Lyra Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Lyra Therapeutics (NASDAQ:LYRA) reported Q2 2025 financial results and highlighted significant progress with its LYR-210 treatment for chronic rhinosinusitis (CRS). The company announced positive Phase 3 ENLIGHTEN 2 trial results in June 2025, meeting its primary endpoint with statistically significant improvement in cardinal symptoms compared to control.
Key financial metrics include cash position of $29.8 million as of June 30, 2025, and a net loss of $7.4 million for Q2 2025, significantly improved from a $48.1 million loss in Q2 2024. The company secured $5.0 million in financing through a registered direct offering, extending cash runway into Q3 2026.
Operational highlights include reengagement with FDA for potential NDA submission, resumed manufacturing activities, and implementation of a 1-for-50 reverse stock split to regain Nasdaq compliance.
Lyra Therapeutics (NASDAQ:LYRA) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha sottolineato importanti progressi con il trattamento LYR-210 per la rinosinusite cronica (CRS). La società ha annunciato a giugno 2025 risultati positivi dello studio di Fase 3 ENLIGHTEN 2, avendo raggiunto l'endpoint primario con un miglioramento statisticamente significativo dei sintomi principali rispetto al controllo.
I principali indicatori finanziari includono una posizione di cassa di 29,8 milioni di dollari al 30 giugno 2025 e una perdita netta di 7,4 milioni di dollari nel Q2 2025, in netto miglioramento rispetto alla perdita di 48,1 milioni nel Q2 2024. La società ha ottenuto 5,0 milioni di dollari di finanziamento tramite un'offerta diretta registrata, estendendo la liquidità fino al terzo trimestre 2026.
Tra gli aspetti operativi: ripresa del confronto con la FDA per una potenziale sottomissione NDA, ripresa delle attività di produzione e attuazione di un accorpamento azionario inverso 1 per 50 per riconquistare la conformità al Nasdaq.
Lyra Therapeutics (NASDAQ:LYRA) presentó los resultados financieros del segundo trimestre de 2025 y destacó avances significativos con su tratamiento LYR-210 para la rinosinusitis crónica (CRS). La compañía anunció en junio de 2025 resultados positivos del ensayo de fase 3 ENLIGHTEN 2, al haber cumplido el objetivo primario con una mejora estadísticamente significativa de los síntomas principales frente al control.
Las métricas financieras clave incluyen una posición de caja de 29,8 millones de dólares al 30 de junio de 2025 y una pérdida neta de 7,4 millones de dólares en el segundo trimestre de 2025, mejorando sustancialmente frente a la pérdida de 48,1 millones en el Q2 2024. La compañía aseguró 5,0 millones de dólares en financiación mediante una colocación directa registrada, extendiendo su pista de efectivo hasta el tercer trimestre de 2026.
Entre los hitos operativos figuran la reanudación del contacto con la FDA para una posible presentación de NDA, la reactivación de la fabricación y la implementación de una consolidación inversa de acciones 1 por 50 para recuperar el cumplimiento con Nasdaq.
Lyra Therapeutics (NASDAQ:LYRA)는 2025년 2분기 실적을 발표하며 만성 부비동염(CRS) 치료제 LYR-210의 의미 있는 진전을 강조했습니다. 회사는 2025년 6월 3상 ENLIGHTEN 2 시험의 긍정적 결과를 공시했으며, 대조군 대비 주요 증상에서 통계적으로 유의한 개선으로 일차 평가변수를 충족했습니다.
핵심 재무 지표로는 2025년 6월 30일 기준 현금 잔고 2,980만 달러와 2025년 2분기 순손실 740만 달러가 있으며, 이는 2024년 2분기 4,810만 달러 손실에서 크게 개선된 수치입니다. 회사는 등록 직판(registered direct offering)을 통해 500만 달러의 자금을 확보해 현금 유동성을 2026년 3분기까지 연장했습니다.
운영상의 주요 내용으로는 잠재적 NDA 제출을 위한 FDA와의 교류 재개, 제조 활동 재개, 그리고 나스닥 규정 준수를 회복하기 위한 1대50 액면병합(리버스 스플릿) 시행이 포함됩니다.
Lyra Therapeutics (NASDAQ:LYRA) a publié ses résultats financiers du deuxième trimestre 2025 et a souligné des progrès significatifs concernant son traitement LYR-210 pour la rhinosinusite chronique (CRS). La société a annoncé en juin 2025 des résultats positifs de l'essai de phase 3 ENLIGHTEN 2, ayant atteint son critère principal avec une amélioration statistiquement significative des symptômes majeurs par rapport au témoin.
