Lyra Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update
May 12 2023 - 7:00AM
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 reported its financial results for the first quarter
ended March 31, 2023 and provided a corporate update.
“We’ve had a highly productive start to 2023,
positioning us for anticipated key data readouts over the next 12
months,” said Maria Palasis, Ph.D., President and CEO of Lyra.
“Enrollment is progressing well in the ENLIGHTEN I pivotal trial of
LYR-210 in pre-surgical CRS, with data expected in the first half
of 2024. Following our successful transition to in-house
manufacturing of clinical supply, we restarted enrollment in
ENLIGHTEN II, the second pivotal trial of LYR-210. Furthermore, we
completed enrollment in the BEACON Phase 2 trial of LYR-220 in
post-surgical CRS, with data expected in Q4 2023. We believe BEACON
will provide further evidence of the efficacy and safety of our
bioresorbable nasal implant to address the unmet needs of CRS
patients and their physicians.”
Lyra Program Highlights
ENLIGHTEN Pivotal Program of LYR-210 in
Surgically Naïve Patients CRS
- Enrollment in the pivotal ENLIGHTEN
I Phase 3 trial is ongoing, with data anticipated in 1H 2024.
- In April 2023, the Company
restarted enrollment in the ENLIGHTEN II trial; enrollment
completion is expected in the second half of 2024.
The ENLIGHTEN program consists of two pivotal
Phase 3 clinical trials, ENLIGHTEN I and ENLIGHTEN II, to evaluate
the efficacy and safety of LYR-210 for the treatment of CRS. Each
trial is enrolling 180 CRS patients who have failed medical
management and have not had prior ethmoid sinus surgery, randomized
2:1 to either LYR-210 (7500µg mometasone furoate (MF)) or control.
The aim of the two pivotal trials is to support a New Drug
Application to the U.S. Food and Drug Administration for
LYR-210.
Lyra announced in November 2022 that it
temporarily paused enrollment in ENLIGHTEN II due to a transition
to in-house manufacturing to ensure consistent clinical supply of
LYR-210. Lyra has successfully manufactured LYR-210 in house to
fully supply both ENLIGHTEN trials.
BEACON Phase 2 Clinical trial of LYR-220
in Post-Surgical CRS
- Enrollment in BEACON is complete,
with data expected in Q4 2023.
The BEACON Phase 2 clinical trial is a 24-week
study evaluating the safety and efficacy of LYR-220 (7500µg MF) in
40 patients with CRS who remain symptomatic despite having had
prior sinus surgery.
In-House Manufacturing
- In Q4 2022, Lyra announced the
transition of manufacturing to in-house, leveraging its expertise
to reliably supply product without relying on third-party
manufacturers. Lyra is now advancing its in-house manufacturing
capabilities to prepare for commercial production.
First Quarter 2023 Financial
Highlights
Cash, cash equivalents and short-term
investments as of March 31, 2023 were $82.7 million, compared with
$97.9 million at December 31, 2022. Based on our current business
plan, we anticipate that our cash, cash equivalents and short-term
investment balance is sufficient to fund our operating expenses and
capital expenditures into mid-second quarter of 2024. Please see
our Quarterly Report filed on Form 10-Q for the three months ended
March 31, 2023 for further information regarding our cash runway
guidance and other financial results.
Research and development expenses for the
quarter ended March 31, 2023 were $12.6 million compared to $8.5
million for the same period in 2022. The increase was primarily
attributable to increased clinical development costs as we
continued to enroll patients in our ENLIGHTEN I Phase 3 clinical
trial and employee related costs of $1.4 million as we increased
our headcount to support additional research and development
activities.
General and administrative expenses for the
quarter ended March 31, 2023 were $5.1 million compared to $3.9
million for the same period in 2022. The increase was primarily
attributable to increased employee related costs mainly driven by
stock-based compensation as well as the write-off of deferred
financing costs of $0.4 million and increase in support costs of
$0.3 million.
Net loss for the first quarter 2023 was $16.3
million compared to $11.9 million for the same period in 2022.
