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Pharma Co. May Have Accelerated FDA Approval in 2024
Research Report

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TRACON Pharmaceuticals Inc. provided an update on enrollment progress for their ongoing Phase 2 ENVASARC clinical trial testing the drug envafolimab to treat sarcoma, reported H.C. Wainwright & Co.

TRACON Pharmaceuticals Inc. (TCON:NASDAQ) provided an update on enrollment progress for their ongoing Phase 2 ENVASARC clinical trial testing the drug envafolimab to treat sarcoma, reported H.C. Wainwright & Co. analyst Edward White in a December 20 research note. White reported that over 70 out of the 80 planned patients have now been enrolled in Cohort C of the study. This cohort is evaluating envafolimab as a single agent given at a dose of 600 milligrams subcutaneously every three weeks.

Envafolimab is a type of subcutaneous antibody designed to target PD-L1. It has been granted Orphan Drug Designation for the treatment of soft tissue sarcoma and has received Fast Track Designation from the FDA for undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). The ongoing Phase 2 pivotal ENVASARC trial by TRACON aims to assess the overall response rate (ORR) of envafolimab specifically in the soft tissue sarcoma subtypes of UPS and MFS.

White noted that in September, it was recommended that the trial continue as is, by the independent data monitoring committee. This was based on a review of 46 patients. 

"The ORR in the initial 46 patients treated with envafolimab monotherapy was 13% by investigator review and was 8.7% by Blinded Independent Central Review (BICR); all responses were confirmed. An additional patient has since achieved an objective response by investigator review, increasing the ORR to 15% by investigator review," wrote White, who pointed out that envafolimab continues to be "well tolerated."

White also stated that if this trend of positive data continues, it could lead to TRACON submitting a BLA to the FDA with an attempt to get accelerated approval in late 2024. 

White commented, "In our opinion, the peak sales of envafolimab in UPS/MFS is US$200-US$300 million, which could expand with additional indications. We expect envafolimab to reach the market in 2025 and to generate sales of US$176M in 2029."

With this news, White gave the company a Buy rating with a price target of US$7. He based this price target on "probability-adjusted revenue forecasts for envafolimab." 

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Disclosures for H.C. Wainwright & Co., TRACON Pharmaceuticals Inc., December 20, 2023

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.

H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Edward White , 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 TRACON Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of November 30, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of TRACON Pharmaceuticals, 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 TRACON Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from TRACON Pharmaceuticals, 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 TRACON Pharmaceuticals, 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. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice.

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