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 ...

Product Development and Clinical Trials - LYR-210 and LYR-220 are designed to provide six months of continuous anti-inflammatory drug therapy for chronic rhinosinusitis (CRS) patients with a single administration[1]. - LYR-210 is currently undergoing a pivotal Phase 3 clinical trial called the ENLIGHTEN program, while LYR-220 has recently completed a Phase 2 clinical trial called BEACON[22][23]. - The Phase 3 ENLIGHTEN I trial, initiated in February 2022, involves approximately 180 adult CRS patients with a 2:1 randomization to receive LYR-210 (7,500 µg) or sham procedure[39]. - Enrollment for the ENLIGHTEN I trial was completed in September 2023, marking a significant milestone in the clinical development of LYR-210[39]. - The Phase 3 ENLIGHTEN II trial, initiated in September 2022, is ongoing and also targets approximately 180 adult CRS patients[40]. - The primary endpoint for both ENLIGHTEN I and ENLIGHTEN II trials is the change from baseline in the composite score of 3 cardinal symptoms at week 24[41]. - The Phase 2 trial reported that approximately 50% of patients experienced a durable response post-removal of LYR-210, with no worsening of 4CS scores from the Week 24 baseline[51]. - The Phase 2 LANTERN trial, LYR-210 at the 7,500 µg dose showed statistically significant improvement in 4CSS at week 16 (-1.47, p=0.021), week 20 (-1.61, p=0.012), and week 24 (-1.64, p=0.016)[47]. - In the Phase 2 trial, LYR-210 demonstrated a clinically relevant improvement in SNOT-22 scores within 2 weeks of treatment[38]. - In the Phase 2 BEACON trial for LYR-220, statistically significant improvement in the composite of the 3 cardinal symptoms of CRS was observed at week 24 (-1.50; p=0.02) and as early as week 4 (-0.87; p=0.037)[64]. - LYR-220 demonstrated a statistically significant improvement in SNOT-22 score at week 24 (-16.8; p=0.007) and sustained improvements throughout the study[65]. Market Potential and Patient Demographics - Approximately 14 million people in the United States are affected by CRS, with an estimated 4 million failing medical management annually[26]. - The estimated prevalence of sinusitis, including CRS, is approximately 30 million people in the U.S., making it the fifth most common condition in adults under 65[26]. - The company estimates that 40% of CRS patients have had prior surgery, representing a significant addressable market for LYR-220[59]. - LYR-210 is designed for patients who have not undergone ethmoid sinus surgery, while LYR-220 targets those who have had such surgery and still require treatment[22][23]. Technology and Drug Delivery - The technology behind LYR-210 and LYR-220 allows for localized delivery of mometasone furoate (MF), minimizing systemic side effects associated with oral steroids[29]. - The proprietary drug delivery technology allows for sustained delivery of medications for six months from a single administration, targeting deep tissues in the ENT passages[70]. - LYR-210 is designed to be administered in a simple, in-office procedure, enhancing convenience for both patients and physicians[32]. - LYR-210 achieved a significant improvement in SNOT-22 scores, with an average change from baseline of -20.5 points at week 24 (p < 0.0001) and -20.0 points at week 25 (p < 0.0001) in the Phase 1 trial[37]. Financial Overview and Funding - The company incurred operating losses of approximately $62.7 million and $55.3 million for the fiscal years ended December 31, 2023, and December 31, 2022, respectively[149]. - The company has not commercialized any products and has never generated revenue from product sales[149]. - The company expects to continue incurring significant additional operating losses for the foreseeable future as it advances product candidates through pre-clinical and clinical development[150]. - The company has a limited operating history and a history of escalating operating losses, making it difficult to evaluate future viability[146]. - The company is dependent on securing additional financing to avoid delays or reductions in research and development programs[154]. - Future funding requirements will depend on various factors, including clinical trial results and regulatory approval timelines[157]. Regulatory Environment - The company must submit a New Drug Application (NDA) to the FDA demonstrating that product candidates are safe and effective for their intended use[150]. - The FDA has a goal of 10 months to review and act on a standard NDA and 6 months for a priority NDA, which significantly impacts the timeline for product approval[104]. - The FDA may require a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of a drug outweigh its risks[106]. - The FDA strictly regulates marketing and promotion of approved drugs, allowing promotion only for approved indications[129]. - The regulatory approval process is lengthy and costly, typically taking many years and requiring substantial resources for research and testing[214]. - The company is subject to extensive regulation by the FDA, requiring substantial time and financial resources for compliance throughout the product development process[96]. Manufacturing and Supply Chain - The company is currently improving manufacturing capabilities and increasing capacity