Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2024

Commission File Number 000-30902

COMPUGEN LTD.

(Translation of registrant’s name into English)

26 Harokmim Street

Holon 5885849, Israel

(Address of Principal Executive Offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F ☒             Form 40-F ☐ 

 

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Compugen Ltd.

 

On March 5, 2024, Compugen Ltd. (the “Company”) issued a press release reporting the Company’s fourth quarter and full year 2023 results (the “Press Release”), a copy of which is furnished as Exhibit 99.1 to this Report on Form 6-K.

With the exception of the quotes attributable to Anat Cohen-Dayag, Ph.D., information contained in the Press Release is hereby incorporated by reference into the Company’s Registration Statement on Form F-3, File No. 333-270985.

Exhibit
Number		Description of Exhibit
99.1		Press Release dated March 5, 2024 – “Compugen Reports Fourth Quarter and Full Year 2023 Results.”

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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.

	COMPUGEN LTD.
Date: March 5, 2024	By:	/s/ Eran Ben Dor
		Eran Ben Dor
		General Counsel

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Exhibit 99.1

FOR IMMEDIATE RELEASE

Compugen Reports Fourth Quarter and Full Year 2023 Results

 

•	Partnership with Gilead on preclinical immuno-oncology program further validates Compugen’s computational discovery, research, and development capabilities

•	Catalyst rich 2024 expected with multiple data readouts and updates planned from Compugen’s diversified portfolio

•	Solid balance sheet with extended cash runway expected to fund operations into 2027

HOLON, ISRAEL, March 5, 2024 - Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today reported financial results for the fourth quarter and full year 2023 and provided a corporate update.

“Our accomplishments in 2023 position us well for an exciting future,” said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. “We advance into an expected catalyst rich 2024, with a solid balance sheet, an expected extended cash runway into 2027 and validating partnerships. We believe we have the tools in place to accelerate value creation through advancement of our diversified pipeline portfolio along with our computational discovery platform which is the engine powering our competitive advantage.”

Dr. Cohen-Dayag added, “Compugen made significant progress in 2023, including a license agreement with Gilead Sciences for our preclinical potential first-in-class, antibody program against IL-18 binding protein, COM503.  The deal, including an upfront payment of $60 million and an additional $30 million near term milestone payment, reflects on our computational discovery, research, and development capabilities. Compugen is expected to lead the Phase 1 development of COM503 and is on track for IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance. In 2023 we also progressed our novel COM701 triple combination strategy with the initiation of two proof-of concept studies, in MSS CRC including patients with liver metastases, and in platinum resistant ovarian cancer and we expect to report data from these studies in the first half of 2024 and the fourth quarter of 2024, respectively. While these are particularly challenging indications to treat having historically failed to respond to immunotherapy, representing a high bar for success, we previously presented encouraging clinical data, supported by immune activation suggesting that the unique biology of PVRIG enables anti-PD-1 activity in these challenging indications. The goal of these studies is to further substantiate our clinical findings including our initial biomarker results, to potentially enable us to move forward with a biomarker enriched development strategy.”

Dr. Cohen-Dayag continued, “In 2023, our partner AstraZeneca continued to make progress advancing rilvegostomig, a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from our COM902, into Phase 3 development in biliary tract cancer. AstraZeneca is also advancing rilvegostomig across multiple other indications and combinations and expects data from two of these Phase 2 trials, in the second half of 2024. This partnership provides further validation to our potential best-in-class anti-TIGIT, COM902, and the extensive clinical program being run by AstraZeneca increases our opportunity for obtaining additional non-dilutive financing through expected future milestone payments and royalties.”

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Upcoming Expected Milestones:

COM701 +COM902 + pembrolizumab proof-of-concept studies

•	Microsatellite stable colorectal cancer - data in the first half of 2024

•	Platinum resistant ovarian cancer - on track to complete enrolment of at least 20 patients in the first quarter of 2024, and data in the fourth quarter of 2024

COM503 (Licenced to Gilead, Compugen responsible through Phase 1 development)

•	IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance

Rilvegostomig (AstraZeneca’s PD-1/TIGIT bispecific, TIGIT component derived from COM902)

•	Data in the second half of 2024 from Phase 1/2 ARTEMIDE-01 trial in advanced/metastatic NSCLC and Phase 2b GEMINI-HBP trial in hepatobiliary cancer

Fourth Quarter and Full Year 2023 Financial Highlights

Cash: As of December 31, 2023, Compugen had approximately $51.1 million in cash, cash equivalents, restricted cash, and cash investments, compared with approximately $83.7 million as of December 31, 2022. The cash balance at the end of 2023 does not include the receipt of the upfront payment of $60 million from Gilead for the licensing of COM503 and the $10 million milestone payment from AstraZeneca on dosing of the first patient in the rilvegostomig Phase 3 trial in biliary tract cancer. Compugen expects to receive from Gilead an additional $30 million milestone payment on COM503 IND clearance in 2024. All payments from Gilead are subject to a 15% withholding tax. During the three months ended December 31, 2023, the Company sold approximately 0.9 million ordinary shares under it’s at the market offering (ATM) facility pursuant to a sales agreement entered into with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $1.9 million. Subsequent to the financial results for the year ended December 31, 2023, a total of approximately 0.3 million shares were sold through the Company’s ATM facility contributing gross proceeds of approximately $0.6 million. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027.  The Company has no debt.

Revenues: Compugen reported approximately $33.5 million in revenues for the fourth quarter and for the year ended December 31, 2023, compared to $7.5 million revenues for each of the comparable periods in 2022. The 2023 recognized revenues include the portion of the upfront payment from the license agreement with Gilead allocated to the license and the $10 million clinical milestone payment from AstraZeneca.

R&D expenses for the fourth quarter and year ended December 31, 2023, increased to approximately $10.9 million, and $34.5 million, respectively, compared with $7.3 million and $30.6 million for the comparable periods in 2022, respectively. The increase in 2023 is mainly due to lower amortization of the deferred participation in R&D expenses following the termination of the agreement with Bristol Myers Squibb, offset by decrease in headcount related expenses. Research and development expenses, as a percentage of total operating expenses, were 78% in 2023 compared to 73% in 2022.

G&A expenses for the fourth quarter and year ended December 31, 2023, were $2.5 million and $9.7 million, respectively, compared with approximately $2.5 million and approximately $10.3 million for the comparable periods in 2022, respectively.

 

Net Income / Loss: During the fourth quarter of 2023, Compugen reported a net profit of $9.7 million, or 11 cents per basic and diluted share, compared to a net loss of $3.1 million, or 4 cents per basic and diluted share in the comparable period of 2022. Net loss for the year ended December 31, 2023, was $18.8 million, or 21 cents per basic and diluted share, compared with a net loss of $33.7 million, or 39 cents per basic and diluted share in the comparable period in 2022.

 

Full financial tables are included below.

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Conference Call and Webcast Information

The Company will hold a conference call today, March 5, 2024, at 8:30 AM ET to review its fourth quarter and full year 2023 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or [phone] internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website.

About Compugen

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has developed two proprietary product candidates: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Compugen also has a clinical stage partnered program, rilvegostomig (previously AZD2936), a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen’s clinical stage anti-TIGIT antibody, COM902, in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. In addition, Compugen’s therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, of which the most advanced program, in IND enabling studies is COM503, which is licensed to Gilead. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby freeing natural IL-18 in the tumor microenvironment to inhibit cancer growth. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen’s shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. 

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as “will,” “may,” “expects,” “anticipates,” “believes,” “potential,” “plan,” “goal,” “estimate,” “likely,” “should,” “confident,” and “intends,” and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statement regarding our expectations regarding IND clearance for COM503, including the timing thereof, and similar statements regarding the initiation, and timing of the Phase 1 study for COM503, statements regarding our expectation that 2024 will be catalyst rich with multiple data readouts and updates planned for Compugen’s diversified portfolio, statements suggesting that the unique biology of PVRIG enables anti-PD-1 activity in MSS CRC including patients with liver metastases, and in platinum resistant ovarian cancer, statements regarding our ability to move forward with an enriched development strategy and statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2027. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen’s business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen’s approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Gaza; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the “Risk Factors” section of Compugen’s most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.

Company contact:

Yvonne Naughton, Ph.D.

Head of Investor Relations and Corporate Communications

Email: [e-mail]

Tel: [phone]  

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COMPUGEN LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(U.S. dollars in thousands, except for share and per share amounts)

		Three Months Ended								Year Ended,
		December 31,								December 31,
		2023				2022				2023				2022
		Unaudited				Unaudited
Revenues			33,459				7,500				33,459				7,500
Cost of revenues			2,004				975				2,004				975
Gross profit			31,455				6,525				31,455				6,525
Operating expenses
Research and development expenses			10,928				7,327				34,472				30,648
Marketing and business development expenses			61				191				244				932
General and administrative expenses			2,482				2,536				9,731				10,319
Total operating expenses			13,471				10,054				44,447				41,899
Operating income (loss)			17,984				(3,529	)			(12,992	)			(35,374	)
Financial and other income, net			735				495				3,208				1,738
Income (loss) before taxes on income			18,719				(3,034	)			(9,784	)			(33,636	)
Taxes on income			9,006				58				8,970				58
Net income (loss)			9,713				(3,092	)			(18,754	)			(33,694	)
Basic and diluted net income (loss) per ordinary share			0.11				(0.04	)			(0.21	)			(0.39	)
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share			88,415,382				86,624,643				87,633,298				86,555,628

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COMPUGEN LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS DATA

(U.S. dollars, in thousands)

		December 31,				December 31,
		2023				2022
ASSETS
Current assets
Cash, cash equivalents, short-term bank deposits and restricted cash			39,308				83,708
Investment in marketable securities			11,742				-
Trade receivables			61,000				-
Other accounts receivable and prepaid expenses			2,529				2,417
Total current assets			114,579				86,125
Non-current assets
Long-term prepaid expenses			1,233				1,899
Severance pay fund			2,977				2,794
Operating lease right to use asset			1,329				1,826
Property and equipment, net			1,216				1,532
Total non-current assets			6,755				8,051
Total assets			121,334				94,176
LIABILITIES AND SHAREHOLDERS EQUITY
Current liabilities
Other accounts payable, accrued expenses and trade payables			14,485				10,981
Short-term deferred revenues			11,149				-
Current maturity of operating lease liability			632				613
Short-term deferred participation in R&D expenses			-				325
Total current liabilities			26,266				11,919
Non-current liabilities
Long-term deferred revenues			25,392				-
Long-term operating lease liability			719				1,312
Accrued severance pay			3,398				3,265
Total non-current liabilities			29,509				4,577
Total shareholders' equity			65,559				77,680
Total liabilities and shareholders' equity			121,344				94,176

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