Lyra Therapeutics, Inc. today reported financial results for the second quarter ended June 30, 2022, and highlighted recent accomplishments.
| Pivotal ENLIGHTEN Phase 3 clinical program and BEACON Phase 2 clinical trial targeting a broad spectrum of chronic rhinosinusitis (CRS) patients, continued enrollment Industry leader Richard Nieman, MD, appointed Chief Medical Officer In April 2022, secured $96.3 million in net proceeds in an at-the-market, private placement of common stock that is expected to support two pivotal data readouts; cash runway extended until mid-2024 WATERTOWN, Mass., Aug. 9, 2022 /PRNewswire/ -- Lyra Therapeutics, Inc. (Nasdaq: LYRA)(“Lyra” or the “Company”), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, today reported financial results for the second quarter ended June 30, 2022, and highlighted recent accomplishments.
“The second quarter marked continued progress for our ongoing clinical programs designed to address the full spectrum of CRS patients. The pivotal ENLIGHTEN Phase 3 program for LYR-210 is actively enrolling patients with chronic rhinosinusitis and surgically naïve anatomy,” said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. “The BEACON Phase 2 trial for LYR-220 is continuing enrollment of CRS patients with recurrent CRS despite surgical intervention. Together these two patient populations represent the roughly four million patients who fail medical management, highlighting the need for new therapies.” “CRS is a highly prevalent inflammatory disease of the paranasal sinuses leading to debilitating symptoms and significant morbidities for which there is no approved therapeutic treatment at this time,” said Dr. Richard Nieman, Chief Medical Officer of Lyra Therapeutics. “While millions of CRS patients are treated by ENT physicians annually in the U.S., many suffer from persistent burdensome symptoms due to limited, ineffective treatment options and are seeking alternatives to invasive, non-curative sinus surgery, or continuous use of biologics. We have the potential to create a new standard of care for these patients and we look forward to the ongoing advancement of LYR-210 and LYR-220 through the clinic.” Corporate Highlights
Clinical Developments for LYR-210 and LYR-220
Second Quarter 2022 Financial Highlights
About Lyra Therapeutics Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra’s XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company’s current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra has two product candidates in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities: LYR-210, for surgically naïve patients is being evaluated in the ENLIGHTEN Phase 3 clinical program, and LYR-220, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the U.S. that fail medical management each year. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the Company’s cash runway through mid-2024, the Company’s pipeline of product candidates, the enrollment and success of the ENLIGHTEN II Phase 3 program, the enrollment and success of the Phase 2 BEACON trial (including the timelines for commencement of the Part 2/randomized portion of the trial in the U.S. later in the third quarter and topline results from the Part 1/non-randomized portion of the trial around year-end), Dr. Nieman’s role at the Company, and the success of the XTreo™ platform. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future; the company’s need for additional funding, which may not be available; the company’s limited operating history; the fact that the company has no approved products; the fact that the company’s product candidates are in various stages of development; or the fact that the company may not be successful in its efforts to identify and successfully commercialize its product candidates; the fact that clinical trials required for the company’s product candidates are expensive and time-consuming, and their outcome is uncertain; the fact that the FDA may not conclude that certain of the company’s product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway; the company’s inability to obtain required regulatory approvals; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the fact that the successful commercialization of the company’s product candidates will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and pricing policies; failure to achieve market acceptance; product liability lawsuits; the fact that the company relies on third parties for the manufacture of materials for its research programs, pre-clinical studies and clinical trials; the company’s reliance on third parties to conduct its preclinical studies and clinical trials; the company’s inability to succeed in establishing and maintaining collaborative relationships; the company’s reliance on certain suppliers critical to its production; failure to obtain and maintain or adequately protect the company’s intellectual property rights; failure to retain key personnel or to recruit qualified personnel; difficulties in managing the company’s growth; effects of natural disasters, terrorism and wars (including the developing conflict between Ukraine and Russia); the fact that the global pandemic caused by COVID-19 could adversely impact the company’s business and operations, including the company’s clinical trials; the fact that the price of the company’s common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company and any securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2022 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. Investor Contact: Media Contact:
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Company Codes: NASDAQ-NMS:LYRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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