Lyra Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results, Provides Corporate Update
- Positive Topline Results for LANTERN Phase 2 Study of LYR-210-
-
- Conference call and webcast today at
Key Fourth Quarter 2020 and Subsequent Highlights
-
Company Announced Positive Topline Results for LANTERN Phase 2 Study of LYR-210. In December, Lyra announced positive topline results from its LANTERN Phase 2 study of LYR-210 for the treatment of Chronic Rhinosinusitis, including:
- LYR-210 is the first nasal implant to achieve a benefit of up to six months after a single administration in a clinical testing, and the first nasal implant to achieve a benefit in both polyp and non-polyp patients in clinical testing.
- 7500 mcg dose achieved statistically significant improvement in both 4 Cardinal Symptoms and SNOT-22 scores at 24 weeks and at several earlier timepoints, compared to control.
- Lyra believes the results support a clear path to regulatory submission for LYR-210 and plans to move forward into a pivotal Phase 3 trial using the 7500 mcg dose, subject to an end of Phase 2 meeting with the FDA.
“The positive results from the LANTERN Phase 2 study point to LYR-210’s potential as an easily administered, six-month treatment for CRS patients who have failed medical management,” said Professor
-
Appointed
Robert Kern , MD, Chief Medical Officer. In February, Lyra announced thatRobert Kern , MD had been named the company’s Chief Medical Officer. In addition to his role at Lyra,Dr. Kern will remain in his current position as the George A. Sisson Professor and Chair,Department of Otolaryngology – Head and Neck Surgery,Northwestern University Feinberg School of Medicine .Dr. Kern is the immediate past president of theAmerican Rhinologic Society and current President of theInternational Society of Inflammation and Allergy of the Nose . He is a renowned physician in the ENT field and a world-leading expert in chronic rhinosinusitis with a proven track record of global leadership in otolaryngology, in both academic research and clinical rhinology.
-
Added
Nancy L. Snyderman , M.D. to Board of Directors. In October, the company announced thatDr. Snyderman had joinedLyra Therapeutics board.Dr. Snyderman is an accomplished otolaryngologist-head and neck surgeon and healthcare systems expert. She most recently served as Chief Medical Editor at NBC News and has more than three decades of experience as a leading voice in healthcare and medicine.Dr. Snyderman currently serves as a board member ofAlkermes (NASDAQ: ALKS) andAxonics Modulation Technologies, Inc. (NASDAQ: AXNX).
“We were pleased to end our first calendar year as a public company by announcing positive topline data from our LANTERN Phase 2 Study for LYR-210. In addition, we recently strengthened our team with the additions of
Financial Highlights
Cash and cash equivalents as of
Research and development expenses for the quarter and full year ended
General and administrative expenses for the fourth quarter and full year ended
Total operating expenses for the quarter ended and full year ended
Net loss for the fourth quarter and full year 2020 was
In terms of financial guidance for 2021, we believe that Lyra has sufficient cash to fund the company through planned operations into 2023.
Conference Call
Individuals interested in listening to the conference call may do so by dialing (833) 519-1249 for domestic callers, or (914) 800-3822 for international callers, and using the conference ID: 6979948; or from the webcast link in the investor relations section of the company’s website at: www.lyratherapeutics.com. The recorded webcast will be available for replay for approximately 30 days following the call.
