PART I [Condensed Consolidated Financial Statements](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Increased net losses for Q3 and 9M 2023 due to higher R&D expenses; current cash sufficient for next 12 months [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$88.5 million** as of September 30, 2023, from **$113.3 million** at year-end 2022, reflecting reduced cash and marketable securities and lower equity Condensed Consolidated Balance Sheet Highlights (in thousands) | | September 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,768 | $24,127 | | Marketable debt securities | $40,266 | $78,129 | | Total current assets | $77,813 | $86,146 | | **Total assets** | **$88,467** | **$113,290** | | **Liabilities & Equity** | | | | Total current liabilities | $6,775 | $5,740 | | **Total liabilities** | **$11,511** | **$11,207** | | **Total stockholders' equity** | **$76,956** | **$102,083** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported increased net losses for Q3 and the first nine months of 2023, primarily due to a significant rise in research and development expenses Operating Results Highlights (in thousands, except per share data) | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $6,218 | $3,466 | $18,608 | $11,819 | | General and administrative | $4,482 | $4,508 | $13,964 | $15,734 | | **Loss from operations** | **($10,700)** | **($7,974)** | **($32,572)** | **($27,553)** | | **Net loss** | **($9,860)** | **($7,691)** | **($30,199)** | **($26,985)** | | Net loss per share | ($0.87) | ($0.68) | ($2.67) | ($2.40) | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$28.9 million** for the first nine months of 2023, while investing activities provided **$38.6 million** from marketable securities maturities Cash Flow Summary for the Nine Months Ended September 30 (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($28,857) | ($21,431) | | Net cash provided by investing activities | $38,589 | $33,295 | | Net cash used in financing activities | ($91) | ($90) | | **Net increase in cash** | **$9,641** | **$11,774** | | Cash at end of period | $34,513 | $48,243 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's biopharmaceutical business, confirm sufficient liquidity for the next twelve months, and provide accounting policy specifics - The company is a clinical-stage biopharmaceutical company focused on transformative therapies for cancer and rare diseases, with its portfolio including TARA-002 (for NMIBC and LMs) and IV Choline Chloride[29](index=29&type=chunk) - Management believes that the company's current financial resources are sufficient to satisfy its estimated liquidity needs for at least **twelve months** from the date of the financial statements' issuance[31](index=31&type=chunk) Stock-Based Compensation Expense (in thousands) | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $419 | $361 | $1,233 | $1,150 | | General and administrative | $1,028 | $1,076 | $3,407 | $4,108 | | **Total** | **$1,447** | **$1,437** | **$4,640** | **$5,258** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical progress for TARA-002, increased R&D spending driving higher net losses, and confirms sufficient liquidity for the next 12 months - The company is conducting a Phase 1 trial (ADVANCED-1) and has initiated a Phase 2 trial (ADVANCED-2) for TARA-002 in Non-Muscle Invasive Bladder Cancer (NMIBC)[99](index=99&type=chunk)[102](index=102&type=chunk) - In October 2023, the company initiated STARBORN-1, a Phase 2 clinical trial of TARA-002 in pediatric patients with lymphatic malformations (LMs)[104](index=104&type=chunk) - As of September 30, 2023, the company had approximately **$74.0 million** in cash, cash equivalents, and marketable debt securities[112](index=112&type=chunk) - Management believes current financial resources are sufficient to satisfy estimated liquidity needs for at least **twelve months** from the report's issuance date[132](index=132&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) R&D expenses significantly increased in Q3 and the nine-month period of 2023 due to expanded clinical trial activities for TARA-002, leading to higher net losses Comparison of Operating Expenses (in thousands) | | Three Months Ended Sep 30, | Change | Nine Months Ended Sep 30, | Change | | :--- | :--- | :--- | :--- | :--- | | | **2023 vs 2022** | | **2023 vs 2022** | | | Research and development | $6,218 vs $3,466 | +$2,752 | $18,608 vs $11,819 | +$6,789 | | General and administrative | $4,482 vs $4,508 | -$26 | $13,964 vs $15,734 | -$1,770 | [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Cash, cash equivalents, and marketable securities totaled **$74.0 million** as of September 30, 2023, a decrease from year-end 2022, with net cash used in operations increasing to **$28.9 million** Liquidity and Cash Flow (in millions) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, & marketable securities | $74.0 | $102.3 | | Working Capital | $71.0 | N/A | - Net cash used in operating activities increased by **$7.4 million** to **$28.9 million** for the nine months ended September 30, 2023, compared to the same period in 2022, driven by a higher net loss and changes in working capital[135](index=135&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Protara Therapeutics, Inc. is not required to provide the information requested under this item - The company stated this item is 'Not applicable'[144](index=144&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The principal executive and financial officers concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[146](index=146&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[148](index=148&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings deemed likely to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that are likely to have a material adverse effect on the business[150](index=150&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks that could materially and adversely affect the company's business, financial condition, and stock price [Risks Related to Financial Condition](index=33&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition) The company faces significant financial risks due to its limited