Exhibit 99.2
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F-2 - F-3 | |
F-4 | |
F-5 | |
F-6 | |
F-7 - F-14 |
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June 30,
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December 31,
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2022
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2021
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Unaudited
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||||||||
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ASSETS
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||||||||
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CURRENT ASSETS:
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||||||||
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Cash and cash equivalents
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$
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$
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Restricted cash
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||||||
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Short-term bank deposits
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Other accounts receivable and prepaid expenses
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Total current assets
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NON-CURRENT ASSETS:
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Long-term prepaid expenses
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Severance pay fund
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Operating lease right to use asset
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Property and equipment, net
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Total non-current assets
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Total assets
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$
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$
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|
||||
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June 30,
|
December 31,
|
|||||||
|
2022
|
2021
|
|||||||
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Unaudited
|
||||||||
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LIABILITIES AND SHAREHOLDERS' EQUITY
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||||||||
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CURRENT LIABILITIES:
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||||||||
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Trade payables
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$
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$
|
|
||||
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Short-term deferred participation in R&D expenses
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||||||
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Current maturity of operating lease liability
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Other accounts payable and accrued expenses
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Total current liabilities
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NON- CURRENT LIABILITIES:
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||||||||
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Long-term deferred participation in R&D expenses
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||||||
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Long term operating lease liability
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||||||
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Accrued severance pay
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||||||
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Total non-current liabilities
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||||||
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COMMITMENTS AND CONTINGENT LIABILITIES (NOTE 4)
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||||||||
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SHAREHOLDERS' EQUITY:
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||||||||
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Share capital:
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||||||||
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Ordinary shares of NIS
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|
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||||||
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Additional paid-in capital
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||||||
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Accumulated deficit
|
(
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)
|
(
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)
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||||
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Total shareholders' equity
|
|
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||||||
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Total liabilities and shareholders' equity
|
$
|
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$
|
|
||||
|
Six months ended
June 30,
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||||||||
|
2022
|
2021
|
|||||||
|
Unaudited
|
||||||||
|
Operating expenses:
|
||||||||
|
Research and development expenses, net
|
$
|
|
$
|
|
||||
|
Marketing and business development expenses
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||||||
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General and administrative expenses
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||||||
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Total operating expenses
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Financial and other income, net
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||||||
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Loss before taxes on income
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||||||
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Taxes on income
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||||||
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Net loss
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$
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$
|
|
||||
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Basic and diluted net loss per share
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$
|
|
$
|
|
||||
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Total comprehensive loss
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$
|
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$
|
|
||||
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Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
|
|
||||||
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Ordinary shares
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Additional paid-in
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Accumulated
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Total shareholders'
|
|||||||||||||||||
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Number
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Amount
|
capital
|
deficit
|
equity
|
||||||||||||||||
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Balance as of January 1, 2021
|
|
$
|
|
$
|
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$
|
(
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)
|
$
|
|
||||||||||
|
Options exercised
|
|
|
|
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|||||||||||||||
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Warrants exercised
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|||||||||||||||
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Issuance of ESPP shares
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|||||||||||||||
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Stock-based compensation issued to employees, directors and non-employees
|
-
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|||||||||||||||
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Net loss
|
-
|
|
|
(
|
)
|
(
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)
|
|||||||||||||
|
Balance as of June 30, 2021 (unaudited)
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
Balance as of January 1, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
Options exercised
|
|
|
|
|
|
|||||||||||||||
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Issuance of ESPP shares
|
|
|
|
|
|
|||||||||||||||
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Stock-based compensation issued to employees, directors and non-employees
|
-
|
|
|
|
|
|||||||||||||||
|
Net loss
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Balance as of June 30, 2022 (unaudited)
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
Six months ended
June 30,
|
||||||||
|
2022
|
2021
|
|||||||
|
Unaudited
|
||||||||
|
Cash flows from operating activities:
|
||||||||
|
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
|
Adjustments required to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Stock-based compensation
|
|
|
||||||
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Depreciation
|
|
|
||||||
|
Decrease in severance pay, net
|
(
|
)
|
(
|
)
|
||||
|
Gain from property and equipment disposal
|
|
(
|
)
|
|||||
|
Decrease in operating lease right of use asset
|
|
|
||||||
|
Decrease (increase) in interest receivables from short-term bank deposits
|
(
|
)
|
|
|||||
|
Decrease in trade receivables
|
|
|
||||||
|
Decrease in other accounts receivable and prepaid expenses
|
|
|
||||||
|
Decrease (increase) in long-term prepaid expenses
|
|
(
|
)
|
|||||
|
Increase (decrease) in trade payables
|
(
|
)
|
|
|||||
|
Increase in other accounts payable and accrued expenses
|
|
|
||||||
|
Decrease in operating lease liability
|
(
|
)
|
(
|
)
|
||||
|
Decrease in deferred participation in R&D expenses
|
(
|
)
|
(
|
)
|
||||
|
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
|
Cash flows from investing activities:
|
||||||||
|
Proceeds from maturity of short-term bank deposits
|
|
|
||||||
|
Investment in short-term bank deposits
|
(
|
)
|
(
|
)
|
||||
|
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
|
Proceeds from sales of property and equipment
|
|
|
||||||
|
Net cash provided by investing activities
|
|
|
||||||
|
Cash flows from financing activities:
|
||||||||
|
Proceeds from issuance of ordinary shares, net
|
|
|
||||||
|
Proceeds from exercise of warrants
|
|
|
||||||
|
Proceeds from exercise of options
|
|
|
||||||
|
Net cash provided by financing activities
|
|
|
||||||
|
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
|
$
|
(
|
)
|
$
|
|
|||
|
Receivables on account of shares
|
$
|
|
$
|
|
||||
| NOTE 1:- |
GENERAL |
| a. |
Compugen (the “Company”) is a clinical-stage, therapeutic discovery and development company utilizing its proprietary computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. The Company’s innovative immuno-oncology pipeline consists of four clinical stage programs, targeting immune checkpoints the Company discovered computationally, COM701, COM902, bapotulimab (formerly known as BAY 1905254) and AZD2936. The Company’s therapeutic pipeline also includes early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, including myeloid targets. The innovative immuno-oncology pipeline, the strategic collaborations and the Company’s computational discovery engine serves as the three key corporate building blocks.
|
| b. |
The Company is headquartered in Holon, Israel. Its clinical development activities operate from its U.S. subsidiary in South San Francisco, California.
|
| c. |
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.
|
| d. |
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 will be solely responsible for all research, development and commercial activities under the agreement. Compugen received a $
|
F - 7
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 1:- |
GENERAL (Cont.) |
| e. |
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, Compugen is responsible for and will continue sponsoring the ongoing two-part Phase 1 trial, which includes the evaluation of the combination of COM701 and Opdivo®. The collaboration was also designed to address potential future combinations, including trials sponsored by Bristol-Myers Squibb to investigate combined inhibition of checkpoint mechanisms, such as PVRIG and TIGIT. Bristol-Myers Squibb and Compugen each supplies its own compound(s) for the studies, and otherwise each party is responsible for all costs associated with the study that it is conducting.
In conjunction with the signing of the Master Clinical Agreement, Bristol-Myers Squibb made a $ |
|
|
On February 14, 2020, the Master Clinical Agreement with Bristol-Myers Squibb was amended to include a triple combination clinical trial to evaluate the safety, tolerability and antitumor activity of COM701 in combination with Opdivo® (nivolumab), and Bristol-Myers Squibb’s antibody targeting TIGIT known as BMS-986207, in patients with advanced solid tumors, instead of the planned expansion of the combined therapy study designed to evaluate the dual combination of COM701 and Opdivo®.
