Form 8-K - Current report

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 9, 2023

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)		(IRS Employer Identification No.)

665 Stockton Drive, Suite 300 Exton, Pennsylvania		19342
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (610) 321-3700

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:

¨	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(s)		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 9, 2023, Immunome, Inc. announced its financial results for the third quarter ended September 30, 2023 in the press release attached here to as Exhibit 99.1 and incorporated herein by reference.

The information in this Current Report on Form 8-K, including Exhibit 99.1, 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 Section 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) Exhibits.

Exhibit No.		Description
99.1		Press Release dated November 9, 2023

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

	IMMUNOME, INC.

Date: November 9, 2023	By:	/s/ Corleen Roche
		Corleen Roche
		Chief Financial Officer

Exhibit 99.1

Logo, company name

Description automatically generated

Immunome Reports Third Quarter 2023 Financial Results

- Completed merger with Morphimmune and concurrent $125 million private placement investment with leading institutional investors -

- Clay B. Siegall, Ph.D., former co-founder & CEO of Seagen, Inc., appointed as Chairman and CEO -

- Bob Lechleider, M.D., appointed as Chief Medical Officer –

- Jean-Jacques Bienaimé, former CEO of BioMarin appointed as member of the Board of Directors -

- Cash runway expected to extend into Q1 2026* -

SEATTLE, WA & EXTON, PA – November 9, 2023 – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

“The merger of Immunome and Morphimmune is a transformative transaction for both companies, resulting in a combined company with a highly focused technology platform based upon strong foundational science, coupled with a strong balance sheet, as we push forward in our mission to develop targeted cancer therapies for patients,” stated Clay B. Siegall, Ph.D., Chairman and Chief Executive Officer of Immunome. “There remains a significant need for innovative and best in class treatments to address unmet medical needs for cancer patients where previous approaches have fallen short.”

Highlights

Immunome and Morphimmune Complete Merger with $125 Million PIPE to Accelerate Development of Novel Targeted Cancer Therapies. In October 2023, Immunome and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, announced that the two companies successfully closed their previously announced merger agreement.

The newly combined company features synergistic platforms that we believe will enable the development of first-in-class and best-in-class targeted cancer therapies across multiple modalities and tumor types.

The concurrent oversubscribed private placement investment of $125 million included participation from Enavate Sciences, EcoR1 Capital, Redmile Group, Janus Henderson Investors, Avidity Partners, Woodline Partners LP, and other leading institutional investors.

IMM-ONC-01: We expect to provide guidance in Q1 2024 regarding our timeline to submit to the FDA an IND for IMM-ONC-01.

¹⁷⁷Lu-FAP: We anticipate an IND submission with the FDA in Q1 2025.

Financial Highlights

Collaboration Revenue: Collaboration Revenue from the Collaboration Agreement with AbbVie for the three months ended September 30, 2023 was $4 million.

Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2023 were $4 million.

General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2023 were $4 million.

Net loss: Net loss for the three months ended September 30, 2023 was $4 million, or $(0.36) per share.

Cash and cash equivalents: As of September 30, 2023, cash and cash equivalents totaled $91million**

About Immunome, Inc.

Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and ADCs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.

For more information, visit www.immunome.com or follow us on Twitter and LinkedIn.

*Assumes receipt of certain collaboration payments.

**Includes $61 million of PIPE proceeds received in the quarter.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “believes,” “plans,” “expects,” “will,” “assumes,” “anticipates,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward looking statements include, but are not limited to, statements regarding Immunome’s anticipated cash runway and the assumed receipt of certain collaboration payments; Immunome’s intent to evaluate synergistic high-value oncology assets; Immunome’s timing and expectation for nominating a potential development candidate and filing NDAs with the FDA; Immunome’s expectation that the combination with Morphimmune will enable to development of first-in-class and best-in-class targeted cancer therapies across multiple modalities and tumor types; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the inability to recognize the anticipated benefits of the merger, which may be affected by, among other things, competition and the ability of Immunome to successfully integrate with Morphimmune; Immunome’s ability to grow and successfully execute on its business plan, including advancing its current pipeline into the clinic and expanding its pipeline through its technology platforms, proprietary toolbox, and through strategic transactions, if any; the ability of Immunome to identify, conduct and complete IND-enabling studies; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect it or the expected benefits of the merger; Immunome’s ability to manage clinical trials or studies; the risk that pre-clinical data may not be predictive of clinical data; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team are not indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with Securities and Exchange Commission (“SEC”) on March 16, 2023, Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC today, , and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations.

