# Protara Therapeutics, Inc. (TARA)

Informational only - not investment advice.

CIK: 0001359931
SIC: 2836 Biological Products, (No Diagnostic Substances)
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2836 Biological Products, (No Diagnostic Substances)](/industry/2836/)
Latest 10-K filed: 2026-03-10
SEC page: https://www.sec.gov/edgar/browse/?CIK=1359931
Filing source: https://www.sec.gov/Archives/edgar/data/1359931/000121390026025433/ea0277639-10k_protara.htm

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Net income | -57439000 | USD | 2025 | 2026-03-10 |
| Assets | 209468000 | USD | 2025 | 2026-03-10 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-10. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001359931.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net income | -28,526,000 | -29,964,000 | -20,729,000 | -7,830,000 | -33,978,000 | -47,252,000 | -65,952,000 | -40,420,000 | -44,596,000 | -57,439,000 |
| Operating income | -28,705,000 | -30,362,000 | -21,372,000 | -7,830,000 | -34,444,000 | -47,489,000 | -67,062,000 | -43,613,000 | -49,154,000 | -64,549,000 |
| Diluted EPS |  |  |  |  |  | -4.21 | -5.86 | -3.57 | -2.17 | -1.34 |
| Operating cash flow | -23,687,000 | -22,352,000 | -23,233,000 | -5,011,000 | -23,407,000 | -34,502,000 | -26,457,000 | -37,557,000 | -35,808,000 | -56,365,000 |
| Capital expenditures | 271,000 | 35,000 | 119,000 | 475,000 | 884,000 | 596,000 | 120,000 | 45,000 | 63,000 | 94,000 |
| Assets | 43,520,000 | 43,979,000 | 23,521,000 | 1,223,000 | 203,157,000 | 172,596,000 | 113,290,000 | 78,954,000 | 181,454,000 | 209,468,000 |
| Liabilities | 5,079,000 | 9,240,000 | 3,078,000 | 3,351,000 | 3,914,000 | 10,682,000 | 11,207,000 | 10,633,000 | 14,320,000 | 13,056,000 |
| Stockholders' equity | 38,441,000 | 34,740,000 | 4,778,000 | -2,128,000 | 199,243,000 | 161,914,000 | 102,083,000 | 68,321,000 | 167,134,000 | 196,412,000 |
| Cash and cash equivalents | 36,392,000 | 21,170,000 | 19,371,000 | 564,000 | 168,598,000 | 35,724,000 | 24,127,000 | 39,586,000 | 162,798,000 | 49,657,000 |
| Free cash flow | -23,958,000 | -22,387,000 | -23,352,000 | -5,486,000 | -24,291,000 | -35,098,000 | -26,577,000 | -37,602,000 | -35,871,000 | -56,459,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Return on equity | -74.21% | -86.25% | -433.84% |  | -17.05% | -29.18% | -64.61% | -59.16% | -26.68% | -29.24% |
| Return on assets | -65.55% | -68.13% | -88.13% |  | -16.72% | -27.38% | -58.22% | -51.19% | -24.58% | -27.42% |
| Liabilities / equity | 0.13 | 0.27 | 0.64 |  | 0.02 | 0.07 | 0.11 | 0.16 | 0.09 | 0.07 |
| Current ratio | 8.42 | 4.71 | 7.55 | 0.23 | 58.13 | 21.66 | 15.01 | 11.17 | 15.71 | 14.58 |

## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-13. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001359931.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2014-Q3 | 2014-09-30 | 2,948,000 |  |  | reported discrete quarter |
| 2014-Q4 | 2014-12-31 | 0.00 |  |  | derived Q4 = FY annual - nine-month YTD |
| 2022-Q2 | 2022-06-30 |  |  | -0.80 | reported discrete quarter |
| 2022-Q3 | 2022-09-30 |  |  | -0.68 | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | -0.80 | reported discrete quarter |
| 2023-Q2 | 2023-03-31 |  | -9,045,000 |  | reported discrete quarter |
| 2023-Q2 | 2023-06-30 |  |  | -1.00 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | -11,294,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 |  |  | -0.87 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 |  | -10,221,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 |  | -11,095,000 | -0.97 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -11,095,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 |  |  | -0.45 | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | -9,513,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 |  |  | -0.50 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 |  | -12,769,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 |  | -11,914,000 | -0.29 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | -11,914,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 |  |  | -0.35 | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | -14,960,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-09-30 |  |  | -0.31 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 |  | -17,307,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 |  | -17,782,000 | -0.31 | reported discrete quarter |

