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Lyra Therapeutics (LYRA) News

Price: $0.122
Market Cap: $8.04M
Avg Volume: 1.01M

Country: US
Industry: Biotechnology
Sector: Healthcare

Beta: -0.18
52W Range: $0.121-6.29
Website: Lyra Therapeutics

Lyra Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

WATERTOWN, Mass., March 13, 2025 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2024 and provided a corporate update.

globenewswire.com

Lyra Therapeutics (LYRA) Upgraded to Strong Buy: Here's What You Should Know

Lyra Therapeutics (LYRA) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

zacks.com

Lyra Therapeutics, Inc. (LYRA) Reports Q3 Loss, Lags Revenue Estimates

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.27 per share a year ago.

zacks.com

Lyra Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

WATERTOWN, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the third quarter ended September 30, 2024 and provided a corporate update.

globenewswire.com

Lyra Therapeutics Fully Enrolls Pivotal Phase 3 ENLIGHTEN 2 Trial of LYR-210 for the Treatment of Chronic Rhinosinusitis

-- Topline Results Expected Q2 2025 -- WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) to the sinonasal passages for the treatment of CRS. Topline results from ENLIGHTEN 2 are expected in Q2 2025.

globenewswire.com

Lyra Therapeutics to Present Study Results for LYR-210 and LYR-220 in Two Presentations at the ARS and AAO-HNS Annual Meetings

WATERTOWN, Mass., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the Company will present results from the Phase 3 ENLIGHTEN 1 study for LYR-210, the company's lead product candidate for CRS, at the 70th Annual Meeting of the American Rhinologic Society (ARS), taking place September 27-28 in Miami. The Company will also present additional results from the Phase 2 BEACON study for LYR-220 in adult patients with CRS who have had prior ethmoid sinus surgery at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), taking place September 28 - October 1 in Miami.

globenewswire.com

Lyra Therapeutics, Inc. (LYRA) Reports Q2 Loss, Tops Revenue Estimates

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.33 per share a year ago.

zacks.com

Lyra Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update

– Primary focus continues to be on upcoming results from ENLIGHTEN 1 Phase 3 extension study in 4Q 2024 and ENLIGHTEN 2 pivotal Phase 3 trial in CRS patients in 1H 2025, as planned –

globenewswire.com

Lyra Therapeutics Announces Cost-Cutting Measures to Preserve Capital

WATERTOWN, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced that it is advancing its goal to preserve capital by implementing a layoff of approximately 75% of its workforce, in addition to other cost-cutting measures.

globenewswire.com

Why Is Lyra Therapeutics (LYRA) Stock Down 90% Today?

Lyra Therapeutics (NASDAQ: LYRA ) stock is falling hard on Monday after the clinical-stage biotechnology company announced results from a Phase 3 clinical trial of LYR-210. LYR-210 is the company's potential treatment for chronic rhinosinusitis currently in development.

investorplace.com

Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210 in Chronic Rhinosinusitis

ENLIGHTEN 1 trial did not meet its primary endpoint Company plans to evaluate full dataset and path forward WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company's Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS).

globenewswire.com

Lyra Therapeutics, Inc. (LYRA) Reports Q1 Loss, Tops Revenue Estimates

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.35 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.44 per share a year ago.

zacks.com

Lyra Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

-- Phase 3 Results from ENLIGHTEN 1 Trial of LYR-210 in Chronic Rhinosinusitis (CRS) Expected in May -- -- Phase 3 Results from ENLIGHTEN 1 Trial of LYR-210 in Chronic Rhinosinusitis (CRS) Expected in May --

globenewswire.com

3 'Buy-Rated' Biotech Stocks Under $10

Today, we look at three small-cap biotech/biopharma stocks. All three have attractive risk/reward profiles and potential catalysts on the horizon. An investment synopsis on all three firms is presented in the paragraphs below.

seekingalpha.com

Lyra Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

WATERTOWN, Mass., April 26, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (the “Company” or “Lyra”), a clinical-stage biotech developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today announced that it has granted non-qualified stock options to purchase a total of 78,400 shares of Lyra Therapeutics common stock to 16 new non-executive employees as an inducement material to their acceptance of employment with Lyra Therapeutics. The employment inducement awards were approved by Lyra's independent directors serving on its Compensation Committee and granted under Lyra's 2022 Employment Inducement Award Plan, as amended, and related form of stock option agreement in accordance with Nasdaq Listing Rule 5635(c)(4).

globenewswire.com

Lyra Therapeutics (LYRA) Soars 6.5%: Is Further Upside Left in the Stock?

Lyra Therapeutics (LYRA) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions could translate into further price increase in the near term.

zacks.com

Lyra Therapeutics (LYRA) Is a Great Choice for 'Trend' Investors, Here's Why

Lyra Therapeutics (LYRA) could be a solid choice for shorter-term investors looking to capitalize on the recent price trend in fundamentally sound stocks. It is one of the many stocks that passed through our shorter-term trading strategy-based screen.

zacks.com

Wall Street Analysts See a 101.81% Upside in Lyra Therapeutics (LYRA): Can the Stock Really Move This High?

The consensus price target hints at a 101.8% upside potential for Lyra Therapeutics (LYRA). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

zacks.com

Lyra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

-- Data from ENLIGHTEN I Pivotal Phase 3 Trial of LYR-210 in Chronic Rhinosinusitis (CRS) Anticipated Q2 2024 -- WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.

globenewswire.com

Here's Why Momentum in Lyra Therapeutics, Inc. (LYRA) Should Keep going

Lyra Therapeutics, Inc. (LYRA) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.

zacks.com

Lyra Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

WATERTOWN, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today announced that it has granted non-qualified stock options to purchase a total of 119,200 shares of Lyra common stock to 18 new non-executive employees as an inducement material to their acceptance of employment with Lyra. The employment inducement awards were approved by Lyra's independent directors serving on its Compensation Committee and granted under the Company's 2022 Inducement Award Plan, as amended, and related form of stock option agreement in accordance with Nasdaq Listing Rule 5635(c)(4).

globenewswire.com

5 Small Drug Stocks to Buy From a Rebounding Industry

Innovation is expected to continue to drive growth of the Medical-Drugs industry. UTHR, ESPR, HRTX, LYRA and ALDX may prove to be good additions to one's portfolio.

zacks.com

Strength Seen in Lyra Therapeutics, Inc. (LYRA): Can Its 6.9% Jump Turn into More Strength?

