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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Newellis Inc | NASDAQ:NUWE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.01 | -0.72% | 1.37 | 1.36 | 1.37 | 1.45 | 1.34 | 1.39 | 92,497 | 15:50:55 |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
No.
|
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
|
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|
|
Smaller reporting company
|
|
Emerging growth company
|
Page Number
|
||
PART I—FINANCIAL INFORMATION
|
||
Item 1
|
3 | |
3
|
||
4
|
||
5 | ||
6 | ||
7 | ||
Item 2
|
15 | |
Item 3
|
23
|
|
Item 4
|
23
|
|
PART II—OTHER INFORMATION
|
||
Item 1
|
23
|
|
Item 1A
|
24
|
|
Item 2
|
26
|
|
Item 3
|
26
|
|
Item 4
|
26
|
|
Item 5
|
26
|
|
Item 6
|
26
|
June 30,
2024
|
December 31,
2023
|
|||||||
ASSETS
|
(Unaudited) |
|||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Accounts receivable
|
|
|
||||||
Inventories, net
|
|
|
||||||
Other current assets
|
|
|
||||||
Total current assets
|
|
|
||||||
Property, plant and equipment, net
|
|
|
||||||
Operating lease right-of-use asset
|
|
|
||||||
Other assets
|
|
|
||||||
TOTAL ASSETS
|
$
|
|
$
|
|
||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current liabilities
|
||||||||
Accounts payable and accrued liabilities
|
$
|
|
$
|
|
||||
Accrued compensation
|
|
|
||||||
Current portion of operating lease liability
|
|
|
||||||
Other current liabilities
|
|
|
||||||
Total current liabilities
|
|
|
||||||
Common stock warrant liability
|
||||||||
Operating lease liability
|
|
|
||||||
Total liabilities
|
|
|
||||||
Commitments and contingencies
|
||||||||
Mezzanine Equity
Series J Convertible Preferred Stock as of June 30, 2024 and December 31, 2023, par value $
|
||||||||
Stockholders’ equity (deficit)
|
||||||||
Series A junior participating preferred stock as of June 30,
2024 and December 31,
2023, par value $
|
|
|
||||||
Series F convertible preferred stock as of June 30, 2024 and December 31, 2023, par value $
|
||||||||
Preferred stock as of June 30, 2024 and December 31, 2023, par value $
|
|
|
||||||
Common stock as of June 30, 2024 and December 31, 2023, par value $
|
|
|
||||||
Additional paid‑in capital
|
|
|
||||||
Accumulated other comprehensive income:
|
||||||||
Foreign currency translation adjustment
|
(
|
)
|
(
|
)
|
||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ equity (deficit)
|
(
|
)
|
|
|||||
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$
|
|
$
|
|
Three months ended
June 30
|
Six months ended
June 30
|
|||||||||||||||
2024
|
2023
|
2024 | 2023 | |||||||||||||
Net sales
|
$
|
|
$
|
|
$ | $ | ||||||||||
Cost of goods sold
|
|
|
||||||||||||||
Gross profit
|
|
|
||||||||||||||
Operating expenses:
|
||||||||||||||||
Selling, general and administrative
|
|
|
||||||||||||||
Research and development
|
|
|
||||||||||||||
Total operating expenses
|
|
|
||||||||||||||
Loss from operations
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Other income (expense), net
|
|
|
( |
) | ||||||||||||
Financing Expense
|
( |
) | ( |
) | ||||||||||||
Change in fair value of warrant liability
|
( |
) | ||||||||||||||
Loss before income taxes
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Income tax expense
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Deemed dividend attributable to Series J Convertible Preferred Stock
|
||||||||||||||||
Net loss attributable to common shareholders
|
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Basic and diluted loss per share
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Weighted average shares outstanding – basic and diluted
|
|
|
||||||||||||||
Other comprehensive loss:
|
||||||||||||||||
Foreign currency translation adjustments
|
$
|
(
|
)
|
$
|
|
$ | ( |
) | $ | ( |
) | |||||
Total comprehensive loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) |
Outstanding
Shares of
Common
Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2022
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||
Net loss
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Unrealized foreign currency translation adjustment
|
— | ( |
) | ( |
) | |||||||||||||||||||
Unrealized gain on marketable securities
|
— | |||||||||||||||||||||||
Stock-based compensation
|
|
|
|
|
|
|
||||||||||||||||||
Issuance costs related to 2022 common stock offering
|
— | ( |
) | ( |
) | |||||||||||||||||||
Issuance of common stock from Preferred Series I stock conversions
|
||||||||||||||||||||||||
Reclassification of warrants to equity |
— | |||||||||||||||||||||||
Issuance of common stock from exercise of warrants
|
||||||||||||||||||||||||
Balance March 31, 2023
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||
Net loss
|
— |
( |
) | ( |
) | |||||||||||||||||||
Unrealized foreign currency translation adjustment |
— | ( |
) | |||||||||||||||||||||
Unrealized gain on marketable securities |
— | ( |
) | ( |
) | |||||||||||||||||||
Stock-based compensation
|
||||||||||||||||||||||||
Issuance costs related to ATM offering |
— | ( |
) | ( |
) | |||||||||||||||||||
Issuance of common stock from ATM offering |
||||||||||||||||||||||||
Balance June 30, 2023
|
$ | $ | $ | ( |
) | $ | ( |
) | $ |
Outstanding
Shares of
Common
Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
|||||||||||
Net loss
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Unrealized foreign currency translation adjustment
|
— | ( |
) | ( |
) | |||||||||||||||||||
Stock-based compensation
|
|
|
|
|
|
|
||||||||||||||||||
Issuance of common stock from conversion of Series J Convertible Preferred Stock
|
||||||||||||||||||||||||
Series J Convertible Preferred Stock deemed dividend
|
— | |||||||||||||||||||||||
Balance March 31, 2024
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
|||||||||||
Net loss
|
— |
( |
) | ( |
) | |||||||||||||||||||
Unrealized foreign currency translation adjustment
