Core Insights - Protara Therapeutics, Inc. is hosting a conference call on November 19, 2025, to discuss new data from the interim analysis of the Phase 2 STARBORN-1 trial for TARA-002, a cell-based therapy for pediatric patients with lymphatic malformations [1][2] Group 1: Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [5] - The company's lead candidate, TARA-002, is in development for non-muscle invasive bladder cancer and lymphatic malformations [5] - TARA-002 has received Rare Pediatric Disease designation from the U.S. FDA for the treatment of lymphatic malformations [3] Group 2: Product Details - TARA-002 is a genetically distinct strain of streptococcus pyogenes that retains immune-stimulating properties while being inactivated [3] - The therapy was developed from the same master cell banks as OK-432, which has been the standard of care in Japan for 30 years [3] - A large Phase 2 trial of OK-432 demonstrated significant clinical success in over 500 patients with lymphatic malformations [3] Group 3: Lymphatic Malformations - Lymphatic malformations are rare congenital conditions affecting lymphatic vessels, often diagnosed in early childhood [4] - More than 50% of lymphatic malformations are detected at birth, with 90% diagnosed before the age of three [4] - Common complications include airway obstruction, intralesional bleeding, and recurrent infections, leading to significant morbidity [4]

Core Insights - Protara Therapeutics, Inc. announced interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for treating non-muscle invasive bladder cancer (NMIBC) [1][2] - The trial data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology from December 2 to December 5, 2025 [1] - TARA-002 is an investigational cell therapy that has received Rare Pediatric Disease Designation from the FDA [3][6] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases [6] - The company's lead candidate, TARA-002, is being evaluated in ongoing Phase 2 trials for NMIBC and lymphatic malformations [6] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [6] Trial Details - The ADVANCED-2 trial includes BCG-Naïve patients with NMIBC, specifically those with carcinoma in situ or CIS [2] - The trial involves an induction course of six weekly intravesical instillations of TARA-002, followed by maintenance treatments [2] - The upcoming poster presentation will include updated safety and efficacy data from 31 enrolled patients [1][3] Disease Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases each year [5] - Bladder cancer is the sixth most common cancer in the United States [5] Mechanism of Action - TARA-002 is hypothesized to activate immune cells in the tumor, leading to a pro-inflammatory response and the release of cytokines [4] - The therapy aims to directly kill tumor cells and enhance the antitumor immune response through immunogenic cell death [4]

Financial Performance - As of September 30, 2025, the company had an accumulated deficit of approximately $285.1 million[132]. - The company expects to continue incurring significant and increasing expenses and operating losses for at least the next few years as it develops and seeks marketing approvals for its product candidates[132]. - Net income (loss) for Q3 2025 was $(13.3) million, compared to $(11.2) million in Q3 2024, representing an increase in loss of $2.1 million[140]. - Total operating expenses for the nine months ended September 30, 2025, were $45.5 million, an increase of $10.6 million compared to the same period in 2024[146]. - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $(39.4) million, an increase of $12.9 million compared to $(26.5) million in the same period of 2024[156]. - The company incurred a net loss of $40.1 million for the nine months ended September 30, 2025, compared to a net loss of $31.8 million for the same period in 2024[151]. - Net cash provided by financing activities was $1.8 million for the nine months ended September 30, 2025, a decrease from $42.0 million for the same period in 2024[158]. Research and Development - The ADVANCED-2 clinical trial for TARA-002 in NMIBC has enrolled 31 patients in Cohort A, with a complete response rate of 100% in BCG-Unresponsive patients at six months[117]. - The CR rate in BCG-Naïve patients was 76% at any time, with 63% at six months[118]. - The company plans to initiate the THRIVE-3 Phase 3 clinical trial for IV Choline Chloride by the end of 2025, with a primary endpoint measuring plasma choline concentration[126]. - In the THRIVE-1 study, 78% of patients dependent on parenteral support were found to be choline deficient, with 63% of those having liver dysfunction[125]. - The STARBORN-1 trial for TARA-002 in lymphatic malformations has enrolled approximately 30 patients, with interim data showing two patients achieving complete response after one injection[129]. - TARA-002 is being developed for both NMIBC and lymphatic malformations, with ongoing studies to explore its potential in combination therapies[121][127]. - IV Choline Chloride has received Orphan Drug Designation from the FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition[123]. - Total research and development expenses for the nine months ended September 30, 2025, were $29.5 million, an increase of approximately $7.3 million compared to the same period in 2024[148]. Cash and Liquidity - The company has approximately $133.6 million in unrestricted cash and cash equivalents as of September 30, 2025[133]. - Unrestricted cash and cash equivalents and marketable debt securities as of September 30, 2025, were $133.6 million, down from $170.3 million as of December 31, 2024[151]. - Cash used in investing activities for the nine months ended September 30, 2025, was approximately $(112.6) million, a significant increase from $(3.3) million in the same period of 2024[157]. - Other income (expense), net for Q3 2025 was $1.5 million, an increase of approximately $0.4 million compared to Q3 2024, driven by higher returns on invested cash[145]. - Cash provided during the nine months ended September 30, 2025, included $2.5 million from the exercise of the Underwriters' Option from the December 2024 Public Offering[158]. - The cash provided during the nine months ended September 30, 2024, was primarily from $42.0 million in proceeds from the April 2024 Private Placement[158]. Obligations and Contingencies - The company has operating lease obligations for its corporate headquarters and manufacturing facilities located in North America[159]. - Certain contracts require milestone payments upon achieving specific development, regulatory, or commercial milestones, but these are not recorded as liabilities until claims are asserted[162]. - Future payments to third parties are contingent on the achievement of certain milestones and are not included on the balance sheet[163]. - The company currently has no off-balance sheet arrangements as defined by SEC regulations[164].

