LYRA Lyra Therapeutics Inc.

6.06
-0.05  -1%
Previous Close 6.11
Open 6.11
52 Week Low 6.1801
52 Week High 16.5
Market Cap $78,786,696
Shares 13,001,105
Float 4,927,081
Enterprise Value $19,825,116
Volume 29,332
Av. Daily Volume 135,259
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Drug Pipeline

Drug Stage Notes
LYR-210
Chronic rhinosinusitis
Phase 3
Phase 3
Phase 3 trial to be initiated at the end of 2021.
LYR-220
Chronic rhinosinusitis
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
LYR-210 - LANTERN
Chronic rhinosinusitis / Chronic Sinusitis
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - December 7, 2020.

Latest News

  1. WATERTOWN, Mass., July 26, 2021 (GLOBE NEWSWIRE) -- 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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced the company will report second quarter 2021 financial results on Monday, August 9, 2021 after the close of market. Lyra will host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss the results and provide a business update.

    Conference Call and Webcast Details
    To access the live call by phone, dial (833) 519-1249 (domestic) or (914) 800-3822 (international) and use the conference ID: 6997916. To access…

    WATERTOWN, Mass., July 26, 2021 (GLOBE NEWSWIRE) -- 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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced the company will report second quarter 2021 financial results on Monday, August 9, 2021 after the close of market. Lyra will host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss the results and provide a business update.

    Conference Call and Webcast Details

    To access the live call by phone, dial (833) 519-1249 (domestic) or (914) 800-3822 (international) and use the conference ID: 6997916. To access a live webcast of the call, please visit the Investor Relations section of the Lyra Therapeutics website at www.lyratherapeutics.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    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.

    Forward-Looking Statement

    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 clinical advancement of LYR-210 for the treatment of CRS. 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 Quarterly 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.

    Media Contact:

    Kathryn Morris

    914-204-6412

    Investor Contact:

    Argot Partners

    212-600-1902



    Primary Logo

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  2. WATERTOWN, Mass., July 12, 2021 (GLOBE NEWSWIRE) -- 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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced that Maria Palasis, Ph.D., Lyra's President and Chief Executive Officer, will present at the William Blair Biotech Focus Conference on Thursday, July 15, 2021 at 10:00 a.m. ET. A live webcast of the fireside chat presentation will be available in the Investor Relations section of the Company's website at https://investors.lyratherapeutics.com. The webcast replay will be available for 30 days following the event.

    About Lyra

    WATERTOWN, Mass., July 12, 2021 (GLOBE NEWSWIRE) -- 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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced that Maria Palasis, Ph.D., Lyra's President and Chief Executive Officer, will present at the William Blair Biotech Focus Conference on Thursday, July 15, 2021 at 10:00 a.m. ET. A live webcast of the fireside chat presentation will be available in the Investor Relations section of the Company's website at https://investors.lyratherapeutics.com. The webcast replay will be available for 30 days following the event.

    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.

    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 clinical advancement of LYR-210 for the treatment of CRS. 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 Quarterly 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.

    Investor Contact:

    Argot Partners

    212-600-1902

    Media Contact:

    Kathryn Morris

    914-204-6412



    Primary Logo

    View Full Article Hide Full Article
  3. -- Results Support 505(b)(2) NDA Pathway for LYR-210

    -- First U.S. Study of LYR-210 Enrolled Rapidly

    WATERTOWN, Mass., June 30, 2021 (GLOBE NEWSWIRE) -- 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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced positive topline results from the company's pharmacokinetic (PK) study of LYR-210. Data obtained from the study are supportive of LYR-210's safety profile and provide a PK bridge to the established safety of mometasone furoate (MF) for a 505(b)(2) pathway for New Drug Approval (NDA) submission.

    The clinical study was…

    -- Results Support 505(b)(2) NDA Pathway for LYR-210

    -- First U.S. Study of LYR-210 Enrolled Rapidly

    WATERTOWN, Mass., June 30, 2021 (GLOBE NEWSWIRE) -- 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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced positive topline results from the company's pharmacokinetic (PK) study of LYR-210. Data obtained from the study are supportive of LYR-210's safety profile and provide a PK bridge to the established safety of mometasone furoate (MF) for a 505(b)(2) pathway for New Drug Approval (NDA) submission.

    The clinical study was a 56-day open label, multi-center, U.S. study of the PK and safety of LYR-210 in adult subjects with chronic rhinosinusitis (CRS). The primary objective of the study was to establish the PK profile of LYR-210. The study enrolled 24 patients, half of whom received LYR-210 2500 µg and the other half received LYR-210 7500 µg. The study indicated that both doses were safe and well tolerated, with the mean maximum plasma concentration (Cmax) observed with the 7500 ug dose well below Cmax established for U.S. Food and Drug Administration-approved formulations of MF. MF blood plasma levels observed during the PK study support LYR-210's ability to deliver consistent and steady dosing over the entire treatment period. This was the first U.S. study of LYR-210 and it was fully enrolled across four sites in 11 weeks.

    "The data from our PK study suggests that LYR-210 can elute mometasone furoate safely, consistently for 6 months, and locally to the inflamed mucosal tissue of CRS patients," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. "These results will support a 505(b)(2) pathway for LYR-210's NDA submission. We are delighted at the rapid pace of enrollment of our first U.S. patients, and believe this bodes well for interest at U.S. sites for our Phase 3 program, which we expect to initiate around the end of the year."

