Lyra Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update
Pivotal ENLIGHTEN Phase 3 clinical program and BEACON Phase 2 clinical trial targeting a broad spectrum of chronic rhinosinusitis (CRS) patients, continued enrollment
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"The second quarter marked continued progress for our ongoing clinical programs designed to address the full spectrum of CRS patients. The pivotal ENLIGHTEN Phase 3 program for LYR-210 is actively enrolling patients with chronic rhinosinusitis and surgically naïve anatomy," said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. "The BEACON Phase 2 trial for LYR-220 is continuing enrollment of CRS patients with recurrent CRS despite surgical intervention. Together these two patient populations represent the roughly four million patients who fail medical management, highlighting the need for new therapies."
"CRS is a highly prevalent inflammatory disease of the paranasal sinuses leading to debilitating symptoms and significant morbidities for which there is no approved therapeutic treatment at this time," said Dr.
Corporate Highlights
- On
July 5, 2022 , Lyra announced the appointment ofRichard Nieman , MD, as Chief Medical Officer, an industry leader with substantialU.S. and global experience in drug development and medical affairs and a proven track record of developing medicines through commercialization and beyond. His prior leadership roles include SVP & Worldwide Medical Head of Immunology at Bristol Myers Squibb (BMS), Head of R&D China at BMS, Global Medical Officer & Head of Medical at Teva, and Head of Asia Pacific Medical at Bayer.Dr. Nieman will guide the Company's late-stage product candidates as they advance in the clinic. - In
April 2022 , Lyra closed a private placement of common stock of approximately$96.3 million in net proceeds with participation by funds affiliated with existing investors:Perceptive Advisors ,North Bridge Venture Partners andPura Vida Investments as well as funds affiliated with new investors:Venrock Healthcare Capital Partners , NantahalaCapital Management, LLC and Samsara BioCapital. The net proceeds, combined with the Company's existing cash balance, is expected to provide sufficient operating capital through mid-2024.
Clinical Developments for LYR-210 and LYR-220
- Enrollment in the pivotal ENLIGHTEN I Phase 3 trial is ongoing, while the ENLIGHTEN II Phase 3 trial is actively screening patients and we expect to enroll the first patient in the third quarter. 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 adults, surgically-naïve CRS patients and enrollment is projected to be completed in mid-year 2023. - In
April 2022 , the first patient was treated inAustralia 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. in the third 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. We believe topline results from the Part 1/non-randomized portion of the trial are anticipated around year-end 2022. - At the 2022 Combined Otolaryngology Spring Meetings (COSM) in
April 2022 , the Company presented two oral presentations that highlighted additional positive clinical data from the LANTERN Phase 2 trial of LYR-210 in adult patients with 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 theAmerican Rhinologic Society . The Company's 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 (7,500µg) over the average baseline SNOT-22 score of 68 at week 24.
Second Quarter 2022 Financial Highlights
- Cash and cash equivalents as of June 30, 2022 were $120.7 million, compared with $33.8 million at March 31, 2022. The Company expects its cash and cash equivalents balance to be sufficient to fund its planned operations through mid-2024.
- Research and development expenses for the quarter ended June 30, 2022 were $10.8 million compared to $7.5 million for the same period in 2021. The increase was primarily driven by an increase in clinical expenses related to the Company's three clinical trials and employee-related expenses.
- General and administrative expenses for the quarter ended
June 30, 2022 were $4.1 million compared to $3.6 million for the same period in 2021. The increase was primarily driven by an increase in employee related costs. - Net loss for the quarter ended June 30, 2022 was $14.5 million compared to $11.0 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 the Company's cash runway through mid-2024, the Company's 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:
ir@lyratx.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 |
Six Months Ended |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Collaboration revenue |
$ |
407 |
$ |
— |
$ |
5,774 |
$ |
— |
||||||||
Operating expenses: |
||||||||||||||||
Research and development |
10,793 |
7,505 |
19,298 |
12,275 |
||||||||||||
General and administrative |
4,132 |
3,560 |
8,020 |
6,621 |
||||||||||||
Total operating expenses |
14,925 |
11,065 |
27,318 |
18,896 |
||||||||||||
Loss from operations |
(14,518) |
(11,065) |
(21,544) |
(18,896) |
||||||||||||
Other income: |
||||||||||||||||
Interest income |
34 |
26 |
48 |
55 |
||||||||||||
Total other income |
34 |
26 |
48 |
55 |
||||||||||||
Net loss |
$ |
(14,484) |
$ |
(11,039) |
$ |
(21,496) |
$ |
(18,841) |
||||||||
Net loss per share attributable to common stockholders—basic and Diluted |
$ |
(0.43) |
$ |
(0.85) |
$ |
(0.91) |
$ |
(1.45) |
||||||||
Weighted-average common shares outstanding—basic and diluted |
33,946,428 |
12,991,837 |
23,535,442 |
12,968,820 |
|
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Condensed Consolidated Balance Sheets |
||||||||
(unaudited) |
||||||||
(in thousands, except share and per share data) |
||||||||
|
|
|||||||
2022 |
2021 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
120,669 |
$ |
45,747 |
||||
Restricted cash |
329 |
— |
||||||
Prepaid expenses and other current assets |
1,383 |
2,171 |
||||||
Total current assets |
122,381 |
47,918 |
||||||
Property and equipment, net |
4,009 |
4,503 |
||||||
Operating lease right-of-use assets |
860 |
1,355 |
||||||
Restricted cash |
1,089 |
329 |
||||||
Other assets |
1,696 |
762 |
||||||
Total assets |
$ |
130,035 |
$ |
54,867 |
||||
Liabilities and Stockholders' Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
1,670 |
$ |
3,125 |
||||
Accrued expenses and other current liabilities |
5,465 |
4,258 |
||||||
Operating lease liabilities |
926 |
1,074 |
||||||
Deferred revenue |
1,811 |
9,789 |
||||||
Total current liabilities |
9,872 |
18,246 |
||||||
Operating lease liabilities, net of current portion |
3 |
379 |
||||||
Deferred revenue, net of current portion |
9,130 |
1,926 |
||||||
Total liabilities |
19,005 |
20,551 |
||||||
Commitments and contingencies |
||||||||
Stockholders' equity: |
||||||||
Preferred stock, and |
— |
— |
||||||
Common stock, and outstanding at |
32 |
13 |
||||||
Additional paid-in capital |
325,891 |
227,700 |
||||||
Accumulated deficit |
(214,893) |
(193,397) |
||||||
Total stockholders' equity |
111,030 |
34,316 |
||||||
Total liabilities and stockholders' equity |
$ |
130,035 |
$ |
54,867 |
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