operating history, lack of revenue, and history of substantial losses, necessitating future capital raises - The company has a limited operating history, has never generated any revenues, and expects to incur significant losses for the foreseeable future[152](index=152&type=chunk)[153](index=153&type=chunk) - The company will need to raise additional financing in the future to fund operations, which may not be available on favorable terms or at all[159](index=159&type=chunk) [Risks Related to Drug/Biologics Development and Commercialization](index=36&type=section&id=Risks%20Related%20to%20Drug%2FBiologics%20Development%20and%20Commercialization) The company's success hinges on the uncertain, long, and expensive clinical development and regulatory approval of its product candidates, TARA-002 and IV Choline Chloride - The company's business depends on the successful clinical development and regulatory approval of its product candidates, TARA-002 and IV Choline Chloride[162](index=162&type=chunk) - The company has never completed a clinical trial or submitted a BLA or NDA, which may lead to greater costs and time than anticipated[164](index=164&type=chunk) - The company relies on third-party CROs to conduct and oversee clinical trials, and if these parties fail to perform, regulatory approval could be jeopardized[165](index=165&type=chunk) [Other Risks Related to Our Business](index=42&type=section&id=Other%20Risks%20Related%20to%20Our%20Business) The company faces significant competition, has limited marketing capabilities, relies entirely on third-party manufacturers, and depends on attracting and retaining key personnel - The company's product candidates, if approved, will face significant competition from established pharmaceutical companies with greater resources[187](index=187&type=chunk) - The company has limited marketing capabilities and no sales organization, which are necessary for successful commercialization[192](index=192&type=chunk) - The company relies completely on third-party contractors to supply and manufacture its product candidates, which exposes it to risks of supply disruption, quality issues, and lack of direct control[218](index=218&type=chunk)[220](index=220&type=chunk) [Risks Related to Our Common Stock](index=52&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock price is expected to be highly volatile, influenced by clinical trial results and regulatory decisions, and it does not anticipate paying dividends - The market price of the company's stock is expected to be highly volatile due to factors common in the biotechnology industry, such as clinical trial outcomes and regulatory news[230](index=230&type=chunk) - The company is a 'smaller reporting company' and can take advantage of reduced disclosure requirements, which may make its stock less attractive to some investors[240](index=240&type=chunk) - The company does not anticipate paying any dividends in the foreseeable future, meaning capital appreciation is the sole potential source of gain for stockholders[241](index=241&type=chunk) [Risk Related to Our Ownership Structure and Governance](index=54&type=section&id=Risk%20Related%20to%20Our%20Ownership%20Structure%20and%20Governance) Certain stockholders hold significant influence over corporate actions, and anti-takeover provisions could impede potential acquisitions or management changes - Certain stockholders have the ability to control or significantly influence matters submitted for stockholder approval, including mergers and significant asset sales[243](index=243&type=chunk) - Anti-takeover provisions in the company's charter documents and Delaware law could delay or prevent an acquisition or a change in management[244](index=244&type=chunk) [Risks Related to Intellectual Property Rights](index=55&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20Rights) The company's success depends on its ability to obtain, maintain, and enforce patents and protect trade secrets globally, while facing the risk of costly infringement lawsuits - The company may not be able to obtain, maintain, or enforce global patent rights of sufficient breadth to prevent third parties from competing[246](index=246&type=chunk) - The company may not be able to protect its intellectual property rights throughout the world, as laws and enforcement differ significantly across jurisdictions[252](index=252&type=chunk) - The company may be sued for infringing the intellectual property rights of third parties, which could be costly and time-consuming and could prevent or delay product development[257](index=257&type=chunk) [General Risk Factors](index=59&type=section&id=General%20Risk%20Factors) The company's IT systems are vulnerable to cyberattacks and security breaches, and it faces stringent and evolving data privacy laws, with non-compliance risking fines and reputational harm - The company's information technology systems and data are vulnerable to compromise from cyberattacks, which could result in regulatory actions, litigation, and business disruptions[263](index=263&type=chunk) - The company is subject to stringent and changing data privacy and security obligations (e.g., CCPA, GDPR), and failure to comply could lead to significant fines, penalties, and harm to its business[276](index=276&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=63&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities during the period - None reported[288](index=288&type=chunk) [Defaults Upon Senior Securities](index=63&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None reported[289](index=289&type=chunk) [Mine Safety Disclosures](index=63&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - None reported[290](index=290&type=chunk) [Other Information](index=63&type=section&id=Item%205.%20Other%20Information) The company reported no other information under this item - None reported[291](index=291&type=chunk) [Exhibits](index=64&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and Inline XBRL data files

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, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36694 Protara Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 345 Park Aven ...