to support larger scale clinical studies and commercialization, with a new lease executed in May 2022 for manufacturing and office space in Waltham, Massachusetts[90]. - The company has transitioned most of its clinical manufacturing from a contract manufacturing organization (CMO) to an in-house facility to produce LYR-210 and LYR-220, with plans to scale up manufacturing capabilities in a new facility in Waltham, Massachusetts[188]. - The company relies on single source suppliers for some components, which may impact the ability to supply products and develop candidates if not managed effectively[89]. - The company plans to enter into manufacturing, supply, and quality agreements with single source suppliers to ensure compliance with regulatory requirements[89]. Competitive Landscape - Key competitive factors for LYR-210 and LYR-220 include efficacy, safety, tolerability, reliability, convenience of administration, price, and reimbursement[87]. - The company faces significant competition in securing collaborations for the development and commercialization of its drug candidates, which may impact its market potential[176]. - The company may not successfully identify and commercialize additional product candidates, which could adversely affect its business strategy and financial position[177]. - The company has not conducted head-to-head trials comparing LYR-210 to other treatments, which could impact its market adoption if results are unfavorable[195]. Challenges and Risks - The company may face challenges in obtaining marketing approvals in international jurisdictions, which could limit its ability to market products globally[174]. - The company has faced challenges in patient enrollment for clinical trials, which could adversely affect the completion of these trials and subsequent regulatory approvals[219]. - The COVID-19 pandemic has caused delays in clinical trials and regulatory inspections, which may continue to affect the approval process[218]. - The company may incur additional operating expenses due to delays in pre-clinical studies or clinical trials, which can arise from various factors including regulatory disagreements and recruitment challenges[181]. - The company has experienced setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, which could delay or prevent regulatory approval[194].

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 -- 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 th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ 480 Arsenal Way Watertown, MA 02472 (I.R.S. Employer Identification No.) (Address of principal executive offices) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) Delaware 84-1700838 (State or other jurisdiction of incorporation or organization) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39273 Lyra Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Dela ...

Product Development and Clinical Trials - LYR-210 is designed to provide up to six months of continuous anti-inflammatory drug therapy for chronic rhinosinusitis (CRS) patients with a single administration[20]. - LYR-220 is being developed for CRS patients who require ongoing treatment despite having undergone sinus surgery, with a Phase 2 clinical trial currently ongoing[22]. - The ENLIGHTEN program for LYR-210 consists of two pivotal trials and is currently ongoing, aiming for FDA approval through a 505(b)(2) New Drug Application[21]. - Phase 3 ENLIGHTEN I trial initiated in February 2022, targeting approximately 180 adult CRS patients who failed prior medical management[39]. - Phase 3 ENLIGHTEN II trial initiated in September 2022, also targeting approximately 180 adult CRS patients[42]. - Enrollment for ENLIGHTEN II paused to align with internal manufacturing timelines, expected to resume in Q2 2023[44]. - The Phase 2 BEACON trial for LYR-220 has completed enrollment in Part 2, which includes approximately 40 symptomatic adult CRS subjects who have had prior bilateral sinus surgery[64]. - The Phase 2 LANTERN trial showed statistically significant improvement in SNOT-22 score at week 24 with a change of -19.0 (p=0.001) for the 7,500 µg dose[49]. - Enrollment for Phase 2 LANTERN trial was discontinued at 67 patients due to COVID-19, below the planned 99 evaluable patients[45]. - The Phase 2 LANTERN clinical trial for LYR-210 enrolled 67 patients, falling short of the planned 99 evaluable patients, which impacted the trial's primary endpoint[166]. - The company has initiated a separate characterization study for LYR-210 to collect additional pharmacokinetic data due to enrollment challenges in the U.S.