Amendment: SEC Form S-1/A filed by Nuwellis Inc.
Delaware
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3845
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68-0533453
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(State or Other Jurisdiction of Incorporation or Organization)
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(Primary Standard Industrial Classification Code Number)
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(I.R.S. Employer
Identification Number)
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒
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Smaller reporting company
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☒
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Emerging growth company
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☐
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3,906 shares of our Common Stock issuable upon the exercise of outstanding stock options, having a weighted average exercise
price of $516.31 per share;
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3,711,820 shares of our Common Stock issuable upon the exercise of outstanding warrants with a weighted-average exercise
price of $18.38 per share;
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68,961 shares of our Common Stock issuable upon the conversion of the 127 outstanding shares of our Series F Convertible
Redeemable Preferred Stock, par value $0.0001 per share (the “Series F Convertible Preferred Stock”);
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62 shares of our Common Stock issuable upon the conversion of the 88 outstanding shares of our Series J Convertible Redeemable
Preferred Stock, par value $0.0001 per share (the “Series J Convertible Preferred Stock”);
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23,762 shares of our Common Stock issuable upon the exercise of 1,920 warrants issued in October 2023 in a best efforts
registered public offering; and
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42,137 shares of our Common Stock reserved for future issuance under our equity incentive plans.
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We have limited history of operations and limited experience in sales and marketing, and we might be unsuccessful in increasing
our sales and cannot assure you that we will ever generate substantial revenue or be profitable.
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We have incurred operating losses since our inception and anticipate that we will continue to incur operating losses in the
near-term. To date, we have been funded by equity financings, and although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we will ever operate
profitably. We will need to raise additional capital to fund
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Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System. We face significant challenges
in expanding market acceptance of the Aquadex System, which could adversely affect our potential sales.
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Nasdaq may delist our common stock from its exchange which could limit your ability to make transactions in our securities and
subject us to additional trading restrictions.
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We depend on a limited number of customers, the loss of which, or failure of which to order our products in a particular period,
could cause our revenues to decline.
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We have limited commercial manufacturing experience and could experience difficulty in producing commercial volumes of the Aquadex
System and related components or may need to depend on third parties for manufacturing.
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We depend upon third-party suppliers, including single source suppliers, making us vulnerable to supply problems and price
fluctuations.
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If we cannot develop adequate distribution, customer service and technical support networks, then we may not be able to market and
distribute the Aquadex System effectively and our sales will suffer.
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We compete against many companies, some of which have longer operating histories, more established products and greater resources
than we do, which may prevent us from achieving further market penetration or improving operating results.
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The competition for qualified personnel is particularly intense in our industry. If we are unable to retain or hire key personnel,
we may not be able to sustain or grow our business.
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Significant additional governmental regulation could subject us to unanticipated delays which would adversely affect our sales.
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Product defects, resulting in lawsuits for product liability, could harm our business, results of operations and financial
condition.
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We may face significant risks associated with international operations, which could have a material adverse effect on our
business, financial condition and results of operations.
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If we are not able to maintain sufficient quality controls, then the approval or clearance of our products by the European Union,
the FDA or other relevant authorities could be withdrawn, delayed or denied and our sales will suffer.
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If we violate any provisions of the Federal Food, Drug, and Cosmetic Act or any other statutes or regulations, then we could be
subject to enforcement actions by the FDA or other governmental agencies.
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We cannot assure you that our products will be safe or that there will not be serious injuries or product malfunctions. Further,
we are required under applicable law to report any circumstances relating to our medically approved products that could result in deaths or serious injuries. These circumstances could trigger recalls, class action lawsuits and other
events that could cause us to incur expenses and may also limit our ability to generate revenues from such products.
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We face significant uncertainty in the industry due to government healthcare reform.
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We are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and
regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.
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Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other
adverse consequences.
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If we acquire other businesses, products or technologies, we could incur additional impairment charges and will be subject to
risks that could hurt our business.
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We may not be able to protect our intellectual property rights effectively, which could have an adverse effect on our business,
financial condition or results of operations.
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Intellectual property litigation could be costly and disruptive to us.
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If we were unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and
system could be adversely affected.
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Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could
cause us to pay substantial damages or limit our ability to commercialize our products.
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We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
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Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us
from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
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The trading price of our common stock price has been, and could continue to be, volatile.
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The rights of holders of our capital stock will be subject to, and could be adversely affected by, the rights of holders of our
outstanding preferred stock and stock that may be issued in the future.
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A more active, liquid trading market for our common stock may not develop, and the price of our common stock may fluctuate
significantly.
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If we do not comply with certain tax regulations, including VAT, and similar regulations, we may be subject to additional taxes,
customs duties, interest, and penalties in material amounts, which could materially harm our financial condition and operating results.
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Our ability to use U.S. net operating loss carryforwards and other tax attributes might be limited.
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We do not intend to pay cash dividends on our common stock in the foreseeable future.
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There may be future sales of our securities or other dilution of our equity, which may adversely affect the market price of our
common stock.
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Name of Selling Securityholder
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Number of
shares of
common stock
beneficially
owned
prior to the
offering
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Maximum
number of
shares of
common stock
to be sold
pursuant to
this prospectus
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Number of
shares of
common stock
beneficially owned
after the offering
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Percentage of
shares of
common stock
beneficially
owned after the
offering
(%)
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(1)
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Armistice Capital, LLC
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878,988
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377,000
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501,988
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24.4
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(2)
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Hudson Bay Master Fund Ltd.
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807,288
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305,300
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501,988
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24.4
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(3)
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Bigger Capital Fund, LP.
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262,701
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139,680
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123,021
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6
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(4)
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District 2 Capital Fund LP
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390,672
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139,678
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250,994
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12.2
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(5)
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Alto Opportunity Master Fund,
SPC – Segregated Master Fund Portfolio B
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339,769
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103,774
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235,995
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11.5
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(6)
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L1 Capital Global Opportunities Master Fund
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372,518
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171,524
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200,994
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9.8
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(7)
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Intracoastal Capital, LLC
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436,078
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185,075
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251,003
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12.2
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*
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Indicates beneficial ownership of less than one percent.
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(1)
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The shares of common stock registered hereby were acquired in the (i) July Private Placement (as defined below) and consist of
224,000 shares of common stock issuable upon the exercise of 112,000 of the July Warrants and (ii) August Private Placement (as defined below) and consist of 153,000 shares of common stock issuable upon the exercise of 153,000 of the
August Warrants. The July Warrants and August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares
of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (“Master Fund”), and may be deemed to be
beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice Capital has sole voting and dispositive
control of the shares reported herein. The address of Master Fund is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.
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(2)
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The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 224,000 shares of
common stock issuable upon the exercise of 112,000 of the July Warrants and (ii) August Private Placement (as defined below) and consist of 81,300 shares of common stock issuable upon the exercise of 81,300 of the August Warrants. The
July Warrants are subject to a beneficial ownership limitation of 9.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the
beneficial ownership limitation. The August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of
common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Hudson Bay Master Fund Ltd, a Cayman Islands exempted company (“Hudson Bay”). Hudson Bay Capital Management LP, the
investment manager of Hudson Bay, has sole voting and dispositive control of the shares reported herein. Sander Gerber is the managing member of Hudson Bay Capital GP LLC, which is the general partner of Hudson Bay Capital Management
LP. Each of Hudson Bay and Sander Gerber disclaims beneficial ownership of the shares reported herein. The address of Hudson Bay is c/o Hudson Bay Capital Management LP, 28 Havemeyer Place, 2nd Floor, Greenwich, CT, 06830.
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(3)
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The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 89,680 shares of
common stock issuable upon the exercise of 44,840 of the July Warrants and (ii) August Private Placement and consist of 50,000 shares of
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(4)
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The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 89,678 shares of
common stock issuable upon the exercise of 44,839 of the July Warrants and (ii) August Private Placement and consist of 50,000 shares of common stock issuable upon the exercise of 50,000 of the August Warrants. The July Warrants and
August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the
beneficial ownership limitation. The shares of common stock are directly held by District 2 Capital Fund, LP, a Delaware limited partnership (“District 2 Capital”), and may be deemed to be beneficially owned by: (i) District 2 GP LLC,
as the general partner of District 2 Capital and (ii) Michael Bigger, as the Managing Member of District 2 GP LLC. District 2 GP LLC has sole voting and dispositive control of the shares reported herein. The address of District 2
Capital is 14 Wall Street, 2 nd Floor, Huntington, New York, 11743.
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(5)
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The shares of common stock registered hereby were acquired in the 2024 Private Placement and consist of 103,774 shares of common
stock issuable upon the exercise of 51,887 of the July Warrants. The July Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after
exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Alto Opportunity Master Fund, SPC – Segregated Master Fund Portfolio B, a Cayman Islands
exempted company (“Alto Opportunity”), and may be deemed to be beneficially owned by: (i) Ayrton Capital, LLC (“Ayrton Capital”), as the investment manager of the Alto Opportunity; and (ii) Waqas Khatri, as the Managing Member of Ayrton
Capital. Ayrton Capital has sole voting and dispositive control of the shares reported herein. The address of Alto Opportunity is c/o Ayrton Capital, 55 Post Road West, 2nd Floor, Westport, Connecticut, 06880.
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(6)
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The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 103,774 shares of
common stock issuable upon the exercise of 51,887 of the July Warrants and (ii) August Private Placement and consist of 67,750 shares of common stock issuable upon the exercise of 67,750 of the August Warrants. The July Warrants and
August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the
beneficial ownership limitation. The shares of common stock are directly held by L1 Capital Global Opportunities Master Fund, a Cayman Islands exempted company (“L1 Capital”), and may be deemed to be beneficially owned by: (i) David
Feldman and (ii) Joel Arber, each of whom are directors of L1, and have shared voting and shared dispositive control of the shares reported herein. The address of L1 Capital is 161A Shedden Road, 1 Artillery Court, PO Box 10085, Grand
Cayman KY1-1001, Cayman Islands.
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(7)
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The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 103,774 shares of
common stock issuable upon the exercise of 51, 887 of the July Warrants and (ii) August Private Placement and consist of 81,301 shares of common stock issuable upon the exercise of 81,301 of the August Warrants. The July Warrants and
August 2024 are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial
ownership limitation. The shares of common stock are directly held by Intracoastal Capital, LLC, a Delaware limited liability company (“Intracoastal”), and may be deemed to be beneficially owned by: (i) Mitchell P. Kopin (“Mr. Kopin”)
and (ii) Daniel B. Asher (“Mr. Asher”), each of whom are managers of Intracoastal, and have shared voting and shared dispositive control of the shares reported herein. The address of Intracoastal Capital is 245 Palm Trail, Delray Beach,
FL 33483.
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each person, or group of affiliated persons, who we know to beneficially own more than 5% of our Common Stock;
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each of our named executive officers and directors; and
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all of our executive officers and directors as a group.
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Name of Beneficial Owner
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Number of
Shares
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Right to
Acquire (1)
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Total
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Aggregate
Percent of
Class (2)
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Executive Officers and Directors
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John L. Erb
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—
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69,028 (4)
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69,028
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3.7%
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Michael McCormick
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—
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595
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595
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*
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Maria Rosa Costanzo, M.D.
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—
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—
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—
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—
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Archelle Georgiou, M.D.
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—
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2 97
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2 97
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*
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Gregory D. Waller
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—
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67
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67
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*
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David McDonald
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—
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2 97
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2 97
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*
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Robert B. Scott
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—
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1 3
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1 3
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*
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Nestor Jaramillo, Jr.
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117
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314
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4 31
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*
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Neil P. Ayotte
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—
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1 11
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1 11
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*
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Lynn Blake
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3
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—
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3
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*
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All current directors and executive officers as a group (9 persons)
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117
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70,722
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70,839
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3.8%
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*
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Less than one percent.
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(1)
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Except as otherwise described below, amounts reflect the number of shares that such holder could acquire through (i) the
exercise of outstanding stock options, (ii) the vesting/settlement of outstanding RSUs, (iii) the exercise of outstanding warrants to purchase common stock, and (iv) the conversion of outstanding Series F Preferred Stock, in each case
within 60 days after August 26, 2024.
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(2)
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Based on 1,866,890 shares outstanding as of August 26, 2024.
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(3)
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Based upon statements in a Schedule 13G filed by Mitchell P. Kopin, Daniel B. Asher, and Intracoastal Capital LLC, pursuant to a
Joint Filing Agreement, on August 2, 2024. According to the Schedule 13G, Mr. Kopin, Mr. Asher and Intracoastal Capital LLC have shared voting and shared dispositive control over 58,888 of the reported shares. The address of Mr. Kopin and
Intracoastal Capital LLC is 245 Palm Trail, Delray Beach, Florida 33483. The address of Mr. Asher is 111 W. Jackson Boulevard, Suite 2000, Chicago, Illinois 60604.
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(4)
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Consists of (i) 67 shares issuable upon the exercise of outstanding stock options and (ii) 68,961 shares issuable upon
conversion of outstanding shares of Series F Convertible Preferred Stock (assuming all 127 shares of Series F Convertible Preferred Stock held by Mr. Erb are converted at once and rounded up to the nearest whole share).
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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block trades in which the broker-dealer will attempt to sell the shares of common stock as agent but may position and resell a
portion of the block as principal to facilitate the transaction;
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
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an exchange distribution in accordance with the rules of the applicable exchange;
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privately negotiated transactions;
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settlement of short sales;
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in transactions through broker-dealers that agree with the Selling Securityholders to sell a specified number of such shares of
common stock at a stipulated price per share of common stock;
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through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
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a combination of any such methods of sale; or
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any other method permitted pursuant to applicable law.
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the number of directors on our board of directors, the classification of our board of directors and the terms of the members of
our board of directors;
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the limitations on removal of any of our directors described below under “Description of our Capital Stock – Anti-Takeover Effects
of Certain Provisions of Our Certificate of Incorporation and Bylaws and Delaware Law;”
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the ability of our directors to fill any vacancy on our board of directors by the affirmative vote of a majority of the directors
then in office under certain circumstances;
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the ability of our board of directors to adopt, amend or repeal our bylaws and the super-majority vote of our stockholders
required to adopt, amend or repeal our bylaws described above;
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the limitation on action of our stockholders by written action described below under “Description of Capital Stock – Anti-Takeover
Effects of Certain Provisions of Our Certificate of Incorporation and Bylaws and Delaware Law;”
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the choice of forum provision described below under “Description of our Capital Stock – Choice of Forum;”
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the limitations on director liability and indemnification described below under the heading “Description of our Capital Stock –
Limitation on Liability of Directors and Indemnification;” and
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the super-majority voting requirement to amend our certificate of incorporation described above.
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providing for our board of directors to be divided into three classes with staggered three-year terms, with only one class of
directors being elected at each annual meeting of our stockholders and the other classes continuing for the remainder of their respective three-year terms;
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authorizing our board of directors to issue from time to time any series of preferred stock and fix the voting powers,
designation, powers, preferences and rights of the shares of such series of preferred stock;
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prohibiting stockholders from acting by written consent in lieu of a meeting;
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requiring advance notice of stockholder intention to put forth director nominees or bring up other business at a stockholders’
meeting;
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prohibiting stockholders from calling a special meeting of stockholders;
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requiring a 662∕3% super-majority stockholder approval in order for stockholders
to alter, amend or repeal certain provisions of our certificate of incorporation;
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requiring a 662∕3% super-majority stockholder approval in order for stockholders
to adopt, amend or repeal our bylaws;
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providing that, subject to the rights of the holders of any series of preferred stock to elect additional directors under
specified circumstances, neither the board of directors nor any individual director may be removed without cause;
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creating the possibility that our board of directors could prevent a coercive takeover of our Company due to the significant
amount of authorized, but unissued shares of our common stock and preferred stock;
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providing that, subject to the rights of the holders of any series of preferred stock, the number of directors shall be fixed from
time to time exclusively by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors; and
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providing that any vacancies on our board of directors under certain circumstances will be filled only by a majority of our board
of directors then in office, even if less than a quorum, and not by the stockholders.
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prior to that date, our board of directors approved either the business combination or the transaction that resulted in the
stockholder becoming an interested stockholder;
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upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of our voting stock outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (but not the outstanding voting stock owned by the interested
stockholder) those shares owned by (i) persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will
be tendered in a tender or exchange offer; or
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on or subsequent to that date, the business combination is approved by our board of directors and authorized at an annual or
special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2∕3% of the outstanding voting stock that is not owned by the interested stockholder.
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any merger or consolidation involving the corporation or a direct or indirect majority-owned subsidiary of the corporation and the
interested stockholder;
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any sale, lease, mortgage, pledge transfer, or other disposition of the assets of the corporation or direct or indirect
majority-owned a subsidiary of the corporation to or with the interested stockholder, which assets have an aggregate value equal to 10% or more of the fair value of the assets on a consolidated basis or the aggregate market value of the
outstanding stock of the corporation;
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subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation or a direct or indirect
majority-owned subsidiary of the corporation of any stock of the corporation or subsidiary to the interested stockholder;
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any transaction involving the corporation or direct or indirect majority-owned subsidiary of the corporation that has the effect
of increasing the proportionate share of the stock or any class or series of the corporation or the subsidiary beneficially owned by the interested stockholder; or
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the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits
by or through the corporation or direct or indirect majority-owned subsidiary of the corporation.
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breach of their duty of loyalty to us or our stockholders;
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act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
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unlawful payment of dividends or redemption of shares as provided in Section 174 of the DGCL; or
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transaction from which the directors derived an improper personal benefit.
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 11, 2024;
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our definitive proxy statement for our 2024 Annual Meeting of Stockholders filed with the SEC on May 17, 2024;
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our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024 and the quarter ended June 30, 2024, filed with the SEC on August 13, 2024;
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our Current Reports on Form 8-K filed with the SEC on February 6, 2024 , March 26, 2024 , May 1, 2024 , May 29, 2024 , June 6,
2024 , June 10, 2024 , June 26, 2024 , July 3, 2024 , July 17, 2024 (as amended on July 17, 2024 ), July 17, 2024 , July 25,
2024 , August 12, 2024 , August 22, 2024 , and August 26, 2024 ; and
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the description of our common stock in our registration statement on Form 10 filed with the SEC on September 30, 2011, including Exhibit 4.14
to our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
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Item 13.
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Other Expenses of Issuance and Distribution.
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Item
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Amount Paid or
to Be Paid
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SEC registration fee
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$415
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FINRA filing fee
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*
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Printing expenses
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*
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Legal fees and expenses
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*
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Accounting fees and expenses
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*
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Transfer agent fees and expenses
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*
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Miscellaneous fees and expenses
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*
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Total
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$ *
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*
|
Except for the SEC registration fee, estimated expenses are not presently known. The foregoing sets forth the general categories of
expenses (other than underwriting discounts and commissions) that we anticipate we will incur in connection with the offering of shares of our common stock under this Registration Statement. To the extent required, any applicable
prospectus supplement will set forth the estimated aggregate amount of expenses payable in respect of any offering of shares of our common stock under this Registration Statement.
|
Item 14.
|
Indemnification of Directors and Officers.
|
•
|
from any breach of the director’s duty of loyalty to us or our stockholders;
|
•
|
from acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
|
•
|
under Section 174 of the DGCL; and
|
•
|
from any transaction from which the director derived an improper personal benefit.
|
Item 15.
|
Recent Sales of Unregistered Securities.
|
•
|
On June 19, 2023, the registrant granted a warrant to DaVita, Inc. (“DaVita”), pursuant to a Supply and Collaboration Agreement
(“Supply Agreement”) dated as of June 19, 2023, 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
warrant represents the right 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, provided that at no time can it be exercised for an
amount of shares that would represent greater than 19.9% ownership in the Company (the “DaVita Warrant”) subject to certain vesting milestones. The DaVita Warrant is expected to vest in four tranches as follows (i): 25% upon the Company’s
receipt of notice to extend the Supply Agreement past the initial pilot-term (the “Ultrafiltration Services Approval”); (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
|
•
|
On July 25, 2024, the registrant closed on a private placement of common stock purchase warrants to purchase 200% of the number
of shares of common stock purchased by the Selling Securityholders in the offering, equal to up to 938,680 shares of common stock, which is the subject of this registration statement. The common stock purchase warrants have an exercise
price of $3.99 per share, are immediately exercisable and expire five years from the date of issuance. If all of the common stock purchase warrants are exercised for cash in full, the gross proceeds would be approximately $3.7 million.
This issuance was made in reliance upon the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.
|
•
|
On August 26, 2024, the registrant closed on a private placement of common stock purchase warrants to purchase 100% of the
number of shares of common stock purchased by the Selling Securityholders in the offering, equal to up to 483,351 shares of common stock, which is the subject of this registration statement. The common stock purchase warrants have an
exercise price of $1.72 per share, are immediately exercisable and expire five years following the date of effectiveness of the registration statement for the purposes of registering the shares of common stock underlying such warrants.
If all of the common stock purchase warrants are exercised for cash in full, the gross proceeds would be approximately $0.8 million. The registrant also offered, as part compensation to the placement agent in connection with the
offering, warrants to purchase up to 14,501 shares of common stock. Such warrants have an exercise price of $3.04425 per share and will expire five years following the commencement of sales pursuant to the offering. This issuance was
made in reliance upon the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.
|
Item 16.
|
Exhibits and Financial Statement Schedules.
|
(a)
|
Exhibits
|
|
| |
|
| |
Incorporated By Reference
|
| |
|
|||||||||
Exhibit
Number
|
| |
Exhibit
Description
|
| |
Form
|
| |
File
Number
|
| |
Date of
First Filing
|
| |
Exhibit
Number
|
| |
Filed
Herewith
|
| |
Fourth Amended and Restated Certificate of Incorporation
|
| |
10
|
| |
001-35312
|
| |
February 1, 2012
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to Fourth Amended and Restated Certificate of
Incorporation
|
| |
8-K
|
| |
001-35312
|
| |
January 13, 2017
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to Fourth Amended and Restated Certificate of
Incorporation
|
| |
8-K
|
| |
001-35312
|
| |
May 23, 2017
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to Fourth Amended and Restated Certificate of
Incorporation
|
| |
8-K
|
| |
001-35312
|
| |
October 12, 2017
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to Fourth Amended and Restated Certificate of
Incorporation
|
| |
8-K
|
| |
001-35312
|
| |
January 2, 2019
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to Fourth Amended and Restated Certificate of
Incorporation
|
| |
8-K/A
|
| |
001-35312
|
| |
October 16, 2020
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to Fourth Amended and Restated Certificate of
Incorporation
|
| |
8-K
|
| |
001-35312
|
| |
April 27, 2021
|
| |
3.1
|
| |
|
|
| |
Certificate of Amendment to 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
|
| |
|
|
| |
Third Amended and Restated Bylaws
|
| |
8-K
|
| |
001-35312
|
| |
April 27, 2021
|
| |
3.2
|
| |
|
|
| |
Amendment to Third Amended and Restated Bylaws
|
| |
8-K
|
| |
001-35312
|
| |
October 5, 2022
|
| |
3.1
|
| |
|
|
| |
Form of Certificate of Designation of Series F Convertible Preferred Stock
|
| |
S-1/A
|
| |
333-221010
|
| |
November 17, 2017
|
| |
3.7
|
| |
|
|
| |
Certificate of Designation of Preferences, Rights and Limitations, filed with
the Delaware Secretary of State on October 16, 2023, with respect to the Series J Convertible Preferred Stock
|
| |
8-K
|
| |
001-35312
|
| |
October 17, 2023
|
| |
3.1
|
| |
|
|
| |
Specimen of Common Stock Certificate
|
| |
10
|
| |
001-35312
|
| |
September 30, 2011
|
| |
4.1
|
| |
|
|
| |
Form of Common Warrant
|
| |
8-K
|
| |
001-35312
|
| |
July 25, 2024
|
| |
4.1
|
| |
|
|
| |
Form of Common Warrant
|
| |
8-K
|
| |
001-35312
|
| |
August 26, 2024
|
| |
4.1
|
| |||
| |
Form of Placement Agent Warrant
|
| |
8-K
|
| |
001-35312
|
| |
August 26, 2024
|
| |
4.2
|
| |
|
|
| |
Opinion of Honigman LLP
|
| |
|
| |
|
| |
|
| |
|
| |
X
|
|
| |
Patent License Agreement between Sunshine Heart, Inc. and Gambro UF
Solutions, Inc. dated August 5, 2016
|
| |
8-K
|
| |
001-35312
|
| |
August 8, 2016
|
| |
10.1
|
| |
|
|
| |
2013 Non-Employee Directors’ Equity Incentive Plan
|
| |
14A
|
| |
001-35312
|
| |
April 5, 2013
|
| |
App. A
|
| |
|
|
| |
|
| |
Incorporated By Reference
|
| |
|
|||||||||
Exhibit
Number
|
| |
Exhibit
Description
|
| |
Form
|
| |
File
Number
|
| |
Date of
First Filing
|
| |
Exhibit
Number
|
| |
Filed
Herewith
|
| |
Form of Stock Option Grant Notice and Option Agreement for 2013 Non-Employee
Directors’ Equity Incentive Plan
|
| |
10-K
|
| |
001-35312
|
| |
May 29, 2013
|
| |
10.2
|
| |
|
|
| |
Form of Restricted Stock Unit Award Grant Notice and Agreement for 2013
Non-Employee Directors’ Equity Incentive Plan
|
| |
10-K
|
| |
001-35312
|
| |
March 20, 2015
|
| |
10.11
|
| |
|
|
| |
New-Hire Equity Incentive Plan
|
| |
10-Q
|
| |
001-35312
|
| |
August 8, 2013
|
| |
10.1
|
| |
|
|
| |
First Amendment to New-Hire Equity Incentive Plan
|
| |
10-Q
|
| |
001-35312
|
| |
November 12, 2013
|
| |
10.1
|
| |
|
|
| |
Second Amendment to New-Hire Equity Incentive Plan
|
| |
S-8
|
| |
333-202904
|
| |
March 20, 2015
|
| |
99.12
|
| |
|
|
| |
Third Amendment to New-Hire Equity Incentive Plan
|
| |
S-8
|
| |
333-210215
|
| |
March 15, 2016
|
| |
99.13
|
| |
|
|
| |
Fourth Amendment to New-Hire Equity Incentive Plan
|
| |
8-K
|
| |
001-35312
|
| |
May 30, 2017
|
| |
10.4
|
| |
|
|
| |
Fifth Amendment to New-Hire Equity Incentive Plan
|
| |
8-K
|
| |
001-35312
|
| |
January 18, 2018
|
| |
10.1
|
| |
|
|
| |
Sixth Amendment to New-Hire Equity Incentive Plan
|
| |
10-Q
|
| |
001-35312
|
| |
August 8, 2019
|
| |
10.2
|
| |
|
|
| |
Seventh Amendment to New-Hire Equity Incentive Plan
|
| |
8-K
|
| |
001-35312
|
| |
December 6, 2019
|
| |
10.1
|
| |
|
|
| |
Eighth Amendment to New-Hire Equity Incentive Plan
|
| |
8-K/A
|
| |
001-35312
|
| |
February 25, 2021
|
| |
10.1
|
| |
|
|
| |
Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity
Incentive Plan
|
| |
10-Q
|
| |
001-35312
|
| |
November 12, 2013
|
| |
10.2
|
| |
|
|
| |
2017 Equity Incentive Plan
|
| |
8-K
|
| |
001-35312
|
| |
May 30, 2017
|
| |
10.1
|
| |
|
|
| |
First Amendment to the 2017 Equity Incentive Plan
|
| |
14A
|
| |
001-35312
|
| |
September 11, 2020
|
| |
App. A
|
| |
|
|
| |
Second Amendment to the 2017 Equity Incentive Plan
|
| |
10-K
|
| |
001-35312
|
| |
March 3, 2023
|
| |
10.17
|
| |
|
|
| |