[Introduction and Regulatory Information](index=1&type=section&id=Introduction%20and%20Regulatory%20Information) [Filing Information](index=1&type=section&id=Filing%20Information) Details Protara Therapeutics' Q1 2023 Form 10-Q filing, covering filer status and outstanding common stock * Protara Therapeutics, Inc. filed a Quarterly Report on Form 10-Q for the period ended March 31, 2023[2](index=2&type=chunk) Filing Status | Indicator | Status | | :-------------------------- | :----- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | * As of May 1, 2023, **11,307,962 shares of common stock** were outstanding[6](index=6&type=chunk) [Cautionary Note Concerning Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Concerning%20Forward-Looking%20Statements) This section cautions that forward-looking statements in the report are subject to risks and uncertainties, potentially causing actual outcomes to differ materially * The report includes forward-looking statements on operations and financial performance, identified by specific predictive terms[9](index=9&type=chunk) * Estimates regarding financial performance, including future revenue, expenses, and capital requirements * Expected cash position and ability to obtain future financing * Expectations for research, development, and commercialization of product candidates (TARA-002 and IV Choline Chloride) * Timing, costs, and outcomes of planned clinical trials * Implementation of business model and strategic plans * All forward-looking statements carry inherent risks and uncertainties that could cause actual results to differ materially, as detailed in Part II, Item 1A, Risk Factors[11](index=11&type=chunk) [Summary of Risks Affecting Our Business](index=6&type=section&id=Summary%20of%20Risks%20Affecting%20Our%20Business) This section outlines principal factors making investment in Protara Therapeutics' securities speculative, including limited operating history, expected losses, and dependence on clinical development * Limited operating history and no generated revenues * Expectation of significant expenses and losses for the foreseeable future, with no guarantee of profitability * Need to raise additional financing, which may not be available on favorable terms * Business success depends on the clinical development and regulatory approval of product candidates (TARA-002 and IV Choline Chloride) * Lack of prior experience in completing clinical trials or BLA/NDA submissions * TARA-002 for lymphatic malformations (LMs) faces challenges as there are no FDA-approved therapies for LMs * Approved product candidates may fail to achieve broad physician and patient adoption * Significant competition for product candidates, if approved * Limited marketing capabilities and no sales organization to commercialize product candidates * Risk of inability to obtain, maintain, or enforce global patent rights * Subject to stringent and changing data privacy and security obligations [PART I – FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Protara Therapeutics' unaudited condensed consolidated financial statements for Q1 2023 and 2022, including balance sheets, statements of operations, equity changes, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | Asset/Liability/Equity | March 31, 2023 (unaudited) | December 31, 2022 | | :-------------------------------- | :------------------------- | :------------------ | | **Assets** | | | | Cash and cash equivalents | $21,035 | $24,127 | | Marketable debt securities | $65,575 | $60,243 | | Total current assets | $94,616 | $86,146 | | Total assets | $106,405 | $113,290 | | **Liabilities** | | | | Accounts payable | $4,081 | $1,586 | | Accrued expenses | $1,396 | $3,237 | | Total current liabilities | $6,410 | $5,740 | | Total liabilities | $11,637 | $11,207 | | **Stockholders' Equity** | | | | Total stockholders' equity | $94,768 | $102,083 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $5,143 | $5,269 | | General and administrative | $4,589 | $5,605 | | Total operating expenses | $9,732 | $10,874 | | Loss from operations | $(9,732) | $(10,874) | | Interest and investment income | $687 | $119 | | Net loss | $(9,045) | $(10,755) | | Net loss per share (basic and diluted) | $(0.80) | $(0.96) | | Comprehensive Loss | $(8,826) | $(11,486) | * Net loss decreased by **$1,710 thousand (15.9%)** from $10,755 thousand in Q1 2022 to **$9,045 thousand** in Q1 2023[20](index=20&type=chunk) * Interest and investment income significantly increased from $119 thousand in Q1 2022 to **$687 thousand** in Q1 2023, a **477% increase**[20](index=20&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Condensed Consolidated Statements of Changes in Stockholders' Equity (in thousands) | Item | Balance at Dec 31, 2022 | Q1 2023 Changes | Balance at Mar 31, 2023 | | :-------------------------------- | :---------------------- | :-------------- | :---------------------- | | Common Stock (shares) | 11,267,389 | 39,364 | 11,306,753 | | Common Stock (amount) | $11 | $0 | $11 | | Additional Paid-in Capital | $262,724 | $1,511 | $264,235 | | Accumulated Deficit | $(159,964) | $(9,045) | $(169,009) | | Accumulated Other Comprehensive Income (Loss) | $(688) | $219 | $(469) | | Total Stockholders' Equity | $102,083 | $(7,315) | $94,768 | * Total stockholders' equity decreased by **$7,315 thousand** from $102,083 thousand at December 31, 2022, to **$94,768 thousand** at March 31, 2023[23](index=23&type=chunk) * The accumulated deficit increased by **$9,045 thousand** due to the net loss for the period[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(12,888) | $(10,961) | | Net cash provided by investing activities | $9,860 | $745 | | Net cash used in financing activities | $(64) | $(72) | | Net decrease in cash and cash equivalents and restricted cash | $(3,092) | $(10,288) | | Cash and cash equivalents and restricted cash - end of period | $21,780 | $26,181 | * Net cash used in operating activities increased by **$1,927 thousand (17.6%)** from $10,961 thousand in Q1 2022 to **$12,888 thousand** in Q1 2023[26](index=26&type=chunk) * Net cash provided by investing activities significantly increased by **$9,115 thousand (1223%)** from $745 thousand in Q1 2022 to **$9,860 thousand** in Q1 2023, primarily due to increased proceeds from marketable debt securities maturities[26](index=26&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization and Nature of the Business](index=12&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[29](index=29&type=chunk) * Portfolio includes TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) * Also developing Intravenous (IV) Choline Chloride for intestinal failure associated liver disease (IFALD) in patients receiving parenteral nutrition (PN) * The Company has no current or near-term revenues and will need additional capital to fund operations[30](index=30&type=chunk) * Current financial resources are believed to be sufficient for at least twelve months from the issuance date of the financial statements[31](index=31&type=chunk) [2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) * The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and SEC rules for interim financial statements, reflecting all necessary adjustments for fair presentation[36](index=36&type=chunk) * The Company adopted ASU 2016-13 (Measurement of Credit Losses on Financial Statements) on January 1, 2023, using a modified retrospective approach, with no material effect on financial position, results of operations, or cash flows[43](index=43&type=chunk) * Management evaluates estimates based on historical and anticipated results, trends, and other reasonable assumptions, with actual results potentially differing from estimates[39](index=39&type=chunk) [3. Fair Value of Financial Instruments](index=14&type=section&id=3.%20Fair%20Value%20of%20Financial%20Instruments) * The Company measures certain financial assets and liabilities at fair value, classified into a three-level hierarchy based on input observability[46](index=46&type=chunk)[48](index=48&type=chunk) Fair Value Hierarchy of Financial Assets (in thousands) as of March 31, 2023 | Item | Level 1 | Level 2 | Level 3 | Total | | :-------------------------- | :------ | :------ | :------ | :------ | | Money market funds | $20,722 | $- | $- | $20,722 | | Restricted cash (money market funds) | $745 | $- | $- | $745 | | Corporate bonds | $- | $68,468 | $- | $68,468 | | Total | $21,467 | $68,468 | $- | $89,935 | * Money market funds are classified as Level 1, while corporate debt securities are classified as Level 2, valued using prices from reputable dealers or pricing services[52](index=52&type=chunk) [4. Marketable Debt Securities](index=16&type=section&id=4.%20Marketable%20Debt%20Securities) * All marketable debt securities are classified as available-for-sale and recorded at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss)[54](index=54&type=chunk)[59](index=59&type=chunk) Marketable Debt Securities (in thousands) as of March 31, 2023 | Item | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | | :-------------------------------------- | :------------- | :--------------- | :---------------- | :------------------- | | Corporate bonds (current) | $66,042 | $5 | $(472) | $65,575 | | Corporate bonds (non-current) | $2,895 | $- | $(2) | $2,893 | | Total | $68,937 | $5 | $(474) | $68,468 | * The Company determined that none of the unrealized loss is related to expected credit losses, as it has the ability and intent to hold all marketable securities to maturity or recovery, and the portfolio consists of investment-grade, high-credit quality institutions[62](index=62&type=chunk) Investment Income (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Interest income | $605 | $529 | | Accretion/(amortization) of discount/premium, net | $82 | $(410) | | Total interest and investment income | $687 | $119 | [5. Prepaid Expenses and Other Current Assets](index=18&type=section&id=5.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid Expenses and Other Current Assets (in thousands) | Item | March 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------- | :---------------- | | Prepaid insurance | $689 | $288 | | Prepaid research and development | $6,250 | $569 | | Prepaid software | $153 | $122 | | Accrued interest on marketable debt securities | $491 | $486 | | Other prepaid expenses | $296 | $184 | | Other current assets | $127 | $127 | | Total | $8,006 | $1,776 | * Prepaid research and development expenses significantly increased from $569 thousand at December 31, 2022, to **$6,250 thousand** at March 31, 2023[64](index=64&type=chunk) [6. Accrued Expenses](index=20&type=section&id=6.%20Accrued%20Expenses) Accrued Expenses (in thousands) | Item | March 31, 2023 | December 31, 2022 | | :---------------------- | :------------- | :---------------- | | Employee Costs | $625 | $2,543 | | Research and development costs | $658 | $512 | | Other expenses | $113 | $182 | | Total | $1,396 | $3,237 | * Employee costs decreased significantly from $2,543 thousand at December 31, 2022, to **$625 thousand** at March 31, 2023[67](index=67&type=chunk) * Research and development costs increased from $512 thousand at December 31, 2022, to **$658 thousand** at March 31, 2023[67](index=67&type=chunk) [7. Leases](index=20&type=section&id=7.