## Macro Cross-References
- [CPIAUCSL](/indicator/CPIAUCSL/): Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- [UNRATE](/indicator/UNRATE/): Unemployment Rate
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [DFEDTARU](/indicator/DFEDTARU/): Federal Funds Target Range - Upper Limit
- [DFEDTARL](/indicator/DFEDTARL/): Federal Funds Target Range - Lower Limit
- [DGS3MO](/indicator/DGS3MO/): Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
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- [DGS30](/indicator/DGS30/): Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
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- [CPILFESL](/indicator/CPILFESL/): Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- [CPIUFDSL](/indicator/CPIUFDSL/): Consumer Price Index for All Urban Consumers: Food
- [CPIENGSL](/indicator/CPIENGSL/): Consumer Price Index for All Urban Consumers: Energy
- [CUSR0000SAH1](/indicator/CUSR0000SAH1/): Consumer Price Index for All Urban Consumers: Shelter
- [PCEPI](/indicator/PCEPI/): Personal Consumption Expenditures: Chain-type Price Index
- [PCEPILFE](/indicator/PCEPILFE/): Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
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- [A191RL1Q225SBEA](/indicator/A191RL1Q225SBEA/): Real Gross Domestic Product: Percent Change from Preceding Period
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- [RSAFS](/indicator/RSAFS/): Advance Retail Sales: Retail Trade
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- [DSPIC96](/indicator/DSPIC96/): Real Disposable Personal Income
- [PSAVERT](/indicator/PSAVERT/): Personal Saving Rate
- [M2SL](/indicator/M2SL/): M2
- [BOPGSTB](/indicator/BOPGSTB/): U.S. International Trade in Goods and Services: Balance
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- [TTLCONS](/indicator/TTLCONS/): Total Construction Spending: Total Construction in the United States
- [RRVRUSQ156N](/indicator/RRVRUSQ156N/): Rental Vacancy Rate in the United States
- [TOTALSL](/indicator/TOTALSL/): Total Consumer Credit Owned and Securitized
- [REVOLSL](/indicator/REVOLSL/): Revolving Consumer Credit Owned and Securitized
- [DRCCLACBS](/indicator/DRCCLACBS/): Delinquency Rate on Credit Card Loans, All Commercial Banks
- [GDP](/indicator/GDP/): Gross Domestic Product
- [GPDI](/indicator/GPDI/): Gross Private Domestic Investment
- [GCE](/indicator/GCE/): Government Consumption Expenditures and Gross Investment
- [PCEC](/indicator/PCEC/): Personal Consumption Expenditures
- [NETEXP](/indicator/NETEXP/): Net Exports of Goods and Services
- [GFDEBTN](/indicator/GFDEBTN/): Federal Debt: Total Public Debt
- [GFDEGDQ188S](/indicator/GFDEGDQ188S/): Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- [FYFSD](/indicator/FYFSD/): Federal Surplus or Deficit
- [FGRECPT](/indicator/FGRECPT/): Federal Government Current Receipts
- [FGEXPND](/indicator/FGEXPND/): Federal Government: Current Expenditures
- [MANEMP](/indicator/MANEMP/): All Employees, Manufacturing
- [USCONS](/indicator/USCONS/): All Employees, Construction
- [USTRADE](/indicator/USTRADE/): All Employees, Retail Trade
- [USFIRE](/indicator/USFIRE/): All Employees, Financial Activities
- [USGOVT](/indicator/USGOVT/): All Employees, Government
- [AWHAETP](/indicator/AWHAETP/): Average Weekly Hours of All Employees, Total Private
- [DGORDER](/indicator/DGORDER/): Manufacturers' New Orders: Durable Goods
- [NEWORDER](/indicator/NEWORDER/): Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- [BUSINV](/indicator/BUSINV/): Total Business Inventories
- [EXPGS](/indicator/EXPGS/): Exports of Goods and Services
- [IMPGS](/indicator/IMPGS/): Imports of Goods and Services
- [IR](/indicator/IR/): Import Price Index (End Use): All Commodities
- [PPIFIS](/indicator/PPIFIS/): Producer Price Index by Commodity: Final Demand

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1359931/000121390026055463/ea0287944-10q_protara.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary.
Confidence: high
Filing date: 2026-05-13
Report date: 2026-03-31

Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations

You should read the following
discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial
statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion
and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy
for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many
factors, including those factors set forth in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K, our
actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the
following discussion and analysis.

