Protara Therapeutics, Inc.

Previous wording

Since inception, we have incurred significant operating losses. As of June 30, 2026, we had an accumulated deficit of approximately $341.9 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next few years as we continue our development of, and seek marketing approvals for, our product candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States.

Current wording

Since inception, we have incurred significant operating losses. As of September 30, 2026, we had an accumulated deficit of approximately $363.6 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next few years as we continue our development of, and seek marketing approvals for, our product candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States.

Previous wording

As of June 30, 2026, we had approximately $161.9 million in unrestricted cash and cash equivalents and marketable debt securities.

Current wording

As of September 30, 2026, we had approximately $143.1 million in unrestricted cash and cash equivalents and marketable debt securities.

Previous wording

We expect to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in the fourth quarter of 2026. Enrollment is complete in the BCG-Naïve cohort of the ADVANCED-2 trial with 31 patients. Although we initiated our ADVANCED-3 trial in June 2026, we have made the strategic decision to redesign the ADVANCED-3 trial to be a multi-cohort, open-label, exploratory trial to evaluate the efficacy and safety of intravesical TARA-002 in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary (Ta/T1) patients across BCG exposures, in order to accelerate and expand the breadth of data available at or around the time of the potential launch of TARA-002 in BCG-Unresponsive CIS patients.

Current wording

We initiated our ADVANCED-3 trial in June 2026 and subsequently announced our intent to redesign the ongoing ADVANCED-3 trial during the third quarter of 2026. The redesigned ADVANCED-3 trial is expected to be a multi-cohort, open-label trial evaluating the efficacy and safety of intravesical TARA-002 in BCG-Naïve and BCG-Exposed CIS (± Ta/T1) and high-grade, high-risk, or HG-HR, papillary (Ta/T1) patients across BCG exposures. The trial is intended to generate a broad body of clinical evidence across HG-HR NMIBC patients. We believe this positions TARA-002 to benefit from the FDA’s recent approach to expand the label of a previously approved product for BCG-Unresponsive CIS NMIBC to include HG-HR BCG-Unresponsive papillary disease based on a single-arm trial.

Previous wording

In January 2026, we initiated THRIVE-3, a registrational Phase 3 clinical trial. 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 and safety of IV Choline Chloride over 24 weeks in adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=100). The primary endpoint of the clinical trial is a pharmacokinetic, or PK, endpoint measuring the change from baseline in plasma choline concentration. We also plan to include a number of secondary endpoints related to liver, bone and memory. We anticipate reporting interim results from the dose-confirmation portion of the trial in the fourth quarter of 2026.

Current wording

In January 2026, we initiated THRIVE-3, a registrational Phase 3 clinical trial. 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 and safety of IV Choline Chloride over 24 weeks in adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=100). The primary endpoint of the clinical trial is a pharmacokinetic, or PK, endpoint measuring the change from baseline in plasma choline concentration. We also plan to include a number of secondary endpoints related to liver, bone and memory. In October 2026, we announced that we completed enrollment of the Phase 2b, open-label dose confirmation phase of the THRIVE-3 clinical trial, which includes 24 patients. We anticipate reporting interim results from the dose-confirmation portion of the trial in the fourth quarter of 2026.

Previous wording

We intend to provide an update on STARBORN-1 and complete enrollment of STARBORN-1 in the fourth quarter of 2026. Based on engagement with the FDA, we intend to submit a Biologics License Application, or BLA, for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027 and will continue to submit safety and efficacy data from the trial on an ongoing basis to support the FDA’s evaluation of the risks and benefits of TARA-002 in LMs.

Current wording

We intend to provide an update on STARBORN-1 and complete enrollment of STARBORN-1 early in the first quarter of 2027. Based on engagement with the FDA, we intend to initiate a rolling Biologics License Application, or BLA, for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027 and will continue to submit safety and efficacy data from the trial on an ongoing basis to support the FDA’s evaluation of the risks and benefits of TARA-002 in LMs.

Previous wording

Research and development expenses were $17.0 million for the three months ended June 30, 2026, which represented an increase of approximately $6.2 million as compared to the three months ended June 30, 2025. This increase was primarily due to a $3.2 million increase in direct expenses for our product candidates and a $3.0 million increase in indirect expenses. The increase in direct expenses was primarily due to higher ongoing costs associated with all of our ongoing clinical trials. The increase in indirect expenses was primarily due to a $1.8 million increase in personnel-related expenses and a $1.2 million increase in research and development expenses not directly attributable to one specific product candidate, which were primarily attributable to chemistry, manufacturing and controls, or CMC, related activities.