%20Leases) * Operating leases are included in operating lease right-of-use (ROU) assets and liabilities on the balance sheets[68](index=68&type=chunk) Lease Cost (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------ | :-------------------------------- | :-------------------------------- | | Operating lease cost | $341 | $341 | | Short-term lease cost | $- | $3 | | Total | $341 | $344 | * The weighted-average remaining lease term for operating leases was **64 months** as of March 31, 2023, with a weighted-average discount rate of **7.0%**[70](index=70&type=chunk) [8. Commitments and Contingencies](index=22&type=section&id=8.%20Commitments%20and%20Contingencies) * The Company has commitments under license and collaboration agreements, lease agreements, and employment agreements, including annual payments, milestone payments, and royalty payments[73](index=73&type=chunk) * Management believes that the ultimate outcome of any legal proceedings and claims would not have a material adverse impact on the Company's financial position or results of operations[74](index=74&type=chunk) [9. Stockholders' Equity](index=22&type=section&id=9.%20Stockholders%27%20Equity) * As of March 31, 2023, the Company had **11,306,753 shares** of common stock issued and outstanding, with **100,000,000 shares** authorized[76](index=76&type=chunk) * **8,027 shares** of Series 1 Convertible Preferred Stock were issued and outstanding, each convertible into **1,000 shares of common stock**[78](index=78&type=chunk) [10. Stock-Based Compensation](index=22&type=section&id=10.%20Stock-Based%20Compensation) * The Company has several equity incentive plans, including the 2020 Inducement Plan, 2017 Equity Incentive Plan, and Amended and Restated 2014 Equity Incentive Plan[80](index=80&type=chunk)[84](index=84&type=chunk)[86](index=86&type=chunk) * As of March 31, 2023, **148,000 shares** remain available under the 2020 Inducement Plan, and **479,501 shares** remain available under the Amended and Restated 2014 Plan[83](index=83&type=chunk)[88](index=88&type=chunk) Stock-Based Compensation Expense (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------------------- | :-------------------------------- | :-------------------------------- | | Restricted stock units | $314 | $314 | | Stock options | $1,261 | $1,565 | | Total | $1,575 | $1,879 | * Total stock-based compensation decreased by **$304 thousand (16.2%)** from $1,879 thousand in Q1 2022 to **$1,575 thousand** in Q1 2023[96](index=96&type=chunk) [11. Net Loss per Common Share](index=25&type=section&id=11.%20Net%20Loss%20per%20Common%20Share) Net Loss per Common Share (Basic and Diluted) | Item | March 31, 2023 | March 31, 2022 | | :-------------------------------------- | :------------- | :------------- | | Net loss attributable to common stockholders | $9,045 | $10,755 | | Weighted-average shares outstanding | 11,303,869 | 11,250,127 | | Net loss per share | $(0.80) | $(0.96) | * Net loss per share improved from **$(0.96)** in Q1 2022 to **$(0.80)** in Q1 2023[97](index=97&type=chunk) * All potential common equivalent shares were excluded from diluted EPS calculation due to their anti-dilutive effect, as the Company was in a net loss position[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Protara Therapeutics' financial condition and results of operations, discussing product development, Q1 2023 performance, liquidity, and future capital needs [Overview](index=26&type=section&id=Overview) * Protara Therapeutics is a clinical-stage biopharmaceutical company developing transformative therapies for cancer and rare diseases[100](index=100&type=chunk) * Portfolio includes TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) * TARA-002 is an investigational cell therapy based on OK-432, approved in Japan and Taiwan for LMs and oncologic indications * Lead oncology program is TARA-002 in NMIBC, with positive preliminary Phase 1a data showing favorable tolerability and anti-tumor activity * The Company selected the 40KE dose for TARA-002 in NMIBC for subsequent clinical trials and plans to initiate ADVANCED-2 (Phase 1b/2) in H2 2023 * TARA-002 received Rare Pediatric Disease designation for LMs and regulatory clearance for STARBORN-1 (Phase 2) in pediatric patients, expected to initiate in Q4 2023 * IV Choline Chloride, an investigational phospholipid substrate replacement therapy, has Orphan Drug and Fast Track Designations for IFALD; prospective prevalence study results expected in Q3 2023 * The Company has incurred significant operating losses (**$169.0 million accumulated deficit** as of March 31, 2023) and does not expect near-term revenues, requiring additional capital[113](index=113&type=chunk)[114](index=114&type=chunk) * As of March 31, 2023, cash, cash equivalents, and marketable debt securities totaled approximately **$89.5 million**[116](index=116&type=chunk) [Financial Overview](index=29&type=section&id=Financial%20Overview) * Research and development expenses primarily cover costs for TARA-002 and IV Choline Chloride development, including employee-related expenses, CROs, CDMOs, clinical trial materials, and regulatory operations * General and administrative expenses