Lyra Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update
Lyra Therapeutics, a biotechnology company, reported its financial results for Q1 2024 and provided an update on its clinical-stage product candidates LYR-210 and LYR-220 for treating chronic rhinosinusitis. LYR-210's Phase 3 results are expected in May, aiming to revolutionize CRS treatment. LYR-220's Phase 2 trial data will be presented in May 2024.
Financially, the company's cash balance decreased to $87.1 million. Research and development expenses increased to $18.2 million, while general and administrative expenses rose to $5.8 million. The net loss for Q1 2024 was $22.5 million.
LYR-210 Phase 3 results expected in May could potentially revolutionize CRS treatment.
LYR-220 Phase 2 trial data presentation in May 2024 highlights progress in product development.
Lyra Therapeutics' cash balance of $87.1 million is sufficient to fund operations into Q1 2025.
Decrease in cash balance from $102.8 million to $87.1 million raises concerns about financial sustainability.
An increase in research and development expenses from $12.6 million to $18.2 million for Q1 2024 may impact profitability.
General and administrative expenses rose from $5.1 million to $5.8 million, potentially affecting overall financial performance.
Insights
The recently reported financial results by Lyra Therapeutics reveal a substantial increase in research and development (R&D) expenses, jumping from $12.6 million to $18.2 million year-over-year. This uptick correlates with the company's clinical advancements, particularly with the ongoing pivotal trials of LYR-210 and the preparation for an end-of-Phase 2 meeting for LYR-220. It is pertinent to note the significance of a robust cash position in biotechnology firms. Lyra's reported cash reserves of $87.1 million, a decrease from the previous quarter's $102.8 million, demonstrate a burn rate that they expect to sustain operations into the first quarter of 2025.
For investors, the short-term financial health of Lyra is secured, but the long-term viability hinges on the outcome of the ENLIGHTEN 1 trial and subsequent FDA approval process. Positive Phase 3 results could be a catalyst for the stock, potentially attracting partnership opportunities or paving the way for commercialization. Conversely, a setback in clinical results can have the opposite effect, highlighting the inherent risks of investing in clinical-stage biotech companies.
From a clinical perspective, the anticipated results from the ENLIGHTEN 1 pivotal Phase 3 clinical trial are pivotal for the future of LYR-210, a bioabsorbable sinonasal implant intended to provide six months of continuous therapy for CRS patients. The evolution of treatment for CRS from Lyra represents a paradigmatic shift from conventional therapy, offering a long-acting therapeutic option.
Investors should acknowledge that the success of LYR-210 and LYR-220 in clinical trials not only demonstrates efficacy and safety but also signals the company's capacity to innovate within the otolaryngology field. The clinical program's success could lead to a substantial market share in the CRS treatment market, particularly important given that current treatments exhibit limitations. However, as with any clinical trial, there are no guarantees of success and this presents a level of risk that must be considered in any investment decision.
-- Phase 3 Results from ENLIGHTEN 1 Trial of LYR-210 in Chronic Rhinosinusitis (CRS) Expected in May --
WATERTOWN, Mass., April 30, 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 first quarter ended March 31, 2024 and provided a corporate update.
“With results imminent for our ENLIGHTEN 1 pivotal Phase 3 study of LYR-210 in CRS, we are laser-focused on delivering the topline data in May,” said Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics. “We believe that LYR-210 has the potential to revolutionize the treatment of CRS by delivering a six-month therapy designed to provide long-acting relief that addresses the widespread need to overcome current treatment limitations faced by millions of patients.”
Lyra Therapeutics is developing LYR-210 and LYR-220, its two product candidates in late-stage development for the treatment of CRS. LYR-210 and LYR-220 are bioabsorbable sinonasal implants designed to be administered in a simple, in-office procedure and are intended to deliver six months of continuous mometasone furoate drug therapy (7500µg MF) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210 is intended for patients with standard anatomy, primarily those who have not undergone ethmoid sinus surgery. LYR-220, a larger implant, is designed for CRS patients whose nasal cavity is enlarged due to previous surgery.
Clinical Program Highlights
ENLIGHTEN Pivotal Program of LYR-210 in CRS Patients who have not had Ethmoid Sinus Surgery
- Results from the ENLIGHTEN 1 pivotal Phase 3 clinical trial of LYR-210 are expected in May 2024.
- Enrollment in ENLIGHTEN 2, the second pivotal Phase 3 trial of LYR-210, is ongoing; enrollment completion is expected in the second half of 2024.
- Results from the ENLIGHTEN 1 52-week extension study are expected in Q4 2024.
The ENLIGHTEN program consists 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. The Company designed each trial to evaluate 180 CRS patients who have failed medical management and who have not had ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate (MF)) or control over 24 weeks. The ENLIGHTEN 1 trial also includes an extension phase to further assess the safety and repeat use of LYR-210 through 52 weeks. The goal of the two pivotal trials is to support a New Drug Application to the U.S. Food and Drug Administration (FDA) for LYR-210.
BEACON Phase 2 Clinical Trial of LYR-220 in CRS Patients who Have Had Ethmoid Sinus Surgery
- The Company plans to present additional secondary endpoint data from the BEACON Phase 2 clinical trial of LYR-220 at the 2024 Combined Otolaryngology Spring Meetings (COSM) being held May 15-19, 2024 in Chicago, IL. The presentation, “Impact of LYR-220 on ethmoid opacification and CRS symptoms in the BEACON study,” is scheduled to take place on May 15, 2024 by Brent A. Senior, M.D., Nathaniel and Sheila Harris Distinguished Professor and Chief, Division of Rhinology, Allergy, and Endoscopic Skull Base Surgery in the Department of Otolaryngology/Head and Neck Surgery, UNC School of Medicine and Coordinating Investigator for the BEACON study.