Overview

We are a New York City based
clinical-stage biopharmaceutical company committed to advancing transformative therapies for the treatment of cancer and rare diseases.
We were founded on the principle of applying modern scientific, regulatory or manufacturing advancements to established mechanisms in
order to create new development opportunities. We prioritize creativity, integrity and tenacity to expedite our goal of bringing life-changing
therapies to people with limited treatment options.

Our portfolio includes two
development programs utilizing TARA-002, an investigational cell therapy based on the broad immunopotentiator, OK-432, which was originally
granted marketing approval by the Japanese Ministry of Health and Welfare as an immunopotentiating cancer therapeutic agent. This cell
therapy is currently approved in Japan and Taiwan for lymphatic malformations, or LMs, and multiple oncologic indications. We have secured
worldwide rights to the asset excluding Japan and Taiwan and are exploring its use in oncology and rare disease indications. TARA-002
was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432 (marketed as Picibanil®
in Japan by Chugai Pharmaceutical Co., Ltd., or Chugai Pharmaceutical). We are currently developing TARA-002 in non-muscle invasive bladder
cancer, or NMIBC, and LMs. We are also pursuing Intravenous, or IV, Choline Chloride, an investigational phospholipid substrate replacement
therapy, for patients receiving parenteral support, or PS, which includes both nutrition and fluids.

We have devoted substantial
efforts to the development of our programs and do not have any approved products and, to date, have not generated any revenues from product
sales. Neither TARA-002 nor IV Choline Chloride have been approved by the U.S. Food and Drug Administration, or FDA, or other comparable
regulatory authorities for use for any indications. We do not expect to generate revenues in the near-term, and it is possible we may
never generate revenues in the future. To finance our current strategic plans, including the conduct of ongoing and future clinical trials
and further research and development costs, we will need to raise additional capital. See “Item 2. Management’s Discussion
and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” for additional information
about our liquidity and capital resource needs.

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.

As a clinical-stage company,
our expenses and results of operations are likely to fluctuate significantly from quarter-to-quarter and year-to-year. We believe that
our period-to-period comparisons of our results of operations should not be relied upon as indicative of our future performance.

As of March 31, 2026, we
had approximately $177.4 million in unrestricted cash and cash equivalents and marketable debt securities.

TARA-002 in NMIBC

Our lead oncology program
is TARA-002 in NMIBC, which is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder
muscle. Bladder cancer is the sixth most common cancer in the U.S., with NMIBC representing approximately 80% of bladder cancer diagnoses.
Approximately 65,000 patients are diagnosed with NMIBC in the U.S. each year. Very few new therapeutics have been approved for NMIBC since
the 1990s and the current standard of care for NMIBC includes intravesical Bacillus Calmette-Guérin, or BCG.

17

Following the completion of our Phase 1a ADVANCED-1 and Phase 1b ADVANCED-1EXP
trials in October 2024 and September 2024, respectively, 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 trial has completed enrollment and enrolled 31 patients with CIS (±
Ta/T1, with Ta defined as non-invasive papillary carcinoma and T1 defined as carcinoma invading the lamina propria) who are either BCG-Naïve
or BCG-Exposed and 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 designed to be registrational based on the
FDA’s August 2024 Draft Guidance for Industry on BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological
Products for Treatment. Trial subjects in ADVANCED-2 receive an induction course, with or without a reinduction, of six weekly intravesical
instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

In February 2026, we presented updated interim data from our ongoing
Phase 2 open-label ADVANCED-2 trial reporting results that continue to support TARA-002’s potential as a new therapy in the NMIBC
treatment landscape and demonstrating meaningful and durable activity in BCG-Unresponsive and BCG-Naïve NMIBC patients.

The dataset includes 43 BCG-Unresponsive patients and 31 BCG-Naïve
patients who received at least one dose of TARA-002; 35 BCG-Unresponsive patients and 29 BCG-Naïve patients completed at least one
response assessment and were evaluable for efficacy as of a January 28, 2026 data cutoff. Complete response, or CR, rates at the six months
and 12 months landmark time points include all participants who were either evaluable at that time point or had experienced disease progression
or treatment failure prior to the scheduled visit.

