Protara Therapeutics, Inc.

Previous wording

Following the completion of Phase 1a and 1b clinical trials to evaluate safety, preliminary efficacy and the dosing of TARA-002, at the 40KE (Klinische Einheit, or KE, is a German term indicating a specified weight of dried cells in vial) dose level, we initiated and are currently conducting our ADVANCED-2 clinical trial. ADVANCED-2 is a Phase 2 open-label clinical trial evaluating intravesical TARA-002 in at least 102 patients with high-grade carcinoma in situ, or CIS. Cohort A of the Phase 2 has completed enrollment and enrolled 31 patients with CIS (± Ta/T1 with Ta defined as non-invasive papillary carcinoma and T1 as defined as carcinoma invading the lamina propria), BCG-Naïve or BCG-Exposed, who have not received intravesical BCG for at least 24 months prior to CIS diagnosis. Cohort B of the Phase 2 trial is expected to enroll 75 to 100 patients with BCG-Unresponsive CIS (± Ta/T1) and is expected to be registrational based on the Food and Drug Administrations, or FDA’s, August 2024 Draft Guidance on BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment.

Current wording

Following the completion of Phase 1a and 1b clinical trials to evaluate safety, preliminary efficacy and the dosing of TARA-002, at the 40KE (Klinische Einheit, or KE, is a German term indicating a specified weight of dried cells in vial) dose level, we initiated and are currently conducting our ADVANCED-2 clinical trial. ADVANCED-2 is a Phase 2 open-label clinical trial evaluating intravesical TARA-002 in patients with high-grade carcinoma in situ, or CIS. Cohort A of the Phase 2 has completed enrollment and enrolled 31 patients with CIS (± Ta/T1 with Ta defined as non-invasive papillary carcinoma and T1 as defined as carcinoma invading the lamina propria), BCG-Naïve or BCG-Exposed, who have not received intravesical BCG for at least 24 months prior to CIS diagnosis. Cohort B of the Phase 2 trial is expected to enroll 75 to 100 patients with BCG-Unresponsive CIS (± Ta/T1) and is expected to be registrational based on the Food and Drug Administrations, or FDA’s, August 2024 Draft Guidance on BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment.

Previous wording

We expect to present an interim analysis from approximately 25 six-month evaluable patients in Cohort B (BCG-Unresponsive) of the ongoing ADVANCED-2 trial at a medical conference in the first quarter of 2026. Following discussions with the FDA, we expect to provide an update on next steps in our BCG-Naïve program in the second half of 2025.

Current wording

We expect to present an interim analysis from approximately 25 six-month evaluable patients in Cohort B (BCG-Unresponsive) of the ongoing ADVANCED-2 trial in the first quarter of 2026. We expect to provide an update on ongoing discussions with the FDA related to the BCG-Naïve clinical program in the fourth quarter of 2025.

Previous wording

We plan to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PS and intend to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the third quarter of 2025. In July 2025, the European Union Clinical Trials Regulation, or EU-CTR, approved the THRIVE-3 clinical trial in the European Union and we expect to begin enrollment in the second half of 2025. 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. The FDA has also granted IV Choline Chloride Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Current wording

We plan to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PS and intend to dose our first patient in THRIVE-3, a registrational Phase 3 clinical trial, by the end of 2025. In July 2025, the European Union Clinical Trials Regulation, or EU-CTR, approved a THRIVE-3 clinical trial in the European Union. 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. The FDA has also granted IV Choline Chloride Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Previous wording

Since inception, we have incurred significant operating losses. As of June 30, 2025, we had an accumulated deficit of approximately $271.9 million. We expect to continue to incur significant and increasing expenses and 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, 2025, we had an accumulated deficit of approximately $285.1 million. We expect to continue to incur significant and increasing expenses and 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, 2025, we had approximately $145.6 million in unrestricted cash and cash equivalents and marketable debt securities.

Current wording

As of September 30, 2025, we had approximately $133.6 million in unrestricted cash and cash equivalents and marketable debt securities.

Previous wording

Research and development expenses were $10.8 million for the three months ended June 30, 2025, which represented an increase of approximately $4.4 million as compared to the three months ended June 30, 2024. This increase was primarily due to a $3.9 million increase in direct expenses for our product candidates. The increase in direct expenses were driven by continued site expansion and enrollment in our ADVANCED-2 NMIBC clinical trial as well as startup costs for our THRIVE-3 IV Choline Chloride clinical trial. The $0.5 million increase in indirect expenses was primarily due to a $0.8 million increase in personnel-related expenses partially offset by a $0.4 million decrease in other research and development expenses not directly attributable to a single product candidate.

