Financial Performance - Protara reported a net loss of $12.8 million, or $0.48 per share, for Q4 2024, compared to a net loss of $10.2 million, or $0.90 per share, in Q4 2023[14]. - For the full year 2024, the net loss was $44.6 million, or $2.17 per share, compared to a net loss of $40.4 million, or $3.57 per share, in 2023[14]. - The company reported a net income (loss) per share of $(0.48) for the three months ended December 31, 2024, compared to $(0.90) for the same period in 2023[21]. - Comprehensive loss for the year ended December 31, 2024, was $44,563,000, compared to $39,763,000 in 2023, reflecting an increase of 12%[21]. - Net loss for the year ended December 31, 2024, was $44,596,000, compared to a net loss of $40,420,000 in 2023, indicating a deterioration of 10%[21]. Cash and Investments - Cash, cash equivalents, and investments totaled $170 million as of December 31, 2024, expected to support operations into 2027[5]. - Cash and cash equivalents rose significantly to $162,798,000 in 2024, up from $39,586,000 in 2023, marking an increase of 311%[19]. - Interest and investment income for the year ended December 31, 2024, was $4,171,000, up from $3,193,000 in 2023, an increase of 30%[21]. Research and Development - Research and development expenses for Q4 2024 increased to $9.5 million from $6.4 million in the prior year, and for the full year increased to $31.7 million from $25.0 million in 2023[14]. - Research and development expenses increased to $31,704,000 in 2024 from $24,989,000 in 2023, a rise of 27%[21]. - Protara continues to explore combination treatment opportunities with TARA-002 in NMIBC patients, indicating significant potential for systemic dosing and combination therapy[8]. - The complete response (CR) rate in the ADVANCED-2 trial for TARA-002 was 72% (13/18) at six months and 70% (14/20) at any time[4]. - Initial data from 12-month evaluable patients in the ADVANCED-2 trial is expected to be reported by mid-2025[3]. - Protara plans to initiate the THRIVE-3 trial of intravenous Choline Chloride in the first half of 2025, with a total of 100 patients expected to be enrolled[6]. - The company expects to provide an interim update from the STARBORN-1 trial of TARA-002 in pediatric lymphatic malformations by the end of the first half of 2025[5]. Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $49,154,000, compared to $43,613,000 in 2023, reflecting an increase of 13%[21]. - General and administrative expenses for Q4 2024 increased slightly to $4.8 million from $4.7 million in the prior year, while full-year expenses decreased to $17.5 million from $18.6 million in 2023[14]. Assets and Equity - Total assets increased to $181,454,000 in 2024 from $78,954,000 in 2023, representing a growth of 130%[19]. - Total stockholders' equity rose to $167,134,000 in 2024, up from $68,321,000 in 2023, an increase of 144%[19]. - The number of common shares outstanding increased to 35,044,772 in 2024 from 11,364,903 in 2023, representing a growth of 208%[19].

Core Insights - Protara Therapeutics, Inc. is focused on developing transformative therapies for cancer and rare diseases, with significant progress reported in their clinical pipeline [2][16] - The company announced positive six-month data from the Phase 2 ADVANCED-2 trial for TARA-002 in non-muscle invasive bladder cancer (NMIBC) and plans to report initial 12-month data by mid-2025 [2][5] - Protara is set to initiate the pivotal THRIVE-3 trial for intravenous Choline Chloride in the first half of 2025, targeting patients on parenteral support [4][5] Recent Progress and Highlights - Positive interim results from the ADVANCED-2 trial showed a complete response (CR) rate of 72% at six months for NMIBC patients [6] - The company has a cash position of $170 million as of December 31, 2024, which is expected to fund operations into 2027 [5][14] - The THRIVE-3 trial will assess the efficacy and safety of IV Choline Chloride over 24 weeks in patients unable to receive oral or enteral nutrition [4][15] Financial Results - For Q4 2024, Protara reported a net loss of $12.8 million, or $0.48 per share, compared to a net loss of $10.2 million, or $0.90 per share, in Q4 2023 [14][20] - Research and development expenses increased to $9.5 million in Q4 2024 from $6.4 million in the prior year, primarily due to clinical trial activities [14][20] - Total operating expenses for the full year 2024 were $49.2 million, up from $43.6 million in 2023 [20]

Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [3] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [3] - Protara is conducting ongoing Phase 2 trials for TARA-002 in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as in pediatric patients with LMs [3] Upcoming Events - Management will participate in a fireside chat at the TD Cowen 45 Annual Health Care Conference on March 5, 2025, at 9:50 am ET in Boston [1] - A live webcast of the fireside chat will be available on the company's website and will be archived for a limited time after the presentation [2] Additional Developments - Protara is also developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]

Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [3] - The company's lead candidate is TARA-002, an investigational cell-based therapy targeting non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [3] - Protara is conducting a Phase 2 trial for TARA-002 in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as a Phase 2 trial in pediatric patients with LMs [3] - Additionally, Protara is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition [3] Upcoming Events - Management will participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 12:40 pm ET [1] - A live webcast of the fireside chat will be available on the company's website and archived for a limited time [2]

Core Insights - Protara Therapeutics reported positive six-month data from the ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) and completed a public offering of approximately $100 million, extending its financial runway into 2027 [1][2][7] - The company anticipates key milestones in 2025, including initial data from 12-month evaluable NMIBC patients in the ADVANCED-2 trial and the commencement of the THRIVE-3 registrational trial of IV Choline Chloride [1][2][3][10] Group 1: TARA-002 in NMIBC - The ADVANCED-2 trial reported a complete response (CR) rate of 72% at six months and 70% at any time for BCG-Unresponsive patients, with a favorable safety profile [3][4] - The company plans to report data on 12-month evaluable patients in mid-2025 and results from a futility analysis of approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 [1][3] - Protara is exploring systemic priming dosing and combination therapy with TARA-002 for NMIBC patients [4] Group 2: IV Choline Chloride - The THRIVE-3 registrational trial for IV Choline Chloride is expected to begin in the first half of 2025, targeting patients dependent on parenteral support [1][10] - Previous studies indicated that 78% of PS-dependent patients were choline deficient, with 63% showing liver dysfunction [10] Group 3: Financial Guidance - Protara reported approximately $81.5 million in cash and equivalents as of September 30, 2024, along with the $100 million from the public offering, which is expected to fund operations into 2027 [7]

Core Insights - Protara Therapeutics, Inc. will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 16, 2025, at 7:30 am PT in San Francisco [1] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [3] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [3] - TARA-002 is currently being evaluated in a Phase 2 trial for NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as in a Phase 2 trial for pediatric patients with LMs [3] - Additionally, Protara is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]

Company Overview - Protara Therapeutics Inc (NASDAQ: TARA) was last reviewed in February 2024, when the stock was trading below its cash value, implying a negative valuation for its entire portfolio of drug candidates [1] Investment Approach - The analyst focuses on small-cap companies with high upside potential relative to downside risk, employing a value-based approach while also exploring special and short situations [1] - The analyst is a trained CPA with industry experience, providing a strong foundation for financial analysis [1] Analyst Position - The analyst holds a beneficial long position in TARA shares through stock ownership, options, or other derivatives [2] - The article represents the analyst's personal opinions and is not influenced by compensation or business relationships with the mentioned company [2]

Core Points - Protara Therapeutics, Inc. has closed an underwritten public offering of 13,690,000 shares of common stock at a price of $6.25 per share, along with pre-funded warrants for 2,325,372 shares at $6.249 each, raising approximately $100 million in gross proceeds [1][2][3] Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 2,402,305 shares at the public offering price [1] - The net proceeds will be used to fund the clinical development of TARA-002 and other clinical programs, as well as for working capital and general corporate purposes [1] Group 2: Underwriters - TD Cowen, Cantor, LifeSci Capital, Oppenheimer & Co., and Scotiabank served as joint book-running managers for the offering [2] Group 3: Regulatory Information - The shares and warrants were issued under an effective shelf registration statement declared effective on November 14, 2023, by the U.S. Securities and Exchange Commission [3]

Core Insights - Protara Therapeutics, Inc. is advancing TARA002, a cell therapy for non-muscle invasive bladder cancer (NMIBC), with interim data from the Phase 2 ADVANCED-2 trial to be presented at the Society of Urologic Oncology's annual meeting in December 2024 [1][3] - The ADVANCED-2 trial includes BCG-unresponsive and BCG-naïve patients, with a focus on safety and efficacy data from approximately 20 enrolled patients [2][3] - TARA-002 is derived from a master cell bank of genetically distinct group A Streptococcus pyogenes and has shown manufacturing comparability with OK432, an approved immunopotentiator [3][4] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases, with TARA-002 as its lead candidate for NMIBC and lymphatic malformations [6] - The company is also developing IV Choline Chloride for patients on parenteral nutrition [6] Industry Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases each year, making it a significant area of focus for treatment advancements [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Delaware 20-4580525 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value per share TARA The Nasdaq Capital Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRAN ...