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP") for interim financial reporting. In the opinion of management of the Company, the accompanying unaudited condensed consolidated interim financial statements reflect all adjustments (which include only normal recurring adjustments) necessary to present fairly, in all material respects, the condensed consolidated financial position of the Company as of September 30, 2024 and the results of its operations and changes in stockholders’ equity for the three and nine months ended September 30, 2024 and 2023 and its cash flows for the nine months ended September 30, 2024 and 2023. The December 31, 2023 condensed consolidated balance sheet was derived from audited financial statements. The Company prepared the condensed consolidated financial statements following the requirements of the U.S. Securities and Exchange Commission (the “SEC”) for interim reporting. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. It is suggested that these condensed consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 12, 2024 (the “2023 Annual Report”). The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year.

Basis of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation.

The significant accounting policies used in preparation of these condensed consolidated financial statements in this Form 10-Q are consistent with those discussed in Note 3, “Significant Accounting Policies,” in our 2023 Annual Report.

Recent Accounting Pronouncements

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to improve reportable segment disclosure requirements, primarily through additional disclosures about significant segment expenses. The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning December 15, 2024, with early adoption permitted. The amendments will be applied retrospectively to all prior periods presented in the financial statements. The Company anticipates the adoption of this standard at December 31, 2024 will result in increased disclosures in the notes to its financial statements.

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2. LIQUIDITY

The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses since inception and as of September 30, 2024, had an accumulated deficit of approximately $467.4 million. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its pre-clinical and clinical programs, strategic alliances, and the development of its administrative organization. The Company expects that its cash, cash equivalents, and investments of approximately $159.4 million at September 30, 2024 will be sufficient to meet its operating and capital requirements at least twelve months from the issuance of this Quarterly Report on Form 10-Q.

The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to the Company. Lack of necessary funds may require the Company to, among other things, delay, scale back or eliminate some or all of the Company’s planned clinical or pre-clinical trials. Refer to Note 12 for additional information related to the Company's recent financings.

3. CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within 90 days from the date of purchase to be cash equivalents. At September 30, 2024 and December 31, 2023, cash equivalents were comprised of money market funds and corporate debt securities with maturities less than 90 days from the date of purchase.

Restricted cash as of September 30, 2024 included security for a stand-by letter of credit issued in favor of a landlord for $0.7 million of which $0.3 million was classified in current assets and $0.4 million was classified in noncurrent assets as of September 30, 2024.

Cash, cash equivalents, and restricted cash consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Cash	$	3,535	$	4,029
Cash equivalents		15,888		9,695
Cash and cash equivalents		19,423		13,724

Restricted cash, current		285		192
Restricted cash, noncurrent		385		478
Restricted cash		670		670
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows	$	20,093	$	14,394

As of September 30, 2024, the Company’s cash and cash equivalents held in the U.S. was approximately $16.2 million and approximately $3.2 million of cash was held in its subsidiaries in the United Kingdom and Australia. As of December 31, 2023, all of the Company’s cash was held in the U.S., except for approximately $3.8 million of cash which was held in its subsidiaries in the United Kingdom and Australia.

Our foreign subsidiaries in the United Kingdom and Australia may qualify for refundable research and development tax credits in the form of cash that were earned on certain research and development expenses incurred primarily outside of the U.S. The Company received $0 and $2.5 million in refundable research and development credits from foreign tax authorities for the three and nine months ended September 30, 2024, respectively. The Company received $0.1 million in refundable research and development credits from foreign tax authorities for the three and nine months ended September 30, 2023. These amounts are recorded in other income (expense), net. No future conditions impact the recognition of these tax credits.

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4. INVESTMENTS

The following table summarizes the Company’s investments as of September 30, 2024 (in thousands):


	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Losses			Fair Value

Debt Securities:
U.S. Treasury securities	$	8,459	$	39	$	-		$	8,498
U.S. government agency securities		27,553		61		-			27,614
Corporate debt securities		103,720		136		(29	)		103,827
Total	$	139,732	$	236	$	(29	)	$	139,939

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of September 30, 2024 (in thousands):


	Amortized Cost		Fair Value

Maturing in one year or less	$	122,520	$	122,660
Maturing after one year but less than three years		17,212		17,279
	$	139,732	$	139,939

The following table summarizes the Company’s investments as of December 31, 2023 (in thousands):


	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Losses			Fair Value

Debt Securities:
Corporate debt securities	$	7,182	$	1	$	(1	)	$	7,182
Total	$	7,182	$	1	$	(1	)	$	7,182

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of December 31, 2023 (in thousands):


	Amortized Cost		Fair Value

Maturing in one year or less	$	7,182	$	7,182
	$	7,182	$	7,182

5. FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of September 30, 2024 (in thousands):


	Level 1		Level 2		Level 3		Total

Assets:
Cash equivalents:
Money market funds	$	14,164	$	—	$	—	$	14,164
Corporate debt securities		—		1,724		—		1,724
Investments:
U.S. Treasury securities		—		8,498		—		8,498
U.S. government agency securities		—		27,614		—		27,614
Corporate debt securities		—		103,827		—		103,827
	$	14,164	$	141,663	$	—	$	155,827

-10-


	Level 1		Level 2		Level 3		Total

Assets:
Cash Equivalents:
Money market funds	$	7,833	$	—	$	—	$	7,833
Corporate debt securities		—		1,862		—		1,862
Investments:
Corporate debt securities		—		7,182		—		7,182
	$	7,833	$	9,044	$	—	$	16,877

Liabilities:
Derivative liabilities	$	—	$	—	$	39	$	39

6. LICENSE AGREEMENTS

The Company entered into a license agreement (the “Jenrin License Agreement”) with Jenrin Discovery, LLC ("Jenrin"), a privately-held Delaware limited liability company, effective September 20, 2018. Pursuant to the Jenrin License Agreement, Jenrin granted the Company exclusive worldwide rights to develop and commercialize the Licensed Products (as defined in the Jenrin License Agreement) which includes the Jenrin library of over 600 compounds and multiple issued and pending patent filings. The compounds are designed to treat inflammatory and fibrotic diseases by targeting the endocannabinoid system.

In consideration of the license and other rights granted by Jenrin, the Company paid Jenrin a $0.3 million upfront cash payment and is obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound it elects to develop based upon the achievement of specified development and regulatory milestones. In addition, the Company is obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, subject to specified reductions.

The Company entered into a license agreement (the “Milky Way License Agreement”) with Milky Way BioPharma, LLC (“Milky Way”), a subsidiary of Panorama Research Inc., effective May 25, 2021. Pursuant to the Milky Way License Agreement, the Company received an exclusive license, under certain patent rights and know-how owned or controlled by Milky Way, to develop, commercialize, and otherwise exploit products containing antibodies against integrin αvβ6 and/or integrin αvβ8 (“Licensed Products”), one of which the Company is referring to as CRB-602. Under the terms of the Milky Way License Agreement, the Company had sole responsibility for research, development, and commercialization of any Licensed Products, and the Company had agreed to use commercially reasonable efforts to perform these activities. The Milky Way Agreement may be terminated earlier in specified situations, including termination for material breach or termination by the Company with advance notice. A notice of termination without reason was executed by the Company and sent to Milky Way on January 25, 2024, terminating the Milky Way Agreement effective as of July 23, 2024.

The Company entered into a license agreement (the “UCSF License Agreement”) with the Regents of the University of California (“The Regents”) effective May 26, 2021. Pursuant to the UCSF License Agreement, the Company received an exclusive license to certain patents relating to humanized antibodies against integrin αvβ8, one of which the Company is referring to as CRB-601, along with non-exclusive licenses to certain related know-how and materials. The Company amended the UCSF License Agreement with The Regents effective November 17, 2022 adding additional antibody patents to the agreement.

In consideration for the license and other rights granted to the Company under the UCSF License Agreement, the Company paid The Regents a license issue fee of $1.5 million. In consideration for the additional antibody patents granted to the Company, the Company paid The Regents a license issue fee of $0.8 million, paid in two equal installments of $0.4 million.

The Company further amended the UCSF License Agreement with The Regents effective August 14, 2023 to incorporate certain new technology rights and amend the payment schedule for the development milestone for the filing of patent rights and the development milestone for the filing of an Investigational New Drug ("IND").

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In addition to the license issuance fees, the Company is obligated to pay an annual license maintenance fee, as well as up to $153.2 million in potential milestone payments, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication, for the achievement of certain development, regulatory, and sales milestones. In addition, the Company is also obligated to pay royalties in the lower, single digits on sales of products falling within the scope of the licensed patents, which is subject to a minimum annual royalty obligation, and a percentage share of certain payments received by the Company from sublicensees or in connection with the sale of the licensed program.

The Company entered into a license agreement (the “CSPC License Agreement”) with CSPC Megalith Biopharmaceutical Co., Ltd. ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, effective February 12, 2023. Pursuant to the CSPC License Agreement, the Company received an exclusive license to develop and commercialize a novel clinical stage antibody drug conjugate targeting Nectin-4, which the Company is referring to as CRB-701, in the U.S., Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia.

In consideration for the license granted to the Company under the CSPC License Agreement, the Company paid CSPC an upfront payment of $7.5 million ($5.0 million paid at signing in the first quarter of 2023 followed by $2.5 million paid in August 2024). The Company is obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay royalties in the low double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

The Company determined that substantially all of the fair value of the Jenrin License Agreement and CSPC License Agreement was attributable to a single in-process research and development asset which did not constitute a business. The Company determined that substantially all of the fair value of the Milky Way License Agreement and the UCSF License Agreement was attributable to separate groups of in-process research and development assets which did not constitute a business. The Company concluded that it did not have any alternative future use for the acquired in-process research and development assets. Thus, the Company recorded the various upfront payments to research and development expenses in the quarter the license deals became effective. The Company will account for the development, regulatory, and sales milestone payments in the period that the relevant milestones are achieved as either research and development expense or as an intangible asset as applicable. As of September 30, 2024, the Company has accrued license costs of $1.6 million included within accrued expenses on the condensed consolidated balance sheet due to The Regents under the UCSF License Agreement for achieved milestone payments (due on December 30, 2024 based upon the amended payment schedule). For the three and nine months ended September 30, 2024, no research and development expense associated with upfront payments or clinical milestones were incurred under any of the above agreements. Research and development expenses associated with upfront payments and clinical milestones were $0 and $9.1 million, respectively, for the three and nine months ended September 30, 2023.

7. PROPERTY AND EQUIPMENT

Property and equipment consisted of the following (in thousands):


	September 30, 2024			December 31, 2023
Computer hardware and software	$	84		$	84
Office furniture and equipment		1,114			1,114
Leasehold improvements		3,331			3,331
Property and equipment, gross		4,529			4,529
Less: accumulated depreciation		(4,010	)		(3,556	)
Property and equipment, net	$	519		$	973

Depreciation expense was $0.2 million and $0.2 million for the three months ended September 30, 2024 and 2023, respectively and $0.5 million and $0.5 million for the nine months ended September 30, 2024 and 2023, respectively.

The Company notes no impairment charges were taken in the three and nine months ended September 30, 2024 and 2023.

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8. COMMITMENTS AND CONTINGENCIES

Operating Lease Commitment

Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at September 30, 2024, the following table summarizes the Company’s maturities of operating lease liabilities as of September 30, 2024 (in thousands):


2024	$	439
2025		1,795
2026		1,688
Total lease payments		3,922

Less: imputed interest		(312	)
Total	$	3,610

Sublease Commitment

Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commenced on October 1, 2021 and was scheduled to end on October 31, 2026, however, it was terminated on June 24, 2024. The Company notes sublease income of $0 and $0.1 million for the three months ended September 30, 2024 and 2023, respectively and $0.2 million and $0.2 million for the nine months ended September 30, 2024 and 2023, respectively was recognized and offset against rent expense.

9. NOTES PAYABLE

D&O Financing

In November 2023, the Company entered into a loan agreement with a financing company for $0.4 million to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $39.0 thousand over a 10-month period. Interest accrues on this loan at an annual rate of 8.15%. Prepaid expenses as of September 30, 2024 and December 31, 2023, included approximately $34.6 thousand and $0.3 million, respectively, related to the underlying insurance policy being financed. The loan was repaid in full during the three months ended September 30, 2024.