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. For more information, please visit
www.lyratx.com and follow us on LinkedIn.
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 mid-second quarter of 2024, 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 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 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.
LYRA THERAPEUTICS, INC. |
Condensed Consolidated Statements of Operations and Comprehensive
Loss |
(in thousands, except share and per share data) |
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
410 |
|
|
$ |
468 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
12,596 |
|
|
|
8,505 |
|
General and administrative |
|
|
5,127 |
|
|
|
3,888 |
|
Total
operating expenses |
|
|
17,723 |
|
|
|
12,393 |
|
Loss
from operations |
|
|
(17,313 |
) |
|
|
(11,925 |
) |
Other
income: |
|
|
|
|
|
|
Interest income |
|
|
1,072 |
|
|
|
14 |
|
Total
other income |
|
|
1,072 |
|
|
|
14 |
|
Loss
before income tax expense |
|
|
(16,241 |
) |
|
|
(11,911 |
) |
Income
tax expense |
|
|
(14 |
) |
|
|
— |
|
Net
loss |
|
|
(16,255 |
) |
|
|
(11,911 |
) |
Other
comprehensive income: |
|
|
|
|
|
|
Unrealized holding loss on short-term investments, net of tax |
|
|
(22 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(16,277 |
) |
|
$ |
(11,911 |
) |
Net loss
per share attributable to common stockholders— |
|
|
|
|
|
|
|
|
basic and diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.92 |
) |
Weighted-average common shares outstanding— |
|
|
|
|
|
|
|
|
basic and diluted |
|
|
36,832,747 |
|
|
|
13,008,779 |
|
LYRA THERAPEUTICS, INC. |
Condensed Consolidated Balance Sheets |
(in thousands, except share and per share data) |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,019 |
|
|
$ |
32,550 |
|
Short-term investments |
|
|
60,688 |
|
|
|
65,344 |
|
Prepaid expenses and other current assets |
|
|
2,092 |
|
|
|
2,935 |
|
Total current assets |
|
|
84,799 |
|
|
|
100,829 |
|
Property
and equipment, net |
|
|
2,004 |
|
|
|
2,243 |
|
Operating lease right-of-use assets |
|
|
1,825 |
|
|
|
2,223 |
|
Restricted cash |
|
|
1,392 |
|
|
|
1,392 |
|
Other
assets |
|
|
3,848 |
|
|
|
3,281 |
|
Total assets |
|
$ |
93,868 |
|
|
$ |
109,968 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,951 |
|
|
$ |
2,616 |
|
Accrued expenses and other current liabilities |
|
|
6,793 |
|
|
|
9,030 |
|
Operating lease liabilities |
|
|
1,900 |
|
|
|
1,549 |
|
Deferred revenue |
|
|
1,510 |
|
|
|
1,275 |
|
Total current liabilities |
|
|
14,154 |
|
|
|
14,470 |
|
Operating lease liabilities, net of current portion |
|
|
191 |
|
|
|
667 |
|
Deferred
revenue, net of current portion |
|
|
13,432 |
|
|
|
14,077 |
|
Total liabilities |
|
|
27,777 |
|
|
|
29,214 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
March 31, |
|
|
|
|
|
|
|
|
2023 and December 31, 2022; no shares issued and outstanding at
March31, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value; 200,000,000 shares authorized at March
31, |
|
|
|
|
|
|
|
|
2023 and December 31, 2022; 31,836,815 and 31,827,659 shares issued
and outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
|
32 |
|
|
|
32 |
|
Additional paid-in capital |
|
|
331,001 |
|
|
|
329,387 |
|
Accumulated other comprehensive income (loss), net of tax |
|
|
(12 |
) |
|
|
10 |
|
Accumulated deficit |
|
|
(264,930 |
) |
|
|
(248,675 |
) |
Total stockholders’ equity |
|
|
66,091 |
|
|
|
80,754 |
|
Total liabilities and stockholders’ equity |
|
$ |
93,868 |
|
|
$ |
109,968 |
|
Contact Information:Ellen
Cavaleri, Investor Relations 615.618.6228 ecavaleri@lyratx.com
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