On August 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported financial results for the second quarter ended June 30, 2019 (Press release, Compugen, AUG 5, 2019, View Source [SID1234538122]).
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"We continued the strong execution of our clinical program throughout the second quarter of 2019," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "This includes the important milestone of first patient dosed in the combination arm of our Phase 1 study of COM701 and Opdivo, which remains on-track to complete enrollment this year. Additionally, the COM701 monotherapy dose escalation arm is progressing, and we look forward to rapidly advancing to the monotherapy expansion cohort later this year accompanied by our targeted, biomarker driven approach. Finally, we are excited to advance our second internally developed asset, COM902, toward an IND filing later this year. These activities and the progress we are making highlight our ability and commitment to translate our computational discoveries into meaningful and exciting clinical cancer immunotherapy programs."
"After utilizing the ATM program together with the streamlined corporate structure implemented in March, we now have sufficient cash resources expected to fund operations through mid-2021. We will remain diligent in effectively using our capital to continue to execute on our pipeline programs and ensure our future growth," added Dr. Cohen-Dayag.
Recent Corporate Highlights
Dosed first patient in the combination arm of the Phase 1 study for COM701, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors. Combination arms of the study are conducted under the clinical collaboration agreement entered into with Bristol-Myers Squibb in October 2018.
Reported at a trial-in-progress poster presentation at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting in June that the sixth dose level patient cohort of COM701 monotherapy has been completed and that no dose-limiting toxicities were found. Clinical and laboratory assessment for safety and tolerability are ongoing for this and earlier dose level patient cohorts.
Awarded U.S. Patent No. 10,351,625 by the U.S. Patent and Trademark Office, which covers the method of use of COM701 in combination with any anti-PD-1 antibody.
Financial Results
R&D expenses for the second quarter ended June 30, 2019 were $4.9 million, compared with $8.0 million for the comparable period in 2018. The decrease in R&D expenses was primarily due to the decrease in preclinical activities related to COM902, most of which were done in 2018, and the cost reduction measures announced by the Company in the first quarter of 2019. This decrease was partially offset by an increase in R&D expenses associated with clinical-related activities for the COM701 Phase 1 trial, which began in the second half of 2018.
Taxes on Income for the second quarter of 2019 reflect a tax benefit of $0.7 million due to a refund of withholding taxes from previous years.
Net loss for the second quarter of 2019 was $6.0 million, or $0.10 per basic and diluted share, compared with a net loss of $10.2 million, or $0.19 per basic and diluted share, in the comparable period of 2018.
As of June 30, 2019, cash, cash related accounts, short-term and long-term bank deposits totaled $37.0 million, compared with $45.7 million at December 31, 2018. The Company has no debt.
During the three months ended June 30, 2019, the Company sold approximately 1.0 million ordinary shares under its "at-the-market" (ATM) facility pursuant to a sales agreement entered into with Cantor Fitzgerald & Co. in May 2018 for aggregate proceeds of approximately $3.8 million, net of commissions to Cantor and expenses related to the offering. Since June 30, 2019, the Company sold approximately 5.2 million ordinary shares under the ATM for aggregate proceeds of approximately $15.5 million, net of commissions to Cantor and expenses related to the offering.
The Company now believes that it has sufficient cash resources to fund its operations through mid-2021 and therefore decided to cancel its remaining ATM program.
Conference Call and Webcast Information
Compugen will hold a conference call to discuss its second quarter 2019 results today, August 5, 2019, at 8:30 AM ET. To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0644 internationally. The conference 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.