Current wording

Research and development expenses were $9.6 million for the three months ended September 30, 2025, which represented an increase of approximately $1.5 million as compared to the three months ended September 30, 2024. This increase was primarily due to a $1.0 million increase in direct expenses for our product candidates. The increase in direct expenses was driven by startup costs for our IV Choline Chloride THRIVE-3 clinical trial. The $0.5 million increase in indirect expenses was primarily due to a $1.0 million increase in personnel-related expenses partially offset by a $0.4 million decrease in other research and development expenses not directly attributable to a single product candidate.

Previous wording

General and administrative expenses were $5.8 million for the three months ended June 30, 2025, which represented an increase of approximately $1.5 million as compared to the three months ended June 30, 2024. This increase was primarily due to an increase of $0.6 million in personnel-related expenses as well as increases of $0.5 million in expenses related to market development, and other professional, consulting, and legal expenses aggregating to $0.2 million.

Current wording

General and administrative expenses were $5.2 million for the three months ended September 30, 2025, which represented an increase of approximately $0.9 million as compared to the three months ended September 30, 2024. This increase was primarily due to an increase of $0.7 million in personnel-related expenses.

Previous wording

Other income (expense), net was $1.6 million for the three months ended June 30, 2025, which represented an increase of approximately $0.5 million as compared to the three months ended June 30, 2024, due primarily to returns on a higher invested balance.

Current wording

Other income (expense), net was $1.5 million for the three months ended September 30, 2025, which represented an increase of approximately $0.4 million as compared to the three months ended September 30, 2024, due primarily to returns on a higher invested balance of unrestricted cash and cash equivalents and marketable debt securities.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The following table summarizes our research and development expenses (in thousands) for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our research and development expenses (in thousands) for the nine months ended September 30, 2025 and 2024:

Previous wording

Research and development expenses were $19.9 million for the six months ended June 30, 2025, which represented an increase of approximately $5.8 million as compared to the six months ended June 30, 2024. This increase was primarily due to a $6.6 million increase in direct expenses for our product candidates. The increase in direct expenses were driven by continued site expansion in our ADVANCED-2 NMIBC clinical trial as well as startup costs for our THRIVE-3 IV Choline Chloride clinical trial. The $0.8 million decrease in indirect expenses was primarily due to a $1.0 million decrease in other research and development expenses not directly attributable to a single product candidate, partially offset by an increase in personnel-related expenses of $0.2 million.

Current wording

Research and development expenses were $29.5 million for the nine months ended September 30, 2025, which represented an increase of approximately $7.3 million as compared to the nine months ended September 30, 2024. This increase was primarily due to a $7.5 million increase in direct expenses for our product candidates. The increase in direct expenses was driven by continued site expansion in our NMIBC ADVANCED-2 clinical trial, as well as startup costs for our IV Choline Chloride THRIVE-3 clinical trial. The $0.2 million decrease in indirect expenses was primarily due to a $1.4 million decrease in other research and development expenses not directly attributable to a single product candidate, partially offset by an increase in personnel-related expenses of $1.2 million.

Previous wording

During the six months ended June 30, 2025, our general and administrative expenses were approximately $10.8 million, which represented an increase of approximately $2.4 million as compared to the six months ended June 30, 2024. This increase was primarily due to an increase of $1.0 million in personnel-related expenses as well as increases of $0.9 million in expenses related to market development, and other professional, consulting, and legal expenses aggregating to $0.2 million.

Current wording

During the nine months ended September 30, 2025, our general and administrative expenses were approximately $16.0 million, which represented an increase of approximately $3.3 million as compared to the nine months ended September 30, 2024. This increase was primarily due to an increase of $1.7 million in personnel-related expenses, as well as increases of $0.9 million in expenses related to market development and patient advocacy, and other professional, consulting, and legal expenses aggregating to $0.4 million.

Previous wording

During the six months ended June 30, 2025, our other income (expense), net was approximately $3.8 million, which represented an increase of approximately $1.9 million as compared to the six months ended June 30, 2024, due primarily to returns on a higher invested balance as well as a $0.5 million increase in other income.

Current wording

During the nine months ended September 30, 2025, our other income (expense), net was approximately $5.3 million, which represented an increase of approximately $2.3 million as compared to the nine months ended September 30, 2024, due primarily to returns on a higher invested balance of unrestricted cash and cash equivalents and marketable debt securities as well as a $0.5 million increase in other income.

Previous wording

As of June 30, 2025 and December 31, 2024, our unrestricted cash and cash equivalents and marketable debt securities were $145.6 million and $170.3 million, respectively. We have not generated revenues since our inception and have incurred net losses of $26.9 million and $20.6 million for the six months ended June 30, 2025 and 2024, respectively and $15.0 million and $9.5 million for the three months ended June 30, 2025 and 2024 respectively. As of June 30, 2025, we had working capital of $115.3 million and stockholder’s equity of $144.4 million. During the six months ended June 30, 2025, net cash flows used in operating activities were $27.0 million, consisting primarily of a net loss of $26.9 million including non-cash expenses of $1.9 million, as well as working capital adjustments of $(2.0) 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, including those described in Note 10 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q (which descriptions are summaries only, do not purport to be complete and are qualified in their entirety by reference to the documents referenced therein and included as an exhibit to this Quarterly Report on Form 10-Q and/or the Annual Report on Form 10-K). In addition, we may receive additional proceeds upon the exercise of the common warrants issued in the April 2024 Private Placement.

