Initial Registration Statement Form S 1

 

 

 

 

 

 

 

Delaware

 

 

3845

 

 

68-0533453

(State or Other Jurisdiction of Incorporation or Organization)

 

 

(Primary Standard Industrial Classification Code Number)

 

 

(I.R.S. Employer

Identification Number)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Large accelerated filer

 

 

 ☐

 

 

Accelerated filer

 

 

 ☐

Non-accelerated filer

 

 

☒

 

 

Smaller reporting company

 

 

☒

 

 

 

 

Emerging growth company

 

 

 ☐

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page

ABOUT THIS PROSPECTUS

 

 

ii

PROSPECTUS SUMMARY

 

 

1

THE OFFERING

 

 

2

SUMMARY OF RISK FACTORS

 

 

4

RISK FACTORS

 

 

6

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

 

9

USE OF PROCEEDS

 

 

10

SELLING SECURITYHOLDERS

 

 

11

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

 

 

15

PLAN OF DISTRIBUTION

 

 

16

DESCRIPTION OF OUR CAPITAL STOCK

 

 

18

LEGAL MATTERS

 

 

27

EXPERTS

 

 

27

WHERE YOU CAN FIND MORE INFORMATION

 

 

28

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

 

 

29

 

 

 

 

•

3,877 shares of our common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise price of $518.86 per share;

•

5,303,264 shares of our common stock issuable upon the exercise of outstanding warrants with a weighted-average exercise price of $12.18 per share;

•

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");

•

67 shares of our common stock issuable upon the conversion of the 95 outstanding shares of our Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share (the "Series J Convertible Preferred Stock");

•

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

•

42,171 shares of our common stock reserved for future issuance under our equity incentive plans.

•

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.

•

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 our operations through May 31, 2025. If additional capital is not available, we will have to delay, reduce or cease operations. These factors raise substantial doubt about the Company's ability to continue as a going concern through the next twelve months.

•

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.

•

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.

•

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.

•

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.

•

We depend upon third-party suppliers, including single source suppliers, making us vulnerable to supply problems and price fluctuations.

•

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.

•

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.

•

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.

•

Significant additional governmental regulation could subject us to unanticipated delays which would adversely affect our sales.

•

Product defects, resulting in lawsuits for product liability, could harm our business, results of operations and financial condition.

•

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.

•

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.

•

If we fail to comply with federal and state laws regarding off-label use of our products, we could face substantial civil and criminal penalties and our business, financial condition, results of operations, and prospects could be adversely affected.

•

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.

•

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.

•

We face significant uncertainty in the industry due to government healthcare reform.

•

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.

•

Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other adverse consequences.

•

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.

•

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.

•

Intellectual property litigation could be costly and disruptive to us.

•

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.

•

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.

•

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

•

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.

•

The trading price of our common stock price has been, and could continue to be, volatile.

•

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.

•

A more active, liquid trading market for our common stock may not develop, and the price of our common stock may fluctuate significantly.

•

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.

•

Our ability to use U.S. net operating loss carryforwards and other tax attributes might be limited.

•

We do not intend to pay cash dividends on our common stock in the foreseeable future.

•

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

Name of Selling Securityholder

 

 

Number of

shares of

common stock

beneficially

owned

prior to the

offering

 

 

Maximum

number of

shares of

common stock

to be sold

pursuant to

this prospectus

 

 

Number of

shares of

common stock

beneficially owned

after the offering

 

 

Percentage of

shares of

common stock

beneficially

owned after the

offering

(%)

(1)

 

 

Armistice Capital, LLC

 

 

2,162,714

 

 

1,190,476

 

 

972,238

 

 

11.99

(2)

 

 

Hudson Bay Master Fund Ltd.

 

 

1,152,987

 

 

847,618

 

 

305,367

 

 

3.77

(3)

 

 

Bigger Capital Fund, LP.

 

 

603,946

 

 

291,746

 

 

312,200

 

 

3.85

(4)

 

 

District 2 Capital Fund LP

 

 

1,032,535

 

 

595,238

 

 

437,297

 

 

5.39

(5)

 

 

Alto Opportunity Master Fund,

SPC - Segregated Master Fund Portfolio B

 

 

113,444

 

 

9,670

 

 

103,774

 

 

1.27

(6)

 

 

L1 Capital Global Opportunities Master Fund

 

 

729,855

 

 

320,000

 

 

409,855

 

 

5.05

(7)

 

 

Intracoastal Capital, LLC

 

 

612,703

 

 

260,000

 

 

352,703

 

 

4.34

(8)

 

 

Connective Capital Emerging Energy QP LP

 

 

175,179

 

 

116,786

 

 

58,393

 

 

*

(9)

 

 

Connective Capital I QP LP

 

 

50,250

 

 

33,500

 

 

16,750

 

 

*

(10)

 

 

Ladenburg Thalmann & Co. Inc.

 

 

27,790

 

 

27,790

 

 

-

 

 

*

(11)

 

 

Nicholas Stergis

 

 

31,652

 

 

31,652

 

 

-

 

 

*

(12)

 

 

David Coherd

 

 

4,193

 

 

4,193

 

 

-

 

 

*

(13)

 

 

Marc Weinberger

 

 

2,096

 

 

2,096

 

 

-

 

 

*

(14)

 

 

Andrew Moorefield

 

 

3,746

 

 

3,746

 

 

-

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

*

Indicates beneficial ownership of less than one percent.

(1)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement (as defined below) and consist of 595,238 shares of common stock issuable upon the exercise of 595,238 of the Series I Warrants and 595,238 shares of common stock issuable upon the exercise of 595,238 of the Series II Warrants. The Series I Warrants and Series II 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.

(2)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 423,809 shares of common stock issuable upon the exercise of 423,809 of the Series I Warrants and 423,809 shares of common stock issuable upon the exercise of 423,809 of the Series II Warrants. The Series I Warrants and Series II 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

(3)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 145,873 shares of common stock issuable upon the exercise of 145,873 of the Series I Warrants and 145,873 shares of common stock issuable upon the exercise of 145,873 of the Series II Warrants. The Series I Warrants and Series II 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 Bigger Capital Fund, LP, a Delaware limited partnership ("Bigger Capital"), and may be deemed to be beneficially owned by: (i) Bigger Capital GP, LLC, as the general partner of Bigger Capital and (ii) Michael Bigger, as the Managing Member of Bigger Capital GP, LLC. Bigger Capital GP, LLC has sole voting and dispositive control of the shares reported herein. The address of Bigger Capital is 11700 W. Charleston Blvd. #170-659, Las Vegas, Nevada, 89135.

(4)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 297,619 shares of common stock issuable upon the exercise of 297,619 of the Series I Warrants and 297,619 shares of common stock issuable upon the exercise of 297,619 of the Series II Warrants. The Series I Warrants and Series II 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.

(5)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 4,835 shares of common stock issuable upon the exercise of 4,835 of the Series I Warrants and 4,835 shares of common stock issuable upon the exercise of 4,835 of the Series II Warrants. The Series I Warrants and Series II 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.

(6)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 160,000 shares of common stock issuable upon the exercise of 160,000 of the Series I Warrants and 160,000 shares of common stock issuable upon the exercise of 160,000 of the Series II Warrants. The Series I Warrants and Series II 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.

(7)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 130,000 shares of common stock issuable upon the exercise of 130,000 of the Series I Warrants and 130,000 shares of common stock issuable upon the exercise of 130,000 of the Series II Warrants. The Series I Warrants and Series II 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 Intracoastal Capital, LLC, a Delaware limited liability company ("Intracoastal"). Mitchell P. Kopin ("Mr. Kopin") and Daniel B. Asher ("Mr. Asher"), each of whom are managers of Intracoastal, have shared voting control and investment discretion over the securities reported herein that are held by Intracoastal. As a result, each of Mr. Kopin and Mr. Asher may be deemed to have beneficial ownership (as determined under Section 13(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act")) of the securities reported herein that are held by Intracoastal.

(8)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 58,393 shares of common stock issuable upon the exercise of 58,393 of the Series I Warrants and 58,393 shares of common stock issuable upon the exercise of 58,393 of the Series II Warrants. The Series I Warrants and Series II 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 Connective Capital Emerging Energy QP LP, a Delaware limited partnership ("Connective Emerging Energy"), and may be deemed to be beneficially owned by: Robert Romero ("Mr. Romero"), who is the Chief Executive Officer of Connective Capital I, and has sole voting and dispositive control of the shares reported herein. The address of Connective Capital is 720 University Avenue, Suite 100, Palo Alto, CA 94301.

(9)

The shares of common stock registered hereby were acquired in the November 2024 Warrant Inducement and consist of 16,750 shares of common stock issuable upon the exercise of 16,750 of the Series I Warrants and 16,750 shares of common stock issuable upon the exercise of 16,750 of the Series II Warrants. The Series I Warrants and Series II 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 Connective Capital I QP LP, a Delaware limited partnership ("Connective Capital I"), and may be deemed to be beneficially owned by: Robert Romero ("Mr. Romero"), who is the Chief Executive Officer of Connective Capital I, and has sole voting and dispositive control of the shares reported herein. The address of Connective Capital is 720 University Avenue, Suite 100, Palo Alto, CA 94301.

(10)

The shares of common stock registered hereby were acquired in the (i) August Private Placement (as defined below) and consist of 5,800 shares of common stock issuable upon the exercise of 5,800 of the August PA Warrants and (ii) November 2024 Warrant

(11)

The shares of common stock registered hereby were acquired in the (i) August Private Placement (as defined below) and consist of 6,913 shares of common stock issuable upon the exercise of 6,913 of the August PA Warrants and (ii) November 2024 Warrant Inducement and consist of 24,739 shares of common stock issuable upon the exercise of 24,739 of the November PA Warrants. The August PA Warrants and November PA 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. Mr. Stergis is affiliated with Ladenberg Thalmann & Co. Inc., a registered broker dealer with a registered address 640 Fifth Avenue, 4th Floor, New York, NY 10019, and has sole voting and dispositive power over the securities held. The Selling Stockholder acquired the Placement Agent Warrants in the ordinary course of business and, at the time the Placement Agent Warrants were acquired, the Selling Stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities.

(12)

The shares of common stock registered hereby were acquired in the (i) August Private Placement (as defined below) and consist of 894 shares of common stock issuable upon the exercise of 894 of the August PA Warrants and (ii) November 2024 Warrant Inducement and consist of 3,299 shares of common stock issuable upon the exercise of 3,299 of the November PA Warrants. The August PA Warrants and November PA 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. Mr. Coherd is affiliated with Ladenberg Thalmann & Co. Inc., a registered broker dealer with a registered address 640 Fifth Avenue, 4th Floor, New York, NY 10019, and has sole voting and dispositive power over the securities held. The Selling Stockholder acquired the Placement Agent Warrants in the ordinary course of business and, at the time the Placement Agent Warrants were acquired, the Selling Stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities.

(13)

The shares of common stock registered hereby were acquired in the (i) August Private Placement (as defined below) and consist of 447 shares of common stock issuable upon the exercise of 447 of the August PA Warrants and (ii) November 2024 Warrant Inducement and consist of 1,649 shares of common stock issuable upon the exercise of 1,649 of the November PA Warrants. The August PA Warrants and November PA 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. Mr. Weinberger is affiliated with Ladenberg Thalmann & Co. Inc., a registered broker dealer with a registered address 640 Fifth Avenue, 4th Floor, New York, NY 10019, and has sole voting and dispositive power over the securities held. The Selling Stockholder acquired the Placement Agent Warrants in the ordinary course of business and, at the time the Placement Agent Warrants were acquired, the Selling Stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities.

(14)

The shares of common stock registered hereby were acquired in the (i) August Private Placement (as defined below) and consist of 447 shares of common stock issuable upon the exercise of 447 of the August PA Warrants and (ii) November 2024 Warrant Inducement and consist of 3,299 shares of common stock issuable upon the exercise of 3,299 of the November PA Warrants. The August PA Warrants and November PA 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. Mr. Moorefield is affiliated with Ladenberg Thalmann & Co. Inc., a registered broker dealer with a registered address 640 Fifth Avenue, 4th Floor, New York, NY 10019, and has sole voting and dispositive power over the securities held. The Selling Stockholder acquired the Placement Agent Warrants in the ordinary course of business and, at the time the Placement Agent Warrants were acquired, the Selling Stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities.

•

each person, or group of affiliated persons, who we know to beneficially own more than 5% of our common stock;

•

each of our named executive officers and directors; and

•

all of our executive officers and directors as a group.

 

 

 

 

 

 

 

 

 

 

 

 

 

Name of Beneficial Owner

 

 

Number of

Shares

 

 

Right to

Acquire⁽¹⁾

 

 

Total

 

 

Aggregate

Percent of

Class⁽²⁾

Executive Officers and Directors

 

 

 

 

 

 

 

 

John L. Erb

 

 

-

 

 

69,028⁽³⁾

 

 

69,028

 

 

1.6%

Michael McCormick

 

 

-

 

 

595

 

 

595

 

 

*

Maria Rosa Costanzo, M.D.

 

 

-

 

 

-

 

 

-

 

 

-

Archelle Georgiou, M.D.

 

 

-

 

 

351

 

 

351

 

 

*

Gregory D. Waller

 

 

-

 

 

67

 

 

67

 

 

*

David McDonald

 

 

-

 

 

351

 

 

351

 

 

*

Robert B. Scott

 

 

-

 

 

181

 

 

181

 

 

*

Nestor Jaramillo, Jr.

 

 

117

 

 

346

 

 

463

 

 

*

Neil P. Ayotte

 

 

-

 

 

121

 

 

121

 

 

*

Lynn Blake

 

 

3

 

 

-

 

 

3

 

 

*

All current directors and executive officers as a group (9 persons)

 

 

117

 

 

71,040

 

 

71,157

 

 

1.6%

 

 

 

 

 

 

 

 

 

 

 

 

 

*

Less than one percent.

(1)

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 November 8, 2024.

(2)

Based on 4,373,968 shares outstanding as of November 8, 2024.

(3)

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).

•

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

•

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;

•

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

•

an exchange distribution in accordance with the rules of the applicable exchange;

•

privately negotiated transactions;

•

settlement of short sales;

•

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;

•

through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

•

a combination of any such methods of sale; or

•

any other method permitted pursuant to applicable law.

•

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;

•

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;"

•

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;

•

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;

•

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;"

•

the choice of forum provision described below under "Description of our Capital Stock - Choice of Forum;"

•

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

•

the super-majority voting requirement to amend our certificate of incorporation described above.

•

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;

•

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;

•

prohibiting stockholders from acting by written consent in lieu of a meeting;

•

requiring advance notice of stockholder intention to put forth director nominees or bring up other business at a stockholders' meeting;

•

prohibiting stockholders from calling a special meeting of stockholders;

•

requiring a 66²∕3% super-majority stockholder approval in order for stockholders to alter, amend or repeal certain provisions of our certificate of incorporation;

•

requiring a 66²∕3% super-majority stockholder approval in order for stockholders to adopt, amend or repeal our bylaws;

•

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;

•

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;

•

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

•

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.

•

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;

•

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

•

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.

•

any merger or consolidation involving the corporation or a direct or indirect majority-owned subsidiary of the corporation and the interested stockholder;

•

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;

•

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;

•

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

•

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.

•

breach of their duty of loyalty to us or our stockholders;

•

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

•

unlawful payment of dividends or redemption of shares as provided in Section 174 of the DGCL; or

•

transaction from which the directors derived an improper personal benefit.

•

our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 11, 2024;

•

our definitive proxy statement for our 2024 Annual Meeting of Stockholders filed with the SEC on May 17, 2024;

•

our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024; the quarter ended June 30, 2024, filed with the SEC on August 13, 2024; and the quarter ended September 30, 2024, filed with the SEC on November 12, 2024;

•

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, August 26, 2024, October 23, 2024, and November 7, 2024; and

•

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.

Item 13.

Other Expenses of Issuance and Distribution.

 

 

 

 

Item

 

 

Amount Paid or

to Be Paid

SEC registration fee

 

 

$1,029.15

FINRA filing fee

 

 

*

Printing expenses

 

 

*

Legal fees and expenses

 

 

*

Accounting fees and expenses

 

 

*

Transfer agent fees and expenses

 

 

*

Miscellaneous fees and expenses

 

 

*

Total

 

 

$*

 

 

 

 

*

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. 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. 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 Ladenburg Thalmann & Co. Inc., 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.

