IMNM Immunome Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):
November 13, 2024

 

 

Immunome, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-39580		77-0694340
(state or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

18702 N. Creek Parkway, Suite 100 Bothell, WA		98011
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: (425) 939-7410

 

N/A

(Former name or former address, if changed since last report.) 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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, $0.0001 par value per share		IMNM		The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

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. ¨

 

 

 

Item 2.02

Results of Operations and Financial Condition.

 

On November 13, 2024, Immunome, Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2024 and provided a business update in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

 

Exhibit Number		Description
99.1		Press Release dated November 13, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

SIGNATURES

 

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

 

Date: November 13, 2024	Immunome, Inc.
	By:	/s/ Max Rosett
	Name:	Max Rosett
	Title:	Chief Financial Officer

 

Exhibit 99.1

 

Immunome Reports Third Quarter 2024 Financial Results and Provides Business Update

 

11/13/2024

 

BOTHELL, Wash. –Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on the development of first-in-class and best-in-class targeted oncology therapies, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.

 

“Immunome continues to advance its pipeline,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “Topline data for the RINGSIDE Part B trial of AL102 is expected in the second half of 2025, and IND submissions for IM-1021 and IM-3050 are on track.”

 

“Our discovery team is focused on discovering ADCs that effectively pursue the novel targets we believe will define the next generation of transformative cancer therapies. In particular, the differentiated profile of HC74, our proprietary TOP1 payload, offers exciting opportunities for portfolio expansion when combined with our large repertoire of antibodies.”

 

Pipeline Highlights

 

Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102.

 

Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed.

 

Third Quarter 2024 Financial Results

 

	·	As of September 30, 2024, cash, cash equivalents and marketable securities totaled $240.1 million. Immunome’s current cash runway is expected to extend into 2026.
	·	Research and development expenses for the quarter ended September 30, 2024 were $37.2 million, including stock-based compensation costs of $1.8 million.
	·	In-process research and development expenses for the quarter ended September 30, 2024 were $6.7 million. These expenses were related to Immunome’s business development activity.
	·	General and administrative expenses for the quarter ended September 30, 2024 were $9.5 million, including stock-based compensation expense of $3.1 million.
	·	Immunome reported a net loss of $47.1 million for the quarter ended September 30, 2024.

 

 

About Immunome, Inc.

 

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugates (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com.

 

Cautionary Statement Regarding Forward-Looking Statements

 

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “expects,” “believe,” “opportunities,” “anticipates” and similar expressions to identify these forward-looking statements. These forward-looking statements include Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial; Immunome’s expected timing for filing an IND for IM-1021 and IM-3050; Immunome’s expectation that it will commence clinical development of IM-1021 and IM-3050 in early 2025; the potential of Immunome’s ADC targets to provide first-in-class or best-in-class potential; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that Immunome’s product candidates and development candidates fail to achieve their intended endpoints; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and successfully execute on its business plan; and other risks and uncertainties indicated from time to time described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, in Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, being filed with the SEC today, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

 

Investor Contact:

 

Max Rosett

 

Chief Financial Officer

 

investors@immunome.com

 

 

Immunome, Inc.

Consolidated Balance Sheets

(Unaudited; In thousands)

 

		September 30, 2024				December 31, 2023				Delta
Assets
Current assets:
Cash and cash equivalents		$	155,568			$	98,679				56,889
Marketable securities			84,562				39,463				45,099
Prepaid expenses and other current assets			3,910				6,561				(2,651	)
Total current assets			244,040				144,703				99,337
Property and equipment, net			7,172				2,073				5,099
Operating right-of-use assets			2,388				1,564				824
Restricted cash			100				100				—
Other long-term assets			3,198				100				3,098
Total assets		$	256,898			$	148,540				108,358
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	3,518			$	3,311				207
Accrued expenses and other current liabilities			26,331				8,025				18,306
Deferred revenue, current			9,679				10,493				(814	)
Total current liabilities			39,528				21,829				17,699
Deferred revenue, non-current			—				5,489				(5,489	)
Operating lease liabilities, net of current portion			2,464				1,340				1,124
Total liabilities			41,992				28,658				13,334
Stockholders’ equity:
Preferred stock			—				—				—
Common stock			6				4				2
Additional paid-in capital			650,351				342,663				307,688
Accumulated other comprehensive income			70				22				48
Accumulated deficit			(435,521	)			(222,807	)			(212,714	)
Total stockholders’ equity			214,906				119,882				95,024
Total liabilities and stockholders’ equity		$	256,898			$	148,540				108,358

 

 

Immunome, Inc.

Consolidated Statements of Operations

(Unaudited; In thousands, except share and per share amounts)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Collaboration revenue		$	2,910			$	3,565			$	6,303			$	10,192
Operating expenses:
In-process research and development			6,706				—				124,972				—
Research and development(1)			37,200				3,823				81,652				13,452
General and administrative(1)			9,526				4,375				22,509				11,617
Total operating expenses			53,432				8,198				229,133				25,069
Loss from operations			(50,522	)			(4,633	)			(222,830	)			(14,877	)
Interest income			3,422				288				10,116				705
Net loss		$	(47,100	)		$	(4,345	)		$	(212,714	)		$	(14,172	)
Net loss per share, basic and diluted		$	(0.78	)		$	(0.36	)		$	(3.72	)		$	(1.16	)
Weighted-average shares outstanding, basic and diluted			60,205,327				12,202,335				57,239,668				12,194,277
Comprehensive loss
Net loss		$	(47,100	)		$	(4,345	)		$	(212,714	)		$	(14,172	)
Unrealized loss on marketable securities			68				—				48				—
Comprehensive loss		$	(47,032	)		$	(4,345	)		$	(212,666	)		$	(14,172	)

 

(1) Amounts include non-cash stock based compensation as follows (in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Research and development		$	1,820			$	466			$	3,244			$	1,323
General and administrative			3,072				617				7,034				2,017
Total share-based compensation expense		$	4,892			$	1,083			$	10,278			$	3,340

 

 

 

v3.24.3

Cover	Nov. 13, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 13, 2024
Entity File Number	001-39580
Entity Registrant Name	Immunome Inc.
Entity Central Index Key	0001472012
Entity Tax Identification Number	77-0694340
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	18702 N. Creek Parkway, Suite 100
Entity Address, City or Town	Bothell
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98011
City Area Code	425
Local Phone Number	939-7410
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	IMNM
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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