On February 24, 2022 Compugen Ltd. (Nasdaq: CGEN, "Compugen", the "Company"), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported financial results for the fourth quarter ended December 31, 2021, and full year 2021 and provided an update on recent Company highlights (Press release, Compugen, FEB 24, 2022, View Source [SID1234608957]).
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"Compugen made excellent progress in 2021. As the leader in the DNAM-1 axis we believe that blocking its complementary pathways has the potential to be a game changer in treating inflamed as well as less inflamed tumors, in patients who do not respond to available therapies. I am particularly excited about the translational data we presented across all the regimens with the most potent immune activation in the triple blockade of PVRIG, TIGIT and PD-1, which complements the early signals of anti-tumor activity we reported in our studies. With COM902, we were the first to present early signals of monotherapy anti-tumor activity with an IgG4 anti-TIGIT antibody, with low Fc-effector function. COM902 also avoided depletion of CD8+ T cells, the most effective anti-cancer immune subset, supporting our strategy to develop an antibody with low Fc effector function said," Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "In 2021 we also presented additional research supporting the differentiation of PVRIG from other immune checkpoints, enhancing our belief that PVRIG may be the missing piece when current immunotherapies have failed, by potentially generating new waves of T cells to infiltrate the tumor microenvironment. I am excited that the totality of results we have presented to date support our DNAM-1 axis hypothesis and set the stage for the next steps for the Company’s clinical program."
Dr. Cohen-Dayag further commented, "I am also pleased that we expanded our collaboration with Bristol Myers Squibb with a $20 million strategic investment and I am happy to see AstraZeneca progressing its TIGIT/PD-1 bispecific, which is derived from our COM902 into the clinic."
Dr. Cohen-Dayag continued, "Looking ahead, this year and next year we will focus on completing clinical study enrollment and delivering meaningful clinical and translational results from the expansion cohorts in our three ongoing combination studies with our two proprietary programs, COM701 and COM902. We expect to report data from fully enrolled cohorts in each of our studies as available starting with the COM701/nivolumab study CRC (MSS) cohort in Q4 2022, and complete enrollment in all cohorts by the end of 2023. The data from these studies will guide our regulatory strategy on a cohort-by-cohort basis."
2022-2023 Expected Milestones:
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Advancing the enrollment of Phase 1 and Phase 1/2 dose expansion studies to evaluate anti-PVRIG and/or anti-TIGIT antibodies in combination with a PD-1 inhibitor:
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COM701/PVRIG plus nivolumab
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COM701/PVRIG plus COM902/TIGIT
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COM701/PVRIG plus nivolumab and Bristol Myers Squibb’s investigational anti-TIGIT antibody, BMS-986207
•
Reporting data from fully enrolled cohorts
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Announcing initial clinical data from the Phase 1 and Phase 1/2 programs starting with COM701/nivolumab study CRC/MSS cohort in Q4 2022
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Completing enrollment of all ongoing studies by end of 2023
Phase 1/Phase 1/2 Dose Expansion Combination Program
Clinical Study
Number of cohorts
Tumor types
Patients per cohort
COM701+ nivolumab
4
Ovarian, Endometrial, Breast, CRC/MSS
20
COM701+ nivolumab + BMS986207
4
Ovarian, Endometrial, HNSCC, PVRL2+ patients
20
COM701 +COM902
3
HNSCC, NSCLC, CRC/MSS
20
2021 Corporate Highlights
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Completed enrollment as planned and presented data from our Phase 1 studies at major medical meetings
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ASCO 2021
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COM701 monotherapy dose escalation and expansion studies
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COM701 + nivolumab dose escalation study
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SITC 2021
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COM902 monotherapy dose escalation
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COM701+ nivolumab + BMS986207 dose escalation
•
COM701 as mono, dual, and triple therapy showed early signals of anti-tumor activity with immune activation and a favorable safety profile
•
COM902 showed early signals of anti-tumor activity, was well tolerated and translational data support choice of an IgG4 anti-TIGIT antibody with less effector function than IgG1
•
Initiated enrollment in the Phase 1, Phase 1/2 dose expansion programs (see table above)
•
Expanded the clinical research collaboration agreement with Bristol Myers Squibb with an equity investment of $20 million
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Received $6 million milestone payment triggered by first patient initiation in AstraZeneca’s Phase 1/2 study of a TIGIT/PD-1 bispecific monoclonal antibody, AZD2939, derived from COM902
•
Expanded research collaboration with Johns Hopkins University for a novel myeloid target discovered by Compugen
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Published review on biology and potential therapeutic relevance of DNAM-1 axis in cancer immunotherapy in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)
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Published preclinical data on the potential of COM902 to enhance anti-tumor immune responses, in Cancer Immunology Immunotherapy
•
Presented research supporting the differentiation of PVRIG from other immune checkpoint inhibitors at the SITC (Free SITC Whitepaper) 2021 Targets for Cancer Immunotherapy seminar series in June, the SITC (Free SITC Whitepaper) in November and translational data from patient biopsies demonstrating immune activation in the TME after treatment with COM701, at the TIGIT Therapies Digital Summit in December
Fourth Quarter and Full Year 2021 Financial Highlights
Cash: As of December 31, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled to approximately $118 million, compared with approximately $124 million as of December 31, 2020. The Company expects its existing cash and cash equivalents and short-term bank deposits, to be sufficient to fund our current level of operations into 2024.
Revenues: Compugen reported no revenue for the fourth quarter of 2021 and a total of $6 million for the year ended December 31, 2021, compared with $2.0 million for each of the comparable periods in 2020. 2021 revenues are related to the milestone payment from AstraZeneca for dosing the first patient in AstraZeneca’s Phase 1/2 study of a TIGIT bispecific monoclonal antibody, derived from COM902.
Cost of revenues: 2021 expenses of approximately $0.7 million are attributed to royalty and milestone payments.
R&D Expenses: Expenses for the fourth quarter and year ended December 31, 2021 were approximately $5.8 million, and approximately $28.7 million, respectively, compared with approximately $8.1 million and approximately $22.8 million for the comparable periods in 2020. The increase in the annual periods is attributed mainly to higher expenses associated with our various clinical studies, manufacturing and related costs, and headcount as the U.S. based clinical team continues to grow to support the expansion of our studies. The decrease in the quarterly period is due to a decrease in manufacturing and related costs.
G&A Expenses: Expenses for the fourth quarter and year ended December 31, 2021 were approximately $2.7 million and approximately $10.9 million, respectively, compared with approximately $2.7 million and approximately $9.8 million for the comparable periods in 2020. The increase in the annual period is mainly due to increased corporate-related expenses.
Net Income/Loss: Net loss for the fourth quarter of 2021 was approximately $8.6 million, or $0.10 per basic and diluted share, compared with a net loss of approximately $8.6 million, or $0.10 per basic and diluted share in the comparable period of 2020. Net loss for the year ended December 31, 2021 was approximately $34.2 million, or $0.41 per basic and diluted share, compared with net loss of approximately $29.7 million, or $0.37 per basic and diluted share in the comparable period of 2020.
Full financial tables are included below.
Conference Call and Webcast Information
The Company will hold a conference call today, February 24, 2022, at 8:30 AM ET to review its fourth quarter and full year 2021 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.