include employee-related costs for executive and administrative functions, professional fees (legal, IP, consulting, accounting), facility costs, and public company compliance expenses * Other income (expense), net, consists of interest income from cash, cash equivalents, and marketable debt securities, and accretion/amortization of investment discounts/premiums * Critical accounting policies include accrued research and development expenses, income taxes, and the valuation of deferred tax assets[123](index=123&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Summary of Results of Operations (in thousands) | Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Period-to-Period Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :---------------------- | | Research and development | $5,143 | $5,269 | $(126) | | General and administrative | $4,589 | $5,605 | $(1,016) |\ | Total operating expenses | $9,732 | $10,874 | $(1,142) | | Loss from operations | $(9,732) | $(10,874) | $1,142 | | Interest and investment income | $687 | $119 | $568 | | Net Loss | $(9,045) | $(10,755) | $1,710 | * Research and development expenses decreased by **$0.1 million (2.4%)** due to ongoing development efforts[127](index=127&type=chunk) * General and administrative expenses decreased by **$1.0 million (18.1%)** primarily due to lower employee-related expenses (**$0.5 million**, including **$0.3 million stock-based compensation**), reduced D&O insurance premiums (**$0.3 million**), and decreased market development activities (**$0.2 million**)[128](index=128&type=chunk) * Other income (expense), net, increased by **$0.6 million (477%)** due to higher market interest rates on marketable debt securities[129](index=129&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) * As of March 31, 2023, cash, cash equivalents, and marketable debt securities were **$89.5 million**, down from **$102.3 million** at December 31, 2022[130](index=130&type=chunk) * Working capital was approximately **$88.2 million** and stockholder's equity was **$94.8 million** as of March 31, 2023[130](index=130&type=chunk) * Cash flows used in operating activities were **$12.9 million** for Q1 2023, primarily due to a net loss of **$9.0 million** and a **$5.8 million** working capital adjustment[130](index=130&type=chunk) * The Company believes current financial resources are sufficient for at least twelve months, but additional capital will be needed for future development plans[131](index=131&type=chunk) * Volatility in capital markets, economic conditions, and rising interest rates may impact access to capital and liquidity[133](index=133&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Period-to-Period Change | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | :---------------------- | | Net cash used in operating activities | $(12,888) | $(10,961) | $(1,927) | | Net cash provided by investing activities | $9,860 | $745 | $9,115 | | Net cash used in financing activities | $(64) | $(72) | $8 | | Net decrease in cash and cash equivalents, and restricted cash | $(3,092) | $(10,288) | $7,196 | * Increase in cash used in operating activities by **$1.9 million**, driven by a **$2.9 million** decrease in working capital and a **$0.8 million** decrease in non-cash items, partially offset by a **$1.7 million** decrease in net loss[135](index=135&type=chunk) * Increase in cash provided by investing activities by **$9.1 million**, primarily from higher proceeds from marketable debt securities maturities[136](index=136&type=chunk) [Contractual and Other Obligations](index=31&type=section&id=Contractual%20and%20Other%20Obligations) * Operating lease obligations include payments for corporate headquarters, development laboratory, and manufacturing facilities[137](index=137&type=chunk) * The Company enters into contracts with CROs, CDMOs, and clinical sites that are generally cancelable upon notice[139](index=139&type=chunk) * Contingent milestone payments to third parties are not included on the balance sheet as their achievement and timing are not fixed and determinable[140](index=140&type=chunk)[141](index=141&type=chunk) [Off-Balance Sheet Arrangements](index=32&type=section&id=Off-Balance%20Sheet%20Arrangements) * The Company did not have any off-balance sheet arrangements during the periods presented[142](index=142&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the Company * This item is not applicable to the Company[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the Company's disclosure controls and procedures, concluding they were effective as of March 31, 2023, 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 March 31, 2023, and concluded they were effective at a reasonable assurance level[145](index=145&type=chunk) * No changes in internal control over financial reporting occurred during the three months ended March 31, 2023, that materially affected or are reasonably likely to materially affect internal control over financial reporting[147](index=147&type=chunk) [PART II – OTHER INFORMATION](index=33&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section states that Protara Therapeutics is not currently a party to any legal proceedings likely to have a material adverse effect on its business, though litigation can still impact the company * The Company is not currently involved in any legal proceedings deemed to have a material adverse effect on its business[149](index=149&type=chunk) * Litigation, regardless of outcome, can adversely impact the