Protara Therapeutics, Inc. develops clinical-stage biotechnology programs for cancer and rare diseases. Company news centers on TARA-002, an investigational cell-based therapy being studied for non-muscle invasive bladder cancer and lymphatic malformations, including updates from the ADVANCED-2 trial in BCG-Unresponsive and BCG-Naïve NMIBC patient groups.
Recurring updates also cover IV Choline Chloride, an investigational phospholipid substrate replacement therapy for patients receiving long-term parenteral support. Other company announcements include clinical-conference presentations, FDA designation updates, financial results, equity compensation grants under Nasdaq rules, and capital-raising activity tied to Protara's development-stage pipeline.
Protara Therapeutics (TARA) announced significant advancements in its TARA-002 program, achieving FDA clearance for its IND application targeting non-muscle invasive bladder cancer (NMIBC). The company plans to initiate a Phase 1 clinical trial by year-end 2021. As of September 30, 2021, Protara reported strong cash reserves of $138.4 million, despite increasing R&D and administrative expenses leading to a net loss of $10.8 million for the quarter. The company also aims to engage the FDA for a trial design in lymphatic malformations.
Protara Therapeutics (Nasdaq: TARA) announced the grant of inducement stock options for 44,000 shares to Mary Grendell, the new General Counsel. Each option has an exercise price of $6.81, equal to the closing price on October 25, 2021. The options will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months, contingent on Ms. Grendell's continued employment. The awards were approved by the Compensation Committee following Nasdaq Listing Rule 5635(c)(4).
Protara Therapeutics (Nasdaq: TARA) has received FDA clearance for its Investigational New Drug (IND) application for TARA-002, a cell-based therapy targeting non-muscle invasive bladder cancer (NMIBC). The company plans to initiate a Phase 1 study by the end of 2021 to evaluate TARA-002's safety, tolerability, and preliminary anti-tumor activity. TARA-002 is derived from the same master cell bank as OK-432, which is already approved for oncologic use in Japan and Taiwan. There is a pressing need for new NMIBC treatments due to rising recurrence rates among patients.
Protara Therapeutics, Inc. (Nasdaq: TARA) will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2021, at 12:25 PM ET. The presentation will be accessible through a webcast on the Company's website and archived for 90 days post-event. Protara focuses on developing transformative therapies for cancer and rare diseases, including its lead program TARA-002 for non-muscle invasive bladder cancer and IV Choline Chloride for intestinal failure-associated liver disease.
Protara Therapeutics (TARA) announced a study revealing that approximately 30% of patients dependent on parenteral nutrition (PN) experience cholestasis, a key pathology of intestinal failure-associated liver disease (IFALD). This highlights an unmet medical need for effective treatments. The company is developing IV Choline Chloride as a replacement therapy for choline deficiency in PN patients, with promising results from prior studies. Protara's ongoing research aims to further investigate IFALD and assess the prevalence of choline deficiency among affected patients.
Protara Therapeutics, Inc. (Nasdaq: TARA) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference, occurring virtually from September 13-15, 2021. The company's prerecorded presentation will be available on September 13, 2021, at 7:00am ET, accessible via the Events and Presentations section on their website. Protara focuses on developing therapies for cancer and rare diseases, including TARA-002 for bladder cancer and lymphatic malformations, as well as IV Choline Chloride for intestinal failure-associated liver disease.
Protara Therapeutics, Inc. (TARA) reported significant progress in developing TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). As of June 30, 2021, the company holds $145 million in cash and investments. They completed IND-enabling studies and are on track to submit an IND application by year-end, aiming to initiate a Phase 1 trial for NMIBC. However, R&D expenses rose to $5.9 million, contributing to a net loss of $12.8 million for Q2 2021, compared to a $7.1 million loss in Q2 2020.
Protara Therapeutics (Nasdaq: TARA) announced management will present at the Ladenburg Thalmann Healthcare Conference on July 14, 2021, at 10:00am ET. This virtual event will allow participants to gain insights into Protara's pipeline, including TARA-002, a cell-based therapy aimed at treating non-muscle invasive bladder cancer and lymphatic malformations.
The presentation will be available via webcast on the company's website, archived for 90 days for investor access.
Protara Therapeutics (Nasdaq: TARA) welcomed Dr. Jane Huang to its Board of Directors, bringing extensive experience in oncology drug development. Dr. Huang's leadership roles include Chief Medical Officer at BeiGene and key positions at Acerta Pharma and Genentech. The appointment aims to enhance Protara's progress in developing TARA-002, a therapy for non-muscle invasive bladder cancer and lymphatic malformations. This move is expected to strengthen Protara's strategic direction as they continue to advance their innovative therapies for cancer and rare diseases.
Protara Therapeutics (Nasdaq: TARA) has announced its participation in two significant virtual investor conferences. The first is the Oppenheimer Rare & Orphan Disease Summit on May 21, 2021, at 11:35 AM ET, followed by the Jefferies Virtual Healthcare Conference on June 2, 2021, at 1:30 PM ET. Investors can access live webcasts of the presentations on the Company's website, which will be archived for 90 days. Protara focuses on developing therapies for cancer and rare diseases, including its lead program, TARA-002.