Parabilis Medicines — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue for the quarter ended September 30, 2026, was $2.1 million from collaboration agreements, compared to $0 in the prior-year period.
• Research and development expenses were $45.6 million for the quarter, an increase of $17.4 million from $28.2 million in the prior-year period, driven by clinical development investment and increased hiring.
• General and administrative expenses were $11.3 million for the quarter, an increase of $4.7 million from $6.6 million in the prior-year period, attributed to higher employee-related costs and public company operating expenses.
• Net loss was $44.5 million for the quarter, compared to $33.5 million in the prior-year period, primarily due to increased operating costs.
• Cash, cash equivalents, and marketable securities totaled $1.1 billion as of September 30, 2026, compared to $27.7 million as of December 31, 2025.
• Total current assets were $879.0 million as of September 30, 2026, compared to $29.4 million as of December 31, 2025.
• Total liabilities were $126.9 million as of September 30, 2026, compared to $97.3 million as of December 31, 2025.
• Stockholders' equity (deficit) was $1.0 billion as of September 30, 2026, compared to a deficit of $526.5 million as of December 31, 2025.
• Deferred revenue was $40.8 million ($13.5 million current, $27.3 million non-current) as of September 30, 2026, compared to $0 in the prior period.
• Term loan, net of discount, was $2.0 million as of September 30, 2026, compared to $13.1 million as of December 31, 2025.
• Convertible preferred stock was $0 as of September 30, 2026, compared to $510.0 million as of December 31, 2025.

Guidance and Future Outlook:

• The company expects its cash position to fund operations into 2030.
• The PEDESTAL Phase 3 registrational trial in desmoid tumors is planned to initiate in the first half of 2027, with topline results anticipated in 2029.
• Translational data demonstrating on-target activity in familial adenomatous polyposis (FAP) is anticipated for disclosure in the first quarter of 2027.
• Clinical data from additional FAP patients is anticipated for disclosure in the first quarter of 2027.
• Updated clinical data for adamantinomatous craniopharyngioma (ACP) is anticipated for disclosure in the first half of 2027.
• Additional clinical data for hepatocellular carcinoma (HCC) is anticipated for disclosure at a medical meeting in the first quarter of 2027.

Business Segments and Product Lines:

• Zolucatetide (Desmoid Tumors): Presented Phase 1/2 data at ESMO Congress 2026 showing a 72.2% objective response rate (13/18) at the 32-week landmark for patients receiving ≥450 mg, and a 100% disease control rate across 46 response-evaluable patients. Safety data from 76 patients showed no treatment discontinuations due to treatment-related adverse events.
• Zolucatetide (FAP): Initiated a dose-ranging clinical cohort to identify the optimal dose and regimen; early observations showed duodenal polyp reductions in two patients.
• Zolucatetide (ACP): Early antitumor activity was observed in three patients.
• Zolucatetide (HCC): Evidence of early activity was observed in a heavily pretreated patient.
• Zolucatetide (MSS CRC): Entered a clinical collaboration with Revolution Medicines to evaluate zolucatetide in combination with zoldonrasib and cetuximab in previously treated RAS G12D mutant microsatellite stable metastatic colorectal cancer; Parabilis will sponsor and conduct the study with equally shared costs.
• Helicon Platform: Continued advancement of preclinical programs including ERG and allosteric ARON degraders in prostate cancer, a β-catenin degrader program, and a strategic collaboration with Regeneron for Antibody-Helicon Conjugates (AHCs).
• Global Trials: Initiated a Phase 1/2 clinical trial of zolucatetide in desmoid tumors in China to support inclusion in the global PEDESTAL Phase 3 trial.

Market and Competitive Landscape:

• The company positions zolucatetide as the first and only direct inhibitor of the β-catenin:TCF interaction, a target historically considered undruggable.
• The company is advancing programs against other historically undruggable targets beyond the Wnt/β-catenin pathway.

Risks and Challenges:

• Forward-looking statements are subject to risks including uncertainties in preclinical and clinical development activities, the ability to obtain regulatory approvals on expected timelines, and dependence on third parties for clinical trials, manufacturing, and commercialization.
• Risks include the need for substantial additional funds to complete development and commercialize product candidates, regulatory developments, intellectual property protection, and the competitive landscape.
• Actual results may differ materially from expectations due to factors such as the ability to attract and retain key personnel and risks related to financial condition.

Management Commentary and Tone:

• CEO Mathai Mammen, M.D., Ph.D., stated that successive clinical updates are building a stronger foundation for zolucatetide, reinforcing confidence in the depth and consistency of desmoid tumor responses and the favorable safety profile.
• Management expressed confidence in being well-positioned to initiate the PEDESTAL trial in the first half of 2027, bringing the company closer to delivering a potentially transformative treatment for desmoid tumors.
• Management highlighted the advancement of zolucatetide's potential as a pipeline in a product across multiple Wnt-driven diseases and the pursuit of a scientifically grounded combination approach in MSS CRC.
• Management noted progress across the portfolio strengthens conviction in the Helicon platform's ability to translate breakthrough science into medicines.

Other Key Points:

• Reached alignment with the U.S. FDA on dose, regimen, and trial design for the upcoming PEDESTAL Phase 3 registrational trial in desmoid tumors.
• Appointed Craig L. Tendler, M.D., to the Board of Directors in August 2026.
• Selected for an oral presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2026.
• CEO will present at the Jefferies Global Healthcare Conference in London on November 16, 2026, and participate in a fireside chat at the Evercore ISI 9th Annual Healthcare Conference on November 30, 2026.
• The company reported $10.4 million in interest income for the quarter, compared to $0.7 million in the prior-year period.
• Unrealized losses on marketable securities were $1.9 million for the quarter.