IMMUNOME, INC.

Condensed Balance Sheets

(In thousands, except share data)

(unaudited)

	September 30, 2023			December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	90,641		$	20,323
Prepaid expenses and other current assets		773			2,326
Total current assets		91,414			22,649
Property and equipment, net		1,172			681
Operating right-of-use asset, net		345			284
Restricted cash		100			100
Deferred offering costs		130			332
Total assets	$	93,161		$	24,046
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	2,786		$	2,400
Accrued expenses and other current liabilities		3,369			4,931
Deferred revenue, current		16,956			—
Total current liabilities		23,111			7,331
Deferred revenue, non-current		2,852			—
Deposit liability		61,000			—
Other long-term liabilities		122			62
Total liabilities		87,085			7,393
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at September 30, 2023 and December 31, 2022, respectively		—			—
Common stock, $0.0001 par value; 200,000,000 shares authorized; 12,202,516 and 12,128,843 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		1			1
Additional paid-in capital		136,248			132,653
Accumulated deficit		(130,173	)		(116,001	)
Total stockholders’ equity		6,076			16,653
Total liabilities and stockholders’ equity	$	93,161		$	24,046

The accompanying notes are an integral part of these unaudited condensed financial statements.

IMMUNOME, INC.

Condensed Statements of Operations

(In thousands, except share and per share data)

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Collaboration revenue	$	3,565		$	—		$	10,192		$	—
Operating expenses:
Research and development		3,823			5,225			13,452			19,020
General and administrative		4,375			3,309			11,617			10,094
Total operating expenses		8,198			8,534			25,069			29,114
Loss from operations		(4,633	)		(8,534	)		(14,877	)		(29,114	)
Interest income		288			1			705			4
Net loss	$	(4,345	)	$	(8,533	)	$	(14,172	)	$	(29,110	)
Deemed dividend arising from warrant modification		—			(622	)		—			(622	)
Net loss attributable to common stockholders		(4,345	)	$	(9,155	)		(14,172	)	$	(29,732	)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.36	)	$	(0.75	)	$	(1.16	)	$	(2.45	)
Weighted-average common shares outstanding, basic and diluted		12,202,335			12,127,501			12,194,277			12,125,947

The accompanying notes are an integral part of these unaudited condensed financial statements.

IMMUNOME, INC.

Condensed Statements of Cash Flows

(In thousands)

(unaudited)

	Nine Months ended September 30,
	2023			2022
Cash flows from operating activities:
Net loss	$	(14,172	)	$	(29,110	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization		306			327
Amortization of right-of-use asset		165			44
Write-off of deferred offering costs		332			—
Share-based compensation		3,340			3,977
Changes in operating assets and liabilities:
Prepaid expenses and other assets		1,553			5,236
Accounts payable		71			62
Accrued expenses and other current liabilities		(1,452	)		(2,471	)
Deferred revenue		19,808			—
Other long-term liabilities		(60	)		(72	)
Net cash provided by (used in) operating activities		9,891			(22,007	)
Cash flows from investing activities:
Purchases of property and equipment		(482	)		(176	)
Net cash used in investing activities		(482	)		(176	)
Cash flows from financing activities:
Payment of offering costs		(125	)		—
Proceeds from PIPE financing		61,000			—
Proceeds from exercise of stock options		—			32
Proceeds from issuance of common stock under ATM, net		34			—
Net cash provided by financing activities		60,909			32
Net increase (decrease) in cash and cash equivalents and restricted cash		70,318			(22,151	)
Cash and cash equivalents and restricted cash at beginning of period		20,423			49,329
Cash and cash equivalents and restricted cash at end of period	$	90,741		$	27,178

Supplemental disclosures of cash flow information:
Operating lease right-of-use asset and lease liability recorded due to lease extension	$	226		$	—
Issuance of common stock to certain board of directors in lieu of accrued compensation	$	221		$	—
Deferred offering costs in accrued expenses and other current liabilities	$	5		$	—
Property and equipment included in accounts payable	$	315		$	—

The accompanying notes are an integral part of these unaudited condensed financial statements.

Investor Contact
Corleen Roche
Chief Financial Officer
investors@immunome.com

Media Contact
Andrew W. Mielach
LifeSci Communications
amielach@lifescicomms.com

Cover	Nov. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 09, 2023
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	665 Stockton Drive, Suite 300
Entity Address, City or Town	Exton
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19342
City Area Code	610
Local Phone Number	321-3700
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