Lyra Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
02 Giugno 2023 - 10:01PM
Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a
clinical-stage biotechnology company developing innovative
therapies for the localized treatment of chronic rhinosinusitis
(CRS), today announced that it has issued an equity-based award
pursuant to its 2022 Inducement Award Plan to its Senior Vice
President of Regulatory Affairs, Allison Nance, upon the
commencement of her employment. The inducement grant was
approved by the Company's independent directors serving on its
Compensation Committee, and was made as a material inducement
to Ms. Nance’s acceptance of employment with Lyra in
accordance with Nasdaq Listing Rule 5635(c)(4) as a component of
her employment compensation. The inducement grant consists of a
non-qualified stock option to purchase an aggregate of 110,000
shares of the Company's common stock. The inducement grant is
subject to the terms and conditions of the award agreement covering
the performance stock option grant and the Company's 2022
Inducement Award Plan, as amended.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage
biotechnology company developing therapies for the localized
treatment of patients with chronic rhinosinusitis (CRS). Lyra has
two investigational product candidates, LYR-210 and LYR-220, in
late-stage development for CRS, a highly prevalent inflammatory
disease of the paranasal sinuses which leads to debilitating
symptoms and significant morbidities. LYR-210 and LYR-220 are
bioresorbable nasal implants designed to be administered in a
brief, 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 surgically naïve
patients and is being evaluated in the ENLIGHTEN Phase 3 clinical
program, while LYR-220, an enlarged implant, is being evaluated in
the BEACON Phase 2 clinical trial in patients who have recurrent
symptoms despite having had prior 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.
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 cash runway into the first quarter of 2025,
the Company’s pipeline of product candidates, the enrollment and
success of the ENLIGHTEN Phase 3 program, the timing for reporting
top line data from the Company’s clinical trials, the Company’s
ability to manufacture its product candidates in-house, the safety
and efficacy of the Company’s product candidates and the success of
the Phase 2 BEACON trial. 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 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 must scale its in-house manufacturing capabilities or rely
on third parties for the manufacture of materials 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 (including the war 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 Quarterly Report
on Form 10-Q filed with the SEC on May 12, 2023 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.
Contact Information:Ellen
Cavaleri, Investor Relations 615.618.6228 ecavaleri@lyratx.com
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