Page | |
F-2 - F-3 | |
F-4 | |
F-5 | |
F-6 | |
F-7 - F-18 |
June 30,
|
December 31,
|
|||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Restricted cash
|
|
|
||||||
Short-term bank deposits
|
|
|
||||||
Restricted short-term bank deposit
|
|
|
||||||
Investment in marketable securities
|
|
|
||||||
Trade receivables
|
|
|
||||||
Other accounts receivable and prepaid expenses
|
|
|
||||||
Total current assets
|
|
|
||||||
NON-CURRENT ASSETS:
|
||||||||
Long-term prepaid expenses
|
|
|
||||||
Severance pay fund
|
|
|
||||||
Operating lease right to use asset
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Total non-current assets
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
June 30,
|
December 31,
|
|||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
LIABILITIES AND SHAREHOLDERS' EQUITY
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Trade payables
|
$
|
|
$
|
|
||||
Short-term deferred revenues
|
|
|
||||||
Current maturity of operating lease liability
|
|
|
||||||
Accrued expenses
|
|
|
||||||
Other accounts payable and accrued expenses
|
|
|
||||||
Total current liabilities
|
|
|
||||||
NON- CURRENT LIABILITIES:
|
||||||||
Long-term deferred revenues
|
|
|
||||||
Long term operating lease liability
|
|
|
||||||
Accrued severance pay
|
|
|
||||||
Total non-current liabilities
|
|
|
||||||
COMMITMENTS AND CONTINGENT LIABILITIES (NOTE 6) |
||||||||
SHAREHOLDERS' EQUITY:
|
||||||||
Share capital:
|
||||||||
Ordinary shares of NIS
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated other comprehensive income (loss)
|
(
|
)
|
|
|||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total shareholders' equity
|
|
|
||||||
Total liabilities and shareholders' equity
|
$
|
|
$
|
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Revenues
|
$
|
|
$
|
|
||||
Cost of revenues
|
|
|
||||||
Gross profit
|
|
|
||||||
Operating expenses:
|
||||||||
Research and development expenses
|
|
|
||||||
Marketing and business development expenses
|
|
|
||||||
General and administrative expenses
|
|
|
||||||
Total operating expenses
|
|
|
||||||
Operating loss
|
(
|
)
|
(
|
)
|
||||
Financial income, net
|
|
|
||||||
Loss before taxes on income
|
(
|
)
|
(
|
)
|
||||
Tax benefit (expense)
|
(
|
)
|
|
|||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Other comprehensive loss:
|
||||||||
Change in unrealized gains (losses) on marketable securities:
|
||||||||
Unrealized gains (losses) arising during the period, net
|
$
|
(
|
)
|
$
|
|
|||
Total comprehensive loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Basic and diluted net loss per share
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
|
|
Ordinary shares
|
Additional paid-in
|
Accumulated
other
comprehensive
|
Accumulated
|
Total shareholders’
|
||||||||||||||||||||
Number
|
Amount
|
capital
|
income
|
deficit
|
equity
|
|||||||||||||||||||
Balance as of January 1, 2023
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||
Issuance of shares, net
|
|
|
|
|
|
|||||||||||||||||||
Stock-based compensation issued to employees, directors and non-employees
|
-
|
|
|
|
|
|||||||||||||||||||
Other comprehensive income (loss) from marketable securities, net
|
-
|
|
|
|
|
|
||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Balance as of June 30, 2023 (unaudited)
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||
Balance as of January 1, 2024
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||
Options exercised
|
|
|
|
|
|
|
||||||||||||||||||
Issuance of shares, net
|
|
|
|
|
|
|
||||||||||||||||||
Stock-based compensation issued to employees, directors and non-employees
|
-
|
|
|
|
|
|
||||||||||||||||||
Other comprehensive loss from marketable securities, net
|
-
|
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Balance as of June 30, 2024 (unaudited)
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments required to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation
|
|
|
||||||
Depreciation
|
|
|
||||||
Amortization of discount on marketable securities
|
(
|
)
|
(
|
)
|
||||
Realized gain on sale of marketable securities, net
|
|
(
|
)
|
|||||
Increase in severance pay, net
|
|
|
||||||
Exchange rate differences loss (gain) on cash balances
|
|
|
||||||
Decrease in operating lease right of use asset
|
|
|
||||||
Increase in interest receivables and exchange differences on short-term bank deposits
|
(
|
)
|
(
|
)
|
||||
Decrease in trade receivables
|
|
|
||||||
Increase in other accounts receivable and prepaid expenses
|
(
|
)
|
(
|
)
|
||||
Decrease (increase) in long-term prepaid expenses
|
|
(
|
)
|
|||||
Decrease in trade payables
|
(
|
)
|
(
|
)
|
||||
Decrease in other accounts payable and accrued expenses
|
(
|
)
|
(
|
)
|
||||
Decrease in operating lease liability
|
(
|
)
|
(
|
)
|
||||
Decrease in deferred revenues
|
(
|
)
|
|
|||||
