UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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 c Lyra Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-1700838 (State or other jurisdicti ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K o (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 c Lyra Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-1700838 (State or other jurisdic ...

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 ...

Dedicated to transforming the lives of patients with debilitating chronic diseases through local, targeted drug therapy INVESTOR PRESENTATION AUGUST 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 eff ...