- An end-of-Phase 2 meeting for LYR-220 with the FDA is anticipated in the second half of 2024.
The Phase 2 BEACON trial was a randomized, controlled, parallel-group study intended to evaluate the safety and placement feasibility of the LYR-220 (7500µg mometasone furoate (MF)) implant, over a 28-week period, in symptomatic CRS patients who have had ethmoid sinus surgery. In September 2023, Lyra Therapeutics announced positive topline results from the BEACON Phase 2 clinical trial of LYR-220 in adult patients with CRS who have recurrent symptoms despite having had surgery.
First Quarter 2024 Financial Highlights
Cash, cash equivalents and short-term investments as of March 31, 2024 were
Research and development expenses for the quarter ended March 31, 2024 were
General and administrative expenses for the quarter ended March 31, 2024 were
Net loss for the first quarter 2024 was
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing therapies for the localized treatment of patients with chronic rhinosinusitis (CRS), a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioabsorbable sinonasal implants designed to be administered in a simple, in-office procedure and are intended to deliver six months of continuous mometasone furoate drug therapy (7500µg MF) to the sinonasal passages. LYR-210 is designed for patients with standard anatomy, primarily those who have not undergone ethmoid sinus surgery, and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged implant, was evaluated in the BEACON Phase 2 clinical trial in patients who have recurrent symptoms despite having had ethmoid sinus surgery. These two product candidates are designed 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. 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 timing of the availability of top-line results for ENLIGHTEN 1, the results from the 52-week extension study of ENLIGHTEN 1 being available in Q4 2024, the completion of enrollment for ENLIGHTEN 2 in the second half of 2024, the presentation of additional secondary endpoint data from the BEACON Phase 2 clinical trial of LYR-220 at COSM on May 15, 2024, whether an end-of-Phase 2 meeting for LYR-220 with the FDA will take place in the second half of 2024, the Company’s cash runway into the first quarter of 2025, , and the safety and efficacy of the Company’s product candidates. 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 additional losses for the foreseeable future; the Company's need for additional funding and ability to operate as a going concern, 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 has never scaled up an in-house manufacturing facility for commercial use; or the fact that the Company may not be successful in its efforts to 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 must scale its in-house manufacturing capabilities for its research programs, pre-clinical studies and clinical trials and commercial supply; 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, terrorism and wars); 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 April 30, 2024 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 | |||||||
| (in thousands, except share and per share data) | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Collaboration revenue | $ | 532 | $ | 410 | |||
| Operating expenses: | |||||||
| Research and development | 18,238 | 12,596 | |||||
| General and administrative | 5,818 | 5,127 | |||||
| Total operating expenses | 24,056 | 17,723 | |||||
| Loss from operations | (23,524 | ) | (17,313 | ) | |||
| Other income: | |||||||
| Interest income | 1,086 | 1,072 | |||||
| Total other income | 1,086 | 1,072 | |||||
| Loss before income tax expense | (22,438 | ) | (16,241 | ) | |||
| Income tax expense | (14 | ) | (14 | ) | |||
| Net loss | (22,452 | ) | (16,255 | ) | |||
| Other comprehensive loss: | |||||||
| Unrealized holding loss on short-term investments, net of tax | (8 | ) | (22 | ) | |||
| Comprehensive loss | $ | (22,460 | ) | $ | (16,277 | ) | |
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.35 | ) | $ | (0.44 | ) | |
| Weighted-average common shares outstanding—basic and diluted | 64,011,360 | 36,832,747 | |||||
| LYRA THERAPEUTICS, INC. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (in thousands, except share data) | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 15,799 | $ | 22,353 | |||
| Short-term investments | 71,319 | 80,400 | |||||
| Prepaid expenses and other current assets | 2,325 | 2,068 | |||||
| Total current assets | 89,443 | 104,821 | |||||
| Property and equipment, net | 3,783 | 2,043 | |||||
| Operating lease right-of-use assets | 45,626 | 33,233 | |||||
| Restricted cash | 1,992 | 1,392 | |||||
| Other assets | 683 | 1,111 | |||||
| Total assets | $ | 141,527 | $ | 142,600 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,844 | $ | 3,131 | |||
| Accrued expenses and other current liabilities | 10,057 | 9,374 | |||||
| Operating lease liabilities | 4,504 | 5,434 | |||||
| Deferred revenue | 1,319 | 1,658 | |||||
| Total current liabilities | 18,724 | 19,597 | |||||
| Operating lease liabilities, net of current portion | 33,356 | 21,447 | |||||
| Deferred revenue, net of current portion | 11,943 | 12,136 | |||||
| Total liabilities | 64,023 | 53,180 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 61 | 57 | |||||
| Additional paid-in capital | 411,225 | 400,685 | |||||
| Accumulated other comprehensive income, net of tax | 25 | 33 | |||||
| Accumulated deficit | (333,807 | ) | (311,355 | ) | |||
| Total stockholders’ equity | 77,504 | 89,420 | |||||
| Total liabilities and stockholders’ equity | $ | 141,527 | $ | 142,600 | |||
Contact Information:
Ellen Cavaleri, Investor Relations
615.618.6228
ecavaleri@lyratx.com
FAQ
When are the Phase 3 results of LYR-210 expected?
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