Les principaux indicateurs financiers incluent une trésorerie de 29,8 millions de dollars au 30 juin 2025 et une perte nette de 7,4 millions de dollars pour le T2 2025, en nette amélioration par rapport à une perte de 48,1 millions au T2 2024. La société a obtenu 5,0 millions de dollars de financement via une offre directe enregistrée, prolongeant sa visibilité de trésorerie jusqu'au troisième trimestre 2026.
Parmi les points opérationnels : reprise des échanges avec la FDA en vue d'un éventuel dépôt de NDA, reprise des activités de fabrication et mise en place d'une consolidation inversée d'actions 1 pour 50 pour retrouver la conformité Nasdaq.
Lyra Therapeutics (NASDAQ:LYRA) meldete die Finanzergebnisse für das zweite Quartal 2025 und hob bedeutende Fortschritte bei der LYR-210-Behandlung gegen chronische Rhinosinusitis (CRS) hervor. Das Unternehmen verkündete im Juni 2025 positive Ergebnisse der Phase-3-Studie ENLIGHTEN 2 und erreichte den primären Endpunkt mit einer statistisch signifikanten Verbesserung der Hauptsymptome gegenüber der Kontrolle.
Wesentliche Finanzkennzahlen sind eine Barbestände von 29,8 Millionen US-Dollar zum 30. Juni 2025 und ein Nettoverlust von 7,4 Millionen US-Dollar im Q2 2025, deutlich verbessert gegenüber einem Verlust von 48,1 Millionen im Q2 2024. Das Unternehmen sicherte sich 5,0 Millionen US-Dollar an Finanzierung durch ein registriertes Direct Offering und verlängerte damit die finanzielle Reichweite bis ins dritte Quartal 2026.
Operationelle Highlights umfassen die Wiederaufnahme des Austauschs mit der FDA zwecks möglicher NDA-Einreichung, die Wiederaufnahme der Produktionstätigkeiten und die Umsetzung einer Reverse-Stock-Split-Transaktion 1-zu-50, um die Nasdaq-Compliance wiederherzustellen.
- ENLIGHTEN 2 Phase 3 trial met primary endpoint with statistically significant improvement in CRS symptoms
- Secured $5.0 million financing with potential additional $9.8 million from warrant exercise
- Cash runway extended into Q3 2026
- Significant reduction in net loss to $7.4M in Q2 2025 from $48.1M in Q2 2024
- Successfully regained Nasdaq compliance following reverse stock split
- R&D expenses decreased by $8.2M year-over-year
- ENLIGHTEN 1 trial did not meet primary or secondary endpoints
- Required 1-for-50 reverse stock split to maintain Nasdaq listing
- Collaboration revenue declined to $183K in Q2 2025 from $598K in Q2 2024
- Restructuring and workforce reduction implemented in May 2024
Insights
Lyra's positive Phase 3 data for LYR-210 provides path forward despite mixed clinical results and challenging financial position.
Lyra Therapeutics' Q2 results reveal a company at a critical inflection point following its mixed ENLIGHTEN clinical program. The positive ENLIGHTEN 2 trial results provide a potential lifeline for LYR-210 in treating chronic rhinosinusitis (CRS) patients without nasal polyps, demonstrating statistically significant improvement in the composite three cardinal symptoms score (-1.13; p=0.0078) at 24 weeks.
The financial position remains precarious with cash decreasing to
Operating expenses have been drastically reduced with R&D decreasing by
The regulatory strategy faces uncertainty due to the failed ENLIGHTEN 1 trial. Lyra is pursuing a Type C meeting with the FDA in H2 2025 to determine if the positive ENLIGHTEN 2 results alone could support an NDA submission for CRS patients without nasal polyps. This represents a narrower but potentially viable commercial opportunity.
The 1-for-50 reverse stock split implemented in May 2025 successfully addressed Nasdaq compliance issues but significantly diluted existing shareholders. With only
– Positive ENLIGHTEN 2 Phase 3 results announced in June 2025 propel business activities in manufacturing, regulatory strategy and ENLIGHTEN clinical dataset analysis to advance path forward for LYR-210 for treatment of chronic rhinosinusitis (CRS) –
– Financing announced in June 2025 extends cash runway into 3Q 2026 –
WATERTOWN, Mass., Aug. 12, 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 second quarter ended June 30, 2025 and provided a corporate update.
"The positive results from our ENLIGHTEN 2 trial have enabled us to secure financing and are providing momentum to optimize our regulatory strategy and resume manufacturing activities, as we pursue our path to advance LYR-210 as a six-month treatment option for millions of patients who do not respond to standard CRS medical management,” said Maria Palasis, Ph.D., President and CEO, Lyra Therapeutics, Inc. “We continue to review and analyze the totality of the dataset from the ENLIGHTEN 1 and ENLIGHTEN 2 trials as we execute on our business strategy and envision the opportunities ahead for LYR-210 to benefit patients with CRS.”