Loan and Security Agreement with K2 HealthVentures LLC

On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a secured Loan and Security Agreement with K2 HealthVentures LLC (“K2HV”), an unrelated third party (the “Loan and Security Agreement”) and received $20.0 million upon signing. On August 1, 2024, the loan matured and the Company made a final payment in the amount of $11.8 million, which represents $10.1 million principal outstanding on the maturity date, $1.6 million final payment and accrued interest. The $1.6 million final payment was amortized over the life of the loan through interest expense, net within the condensed consolidated statements of operations and comprehensive loss. Interest payments were made monthly and accrued at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%.

The Company entered into an Amendment to the Loan and Security Agreement (the "Amended Loan and Security Agreement") on October 25, 2022. Pursuant to the Amended Loan and Security Agreement, K2HV could elect to convert up to $5.0 million of the outstanding loan balance into shares of the Company’s common stock at conversion prices as follows: $0.9 million of the loan at $4.50 per share, $1.1 million at $7.875 per share, and $3.0 million at $282.00 per share. On June 1, 2023, K2HV converted $0.9 million of the outstanding loan balance into 194,444 shares of the Company's stock at a conversion price of $4.50 per share. On March 6, 2024, K2HV converted $1.1 million of the outstanding loan balance into 142,857 shares of the Company's stock at a conversion price of $7.875 per share.

In connection with the Loan and Security Agreement, on July 28, 2020, the Company issued K2HV a warrant to purchase up to 2,873 common shares (the “K2 Warrant”) at an exercise price of $208.80. The K2 Warrant may be exercised either for cash or on a cashless “net exercise” basis and expires on July 28, 2030.

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The total debt discount related to the Amended Loan and Security Agreement of approximately $3.0 million was charged to interest expense using the effective interest method over the term of the debt. At December 31, 2023, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, approximates carrying value. Interest expense for the three and nine months ended September 30, 2024 was approximately $0.4 million and $1.8 million, respectively. Interest expense for the three and nine months ended September 30, 2023 was $1.0 million and $2.9 million, respectively.

The net carrying amounts of the liability components consists of the following (in thousands):


	September 30, 2024		December 31, 2023

Principal	$	—	$	16,304
Less: debt discount		—		(2,954	)
Accretion of debt discount		—		2,558
Net carrying amount	$	—	$	15,908

10. ACCRUED EXPENSES

Accrued expenses consisted of the following (in thousands):


	September 30, 2024		December 31, 2023

Accrued pre-clinical and clinical costs	$	1,628	$	1,449
Accrued product development costs		1,671		745
Accrued license costs		1,625		4,825
Accrued compensation		1,823		2,326
Accrued administrative costs		429		343
Accrued interest		—		1,342
Total	$	7,176	$	11,030

11. NET LOSS PER COMMON SHARE

The following table sets forth the computation of basic and diluted earnings per share for the three and nine months ended September 30, 2024 and 2023 (in thousands except share and per share amounts):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
Net loss	$	(13,783	)	$	(10,053	)	$	(30,679	)	$	(36,582	)
Weighted average number of common shares-basic		12,014,700			4,423,617			10,490,981			4,295,178
Net loss per share of common stock-basic	$	(1.15	)	$	(2.27	)	$	(2.92	)	$	(8.52	)

Stock options and warrants that have not been exercised and unvested restricted stock units (see Notes 13 and 14) have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive.

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12. STOCKHOLDERS' EQUITY

Preferred Stock

The Company has authorized 10,000,000 shares of preferred stock, $0.0001 par value per share, of which 0 shares were issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

Common Stock

The Company has authorized 300,000,000 shares of common stock, $0.0001 par value per share, of which 12,179,482 and 4,423,683 shares were issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

Public Offering

On January 31, 2024, the Company entered into an underwriting agreement with Jefferies LLC (“Jefferies”), as representative of the several underwriters, relating to an underwritten public offering of 4,325,000 shares of the Company’s common stock, par value $0.0001, at a price to the public of $19.00 per share. The underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, Jefferies gave notice to the Company of the underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, the Company completed the public offering raising gross proceeds of approximately $94.5 million and net proceeds of $88.6 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Open Market Sale Agreement

On May 31, 2023, the Company entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (as amended, the “Open Market Sale Agreement”) with Jefferies, as sales agent. Under the Open Market Sale Agreement, the Company may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million (the “2024 Open Market Offering”).

Under the Open Market Sale Agreement, Jefferies may sell the common stock by any method permitted by law deemed to be an “at-the-market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company may sell common stock in amounts and at times to be determined by the Company subject to the terms and conditions of the Open Market Sale Agreement, but the Company has no obligation to sell any of the common stock in the 2024 Open Market Offering.

The Company has agreed to pay Jefferies a commission of 3.0% of the aggregate gross proceeds from each sale of common stock and have agreed to provide Jefferies with customary indemnification and contribution rights. The Company has also agreed to reimburse Jefferies for certain specified expenses.

During the three and nine months ended September 30, 2024, the Company sold an aggregate of 663,730 and 2,484,517 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $35.6 million and $91.4 million, respectively. As of September 30, 2024, approximately $76.4 million was available for issuance and sale under the 2024 Open Market Offering.

During the three and nine months ended September 30, 2023, the Company sold an aggregate of 942 and 14,106 shares of common stock under the Open Market Sale Agreement, for net proceeds of approximately $7.0 thousand and $0.1 million, respectively.

Other Common Stock Transactions

During the three and nine months ended September 30, 2024, the Company issued 0 and 142,857 shares of common stock in a conversion pursuant to the K2HV Amended Loan and Security Agreement, respectively.

During the three and nine months ended September 30, 2023, the Company issued 0 and 194,444 shares of common stock in a conversion pursuant to the K2HV Amended Loan and Security Agreement, respectively.

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During the three and nine months ended September 30, 2024, the Company issued 2,588 and 136,664 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $0.1 million and $2.0 million from those exercises, respectively.

During the three and nine months ended September 30, 2023, the Company issued 0 and 43,836 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $0 and $0.1 million from those exercises, respectively.

During the three and nine months ended September 30, 2024, the Company issued 3,511 and 7,275 shares of common stock from the vesting of shares from restricted stock, respectively, of which 2,783 were issued under the 2024 Plan and the remaining were issued under the 2014 Plan. No shares of common stock were issued during the three and nine months ended September 30, 2023 from the vesting of shares from restricted stock under the 2014 Plan or 2024 Plan.

During the three and nine months ended September 30, 2024, the Company issued 4,649 shares of common stock pursuant to a professional services agreement with an investor relations service provider. No shares of common stock were issued pursuant to a professional services agreement during the three and nine months ended September 30, 2023.

During the three and nine months ended September 30, 2024, the Company issued 6,087 shares of common stock upon the exercise of warrants. No warrants were exercised during the three and nine months ended September 30, 2023.

13. STOCK-BASED COMPENSATION AWARDS

On May 16, 2024, the Company's stockholders approved the 2024 Equity Compensation Plan (the “2024 Plan”) authorizing the issuance of up to 2,000,000 shares, succeeding the 2014 Equity Incentive Plan (the “2014 Plan”), under which no further grants may be made pursuant to the terms of the 2014 Plan. Pursuant to the 2024 Plan, the board of directors may grant nonqualified stock options, incentive stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”), performance shares, performance units, incentive bonus awards, other cash-based awards and other stock-based awards to employees, officers, non-employee directors, and other individual service providers.

Under the terms of the 2024 Plan and 2014 Plan, the Company granted stock options and RSUs to employees, officers, non-employee directors, consultants and advisors. Stock options have a ten-year term and an exercise price equal to the fair market value of a share of our common stock on the grant date. Stock options generally vest over four years with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal monthly installments thereafter, except for grants to non-employee directors that vest annually. RSUs generally vest over a period of one to four years in annual installments beginning on the first anniversary of the grant date.

As of September 30, 2024, an aggregate of 910,009 shares of common stock were reserved for issuance upon the exercise or vesting of outstanding awards under the 2014 Plan. No additional grants can be made under the 2014 Plan.

As of September 30, 2024, an aggregate of 88,561 shares of common stock were reserved for issuance upon the exercise or vesting of outstanding awards and up to 1,908,656 shares of common stock may be issued pursuant to awards granted under the 2024 Plan.

Stock-based Compensation Expense

In connection with all stock-based compensation awards, total non-cash, stock-based compensation expense recognized in the condensed consolidated statements of operations and comprehensive loss was as follows (in thousands):


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

Research and development expenses	$	305	$	96	$	709	$	286
General and administrative expenses		1,938		725		3,804		2,385
Total stock-based compensation	$	2,243	$	821	$	4,513	$	2,671

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The total stock-based compensation expense recognized by award type was as follows (in thousands):


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

Stock options	$	1,509	$	815	$	3,231	$	2,658
Restricted stock units		734		6		1,282		13
Total stock-based compensation	$	2,243	$	821	$	4,513	$	2,671

Stock Options

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes stock option pricing model that uses the assumptions noted in the following table, except for the expected term for non-employees as noted in the following paragraph. The expected term of employee and non-employee director stock options granted under the 2014 Plan and 2024 Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited operating history. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among our employee population. For non-employee stock options, excluding directors, the Company has elected to utilize the contractual term as the expected term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with that used to value the stock option. The Company accounts for forfeitures as they occur.

The weighted average assumptions used principally in determining the fair value of stock options granted to employees and non-employee directors were as follows:


	Nine Months Ended September 30,
	2024			2023
Risk-free interest rate		4.23	%		3.82	%
Expected dividend yield		0	%	0%
Expected term in years (employee options)		6.17		6.25
Expected volatility		124.46	%		101.41	%

A summary of stock option activity for the nine months ended September 30, 2024 is presented below:


Stock Options	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term in Years		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2023		708,762		$	63.96
Granted		245,791			28.19
Exercised		(136,664	)		14.63
Forfeited or canceled		(54,879	)		9.29
Expired		(18,678	)		70.73
Outstanding at September 30, 2024		744,332		$	65.07		6.93	$	2,600
Exercisable at September 30, 2024		389,369		$	103.21		5.09	$	1,200

The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 was $25.17 and $4.20 per share, respectively. The aggregate intrinsic value of stock options exercised during the nine months ended September 30, 2024 and 2023 was approximately $1.1 million and $0.1 million, respectively. As of September 30, 2024, there was approximately $6.1 million of total unrecognized compensation expense, related to non-vested share-based stock option compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a weighted average period of 1.45 years as of September 30, 2024.

Restricted Stock Units

A RSU represents the right to receive one share of our common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of our common stock on the date of grant. The Company accounts for forfeitures as they occur.

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A summary of RSU activity for the nine months ended September 30, 2024 is presented below:


RSU's	Number of Shares Underlying RSUs			Weighted Average Grant Date Fair Value
Unvested at December 31, 2023		17,911		$	5.14
Granted		245,795		$	27.84
Forfeited		(2,193	)	$	17.15
Vested		(7,275	)	$	19.04
Unvested at September 30, 2024		254,238		$	26.59

As of September 30, 2024, there was $5.7 million of unrecognized compensation expense related to unvested RSUs, which are expected to be recognized over a weighted average period of 1.98 years.

14. WARRANTS

During the three and nine months ended September 30, 2024, the Company issued 6,087 shares of common stock upon the exercise of warrants.

No warrants were exercised during the three and nine months ended September 30, 2023.

At September 30, 2024, there were warrants outstanding to purchase 36,207 shares of common stock with a weighted average exercise price of $381.14 and a weighted average remaining life of 0.76 years.

On January 26, 2018, the Company entered into an Investment Agreement with the Cystic Fibrosis Foundation ("CFF") that included issuance of a warrant to purchase an aggregate of 33,334 shares of the Company’s common stock (the “CFF Warrant”) at an exercise price of $396.00 per share. The CFF Warrant is currently exercisable for 33,334 shares of the Company’s common stock and expires on January 26, 2025.

On July 28, 2020, the Company entered into the Loan and Security Agreement with K2HV and in connection with the funding of $20.0 million, the Company issued a warrant exercisable for 2,873 shares of the Company’s common stock (the “K2 Warrant”) at an exercise price of $208.80 per share. The K2 Warrant is immediately exercisable for 2,873 shares and expires on July 28, 2030.

On October 16, 2020, the Company entered into a professional services agreement with an investor relations service provider. Pursuant to the agreement, the Company issued warrants exercisable for a total of 14,000 shares of the Company’s common stock (the “Warrants”) at an exercise price of $32.10 per share. The Warrants became fully vested on October 19, 2021 and expire on November 3, 2025. The Warrants were exercised in full on a cashless basis, resulting in the issuance of 6,087 shares of common stock during the three and nine months ended September 30, 2024. No cash proceeds were received and the exercise price settled by reducing the total shares issued in lieu of cash payment.