For the BCG-Unresponsive cohort, the CR rate at any time was 65.7%
(23/35). The CR rate was 68.2% (15/22) at six months and 33.3% (5/15) at 12 months. Among responders, the Kaplan-Meier, or KM, estimated
probability of maintaining a CR for six months was 71.1% (95% confidence interval, or CI: 46.7, 95.5), and 100% (5/5) maintained their
CR from nine to 12 months. Re-induction therapy successfully converted 61.5% (8/13) non-responders to a CR at six months.

For the BCG-Naïve cohort, the CR rate at any time was 72.4% (21/29).
The CR rate was 66.7% (18/27) at six months and 57.9% (11/19) 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), and 100% (11/11) maintained their CR from nine to 12 months. Re-induction therapy
successfully converted 66.7% (4/6) non-responders to a CR at six months.

The majority of treatment-related
adverse events, or TRAEs, were Grade 1 and transient with no Grade 3 or greater TRAEs and no related serious adverse events, or SAEs,
as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly occurring TRAEs were dysuria (14%),
bladder spasm (9%), fatigue (7%) and micturition urgency (5%).

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%.

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.

18

In addition to our existing
clinical trials in NMIBC, we plan to continue to explore the anti-tumor activity related to the administration of TARA-002 via systemic
administration. We continue to believe that combination therapy may play a meaningful role in the NMIBC treatment paradigm and intend
to evaluate TARA-002 in combination with other therapies. Given what we have observed to date of TARA-002’s mechanism of action
and safety profile, we believe it has strong potential as a combination agent, and we continue to evaluate potential combination therapy
options for our clinical program. We also continue to conduct non-clinical studies on TARA-002 to better characterize the mechanism of
action to help us understand how TARA-002 may perform in potential combinations with other agents used to treat NMIBC, and to help us
define other cancer targets for TARA-002, both within urothelial cancer and other types of cancer affecting different parts of the body.

IV Choline Chloride for
Patients on PS

We are also pursuing IV Choline
Chloride, an investigational phospholipid substrate replacement therapy, for patients receiving PS which includes both nutrition and fluids.
Choline is a known important substrate for phospholipids that are critical for healthy liver function and also plays an important role
in modulating gene expression, cell membrane signaling, brain development, neurotransmission, muscle function and bone health. PS patients
are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline.
Every year in the U.S. there are approximately 90,000 people who require PS at home and of those approximately 30,000 are on long-term
PS. IV Choline Chloride has the potential to become the first FDA-approved IV choline formulation for PS patients.

An IV formulation of choline is recommended for patients on parenteral
nutrition, or PN, by the American Society for Parenteral and Enteral Nutrition, or ASPEN, in their Recommendations for Changes in Commercially
Available Parenteral Multivitamin and Multi–Trace Element Products, as well as by the European Society for Clinical Nutrition and
Metabolism, or ESPEN, in their Guideline on Home Parenteral Nutrition. IV Choline Chloride has been granted Orphan Drug Designation, or
ODD, by the FDA for the prevention and/or treatment of choline deficiency in patients on

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A

Extracted from Item 7 to the first post-MD&A boundary after HTML sanitization.
Confidence: high

Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

You
should read the following discussion and analysis of our financial condition and results of operations together with our financial statements
and related notes appearing elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis
or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business
and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including
those factors set forth in the “Risk Factors” section of this document, our actual results could differ materially from the
results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

Overview

We
are a New York City based clinical-stage biopharmaceutical company committed to advancing transformative therapies for the treatment
of cancer and rare diseases. We were founded on the principle of applying modern scientific, regulatory or manufacturing advancements
to established mechanisms in order to create new development opportunities. We prioritize creativity, integrity and tenacity to expedite
our goal of bringing life-changing therapies to people with limited treatment options.

Our
portfolio includes two development programs utilizing TARA-002, an investigational cell therapy based on the broad immunopotentiator,
OK-432, which was originally granted marketing approval by the Japanese Ministry of Health and Welfare as an immunopotentiating cancer
therapeutic agent. This cell therapy is currently approved in Japan and Taiwan for LMs and multiple oncologic indications. We have secured
worldwide rights to the asset excluding Japan and Taiwan and are exploring its use in oncology and rare disease indications. TARA-002
was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432 (marketed as Picibanil®
in Japan by Chugai Pharmaceutical). We are currently developing TARA-002 in NMIBC and in LMs.