Lyra Therapeutics, Inc. (LYRA) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

zacks.com

What Makes Lyra Therapeutics, Inc. (LYRA) a Good Fit for 'Trend Investing'

Lyra Therapeutics, Inc. (LYRA) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.

zacks.com

4 Drug Stocks Rising More Than 40% in 2023 With Room to Grow

Novo Nordisk (NVO), Journey Medical Corporation (DERM), Lyra Therapeutics (LYRA) and Fusion Pharmaceuticals (FUSN) have returned 40% or higher year to date and have room for more growth in 2024.

zacks.com

5 Small Drug Stocks to Buy on Hopes of Better Prospects in the New Year

Innovation is expected to continue driving growth in the Medical-Drugs industry. DERM, LYRA, AUPH, ALPN and HARP may prove to be good additions to one's portfolio.

zacks.com

Lyra Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

– Additional Phase 2 BEACON trial CT scan data demonstrated statistically significant improvement in sinus opacification with LYR-220 and provided radiological evidence of improvement in chronic rhinosinusitis (CRS) patients who have had prior ethmoid sinus surgery –

globenewswire.com

Lyra Therapeutics to Participate in Upcoming Investor Conferences

WATERTOWN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that Maria Palasis, Ph.D., President and Chief Executive Officer, will participate in the following investor conferences in November:

globenewswire.com

Lyra Therapeutics Announces Appointment of Ronan O'Brien as Chief Legal Officer

WATERTOWN, Mass., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of chronic rhinosinusitis (“CRS”), today announced the appointment of Ronan O'Brien, as Chief Legal Officer, effective October 16, 2023.

globenewswire.com

Lyra Therapeutics: Hold For Phase 3 Topline

Lyra Therapeutics has two product candidates in clinical trials for Chronic rhinosinusitis (CRS) patients. Both candidates, LYR-210 and LYR-220, show promising efficacy data, with LYR-210 in phase 3 trials and LYR-220 in phase 2 trials. Lyra has a market cap of $190mn and enough cash to sustain operations until 2025, but more cash would be desirable.

seekingalpha.com

Lyra Therapeutics' Nasal Matrix In Focus: Sniffing Out Opportunity

Lyra Therapeutics' LYR-220 shows promise in addressing chronic rhinosinusitis, targeting a patient demographic that doesn't respond to current treatments. The company maintains a stable balance sheet with a 24-month cash runway and a healthy asset-to-liability ratio. The upcoming ENLIGHTEN 1 Phase 3 trial could significantly impact the company's clinical and financial trajectory.

seekingalpha.com

Lyra (LYRA) Posts Upbeat Data on Rhinosinusitis Study, Stock Up

Lyra (LYRA) gains on positive data from mid-stage study of LYR-220, treating patients with chronic rhinosinusitis who have had ethmoid sinus surgery.

zacks.com

Lyra Therapeutics Announces Positive Topline Results from BEACON Phase 2 Study of LYR-220 for the Treatment of Chronic Rhinosinusitis (CRS) in Patients with Prior Ethmoid Sinus Surgery

Study demonstrates statistically significant and clinically relevant improvements in 3 Cardinal Symptoms and SNOT-22 scores at 24 weeks

globenewswire.com

Lyra Therapeutics Fully Enrolls Pivotal Phase 3 ENLIGHTEN I Trial of LYR-210 for the Treatment of Chronic Rhinosinusitis

WATERTOWN, Mass., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN I clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled.

globenewswire.com

Lyra Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

-- ENLIGHTEN I Pivotal Phase 3 Trial of LYR-210 in Pre-Surgical Chronic Rhinosinusitis (CRS) on Track to Complete Enrollment in the Coming Weeks, with Data Expected in 1H 2024 -- -- Initial Topline Results from BEACON Phase 2 Trial of LYR-220 in Post-Surgical CRS Now Anticipated Earlier Than Expected, in September 2023 --

globenewswire.com

Lyra Therapeutics to Present at William Blair Virtual Biotechnology Conference

WATERTOWN, Mass., July 13, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of patients with chronic rhinosinusitis (CRS), today announced that Maria Palasis, Ph.D., President and Chief Executive Officer, will present at the William Blair Virtual Biotechnology Conference, “Transitioning Biotech Breakthroughs to Commercial Success,” on Tuesday, July 18, 2023 from 10:00 – 10:45 a.m. ET.

globenewswire.com

Lyra Therapeutics Extends Gains After Insider Transactions Disclosures

Friday's impressive 13% surge in the shares of Lyra Therapeutics (US:LYRA) carried over into the new week as investors pushed the LYRA stock price up a further 8.6% on Monday.

247wallst.com

Lyra Therapeutics to Present at Jefferies Healthcare Conference

WATERTOWN, Mass., June 02, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of patients with chronic rhinosinusitis (CRS), today announced that Maria Palasis, Ph.D., President and Chief Executive Officer, will present at the Jefferies Healthcare Conference in New York, NY on Wednesday, June 7, 2023, at 10:30 a.m. ET.

globenewswire.com

Lyra Therapeutics to Present at Bank of America Securities 2023 Healthcare Conference

WATERTOWN, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of patients with chronic rhinosinusitis (CRS), today announced that Maria Palasis, Ph.D., President and Chief Executive Officer, will present at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023, at 4:35 p.m. PT.

globenewswire.com

Lyra Therapeutics to Present Additional LANTERN Phase 2 Study Results for LYR‑210 in Two Oral Presentations at ARS Annual Meeting

WATERTOWN, Mass. , Aug. 29, 2022 /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 the company will present additional Phase 2 results from the LANTERN study for LYR‑210, the company's lead product candidate for chronic rhinosinusitis, at the 68th Annual Meeting of the American Rhinologic Society (ARS), taking place September 9-10, 2022 in Philadelphia.

prnewswire.com

Lyra Therapeutics, Inc. (LYRA) Reports Q2 Loss, Lags Revenue Estimates

Lyra Therapeutics, Inc. (LYRA) delivered earnings and revenue surprises of -26.47% and 92.42%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

zacks.com

Lyra Therapeutics to Present at Upcoming Investor Conferences

WATERTOWN, Mass. , May 26, 2022 /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.

prnewswire.com

Lyra Therapeutics: Progress In The Clinic

Phase 3 trials for LYR-210 are underway. LYR-210 has shown an excellent efficacy and safety profile.

seekingalpha.com

7 Stocks to Watch for Major Insider Trading Clues

These seven stocks show varying degrees of insider trading, which can provide a hint regarding each company or fund's performance. The post 7 Stocks to Watch for Major Insider Trading Clues appeared first on InvestorPlace.

investorplace.com

Lyra Therapeutics Stock Surges On Equity Raise Of $100M

Lyra Therapeutics Inc (NASDAQ: LYRA) has announced a private placement of approximately $100.5 million. The Company has offered 18.8 million common shares at $4.22 per share and pre-funded warrants to purchase an aggregate of 5 million shares with an exercise price of $0.001 per share,.

benzinga.com

Lyra Therapeutics Kickstarts LYR-210 Pivotal Program in Surgically Naïve Chronic Rhinosinusitis Patients

Lyra Therapeutics Inc (NASDAQ: LYRA) has initiated its Phase 3 ENLIGHTEN I trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients. LYR-210 is designed to be administered in a brief, non-invasive, in-office procedure and deliver up to six months of continuous anti-inflammatory medication to the sinonasal passages.

benzinga.com

Lyra Therapeutics to Present at Upcoming Virtual Investor Conferences

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.

prnewswire.com

Lyra Therapeutics, Inc. (LYRA) CEO Maria Palasis on Q3 2021 Results - Earnings Call Transcript

seekingalpha.com

Lyra Therapeutics Presents New Positive Phase 2 LANTERN 6-Month Follow-Up and LYR-210 Pharmacokinetic Data, and LANTERN Manuscript Wins Award at the 67th Annual Meeting of the American Rhinologic Society

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.

prnewswire.com

Lyra Therapeutics Announces Publication of Positive LANTERN Results in the International Forum of Allergy & Rhinology

LYR-210 is the First Drug-Eluting Product Candidate to Demonstrate Statistically Significant Symptom Improvement for Six Months with a Single Administration in Surgically Naïve Chronic Rhinosinusitis Patients

globenewswire.com

Lyra Therapeutics Announces Publication of Preclinical Pharmacokinetics and Drug Release characterization for XTreo™ Technology Platform in the American Journal of Rhinology & Allergy

Results demonstrate XTreo™ technology platform provides targeted and sustained dosing of anti-inflammatory medication

globenewswire.com

Lyra Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

WATERTOWN, Mass., Sept. 07, 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 in a virtual format at the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be made available for on-demand viewing on Monday, September 13, 2021 at 7:00 a.m. ET.

globenewswire.com

New Strong Sell Stocks for August 20th

ADXN, CSSE, HSDT, LYRA, and TRVN have been added to the Zacks Rank #5 (Strong Sell) List on August 20, 2021.

zacks.com

Lyra Therapeutics to Host Virtual Chronic Rhinosinusitis KOL Event on August 31

WATERTOWN, Mass., Aug. 17, 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 will host Chronic Rhinosinusitis (CRS) Key Opinion Leader Event on Tuesday, August 31, 2021 from 3:00 p.m. - 4:30 p.m. ET.

globenewswire.com

New Strong Sell Stocks for August 12th

WKHS, SPCE, PASG, LYRA, and GO have been added to the Zacks Rank #5 (Strong Sell) List on August 12, 2021

zacks.com

Lyra Therapeutics, Inc. (LYRA) CEO Maria Palasis on Q2 2021 Results - Earnings Call Transcript

seekingalpha.com

Lyra Therapeutics to Present at Upcoming Virtual Healthcare Conference

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.

globenewswire.com

Lyra Therapeutics Announces Positive Topline Results of Pharmacokinetic Study of LYR-210 in Patients with Chronic Rhinosinusitis

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

globenewswire.com

Lyra Therapeutics Stock Is Trading Higher After Positive FDA Meeting Outcome For Rhinosinusitis Program

Lyra Therapeutics Inc (NASDAQ: LYRA) announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the 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.

benzinga.com

Lyra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for LYR-210 for the Treatment of Chronic Rhinosinusitis

WATERTOWN, Mass.--(BUSINESS WIRE)--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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Lyra Therapeutics与联拓生物宣布达成战略合作和独家许可协议，将携手在大中华地区和亚洲其他市场对LYR-210进行开发和商业化