Current wording

Research and development expenses were $16.8 million for the three months ended September 30, 2026, which represented an increase of approximately $7.2 million as compared to the three months ended September 30, 2025. This increase was primarily due to a $4.4 million increase in direct expenses for our product candidates and a $2.8 million increase in indirect expenses. The increase in direct expenses was primarily due to higher ongoing costs associated with all of our ongoing clinical trials. The increase in indirect expenses was primarily due to a $2.0 million increase in personnel-related expenses and a $0.8 million increase in research and development expenses not directly attributable to one specific product candidate, primarily related to TARA-002 chemistry, manufacturing and controls, or CMC, related activities.

Previous wording

General and administrative expenses were $6.4 million for the three months ended June 30, 2026, which represented an increase of approximately $0.6 million as compared to the three months ended June 30, 2025. This increase was primarily due to an increase of $0.7 million in personnel-related expenses, offset by a decrease of $0.1 million in other general and administrative expenses.

Current wording

General and administrative expenses were $6.3 million for the three months ended September 30, 2026, which represented an increase of approximately $1.2 million as compared to the three months ended September 30, 2025. This increase was primarily due to an increase of $0.6 million in personnel-related expenses and an increase of $0.6 million in other general and administrative expenses.

Previous wording

Research and development expenses were $30.5 million for the six months ended June 30, 2026, which represented an increase of approximately $10.6 million as compared to the six months ended June 30, 2025. This increase was primarily due to a $5.4 million increase in direct expenses for our product candidates and a $5.2 million increase in indirect expenses. The increase in direct expenses was primarily due to higher ongoing costs associated with all of our ongoing clinical trials. The increase in indirect expenses was primarily due to a $3.3 million increase in personnel-related expenses and a $1.8 million increase in research and development expenses not directly attributable to one specific product candidate, which were primarily attributable to CMC related activities.

Current wording

Research and development expenses were $47.3 million for the nine months ended September 30, 2026, which represented an increase of approximately $17.8 million as compared to the nine months ended September 30, 2025. This increase was primarily due to a $9.8 million increase in direct expenses for our product candidates and a $8.0 million increase in indirect expenses. The increase in direct expenses was primarily due to higher ongoing costs associated with all of our ongoing clinical trials. The increase in indirect expenses was primarily due to a $5.3 million increase in personnel-related expenses and a $2.7 million increase in research and development expenses not directly attributable to one specific product candidate, primarily related to TARA-002 CMC related activities.

Previous wording

General and administrative expenses were $12.4 million for the six months ended June 30, 2026, which represented an increase of approximately $1.6 million as compared to the six months ended June 30, 2025. This increase was primarily due to an increase of $1.6 million in personnel-related expenses, as well as an increase of $0.1 million in other general and administrative expenses.

Current wording

General and administrative expenses were $18.8 million for the nine months ended September 30, 2026, which represented an increase of approximately $2.8 million as compared to the nine months ended September 30, 2025. This increase was primarily due to an increase of $2.2 million in personnel-related expenses, as well as an increase of $0.7 million in other general and administrative expenses.

Previous wording

Other income (expense), net was $3.5 million for the six months ended June 30, 2026, which represented a decrease of approximately $0.3 million as compared to the six months ended June 30, 2025. The decrease was driven by a $0.5 million decrease in other income (expense) due to nonrecurring refundable tax credits received in the six months ended June 30, 2025, offset by a $0.2 million increase in interest and investment income in the six months ended June 30, 2026.

Current wording

Other income (expense), net was $5.0 million for the nine months ended September 30, 2026, which represented a decrease of approximately $0.4 million as compared to the nine months ended September 30, 2025. The decrease was driven by a $0.5 million decrease in other income (expense) due to nonrecurring refundable tax credits received in the nine months ended September 30, 2025, offset by a $0.1 million increase in interest and investment income in the nine months ended September 30, 2026.

Previous wording

As of June 30, 2026 and December 31, 2025, our unrestricted cash and cash equivalents, and marketable debt securities were $161.9 million and $197.9 million, respectively. We have not generated revenues since our inception and have incurred net losses of $39.5 million and $26.9 million for the six months ended June 30, 2026 and 2025, respectively and $21.7 million and $15.0 million for the three months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had working capital of $132.8 million and stockholder’s equity of $161.3 million. During the six months ended June 30, 2026, net cash flows used in operating activities were $36.7 million, consisting primarily of a net loss of $39.5 million and cash used for changes in operating assets and liabilities of $0.4 million. These uses of cash were offset by non-cash expenses of approximately $3.1 million. Since inception, we have met our liquidity requirements principally through the sale of our common stock, preferred stock and pre-funded warrants in private placements and public offerings.

Current wording

As of September 30, 2026 and December 31, 2025, our unrestricted cash and cash equivalents, and marketable debt securities were $143.1 million and $197.9 million, respectively. We have not generated revenues since our inception and have incurred net losses of $61.1 million and $40.1 million for the nine months ended September 30, 2026 and 2025, respectively, and $21.7 million and $13.3 million for the three months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had working capital of $115.3 million and stockholders’ equity of $141.0 million. During the nine months ended September 30, 2026, net cash flows used in operating activities were $55.2 million, consisting primarily of a net loss of $61.1 million including non-cash expenses of $4.9 million. These uses of cash were offset by net cash provided by changes in operating assets and liabilities of $1.1 million. Since inception, we have met our liquidity requirements principally through the sale of our common stock, preferred stock and pre-funded warrants in private placements and public offerings.