|
— | ( |
) | ( |
) | |||||||||||||||||||
Stock-based compensation
|
||||||||||||||||||||||||
Issuance of common stock, net |
( |
) | ( |
) | ||||||||||||||||||||
Balance June 30, 2024
|
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) |
Six months ended
June 30
|
||||||||
2024
|
2023
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to cash flows used in operating activities:
|
||||||||
Depreciation and amortization
|
|
|
||||||
Stock-based compensation expense
|
|
|
||||||
Change in fair value of warrant liability
|
( |
) | ||||||
Warrant financing costs
|
||||||||
Net realized gain on marketable securities
|
( |
) | ||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
|
|
||||||
Inventory, net
|
|
(
|
)
|
|||||
Other current assets
|
(
|
)
|
(
|
)
|
||||
Other assets and liabilities
|
|
(
|
)
|
|||||
Accounts payable and accrued expenses
|
|
(
|
)
|
|||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Investing Activities:
|
||||||||
Proceeds from sale of marketable securities
|
||||||||
Additions to intangible assets
|
( |
) | ||||||
Purchases of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash provided by (used in) investing activities
|
(
|
)
|
|
|||||
Financing Activities:
|
||||||||
Issuance of common stock from offering
|
||||||||
Proceeds from the exercise of Series J Convertible Preferred Warrants
|
||||||||
Proceeds from ATM stock offerings, net
|
||||||||
Net cash provided by financing activities |
|
|
||||||
Effect of exchange rate changes on cash
|
(
|
)
|
(
|
)
|
||||
Net decrease in cash and cash equivalents
|
(
|
)
|
(
|
)
|
||||
Cash and cash equivalents - beginning of period
|
|
|
||||||
Cash and cash equivalents - end of period
|
$
|
|
$
|
|
||||
Supplemental cash flow information |
||||||||
Issuance of Series J Preferred Stock for exercise of Warrants
|
$ | $ | ||||||
Issuance of Common Stock for conversion of Series J Preferred Stock
|
$ | $ | ||||||
Deemed dividend on Series J Preferred Stock
|
$ | ( |
) | $ | ||||
Common stock offering costs included in prepaids
|
$ | $ |
(in thousands)
|
June 30,
2024
|
December 31,
2023
|
||||||
Finished Goods
|
$
|
|
$
|
|
||||
Work in Process
|
|
|
||||||
Raw Materials
|
|
|
||||||
Inventory Reserves |
( |
) | ( |
) | ||||
Total
|
$
|
|
$
|
|
June 30
|
||||||||
2024
|
2023
|
|||||||
Stock options
|
|
|
||||||
Warrants to purchase common stock
|
|
|
||||||
Series F convertible preferred stock
|
|
|
||||||
Series J convertible preferred stock | ||||||||
Total
|
|
|
Three months ended
June 30
|
Six months ended
June 30
|
|||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
(in thousands, except per share amounts)
|
||||||||||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Deemed dividend attributable to Series J Convertible Preferred Stock
|
||||||||||||||||
Net loss attributable to common shareholders |
$ |
( |
) | $ |
( |
) | $ |
( |
) | $ |
( |
) | ||||
Weighted average shares outstanding
|
|
|
||||||||||||||
Basic and diluted loss per share
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) |
Three months ended
June 30
|
Six
months ended
June 30
|
|||||||||||||||
(in thousands)
|
2024
|
2023
|
2024
|
2023
|
||||||||||||
Selling, general and administrative expense
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Research and development expense
|
|
|
|
|
||||||||||||
Total stock-based compensation expense
|
$
|
|
$
|
|
$
|
|
$
|
|
Three months ended
|
Six months ended
|
|||||||||||||||
June 30
|
June 30
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
Expected volatility
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Expected Life of options (years)
|
|
|
|
|
||||||||||||
Expected dividend yield
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Risk-free interest rate
|
|
%
|
|
%
|
|
%
|
|
%
|
●
|
Level 1 - Financial instruments with unadjusted quoted prices listed on active market exchanges.
|
●
|
Level 2 - Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over-the-counter traded financial instruments. The prices for the financial instruments are determined using prices for
recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.
|
●
|
Level 3 - Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using
significant unobservable inputs or valuation techniques.
|
(in thousands)
|
||||
Balance at December 31, 2022
|
$
|
|
||
Change in fair value
|
|
|||
Issuance of Common Stock for exercise of Series I warrants |
( |
) | ||
October 17, 2023, issuance of Series J warrants | ||||
Exercise of Series J warrants | ( |
) | ||
Change in fair value | ( |
) | ||
Balance at December 31, 2023
|
|
|||
Exercise of Series J warrants
|
( |
) | ||
April 30, 2024, issuance of common warrants | |
|||
Change in fair value |
( |
) | ||
Balance at June 30, 2024 | $ |
Three months ended
June 30, 2024
|
Three months ended
June 30, 2023
|
Increase (Decrease)
|
% Change
|
|||||||||||
$
|
2,194
|
$
|
2,075
|
$
|
119
|
5.7
|
%
|
(in thousands)
|
Three months ended
June 30, 2024
|
Three months ended
June 30, 2023
|
Increase (Decrease)
|
% Change
|
|||||||||||||
Cost of goods sold
|
$
|
720
|
$
|
928
|
$
|
(208
|
)
|
(22.4
|
)%
|
||||||||
Selling, general and administrative
|
$
|
3,236
|
$
|
4,664
|
$
|
(1,428
|
)
|
(30.6
|
)% | ||||||||
Research and development
|
$
|
558
|
$
|
1,505
|
$
|
(947
|
)
|
(62.9
|
)% |
Six months ended
June 30, 2024
|
Six months ended
June 30, 2023
|
Increase (Decrease)
|
% Change
|
|||||||||||
$
|
4,051
|
$
|
3,901
|
$
|
150
|
3.8
|
%
|
(in thousands)
|
Six months ended
June 30, 2024
|
Six months ended
June 30, 2023
|
Increase (Decrease)
|
% Change
|
|||||||||||||
Cost of goods sold
|
$
|
1,386
|
$
|
1,687
|
$
|
(301
|
)
|
(17.8
|
)%
|
||||||||
Selling, general and administrative
|
$
|
7,842
|
$
|
10,154
|
$
|
(2,312
|
)
|
(22.8
|
)%
|
||||||||
Research and development
|
$
|
1,892
|
$
|
2,933
|
$
|
(1,041
|
)
|
(35.5
|
)%
|
ITEM 2.