沃特敦（美国马萨诸塞州）、上海（中国）和普林斯顿（美国新泽西州）--(BUSINESS WIRE)--Lyra Therapeutics, Inc.（纳斯达克：LYRA）是一家处于临床阶段的医药公司，专注于利用其独家XTreoTM平台进行精准、持续、局部给药的方式将药物输送至耳鼻喉（ENT）通道及其他病变组织区域。联拓生物（LianBio）是一家专注于为中国和亚洲主要市场的患者带来颠覆性药物的生物制药公司。二者于今日宣布已达成战略合作和独家许可协议，双方将携手在大中华区（中国大陆以及港澳台地区）、韩国、新加坡和泰国，对LYR-210进行开发和商业化。LYR-210是一款处于临床晚期开发阶段的鼻内抗炎药物基质，旨在治疗慢性鼻窦炎(CRS)，一种削弱鼻腔功能的炎症疾病。根据协议条款， Lyra将获得1200万美元的首付款，并有资格获得最高可达1.35亿美元的开发、监管和商业化里程碑付款。商业化启动后，根据LYR-210在各个授权地区的净销售情况，Lyra还可获得低两位数的分层销售分成。LYR-210在合作区域内的全部开发和商业化费用将由联拓生物承担，而Lyra仍将拥有LYR-210在合作区域外的一切权利。作为协议的一部分，联拓生物还将获得在许可区域内开发和商业化Lyra的LYR-220的优先权利。LYR-220是一种鼻内抗炎药物基质，用于治疗既往接受过鼻窦手术但仍有持续性鼻窦炎的患者。 “我们很高兴与联拓生物达成战略联盟，从而扩大LYR-210的全球业务范围，通过创新药物治疗方案代替手术，以造福数百万慢性鼻窦炎患者。”Lyra首席执行官Maria Palasis博士表示，“联拓生物团队在药物开发方面拥有深厚的专业知识和优势，能够在这些亚洲区域内成功实现LYR-210的商业化。此次合作能够将我们的新型综合性耳鼻喉药物和药物输送方案带给广大亚洲市场的患者，同时也为公司的全球商业化战略布局提供支撑。” “当前，经药物治疗无效的慢性鼻窦炎患者只能通过十分有限的侵入性治疗方案来控制疾病。”联拓生物首席执行官王轶喆博士表示，“迄今为止进行的临床研究证明，一次性LYR-210治疗可为患鼻息肉和不患鼻息肉的慢性鼻窦炎患者提供持续长达6个月的临床症状改善。面对中国超过8800万慢性鼻窦炎成年患者，我们相信LYR-210有潜力解决其巨大未满足的治疗需求，并显著提高亚洲地区患者的治疗标准。” 关于LYR-210 LYR-210是一款依托Lyra独有的XTreo™平台研发的候选产品，能够通过单次治疗为慢性鼻窦炎患者提供连续长达6个月的局部抗炎治疗。LYR-210是一款为数百万经药物治疗失败的慢性鼻窦炎患者设计的可替代鼻窦手术的非侵入性治疗方案。在一项二期临床研究（LANTERN）中，LYR-210（7500微克）在6个月的症状评分中显示出快速、有临床意义和持久的症状改善。关于Lyra Therapeutics Lyra Therapeutics, Inc.是一家处于临床阶段的医药公司，专注于利用其独家XTreoTM平台进行精准、持续、局部给药的方式将药物输送至传统治疗方法无法到达的耳鼻喉（ENT）通道及其他病变组织区域。Lyra的XTreoTM平台由生物相容性网状支架、改造的弹性基质和多功能聚合物药物复合物所组成。公司目前的产品管线针对的是耳鼻喉通道的深层组织，旨在通过单次、非侵入性门诊治疗为患者提供可持续数月的药物治疗。Lyra的主要候选产品LYR-210目前正处于临床晚期开发阶段，用于慢性鼻窦炎的治疗，可为患者的鼻窦通道提供长达6个月的持续抗炎药物治疗。如需了解详细信息，请访问www.lyratherapeutics.com。关于联拓生物联拓生物（LianBio）的使命是通过与全球领先的生物制药公司达成战略合作关系，以高效的产品开发为大中华区和亚洲其他主要市场的患者提供最佳的科学性突破疗法。通过与世界级合作伙伴在不同的治疗领域和地域进行合作，联拓生物建立了基于疾病相关性的产品管线，并通过转化机制和精准疗法来改善患者病情。如需了解详细信息，请访问www.lianbio.com。前瞻性陈述本新闻稿中包含某些“前瞻性”陈述，这些陈述依照《1995年美国私有证券诉讼改革法案》所作。本新闻稿中包含的所有非历史事实陈述，均应视为前瞻性陈述，包括与公司对LYR-210和LYR-220临床开发和潜在商业化及优势有关的陈述，以及公司与联拓生物战略合作伙伴关系和许可协议的成功与否。这些陈述既不是承诺，也非保证，且涉及已知和未知的风险、不确定因素和其他重要因素，其可能导致公司的实际结果、业绩或成就与前瞻性陈述中所明示或默示的任何未来结果、业绩或成就之间存在重大差异，具体包括但不限于以下内容：公司自成立以来已承受重大损失，并且在可预见的将来预计会继续承受损失；公司需要额外的资金，但可能无法获得；公司有限的经营历史；公司有并未获批的产品；公司的几款候选产品均处于不同的开发阶段；公司可能无法成功确定其候选产品并使其商业化；公司的候选产品需要进行昂贵并耗时的临床试验，且结果存在不确定性；美国食品和药物管理局（FDA）或将不认为公司的某些候选产品符合Section 505(b)(2)监管审批路径的要求；公司无力获得必要的监管审批；近期及将来颁布法律所带来的影响；可能出现系统故障或安全漏洞；重要竞争所带来的影响；公司的候选产品能否成功商业化，某种程度上取决于政府机构和医疗保险公司所设定的承保范围、报销水平和定价政策；未能被市场所接受；产品责任诉讼；公司的研究计划、临床前研究和临床试验所需材料，均依赖第三方进行制造；公司依赖第三方进行临床前研究和临床试验；公司无法成功建立并维持合作关系；公司的关键生产环节依赖某些供应商；未能获得并维持或充分保护公司的知识产权；未能留住关键人员或招到合格人员；公司的增长管理出现困难；自然灾害造成的影响；全球新冠疫情可能会对公司的业务和运营（包括临床试验）产生的不利影响；公司的普通股价格可能会出现大幅波动；经营上市公司和涉及任何证券集体诉讼需要耗费大量成本和管理时间。除以上因素外，还包括公司于2021年5月11日向美国证券交易委员会（SEC）提交年报（Form 10-Q）中的“风险因素”内容以及公司向SEC提交的其他文件中描述的重要因素，所有这些均可能导致实际结果与本新闻稿的前瞻性陈述中所明示或暗示的内容存在重大差异。任何此类前瞻性陈述仅代表管理层截至本新闻稿发布之日的预估。尽管公司可能会选择在将来的某个时刻更新此类前瞻性陈述，但公司并没有该义务，即使后续事件会导致公司的观点发生变化。

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

WATERTOWN, Mass. & SHANGHAI & PRINCETON, N.J.--(BUSINESS WIRE)--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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Lyra Therapeutics to Present at the William Blair 41st Annual Growth Stock Conference

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Lyra Therapeutics To Present At The Jefferies Virtual Healthcare Conference

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Lyra Therapeutics, Inc. (LYRA) CEO Maria Palasis on Q1 2021 Results - Earnings Call Transcript

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Lyra Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update

