UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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 June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36694 Protara Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporat ...

Exhibit 99.1 ● The Company remains on track to dose the first patient in THRIVE-3, a registrational Phase 3 clinical trial, in the third quarter of 2025. In addition, following the recent clinical trial approval by the European Union Clinical Trials Regulation, the Company expects to begin enrollment across the EU in the coming months. THRIVE-3 is a seamless Phase 2b/3 trial with a dose confirmation portion (n=24) followed by a double-blinded, randomized, placebo-controlled portion to assess the efficacy an ...

Group 1 - Protara Therapeutics has been added to the Russell 3000 Index, effective June 30, 2025, reflecting the company's progress in executing its pipeline [1][2] - The inclusion in the Russell 3000 Index enhances Protara's visibility among the financial community, which is crucial for attracting investment and generating shareholder value [2] - The Russell US Indexes reconstitution captures the 4,000 largest U.S. stocks ranked by market capitalization, with approximately $10.6 trillion in assets benchmarked against these indices as of June 2024 [2] Group 2 - Protara is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with its lead candidate being TARA-002 [3] - TARA-002 is currently undergoing Phase 2 trials for non-muscle invasive bladder cancer and lymphatic malformations, targeting patients unresponsive to Bacillus Calmette-Guérin treatment [3] - The company is also developing IV Choline Chloride for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]

Core Insights - Protara Therapeutics has appointed William "Bill" Conkling as Chief Commercial Officer, bringing over 20 years of experience in developing and commercializing therapies for cancer and rare diseases [1][2][3] - The company is positioned for growth with a potentially best-in-class bladder cancer therapy and two de-risked rare disease programs, aiming to significantly impact patient outcomes [2][5] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on transformative therapies for cancer and rare diseases, with its lead candidate TARA-002 in development for non-muscle invasive bladder cancer and lymphatic malformations [5] - The company is conducting ongoing Phase 2 trials for TARA-002 in patients with carcinoma in situ who are unresponsive or naïve to Bacillus Calmette-Guérin treatment, as well as in pediatric patients with lymphatic malformations [5] Leadership Background - Bill Conkling previously served as President and CEO of Rafael Holdings, where he built the commercial organization and developed go-to-market strategies [2][3] - He has extensive experience in the oncology field, having led the U.S. commercial organization for the launch of Trodelvy at Immunomedics and held key roles at Novartis Pharmaceuticals, including the commercialization of Kymriah [3][4] Stock Options and Awards - As part of his employment, Mr. Conkling received an inducement grant of options to purchase 200,000 shares at an exercise price of $3.30, along with a restricted stock unit award for 50,000 shares [6] - The options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly over the following 36 months [6]

Protara Therapeutics (TARA) FY Conference Summary Company Overview - **Company**: Protara Therapeutics - **Focus**: Development of innovative therapies for oncology, specifically targeting non-muscle invasive bladder cancer (NMIBC) with their lead program, TAR-002 Key Points and Arguments Product Development and Mechanism of Action - **TAR-002**: An investigational, genetically distinct strain of *Streptococcus pyogenes* designed to retain immune-stimulating properties through a proprietary manufacturing process [3][4] - **Comparison with BCG**: - Both TAR-002 and BCG are bacterial immune potentiators that drive a TH1 pro-inflammatory response, critical for antitumor immunity [5] - TAR-002 acts as a TLR2 agonist, while BCG is a TLR4 agonist, leading to significantly stronger tumor cell killing and higher upregulation of pro-inflammatory cytokines like TNF-alpha and interferon-gamma [6] - TAR-002 downregulates IL-8, which is associated with bladder cancer recurrence, contrasting with BCG's upregulation of IL-8 [7] Clinical Data and Efficacy Expectations - **Durable Responses**: Nonclinical studies show around 70% of mice remain cancer-free at the 60-day mark, indicating potential for durable clinical responses [7] - **Efficacy Benchmarks**: - A competitive complete response rate (CRR) of 30% is needed to be considered viable, with 40% being competitive and 50% considered best-in-class [12][13] - Initial data suggests a CRR of 63% at six months and 43% at twelve months in BCG-naive patients, with a total CRR of 76% [41] Enrollment and Market Strategy - **Enrollment Progress**: Enrollment is progressing well, with 30 sites in the US and approvals in Japan and China, aiming for full enrollment by spring 2026 [19][20] - **Patient Population**: The study is expected to have a similar split of 75% CIS and 25% concomitant papillary patients, consistent with other studies in this patient population [23][22] Competitive Landscape and Market Opportunity - **Market Size**: The addressable market is estimated at around $5 billion, with a significant number of patients seeking to avoid cystectomy [26] - **Treatment Sequencing**: Future treatment strategies may involve sequencing immune potentiators and cytotoxic drugs, enhancing the potential for TAR-002 in the treatment landscape [26] Regulatory and Development Plans - **FDA Engagement**: Plans to engage with the FDA regarding registrational studies for TAR-002, particularly in the BCG-naive setting, acknowledging the need for alternative treatment options [43][44] - **Comparative Studies**: Proposals to use chemotherapy as a comparator in studies, reflecting real-world treatment practices [46] Upcoming Catalysts - **Key Data Releases**: Anticipated data on 25 BCG unresponsive patients by the end of the year, along with updates on other ongoing studies [50][51] Additional Important Insights - **Tolerability and Administration**: TAR-002 is noted for its favorable tolerability profile, which may facilitate its adoption in community settings where treatment disruptions are less feasible [37][38] - **Long-term Development**: The company aims to position TAR-002 as a viable alternative to BCG, especially for patients who cannot access or tolerate standard BCG therapy [42][44] This summary encapsulates the critical insights from the Protara Therapeutics conference, highlighting the company's strategic direction, product differentiation, and market potential in the oncology space.