|
UNREGISTERED SALES OF EQUITY SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
Incorporated By Reference
|
|||||||||||||
Exhibit
Number |
Exhibit Description
|
Form
|
File
Number |
Date of First Filing
|
Exhibit
Number |
Filed
Herewith |
Furnished Herewith
|
||||||
|
Fourth Amended and Restated Certificate of Incorporation
|
10
|
001-35312
|
February 1, 2012
|
3.1
|
||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
January 13, 2017
|
3.1
|
||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
May 23, 2017
|
3.1
|
||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
October 12, 2017
|
3.1
|
||||||||
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K/A
|
001-35312
|
October 16, 2020
|
3.1
|
|||||||||
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
January 2, 2019
|
3.1
|
|||||||||
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
April 27, 2021
|
3.1
|
|||||||||
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
December 9, 2022
|
3.1
|
|||||||||
Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
June 26, 2024
|
3.1
|
|||||||||
Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock
|
S-1/A
|
333-221010
|
November 17, 2017
|
3.7
|
|||||||||
Certificate of Designation of Preferences, Rights and Limitations of Series J Convertible Preferred Stock
|
8-K
|
001-35312
|
October 17, 2023
|
3.1
|
|||||||||
Second Amended and Restated Bylaws
|
8-K
|
001-35312
|
April 27, 2021
|
3.2
|
Incorporated By Reference
|
|||||||||||||
Exhibit
Number |
Exhibit Description
|
Form
|
File
Number |
Date of First Filing
|
Exhibit
Number |
Filed
Herewith |
Furnished Herewith
|
Amendment to Second Amended and Restated Bylaws
|
8-K
|
001-35312
|
October 5, 2022
|
3.1
|
|||||||||
Form of Warrant to Purchase Shares of Common Stock
|
8-K
|
001-35312
|
May 1, 2024
|
4.1
|
|||||||||
Form of Pre-Funded Warrant to Purchase Shares of Common Stock
|
8-K
|
001-35312
|
May 1, 2024
|
4.2
|
|||||||||
Form of Common Warrant
|
8-K
|
001-35312
|
July 25, 2024
|
4.1
|
|||||||||
Form of Warrant Agency Agreement
|
8-K
|
001-35312
|
May 1, 2024
|
4.3
|
|||||||||
Form of Securities Purchase Agreement, dated as of April 26, 2024, by and among Nuwellis, Inc. and the purchasers identified on the signature pages thereto
|
8-K
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001-35312
|
May 1, 2024
|
10.1
|
|||||||||
Placement Agency Agreement dated as of April 26, 2024, by and between Nuwellis, Inc. and Roth Capital Partners, LLC
|
8-K
|
001-35312
|
May 1, 2024
|
1.1
|
|||||||||
First Amendment to Supply and Collaboration Agreement dated as of May 31, 2024 by and between the Company and DaVita Inc.
|
8-K
|
001-35312
|
June 6, 2024
|
10.1
|
|||||||||
Form of Securities Purchase Agreement
|
8-K
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001-35312
|
July 25, 2024
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10.2
|
|||||||||
Placement Agency Agreement dated July 24, 2024 between Nuwellis, Inc. and Roth Capital Partners LLC
|
8-K
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001-35312
|
July 25,2024
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10.1
|
|||||||||
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
101.INS
|
Inline XBRL Instance Document
|
X
|
|||||||||||
101.SCH
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Inline XBRL Taxonomy Extension Schema Document
|
X
|
Incorporated By Reference
|
||||||||||||
Exhibit Number |
Exhibit Description
|
Form
|
File Number |
Date of First Filing | Exhibit Number |
Filed Herewith |
Furnished Herewith | |||||
101.CAL
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Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
|
X | |||||||||
101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
|
X | |||||||||
101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|
X | |||||||||
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
|
X |
104
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
|
X
|
Nuwellis, Inc.
|
|||
Date: August 13, 2024
|
By:
|
/s/ Nestor Jaramillo, Jr.
|
|
Nestor Jaramillo, Jr.
|
|||
President and Chief Executive Officer
|
|||
Date: August 13, 2024
|
By:
|
/s/ Robert Scott
|
|
Robert Scott
|
|||
Chief Financial Officer
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Nuwellis, Inc. for the quarterly period ended June 30, 2024;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report;
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the
case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the
registrant’s board of directors (or persons performing the equivalent functions):
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Nestor Jaramillo, Jr.
|
||
President and Chief Executive Officer
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Nuwellis, Inc. for the quarterly period ended June 30, 2024.
|
3. |
4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end
of the period covered by this report based on such evaluation; and
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the
case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Robert Scott
|
||
Robert Scott
|
||
Chief Financial Officer
|
/s/ Nestor Jaramillo, Jr.
|
||
Nestor Jaramillo, Jr.
|
||
President and Chief Executive Officer
|
(1) |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Robert Scott
|
||
Robert Scott
|
||
Chief Financial Officer
|
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
|
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||
Net sales | $ 2,194 | $ 2,075 | $ 4,051 | $ 3,901 |
Cost of goods sold | 720 | 928 | 1,386 | 1,687 |
Gross profit | 1,474 | 1,147 | 2,665 | 2,214 |
Operating expenses: | ||||
Selling, general and administrative | 3,236 | 4,664 | 7,842 | 10,154 |
Research and development | 558 | 1,505 | 1,892 | 2,933 |
Total operating expenses | 3,794 | 6,169 | 9,734 | 13,087 |
Loss from operations | (2,320) | (5,022) | (7,069) | (10,873) |
Other income (expense), net | 6 | 179 | (95) | 302 |
Financing Expense | (5,607) | 0 | (5,607) | 0 |
Change in fair value of warrant liability | 198 | 0 | 720 | (755) |
Loss before income taxes | (7,723) | (4,843) | (12,051) | (11,326) |
Income tax expense | (2) | (2) | (4) | (4) |
Net loss | (7,725) | (4,845) | (12,055) | (11,330) |
Deemed dividend attributable to Series J Convertible Preferred Stock | 0 | 0 | 541 | 0 |
Net loss attributable to common shareholders | $ (7,725) | $ (4,845) | $ (11,514) | $ (11,330) |
Basic loss per share (in dollars per share) | $ (18.85) | $ (127.65) | $ (40.91) | $ (323.15) |
Diluted loss per share (in dollars per share) | $ (18.85) | $ (127.65) | $ (40.91) | $ (323.15) |
Weighted average shares outstanding - basic (in shares) | 409,690 | 37,949 | 294,649 | 35,060 |
Weighted average shares outstanding - diluted (in shares) | 409,690 | 37,949 | 294,649 | 35,060 |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | $ (2) | $ 1 | $ (11) | $ (6) |
Total comprehensive loss | $ (7,727) | $ (4,844) | $ (12,066) | $ (11,336) |
Nature of Business and Basis of Presentation |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Nature of Business and Basis of Presentation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Nature of Business and Basis of Presentation |
Note 1 –
Nature of Business and Basis of Presentation
Nature of Business: Nuwellis, Inc. (the “Company”) is a medical technology company focused on developing, manufacturing, and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively,
the “Aquadex System”) for ultrafiltration therapy. The Aquadex System is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg. or
more whose fluid overload is unresponsive to medical management, including diuretics. Nuwellis, Inc. is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Ireland. The Company’s common stock began trading on the
Nasdaq Capital Market in February 2012.