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Item 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those under “Risk Factors.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

•

our history of operating losses;

•

our current and future capital requirements and our ability to satisfy our capital needs;

•

our ability to complete required clinical trials of our product and obtain approval from the FDA or other regulatory agents in different jurisdictions;

•

our ability to internally develop new product candidates, intellectual property, and other product candidates we may acquire and/or license;

•

our ability to maintain or protect the validity of our patents and other intellectual property;

•

our ability to retain key executive members;

•

interpretations of current laws and the passages of future laws;

•

acceptance of our business model by investors;

•

the accuracy of our estimates regarding expenses and capital requirements; and

•

our ability to adequately support growth.

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. Please see “Risk Factors” for additional risks which could adversely impact our business and financial performance.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs, or projections will result or be achieved or accomplished.

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Overview

Corbus Pharmaceuticals Holdings, Inc. (the “Company,” “Corbus,” “we,” “us,” or “our”) is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate (“ADC”) that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload; and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 (“CB1”) receptor inverse agonist for the treatment of obesity.

Our oncology pipeline:

•

CRB-701 is a next-generation ADC targeting the expression of Nectin-4 on cancer cells to release a cytotoxic payload. In February 2023, we obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. (“CSPC”), a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize the drug in the United States (“U.S.”), Canada, the European Union (including the European Free Trade Area), the United Kingdom (“U.K.”) and Australia (the “CSPC License Agreement”). The Investigational New Drug (“IND”) application for CRB-701 was cleared by the U.S. Food and Drug Administration (“FDA”) in 2022 and the drug is currently being investigated by CSPC in a Phase 1 clinical trial in patients with advanced solid tumors in China. On June 1, 2024, updated clinical data was presented at ASCO 2024 by CSPC building upon the data presented at ASCO-GU on January 26, 2024. The larger data set included 37 patients of whom 25 patients reflective of seven dose levels had been evaluated for efficacy at the time of the data cut. The emerging clinical data shows that CRB-701 was well-tolerated and demonstrated an overall response rate (“ORR”) of 44% and a disease control rate (“DCR”) of 78% in metastatic urothelial cancer (“mUC”) and 43% ORR and 86% DCR in cervical cancer. No dose limiting toxicities (“DLTs”) have been observed to date in doses up to and including 4.5 mg/Kg.

On April 2, 2024, the first patient was dosed in our bridging Phase 1 clinical trial being conducted in the U.S. and Europe and in October 2024, the Company completed enrollment in the dose escalation phase of the study. The Phase 1 trial is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors associated with known high expression of Nectin-4. The Phase 1 study has a three-part design. The Part A dose escalation of the Phase 1 study is evaluating four predetermined doses (1.8 mg/Kg, 2.7 mg/Kg, 3.6 mg/Kg and 4.5 mg/Kg) and is being followed by Part B (dose optimization) and Part C (dose expansion) that will determine the recommended/optimized doses and seek preliminary efficacy signals.

•

CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ found on cancer cells. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with an anti-PD-1 checkpoint inhibitor compared to each single agent on its own. The data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, thus potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for patients with solid tumors in combination with existing therapies, including checkpoint inhibitors. On January 9, 2024, we announced that the FDA cleared the IND for CRB-601 and we expect to enroll the first patient in a Phase 1 study in Q4 2024.

Our obesity pipeline:

•

CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. We are currently conducting IND-enabling studies and we expect to treat the first patient in a Phase 1 study in the first quarter of 2025.

In diet-induced obesity (“DIO”) mouse models, CRB-913 demonstrates a reduction in body weight, body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and improvements in liver histology. CRB-913 when used in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide) provides additive weight loss in DIO mice. Furthermore in DIO mice, weight loss induced by an incretin analog (semaglutide) is maintained post withdrawal by replacing it with CRB-913.

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Recent Developments

Open Market Sale Agreement

On May 31, 2023, we entered into the Open Market Sale Agreement with Jefferies, as sales agent. Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million. During the three and nine months ended September 30, 2024, we sold an aggregate of 663,730 and 2,484,517 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $35.6 million and $91.4 million, respectively. As of September 30, 2024, approximately $76.4 million was available for issuance and sale under the Open Market Sale Agreement.

Loan and Security Agreement with K2 HealthVentures LLC

The loan from K2HV matured on August 1, 2024 and we made the final payment in the amount of $11.8 million, which represents $10.1 million principal outstanding on the maturity date, $1.6 million final payment and accrued interest.

Financial Operations Overview

We are an oncology and obesity company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at September 30, 2024, we had an accumulated deficit of approximately $467.4 million. Our net losses for the three months ended September 30, 2024 and 2023, were approximately $13.8 million and $10.1 million, respectively. For the nine months ended September 30, 2024 and 2023, our net losses were approximately $30.7 million and $36.6 million, respectively.

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to increase in 2024 as compared to 2023 as we incur Phase 1 clinical trial costs for both CRB-701 and CRB-601. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.

We expect to continue to incur operating losses for at least the next several years in connection with our ongoing activities, as we:

•

conduct pre-clinical and clinical trials for our product candidates;

•

continue our research and development efforts; and

•

manufacture and purchase drugs for clinical studies.

Critical Accounting Estimates

Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenue, costs of expenses and related disclosures in the condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

There have been no changes to the critical accounting estimates we identified in "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in our 2023 Annual Report.

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Results of Operations

Comparison of Three Months Ended September 30, 2024 and 2023

The following table summarizes our operating expenses for the three months ended September 30, 2024 and 2023 (in thousands):


	Three Months Ended September 30,
	2024		2023		$ Change		% Change

Research and development expense	$	10,808	$	6,551	$	4,257		65	%
General and administrative expense		4,697		2,937		1,760		60	%
Total operating expenses	$	15,505	$	9,488	$	6,017		63	%

Research and Development. Research and development expenses for the three months ended September 30, 2024 totaled approximately $10.8 million, an increase of $4.3 million from approximately $6.6 million recorded for the three months ended September 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was primarily attributable to increases of $3.2 million primarily related to CRB-701 clinical trial costs with our contract research organizations ("CROs") and clinical sites, $1.0 million in CRB-913 IND-enabling studies, and $0.4 million in higher compensation costs mainly due to stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants. These increases are offset by a $0.7 million decrease in manufacturing costs for CRB-601.

We have a subsidiary in each of the U.K. and Australia and approximately 41% and 64% of research and development expenses recorded for the three months ended September 30, 2024 and 2023, respectively was recorded in these entities.

General and Administrative. General and administrative expenses for the three months ended September 30, 2024 totaled approximately $4.7 million, an increase of $1.8 million from approximately $2.9 million recorded for the three months ended September 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was attributable to increases in stock-based compensation costs of $1.2 million primarily due to stock options being granted at higher current fair values as compared to earlier grants and a $0.4 million increase in investor relations expense primarily due to issuing common stock pursuant to a professional services agreement with a service provider.

Other Income (Expense), net. The following table summarizes our other income (expense) for the three months ended September 30, 2024 and 2023 (in thousands):


	Three Months Ended September 30,
	2024			2023			$ Change		% Change

Other income, net	$	713		$	218		$	495		227	%
Interest income		1,189			217			972		448	%
Interest expense		(381	)		(980	)		599		-61	%
Foreign currency transaction gain (loss), net		201			(20	)		221		-1105	%
Other income (expense), net	$	1,722		$	(565	)	$	2,287		-405	%

Other income (expense), net for the three months ended September 30, 2024 was approximately $1.7 million in income as compared to other expense of approximately $0.6 million recorded for the three months ended September 30, 2023. The increase of $2.3 million in 2024 as compared to 2023 was primarily attributable to higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.

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Comparison of Nine Months Ended September 30, 2024 and 2023

The following table summarizes our operating expenses for the nine months ended September 30, 2024 (in thousands):


	Nine Months Ended September 30,
	2024		2023		$ Change			% Change

Research and development expense	$	23,435	$	24,188	$	(753	)		-3	%
General and administrative expense		12,681		10,786		1,895			18	%
Total operating expenses	$	36,116	$	34,974	$	1,142			3	%

Research and Development. Research and development expenses for the nine months ended September 30, 2024 totaled approximately $23.4 million, a decrease of $0.8 million from approximately $24.2 million recorded for the nine months ended September 30, 2023. The decrease in fiscal 2024 as compared to fiscal 2023 was primarily attributable to decreases in licensing costs of $7.5 million associated with the CSPC License Agreement and $1.2 million associated with the achievement of a development milestone under the UCSF License Agreement, as well as a decrease of $0.6 million in sponsored research agreement expense as the contract ended in January 2024. These decreases are offset by a $6.6 million increase in CRB-701 clinical trial costs with our CROs and clinical sites, as well as an increase of $0.8 million in CRB-913 IND-enabling studies, $0.5 million increase in manufacturing costs primarily related to CRB-701, and $0.5 million in higher compensation costs primarily related to stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants.

We have a subsidiary in each of the U.K. and Australia and approximately 37% and 32% of research and development expenses recorded for the nine months ended September 30, 2024 and 2023, respectively, was recorded in these entities.

General and Administrative. General and administrative expenses for the nine months ended September 30, 2024 totaled approximately $12.7 million, an increase of $1.9 million from approximately $10.8 million recorded for the nine months ended September 30, 2023. The increase in fiscal 2024 as compared to fiscal 2023 was attributable to increases in stock-based compensation costs of $1.4 million primarily due to stock options being granted at higher current fair values as compared to earlier grants, a $0.4 million increase in investor relations expense primarily due to issuing common stock pursuant to a professional services agreement with a service provider, a $0.4 million increase in legal costs and franchise taxes, and additional bonus expense of $0.3 million due to higher bonus accruals. These increases were offset by a $0.8 million reduction in salary expense due to a prior year reduction in staff.

Other Income (Expense), net. The following table summarizes our other income (expense) for the nine months ended September 30, 2024 (in thousands):


	Nine Months Ended September 30,
	2024			2023			$ Change		% Change

Other income, net	$	4,317		$	630		$	3,687		585	%
Interest income		2,757			711			2,046		288	%
Interest expense		(1,872	)		(2,928	)		1,056		-36	%
Change in fair value of derivative liability		39			—			39		—
Foreign currency transaction gain (loss), net		196			(21	)		217		-1033	%
Other income (expense), net	$	5,437		$	(1,608	)	$	7,045		-438	%

Other income (expense), net for the nine months ended September 30, 2024 was approximately $5.4 million in income as compared to other expense of approximately $1.6 million recorded for the nine months ended September 30, 2023. The increase of $7.0 million in 2024 as compared to 2023 was primarily attributable to receipt of refundable research and development credits from a foreign tax authority of approximately $2.5 million in 2024, as well as higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.

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Liquidity and Capital Resources

Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At September 30, 2024, our accumulated deficit since inception was approximately $467.4 million.

At September 30, 2024, we had total current assets of approximately $160.9 million and current liabilities of approximately $11.6 million, resulting in working capital of approximately $149.3 million. Of our total cash, cash equivalents, investments, and restricted cash of $160.0 million at September 30, 2024, approximately $156.8 million was held within the U.S.

Cash Flows

The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):


	Nine Months Ended September 30,
	2024			2023

Net cash used in operating activities	$	(30,852	)	$	(30,092	)
Net cash (used in) provided by investing activities		(130,040	)		25,254
Net cash provided by (used in) financing activities		166,591			(916	)
Net increase (decrease) in cash, cash equivalents, and restricted cash	$	5,699		$	(5,754	)

Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $30.9 million, which includes a net loss of approximately $30.7 million, adjusted for non-cash expenses of approximately $2.9 million largely related to stock-based compensation expense offset by net amortization on discount of investments, and approximately $3.0 million of cash used in net working capital items principally due to decreases in accrued expenses and operating lease liabilities offset by a decrease in prepaid expenses and other current assets.

Cash used by investing activities for the nine months ended September 30, 2024 totaled approximately $130.0 million, which was principally related to purchases of investments.

Cash provided by financing activities for the nine months ended September 30, 2024 totaled approximately $166.6 million, which was related to the issuance of common stock. On January 31, 2024, we entered into an underwriting agreement with Jefferies, as representative of the underwriters, relating to an underwritten public offering of 4,325,000 shares of our common stock at a price to the public of $19.00 per share. The underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, Jefferies gave notice of the underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, we completed the public offering raising gross proceeds of approximately $94.5 million and net proceeds of $88.6 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. In addition, for the nine months ended September 30, 2024, we sold an aggregate of 2,484,517 shares of common stock under the Open Market Sale Agreement, for net proceeds of approximately $91.4 million.

