Lyra Therapeutics Announces Closing of $50.0 Million Private Placement
June 01 2023 - 7:29AM
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 the closing of its previously announced
private placement of common stock, pre-funded warrants to purchase
common stock and purchase warrants to purchase common stock,
resulting in gross proceeds of approximately $50.0 million. The
private placement includes participation from new and existing
investors, including Perceptive Advisors, Venrock Healthcare
Capital Partners, Armistice Capital, Surveyor Capital (a Citadel
company), North Bridge Venture Partners, Nantahala Capital, Samsara
BioCapital, and Woodline Partners LP.
“We are pleased by the support from this
high-quality group of investors as we complete our pivotal clinical
trials of LYR-210 and advance our in-house commercial manufacturing
capabilities to bring our localized drug therapy to CRS patients
and physicians,” said Maria Palasis, Ph.D., President and Chief
Executive Officer of Lyra. “This financing strengthens our balance
sheet beyond key milestones, including the completion of ENLIGHTEN
I, with topline results anticipated in the first half of 2024.”
Lyra ended the first quarter of 2023 with cash,
cash equivalents and short-term investments of $82.7 million.
Combined with the net proceeds from the private placement, the
Company anticipates that it will have sufficient cash, cash
equivalents and short-term investments to fund current planned
operations into the first quarter of 2025.
“This offering gives us greater leverage to
achieve our key objectives over the next year,” said Harlan W.
Waksal, MD, Executive Chairman of Lyra Therapeutics. “In addition
to providing resources and the flexibility to advance our
late-stage product candidates, the financing enhances our ability
to complete activities required for regulatory submission of
LYR-210 and strengthens the foundation for our in-house commercial
manufacturing operations.”
Under the terms of the private placement, Lyra
issued and sold (i) approximately 17.7 million shares of the
Company's common stock and pre-funded warrants to purchase
approximately 2.4 million shares of the Company's common stock,
with an exercise price of $0.001 per share, and (ii) accompanying
common stock purchase warrants to purchase approximately 10.0
million shares of common stock, with an exercise price of $2.673
per share. The combined effective purchase price per share (or
pre-funded warrant to purchase one share) and accompanying purchase
warrant to purchase one-half of one share was $2.4925 (less the
exercise price of the pre-funded warrant, if applicable). Each
pre-funded warrant will be exercisable immediately and will expire
on May 31, 2028. Each common stock purchase warrant will be
exercisable at any time on or after November 30, 2023 and will
expire on November 30, 2028.
Cantor Fitzgerald & Co. and William Blair
& Company, L.L.C. acted as joint lead placement agents for the
financing. H.C. Wainwright & Co. acted as co-placement agent
for the financing.
The securities sold in this private placement
have not been registered under the Securities Act of 1933, as
amended, and may not be offered or sold in the U.S. except pursuant
to an effective registration statement or an applicable exemption
from the registration requirements.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy the foregoing
securities, nor shall there be any sale of these securities in any
state or other jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or other
jurisdiction.
About Lyra
TherapeuticsLyra 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 StatementsThis
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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