LYRA Lyra Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
LYR-220 (BEACON)
Chronic rhinosinusitis
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated month in November 2021.
|
|
LYR-210 - LANTERN
Chronic rhinosinusitis / Chronic Sinusitis
|
Phase 2
Phase 2
|
Phase 2 trial did not meet primary endpoint - December 7, 2020. Additional Phase 2 data of the PK study outcomes showed that Mometasone Furoate (MF) blood levels were constant over the 56 days, providing further evidence that LYR-210 delivers a consistent and steady daily dose of MF with accompanying rapid symptom relief during this time period, noted October 4, 2021.
|
|
LYR-210 - ENLIGHTEN
Chronic rhinosinusitis
|
Phase 3
Phase 3
|
Phase 3 trial to be initiated at the end of 2021.
|
Latest News
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WATERTOWN, Mass., Nov. 11, 2021 /PRNewswire/ -- 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 in a virtual format at three upcoming investor conferences:
The Jefferies London Healthcare Conference – on-demand fireside chat available beginning November 18, 2021 at 3:00 a.m. ET
The Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum – corporate presentation on November 18, 2021 at 9:00 a.m. ET
The Evercore ISI 4th Annual HealthCONx Virtual Conference – fireside chat on December 1, 2021 at 3:55 p.m. ET
Webcasts of the virtual presentations will be available in the Investor Relations section of the Company's website at https://investors.lyratherapeutics.com at the times and dates specified above. Webcast replays will be available for 30 days following each 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 up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. 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 date and time of each presentation and the company's pipeline. 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; our 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 November 9, 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
[email protected]Media Contact:
Kathryn Morris
914-204-6412
[email protected]
View original content to download multimedia:https://www.prnewswire.com/news-releases/lyra-therapeutics-to-present-at-upcoming-virtual-investor-conferences-301421717.htmlSOURCE Lyra Therapeutics, Inc.
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WATERTOWN, Mass., Nov. 9, 2021 /PRNewswire/ -- 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 reported financial results for the quarter ended September 30, 2021, and highlighted recent accomplishments.
Company Highlights
- Lyra expects to initiate the LYR-220 Phase 2 BEACON study in post-surgical chronic rhinosinusitis (CRS) patients this month, and remains on track to initiate the LYR-210 Phase 3 ENLIGHTEN program in surgically-naïve CRS patients around the end of the year.
- At the 67th Annual Meeting of the American Rhinologic Society (ARS), new positive data on LYR-210 were the subject of two presentations. The Phase 2 LANTERN 6-month post-treatment evaluation showed continued safety and that approximately half of treated CRS patients experienced a durable response six months post LYR-210 removal. The recently completed pharmacokinetic (PK) study showed that Mometasone Furoate (MF) blood levels were constant over the 56 days, providing further evidence that LYR-210 delivers a steady daily dose of MF with accompanying rapid symptom relief during this time period. The study showed LYR-210 to be effective in patients with less severe disease, with subjects' average baseline SNOT-22 scores of 36 points, compared to 68 points in the LANTERN study. The PK study was selected as a top clinical presentation at the meeting.
- In September, the Company appointed Jason Cavalier as Chief Financial Officer. Mr. Cavalier is a highly experienced investment banker with an extensive background in advising companies on financing and strategic alternatives, most recently serving at Cantor Fitzgerald as Managing Director, Head of Life Sciences Mergers & Acquisitions. He succeeds Don Elsey, who retired as the Company's CFO and is currently serving in an advisory role to assist with the transition.
- The LYR-210 Phase 2 LANTERN manuscript was published online in the peer-review journal, International Forum of Allergy & Rhinology, and also won the ARS Annual Meeting 2021 Clinical Science Maurice Cottle Award.
- Preclinical data on Lyra's XTreo™ platform were published online in the peer-review journal, American Journal of Rhinology & Allergy. The results demonstrate that XTreo™ technology platform provides targeted and sustained dosing of anti-inflammatory medication.
- The Company hosted two virtual events, in August and October, featuring key opinion leaders in CRS.