Previous wording

We believe that our current financial resources are sufficient to satisfy our estimated liquidity needs for at least 12 months from the date of issuance of our condensed consolidated financial statements included elsewhere in this Quarterly Report on this Form 10-Q.

Current wording

We believe that our current financial resources are sufficient to satisfy our estimated liquidity needs for at least 12 months from the date of issuance of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

As a result of volatility in the capital markets, economic conditions, general global economic uncertainty, political and regulatory change, global pandemics and other factors, we do not know whether additional capital will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. If we are unable to raise additional capital due to volatile global financial markets, general economic uncertainty or other factors, we may need to curtail planned development activities. Despite recent moderation, the sustained elevated interest rates in recent years have had, and may continue to have, a negative effect on market prices for common stock of public companies, especially those in the biotech industry and those that have no current or near-term revenue. Further, a recession or market correction, supply chain disruptions and/or inflation could materially affect our business and the value of our common stock.

Current wording

As a result of volatility in the capital markets, economic conditions, general global economic uncertainty, political and regulatory change, global pandemics and other factors, we do not know whether additional capital will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. If we are unable to raise additional capital due to volatile global financial markets, general economic uncertainty or other factors, we may need to curtail planned development activities. Interest rates have increased in recent months and may continue to increase, and as a result may have a negative effect on market prices for common stock of public companies, especially those in the biotech industry and those that have no current or near-term revenue. Further, a recession or market correction, supply chain disruptions and/or inflation could materially affect our business and the value of our common stock.

Previous wording

Net cash provided by (used in) operating activities was approximately $(36.7) million for the six months ended June 30, 2026 compared to approximately $(27.0) million for the six months ended June 30, 2025. The increase of approximately $9.8 million in cash used in operating activities was primarily driven by an increase in net loss of $12.6 million, offset by a decrease in cash used for operating assets and liabilities, primarily related to changes in other assets, accrued expenses, other current liabilities, and accounts payable, resulting principally from the timing of payments to our service providers of $(1.6) million and, an increase in non-cash items, consisting principally of accretion of discount on marketable debt securities and stock-based compensation expense of $1.2 million.

Current wording

Net cash provided by (used in) operating activities was approximately $(55.2) million for the nine months ended September 30, 2026 compared to approximately $(39.4) million for the nine months ended September 30, 2025. The increase of approximately $15.8 million in cash used in operating activities was primarily driven by an increase in net loss of $21.0 million, offset by an increase in non-cash net operating costs of $2.0 million and a decrease of $3.3 million in operating assets and liabilities, primarily related to changes in other assets, accrued expenses, other current liabilities, and accounts payable, resulting principally from the timing of payments to our service providers.

Previous wording

Net cash provided by (used in) investing activities was approximately $3.0 million for the six months ended June 30, 2026 compared to approximately $(106.1) million for the six months ended June 30, 2025. The decrease in cash used of $109.1 million resulted primarily from a decrease in purchases of marketable debt securities of $54.4 million as well as an increase in proceeds from marketable debt securities matured and redeemed of $55.0 million.

Current wording

Net cash provided by (used in) investing activities was approximately $29.1 million for the nine months ended September 30, 2026 compared to approximately $(112.6) million for the nine months ended September 30, 2025. The decrease in cash used of $141.7 million resulted primarily from a decrease in purchases of marketable debt securities of $67.1 million as well as an increase in proceeds from marketable debt securities matured and redeemed of $75.7 million offset slightly by an increase in purchases of fixed assets of $1.0 million.

Previous wording

Net cash provided by (used in) financing activities was $1.1 million for the six months ended June 30, 2026 compared to $1.7 million for the six months ended June 30, 2025. The $0.6 million decrease was primarily driven by proceeds received in the prior-year period of $1.9 million from the net proceeds of the December 2024 Public Offering, as compared to $1.9 million in proceeds from the exercise of common warrants offset against offering costs paid during the current period of $0.5 million in connection with public offerings.

Current wording

Net cash provided by (used in) financing activities was $1.5 million for the nine months ended September 30, 2026 compared to $1.8 million for the nine months ended September 30, 2025. The $0.2 million decrease was primarily driven by proceeds received in the prior-year period of $1.9 million from the net proceeds of the December 2024 Public Offering, as compared to $1.9 million in proceeds from the exercise of common warrants as well as $0.4 million in proceeds from the exercise of stock options offset against offering costs paid during the current period of $0.5 million in connection with public offerings.