Future Funding Requirements

We expect our cash, cash equivalents, and investments of approximately $159.4 million at September 30, 2024 will be sufficient to meet our operating and capital requirements to support our operations through the third quarter of 2027, based on current planned expenditures.

We will need to raise significant additional capital to continue to fund the clinical trials for CRB-701, CRB-601 and CRB-913. We may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.

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The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all of our planned clinical trials.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors, other than future royalty payments under license agreements discussed as follows:

License Agreement with Jenrin

Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC (“Jenrin”), we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions.

The Jenrin License Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on the later of seven years from such first commercial sale or the expiration of the last to expire of the applicable patents in that country. The Jenrin License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the Jenrin License Agreement by either party, termination by Jenrin in specified circumstances, termination by Corbus with advance notice, and termination upon a party’s insolvency or bankruptcy.

License Agreement with Milky Way

Pursuant to the terms of the license agreement (the "Milky Way License Agreement") with Milky Way BioPharma, LLC (“Milky Way”), we were obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we were obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way License Agreement.

The Milky Way License Agreement will remain in effect on a Licensed Product-by-License Product and country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The "Royalty Term" means the period beginning from the First Commercial Sale of the Licensed Product in the country until the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that covers the composition of matter of the Licensed Product, the manufacture of the Licensed Product in the country, or a method of use of the Licensed Product for an indication for which Regulatory Approval has been obtained in the country. The Milky Way License Agreement may be terminated earlier in specified situations, including termination for material breach or termination by us with advance notice. A notice of termination without reason was executed by us and sent to Milky Way on January 25, 2024, terminating the Milky Way Agreement effective as of July 23, 2024.

License Agreement with UCSF

Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay potential milestone payments totaling up to $153.2 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication. In addition, we are obligated to pay royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.

The UCSF License Agreement will remain in effect until the expiration or abandonment of the last of the Patent Rights licensed. The Royalty Term is the duration of Patent Rights in that country covering the applicable Licensed Product or Licensed Services Sold in the country. The UCSF License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by us with advance notice, and termination upon a party's bankruptcy.

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License Agreement with CSPC

Pursuant to the terms of the CSPC License Agreement with CSPC, we are obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

The CSPC License Agreement will remain in effect on a Licensed Product and on a country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The Royalty Term is the period beginning from the First Commercial Sale of the Licensed Product in the country until the later of the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that Covers the Licensed product, 10 years after the date of the First Commercial Sale in the country, or expiration of the Regulatory Exclusivity for the Licensed Product in the country. The CSPC License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by Corbus with advance notice, and termination upon a party's bankruptcy.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Not Applicable.

Item 4. Controls and Procedures.

Evaluation of Our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our principal executive officer and our principal financial officer, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act, as amended) as of the end of the period covered by this report.

Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that the information required to be disclosed by us in such reports is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period to which this report relates that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II — OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently subject to any material legal proceedings. However, we may from time to time become a party to various legal proceedings arising in the ordinary course of our business.

Item 1A. Risk Factors.

Except as set forth below, there have been no material changes in or additions to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2023.

We are, and will be, completely dependent on third parties to manufacture our drug candidates, and our commercialization of our drug candidates could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of our drug candidates or fail to do so at acceptable quality levels or prices.

We do not currently have, nor do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredients of our drug candidates, or the finished drug products, for use in our clinical trials or for commercial product, if any. As a result, we will be obligated to rely on contract manufacturers if and when our drug candidates are approved for commercialization.

We currently rely on contract suppliers for the manufacturing of our drug candidates. We have limited experience contracting third parties to manufacture our drug candidates and we do not control the manufacturing processes of, and are completely dependent on, our contract manufacturing partners for compliance with current good manufacturing practices ("cGMPs") for manufacture of all active drug substances and finished drug products. These cGMP regulations cover all aspects of the manufacturing, testing, quality control and record keeping relating to our drug candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our drug candidates, if approved.

Our contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. We will not have control over our contract manufacturers’ compliance with these regulations and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market our drug candidates, delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business. In addition, we will not have control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Failure by our contract manufacturers to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for or market our drug candidates.

If, for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with them and we cannot be certain that any such third parties will have the manufacturing capacity to meet future requirements. If these manufacturers or any alternate manufacturer of finished drug product experiences any significant difficulties in its respective manufacturing processes for our active pharmaceutical ingredient, or API, or our finished products or should cease doing business with us, we could experience significant interruptions in the supply of our drug candidates or may not be able to create a supply of our drug candidates at all. Were we to encounter manufacturing issues, our ability to produce a sufficient supply of our drug candidates might be negatively affected. Our inability to coordinate the efforts of our third-party manufacturing partners, or the lack of capacity available at our third-party manufacturing partners, could impair our ability to supply our drug candidates at required levels. Because of the significant regulatory requirements that we would need to satisfy in order to qualify a new bulk or finished product manufacturer, if we face these or other difficulties with our current manufacturing partners, we could experience significant interruptions in the supply of our drug candidates if we decided to transfer the manufacture of our drug candidates to one or more alternative manufacturers in an effort to deal with the difficulties.

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In addition, we currently rely on foreign third parties to manufacture certain materials used in clinical trials of our product candidates or to provide services in connection with certain clinical trials and will likely continue to rely on foreign third parties in the future. Foreign third parties may be subject to U.S. legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory requirements. Any manufacturing problem or the loss of a contract manufacturer could be disruptive to our operations and result in lost sales. Additionally, we rely on third parties to supply the raw materials needed to manufacture our potential products. Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability, and quality. Any unanticipated disruption to a future contract manufacturer caused by problems at suppliers could delay shipment of our drug candidates, increase our cost of goods sold and result in lost sales.

We cannot guarantee that our manufacturing and supply partners will be able to manufacture our drug candidates at commercial scale on a cost-effective basis. If the commercial-scale manufacturing costs of our drug candidates are higher than expected, these costs may significantly impact our operating results. In order to reduce costs, we may need to develop and implement process improvements. However, in order to do so, we will need, from time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject to approval by such regulatory authorities. We cannot be sure that we will receive these necessary approvals or that these approvals will be granted in a timely fashion. We also cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing process. If we cannot enhance and optimize output, we may not be able to reduce our costs over time.

We expect that we will rely on third parties to assist us in conducting clinical trials for our drug candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business would be substantially harmed.

We expect to enter into agreements with third-party CROs to assist us in conducting and managing our clinical programs, including contracting with clinical sites to perform our clinical studies. We plan to rely on these parties for execution of clinical studies for our drug candidates and we will control only certain aspects of conducting the clinical studies. Nevertheless, we will be responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs and clinical sites will not relieve us of our regulatory responsibilities. We and our CROs will be required to comply with cGCPs, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities for any products in clinical development. The FDA enforces these cGCP regulations through periodic inspections of trial sponsors, principal investigators and trial sites. If we or our CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our clinical trials comply with cGCPs. In addition, our clinical trials must be conducted with products produced under cGMP regulations and will require a large number of test subjects. Our failure or the failure of our CROs or clinical sites to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil and criminal penalties.

Although we intend to design the clinical trials for our drug candidates in consultation with CROs, we expect that the CROs will manage and assist us with the clinical trials conducted at contracted clinical sites. As a result, many important aspects of our drug development programs would be outside of our direct control. In addition, the CROs and clinical sites may not perform all of their obligations under arrangements with us or in compliance with regulatory requirements. If the CROs or clinical sites do not perform clinical trials in a satisfactory manner, or if they breach their obligations to us or fail to comply with regulatory requirements, the development and commercialization of our drug candidates for the subject indications may be delayed or our development program materially and irreversibly harmed. We cannot control the amount and timing of resources these CROs and clinical sites will devote to our program or our drug candidates. If we are unable to rely on clinical data collected by our CROs, we could be required to repeat, extend the duration of, or increase the size of our clinical trials, which could significantly delay commercialization and require significantly greater expenditures.

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In addition, we currently rely on foreign CROs to manufacture certain materials used in clinical trials of our product candidates or to provide services in connection with certain clinical trials and will likely continue to rely on foreign CROs in the future. Foreign CROs may be subject to U.S. legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory requirements. If any of our relationships with these third-party CROs or clinical sites terminate, we may not be able to enter into arrangements with alternative CROs or clinical sites. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any such clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates. As a result, our financial results and the commercial prospects for our drug candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Changes in geopolitical conditions, U.S.-China trade relations and other factors beyond our control may adversely impact our business and operating results.

Our operations and performance depend, in part, on global and regional economic and geopolitical conditions, given our current third-party license agreement with CSPC, which is headquartered in China. Changes in U.S.-China trade policies, including the proposed BIOSECURE bill, and a number of other economic and geopolitical factors both in China and abroad could have a material adverse effect on our business, financial condition, results of operations or prospects. Such factors may include:

•

instability in political or economic conditions, such as inflation, recession, foreign currency exchange restrictions and devaluations, restrictive governmental controls on the movement and repatriation of earnings and capital, and actual or anticipated military or political conflicts, particularly in emerging markets;

•

expanded jurisdiction of the Committee for Foreign Investment in the U.S. (CFIUS); and

•

intergovernmental conflicts or actions, such as armed conflict, trade wars, retaliatory tariffs, and acts of terrorism or war.

As a result of these events, our ability to obtain data or regulatory support from our China-based licensing partner may be limited or adversely affected, and we may ourselves be subject to sanctions, diminished public perception and operational constraints.

Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts.

Our success depends in part on avoiding infringement of the proprietary technologies of others. The pharmaceutical industry has been characterized by frequent litigation regarding patent and other intellectual property rights. Identification of third-party patent rights that may be relevant to our proprietary technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases, and the difficulty in assessing the meaning of patent claims. Additionally, because patent applications are maintained in secrecy until the application is published, we may be unaware of third-party patents that may be infringed by any of our product candidates. There may be certain issued patents and patent applications claiming subject matter that we may be required to license in order to research, develop or commercialize our product candidates, and we do not know if such patents and patent applications would be available to license on commercially reasonable terms, or at all. Any claims of patent infringement asserted by third parties would be time-consuming and may:

•

result in costly litigation;

•

divert the time and attention of our technical personnel and management;

•

prevent us from commercializing a product until the asserted patent expires or is held finally invalid or not infringed in a court of law;

•

require us to cease or modify our use of the technology and/or develop non-infringing technology; or

•

require us to enter into royalty or licensing agreements.

-29-

Although no third party has asserted a claim of infringement against us, others may hold proprietary rights that could prevent our product candidates from being marketed. We are aware of patents or patent applications owned by third parties that relate to some aspects of our programs that are still in development. In some cases, because we have not determined the final methods of manufacture, the method of administration or the therapeutic compositions for these programs, we cannot determine whether rights under such third-party positions will be needed. In addition, in some cases, we believe that the claims of these patents are invalid or not infringed or will expire before commercialization. However, if such patents are needed and found to be valid and infringed, we could be required to obtain licenses, which might not be available on commercially reasonable terms, or to cease or delay commercializing certain product candidates, or to change our programs to avoid infringement. Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating to our product candidates or our processes could subject us to potential liability for damages and require us to obtain a license to continue to manufacture or market our product candidates. We cannot predict whether we would prevail in any such actions or that any license required under any of these patents would be made available on commercially acceptable terms, if at all. In addition, we cannot be sure that we could redesign any product candidates or processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent us from developing and commercializing our product candidates, which could harm our business, financial condition, and operating results.

A number of companies, including several major pharmaceutical companies, have conducted research in the same therapeutic areas as our company, which resulted in the filing of many patent applications in the same areas as our research. If we were to challenge the validity of these or any U.S.-issued patent in court, we would need to overcome a statutory presumption of validity that attaches to every U.S.-issued patent. This means that, in order to prevail, we would have to present clear and convincing evidence as to the invalidity of the patent’s claims.

If we were to challenge the validity of these or any U.S. issued patent in an administrative trial before the Patent Trial and Appeal Board in the U.S. Patent and Trademark Office, we would have to prove that the claims are unpatentable by a preponderance of the evidence. There is no assurance that a jury and/or court would find in our favor on questions of infringement, validity, or enforceability.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

On August 21, 2024, the Company issued 4,649 shares of common stock to a service provider in connection with services rendered to the Company. Such issuance was exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Director and Officer Trading Arrangements

On August 29, 2024, John Jenkins M.D., a member of the board of directors, adopted a Rule 10b5-1 plan providing for the sale of up to 5,436 shares of the Company’s common stock. Pursuant to this plan, Dr. Jenkins may sell shares of common stock beginning on November 30, 2024, subject to the terms of the agreement, and the plan terminates on November 29, 2025. The trading arrangement is intended to satisfy the affirmative defense of Rule 10b5-1(c).

