Full Press Release Details
Lyra Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
Treated first patient in pivotal Phase 3 ENLIGHTEN program for surgically na ve chronic rhinosinusitis patients
Initiated BEACON Phase 2 trial for LYR-220 in chronic rhinosinusitis patients with post-surgical anatomy
Appointed Harlan W. Waksal, MD, as Executive Chairman
WATERTOWN, Mass., March 9, 2022 - 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 December 31, 2021, and highlighted recent accomplishments and upcoming milestones.
"2021 was a highly productive year for Lyra as we advanced our clinical programs in our first indication - chronic rhinosinusitis, or CRS - with the first patient treated in the pivotal Phase 3 ENLIGHTEN program for LYR-210 in patients with surgically-na ve anatomy and the initiation of the Phase 2 BEACON study for LYR-220 to treat CRS patients with post-surgical anatomy," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics.
Dr. Palasis added: "We expect 2022 to be a pivotal year as we enroll both late-stage clinical programs, report clinical data for Part 1 of the Phase 2 BEACON study around year end and present additional clinical data at the Combined Otolaryngology Spring Meetings (COSM) that further distinguishes LYR-210 from current treatment options. With a portfolio of products to cover both surgically-na ve and post-surgical CRS patients, Lyra is poised to excel in the estimated $6 billion target addressable market for CRS."
Key Fourth Quarter 2021 and Subsequent Highlights
Key Additional Milestones Anticipated in 2022
Financial Highlights
About Lyra Therapeutics
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 our pipeline of product candidates, the enrollment and success of the ENLIGHTEN II Phase 3 study, the enrollment and success of the Phase 2 BEACON study, the success of the XTreo platform, presentation of additional clinical data at COSM, and our ability to capture market share. 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; or 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, terrorism and wars (including the developing conflict between Ukraine and Russia); 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 Annual Report on Form 10-K filed with the SEC on March 9, 2022 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.
Consolidated Statements of Operations
(in thousands, except share and per share data)
| Year Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Collaboration revenue | $ | 285 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 29,694 | 12,522 | ||||||
| General and administrative | 14,206 | 9,687 | ||||||
| Total operating expenses | 43,900 | 22,209 | ||||||
| Loss from operations | (43,615 | ) | (22,209 | ) | ||||
| Other income: | ||||||||
| Interest income | 102 | 82 | ||||||
| Total other income | 102 | 82 | ||||||
| Net loss | $ | (43,513 | ) | $ | (22,127 | ) | ||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (3.35 | ) | $ | (2.59 | ) | ||
| Weighted-average common shares outstanding-basic and diluted | 12,986,101 | 8,590,205 |
LYRA THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 45,747 | $ | 74,593 | ||||
| Prepaid expenses and other current assets | 2,171 | 1,324 | ||||||
| Total current assets | 47,918 | 75,917 | ||||||
| Property and equipment, net | 4,503 | 2,165 | ||||||
| Operating lease right-of-use assets | 1,355 | 2,301 | ||||||
| Restricted cash | 329 | 329 | ||||||
| Other assets | 762 | 118 | ||||||
| Total assets | $ | 54,867 | $ | 80,830 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,125 | $ | 922 | ||||
| Accrued expenses and other current liabilities | 4,258 | 2,977 | ||||||
| Operating lease liabilities | 1,074 | 985 | ||||||
| Deferred revenue | 9,789 | - | ||||||
| Total current liabilities | 18,246 | 4,884 | ||||||
| Operating lease liabilities, net of current portion | 379 | 1,454 | ||||||
| Deferred revenue, net of current portion | 1,926 | - | ||||||
| Total liabilities | 20,551 | 6,338 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2021 and 2020; 13,007,178 and 12,932,377 shares issued and outstanding at December 31, 2021 and 2020, respectively | 13 | 13 | ||||||
| Additional paid-in capital | 227,700 | 224,363 | ||||||
| Accumulated deficit | (193,397 | ) | (149,884 | ) | ||||
| Total stockholders' equity | 34,316 | 74,492 | ||||||
| Total liabilities and stock and stockholders' equity | $ | 54,867 | $ | 80,830 |