On March 10, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that four abstracts have been accepted for poster presentation at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 17th – 22nd at San Diego Convention Center, San Diego, CA.

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The accepted abstracts highlight research related to BriaCell’s cellular immunotherapy platform, including the Company’s ongoing pivotal Phase 3 study of Bria-IMTᵀᴹ in combination with an immune checkpoint inhibitor (ClinicalTrials.gov identifier: NCT06072612) and research supporting Bria-OTS+ᵀᴹ, BriaCell’s next-generation personalized off-the-shelf immunotherapy program.

Poster titles and presentation details will become available on March 17, 2026 at 4:30 PM ET, when the abstracts will be published in the online Proceedings of AACR (Free AACR Whitepaper).

(Press release, BriaCell Therapeutics, MAR 10, 2026, View Source [SID1234663436])

On March 10, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the full year ended December 31, 2025 and provided an update on its R&D pipeline and other corporate developments.

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"Since the announcement of our strategic shift in November of 2025, our team continues to operate with a clear focus on steady execution on our JAK2V617F inhibitor and KAT6 degrader programs, most recently evidenced by the timely clearance of the IND for PRT12396." stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We continue to remain on track to have both PRT12396 and PRT13722 in clinical development this year, which will position the Company for potential key data catalysts from both of these potentially differentiated modalities in 2027."

Program Updates and Upcoming Milestones

Mutant selective JAK2V617F JH2 inhibitor program

JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs. Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

PRT12396, Prelude’s lead, mutant-selective JAK2V617F inhibitor received IND clearance from the U.S. Food and Drug Administration, as previously announced in February 2026 and anticipates initiating a Phase 1 study in the 2nd quarter of 2026.

The Phase 1 study of PRT12396 is an open-label, multi-center study in patients with high-risk PV and intermediate and high-risk MF.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Highly selective KAT6A oral degrader program

KAT6 is an emerging and recently validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. The Company has selected a development candidate and remains on track to file an IND in mid-2026 with phase 1 study initiation planned in the 2nd half of 2026. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B.

The Company presented initial preclinical data supporting this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2025. The presentation can be found at Publications – Prelude Therapeutics.

Degrader payloads for next generation DACs

Prelude is leveraging our expertise in targeted protein degradation to discover and develop novel degrader payloads for use with next generation DACs. We have developed highly potent SMARCA2/4 and CDK9 degrader payloads optimized for efficacy, tolerability and developability when coupled to a wide range of different antibodies.

The Company has amended and expanded the scope of our existing DAC collaboration with AbCellera Biologics. This enables AbCellera to use our degrader payloads on additional undisclosed antibody targets of interest and also enables Prelude to utilize our degrader payloads in licensing arrangements with other potential partners. The Company’s payloads and corresponding payload-linkers are available for licensing to partners to expand the reach of this new technology.

We have recently published preclinical data demonstrating that next generation DACs using Prelude degrader payloads have potential for significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. These data can be found at: Publications – Prelude Therapeutics

Mutated calreticulin (mCALR) DAC discovery program

Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25-35% of patients with MF and essential thrombocythemia (ET). Recently, a mCALR-targeted monoclonal antibody demonstrated robust clinical activity in high-risk ET patients. Prelude is exploring mCALR-targeted DACs using the Company’s proprietary degrader payloads as a differentiated approach for patients with CALR mutations. This early discovery program is wholly owned and controlled by Prelude.

The Company presented the preclinical data from the program at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress in June and the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting in December 2025. The presentations can be found at Publications – Prelude Therapeutics.

Upcoming Investor Conference

The Company will participate in the Citizens Life Sciences Conference taking place in Miami, FL. On Tuesday, March 10, 2026 at 3:25 PM ET, Kris Vaddi, Ph.D., Chief Executive Officer, Peggy Scherle, Ph.D., Chief Scientific Officer and Bryant Lim, Chief Financial Officer will participate in a fireside chat.

A live webcast of the fireside chat can be accessed here and on the Company’s website under Events and Presentations. The recording will be archived and available on the Company’s website for 90 days.