No other directors or officers adopted, modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the third quarter of 2024.

-30-

Item 6. Exhibits.

The exhibits listed below are filed or furnished as part of this Quarterly Report on Form 10-Q.

EXHIBIT INDEX


Exhibit No.		Description

3.1		Amended and Restated Certificate of Incorporation of the Company, as amended (incorporated by reference to Exhibit 3.1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 7, 2023).

3.2		Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 7, 2023).

31.1		Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*

31.2		Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*

32.1		Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).**

32.2		Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).**

101.INS		Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH		Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents.

104		Cover Page Interactive Data File formatted as Inline XBRL and contained in Exhibit 101.


*	Filed herewith.
**	Furnished, not filed.
†	Indicates a management contract or compensation plan, contract or arrangement.

-31-

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


	Corbus Pharmaceuticals Holdings, Inc.

Date: November 7, 2024	By:	/s/ Yuval Cohen
	Name:	Yuval Cohen
	Title:	Chief Executive Officer
		(Principal Executive Officer)

Date: November 7, 2024	By:	/s/ Sean Moran
	Name:	Sean Moran
	Title:	Chief Financial Officer
		(Principal Financial Officer and Chief Accounting Officer)

-32-

Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT

TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Yuval Cohen, certify that:

I have reviewed this quarterly report on Form 10-Q for the period ended September 30, 2024 of Corbus Pharmaceuticals Holdings, Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


	Date: November 7, 2024

	/s/ Yuval Cohen
	Yuval Cohen
	Chief Executive Officer
	(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT

TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Sean M. Moran, certify that:

I have reviewed this quarterly report on Form 10-Q for the period ended September 30, 2024 of Corbus Pharmaceuticals Holdings, Inc.;

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


	Date: November 7, 2024

	/s/ Sean Moran
	Sean Moran
	Chief Financial Officer
	(Principal Financial Officer and Chief Accounting Officer)

Exhibit 32.1

Certification of Chief Executive Officer Pursuant to

18 U.S.C. Section 1350,

as Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

This Certification is being filed pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of the Sarbanes-Oxley Act of 2002. This Certification is included solely for the purposes of complying with the provisions of Section 906 of the Sarbanes-Oxley Act and is not intended to be used for any other purpose. In connection with the accompanying Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (the “Quarterly Report”) of Corbus Pharmaceuticals Holdings, Inc. (the “Company”), the undersigned hereby certifies in his capacity as an officer of the Company that to such officer’s knowledge:

(1) The Quarterly Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


	By:	/s/ Yuval Cohen
Dated: November 7, 2024		Yuval Cohen
		Chief Executive Officer
		(Principal Executive Officer)

Exhibit 32.2

Certification of Chief Financial Officer Pursuant to

18 U.S.C. Section 1350,

as Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

This Certification is being filed pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of the Sarbanes-Oxley Act of 2002. This Certification is included solely for the purposes of complying with the provisions of Section 906 of the Sarbanes-Oxley Act and is not intended to be used for any other purpose. In connection with the accompanying Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, (the “Quarterly Report”) of Corbus Pharmaceuticals Holdings, Inc. (the “Company”), the undersigned hereby certifies in his capacity as an officer of the Company that to such officer’s knowledge:

(1) The Quarterly Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


	By:	/s/ Sean Moran
Dated: November 7, 2024		Sean Moran
		Chief Financial Officer
		(Principal Financial Officer and Chief Accounting Officer)

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2024	Nov. 04, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Current Fiscal Year End Date	--12-31
Entity File Number	001-37348
Entity Registrant Name	Corbus Pharmaceuticals Holdings, Inc.
Entity Central Index Key	0001595097
Entity Tax Identification Number	46-4348039
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	500 River Ridge Drive
Entity Address, City or Town	Norwood
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02062
City Area Code	(617)
Local Phone Number	963-0100
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	CRBP
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		12,179,482

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 19,423	$ 13,724
Investments	139,939	7,182
Restricted cash	285	192
Prepaid expenses and other current assets	1,243	2,448
Total current assets	160,890	23,546
Restricted cash	385	478
Property and equipment, net	519	973
Operating lease right of use assets	2,377	3,063
Other assets	0	212
Total assets	164,171	28,272
Current liabilities:
Notes payable	0	301
Accounts payable	2,887	3,179
Accrued expenses	7,176	11,030
Derivative liability	0	39
Operating lease liabilities, current	1,562	1,437
Loan payable	0	15,908
Total current liabilities	11,625	31,894
Other long-term liabilities	0	44
Operating lease liabilities, noncurrent	2,048	3,239
Total liabilities	13,673	35,177
Stockholders' equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2024 and December 31, 2023.	0	0
Common stock, $0.0001 par value; 300,000,000 shares authorized,12,179,482 and 4,423,683 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	1	0
Additional paid-in capital	617,653	429,780
Accumulated deficit	(467,363)	(436,684)
Accumulated other comprehensive gain (loss)	207	(1)
Total stockholders equity (deficit)	150,498	(6,905)
Total liabilities and stockholders’ equity	$ 164,171	$ 28,272

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred Stock, Par or Stated Value Per Share	$ 0.0001	$ 0.0001
Preferred Stock, Shares Authorized	10,000,000	10,000,000
Preferred Stock, Shares Issued	0	0
Preferred Stock, Shares Outstanding	0	0
Common Stock, Par or Stated Value Per Share	$ 0.0001	$ 0.0001
Common Stock, Shares Authorized	300,000,000	300,000,000
Common Stock, Shares, Issued	12,179,482	4,423,683
Common Stock, Shares, Outstanding	12,179,482	4,423,683

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating expenses:
Research and development	$ 10,808	$ 6,551	$ 23,435	$ 24,188
General and administrative	4,697	2,937	12,681	10,786
Total operating expenses	15,505	9,488	36,116	34,974
Operating loss	(15,505)	(9,488)	(36,116)	(34,974)
Other income (expense), net:
Other income, net	713	218	4,317	630
Interest income	1,189	217	2,757	711
Interest expense	(381)	(980)	(1,872)	(2,928)
Change in fair value of derivative liability	0	0	39	0
Foreign currency transaction gain (loss), net	201	(20)	196	(21)
Other income (expense), net	1,722	(565)	5,437	(1,608)
Net loss	$ (13,783)	$ (10,053)	$ (30,679)	$ (36,582)
Net loss per share, basic	$ (1.15)	$ (2.27)	$ (2.92)	$ (8.52)
Net loss per share, diluted	$ (1.15)	$ (2.27)	$ (2.92)	$ (8.52)
Weighted average number of common shares outstanding, basic	12,014,700	4,423,617	10,490,981	4,295,178
Weighted average number of common shares outstanding, diluted	12,014,700	4,423,617	10,490,981	4,295,178
Comprehensive loss:
Net Income (Loss)	$ (13,783)	$ (10,053)	$ (30,679)	$ (36,582)
Other comprehensive (loss) income :
Change in unrealized (loss) gain on marketable debt securities	595	16	208	119
Total other comprehensive (loss) income	595	16	208	119
Total comprehensive loss	$ (13,188)	$ (10,037)	$ (30,471)	$ (36,463)

Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	AOCI Attributable to Parent [Member]
Beginning balance, value at Dec. 31, 2022	$ 32,990	$ 0	$ 425,196	$ (392,080)	$ (126)
Beginning balance, shares at Dec. 31, 2022		4,171,297
Issuance of common stock, net of issuance costs	109		109
Issuance of common stock, net of issuance costs, shares		14,106
Issuance of common stock upon conversion of K2 Loan and Security Agreement, Shares		194,444
Issuance of common stock upon conversion of K2 Loan and Security Agreement, Value	875		875
Issuance of common stock upon exercise of stock options	130		130
Issuance of common stock upon exercise of stock options, shares		43,836
Stock-based compensation expense	2,671		2,671
Change in unrealized gain (loss) on marketable debt securities	119				119
Net loss	(36,582)			(36,582)
Ending balance, value at Sep. 30, 2023	312	$ 0	428,981	(428,662)	(7)
Ending balance, shares at Sep. 30, 2023		4,423,683
Beginning balance, value at Jun. 30, 2023	9,521	$ 0	428,153	(418,609)	(23)
Beginning balance, shares at Jun. 30, 2023		4,422,741
Issuance of common stock, net of issuance costs	7		7
Issuance of common stock, net of issuance costs, shares		942
Stock-based compensation expense	821		821
Change in unrealized gain (loss) on marketable debt securities	16				16
Net loss	(10,053)			(10,053)
Ending balance, value at Sep. 30, 2023	312	$ 0	428,981	(428,662)	(7)
Ending balance, shares at Sep. 30, 2023		4,423,683
Beginning balance, value at Dec. 31, 2023	(6,905)	$ 0	429,780	(436,684)	(1)
Beginning balance, shares at Dec. 31, 2023		4,423,683
Issuance of common stock, net of issuance costs	180,237	$ 1	180,236
Issuance of common stock, net of issuance costs, shares		7,462,916
Issuance of common stock upon cashless exercise of warrants, shares		6,087
Issuance of common stock upon conversion of K2 Loan and Security Agreement, Shares		142,857
Issuance of common stock upon conversion of K2 Loan and Security Agreement, Value	1,125		1,125
Issuance of common stock upon exercise of stock options	$ 1,999		1,999
Issuance of common stock upon exercise of stock options, shares	136,664	136,664
Issuance of common stock upon vesting of restricted stock, shares		7,275
Stock-based compensation expense	$ 4,513		4,513
Change in unrealized gain (loss) on marketable debt securities	208				208
Net loss	(30,679)			(30,679)
Ending balance, value at Sep. 30, 2024	150,498	$ 1	617,653	(467,363)	207
Ending balance, shares at Sep. 30, 2024		12,179,482
Beginning balance, value at Jun. 30, 2024	125,543	$ 1	579,510	(453,580)	(388)
Beginning balance, shares at Jun. 30, 2024		11,498,917
Issuance of common stock, net of issuance costs	35,842		35,842
Issuance of common stock, net of issuance costs, shares		668,379
Issuance of common stock upon cashless exercise of warrants, shares		6,087
Issuance of common stock upon exercise of stock options	58		58
Issuance of common stock upon exercise of stock options, shares		2,588
Issuance of common stock upon vesting of restricted stock, shares		3,511
Stock-based compensation expense	2,243		2,243
Change in unrealized gain (loss) on marketable debt securities	595				595
Net loss	(13,783)			(13,783)
Ending balance, value at Sep. 30, 2024	$ 150,498	$ 1	$ 617,653	$ (467,363)	$ 207
Ending balance, shares at Sep. 30, 2024		12,179,482

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (30,679)	$ (36,582)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	4,513	2,671
Depreciation expense	454	493
Net amortization on discount of investments	(2,500)	(426)
Amortization of debt discount	396	634
Other	(10)	13
Changes in operating assets and liabilities:
Decrease (increase) in prepaid expenses and other current assets	1,129	(1,377)
Decrease (increase) in other assets	212	(46)
Decrease in operating lease right of use asset	686	606
(Decrease) increase in other long-term liabilities	(44)	797
(Decrease) increase in accounts payable	(75)	2,527
(Decrease) increase in accrued expenses	(3,868)	1,547
Decrease in operating lease liabilities	(1,066)	(949)
Net cash used in operating activities	(30,852)	(30,092)
Cash flows from investing activities:
Purchases of investments	(169,563)	(30,556)
Proceeds from sales and maturities of investments	39,523	55,810
Net cash (used in) provided by investing activities	(130,040)	25,254
Cash flows from financing activities:
Proceeds from issuance of common stock, net	182,071	127
Repayment of notes payable	(301)	(353)
Repayment of long-term borrowings	(15,179)	(690)
Net cash provided by (used in) financing activities	166,591	(916)
Net increase (decrease) in cash, cash equivalents, and restricted cash	5,699	(5,754)
Cash, cash equivalents, and restricted cash at beginning of the period	14,394	17,673
Cash, cash equivalents, and restricted cash at end of the period	20,093	11,919
Supplemental disclosure of cash flow information and non-cash transactions:
Cash paid during the period for interest	2,818	1,986
Write off of fully depreciated property and equipment	0	178
Common stock issuance costs not yet paid	75	0
Issuance of common stock for conversion of convertible debt	$ 1,125	$ 875

