UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): November 16, 2020
Windtree Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
000-26422 |
94-3171943 |
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(State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
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2600 Kelly Road, Suite 100, Warrington, Pennsylvania |
18976 |
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(Address of principal executive offices) |
(Zip Code) |
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Registrant’s telephone number, including area code: (215) 488-9300
Not Applicable
(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 (see General Instruction A.2. below):
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
WINT |
The Nasdaq Capital 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. ☐
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Item 2.02 |
Results of Operations and Financial Condition |
On November 16, 2020, Windtree Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2020. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
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Item 7.01 |
Regulation FD Disclosure |
On November 16, 2020, the Company released an investor presentation to be used in presentations to investors from time to time. A copy of this investor presentation is attached hereto as Exhibit 99.2.
The information contained in each of Item 2.02 (including Exhibit 99.1) and Item 7.01 (including Exhibit 99.2) is being furnished and 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 and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
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Exhibit |
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Document |
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99.1 |
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| 99.2 | Windtree Therapeutics, Inc. Investor Presentation |
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, thereunto duly authorized.
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Windtree Therapeutics, Inc. |
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By: |
/s/ Craig Fraser |
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Name: |
Craig Fraser |
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Title: |
President and Chief Executive Officer |
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Date: November 16, 2020
Exhibit 99.1
Windtree Therapeutics Reports Third Quarter 2020
Financial Results and Provides Key Business Updates
WARRINGTON, PA – November 16, 2020 – Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today reported financial results for the third quarter ended September 30, 2020 and provided key business updates.
Key Business and Financial Updates
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Announced the dosing of the first patient in the Company’s Phase 2 study of istaroxime for the acute treatment of early cardiogenic shock. The Phase 2 study is an international, randomized, double blind, placebo controlled study to assess the effect of istaroxime in patients with early cardiogenic shock due to heart failure. This study will include 60 patients (30 assigned to istaroxime and 30 assigned to placebo) receiving study drug infusion over 24 hours. The primary endpoint is the change in systolic blood pressure over six hours after initiating the infusion. Secondary endpoints will include characterization of blood pressure changes over 24 hours, the number of patients requiring rescue therapy (vasopressors, inotropes or mechanical devices), assessment of renal function and measures associated with safety and tolerability. |
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Announced U.S. Food and Drug Administration (FDA) acceptance of an Investigational New Drug application for a Phase 2 clinical trial studying lyophilized lucinactant, its synthetic KL4 surfactant, in COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS) patients. The initial study will evaluate changes in physiological parameters in patients who are intubated and mechanically ventilated for COVID-19 associated lung injury and ARDS. The study will evaluate the dosing regimen, tolerability, and functional changes in gas exchange and lung compliance after KL4 surfactant administration. The Company plans to enroll up to 20 patients with COVID-19 and ARDS who are on mechanical ventilation, from 4 to 5 U.S. sites beginning in the fourth quarter with results expected in one to two quarters. |
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With Windtree focused on KL4 surfactant development in COVID-19 lung Injury, it has been decided Lee’s Pharmaceutical (HK) (the license partner for KL4 surfactant in Asia) will execute the AEROSURF bridge study in premature infants with respiratory distress syndrome (RDS) within its licensed territory. Lee’s will continue to fund clinical development of Aerosurf with Windtree providing technical support. |
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Presented a corporate overview at the virtual H.C. Wainwright 22nd Annual Global Investment Conference in September. |
“Windtree has made significant progress on advancing our clinical and regulatory goals over the past quarter,” said Craig Fraser, president, and chief executive officer of Windtree. “With the IND acceptance by the FDA, we expect to start our clinical trial for the treatment of COVID-19 associated lung injury in the next several weeks. We are working with top insitutions and investigators and both interest and urgency for the study has only increased given the recent surge in COVID-19 rates and the further understanding of the harmful impact of the virus on these patients’ lungs. In the third quarter we were also pleased to start dosing in our Phase 2 trial of istaroxime for the treatment of early cardiogenic shock in heart failure patients and will continue to work to expand sites to ramp enrollment for this trial globally. We continue to focus on the successful execution of our planned upcoming milestones this quarter, and anticipate 2021 to be another meaningful year with important milestones and pipeline progress including the planned start of the next acute heart failure study with istaroxime.”
Select Financial Results for the Third Quarter ended September 30, 2020
For the third quarter ended September 30, 2020, the Company reported an operating loss of $8.7 million, compared to an operating loss of $7.2 million in the third quarter of 2019.
Research and development expenses were $3.9 million for the third quarter of 2020, compared to $3.8 million for the third quarter of 2019. The increase in research and development expenses is primarily due to increases in clinical program costs.
General and administrative expenses for the third quarter of 2020 were $4.8 million, compared to $3.4 million for the third quarter of 2019. The increase in general and administrative expenses is primarily due to an increase in professional fees and $0.9 million in severance costs associated with the departure of two exectuives during the third quarter of 2020.
The Company reported a net loss of $9.0 million ($0.54 per basic share) on 16.6 million weighted-average common shares outstanding for the quarter ended September 30, 2020, compared to a net loss of $7.1 million ($0.66 per basic share) on 10.7 million weighted average common shares outstanding for the comparable period in 2019.