In August 2016, the Company acquired the business associated with the Aquadex System
(the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. On April 27, 2021, the Company announced that it was changing its name from CHF
Solutions, Inc. to Nuwellis, Inc. to reflect the expansion of its customer base from treating fluid imbalance resulting from congestive heart failure to also include critical care and pediatric applications.
Principles of Consolidation: The accompanying condensed consolidated balance sheet as of December 31, 2023, which has been derived from the consolidated audited financial statements, and the unaudited
condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q
and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not
include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial
statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily
indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates.
These condensed
consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2023 and 2022 and through
June 30, 2024, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. Since the company’s inception and as of June 30, 2024, the Company had an accumulated deficit of $299.7 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able
to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the
next twelve months. The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including
investments in its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex
System, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the
Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the
Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability.
On April 30, the Company closed on a best efforts public
offering of 240,571 shares of its common stock, 80,854 shares of its common stock for pre-funded warrants and warrants to purchase up to an aggregate of 482,146 shares of its common stock at a combined public offering price $8.40
per share. All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase
shares of common stock. The warrants
have an exercise price of $14.00 per share, were exercisable immediately upon issuance, and will expire five years following the date of issuance. Each whole common warrant entitles the holder thereof to purchase one share of common stock.The common warrants contain a reset of the exercise price, effective upon the Warrant Stockholder Approval, to a price equal to the
lesser of (i) the then exercise price, (ii) the lowest volume weighted average price for the trading days immediately following
the date we effect a reverse stock split in the future and (iii) if we effect a reverse stock split prior to obtaining the Warrant Stockholder Approval, the lowest volume weighted average price for the five trading days immediately following
the date we obtain the Warrant Stockholder Approval. The Company secured the Warrant Stockholder Approval on June 6, 2024. Subsequent to June 30 2024, the number of shares underlying the common warrants were adjusted to 2,710,734 shares and the exercise price was adjusted to $2.49 per share. In addition, the common warrants provided for, full ratchet anti-dilution adjustment to the exercise price and number of shares underlying the common warrants upon our
issuance of our common stock or common stock equivalents at a price per share that is less than the exercise price of the common warrants, subject to certain exemptions. In no event will the exercise price of the common warrants with respect to
either adjustment be reduced below a floor price of $0.06.
The gross proceeds to the Company from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million.
On July 24, 2024, the Company announced that it had entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 469,340 shares of the Company’s common stock at a price of $4.24 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.
In addition, in a concurrent private placement, the
Company will issue to the investors warrants to purchase up to 938,680 shares of common stock. The warrants have an exercise price
of $3.99 per share, will be exercisable immediately following the date of issuance and will have a term of five years from the date of issuance.
The closing of the registered direct offering and the
concurrent private placement occurred on or about July 25, 2024, subject to the satisfaction of the customary closing conditions.
The gross proceeds to the Company from the registered
direct offering and the concurrent private placement, before deducting the placement agent fees and other offering expenses payable by the Company, were approximately $2.0 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes.
Understanding the near-term need to raise capital, the Company has recently undertaken steps to reduce our monthly cash burn rate by approximately 40%, balanced against our strategic growth initiatives, which will provide more flexibility in anticipation of tougher capital market conditions
for microcap companies like Nuwellis. These reductions include, but are not limited to the following: selected job eliminations, a reduction of the salaries for members of senior management, no merit increases to the base salaries of any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, no cash bonuses to any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, a
reduction in Board of Director and committee fees, temporary suspension of company 401k match, travel reductions, and reductions to select professional services.
The Company believes that its existing capital resources will be
sufficient to support its operating plan through October 31, 2024. However, the Company will seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no
assurance we will be successful in raising additional capital.
Revenue Recognition: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers, which the
Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for
those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended June 30, 2024, two customers represented 16% and 12% of net sales. For the six months ended June 30, 2024, two customers each represented 19% and 11% of net sales. For the three months ended June 30, 2023, two customers represented 16% and 13% of net sales. For the six months ended June 30, 2023, two
customers each represented 14% and 13%
of net sales.
Accounts Receivable: Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its
ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and will provide an allowance for credit
losses when collection becomes doubtful. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related
allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of June
30, 2024, or December 31, 2023. As of June 30, 2024, one customer represented 27% of the
accounts receivable balance. As of December 31, 2023, two customers represented 14% and 15% of the total accounts receivable balance.
Inventories: Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method.
Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following:
Loss per Share: Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding.
See Note 3 – Stockholders’ Equity below for additional disclosures.
Diluted earnings per share is computed based on the net loss
allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been
issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred
stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans.
The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be
anti-dilutive as of the end of each period presented:
The following table reconciles reported net loss with reported net loss per share for each of the three and six months ended June 30:
Subsequent Events: The Company evaluates events
through the date the condensed consolidated financial statements are filed for events requiring adjustment to or disclosure in the condensed consolidated financial statements. See note 9 – Subsequent Events for additional disclosures.
|
Revenue Recognition |
6 Months Ended |
---|---|
Jun. 30, 2024 | |
Revenue Recognition [Abstract] | |
Revenue Recognition |
Note 2 – Revenue Recognition
Net Sales: The Company sells its products in the United States primarily through a direct salesforce. Customers who purchase the Company’s products
include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Belarus, Brazil, Colombia, The Czech
Republic, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Panama, Romania, Singapore, Slovak Republic, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. These distributors resell the Company’s products
to hospitals and clinics in their respective geographies. International revenue represents 3% and 5% of net sales for the three months ended June 30, 2024 and 2023, and 4%
of net sales for both the six months ended June 30,
2024 and 2023, respectively.