WATERTOWN, Mass.--(BUSINESS WIRE)--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 reported financial results for the quarter ended March 31, 2021 and provided a corporate update. Key First Quarter 2021 and Subsequent Highlights Presented positive full data set from LANTERN Phase 2 Study of LYR-210 at COSM 2021 Virtual Event. In April, the company presented the positive full data set from its LANTERN Phase 2 study of LYR-210 for the treatment of chronic rhinosinusitis (CRS) at the COSM 2021 Virtual Event. The new data demonstrated that LYR-210 is effective in both non-polyp and polyp patients in a clinical trial with 100% of patients in both groups achieving SNOT-22 MCID at week 24 at 7500 µg. Further, LYR-210 decreased ethmoid opacification at week 24 as well as reduced patient need for rescue medication. Previously, Lyra announced positive topline from the data in December 2020. We expect that the results from Lyra’s LANTERN Phase 2 Study will be used to design a Phase 3 pivotal trial, subject to an End-of-Phase 2 meeting with the FDA in the second quarter 2021. Tech transfer to Contract Manufacturing Organization (CMO) on Track. The company commenced our first manufacturing lot at our CMO to support the IND supplement and the commencement of our phase 3 clinical trial for LYR-210 around the end of the year. Appointed Robert Kern, MD, as Chief Medical Officer. In February, the company appointed Dr. Robert Kern as Chief Medical Officer. Dr. Kern is a highly regarded clinician and researcher in the field of sinonasal disorders. With more than 30 years of experience in the ENT medical field and currently serving as the George A. Sisson Professor and Chair, Department of Otolaryngology – Head and Neck Surgery at Northwestern University Feinberg School of Medicine. Dr. Kern is expected to be a valuable asset to the company as clinical trials progress for LYR-210 and LYR-220. “We were thrilled to present the full data set from our LANTERN Phase 2 Study of LYR-210 at the virtual COSM event, and to share data that we believe demonstrates how effective our product candidate is at treating chronic rhinosinusitis. Dr. Cervin did a wonderful job detailing the symptom improvements observed in both polyp and non-polyp patients, as well as revealing evidence of disease modification through patient’s improved bilateral ethmoid Zinreich scores,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. “Additionally, we announced a separate analysis of the LANTERN study that showed statistically significant improvement in a composite of three cardinal symptoms, which includes nasal blockage, nasal discharge and facial pain, that we believe could inform our design for a pivotal Phase 3 study.” Dr. Palasis continued: “Turning to the near term, we intend to share results from our PK study of LYR-210 in the second quarter, and to share feedback from our End-of Phase-2 meeting with the FDA around mid-year. Subject to guidance from the FDA, we then plan to initiate a Phase 2 trial for LYR-220 in the second half of 2021, and a Phase 3 trial of LYR-210 around the end of the year.” Financial Highlights Cash and cash equivalents as of March 31, 2021 were $66.1 million, compared with $74.6 million at December 31, 2020. Research and development expenses for the quarter ended March 31, 2021 were $4.8 million compared to $3.0 million for the same period in 2020. General and administrative expenses for the first quarter 2021 were $3.1 million compared to $1.3 million for the same period in 2020. Total operating expenses for the quarter ended March 31, 2021 were $7.8 million compared to $4.2 million for the same period in 2020. Net loss for the first quarter was $7.8 million compared to $4.2 million for the same period in 2020. In terms of financial guidance for 2021, management believes Lyra has sufficient cash to fund the company through planned operations into 2023. Conference Call Individuals interested in listening to the conference call may do so by dialing (833) 519-1249 for domestic callers, or (914) 800-3822 for international callers, and using the conference ID: 3067707; or from the webcast link in the investor relations section of the company’s 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 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 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 development of LYR-210 and LYR-220, including the anticipated timeline for sharing results of the company’s studies and meetings with the FDA, and initiating future clinical trials. 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. 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, 2021 2020 Operating expenses: Research and development $ 4,770 $ 2,964 General and administrative 3,061 1,284 Total operating expenses 7,831 4,248 Loss from operations (7,831 ) (4,248 ) Other income: Interest income 29 16 Total other income 29 16 Net loss $ (7,802 ) $ (4,232 ) Comprehensive loss $ (7,802 ) $ (4,232 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.60 ) $ (18.70 ) Weighted-average common shares outstanding—basic and diluted 12,945,546 230,860 LYRA THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share data) March 31, December 31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 66,105 $ 74,593 Prepaid expenses and other current assets 1,246 1,324 Total current assets 67,351 75,917 Property and equipment, net 3,168 2,165 Operating lease right-of-use assets 2,069 2,301 Restricted cash 329 329 Other assets — 118 Total assets $ 72,917 $ 80,830 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 1,169 $ 922 Accrued expenses and other current liabilities 1,994 2,977 Operating lease liabilities 1,007 985 Total current liabilities 4,170 4,884 Operating lease liabilities, net of current portion 1,196 1,454 Total liabilities 5,366 6,338 Commitments and contingencies (Note 9) Stockholders’ equity: Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; 12,962,768 and 12,932,377 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively 13 13 Additional paid-in capital 225,224 224,363 Accumulated deficit (157,686 ) (149,884 ) Total stockholders’ equity 67,551 74,492 Total liabilities and stockholders’ equity $ 72,917 $ 80,830

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Lyra Therapeutics to Present at the BofA Securities 2021 Virtual Health Care Conference

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Lyra Therapeutics to Report First Quarter 2021 Financial Results and Provide Corporate Update

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Lyra Therapeutics Presents Positive Full Data Set from LANTERN Phase 2 Study of LYR-210 at COSM 2021 Virtual

WATERTOWN, Mass.--(BUSINESS WIRE)--Lyra Therapeutics Presents Positive Full Data Set from LANTERN Phase 2 Study of LYR-210 at COSM 2021 Virtual

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Lyra Therapeutics to Present LANTERN Phase 2 Study Results for LYR‑210 in Oral Presentation at COSM 2021 Virtual

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Lyra Therapeutics, Inc. (LYRA) CEO Maria Palasis on Q4 2020 Results - Earnings Call Transcript

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Lyra Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results, Provides Corporate Update

WATERTOWN, Mass.--(BUSINESS WIRE)--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 reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update. Key Fourth Quarter 2020 and Subsequent Highlights Company Announced Positive Topline Results for 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, including: LYR-210 is the first nasal implant to achieve a benefit of up to six months after a single administration in a clinical testing, and the first nasal implant to achieve a benefit in both polyp and non-polyp patients in clinical testing. 7500 mcg dose achieved statistically significant improvement in both 4 Cardinal Symptoms and SNOT-22 scores at 24 weeks and at several earlier timepoints, compared to control. Lyra believes the results support a clear path to regulatory submission for LYR-210 and plans to move forward into a pivotal Phase 3 trial using the 7500 mcg dose, subject to an end of Phase 2 meeting with the FDA. LYR-210 is the first nasal implant to achieve a benefit of up to six months after a single administration in a clinical testing, and the first nasal implant to achieve a benefit in both polyp and non-polyp patients in clinical testing. 7500 mcg dose achieved statistically significant improvement in both 4 Cardinal Symptoms and SNOT-22 scores at 24 weeks and at several earlier timepoints, compared to control. Lyra believes the results support a clear path to regulatory submission for LYR-210 and plans to move forward into a pivotal Phase 3 trial using the 7500 mcg dose, subject to an end of Phase 2 meeting with the FDA. “The positive results from the LANTERN Phase 2 study point to LYR-210’s potential as an easily administered, six-month treatment for CRS patients who have failed medical management,” said Professor Anders Cervin, Garnett Passe and Rodney Williams Foundation Chair in Otolaryngology at the University of Queensland, and a Principal Investigator for Lyra’s LANTERN trial. “An intranasal implant, like LYR-210, ensures treatment compliance on the part of patients and efficiently delivers drug directly to inflamed tissue. Based on these results, I believe LYR-210 could represent a viable alternative to invasive nasal surgery for CRS patients, with as few as two ENT office visits a year.” Appointed Robert Kern, MD, Chief Medical Officer. In February, Lyra announced that Robert Kern, MD had been named the company’s Chief Medical Officer. In addition to his role at Lyra, Dr. Kern will 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 renowned physician in the ENT field and a world-leading expert in chronic rhinosinusitis with a proven track record of global leadership in otolaryngology, in both academic research and clinical rhinology. Added Nancy L. Snyderman, M.D. to Board of Directors. In October, the company announced that Dr. Snyderman had joined Lyra Therapeutics board. Dr. Snyderman is an accomplished otolaryngologist-head and neck surgeon and healthcare systems expert. She most recently served as Chief Medical Editor at NBC News and has more than three decades of experience as a leading voice in healthcare and medicine. Dr. Snyderman currently serves as a board member of Alkermes (NASDAQ: ALKS) and Axonics Modulation Technologies, Inc. (NASDAQ: AXNX). “We were pleased to end our first calendar year as a public company by announcing positive topline data from our LANTERN Phase 2 Study for LYR-210. In addition, we recently strengthened our team with the additions of Dr. Kern to our management team and Dr. Snyderman to our board,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. “Looking ahead, 2021 should be another pivotal year for Lyra as we read out the data from our PK study and plan to conduct an end of Phase 2 meeting with the FDA for LYR-210, followed by the potential initiation of a Phase 2 study for LYR-220 in the second half, and a Phase 3 pivotal trial of LYR-210 at the end of the year. I look forward to updating you on our progress.” Financial Highlights Cash and cash equivalents as of December 31, 2020 were $74.6 million, compared with $81.6 million as of September 30, 2020. Research and development expenses for the quarter and full year ended December 31, 2020 were $3.7 million and $12.5 million, respectively, compared to $3.0 million and $12.0 million for the same periods in 2019, respectively. General and administrative expenses for the fourth quarter and full year ended December 31, 2020 were $3.3 million and $9.7 million, respectively, compared to $1.4 million and $4.5 million for the same periods in 2019, respectively. Total operating expenses for the quarter ended and full year ended December 31, 2020 were $7.1 million and $22.2 million, respectively, compared to $4.4 million and $16.5 million for the same periods in 2019, respectively. Net loss for the fourth quarter and full year 2020 was $7.0 million and $22.1 million, respectively, compared to $4.4 million and $16.3 million for the same periods in 2019, respectively. In terms of financial guidance for 2021, we believe that Lyra has sufficient cash to fund the company through planned operations into 2023. Conference Call Individuals interested in listening to the conference call may do so by dialing (833) 519-1249 for domestic callers, or (914) 800-3822 for international callers, and using the conference ID: 6979948; or from the webcast link in the investor relations section of the company’s website at: www.lyratherapeutics.com. The recorded webcast will be available for replay for approximately 30 days following the call. Annual Meeting Date The Board of Directors of Lyra Therapeutics, Inc. has established May 26, 2021 as the date of its Annual Meeting of Stockholders (the “2021 Annual Meeting”). The 2021 Annual Meeting will be held virtually by means of remote communication. The details of the virtual annual meeting, including how stockholders can log into the virtual meeting, vote and submit questions, will be disclosed in the Company’s definitive proxy statement for the 2021 Annual Meeting to be filed with the Securities and Exchange Commission. Any stockholder seeking to bring business before the 2021 Annual Meeting or to nominate a director must provide timely notice, as set forth in the Company’s Amended and Restated Bylaws (the “Bylaws”). Specifically, written notice of any proposed business or nomination must be received at the Company’s principal executive offices no later than the close of business on March 19, 2021 (which is the tenth day following this public announcement of the date of the 2021 Annual Meeting). Any notice of proposed business or nomination must comply with the specific requirements set forth in the Company’s Bylaws. 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 (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. 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 and its financial guidance for 2021. 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-K filed with the SEC on March 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. LYRA THERAPEUTICS, INC. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) Year Ended December 31, 2020 2019 Operating expenses: Research and development $ 12,522 $ 12,032 General and administrative 9,687 4,487 Total operating expenses 22,209 16,519 Loss from operations (22,209 ) (16,519 ) Other income: Interest income 82 213 Total other income 82 213 Net loss $ (22,127 ) $ (16,306 ) Comprehensive loss $ (22,127 ) $ (16,306 ) Net loss per share attributable to common stockholders—basic and diluted $ (2.59 ) $ (82.23 ) Weighted-average common shares outstanding—basic and diluted 8,590,205 202,093 LYRA THERAPEUTICS, INC. Consolidated Balance Sheets (in thousands, except share and per share data) December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 74,593 $ 9,808 Prepaid expenses and other current assets 1,324 311 Total current assets 75,917 10,119 Property and equipment, net 2,165 237 Operating lease right-of-use assets 2,301 3,182 Restricted cash 329 329 Other assets 118 1,096 Total assets $ 80,830 $ 14,963 Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable $ 922 $ 1,069 Accrued expenses and other current liabilities 2,977 3,240 Operating lease liabilities 985 899 Total current liabilities 4,884 5,208 Operating lease liabilities, net of current portion 1,454 2,427 Total liabilities 6,338 7,635 Commitments and contingencies (Note 11) Series A-1 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 34,017,033 shares authorized, issued and outstanding at December 31, 2019 — 39,742 Series A-2 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 26,680,202 shares authorized, issued and outstanding at December 31, 2019 — 18,393 Series A-3 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 30,070,487 shares authorized, issued and outstanding at December 31, 2019 — 38,114 Series A-4 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 19,999,999 shares authorized, issued and outstanding at December 31, 2019 — 6,000 Series B redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 100,018,619 shares authorized and 98,351,953 shares issued and outstanding at December 31, 2019 — 28,417 Series C redeemable convertible preferred stock, $0.001 par value; no shares authorized, issued or outstanding at December 31, 2020 and 2019 — — Total redeemable convertible preferred stock — 130,666 Stockholders’ equity (deficit): Common stock, $0.001 par value; 200,000,000 and 275,000,000 shares authorized at December 31, 2020 and 2019, respectively; 12,932,377 and 230,860 shares issued and outstanding at December 31, 2020 and 2019, respectively 13 — Additional paid-in capital 224,363 4,419 Accumulated deficit (149,884 ) (127,757 ) Total stockholders’ equity (deficit) 74,492 (123,338 ) Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $ 80,830 $ 14,963

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Lyra Therapeutics to Report Fourth Quarter and Full Year 2020 Financial Results and Provide Corporate Update

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Why Earnings Season Could Be Great for Lyra Therapeutics (LYRA)

Lyra Therapeutics (LYRA) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

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Lyra Therapeutics Announces Appointment of Robert Kern, MD, as Chief Medical Officer

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Lyra Therapeutics Provides Corporate Update and Anticipated Milestones for 2021

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INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Lyra Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES--(BUSINESS WIRE)--The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Lyra Therapeutics, Inc. (“Lyra” or “the Company”) (NASDAQ: LYRA) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at brian@schallfirm.com. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

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INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Lyra Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

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Lyra Therapeutics Announces Positive Topline Results for LANTERN Phase 2 Randomized Controlled Study of LYR-210 for the Treatment of Chronic Rhinosinusitis With and Without Nasal Polyps