Current wording

As of September 30, 2025 and December 31, 2024, our unrestricted cash and cash equivalents and marketable debt securities were $133.6 million and $170.3 million, respectively. We have not generated revenues since our inception and have incurred net losses of $40.1 million and $31.8 million for the nine months ended September 30, 2025 and 2024, respectively, and $13.3 million and $11.2 million for the three months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had working capital of $125.7 million and stockholder’s equity of $132.3 million. During the nine months ended September 30, 2025, net cash flows used in operating activities were $39.4 million, consisting primarily of a net loss of $40.1 million including non-cash expenses of $2.9 million, as well as cash used for changes in operating assets and liabilities of $2.2 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, including those described in Note 10 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q (which descriptions are summaries only, do not purport to be complete and are qualified in their entirety by reference to the documents referenced therein and included as an exhibit to this Quarterly Report on Form 10-Q and/or the Annual Report on Form 10-K). In addition, we may receive additional proceeds upon the exercise of the common warrants issued in the April 2024 Private Placement.

Previous wording

The following table summarizes our sources and uses of cash (in thousands) for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our sources and uses of cash (in thousands) for the nine months ended September 30, 2025 and 2024:

Previous wording

Net cash provided by (used in) operating activities was approximately $(27.0) million for the six months ended June 30, 2025 compared to approximately $(18.1) million for the six months ended June 30, 2024. The increase of approximately $8.9 million in cash used in operating activities was primarily driven by an increase in net loss of $6.3 million, an increase in working capital adjustments of $1.7 million, primarily related to changes in prepaid expenses and other current assets, accounts payable, and accrued expenses resulting from the timing of payments to our service providers as well as a $1.0 million decrease in non-cash items, consisting principally of stock-based compensation expense and accretion of discount on marketable debt securities.

Current wording

Net cash provided by (used in) operating activities was approximately $(39.4) million for the nine months ended September 30, 2025 compared to approximately $(26.5) million for the nine months ended September 30, 2024. The increase of approximately $12.9 million in cash used in operating activities was primarily driven by an increase in net loss of $8.3 million, an increase in cash used for changes in operating assets and liabilities of $3.7 million, primarily related to changes in prepaid expenses and other current assets, accounts payable, and accrued expenses resulting from the timing of payments to our service providers, as well as a $0.9 million decrease in non-cash items, consisting principally of stock-based compensation expense and accretion of discount on marketable debt securities.

Previous wording

Net cash provided by (used in) investing activities was approximately $(106.1) million for the six months ended June 30, 2025 compared to approximately $26.0 million for the six months ended June 30, 2024. The change in cash provided by (used in) investing activities of $132.1 million resulted primarily from an increase of $117.5 million in marketable debt securities purchased as well as a decrease of $14.6 million in proceeds from maturity of marketable debt securities.

Current wording

Net cash provided by (used in) investing activities was approximately $(112.6) million for the nine months ended September 30, 2025 compared to approximately $(3.3) million for the nine months ended September 30, 2024. The change in cash provided by (used in) investing activities of $109.2 million resulted primarily from an increase of $112.5 million in marketable debt securities purchased offset slightly by an increase of $3.3 million in proceeds from maturity of marketable debt securities.

Previous wording

Net cash provided by (used in) financing activities was $1.7 million for the six months ended June 30, 2025 compared to $42.0 million for the six months ended June 30, 2024. The cash provided during the six months ended June 30, 2025 consisted principally of the proceeds of $2.5 million from the exercise of the Underwriters’ Option from the December 2024 Public Offering net of offering costs offset slightly by $0.6 million in offering costs paid related to the December 2024 Public Offering. The cash provided during the six months ended June 30, 2024, consisted principally of $42.0 million from 2024 April Private Placement proceeds net of offering costs.

Current wording

Net cash provided by (used in) financing activities was $1.8 million for the nine months ended September 30, 2025 compared to $42.0 million for the nine months ended September 30, 2024. The cash provided during the nine months ended September 30, 2025 consisted principally of the proceeds of $2.5 million from the exercise of the Underwriters’ Option from the December 2024 Public Offering net of offering costs offset by $0.6 million in offering costs paid in the first quarter of 2025 related to the December 2024 Public Offering. The cash provided during the nine months ended September 30, 2024, consisted principally of $42.0 million from 2024 April Private Placement proceeds net of offering costs.