Revenue from product sales is recognized when the customer or distributor obtains control of the
product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point unless the customer requests that control
and title to the inventory transfer upon delivery.
Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable
estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations
under the contract. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers whose related revenue is recognized over time. This
revenue represents less than 1% of net sales for the three and six months ended June 30, 2024 and 2023. The unfulfilled performance
obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the condensed consolidated balance sheets. The majority of the deferred revenue is expected to be recognized
within one year.
Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and
remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after
control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold.
Product Returns: The Company
offers customers a limited right of return for its products in case of non-conformity or performance issues. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of
revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using available industry data and its own historical sales and returns information. The Company has received minimal
returns to date and believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns.
|
Stockholders' Equity |
6 Months Ended |
---|---|
Jun. 30, 2024 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity |
Note 3 – Stockholders’ Equity
Series F Convertible Preferred Stock: On November 27, 2017, the Company closed on an underwritten public offering of Series F convertible preferred
stock and warrants to purchase shares of common stock The Series F convertible preferred stock has full ratchet price-based anti-dilution protection, subject to customary carve-outs, in the event of a down-round financing at a price per
share below the conversion price of the Series F convertible preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F convertible preferred stock and the daily dollar trading volume for each trading day during such period exceeds $7,000,000). Effective for every stock offering or reverse stock split, the conversion price of the Series F convertible preferred stock has been
recalculated based on the offering price.
As of July 25, 2024 (the most recent stock
offering), the conversion price of the Series F convertible preferred stock was recalculated to $235.85. As of June 30, 2024 and December
31, 2023, 127 shares of the Series F convertible preferred stock remained outstanding.
2023 At-the-Market Program: In March 2023, the Company filed a Prospectus Supplement to its Registration Statement on Form S-3 with the SEC in connection with a
proposed At-the-Market Securities offering (the “At-the-Market Program”). During 2023, the Company issued 18,781 shares of common
stock under the At-the-Market Program for gross proceeds of approximately $2.3 million. Net proceeds totaled approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company terminated its
At-the-Market Program in July of 2024.
Supply Agreement Warrants: On June 19, 2023, we
entered into a Supply and Collaboration Agreement (the “Supply Agreement”) with DaVita Inc., a Delaware corporation (“DaVita”),
pursuant to which DaVita will pilot the Aquadex ultrafiltration therapy system to treat adult patients with congestive heart failure and related conditions within select U.S. markets. The pilot program is expected to launch by the end of fourth
quarter 2023 and extend through May 31, 2024 (the “Pilot”). On May 31, 2024, DaVita and Nuwellis amended the Supply and Collaboration Agreement extending the Pilot term through August
31, 2024. Through the Pilot, ultrafiltration therapy using Aquadex will be offered at a combination of DaVita’s hospital customer and outpatient center locations, with both companies collaborating on the roll-out of the therapy, clinician
training, and patient support. At the conclusion of the Pilot, DaVita has the option, in its sole discretion, to extend the Supply Agreement with the Company for continued provision of both inpatient and outpatient ultrafiltration services for up
to 10 years (“Ultrafiltration Services Approval”).
In conjunction with the Supply Agreement, the
Company issued DaVita a warrant to purchase up to an aggregate of 36,830 shares of common stock of the Company, par value $0.0001 per share, at an exercise price of $115.49
per share (the “DaVita Warrant”), provided that at no time can the DaVita Warrant be exercised for an amount of shares that would represent greater than 19.9% ownership in the Company subject to certain vesting milestones. The DaVita Warrant is expected to vest in four tranches as follows: (i) 25% upon receipt of notice to extend
the Supply Agreement past the initial pilot-term; (ii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s
efforts pursuant to the Supply Agreement within twelve months of Ultrafiltration Services Approval; (iii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twenty-four months of Ultrafiltration Services Approval; and (iv) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within thirty-six months of Ultrafiltration Services Approval. This warrant had not
vested as of June 30, 2024.
The Company evaluated the accounting treatment for the DaVita Warrant pursuant to ASC
718, “Stock Compensation,” and ASC 480, “Distinguishing Liabilities from Equity,” and concluded that the DaVita Warrant should be classified as an equity instrument on the balance sheet as of June 30, 2024. In accordance with this treatment, the
Company’s management concluded none of the performance-based vesting conditions of the DaVita warrant were probable of vesting as of June 30, 2024, and therefore, no expense associated with the DaVita Warrant was recognized in the Company’s
financial statements as of that date. The Company will continue to evaluate the probability of achieving the performance milestones associated with the DaVita Supply Agreement and will record the related equity-based expense in its financial
statements based on the grant date fair value of the DaVita Warrant when management deems it is probable that the performance-based vesting conditions will be achieved.
October 2023 Offering: On October 12, 2023, Nuwellis, Inc. entered
into a Placement Agency Agreement with Lake Street Capital Markets, LLC and Maxim Group LLC, pursuant to which the Company issued and sold, in a best efforts registered public offering by the Company, 150,000 units, with each Unit consisting of (A) one share of
the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, and (B) one warrant to purchase one-half of one (0.50)
share of Series J Convertible Preferred Stock, at a price to the public of $15.00 per Unit, less placement agent fees and
commissions. The public offering price of $15.00 per Unit reflects the issuance of the Series J Convertible Preferred Stock with an
original issue discount of 40%. The Company also registered under the Registration Statement (as defined below) an additional 362,933 shares of Series J Convertible Preferred Stock that will be issued, if and when the Company’s Board of Directors declares such dividends, as
paid in-kind dividends and the shares of Common Stock issuable upon conversion of the Series J Convertible Preferred Stock issued as PIK dividends.
The Units, the shares of Series J Convertible Preferred Stock, the Warrants, the PIK Dividend Shares, the PIK Conversion Shares as well as the shares of Series J
Convertible Preferred Stock issuable upon exercise of the Warrants and the shares of the Company’s common stock, par value $0.0001 per
share, issuable upon conversion of the Series J Convertible Preferred Stock, were offered and sold by the Company pursuant to an effective registration statement on Form S-1. The closing of the Offering contemplated by the Placement Agency
Agreement occurred on October 17, 2023.