[167]. - The company has faced challenges in patient enrollment for clinical trials, which could delay regulatory approvals and increase costs[212]. Safety and Efficacy - LYR-210 Phase 1 trial achieved primary safety endpoint with 2,500 µg well tolerated over 24 weeks[37]. - Significant improvement in SNOT-22 scores observed, with an average change from baseline of -20.5 points at week 24 (p < 0.0001)[37]. - LYR-210 was safe and well tolerated, with no treatment-related serious adverse events reported[51]. - The most common reported adverse events in the Phase 1 trial included nasopharyngitis and upper respiratory tract infections, with one serious event deemed unrelated to LYR-210[57]. - In the Phase 2 LANTERN clinical trial, treatment-related adverse events were reported in 16 patients, with most being mild or moderate[218]. - LYR-210 demonstrated a durable response in approximately 50% of patients post-treatment, with no worsening of 4CS scores from the Week 24 baseline[52]. - At the 7,500 µg dose, LYR-210 achieved statistically significant improvement in 4CSS at week 16 (-1.47) (p=0.021), week 20 (-1.61) (p=0.012), and week 24 (-1.64) (p=0.016)[49]. Market Potential and Commercialization - Approximately 14 million people in the United States are affected by CRS, with an estimated 8 million treated annually by physicians, and about 4 million failing medical management each year[25]. - The company aims to build a commercialization infrastructure in the U.S. market for LYR-210 and LYR-220 upon FDA approval[28]. - LYR-220 is positioned to treat CRS patients post-surgery, addressing a market where no FDA-approved products currently exist for non-polyp patients[62]. - Approximately 40% of CRS patients present to ENT physicians have had prior surgery, representing a significant addressable market for LYR-220[61]. - LYR-210 is designed to be a preferred alternative to surgery, potentially reducing healthcare costs associated with surgical interventions[30]. - The company plans to build a targeted in-house sales force to engage ENT physicians who perform 80% of the CRS procedural volume[75]. Regulatory Environment - The FDA has a goal of 10 months to review and act on a standard New Drug Application (NDA) and 6 months for a priority NDA[101]. - The company must navigate extensive regulations for research, development, testing, and marketing of pharmaceutical products[91]. - The FDA may require submission of a risk evaluation and mitigation strategy (REMS) plan to ensure the benefits of the drug outweigh its risks[103]. - The FDA may accept foreign clinical trial data for NDA approval if conducted under IND or meets GCP requirements, potentially validating data through on-site inspections[107]. - The approval process for drug-device combinations like LYR-210 and LYR-220 may be more complex, potentially leading to delays[197]. - Regulatory approval pathways under Section 505(b)(2) may take longer and be more complicated than anticipated, impacting timelines[192]. - The company is subject to inspections by the FDA to ensure compliance with current Good Manufacturing Practice (cGMP) requirements before NDA approval[106]. Financial Performance and Funding - The company incurred operating losses of approximately $55.3 million and $43.5 million for the fiscal years ended December 31, 2022, and December 31, 2021, respectively[146]. - The company has not commercialized any products and has never generated any revenue from product sales[146]. - The company expects to continue incurring significant additional operating losses for the foreseeable future as it advances product candidates through pre-clinical and clinical development[147]. - The company will require substantial funds to further develop, manufacture, obtain approval for, and commercialize its product candidates, including LYR-210 and LYR-220[151]. - The company may need to raise additional capital through equity offerings or debt financings, which could dilute existing shareholders[154]. - The company believes its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditures into mid-2024[152]. - The company has devoted almost all of its financial resources to research and development, including pre-clinical development activities[146]. Intellectual Property - As of December 31, 2022, the company owns 24 issued U.S. patents and 16 foreign issued patents, with a focus on its technology LYR-210 and LYR-220[88]. - The first lineage of patents dates from 2009, providing potential protection until 2030, while the fourth lineage, filed in 2021, could provide protection until 2042[89]. - The LianBio License Agreement grants exclusive rights to develop and commercialize LYR-210 in Greater China and other territories[170]. - The company is subject to various obligations under its license agreements, which may divert management's attention from research and development[170]. Challenges and Risks - The company may face significant challenges in transitioning from a research and development focus to supporting commercial activities[144]. - The company may not successfully identify or commercialize additional product candidates, which could adversely affect its business strategy and financial position[175]. - Clinical trials are expensive and time-consuming, with high risks of failure that could impair the ability to commercialize product candidates[178]. - The unpredictability of clinical trial results poses a significant risk to the company's ability to obtain regulatory approval for its product candidates[208]. - The company may experience delays in clinical trials due to various factors, including regulatory disagreements and patient recruitment challenges[180]. - Serious adverse events during clinical trials could lead to interruptions or halts in development, affecting the company's prospects[217]. - The company has experienced delays in regulatory inspections due to the COVID-19 pandemic, which may impact its ability to submit regulatory applications[211].