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (13,783)	$ (10,053)	$ (30,679)	$ (36,582)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024 shares
Trading Arrangements, by Individual
Material Terms of Trading Arrangement	On August 29, 2024, John Jenkins M.D., a member of the board of directors, adopted a Rule 10b5-1 plan providing for the sale of up to 5,436 shares of the Company’s common stock. Pursuant to this plan, Dr. Jenkins may sell shares of common stock beginning on November 30, 2024, subject to the terms of the agreement, and the plan terminates on November 29, 2025. The trading arrangement is intended to satisfy the affirmative defense of Rule 10b5-1(c). No other directors or officers adopted, modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the third quarter of 2024.
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false
Rule 10b5-1 Arrangement Modified	false
Non Rule 10b5-1 Arrangement Modified	false
John Jenkins M.D [Member]
Trading Arrangements, by Individual
Name	John Jenkins M.D
Title	board of directors
Rule 10b5-1 Arrangement Adopted	true
Adoption Date	August 29, 2024
Rule 10b5-1 Arrangement Terminated	true
Termination Date	November 29, 2025
Arrangement Duration	457 days
Aggregate Available	5,436

NATURE OF BUSINESS AND BASIS OF PRESENTATION

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

NATURE OF BUSINESS AND BASIS OF PRESENTATION

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

Nature of Business

Basis of Presentation

Basis of Consolidation

Recent Accounting Pronouncements

LIQUIDITY

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

LIQUIDITY

2. LIQUIDITY

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

9 Months Ended

Sep. 30, 2024

Cash and Cash Equivalents [Abstract]

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

3. CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

Cash, cash equivalents, and restricted cash consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Cash	$	3,535	$	4,029
Cash equivalents		15,888		9,695
Cash and cash equivalents		19,423		13,724

Restricted cash, current		285		192
Restricted cash, noncurrent		385		478
Restricted cash		670		670
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows	$	20,093	$	14,394

INVESTMENTS

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

INVESTMENTS

4. INVESTMENTS

The following table summarizes the Company’s investments as of September 30, 2024 (in thousands):


	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Losses			Fair Value

Debt Securities:
U.S. Treasury securities	$	8,459	$	39	$	-		$	8,498
U.S. government agency securities		27,553		61		-			27,614
Corporate debt securities		103,720		136		(29	)		103,827
Total	$	139,732	$	236	$	(29	)	$	139,939

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of September 30, 2024 (in thousands):


	Amortized Cost		Fair Value

Maturing in one year or less	$	122,520	$	122,660
Maturing after one year but less than three years		17,212		17,279
	$	139,732	$	139,939

The following table summarizes the Company’s investments as of December 31, 2023 (in thousands):


	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Losses			Fair Value

Debt Securities:
Corporate debt securities	$	7,182	$	1	$	(1	)	$	7,182
Total	$	7,182	$	1	$	(1	)	$	7,182

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of December 31, 2023 (in thousands):


	Amortized Cost		Fair Value

Maturing in one year or less	$	7,182	$	7,182
	$	7,182	$	7,182

FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES

5. FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES


	Level 1		Level 2		Level 3		Total

Assets:
Cash equivalents:
Money market funds	$	14,164	$	—	$	—	$	14,164
Corporate debt securities		—		1,724		—		1,724
Investments:
U.S. Treasury securities		—		8,498		—		8,498
U.S. government agency securities		—		27,614		—		27,614
Corporate debt securities		—		103,827		—		103,827
	$	14,164	$	141,663	$	—	$	155,827


	Level 1		Level 2		Level 3		Total

Assets:
Cash Equivalents:
Money market funds	$	7,833	$	—	$	—	$	7,833
Corporate debt securities		—		1,862		—		1,862
Investments:
Corporate debt securities		—		7,182		—		7,182
	$	7,833	$	9,044	$	—	$	16,877

Liabilities:
Derivative liabilities	$	—	$	—	$	39	$	39

LICENSE AGREEMENTS

9 Months Ended

Sep. 30, 2024

License Agreements

LICENSE AGREEMENTS

6. LICENSE AGREEMENTS

PROPERTY AND EQUIPMENT

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

PROPERTY AND EQUIPMENT

7. PROPERTY AND EQUIPMENT

Property and equipment consisted of the following (in thousands):


	September 30, 2024			December 31, 2023
Computer hardware and software	$	84		$	84
Office furniture and equipment		1,114			1,114
Leasehold improvements		3,331			3,331
Property and equipment, gross		4,529			4,529
Less: accumulated depreciation		(4,010	)		(3,556	)
Property and equipment, net	$	519		$	973

The Company notes no impairment charges were taken in the three and nine months ended September 30, 2024 and 2023.

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

8. COMMITMENTS AND CONTINGENCIES

Operating Lease Commitment


2024	$	439
2025		1,795
2026		1,688
Total lease payments		3,922

Less: imputed interest		(312	)
Total	$	3,610

Sublease Commitment

NOTES PAYABLE

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

NOTES PAYABLE

9. NOTES PAYABLE

D&O Financing

Loan and Security Agreement with K2 HealthVentures LLC

The net carrying amounts of the liability components consists of the following (in thousands):


	September 30, 2024		December 31, 2023

Principal	$	—	$	16,304
Less: debt discount		—		(2,954	)
Accretion of debt discount		—		2,558
Net carrying amount	$	—	$	15,908

ACCRUED EXPENSES

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

ACCRUED EXPENSES

10. ACCRUED EXPENSES

Accrued expenses consisted of the following (in thousands):


	September 30, 2024		December 31, 2023

Accrued pre-clinical and clinical costs	$	1,628	$	1,449
Accrued product development costs		1,671		745
Accrued license costs		1,625		4,825
Accrued compensation		1,823		2,326
Accrued administrative costs		429		343
Accrued interest		—		1,342
Total	$	7,176	$	11,030

NET LOSS PER COMMON SHARE

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Net Loss Per Common Share

11. NET LOSS PER COMMON SHARE


	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
Net loss	$	(13,783	)	$	(10,053	)	$	(30,679	)	$	(36,582	)
Weighted average number of common shares-basic		12,014,700			4,423,617			10,490,981			4,295,178
Net loss per share of common stock-basic	$	(1.15	)	$	(2.27	)	$	(2.92	)	$	(8.52	)

COMMON STOCK

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

STOCKHOLDERS' EQUITY

12. STOCKHOLDERS' EQUITY

Preferred Stock

Common Stock

Public Offering

Open Market Sale Agreement

Other Common Stock Transactions

STOCKHOLDERS' EQUITY

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

STOCKHOLDERS' EQUITY

12. STOCKHOLDERS' EQUITY

Preferred Stock

Common Stock

Public Offering

Open Market Sale Agreement

Other Common Stock Transactions

STOCK-BASED COMPENSATION AWARDS

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

STOCK-BASED COMPENSATION AWARDS

Stock-based Compensation Expense


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

Research and development expenses	$	305	$	96	$	709	$	286
General and administrative expenses		1,938		725		3,804		2,385
Total stock-based compensation	$	2,243	$	821	$	4,513	$	2,671

The total stock-based compensation expense recognized by award type was as follows (in thousands):


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

Stock options	$	1,509	$	815	$	3,231	$	2,658
Restricted stock units		734		6		1,282		13
Total stock-based compensation	$	2,243	$	821	$	4,513	$	2,671

Stock Options

The weighted average assumptions used principally in determining the fair value of stock options granted to employees and non-employee directors were as follows:


	Nine Months Ended September 30,
	2024			2023
Risk-free interest rate		4.23	%		3.82	%
Expected dividend yield		0	%	0%
Expected term in years (employee options)		6.17		6.25
Expected volatility		124.46	%		101.41	%

A summary of stock option activity for the nine months ended September 30, 2024 is presented below:


Stock Options	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term in Years		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2023		708,762		$	63.96
Granted		245,791			28.19
Exercised		(136,664	)		14.63
Forfeited or canceled		(54,879	)		9.29
Expired		(18,678	)		70.73
Outstanding at September 30, 2024		744,332		$	65.07		6.93	$	2,600
Exercisable at September 30, 2024		389,369		$	103.21		5.09	$	1,200

Restricted Stock Units

A summary of RSU activity for the nine months ended September 30, 2024 is presented below:


RSU's	Number of Shares Underlying RSUs			Weighted Average Grant Date Fair Value
Unvested at December 31, 2023		17,911		$	5.14
Granted		245,795		$	27.84
Forfeited		(2,193	)	$	17.15
Vested		(7,275	)	$	19.04
Unvested at September 30, 2024		254,238		$	26.59

As of September 30, 2024, there was $5.7 million of unrecognized compensation expense related to unvested RSUs, which are expected to be recognized over a weighted average period of 1.98 years.

WARRANTS

9 Months Ended

Sep. 30, 2024

Warrants

WARRANTS

14. WARRANTS

During the three and nine months ended September 30, 2024, the Company issued 6,087 shares of common stock upon the exercise of warrants.

No warrants were exercised during the three and nine months ended September 30, 2023.

At September 30, 2024, there were warrants outstanding to purchase 36,207 shares of common stock with a weighted average exercise price of $381.14 and a weighted average remaining life of 0.76 years.

NATURE OF BUSINESS AND BASIS OF PRESENTATION (Policies)	9 Months Ended
NATURE OF BUSINESS AND BASIS OF PRESENTATION (Policies)	Sep. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP") for interim financial reporting. In the opinion of management of the Company, the accompanying unaudited condensed consolidated interim financial statements reflect all adjustments (which include only normal recurring adjustments) necessary to present fairly, in all material respects, the condensed consolidated financial position of the Company as of September 30, 2024 and the results of its operations and changes in stockholders’ equity for the three and nine months ended September 30, 2024 and 2023 and its cash flows for the nine months ended September 30, 2024 and 2023. The December 31, 2023 condensed consolidated balance sheet was derived from audited financial statements. The Company prepared the condensed consolidated financial statements following the requirements of the U.S. Securities and Exchange Commission (the “SEC”) for interim reporting. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. It is suggested that these condensed consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 12, 2024 (the “2023 Annual Report”). The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year.
Basis of Consolidation	Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. The significant accounting policies used in preparation of these condensed consolidated financial statements in this Form 10-Q are consistent with those discussed in Note 3, “Significant Accounting Policies,” in our 2023 Annual Report. Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to improve reportable segment disclosure requirements, primarily through additional disclosures about significant segment expenses. The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning December 15, 2024, with early adoption permitted. The amendments will be applied retrospectively to all prior periods presented in the financial statements. The Company anticipates the adoption of this standard at December 31, 2024 will result in increased disclosures in the notes to its financial statements.