We are also pursuing IV
Choline Chloride, an investigational phospholipid substrate replacement therapy, for patients receiving PS which includes both nutrition
and fluids. Choline is a known important substrate for phospholipids that are critical for healthy liver function and also plays an important
role in modulating gene expression, cell membrane signaling, brain development, neurotransmission, muscle function and bone health. PS
patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing
choline. See “Item 1. Business” for additional information regarding our various clinical trial programs.

We have devoted substantial
efforts to the development of our programs and do not have any approved products and, to date, have not generated any revenues from product
sales. Neither TARA-002 nor IV Choline Chloride have been approved by the FDA or other comparable regulatory authorities for use for any
indications. We do not expect to generate revenues in the near-term, and it is possible we may never generate revenues in the future.
To finance our current strategic plans, including the conduct of ongoing and future clinical trials and further research and development
costs, we will need to raise additional capital. See “Item 7. Management’s Discussion and Analysis of Financial Condition
and Results of Operations—Liquidity and Capital Resources” for additional information about our liquidity and capital
resource needs.

Since inception, we have
incurred significant operating losses. As of December 31, 2025, we had an accumulated deficit of approximately $302.4 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 U.S.

As
a clinical-stage company, our expenses and results of operations are likely to fluctuate significantly from quarter-to-quarter and year-to-year.
We believe that our period-to-period comparisons of our results of operations should not be relied upon as indicative of our future performance.

As
of December 31, 2025, we had approximately $197.9 million in unrestricted cash and cash equivalents, and marketable debt securities.

79

Financial
Overview

Research
and Development

Research
and development expenses consist primarily of costs incurred for the development of our current and potential future product candidates,
which include personnel-related expenses, including salaries, benefits, travel and stock-based compensation expense, external expenses
incurred under agreements with CROs or CDMOs, the cost of acquiring, developing and manufacturing clinical trial materials, clinical
and non-clinical related costs and costs associated with regulatory operations and facilities, which includes depreciation and other
expenses such as rent, maintenance and other supplies.

General
and Administrative

General and administrative
expenses consist primarily of personnel-related costs, including salaries, benefits, travel expenses and stock-based compensation, for
executive management and other administrative personnel. General and administrative expenses also include professional fees for legal,
investor relations, consulting, auditing and accounting services, business and market development activities, as well as costs related
to human resources, information technology and facilities. In addition, these expenses include costs associated with operating as a public
company, such as expenses related to our Nasdaq listing and SEC compliance and director and officer liability insurance premiums.

Other
Income (Expense), net

Other income (expense), net
consists of interest and investment income (expense) and other income (expense). Interest and investment income (expense) consists of
interest and dividend income on our cash and cash equivalents and marketable debt securities and amortization of premiums and/or accretion
of discounts. Other income (expense) may also include non-operating items, such as refundable tax credits and other miscellaneous income
not related to our core operating activities.

Critical
Accounting Policies and Significant Judgments and Estimates

Our
management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or
GAAP. The preparation of consolidated financial statements in conformity with GAAP requires us to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and other
market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ materially
from those estimates or assumptions.

While
our significant accounting policies are described in more detail in the notes to our consolidated financial statements and related notes
appearing elsewhere in this Annual Report on this Form 10-K, we believe the following accounting policies to be most critical to the
judgments and estimates used in the preparation of our financial statements.

Our critical accounting policy
is the accounting for research and development prepaid and accrued expenses.

Research
and Development Prepaid and Accrued Expenses

We
record accruals for estimated costs of research, preclinical, non-clinical, clinical and manufacturing development within accrued expenses
which are significant components of research and development expenses. A substantial portion of our ongoing research and development
activities are conducted by third-party service providers. We accrue costs incurred under these third-party arrangements based on estimates
of actual work completed in accordance with the respective agreements. We determine the estimated costs to accrue through discussions
with internal personnel and our external service providers as to the percentage of completion of the services and the agreed-upon fees
to be paid for such services. Payments made to third parties under these arrangements in advance of performance of the related services
are recorded as prepaid expenses until the services are rendered.