INVESTOR PRESENTATION NOVEMBER 2022 DISCLAIMER This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the company's clinical advancement and efficacy of LYR-210 and LYR220 for the treatment of CRS and our expectations regarding the LYR-210 Phase 3 ENLIGHTEN prog ...

PART I. FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited financial statements for the period ended September 30, 2022, reflect significant asset growth from financing, continued net losses, and increased operating expenses for clinical development [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2022, the balance sheet reflects substantial increases in liquidity and stockholders' equity from April 2022 financing, alongside a widening accumulated deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $109,558 | $45,747 | | Total current assets | $112,230 | $47,918 | | Total assets | $119,463 | $54,867 | | **Liabilities & Equity** | | | | Total liabilities | $26,241 | $20,551 | | Accumulated deficit | $(234,440) | $(193,397) | | Total stockholders' equity | $93,222 | $34,316 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and nine months ended September 30, 2022, the company reported increased net losses driven by significantly higher operating expenses, particularly R&D costs for clinical trials Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $359 | $14 | $1,352 | $14 | | Research and development | $10,048 | $7,077 | $29,346 | $19,352 | | General and administrative | $5,137 | $4,018 | $13,157 | $10,639 | | Loss from operations | $(14,826) | $(11,081) | $(41,151) | $(29,977) | | Net loss | $(14,766) | $(11,055) | $(41,043) | $(29,896) | | Net loss per share | $(0.40) | $(0.85) | $(1.47) | $(2.30) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity significantly increased to **$93.2 million** by September 30, 2022, primarily due to **$96.3 million** net proceeds from Q2 2022 stock and warrant issuance, partially offset by net losses - In the second quarter of 2022, the company issued common stock and pre-funded warrants, resulting in net proceeds of **$96.25 million** after issuance costs[24](index=24&type=chunk) - The accumulated deficit increased from **$193.4 million** at December 31, 2021, to **$234.4 million** at September 30, 2022, reflecting ongoing net losses[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operating activities significantly increased, while net cash provided by financing activities from the April 2022 stock sale led to a substantial net increase in cash Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(31,221) | $(14,523) | | Net cash used in investing activities | $(136) | $(2,302) | | Net cash provided by financing activities | $96,257 | $363 | | **Net increase (decrease) in cash** | **$64,900** | **$(16,462)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's clinical-stage operations, liquidity position, and significant agreements, including the April 2022 financing and LianBio collaboration revenue recognition - The company is a clinical-stage therapeutics company focused on ENT diseases with an accumulated deficit of approximately **$234.4 million** at September 30, 2022[30](index=30&type=chunk)[32](index=32&type=chunk) - Management believes cash and cash equivalents of **$109.6 million** as of September 30, 2022, will be sufficient to fund operations for at least one year[32](index=32&type=chunk)[33](index=33&type=chunk) - In April 2022, the company raised gross proceeds of approximately **$100.5 million** (**$96.3 million** net) through a private placement of common stock and pre-funded warrants[56](index=56&type=chunk) - The LianBio License Agreement included a **$12.0 million** upfront payment and a **$5.0 million** development milestone payment received in February 2022, with revenue recognized as performance obligations are satisfied[83](index=83&type=chunk)[87](index=87&type=chunk)[90](index=90&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes the company's ENT disease focus, clinical trial advancements, operational adjustments, increased operating losses, and enhanced liquidity from recent financing - The company's lead product candidate, LYR-210, is in a Phase 3 program (ENLIGHTEN I and ENLIGHTEN II) for surgery-naïve CRS patients[105](index=105&type=chunk) - Enrollment in the ENLIGHTEN II trial was paused to align with internal manufacturing timelines for clinical trial supply, with resumption expected in Q3 2023[107](index=107&type=chunk) Results of Operations Comparison (in thousands) | Period | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | :--- | | **Three Months** | R&D Expenses | $10,048 | $7,077 | $2,971 | | | G&A Expenses | $5,137 | $4,018 | $1,119 | | | Net Loss | $(14,766) | $(11,055) | $(3,711) | | **Nine