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH (Tables)

9 Months Ended

Sep. 30, 2024

Cash and Cash Equivalents [Abstract]

Schedule of cash, cash equivalents and restricted cash

Cash, cash equivalents, and restricted cash consist of the following (in thousands):


	September 30, 2024		December 31, 2023
Cash	$	3,535	$	4,029
Cash equivalents		15,888		9,695
Cash and cash equivalents		19,423		13,724

Restricted cash, current		285		192
Restricted cash, noncurrent		385		478
Restricted cash		670		670
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows	$	20,093	$	14,394

INVESTMENTS (Tables)

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

SUMMARY OF MARKETABLE SECURITIES

The following table summarizes the Company’s investments as of September 30, 2024 (in thousands):


	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Losses			Fair Value

Debt Securities:
U.S. Treasury securities	$	8,459	$	39	$	-		$	8,498
U.S. government agency securities		27,553		61		-			27,614
Corporate debt securities		103,720		136		(29	)		103,827
Total	$	139,732	$	236	$	(29	)	$	139,939

The following table summarizes the Company’s investments as of December 31, 2023 (in thousands):


	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Losses			Fair Value

Debt Securities:
Corporate debt securities	$	7,182	$	1	$	(1	)	$	7,182
Total	$	7,182	$	1	$	(1	)	$	7,182

SCHEDULE OF AVAILABLE FOR SALE DEBT SECURITIES BY CONTRACTUAL MATURITY

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of September 30, 2024 (in thousands):


	Amortized Cost		Fair Value

Maturing in one year or less	$	122,520	$	122,660
Maturing after one year but less than three years		17,212		17,279
	$	139,732	$	139,939

The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of December 31, 2023 (in thousands):


	Amortized Cost		Fair Value

Maturing in one year or less	$	7,182	$	7,182
	$	7,182	$	7,182

FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS

September 30, 2024 (in thousands):


	Level 1		Level 2		Level 3		Total

Assets:
Cash equivalents:
Money market funds	$	14,164	$	—	$	—	$	14,164
Corporate debt securities		—		1,724		—		1,724
Investments:
U.S. Treasury securities		—		8,498		—		8,498
U.S. government agency securities		—		27,614		—		27,614
Corporate debt securities		—		103,827		—		103,827
	$	14,164	$	141,663	$	—	$	155,827


	Level 1		Level 2		Level 3		Total

Assets:
Cash Equivalents:
Money market funds	$	7,833	$	—	$	—	$	7,833
Corporate debt securities		—		1,862		—		1,862
Investments:
Corporate debt securities		—		7,182		—		7,182
	$	7,833	$	9,044	$	—	$	16,877

Liabilities:
Derivative liabilities	$	—	$	—	$	39	$	39

PROPERTY AND EQUIPMENT (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

SUMMARY OF PROPERTY AND EQUIPMENT

Property and equipment consisted of the following (in thousands):


	September 30, 2024			December 31, 2023
Computer hardware and software	$	84		$	84
Office furniture and equipment		1,114			1,114
Leasehold improvements		3,331			3,331
Property and equipment, gross		4,529			4,529
Less: accumulated depreciation		(4,010	)		(3,556	)
Property and equipment, net	$	519		$	973

COMMITMENTS AND CONTINGENCIES (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES


2024	$	439
2025		1,795
2026		1,688
Total lease payments		3,922

Less: imputed interest		(312	)
Total	$	3,610

NOTES PAYABLE (Tables)

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

SCHEDULE OF NOTES PAYABLE

The net carrying amounts of the liability components consists of the following (in thousands):


	September 30, 2024		December 31, 2023

Principal	$	—	$	16,304
Less: debt discount		—		(2,954	)
Accretion of debt discount		—		2,558
Net carrying amount	$	—	$	15,908

ACCRUED EXPENSES (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

SCHEDULE OF ACCRUED EXPENSES

Accrued expenses consisted of the following (in thousands):


	September 30, 2024		December 31, 2023

Accrued pre-clinical and clinical costs	$	1,628	$	1,449
Accrued product development costs		1,671		745
Accrued license costs		1,625		4,825
Accrued compensation		1,823		2,326
Accrued administrative costs		429		343
Accrued interest		—		1,342
Total	$	7,176	$	11,030

NET LOSS PER COMMON SHARE (Tables)

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE


	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
Net loss	$	(13,783	)	$	(10,053	)	$	(30,679	)	$	(36,582	)
Weighted average number of common shares-basic		12,014,700			4,423,617			10,490,981			4,295,178
Net loss per share of common stock-basic	$	(1.15	)	$	(2.27	)	$	(2.92	)	$	(8.52	)

STOCK-BASED COMPENSATION AWARDS (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE


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

Research and development expenses	$	305	$	96	$	709	$	286
General and administrative expenses		1,938		725		3,804		2,385
Total stock-based compensation	$	2,243	$	821	$	4,513	$	2,671

The total stock-based compensation expense recognized by award type was as follows (in thousands):


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

Stock options	$	1,509	$	815	$	3,231	$	2,658
Restricted stock units		734		6		1,282		13
Total stock-based compensation	$	2,243	$	821	$	4,513	$	2,671

SUMMARY OF FAIR VALUE OF OPTIONS GRANTED

The weighted average assumptions used principally in determining the fair value of stock options granted to employees and non-employee directors were as follows:


	Nine Months Ended September 30,
	2024			2023
Risk-free interest rate		4.23	%		3.82	%
Expected dividend yield		0	%	0%
Expected term in years (employee options)		6.17		6.25
Expected volatility		124.46	%		101.41	%

SUMMARY OF OPTION ACTIVITY

A summary of stock option activity for the nine months ended September 30, 2024 is presented below:


Stock Options	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term in Years		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2023		708,762		$	63.96
Granted		245,791			28.19
Exercised		(136,664	)		14.63
Forfeited or canceled		(54,879	)		9.29
Expired		(18,678	)		70.73
Outstanding at September 30, 2024		744,332		$	65.07		6.93	$	2,600
Exercisable at September 30, 2024		389,369		$	103.21		5.09	$	1,200

SUMMARY OF RSU ACTIVITY

A summary of RSU activity for the nine months ended September 30, 2024 is presented below:


RSU's	Number of Shares Underlying RSUs			Weighted Average Grant Date Fair Value
Unvested at December 31, 2023		17,911		$	5.14
Granted		245,795		$	27.84
Forfeited		(2,193	)	$	17.15
Vested		(7,275	)	$	19.04
Unvested at September 30, 2024		254,238		$	26.59

LIQUIDITY (Details Narrative) - USD ($) $ in Thousands			9 Months Ended
LIQUIDITY (Details Narrative) - USD ($) $ in Thousands	Feb. 02, 2024	Jan. 31, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	May 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Retained earnings (accumulated deficit)			$ 467,363		$ 436,684
Cash, cash equivalents and marketable debt securities			159,400
Proceeds from Issuance of Common Stock			$ 182,071	$ 127
Jefferies LLC [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sale of Stock, Number of Shares Issued in Transaction		4,325,000
Proceeds from Issuance of Common Stock	$ 94,500
May 31, 2023 Market Sale Agreement \| Jefferies LLC [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Commission percentage						3.00%

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Cash and Cash Equivalents [Abstract]
Cash	$ 3,535	$ 4,029
Cash equivalents	15,888	9,695
Cash and cash equivalents	19,423	13,724
Restricted cash, current	285	192
Restricted Cash, noncurrent	385	478
Restricted cash	670	670
Total cash, cash equivalents, and restricted cash shown in the statement of cashflows	$ 20,093	$ 14,394

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH (Details Narrative) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Cash and Cash Equivalents [Line Items]
Restricted Cash, noncurrent	$ 385		$ 385		$ 478
Restricted cash	670		670		670
Restricted cash	285		285		192
Other Operating Income (Expense), Net	0	$ 100	2,500	$ 100
Letter of Credit [Member]
Cash and Cash Equivalents [Line Items]
Restricted Cash, noncurrent	400		400
Restricted cash	700		700
Restricted cash	300		300
UNITED STATES
Cash and Cash Equivalents [Line Items]
Cash held in subsidiary	16,200		16,200
UNITED KINGDOM
Cash and Cash Equivalents [Line Items]
Cash held in subsidiary	$ 3,200		$ 3,200		$ 3,800

INVESTMENTS - SUMMARY OF INVESTMENTS (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Net Investment Income [Line Items]
Debt Securities, Available-for-sale, Amortized Cost	$ 139,732	$ 7,182
Debt Securities, Available-for-sale	139,939	7,182
Available for Sale Other Investments And Debt Securities Amortized Cost Basis	139,732	7,182
Other Investments and Debt Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax	236	1
Other Investments and Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax	(29)	(1)
Other Investments and Debt Securities, Available-for-sale	139,939	7,182
US Treasury Securities [Member]
Net Investment Income [Line Items]
Debt Securities, Available-for-sale, Amortized Cost	8,459
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax	39
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax	0
Debt Securities, Available-for-sale	8,498
U.S. government agency securities [Member]
Net Investment Income [Line Items]
Debt Securities, Available-for-sale, Amortized Cost	27,553
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax	61
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax	0
Debt Securities, Available-for-sale	27,614
Corporate Debt Securities [Member]
Net Investment Income [Line Items]
Debt Securities, Available-for-sale, Amortized Cost	103,720	7,182
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax	136	1
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax	(29)	(1)
Debt Securities, Available-for-sale	$ 103,827	$ 7,182

INVESTMENTS - Summarizes the Amortized Cost and Fair Value (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]
Amortized Cost, Maturing in one year or less	$ 122,520	$ 7,182
Amortized cost, Maturing after one year but less than three years	17,212
Debt Securities, Available-for-sale, Amortized Cost	139,732	7,182
Fair Value, Maturing in one year or less	122,660	7,182
Fair Value, Maturing after one year but less than three years	17,279
Debt Securities, Available-for-sale, Fair Value	$ 139,939	$ 7,182

MARKETABLE SECURITIES (Details Narrative) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]
Debt Securities, Available-for-sale	$ 139,939	$ 7,182

FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES - SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets, Fair Value	$ 155,827	$ 16,877
Liabilities, Fair Value		39
Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	14,164	7,833
Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	1,724	1,862
Marketable Securities, Fair Value	103,827	7,182
US Treasury Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	8,498
U.S. government agency securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	27,614
Fair Value, Inputs, Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets, Fair Value	14,164	7,833
Liabilities, Fair Value		0
Fair Value, Inputs, Level 1 [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	14,164	7,833
Fair Value, Inputs, Level 1 [Member] \| Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	0	0
Marketable Securities, Fair Value	0	0
Fair Value, Inputs, Level 1 [Member] \| US Treasury Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	0
Fair Value, Inputs, Level 1 [Member] \| U.S. government agency securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	0
Fair Value, Inputs, Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets, Fair Value	141,663	9,044
Liabilities, Fair Value		0
Fair Value, Inputs, Level 2 [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	0	0
Fair Value, Inputs, Level 2 [Member] \| Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	1,724	1,862
Marketable Securities, Fair Value	103,827	7,182
Fair Value, Inputs, Level 2 [Member] \| US Treasury Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	8,498
Fair Value, Inputs, Level 2 [Member] \| U.S. government agency securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	27,614
Fair Value, Inputs, Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets, Fair Value	0	0
Liabilities, Fair Value		39
Fair Value, Inputs, Level 3 [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	0	0
Fair Value, Inputs, Level 3 [Member] \| Corporate Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash Equivalents, Fair Value	0	0
Marketable Securities, Fair Value	0	$ 0
Fair Value, Inputs, Level 3 [Member] \| US Treasury Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	0
Fair Value, Inputs, Level 3 [Member] \| U.S. government agency securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities, Fair Value	$ 0

LICENSE AGREEMENTS (Details Narrative) - USD ($)					3 Months Ended			9 Months Ended
LICENSE AGREEMENTS (Details Narrative) - USD ($)	Feb. 12, 2023	Nov. 17, 2022	May 26, 2021	Sep. 20, 2018	Sep. 30, 2024	Sep. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sales Milestone Payment					$ 0	$ 0		$ 0	$ 9,100,000
Other Liabilities, Noncurrent					$ 0			0		$ 44,000
Jenrin Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront cash payment				$ 300,000
Jenrin Agreement [Member] \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone payments				$ 18,400,000
UCSF Lincense Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License issuance fee		$ 800,000	$ 1,500,000
Installment of license issuance fee		$ 400,000
Additional payment of indication milestone			50,000
UCSF Lincense Agreement [Member] \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone payments			$ 153,200,000
Cspc License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront cash payment	$ 7,500,000
Accrued pre-clinical cost								$ 1,600,000
Cspc License Agreement [Member] \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone payments	555,000,000
Installment of license issuance fee							$ 5,000,000
Cspc License Agreement [Member] \| Minimum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone payments	130,000,000
Installment of license issuance fee	$ 2,500,000

PROPERTY AND EQUIPMENT - SUMMARY OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 4,529	$ 4,529
Less: accumulated depreciation	(4,010)	(3,556)
Property an equipment, net	519	973
Computer Hardware and Software [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	84	84
Office Furniture and Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,114	1,114
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 3,331	$ 3,331

PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Property, Plant and Equipment [Abstract]
Depreciation	$ 0.2	$ 0.2	$ 0.5	$ 0.5
Impairment charges	$ 0.0	$ 0.0	$ 0.0	$ 0.0

COMMITMENTS AND CONTINGENCIES - SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Commitments and Contingencies Disclosure [Abstract]
2024	$ 439
2025	1,795
2026	1,688
Total lease payments	3,922
Less: imputed interest	(312)
Total	$ 3,610

COMMITMENTS AND CONTINGENCIES (Details Narrative) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Aug. 26, 2021 ft²
Commitments and Contingencies Disclosure [Abstract]
Sublease to third party					12,112
Sublease area total					30,023
Sublease agreement, Description			Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commenced on October 1, 2021 and was scheduled to end on October 31, 2026, however, it was terminated on June 24, 2024. The Company notes sublease income of $0 and $0.1 million for the three months ended September 30, 2024 and 2023, respectively and $0.2 million and $0.2 million for the nine months ended September 30, 2024 and 2023, respectively was recognized and offset against rent expense.
Subleases Income \| $	$ 0.0	$ 0.1	$ 0.2	$ 0.2

