Advanced zolucatetide across multiple Wnt/<BETA>-catenin-driven diseases, including progress toward planned Phase 3 registrational trial in desmoid tumors

Announced strategic research collaboration with Regeneron to develop Antibody-Helicon Conjugates, expanding application of company's proprietary Helicon$(TM)$ platform; received $125M in upfront consideration and equity investment, with the potential for up to $2.2B in milestone payments plus tiered royalties

Ended the second quarter with a strong financial position with $1.1B in cash, cash equivalents and marketable securities, following completion of $770.5M initial public offering and other transactions, expected to fund operations into 2030

CAMBRIDGE, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today reported financial results and business updates for the second quarter ended June 30, 2026.

"This quarter marked meaningful progress toward our long-term vision as we continued advancing zolucatetide across multiple Wnt/<BETA>-catenin-driven diseases, including toward planned registrational development in desmoid tumors, while also extending the reach of our Helicon(TM) platform through our strategic research collaboration with Regeneron focused on developing Antibody-Helicon Conjugates," said Mathai Mammen, M.D., Ph.D., Chairman, President and Chief Executive Officer of Parabilis Medicines.

Dr. Mammen continued, "The body of encouraging clinical evidence for zolucatetide has strengthened our conviction both in its potential to transform the treatment of patients with Wnt/<BETA>-catenin-driven diseases and in the broader ability of Helicons to unlock biologically important intracellular targets that have historically been beyond the reach of conventional therapeutic approaches. With a strong balance sheet following our successful initial public offering, we believe we are well positioned to deliver important clinical and regulatory milestones over the coming quarters as we continue advancing medicines designed to target the causal biology and deliver meaningful impact for patients with serious diseases."

Recent Business Highlights & Anticipated Milestones

Continued Advancement of Zolucatetide

Zolucatetide is Parabilis' lead investigational Helicon and the first and only direct inhibitor of the <BETA>-catenin:TCF interaction in clinical development. The investigational therapy is being evaluated as a "pipeline in a product" across multiple Wnt/<BETA>-catenin-driven diseases, with promising early clinical data demonstrating its potential in desmoid tumors, with familial adenomatous polyposis (FAP) and adamantinomatous craniopharyngioma $(ACP)$ as potential genetically anchored expansion opportunities.

Desmoid tumors

   -- Abstract accepted for oral presentation at the European Society for 
      Medical Oncology (ESMO) Congress 2026 (Oct. 23-27, Madrid), with a plan 
      to share clinical data from the February data cut from the ongoing Phase 
      1/2 study of zolucatetide in desmoid tumor patients 
 
   -- Expect to present more mature clinical data from the ongoing Phase 1/2 
      study in desmoid tumors during the fourth quarter of 2026 
 
   -- Expect to engage with the U.S. Food and Drug Administration (FDA) during 
      the fourth quarter of 2026 to discuss and align on the planned 
      registrational Phase 3 trial 
 
   -- On track to initiate Phase 3 registrational trial in the first half of 
      2027 

Familial adenomatous polyposis (FAP)

   -- Expect to initiate enrollment in a dedicated clinical cohort evaluating 
      zolucatetide in patients with FAP during the second half of 2026 
 
   -- Anticipate disclosing additional FAP data in the first quarter of 2027 

Adamantinomatous craniopharyngioma (ACP)

   -- Expect to share clinical data from additional patients in the first half 
      of 2027 for ACP, a locally aggressive tumor arising near the pituitary 
      gland associated with significant lifelong morbidity and no approved drug 
      therapies, with a conservatively estimated 15-year prevalence of 
      approximately 5,000 to 9,000 patients in the U.S. 

Additional Wnt-driven tumors

   -- Continue to enroll patients across additional cohorts evaluating 
      zolucatetide across additional indications with high unmet medical need, 
      including hepatocellular carcinoma $(HCC)$, colorectal cancer $(CRC)$ in 
      rational combinations, and other Wnt-driven solid tumors 
 
   -- Correspondence published in the New England Journal of Medicine (NEJM) 
      demonstrates durable clinical and radiologic response to zolucatetide in 
      a patient with recurrent ameloblastoma -- a locally aggressive tumor of 
      the jaw -- driven by Wnt/<BETA>-catenin pathway alterations, providing 
      further clinical validation of zolucatetide's mechanism of action 

Expanded the Application of the Helicon Platform

During the second quarter of 2026, Parabilis continued to expand the reach of its proprietary Helicon platform through strategic partnerships and advancement of its wholly-owned discovery pipeline.

   -- Announced a strategic collaboration with Regeneron Pharmaceuticals, Inc. 
      focused on developing Antibody-Helicon Conjugates (AHCs), a novel 
      therapeutic modality combining Regeneron's VelocImmune$(R)$ antibody 
      technologies with Parabilis' proprietary Helicon platform to selectively 
      target undruggable and challenging intracellular disease-driving 
      proteins; Parabilis received $125 million, including $50 million in 
      upfront consideration and a $75 million equity investment, and the 
      collaboration provides the potential for up to approximately $2.2 billion 
      in development, regulatory and commercial milestone payments, plus up to 
      low double-digit tiered royalties 
 
   -- Continued advancing multiple wholly owned Helicon-based preclinical 
      programs targeting historically undruggable intracellular proteins, 
      including ERG and allosteric ARON degraders in prostate cancer and a 
      <BETA>-catenin degrader program 

Strengthened Leadership and Governance

Parabilis continued to strengthen its leadership team and Board of Directors to support the Company's next phase of growth as a public company.

   -- Expanded the Company's executive leadership team through the appointments 
      of Helen Ho, Ph.D., as Chief Business & Strategy Officer, and Tom 
      Kotarakos as Chief Financial Officer 
 
   -- Appointed Alan M. Sebulsky to the Board of Directors, bringing more than 
      three decades of biopharmaceutical finance and operational leadership 
      experience 

Completed Initial Public Offering

During the quarter, Parabilis successfully completed its upsized initial public offering, raising a total of $770.5 million (before offering expenses), strengthening the Company's balance sheet to support the continued advancement of its clinical pipeline and proprietary Helicon(TM) platform.

   -- Closed upsized initial public offering of common stock, including the 
      full exercise of the underwriters' option to purchase additional shares, 
      at an initial public offering price of $20.00 per share 
 
   -- Completed a concurrent private placement with Regeneron resulting in 
      gross proceeds of approximately $75 million 
 
   -- Began trading on the Nasdaq Global Select Market under the ticker 
      symbol "PBLS" on June 10, 2026 

Second Quarter Financial Results

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

R&D expenses: Research and development expenses were $39.4 million for the quarter ended June 30, 2026, compared to $30.1 million for the comparable prior year period. The increase of $9.3 million was primarily driven by ongoing investment in the clinical development of zolucatetide across a number of indications, increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline, and progression of the Company's preclinical <BETA>-catenin, ERG, and AR$(ON)$ degrader programs.

G&A expenses: General and administrative expenses were $11.7 million for the quarter ended June 30, 2026, compared to $6.4 million for the comparable prior year period. The increase of $5.3 million was primarily due 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 $52.5 million for the quarter ended June 30, 2026, compared to $34.8 million for the comparable prior year period. The increase in net loss of $17.7 million was primarily driven by increased operating expenses.

About Parabilis Medicines