Months** | R&D Expenses | $29,346 | $19,352 | $9,994 | | | G&A Expenses | $13,157 | $10,639 | $2,518 | | | Net Loss | $(41,043) | $(29,896) | $(11,147) | - As of September 30, 2022, the company had cash and cash equivalents of **$109.6 million**, which is expected to fund operations and capital expenditures through mid-2024[117](index=117&type=chunk)[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Lyra Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[171](index=171&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management identified a material weakness in internal control over financial reporting, resulting in financial statement restatements and ineffective disclosure controls, with a remediation plan underway - A material weakness was identified in internal control over financial reporting concerning the allocation of the transaction price for the LianBio License Agreement[175](index=175&type=chunk) - This material weakness resulted in a restatement of the financial statements for the three months ended March 31, 2022, and the three and six months ended June 30, 2022[175](index=175&type=chunk) - As a result of the material weakness, the CEO and CFO concluded that the company's disclosure controls and procedures were not effective as of September 30, 2022[173](index=173&type=chunk) - A remediation plan is underway, which includes enhancing review procedures for complex transactions and augmenting staff with outside technical accounting resources[176](index=176&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in legal claims or actions expected to materially adversely affect its financial condition or operations - Management believes there are currently no pending claims or actions against the company that would have a material adverse effect on its business[181](index=181&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company outlines numerous material risks, including ongoing operating losses, capital needs, internal control weaknesses, high dependency on LYR-210, clinical trial uncertainties, reliance on third parties, and market acceptance challenges - The company has a history of significant operating losses and expects to incur additional losses for the foreseeable future, requiring substantial additional funding to continue operations[186](index=186&type=chunk)[190](index=190&type=chunk) - A material weakness in internal control over financial reporting was identified, which, if not remediated, could adversely affect the business and stock price[197](index=197&type=chunk) - The business is highly dependent on the success of its most advanced product candidate, LYR-210, which faces uncertain clinical trial outcomes and regulatory approval processes[205](index=205&type=chunk) - The company relies on third parties for manufacturing and conducting clinical trials, which introduces risks related to supply, quality control, and trial execution[350](index=350&type=chunk)[355](index=355&type=chunk) - The COVID-19 pandemic has previously disrupted clinical trials, such as the Phase 2 LANTERN trial, and may continue to adversely impact business operations[411](index=411&type=chunk)[412](index=412&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=91&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - The company reported no unregistered sales of equity securities for the period[448](index=448&type=chunk) [Defaults Upon Senior Securities](index=91&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - The company reported no defaults upon senior securities[448](index=448&type=chunk) [Mine Safety Disclosures](index=92&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable to the company's operations[449](index=449&type=chunk) [Other Information](index=92&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - The company reported no other information for the period[450](index=450&type=chunk) [Exhibits](index=93&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including agreement amendments and officer certifications - Exhibits filed include the First Amendment to the License and Collaboration Agreement with LianBio and certifications required by the Sarbanes-Oxley Act[451](index=451&type=chunk)

Correlation between SNOT-22 and cardinal symptom composite scores in CRS Brent A. Senior, MD1*, Anders Cervin, MD, PhD2, Joanne Rimmer, MD3, Agnieszka Wrobel, MD, PhD4, Lindsay Brayton, BA5, James Shao, MS5, Vineeta Belanger, PhD5, Robert C. Kern, MD6 1Department of Otolaryngology - Head & Neck Surgery, University of North Carolina, Chapel Hill, NC, USA; 2University of Queensland Centre for Clinical Research, Royal Brisbane & Women's Hospital Campus, Herston, QLD, Australia; 3Monash Health and Department of ...