Financial Performance - Protara reported a net loss of $13.3 million, or $0.31 per share, for Q3 2025, compared to a net loss of $11.2 million, or $0.50 per share, in Q3 2024[11]. - Net income (loss) for Q3 2025 was $(13,258) million, compared to $(11,219) million in Q3 2024, reflecting a decline of 18.2%[22]. - Net income (loss) per share attributable to common stockholders for Q3 2025 was $(0.31), an improvement from $(0.50) in Q3 2024[22]. - Comprehensive income (loss) for the nine months ended September 30, 2025, was $(39,991) million, compared to $(31,767) million for the same period in 2024, indicating a decline of 25.8%[22]. - Total net income (loss) for the nine months ended September 30, 2025, was $(40,132) million, compared to $(31,827) million for the same period in 2024, a decline of 26.0%[22]. Expenses - Research and development expenses increased to $9.6 million in Q3 2025 from $8.1 million in the prior year, primarily due to a $0.9 million increase in startup costs for the IV Choline Chloride THRIVE-3 clinical trial[11]. - General and administrative expenses rose to $5.2 million in Q3 2025 from $4.3 million in the prior year, mainly due to a $0.7 million increase in personnel-related expenses[11]. - Total operating expenses for Q3 2025 were $14,760 million, up from $12,330 million in Q3 2024, representing an increase of 19.7%[22]. - Research and development expenses increased to $9,591 million in Q3 2025 from $8,070 million in Q3 2024, a rise of 18.8%[22]. - General and administrative expenses rose to $5,169 million in Q3 2025 from $4,260 million in Q3 2024, an increase of 21.3%[22]. Assets and Cash Position - As of September 30, 2025, Protara had cash, cash equivalents, and investments totaling approximately $134 million, expected to support operations into mid-2027[4]. - Protara's total assets decreased to $144.6 million as of September 30, 2025, down from $181.5 million at the end of 2024[20]. Clinical Trials and Research - The company anticipates reporting interim results from approximately 25 six-month evaluable NMIBC patients in Q1 2026[5]. - Protara expects to dose the first patient in the THRIVE-3 trial by year-end 2025, which is a seamless Phase 2b/3 trial involving 105 patients[10]. - The Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients is on track to provide an interim update in Q4 2025[4]. - The company continues to evaluate subcutaneous dosing combined with intravesical dosing for TARA-002 in NMIBC patients[5]. Recognition and Culture - Protara was recognized among BioSpace's Best Places to Work in November 2025, highlighting its strong culture and innovation[8]. Shareholder Information - Weighted-average shares outstanding increased to 42,272,104 in Q3 2025 from 22,329,772 in Q3 2024, showing a significant increase in share count[22]. - Interest and investment income for Q3 2025 was $1,502 million, up from $1,111 million in Q3 2024, marking an increase of 35.2%[22]. Other Comprehensive Income - Other comprehensive income for Q3 2025 included a net unrealized gain of $66 million on marketable debt securities, compared to a gain of $29 million in Q3 2024[22].