Form of Stock Option Grant Notice and Option Agreement for 2017 Equity Incentive
Plan
|
| |
8-K
|
| |
001-35312
|
| |
May 30, 2017
|
| |
10.2
|
| |
|
|
| |
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement
for 2017 Equity Incentive Plan
|
| |
8-K
|
| |
001-35312
|
| |
May 30, 2017
|
| |
10.3
|
| |
|
|
| |
Nuwellis, Inc. 2021 Inducement Plan
|
| |
8-K
|
| |
001-35312
|
| |
May 20, 2021
|
| |
10.1
|
| |
|
|
| |
First Amendment to the 2021 Inducement Plan
|
| |
8-K
|
| |
001-35312
|
| |
April 21, 2022
|
| |
10.1
|
| |
|
|
| |
Second Amendment to the 2021 Inducement Plan
|
| |
8-K
|
| |
001-35312
|
| |
March 1, 2023
|
| |
10.1
|
| |
|
|
| |
Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under
the Nuwellis, Inc. 2021 Inducement Plan
|
| |
8-K
|
| |
001-35312
|
| |
May 20, 2021
|
| |
10.2
|
| |
|
|
| |
Form of Indemnity Agreement for the Company’s executive officers and directors
|
| |
10
|
| |
001-35312
|
| |
September 30, 2011
|
| |
10.1
|
| |
|
|
| |
Form of Change in Control Agreement for the Company’s executive officers
|
| |
10-K
|
| |
001-35312
|
| |
March 20, 2015
|
| |
10.16
|
| |
|
|
| |
Non-Employee Director Compensation Policy (effective January 1, 2023)
|
| |
10-K
|
| |
001-35312
|
| |
March 3, 2023
|
| |
10.27
|
| |
|
|
| |
|
| |
Incorporated By Reference
|
| |
|
|||||||||
Exhibit
Number
|
| |
Exhibit
Description
|
| |
Form
|
| |
File
Number
|
| |
Date of
First Filing
|
| |
Exhibit
Number
|
| |
Filed
Herewith
|
| |
Lease Agreement dated October 21, 2011 by and between the Company and Silver
Prairie Crossroads, LLC
|
| |
10
|
| |
001-35312
|
| |
December 16, 2011
|
| |
10.18
|
| |
|
|
| |
Second Amendment to Lease, dated as of April 20, 2015, by and between the
Company and Capital Partners Industrial Fund I, LLLP dba Prairie Crossroads Business Center
|
| |
8-K
|
| |
001-35312
|
| |
April 23, 2015
|
| |
10.1
|
| |
|
|
| |
Third Amendment to Lease, dated as of August 3, 2018, by and between the Company
and Capital Partners Industrial Fund I, LLLP
|
| |
10-Q
|
| |
001-35312
|
| |
November 7, 2018
|
| |
10.2
|
| |
|
|
| |
Fourth Amendment to Lease, dated as of November 18, 2021, by and between the
Company and Capital Partners Industrial Fund I, LLLP
|
| |
8-K
|
| |
001-35312
|
| |
November 23, 2021
|
| |
10.1
|
| |
|
|
| |
Executive Employment Agreement between Sunshine Heart, Inc. and John L. Erb,
dated March 1, 2016
|
| |
8-K
|
| |
001-35312
|
| |
March 2, 2016
|
| |
10.1
|
| |
|
|
| |
Letter Agreement dated February 15, 2017 among the Company, Sabby Volatility
Warrant Master Fund, Ltd. and Sabby Healthcare Master Fund, Ltd.
|
| |
8-K
|
| |
003-35312
|
| |
February 16, 2017
|
| |
10.1
|
| |
|
|
| |
Warrant Agency Agreement between the Company and American Stock Transfer &
Trust Company, LLC dated April 24, 2017
|
| |
8-K
|
| |
001-35312
|
| |
April 25, 2017
|
| |
10.1
|
| |
|
|
| |
Form of Warrant Reprice Agreement
|
| |
8-K
|
| |
001-35312
|
| |
June 29, 2018
|
| |
10.1
|
| |
|
|
| |
Warrant Agency Agreement, dated as of March 12, 2019, between the Company and
American Stock Transfer & Trust Company, LLC
|
| |
8-K
|
| |
001-35312
|
| |
March 13, 2019
|
| |
4.2
|
| |
|
|
| |
Underwriting Agreement, dated as of March 8, 2019, by and between the Company
and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
March 13, 2019
|
| |
1.1
|
| |
|
|
| |
Form of Employee Proprietary Information, Inventions Assignment and
Non-Competition Agreement for the Company’s employees, including executive officers
|
| |
10-Q
|
| |
001-35312
|
| |
May, 9, 2019
|
| |
10.3
|
| |
|
|
| |
Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12,
2019
|
| |
10-Q
|
| |
001-35312
|
| |
May 9, 2019
|
| |
10.5
|
| |
|
|
| |
Placement Agency Agreement, dated as of October 23, 2019, by and between the
Company and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
October 23, 2019
|
| |
1.1
|
| |
|
|
| |
Form of Securities Purchase Agreement, dated as of October 23, 2019, by and
among the Company and the purchasers identified on the signature pages thereto
|
| |
8-K
|
| |
001-35312
|
| |
October 23, 2019
|
| |
10.1
|
| |
|
|
| |
Placement Agency Agreement, dated as of November 4, 2019, by and between the
Company and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
November 4, 2019
|
| |
1.1
|
| |
|
|
| |
|
| |
Incorporated By Reference
|
| |
|
|||||||||
Exhibit
Number
|
| |
Exhibit
Description
|
| |
Form
|
| |
File
Number
|
| |
Date of
First Filing
|
| |
Exhibit
Number
|
| |
Filed
Herewith
|
| |
Form of Securities Purchase Agreement, dated as of November 4, 2019, by and
among the Company and the purchasers identified on the signature pages thereto
|
| |
8-K
|
| |
001-35312
|
| |
November 4, 2019
|
| |
10.1
|
| |
|
|
| |
Underwriting Agreement dated as of January 24, 2020, by and between the Company
and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
January 29, 2020
|
| |
1.1
|
| |
|
|
| |
Warrant Agency Agreement, dated as of January 28, 2020, between the Company and
American Stock Transfer & Trust Company, LLC.
