On November 12, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the third quarter ended September 30, 2021 (Press release, Compugen, NOV 12, 2021, View Source [SID1234595497]).
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"Our leadership position in the DNAM axis was strengthened in the third quarter, with key data release, expansion cohort studies initiations and continued progress with our partners including a $20 million strategic equity investment from Bristol Myers Squibb," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The favorable safety and tolerability data from the COM701 triple combination dose escalation study combined with the translational results showing potent immune activation are supportive of our DNAM axis hypothesis and serve as an important milestone enabling our continued advancement of the triple blockade of PVRIG, TIGIT and PD-1 in select biomarker informed tumor types. Data from the COM902 dose escalation study support our choice of a reduced Fc function anti-TIGIT antibody with encouraging preliminary anti-tumor activity in the heavily pretreated patients in a dose escalation setting, and showed a favorable safety profile, while avoiding depletion of immune cell populations that are critical for driving anti-tumor activity."
Dr. Cohen-Dayag continued, "We also continue to push forward the scientific foundation that underlies our success in the clinic, and our recent translational data from COM701 at SITC (Free SITC Whitepaper) reinforces our hypothesis of PVRIG as a differentiated and distinct checkpoint pathway in the DNAM axis. We are particularly encouraged by the preclinical data that suggest blockade of PVRIG may enhance memory stem-like T cell – dendritic cell interactions to drive T cell expansion and differentiation which ultimately may enable clinical responses in less inflamed tumor types. These data, combined with the translational results from our triple combination study are supportive of our DNAM axis hypothesis. We believe the growing commitment from Bristol Myers Squibb, along with the advancement of AstraZeneca’s COM902 derived TIGIT/PD-1 bispecific in the clinic, provide important external validation to our approach, and we will continue our steady execution to maintain our first mover advantage in the space."
Recent and Third Quarter 2021 Corporate Highlights
Presenting preliminary results from Phase 1/2 dose escalation study of COM701 with Opdivo and BMS-986207 at SITC (Free SITC Whitepaper)
Combination therapy was well tolerated with favorable safety profile clearing the path for evaluation of triple blockade in select biomarker informed tumor types
Translational data supportive of potent immune activation with triple combination regimen
Presenting preliminary results from Phase 1 dose escalation monotherapy study of COM902 at SITC (Free SITC Whitepaper)
COM902 was well tolerated with a favorable safety profile and a maximum tolerated dose was not reached
Encouraging preliminary anti-tumor activity in a heavily pretreated heterogenous population with 9 of 18 patients (50%) achieving best responses of stable disease (SD) and 3 patients remaining on treatment study for ≥6 months.
Treatment with COM902 avoided depletion of major TIGIT positive expressing lymphocytes including CD4, CD8 and NK cells, supporting Compugen’s rationale for choosing an IgG4, reduced Fc effector function anti-TIGIT antibody
Presenting translational data supporting the differentiation of PVRIG compared to TIGIT and PD-1 as a novel DNAM axis checkpoint at SITC (Free SITC Whitepaper)
Data demonstrated unique dominant expression of PVRIG on early memory (stem-like) T cells and its ligand PVRL2 is highly expressed across dendritic cell subtypes
Induction of activated dendritic cell markers observed in serum of two patients who clinically responded to treatment of COM701 in combination with nivolumab
Preliminary data suggest that blockade of PVRIG/PVRL2 may enhance stem-memory T cell – dendritic cells interaction potentially resulting in increased T cell expansion, differentiation, and infiltration also in less ‘inflamed’ tumors
Announced collaboration expansion with Bristol Myers Squibb alongside $20 million equity investment
Announced milestone payment from AstraZeneca triggered by first patient dosed with TIGIT bispecific derived from COM902
Dosed the first patient in the Phase 1 dual combination cohort expansion study of COM902 and COM701 in select tumor types for the first ever clinical evaluation of dual blockade of PVRIG and TIGIT in a PD-1 free regimen
COM902 monotherapy expansion cohort is enrolling up to 10 patients
Financial Results
Revenues for the third quarter ended September 30, 2021, were $6 million, related to the milestone from AstraZeneca triggered by the dosing of the first patient in AstraZeneca’ Phase 1/2 study of a TIGIT bispecific derived from COM902.
Cost of revenues of $0.7 million are mainly attributed to royalty and milestone payments.
R&D expenses for the third quarter ended September 30, 2021, were $8.7 million compared with $5.5 million for the comparable period in 2020. The increase reflects the expansion and initiation of additional clinical studies during 2021 as well as increased drug manufacturing activities.
Net loss for the third quarter of 2021 was $6.2 million, or $0.07 per basic and diluted share, compared with a net loss of $7.8 million, or $0.09 per basic and diluted share, in the comparable period of 2020.
As of September 30, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $102 million compared with approximately $124 million on December 31, 2020. The cash balance as of September 30, 2021, does not include the $20 million equity investment from Bristol Myers Squibb nor the $6 million milestone payment from AstraZeneca expected in the fourth quarter. 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, November 12, 2021, at 8:30 AM ET to review its third quarter 2021 results including data being presented at SITC (Free SITC Whitepaper). To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call and slides will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, the slides and a replay will be available on the Company’s website.