On October 17, 2023, the Company also entered into a warrant agency agreement with the Company’s transfer agent, Equiniti Trust Company, LLC, who will act as warrant
agent for the Company, setting forth the terms and conditions of the Warrants sold in this Offering.
Each Warrant has an exercise price of $262.50 per
one-half of one (0.5) share of Series J Convertible Preferred Stock, is immediately exercisable and will expire three (3) years from the date of issuance.
There is no established trading market for the Series J Convertible Preferred Stock or the Warrants and we do not expect a market to develop. In addition, we do not
intend to list the Series J Convertible Preferred Stock or the Warrants on The Nasdaq Capital Market or any other national securities exchange or any other nationally recognized trading system.
The gross proceeds to the Company from the October 17, 2023, Offering were $2.25 million. Net proceeds were approximately $1.5 million after deducting placement agent fees and
commissions and Offering expenses payable by the Company. The Company used the net proceeds from the Offering for working capital and for general corporate purposes.
The Series J Convertible Preferred Stock is classified as mezzanine equity and
accreted to reflect its redemption value as of each reporting date. The accretion will be reflected as a deemed dividend adjustment to arrive at net loss attributed to common stockholders for earnings per share calculations.
The Warrants are recorded as a liability and re-measured at fair value as of each reporting date with fair value changes being recorded as non-operating income or expense. The Warrants
were valued on day 1 and exceeded the gross proceeds of the offering. This resulted in a day 1 financing expense of $2.7 million.
April 2024 Offering: On April 30, the Company closed on a best efforts public
offering of 240,571 shares of its common stock, 80,854 shares of its common stock for pre-funded warrants and warrants to purchase up to an aggregate of 482,146 shares of its common stock at a combined public offering price $8.40
per share. All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase shares of common stock. The
warrants have an exercise price of $14.00 per share, were exercisable immediately upon issuance, and will expire five years following the date of issuance. Each whole common warrant entitles the holder thereof to purchase one share of common stock.
The common warrants contain a
reset of the exercise price, effective upon the Warrant Stockholder Approval, to a price equal to the lesser of (i) the then exercise price, (ii) the lowest volume weighted average price for the
trading days immediately following the date we effect a reverse stock split in the future and (iii) if we effect a reverse stock split prior to obtaining the Warrant Stockholder Approval, the lowest volume weighted average price for the trading days immediately following the date we obtain the Warrant Stockholder Approval. The Company secured the Warrant Stockholder Approval on June 6, 2024. Subsequent to June 30 2024, the number of shares underlying the common warrants were adjusted to 2,710,734 shares and the exercise price was adjusted to $2.49 per share. In addition, the common warrants provided forfull ratchet anti-dilution adjustment to the exercise price and number of shares underlying the common warrants upon our issuance of our common stock or common stock equivalents at a price per share that is less than the exercise price of the common warrants, subject to certain exemptions. In no event will the exercise price of the common warrants with respect to either adjustment be reduced below a floor price of $0.06. The gross proceeds to the Company
from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million.
The warrants offered in this
financing are currently classified as a liability on the balance sheet. An independent valuation of the warrants was performed and reviewed with management, and the valuation at issuance was $7.8 million and at June 30, 2024, was $8.0 million,
representing a warrant liability increase of $0.2 million from issuance. The $0.2 million warrant liability increase from issuance has been reported on the Condensed Consolidated Statement of Operations as a “Change in fair value of warrant liability”. The
warrant valuation of $8.0 million exceeded the gross proceeds of $2.7 million. Accordingly if the warrant valuation exceeds the gross proceeds, the difference will be recorded as ‘Day 1 interest’. You will find this difference, along with other
issuance costs (discounts, legal, printing) reported on the Condensed Consolidated Statement of Operations as “Warrant valuation expense”.
Underwriter and Placement Agent Fees: In connection with the offerings described above, the Company paid the underwriter or placement agent, as applicable, an aggregate cash fee of either 7% or 8% of the aggregate gross proceeds raised in each of the offerings, except with respect to the issuances made pursuant to the At-the-Market Program, for which the placement fee was equal to 3% of the aggregate gross proceeds. At the Company’s annual meeting of stockholders on June 6, 2024, its stockholders
approved a proposal to amend the Company’s Fourth Amended and Restated Certificate of Incorporation to effect such a reverse split of the Company’s outstanding Common Stock at a ratio in the range of “Reverse Stock Split”). On June 27, 2024, the Company filed with the Secretary of State of the State of Delaware a
Certificate of Amendment to its Certificate of Incorporation (the “Certificate of Amendment”) to affect the Reverse Stock Split. The Reverse Stock Split became effective as of 5:00
p.m. Eastern Time on June 27, 2024, and the Company’s common stock began trading on a split-adjusted basis when the market opened on June 28, 2024. All share and per-share amounts have been retroactively adjusted to reflect the reverse stock
splits for all periods presented.
to to be determined at the discretion of our Board of Directors. On June 26, 2024, the Company’s board of directors approved a reverse stock split of the Company’s issued and outstanding shares of common stock (the |
Stock-Based Compensation |
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Stock-Based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation |
Note 4 - Stock-Based
Compensation
Under the fair value recognition provisions of
U.S. GAAP for accounting for stock-based compensation the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is
generally the vesting period.
The following table presents the
classification of stock-based compensation expense recognized for the periods below:
During the three months ended June 30, 2024 and 2023, under the 2017 Equity Incentive Plan, and the 2021 Inducement Plan,
the Company granted 1 and 267
stock options, respectively, to its directors, officers and employees. During the six months ended June 30, 2024 and 2023, the Company granted 1,264
and 2,937 stock options, respectively, to its directors, officers and employees. Vesting generally occurs over an immediate to 48-month period based on a time-of-service condition. The weighted-average grant date fair value of the stock-options issued during the three months
ended June 30, 2024 and 2023 was $8.75 and $103.52 per share, respectively. The weighted-average grant date fair value of the stock options issued during the six months ended June 30, 2024 and 2023 was $24.14 and $258.19 per share, respectively.
The total number of stock options outstanding as of June 30, 2024 and June 30, 2023 was 3,979 and 3,164, respectively.
