On February 25, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Compugen, FEB 25, 2021, View Source [SID1234575719]).
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"Our encouraging new data reinforces our conviction in our clinical development strategy to comprehensively evaluate dual and triple blockade of DNAM axis members, PVRIG and TIGIT, along with the intersecting PD-1 pathway, across our clinical studies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We have now observed durable responses in patients treated with COM701 as a monotherapy and in combination with Opdivo, including a patient with a confirmed complete response we reported earlier today. Most notably, the durable responses and signals of anti-tumor activity reported across our COM701 studies were achieved in highly refractory patients in indications usually unresponsive to available checkpoint inhibitors. These encouraging signals demonstrate that COM701 is clinically active and strengthen our hypothesis that PVRIG is an important new checkpoint target for immunotherapy and served as the basis for expanding our collaboration with Bristol Myers Squibb."
Dr. Cohen-Dayag added, "With these data in hand, we are now focused on executing across our expanded clinical programs. Most importantly, as the only company with wholly owned clinical assets targeting PVRIG and TIGIT, we are uniquely positioned to evaluate PVRIG in monotherapy and in dual blockade with PD-1 or TIGIT, as well as the triple blockade of PVRIG with PD-1 and TIGIT. We expect to initiate our combination study for COM701 with COM902 in the second half of this year and to share initial data from our COM902 monotherapy and triple combination dose escalation studies in the fourth quarter of this year. We look forward to further revealing the potential of DNAM axis blockade to expand the reach of immunotherapy to patients unresponsive or refractory to current treatment options."
Recent and Fourth Quarter 2020 Corporate Highlights
Announced updated data from COM701 monotherapy and combination with Opdivo (nivolumab) studies
Announced expansion of clinical collaboration agreement with Bristol Myers Squibb with planned Phase 1b cohort expansion study evaluating COM701 with Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers. The study is on track to initiate in the second quarter of 2021
Announced first development milestone of $2 million received under the license agreement with AstraZeneca for the development of bispecific and multi-specific antibody products
Presented preclinical data at the 2020 TIGIT Therapies Digital Summit demonstrating the potential of PVRIG inhibition to enhance T cell priming and infiltration into both inflamed and less inflamed tumors, as well as providing further support for the therapeutic combination of TIGIT and PD-1 inhibitors to address patient populations who do not benefit from available immune checkpoint inhibitors
Expanded IP portfolio for COM902 with composition of matter patent in China, in addition to composition of matter and use patents for COM902 previously issued in the United States and Europe
Financial Results
Revenues for the fourth quarter ended December 31, 2020, were $2.0 million, related to the milestone payment in the license agreement with AstraZeneca for the development of bispecific and multi-specific antibody products.
R&D expenses for the fourth quarter and year ended December 31, 2020, were $8.1 million, and $22.8 million, respectively, compared with $4.3 million and $19.8 million for the comparable periods in 2019. The increase in both cases is attributed mostly to increase in expenses associated with our various Phase 1 clinical studies, COM701 and COM902 manufacturing and other chemistry, manufacturing and controls activities.
General and administrative expenses for the fourth quarter and year ended December 31, 2020, were $2.7 million, and $9.8 million, respectively, compared with $2.2 million and $8.4 million for the comparable periods in 2019. The increase in both the quarterly and annual periods is attributed mainly to headcount-related expenses and increased corporate-related expenses.
Net loss for the fourth quarter of 2020 was $8.6 million, or $0.10 per basic and diluted share, compared with a net loss of $6.5 million, or $0.10 per basic and diluted share, in the comparable period of 2019. Net loss for the year ended December 31, 2020 was $29.7 million, or $0.37 per basic and diluted share, compared with a net loss of $27.3 million, or $0.43 per basic and diluted share, for the year ended December 31, 2019.
As of December 31, 2020, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $124.4 million, compared with approximately $43.9 million on December 31, 2019. The Company has no debt.
Opdivo is a registered trademark of Bristol Myers Squibb.
Conference Call and Webcast Information
The Company will hold a conference call today, February 25, 2021, at 8:30 AM ET to review its fourth quarter and full year 2020 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.