Lyra Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update
In
Pivotal ENLIGHTEN Phase 3 clinical program and BEACON Phase 2 clinical trial targeting a broad spectrum of CRS patients actively recruiting patients
"The first quarter marked progress in our two ongoing clinical programs: the pivotal ENLIGHTEN Phase 3 program and the BEACON Phase 2 trial, both of which are actively recruiting patients with chronic rhinosinusitis," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics.
"The recent capital raise of approximately
Corporate Highlights
- In
April 2022 , Lyra closed a private placement of common stock of approximately$100.5 million in gross proceeds with participation by funds affiliated with existing investors:Perceptive Advisors ,North Bridge Venture Partners and Pura Vida Investments as well as funds affiliated with new investors:Venrock Healthcare Capital Partners ,Nantahala Capital Management, LLC and Samsara BioCapital. The proceeds, combined with the Company's existing cash balance and anticipated milestones, under its license agreement withLianBio , is expected to provide sufficient operating capital through mid-2024.
Clinical Developments for LYR-210 and LYR-220
- At the 2022 Combined Otolaryngology Spring Meetings (COSM), two oral presentations were presented that highlighted additional positive clinical data from the LANTERN Phase 2 trial of LYR-210 in adult patients with chronic rhinosinusitis (CRS). The Company's oral presentation on the impact of long-acting implantable corticosteroid matrices in CRS patients was selected as a top clinical abstract by the
American Rhinologic Society . A second presentation highlighted clinically meaningful improvement in mental and physical quality of life outcomes for CRS patients. These results are supportive of the previously reported, statistically significant 40-point improvement for LYR-210 (7500µg) over the average baseline SNOT-22 score of 68 at week 24. - Enrollment in the pivotal ENLIGHTEN I Phase 3 trial is ongoing, while the initiation of the ENLIGHTEN II Phase 3 trial is targeted to begin mid-year. Both ENLIGHTEN trials are expected to enroll patients in the
U.S. andEurope . The global ENLIGHTEN Phase 3 program is expected to include a total of 360 adult, surgically-naïve CRS patients and enrollment is on track to be completed in the first half of 2023.
- Last month, the first patient was treated in
Australia in the Part 1/non-randomized portion of the BEACON Phase 2 trial for LYR-220 for the treatment of adult CRS patients who remain symptomatic despite having had a prior sinus surgery. The Part 2/randomized portion of the trial is anticipated to commence in theU.S. later in the second quarter. The BEACON Phase 2 trial is expected to include approximately 70 symptomatic adult CRS subjects who have had a prior sinus surgery, with enrollment anticipated to be complete around the end of 2022. Topline results from the Part 1/non-randomized portion of the trial are anticipated around year-end.
First Quarter 2022 Financial Highlights
- Cash and cash equivalents as of March 31, 2022 were $33.8 million, compared with $45.7 million at December 31, 2021, and Lyra received an additional
$100.5 million of gross proceeds from theApril 2022 private placement. The Company expects its cash balance to be sufficient to fund its planned operations through mid-2024. - Research and development expenses for the quarter ended March 31, 2022 were $8.5 million compared to $4.8 million for the same period in 2021. The increase was primarily driven by an increase in clinical expenses, product development and manufacturing expenses, employee-related expenses and consulting costs related to the Company's three clinical trials.
- General and administrative expenses for the first quarter 2022 were $3.9 million compared to $3.1 million for the same period in 2021. The increase was primarily driven by an increase in professional and consulting expenses and employee related costs.
- Total operating expenses for the quarter ended March 31, 2022 were $12.4 million compared to $7.8 million for the same period in 2021.
- Net loss for the first quarter 2022 was $7.0 million compared to $7.8 million for the same period in 2021.
About Lyra Therapeutics
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 our cash runway through 2024 and the use of proceeds from the April private placement, our pipeline of product candidates, the enrollment and success of the ENLIGHTEN II Phase 3 program, the enrollment and success of the Phase 2 BEACON trial (including the timelines for commencement of the Part 2/randomized portion of the trial in the
Investor Contact:
212-600-1902
lyra@argotpartners.com
Media Contact:
914-204-6412
kathryn@theyatesnetwork.com
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Condensed Consolidated Statements of Operations |
||||||||
(unaudited) |
||||||||
(in thousands, except share and per share data) |
||||||||
Three Months Ended |
||||||||
2022 |
2021 |
|||||||
Collaboration revenue |
$ |
5,367 |
$ |
— |
||||
Operating expenses: |
||||||||
Research and development |
8,505 |
4,770 |
||||||
General and administrative |
3,888 |
3,061 |
||||||
Total operating expenses |
12,393 |
7,831 |
||||||
Loss from operations |
(7,026) |
(7,831) |
||||||
Other income: |
||||||||
Interest income |
14 |
29 |
||||||
Total other income |
14 |
29 |
||||||
Net loss |
$ |
(7,012) |
$ |
(7,802) |
||||
Net loss per share attributable to common stockholders—basic and diluted |
$ |
(0.54) |
$ |
(0.60) |
||||
Weighted-average common shares outstanding—basic and diluted |
13,008,779 |
12,945,546 |
|
||||||||
Condensed Consolidated Balance Sheets |
||||||||
(unaudited) |
||||||||
(in thousands, except share and per share data) |
||||||||
|
|
|||||||
2022 |
2021 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
33,755 |
$ |
45,747 |
||||
Collaboration revenue receivable |
5,000 |
— |
||||||
Prepaid expenses and other current assets |
1,800 |
2,171 |
||||||
Total current assets |
40,555 |
47,918 |
||||||
Property and equipment, net |
4,275 |
4,503 |
||||||
Operating lease right-of-use assets |
1,109 |
1,355 |
||||||
Restricted cash |
329 |
329 |
||||||
Other assets |
1,077 |
762 |
||||||
Total assets |
$ |
47,345 |
$ |
54,867 |
||||
Liabilities and Stockholders' Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
2,408 |
$ |
3,125 |
||||
Accrued expenses and other current liabilities |
4,237 |
4,258 |
||||||
Operating lease liabilities |
1,097 |
1,074 |
||||||
Deferred revenue |
10,060 |
9,789 |
||||||
Total current liabilities |
17,802 |
18,246 |
||||||
Operating lease liabilities, net of current portion |
99 |
379 |
||||||
Deferred revenue, net of current portion |
1,288 |
1,926 |
||||||
Total liabilities |
19,189 |
20,551 |
||||||
Commitments and contingencies |
||||||||
Stockholders' equity: |
||||||||
Common stock, |
13 |
13 |
||||||
Additional paid-in capital |
228,552 |
227,700 |
||||||
Accumulated deficit |
(200,409) |
(193,397) |
||||||
Total stockholders' equity |
28,156 |
34,316 |
||||||
Total liabilities and stockholders' equity |
$ |
47,345 |
$ |
54,867 |
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