WATERTOWN, Mass.--(BUSINESS WIRE)--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 positive topline results from the LANTERN Phase 2 study of LYR-210 for chronic rhinosinusitis (CRS). The LANTERN study was a randomized, patient blinded, controlled clinical trial designed to evaluate the efficacy and safety of LYR-210 in adult patients with CRS, including patients with and without nasal polyps, who had not previously undergone sinus surgery. CRS is diagnosed when 2 or more of the 4 cardinal symptoms (4CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure, and reduction or loss of sense of smell) persist for 12 weeks or longer and when inflammation is confirmed via endoscopy or a CT scan. The multi-center study enrolled 67 patients at sites in Europe, New Zealand and Australia. Patients in the study were randomized 1:1:1 into three groups: 7500 mcg (21 patients) or 2500 mcg (23 patients) of continuous mometasone furoate therapy, or control (23 patients). LYR-210 is an investigational product candidate designed to be administered in-office, into the sinonasal passages, and to deliver a sustained release therapeutic up to six months at difficult-to-access nasal inflammation sites without the need for patient compliance, as a non-invasive alternative to surgery for patients who have failed medical management. Topline Results Although not statistically significant at week 4, at the 7500 mcg dose, LYR-210 achieved statistically significant improvement in a composite score of the 4CS of CRS in favor of the treatment arm at weeks 16 (-1.47) (p=0.021), 20 (-1.61) (p=0.012) and 24 (-1.64) (p=0.016). Furthermore, the 7500 mcg dose of LYR-210 achieved statistically significant improvement in SNOT-22 score in favor of the treatment arm at weeks 8 (-12.2) (p=0.039), 16 (-15.0) (p=0.008), 20 (-18.4) (p=0.001), and 24 (-19.0) (p=0.001). LYR-210 was observed to be safe and well-tolerated at all doses in the study, and no treatment-related serious adverse events were reported. Adverse events were generally mild to moderate in nature and in line with the known safety profile of mometasone furoate. “We are delighted to share this positive data from our LANTERN trial, which represents a major milestone for Lyra, and which shows the potential for LYR-210 to improve a composite of cardinal symptoms of CRS for up to 24 weeks. We believe this trial represents the first time a nasal implant has achieved six months of benefit for CRS patients via a single administration in clinical testing. These data are yet more remarkable given it was achieved during the COVID-19 pandemic, which caused us to curtail enrollment sooner than originally planned,” said Maria Palasis, PhD, CEO of Lyra Therapeutics. “Furthermore, the 4CS efficacy data is backed up by impressive SNOT-22 scores, supporting the potential pronounced treatment effect of LYR-210.” Maria Palasis continued: “Importantly, this is the first time that a drug-releasing nasal implant has been observed to improve symptoms in both non-polyp and polyp patients, and also marks the first time such an implant has exhibited a dose response, which we believe validates our underlying XTreo™ platform. We believe these results confirm our pathway to regulatory submission, and we will move forward quickly to initiate a Phase 3 study in CRS, subject to a planned end-of-Phase 2 meeting with the FDA. In addition, we are continuing our development efforts for LYR-220, for CRS patients who have already undergone sinus surgery. I would like to thank everyone involved in the LANTERN study and look forward to updating you on our next steps as we seek to change the treatment paradigm for long-underserved CRS patients.” Other takeaways from the LANTERN study include: While a strong treatment effect was observed at week 4, the LANTERN study’s primary endpoint of change from baseline in a composite of 4CS scores at week 4 was not met at either dose (7500 mcg: (-0.36) (p=0.306); 2500 mcg: (0.04) (p=0.525)), we believe primarily due to curtailed enrollment resulting from COVID-19. Given the comparable safety profile of LYR-210 at both 2500 mcg and 7500 mcg doses, Lyra anticipates progressing the LYR-210 program at the 7500 mcg dose level. Full results from the LANTERN study will be submitted for future presentation at an upcoming scientific meeting. Based on these results Lyra plans to initiate a pivotal Phase 3 study for LYR-210 in chronic rhinosinusitis for both non-polyp and polyp patients. “The LANTERN study results are very exciting to those of us in the ENT community who are eager to embrace new treatment options for CRS, including alternatives to surgery. Based on my experience in Lyra’s Phase 1 and Phase 2 studies for LYR-210, I believe a drug-releasing nasal implant that may offer up to six months treatment would represent an important innovation for CRS patients,” said A/Prof Joanne Rimmer, an ENT surgeon and rhinologist at Monash Health, Associate Professor at Monash University in Melbourne, Australia, and an investigator in the LANTERN study. “The in-office procedure of placing LYR-210 into a patient’s nose is straightforward, suggesting that LYR-210 may have the potential to improve quality of life for patients who have failed medical management while offering an alternative to invasive surgical procedures.” “CRS is a chronic, lifelong condition, and there continues to be a need for innovation for the millions of people suffering from this inflammatory disease. As such, the LANTERN results are very encouraging, particularly as there are currently no FDA-approved therapeutic treatments for CRS patients without nasal polyps, despite that patient population representing approximately 70-90% of all CRS patients,” said Robert Kern, MD, Chair of Otolaryngology, Head and Neck Surgery, at Northwestern Medical Center and Professor of Otolaryngology at the Feinberg School of Medicine at Northwestern. “I believe this innovative long-acting investigational treatment has the potential to make a meaningfully positive impact on patients’ quality of life and offer an appealing alternative to invasive medical procedures.” Conference Call The company plans to host a conference call to discuss the results today at 8:30 am ET. Individuals interested in listening to the conference call may do so by dialing (833) 519 1249 for domestic callers, or (914) 800 3822 for international callers and reference conference ID: 5134448; or from the webcast link in the investor relations section of the company’s website at: www.lyratherapeutics.com. The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Lyra requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone. LANTERN Phase 2 Trial Design The Phase 2 LANTERN study was conducted in 67 adult patients with CRS, including patients with and without nasal polyps who had not undergone sinus surgery. Patients in the study were randomized 1:1:1 into three groups to receive in-office bilateral nasal administration of either one of two long-acting dose levels of LYR-210, 7500 mcg (21 patients) or 2500 mcg (23 patients) of continuous anti-inflammatory drug therapy, mometasone furoate, or control (23 patients). The multi-center study was conducted at sites in Europe, New Zealand and Australia. The trial was originally designed to enroll 99 evaluable patients with the potential to increase to up to 150 patients and was initiated in May 2019. However, in light of developments relating to the COVID-19 global pandemic we discontinued enrollment at 67 patients in our Phase 2 LANTERN clinical trial. As a result of the decrease in the number of patients enrolled from planned (99) to actually enrolled (67) patients in our Phase 2 LANTERN clinical trial, a greater magnitude of change in composite score of the seven-day average of four cardinal symptoms from baseline at week 4 and/or a smaller standard deviation associated with the change from baseline at week 4 was required in order for the trial to achieve statistical significance for the primary endpoint. 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 @LyraTx. 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 lead product candidate LYR-210, the presentation of top-line results relating to the Company’s Phase 2 LANTERN clinical trial for LYR-210 and the Company’s plans to initiate a pivotal Phase 3 study for LYR-210 in CRS for both non-polyp and polyp patients. 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.

