Full Press Release Details
Lyra Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update
WATERTOWN, Mass., Nov. 9, 2021 - 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 reported financial results for the quarter ended September 30, 2021, and highlighted recent accomplishments.
"We are incredibly proud of Lyra's recent progress, with a growing body of clinical evidence supporting the potential for LYR-210 to become the new standard of care for chronic rhinosinusitis," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. "Key opinion leaders in CRS are also sharing their enthusiasm for how they believe LYR-210 will provide a much-needed treatment option for the majority of their CRS patients, who fail medical management today. Looking ahead to the remainder of this year, we are excited to be initiating two later-stage clinical studies, our Phase 3 ENLIGHTEN study for LYR-210 and our Phase 2 BEACON study for LYR-220, in surgically-na ve and post-surgical CRS patients, respectively. Together these two products are designed to address the full range of CRS patients that present to an ENT office."
Third Quarter 2021 Financial Highlights
Conference Call and Webcast Details
LYRA will host a conference call and live webcast today at 4:30 p.m. ET. To access the live call by phone, dial (833) 519-1249 (domestic) or (914) 800-3822 (international) and use the conference ID: 5064627. To access the live webcast of the call, please visit the Investor Relations section of the Lyra Therapeutics website at https://investors.lyratherapeutics.com/. The recorded webcast will be available for replay for approximately 30 days following the call.
About Lyra Therapeutics
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 plans for the LYR-220 Phase 2 BEACON study in post-surgical chronic rhinosinusitis (CRS) patients and the LYR-210 Phase 3 ENLIGHTEN program in surgically-na ve CRS patients, as well as the sufficiency of the company's cash balance to fund its planned operations through 2022. 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; our 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 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.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Collaboration revenue | $ | 14 | $ | - | $ | 14 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,077 | 3,712 | 19,352 | 8,779 | ||||||||||||
| General and administrative | 4,018 | 2,651 | 10,639 | 6,377 | ||||||||||||
| Total operating expenses | 11,095 | 6,363 | 29,991 | 15,156 | ||||||||||||
| Loss from operations | (11,081 | ) | (6,363 | ) | (29,977 | ) | (15,156 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 26 | 29 | 81 | 50 | ||||||||||||
| Total other income | 26 | 29 | 81 | 50 | ||||||||||||
| Net loss | $ | (11,055 | ) | $ | (6,334 | ) | $ | (29,896 | ) | $ | (15,106 | ) | ||||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (0.85 | ) | $ | (0.49 | ) | $ | (2.30 | ) | $ | (2.13 | ) | ||||
| Weighted-average common shares outstanding-basic and diluted | 13,001,514 | 12,924,682 | 12,979,837 | 7,133,967 |
LYRA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 58,131 | $ | 74,593 | ||||
| Prepaid expenses and other current assets | 2,755 | 1,324 | ||||||
| Total current assets | 60,886 | 75,917 | ||||||
| Property and equipment, net | 4,706 | 2,165 | ||||||
| Operating lease right-of-use assets | 1,596 | 2,301 | ||||||
| Restricted cash | 329 | 329 | ||||||
| Other assets | 245 | 118 | ||||||
| Total assets | $ | 67,762 | $ | 80,830 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,912 | $ | 922 | ||||
| Accrued expenses and other current liabilities | 3,968 | 2,977 | ||||||
| Operating lease liabilities | 1,052 | 985 | ||||||
| Deferred revenue | 9,841 | - | ||||||
| Total current liabilities | 17,773 | 4,884 | ||||||
| Operating lease liabilities, net of current portion | 656 | 1,454 | ||||||
| Deferred revenue, net of current portion | 2,145 | - | ||||||
| Total liabilities | 20,574 | 6,338 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2021 and December 31, 2020; 13,004,578 and 12,932,377 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 13 | 13 | ||||||
| Additional paid-in capital | 226,955 | 224,363 | ||||||
| Accumulated deficit | (179,780 | ) | (149,884 | ) | ||||
| Total stockholders' equity | 47,188 | 74,492 | ||||||
| Total liabilities and stockholders' equity | $ | 67,762 | $ | 80,830 |