Full Year 2025 Financial Results 

Cash, Cash Equivalents, Restricted cash and Marketable securities:

Cash, cash equivalents, restricted cash and marketable securities as of December 31, 2025 were $106.4 million. The Company anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into the second quarter of 2027.

Research and Development (R&D) Expenses:

For the year ended December 31, 2025, R&D expense decreased to $94.3 from $118.0 million for the prior year period. Included in the R&D expense for the year ended December 31, 2025 was $6.9 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $12.1 million for year ended December 31, 2024. Along with the decrease in stock-based compensation expense, research and development expenses decreased due to a decrease in expense related to our discontinued clinical trials. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the year ended December 31, 2025, G&A expenses decreased to $22.4 million from $28.7 million for the prior year period. Included in general and administrative expenses for the year ended December 31, 2025, was $5.0 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $9.2 million for year ended December 31, 2024. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation along with a decrease in employee-related expenses.

Net Loss:

For the year ended December 31, 2025, net loss was $99.5 million, or $1.29 per share compared to $127.2 million, or $1.68 per share, for the prior year period. Included in the net loss for the year ended December 31, 2025, was $11.9 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options due in part to fewer employees, as compared to $21.3 million for the same period in 2024.

(Press release, Prelude Therapeutics, MAR 10, 2026, View Source [SID1234663420])

On March 10, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported that management has executed a service agreement with FyoniBio GmbH (formerly Glycotope, est. 2010), a German Contract Development Organization (CDO) based in Berlin for establishing and validating a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. The objective is to quantify the Company’s lead asset, PRP, consisting of two proenzymes trypsinogen and chymotrypsinogen, as well as their activated enzyme forms trypsin and chymotrypsin from human serum during the Phase 1b, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors.

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The purpose and design of the study will be used as an important tool to measure the concentration of PRP and its analytes over time upon administration to advanced cancer patients suffering from solid tumors. Results from the PK assay will evaluate the systemic concentration of PRP sufficient to expect anti-tumor activity in patients whilst carefully evaluating their response according to safety and tolerability parameters. Secondary efficacy endpoints will also be observed to support duration of treatment for responders. The LC-MS PK assay should offer a robust method to quantify all four analytes in patients’ serum with a maximum sensitivity of at least 0.1µg/mL, sufficient to monitor the concentration of PRP in patients during the FIH study.

"Establishing and validating our PK method for the First-In-Human study is one of three key activities in preparation for this pivotal milestone. The other two are the GMP manufacture of PRP and clinical trial application for the study which we are actively undertaking," said Dr Ralf Brandt, Propanc’s Research and Development Director. "FyoniBio provides expertise in assisting biotech companies bringing biologics from early development to the clinic. My clinical research team and I are confident that the method development work initiated will successfully translate into a fully validated method that will support our team’s decision-making processes for the upcoming study which we plan to commence in the fourth calendar quarter of this year."

(Press release, Propanc, MAR 10, 2026, View Source [SID1234663421])

On March 10, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent operational updates.

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"Building off the meaningful progress achieved across our ZYNLONTA clinical program in DLBCL and through investigator-initiated trials in indolent lymphomas this past year, we believe we have laid the foundation for multiple anticipated value-creating catalysts," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We expect topline LOTIS-5 results in the second quarter, followed by full LOTIS-5 and LOTIS-7 results in 2L+ DLBCL by the end of 2026 and, assuming positive data, potential compendia inclusions in first half of 2027 with LOTIS-5 regulatory approval to follow. Supported by an expected cash runway at least into 2028, we are confident we will drive significant potential long-term growth beginning in 2027."

Fourth Quarter 2025 Operational Updates and Upcoming Milestones

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) once the pre-specified number of approximately 262 progression-free survival events is reached and data are available. Full results are anticipated to be published by the end of 2026. Assuming positive results, the Company will file a supplemental Biologics License Application (sBLA) submission with the U.S. Food and Drug Administration (FDA), with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL to follow in mid-2027.