80

Results
of Operations

Comparison
of the Years Ended December 31, 2025 and 2024

The
following table summarizes our results of operations (in thousands):

For
the Years Ended

December 31,

Period
-to-

Period

2025

2024

Change

Operating expenses:

Research and
development

$

42,633

$

31,704

$

10,929

General
and administrative

21,916

17,450

4,466

Total
operating expenses

64,549

49,154

15,395

Income (Loss) from operations

(64,549

)

(49,154

)

(15,395

)

Other income (expense), net:

Interest and investment
income (expense)

6,380

4,171

2,209

Other
income (expense)

730

387

343

Other
income (expense), net

7,110

4,558

2,552

Net income (loss)

$

(57,439

)

$

(44,596

)

$

(12,843

)

Research
and development expenses

The
following table summarizes our research and development expenses (in thousands):

For
the Years Ended

December 31,

Period
-to-

Period

2025

2024

Change

Direct expenses by product candidate:

TARA-002 in
NMIBC

$

18,377

$

12,306

$

6,071

TARA-002 in LMs

2,606

2,558

48

IV
Choline Chloride

8,501

4,555

3,946

Total direct expenses by
product candidate

29,484

19,419

10,065

Indirect research and
development expenses

13,149

12,285

864

Total

$

42,633

$

31,704

$

10,929

Research and development
expenses were $42.6 million for the year ended December 31, 2025, which represented an increase of approximately $10.9 million as compared
to the year ended December 31, 2024. This increase was primarily due to a $10.1 million increase in direct expenses for our product candidates
and a $0.9 million increase in indirect expenses. The increase in direct expenses was primarily due to site expansion and enrollment efforts
for the ADVANCED-2 trial for NMIBC, start-up costs related to the ADVANCED-3 trial for NMIBC, as well as start-up and enrollment costs
related to the THRIVE-3 trial for IV Choline Chloride. The increase in indirect expenses was primarily due to a $2.0 million increase
in personnel-related expenses offset by a decrease of $1.1 million in research and development expenses not directly attributable to one
specific product candidate.

General
and administrative expenses

The
following table summarizes our general and administrative expenses (in thousands):

For
the Years Ended

December 31,

Period
-to-

Period

2025

2024

Change

Personnel-related
expenses, including stock-based compensation

$

11,207

$

8,867

$

2,340

Other general and administrative
expenses

10,709

8,583

2,126

Total

$

21,916

$

17,450

$

4,466

81

General and administrative
expenses were $21.9 million for the year ended December 31, 2025, which represented an increase of approximately $4.5 million as compared
to the year ended December 31, 2024. This increase was primarily due to an increase of $2.3 million in personnel-related expenses, as
well as an increase of $2.1 million in other general and administrative expenses primarily related to professional and consulting services.

Other
income (expense), net

Other income (expense), net
was $7.1 million for the year ended December 31, 2025, which represented an increase of approximately $2.6 million as compared to the
year ended December 31, 2024. The $2.2 million increase in interest and investment income (expense) is due primarily to investment returns
on a higher invested balance. The $0.3 million increase in other income (expense) is due to an increase in refundable tax credits received
in the year ended December 31, 2025. 

Liquidity
and Capital Resources

Overview

As
of December 31, 2025 and 2024, our unrestricted cash and cash equivalents, and marketable debt securities were $197.9 million and $170.3
million, respectively. We have not generated revenues since our inception and have incurred net losses of approximately $57.4 million
and $44.6 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had working capital of approximately
$148.6 million and stockholder’s equity of approximately $196.4 million. During the year ended December 31, 2025, cash flows used
in operating activities were approximately $56.4 million, consisting primarily of a net loss of approximately $57.4 million, which includes
non-cash activities of approximately $4.0 million, inclusive of $3.8 million in stock-based compensation expense, as well as cash used
for changes in operating assets and liabilities of $2.9 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 of securities and public offerings
of securities. In addition, we may receive proceeds upon the exercise of the common warrants issued in the April 2024 private placement
described below.

Liquidity

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, or the December 2024 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, or the December
2025 Public Offering, under the Shelf Registration Statement. The net proceeds were approximately $80.4 million.

In April 2024, the Company entered into a private placement transaction,
or the April 2024 Private Placement, whereby the Company sold and issued common stock, warrants and in, in some circumstances, pre-funded
warrants to certain purchasers. At the close of the April 2024 Private Placement, the Company received approximately $45.0 million in
gross proceeds. The net proceeds were approximately $42.0 million. Additionally, as part of the April 2024 Private Placement, purchasers
were offered common warrants. Common warrants exercised as of December 31, 2025 have resulted in $3.8 million in proceeds and, if exercised,
proceeds from the remaining common warrants as of December 31, 2025 could result in an additional $53.1 million.