Core Insights - Protara Therapeutics reported significant advancements in its clinical programs, particularly in the development of TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][5][10] - The company is on track to report interim results from its ADVANCED-2 trial in NMIBC patients in Q1 2026 and expects to provide updates on its STARBORN-1 trial for pediatric LMs in Q4 2025 [6][7] Clinical Development Updates - TARA-002 is being evaluated in the ADVANCED-2 trial for NMIBC, with interim results expected from approximately 25 BCG-Unresponsive patients in early 2026 [6][7] - The STARBORN-1 trial for TARA-002 in pediatric patients with LMs is progressing, with an interim update anticipated in Q4 2025 [5][6] - The THRIVE-3 trial for IV Choline Chloride is set to dose its first patient by the end of 2025, focusing on patients dependent on parenteral support [6][7] Financial Performance - As of September 30, 2025, Protara had approximately $134 million in cash and investments, expected to fund operations into mid-2027 [6][15] - Research and development expenses increased to $9.6 million in Q3 2025 from $8.1 million in the same period of 2024, primarily due to startup costs for the THRIVE-3 trial [15][23] - The company reported a net loss of $13.3 million, or $0.31 per share, for Q3 2025, compared to a net loss of $11.2 million, or $0.50 per share, in Q3 2024 [15][23] Corporate Recognition - Protara was recognized as one of BioSpace's Best Places to Work in November 2025, highlighting its strong culture and commitment to innovation [8]

Core Insights - Protara Therapeutics, Inc. has been recognized as one of the Best Places to Work by BioSpace for 2026, highlighting its status as a desirable employer in the biotech sector [1][2] - The company is particularly noted for its commitment to fostering a vibrant workplace culture that attracts top talent and inspires employees [2][3] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [4] - 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) [4] - Protara is currently conducting a Phase 2 trial for TARA-002 in NMIBC patients who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as a Phase 2 trial in pediatric patients with LMs [4] - Additionally, the company is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition [4] Workplace Environment - Protara is located in the Flatiron District of New York City and emphasizes a modern, collaborative working environment that values integrity, tenacity, and teamwork [3] - The company offers competitive benefits and prioritizes professional development, inclusivity, and work-life balance [3] - The Best Places to Work nominations were based on votes from over 7,500 life sciences professionals, who evaluated companies on various attributes including compensation, innovation, and culture [3]

Core Insights - Protara Therapeutics is a clinical-stage biotech company focused on developing treatments for cancer and rare diseases, with its lead program TARA-002 targeting non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][8] - TARA-002 utilizes a novel approach derived from a genetically distinct cell bank, functioning through dual mechanisms of directly killing tumor cells and stimulating an immune response [1][8] - The company is also advancing IV Choline Chloride for patients requiring parenteral nutrition, addressing a significant unmet need [10] TARA-002 Development - TARA-002 is currently being evaluated in a mid-stage study called ADVANCED-2 for NMIBC, showing promising early results with a 67% complete remission rate in BCG-unresponsive patients at six months [8][12] - In the Phase 2 STARBORN-1 trial for lymphatic malformations, two out of three pediatric patients achieved complete response after one injection, indicating a favorable safety profile [9][12] - Protara plans to deliver interim results for both trials in 1Q26 and 4Q25, respectively [8][9] Market Potential and Analyst Sentiment - Analysts project TARA-002 represents a potential market opportunity exceeding $500 million, with a strong buy consensus rating and a price target suggesting an 840% upside [12][13] - The average price target from analysts for TARA shares is $24.20, indicating a potential upside of approximately 659% [13] Financial Performance of Alpha Teknova - Alpha Teknova reported $10.3 million in revenue for 2Q25, a 7.3% year-over-year increase, with a reaffirmed full-year revenue guidance of $39-42 million [17] - The company is positioned to benefit from growth in the bioprocessing market, with expectations of over 20% revenue growth and 30%+ adjusted EBITDA margins in the long term [19][20] Analyst Ratings for Alpha Teknova - Alpha Teknova holds a strong buy consensus rating, with a price target of $12 indicating a potential one-year upside of approximately 159% [20]