"We are incredibly proud of Lyra's recent progress, with a growing body of clinical evidence supporting the potential for LYR-210 to become the new standard of care for chronic rhinosinusitis," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. "Key opinion leaders in CRS are also sharing their enthusiasm for how they believe LYR-210 will provide a much-needed treatment option for the majority of their CRS patients, who fail medical management today. Looking ahead to the remainder of this year, we are excited to be initiating two later-stage clinical studies, our Phase 3 ENLIGHTEN study for LYR-210 and our Phase 2 BEACON study for LYR-220, in surgically-naïve and post-surgical CRS patients, respectively. Together these two products are designed to address the full range of CRS patients that present to an ENT office."
Third Quarter 2021 Financial Highlights
- Cash and cash equivalents as of September 30, 2021 were $58.1 million, compared with $69.0 million at June 30, 2021. The Company expects its cash balance to be sufficient to fund its planned operations through 2022.
- Research and development expenses for the quarter ended September 30, 2021 were $7.1 million compared to $3.7 million for the same period in 2020, primarily attributable to an increase in product development and manufacturing expenses and an increase in research and development headcount and consulting expenses.
- General and administrative expenses for the third quarter 2021 were $4.0 million compared to $2.7 million for the same period in 2020, primarily attributable to an increase in professional and consulting expenses, stock-based compensation and general and administrative headcount.
- Total operating expenses for the quarter ended September 30, 2021 were $11.1 million compared to $6.4 million for the same period in 2020.
- Net loss for the third quarter was $11.1 million compared to $6.3 million for the same period in 2020.
Conference Call and Webcast Details
LYRA will host a conference call and live webcast today at 4:30 p.m. ET. To access the live call by phone, dial (833) 519-1249 (domestic) or (914) 800-3822 (international) and use the conference ID: 5064627. To access the live webcast of the call, please visit the Investor Relations section of the Lyra Therapeutics website at https://investors.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 up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. 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 plans for the LYR-220 Phase 2 BEACON study in post-surgical chronic rhinosinusitis (CRS) patients and the LYR-210 Phase 3 ENLIGHTEN program in surgically-naïve CRS patients, as well as the sufficiency of the company's cash balance to fund its planned operations through 2022. 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; our 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 November 9, 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
[email protected]Media Contact:
Kathryn Morris
914-204-6412
[email protected]LYRA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
Collaboration revenue
$
14
$
—
$
14
$
—
Operating expenses:
Research and development
7,077
3,712
19,352
8,779
General and administrative
4,018
2,651
10,639
6,377
Total operating expenses
11,095
6,363
29,991
15,156
Loss from operations
(11,081)
(6,363)
(29,977)
(15,156)
Other income:
Interest income
26
29
81
50
Total other income
26
29
81
50
Net loss
$
(11,055)
$
(6,334)
$
(29,896)
$
(15,106)
Net loss per share attributable to common stockholders—basic and diluted
$
(0.85)
$
(0.49)
$
(2.30)
$
(2.13)
Weighted-average common shares outstanding—basic and diluted
13,001,514
12,924,682
12,979,837
7,133,967
LYRA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share data)
September 30,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
58,131
$
74,593
Prepaid expenses and other current assets
2,755
1,324
Total current assets
60,886
75,917
Property and equipment, net
4,706
2,165
Operating lease right-of-use assets
1,596
2,301
Restricted cash
329
329
Other assets
245
118
Total assets
$
67,762
$
80,830
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
2,912
$
922
Accrued expenses and other current liabilities
3,968
2,977
Operating lease liabilities
1,052
985
Deferred revenue
9,841
—
Total current liabilities
17,773
4,884
Operating lease liabilities, net of current portion
656
1,454
Deferred revenue, net of current portion
2,145
—
Total liabilities
20,574
6,338
Commitments and contingencies
Stockholders' equity:
Common stock, $0.001 par value; 200,000,000 shares authorized at
September 30, 2021 and December 31, 2020; 13,004,578 and
12,932,377 shares issued and outstanding at September 30, 2021
and December 31, 2020, respectively13
13
Additional paid-in capital
226,955
224,363
Accumulated deficit
(179,780)
(149,884)
Total stockholders' equity
47,188
74,492
Total liabilities and stockholders' equity
$
67,762
$
80,830
View original content to download multimedia:https://www.prnewswire.com/news-releases/lyra-therapeutics-reports-third-quarter-2021-financial-results-and-provides-corporate-update-301420298.htmlSOURCE Lyra Therapeutics, Inc.