|
| |
8-K
|
| |
001-35312
|
| |
January 29, 2020
|
| |
4.2
|
| |
|
|
| |
Placement Agency Agreement, dated as of March 19, 2020, by and between the
Company and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
March 20, 2020
|
| |
1.1
|
| |
|
|
| |
Form of Securities Purchase Agreement, dated as of March 19, 2020, by and among
the Company and the purchasers identified on the signature pages thereto
|
| |
8-K
|
| |
001-35312
|
| |
March 20, 2020
|
| |
10.1
|
| |
|
|
| |
Placement Agency Agreement, dated as of March 30, 2020, by and between the
Company and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
March 30, 2020
|
| |
1.1
|
| |
|
|
| |
Form of Securities Purchase Agreement, dated as of March 30, 2020, by and among
the Company and the purchasers identified on the signature pages thereto
|
| |
8-K
|
| |
001-35312
|
| |
March 30, 2020
|
| |
10.1
|
| |
|
|
| |
Form of Securities Purchase Agreement, dated as of May 1, 2020, by and among the
Company and the purchasers identified on the signature pages thereto
|
| |
8-K
|
| |
001-35312
|
| |
May 4, 2020
|
| |
10.1
|
| |
|
|
| |
Underwriting Agreement, dated as of August 19, 2020, by and between the Company
and Ladenburg Thalman & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
August 21, 2020
|
| |
1.1
|
| |
|
|
| |
Warrant Agency Agreement, dated as of August 21, 2020, between the Company and
American Stock Transfer & Trust Company, LLC
|
| |
8-K
|
| |
001-35312
|
| |
August 21, 2020
|
| |
4.2
|
| |
|
|
| |
Executive Employment Agreement, dated January 16, 2021, by and between the
Company and Nestor Jaramillo, Jr.
|
| |
8-K
|
| |
001-35312
|
| |
January 19, 2021
|
| |
10.1
|
| |
|
|
| |
Executive Employment Agreement, dated January 16, 2021, by and between the
Company and John L. Erb
|
| |
8-K
|
| |
001-35312
|
| |
January 19, 2021
|
| |
10.2
|
| |
|
|
| |
Offer letter by and between the Company and Neil P. Ayotte, effective as of
June 7, 2021
|
| |
10-Q
|
| |
001-35312
|
| |
August 12, 2021
|
| |
10.4
|
| |
|
|
| |
Underwriting Agreement dated September 15, 2021, between the Company and
Ladenburg Thalmann & Co. Inc., as the Representative of the several underwriters named in Schedule I thereto.
|
| |
8-K
|
| |
001-35312
|
| |
September 17, 2021
|
| |
1.1
|
| |
|
|
| |
|
| |
Incorporated By Reference
|
| |
|
|||||||||
Exhibit
Number
|
| |
Exhibit
Description
|
| |
Form
|
| |
File
Number
|
| |
Date of
First Filing
|
| |
Exhibit
Number
|
| |
Filed
Herewith
|
| |
Warrant Agency Agreement, dated as of October 18, 2022, between the Company and
American Stock Transfer & Trust Company, LLC
|
| |
8-K
|
| |
001-35312
|
| |
October 18, 2022
|
| |
4.2
|
| |
|
|
| |
Leak-Out Agreement
|
| |
S-1/A
|
| |
333-267368
|
| |
September 30, 2022
|
| |
10.70
|
| |
|
|
| |
Offer Letter by and between the Company and Lynn Blake, effective as of
October 19, 2022
|
| |
8-K
|
| |
001-35312
|
| |
October 5, 2022
|
| |
10.1
|
| |
|
|
| |
First Amendment to Offer Letter between the Company and Lynn Blake
|
| |
8-K
|
| |
001-35312
|
| |
December 9, 2022
|
| |
10.1
|
| |
|
|
| |
Underwriting Agreement dated as of October 14, 2022, by and between Nuwellis,
Inc. and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
October 18, 2022
|
| |
1.1
|
| |
|
|
| |
License and Distribution Agreement with SeaStar Medical Holding Corporation,
dated as of December 27, 2022
|
| |
10-K
|
| |
001-35312
|
| |
March 3, 2023
|
| |
10.63
|
| |
|
|
| |
Supply and Collaboration Agreement dated as of June 19, 2023 by and between the
Company and DaVita Inc.
|
| |
8-K
|
| |
001-35312
|
| |
June 21, 2023
|
| |
10.1
|
| |
|
|
| |
Registration Rights Agreement dated as of June 19, 2023 by and between the
Company and DaVita Inc.
|
| |
8-K
|
| |
001-35312
|
| |
June 21, 2023
|
| |
10.2
|
| |
|
|
| |
DaVita Inc. Common Stock Warrant Agreement
|
| |
8-K
|
| |
001-35312
|
| |
June 21, 2023
|
| |
4.1
|
| |
|
|
| |
Transition Agreement dated August 4, 2023 by and between Nuwellis, Inc. and Lynn
Blake
|
| |
8-K
|
| |
001-35312
|
| |
August 8, 2023
|
| |
10.1
|
| |
|
|
| |
Offer Letter by and between Nuwellis, Inc. and Robert B. Scott, effective as of
September 2, 2023
|
| |
8-K
|
| |
001-35312
|
| |
August 18, 2023
|
| |
10.1
|
| |
|
|
| |
Placement Agency Agreement dated as of October 12, 2023, by and between
Nuwellis, Inc., Lake Street Capital Markets, LLC and Maxim Group LLC
|
| |
8-K
|
| |
001-35312
|
| |
October 17, 2023
|
| |
1.1
|
| |
|
|
| |
Form of Securities Purchase Agreement
|
| |
S-1/A
|
| |
333-274610
|
| |
September 29, 2023
|
| |
10.69
|
| |
|
|
| |
Form of Warrant Agency Agreement
|
| |
8-K
|
| |
001-35312
|
| |
October 17, 2023
|
| |
4.2
|
| |
|
|
| |
Consulting Agreement dated August 4, 2023 by and between Nuwellis, Inc. and Lunn
Blake
|
| |
8-K
|
| |
001-35312
|
| |
August 8, 2023
|
| |
10.2
|
| |
|
|
| |
Form of Securities Purchase Agreement
|
| |
8-K
|
| |
001-35312
|
| |
May 1, 2024
|
| |
10.1
|
| |
|
|
| |
Form of Warrant Agency Agreement
|
| |
8-K
|
| |
001-35312
|
| |
May 1, 2024
|
| |
4.3
|
| |
|
|
| |
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 Nuwellis, Inc. and DaVita Inc.