Summary of Protara Therapeutics FY Conference Call Company Overview - **Company**: Protara Therapeutics (NasdaqGM:TARA) - **Date of Conference**: September 09, 2025 Key Industry and Company Insights Lymphatic Malformations - The largest data set on lymphatic malformations was generated by the University of Iowa, involving over 550 patients across 27 centers [1] - Protara is preparing a registration package for FDA submission, leveraging this data set and experience from Japan to seek accelerated approval [1] - TARA-002 is positioned as a treatment for BCG-unresponsive patients, with a focus on its unique mechanism of action compared to BCG [2][3] Mechanism of Action - TARA-002 acts as a TLR2/NOD2 activator, differing significantly from BCG, which is a TLR4 activator [2] - TARA-002 has demonstrated three-year stability at refrigerated temperatures and can be administered easily without special handling [2] - The drug upregulates key cytokines such as TNF-alpha, interferon-gamma, and IL-12, which are important for immune activation, while down-regulating IL-8, associated with recurrence [3][4] Clinical Trials and Data - Protara is currently enrolling patients in an Advanced II study for NMIBC (non-muscle invasive bladder cancer) and plans to publish interim data in February [4] - The company has reported a complete response rate of over 70% at six months and over 40% at twelve months in BCG-naive patients [6] - A significant portion of BCG-eligible patients (approximately 35%) do not receive BCG treatment, presenting an opportunity for TARA-002 [5] Safety and Efficacy - TARA-002 has shown no treatment-related grade 3 adverse events, with common side effects being mild and related to administration [7] - The administration process is straightforward, with efficacy comparable to other products in development [8] IV Choline Chloride Program - Protara is also developing IV Choline Chloride as a therapy for patients on parenteral support, addressing metabolic deficiencies [9][10] - The pivotal study aims to demonstrate elevated choline levels in serum as a primary endpoint, with interim data expected in mid-2026 [10][11] Market Potential and Future Directions - The incidence of lymphatic malformations is estimated at 1 in 2,000 to 1 in 4,000 live births, with a significant portion being macrocystic [15][16] - Protara aims to expand TARA-002's application to other maxillofacial cysts, potentially addressing a larger patient population [17] - The company holds $146 million in cash, sufficient to fund operations through 2027 and multiple catalysts in 2026 [18] Additional Important Points - Protara is actively engaging with the FDA regarding study designs for BCG alternative settings [5] - The company is focused on differentiating its product profile to drive adoption in a competitive market [7] - The ongoing studies and data collection are critical for establishing TARA-002's efficacy and safety in various patient populations [12][14]

Protara Therapeutics (TARA) Conference Call Summary Company Overview - Protara Therapeutics is a development-stage company focused on oncology and rare diseases, with two main franchises: oncology (specifically bladder cancer) and rare diseases [2][3] Oncology Segment TARA-002 Program - TARA-002 is a genetically distinct strain of Streptococcus pyogenes, currently in registrational studies for non-muscle invasive bladder cancer (NMIBC) [2] - The program aims to leverage established biological mechanisms and evolving science to accelerate development and commercialization [2] - Previous data releases showed a 100% complete response rate in a small cohort of BCG-unresponsive carcinoma in situ (CIS) patients, with 80% at six months and over 60% at 12 months [5][6] - Upcoming data release will include 18-month data for both BCG-unresponsive and BCG-naive patients [7][8] Competitive Landscape - Competitive response rates are discussed, with a threshold of 50% complete response at six months to be part of the conversation, and 75% or higher considered a "category killer" [9][10] - Protara aims to differentiate TARA-002 by its ease of administration, similar to BCG, and a favorable safety profile [29][30] Enrollment and Regulatory Pathway - Enrollment is proceeding as expected, with a focus on the right patient population [31] - The company is actively adding international sites to enhance enrollment, particularly in the BCG-unresponsive cohort [31] - Discussions with the FDA regarding the regulatory pathway for BCG-naive patients are ongoing, with updates expected by the end of the year [44] Rare Disease Segment IV Choline Chloride Program - The Thrive 3 trial is a phase 2B3 seamless design study, currently facing enrollment challenges in the U.S. due to competition for hospital beds [46][47] - European sites are expected to enroll significantly more patients, with one site in France having 500 patients on parenteral support [49][50] - Initial data from the Thrive 3 trial is anticipated by the summer of 2026 [51] Key Priorities - The primary focus for the upcoming year is on patient enrollment across both oncology and rare disease programs [52][54] Additional Insights - The management team has extensive experience in biotech and drug development, which informs their strategic approach [3] - Protara's strategy includes a focus on manufacturing capabilities and cost of goods sold, which allows for competitive pricing and distribution flexibility [30]