Company due to defense and settlement costs and diversion of management resources[149](index=149&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines various risks that could materially and adversely affect Protara Therapeutics' business, financial condition, results of operations, and future growth prospects [Risks Related to Our Financial Condition](index=33&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition) * Limited operating history and no revenue generation, making future viability assessment difficult * Expectation of significant expenses and losses for the foreseeable future, with no guarantee of profitability * Need to raise substantial additional financing, which may not be available on favorable terms or at all, potentially leading to dilution or restrictive debt covenants * Impact of COVID-19 pandemic and other macroeconomic factors (e.g., supply chain disruptions, inflation, rising interest rates) on business, clinical development, and access to capital * Potential limitations on the ability to use net operating loss carryforwards and other tax attributes due to ownership changes or state law restrictions [Risks Related to Drug/Biologics Development and Commercialization](index=36&type=section&id=Risks%20Related%20to%20Drug%2FBiologics%20Development%20and%20Commercialization) * Business success is highly dependent on the successful clinical development and regulatory approval of TARA-002 and IV Choline Chloride * Clinical trials may fail to demonstrate safety and efficacy, or serious adverse effects may be identified, leading to increased costs or abandonment of development * Lack of prior experience in completing clinical trials or BLA/NDA submissions as a company * Reliance on third-party CROs and other parties to conduct clinical trials, with risks of non-compliance or termination of involvement * Interim, topline, and preliminary data from clinical trials are subject to change and audit, potentially differing from final results * Expansion of clinical trials outside the U.S. carries risks that foreign data may not be accepted by regulatory authorities * TARA-002 for LMs faces challenges as there are no FDA-approved therapies, making timing and costs of development difficult to predict * Product candidates may cause undesirable side effects, delaying or preventing regulatory approval or limiting commercial profile * Fast track designation for IV Choline Chloride does not guarantee faster development or approval * Rare Pediatric Disease Designation for TARA-002 for LMs does not guarantee a priority review voucher or faster approval * Even if approved, product candidates may fail to achieve broad physician and patient adoption necessary for commercial success * Adverse developments with OK-432/Picibanil (originator therapy to TARA-002) by third parties could affect TARA-002's approval or commercialization * The Company may choose to discontinue development or commercialization of product candidates at any time, resulting in loss of investment [Other Risks Related to Our Business](index=43&type=section&id=Other%20Risks%20Related%20to%20Our%20Business) * Product candidates, if approved, will face significant competition from companies with greater resources and capabilities * TARA-002 and future biologic product candidates may face biosimilar competition sooner than anticipated due to the BPCIA * Limited marketing capabilities and no sales organization, requiring the Company to build or partner for commercialization * Exclusive rights to TARA-002 materials and technology (outside Japan/Taiwan) expire by June 17, 2030, after which rights become non-exclusive, potentially leading to increased competition * Ongoing regulatory review post-approval could lead to restrictions, costly post-approval studies, or suspension/termination of sales * Exposure to product liability claims, with potential for substantial liability if insurance coverage is inadequate * Risks of misconduct or improper activities by employees, contractors, or partners, leading to regulatory actions or penalties * Risks related to off-label use promotion of product candidates, if approved, potentially leading to significant liability * Inability to achieve and maintain coverage and adequate reimbursement for TARA-002 or IV Choline Chloride could hinder commercial success * Healthcare reform measures, including drug pricing reforms (e.g., Inflation Reduction Act of 2022), could negatively impact profitability and demand for products [General Risk Factors](index=46&type=section&id=General%20Risk%20Factors) * Risks related to in-licensing and acquiring product candidates, including increased expenses, integration challenges, and diversion of management attention * Failure to successfully in-license, acquire, develop, and market additional product candidates would impair business growth * Reliance on collaborations with third parties for successful development and commercialization of product candidates, subject to risks of partner performance and control * Complete reliance on third-party contractors for supply, manufacturing, and distribution of clinical and commercial drug supplies, including sole-source suppliers, posing risks of production difficulties, quality issues, and supply disruptions * Complexity of biologic manufacturing and potential difficulties encountered by CDMOs could delay or stop supply for clinical trials or commercialization * Failure to attract and retain management and other key personnel could impede business