UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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:
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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 May 12, 2023, Impel Pharmaceuticals Inc. issued a press release announcing its financial results for the quarter ended March 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this report.
The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities 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 No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURE
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.
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IMPEL PHARMACEUTICALS, INC. |
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Date: May 12, 2023 |
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By: |
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/s/ Michael Kalb |
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Michael Kalb |
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Chief Financial Officer |
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IMPEL PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Trudhesa® Achieved nTRx of Over 18.5K in Q1 2023; Increase of 112% vs. Q1 2022
Trudhesa Net Product Revenue in Q1 2023 Increased 149% vs. Q1 2022 to $4.4 Million
Impel to Host Investor Conference Call Today at 8:30 a.m. ET
SEATTLE, May 12, 2023 — Impel Pharmaceuticals Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today reported financial results for the first quarter ended March 31, 2023 and provided a business update.
“Following our strategic reprioritization to focus the company on maximizing the growth potential of Trudhesa®, we are pleased with the significant increases in reimbursed prescriptions and new patient starts over the first quarter of 2023,” said Adrian Adams, Chairman of the Board and Chief Executive Officer of Impel Pharmaceuticals. “Additionally, the ongoing feedback we are receiving from our growing prescriber base on the compelling safety and efficacy profile of Trudhesa reinforces the value-creation opportunity for our shareholders. This is further reflected in the prescription momentum we are seeing in the second quarter of this year.”
Recent Corporate Highlights
Trudhesa® (Dihydroergotamine Mesylate) Nasal Spray (0.725 Mg Per Spray)
Company Developments
Financial Results for First Quarter 2023
Trudhesa Guidance for 2023
Conference Call Information
Impel Pharmaceuticals’ Executive Management will host a live conference call and webcast at 8:30 a.m. ET today to discuss the first quarter 2023 financial results and provide a corporate and business update. To access the live conference call, please register using the conference link: Conference Registration (vevent.com). A live webcast of the event will be available on the Investors section of the Impel Pharmaceuticals website at https://investors.impelpharma.com/. A replay of the webcast and accompanying slides will be available on the Impel Pharmaceuticals website following the event.
About Impel Pharmaceuticals
Impel Pharmaceuticals is a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs. Impel offers treatments that pair its proprietary POD® technology with well-established therapeutics. In September 2021, Impel received U.S. FDA approval for its first product, Trudhesa® nasal spray, which is approved in the U.S. for the acute treatment of migraine with or without aura in adults. In addition to Trudhesa, the Company continues to address patient needs via licensing and partnerships.
About Impel’s Precision Olfactory Delivery (POD®) Technology:
Impel’s proprietary POD® technology is able to deliver a range of therapeutic molecules and formulations into the vascular-rich upper nasal space, believed to be a gateway for unlocking the previously unrealized full potential of these molecules. By delivering predictable doses of drug directly to the upper nasal space, Impel’s precision performance technology has the goal of enabling increased and consistent absorption of drug, overriding the high variability associated with other nasal delivery systems, yet without the need for an injection. While an ideal target for drug administration, to date no technology has been able to consistently deliver drugs to the upper nasal space. By utilizing this route of administration, Impel Pharmaceuticals has been able to demonstrate blood concentration levels for its investigational therapies that are comparable to intramuscular (IM) administration and can even reach intravenous (IV)-like systemic levels quickly, which could transform the treatment landscape for a broad range of disorders. Importantly, the POD® technology offers propellant-enabled delivery of dry powder and liquid formulations that eliminates the need for coordination of breathing, allowing for self- or caregiver-administration in a manner that may improve patient outcome, comfort, and potentially, compliance.
About Trudhesa®
Indication
Trudhesa® is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.
Important Safety Information
Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together. |
Do not use Trudhesa if you:
Before taking Trudhesa, tell your doctor if:
The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis. Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.
You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.
Contact your doctor immediately if you experience:
The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.Trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.