PART I – FINANCIAL INFORMATION This section presents Protara Therapeutics, Inc.'s unaudited condensed consolidated financial statements and detailed notes on accounting policies, financial instruments, and equity activities [Item 1. Condensed Consolidated Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Protara Therapeutics, Inc.'s unaudited condensed consolidated financial statements and detailed notes on accounting policies, financial instruments, and equity activities [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $31,496 | $162,798 | | Marketable debt securities | $90,720 | $7,494 | | Total current assets | $125,091 | $172,155 | | Total assets | $156,933 | $181,454 | | Total current liabilities | $9,761 | $10,961 | | Total liabilities | $12,510 | $14,320 | | Total stockholders' equity | $144,423 | $167,134 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $10,770 | $6,387 | $19,918 | $14,135 | | General and administrative | $5,816 | $4,274 | $10,792 | $8,377 | | Total operating expenses | $16,586 | $10,661 | $30,710 | $22,512 | | Net income (loss) | $(14,960) | $(9,513) | $(26,874) | $(20,608) | | Net income (loss) per share, basic and diluted | $(0.35) | $(0.45) | $(0.65) | $(1.26) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$167,134 thousand** at December 31, 2024, to **$144,423 thousand** at June 30, 2025, primarily due to a net loss of **$14,960 thousand** for the three months ended June 30, 2025, and **$11,914 thousand** for the three months ended March 31, 2025[21](index=21&type=chunk) - Common stock shares outstanding increased from 35,044,772 at December 31, 2024, to 38,581,863 at June 30, 2025, driven by conversions of Series 1 Preferred Stock, exercise of pre-funded warrants, and the Underwriters' Option[21](index=21&type=chunk) - Additional paid-in capital increased from **$412,077 thousand** to **$416,161 thousand**, reflecting proceeds from equity issuances and stock-based compensation[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(26,963) | $(18,066) | | Net cash used in investing activities | $(106,077) | $26,045 | | Net cash provided by financing activities | $1,738 | $42,016 | | Net increase (decrease) in cash and restricted cash | $(131,302) | $49,995 | | Cash and cash equivalents and restricted cash - end of period | $32,241 | $90,326 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization and Nature of the Business](index=10&type=section&id=1.%20Organization%20and%20Nature%20of%20the%20Business) - Protara Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on cancer and rare diseases, with development programs for TARA-002 (non-muscle invasive bladder cancer and lymphatic malformations) and IV Choline Chloride (patients receiving parenteral support)[25](index=25&type=chunk) - The Company has no current or near-term revenues and will require additional capital to fund its drug development efforts, though current financial resources are deemed sufficient for at least the next twelve months[26](index=26&type=chunk)[27](index=27&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - The financial statements are unaudited and prepared in accordance with GAAP and SEC rules for interim statements, and should be read with the 2024 Annual Report on Form 10-K[36](index=36&type=chunk) - Stock-based compensation for stock options, RSUs, and ESPP is measured at fair value on grant date and recognized over the vesting period, using models like Black-Scholes for options and ESPP[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) - The Company is evaluating new FASB ASUs (2023-09 on Income Tax Disclosures and 2024-03 on Expense Disaggregation Disclosures) but does not anticipate a material impact on its consolidated financial statements from ASU 2023-09[38](index=38&type=chunk)[39](index=39&type=chunk) [3. Fair Value of Financial Instruments](index=11&type=section&id=3.%20Fair%20Value%20of%20Financial%20Instruments) - Fair value measurements are categorized into a three-level hierarchy based on input observability (Level 1: quoted prices in active markets; Level 2: observable inputs other than Level 1; Level 3: unobservable inputs)[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) Fair Value of Financial Assets (in thousands) | Financial Asset (in thousands) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | Total (June 30, 2025) | | :----------------------------- | :---------------------- | :---------------------- | :-------------------- | | Money market funds | $30,983 | - | $30,983 | | Restricted cash (money market funds) | $745 | - | $745 | | Corporate bonds | - | $81,141 | $81,141 | | U.S. Treasury securities | $32,971 | - | $32,971 | | **Total** | **$64,699** | **$81,141** | **$145,840** | Fair Value of Financial Assets (in thousands) | Financial Asset (in thousands) | Level 1 (Dec 31, 2024) | Level 2 (Dec 31, 2024) | Total (Dec 31, 2024) | | :----------------------------- | :--------------------- | :--------------------- | :------------------- | | Money market funds | $162,297 | - | $162,297 | | Restricted cash (money market funds) | $745 | - | $745 | | U.S. Treasury securities | $7,494 | - | $7,494 | | **Total** | **$170,536** | **-** | **$170,536** | [4. Marketable Debt Securities](index=13&type=section&id=4.