|
| |
8-K
|
| |
001-35312
|
| |
June 6, 2024
|
| |
10.1
|
| |
|
|
| |
Placement Agency Agreement dated as of July 24, 2024, by and between Nuwellis,
Inc., and Roth Capital Partners, LLC
|
| |
8-K
|
| |
001-35312
|
| |
July 25, 2024
|
| |
10.1
|
| |
|
|
| |
|
| |
Incorporated By Reference
|
| |
|
|||||||||
Exhibit
Number
|
| |
Exhibit
Description
|
| |
Form
|
| |
File
Number
|
| |
Date of
First Filing
|
| |
Exhibit
Number
|
| |
Filed
Herewith
|
| |
Form of Securities Purchase Agreement
|
| |
8-K
|
| |
001-35312
|
| |
July 25, 2024
|
| |
10.2
|
| |
|
|
| |
Termination Agreement to the Supply and Collaboration Agreement, dated August
21, 2024
|
| |
8-K
|
| |
001-35312
|
| |
August 22, 2024
|
| |
10.1
|
| |||
| |
Placement Agency Agreement dated as of August 23, 2024, by and between
Nuwellis, Inc., and Ladenburg Thalmann & Co. Inc.
|
| |
8-K
|
| |
001-35312
|
| |
August 26, 2024
|
| |
10.1
|
| |
|
|
| |
Form of Securities Purchase Agreement
|
| |
8-K
|
| |
001-35312
|
| |
August 26, 2024
|
| |
10.2
|
| |
|
|
| |
List of Subsidiaries
|
| |
10-K
|
| |
001-35312
|
| |
March 11, 2024
|
| |
21
|
| |
|
|
| |
Consent of Baker Tilly US, LLP
|
| |
|
| |
|
| |
|
| |
|
| |
X
|
|
| |
Consent of Honigman LLP
|
| |
|
| |
|
| |
|
| |
|
| |
Included in Exhibit 5.1
|
|
| |
Power of Attorney
|
| |
S-1
|
| |
333-281563
|
| |
August 15, 2024
|
| |
24.1
|
| |
|
|
| |
Filing Fee Table
|
| |
|
| |
|
| |
|
| |
|
| |
X
|
+
|
Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule
and/or exhibit will be furnished to the SEC upon request. Certain portions of the License and Distribution Agreement, Warrant Agreement, and Supply and Collaboration Agreement have been redacted pursuant to Item 601(b)(10)(iv) of
Regulation S-K because the Company customarily and actually treats the redacted information as private or confidential and the omitted information is not material. Copies of the unredacted License and Distribution Agreement, Warrant
Agreement, and Supply and Collaboration Agreement will be furnished to the SEC upon request.
|
(b)
|
Financial Statement Schedules.
|
Item 17.
|
Undertakings.
|
(a)
|
The undersigned Registrant hereby undertakes:
|
(1)
|
To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:
|
(i)
|
To include any prospectus required by Section 10(a)(3) of the Securities Act;
|
(ii)
|
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume
of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of
prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Filing Fee
Tables” table in the effective registration statement; and
|
(iii)
|
To include any material information with respect to the plan of distribution not previously disclosed in the registration
statement or any material change to such information in the registration statement;
|
(2)
|
That, for the purpose of determining any liability under the Securities Act, each such post- effective amendment shall be deemed
to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
(3)
|
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at
the termination of the offering.
|
(4)
|
That, for the purpose of determining liability under the Securities Act to any purchaser,
|
(i)
|
each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of
the date the filed prospectus was deemed part of and included in the registration statement; and
|
(ii)
|
each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the
registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B,
for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which
that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
|
(b)
|
The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing
of the Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated
by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
(c)
|
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and
controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and
is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in
the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
|
|
| |
NUWELLIS, INC.
|
|||
|
| |
|
| |
|
|
| |
By:
|
| |
/s/ Nestor Jaramillo, Jr.
|
|
| |
|
| |
Nestor Jaramillo, Jr.
Chief Executive Officer
|
Signature
|
| |
Title
|
| |
Date
|
|
|
| |
|
| |
|
|
*
|
| |
Chairman of the Board
|
| |
August 28, 2024
|
|
John L. Erb
|
| |
|
| |||
|
| |
|
| |
|
|
*
|
| |
President, Chief Executive
Officer and Director (principal executive officer)
|
| |
August 28, 2024
|
|
Nestor Jaramillo, Jr.
|
| |
|
| |||
|
| |
|
| |
|
|
*
|
| |
Chief Financial Officer (principal financial officer
and principal accounting officer)
|
| |
August 28, 2024
|
|
Robert B. Scott
|
| |
|
| |
|
|
|
| |
|
| |
|
|
*
|
| |
Director
|
| |
August 28, 2024
|
|
Maria Rosa Costanzo, M.D.
|
| |
|
| |
|
|
|
| |
|
| |
|
|
*
|
| |
Director
|
| |
August 28, 2024
|
|
Michael McCormick
|
| |
|
| |
|
|
|
| |
|
| |
|
|
*
|
| |
Director
|
| |
August 28, 2024
|
|
Archelle Georgiou, M.D.
|
| |
|
| |
|
|
|
| |
|
| |
|
|
*
|
| |
Director
|
| |
August 28, 2024
|
|
Gregory Waller
|
| |
|
| |
|
|
|
| |
|
| |
|
|
*
|
| |
Director
|
| |
August 28, 2024
|
|
David McDonald
|
| |
|
|
* By:
|
| |
/s/ Nestor Jaramillo, Jr.
|
| |
|
|
| |
Nestor Jaramillo, Jr.
|
| |
|
|
| |
Attorney-in-fact
|
| |
|