•

On November 5, 2024, the Company entered into Inducement Letters with the Selling Securityholders to immediately exercise approximately 1.8 million of the common stock purchase warrants issued by the Company on April 30, 2024 (the "April 2024 Warrants") held by such investors. In consideration for exercising the April 2024 Warrants, pursuant to the terms of the Inducement Letters, the Company issued to the investors new Series I Warrants and new Series II Warrants, in each case, to purchase up to an aggregate of 1,832,517 shares of common stock, equal to 100% of the number of shares of common stock issued pursuant to the immediate exercise of the corresponding April 2024 Warrants. The Series I Warrant has an exercise price of $1.94, is exercisable six (6) months from the date of issuance and has a term of five (5) years from the date of initial exercise. The Series II Warrant has an exercise price of $1.94, is exercisable six (6) months from the date of issuance and has a term of two (2) years from the date of initial exercise. The registrant also offered, as part compensation to Ladenburg Thalmann & Co. Inc., the placement agent, in connection with the offering, warrants to purchase up to 54,976 shares of common stock. Such warrants have an exercise price of $3.465 per share and will expire five years following the commencement of sales pursuant to the offering. The Series I Warrants, Series II Warrants, and November PA Warrants were issued to the Selling Securityholders, which are institutional accredited investors, in a private placement in reliance upon the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) and Regulation D promulgated under the Securities Act.

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

3.1

 

 

Fourth Amended and Restated Certificate of Incorporation

 

 

10

 

 

001-35312

 

 

February 1, 2012

 

 

3.1

 

 

3.2

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

January 13, 2017

 

 

3.1

 

 

3.3

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

May 23, 2017

 

 

3.1

 

 

3.4

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

October 12, 2017

 

 

3.1

 

 

3.5

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

January 2, 2019

 

 

3.1

 

 

3.6

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K/A

 

 

001-35312

 

 

October 16, 2020

 

 

3.1

 

 

3.7

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

April 27, 2021

 

 

3.1

 

 

3.8

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

December 9, 2022

 

 

3.1

 

 

3.9

 

 

Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation

 

 

8-K

 

 

001-35312

 

 

June 26, 2024

 

 

3.1

 

 

3.10

 

 

Third Amended and Restated Bylaws

 

 

10-Q

 

 

001-35312

 

 

November 12, 2024

 

 

3.13

 

 

3.11

 

 

Amendment to Third Amended and Restated Bylaws

 

 

10-Q

 

 

001-35312

 

 

November 12, 2024

 

 

3.14

 

 

3.12

 

 

Form of Certificate of Designation of Series F Convertible Preferred Stock

 

 

S-1/A

 

 

333-221010

 

 

November 17, 2017

 

 

3.7

 

 

3.13

 

 

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

 

 

4.1

 

 

Specimen of Common Stock Certificate

 

 

10

 

 

001-35312

 

 

September 30, 2011

 

 

4.1

 

 

4.2

 

 

Form of Common Warrant

 

 

8-K

 

 

001-35312

 

 

July 25, 2024

 

 

4.1

 

 

4.3

 

 

Form of Common Warrant

 

 

8-K

 

 

001-35312

 

 

August 26, 2024

 

 

4.1

 

 

4.4

 

 

Form of Placement Agent Warrant

 

 

8-K

 

 

001-35312

 

 

August 26, 2024

 

 

4.2

 

 

4.5

 

 

Form of Series I Common Stock Purchase Warrant

 

 

8-K

 

 

001-35312

 

 

November 7, 2024

 

 

4.1

 

 

4.6

 

 

Form of Series II Common Stock Purchase Warrant

 

 

8-K

 

 

001-35312

 

 

November 7, 2024

 

 

4.2

 

 

4.7

 

 

Form of Placement Agent Warrant

 

 

8-K

 

 

001-35312

 

 

November 7, 2024

 

 

4.3

 

 

5.1

 

 

Opinion of Honigman LLP

 

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Incorporated By Reference

 

 

Exhibit

Number

 

 

Exhibit

Description

 

 

Form

 

 

File

Number

 

 

Date of

First Filing

 

 

Exhibit

Number

 

 

Filed

Herewith

10.1

 

 

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

 

 

10.2

 

 

2013 Non-Employee Directors' Equity Incentive Plan

 

 

14A

 

 

001-35312

 

 

April 5, 2013

 

 

App. A

 

 

10.3

 

 

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

 

 

10.4

 

 

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

 

 

10.5

 

 

New-Hire Equity Incentive Plan

 

 

10-Q

 

 

001-35312

 

 

August 8, 2013

 

 

10.1

 

 

10.6

 

 

First Amendment to New-Hire Equity Incentive Plan

 

 

10-Q

 

 

001-35312

 

 