plan implementation * Adverse effects from natural disasters, pandemics, catastrophic events, terrorism, and war, which could disrupt business operations and clinical trials (e.g., in Ukraine) * Highly volatile stock price due to clinical trial results, regulatory approvals, commercial success, manufacturing issues, financing, competition, and general market fluctuations * Incurrence of significant costs and demands on management due to compliance with laws and regulations affecting public companies (e.g., Sarbanes-Oxley Act) * Risk of impaired ability to produce accurate financial statements if proper and effective internal controls are not maintained * Ability to take advantage of reduced disclosure and governance requirements as a smaller reporting company, which might make common stock less attractive to investors * No anticipated dividend payments in the foreseeable future, making capital appreciation the sole source of gain for stockholders * Potential decline in stock price and trading volume if equity research analysts do not publish research or publish unfavorable reports * Certain stockholders have significant control or influence over matters requiring stockholder approval * Anti-takeover provisions in charter documents and Delaware law could make business acquisition more difficult and prevent management replacement * Exclusive forum provision in certificate of incorporation for certain disputes could limit stockholders' ability to obtain a favorable judicial forum * Inability to obtain, maintain, or enforce global patent rights or other intellectual property rights of sufficient breadth to prevent third-party competition * Risks that proprietary trade secrets and unpatented know-how may become known or be independently discovered * Difficulties in protecting intellectual property rights throughout the world, especially in foreign jurisdictions with differing laws and enforcement mechanisms * Patent protection could be reduced or eliminated due to non-compliance with procedural, document submission, and fee payment requirements of governmental patent agencies * Loss of license rights or increased financial obligations if the Company fails to comply with intellectual property license agreements * Costly and time-consuming litigation if sued for infringing third parties' intellectual property rights * Claims that officers, directors, employees, or consultants have wrongfully used or disclosed alleged trade secrets of former employers or customers * Adverse consequences from compromised information technology systems or data, including regulatory investigations, litigation, fines, and business disruptions * Stringent and changing obligations related to data privacy and security (e.g., CCPA, CPRA, EU GDPR, UK GDPR), with potential for regulatory actions, litigation, and business disruption if not complied with [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=64&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report for the period * No unregistered sales of equity securities or use of proceeds to report[290](index=290&type=chunk) [Item 3. Defaults Upon Senior Securities](index=64&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period * No defaults upon senior securities to report[291](index=291&type=chunk) [Item 4. Mine Safety Disclosures](index=64&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that there are no mine safety disclosures applicable to the Company * No mine safety disclosures to report[292](index=292&type=chunk) [Item 5. Other Information](index=64&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report for the period * No other information to report[293](index=293&type=chunk) [Item 6. Exhibits](index=65&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including various corporate documents, agreements, and certifications * The Exhibit Index lists corporate documents (e.g., Certificate of Incorporation, By-laws), agreements (e.g., Registration Rights Agreement, Executive Employment Agreement), and certifications (e.g., CEO/CFO certifications) filed with the report[295](index=295&type=chunk)[297](index=297&type=chunk) [SIGNATURES](index=67&type=section&id=SIGNATURES) This section contains the signatures of the Chief Executive Officer and Chief Financial Officer, certifying the filing of the report on behalf of Protara Therapeutics, Inc * The report is signed by Jesse Shefferman, Chief Executive Officer, and Patrick Fabbio, Chief Financial Officer, on May 4, 2023[302](index=302&type=chunk)

. Statements contained in this presentation regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words or expressions referencing future events, conditions or circumstances that c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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) Delaware 20-4580525 (State or other jurisdic ...

�RBOTARA CORPORATE PRESENTATION . . . . . . . . i . November 2022 FORWARD LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" ...

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 September 30, 2022 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 incor ...

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, 2022 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 ...

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 March 31, 2022 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 incorpora ...

PROTARA THERAPEUTICS CORPORATE PRESENTATION March 2022 FORWARD LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other wo ...