On November 12, 2026 Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, reported financial results and business updates for the third quarter ended September 30, 2026.

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"With each successive clinical update, we are building a stronger foundation for zolucatetide as a unique medicine with the potential to make a meaningful difference for patients across multiple diseases," said Mathai Mammen, M.D., Ph.D., Chairman, Chief Executive Officer and President of Parabilis Medicines. "The updated results presented at ESMO (Free ESMO Whitepaper) further reinforce our confidence in the depth and consistency of desmoid tumor responses, alongside a favorable safety and tolerability profile. With our Phase 3 dosing, regimen and trial design aligned with the FDA, we are well positioned to initiate PEDESTAL in the first half of 2027, bringing us closer to delivering a potentially transformative treatment for patients with desmoid tumors."

Dr. Mammen continued, "We are also continuing to deliver on zolucatetide’s potential to become a pipeline in a product, advancing development in FAP, adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and other Wnt-driven diseases, while pursuing a scientifically grounded combination approach in MSS CRC through our collaboration with Revolution Medicines. In parallel, we are selectively advancing a broader pipeline of programs against other historically undruggable targets. The progress across our portfolio continues to strengthen our conviction in the ability of our HeliconTM platform to repeatedly translate breakthrough science into medicines that can meaningfully improve patients’ lives."

Recent Business Highlights and Anticipated Milestones

Continued Advancement of Zolucatetide

Desmoid tumors

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Presented compelling clinical data from a June 22, 2026, data cut of the ongoing Phase 1/2 trial of zolucatetide at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, demonstrating:
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An objective response rate (ORR) of 72.2% (13/18) among patients evaluable at the 32-week landmark who received a starting dose of ≥450 mg
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A disease control rate (DCR) of 100%, with no disease progression, across all 46 response-evaluable patients receiving a starting dose of ≥450 mg
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A favorable safety and tolerability profile now shown in 76 patients, with no treatment discontinuations due to treatment-related adverse events (TRAEs)
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Reached alignment with the U.S. Food and Drug Administration (FDA) on a global Phase 3 trial design; plan to initiate the randomized, double-blind PEDESTAL Phase 3 registrational trial in the first half of 2027 with topline results anticipated in 2029
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Selected for an oral presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2026, featuring data from the June 22, 2026, data cut
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Initiated a Phase 1/2 clinical trial of zolucatetide in patients with desmoid tumors in China to support the planned inclusion of patients in China in the global PEDESTAL Phase 3 registrational trial
Familial adenomatous polyposis

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Initiated a dose-ranging clinical cohort as part of the ongoing Phase 1/2 trial to evaluate zolucatetide in patients with FAP and identify the optimal dose and regimen
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Anticipate disclosing translational data demonstrating on-target activity at a medical meeting in the first quarter of 2027

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Anticipate disclosing clinical data from additional patients with FAP in the first quarter of 2027, building on compelling early observations of duodenal polyp reductions in two patients
Adamantinomatous craniopharyngioma

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Anticipate disclosing updated clinical data from additional patients with ACP in the first half of 2027, building on encouraging early antitumor activity in three patients
Hepatocellular carcinoma and additional Wnt/β-catenin-driven tumors

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Anticipate disclosing additional clinical data in HCC at a medical meeting in the first quarter of 2027, building on evidence of early activity in a heavily pretreated patient
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Continue evaluating zolucatetide across additional Wnt/β-catenin-driven tumor types as part of the ongoing Phase 1/2 clinical trial
Clinical collaboration with Revolution Medicines in RAS G12D mutant MSS CRC

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Entered into a clinical collaboration with Revolution Medicines (RevMed) to evaluate zolucatetide in combination with RevMed’s zoldonrasib, an investigational, oral RAS(ON) G12D-selective covalent tri-complex inhibitor, and cetuximab, an EGFR inhibitor, in patients with previously treated RAS G12D mutant MSS CRC; Parabilis will sponsor and conduct the study, with RevMed supplying zoldonrasib and equally sharing the costs of the trial
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Supported by clinical translational data from the Phase 1/2 trial showing reciprocal upregulation of mitogen-activated protein kinase (MAPK) and downregulation of the Wnt pathway in patients with MSS CRC treated with zolucatetide, alongside a manageable safety and tolerability profile
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Also supported by preclinical data showing enhanced tumor growth inhibition when zolucatetide was combined with zoldonrasib in a CRC patient-derived xenograft model
Advancement of the Helicon Platform and Discovery Pipeline

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Continued advancing wholly owned preclinical programs, including ERG and allosteric ARON degraders in prostate cancer and a β-catenin degrader program, alongside ongoing research under the strategic collaboration with Regeneron to develop Antibody-Helicon Conjugates (AHCs) targeting intracellular proteins

Corporate Updates

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Appointed Craig L. Tendler, M.D., to the Board of Directors in August 2026, bringing extensive oncology drug development and regulatory experience
Upcoming Investor Conferences
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Announced that Mathai Mammen, M.D., Ph.D., Chairman, CEO and President, will deliver a company presentation at the Jefferies Global Healthcare Conference in London, UK, on Monday, November 16, 2026, at 12:30 p.m. GMT / 7:30 a.m. EST, and participate in a fireside chat at the Evercore ISI 9th Annual Healthcare Conference on Monday, November 30, 2026, at 3:50 p.m. EST; webcasts will be available at View Source
Third Quarter 2026 Financial Results

Cash position and runway: Cash, cash equivalents and marketable securities were $1.1 billion as of September 30, 2026, compared to $27.7 million as of December 31, 2025. The Company’s cash, cash equivalents and marketable securities as of September 30, 2026, are expected to fund operations into 2030.

Revenue: Revenues for the quarter ended September 30, 2026, were $2.1 million from collaboration agreements, compared to no revenue for the comparable prior-year period.

R&D expenses: Research and development expenses were $45.6 million for the quarter ended September 30, 2026, compared to $28.2 million for the comparable prior-year period. The increase of $17.4 million was primarily driven by ongoing investment in the clinical development of zolucatetide across a number of indications and increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline.

G&A expenses: General and administrative expenses were $11.3 million for the quarter ended September 30, 2026, compared to $6.6 million for the comparable prior-year period. The increase of $4.7 million was primarily attributable to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth as it advances its clinical programs and expenses associated with operating as a public company.

Net loss: Net loss was $44.5 million for the quarter ended September 30, 2026, compared to $33.5 million for the comparable prior-year period. The increase in net loss of $11.0 million was primarily driven by increased operating costs.

(Press release, Parabilis Medicines, NOV 12, 2026, View Source [SID1234674681])