    "LYR-210 is highly convenient to implant and explant in a routine office visit and seamlessly conforms to the patient's nasal anatomy which enables continuous treatment for up to six-months with one application," said Randall Ow, MD, FACS, FARS, FAAOA, FAPCR, of Sacramento Ear Nose & Throat, and an investigator in the PK study. "LYR-210 has the potential to address a broad patient population and could provide a meaningful treatment option to CRS patients who fail medical management."

    Lyra will present the data from its PK study of LYR-210 during a podium presentation at the upcoming American Rhinologic Society Annual meeting in October 2021.

    About LYR-210

    LYR-210 is an investigational product candidate that utilizes Lyra's proprietary XTreoTM platform to enable six months of local, intra-nasal, 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. It is a bioresorbable polymeric matrix designed to be administered in a brief, non-invasive, in-office procedure and is intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages. In the LANTERN Phase 2 study, LYR-210 (7500 µg) demonstrated rapid, clinically meaningful and durable symptom improvement in CRS three cardinal symptoms (3CS) over six months. There are approximately 14 million patients with CRS in the US, approximately 4 million of whom fail current standard of care medical management.

    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.

    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 clinical advancement of LYR-210 for the treatment of CRS. 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 Quarterly 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.

    Investor Contact:

    Argot Partners

    212-600-1902

    Media Contact:

    Kathryn Morris

    914-204-6412



    Primary Logo

    View Full Article Hide Full Article
  4. Single primary endpoint defined as three cardinal symptoms at 24 weeks

    Company to host conference call at 5:00 PM ET today

    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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for LYR-210, its lead candidate for the treatment of chronic rhinosinusitis (CRS).

    Lyra and the FDA established key elements of the Phase 3 program to support a 505(b)(2) new drug application for LYR-210 for the treatment of CRS. The single primary…

    Single primary endpoint defined as three cardinal symptoms at 24 weeks

    Company to host conference call at 5:00 PM ET today

    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 the ear, nose and throat (ENT) passages and other diseased tissues, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for LYR-210, its lead candidate for the treatment of chronic rhinosinusitis (CRS).

    Lyra and the FDA established key elements of the Phase 3 program to support a 505(b)(2) new drug application for LYR-210 for the treatment of CRS. The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms (3CS) of CRS: nasal blockage, nasal discharge, and facial pain. Based on the Agency's suggestion, Lyra intends to enroll a total of approximately 350 subjects split into two replicate, largely concurrent Phase 3 clinical trials, each powered to >95% to detect statistical significance. Both studies will evaluate a 7500µg dose of LYR-210, and additional key clinical aspects of the studies will also be the same.

    This Phase 3 program provides the opportunity for an earlier read-out in one study, and the flexibility to potentially include patients from recently-licensed territory in Asia in the second study, without materially increasing the estimated cost or duration of the pivotal program overall. Additional outcomes from the EOP2 meeting include that Lyra's pharmacokinetic data and previously conducted non-clinical studies support a 505(b)(2) pathway, and that the Company's CMC specifications and stability plans are sufficient to move forward.

    "We are extremely pleased with this single primary endpoint given that in the Phase 2 LANTERN study, LYR-210 showed a highly statistically significant improvement in the three cardinal symptoms versus control at 24 weeks," said Robert Kern, M.D., Chief Medical Officer of Lyra Therapeutics. "LYR-210, our novel, integrated drug and delivery solution has the potential to disrupt the treatment paradigm for the millions of patients with chronic rhinosinusitis who fail medical management and currently have no alternative to surgery."

    "Following our successful End of Phase 2 meeting with the FDA, we believe that we have a clear path forward to advance LYR-210's clinical development for the treatment of CRS. The design of our U.S. Phase 3 program, with two largely replicate concurrent studies, provides an opportunity to incorporate Chinese sites, which could support approval in the Asian territories," said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. "We thank the FDA for a productive meeting to advance LYR-210's pivotal development for the treatment of CRS and we look forward to initiating our Phase 3 program at the end of this year."

    Conference Call Information

    Lyra will host a conference call and live webcast today, Tuesday, June 8, 2021, at 5:00 p.m. ET. Participants interested in listening to the conference call may do so by dialing (833)-519-1249 (domestic) or (914) 800-3822 (international) and referencing conference ID: 1364558. Participants may access the live webcast on Lyra's Investor Relations website, where it will be archived for 30 days.

    About LYR-210

    LYR-210 is an investigational product candidate that utilizes Lyra's proprietary XTreoTM platform to enable six months of local, intra-nasal, 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. It is a bioresorbable polymeric matrix designed to be administered in a brief, non-invasive, in-office procedure and is intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages. In the LANTERN Phase 2 study, LYR-210 (7500mcg) demonstrated rapid, clinically meaningful and durable symptom improvement in CRS three cardinal symptoms (3CS) over six months. There are approximately 14 million patients with CRS in the US, approximately 4 million of whom fail current standard of care medical management.

    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.

    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 clinical advancement of LYR-210 for the treatment of CRS. 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 Quarterly 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.

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  5. 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…

    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.

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