Pursuant to the Master Clinical Agreement, as amended, the Company sponsors the two-part Phase 1/2 trial, which includes the evaluation of the triple combination of COM701, Opdivo® and BMS-986207, in patients with advanced solid tumors where Bristol-Myers Squibb provides Opdivo® and BMS-986207 at no cost to the Company.
As part of the said amendment, it was agreed that the Company will complete the dose escalation arm of the dual combination of COM701 with Opdivo® under the Phase 1 study and will not continue the expansion cohorts of the dual combination.
On February 19, 2021, the Master Clinical Agreement was further amended to include an expansion of the Phase 1 combination study designed to evaluate the dual combination of COM701 and Opdivo® in patients with advanced solid tumors, where Compugen is responsible for and sponsors the expansion cohort and Bristol-Myers Squibb provides Opdivo® at no cost to us for this study.
On November 10, 2021, the Agreement was further amended to establish a joint steering committee (alongside the existing joint development committee which acts at an operational level) to facilitate strategic oversight and guidance for the programs run under the collaboration.
In conjunction with the signing of the amendment to the Agreement in November 2021, Bristol-Myers Squibb made a $
|
F - 8
NOTES TO 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, 2021. The significant accounting policies applied in the annual financial statements of the Company as of December 31, 2021, are applied consistently in these interim consolidated financial statements. |
| NOTE 3:- |
UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
|
| NOTE 4:- |
COMMITMENTS AND CONTINGENCIES
|
| a. |
The Company provided bank guarantees in the amount of $
|
| b. |
The Company received in the past grants from 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, 2022 and 2021, the Company did not incur Contingent Fees.
|
F - 9
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 4:- |
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, 2022 and 2021 the Company incurred milestone payments in the amounts of $
|
| NOTE 5:- |
SHAREHOLDERS' EQUITY
|
| a. |
Issuance of Shares:
|
F - 10
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 5:- |
SHAREHOLDERS’ EQUITY (Cont.)
|
F - 11
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 5:- |
SHAREHOLDERS’ EQUITY (Cont.)
|
| b. |
Stock option plan:
|
|
Six months ended
June 30,
|
||||||||
|
2022
|
2021
|
|||||||
|
Unaudited
|
||||||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Risk-free interest rate
|
|
%
|
|
%
|
||||
|
Dividend yield
|
|
%
|
|
%
|
||||
|
Expected life (years)
|
|
|
||||||
| c. |
Employee Stock Purchase Plan:
|
F - 12
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 5:- |
SHAREHOLDERS’ EQUITY (Cont.)
|
|
Six months ended
June 30,
|
||||||||
|
2022
|
2021
|
|||||||
|
Unaudited
|
||||||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Risk-free interest rate
|
|
%
|
|
%
|
||||
|
Dividend yield
|
|
%
|
|
%
|
||||
|
Expected life (years)
|
|
|
||||||
| NOTE 6:- |
FINANCIAL AND OTHER INCOME, NET |
|
Six months ended
June 30,
|
||||||||
|
2022
|
2021
|
|||||||
|
Unaudited
|
||||||||
|
Interest income
|
$
|
|
$
|
|
||||
|
Exchange rate differences and other
|
|
|
||||||
|
Financial and other income, net
|
$
|
|
$
|
|
||||
| NOTE 7:- |
RELATED PARTY BALANCES AND TRANSACTIONS |
|
June 30,
2022
|
December 31,
2021 |
|||||||
|
Unaudited
|
||||||||
|
Trade and other payables (a)
|
$
|
|
$
|
|
||||
|
Six months ended
June 30,
|
||||||||
|
2022
|
2021
|
|||||||
|
Unaudited
|
||||||||
|
Amounts charged to:
|
||||||||
|
Research and development expenses (a)
|
$
|
|
$
|
|
||||
| (a) |
|
F - 13
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 8:- |
SUBSEQUENT EVENTS
|