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Trial Results Validate New Drug-Delivering Nasal Implant
Research Report

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This product candidate presents a compelling approach to treating post-surgery chronic rhinosinusitis patients, noted an H.C. Wainwright & Co. report.

Lyra Therapeutics Inc. (LYRA:NASDAQ) announced positive topline clinical trial data on its second product candidate LYR-220, reported H.C. Wainwright & Co. analyst Matthew Caufield in a September 12 research note. LYR-220 is a nasal implant designed to deliver medicine directly to the sinonasal tissues, as conventional therapies cannot do so, in patients with chronic rhinosinusitis (CRS).

LYR-220, delivering the corticosteroid, mometasone furoate, on a long-acting basis, is being evaluated in CRS patients with postsurgical anatomy in the Phase 2 BEACON trial. Lyra's similar lead product candidate, LYR-210, is being assessed in surgically naïve CRS patients in the Phase 3 ENLIGHTEN study.

"Ultimately, we view the platform as potentially treating the range of CRS disease, whether nasal anatomy is surgically naïve or post-surgical and with durable six-month anti-inflammatory delivery," Caufield commented.

Current management of CRS patients includes saline rinses, topical nasal steroids, oral steroids, and, sometimes, repeated nasal surgeries. Caufield pointed out there is no approved, on-label therapy for about 80% of the 8 million treated, polyp-free CRS patients in the U.S.

Compelling Potential Gain

Given the positive Phase 2 BEACON trial update, H.C. Wainwright reiterated its target price on Lyra of US$12 per share, noted Caufield. In comparison, the biotech's current price is about US$4.28 per share. The projected return for investors, therefore, is significant, at 180%.

Lyra is a Buy.

Interpretation of the Data

Caufield provided the main takeaways from the topline BEACON data:

1) Overall, these new results provide proof of concept and validate Lyra's nasal implant in this CRS population, patients who have had a bilateral ethmoidectomy and remain symptomatic.

2) Early and sustained improvement on the sinonasal outcome test score as early as two weeks carried forward through Week 24, "notably at almost twice the minimal clinically important difference," noted Caufield.

3) LYR-220 met the endpoint of improved 3CS composite score with a statistically significant result. This same endpoint is being evaluated in the Phase 3 ENLIGHTEN trial. Were the endpoint met in ENLIGHTEN, this would present an "opportunity for comprehensive CRS therapy," Caufield wrote.

4) Significant individual improvements shown in the study included reduced nasal blockage, nasal discharge, and facial pain and pressure.

5) Improvement could persist into the period off of treatment, and upcoming Phase 2 data through 28 weeks should shed light on this. Even in the event implants were to be replaced twice a year, purported Caufield, the improvement would still be greater than with noncurative surgeries or off-label nasal corticosteroid use.

"With the Phase 2 BEACON trial evaluating LYR-220 safety, tolerability, pharmacokinetics, and efficacy, we believe the therapeutic profile, without significant adverse events, presents a compelling approach to current postsurgical unmet need," Caufield wrote.

Treating a Range of Disease

The positive topline LYR-220 Phase 2 data bode well for Lyra's lead product candidate LYR-210 in the Phase 3 ENLIGHTEN clinical trial, in progress, wrote Caufield. Topline data from ENLIGHTEN are expected in H1/24.

"We specifically believe the Phase 3 ENLIGHTEN program is positioned for success," Caufield added.

LYR-210 could be an option for patients earlier on in treatment, and for patients not wanting ongoing nasal surgeries, Caufield pointed out. Further, insertion of a nasal implant in the office setting for durable drug release is straightforward, thereby aiding patient retention.

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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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Disclosures for H.C. Wainwright & Co., Lyra Therapeutics Inc., September 12, 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, Matthew Caufield 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 Lyra Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of August 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Lyra Therapeutics, 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 Lyra Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did receive compensation from Lyra Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Lyra Therapeutics, Inc. during the past 12 months. The Firm does not make a market in Lyra Therapeutics, 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. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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