We
are in the business of developing biopharmaceuticals and have no current or near-term revenues. We have incurred substantial clinical
and other costs in our drug development efforts. We will need to raise additional capital in order to fully realize management’s
plans.

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 consolidated financial statements included elsewhere in this Annual Report on this Form 10-K.

82

As a result of volatility
in the capital markets, economic conditions, general global economic uncertainty, political 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.

Cash
Flows

The
following table summarizes our sources and uses of cash (in thousands):

For
the Years Ended

December 31,

Period
-to-

Period

2025

2024

Change

Net cash provided by (used in)
operating activities

$

(56,365

)

$

(35,808

)

$

(20,557

)

Net cash provided by (used in) investing activities

(139,491

)

19,155

(158,646

)

Net cash provided by
(used in) financing activities

82,715

139,865

(57,150

)

Net increase (decrease)
in cash and cash equivalents, and restricted cash

$

(113,141

)

$

123,212

(236,353

)

Comparison
of the Years Ended December 31, 2025 and 2024

Net cash provided by (used
in) operating activities was approximately $(56.4) million for the year ended December 31, 2025 compared to approximately $(35.8) million
for the year ended December 31, 2024. The increase of approximately $20.6 million in cash used in operating activities was primarily driven
by an increase in net loss of $12.8 million, an increase in cash used for operating assets and liabilities, primarily related to changes
in prepaid expenses and other current assets, accounts payable, and accrued expenses and other current liabilities, resulting from the
timing of payments to our service providers of $6.9 million, and by a decrease in non-cash items, consisting principally of accretion
of discount on marketable debt securities and stock-based compensation expense of $0.8 million.

Net cash provided by (used
in) investing activities was approximately $(139.5) million for the year ended December 31, 2025 compared to approximately $19.2 million
for the year ended December 31, 2024. The increase in cash used of $158.7 million resulted primarily from an increase in purchases of
marketable debt securities of $175.2 million offset slightly by an increase in proceeds from marketable debt securities matured and redeemed
of $16.6 million.

Net cash provided by (used
in) financing activities was $82.7 million for the year ended December 31, 2025 compared to $139.9 million for the year ended December
31, 2024. The decrease of approximately $57.2 million resulted primarily from less capital being raised from public and private offerings
in the year ended December 31, 2025 as compared to the year ended December 31, 2024 of $53.1 million. During the year ended December 31,
2025, cash provided by financing activities related to public offerings was $82.9 million as compared to December 31, 2024 where cash
provided by financing activities related to private and public offerings was $136.0 million. Additionally, during the year ended December
31, 2024 cash provided by financing activities related to the exercise of common warrants was $3.8 million.

83

Contractual
and Other Obligations

Operating
lease obligations

Our
operating lease obligations primarily consist of lease payments on our corporate headquarters in New York, New York, as well as lease
payments for our development laboratory, a manufacturing facility and an additional manufacturing space, all located in North America
which are described in further detail in Note 9 of our consolidated financial statements included in this Annual Report on Form 10-K.
Future contractual payments on operating lease obligations due within one year of December 31, 2025 are $1.4 million, and future contractual
payments on operating lease obligations due greater than one year from December 31, 2025 are $2.2 million.

Other
obligations

From
time to time, we enter into certain types of contracts that contingently require us to indemnify parties against third-party claims,
supply agreements, and agreements with directors and officers. The terms of such obligations vary by contract and in most instances a
maximum dollar amount is not explicitly stated therein. Generally, amounts under these contracts cannot be reasonably estimated until
a specific claim is asserted, thus no liabilities have been recorded for these obligations on our consolidated balance sheet for the
periods presented.

We
enter into contracts in the normal course of business with CROs and clinical sites for the conduct of clinical trials, non-clinical research
studies, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services. These contracts
generally provide for termination on notice, and therefore are cancelable contracts.

Certain
of these agreements require us to pay milestones to such third parties upon achievement of certain development, regulatory or commercial
milestones as further described in Note 10 of our consolidated financial statements included in this Annual Report on Form 10-K. Amounts
related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement
of certain development, regulatory approval and commercial milestones, which may not be achieved.

We
also have obligations to make future payments to third parties that become due and payable on the achievement of certain milestones,
including future payments to third parties with whom we have entered into research, development and commercialization agreements. We
have not included these commitments on our consolidated balance sheet for the periods presented because the achievement and timing of
these milestones is not fixed and determinable.