LYRA Lyra Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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LYR-210
PK trial
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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LYR-220
Chronic rhinosinusitis
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Phase 2
Phase 2
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Phase 2 trial to be initiated 2H 2021.
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LYR-210 - LANTERN
Chronic rhinosinusitis / Chronic Sinusitis
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Phase 2
Phase 2
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Phase 2 trial did not meet primary endpoint - December 7, 2020.
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Latest News
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Thought leader in the ENT treatment community brings insight from clinical practice to next stage of development for LYR-210 and pipeline
Lyra Therapeutics, Inc. (NASDAQ:LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today announced that Robert Kern, MD has been named Chief Medical Officer. He will also remain in his current position as the George A. Sisson Professor and Chair, Department of Otolaryngology – Head and Neck Surgery, Northwestern University Feinberg School of Medicine. Dr. Kern is the immediate past president of the American Rhinologic Society and current President of the International Society of Inflammation and Allergy of the Nose. He is a highly regarded clinician and researcher with a long history of leadership in the field of sinonasal disorders.
"We are excited to welcome Dr. Kern, who is a renowned physician in the ENT field and a world-leading expert in chronic rhinosinusitis, to the Lyra team as our Chief Medical Officer, to oversee the development of our clinical pipeline," said Maria Palasis, PhD, CEO of Lyra Therapeutics. "Dr. Kern has a proven track record of global leadership in otolaryngology, in both academic research and clinical rhinology, that we believe will prove invaluable to Lyra's successful development of LYR-210 and LYR-220."
"I know firsthand the enormous need for new treatment options for CRS patients, and I am enthusiastic to guide the next phase of clinical development for LYR-210 and LYR-220," said Dr. Kern. "Lyra established a clear proof of concept for LYR-210 with the recent positive LANTERN Phase 2 results, and I am pleased to join the dynamic leadership team to help advance Lyra's next stage of growth as we work together to address the needs of underserved patients chronically suffering with CRS."
Dr. Kern has 30 years of experience in the ENT medical field. He joined the Northwestern faculty over two decades ago, and was appointed as Chair of the Department of Otolaryngology in 2006. His ENT clinical practice focuses around complex sinonasal disease and endoscopic skull base surgery and he has authored more than 200 peer-reviewed articles.
Dr. Kern attended medical school at the Jefferson Medical College of Thomas Jefferson University and completed an otolaryngology residency at Wayne State University as well as a two-year National Institutes of Health (NIH) research training fellowship. He has an undergraduate degree from Georgetown University.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases. The company's lead product candidate, LYR-210, is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS) in patients who have not undergone surgery for the disease. Lyra is also developing LYR-220 for CRS patients who have undergone a prior surgery and have persistent disease. Beyond CRS, the company believes its XTreo™ platform, comprised of drug administered through a bioresorbable polymeric matrix, has the potential to address other disease areas by precisely, consistently and locally delivering medicines for sustained periods with a single administration.
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 development of LYR-210 and LYR-220. 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 November 10, 2020 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/20210217005295/en/
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Lyra Therapeutics, Inc. (NASDAQ:LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today provided a corporate update and anticipated milestones for 2021.
Corporate Update & Anticipated Milestones for 2021
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LYR-210: Announced Positive Topline Results for the company's LANTERN Phase 2 Study of LYR-210. In December, Lyra announced positive topline results from its LANTERN Phase 2 study of LYR-210 for the treatment of Chronic Rhinosinusitis (CRS), including:
- 7500 mcg dose achieved statistically significant improvement in a composite score of the 4 Cardinal Symptoms of CRS at weeks 16, 20 & 24 compared to control.
- 7500 mcg achieved statistically significant improvement in SNOT-22 at weeks 8, 16, 20 & 24 compared to control.
- LYR-210 is the first nasal implant to achieve a benefit of up to six months after a single administration in clinical testing, and the first nasal implant to achieve a benefit in both polyp and non-polyp patients in clinical testing.
- Lyra believes the results support a clear path to regulatory submission for LYR-210 and plans to move forward to a pivotal Phase 3 trial using the 7500 mcg dose.