November 12, 2013

 

 

10.1

 

 

10.7

 

 

Second Amendment to New-Hire Equity Incentive Plan

 

 

S-8

 

 

333-202904

 

 

March 20, 2015

 

 

99.12

 

 

10.8

 

 

Third Amendment to New-Hire Equity Incentive Plan

 

 

S-8

 

 

333-210215

 

 

March 15, 2016

 

 

99.13

 

 

10.9

 

 

Fourth Amendment to New-Hire Equity Incentive Plan

 

 

8-K

 

 

001-35312

 

 

May 30, 2017

 

 

10.4

 

 

10.10

 

 

Fifth Amendment to New-Hire Equity Incentive Plan

 

 

8-K

 

 

001-35312

 

 

January 18, 2018

 

 

10.1

 

 

10.11

 

 

Sixth Amendment to New-Hire Equity Incentive Plan

 

 

10-Q

 

 

001-35312

 

 

August 8, 2019

 

 

10.2

 

 

10.12

 

 

Seventh Amendment to New-Hire Equity Incentive Plan

 

 

8-K

 

 

001-35312

 

 

December 6, 2019

 

 

10.1

 

 

10.13

 

 

Eighth Amendment to New-Hire Equity Incentive Plan

 

 

8-K/A

 

 

001-35312

 

 

February 25, 2021

 

 

10.1

 

 

10.14

 

 

Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan

 

 

10-Q

 

 

001-35312

 

 

November 12, 2013

 

 

10.2

 

 

10.15

 

 

2017 Equity Incentive Plan

 

 

8-K

 

 

001-35312

 

 

May 30, 2017

 

 

10.1

 

 

10.16

 

 

First Amendment to the 2017 Equity Incentive Plan

 

 

14A

 

 

001-35312

 

 

September 11, 2020

 

 

App. A

 

 

10.17

 

 

Second Amendment to the 2017 Equity Incentive Plan

 

 

10-K

 

 

001-35312

 

 

March 3, 2023

 

 

10.17

 

 

10.18

 

 

Form of Stock Option Grant Notice and Option Agreement for 2017 Equity Incentive Plan

 

 

8-K

 

 

001-35312

 

 

May 30, 2017

 

 

10.2

 

 

10.19

 

 

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

 

 

10.20

 

 

Nuwellis, Inc. 2021 Inducement Plan

 

 

8-K

 

 

001-35312

 

 

May 20, 2021

 

 

10.1

 

 

10.21

 

 

First Amendment to the 2021 Inducement Plan

 

 

8-K

 

 

001-35312

 

 

April 21, 2022

 

 

10.1

 

 

10.22

 

 

Second Amendment to the 2021 Inducement Plan

 

 

8-K

 

 

001-35312

 

 

March 1, 2023

 

 

10.1

 

 

10.23

 

 

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

 

 

10.24

 

 

Form of Indemnity Agreement for the Company's executive officers and directors

 

 

10

 

 

001-35312

 

 

September 30, 2011

 

 

10.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Incorporated By Reference

 

 

Exhibit

Number

 

 

Exhibit

Description

 

 

Form

 

 

File

Number

 

 

Date of

First Filing

 

 

Exhibit

Number

 

 

Filed

Herewith

10.25

 

 

Form of Change in Control Agreement for the Company's executive officers

 

 

10-K

 

 

001-35312

 

 

March 20, 2015

 

 

10.16

 

 

10.26

 

 

Non-Employee Director Compensation Policy (effective January 1, 2023)

 

 

10-K

 

 

001-35312

 

 

March 3, 2023

 

 

10.27

 

 

10.27

 

 

Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC

 

 

10

 

 

001-35312

 

 

December 16, 2011

 

 

10.18

 

 

10.28

 

 

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

 

 

10.29

 

 

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

 

 

10.30

 

 

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

 

 

10.31

 

 

Executive Employment Agreement between Sunshine Heart, Inc. and John L. Erb, dated March 1, 2016

 

 

8-K

 

 

001-35312

 

 

March 2, 2016

 

 

10.1

 

 

10.32

 

 

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

 

 

10.33

 

 

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

 

 

10.34

 

 

Form of Warrant Reprice Agreement

 

 

8-K

 

 

001-35312

 

 

June 29, 2018

 

 

10.1

 

 

10.35

 

 

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

 

 

10.36

 

 