NOTES PAYABLE - SCHEDULE OF NOTES PAYABLE (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Debt Disclosure [Abstract]
Principal	$ 0	$ 16,304
Less: debt discount	0	(2,954)
Accretion of Debt Discount	0	2,558
Net Carrying amount	$ 0	$ 15,908

NOTES PAYABLE (Details Narrative) - USD ($)					1 Months Ended	3 Months Ended		9 Months Ended
NOTES PAYABLE (Details Narrative) - USD ($)	Aug. 01, 2024	Mar. 06, 2024	Jun. 01, 2023	Jul. 28, 2020	Nov. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt Instrument, Unamortized Discount						$ 0		$ 0		$ 2,954,000
Interest Expense, Debt						400,000	$ 1,000,000	1,800,000	$ 2,900,000
Debt Instrument, Face Amount						0		0		16,304,000
Lenders [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt Instrument, Unamortized Discount						3,000,000		3,000,000
Share-Based Payment Arrangement, Tranche One [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt Instrument, Face Amount				$ 20,000,000
Insurance Policy [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Prepaid expenses						$ 34,600		34,600		$ 300,000
Loan Agreement [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Notes payable					$ 400,000
Monthly principal and interest payments					$ 39,000
Monthly loan payments term					10-month period
Annual interest rate					8.15%
Loan Agreement [Member] \| K2 HealthVentures LLC [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt conversion amount		$ 1,100,000	$ 900,000					5,000,000
Debt conversion per share		$ 7.875	$ 4.5
Warrants to purchase shares of common stock, exercised		142,857	194,444	2,873
Warrant exercisable price per share				$ 208.8
Loan Agreement [Member] \| K2 HealthVentures LLC [Member] \| Share-Based Payment Arrangement, Tranche One [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Secured debt				$ 20,000,000
Loan Agreement [Member] \| Debt 1a [Member] \| K2 HealthVentures LLC [Member] \| Minimum [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt conversion amount								$ 900,000
Debt conversion per share						$ 4.5		$ 4.5
Loan Agreement [Member] \| Debt 1b [Member] \| K2 HealthVentures LLC [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt conversion amount								$ 1,100,000
Debt conversion per share						7.875		$ 7.875
Loan Agreement [Member] \| Debt 2 [Member] \| K2 HealthVentures LLC [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt conversion amount								$ 3,000,000
Debt conversion per share						$ 282		$ 282
Amended loan agreement [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Final payment	$ 1,600,000
Loan Maturity Final Amount	11,800,000
Debt Instrument Outstanding principal Amount	10,100,000
Debt Instrument, Periodic Payment, Interest	$ 1,600,000
Amended loan agreement [Member] \| K2 HealthVentures LLC [Member]
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items]
Debt description				Interest payments were made monthly and accrued at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%.

ACCRUED EXPENSES - SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued pre-clinical and clinical costs	$ 1,628	$ 1,449
Accrued product development costs	1,671	745
Accrued license costs	1,625	4,825
Accrued compensation	1,823	2,326
Accrued administrative costs	429	343
Accrued interest	0	1,342
Total	$ 7,176	$ 11,030

DEVELOPMENT AWARDS (Details Narrative) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Entity Listings [Line Items]
Loans Payable	$ 0	$ 15,908

PREFERRED STOCK (Additional Information) (Details) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Preferred Stock, Shares Authorized	10,000,000	10,000,000
Preferred Stock, Par or Stated Value Per Share	$ 0.0001	$ 0.0001
Preferred Stock, Shares Outstanding	0	0
Preferred Stock, Shares Issued	0	0

NET LOSS PER COMMON SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Accounting Policies [Abstract]
Net Income (Loss)	$ (13,783)	$ (10,053)	$ (30,679)	$ (36,582)
Weighted average number of common shares outstanding, basic	12,014,700	4,423,617	10,490,981	4,295,178
Net loss per share of common stock-basic	$ (1.15)	$ (2.27)	$ (2.92)	$ (8.52)

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)			3 Months Ended		9 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Feb. 02, 2024	Jan. 31, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	May 31, 2023
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Common stock, shares authorized			300,000,000		300,000,000		300,000,000
Preferred Stock, Shares Authorized			10,000,000		10,000,000		10,000,000
Preferred Stock, Par or Stated Value Per Share			$ 0.0001		$ 0.0001		$ 0.0001
Preferred Stock, Shares Issued			0		0		0
Preferred Stock, Shares Outstanding			0		0		0
Common stock, par value			$ 0.0001		$ 0.0001		$ 0.0001
Common stock, shares issued			12,179,482		12,179,482		4,423,683
Common stock, shares outstanding			12,179,482		12,179,482		4,423,683
Gross proceeds from sale of stock					$ 182,071,000	$ 127,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period					136,664
Restricted Common Stock [Member] \| 2014 Plan
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Common stock issued			3,511	0	7,275	0
Restricted Common Stock [Member] \| 2024 Plan
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Common stock issued					2,783
Warrant [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Exercised				0		0
Common stock issued			6,087		6,087
Equity Option [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period			2,588	0	136,664	43,836
Proceeds from Stock Options Exercised			$ 100,000		$ 2,000,000	$ 100,000
Jefferies LLC [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Common stock, par value		$ 0.0001
additional shares of common stock		648,750
Aggregate common stock sold, shares		4,325,000
Purchase price per share		$ 19
Gross proceeds from sale of stock	$ 94,500,000
Net Poceeds after deducting Underwriting Discounts and Commissions	$ 88,600,000
Professional Services Agreement [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Common stock issued			4,649	0	4,649	0
May 2023 Sale Agreement [Member] \| Jefferies LLC [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Sale of common stock offering price								$ 150,000,000
K2HV Amended Loan and Security Agreement [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Common stock issued			0	0	142,857	194,444
Open Market Sale Agreement [Member]
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items]
Gross proceeds from sale of stock			$ 35,600,000	$ 7,000	$ 91,400,000	$ 100,000
Proceeds from Issuance or Sale					$ 76,400,000
Common stock issued			663,730	942	2,484,517	14,106

STOCK BASED COMPENSATION AWARDS - SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation	$ 2,243	$ 821	$ 4,513	$ 2,671
Research and Development Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation	305	96	709	286
General and Administrative Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation	1,938	725	3,804	2,385
Stock options [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation	1,509	815	3,231	2,658
Restricted Stock Units RSU [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation	$ 734	$ 6	$ 1,282	$ 13

STOCK BASED COMPENSATION AWARDS - SUMMARY OF FAIR VALUE OF OPTIONS GRANTED (Details) - Employee Stock Option	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Option Indexed to Issuer's Equity [Line Items]
Risk free interest rate	4.23%	3.82%
Expected dividend yield	0.00%	0.00%
Expected term in years (employee options)	6 years 2 months 1 day	6 years 3 months
Expected volatility	124.46%	101.41%

STOCK BASED COMPENSATION AWARDS - SUMMARY OF OPTION ACTIVITY (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]
Shares, Outstanding, Beginning balance	708,762
Number of Shares Granted	245,791
Shares, Exercised	(136,664)
Shares,Forfeited or canceled	(54,879)
Shares, Expired	(18,678)
Shares, Outstanding, Ending balance	744,332
Shares, Exercisable	389,369
Weighted Average Exercise Price, Outstanding, Beginning balance	$ 63.96
Weighted Average Exercise Price, Granted	28.19
Weighted Average Exercise Price, Exercised	14.63
Weighted Average Exercise Price, Forfeited or canceled	9.29
Weighted Average Exercise Price , Expired	70.73
Weighted Average Exercise Price, Outstanding, Ending balance	65.07
Weighted Average Exercise Price, Exercisable	$ 103.21
Weighted Average Remaining Contractual Term in Years, Outstanding	6 years 11 months 4 days
Weighted Average Remaining Contractual Term in Years, Exercisable	5 years 1 month 2 days
Average Intrinsic Value, Outstanding	$ 2,600
Average Intrinsic Value, Exercisable	$ 1,200

STOCK BASED COMPENSATION AWARDS - SCHEDULE OF RESTRICTED STOCK UNITS (Details)	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Shares Granted	245,791
Non-vested stock options [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Shares Unvested at December 31, 2023	17,911
Number of Shares Granted	245,795
Number of Shares Forfeited	(2,193)
Number of Shares Vested	(7,275)
Number of Shares Unvested as September 30 2024	254,238
Weighted Average Grant Date Fair Value Unvested at December 31, 2023 \| $ / shares	$ 5.14
Weighte Average Grant Date Fair Value Options Granted \| $ / shares	27.84
Weighte Average Grant Date Fair Value Options Forfeited \| $ / shares	17.15
Weighte Average Grant Date Fair Value Options Vested \| $ / shares	19.04
Weighte Average Grant Date Fair Value Options Unvested at June 30 2024 \| $ / shares	$ 26.59

STOCK BASED COMPENSATION AWARDS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Issuance of common stock upon exercise of stock options, shares			136,664
Total unrecognized compensation expense	$ 5.7		$ 5.7
Share-based compensation expense, recognized over a weighted average			1 year 11 months 23 days
Number of Shares Granted			245,791
Equity Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Issuance of common stock upon exercise of stock options, shares	2,588	0	136,664	43,836
Weighte Average Grant Date Fair Value Options Granted			$ 25.17	$ 4.2
Average intrinsic value of options exercised			$ 1.1	$ 0.1
Total unrecognized compensation expense	$ 6.1		$ 6.1
Share-based compensation expense, recognized over a weighted average			1 year 5 months 12 days
Common Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Issuance of common stock upon exercise of stock options, shares	2,588		136,664	43,836
2014 Equity Incentive Plan [Member] \| Common Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Shares Vested			910,009
Issuance of common stock upon exercise of stock options, shares			910,009
Number of Shares Granted			0
2024 Plan and 2024 Equity Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Percentage of outstanding common shares			25.00%
2024 Equity Compensation Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares reserved for issuance	2,000,000		2,000,000
2024 Equity Compensation Plan [Member] \| Common Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Issuance of common stock upon exercise of stock options, shares			88,561
Number of Shares Granted			1,908,656

WARRANTS (Details Narrative) - USD ($)				3 Months Ended		9 Months Ended
WARRANTS (Details Narrative) - USD ($)	Mar. 06, 2024	Jun. 01, 2023	Jul. 28, 2020	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Oct. 16, 2020	Jan. 26, 2018
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number				389,369		389,369
Debt face amount				$ 0		$ 0		$ 16,304,000
Cash Proceeds									$ 0
Share-based Payment Arrangement, Tranche One [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Debt face amount			$ 20,000,000
CFF Warrant [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Warrants outstanding to purchase of common stock shares										33,334
Exercise price of warrants										$ 396
Investment Agreement [Member] \| CFF Warrant [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Warrants outstanding to purchase of common stock shares				36,207		36,207
Exercise price of warrants				$ 381.14		$ 381.14
Weighted average remaining life of warrants						9 months 3 days
Warrant expire date				Jan. 26, 2025		Jan. 26, 2025
Loan Agreement [Member] \| K2 HealthVentures LLC [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Warrants to purchase shares of common stock, exercised	142,857	194,444	2,873
Exercise price of warrants			$ 208.8
Loan Agreement [Member] \| K2 Warrant [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Warrants to purchase shares of common stock, exercised			2,873
Warrants outstanding to purchase of common stock shares			2,873
Exercise price of warrants			$ 208.8
Warrant expire date			Jul. 28, 2030
Professional Services Agreement [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Issuance of common stock, net of issuance costs, shares				4,649	0	4,649	0
Professional Services Agreement [Member] \| Warrants [Member] \| Investor Relations Service Provider [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Warrants outstanding to purchase of common stock shares									14,000
Exercise price of warrants									$ 32.1
Warrant expire date									Nov. 03, 2025
Warrant [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Issuance of common stock, net of issuance costs, shares				6,087		6,087
Warrants to purchase shares of common stock, exercised					0		0

SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Derivative Instruments and Hedging Activities Disclosure [Abstract]
Change in fair value of derivative liabilities	$ 0	$ 0	$ (39)	$ 0

DERIVATIVE LIABILITY (Details Narrative) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Jul. 28, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Gain (Loss) on Sale of Derivatives	$ 0	$ 0	$ 39	$ 0
Loan Agreement [Member] \| K2 HealthVentures LLC [Member] \| Share-based Payment Arrangement, Tranche One [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Secured debt					$ 20,000