Cautionary Note on Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential clinical benefits of Trudhesa®, the market opportunities of Trudhesa within the migraine market, the speed of uptake and market growth of Trudhesa, the effectiveness of the Trudhesa sales force, and Impel’s cash runway. Forward-looking statements can be identified by words such as: “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. These statements are subject to numerous risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including but not limited to, Impel’s ability to maintain regulatory approval of Trudhesa, its ability to execute its commercialization strategy for Trudhesa, its ability to develop, manufacture and commercialize any other product candidates including plans to address additional indications for which Impel may pursue regulatory approval, and the effects of macroeconomic conditions on business operations and any future clinical programs. Many of these risks are described in greater detail in Impel’s filings with the Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date of this press release. Impel 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.
Impel, POD, Trudhesa and the Impel logo are registered trademarks of Impel Pharmaceuticals Inc. To learn more about Impel Pharmaceuticals, please visit our website at https://impelpharma.com.
Impel Pharmaceuticals Inc. |
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For the Three Months Ended |
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2023 |
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2022 |
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Product revenue, net |
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4,372 |
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$ |
1,759 |
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Cost of goods sold |
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2,285 |
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1,033 |
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Gross profit |
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2,087 |
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726 |
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Operating expenses: |
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Research and development |
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3,003 |
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3,650 |
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Selling, general and administrative |
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22,037 |
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19,799 |
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Restructuring |
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1,483 |
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— |
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Total operating expenses |
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26,523 |
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23,449 |
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Loss from operations |
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(24,436 |
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(22,723 |
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Other income (expense), net : |
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Interest income (expense), net |
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(2,933 |
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(4,427 |
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Other income (expense), net |
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(2,698 |
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180 |
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Total other income (expense), net |
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(5,631 |
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(4,247 |
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Loss before income taxes |
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(30,067 |
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(26,970 |
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Provision (benefit) for income taxes |
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— |
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— |
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Net loss and comprehensive loss |
$ |
(30,067 |
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$ |
(26,970 |
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Net loss per share, basic and diluted |
$ |
(1.27 |
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$ |
(1.17 |
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Weighted-average shares used in computing net loss per share — basic and diluted |
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23,745,871 |
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23,143,773 |
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IMPEL PHARMACEUTICALS INC. |
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March 31, 2023 |
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December 31, 2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
35,465 |
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$ |
60,654 |
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Trade receivables, net |
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6,280 |
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7,444 |
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Inventory |
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8,014 |
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8,427 |
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Prepaid expenses and other current assets |
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2,125 |
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3,284 |
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Total current assets |
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51,884 |
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79,809 |
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Property and equipment, net |
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4,081 |
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3,863 |
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Operating lease right-of-use assets |
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4,833 |
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3,132 |
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Other assets |
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3,931 |
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1,746 |
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Total assets |
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$ |
64,729 |
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$ |
88,550 |
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Liabilities and stockholders’ (deficit) equity |
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Current liabilities: |
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Accounts payable |
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$ |
6,133 |
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$ |
6,092 |
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Accrued liabilities and other liabilities |
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11,723 |
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12,503 |
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Current portion of deferred royalty obligation |
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2,690 |
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2,027 |
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Current portion of operating lease liability |
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1,736 |
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1,541 |
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Total current liabilities |
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22,282 |
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22,163 |
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Operating lease liability, net of current portion |
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3,074 |
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1,573 |
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Deferred royalty obligation, net of current portion |
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64,183 |
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60,899 |
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Long-term debt |
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48,095 |
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48,072 |
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Total liabilities |
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137,634 |
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132,707 |
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Commitments and contingencies |
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Stockholders’ (deficit) equity: |
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Preferred stock, $0.001 par value; 10,000,000 shares authorized: none issued |
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— |
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— |
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Common stock, $0.001 par value; 300,000,000 shares authorized; 23,746,257 and 23,739,313 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively |
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24 |
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24 |
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Additional paid-in capital |
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278,248 |
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276,929 |
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Accumulated deficit |
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(351,177 |
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(321,110 |
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Total stockholders’ (deficit) equity |
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(72,905 |
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(44,157 |
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Total liabilities and stockholders’ (deficit) equity |
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$ |
64,729 |
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$ |
88,550 |
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Contact:
Investor Relations:
Christina Tartaglia
Stern Investor Relations
Phone: (1) 212-362-1200
Email: christina.tartaglia@sternir.com
Media Relations:
Melyssa Weible
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: mweible@elixirhealthpr.com