Lyra Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Recent Accomplishments
- Successful EOP2 FDA meeting for LYR-210 in CRS; Phase 3 program on track to begin around year-end 2021 -
- Licensing agreement with LianBio for LYR-210 in
- Positive topline results of LYR-210 PK study support 505(b)(2) NDA pathway -
Recent Company Highlights
- In June, Lyra announced the positive outcome of its End-of-Phase 2 meeting with the
U.S. Food and Drug Administration(FDA) for LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS). Lyra and the FDA established key elements of the Phase 3 program to support a 505(b)(2) new drug application, including the single primary endpoint, which will evaluate improvement at week 24 using a composite score of three cardinal symptoms of CRS.
- Lyra announced a strategic partnership and exclusive license agreement with LianBio to develop and commercialize LYR-210 in
Greater Chinaand other Asian markets. Lyra received an upfront payment of $12 millionand is eligible to receive up to $135 millionin future payments based upon development, regulatory and commercialization milestones, as well as low double-digit royalties on net sales of LYR-210 in the licensed territories.
- The Company announced positive topline results of a pharmacokinetic (PK) study of LYR-210 in patients with CRS. The data were supportive of LYR-210’s safety profile and provide a PK bridge to the established safety of mometasone furoate for a 505(b)(2) pathway for New Drug Approval (NDA) submission.
“Following our successful End-of-Phase 2 meeting with the FDA, we believe that we have a clear path forward to advance LYR-210 into Phase 3 clinical development for the treatment of Chronic Rhinosinusitis, which we expect to begin around year-end,” said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. “Our second CRS product, LYR-220 for post-surgical CRS patients, is also advancing and remains on track to enter Phase 2 later this year. We believe LYR-210 and LYR-220 will disrupt the current CRS treatment landscape by providing a new pharmacologic solution for the full spectrum of the 4 million
Second Quarter 2021 Financial Highlights
- Cash and cash equivalents as of
June 30, 2021were $69.0 million, compared with $74.6 millionat December 31, 2020. The Company expects its cash balance to be sufficient to fund its planned operations into 2023.
- Research and development expenses for the quarter ended
June 30, 2021were $7.5 millioncompared to $2.1 millionfor the same period in 2020.
- General and administrative expenses for the second quarter 2021 were
$3.6 millioncompared to $2.4 millionfor the same period in 2020.
- Total operating expenses for the quarter ended
June 30, 2021were $11.1 millioncompared to $4.5 millionfor the same period in 2020.
- Net loss for the second quarter was
$11.0 millioncompared to $4.5 millionfor the same period in 2020.
Conference Call and Webcast Details
LYRA will host a conference call and live webcast today at
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 company’s clinical advancement of LYR-210 for the treatment of CRS and our expectations regarding the development and commercialization of LYR-210 pursuant to the terms of the LianBio License Agreement. 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
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development||$||7,505||$||2,103||$||12,275||$||5,067|
|General and administrative||3,560||2,442||6,621||3,726|
|Total operating expenses||11,065||4,545||18,896||8,793|
|Loss from operations||(11,065||)||(4,545||)||(18,896||)||(8,793||)|
|Total other income||26||5||55||21|
|Net loss per share attributable to common stockholders—basic and diluted||$||(0.85||)||$||(0.56||)||$||(1.45||)||$||(2.11||)|
|Weighted-average common shares outstanding—basic and diluted||12,991,837||8,182,725||12,968,820||4,206,793|
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|Cash and cash equivalents||$||69,046||$||74,593|
|Prepaid expenses and other current assets||1,027||1,324|
|Total current assets||70,073||75,917|
|Property and equipment, net||3,853||2,165|
|Operating lease right-of-use assets||1,834||2,301|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and other current liabilities||2,976||2,977|
|Operating lease liabilities||1,029||985|
|Total current liabilities||5,904||4,884|
|Operating lease liabilities, net of current portion||929||1,454|
|Commitments and contingencies (Note 9)|
|Additional paid-in capital||226,211||224,363|
|Total stockholders’ equity||57,499||74,492|
|Total liabilities and stockholders’ equity||$||76,332||$||80,830|
Source: Lyra Therapeutics