Financial Data and Key Metrics Changes - The company reported a 67% complete response (CR) rate in the pivotal BCG unresponsive cohort as of April, indicating strong performance in this segment [13][21]. - The target for the unresponsive dataset is a CR rate in the sixties, potentially reaching the seventies, which would be competitive with existing therapies [21]. Business Line Data and Key Metrics Changes - The lead asset, Tara 002, is positioned as a broad-spectrum immunopotentiator, with a focus on muscle invasive bladder cancer (MIBC) and non-muscle invasive bladder cancer (NMIBC) [10][12]. - The company is in late-stage development across three programs, including Tara 002 and IV choline chloride phospholipid substrate replacement therapy, indicating a diversified pipeline [9]. Market Data and Key Metrics Changes - The unmet need in NMIBC is characterized by a strong motivation to reduce cystectomies, with the company aiming to address this through innovative treatment options [10][11]. - The competitive landscape includes various mechanisms of action, with the company’s product being the only broad-spectrum immunopotentiator in late-stage development [12]. Company Strategy and Development Direction - The company aims to redefine risk in its portfolio by understanding and containing risks associated with each asset, particularly in the context of evolving regulatory and manufacturing landscapes [5][9]. - The strategy includes engaging with the FDA to demonstrate that standard of care for BCG eligible patients extends beyond just BCG, incorporating other chemotherapeutics [24][26]. Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of real-world evidence in shaping trial designs and regulatory interactions, particularly in the context of BCG shortages [24][26]. - The company anticipates that as the dataset broadens, fewer patients will require reinduction, which could enhance the overall treatment profile [30]. Other Important Information - The company is conducting a single-arm open-label study for Tara 002 in pediatric nonmalignant diseases, which has garnered interest due to its potential and existing standard of care in Japan [9]. - The company emphasizes the importance of tolerability and ease of use in community settings, which could drive adoption among urologists [36][38]. Q&A Session Summary Question: What is the unmet need in NMIBC and how does Tara 002 address it? - The unmet need is categorized into three buckets, with a focus on reducing cystectomies and addressing the heterogeneous nature of the disease through various treatment modalities [10][11]. Question: What benchmarks should be set for the six-month data in the BCG unresponsive cohort? - The company targets a CR rate of around 75% in CIS only patients, with expectations that the overall CR rate will be in the sixties or seventies [21]. Question: How does the company plan to approach the FDA regarding registrational studies? - The company plans to present real-world evidence to the FDA, arguing that the standard of care includes both BCG and other chemotherapeutics due to BCG shortages [24][26]. Question: What are the key differentiating factors for Tara 002 in the NMIBC space? - Key differentiators include the drug's tolerability, safety profile, and the ability to be integrated into existing workflows without causing disruptions [36][38].