- LYR-210: End of Phase 2 Meeting with FDA Expected Mid 2021. The company anticipates meeting with the FDA mid-2021 to discuss the results from the LANTERN Phase 2 trial, and intends to initiate a pivotal Phase 3 trial at the end of 2021.
- LYR-210: Results From PK (pharmacokinetic) Study Expected 2Q 2021. Lyra Therapeutics expects to announce data from its ongoing PK study, which has completed enrollment at 24 patients in the U.S., in the second quarter. The company expects to use the data from this study to support LYR-210's path to regulatory approval through a 505(b)(2) New Drug Application.
- LYR-220: Initiation of Phase 2 Study in 2H 2021. Lyra anticipates initiating a Phase 2 study for LYR-220 in the late second half of 2021. The company believes the LANTERN study validates its XTreo™ platform and also plans to utilize the 7500 mcg for LYR-220.
- Cash runway into 2023. Lyra maintains a strong balance sheet and reaffirms its previously announced guidance of having sufficient cash to fund operations into 2023. Cash and equivalents as of 31 December 2020 was $74.6 million, which exceeds prior guidance of $67-70 million.
"Having recently announced positive topline results from our LANTERN Phase 2 study of LYR-210, we enter 2021 planning and preparing for our pivotal trial, as we seek to continue development of this innovative product candidate and to ultimately bring it to millions of underserved CRS patients," said Maria Palasis, Ph.D., CEO of Lyra Therapeutics. "In addition, Lyra intends to initiate a Phase 2 trial for LYR-220 and to explore the further opportunities we believe exist for our now validated XTreo platform."
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases. The company's lead product candidate, LYR-210, is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS) in patients who have not undergone surgery for the disease. Lyra is also developing LYR-220 for CRS patients who have undergone a prior surgery and have persistent disease. Beyond CRS, the company believes its XTreo™ platform, comprised of drug administered through a bioresorbable polymeric matrix, has the potential to address other disease areas by precisely, consistently and locally delivering medicines for sustained periods with a single administration.
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 lead product candidate LYR-210, the presentation of top-line results relating to the Company's Phase 2 LANTERN clinical trial for LYR-210, the Company's plans to initiate a pivotal Phase 3 study for LYR-210 at the end of 2021, the Company's anticipated announcement and use of data from its ongoing PK study, the Company's initiation of a Phase 2 study for LYR-220, and its cash guidance. 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 November 10, 2020 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/20210122005087/en/
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LYR-210: Announced Positive Topline Results for the company's LANTERN Phase 2 Study of LYR-210. In December, Lyra announced positive topline results from its LANTERN Phase 2 study of LYR-210 for the treatment of Chronic Rhinosinusitis (CRS), including:
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WATERTOWN, Mass., May 28, 2020 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (NASDAQ:LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat diseases, today reported financial results for the quarter ended March 31, 2020 and provided a corporate update.
Key First Quarter 2020 and Subsequent Highlights
- Announced Closing of Initial Public Offering and Exercise in Full of Underwriters' Option to Purchase Additional Shares. In May, Lyra announced the closing of its initial public offering of 4,025,000 shares of common stock at a public offering price of $16.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 525,000 additional shares. The gross proceeds to Lyra, before underwriting discounts and commissions and fees and expenses, were approximately $64 million. Lyra's common stock began trading on The Nasdaq Global Market on May 1, 2020 under the ticker symbol "LYRA.".
- Completed Series C Financing. In January, Lyra completed a Series C financing which raised approximately $30 million in new funds. The investment was led by Perceptive Advisors and included new investors including Clifton Capital as well as participation by existing investors RA Capital Management, Soleus Capital, ArrowMark Partners, Polaris Venture Partners, North Bridge Venture Partners and Intersouth Partners.
- Announced FDA Clearance of IND for a Phase 2 Clinical Trial of LYR-210 for Chronic Rhinosinusitis. In January, Lyra announced that the U.S. Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application for LYR-210 for the treatment of chronic rhinosinusitis (CRS). Prior to the COVID-19 pandemic, Lyra planned to open U.S. sites for its Phase 2 LANTERN clinical trial. However, in light of the fallout from COVID-19, the company decided to discontinue enrollment in the trial at 67 patients and not to open any sites in the U.S. Lyra plans instead to leverage remote electronic data collection to complete clinical assessments and generate sufficient information to design a Phase 3 clinical trial.