Annual Meeting Date
The Board of Directors of
Any stockholder seeking to bring business before the 2021 Annual Meeting or to nominate a director must provide timely notice, as set forth in the Company’s Amended and Restated Bylaws (the “Bylaws”). Specifically, written notice of any proposed business or nomination must be received at the Company’s principal executive offices no later than the close of business on
About
For more information, please visit www.lyratherapeutics.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 company’s lead product candidate LYR-210 and its financial guidance for 2021. 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; 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 Annual Report on Form 10-K filed with the
Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) |
|||||||||||
|
|
|
|
|
|
|
|
|
|||
|
|
Year Ended
|
|
||||||||
|
|
2020 |
|
|
|
|
2019 |
|
|
||
Operating expenses: |
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
12,522 |
|
|
|
|
$ |
12,032 |
|
|
General and administrative |
|
|
9,687 |
|
|
|
|
|
4,487 |
|
|
Total operating expenses |
|
|
22,209 |
|
|
|
|
|
16,519 |
|
|
Loss from operations |
|
|
(22,209 |
) |
|
|
|
(16,519 |
) |
||
Other income: |
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
82 |
|
|
|
|
|
213 |
|
|
Total other income |
|
|
82 |
|
|
|
|
|
213 |
|
|
Net loss |
|
$ |
(22,127 |
) |
|
|
$ |
(16,306 |
) |
||
Comprehensive loss |
|
$ |
(22,127 |
) |
|
|
$ |
(16,306 |
) |
||
Net loss per share attributable to common stockholders—basic and diluted |
|
$ |
(2.59 |
) |
|
$ |
(82.23 |
) |
|||
Weighted-average common shares outstanding—basic and diluted |
|
|
8,590,205 |
|
|
|
|
|
202,093 |
|
|
Consolidated Balance Sheets (in thousands, except share and per share data) |
||||||||||
|
|
|
|
|||||||
|
|
2020 |
|
|
|
2019 |
|
|
||
Assets |
|
|
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
74,593 |
|
|
|
$ |
9,808 |
|
|
Prepaid expenses and other current assets |
|
|
1,324 |
|
|
|
|
311 |
|
|
Total current assets |
|
|
75,917 |
|
|
|
|
10,119 |
|
|
Property and equipment, net |
|
|
2,165 |
|
|
|
|
237 |
|
|
Operating lease right-of-use assets |
|
|
2,301 |
|
|
|
|
3,182 |
|
|
Restricted cash |
|
|
329 |
|
|
|
|
329 |
|
|
Other assets |
|
|
118 |
|
|
|
|
1,096 |
|
|
Total assets |
|
$ |
80,830 |
|
|
|
$ |
14,963 |
|
|
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
|
|
||
Accounts payable |
|
$ |
922 |
|
|
|
$ |
1,069 |
|
|
Accrued expenses and other current liabilities |
|
|
2,977 |
|
|
|
|
3,240 |
|
|
Operating lease liabilities |
|
|
985 |
|
|
|
|
899 |
|
|
Total current liabilities |
|
|
4,884 |
|
|
|
|
5,208 |
|
|
Operating lease liabilities, net of current portion |
|
|
1,454 |
|
|
|
|
2,427 |
|
|
Total liabilities |
|
|
6,338 |
|
|
|
|
7,635 |
|
|
Commitments and contingencies (Note 11) |
|
|
|
|
|
|
|
|
||
Series A-1 redeemable convertible preferred stock, |
|
|
— |
|
|
|
|
39,742 |
|
|
Series A-2 redeemable convertible preferred stock, |
|
|
— |
|
|
|
|
18,393 |
|
|
Series A-3 redeemable convertible preferred stock, |
|
|
— |
|
|
|
|
38,114 |
|
|
Series A-4 redeemable convertible preferred stock, |
|
|
— |
|
|
|
|
6,000 |
|
|
Series B redeemable convertible preferred stock, |
|
|
— |
|
|
|
|
28,417 |
|
|
Series C redeemable convertible preferred stock, |
|
|
— |
|
|
|
|
— |
|
|
Total redeemable convertible preferred stock |
|
|
— |
|
|
|
|
130,666 |
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
||
Common stock, |
|
|
13 |
|
|
|
|
— |
|
|
Additional paid-in capital |
|
|
224,363 |
|
|
|
|
4,419 |
|
|
Accumulated deficit |
|
|
(149,884 |
) |
|
|
(127,757 |
) |
||
Total stockholders’ equity (deficit) |
|
|
74,492 |
|
|
|
|
(123,338 |
) |
|
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
|
$ |
80,830 |
|
|
|
$ |
14,963 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210309005931/en/
Media Contact:
914-204-6412
kathryn@theyatesnetwork.com
Investor Contact:
619-916-7620
laurence@gilmartinir.com
Source: