Protara Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 11, 2026
TARA$2.30+8.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001213900-26-055463
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001213900-26-087508
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 81 previous paragraphs and 94 current paragraphs.
64 unchanged; 14 reworded; 10 added; 2 removed; 1 previous and 6 current paragraphs rearranged.
Tables are not compared: 4 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
In May 2026, we presented additional updated interim data from our ongoing Phase 2 open-label ADVANCED-2 trial demonstrating meaningful and durable activity in BCG-Naïve NMIBC patients. The dataset included a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5, 2026 data cutoff. The CR rate at any time was 72.4% (21/29). The CR rate was 66.7% (18/27) at six months and 55.0% (11/20) at 12 months. Among responders, the KM estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4). 91.7% (11/12) maintained their CR from nine to 12 months and 66.7% (4/6) of re-induced patients converted to a CR at six months.
Current report
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 report
In May 2026, we presented updated interim safety and durability data from STARBORN-1 at the International Society for the Study of Vascular Anomalies World Congress in Philadelphia, Pennsylvania. As of an April 10, 2026 data cutoff, TARA-002 demonstrated clinical success in 83% (10/12) of participants that completed treatment and in 100% (10/10) of evaluable patients. All seven participants that reached the 32-week post-treatment assessment remained disease free as of the data cutoff. The majority of AEs were mild to moderate, with no serious AEs reported. The most common AEs were swelling and fatigue, and most were transient and resolved within a few days.
Current report
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 report
Other income (expense), net was $1.7 million for the three months ended June 30, 2026, which represented an increase of approximately $0.1 million as compared to the three months ended June 30, 2025. The increase was driven by higher interest and investment income in the three months ended June 30, 2026.
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Current report
Research and development expenses
Current report
General and administrative expenses
Current report
Other income (expense), net
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Removed paragraphs (2)
Previous report
We expect to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in the second half of 2026. Enrollment is complete in the BCG-Naïve cohort of the ADVANCED-2 trial with 31 patients. We are planning a proposed registrational trial in BCG-Naïve and potentially BCG-Exposed patients. The FDA has agreed that BCG is not required as a comparator and that intravesical chemotherapy is an acceptable comparator to TARA-002 in BCG-Naïve patients. We are continuing to engage with the FDA on aspects of the analysis plan, and we intend to initiate the ADVANCED-3 trial in the second half of 2026.
Previous report
In September 2024, we presented the results of THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on PS in the U.S., U.K. and Europe. The study found that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis and hepatobiliary injury, underscoring the need for IV Choline supplementation in this patient population.
Reworded paragraphs (14)
Previous wording
Since inception, we have incurred significant operating losses. As of March 31, 2026, we had an accumulated deficit of approximately $320.2 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 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.
Previous wording
As of March 31, 2026, we had approximately $177.4 million in unrestricted cash and cash equivalents and marketable debt securities.
Current wording
As of June 30, 2026, we had approximately $161.9 million in unrestricted cash and cash equivalents and marketable debt securities.
Previous wording
In March 2026, we announced that we have received confirmation on the six-month CR rate of the 25th BCG-Unresponsive patient in our ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with CIS (± Ta/T1) NMIBC. The average six-month CR rate in the 25 BCG-Unresponsive patients is 68.0%, which is consistent with the 68.2% CR rate at six months that was announced by us in February 2026, and is meaningfully above 41.9%.
Current wording
In March 2026, we announced that we have received confirmation on the six-month CR rate of the 25th BCG-Unresponsive patient in our ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with CIS (± Ta/T1) NMIBC. The average six-month CR rate in the 25 BCG-Unresponsive patients was 68.0%, which was consistent with the 68.2% CR rate at six months that was announced by us in February 2026, and was meaningfully above 41.9%.
Previous wording
In January 2026, we advanced the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PS and 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 second half 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. We anticipate reporting interim results from the dose-confirmation portion of the trial in the fourth quarter of 2026.
Previous wording
Based on engagement with the FDA, we intend to submit a Biologics License Application 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 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.
Previous wording
Research and development expenses were $13.6 million for the three months ended March 31, 2026, which represented an increase of approximately $4.4 million as compared to the three months ended March 31, 2025. This increase was primarily due to a $2.2 million increase in direct expenses for our product candidates and a $2.2 million increase in indirect expenses. The increase in direct expenses was primarily due to higher ongoing costs associated with the ADVANCED-2 trial for NMIBC as well as start-up costs related to the ADVANCED-3 trial for NMIBC. The increase in indirect expenses was primarily due to a $1.5 million increase in personnel-related expenses and a $0.7 million increase in research and development expenses not directly attributable to one specific product candidate.
Current 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.
Previous wording
General and administrative expenses were $6.1 million for the three months ended March 31, 2026, which represented an increase of approximately $1.1 million as compared to the three months ended March 31, 2025. This increase was primarily due to an increase of $0.9 million in personnel-related expenses, as well as an increase of $0.2 million in other general and administrative expenses.
Current 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.
Previous wording
Other income (expense), net was $1.8 million for the three months ended March 31, 2026, which represented a decrease of approximately $0.4 million as compared to the three months ended March 31, 2025. The decrease was driven by a $0.5 million decrease in other income (expense) due to nonrecurring refundable tax credits received in the three months ended March 31, 2025.
Current 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.
Previous wording
As of March 31, 2026 and December 31, 2025, our unrestricted cash and cash equivalents, and marketable debt securities were $177.4 million and $197.9 million, respectively. We have not generated revenues since our inception and have incurred net losses of $17.8 million and $11.9 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had working capital of $131.1 million and stockholder’s equity of $181.2 million. During the three months ended March 31, 2026, net cash flows used in operating activities were $21.3 million, consisting primarily of a net loss of $17.8 million including non-cash expenses of $1.5 million, as well as cash used for changes in operating assets and liabilities of $5.1 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. 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 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.
Previous wording
On November 3, 2023, we filed a shelf registration statement on Form S-3, or the Shelf Registration Statement, which became effective in November 2023. The Shelf Registration Statement permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination. In December 2024, we sold and issued approximately $102.8 million in gross proceeds of common stock and pre-funded warrants in a public offering under the Shelf Registration Statement. The net proceeds were approximately $95.9 million. In December 2025, we sold and issued approximately $86.3 million in gross proceeds of common stock in a public offering under the Shelf Registration Statement. The net proceeds were approximately $80.4 million.
Current wording
On November 3, 2023, we filed a shelf registration statement on Form S-3, or the Shelf Registration Statement, which became effective in November 2023. The Shelf Registration Statement permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination. In December 2024, we sold and issued approximately $102.8 million in gross proceeds of common stock and pre-funded warrants in a public offering under the Shelf Registration Statement. The net proceeds were approximately $95.9 million. In December 2025, we sold and issued approximately $86.3 million in gross proceeds of common stock in a public offering under the Shelf Registration Statement. The net proceeds were approximately $80.4 million. The remaining unsold securities under this shelf were rolled into a new shelf filed in May 2026 as described below.
Previous wording
As part of the April 2024 Private Placement, purchasers were offered common warrants. Common warrants exercised as of March 31, 2026 have resulted in $5.7 million in proceeds and, if exercised, proceeds from the remaining common warrants as of March 31, 2026 could result in an additional $51.2 million. The common warrants outstanding are set to expire on June 29, 2026.
Current wording
As part of the April 2024 Private Placement, purchasers were offered common warrants. Through June 29, 2026, common warrants exercised resulted in $5.7 million in proceeds. The remaining unexercised common warrants expired on June 29, 2026.
Previous wording
Net cash provided by (used in) operating activities was approximately $(21.3) million for the three months ended March 31, 2026 compared to approximately $(14.7) million for the three months ended March 31, 2025. The increase of approximately $6.6 million in cash used in operating activities was primarily driven by an increase in net loss of $5.9 million, an increase in cash used for operating assets and liabilities, primarily related to changes in other assets, accrued expenses and other current liabilities, offset by a decrease in accounts payable, resulting principally from the timing of payments to our service providers of $1.3 million, and by an increase in non-cash items, consisting principally of accretion of discount on marketable debt securities and stock-based compensation expense of $0.5 million.
Current 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.
Previous wording
Net cash provided by (used in) investing activities was approximately $(14.7) million for the three months ended March 31, 2026 compared to approximately $(58.4) million for the three months ended March 31, 2025. The decrease in cash used of $43.6 million resulted primarily from a decrease in purchases of marketable debt securities of $22.0 million as well as an increase in proceeds from marketable debt securities matured and redeemed of $21.6 million.
Current 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.
Previous wording
Net cash provided by (used in) financing activities was $1.1 million for the three months ended March 31, 2026 compared to $1.7 million for the three months ended March 31, 2025. The $0.6 million decrease was primarily driven by proceeds received in the prior-year period of $2.5 million from the net proceeds of the underwriters’ overallotment option exercised in connection with the December 2024 Public Offering, as compared to, proceeds received during the current period of $1.9 million from the exercise of common warrants.
Current 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.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
The majority of TRAEs were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria.
Current report — wording carried from elsewhere
The following table summarizes our results of operations (in thousands):
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses (in thousands):
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
The following table summarizes our general and administrative expenses (in thousands):
Current report — wording carried from elsewhere
On May 14, 2026, we filed a shelf registration statement on Form S-3, or the 2026 Shelf Registration Statement, which became effective in May 2026. The 2026 Shelf Registration Statement permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $300.0 million in common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination. In May 2026, we entered into a sales agreement with TD Securities (USA) LLC, as sales agent, pursuant to which we may offer and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $100.0 million, or the ATM Program. As of June 30, 2026, no shares have been sold under the ATM Program.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Comparison of the Three Months Ended March 31, 2026 and 2025