The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and six months
ended June 30, 2024 and 2023:
During the three months ended June 30, 2024 and 2023, 472 and 32 stock options vested, respectively, and 91 and 79 stock options were expired
or forfeited during these periods, respectively. During the six months ended June 30, 2024 and 2023, 1,347 and 60 stock options vested, respectively, and 363
and 84 stock options were expired or forfeited during these periods, respectively. During the three and six months ended June 30, 2024
and 2023, no options were exercised.
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Fair Value of Financial Instruments |
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Fair Value of Financial Instruments |
Note 5—Fair Value of Financial Instruments
The Company’s financial instruments consist of cash and cash equivalents and warrants.
Pursuant to the requirements of Accounting Standards Codification (“ASC”) Topic 820 “Fair Value Measurement,” the Company’s financial assets and
liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories:
The fair value of the Company’s common and preferred stock warrant liabilities related to the investor warrants issued in the October 2023, October
2022 and April 2024 public offerings was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy.
The following is a roll-forward of the fair value of the Level 3 warrants:
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Income Taxes |
6 Months Ended |
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Jun. 30, 2024 | |
Income Taxes [Abstract] | |
Income Taxes |
Note 6 – Income Taxes
The Company provides for a valuation allowance when it is more
likely than not that it will not realize a portion of its deferred tax assets. The Company has established a full valuation allowance for its U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated
in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying condensed consolidated financial statements.
As of June 30, 2024, there were no material changes to what the
Company disclosed regarding tax uncertainties or penalties in its Annual Report on Form 10-K for the year ended December 31, 2023.
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Operating Leases |
6 Months Ended |
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Jun. 30, 2024 | |
Operating Leases [Abstract] | |
Operating Leases |
Note 7—Operating Leases
The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for office and manufacturing space under
a non-cancelable operating lease that expires in March 2027. In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022 to March 31, 2027. This facility serves as our corporate
headquarters and houses substantially all our functional departments. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $34,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease. Beginning on
April 1, 2022, the annual base rent was $10.50 per square foot, subject to future annual increases of $0.32 to $0.34 per square foot.
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Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2024 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies |
Note 8—Commitments and Contingencies
Employee Retirement Plan: The Company has a 401(k) retirement plan that
provides retirement benefits to all eligible U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees’
contributions at the discretion of the Company.
Milestone Payment: On December 27, 2022, the Company entered into a license and distribution agreement with SeaStar Medical Holding Corporation, (Nasdaq:
ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, is appointing the Company as the exclusive U.S. distributor to promote, advertise,
market, distribute and sell certain products. As a part of this agreement, the Company agreed to pay SeaStar, a milestone payment of $450,000,
upon its receipt of a Human Device Exemption (HDE) approval from the U.S. Food and Drug Administration’s (FDA). This payment is due on the later to occur of 30 days after achievement of the milestone event or April 1, 2024. As of December 31, 2023, the Company concluded it was probable HDE approval would be obtained and recorded a
liability of $450,000 on the consolidated balance sheet. On February 22, 2024, SeaStar obtained HDE approval. As of June 30, 2024, the milestone
payment has been paid.
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Subsequent Events |
6 Months Ended |
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Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events |
Note 9- Subsequent Events
Public Offering: On July 24, 2024, the Company announced that it had entered into a definitive
securities purchase agreement with certain institutional investors for the purchase and sale of 469,340 shares of the Company’s
common stock at a price of $4.24 per share of common stock in a registered direct offering priced at-the-market under Nasdaq
rules.
In addition, in a concurrent private placement, the Company will issue to the investors warrants to purchase up to 938,680 shares of common stock. The warrants have an exercise price of $3.99
per share, will be exercisable immediately following the date of issuance and will have a term of five years from the date of
issuance.
The closing of the registered direct offering and the concurrent private placement occurred on or about July 25, 2024, subject to the satisfaction of the customary closing conditions. The gross proceeds to the Company from the registered direct offering and the concurrent private placement, before deducting the placement agent fees and other offering expenses payable by the Company, were approximately $2.0 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes. |
Insider Trading Arrangement |
3 Months Ended |
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Jun. 30, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Nature of Business and Basis of Presentation (Policies) |
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Principles of Consolidation |
Principles of Consolidation: The accompanying condensed consolidated balance sheet as of December 31, 2023, which has been derived from the consolidated audited financial statements, and the unaudited
condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q
and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not
include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial
statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily
indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates.
These condensed
consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
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Going Concern |
Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2023 and 2022 and through
June 30, 2024, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. Since the company’s inception and as of June 30, 2024, the Company had an accumulated deficit of $299.7 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able
to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the
next twelve months. The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including
investments in its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex
System, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the
Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the
Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability.
On April 30, the Company closed on a best efforts public
offering of 240,571 shares of its common stock, 80,854 shares of its common stock for pre-funded warrants and warrants to purchase up to an aggregate of 482,146 shares of its common stock at a combined public offering price $8.40
per share. All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase
shares of common stock. The warrants
have an exercise price of $14.00 per share, were exercisable immediately upon issuance, and will expire five years following the date of issuance. Each whole common warrant entitles the holder thereof to purchase one share of common stock.The common warrants contain a reset of the exercise price, effective upon the Warrant Stockholder Approval, to a price equal to the
lesser of (i) the then exercise price, (ii) the lowest volume weighted average price for the trading days immediately following
the date we effect a reverse stock split in the future and (iii) if we effect a reverse stock split prior to obtaining the Warrant Stockholder Approval, the lowest volume weighted average price for the five trading days immediately following
the date we obtain the Warrant Stockholder Approval. The Company secured the Warrant Stockholder Approval on June 6, 2024. Subsequent to June 30 2024, the number of shares underlying the common warrants were adjusted to 2,710,734 shares and the exercise price was adjusted to $2.49 per share. In addition, the common warrants provided for, full ratchet anti-dilution adjustment to the exercise price and number of shares underlying the common warrants upon our
issuance of our common stock or common stock equivalents at a price per share that is less than the exercise price of the common warrants, subject to certain exemptions. In no event will the exercise price of the common warrants with respect to
either adjustment be reduced below a floor price of $0.06.
The gross proceeds to the Company from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million.
On July 24, 2024, the Company announced that it had entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 469,340 shares of the Company’s common stock at a price of $4.24 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.