Decrease in deferred participation in R&D expenses
|
|
(
|
)
|
|||||
Net cash provided by (used in) operating activities
|
|
(
|
)
|
|||||
Cash flows from investing activities:
|
||||||||
Proceeds from maturity of short-term bank deposits
|
|
|
||||||
Investment in short-term bank deposits
|
(
|
)
|
(
|
)
|
||||
Proceeds from maturity of marketable securities
|
|
|
||||||
Investment in marketable securities
|
(
|
)
|
(
|
)
|
||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash provided by (used in) investing activities
|
(
|
)
|
|
|||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of ordinary shares, net
|
|
|
||||||
Proceeds from exercise of options
|
|
|
||||||
Net cash provided by financing activities
|
|
|
||||||
Effect of exchange rate changes on cash
|
(
|
)
|
(
|
)
|
||||
Increase (decrease) in cash, cash equivalents and restricted cash
|
(
|
)
|
|
|||||
Cash, cash equivalents and restricted cash at the beginning of the period
|
|
|
||||||
Cash, cash equivalents and restricted cash at the end of the period
|
$
|
|
$
|
|
||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||
Purchase of property and equipment
|
$
|
|
$
|
(
|
)
|
|||
Right-of-use asset obtained in exchange for operating lease liability
|
$
|
|
$
|
|
||||
Issuance expenses
|
$
|
|
$
|
|
NOTE 1:- |
GENERAL
|
a. |
Compugen Ltd. (the “Company”) is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify novel drug targets and new biological pathways to develop therapeutics in the field of cancer immunotherapy. The Company’s innovative immuno-oncology pipeline consists of three clinical stage programs, COM701, COM902 and rilvegostomig, targeting immune checkpoints the Company discovered computationally. Two programs that are pursued internally, COM701, a potential first-in-class anti-PVRIG antibody, and COM902, a potential best-in-class therapeutic anti-TIGIT antibody, are in Phase 1 clinical trials and have been evaluated for the treatment of solid tumors as a monotherapy and in combination of dual (PVRIG/PD-1, PVRIG/TIGIT) and triple (PVRIG/PD-1/TIGIT) blockade. Rilvegostomig, a novel anti PD-1/TIGIT bispecific antibody with a TIGIT specific component that is derived from the Company’s COM902 antibody, is being developed by AstraZeneca pursuant to an exclusive license agreement between the Company and AstraZeneca and is being evaluated in multiple clinical trials, including in Phase 3 clinical trials. The Company’s therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance. The Company’s most advanced early-stage program, COM503, was licensed to Gilead Sciences, Inc. (“Gilead”) in December 2023, see also Note 12. 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. The Company’s business model is to selectively enter into collaborations for our novel targets and drug product candidates at various stages of research and development under various revenue-sharing arrangements.
|
b. |
The Company is headquartered in Holon, Israel.
|
c. |
The Company has incurred losses in the amount of $
|
d. |
On August 5, 2013, the Company entered into a Research and Development Collaboration and License Agreement (“Bayer Agreement”) with Bayer Pharma AG (“Bayer”) for the research, development, and commercialization of antibody-based therapeutics against two novel Compugen-discovered immune checkpoint regulators.
|
|
F - 7
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1:- |
GENERAL (Cont.)
|
e. |
Effective March 30, 2018, the Company entered into an exclusive license agreement with MedImmune Limited, the global biologics research and development arm of AstraZeneca (“AstraZeneca”) to enable the development of bi-specific and multi-specific immuno-oncology antibody products. Under the terms of the agreement, Compugen provided an exclusive license to AstraZeneca for the development of bi-specific and multi-specific antibody products derived from COM902. AstraZeneca has the right to create multiple products under this license and is solely responsible for all research, development and commercial activities under the agreement. In connection with such license agreement, AstraZeneca developed rilvegostomig, a novel PD-/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902. Rilvegostomig entered the clinic in September 2021, initiated a Phase 3 with first patient dosing in the first indication Phase 3 study in December 2023, and first patient dosing in the second indication Phase 3 study in May 2024. Compugen received a $
|
f. |
On October 10, 2018, the Company entered into a Master Clinical Trial Collaboration Agreement (the “Master Clinical Agreement”) with Bristol Myers Squibb Company (“Bristol Myers Squibb”) to evaluate the safety and tolerability of Compugen’s COM701 in combination with Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo® (nivolumab), in patients with advanced solid tumors.
