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26 Harokmim Street
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Holon 5885849, Israel
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(Address of Principal Executive Offices)
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Exhibit
Number
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Description of Exhibit
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COMPUGEN LTD.
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Date: May 6, 2020
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By:
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/s/ Eran Ben Dor
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Eran Ben Dor
General Counsel
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• |
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
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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.
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◾ |
No increased toxicity was observed in the combination arm.
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◾ |
No patients discontinued treatment due to toxicity of any study drug.
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o |
Preliminary COM701 pharmacokinetic data supports IV Q4 weeks dosing, allowing dosing schedule aligned with Opdivo®.
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o |
Encouraging disease control rates of 69% (11/16) for monotherapy and 75% (9/12) for the combination arm.
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◾ |
50% of patients (6/12) in the combination arm remain on study, some with continued responses observed beyond 200 days of treatment.
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o |
Durable responses of stable disease for over six months in six of 28 patients (21%) across treatment arms.
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o |
The two patients previously reported with confirmed partial responses, one from the monotherapy arm (microsatellite stable primary peritoneal cancer) and one from
the combination arm (microsatellite stable colorectal cancer), remain on treatment.
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o |
Enrollment in the COM701 monotherapy dose escalation arm is completed and enrollment in the combination dose escalation arm at 20 mg/kg IV Q4 weeks is ongoing.
Enrollment in the monotherapy expansion cohorts is expected to begin in Q2 2020.
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• |
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.
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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 investigational TIGIT inhibitor. This study is expected to begin in 2H 2020.
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Strengthened intellectual property portfolio
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o |
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.
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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.
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o |
Granted EPO Patent No. 3258951, covering the use of any anti-PVRIG antibody that activates T cells and/or NK cells, in the treatment of cancer.
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• |
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®.
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Completed an underwritten public offering of 8,816,339 ordinary shares (including the shares issued in Q2 upon exercise of the underwriters’ option) at $9.00 per
share. The net proceeds from the offering were approximately $74 million, after deducting underwriting discounts and commissions and other offering expenses that were paid by the Company.
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COMPUGEN LTD.
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||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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||||||||
(U.S. dollars in thousands, except for share and per-share amounts)
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||||||||
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Three Months Ended
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|||||||
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March 31,
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|||||||
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2020
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2019
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||||||
Unaudited
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Unaudited
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|||||||
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Revenues
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-
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-
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||||||
Cost of revenues
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-
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-
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Gross profit
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-
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-
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||||||
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||||||||
Operating expenses
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Research and development expenses
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4,712
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6,335
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||||||
Marketing and business development expenses
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210
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213
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||||||
General and administrative expenses
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2,476
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1,966
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Total operating expenses
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7,398
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8,514
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Operating loss
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(7,398
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)
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(8,514
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)
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Financial and other income, net
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270
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106
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Loss before taxes on income
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(7,128
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)
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(8,408
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)
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Taxes on income
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-
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-
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Net loss
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(7,128
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)
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(8,408
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)
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||||||||
Basic and diluted net loss per ordinary share
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(0.10
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)
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(0.14
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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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70,276,521
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60,016,734
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COMPUGEN LTD.
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||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS DATA
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||||||||
(U.S. dollars, in thousands)
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||||||||
March 31,
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December 31,
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|||||||
2020
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2019
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|||||||
Unaudited
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||||||||
ASSETS
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Current assets
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Cash, cash equivalents, short-term bank deposits and restricted cash
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121,192
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43,879
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||||||
Other accounts receivable and prepaid expenses
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1,093
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1,121
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Total current assets
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122,285
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45,000
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Non-current assets
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Long-term prepaid expenses
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1,165
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693
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Severance pay fund
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2,426
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2,485
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Operating lease right to use asset
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3,088
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3,247
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Property and equipment, net
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2,182
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2,338
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Total non-current assets
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8,861
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8,763
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Total assets
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131,146
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53,763
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LIABILITIES AND SHAREHOLDERS EQUITY
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Current liabilities
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||||||||
Other accounts payable, accrued expenses and trade payables
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7,376
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5,445
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Current maturity of operating lease liability
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489
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600
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Short-term deferred participation in R&D expenses
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842
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774
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Total current liabilities
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8,707
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6,819
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Non-current liabilities
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||||||||
Long-term deferred participation in R&D expenses
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2,454
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2,691
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Long-term operating lease liability
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2,816
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2,978
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Accrued severance pay
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3,055
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2,954
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Total non-current liabilities
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8,325
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8,623
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||||||
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Total shareholders' equity
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114,114
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38,321
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Total liabilities and shareholders' equity
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131,146
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53,763
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