Recent Business Highlights
- On June 27, Lyra announced a registered direct offering of common stock and pre-funded warrants pursuant to an effective shelf registration statement on Form S-3, as well as a concurrent private placement of warrants exempt from registration pursuant to Section 4(a)(2) and/or Rule 506 of the Securities Act of 1933, as amended, with gross proceeds to Lyra of approximately
$5.0 million . With this financing, the Company expects its cash runway to extend into the third quarter of 2026. In addition, if the holders of the private placement warrants exercise such warrants in full in cash, the Company would receive additional gross proceeds of approximately$9.8 million , before deducting the placement agent’s fees. Lyra intends to use the net proceeds from the offering for working capital and other general corporate purposes, including potential clinical development, manufacturing and other expenses for LYR-210. - Lyra has reengaged with the U.S. Food and Drug Administration (FDA) following the positive results from the ENLIGHTEN 2 Phase 3 study in early June. The Company is preparing for an upcoming Type C meeting with the FDA in the second half of 2025, in order to align on a path forward for an NDA submission for LYR-210 as a treatment for CRS patients without nasal polyps.
- Lyra has resumed in-house chemistry, manufacturing and controls (CMC) activities to prepare for manufacturing LYR-210 for potential, future clinical trials and for compliance with applicable CMC regulations.
- On May 27, Lyra implemented a 1-for-50 reverse stock split of the Company’s common stock in order to regain compliance with Nasdaq’s
$1.00 m inimum bid price requirement. - On June 13, Nasdaq notified the Company that it had regained compliance with the
$1.00 m inimum bid price requirement.
Highlights from ENLIGHTEN 2 Statistically Significant Phase 3 Results for LYR-210 in CRS
- On June 2, Lyra announced topline results from the Phase 3 ENLIGHTEN 2 trial showing that LYR-210 met its primary endpoint. LYR-210 demonstrated statistically significant improvement compared to sham control in a composite of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at week 24 (-1.13; p=0.0078) in patients without nasal polyps. Consistent with previous studies, LYR-210 was generally well tolerated, with no product-related serious adverse events.
- The ENLIGHTEN 2 trial also met the key secondary endpoints of 3CS at 24 weeks in the full population (i.e., patients with and without nasal polyps) (-0.90; p=0.0209) and in the clinically-validated SNOT-22 score at 24 weeks (-8.7; p=0.0101), with symptom improvement observed as early as week 4.
- Additionally, in pooled data from ENLIGHTEN 2 and ENLIGHTEN 1 trials in 64 CRS patients with nasal polyps, LYR-210 demonstrated a consistent positive trend over 24 weeks in multiple key efficacy endpoints.
The ENLIGHTEN program consisted of two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. While the ENLIGHTEN 2 trial met its primary endpoint and key secondary endpoints, the ENLIGHTEN 1 trial did not meet the primary endpoint or secondary endpoints, as previously reported in May 2024. Each ENLIGHTEN trial enrolled approximately 180 CRS patients who failed medical management and did not have prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate) or sham control for 24 weeks.
Second Quarter 2025 Financial Highlights
Cash and cash equivalents as of June 30, 2025 were
Research and development expenses decreased by
The decrease in research and development expenses for the three months ended June 30, 2025 was primarily attributable to a decrease in clinical related costs of
General and administrative expenses decreased by
The decrease in general and administrative expenses for the three months ended June 30, 2025 was primarily driven by a decrease in professional, consulting and public company fees of
The Company incurred no impairment costs related to property and equipment for the three months ended June 30, 2025 compared to
The Company incurred no impairment costs related to our right-of-use assets for the three months ended June 30, 2025 and incurred
The Company incurred restructuring charges in the amount of
Net loss for the second quarter 2025 was
| LYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Collaboration revenue | $ | 183 | $ | 598 | $ | 366 | $ | 1,130 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,110 | 13,264 | 9,986 | 31,502 | ||||||||||||
| General and administrative | 3,501 | 5,139 | 6,764 | 10,957 | ||||||||||||
| Impairment of property and equipment | — | 1,883 | — | 1,883 | ||||||||||||
| Impairment of right-of-use assets | — | 22,836 | — | 22,836 | ||||||||||||
| Restructuring and other related charges | 398 | 6,450 | 1,283 | 6,450 | ||||||||||||
| Total operating expenses | 9,009 | 49,572 | 18,033 | 73,628 | ||||||||||||
| Loss from operations | (8,826 | ) | (48,974 | ) | (17,667 | ) | (72,498 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 410 | 855 | 708 | 1,941 | ||||||||||||
| Other income | 981 | — | 981 | — | ||||||||||||
| Total other income | 1,391 | 855 | 1,689 | 1,941 | ||||||||||||
| Loss before income tax expense | (7,435 | ) | (48,119 | ) | (15,978 | ) | (70,557 | ) | ||||||||
| Income tax expense | (2 | ) | (12 | ) | (6 | ) | (26 | ) | ||||||||
| Net loss | (7,437 | ) | (48,131 | ) | (15,984 | ) | (70,583 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized holding loss on short-term investments, net of tax | — | (29 | ) | — | (37 | ) | ||||||||||
| Comprehensive loss | $ | (7,437 | ) | $ | (48,160 | ) | $ | (15,984 | ) | $ | (70,620 | ) | ||||
| Net loss per share attributable to common stockholders— basic and diluted | $ | (5.51 | ) | $ | (36.76 | ) | $ | (12.00 | ) | $ | (54.51 | ) | ||||
| Weighted-average common shares outstanding— basic and diluted | 1,348,630 | 1,309,193 | 1,331,985 | 1,294,790 | ||||||||||||
Share information reflects the effect of a 1-for-50 reverse stock split.