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WATERTOWN, Mass., Nov. 2, 2021 /PRNewswire/ -- 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 will report third quarter 2021 financial results on Tuesday, November 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: 5064627. 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 up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. 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 plans for the LYR-220 Phase 2 BEACON study in post-surgical chronic rhinosinusitis (CRS) patients and the LYR-210 Phase 3 ENGLIGHTEN program in surgically-naïve CRS patients, as well as the sufficiency of the company's cash balance to fund its planned operations into 2023. 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; our 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 August 9, 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
[email protected]Media Contact:
Kathryn Morris
914-204-6412
[email protected]
View original content to download multimedia:https://www.prnewswire.com/news-releases/lyra-therapeutics-to-report-third-quarter-2021-financial-results-on-november-9-301413465.htmlSOURCE Lyra Therapeutics, Inc.
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WATERTOWN, Mass., Oct. 19, 2021 /PRNewswire/ -- 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 will host a virtual event with leading chronic rhinosinusitis (CRS) experts to highlight the Company's LYR-210 and LYR-220 clinical programs on Wednesday, October 27, 2021 from 2:00 p.m. – 3:00 p.m. ET.
The program will feature presentations by two renowned key opinion leaders in CRS:
- Randall A. Ow, MD, FACS, FARS, FAAOA, FAPCR, is a practicing Otolaryngologist at Sacramento Ear, Nose & Throat and President and Chief Medical Officer of DaVinci Research. Dr. Ow was the principal investigator in the LYR-210 pharmacokinetic study and will provide an overview of the study's results, which he presented recently at the 67th Annual Meeting of the American Rhinology Society (ARS).
- Zachary Soler, MD, MSc, Associate Professor of Otolaryngology at Medical University of South Carolina (MUSC) and practicing Otolaryngologist at the MUSC Sinus Center. Dr. Soler is a Global Coordinating Principal Investigator for Lyra's upcoming Phase 3 ENLIGHTEN program for LYR-210, and will provide an overview of the 6-month follow up data from the LANTERN Phase 2 study of LYR-210, which were recently presented at ARS.
During the virtual event, Lyra management will also provide an update on the upcoming Phase 2 BEACON study of LYR-220 and upcoming Phase 3 ENLIGHTEN program for LYR-210. A live webcast and slide 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 following the event.
Lyra has two product candidates in development for the estimated four million CRS patients in the U.S. each year that fail medical management: LYR-210 for surgically naive patients, and LYR-220 for patients who have recurrent symptoms despite surgery. The Company expects to begin its Phase 2 BEACON study for LYR-220 and Phase 3 ENLIGHTEN study for LYR-210 around the end of 2021.
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's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. 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 and efficacy of LYR-210 for the treatment of CRS and our expectations regarding the upcoming Phase 3 ENLIGHTEN program and Phase 2 BEACON program. 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; our 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 August 9, 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
[email protected]Media Contact:
Kathryn Morris
914-204-6412
[email protected]
View original content to download multimedia:https://www.prnewswire.com/news-releases/lyra-therapeutics-to-highlight-lyr-210-and-lyr-220-clinical-programs-at-virtual-event-with-leading-clinical-crs-experts-301402821.htmlSOURCE Lyra Therapeutics, Inc.
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WATERTOWN, Mass., Oct. 4, 2021 /PRNewswire/ -- 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, announced that new, positive LYR-210 data from the LANTERN 6-month post-treatment evaluation and recently completed pharmacokinetic study, were the subject of two oral presentations at the 67th Annual Meeting of the American Rhinologic Society (ARS) on October 1-2. The PK study was selected as a top clinical presentation at the meeting; additionally, the LANTERN Phase 2 manuscript won the ARS Annual Meeting 2021 Clinical Science Maurice Cottle Award.
Joanne Rimmer, MBBS, MA, FRCS (ORL-HNS), FRACS, Clinical Associate Professor and Otolaryngologist at Monash University in Melbourne, Australia, and an investigator in the LANTERN study, presented the LANTERN 6-month post-treatment outcomes, which showed continued safety and that about half of treated chronic rhinosinusitis (CRS) patients experienced a durable response six months post LYR-210 removal.
"The LANTERN 6-month post-treatment outcomes indicate a lasting treatment effect post-removal of LYR-210, while the control group showed worsening CRS symptoms from the Week 24 baseline," commented A/Prof. Rimmer. "A lack of strong rebound in CRS symptoms post-treatment and removal is very exciting, with potential long-term benefit for CRS patients. LYR-210 is a promising new treatment alternative for this chronic disease."
