We use cookies to improve your experience, analyze site usage, and show relevant ads. Go to our Privacy Policy for details.
The call emphasized substantial clinical progress and clear near-term development and regulatory plans for Varseta-M (robust ORR 20%–32% and ~7 months PFS, completed optimization enrollment, combination and expansion strategies), backed by a materially strengthened balance sheet (cash up ~152.9%) and runway into H2 2028. Key risks remain operational and clinical: a large year-over-year revenue decline driven by completed collaborations, modest increases in operating costs, and the need to confirm that Grade 3 diarrhea can be reliably managed in the full optimization cohort and over longer follow-up. Overall, the positive clinical momentum and strong cash position outweigh the near-term financial and clinical uncertainties.
CytomX guided that, as of March 31, 2026, it holds $346.7M in cash, cash equivalents and investments (up from $137.1M on Dec 31, 2025), providing runway to at least the second half of 2028 and enabling prioritized investment in Varseta‑M; Q1 revenue was $10.3M (vs $50.9M Y/Y) with operating expenses of $29.8M (R&D $19.2M, G&A $10.6M). Clinically, they completed enrollment in dose‑optimization cohorts (40 patients across 8.6 and 10 mg/kg adjusted‑IBW doses), bringing Phase I enrollment to 113 patients, and expect an overall Phase I safety/efficacy update in H2 2026 (including PFS for the optimization cohort and an initial OS look) to inform FDA interactions and select a registrational dose and pivotal study targeted to begin in H1 2027. They also guided that Varseta‑M + bevacizumab data are expected by H1 2027, a Phase I/II chemo combination study will begin in H2 2026, non‑CRC expansion cohorts are planned in H2 2026, and initial CX‑801 data are expected by year‑end 2026; prior clinical metrics cited include confirmed ORR of 20–32%, median PFS ≈7 months, and an early grade‑3 diarrhea rate of ~10% in the first 20 optimization patients (with a target to manage grade‑3 events into the ~10–20% range).
Phase I updated efficacy in late-line metastatic colorectal cancer: confirmed overall response rate (ORR) between 20% and 32% and median progression-free survival (PFS) of approximately 7 months — materially higher than current therapies which show single-digit ORRs and only a few months of PFS.
Dose optimization cohorts now fully enrolled with 40 patients at 8.6 and 10 mg/kg, taking total Phase I enrollment to 113 patients. Company on track to prioritize one dose and advance into a registrational (pivotal) late-line CRC study targeted for the first half of 2027.
Updated adverse event management strategies (upfront loperamide and budesonide) showed preliminary improvement: initial look from the first 20 optimization patients reported Grade 3 diarrhea at ~10%. Company target is to manage Grade 3 diarrhea into a 10%–20% range.
Initiated Varseta-M + bevacizumab combination (q2w and q4w schedules) with initial data expected by H1 2027; plan to start a Phase I/II chemotherapy (triplet including bevacizumab) combination study in H2 2026; Phase I expansion cohorts in additional EpCAM-expressing indications planned in H2 2026 to support pan-tumor strategy.
CX-801 advanced to the fourth dose level in monotherapy (exceeding approved clinical dose of unmasked interferon alpha-2b) and has been well tolerated to date. Combination dose escalation with KEYTRUDA is enrolling (third dose level). Initial clinical data expected by year-end.
Closed financing in March and ended Q1 2026 with $346.7 million in cash, cash equivalents and investments versus $137.1 million at 12/31/2025 — a cash increase of ~152.9% — with projected runway to at least the second half of 2028, enabling planned advancement of Varseta-M into a registrational study.
Company communicated disciplined capital allocation with near- to medium-term prioritization of Varseta-M programs (monotherapy registrational path, bev and chemo combinations, and non-CRC expansions) and expectations to deliver multiple clinical readouts through 2026–2027.
Company expects an overall Phase I data update including safety and efficacy from the monotherapy dose optimization in the second half of 2026, and multiple FDA interactions in 2026 to inform dose selection and registrational study design.
Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeutics First Quarter 2026 Financial Results Call. Please be advised that today's conference is being recorded. I would now like to hand the call over to your host for today, Chris Ogden, CytomX's Chief Financial Officer. Please go ahead.
Thank you. Good afternoon and thank you for joining us. Before we begin, I would like to remind everyone that during this call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise. Earlier this afternoon, we issued a press release that includes a summary of our first quarter 2026 financial results and highlights recent progress at CytomX. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC.
Additionally, the press release, recording of this call and our SEC filings can be found under the Investors and News section of our website. With me on the call today is Dr. Sean McCarthy, CytomX's Chief Executive Officer and Chairman. Sean will provide an update on our pipeline and company progress before I cover the financials for the quarter. We will then conclude with a Q&A session. Wi...