| LYRA THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) | ||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,784 | $ | 40,577 | ||||
| Prepaid expenses and other current assets | 1,279 | 2,448 | ||||||
| Total current assets | 31,063 | 43,025 | ||||||
| Property and equipment, net | 1,159 | 1,404 | ||||||
| Operating lease right-of-use assets | 18,358 | 19,924 | ||||||
| Restricted cash | 1,993 | 1,993 | ||||||
| Total assets | $ | 52,573 | $ | 66,346 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 680 | $ | 1,179 | ||||
| Restructuring liability | 3,486 | 4,347 | ||||||
| Accrued expenses and other current liabilities | 2,413 | 2,586 | ||||||
| Operating lease liabilities | 4,552 | 4,121 | ||||||
| Deferred revenue | 32 | 398 | ||||||
| Total current liabilities | 11,163 | 12,631 | ||||||
| Operating lease liabilities, net of current portion | 27,926 | 30,259 | ||||||
| Deferred revenue, net of current portion | 11,862 | 11,862 | ||||||
| Total liabilities | 50,951 | 54,752 | ||||||
| Commitments and contingencies (Note 14) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024 | — | — | ||||||
| Common stock, June 30, 2025 and December 31, 2024; 1,625,376 and 1,310,308 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 2 | 1 | ||||||
| Additional paid-in capital | 422,394 | 416,383 | ||||||
| Accumulated deficit | (420,774 | ) | (404,790 | ) | ||||
| Total stockholders’ equity | 1,622 | 11,594 | ||||||
| Total liabilities and stockholders’ equity | $ | 52,573 | $ | 66,346 | ||||
Share information reflects the effect of a 1-for-50 reverse stock split.
About LYR-210
LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. LYR-210 is being evaluated in the ENLIGHTEN pivotal Phase 3 clinical program.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210, the company’s lead product candidate, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with and without nasal polyps. The Company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.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. The words “believe,” “may,” “will,” “plan”, “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. 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 cash runway into the third quarter of 2026, whether LYR-210 could potentially benefit patients with CRS with or without polyps, the safety, efficacy, potential benefits of, and clinical design or progress of any of LYR-210 at any dosage or in any indication; the in-house CMC activities to prepare for manufacturing LYR-210 for potential, future clinical trials and for compliance with applicable CMC regulations; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates, including the anticipated Type C meeting with the FDA; the Company’s business strategy and plans; and the timing of any of the foregoing. 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 Company’s failure to meet its primary endpoint in its ENLIGHTEN 1 Phase 3 clinical trial; the fact that the Company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future; the Company's need for additional funding, which may not be available; the Company’s ability to continue as a going concern; the Company’s limited operating history; the fact that the Company has no approved products; the fact that clinical trial data is subject to change until the completion of the applicable clinical study report; the fact that clinical trials required for the Company’s product candidates are expensive and time-consuming, and their outcome is uncertain; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the Company's reliance on third parties to conduct its preclinical studies and clinical trials; failure to obtain and maintain or adequately protect the Company's intellectual property rights; failure to retain key personnel; the fact that the price of the Company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company and any securities class action litigation. These and other important factors discussed under the caption "Risk Factors" in the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 12, 2025 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.
Contact Information: Jason Cavalier, Chief Financial Officer 917.584.7668 jcavalier@lyratx.com Media Contact: Kathryn Morris, The Yates Network LLC 914.204.6412 kathryn@theyatesnetwork.com
FAQ
What were the key results of LYRA's ENLIGHTEN 2 Phase 3 trial for LYR-210?
How much cash does Lyra Therapeutics have and how long will it last?
What was Lyra's net loss for Q2 2025 compared to Q2 2024?
What is LYRA's next regulatory step for LYR-210?
How did the 1-for-50 reverse stock split affect LYRA's Nasdaq compliance?