LOTIS-7 trial ongoing with data anticipated by year-end. In December 2025, the Company reported updated data from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory (r/r) DLBCL. The data demonstrated an 89.8% best overall response rate and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of six months follow-up. The LOTIS-7 trial is ongoing at the selected 150 µg/kg dose and the Company plans to share full data at a medical meeting and through publication by the end of 2026. The Company plans to assess regulatory and compendia strategies.

Ongoing investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies. The Company anticipates publication of data from the University of Miami Sylvester Comprehensive Cancer Center-led multi-center trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and as a monotherapy to treat marginal zone lymphoma (MZL) between the end of 2026 and mid-2027. Assuming positive data, the Company intends to assess potential regulatory and compendia pathways.

Fourth Quarter and Full Year 2025 Financial Results

Product Revenues: Net product revenues were $22.3 million and $73.6 million for the fourth quarter and full year ended December 31, 2025, as compared to $16.4 million and $69.3 million for the same periods in 2024. The quarter-over-quarter increase in revenue primarily reflected variability in customer ordering, with underlying demand broadly stable. The increase for the full year was driven by higher selling price and relatively flat volume year-over-year.

Research and Development (R&D) Expense: R&D expense was $18.2 million and $104.0 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to R&D expense of $27.1 million and $109.6 million for the same periods in 2024. The decrease in R&D costs quarter-over quarter was primarily driven by a reduction in spending on discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease in R&D costs for the full year was driven by a reduction in spending on discontinued programs, partially offset by expenditure associated with completion of the IND-enabling activities for our PSMA-targeting ADC and our ongoing ZYNLONTA clinical trials.

Selling and Marketing (S&M) Expense: S&M expense was $12.0 million and $43.4 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to S&M expense of $11.3 million and $44.0 million for the same periods in 2024. S&M expense remained relatively flat period-over-period.

General & Administrative (G&A) Expense: G&A expense was $9.5 million and $36.6 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to G&A expense of $9.6 million and $41.9 million for the same periods in 2024. G&A expense remained relatively flat quarter-over-quarter. The reduction in G&A expense for the full year was primarily due to lower external professional fees.

Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $0.3 million in income for the fourth quarter and $13.1 million in restructuring, impairment and other related costs for the full year ended December 31, 2025, which consisted of $6.0 million in employee severance and related benefit costs, $5.8 million in non-cash impairment of assets and $1.3 million in dilapidations, lease termination, legal fees, and other related costs in connection with the closure of the UK facility.

Total operating expenses and adjusted total operating expenses: Total operating expenses were $41.0 million and $202.9 million for the fourth quarter and full year ended December 31, 2025, respectively, as compared to $49.3 million and $201.5 million for the fourth quarter and full year ended December 31, 2025, respectively. On a non-GAAP basis, total adjusted operating expenses were $39.4 million and $181.3 million for the quarter and full year ended December 31, 2025, respectively, as compared to $46.6 million and $193.8 million for the quarter and full year ended December 31, 2024, respectively. The reduction in total adjusted operating expenses for the fourth quarter was primarily driven by lower R&D expenses. The decrease in total adjusted operating expenses for the full year was a result of lower R&D, G&A and S&M expenses.

Net Loss: Net loss for the quarter ended December 31, 2025, was $6.4 million, or a net loss of $0.04 per basic and diluted share, as compared to net loss of $30.7 million, or a net loss of $0.29 per basic and diluted share for the same period in 2024. Net loss for the full year ended December 31, 2025, was $142.6 million, or a net loss of $1.12 per basic and diluted share, as compared to net loss of $157.8 million, or a net loss of $1.62 per basic and diluted share for the full year ended December 31, 2024. The lower net loss over both periods was primarily due to a higher cumulative catch-up adjustment gain associated with our deferred royalty obligation and reduced R&D expense, partially offset by the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan.

Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $13.5 million, or an adjusted net loss of $0.09 per basic and diluted share for the quarter ended December 31, 2025, as compared to an adjusted net loss of $26.5 million, or $0.25 per basic and diluted share, for the same period in 2024. Adjusted net loss for the full year ended December 31, 2025, was $91.7 million, or an adjusted net loss of $0.72 per basic and diluted share, as compared to net loss of $111.4 million, or an adjusted net loss of $1.15 per basic and diluted share for the full year ended December 31, 2024. The decrease in adjusted net loss over both periods was due to lower operating expenses and a higher number of weighted average shares outstanding.

Cash and cash equivalents: As of December 31, 2025, cash and cash equivalents were $261.3 million, compared to $250.9 million as of December 31, 2024, providing expected cash runway at least into 2028. The Company significantly strengthened its cash and cash equivalents position by entering into a $100 million PIPE financing in June 2025 and a $60.0 million PIPE financing in October 2025 with certain institutional investors, which raised $150.8 million in total after deducting placement agent fees and offering expenses.

Subsequent event

Amended HealthCare Royalty Financing Agreement.

In February 2026, ADC Therapeutics entered into an amendment to its royalty purchase agreement with entities managed by HealthCare Royalty, offering greater strategic flexibility to the Company. The new agreement reduces the change of control payment from $750 million to $150 million through the end of 2027, and to $200 million thereafter. In the event of a change of control, HealthCare Royalty will continue to receive royalties on sales by the acquirer until the original royalty cap is reached. In return, HealthCare Royalty has been granted warrants to purchase approximately 9.8 million common shares, with an exercise price of $3.81 per share. These warrants are exercisable until December 31, 2030, and are subject to a lock-up through the end of 2027.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2025 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, MAR 10, 2026, View Source [SID1234663406])

On March 10, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, reported a business update and announced financial results for the fourth quarter and full year ended December 31, 2025.

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"Over the last few months, we reported meaningful clinical and regulatory progress across our portfolio of late-stage programs and are building on this momentum as we advance toward several important milestones in 2026," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "For TARA-002 in non-muscle invasive bladder cancer (NMIBC), the clinical dataset continues to support its potential as a differentiated intravesical therapy with compelling efficacy, a favorable safety profile and a streamlined approach to administration in the clinical setting for both Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve patients. We remain on track to complete enrollment in our BCG-Unresponsive registrational cohort in the ADVANCED-2 trial and to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in the second half of 2026."

Mr. Shefferman added, "For our rare disease programs, we reported positive interim results for TARA-002 in lymphatic malformations (LMs), followed by the receipt of Breakthrough Therapy and Fast Track designations for TARA-002 in LMs from the U.S. Food and Drug Administration (FDA). We are working with the FDA to bring this promising treatment to patients expeditiously and expect to provide a regulatory update in the first half of 2026. In addition, our THRIVE-3 registrational trial of intravenous (IV) Choline Chloride for patients on parenteral support remains on track, with interim results expected in the second half of 2026. With cash runway into 2028, we are well positioned to continue executing across our pipeline and advance our mission of delivering transformational therapies for patients with cancer and rare diseases."

Recent Progress and Highlights

TARA-002 in NMIBC

At the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2026, the Company announced updated interim results from the ADVANCED-2 trial in evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are BCG-Unresponsive and BCG-Naïve. As of the January 28, 2026 data cutoff:
In the BCG-Unresponsive cohort of patients, TARA-002 demonstrated a complete response (CR) rate at any time of 65.7% (23/35) with CR rates of 68.2% (15/22) at six months and 33.3% (5/12) at 12 months. Among responders, the Kaplan-Meier (KM) estimated probability of maintaining a CR for six months was 71.1% (95% CI: 46.7, 95.5). Additionally, among responders, 100% (5 of 5) maintained their CR from nine to 12 months. Re-induction therapy was successful with 61.5% (8 of 13) of re-induced patients converting to a CR at six months.
In the BCG-Naïve cohort of patients, TARA-002 demonstrated a CR rate at any time of 72.4% (21/29) with CR rates of 66.7% (18 of 27) at six months and 57.9% (11 of 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). In addition, among responders, 100% (11 of 11) maintained their CR from nine to 12 months. Re-induction therapy was successful with 66.7% (4 of 6) of re-induced patients converting to a CR at six months.
The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient with no Grade 3 or greater TRAEs and no related serious adverse events as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most common TRAEs were dysuria, bladder spasm, fatigue and micturition urgency. Most bladder irritations resolved shortly after administration or within a few hours to a few days.
The Company has completed enrollment of the BCG-Naïve cohort and expects to complete enrollment of the BCG-Unresponsive cohort in the second half of 2026.
The Company remains on track to commence ADVANCED-3, a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-Naïve patients (who have never been exposed and those who have not received BCG within the last 24 months and are ineligible to receive BCG, have a contraindication to BCG, cannot tolerate BCG, do not have access to BCG or refuse BCG) in the second half of 2026.
TARA-002 in LMs