Pursuant to the Master Clinical Agreement, as amended from time to time, Compugen sponsored the trials, which included the evaluation of the combination of COM701 and Opdivo® ± Bristol Myers Squibb investigational anti-TIGIT, BMS-986207. Bristol Myers Squibb and Compugen each supplies its own compound(s) for the studies.
In conjunction with the signing of the Master Clinical Agreement, Bristol Myers Squibb made a $ Among several amendments to the Master Clinical Agreement, on November 10, 2021, the agreement was further amended and in conjunction with the signing of the amendment to the Agreement, Bristol Myers Squibb made a $
On August 3, 2022, the Company and Bristol Myers Squibb entered into a letter agreement pursuant to which the Master Clinical Agreement, as amended from time to time, was terminated as of such date. |
F - 8
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1:- |
GENERAL (Cont.)
|
g. |
On December 18, 2023, the Company entered into an exclusive license agreement (the “License Agreement”) with Gilead Sciences, Inc. (“Gilead”), pursuant to which the Company granted Gilead an exclusive license under the Company’s pre-clinical antibody program against IL-18 binding protein and all intellectual property rights subsisting therein, to use, research, develop, manufacture and commercialize products, including the Company’s COM503 product candidate (“COM503 License”), and additional products that may be so developed by Gilead (together with COM503, the “Licensed Products”).
Pursuant to the License Agreement, Gilead paid the Company a one-time, upfront payment of $ The Company will be responsible for conducting a Phase 1 clinical trial for COM503, including handling the regulatory matters in connection therewith, and will bear the costs of such trial (including the COM503 drug supply), with Gilead providing at no cost an anti- PD-1/PD-L1 antibody for such trial. In certain circumstances, Gilead may assume the role of conducting the Phase 1 clinical trial. Upon completion of the Phase 1 clinical trial for COM503, the Company will initiate the transfer of development activities related to COM503 to Gilead, following which, Gilead will have sole responsibility to develop and commercialize the Licensed Products. During the term of the License Agreement, the Company is prohibited from researching, developing, making, and commercializing any compounds, molecules, products or treatment methods that are directed to IL-18 or any companion diagnostics for an IL-18 product. Unless terminated early by a party pursuant to its terms, the License Agreement will continue in effect on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration of the last royalty term in such country. Gilead withheld at source The License Agreement contains customary representations, warranties, covenants, and terms governing the prosecution and enforcement of certain intellectual property and issues related to technology transfer, manufacturing transfer, provisions with respect to establishment of joint steering committee and its governance covenants with respect change of control and others. |
F - 9
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 2:- |
SIGNIFICANT ACCOUNTING POLICIES
|
These unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes for the year ended December 31, 2023. The significant accounting policies applied in the annual consolidated financial statements of the Company as of December 31, 2023, are applied consistently in these interim consolidated financial statements.
Recently Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09.
|
NOTE 3:- |
UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
|
F - 10
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 4:- |
MARKETABLE SECURITIES
|
Amortized cost
|
Gross unrealized gains
|
Gross unrealized losses
|
Fair value
|
|||||||||||||
As of June 30, 2024:
|
||||||||||||||||
Available-for-sale – matures within one year:
|
||||||||||||||||
Governmental bonds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
As of December 31, 2023:
|
||||||||||||||||
Available-for-sale – matures within one year:
|
||||||||||||||||
Governmental bonds
|
$
|
|
$
|
|
$
|
|
$
|
|
* |
Represents an amount lower than $1
|
Less than 12 months
|
12 months or greater
|
|||||||||||||||
Fair value
|
Gross unrealized loss
|
Fair value
|
Gross
unrealized loss
|
|||||||||||||
As of June 30, 2024
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
As of December 31, 2023
|
$
|
|
$
|
|
$
|
|
$
|
|
* |
Represents an amount lower than $1.
|
F - 11
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 5:- |
FAIR VALUE MEASUREMENTS
|
Fair value measurements
as of
|
||||||||||||
Description
|
Fair Value
Hierarchy
|
June 30,
2024
|
June 30,
2023
|
|||||||||
|
Unaudited |
Unaudited |
||||||||||
Assets:
|
||||||||||||
Short-term investments:
|
||||||||||||
U.S. government bonds
|
Level 2
|
$
|
|
$
|
|
NOTE 6:- |
COMMITMENTS AND CONTINGENCIES
|
a. |
The Company provided bank guarantees in the amount of $
|
b. |
Under the office of the Israel Innovation Authority of the Israeli Ministry of Industry, Trade and Labor, formerly known as the Office of the Chief Scientist (“IIA”), the Company is not obligated to repay any amounts received from the IIA if it does not generate any income from products which incorporate technologies which were funded by such research program(s).
