
| • |
Announced FDA clearance of IND application for Phase 1/2 triple combination study of COM701 with Bristol Myers Squibb’s Opdivo® (nivolumab) and TIGIT inhibitor.
|
| o |
Designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1.
|
| o |
Complementary to the Company’s clinical strategy, the study will accelerate clinical evaluation of Compugen’s DNAM axis hypothesis and biomarker-driven approach in advanced solid tumors to broaden the patient population responsive to
cancer immunotherapy.
|
| o |
Initiation of triple combination study remains on-track to begin during 2H 2020.
|
| • |
Dosed the first patient in the monotherapy expansion cohort in the ongoing Phase 1 clinical trial of COM701.
|
| • |
Presented updated data from the dose escalation arms of the Phase 1 trial of COM701 in patients with advanced solid tumors at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I (highlights):
|
| o |
COM701 was well-tolerated through 20 mg/kg IV Q4 weeks as a monotherapy and 10 mg/kg IV Q4 weeks in combination with Opdivo® (480 mg IV Q4 weeks) with no dose-limiting toxicities reported.
|
| o |
Encouraging disease control rates of 69% (11/16) for monotherapy and 75% (9/12) for the combination arm.
|
| ◾ |
50% of patients (6/12) in the combination arm remain on study, some with continued responses observed beyond 200 days of treatment.
|
| o |
Durable responses of stable disease for over six months in six of 28 patients (21%) across treatment arms.
|
| o |
Two confirmed partial responses, one from the monotherapy arm (microsatellite stable primary peritoneal cancer) and one from the combination arm (microsatellite stable colorectal cancer); both patients remained on treatment at the
presentation date.
|
| • |
Dosed the first patient in a Phase 1 dose escalation clinical trial of COM902, an immuno-oncology therapeutic antibody targeting TIGIT, in patients with advanced malignancies.
|
| • |
Granted EPO Patent No. 3295951, covering the composition of matter for COM701 and backup antibodies including any anti-PVRIG antibody having the binding fragments of COM701 or backup antibodies for the treatment of cancer.
|
| • |
Published a peer-reviewed paper in Cancer Immunology Research in collaboration with Bayer, demonstrating in vitro T cell activation and in vivo anti-tumor activity of BAY 1905254, a first-in-class immuno-oncology antibody targeting ILDR2. ILDR2 is a novel immune checkpoint discovered computationally by Compugen which is currently being
evaluated by Bayer in a Phase 1 study as monotherapy and in combination with Keytruda®.
|
|
COMPUGEN LTD.
|
||||||||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
||||||||||||||||
|
(U.S. dollars in thousands, except for share and per share amounts)
|
||||||||||||||||
|
Three Months Ended
|
Six Months Ended,
|
|||||||||||||||
|
June 30,
|
June 30,
|
|||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
|||||||||||||
|
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
|
Operating expenses
|
||||||||||||||||
|
Research and development expenses
|
4,447
|
4,870
|
9,159
|
11,205
|
||||||||||||
|
Marketing and business development expenses
|
204
|
175
|
414
|
388
|
||||||||||||
|
General and administrative expenses
|
2,131
|
1,962
|
4,607
|
3,928
|
||||||||||||
|
Total operating expenses
|
6,782
|
7,007
|
14,180
|
15,521
|
||||||||||||
|
Financial and other income, net
|
536
|
308
|
806
|
414
|
||||||||||||
|
Loss before taxes on income
|
(6,246
|
)
|
(6,699
|
)
|
(13,374
|
)
|
(15,107
|
)
|
||||||||
|
Taxes on income
|
-
|
722
|
-
|
722
|
||||||||||||
|
Net loss
|
(6,246
|
)
|
(5,977
|
)
|
(13,374
|
)
|
(14,385
|
)
|
||||||||
|
Basic and diluted net loss per ordinary share
|
(0.08
|
)
|
(0.10
|
)
|
(0.18
|
)
|
(0.24
|
)
|
||||||||
|
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
81,273,240
|
61,479,162
|
75,774,881
|
60,747,948
|
||||||||||||
|
COMPUGEN LTD.
|
||||||||
|
CONDENSED CONSOLIDATED BALANCE SHEETS DATA
|
||||||||
|
(U.S. dollars, in thousands)
|
||||||||
|
June 30,
|
December 31,
|
|||||||
|
2020
|
2019
|
|||||||
|
Unaudited
|
||||||||
|
ASSETS
|
||||||||
|
|
||||||||
|
Current assets
|
||||||||
|
Cash, cash equivalents, short-term bank deposits and restricted cash
|
136,066
|
43,879
|
||||||
|
Other accounts receivable and prepaid expenses
|
1,088
|
1,121
|
||||||
|
Total current assets
|
137,154
|
45,000
|
||||||
|
Non-current assets
|
||||||||
|
Long-term prepaid expenses
|
1,219
|
693
|
||||||
|
Severance pay fund
|
2,513
|
2,485
|
||||||
|
Operating lease right to use asset
|
3,012
|
3,247
|
||||||
|
Property and equipment, net
|
2,022
|
2,338
|
||||||
|
Total non-current assets
|
8,766
|
8,763
|
||||||
|
Total assets
|
145,920
|
53,763
|
||||||
|
LIABILITIES AND SHAREHOLDERS EQUITY
|
||||||||
|
Current liabilities
|
||||||||
|
Other accounts payable, accrued expenses and trade payables
|
6,793
|
5,445
|
||||||
|
Current maturity of operating lease liability
|
519
|
600
|
||||||
|
Short-term deferred participation in R&D expenses
|
750
|
774
|
||||||
|
Total current liabilities
|
8,062
|
6,819
|
||||||
|
Non-current liabilities
|
||||||||
|
Long-term deferred participation in R&D expenses
|
2,421
|
2,691
|
||||||
|
Long-term operating lease liability
|
2,788
|
2,978
|
||||||
|
Accrued severance pay
|
3,182
|
2,954
|
||||||
|
Total non-current liabilities
|
8,391
|
8,623
|
||||||
|
|
||||||||
|
Total shareholders' equity
|
129,467
|
38,321
|
||||||
|
Total liabilities and shareholders' equity
|
145,920
|
53,763
|
||||||