UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 9, 2021
LYRA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|
Delaware |
001-39273 |
84-1700838 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
|
|
|
|
480 Arsenal Way
Watertown, MA 02472
(Address of principal executive offices) (Zip Code)
(617) 393-4600
(Registrant’s telephone number, include area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
Common Stock, $0.001 par value per share |
|
LYRA |
|
The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On August 9, 2021, Lyra Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2021. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
|
|
|
|
|
Exhibit |
|
Description |
|
|
|
|
|
99.1 |
|
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
|
|
LYRA THERAPEUTICS, INC. |
||
|
|
|
|
|
|||
|
Date: August 9, 2021 |
|
|
|
By: |
|
/s/ R. Don Elsey |
|
|
|
|
|
|
|
R. Don Elsey |
|
|
|
|
|
|
|
Chief Financial Officer |
Exhibit 99.1
Lyra Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Recent Accomplishments
|
|
- |
Successful EOP2 FDA meeting for LYR-210 in CRS; Phase 3 program on track to begin around year-end 2021 - |
|
|
- |
Licensing agreement with LianBio for LYR-210 in Greater China and other Asian markets - |
|
|
- |
Positive topline results of LYR-210 PK study support 505(b)(2) NDA pathway - |
WATERTOWN, MA – August 9, 2021 - Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, today reported financial results for the quarter ended June 30, 2021, and highlighted recent accomplishments.
Recent Company Highlights
|
|
• |
In June, Lyra announced the positive outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS). Lyra and the FDA established key elements of the Phase 3 program to support a 505(b)(2) new drug application, including the single primary endpoint, which will evaluate improvement at week 24 using a composite score of three cardinal symptoms of CRS. |
|
|
• |
Lyra announced a strategic partnership and exclusive license agreement with LianBio to develop and commercialize LYR-210 in Greater China and other Asian markets. Lyra received an upfront payment of $12 million and is eligible to receive up to $135 million in future payments based upon development, regulatory and commercialization milestones, as well as low double-digit royalties on net sales of LYR-210 in the licensed territories. |
|
|
• |
The Company announced positive topline results of a pharmacokinetic (PK) study of LYR-210 in patients with CRS. The data were supportive of LYR-210’s safety profile and provide a PK bridge to the established safety of mometasone furoate for a 505(b)(2) pathway for New Drug Approval (NDA) submission. |
“Following our successful End-of-Phase 2 meeting with the FDA, we believe that we have a clear path forward to advance LYR-210 into Phase 3 clinical development for the treatment of Chronic Rhinosinusitis, which we expect to begin around year-end,” said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. “Our second CRS product, LYR-220 for post-surgical CRS patients, is also advancing and remains on track to enter Phase 2 later this year. We believe LYR-210 and LYR-220 will disrupt the current CRS treatment landscape by providing a new pharmacologic solution for the full spectrum of the 4 million U.S. CRS patients who fail medical management each year.”
Second Quarter 2021 Financial Highlights
|
|
• |
Cash and cash equivalents as of June 30, 2021 were $69.0 million, compared with $74.6 million at December 31, 2020. The Company expects its cash balance to be sufficient to fund its planned operations into 2023. |
|
|
• |
Research and development expenses for the quarter ended June 30, 2021 were $7.5 million compared to $2.1 million for the same period in 2020. |
|
|
• |
General and administrative expenses for the second quarter 2021 were $3.6 million compared to $2.4 million for the same period in 2020. |
|
|
• |
Total operating expenses for the quarter ended June 30, 2021 were $11.1 million compared to $4.5 million for the same period in 2020. |
|
|
• |
Net loss for the second quarter was $11.0 million compared to $4.5 million for the same period in 2020. |
Conference Call and Webcast Details
LYRA will host a conference call and live webcast today at 4:30 p.m. ET. To access the live call by phone, dial (833) 519-1249 (domestic) or (914) 800-3822 (international) and use the conference ID: 6997916. To access the live webcast of the call, please visit the Investor Relations section of the Lyra Therapeutics website at https://investors.lyratherapeutics.com/. The recorded webcast will be available for replay for approximately 30 days following the call.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra’s XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company’s current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for months following a single non-invasive, in-office administration. Lyra’s lead product candidate, LYR-210, is in late-stage clinical development for the treatment of chronic rhinosinusitis and is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.
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 clinical advancement of LYR-210 for the treatment of CRS and our expectations regarding the development and commercialization of LYR-210 pursuant to the terms of the LianBio License Agreement. 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 losses for the foreseeable future; the company’s need for additional funding, 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; our 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
relies on third parties for the manufacture of materials for its research programs, pre-clinical studies and clinical trials; 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; 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 11, 2021 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.
Media Contact:
Kathryn Morris
914-204-6412
kathryn@theyatesnetwork.com
Investor Contact:
Argot Partners
212-600-1902
lyra@argotpartners.com
LYRA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
7,505 |
|
|
$ |
2,103 |
|
|
$ |
12,275 |
|
|
$ |
5,067 |
|
|
General and administrative |
|
|
3,560 |
|
|
|
2,442 |
|
|
|
6,621 |
|
|
|
3,726 |
|
|
Total operating expenses |
|
|
11,065 |
|
|
|
4,545 |
|
|
|
18,896 |
|
|
|
8,793 |
|
|
Loss from operations |
|
|
(11,065 |
) |
|
|
(4,545 |
) |
|
|
(18,896 |
) |
|
|
(8,793 |
) |
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
26 |
|
|
|
5 |
|
|
|
55 |
|
|
|
21 |
|
|
Total other income |
|
|
26 |
|
|
|
5 |
|
|
|
55 |
|
|
|
21 |
|
|
Net loss |
|
$ |
(11,039 |
) |
|
$ |
(4,540 |
) |
|
$ |
(18,841 |
) |
|
$ |
(8,772 |
) |
|
Net loss per share attributable to common stockholders—basic and diluted |
|
$ |
(0.85 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.45 |
) |
|
$ |
(2.11 |
) |
|
Weighted-average common shares outstanding—basic and diluted |
|
|
12,991,837 |
|
|
|
8,182,725 |
|
|
|
12,968,820 |
|
|
|
4,206,793 |
|
LYRA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share data)
|
|
June 30, |
|
|
December 31, |
|
|||
|
|
|
2021 |
|
|
2020 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
69,046 |
|
|
$ |
74,593 |
|
|
Prepaid expenses and other current assets |
|
|
1,027 |
|
|
|
1,324 |
|
|
Total current assets |
|
|
70,073 |
|
|
|
75,917 |
|
|
Property and equipment, net |
|
|
3,853 |
|
|
|
2,165 |
|
|
Operating lease right-of-use assets |
|
|
1,834 |
|
|
|
2,301 |
|
|
Restricted cash |
|
|
329 |
|
|
|
329 |
|
|
Other assets |
|
|
243 |
|
|
|
118 |
|
|
Total assets |
|
$ |
76,332 |
|
|
$ |
80,830 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,899 |
|
|
$ |
922 |
|
|
Accrued expenses and other current liabilities |
|
|
2,976 |
|
|
|
2,977 |
|
|
Operating lease liabilities |
|
|
1,029 |
|
|
|
985 |
|
|
Total current liabilities |
|
|
5,904 |
|
|
|
4,884 |
|
|
Operating lease liabilities, net of current portion |
|
|
929 |
|
|
|
1,454 |
|
|
Deferred revenue |
|
|
12,000 |
|
|
|
— |
|
|
Total liabilities |
|
|
18,833 |
|
|
|
6,338 |
|
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2021 and December 31, 2020; 13,001,105 and 12,932,377 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively |
|
|
13 |
|
|
|
13 |
|
|
Additional paid-in capital |
|
|
226,211 |
|
|
|
224,363 |
|
|
Accumulated deficit |
|
|
(168,725 |
) |
|
|
(149,884 |
) |
|
Total stockholders’ equity |
|
|
57,499 |
|
|
|
74,492 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
76,332 |
|
|
$ |
80,830 |
|