Lyra Therapeutics and LianBio Announce Strategic Partnership and Exclusive License Agreement to Develop and Commercialize LYR-210 in Greater China and Other Asian Markets

Partnership opens expanded opportunity for LYR-210 to address chronic rhinosinusitis, a disease affecting approximately 88 million adults in China

Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to ear, nose and throat (ENT) passages and other diseased tissues, and LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, today announced a strategic partnership and exclusive license agreement for the development and commercialization of LYR-210 in Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore and Thailand. LYR-210 is an anti-inflammatory, intra-nasal drug matrix in late-stage development that is designed to treat chronic rhinosinusitis (CRS), a debilitating inflammatory disease of the nasal passages.

Under the terms of the agreement, Lyra will receive an upfront payment of $12 million and is eligible to receive up to $135 million in future payments based upon the achievement of specified development, regulatory and commercialization milestones. Upon commercialization on a region-by-region basis, Lyra also will be entitled to receive low double-digit royalties based on net sales of LYR-210 in the licensed territories. LianBio will be responsible for the clinical development and commercialization of LYR-210 in the licensed territories, and Lyra will retain all rights to LYR-210 in all other geographies. As part of the agreement, LianBio will also have the first right to obtain development and commercial rights in the licensed territories to Lyra’s LYR-220, an anti-inflammatory, intra-nasal, drug matrix in development for the treatment of CRS patients who have undergone a prior sinus surgery but continue to have persistent disease.

“We are delighted to enter into this strategic alliance with LianBio to expand the global reach of LYR-210 for millions of CRS patients who need new and innovative treatment alternatives to surgery,” said Maria Palasis, Ph.D., CEO of Lyra. “The LianBio team has deep expertise in drug development and is well positioned to successfully commercialize LYR-210 in these Asian territories. The introduction of our novel, integrated ENT drug and delivery solution to the large patient populations in Asian markets supports our planned global commercialization strategy.”

“CRS patients who have failed medical management are currently left with limited and invasive options to manage their disease,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “In clinical studies conducted to date, LYR-210 has demonstrated six months of clinically meaningful symptom improvement following a single administration in patients with and without polyps. With an estimated 88 million adult CRS patients in China alone, we believe LYR-210 has the potential to address a significant unmet medical need and meaningfully improve the standard of care for patients in Asia.”

About LYR-210

LYR-210 is an investigational product candidate that utilizes Lyra’s proprietary XTreo™ platform to enable six months of local anti-inflammatory therapy from a single treatment for chronic rhinosinusitis (CRS). LYR-210 is designed as a non-invasive alternative to sinus surgery for the millions of CRS patients who have failed medical management. In the LANTERN Phase 2 clinical trial, LYR-210 (7500mcg) demonstrated rapid, clinically meaningful and durable symptom improvement in symptom scores over six months.

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 months following a single non-invasive, in-office administration. Lyra’s lead product candidate, LYR-210, is in late-stage clinical development for the treatment of chronic rhinosinusitis and is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.

About LianBio

LianBio’s mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in Greater China and other major Asian markets through partnerships that provide access to the best science-driven therapeutic discoveries. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a pipeline based on disease relevance and the ability to impact patients with transformative mechanisms and precision-based therapeutics. For more information, please visit www.lianbio.com.

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 clinical development, potential commercialization and potential benefits of LYR-210 and LYR-220, and the success of the company’s strategic partnership and license agreement with LianBio. 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 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; 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; 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 Annual Report on Form 10-Q filed with the SEC on May 11, 2021 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005399/en/