%20Marketable%20Debt%20Securities) - All marketable debt securities are classified as available-for-sale, with unrealized gains and losses reported in accumulated other comprehensive income (loss)[52](index=52&type=chunk) Marketable Debt Securities (in thousands) | Marketable Debt Securities (in thousands) | Amortized Cost (June 30, 2025) | Unrealized Gains (June 30, 2025) | Unrealized Losses (June 30, 2025) | Estimated Fair Value (June 30, 2025) | | :---------------------------------------- | :----------------------------- | :------------------------------- | :-------------------------------- | :----------------------------------- | | U.S. Treasury securities (current) | $27,920 | $31 | $(1) | $27,950 | | U.S. Treasury securities (non-current) | $5,001 | $20 | - | $5,021 | | Corporate bonds (current) | $62,790 | $17 | $(37) | $62,770 | | Corporate bonds (non-current) | $18,324 | $52 | $(5) | $18,371 | | **Total** | **$114,035** | **$120** | **$(43)** | **$114,112** | Interest and Investment Income (in thousands) | Interest and Investment Income (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Interest income | $1,223 | $1,130 | $2,778 | $1,809 | | Accretion of discount (Amortization of premium), net | $389 | $7 | $555 | $75 | | Dividend income | $14 | $11 | $22 | $20 | | **Total** | **$1,626** | **$1,148** | **$3,355** | **$1,904** | [5. Prepaid Expenses and Other Current Assets](index=17&type=section&id=5.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid Expenses and Other Current Assets (in thousands) | Prepaid Expenses and Other Current Assets (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Prepaid research and development | $1,279 | $853 | | Prepaid insurance | $318 | $622 | | Accrued interest on marketable debt securities | $890 | - | | Other prepaid expenses and current assets | $388 | $298 | | **Total** | **$2,875** | **$1,863** | [6. Other Assets](index=17&type=section&id=6.%20Other%20Assets) Other Assets (in thousands) | Other Assets (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Prepaid research and development, non-current | $3,039 | $3,245 | | Other non-current assets | $29 | $27 | | **Total** | **$3,068** | **$3,272** | [7. Accrued Expenses and Other Current Liabilities](index=17&type=section&id=7.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expenses and Other Current Liabilities (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------------- | :------------ | :---------------- | | Research and development costs | $1,445 | $2,740 | | Employee costs | $1,484 | $2,533 | | Other expenses | $334 | $135 | | **Total** | **$3,263** | **$5,408** | [8. Leases](index=17&type=section&id=8.%20Leases) - Operating lease expense was **$338 thousand** for both three-month periods ended June 30, 2025 and 2024, and **$676 thousand** for both six-month periods[63](index=63&type=chunk)[64](index=64&type=chunk) - As of June 30, 2025, the weighted-average remaining lease term for operating leases was 37 months, with a weighted-average discount rate of 7.0%[65](index=65&type=chunk) Operating Lease Payments (in thousands) | Operating Lease Payments (in thousands) | Amount | | :------------------------------------ | :----- | | 2025 (excluding six months ended June 30, 2025) | $715 | | 2026 | $1,429 | | 2027 | $1,429 | | 2028 | $718 | | 2029 | $87 | | **Total future operating lease payments** | **$4,378** | | Less: imputed interest | $430 | | **Present value of future minimum lease payments** | **$3,948** | [9. Commitments and Contingencies](index=19&type=section&id=9.%20Commitments%20and%20Contingencies) - The Company has commitments under license and collaboration agreements, lease agreements, and employment agreements, including annual payments, milestone payments, and royalties[66](index=66&type=chunk) - Management believes that the ultimate outcome of any legal proceedings and claims arising in the ordinary course of business would not have a material adverse impact on the Company's financial position or results of operations[67](index=67&type=chunk) [10. Stockholders' Equity](index=19&type=section&id=10.%20Stockholders'%20Equity) - As of June 30, 2025, **38,581,863 shares** of common stock were issued and outstanding, up from 35,044,772 at December 31, 2024[69](index=69&type=chunk) - During the six months ended June 30, 2025, approximately **2,376 shares of Series 1 Convertible Preferred Stock** were converted into **2,376,244 shares of common stock**, reducing outstanding preferred shares to 5,615[71](index=71&type=chunk)[72](index=72&type=chunk) - The April 2024 Private Placement generated net proceeds of approximately **$41,964 thousand** from the sale of common stock and pre-funded warrants, with associated common warrants exercisable at $5.25 per share[75](index=75&type=chunk) - The December 2024 Public Offering resulted in net proceeds of approximately **$93.4 million**, and the partial exercise of the Underwriters' Option in January 2025 generated an additional **$2.5 million** net proceeds[86](index=86&type=chunk)[90](index=90&type=chunk) [11. Stock-Based Compensation](index=23&type=section&id=11.