Lyra Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update
- On course to report topline Phase 2 LANTERN study results in
Key Third Quarter 2020 and Subsequent Highlights
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Company On Track to Report Topline Phase 2 Results for LYR-210 in the Treatment of Chronic Rhinosinusitis. Despite the challenges that COVID-19 has posed for the biotechnology community more generally,
Lyra Therapeutics is pleased to report that it remains on track to announce topline Phase 2 results from its LANTERN study of LYR-210 in chronic rhinosinusitis (CRS) in December.
-
Appointed
Nancy L. Snyderman to Board of Directors. In October, the company announced thatDr. Snyderman joined theLyra Therapeutics board.Dr. Snyderman is an accomplished Otolaryngologist-Head and Neck Surgeon and healthcare systems expert. She most recently served as Chief Medical Editor at NBC News and has more than three decades of experience as a leading voice in healthcare and medicine.Dr. Snyderman currently serves as a board member ofAlkermes (NASDAQ: ALKS) andAxonics Modulation Technologies, Inc. (NASDAQ: AXNX).
-
Presented Clinical Data at the 66th Annual Meeting of the
American Rhinologic Society (ARS) Demonstrating LYR-210’s Local Anti-Inflammatory Effects for the Treatment of Chronic Rhinosinusitis. In September, Lyra presented data showing that LYR-210 demonstrated a significant reduction of sinonasal Type 2 inflammation in surgically naïve patients with chronic rhinosinusitis (CRS). The reduction of Type 2 inflammation suggested a correlation with rhinologic symptom improvement in CRS and could be a potential measure of LYR-210’s local anti-inflammatory effects at the site of inflammation in the sinonasal passages. The results showing LYR-210’s influence on local Type 2 inflammatory response in CRS patients were secondary findings from the company’s Phase 1 clinical study of LYR-210.
“Having completed our IPO in the second quarter, we were fully focused in the third quarter on executing our development plans for LYR-210 and LYR-220. I’m pleased to report that we are on track to deliver topline Phase 2 results from our LANTERN study in December, which we believe will be an important milestone for the company and shareholders alike,” said Maria Palasis, Ph.D., President and Chief Executive Officer of
Financial Highlights
Cash, cash equivalents as of
Research and development expenses for the quarter ended
General and administrative expenses for the third quarter 2020 were
Total operating expenses for the quarter ended
Net loss for the third quarter was
In terms of financial guidance, Lyra believes its current cash position is sufficient to fund the company through a planned Phase 3 study of LYR-210 in chronic rhinosinusitis. Additionally, the company projects its year-end 2020 cash balance will be in the range of
About
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Forward-Looking Statement
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 lead product candidate LYR-210 and its cash balance for fiscal year ended
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(unaudited) |
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(in thousands, except share and per share data) |
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Three Months Ended
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Nine Months Ended
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2020 |
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2019 |
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2020 |
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2019 |
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Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,712 |
|
|
$ |
2,841 |
|
|
$ |
8,779 |
|
|
$ |
9,021 |
|
General and administrative |
|
|
2,651 |
|
|
|
1,385 |
|
|
|
6,377 |
|
|
|
3,110 |
|
Total operating expenses |
|
|
6,363 |
|
|
|
4,226 |
|
|
|
15,156 |
|
|
|
12,131 |
|
Loss from operations |
|
|
(6,363 |
) |
|
|
(4,226 |
) |
|
|
(15,156 |
) |
|
|
(12,131 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
29 |
|
|
|
63 |
|
|
|
50 |
|
|
|
178 |
|
Total other income |
|
|
29 |
|
|
|
63 |
|
|
|
50 |
|
|
|
178 |
|
Net loss |
|
$ |
(6,334 |
) |
|
$ |
(4,163 |
) |
|
$ |
(15,106 |
) |
|
$ |
(11,953 |
) |
Comprehensive loss |
|
$ |
(6,334 |
) |
|
$ |
(4,163 |
) |
|
$ |
(15,106 |
) |
|
$ |
(11,953 |
) |
Net loss per share attributable to common stockholders—basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(19.20 |
) |
|
$ |
(2.13 |
) |
|
$ |
(63.33 |
) |
Weighted-average common shares outstanding—basic and diluted |
|
|
12,924,682 |
|
|
|
220,902 |
|
|
|
7,133,967 |
|
|
|
192,433 |
|
|
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Condensed Consolidated Balance Sheets |
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(unaudited) |
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(in thousands, except share and per share data) |
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2020 |
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2019 |
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Assets |
|
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
81,555 |
|
|
$ |
9,808 |
|
Prepaid expenses and other current assets |
|
|
2,000 |
|
|
|
311 |
|
Total current assets |
|
|
83,555 |
|
|
|
10,119 |
|
Property and equipment, net |
|
|
917 |
|
|
|
237 |
|
Operating lease right-of-use assets |
|
|
2,529 |
|
|
|
3,182 |
|
Restricted cash |
|
|
329 |
|
|
|
329 |
|
Deferred offering costs |
|
|
— |
|
|
|
1,096 |
|
Total assets |
|
$ |
87,330 |
|
|
$ |
14,963 |
|
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
|
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Accounts payable |
|
$ |
530 |
|
|
$ |
1,069 |
|
Accrued expenses and other current liabilities |
|
|
3,214 |
|
|
|
3,240 |
|
Operating lease liabilities |
|
|
964 |
|
|
|
899 |
|
Total current liabilities |
|
|
4,708 |
|
|
|
5,208 |
|
Operating lease liabilities, net of current portion |
|
|
1,708 |
|
|
|
2,427 |
|
Total liabilities |
|
|
6,416 |
|
|
|
7,635 |
|
Commitments and contingencies (Note 11) |
|
|
|
|
|
|
|
|
Series A-1 redeemable convertible preferred stock, |
|
|
— |
|
|
|
39,742 |
|
Series A-2 redeemable convertible preferred stock, |
|
|
— |
|
|
|
18,393 |
|
Series A-3 redeemable convertible preferred stock, |
|
|
— |
|
|
|
38,114 |
|
Series A-4 redeemable convertible preferred stock, |
|
|
— |
|
|
|
6,000 |
|
Series B redeemable convertible preferred stock, |
|
|
— |
|
|
|
28,417 |
|
Series C redeemable convertible preferred stock, |
|
|
— |
|
|
|
— |
|
Total redeemable convertible preferred stock |
|
|
— |
|
|
|
130,666 |
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
Common stock, |
|
|
13 |
|
|
|
— |
|
Additional paid-in capital |
|
|
223,764 |
|
|
|
4,419 |
|
Accumulated deficit |
|
|
(142,863 |
) |
|
|
(127,757 |
) |
Total stockholders’ equity (deficit) |
|
|
80,914 |
|
|
|
(123,338 |
) |
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
|
$ |
87,330 |
|
|
$ |
14,963 |
|
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