New Cell Treatment for Bladder Cancer Shows Promise
Research Report

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Disclosures for H.C. Wainwright & Co., Protara Therapeutics Inc., April 28, 2025

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H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Andres Y. Maldonado, PhD and Andrew S. Fein , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Protara Therapeutics, Inc. and CG Oncology, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of March 31, 2025 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Protara Therapeutics, Inc. and CG Oncology, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Protara Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Protara Therapeutics, Inc. and CG Oncology, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Protara Therapeutics, Inc. and CG Oncology, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.

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Protara Therapeutics Inc.'s (TARA:NASDAQ) updated interim data from the ongoing phase 2 ADVANCED-2 trial showed "a promising efficacy signal," reported H.C. Wainwright & Co. Analyst Dr. Andres Maldonado in an April 28 research note. The biopharma presented the results at the recent American Urological Association's 2025 annual meeting.

ADVANCED-2 is evaluating Protara's TARA-002 cell therapy in patients with high-grade nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ plus or minus Ta/T1. This population encompasses both Bacillus Calmette-Guérin (BCG)-unresponsive and -naive patients.

"We continue to view TARA-002 as the best-in-class, earlier-stage asset capable of filling gaps that [competitors] cretostimogene and TAR-200 may leave behind, while also carving an additional path in the maintenance setting," Maldonado wrote.

432% Return Potential

The analyst reiterated H.C. Wainwright's US$23 per share target price on the U.S.-based life sciences company, trading at the time of the report at about US$4.32 per share. Based on these prices, the implied return for investors is 432%.

Protara remains a Buy.

Complete Response Rates

Maldonado reported the main points of the trial data Protara covered in its poster session at the AUA meeting. BCG-unresponsive patients were shown to have the greatest benefit. Among the five patients, 100% experienced a complete response rate at any time. For two out of three patients (67%), durability lasted 12 months.

Among BCG-naïve patients, the high-grade complete response rate at any time was 76%, with 16 out of 21 patients achieving it. As for durability, 62.5% maintained complete response at six and nine months. This dropped to 43% for 12 months.

Of note, BCG-naïve patients who achieved complete response by Month 3 showed favorable durability; 86% of them maintained the response through Month 6, 75% through Month 9. Further, patients who initially did not achieve a complete response were able to achieve a durable response with additional instillations.

"While we do expect overall complete response rates to come down slightly, particularly in the BCG-unresponsive setting, we believe there remains enough cushion to support a compelling treatment profile," commented Maldonado.

Room For Others in Market

The complete response rate shown with competitors' treatments presents opportunity for other players in the field, including Protara, noted Maldonado, after speaking to the company's management at the AUA meeting. Specifically, the complete response rates at 12 months seen clinically with either CG Oncology Inc.'s (CGON:NASDAQ) cretostimogene or Johnson & Johnson's (JNJ:NYSE) TAR-200 were 46% at best and are expected to decline further.

That said, Protara management emphasized that while the results for TARA-002 so far are encouraging, "continued maturation of 12- and 24-month durability will be critical to fully realize the therapy's commercial potential."

Accordingly, enrollment in the BCG-unresponsive cohort of ADVANCED-2 is to continue, and further data should confirm TAR-002's profile relative to TAR-200, cretostimogene and Adstiladrin.

Safety Profile Favorable

TARA-002 was shown to be safe in both BCG-naïve (30 patients) and -unresponsive (13 patients) groups without dose-limiting toxicities. There were no treatment-related serious adverse events, discontinuations or deaths.

Of the 43 study patients, some experienced treatment-emergent adverse events, mostly Grade 1 and short-lived. They tended to be related to the urinary system, such as bladder spasm and urinary tract infections.

"The high initial complete response rates, early durability signals and benign safety profile position TARA-002 as a potentially valuable entrant into a competitive NMIBC field," wrote Maldonado.

Key Opinion Leaders' Feedback

Also at the AUA meeting, Maldonado sought out various key opinion leaders' thoughts on TARA-002. Consensus was that were its efficacy to be durable over the long term, adoption of TARA-002 likely would be high. If so, it could capture two market segments. One is community urology practices where operational efficiency is paramount. Community urologists highlighted TARA-002's BCG-like administration as a major advantage; it is done through simple catheter instillation and does not require cystoscopic placement or extended patient monitoring.

The other market segment is academic centers focused on long-term outcomes. Academic key opinion leaders indicated that TARA-002 could emerge as a viable bladder-sparing option, again if longer-term durability of efficacy is shown. They also said that if the clinical benefit were robust, they would be willing to tolerate more complex administration or greater immune-related side effects.

Efficacy and Simplicity

Maldonado explained that cretostimogene's place in the evolving and crowded NMIBC treatment space may be that of a bladder-sparing regimen driven by durable immunologic response in BCG-unresponsive carcinoma in situ patients. TAR-200's spot is shaping up to be the high-intensity local chemotherapy arena.

Thus, TARA-002, based on key opinion leader input and emerging clinical data, potentially could provide a different value proposition from its competitors, one based on operational simplicity and immunostimulatory efficacy.

"As the BCG supply environment remains variable and the need for bladder-sparing options grows, we believe TARA-002 has the potential to carve out meaningful market share both as a frontline alternative and as a post-BCG salvage option, pending continued clinical validation," added Maldonado.