In January 2026, the Company announced that the FDA granted TARA-002 Fast Track and Breakthrough Therapy designations for the treatment of pediatric patients with macrocystic and mixed cystic LMs. TARA-002 was previously granted Rare Pediatric Disease designation for the treatment of LMs.
The Company remains on track to share a regulatory update on the registrational path for TARA-002 in LMs in the first half of 2026.
IV Choline Chloride for Patients on Parenteral Support (PS)

THRIVE-3, the Company’s registrational Phase 3 clinical trial, is ongoing, and the Company expects to report interim results in the second half of 2026.
Corporate Update

Fourth Quarter and Full Year 2025 Financial Results

As of December 31, 2025, unrestricted cash and cash equivalents and marketable debt securities totaled $197.9 million, including proceeds from the Company’s $86.3 million public offering in December 2025. The Company expects its cash and cash equivalents and marketable debt securities will be sufficient to fund its planned operations and milestones into 2028.
Research and development expenses for the fourth quarter of 2025 increased to $13.1 million from $9.5 million for the prior year period, and for the full year increased to $42.6 million compared to $31.7 million for 2024. The fourth quarter and full year increases were primarily due to the start-up and advancement of clinical trials across our portfolio.
General and administrative expenses for the fourth quarter of 2025 increased to $6.0 million from $4.8 million for the prior year period, and for the full year increased to $21.9 million compared to $17.5 million for 2024. The fourth quarter and full year increases were primarily due to increases in personnel-related expenses and other general and administrative expenses primarily related to professional and consulting services.
For the fourth quarter of 2025, Protara incurred a net loss of $17.3 million, or $0.37 per share, compared with a net loss of $12.8 million, or $0.48 per share, for the same period in 2024. Net loss for the year ended December 31, 2025 was $57.4 million, or $1.34 per share, compared with a net loss of $44.6 million, or $2.17 per share, for the year ended December 31, 2024. Net loss for the fourth quarter of 2025 included approximately $1.0 million in stock-based compensation expenses. Net loss for the year ended December 31, 2025 included approximately $3.8 million in stock-based compensation expenses.
About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). Trial subjects received 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. The BCG-Unresponsive cohort 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.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Breakthrough and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Lymphatic Malformations

Lymphatic Malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Protara’s focus is on macrocystic and mixed cystic LMs, for which there are no currently approved therapies. They are most frequently present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels and lymphatics; recurrent infection; and cosmetic and other functional disabilities. TARA-002 has been granted Rare Pediatric Disease, Breakthrough Therapy and Fast Track designations by the FDA for the treatment of LMs.

About IV Choline Chloride for Patients on Parenteral Support

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function and play an important role in modulating gene expression, cell membrane signaling, brain development and 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. Approximately 78% of patients dependent on PS are choline-deficient and of those approximately 63% have some degree of liver dysfunction, which can lead to hepatic failure. 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. It has been granted Orphan Drug designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition and has been granted Fast Track designation as a source of choline when oral or enteral nutrition is not possible, insufficient or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline composition and a U.S. patent claiming a method for treating choline deficiency with a choline composition, each with a term expiring in 2041.

(Press release, Protara Therapeutics, MAR 10, 2026, View Source [SID1234663422])