As of September 30, 2020, the Company reported cash and cash equivalents of $22.4 million which is expected to be sufficient to fund operations through at least the next twelve months.
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which will be filed with the Securities and Exchange Commission on November 16, 2020, which includes detailed discussions about the Company’s business plans and operations, financial condition and results of operations.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis. Using new clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate istaroxime being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock in heart failure. Windtree has also focused on developing AEROSURF® as a non-invasive surfactant treatment for premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee’s HK, while Windtree evaluates other uses for its synthetic KL4 surfactant for the treatment of acute pulmonary conditions including lung injury due to COVID-19 infection. Also in its portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
For more information, please visit the Company's website at www.windtreetx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company's clinical trials or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime, AEROSURF®, KL4 surfactant and the Company's other product candidates; the Company's ability to secure significant additional capital as and when needed; the Company's ability to access the debt or equity markets; the Company's ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company's clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company's product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company's efforts to maintain and protect the patents and licenses related to its product candidates; risks related to the size and growth potential of the markets for the Company's product candidates, and the Company's ability to service those markets; the Company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; and the rate and degree of market acceptance of the Company's product candidates, if approved. These and other risks are described in the Company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contact Information:
Monique Kosse
LifeSci Advisors
212.915.3820 or monique@lifesciadvisors.com
Media contact:
Darren Opland, Ph.D.
LifeSci Communications
646.627.8387 or darren@lifescicomms.com
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
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September 30, |
December 31, |
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Unaudited |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
$ | 22,356 | $ | 22,578 | ||||
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Prepaid expenses and other current assets |
1,692 | 1,283 | ||||||
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Total current assets |
24,048 | 23,861 | ||||||
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Property and equipment, net |
702 | 798 | ||||||
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Restricted cash |
154 | 154 | ||||||
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Operating lease right-of-use assets |
855 | 1,390 | ||||||
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Intangible assets |
77,090 | 77,090 | ||||||
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Goodwill |
15,682 | 15,682 | ||||||
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Total assets |
$ | 118,531 | $ | 118,975 | ||||
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LIABILITIES & STOCKHOLDERS' EQUITY |
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Current Liabilities: |
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Accounts payable |
$ | 726 | $ | 1,708 | ||||
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Collaboration and device development payable, net |
- | 1,972 | ||||||
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Accrued expenses |
4,279 | 3,226 | ||||||
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Operating lease liabilities - current portion |
605 | 750 | ||||||
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Loans payable - current portion |
704 | 161 | ||||||
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Total current liabilities |
6,314 | 7,817 | ||||||
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Operating lease liabilities - non-current portion |
358 | 794 | ||||||
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Loans payable - non-current portion |
2,364 | 4,608 | ||||||
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Restructured debt liability - contingent milestone payments |
15,000 | 15,000 | ||||||
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Other liabilities |
2,400 | - | ||||||
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Deferred tax liabilities |
16,370 | 15,821 | ||||||
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Total liabilities |
42,806 | 44,040 | ||||||
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Stockholders' Equity: |
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019 |
- | - | ||||||
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Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2020 and December 31, 2019; 16,921,506 and 13,697,419 shares issued at September 30, 2020 and December 31, 2019, respectively; 16,921,482 and 13,697,395 shares outstanding at September 30, 2020 and December 31, 2019, respectively |
17 | 14 | ||||||
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Additional paid-in capital |
788,996 | 763,097 | ||||||
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Accumulated deficit |
(710,234 |
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(685,122 |
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Treasury stock (at cost); 24 shares |
(3,054 |
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(3,054 |
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Total stockholders' equity |
75,725 | 74,935 | ||||||
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Total liabilities & stockholders' equity |
$ | 118,531 | $ | 118,975 | ||||
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
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Three Months Ended |
Nine Months Ended |
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September 30, |
September 30, |
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2020 |
2019 |
2020 |
2019 |
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Revenues: |
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License revenue with affiliate |
$ | - | $ | - | $ | - | $ | 198 | ||||||||
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Total revenues |
- | - | - | 198 | ||||||||||||
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Expenses: |
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Research and development |
3,882 | 3,792 | 11,838 | 10,547 | ||||||||||||
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General and administrative |
4,823 | 3,395 | 11,518 | 9,990 | ||||||||||||
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Total operating expenses |
8,705 | 7,187 | 23,356 | 20,537 | ||||||||||||
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Operating loss |
(8,705 |
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(7,187 |
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(23,356 |
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(20,339 |
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Other (expense) income: |
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Interest income |
21 | 25 | 115 | 124 | ||||||||||||
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Interest expense |
(46 |
) |
(105 |
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(121 |
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(358 |
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Other (expense) income, net |
(290 |
) |
141 | (1,750 |
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473 | ||||||||||
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Total other (expense) income, net |
(315 |
) |
61 | (1,756 |
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239 | ||||||||||
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Net loss |
$ | (9,020 |
) |
$ | (7,126 |
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$ | (25,112 |
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$ | (20,100 |
) |
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Net loss per common share |
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Basic and diluted |
$ | (0.54 |
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$ | (0.66 |
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$ | (1.65 |
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$ | (1.87 |
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Weighted average number of common shares outstanding |
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Basic and diluted |
16,579 | 10,730 | 15,228 | 10,724 | ||||||||||||
Exhibit 99.2
