On February 27, 2023 Compugen Ltd. (Nasdaq: CGEN), ("Compugen", the "Company"), a clinical-stage cancer immunotherapy company and pioneer in computational target discovery, reported financial results for the fourth quarter and full year 2022 and provided an update on its main highlights from 2022 and future plans (Press release, Compugen, FEB 27, 2023, View Source [SID1234627719]).

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"Compugen made significant progress in 2022, including the presentation of encouraging data from sixty patients in tumor types typically not responding to immunotherapy, namely platinum resistant ovarian cancer (PROC) and microsatellite stable colorectal cancer (MSS CRC)," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "Reporting clinical responses along with immune activation in patients with less immunogenic cancers is strongly suggestive of a COM701 mediated effect and consistent with our extensive understanding of the biology and data collected from biopsies. I am excited that we are on track to dose the first patients in two small proof of concept studies with COM701 in combination with COM902 and pembrolizumab in these indications in the first and second quarter of this year. The goal of these studies is to further substantiate the evidence, gain more insights into the contribution of components and build on the extensive biomarker work we are doing to identify the patients most likely to respond, to inform on next steps for a potential path to registration in these indications."

Dr. Cohen-Dayag added, "I am delighted to see the progress AstraZeneca is making with their PD-1/TIGIT bispecific antibody, rilvegostomig, derived from our Fc reduced effector function anti-TIGIT, COM902. In 2022, AstraZeneca advanced rilvegostimub into Phase 2 studies in metastatic non-small cell lung cancer, triggering a $7.5 million milestone payment for Compugen. They also expanded the rilvegostomig development program across multiple indications and combinations with plans to initiate a new Phase 3 study in 2023. It is validating for COM902, to see multiple companies advancing their TIGIT programs and in particular programs with differentiated anti-TIGIT antibodies with reduced or inactive Fc effector function. However, it has always been our belief that blocking only TIGIT may not be enough, even by adding PD-1 blockade, and blocking PVRIG may be required to sensitize tumors to PD-1 and possibly TIGIT blockade. This is the basis of our differentiated triple combination clinical strategy which starts to play out in the clinic."

Dr. Cohen-Dayag continued, "We are very excited about our latest discovery of a novel way to harness cytokine biology for anti-cancer therapeutics discovered using our computational discovery capabilities. We identified a known pathway in cancer, the immunostimulatory cytokine interleukin-18 (IL-18), a T and NK cell activator which is highly expressed in the tumor microenvironment but is inhibited by another soluble protein, interleukin-18 binding protein, which prevents its biological activity against tumors. As this is one of the rare cytokines that is naturally blocked by an endogenous binding protein, it presents a unique opportunity to use an antibody to release the blockade of IL-18 to enable its natural immune stimulatory activity, mostly at the tumor bed with minimal peripheral activation of the immune system. We believe this approach may overcome inherent challenges that therapeutic cytokines are facing, when given systemically. COM503 is a potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing the natural IL-18 into the tumor microenvironment to inhibit cancer growth. We are currently advancing COM503 into IND enabling studies and plan to file an IND in 2024."

Upcoming Expected Milestones:

Microsatellite Stable Colorectal Cancer Proof of Concept Study

•
On track to dose first patients in Q1 2023
•
Complete enrollment by the end of 2023
•
Report initial findings by the end of 2023
•
Report full data in H1 2024

Platinum Resistant Ovarian Cancer Proof of Concept Study

•
On track to dose first patient in Q2 2023
•
Complete 50% enrollment by the end of 2023
•
Report initial findings by the end of 2023
•
Complete full enrollment in H1 2024

Additional data from cohort expansion studies (COM701 + nivolumab +/-BMS-986207)

•
Continue to monitor patients in studies with Bristol Myers Squibb
•
Report findings including PROC longer term follow-up and data collected from biopsies in 2023

COM503

•
Present pre-clinical data in 2023
•
File an IND in 2024

Proof of Concept Studies
Treatment
Tumor type
Number
of patients
Inclusion
criteria
COM701+ COM902+ pembrolizumab
Metastatic microsatellite stable colorectal cancer
(MSS CRC)
Up to 20
≤ 3L prior therapy
PD- (L)1 naive
Includes liver metastases

COM701+ COM902+ pembrolizumab (*)
Platinum resistant ovarian cancer
(PROC)
Up to 40
≤ 3 lines of prior therapy
ICI naïve
Includes all histologies

*Following completion of enrollment of the first 20 PROC patients in the triplet arm, the intention is to evaluate the addition of a doublet arm of up to 20 patients, without anti-TIGIT, COM902

Fourth Quarter 2022 and Full Year 2022 Financial Highlights

Cash: As of December 31, 2022, Compugen had approximately $83.7 million in cash, cash equivalents, restricted cash and short-term bank deposits compared with approximately $117.8 million as of December 31, 2021. Compugen expects that its current cash will be sufficient to fund its operating plans at least through the end of 2024. The Company has no debt.

Revenues: Compugen reported $7.5 million in revenue for the fourth quarter and for the year ended December 31, 2022, compared to no revenue and $6.0 million revenue for each of the comparable periods in 2021, respectively.

R&D expenses for the fourth quarter and year ended December 31, 2022, were $7.3 million, and $30.6 million, respectively, compared with $5.8 million and $28.7 million for the comparable periods in 2021. Research and development expenses, as a percentage of total operating expenses, were 73% in 2022 compared to 71% in 2021.

G&A expenses for the fourth quarter and year ended December 31, 2022 were $2.5 million and $10.3 million, respectively, compared with approximately $2.7 million and approximately $10.9 million for the comparable periods in 2021.

Net Income / Loss: During the fourth quarter, Compugen reported a net loss of $3.1 million, or 4 cents per basic and diluted share, compared to a net loss of $8.6 million, or 10 cents per basic and diluted share in the comparable period of 2021. Net loss for the year ended December 31, 2022, was $33.7 million, or 39 cents per basic and diluted share, compared with a net loss of $34.2 million, or 41 cents per basic and diluted share in the comparable period in 2021.

2023 cash guidance: Compugen expects 2023 cash burn to be in the range of $37 to $39 million.

Full financial tables are included below.