|
26 Harokmim Street
|
Holon 5885849, Israel
|
(Address of principal executive office)
|
Exhibit
|
|
Number
|
Description of Exhibit
|
|
COMPUGEN LTD.
|
||
|
|||
Date: February 20, 2020
|
By:
|
/s/ Eran Ben Dor
|
|
|
|
Eran Ben Dor
General Counsel
|
|
• |
Announced plans to expand the Bristol-Myers Squibb collaboration with a Phase 1/2 triple combination study to evaluate COM701 in combination with Opdivo® and
BMS-986207, Bristol-Myers Squibb’s TIGIT inhibitor. The study is expected to begin in 2H 2020.
|
• |
Presented initial clinical findings from ongoing Phase 1 trial of COM701 in patients with advanced solid tumors at the annual meeting of the Society for Immunotherapy of Cancer (SITC 2019)
|
o |
COM701 was well-tolerated with no dose-limiting toxicities observed.
|
o |
Initial signals of anti-tumor activity were observed in the heavily pretreated, all-comers patient population enrolled in the study.
|
• |
Presented trial-in-progress data at ASCO-SITC Clinical Immuno-Oncology Symposium from the Phase 1 study evaluating COM701 as a monotherapy and in combination with Opdivo® (nivolumab)
|
o |
Enrollment in the eighth dose level patient cohort of 20mg/kg at Q4 weekly dosing schedule is ongoing in the monotherapy dose escalation study.
|
o |
Enrollment in the fourth dose level patient cohort at Q4 weekly dosing schedule in the combination dose escalation study of COM701 with Opdivo® has
been completed. No dose-limiting toxicities have been reported.
|
• |
Announced Investigational New Drug application clearance by the U.S. Food and Drug Administration for COM902. A Phase 1 trial in patients with advanced malignancies is expected to begin in early 2020.
|
• |
Presented new preclinical data on COM902 at SITC 2019, supporting its potential best-in-class binding affinity and clinical use as a cancer immunotherapy treatment in combination with COM701 and PD-1 inhibitors.
|
• |
Strengthened intellectual property portfolio related to COM701 and COM902
|
o |
Granted U.S. Patent No. 10,213,505, covering the composition of COM701 and backup antibodies.
|
o |
Granted U.S. Patent No. 10,227,408, covering the composition of an anti-PVRIG antibody having complementarity-determining regions (CDRs) of COM701 and backup antibodies.
|
o |
Granted U.S. Patent No. 10,351,625, covering the method of use of COM701 or backup antibody in combination with anti-PD-1 antibodies.
|
o |
Granted EPO Patent No. EP3347379, covering the composition of matter of COM902, alone or with second antibody that binds to a human checkpoint receptor protein, including PD-1 and its use.
|
o |
Granted EPO Patent No. EP3258951, covering the use of any anti-PVRIG antibody that activates T cells and/or NK cells, in the treatment of cancer.
|
o |
Granted U.S. Patent No. 10,550,173, covering methods of screening for anti-PVRIG antibodies that inhibit the binding of PVRIG with PVRL2.
|
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,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Unaudited
|
Unaudited
|
|||||||||||||||
Revenues
|
-
|
-
|
-
|
17,800
|
||||||||||||
Cost of revenues
|
-
|
-
|
-
|
1,034
|
||||||||||||
Gross profit
|
-
|
-
|
-
|
16,766
|
||||||||||||
Operating expenses
|
||||||||||||||||
Research and development expenses
|
4,314
|
7,464
|
19,816
|
30,318
|
||||||||||||
Marketing and business development expenses
|
159
|
245
|
651
|
1,634
|
||||||||||||
General and administrative expenses
|
2,220
|
1,967
|
8,412
|
8,041
|
||||||||||||
Total operating expenses
|
6,693
|
9,676
|
28,879
|
39,993
|
||||||||||||
Operating loss
|
(6,693
|
)
|
(9,676
|
)
|
(28,879
|
)
|
(23,227
|
)
|
||||||||
Financial and other income, net
|
232
|
277
|
820
|
628
|
||||||||||||
Loss before taxes on income
|
(6,461
|
)
|
(9,399
|
)
|
(28,059
|
)
|
(22,599
|
)
|
||||||||
Taxes on income
|
-
|
-
|
722
|
-
|
||||||||||||
Net loss
|
(6,461
|
)
|
(9,399
|
)
|
(27,337
|
)
|
(22,599
|
)
|
||||||||
Basic and diluted net loss per ordinary share
|
(0.10
|
)
|
(0.16
|
)
|
(0.43
|
)
|
(0.41
|
)
|
||||||||
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
67,644,946
|
59,542,963
|
63,636,673
|
55,277,428
|
COMPUGEN LTD.
|
CONDENSED CONSOLIDATED BALANCE SHEETS DATA
|
(U.S. dollars, in thousands)
|
December 31,
|
December 31,
|
|||||||
2019
|
2018
|
|||||||
ASSETS
|
||||||||
|
||||||||
Current assets
|
||||||||
Cash, cash equivalents, short-term bank deposits and restricted cash
|
43,879
|
45,675
|
||||||
Other accounts receivable and prepaid expenses
|
1,121
|
903
|
||||||
Total current assets
|
45,000
|
46,578
|
||||||
Non-current assets
|
||||||||
Long-term prepaid expenses
|
693
|
776
|
||||||
Severance pay fund
|
2,485
|
2,454
|
||||||
Operating lease right to use asset
|
3,247
|
-
|
||||||
Property and equipment, net
|
2,338
|
3,372
|
||||||
Total non-current assets
|
8,763
|
6,602
|
||||||
Total assets
|
53,763
|
53,180
|
||||||
LIABILITIES AND SHAREHOLDERS EQUITY
|
||||||||
Current liabilities
|
||||||||
Other accounts payable, accrued expenses and trade payables
|
5,445
|
8,900
|
||||||
Current maturity of operating lease liability
|
600
|
-
|
||||||
Short-term deferred participation in R&D expenses
|
774
|
1,089
|
||||||
Total current liabilities
|
6,819
|
9,989
|
||||||
Non-current liabilities
|
||||||||
Long-term deferred participation in R&D expenses
|
2,691
|
3,003
|
||||||
Long-term operating lease liability
|
2,978
|
-
|
||||||
Accrued severance pay
|
2,954
|
2,945
|
||||||
Total non-current liabilities
|
8,623
|
5,948
|
||||||
|
||||||||
Total shareholders' equity
|
38,321
|
37,243
|
||||||
Total liabilities and shareholders' equity
|
53,763
|
53,180
|