%20Stock-Based%20Compensation) - The Company operates several equity incentive plans (2014, 2017, 2020 Inducement, 2024 EIP) and an Employee Stock Purchase Plan (2024 ESPP) to grant stock options, RSUs, and other awards[91](index=91&type=chunk)[97](index=97&type=chunk)[100](index=100&type=chunk)[102](index=102&type=chunk)[104](index=104&type=chunk) - The 2024 EIP was amended to increase shares available for grant by **2,800,000** to **4,300,000 shares**[102](index=102&type=chunk) RSU Activity | RSU Activity | Non-vested as of Dec 31, 2024 | Granted | Forfeited | Vested | Non-vested as of June 30, 2025 | | :------------- | :---------------------------- | :------ | :-------- | :----- | :----------------------------- | | Restricted Stock Units | 295,914 | 355,131 | (9,689) | (130,411) | 510,945 | | Weighted Average Grant Date Fair Value | $2.69 | $4.27 | $3.41 | $3.32 | $3.61 | Stock Option Activity | Stock Option Activity | Outstanding as of Dec 31, 2024 | Granted | Exercised | Forfeited | Outstanding as of June 30, 2025 | | :-------------------- | :----------------------------- | :------ | :-------- | :-------- | :------------------------------ | | Options | 3,855,478 | 1,735,363 | (2,842) | (24,972) | 5,563,027 | | Weighted Average Exercise Price | $7.30 | $4.17 | $2.91 | $3.46 | $6.34 | Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Stock options | $736 | $953 | $1,448 | $2,028 | | Restricted stock units | $167 | $111 | $288 | $262 | | **Total** | **$903** | **$1,064** | **$1,736** | **$2,290** | [12. Net Income (Loss) per Common Share](index=29&type=section&id=12.%20Net%20Income%20(Loss)%20per%20Common%20Share) Net Income (Loss) per Common Share (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) attributable to common stockholders (in thousands) | $(14,960) | $(9,513) | $(26,874) | $(20,608) | | Weighted-average shares outstanding, basic and diluted | 42,270,855 | 21,233,163 | 41,493,714 | 16,327,056 | | Net income (loss) per share, basic and diluted | $(0.35) | $(0.45) | $(0.65) | $(1.26) | - Due to net loss positions, basic and diluted EPS are the same, as potential common equivalent shares (April 2024 Common Warrants, Series 1 Convertible Preferred Stock, Stock options, Restricted stock units) were anti-dilutive[115](index=115&type=chunk) [13. Segment Information](index=29&type=section&id=13.%20Segment%20Information) - The Company operates as a single reportable segment, with the CEO acting as the chief operating decision maker (CODM) who reviews consolidated net income (loss) and total consolidated assets[116](index=116&type=chunk) Research and Development Expenses (in thousands) | Research and Development Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | TARA-002 in NMIBC | $4,898 | $2,164 | $8,455 | $4,954 | | TARA-002 in LMs | $477 | $598 | $1,027 | $1,531 | | IV Choline Chloride | $1,852 | $539 | $4,367 | $797 | | Other research and development | $3,317 | $2,849 | $5,651 | $6,242 | | **Total R&D Expenses** | **$10,770** | **$6,387** | **$19,918** | **$14,135** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Protara Therapeutics' financial condition, operational results, clinical trial progress, and liquidity for the reported periods [Overview](index=31&type=section&id=Overview) - Protara Therapeutics is a clinical-stage biopharmaceutical company developing transformative therapies for cancer and rare diseases, with a portfolio including TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs), and IV Choline Chloride for patients on parenteral support (PS)[121](index=121&type=chunk)[122](index=122&type=chunk) - TARA-002 in NMIBC: Interim data from ADVANCED-2 trial showed a **100% complete response (CR) rate** at any time in BCG-Unresponsive patients (5/5), with CR rates of **100% at six months**, **80% at nine months**, and **67% at 12 months**. For BCG-Naïve patients, the CR rate at any time was **76% (16/21)**[126](index=126&type=chunk)[127](index=127&type=chunk) - IV Choline Chloride: FDA alignment on a registrational path for a broader indication as a source of choline for PS patients. THRIVE-1 study found **78% of PS patients were choline deficient**. A registrational Phase 3 clinical trial (THRIVE-3) is planned for Q3 2025, with EU-CTR approval already secured[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) - TARA-002 in LMs: STARBORN-1 Phase 2 trial interim data showed **two out of three patients achieved a complete response** after one injection. An interim update is expected in Q4 2025[137](index=137&type=chunk)[138](index=138&type=chunk) - The Company has an accumulated deficit of approximately **$271.9 million** as of June 30, 2025, and expects to incur significant operating losses as it advances product candidates[141](index=141&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Results of Operations (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | | :-------------------- | :------------------------------- | :------------------------------- | :----- | | Research and development | $10,770 | $6,387 | $4,383 | | General and administrative | $5,816 | $4,274 | $1,542 | | Total operating expenses | $16,586 | $10,661 | $5,925 | | Net income (loss) | $(14,960) | $(9,513) | $(5,447) | | Interest and investment income | $1,626 | $1,148 | $478 | - Research and development expenses increased by **$4.4 million** for the three months ended June 30, 2025, primarily due to increased direct expenses for ADVANCED-2 NMIBC clinical trial and startup costs for THRIVE-3 IV Choline Chloride clinical trial[151](index=151&type=chunk) Results of Operations (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | | Research and development | $19,918 | $14,135 | $5,783 | | General and administrative | $10,792 | $8,377 | $2,415 | | Total operating expenses | $30,710 | $22,512 | $8,198 | | Net income (loss) | $(26,874) | $(20,608) | $(6,266) | | Interest and investment income | $3,355 | $1,904 | $1,451 | | Other income | $481 | - | $481 | - General and administrative expenses increased by **$2.4 million** for the six months ended June 30, 2025, mainly due to higher personnel-related expenses and market development costs[156](index=156&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, unrestricted cash, cash equivalents, and marketable debt securities totaled **$145.6 million**, down from **$170.3 million** at December 31, 2024[158](index=158&type=chunk) - Net cash used in operating activities increased to **$(27.0) million** for the six months ended June 30, 2025, compared to **$(18.1) million** in the prior year, driven by increased net loss and working capital adjustments[164](index=164&type=chunk) - Net cash used in investing activities was **$(106.1) million** for the six months ended June 30, 2025, a significant change from **$26.0 million** provided in the prior year, primarily due to increased purchases of marketable debt securities[165](index=165&type=chunk) - Net cash provided by financing activities decreased to **$1.7 million** for the six months ended June 30, 2025, from **$42.0 million** in the prior year, reflecting proceeds from the Underwriters' Option exercise versus the 2024 April Private Placement[166](index=166&type=chunk) - The Company believes its current financial resources are sufficient for at least twelve months from the filing date, but acknowledges capital market volatility and economic conditions may impact future capital availability[160](index=160&type=chunk)[162](index=162&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms no applicable quantitative and qualitative disclosures about market risk for the reporting period - Not applicable for this reporting period[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and procedures, concluding their effectiveness with no material changes in internal control over financial reporting - Management, including the principal executive and financial officers, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level[175](index=175&type=chunk)[176](index=176&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[178](index=178&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in legal proceedings expected to have a material adverse effect on its business - The Company is not currently involved in any legal proceedings deemed to have a material adverse effect on its business[180](index=180&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from the prior Annual Report on Form 10-K - No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[181](index=181&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None to report[182](index=182&type=chunk) [Item 3. Defaults Upon Senior Securities](index=42&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None to report[183](index=183&type=chunk) [Item 4. Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Not applicable[184](index=184&type=chunk) [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) CEO Jesse Shefferman terminated a Rule 10b5-1 trading arrangement on June 11, 2025 - CEO Jesse Shefferman terminated a Rule 10b5-1 trading arrangement on June 11, 2025, which had provided for the sale of up to 76,501 shares of common stock[185](index=185&type=chunk) - No other director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[186](index=186&type=chunk) [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including employment agreements and certifications Exhibits | Exhibit No. | Description | | :------------ | :---------- | | 10.1† | Executive Employment Agreement with Leonardo Nicacio, M.D. | | 10.2*† | Executive Employment Agreement with William Conkling. | | 10.3*† | 2024 Equity Incentive Plan, as Amended. | | 31.1* | Certification of Principal Executive Officer. | | 31.2* | Certification of Principal Financial Officer. | | 32.1** | Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350. | | 101.INS* | Interactive Data Files (Inline XBRL). | | 104 | Cover Page Interactive Data File. | [SIGNATURES](index=44&type=section&id=SIGNATURES) The report includes duly authorized signatures from the CEO and CFO, affirming the filing on August 11, 2025 - The report was signed by Jesse Shefferman, Chief Executive Officer, and Patrick Fabbio, Chief Financial Officer, on August 11, 2025[196](index=196&type=chunk)