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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Compugen Ltd | NASDAQ:CGEN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.08 | 3.83% | 2.17 | 2.17 | 2.22 | 2.2199 | 2.08 | 2.08 | 312,724 | 21:30:54 |
Exhibit
|
|
Number
|
Description of Exhibit
|
COMPUGEN LTD.
|
|||
Date: November 7, 2023
|
By:
|
/s/ Eran Ben Dor
|
|
Eran Ben Dor
|
|||
General Counsel
|
• |
Rilvegostomig, AstraZeneca’s (LSE/STO/Nasdaq: AZN) PD-1/TIGIT bi-specific derived from Compugen’s COM902, has progressed into Phase 3 as adjuvant therapy for biliary
tract cancer after resection in combination with chemotherapy
|
• |
Clinical data presented at SITC 2023 reinforces COM701 (anti-PVRIG) mediated anti-tumor activity in tumors typically not responding to immunotherapy and initial data
suggest PVRL2 as a potential biomarker for COM701 combinations in certain indications
|
• |
Enrollment completed in proof-of-concept study evaluating triple blockade of DNAM-1 axis with COM701 + COM902 (anti-TIGIT) + pembrolizumab in patients with metastatic
microsatellite stable colorectal cancer
|
• |
Pre-clinical data presented at SITC 2023 highlights COM503’s potential leading edge with an antibody approach to harness IL-18 cytokine biology to treat cancer
|
• |
Q4 2023: Rilvegostomig, AstraZeneca’s PD-1/TIGIT bi-specific
derived from Compugen’s COM902 progressed into Phase 3 as adjuvant therapy for biliary tract cancer after resection in combination with chemotherapy.
|
• |
Q4 2023: Microsatellite stable colorectal cancer study;
enrollment of 20 patients complete.
|
• |
Q3-Q4 2023: Activation of additional sites in platinum
resistant ovarian cancer study resulting in increase in enrollment. However, enrollment completion of up to 20 patients will move into 2024.
|
• |
SITC 2023: Presentation of new translational data and initial
biomarker data from platinum resistant ovarian cancer studies evaluating COM701 + nivolumab ± BMS anti-TIGIT, supporting a COM701 mediated clinical benefit and initial data to suggest PVRL2 as a potential biomarker to help enrich for
patients who may derive benefit from COM701 combinations.
|
• |
SITC 2023: Presentation of longer-term patient follow up from
platinum resistant ovarian cancer study evaluating COM701 + nivolumab + BMS anti-TIGIT showing clinically meaningful durable responses, with a trend that compares favorably to standard of care.
|
• |
SITC 2023: Presentation of new data from the metastatic breast
cancer cohort expansion study of patients treated with COM701 and nivolumab, another indication showing clinical benefit in patients typically not responding to immunotherapy with initial data showing that baseline PVRL2 levels are higher
in patients with clinical benefit supporting the findings in platinum resistant ovarian cancer patients.
|
• |
SITC 2023: Presentation of new data from COM503, Compugen’s
lead pre-clinical program, showing sufficient levels of tumor IL-18 to provoke anti-tumor activity following antibody blockade of IL-18BP with potential favorable therapeutic window compared to recombinant cytokines.
|
• |
ESMO October 2023: Presentation of additional clinical data by
partner AstraZeneca on rilvegostomig, a PD-1/TIGIT bispecific derived from COM902, establishing its safety and pharmacokinetic profile and showing anti-tumor activity in checkpoint inhibitor experienced NSCLC patients who typically do not
respond to immunotherapy.
|
• |
Report data from ongoing triple combination (COM701 + COM902 + pembrolizumab) proof-of-concept study in microsatellite stable colorectal in H1 2024.
|
• |
Complete enrollment of up to 20 patients and present data from ongoing triple combination (COM701 + COM902 + pembrolizumab) proof-of-concept study platinum resistant
ovarian cancer in 2024.
|
• |
File IND for COM503 in 2024
|
COMPUGEN LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(U.S. dollars in thousands, except for share and per share amounts)
|
Three Months Ended
|
Nine Months Ended,
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
Operating expenses
|
||||||||||||||||
Research and development expenses
|
8,338
|
9,339
|
23,544
|
23,321
|
||||||||||||
Marketing and business development expenses
|
18
|
263
|
183
|
741
|
||||||||||||
General and administrative expenses
|
2,272
|
2,610
|
7,249
|
7,783
|
||||||||||||
Total operating expenses
|
10,628
|
12,212
|
30,976
|
31,845
|
||||||||||||
Financial and other income, net
|
776
|
464
|
2,473
|
1,243
|
||||||||||||
Loss before taxes on income
|
(9,852
|
)
|
(11,748
|
)
|
(28,503
|
)
|
(30,602
|
)
|
||||||||
Tax benefit
|
-
|
-
|
36
|
-
|
||||||||||||
Net loss
|
(9,852
|
)
|
(11,748
|
)
|
(28,467
|
)
|
(30,602
|
)
|
||||||||
Basic and diluted net loss per ordinary share
|
(0.11
|
)
|
(0.14
|
)
|
(0.33
|
)
|
(0.35
|
)
|
||||||||
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
88,310,329
|
86,624,643
|
87,372,604
|
86,532,622
|
COMPUGEN LTD.
|
CONDENSED CONSOLIDATED BALANCE SHEETS DATA
|
(U.S. dollars, in thousands)
|
September 30,
|
December 31,
|
|||||||
2023
|
2022
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
|
||||||||
Current assets
|
||||||||
Cash, cash equivalents, short-term bank deposits and restricted cash
|
47,782
|
83,708
|
||||||
Investment in marketable securities
|
9,725
|
-
|
||||||
Other accounts receivable and prepaid expenses
|
2,763
|
2,417
|
||||||
Total current assets
|
60,270
|
86,125
|
||||||
Non-current assets
|
||||||||
Long-term prepaid expenses
|
1,906
|
1,899
|
||||||
Severance pay fund
|
2,772
|
2,794
|
||||||
Operating lease right to use asset
|
1,432
|
1,826
|
||||||
Property and equipment, net
|
1,231
|
1,532
|
||||||
Total non-current assets
|
7,341
|
8,051
|
||||||
Total assets
|
67,611
|
94,176
|
||||||
LIABILITIES AND SHAREHOLDERS EQUITY
|
||||||||
Current liabilities
|
||||||||
Other accounts payable, accrued expenses and trade payables
|
9,784
|
10,981
|
||||||
Current maturity of operating lease liability
|
592
|
613
|
||||||
Short-term deferred participation in R&D expenses
|
-
|
325
|
||||||
Total current liabilities
|
10,376
|
11,919
|
||||||
Non-current liabilities
|
||||||||
Long-term operating lease liability
|
818
|
1,312
|
||||||
Accrued severance pay
|
3,190
|
3,265
|
||||||
Total non-current liabilities
|
4,008
|
4,577
|
||||||
|
||||||||
Total shareholders' equity
|
53,227
|
77,680
|
||||||
Total liabilities and shareholders' equity
|
67,611
|
94,176
|
1 Year Compugen Chart |
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