CytomX Therapeutics Q2 Earnings Call Highlights

Key Points

• Varseta-M remains CytomX’s primary focus: The Phase I monotherapy study has enrolled 113 patients, with a broader clinical update expected by the end of 2026 and a potential registrational study planned for the first half of 2027.
• CytomX is expanding Varseta-M into earlier-line colorectal cancer through combinations with bevacizumab, 5-fluorouracil and leucovorin, while also launching Phase I cohorts in gastric, pancreatic and biliary tract cancers.
• Financially, the company reported $330.3 million in cash and investments at June 30 and received a subsequent $37 million Regeneron payment, extending its expected cash runway into at least the second half of 2028 despite lower quarterly revenue and higher operating expenses.

CytomX Therapeutics NASDAQ: CTMX said its second-quarter focus remained on advancing Varseta-M, an EpCAM-targeting antibody-drug conjugate being developed for metastatic colorectal cancer, while expanding the program into combination regimens and additional gastrointestinal cancers.

Chief Executive Officer and Chairman Sean McCarthy said the company has enrolled 113 patients in its overall Phase I Varseta-M monotherapy study, spanning dose escalation, expansion and optimization cohorts. Enrollment in dose optimization was completed in April, with 40 patients enrolled across 8.6 mg/kg and 10 mg/kg dose levels using adjusted ideal body weight dosing.

The company plans to provide a Phase I update by the end of 2026 covering the broader 113-patient study. The update is expected to focus on dose selection for monotherapy and support planning for a first registrational study, which CytomX aims to begin in the first half of 2027.

Registrational Strategy Remains Under Review

McCarthy said CytomX continues to view both third-line and fourth-line colorectal cancer as potential settings for Varseta-M’s initial registrational study, with the eventual decision depending on emerging clinical data. The company expects to communicate its strategy later in 2026.

During the question-and-answer session, McCarthy said the company expects its year-end update to include a preliminary progression-free survival assessment from the dose-optimization cohorts, as well as an initial look at overall survival from patients in the dose-escalation and expansion portions of the study.

He said CytomX’s baseline assumption is that overall survival would serve as the primary endpoint in a late-line colorectal cancer registrational study. Potential comparators would differ by treatment setting. In fourth-line disease, the company is evaluating options including fruquintinib, regorafenib or physician’s choice, while a third-line study would most likely use bevacizumab plus LONSURF as a comparator, McCarthy said.

McCarthy cited benchmarks discussed on the call for late-line treatments, including low-single-digit response rates and several months of progression-free survival in fourth-line disease. For third-line bevacizumab plus LONSURF, he referenced progression-free survival of roughly 4.5 to 5.5 months and overall survival of nine to 10 months. CytomX previously reported preliminary progression-free survival of 6.8 to 7.1 months at the 8.6 mg/kg and 10 mg/kg dose levels in March.

Combination Studies Target Earlier-Line Treatment

CytomX is also evaluating Varseta-M in combination with bevacizumab, a component of colorectal cancer treatment regimens across earlier and later lines of therapy. The ongoing Phase I cohort is studying every-two-week and every-four-week schedules designed to align with bevacizumab treatment schedules.

The company is continuing to enroll late-line patients in the bevacizumab combination study and expects to move toward earlier-line patients after selecting a go-forward dose and schedule. Initial clinical data are expected in the first half of 2027.

McCarthy said the company is using the same loperamide and budesonide prophylaxis strategy in the bevacizumab combination cohort as in monotherapy dose optimization. He said CytomX had previously reported that grade 3 diarrhea after the first several months of prophylaxis experience had been reduced to 10%.

The company plans to initiate another Phase I/II study in the fourth quarter that will evaluate escalating Varseta-M doses in combination with bevacizumab, 5-fluorouracil and leucovorin in second-line colorectal cancer. CytomX said the study is intended to support its goal of replacing irinotecan with Varseta-M in earlier-line therapy.

McCarthy said all patients treated with Varseta-M to date have received irinotecan as part of their treatment history because they were in late-line settings. The planned second-line combination study is expected to help the company gain experience with Varseta-M in irinotecan-naive patients over time.

Expansion Into Other Gastrointestinal Cancers

CytomX announced plans to initiate Phase I expansion cohorts for Varseta-M in gastric and gastroesophageal junction cancer, pancreatic ductal adenocarcinoma and biliary tract cancer. The company plans to enroll about 20 patients in each tumor type to evaluate antitumor activity and safety before determining potential next steps.

The company expects to enroll an unselected population in gastric and gastroesophageal junction cancer because of the expected prevalence of EpCAM expression. It plans to screen pancreatic and biliary tract cancer patients for EpCAM expression.

McCarthy said EpCAM is expressed at some level in nearly all pancreatic and biliary tract cancer patients based on published literature and the company’s studies using its immunohistochemistry assay. He said approximately 50% to 60% of patients may be considered EpCAM-high, depending on the definition, though CytomX has not disclosed its cutoff for high expression.

“We think it makes sense to at least start” with higher EpCAM-expressing patients in pancreatic and biliary tract cancers, McCarthy said, while noting the company is still learning about the relationship between EpCAM levels and Varseta-M activity.

CX-801 and Regeneron Collaboration Progress

CytomX also reported progress for CX-801, its masked interferon alfa-2b program in checkpoint-refractory melanoma. The monotherapy portion of the Phase I study has reached its fourth dose level, while the combination study with KEYTRUDA has cleared its third dose level and continues enrollment.

McCarthy said CX-801 monotherapy has been generally well tolerated to date, including at doses exceeding levels achieved with commercially available unmasked interferon alfa-2b. Initial clinical data from the melanoma study are expected in the first half of 2027.

During the quarter, CytomX announced an expanded collaboration with Regeneron focused on next-generation masked bispecific immunotherapies. Chief Financial Officer Chris Ogden said CytomX received a $37 million payment from Regeneron in July after the selection of two additional targets under the collaboration.

Ogden said the payment was not included in CytomX’s June 30 cash balance and will be recognized as revenue over time as work is performed on the preclinical programs.

Second-Quarter Financial Results

• Cash, cash equivalents and investments totaled $330.3 million as of June 30, compared with $346.7 million as of March 31.
• The June 30 balance did not include the $37 million July payment from Regeneron. Ogden said pro forma cash was about $367 million after that payment.
• Total revenue was $1.4 million, down from $18.7 million in the second quarter of 2025, primarily due to the conclusion of the Bristol Myers Squibb collaboration in 2025 and the Astellas collaboration in the first half of 2026.
• Operating expenses increased to $25.2 million from $19.9 million a year earlier.
• Research and development expense rose to $17.6 million, driven primarily by Varseta-M manufacturing, personnel costs and other research and development expenses.
• General and administrative expense increased to $7.6 million from $6.6 million, primarily because of higher consulting costs.

Ogden said CytomX expects its existing balance sheet to provide cash runway into at least the second half of 2028, supporting its planned registrational study for Varseta-M, earlier-line combination development and expansion into other EpCAM-expressing cancers.

About CytomX Therapeutics (NASDAQ:CTMX)

CytomX Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation therapeutics based on its proprietary Probody® platform. The company engineers masked antibody prodrugs that remain inactive in healthy tissue but are selectively activated in the tumor microenvironment. This approach is designed to enhance the safety and tolerability of antibody-based therapies, particularly those targeting immuno-oncology pathways.

At the core of CytomX's pipeline is Pacmilimab (CX-072), an anti–PD-L1 Probody therapeutic currently undergoing clinical evaluation for multiple solid tumor indications.

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