Next milestones for 2024
Program Highlights
BEACON Phase 2 Clinical Trial of LYR-220 in Patients With RSC Who Have Undergone Prior Ethmoid Sinus Surgery
The Phase 2 BEACON trial is a randomized, controlled, parallel-group study designed to compare the protection and feasibility of striking the LYR-220 matrix (7500 μg MF), over a 28-week period, in symptomatic patients with RSC who have had a history of ESS. The review consisted of two components: the first component designed primarily to compare the feasibility and tolerability of two 7500 μg MF matrix designs; in Part 2, 42 patients were randomized in a 1:1 ratio to obtain LYR-220 or a sham control.
The ENLIGHTEN program includes two pivotal Phase 3 clinical trials, ENLIGHTEN I and ENLIGHTEN II, to compare the efficacy and protection of LYR-210 for the treatment of RSC. The company designed each trial to compare 180 patients with CSR who had not achieved medical control. and had not in the past undergone ESS, randomized in a 2:1 ratio to obtain LYR-210 (7500 μg mometasone furoate (MF)) or a control organization for 24 weeks. The ENLIGHTEN I trial also includes an extension phase to an additional 52-week study to compare the protection and repeated use of LYR-210. The goal of the two pivotal trials is to assist in the application of a new drug to the FDA for LYR-210.
Fourth Quarter and Full Year 2023 Financial Highlights
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS). Lyra has two product applicants, LYR-210 and LYR-220, in late-stage progression for the treatment of CRS, a highly prevalent inflammatory disease of the paranasal sinuses that causes debilitating symptoms and significant morbidity. LYR-210 and LYR-220 are bioabsorbable nasal inserts designed to be administered in an in-office undeniable procedure and are intended to provide six months of uninterrupted pharmacological healing with mometasone furoate (7500 mcg MF) to the nasal passages. sinusitis for the treatment of CRS with a single administration. LYR-210, which is currently being evaluated in the ENLIGHTEN Phase 3 clinical program, is smaller in size and is intended for patients with narrow anatomy, primarily patients who have not undergone ethmoid sinus surgery. LYR-220 is a larger insert designed for CRS patients who have an enlarged nasal cavity due to previous ethmoid sinus surgery. These two product applicants are designed to treat the 4 million CRS patients in the United States who fail medical screening each year. For more information, visit www. lyratx. com and follow us on LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “possibly,” “will,” “estimate,” “continue,” “anticipate,” ” will”, “expects” and similar expressions are intended to identify forward-looking statements. All statements contained in this press release that do not relate to past facts deserve to be considered forward-looking statements, adding statements related to the Company’s cash flow to the first quarter of 2025, the board and the good fortune of ENLIGHTEN Phase 3. and BEACON program. Phase 2 Program, the schedule to report key insights from the Company’s clinical trials, adding ENLIGHTEN I, if the positive effects of our studies of our nasal program to treat CRS, if our product applicants maintain a constant dose of corticosteroids at the site of the disease for six months with a single administration, the expected demand and duration of the market for our product applicants, as well as the protection and effectiveness of our product applicants. These statements are neither promises nor guarantees, but involve known and unknown dangers, uncertainties and other vital points that could possibly cause the actual effects, functionality or achievements of the Company to be materially different from the actual effects, functionality or achievements of the Company. or long-term achievements expressed or implied over the long term. forward-looking statements, including, among others, the following: that the Company has incurred significant losses since its inception and expects to incur further losses in the foreseeable long term; the Company’s need to obtain additional financing, which may not be available; the Company’s ability to continue as a going concern; the Company’s limited operating history; the fact that the Company does not have approved products; the fact that applicants for the Company’s products are in other stages of expansion; the fact that clinical trial data is subject to update until the corresponding clinical study report is completed, or the fact that the Company may not have luck in its efforts to successfully identify and advertise applicants for its products ; the fact that the clinical trials required for applicants for the Company’s products are expensive and time-consuming, and their final results are uncertain; the fact that the FDA would likely not conclude that applicants for the Company’s products meet the requirements of the Section 505(b)(2) regulatory approval process; the Company’s possible inability to discharge required regulatory approvals; the effects of recently enacted and long-term legislation; the option of formula errors or security breaches; effects of significant competition; that successful advertising by applicants for the Company’s products will depend in part on the extent to which government and health insurers identify sufficiently good coverage, reimbursement levels and pricing policies; not download market acceptance; product liskill suits; the Company’s desire to expand its internal manufacturing functions or rely on third-party components for tissue manufacturing for its educational programs, preclinical studies and clinical trials and advertising supply; the Company’s dependence on third-party components to conduct its preclinical studies and clinical trials; the Company’s inability to identify and maintain collaborative relationships; the Company’s commitment to certain essential suppliers for its production; failure to download and sufficiently maintain or protect the rights to the Company’s intellectual assets; lack of skills to retain a key body of workers or hire a qualified body of workers; difficulties in managing the expansion of the Company; the effects of natural disasters, terrorism and wars; the fact that the global pandemic caused by COVID-19 may also have a negative effect on the Company’s business and operations, including the Company’s clinical trials; the fact that the value of the Company’s common inventory is likely to be volatile and vary significantly; Significant pricing and control time required due to operating as a public company and any securities elegance action litigation. These and other vital points discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2024 and in its other filings with the SEC may also cause the actual effects differ materially from those indicated by the forward-looking statements made in this press release. These forward-looking statements constitute control estimates as of the date of this press release. Although the Company may elect to update such forward-looking statements at some point in the long term, it disclaims any legal responsibility to do so, even if future events cause its outlook to be superseded.
Contact Information:Ellen Cavaleri, Investor Relations 615. 618. 6228 ecavaleri@lyratx. com