Randall A. Ow, MD, FACS, FARS, FAAOA, FAPCR, Otolaryngologist at Sacramento Ear, Nose & Throat, and principal investigator in the LYR-210 pharmacokinetic study, presented the PK study outcomes, which showed that Mometasone Furoate (MF) blood levels were constant over the 56 days, providing further evidence that LYR-210 delivers a consistent and steady daily dose of MF with accompanying rapid symptom relief during this time period.
"There is a need for long-acting, local CRS treatments that deliver a targeted and constant therapeutic dose to the site of the disease, while alleviating need for daily adherence," said Dr. Ow. "This release profile is exactly what I would want in an anti-inflammatory implant and the symptom improvement observed with LYR-210 is quite meaningful. LYR-210 is highly convenient to administer and remove in a routine office visit and has the potential to provide an impactful treatment option for a broad CRS patient population."
"The LANTERN follow-up and PK data presented at ARS underscore our belief in LYR-210's potential to disrupt the CRS treatment landscape for the millions of U.S. CRS patients who fail medical management each year," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. "We are extremely proud that the LANTERN Phase 2 manuscript was recognized with the 2021 Maurice Cottle Award, granted by ARS for the best clinical rhinologic research paper of the year. We look forward to advancing the clinical development of LYR-210, and our second candidate, LYR-220 for post-surgical CRS patients, into the Phase 3 ENLIGHTEN program and Phase 2 BEACON program, respectively, around the end of this year."
LANTERN Study and 6-Month Post-Treatment Safety Follow-up
In the Phase 2, multicenter, blinded, randomized, controlled, dose-ranging LANTERN study of LYR-210 in surgically naïve adult CRS patients who had failed previous medical management, LYR-210 was shown to be safe and well-tolerated over the 24-week treatment period. LYR-210 (7500μg) demonstrated significant, rapid, durable, dose-dependent, global symptom improvement, based on composite Cardinal Symptoms (CS) scores and Sino-Nasal Outcome Test (SNOT-22), achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control.
After 24 weeks, LYR-210 drug matrices were removed, and patients then underwent a 24-week post-treatment follow-up. The main objective of the post-treatment period was to assess long-term safety post-removal. Key results include:
- LYR-210 continued to show strong safety through 24 weeks post-treatment with no increased incidence of treatment-related AEs.
- Approximately 50% of patients experienced a durable response post-removal of LYR-210 (7500μg), with no worsening of Cardinal Symptom scores from the Week 24 baseline, compared to approximately 90% of control patients who either experienced a worsening of Cardinal Symptom scores from the Week 24 baseline or required a rescue treatment.
LYR-210 Pharmacokinetic Study
The study was designed to characterize the early PK profile and systemic exposure of mometasone furoate (MF) of two doses (7500µg and 2500µg) of LYR-210 for up to 56 days. Plasma MF concentrations were evaluated at nine different time points throughout the study: one hour post-placement of LYR-210 (Day 1), and Days 2, 3, 7, 14, 21, 28, 42, and 56. Key results include:
- LYR-210 was safe and well-tolerated with zero serious adverse events, and achieved 100% placement success.
- LYR-210 delivered a constant and steady daily dose of MF over the 56 days. The steady state MF plasma concentration was 41.2pg/ml and 12.2 pg/ml over the treatment duration for 7500µg and 2500µg, respectively.
- Approximately 20% of the drug was released from LYR-210 during the 56-day study period, supporting the established 24-week drug profile.
- LYR-210 achieved clinically relevant improvement in SNOT-22 within 2 weeks of treatment, with 37.5% of patients reporting a normal SNOT-22 score (< 8) on Day 56.
About LYR-210 for Chronic Rhinosinusitis
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 administration 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 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 (7500µg) demonstrated rapid, clinically meaningful and durable symptom improvement as measured by the SNOT-22 score and a cardinal symptom score over six months. The LANTERN study, winner of the 2021 American Rhinology Society 2021 Maurice Cottle Award, has been published in the International Forum of Allergy & Rhinology. 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 up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. 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 and efficacy of LYR-210 for the treatment of CRS and our expectations regarding the upcoming Phase 3 ENLIGHTEN program and Phase 2 BEACON program. 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; our 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 August 9, 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.
SOURCE Lyra Therapeutics, Inc.
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