"Lyra made substantial progress in the first quarter of 2020, FDA's approval of our IND for LYR-210, the closing of our Series C financing, and most recently our Nasdaq listing," said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. "The achievement of these milestones positions Lyra to further progress our CRS product candidates, LYR-210 and LYR-220, both of which utilize our proprietary XTreo™ platform. I would like to thank all of Lyra's stakeholders for their support, and I look forward to updating you on our clinical and corporate progress in the coming months and years."
Financial Highlights
Cash, cash equivalents as of March 31, 2020 were $35.2 million. This figure does not include proceeds from Lyra's subsequent IPO, the gross proceeds from which, before underwriting discounts and commissions and fees and expenses, were approximately $64 million.
Research and development expenses for the quarter ended March 31, 2020 were $3.0 million compared to $2.8 million for the same period in 2019. This was driven primarily by an increase in clinical expenses associated with the Ph2 trial of LYR-210.
General and administrative expenses for the first quarter 2020 were $1.3 million compared to $0.9 million for the same period in 2019. This increase was driven primarily by additional headcount and support expenses in preparation for our public offering.
Total operating expenses for the quarter ended March 31, 2020 were $4.2 million compared to $3.6 million for the same period in 2019.
Net loss for the first quarter was $4.2 million compared to $3.6 million for the same period in 2019.
About Lyra Therapeutics, Inc.
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat diseases. The company's proprietary technology platform, XTreo™, is designed to precisely and consistently deliver medicines directly to the affected tissue for sustained periods with a single administration. The company's initial product candidates, LYR-210 and LYR-220, are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and intended to deliver up to six months of continuous drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS). The therapeutic embedded within LYR-210 and LYR-220 is mometasone furoate, which is the active ingredient in various FDA-approved drugs and has a well-established efficacy and safety profile. CRS is an inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities and affects approximately 14 million people in the United States. The company is advancing LYR-210 as a potential preferred alternative to surgery in an ongoing Phase 2 clinical trial for CRS patients who have failed medical management. In its Phase 1 clinical trial, LYR-210 met its primary safety endpoint, and it was observed that patients generally experienced significant and rapid, clinically meaningful and durable improvement in SNOT-22 scores, an established patient symptom severity scale, through week 25, which was the end of the trial. The company is also developing LYR-220 for use in CRS patients who have an enlarged nasal cavity due to sinus surgery but continue to require treatment to manage CRS symptoms. Beyond CRS, the company believes its XTreo platform has potential applications in other disease areas, which it is actively exploring to further broaden the platform's therapeutic potential.
For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn.
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 without limitation statements regarding our product candidate development, the status of our Phase 2 clinical trial of LYR‑210, planned clinical trials for LYR-220, and the sufficiency of our cash, cash equivalents and short-term investments, including in light of the COVID-19 pandemic. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Lyra'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: our plans to develop and commercialize product candidates; the timing of ongoing or planned clinical trials for LYR-210, LYR-220 and any future product candidates; the timing of and ability to obtain and maintain regulatory approvals; the clinical utility of our product candidates; commercialization, marketing and manufacturing capabilities and strategy; expectations about the willingness of healthcare professionals to use LYR-210, LYR-220 and any future product candidates; our intellectual property position; our ability to raise additional funds through equity or debt financings or through collaborations, licensing arrangements or other sources; our competitive position and developments and projections relating to our competitors or our industry; our ability to identify, recruit and retain key personnel; impact of laws and regulations; risks associated with the COVID-19 global pandemic, which may adversely impact Lyra's business and clinical trials; plans to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives; research