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 75-100 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CIS (± Ta/T1) and is expected to be registrational based on the Food and Drug Administrations, or FDA’s, August 2024 Draft Guidance on BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment.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 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CIS (± Ta/T1) and is expected to be registrational based on the Food and Drug Administrations, or FDA’s, August 2024 Draft Guidance on BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment.

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. 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 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.

Previous wording

In September 2024, we announced interim data from the first safety cohort in the STARBORN-1 trial. Of three patients treated in the first cohort, which enrolled individuals six years to less than 18 years of age, two patients treated with TARA-002 achieved a CR after receiving one injection of TARA-002; the responses were seen in a patient with a macrocystic LM and a patient with a maxillofacial cyst called a ranula. The tolerability observed in this cohort was consistent with patients’ historical experience with OK-432 and included treatment emergent adverse events, or TEAEs, of pain, swelling, fatigue and body temperature increases. All TEAEs were mild to moderate and resolved. We expect to provide an interim update from our STARBORN-1 trial in the second half of 2025.

Current wording

In September 2024, we announced interim data from the first safety cohort in the STARBORN-1 trial. Of three patients treated in the first cohort, which enrolled individuals six years to less than 18 years of age, two patients treated with TARA-002 achieved a CR after receiving one injection of TARA-002; the responses were seen in a patient with a macrocystic LM and a patient with a maxillofacial cyst called a ranula. The tolerability observed in this cohort was consistent with patients’ historical experience with OK-432 and included treatment emergent adverse events, or TEAEs, of pain, swelling, fatigue and body temperature increases. All TEAEs were mild to moderate and resolved. We expect to provide an interim update from our STARBORN-1 trial in the fourth quarter of 2025.

Previous wording

Since inception, we have incurred significant operating losses. As of March 31, 2025, we had an accumulated deficit of approximately $256.9 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 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.

Previous wording

As of March 31, 2025, we had approximately $157.5 million in unrestricted cash and cash equivalents and marketable debt securities.

Current wording

As of June 30, 2025, we had approximately $145.6 million in unrestricted cash and cash equivalents and marketable debt securities.

Previous wording

Research and development expenses were $9.1 million for the three months ended March 31, 2025, which represented an increase of approximately $1.4 million as compared to the three months ended March 31, 2024. This increase was primarily due to a $2.6 million increase in direct expenses for our product candidates partially offset by a $1.2 million decrease in indirect expenses. The decrease in indirect expenses was primarily due to a $0.7 million decrease in personnel-related expenses and a decrease of $0.6 other research and development expenses not directly attributable to a single product candidate.

Current 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.

Previous wording

General and administrative expenses were $5.0 million for the three months ended March 31, 2025, which represented an increase of approximately $0.9 million as compared to the three months ended March 31, 2024. This increase was primarily due to an increase of $0.4 million in personnel-related expenses as well as increases in market development and investor relations activities of $0.2 million and $0.2 million, respectively.

Current 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.

Previous wording

Other income (expense), net was $2.2 million for the three months ended March 31, 2025, which represented an increase of approximately $1.5 million as compared to the three months ended March 31, 2024, due primarily to higher investment returns on a higher invested balance as well as a $0.5 million increase in other income.

Current 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.

Previous wording

As of March 31, 2025 and December 31, 2024, our unrestricted cash and cash equivalents and marketable debt securities were $157.5 million and $170.3 million, respectively. We have not generated revenues since our inception and have incurred net losses of $11.9 million and $11.1 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had working capital of $119.5 million and stockholder’s equity of $158.5 million. During the three months ended March 31, 2025, net cash flows used in operating activities were $14.7 million, consisting primarily of a net loss of $11.9 million including non-cash expenses of $1.0 million, as well as working capital adjustments of $(3.8) 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. More recently, on January 8, 2025, the Underwriters of the December 2024 Public Offering notified us of their determination to exercise the Underwriters’ Option in part, and purchased an additional 438,738 shares of common stock, at the public offering price less underwriting discounts and commissions, which resulted in net proceeds of approximately $2.5 million after deducting placement agent fees and offering expenses.

Current 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.

Previous wording

As a result of volatility in the capital markets, economic conditions, general global economic uncertainty, political and regulatory change and uncertainty, 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 continued 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 and uncertainty, global pandemics, tariffs and governmental trade policies, as well as 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 continued inflation could materially affect our business and the value of our common stock.

Previous wording

The following table summarizes our sources and uses of cash (in thousands) for the three months ended March 31, 2025 and 2024:

Current wording

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

Previous wording

Net cash provided by (used in) operating activities was approximately $(14.7) million for the three months ended March 31, 2025 compared to approximately $(10.4) million for the three months ended December 31, 2024. The increase of approximately $4.3 million in cash used in operating activities was primarily driven by an increase in working capital adjustments, 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 of $3.0 million as well as an increase in net loss of $0.8 million and a $0.5 million decrease in non-cash items, consisting principally of stock-based compensation expense.

Current 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.

Previous wording

Net cash provided by (used in) investing activities was approximately $(58.4) million for the three months ended March 31, 2025 compared to approximately $23.1 million for the three months ended March 31, 2024. The change in cash provided by (used in) investing activities of $81.5 million resulted primarily from an increase of $65.8 million in marketable debt securities purchased as well as a decrease of $15.6 million in proceeds from marketable debt securities matured.

Current 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.

Previous wording

Net cash provided by (used in) financing activities was $1.7 million for the three months ended March 31, 2025 compared to $(0.1) million for the three months ended March 31, 2024. The change in cash provided by (used in) financing activities of approximately $1.8 million resulted primarily from the net proceeds of $2.5 million from the issuance of common stock in connection with the exercise of the Underwriters’ option, offset partially by $0.6 million of cash paid in connection with the December 2024 Public Offering.

Current 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.