|
c. |
On June 25, 2012, the Company entered into an Antibodies Discovery Collaboration Agreement (the “Antibodies Discovery Agreement”) with a U.S. antibody technology company (“mAb Technology Company”), providing an established source for fully human mAbs. Under the Antibodies Discovery Agreement, the mAb Technology Company is entitled to certain royalties that could be eliminated upon payment of certain one-time fees (all milestone and royalties payments referred together as “Contingent Fees”). For the six-month periods ended June 30, 2024 and 2023, the Company did not incur Contingent Fees.
|
F - 12
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 6:- |
COMMITMENTS AND CONTINGENCIES (Cont.)
|
d. |
On
|
e. |
Effective as of January 5, 2018, the Company entered into a Commercial License Agreement (“CLA”) with a European cell line development company. Under the agreement the Company is required to pay an annual maintenance fee, certain amounts upon the occurrence of specified milestones events, and
|
f. |
Effective as of October 28, 2020, the Company entered into a collaboration agreement with a U.S. antibody discovery and optimization company for generation and optimization of therapeutic antibodies for the Company. Under the agreement, the Company is required to pay service fees per services performed and certain amounts upon the occurrence of specified milestones events, and single-digit percent royalties on annual net sales with respect to each product sold that comprises or contains one or more antibodies so generated or optimized. The royalty rate is dependent upon the product type and any third-party contribution. For the six-month periods ended June 30, 2024 and 2023 the Company did not incur milestone payments.
|
NOTE 7:- |
SHAREHOLDERS' EQUITY
|
a. |
Issuance of Shares:
|
F - 13
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 7:- |
SHAREHOLDERS’ EQUITY (Cont.)
|
F - 14
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 7:- |
SHAREHOLDERS’ EQUITY (Cont.)
|
b. |
Share option plan:
|
Number of options
|
Weighted average exercise
price
|
Weighted average remaining contractual life
|
Aggregate intrinsic
value
|
|||||||||||||
$
|
Years
|
$
|
||||||||||||||
Options outstanding at beginning of year
|
|
|
|
|
||||||||||||
Options granted
|
|
|
||||||||||||||
Options exercised
|
(
|
)
|
|
|||||||||||||
Options forfeited
|
(
|
)
|
|
|||||||||||||
Options expired
|
(
|
)
|
|
|||||||||||||
Options outstanding at end of year
|
|
|
|
|
||||||||||||
Exercisable at end of year
|
|
|
|
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Volatility
|
|
%
|
|
%
|
||||
Risk-free interest rate
|
|
%
|
|
%
|
||||
Dividend yield
|
|
%
|
|
%
|
||||
Expected life (years)
|
|
|
F - 15
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 7:- |
SHAREHOLDERS’ EQUITY (Cont.)
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Research and development expenses
|
$
|
|
$
|
|
||||
Marketing and business development expenses
|
|
(
|
)
|
|||||
General and administrative expenses
|
|
|
||||||
Financial and other income, net
|
$
|
|
$
|
|
NOTE 8:- |
FINANCIAL INCOME, NET
|
|
Six months ended
June 30,
|
|||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Interest income
|
$
|
|
$
|
|
||||
Amortization of discount on marketable securities, net
|
|
|
||||||
Exchange rate differences and other
|
(
|
)
|
|
|||||
Financial and other income, net
|
$
|
|
$
|
|
F - 16
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 9:- |
REVENUES
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Revenue from sales to customers:
|
||||||||
United States
|
$
|
|
$
|
|
||||
Europe
|
|
|
||||||
Total revenues
|
$
|
|
$
|
|
NOTE 10:- |
RELATED PARTY BALANCES AND TRANSACTIONS
|
June 30,
2024
|
December 31,
2023
|
|||||||
Unaudited
|
||||||||
Trade and other payables (a)
|
$
|
|
$
|
|
F - 17
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 10:- |
RELATED PARTY BALANCES AND TRANSACTIONS (Cont.)
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Amounts charged to:
|
||||||||
Research and development expenses (a)
|
$
|
|
$
|
|
(a) |
|
NOTE 11:- |
LOSSES PER SHARE
|
Six months ended
June 30,
|
||||||||
2024
|
2023
|
|||||||
Unaudited
|
||||||||
Numerator:
|
||||||||
Net loss for basic and diluted loss per share
|
$
|
|
$
|
|
||||
Denominator:
|
||||||||
Weighted average number of ordinary shares
|
||||||||
used in computing basic and diluted net loss per share
|
|
|
||||||
Basic and diluted loss per ordinary share
|
$
|
(
|
)
|
$
|
(
|
)
|
NOTE 12:- |
SUBSEQUENT EVENTS
|