In addition, in a concurrent private placement, the
Company will issue to the investors warrants to purchase up to 938,680 shares of common stock. The warrants have an exercise price
of $3.99 per share, will be exercisable immediately following the date of issuance and will have a term of five years from the date of issuance.
The closing of the registered direct offering and the
concurrent private placement occurred on or about July 25, 2024, subject to the satisfaction of the customary closing conditions.
The gross proceeds to the Company from the registered
direct offering and the concurrent private placement, before deducting the placement agent fees and other offering expenses payable by the Company, were approximately $2.0 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes.
Understanding the near-term need to raise capital, the Company has recently undertaken steps to reduce our monthly cash burn rate by approximately 40%, balanced against our strategic growth initiatives, which will provide more flexibility in anticipation of tougher capital market conditions
for microcap companies like Nuwellis. These reductions include, but are not limited to the following: selected job eliminations, a reduction of the salaries for members of senior management, no merit increases to the base salaries of any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, no cash bonuses to any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, a
reduction in Board of Director and committee fees, temporary suspension of company 401k match, travel reductions, and reductions to select professional services.
The Company believes that its existing capital resources will be
sufficient to support its operating plan through October 31, 2024. However, the Company will seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no
assurance we will be successful in raising additional capital.
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Revenue Recognition |
Revenue Recognition: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers, which the
Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for
those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended June 30, 2024, two customers represented 16% and 12% of net sales. For the six months ended June 30, 2024, two customers each represented 19% and 11% of net sales. For the three months ended June 30, 2023, two customers represented 16% and 13% of net sales. For the six months ended June 30, 2023, two
customers each represented 14% and 13%
of net sales.
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Accounts Receivable |
Accounts Receivable: Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its
ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and will provide an allowance for credit
losses when collection becomes doubtful. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related
allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of June
30, 2024, or December 31, 2023. As of June 30, 2024, one customer represented 27% of the
accounts receivable balance. As of December 31, 2023, two customers represented 14% and 15% of the total accounts receivable balance.
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Inventories |
Inventories: Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method.
Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following:
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Loss per Share |
Loss per Share: Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding.
See Note 3 – Stockholders’ Equity below for additional disclosures.
Diluted earnings per share is computed based on the net loss
allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been
issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred
stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans.
The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be
anti-dilutive as of the end of each period presented:
The following table reconciles reported net loss with reported net loss per share for each of the three and six months ended June 30:
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Subsequent Events |
Subsequent Events: The Company evaluates events
through the date the condensed consolidated financial statements are filed for events requiring adjustment to or disclosure in the condensed consolidated financial statements. See note 9 – Subsequent Events for additional disclosures.
|
Nature of Business and Basis of Presentation (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Nature of Business and Basis of Presentation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | Inventories consisted of the following:
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Potential Shares of Common Stock not Included in Diluted Net Loss Per Share |
The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be
anti-dilutive as of the end of each period presented:
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Reconciliation of Reported Net Loss with Reported Net Loss Per Share |
The following table reconciles reported net loss with reported net loss per share for each of the three and six months ended June 30:
|
Stock-Based Compensation (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Classification of Stock-Based Compensation Expense |
The following table presents the
classification of stock-based compensation expense recognized for the periods below:
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Weighted Average Assumptions used in Black-Scholes Option Pricing Model |
The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and six months
ended June 30, 2024 and 2023:
|
Fair Value of Financial Instruments (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Financial Instruments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roll-Forward of Fair Value of Level 3 Warrants |
The following is a roll-forward of the fair value of the Level 3 warrants:
|
Revenue Recognition (Details) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
|
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-07-01 | ||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||
Expected timing of satisfaction, period | 1 year | 1 year | ||
Sales Revenue [Member] | Customer Concentration Risk [Member] | Revenue Recognized over Time [Member] | Maximum [Member] | ||||
Revenue, Performance Obligation [Abstract] | ||||
Percentage of net sales | 1.00% | 1.00% | 1.00% | 1.00% |
Sales Revenue [Member] | Customer Concentration Risk [Member] | International [Member] | Revenue Recognized over Time [Member] | Maximum [Member] | ||||
Revenue, Performance Obligation [Abstract] | ||||
Percentage of net sales | 3.00% | 5.00% | 4.00% | 4.00% |
Fair Value of Financial Instruments (Details) - Warrants [Member] - USD ($) $ in Thousands |
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2024 |
Dec. 31, 2023 |
|
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Beginning balance | $ 2,843 | $ 6,868 |
Exercise of warrants | (1,357) | |
Change in fair value | (900) | |
Ending balance | 8,579 | 2,843 |
October 18, 2022 Series I Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance of Common Stock for exercise of warrants | (7,623) | |
Change in fair value | 755 | |
October 17, 2023 Series J Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance | 4,965 | |
Exercise of warrants | (536) | |
Change in fair value | $ (1,586) | |
April 30, 2024 Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance | $ 7,993 |
Operating Leases (Details) $ in Thousands |
6 Months Ended |
---|---|
Jun. 30, 2024
USD ($)
ft²
$ / ft²
| |
Operating Leases [Abstract] | |
Area of property leased under operating lease | ft² | 23,000 |
Monthly rent and common area maintenance charges | $ | $ 34 |
Annual base rent (per square foot) | 10.5 |
Minimum [Member] | |
Operating Leases [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.32 |
Maximum [Member] | |
Operating Leases [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.34 |
Commitments and Contingencies (Details) - SeaStar Medical Holding Corporation [Member] - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2024 |
Dec. 27, 2022 |
|
Commitments and Contingencies [Abstract] | ||
Milestone payment due | $ 450 | |
Payment period after achievement of milestone event | 30 days |
Subsequent Events (Details) - Subsequent Event [Member] - Securities Purchase Agreement [Member] $ / shares in Units, $ in Millions |
Jul. 24, 2024
USD ($)
$ / shares
shares
|
---|---|
Stockholders' equity [Abstract] | |
Issuance of stock (in shares) | shares | 469,340 |
Common stock offering price per share (in dollars per share) | $ / shares | $ 4.24 |
Aggregate purchase of warrants (in shares) | shares | 938,680 |
Warrant exercise price per share (in dollars per share) | $ / shares | $ 3.99 |
Warrant expiry period | 5 years |
Gross proceeds before deducting the placement agent fees and other offering expenses | $ | $ 2.0 |
1 Year Newellis Chart |
1 Month Newellis Chart |
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