Protara Therapeutics Updates on Q3 2024 Results and Progress

Protara Therapeutics Reports Progress and Financial Update

NEW YORK - Protara Therapeutics, Inc. (NASDAQ: TARA) announced its financial results for the third quarter of 2024 and provided an insight into its ongoing business initiatives.

Significant Milestones in Clinical Trials

Protara is currently on schedule to release interim findings for the ADVANCED-2 trial of TARA-002, specifically in non-muscle invasive bladder cancer (NMIBC) patients. This study focuses on patients showing no response to Bacillus Calmette-Guérin (BCG) therapy, a critical demographic as the company seeks to enhance treatment options.

Upcoming Data Releases

Anticipated updates include interim data from six-month evaluable participants, expected within the fourth quarter of the year. Furthermore, the company aims to share interim 12-month data by mid-2025, showcasing its commitment to transparency and progress in clinical outcomes.

Expanding Therapeutic Applications

In the realm of pediatric lymphatic malformations (LMs), TARA-002 has exhibited promising outcomes in early cohorts of the STARBORN-1 trial. These results point to a generally favorable safety profile and efficacy, with additional data from subsequent cohorts expected in the first half of 2025, reinforcing the company’s strategy to address diverse and challenging medical conditions.

Development of IV Choline Chloride

Protara recently received Fast Track designation from the FDA for its IV Choline Chloride development. This injectable therapy aims to support patients who cannot meet their nutrient needs via traditional oral or enteral methods. The first patient in the THRIVE-3 registrational trial is anticipated to be dosed in early 2025, marking an important step forward for the company in this critical area of nutrition support.

Financial Overview for Q3 2024

As of the end of September 2024, Protara had approximately $81.5 million in cash and cash equivalents to support its planned operations through 2026. The research and development expenses increased this quarter to $8.1 million, reflecting the ongoing investment in TARA-002 and IV Choline Chloride. In contrast, general and administrative costs showed a slight decrease, highlighting the company’s efficient operational strategies.

Net Loss Evaluation

Protara incurred a net loss of $11.2 million for the third quarter of 2024, translating to $0.50 per share. This compares to a net loss of $9.9 million, or $0.87 per share, for the same period in the previous year. Such losses are common in clinical-stage companies and underscore the ongoing investments being made in their promising therapeutic candidates.

About TARA-002

TARA-002 is an investigational cell therapy that targets both NMIBC and LMs and has been granted Rare Pediatric Disease Designation by the FDA. By inducing an immune response, TARA-002 aims to enhance the patient outcomes in cancers where traditional therapies may fall short.

Understanding Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer remains a prevalent condition, with NMIBC accounting for around 80% of diagnoses. Protara's commitment to this patient population showcases its desire to address serious unmet medical needs effectively.

A Look at Lymphatic Malformations (LMs)

LMs represent a serious challenge in pediatric medicine, often resulting in significant complications. Protara’s research is vital in pushing the envelope for innovative treatment options for these pediatric patients critically affected by the condition.

Details on IV Choline Chloride

As a novel therapy for patients on parenteral nutrition, IV Choline Chloride offers essential support in maintaining choline levels that are crucial for numerous bodily functions, particularly in individuals unable to ingest traditional nutrition.

About Protara Therapeutics, Inc.

Protara is dedicated to innovating therapies targeting cancer and rare diseases, with TARA-002 being a central focus of its development pipeline. With ongoing trials and solid financial backing, the company is on track to bring significant advancements to the market.

Company Contact:

Justine O'Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836

Frequently Asked Questions

What recent developments have occurred at Protara Therapeutics?

Protara announced it remains on track with its clinical trials for TARA-002 and IV Choline Chloride, with key data expected soon.

What is the primary focus of TARA-002?

TARA-002 is aimed at treating non-muscle invasive bladder cancer and lymphatic malformations, demonstrating promise in clinical trials.

How did Protara's financial performance fare in Q3 2024?

The company reported a net loss of $11.2 million, with a substantial amount of cash reserves ensuring strategic developments continue through 2026.

What regulatory recognition did Protara receive for IV Choline Chloride?

The FDA awarded Protara Fast Track designation for IV Choline Chloride, facilitating its development for parenteral nutrition patients.

When can we expect new data from Protara's trials?

Protara is set to report interim data from its ADVANCED-2 trial in Q4 2024 and the STARBORN-1 trial in the first half of 2025.

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