and development costs; estimates and statements regarding our future revenue, future results of operations and financial position; our business strategy; research and development costs; and plans and objectives of management for future operations. These and other important factors discussed under the caption "Risk Factors" in Lyra's final prospectus dated April 30, 2020 and filed pursuant to Rule 424(b)(4) on May 1, 2020 with the U.S. Securities and Exchange Commission, and Lyra's 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 forward-looking statements speak only as of the date of this press release and are based on information available to Lyra as of the date of this release, and Lyra assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact:
Kathryn Morris
914-204-6412
[email protected]Investor Contact:
Laurence Watts
619-916-7620
[email protected]LYRA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share data)Three Months Ended
March 31,2020 2019 Operating expenses: Research and development $ 2,964 $ 2,764 General and administrative 1,284 860 Total operating expenses 4,248 3,624 Loss from operations (4,248 ) (3,624 ) Other income: Interest income 16 35 Total other income 16 35 Net loss $ (4,232 ) $ (3,589 ) Comprehensive loss $ (4,232 ) $ (3,589 ) Net loss per share attributable to common stockholders—basic and diluted $ (18.70 ) $ (21.54 ) Weighted-average common shares outstanding—basic and diluted 230,860 170,156 LYRA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share data)March 31, December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 35,247 $ 9,808 Prepaid expenses and other current assets 293 311 Total current assets 35,540 10,119 Property and equipment, net 284 237 Operating lease right-of-use asset 2,963 3,182 Restricted cash 329 329 Deferred offering costs 1,650 1,096 Total assets $ 40,766 $ 14,963 Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit Current liabilities: Accounts payable $ 1,358 $ 1,069 Accrued expenses and other current liabilities 2,881 3,240 Operating lease liability 919 899 Total current liabilities 5,158 5,208 Operating lease liability, net of current portion 2,192 2,427 Total liabilities 7,350 7,635 Commitments and contingencies Series A-1 redeemable convertible preferred stock, $0.001 par value; 34,017,033 shares
authorized, issued and outstanding at March 31, 2020 and December 31, 2019 (aggregate
liquidation preference of $14,157 at March 31, 2020)39,742 39,742 Series A-2 redeemable convertible preferred stock, $0.001 par value; 26,680,202 shares
authorized, issued and outstanding at March 31, 2020 and December 31, 2019 (aggregate
liquidation preference of $9,063 at March 31, 2020)18,393 18,393 Series A-3 redeemable convertible preferred stock, $0.001 par value; 30,070,487 shares
authorized, issued and outstanding at March 31, 2020 and December 31, 2019 (aggregate
liquidation preference of $18,779 at March 31, 2020)38,114 38,114 Series A-4 redeemable convertible preferred stock, $0.001 par value; 19,999,999 shares
authorized, issued and outstanding at March 31, 2020 and December 31, 2019 (aggregate
liquidation preference of $6,000 at March 31, 2020)6,000 6,000 Series B redeemable convertible preferred stock, $0.001 par value; 98,351,953 and 100,018,619
shares authorized at March 31, 2020 and December 31, 2019, respectively; 98,351,953 shares
issued and outstanding at March 31, 2020 and December 31, 2019 (aggregate
liquidation preference of $29,506 at March 31, 2020)28,496 28,417 Series C redeemable convertible preferred stock, $0.001 par value; 90,180,614 shares
authorized at March 31, 2020; 78,306,611 shares issued and outstanding at March 31, 2020
(aggregate liquidation preference of $30,392 at March 31, 2020)29,452 — Total redeemable convertible preferred stock 160,197 130,666 Stockholders' deficit: Common stock, $0.001 par value; 400,000,000 and 275,000,000 shares authorized at
March 31, 2020 and December 31, 2019, respectively; 230,860 shares issued and
outstanding at March 31, 2020 and December 31, 2019— — Additional paid-in capital 5,208 4,419 Accumulated deficit (131,989 ) (127,757 ) Total stockholders' deficit (126,781 ) (123,338 ) Total liabilities, redeemable convertible preferred stock and stockholders'
deficit$ 40,766 $ 14,963 
- Announced Closing of Initial Public Offering and Exercise in Full of Underwriters' Option to Purchase Additional Shares. In May, Lyra announced the closing of its initial public offering of 4,025,000 shares of common stock at a public offering price of $16.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 525,000 additional shares. The gross proceeds to Lyra, before underwriting discounts and commissions and fees and expenses, were approximately $64 million. Lyra's common stock began trading on The Nasdaq Global Market on May 1, 2020 under the ticker symbol "LYRA.".