PART I – FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Q1 2025 unaudited condensed consolidated financial statements report a $11.9 million net loss, increased cash usage, and decreased total assets [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $168.6 million, primarily due to a significant reduction in cash and cash equivalents, while liabilities and equity also declined Condensed Consolidated Balance Sheets (in thousands) | | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $91,461 | $162,798 | | Total current assets | $126,532 | $172,155 | | **Total assets** | **$168,559** | **$181,454** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $7,018 | $10,961 | | **Total liabilities** | **$10,075** | **$14,320** | | **Total stockholders' equity** | **$158,484** | **$167,134** | | **Total liabilities and stockholders' equity** | **$168,559** | **$181,454** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2025, the net loss increased to $11.9 million due to higher operating expenses, primarily from increased research and development activities, resulting in a net loss per share of $(0.29) Condensed Consolidated Statements of Operations (in thousands) | | For the Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025** | **2024** | | Research and development | $9,148 | $7,748 | | General and administrative | $4,976 | $4,103 | | **Total operating expenses** | **$14,124** | **$11,851** | | **Income (Loss) from operations** | **$(14,124)** | **$(11,851)** | | Other income (expense), net | $2,210 | $756 | | **Net income (loss)** | **$(11,914)** | **$(11,095)** | | **Net income (loss) per share, basic and diluted** | **$(0.29)** | **$(0.97)** | | Weighted-average shares outstanding, basic and diluted | 40,707,937 | 11,420,948 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $14.7 million in Q1 2025, with a significant shift to cash used in investing activities, resulting in a net decrease of $71.3 million in cash and equivalents Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025** | **2024** | | Net cash provided by (used in) operating activities | $(14,713) | $(10,379) | | Net cash provided by (used in) investing activities | $(58,354) | $23,100 | | Net cash provided by (used in) financing activities | $1,730 | $(76) | | **Net increase (decrease) in cash and cash equivalents and restricted cash** | **$(71,337)** | **$12,645** | | Cash and cash equivalents and restricted cash - beginning of period | $163,543 | $40,331 | | **Cash and cash equivalents and restricted cash - end of period** | **$92,206** | **$52,976** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes describe the company as a clinical-stage biopharmaceutical firm with no revenue, detailing recent capital raises and R&D expense drivers, while affirming sufficient financial resources for the next twelve months - The company is a clinical-stage biopharmaceutical company focused on therapies for cancer and rare diseases, including TARA-002 for NMIBC and LMs, and IV Choline Chloride for patients on parenteral support[26](index=26&type=chunk) - The company believes its current financial resources are **sufficient to fund operations for at least twelve months** from the financial statement issuance date[28](index=28&type=chunk) - In April 2024, the company completed a private placement, resulting in net proceeds of **approximately $42.0 million**[68](index=68&type=chunk) - In December 2024, the company closed a public offering with net proceeds of **approximately $93.4 million**. In January 2025, the underwriters partially exercised their option, providing additional net proceeds of **approximately $2.5 million**[79](index=79&type=chunk)[83](index=83&type=chunk) R&D Expenses by Program (in thousands) | Program | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | TARA-002 in NMIBC | $3,557 | $2,789 | | TARA-002 in LMs | $549 | $933 | | IV Choline Chloride | $2,515 | $258 | | Other research and development | $2,335 | $3,394 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical program advancements, increased R&D expenses, a $11.9 million net loss, and $157.5 million in cash, deemed sufficient for the next year [Overview and Clinical Program Updates](index=29&type=section&id=Overview%20and%20Clinical%20Program%20Updates) Protara, a clinical-stage biopharmaceutical company, is advancing TARA-002 for NMIBC and LMs, and IV Choline Chloride, with positive interim Phase 2 data and plans for a registrational Phase 3 trial in Q3 2025 - The lead oncology program is TARA-002 for NMIBC. The ADVANCED-2 Phase 2 trial is ongoing, with Cohort B expected to be registrational[117](index=117&type=chunk)[119](index=119&type=chunk) - Interim data from the ADVANCED-2 trial (BCG-Unresponsive cohort) showed a **100% complete response (CR) rate** at six months (5/5 patients) and **67% at 12 months** (2/3 patients)[120](index=120&type=chunk) - The company plans to initiate THRIVE-3, a registrational Phase 3 trial for IV Choline Chloride, in the third quarter of 2025[130](index=130&type=chunk) - The STARBORN-1 Phase 2 trial for TARA-002 in LMs is ongoing, with interim data showing **two of three patients achieved a complete response** after one injection[132](index=132&type=chunk)[133](index=133&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Total operating expenses increased to $14.1 million in Q1 2025, driven by higher R&D costs for the IV Choline Chloride program and increased G&A expenses, while other income also rose Comparison of Operations (in thousands) | | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $9,148 | $7,748 | $1,400 | | General and administrative | $4,976 | $4,103 | $873 | | **Total operating expenses** | **$14,124** | **$11,851** | **$2,273** | | **Net income (loss)** | **$(11,914)** | **$(11,095)** | **$(819)** | - The increase in R&D expenses was primarily due to a **$2.6 million** increase in direct expenses for product candidates, mainly a **$2.3 million** increase for the IV Choline Chloride program[146](index=146&type=chunk) - The increase in G&A expenses was primarily due to a **$0.4 million** increase in personnel-related expenses and a combined **$0.4 million** increase in market development and investor relations activities[147](index=147&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $157.5 million in unrestricted cash and marketable securities, with $14.7 million used in operations, and believes current resources are sufficient for the next twelve months - As of March 31, 2025, the company had **$157.5 million** in unrestricted cash and cash equivalents and marketable debt securities[149](index=149&type=chunk) - The company believes its current financial resources are **sufficient to satisfy estimated liquidity needs for at least twelve months**[151](index=151&type=chunk) Cash Flow Summary (in thousands) | | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,713) | $(10,379) | | Net cash (used in) provided by investing activities | $(58,354) | $23,100 | | Net cash provided by (used in) financing activities | $1,730 | $(76) | - The **$81.5 million** change in investing cash flow was primarily due to a **$65.8 million** increase in purchases of marketable debt securities and a **$15.6 million** decrease in proceeds from maturities[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company for this reporting period - **Not applicable**[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were **effective at the reasonable assurance level**[166](index=166&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[168](index=168&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - The company is **not currently a party to any legal proceedings that management believes would likely have a material adverse effect** on the business[170](index=170&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - There were **no material changes to the risk factors** previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[171](index=171&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2025, 1,191 shares of Series 1 Convertible Preferred Stock were converted into 1,190,996 shares of common stock, stemming from a January 2020 private placement - During the three months ended March 31, 2025, **1,191 shares** of Series 1 Convertible Preferred Stock were converted into **1,190,996 shares** of common stock[172](index=172&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, no director or officer of the company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - **No director or officer adopted or terminated** a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter[176](index=176&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate governance documents, agreements related to securities, and officer certifications

[Recent Progress and Highlights](index=2&type=section&id=Recent%20Progress%20and%20Highlights) Protara reported significant Q1 2025 clinical progress, including positive interim ADVANCED-2 trial results for TARA-002 in NMIBC and plans to initiate the THRIVE-3 trial for IV Choline Chloride in Q3 2025 [TARA-002 in NMIBC](index=2&type=section&id=TARA-002%20in%20NMIBC) - At the AUA 2025 Annual Meeting, updated interim results from the ADVANCED-2 trial were presented, showing promising complete response (CR) rates for TARA-002[8](index=8&type=chunk) ADVANCED-2 Trial Interim Results (as of April 16, 2025) | Patient Cohort | CR Rate (Any Time) | 12-Month CR Rate | | :--- | :--- | :--- | | BCG-Unresponsive | 100% (5/5) | 67% (2/3) | | BCG-Naïve | 76% (16/21) | 43% (3/7) | - TARA-002 was generally well-tolerated, with the majority of adverse events being Grade 1 and transient, and no Grade 3 or greater treatment-related adverse events reported[8](index=8&type=chunk) - Future milestones include announcing interim results from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 and providing an update on the planned BCG-Naïve registrational trial design in H2 2025[8](index=8&type=chunk) [IV Choline Chloride for Patients on Parenteral Support (PS)](index=2&type=section&id=IV%20Choline%20Chloride%20for%20Patients%20on%20Parenteral%20Support%20%28PS%29) - The company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the **third quarter of 2025**[6](index=6&type=chunk) - THRIVE-3 is a seamless Phase 2b/3 trial to assess the efficacy and safety of IV Choline Chloride in adolescents and adults on long-term parenteral support[6](index=6&type=chunk) - IV Choline Chloride has previously been granted Fast Track designation by the FDA[6](index=6&type=chunk) [TARA-002 in Lymphatic Malformations (LMs)](index=2&type=section&id=TARA-002%20in%20Lymphatic%20Malformations%20%28LMs%29) - Dosing is progressing in the Phase 2 STARBORN-1 trial for pediatric patients with macrocystic and mixed cystic LMs[7](index=7&type=chunk) - An interim update from the STARBORN-1 trial is planned for the **second half of 2025**[7](index=7&type=chunk) [Corporate Update](index=3&type=section&id=Corporate%20Update) In April 2025, Protara significantly strengthened its leadership team with the strategic appointments of a new Chief Medical Officer and a new Chief People Officer, bringing extensive experience in oncology, drug development, and life sciences organizational growth - Appointed Leonardo Viana Nicacio, M.D., as Chief Medical Officer. Dr. Nicacio has nearly **20 years of experience** in oncology, drug development, and regulatory affairs, previously serving at Stemline Therapeutics[9](index=9&type=chunk) - Appointed Shane Williams, Ph.D., as VP, Head of Human Resources, Chief People Officer. Dr. Williams has a strong background in driving growth and building high-performing teams, most recently at Century Therapeutics[9](index=9&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) Protara reported a net loss of **$11.9 million** for Q1 2025, up from **$11.1 million** in Q1 2024 due to increased clinical trial and personnel costs, while maintaining a strong financial position with **$157.5 million** in cash, cash equivalents, and investments, projected to fund operations into 2027 Q1 2025 vs. Q1 2024 Financial Performance (in millions, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research & Development Expenses | $9.1 | $7.7 | | General & Administrative Expenses | $5.0 | $4.1 | | Net Loss | $11.9 | $11.1 | | Net Loss Per Share | $0.29 | $0.97 | - The increase in R&D expenses was mainly due to a **$2.6 million** rise in clinical trial activities for TARA-002 and IV Choline[13](index=13&type=chunk) - The increase in G&A expenses was primarily driven by higher personnel-related costs and professional fees[13](index=13&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section includes the unaudited condensed consolidated balance sheets as of March 31, 2025, compared to December 31, 2024, and the unaudited condensed consolidated statements of operations for the three-month periods ending March 31, 2025, and 2024 [Unaudited Condensed Consolidated Balance Sheets](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $91,461 | $162,798 | | Total current assets | $126,532 | $172,155 | | Total assets | $168,559 | $181,454 | | Total current liabilities | $7,018 | $10,961 | | Total liabilities | $10,075 | $14,320 | | Total stockholders' equity | $158,484 | $167,134 | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $14,124 | $11,851 | | Income (Loss) from operations | $(14,124) | $(11,851) | | Net income (loss) | $(11,914) | $(11,095) | | Net income (loss) per share | $(0.29) | $(0.97) | | Weighted-average shares outstanding | 40,707,937 | 11,420,948 |

