Compugen Ltd 2026 Q2 Earnings Call

Good morning and good afternoon, everyone, welcome to Compugen's second quarter 2026 financial results conference call. With us today are Dr. Eran Ophir, President and Chief Executive Officer, and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, will join us for the Q&A portion of the call. Before we begin, I'd like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts, and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, including disclosure of clinical data, financial and accounting-related matters, as well as statements regarding our cash position and cash runway. We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, and that actual results, performance, or achievements of the company may differ materially.

These statements are subject to known and unknown risks and uncertainties, we refer you to our SEC filings for more details on these risks, including the company's most recent annual report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I'll now turn the call over to Eran.

Thank you, Lindsey, good morning, everyone. Q2 was a quarter of steady advancement, I'm pleased with the progress we have made across every part of the company. Our science continues to advance in the clinic, our partnerships are advancing on strong footing. Our MAIA-ovarian trial in platinum-sensitive ovarian cancer is progressing and is on track for the interim analysis by Q1 2027. We're encouraged to see AstraZeneca continue to build momentum behind rilvegostomig by initiating a new phase III trial in urothelial carcinoma and with new data at ASCO from the GEMINI study in hepatobiliary cancer and the investigator-initiated I-SPY trial in breast cancer. Lastly, our collaboration with Gilead on GS-0321 continued to progress as planned, underpinning all of this is the same disciplined, data-driven approach that has always defined Compugen. Let me take each program one by one.

Starting with our only owned program, COM701, a potential first-in-class anti-PVRIG antibody. We continue to make good progress with MAIA-ovarian, our sponsored randomized placebo-controlled adaptive platform trial evaluating COM701 as maintenance monotherapy in patients with second and third line relapsed platinum-sensitive ovarian cancer in a setting with no approved maintenance treatment option and significant unmet needs. We anticipate the interim analysis with median progression-free survival data by the first quarter of 2027. During this quarter, we were pleased to present a trial-in-progress poster on MAIA-ovarian at the ESMO Gynaecological Cancers Congress in Copenhagen. The poster underscored the strong biological and clinical rationale for evaluating COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints like PD-1 and TIGIT, its high expression in ovarian cancer, and the durable responses previously observed with COM701 in mono and combination therapy in heavily pretreated platinum-resistant patients.

As we prepare for the MAIA-ovarian interim analysis, we have been keeping close tabs on the emerging external data to keep our own expectations anchored in the current clinical context. Two recent clinical trials in relapsed platinum-sensitive ovarian cancer that included patients who have been pretreated with PARP inhibitors or bevacizumab, or both, have shown median progression-free survival for the control arm of less than three months. While the patient population of these two trials is not identical and more heavily pretreated than the MAIA trial population, based on these data, we estimate the median PFS of the placebo control group in our trial to be approximately four months. As a reminder, patients with ovarian cancer are divided into either platinum-sensitive or platinum-resistant categories, with the difference being the duration of their platinum-free interval.

If a patient relapses in less than six months following platinum-based chemotherapy, they move into platinum-resistant category, where further platinum therapy is generally no longer considered effective and treatment shifts to non-platinum options. For the interim analysis, we define clinically meaningful success as COM701 helping patients remain progression free for at least six months after platinum-based chemotherapy. Achieving these thresholds maintains patients as platinum sensitive for longer, delays their transition to platinum-resistant disease, and give patients a valuable recovery break from the intensity of chemotherapy. Thereby improving quality of life while preserving additional treatment options and potentially changing their disease course. Overall, we believe COM701's antitumor activity will be best assessed by the totality of the data comparing the treatment effects against our blinded randomized control arm. MAIA is an exploratory trial designed to evaluate COM701 monotherapy and the magnitude of its effects.

It is not a registrational trial powered to demonstrate a statistical difference between the two treatment groups. Nevertheless, we believe that comparing COM701 as a monotherapy against a placebo control will allow us to draw clear conclusions about its clinical activity. Looking ahead, we believe that clear prolongation of PFS in these patients could inform a registration path for COM701 and establish it as a potential backbone for drug combinations in this population, while also enabling a potential broader clinical development plan across earlier and later lines of ovarian cancer treatment, as well as in other indications where clinical signals were previously seen for COM701. Turning to rilvegostomig, the PD-1/TIGIT bispecific antibody being advanced by our partner, AstraZeneca, the TIGIT component of which is derived from our fully owned COM902 program.

In the last week, AZ has added a 12th phase III trial to the overall rilve program in participants with high-risk muscle-invasive urothelial carcinoma. In this trial, rilvegostomig will be combined with Dato-DXd, their approved TROP2 ADC, and tested in adjuvant settings against standard of care. This new phase III trial, TROPION-Urothelial-04, follows the phase II TROPION-PanTumor03 study in which rilve plus Dato-DXd combo showed an encouraging efficacy and a manageable safety profile in metastatic urothelial carcinoma. We are also encouraged by the additional rilve data AstraZeneca presented at 2026 ASCO annual meeting, which we believe continues to support the differentiated profile of this bispecific and its potential as an immune oncology backbone across multiple tumor types. In advanced biliary tract cancer, AstraZeneca presented an updated analysis from the GEMINI-Hepatobiliary study of rilve in combination with chemotherapy in the first-line setting.

This was the first overall survival data readout from rilve. As AstraZeneca highlights in their ASCO investor call, the 16.8 months of overall survival was a clear example of prolonged stabilization of responses seen with rilve across clinical trials, and the profile continues to support rilve combination potential. In comparison, historical trial for first-line BTC showed overall survival duration of less than 13 months. The data showed encouraging efficacy together with manageable safety profile, both of which we view as promising signals in the settings of high unmet needs, while recognizing that longer follow-up and randomized data from the ongoing phase III trial in this setting will ultimately be needed to validate these findings. As AstraZeneca continues to advance rilvegostomig across its broad late-stage program, we believe this sustained investment reflects ongoing confidence in rilvegostomig.

As a reminder, AZ has previously guided that rilve has a non-risk adjusted peak year revenue potential of over $5 billion, and we remain eligible for future milestones of $195 million and up to mid-single-digit tiered royalties tied to rilvegostomig progress and success. Moving to GS-0321, formerly known as COM503, our potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. GS-0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing phase I dose-escalation trial continues to progress as planned. As a reminder, we have received $90 million so far from Gilead on this asset, and we are eligible to receive up to $758 million in additional milestones payment, plus single digits to low double-digit tiered royalties.

Moving to our early pipeline fueled by Unigen, our AI machine learning-powered computational discovery platform, which has been developed and refined for more than a decade to identify novel drug targets and biological pathways grounded in human disease biology. As we have said before, our focus is not on using AI to optimize known biology, but on uncovering innovative opportunities to activate the immune system against cancer. Unigen has already discovered the targets of COM701, COM902, and GS-0321, and we remain committed to identifying and advancing the next generation of immune oncology innovation. With that, I will turn the call over to David to review the financials.

Thanks, Eran, and thank you all for joining us today. We finished the first half of 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows, is expected to fund our operating plans into 2029. We anticipate using this runway to continue advancing our COM701 platinum-sensitive ovarian cancer trial, MAIA-ovarian, and to support the progression of GS-0321 in the clinic, together with continuous investment in our early-stage pipeline.

Going into the details, I will start with our cash balance. As of June 30, 2026, we had approximately $125.3 million in cash equivalents, short-term bank deposits, and investment in marketable securities. Revenues for the second quarter of 2026 were approximately $2.6 million compared to approximately $1.3 million of revenue for the comparable period in 2025. The revenues in the second quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. Expenses for the second quarter of 2026 were in line with our plans. R&D expenses for the second quarter of 2026 were approximately $6.3 million compared to approximately $5.6 million in the second quarter of 2025. Our G&A expenses were approximately $2.3 million for the second quarter of 2026, compared to $2.2 million for the second quarter of 2025.