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

 

 

10.37

 

 

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

 

 

10.38

 

 

Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12, 2019

 

 

10-Q

 

 

001-35312

 

 

May 9, 2019

 

 

10.5

 

 

10.39

 

 

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

 

 

10.40

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Incorporated By Reference

 

 

Exhibit

Number

 

 

Exhibit

Description

 

 

Form

 

 

File

Number

 

 

Date of

First Filing

 

 

Exhibit

Number

 

 

Filed

Herewith

10.41

 

 

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

 

 

10.42

 

 

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

 

 

10.43

 

 

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

 

 

10.44

 

 

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

 

 

10.45

 

 

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

 

 

10.46

 

 

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

 

 

10.47

 

 

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

 

 

10.48

 

 

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

 

 

10.49

 

 

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

 

 

10.50

 

 

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

 

 

10.51

 

 

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

 

 

10.52

 

 

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

 

 

10.53

 

 

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

 

 

10.54

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Incorporated By Reference

 

 

Exhibit

Number

 

 

Exhibit

Description

 

 

Form

 

 

File

Number

 

 

Date of

First Filing

 

 

Exhibit

Number

 

 

Filed

Herewith

10.55

 

 

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

 

 

10.56

 

 

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

 

 

10.57

 

 

Leak-Out Agreement

 

 

S-1/A

 

 

333-267368

 

 

September 30, 2022

 

 

10.70

 

 

10.58

 

 

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

 

 

10.59

 

 

First Amendment to Offer Letter between the Company and Lynn Blake

 

 

8-K

 

 

001-35312

 

 

December 9, 2022

 

 

10.1

 

 

10.60

 

 

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

 

 

10.61

 

 

Transition Agreement dated August 4, 2023 by and between Nuwellis, Inc. and Lynn Blake

 

 

8-K

 

 

001-35312

 

 

August 8, 2023

 

 

10.1

 

 

10.62

 

 

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

 

 

10.63

 

 

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

 

 

10.64

 

 

Form of Securities Purchase Agreement

 

 

S-1/A

 

 

333-274610

 

 

September 29, 2023

 

 

10.69

 

 

10.65

 

 

Form of Warrant Agency Agreement

 

 

8-K

 

 

001-35312

 

 

October 17, 2023

 

 

4.2

 

 

10.66

 

 

Consulting Agreement dated August 4, 2023 by and between Nuwellis, Inc. and Lynn Blake

 

 

8-K

 

 

001-35312

 

 

August 8, 2023

 

 

10.2

 

 

10.67

 

 

Form of Securities Purchase Agreement

 

 

8-K

 

 

001-35312

 

 

May 1, 2024

 

 

10.1

 

 

10.68

 

 

Form of Warrant Agency Agreement

 

 

8-K

 

 

001-35312

 

 

May 1, 2024

 

 

4.3

 

 

10.69

 

 

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

 

 

10.70

 

 

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

 

 

10.71

 

 

Form of Securities Purchase Agreement

 

 

8-K

 

 

001-35312

 

 

July 25, 2024

 

 

10.2

 

 

10.72

 

 

Termination Agreement to the Supply and Collaboration Agreement, dated August 21, 2024

 

 

8-K

 

 

001-35312

 

 

August 22, 2024

 

 

10.1

 

 

10.73

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Incorporated By Reference

 

 

Exhibit

Number

 

 

Exhibit

Description

 

 

Form

 

 

File

Number

 

 

Date of

First Filing

 

 

Exhibit

Number

 

 

Filed

Herewith

10.74

 

 

Form of Securities Purchase Agreement

 

 

8-K

 

 

001-35312

 

 

August 26, 2024

 

 

10.2

 

 

10.75

 

 

Confidential Settlement Agreement & Release with SeaStar Medical Holding Corproation, dated October 20, 2024

 

 

8-K

 

 

001-35312

 

 

October 23, 2024

 

 

10.1

 

 

10.76

 

 

Form of Warrant Inducement Offer Letter

 

 

8-K

 

 

001-35312

 

 

November 7, 2024

 

 

10.1

 

 

21

 

 

List of Subsidiaries

 

 

10-K

 

 

001-35312

 

 

March 11, 2024

 

 

21

 

 

23.1

 

 

Consent of Baker Tilly US, LLP

 

 

 

 

 

 

 

 

 

 

X

23.2