On May 6, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the first quarter ended March 31, 2020 (Press release, Compugen, MAY 6, 2020, View Source [SID1234557086]).

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"We have entered 2020 well positioned and with significant momentum to advance our clinical programs that address novel, internally-discovered, drug targets for cancer immunotherapy," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "On the clinical front, we recently presented at AACR (Free AACR Whitepaper) updated data from our ongoing Phase 1 dose escalation study of COM701 as a monotherapy and in combination with Opdivo. These encouraging data, which include signals of durable disease control and confirmed partial responses both in the monotherapy and combination arms, further confirm our hypothesis that by blocking PVRIG, an important new checkpoint, COM701 has the potential to broaden the patient population that can benefit from cancer immunotherapy. We also dosed the first patient in the Phase 1 study for COM902, our anti-TIGIT therapeutic antibody, which would enable us to clinically evaluate the dual blockade of PVRIG and TIGIT inhibitory pathways in the DNAM axis."

Dr. Cohen-Dayag added, "Our continued progress and execution enabled us to successfully raise approximately $79 million through an underwritten public offering, which we believe is testament to the growing recognition of our science-driven approach backed by our computational discovery capabilities. With our strengthened balance sheet, we are well positioned to continue our strategic clinical development plans which will be expanded to also include a third clinical trial, a Phase 1/2 triple combination study testing COM701 with Bristol-Myers Squibb’s Opdivo and their investigational TIGIT inhibitor in the second half of this year, as well as advance our early-stage programs to propel our future therapeutic pipeline. We are fortunate that, to date, the COVID-19 pandemic has not significantly impacted our operations, including our clinical development timelines. For now, we are not changing the anticipated data readouts and milestones timelines we previously provided. We are grateful to our employees and clinical investigators for their continued hard work and dedication. In these unique circumstances we remain focused on advancing our clinical and early-stage programs to maintain positive momentum to achieve our goals."

First Quarter 2020 and Recent Highlights

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) (Free AACR Whitepaper) Virtual Annual Meeting I

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.

No increased toxicity was observed in the combination arm.

No patients discontinued treatment due to toxicity of any study drug.

Preliminary COM701 pharmacokinetic data supports IV Q4 weeks dosing, allowing dosing schedule aligned with Opdivo.

Encouraging disease control rates of 69% (11/16) for monotherapy and 75% (9/12) for the combination arm.

50% of patients (6/12) in the combination arm remain on study, some with continued responses observed beyond 200 days of treatment.

Durable responses of stable disease for over six months in six of 28 patients (21%) across treatment arms.

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.

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.

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.

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.

Strengthened intellectual property portfolio

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.

Granted U.S. Patent No. 10,550,173, covering methods of screening for anti-PVRIG antibodies that inhibit the binding of PVRIG with PVRL2.

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.

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.

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.

Financial Results
Research and development expenses for the first quarter ended March 31, 2020 were $4.7 million, compared with $6.3 million in the comparable quarter in 2019. The decrease is attributed mostly to the restructuring process announced at the end of the first quarter of 2019 offset by an increase in expenses associated with clinical-related activities.

Net loss for the first quarter of 2020 was $7.1 million, or $0.10 per basic and diluted share, compared with a net loss of $8.4 million, or $0.14 per basic and diluted share, in the comparable quarter of 2019.

As of March 31, 2020, cash, cash related accounts and short-term and long-term bank deposits totaled approximately $121.2 million, compared with approximately $43.9 million as of December 31, 2019. The increase in cash balances during the first quarter is attributed to approximately $70 million of net proceeds from the underwritten public offering (excluding the shares issued upon exercise of the underwriters’ option in the second quarter), $5.2 million from the exercise of warrants and $7.2 million from the exercise of employee options, offset by operating expenses and working capital. The Company has no debt.

Conference Call and Webcast Information
The Company will hold a conference call today, May 6, 2020, at 8:30 AM ET to review its first quarter 2020 results. To access the conference call by telephone, please dial 1-888-407-2553 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.