Protara Therapeutics Reports Q2 2024 Financials and Business Update

Protara Therapeutics, Inc., a clinical-stage biotechnology company, provided a business update alongside its financial results for Q2 2024. The company is progressing its mission to develop transformative therapies for cancer and rare diseases.

Progress in TARA-002 for NMIBC

Protara reported positive three-month data from its TARA-002 program targeting non-muscle invasive bladder cancer (NMIBC). This data suggests that TARA-002 could become a significant treatment option for NMIBC. Protara intends to present interim data from the ongoing ADVANCED-2 trial in Q4 2024, focusing on approximately ten six-month evaluable patients. The trial includes patients who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy and BCG-naïve patients. Furthermore, Protara has completed enrollment for a three-patient exploratory dosing cohort at an 80KE1 dose, with results expected by year-end. The company is also investigating combination therapies with TARA-002, leveraging its mechanism of action and safety profile.

IV Choline Chloride Development

In April 2024, Protara announced alignment with the FDA on a developmental path for IV Choline Chloride, intended for patients on long-term parenteral nutrition (PN) who cannot synthesize choline from oral or enteral sources. The company aims to commence patient dosing in a pivotal trial in Q1 2025.

Progress in TARA-002 for Lymphatic Malformations (LMs)

The STARBORN-1 trial, assessing TARA-002 in pediatric patients with lymphatic malformations (LMs), is advancing well. The first safety cohort is fully enrolled, and the second cohort will begin soon. This Phase 2 trial will include around 30 pediatric patients, assessing clinical success via reduction in total LM volume. Protara also sees potential for TARA-002 to treat other maxillofacial cysts in the future, based on historical data and recent case studies.

Financial Update

As of June 30, 2024, Protara's cash, cash equivalents, and marketable securities totaled approximately $89.6 million, bolstered by the $42 million net proceeds from the April 2024 private placement. These resources are projected to fund operations into 2026. For Q2 2024, research and development expenses decreased to $6.4 million from $7.2 million in the previous year, mainly due to reduced non-clinical and clinical trial expenses for TARA-002. General and administrative costs also decreased to $4.3 million from $4.9 million, largely due to reduced stock-based compensation and market development activities. Protara reported a net loss of $9.5 million, or $0.45 per share, compared to $11.3 million, or $1.00 per share, in Q2 2023.

Corporate Developments

In June 2024, Protara appointed Lisa Schlesinger as Vice President, Head of New Product Development and Market Access.

About Protara and Its Lead Candidates

Protara’s portfolio includes TARA-002, an investigational cell-based therapy in development for NMIBC and LMs. TARA-002 has shown promise as a broad immunopotentiator and is being actively tested in clinical trials. Protara is also developing IV Choline Chloride for patients requiring parenteral nutrition, aiming to address choline deficiency that can lead to liver damage.

Conclusion

Protara Therapeutics is advancing multiple clinical programs with promising interim results. The company is well-positioned financially to continue its research and development efforts, with significant milestones anticipated in the near future.

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