Reported positive interim results demonstrating durable responses in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 in NMIBC Results from planned interim analysis of approximately 25 six-month evaluable BCG-Unresponsive patients expected by the end of 2025 Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support expected in Q3 2025Strengthened leadership team with key appointments of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, ...

TARA-002 Product Characteristics - TARA-002 is a lyophilized, inactivated Group A Streptococcus pyogenes [8] - TARA-002 is an investigational, genetically distinct strain of Streptococcus pyogenes that is inactivated while retaining its immune-stimulating properties [10] - TARA-002 activates Th1 Immune Cascade [12] Clinical Trial Results in BCG-Unresponsive Patients - TARA-002 monotherapy demonstrates a 100% complete response rate at any time in BCG-unresponsive participants [14] - Specifically, 5 out of 5 (100%) BCG-unresponsive patients with CIS only achieved a high-grade complete response at any time [15] - At Month 6, 5 out of 5 (100%) BCG-unresponsive patients with CIS only achieved a high-grade complete response [15] - At Month 12, 2 out of 3 (66.7%) BCG-unresponsive patients with CIS only achieved a high-grade complete response [15] Clinical Trial Results in BCG-Naïve Patients - TARA-002 monotherapy demonstrates a 76.2% complete response rate at any time in BCG-naïve participants [22, 23] - Specifically, 10 out of 11 (90.9%) BCG-naïve patients with CIS only achieved a high-grade complete response at any time [23] - At Month 6, 5 out of 6 (83.3%) BCG-naïve patients with CIS only achieved a high-grade complete response [23] - At Month 12, 3 out of 5 (60.0%) BCG-naïve patients with CIS only achieved a high-grade complete response [23] Safety Profile - Across both BCG-unresponsive and BCG-naïve patients (N=43), 74% experienced any grade of treatment-emergent adverse events (TEAEs) [25] - 30% of participants experienced related TEAEs [25] - No Grade 4/5 treatment-related adverse events were observed [7, 25]