Nov 6, 2026, 8:05 AM ETHealthcare

Protara Therapeutics — Third Quarter 2026 Earnings Summary

TARAPROTARA THERAPEUTICS INC

Financial Performance

Reported a net loss of $21.7 million ($0.35 per share) for the quarter ended September 30, 2026, compared to a net loss of $13.3 million ($0.31 per share) in the prior-year period.
Research and development expenses increased to $16.8 million from $9.6 million in the prior-year period, driven by $4.4 million in higher clinical trial costs, $2.0 million in personnel expenses, and $0.8 million in non-program specific R&D costs.
General and administrative expenses rose to $6.3 million from $5.2 million in the prior-year period, primarily due to $0.6 million in personnel-related expenses and $0.6 million in other G&A expenses.
Cash, cash equivalents, and marketable debt securities totaled $143.1 million as of September 30, 2026, with unrestricted cash and cash equivalents at $25.15 million and marketable debt securities at $117.93 million ($101.9 million current + $16.03 million non-current).
Total assets decreased to $156.5 million as of September 30, 2026, from $209.5 million as of December 31, 2025.
Total liabilities increased to $15.5 million as of September 30, 2026, from $13.1 million as of December 31, 2025.
Stockholders' equity decreased to $141.0 million as of September 30, 2026, from $196.4 million as of December 31, 2025.
For the nine months ended September 30, 2026, the company reported a net loss of $61.1 million ($1.01 per share) compared to $40.1 million ($0.96 per share) in the prior-year period.

Expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial for TARA-002 in NMIBC by year-end 2026.
Now expects to complete enrollment in the registrational STARBORN-1 trial for TARA-002 in LMs in early 2027.
Plans to initiate a rolling Biologics License Application (BLA) submission for TARA-002 in LMs in the second half of 2027.
Remains on track to report interim results from the Phase 2b portion of the THRIVE-3 trial for IV Choline Chloride by year-end 2026.
Cash reserves are expected to support planned operations and milestones into 2028.

TARA-002 in NMIBC: Announced intent to redesign the ongoing ADVANCED-3 trial into a multi-cohort, open-label trial evaluating efficacy and safety in BCG-Naïve and BCG-Exposed CIS and high-grade, high-risk papillary patients.
TARA-002 in LMs: Program holds Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy, and Fast Track designations from the FDA.
IV Choline Chloride: Completed enrollment of the Phase 2b portion of the THRIVE-3 trial, which enrolled 24 patients dependent on long-term parenteral support.
Manufacturing: Acquired TARA-002 manufacturing-related assets from Novex Innovations to bring manufacturing in-house and secure dedicated capacity ahead of potential commercial launch.

NMIBC represents approximately 80% of bladder cancer diagnoses in the U.S., affecting approximately 65,000 patients annually.
No currently approved therapies exist for macrocystic and mixed cystic Lymphatic Malformations (LMs).
No available parenteral support formulations currently contain choline; IV Choline Chloride aims to be the first FDA-approved IV choline formulation for this indication.
The company believes its NMIBC trial design positions TARA-002 to benefit from a recent FDA approach to expand labels for BCG-Unresponsive CIS NMIBC to include high-grade, high-risk papillary disease based on single-arm trials.

Forward-looking statements regarding clinical trial timing, regulatory interactions, and financial guidance are subject to risks and uncertainties that could cause actual results to differ materially.
Risks include potential delays in clinical trial initiation or completion, regulatory filing timing, market volatility affecting cash reserves, and the ability to obtain sufficient financing.
Specific risks involve the failure to attract and retain key personnel, changes in competitive landscape, and general economic or regulatory conditions.

CEO Jesse Shefferman stated the company continues to deliver across its late-stage portfolio, positioning itself to close the year with strong momentum and set the stage for an impactful 2027.
Management expressed confidence that TARA-002 has the potential to be a preferred treatment option for NMIBC patients.
The company is excited to bring manufacturing capability in-house to advance late-stage trials and prepare for commercial launches in LMs and NMIBC.

Entered into an asset purchase agreement with Novex Innovations, LLC on November 4, 2026, for TARA-002 manufacturing-related assets for an aggregate purchase price of $8.75 million.
The Novex transaction included an assembled workforce, inventory, intellectual property, contracts, equipment, permits, regulatory documentation, and records, along with a transition services agreement and a lease for a research and manufacturing facility.
Novex has manufactured TARA-002 for Protara since 2019 under a Manufacturing Services Agreement.
Protara holds U.S. patents for a choline composition and a method of treating choline deficiency, both expiring in 2041.
TARA-002 is a first-in-class TLR2/NOD2 agonist derived from inactivated Streptococcus pyogenes, developed from the same master cell bank as OK-432 (Picibanil®).