businesswire.com

Lyra Therapeutics to Participate in Fireside Chat at the Jefferies Virtual London Healthcare Conference

businesswire.com

Lyra Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update

WATERTOWN, Mass.--(BUSINESS WIRE)--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 reported financial results for the quarter ended September 30, 2020 and provided a corporate update. Key Third Quarter 2020 and Subsequent Highlights Company On Track to Report Topline Phase 2 Results for LYR-210 in the Treatment of Chronic Rhinosinusitis. Despite the challenges that COVID-19 has posed for the biotechnology community more generally, Lyra Therapeutics is pleased to report that it remains on track to announce topline Phase 2 results from its LANTERN study of LYR-210 in chronic rhinosinusitis (CRS) in December. Appointed Nancy L. Snyderman to Board of Directors. In October, the company announced that Dr. Snyderman joined the Lyra Therapeutics board. Dr. Snyderman is an accomplished Otolaryngologist-Head and Neck Surgeon and healthcare systems expert. She most recently served as Chief Medical Editor at NBC News and has more than three decades of experience as a leading voice in healthcare and medicine. Dr. Snyderman currently serves as a board member of Alkermes (NASDAQ: ALKS) and Axonics Modulation Technologies, Inc. (NASDAQ: AXNX). Presented Clinical Data at the 66th Annual Meeting of the American Rhinologic Society (ARS) Demonstrating LYR-210’s Local Anti-Inflammatory Effects for the Treatment of Chronic Rhinosinusitis. In September, Lyra presented data showing that LYR-210 demonstrated a significant reduction of sinonasal Type 2 inflammation in surgically naïve patients with chronic rhinosinusitis (CRS). The reduction of Type 2 inflammation suggested a correlation with rhinologic symptom improvement in CRS and could be a potential measure of LYR-210’s local anti-inflammatory effects at the site of inflammation in the sinonasal passages. The results showing LYR-210’s influence on local Type 2 inflammatory response in CRS patients were secondary findings from the company’s Phase 1 clinical study of LYR-210. “Having completed our IPO in the second quarter, we were fully focused in the third quarter on executing our development plans for LYR-210 and LYR-220. I’m pleased to report that we are on track to deliver topline Phase 2 results from our LANTERN study in December, which we believe will be an important milestone for the company and shareholders alike,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. “We have also continued to build awareness about LYR-210 throughout the scientific and medical communities, with ongoing outreach and three presentations at the ARS Annual Meeting. In addition, I am delighted to welcome Dr. Nancy Snyderman to our board. Nancy has a deep understanding of the value of medical innovation as well as the barriers that must be overcome in order to bring new therapies to ENT physicians and patients and will bring a valuable perspective to Lyra.” Financial Highlights Cash, cash equivalents as of September 30, 2020 were $81.6 million, compared with $86.6 million as of June 30, 2020. Research and development expenses for the quarter ended September 30, 2020 were $3.7 million compared to $2.8 million for the same period in 2019. General and administrative expenses for the third quarter 2020 were $2.7 million compared to $1.4 million for the same period in 2019. Total operating expenses for the quarter ended September 30, 2020 were $6.4 million compared to $4.2 million for the same period in 2019. Net loss for the third quarter was $6.3 million compared to $4.2 million for the same period in 2019. In terms of financial guidance, Lyra believes its current cash position is sufficient to fund the company through a planned Phase 3 study of LYR-210 in chronic rhinosinusitis. Additionally, the company projects its year-end 2020 cash balance will be in the range of $67-70 million. 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 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 lead product candidate LYR-210 and its cash balance for fiscal year ended December 31, 2020. 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. LYRA THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Operating expenses: Research and development $ 3,712 $ 2,841 $ 8,779 $ 9,021 General and administrative 2,651 1,385 6,377 3,110 Total operating expenses 6,363 4,226 15,156 12,131 Loss from operations (6,363 ) (4,226 ) (15,156 ) (12,131 ) Other income: Interest income 29 63 50 178 Total other income 29 63 50 178 Net loss $ (6,334 ) $ (4,163 ) $ (15,106 ) $ (11,953 ) Comprehensive loss $ (6,334 ) $ (4,163 ) $ (15,106 ) $ (11,953 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.49 ) $ (19.20 ) $ (2.13 ) $ (63.33 ) Weighted-average common shares outstanding—basic and diluted 12,924,682 220,902 7,133,967 192,433 LYRA THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share data) September 30, December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 81,555 $ 9,808 Prepaid expenses and other current assets 2,000 311 Total current assets 83,555 10,119 Property and equipment, net 917 237 Operating lease right-of-use assets 2,529 3,182 Restricted cash 329 329 Deferred offering costs — 1,096 Total assets $ 87,330 $ 14,963 Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable $ 530 $ 1,069 Accrued expenses and other current liabilities 3,214 3,240 Operating lease liabilities 964 899 Total current liabilities 4,708 5,208 Operating lease liabilities, net of current portion 1,708 2,427 Total liabilities 6,416 7,635 Commitments and contingencies (Note 11) Series A-1 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at September 30, 2020; 34,017,033 shares authorized, issued and outstanding at December 31, 2019 — 39,742 Series A-2 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at September 30, 2020; 26,680,202 shares authorized, issued and outstanding at December 31, 2019 — 18,393 Series A-3 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at September 30, 2020; 30,070,487 shares authorized, issued and outstanding at December 31, 2019 — 38,114 Series A-4 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at September 30, 2020; 19,999,999 shares authorized, issued and outstanding at December 31, 2019 — 6,000 Series B redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at September 30, 2020; 100,018,619 shares authorized and 98,351,953 shares issued and outstanding at December 31, 2019 — 28,417 Series C redeemable convertible preferred stock, $0.001 par value; no shares authorized, issued or outstanding at September 30, 2020 and December 31, 2019 — — Total redeemable convertible preferred stock — 130,666 Stockholders’ equity (deficit): Common stock, $0.001 par value; 200,000,000 and 275,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 12,924,817 and 230,860 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 13 — Additional paid-in capital 223,764 4,419 Accumulated deficit (142,863 ) (127,757 ) Total stockholders’ equity (deficit) 80,914 (123,338 ) Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $ 87,330 $ 14,963

businesswire.com

Lyra Therapeutics Appoints Nancy L. Snyderman To Its Board of Directors

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Lyra Therapeutics (NASDAQ:LYRA) and Antares Pharma (NASDAQ:ATRS) are both small-cap medical companies, but which is the superior business? We will contrast the two businesses based on the strength of their valuation, profitability, dividends, analyst recommendations, earnings, institutional ownership and risk. Analyst Recommendations This is a summary of current ratings and price targets for Lyra Therapeutics […]

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INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Lyra Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm