UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

☒     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2021

 

OR

 

☐     TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934

 

From the transition period from                to           

 

Commission File Number 001-37853

 

AZURRX BIOPHARMA, INC.

(Exact name of small business issuer as specified in its charter)

  

Delaware

 

46-4993860

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

 

777 Yamato Road, Suite 502

Boca Raton, Florida 33431

(Address of principal executive offices)

 

(561) 589-7020

(Issuer’s telephone number)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

 

Trading Symbol

 

Name of Each Exchange on Which Registered

Common stock, par value $0.0001 per share

 

AZRX

 

Nasdaq Capital Market

 

Securities registered under Section 12(g) of the Exchange Act: None

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒     No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Sec.232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒     No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐     No ☒

 

There were 93,261,897 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of August 13, 2021.

 

 

 

  

TABLE OF CONTENTS

 

 

 

Page

 

 

 

 

 

 

PART I. FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

Unaudited Consolidated Financial Statements

 

1

 

 

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 36

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 42

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

 42

 

 

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

 43

 

 

 

 

 

 

Item 1A.

Risk Factors

 

 43

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

 43

 

 

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

 43

 

 

 

 

 

 

Item 4.

Mine Safety Disclosures

 

 43

 

 

 

 

 

 

Item 5.

Other Information

 

 43

 

 

 

 

 

 

Item 6.

Exhibits

 

 44

 

 

 

-i-

Table of Contents

   

PART I 

 

FINANCIAL INFORMATION

 

ITEM 1. UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

In our opinion, the accompanying unaudited consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to present fairly our financial position, results of operations, and cash flows for the interim periods presented. We have consolidated such financial statements in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”). Therefore, such financial statements do not include all disclosures required by accounting principles generally accepted in the United States of America. In preparing these unaudited consolidated financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through the date the unaudited consolidated financial statements were issued by filing with the SEC.

 

These financial statements should be read in conjunction with our audited financial statements for the year ended December 31, 2020 included in our Annual Report filed on Form 10-K, filed with the SEC on March 31, 2021.

 

The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the fiscal year ending December 31, 2021.

 

 
1

Table of Contents

  

AZURRX BIOPHARMA, INC.

Consolidated Balance Sheets (unaudited)

  

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$ 8,074,491

 

 

$ 6,062,141

 

Other receivables

 

 

-

 

 

 

551,489

 

Prepaid expenses

 

 

540,786

 

 

 

1,256,154

 

Total Current Assets

 

 

8,615,277

 

 

 

7,869,784

 

 

 

 

 

 

 

 

 

 

Property, equipment, and leasehold improvements, net

 

 

89,243

 

 

 

18,329

 

 

 

 

 

 

 

 

 

 

Other Assets:

 

 

 

 

 

 

 

 

Patents, net

 

 

2,615,762

 

 

 

2,879,536

 

Goodwill

 

 

1,991,287

 

 

 

2,054,048

 

Operating lease right-of-use assets

 

 

395,634

 

 

 

74,238

 

Deposits

 

 

69,596

 

 

 

27,920

 

Total Other Assets

 

 

5,072,279

 

 

 

5,035,742

 

Total Assets

 

$ 13,776,799

 

 

$ 12,923,855

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$ 4,643,885

 

 

$ 1,685,603

 

Payable related to license agreement

 

 

1,250,000

 

 

 

13,250,000

 

Accrued dividend payable

 

 

231,043

 

 

 

-

 

Note payable

 

 

139,569

 

 

 

552,405

 

Other current liabilities

 

 

189,625

 

 

 

57,417

 

Total Current Liabilities

 

 

6,454,122

 

 

 

15,545,425

 

 

 

 

 

 

 

 

 

 

Other liabilities

 

 

285,753

 

 

 

19,123

 

Total Liabilities

 

 

6,739,875

 

 

 

15,564,548

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

Common stock - Par value $0.0001 per share; 250,000,000 shares authorized; 82,585,075 and 31,150,309 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively.

 

 

8,260

 

 

 

3,115

 

Series B preferred stock- Par value $0.0001 per share; 5,194.81 shares authorized; 676.05 and 2,773.6 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively.

 

 

-

 

 

 

-

 

Series C preferred stock- Par value $0.0001 per share; 57,000 shares authorized; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020.

 

 

-

 

 

 

-

 

Additional paid-in capital

 

 

120,584,938

 

 

 

93,834,936

 

Accumulated deficit

 

 

(112,330,771 )

 

 

(95,366,198 )

Accumulated other comprehensive loss

 

 

(1,225,503 )

 

 

(1,112,546 )

Total Stockholders’ Equity

 

 

7,036,924

 

 

 

(2,640,693 )

Total Liabilities and Stockholders’ Equity

 

$ 13,776,799

 

 

$ 12,923,855

 

 

See accompanying notes to consolidated financial statements

 

 
2

Table of Contents

 

AZURRX BIOPHARMA, INC.

Consolidated Statements of Operations and Comprehensive Loss (unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$ 5,647,798

 

 

$ 1,089,177

 

 

$ 8,163,825

 

 

$ 2,642,537

 

General and administrative expenses

 

 

3,629,090

 

 

 

1,304,527

 

 

 

9,326,604

 

 

 

2,679,618

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(9,276,888 )

 

 

(2,393,704 )

 

 

(17,490,429 )

 

 

(5,322,155 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,954 )

 

 

(2,302,174 )

 

 

(8,098 )

 

 

(4,635,013 )

Other income

 

 

898

 

 

 

-

 

 

 

1,601

 

 

 

-

 

Change in fair value of liability

 

 

 

 

 

 

-

 

 

 

532,353

 

 

 

-

 

Total other income (expenses)

 

 

(2,056 )

 

 

(2,302,174 )

 

 

525,856

 

 

 

(4,635,013 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$ (9,278,944 )

 

$ (4,695,878 )

 

$ (16,964,573 )

 

$ (9,957,168 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

21,840

 

 

 

(163,719 )

 

 

(112,957 )

 

 

(6,225 )

Total comprehensive loss

 

$ (9,257,104 )

 

$ (4,859,597 )

 

$ (17,077,530 )

 

$ (9,963,393 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$ (9,278,944 )

 

$ (4,695,878 )

 

$ (16,964,573 )

 

$ (9,957,168 )

Deemed dividend on preferred stock issuances

 

 

-

 

 

 

-

 

 

 

(4,507,125 )

 

 

-

 

Deemed dividend on preferred stock exchanges

 

 

(3,424,205 )

 

 

-

 

 

 

(21,008,253 )

 

 

-

 

Preferred stock dividends

 

 

(26,661 )

 

 

-

 

 

 

(231,043 )

 

 

-

 

Net loss applicable to common shareholders

 

$ (12,729,810 )

 

$ (4,695,878 )

 

$ (42,710,994 )

 

$ (9,957,168 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted weighted average shares outstanding

 

 

78,124,399

 

 

 

28,016,478

 

 

 

66,799,183

 

 

 

27,479,140

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share - basic and diluted

 

$ (0.16 )

 

$ (0.17 )

 

$ (0.64 )

 

$ (0.36 )

 

See accompanying notes to consolidated financial statements

  

 
3

Table of Contents

  

AZURRX BIOPHARMA, INC.

Consolidated Statements of Changes in Stockholders’ Equity (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

Other

 

 

 

 

 

 

 

Common Stock

 

 

Paid In

 

 

Accumulated

 

 

Comprehensive

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, April 1, 2020

 

 

27,157,651

 

 

$ 2,716

 

 

$ 72,103,490

 

 

$ (67,956,022 )

 

$ (1,109,061 )

 

$ 3,041,123

 

Common stock issued to Lincoln Park for Equity Purchase agreement

 

 

1,345,199

 

 

 

134

 

 

 

844,214

 

 

 

-

 

 

 

-

 

 

 

844,348

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

176,676

 

 

 

-

 

 

 

-

 

 

 

176,676

 

Foreign currency translation adjustment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(163,719 )

 

 

(163,719 )

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(4,695,878 )

 

 

-

 

 

 

(4,695,878 )

Balance, June 30, 2020

 

 

28,502,850

 

 

$ 2,850

 

 

$ 73,124,380

 

 

$ (72,651,900 )

 

$ (1,272,780 )

 

$ (797,450 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

Additional

 

 

 

 

Other

 

 

 

 

 

Common Stock

 

 

Paid In

 

 

Accumulated

 

 

Comprehensive

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, January 1, 2020

 

 

26,800,519

 

 

$ 2,680

 

 

$ 68,575,851

 

 

$ (62,694,732 )

 

$ (1,266,555 )

 

$ 4,617,244

 

Common stock issued to settle accounts payable

 

 

105,937

 

 

 

11

 

 

 

131,126

 

 

 

-

 

 

 

-

 

 

 

131,137

 

Common stock issued to consultants

 

 

101,195

 

 

 

10

 

 

 

87,095

 

 

 

-

 

 

 

-

 

 

 

87,105

 

Common stock issued to Lincoln Park for Equity Purchase agreement

 

 

1,495,199

 

 

 

149

 

 

 

988,199

 

 

 

-

 

 

 

-

 

 

 

988,348

 

Warrants issued in association with convertible debt issuances

 

 

-

 

 

 

-

 

 

 

1,252,558

 

 

 

-

 

 

 

-

 

 

 

1,252,558

 

Beneficial conversion feature on convertible debt issuances

 

 

-

 

 

 

-

 

 

 

1,838,422

 

 

 

-

 

 

 

-

 

 

 

1,838,422

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

251,129

 

 

 

-

 

 

 

-

 

 

 

251,129

 

Foreign currency translation adjustment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(6,225 )

 

 

(6,225 )

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(9,957,168 )

 

 

-

 

 

 

(9,957,168 )

Balance, June 30, 2020

 

 

28,502,850

 

 

$ 2,850

 

 

$ 73,124,380

 

 

$ (72,651,900 )

 

$ (1,272,780 )

 

$ (797,450 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

Series C Convertible

 

 

Series B Convertible

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Other

 

 

 

 

 

 

Preferred Stock

 

 

Preferred Stock

 

 

Common Stock

 

 

Paid In

 

 

Accumulated

 

 

Comprehensive

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Total

 

Balance, April 1, 2021

 

 

-

 

 

$ -

 

 

 

1,209

 

 

$ -

 

 

 

74,926,902

 

 

$ 7,493

 

 

$ 118,693,364

 

 

$ (103,051,827 )

 

$ (1,247,343 )

 

$ 14,401,687

 

Issuance of Series C preferred stock upon exchange of Series B preferred stock

 

 

5,639

 

 

 

-

 

 

 

(533 )

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(422 )

 

 

-

 

 

 

-

 

 

 

(422 )

Warrants issued in connection with exchange of Series B preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,424,626

 

 

 

-

 

 

 

-

 

 

 

3,424,626

 

Deemed dividend related to exchange of Series B preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,424,205 )

 

 

-

 

 

 

-

 

 

 

(3,424,205 )

Dividends on preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(26,661 )

 

 

-

 

 

 

-

 

 

 

(26,661 )

Common stock and pre-funded warrants issued upon conversion of Series C preferred stock

 

 

(5,639 )

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,639,153

 

 

 

564

 

 

 

(564 )

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock at-the-market for cash, net of offering costs

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,495,645

 

 

 

150

 

 

 

1,174,198

 

 

 

-

 

 

 

-

 

 

 

1,174,348

 

Common stock issued upon exercise of warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

328,375

 

 

 

33

 

 

 

282,755

 

 

 

-

 

 

 

-

 

 

 

282,788

 

Common stock and warrants issued to consultants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

195,000

 

 

 

20

 

 

 

147,791

 

 

 

-

 

 

 

-

 

 

 

147,811

 

Settlement with former placement agent

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

314,056

 

 

 

-

 

 

 

-

 

 

 

314,056

 

Foreign currency translation adjustment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

21,840

 

 

 

21,840

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(9,278,944 )

 

 

-

 

 

 

(9,278,944 )

Balance, June 30, 2021

 

 

-

 

 

$ -

 

 

 

676

 

 

$ -

 

 

 

82,585,075

 

 

$ 8,260

 

 

$ 120,584,938

 

 

$ (112,330,771 )

 

$ (1,225,503 )

 

$ 7,036,924

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

Series C Convertible

 

 

Series B Convertible

 

 

 

 

 

 

 

Additional

 

 

 

 

Other

 

 

 

 

 

 

Preferred Stock

 

 

Preferred Stock

 

 

Common Stock

 

 

Paid In

 

 

Accumulated

 

 

Comprehensive

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Total

 

Balance, January 1, 2021

 

 

-

 

 

$ -

 

 

 

2,774

 

 

$ -

 

 

 

31,150,309

 

 

$ 3,115

 

 

$ 93,834,936

 

 

$ (95,366,198 )

 

$ (1,112,546 )

 

$ (2,640,693 )

Issuance of Series C preferred stock and warrants for cash, net of offering costs

 

 

10,667

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

7,105,167

 

 

 

-

 

 

 

-

 

 

 

7,105,168

 

Issuance of Series C preferred stock for license acquired

 

 

3,290

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,467,648

 

 

 

-

 

 

 

-

 

 

 

2,467,649

 

Beneficial conversion feature of Series C preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,507,125

 

 

 

-

 

 

 

-

 

 

 

4,507,125

 

Deemed dividend of Series C preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(4,507,125 )

 

 

-

 

 

 

-

 

 

 

(4,507,125 )

Issuance of Series C preferred stock upon exchange of Series B preferred stock

 

 

19,140

 

 

 

1

 

 

 

(1,839 )

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,431 )

 

 

-

 

 

 

-

 

 

 

(1,430 )

Warrants issued in connection with exchange of Series B preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

21,009,683

 

 

 

-

 

 

 

-

 

 

 

21,009,683

 

Deemed dividend related to exchange of Series B preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(21,008,253 )

 

 

-

 

 

 

-

 

 

 

(21,008,253 )

Common stock issued upon conversion of Series B preferred stock

 

 

-

 

 

 

-

 

 

 

(259 )

 

 

-

 

 

 

2,582,782

 

 

 

258

 

 

 

(258 )

 

 

-

 

 

 

-

 

 

 

-

 

Dividends on preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(231,043 )

 

 

-

 

 

 

-

 

 

 

(231,043 )

Common stock and pre-funded warrants issued upon conversion of Series C preferred stock

 

 

(33,097 )

 

 

(3 )

 

 

-

 

 

 

-

 

 

 

31,254,595

 

 

 

3,126

 

 

 

(3,123 )

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock, pre-funded warrants and warrants for cash, net of offering costs

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,800,000

 

 

 

580

 

 

 

9,058,710

 

 

 

-

 

 

 

-

 

 

 

9,059,290

 

Issuance of common stock at-the-market for cash, net of offering costs

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,495,645

 

 

 

150

 

 

 

1,174,198

 

 

 

-

 

 

 

-

 

 

 

1,174,348

 

Common stock issued upon exercise of warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

9,456,443

 

 

 

946

 

 

 

4,905,684

 

 

 

-

 

 

 

-

 

 

 

4,906,630

 

Common stock and warrants issued to consultants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

770,301

 

 

 

78

 

 

 

1,092,232

 

 

 

-

 

 

 

-

 

 

 

1,092,310

 

Settlement with former placement agent

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

75,000

 

 

 

7

 

 

 

94,492

 

 

 

-

 

 

 

-

 

 

 

94,499

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,086,296

 

 

 

-

 

 

 

-

 

 

 

1,086,296

 

Foreign currency translation adjustment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(112,957 )

 

 

(112,957 )

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(16,964,573 )

 

 

-

 

 

 

(16,964,573 )

Balance, June 30, 2021

 

 

-

 

 

$ -

 

 

 

676

 

 

$ -

 

 

 

82,585,075

 

 

$ 8,260

 

 

$ 120,584,938

 

 

$ (112,330,771 )

 

$ (1,225,503 )

 

$ 7,036,924

 

 

See accompanying notes to consolidated financial statements

 

 
4

Table of Contents

 

AZURRX BIOPHARMA, INC.

Consolidated Statements of Cash Flows (unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

Net loss

 

$ (16,964,573 )

 

$ (9,957,168 )

Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:

 

 

 

 

 

 

 

 

Depreciation

 

 

3,014

 

 

 

18,368

 

Amortization

 

 

263,774

 

 

 

263,774

 

Non-cash lease expense

 

 

(4,855 )

 

 

(6,065 )

Common stock issued to settle accounts payable

 

 

-

 

 

 

131,137

 

Change in fair value of liability

 

 

(532,353 )

 

 

-

 

Stock-based compensation

 

 

1,086,296

 

 

 

230,126

 

Restricted stock granted to employees/directors

 

 

-

 

 

 

21,003

 

Common stock granted to consultants

 

 

1,186,809

 

 

 

87,105

 

Accreted interest on convertible debt

 

 

-

 

 

 

319,196

 

Accretion of debt discount

 

 

-

 

 

 

4,203,182

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivables

 

 

-

 

 

 

(36,033 )

Other receivables

 

 

551,489

 

 

 

2,548,659

 

Prepaid expenses

 

 

715,368

 

 

 

274,019

 

Right of use assets

 

 

(316,541 )

 

 

(108,447 )

Deposits

 

 

(41,676 )

 

 

5,000

 

Accounts payable and accrued expenses

 

 

2,958,282

 

 

 

(571,728 )

Deferred offering costs

 

 

-

 

 

 

(192,071 )

Accrued dividends payable

 

 

-

 

 

 

-

 

Other liabilities

 

 

398,838

 

 

 

135,210

 

Net cash used in operating activities

 

 

(10,696,128 )

 

 

(2,634,733 )

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(73,928 )

 

 

(2,808 )

Payment made related to license agreement

 

 

(9,000,000 )

 

 

-

 

Net cash used in investing activities

 

 

(9,073,928 )

 

 

(2,808 )

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of notes payable, net

 

 

-

 

 

 

179,418

 

Proceeds from issuance of preferred stock, net

 

 

7,105,168

 

 

 

-

 

Proceeds from issuance of common stock, net

 

 

10,233,638

 

 

 

988,348

 

Proceeds from exercise of warrants

 

 

4,906,630

 

 

 

-

 

Proceeds from issuance of convertible debt, net

 

 

-

 

 

 

3,227,002

 

Repayments of convertible debt

 

 

-

 

 

 

(450,000 )

Repayments of note payable

 

 

(412,836 )

 

 

(511,173 )

Net cash provided by financing activities

 

 

21,832,600

 

 

 

3,433,595

 

 

 

 

 

 

 

 

 

 

Increase in cash

 

 

2,062,544

 

 

 

796,054

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash

 

 

(50,194 )

 

 

13,100

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents, beginning balance

 

 

6,062,141

 

 

 

175,796

 

Cash and cash equivalents, ending balance

 

$ 8,074,491

 

 

$ 984,950

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$ -

 

 

$ 104,153

 

Cash paid for income taxes

 

$ -

 

 

$ -

 

 

 

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Deemed dividend on preferred stock issuances

 

$ (4,507,125 )

 

$ -

 

Deemed dividend on preferred stock exchanges

 

$ (21,008,253 )

 

$ -

 

Accrued dividends on preferred stock

 

$ (231,043 )

 

$ -

 

Issuance of preferred stock to settle liability related to license agreement

 

$ 2,467,649

 

 

$ -

 

     

See accompanying notes to consolidated financial statements

 

 
5

Table of Contents

 

AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

   

Note 1 - The Company and Basis of Presentation

 

The Company

 

AzurRx BioPharma, Inc. (“AzurRx” or “Parent”) was incorporated on January 30, 2014 in the State of Delaware. In June 2014, the Company acquired 100% of the issued and outstanding capital stock of AzurRx SAS (formerly “ProteaBio Europe SAS”), a company incorporated in October 2008 under the laws of France. Parent and its wholly owned subsidiary, AzurRx SAS (“ABS”), are collectively referred to as the “Company”.

 

The Company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. We are focused on developing our pipeline of gut-restricted GI clinical drug candidates, including MS1819 and niclosamide.

 

Our lead drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”) and chronic pancreatitis, currently in two Phase 2 clinical trials for CF. In March 2021, we announced topline results from our Phase 2b OPTION 2 monotherapy trial, and in May 2021, we announced positive interim results from the first 18 patients in our Phase 2 Combination trial in Europe.

 

In 2021, we are launching two new clinical programs using proprietary formulations of niclosamide, a small molecule with anthelminthic, anti-viral and anti-inflammatory properties. The first FW-1022, is for Severe Acute Respiratory Syndrome Coronavirus 2 (“COVID-19”) gastrointestinal infections. In April 2021, we launched the Phase 2 RESERVOIR COVID-19 GI clinical trial using a proprietary oral immediate-release tablet formulation of micronized niclosamide. The second, FW-420, is for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-Associated Colitis (“ICI-AC”) and diarrhea in advanced stage oncology patients. We are preparing to initiate our Phase 1b/2a PASSPORT ICI-AC trial using both an oral immediate-release tablet and a topical rectal enema foam formulations of niclosamide in the second half of 2021.

 

Since its inception, the Company has devoted substantially all its efforts to research and development, business development, and raising capital, and has primarily financed its operations through issuance of common stock, convertible preferred stock, convertible debt, and other debt/equity instruments. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund clinical trials and operations.

 

Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. As of June 30, 2021, the Company had approximately $8.1 million in cash and cash equivalents. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. The Company has an accumulated deficit of approximately $112.3 million as of June 30, 2021.

 

The Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our business. The extent to which the ongoing COVID-19 pandemic impacts our business, our clinical development and regulatory efforts, our corporate development objectives and the value of and market for our Common Stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

 

In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the biotechnology and pharmaceutical industries with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its drug candidates; delays or problems in the manufacture and supply of its drug candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or drug candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above.

 

 
6

Table of Contents

 

AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

   

Basis of Presentation and Principles of Consolidation

 

The accompanying unaudited interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and include the accounts of AzurRx and its wholly owned subsidiary, AzurRx SAS. Intercompany transactions and balances have been eliminated upon consolidation.

 

In our opinion, the accompanying unaudited interim consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2020, has been derived from audited financial statements of that date. The unaudited interim consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the SEC. The Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report Form 10-K for the year ended December 31, 2020, filed with the SEC on March 31, 2021.

 

Going Concern Uncertainty

 

The accompanying unaudited interim consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On June 30, 2021, we had cash and cash equivalents of approximately $8.1 million, and an accumulated deficit of approximately $112.3 million. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations.

 

Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements

 

Use of Estimates

 

The accompanying unaudited consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill, intangible assets, and contingent consideration), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. All cash balances were highly liquid on June 30, 2021, and December 31, 2020, respectively.

 

Concentrations of Credit Risk

 

Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. On June 30, 2021, and December 31, 2020, the Company had approximately $3.8 million and $2.7 million, respectively, in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions.

 

The Company also has exposure to foreign currency risk as its subsidiary in France has a functional currency in Euros.

 

 
7

Table of Contents

 

AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

  

Debt Instruments

 

Detachable warrants issued in conjunction with debt are measured at their relative fair value, if they are determined to be equity instrument, or their fair value, if they are determined to be liability instruments, and recorded as a debt discount. Conversion features that are in the money at the commitment date constitute a beneficial conversion feature that is measured at its intrinsic value and recognized as debt discount. Debt discount is amortized as interest expense over the maturity period of the debt using the effective interest method. Contingent beneficial conversion features are recognized when the contingency has been resolved.

 

Debt Issuance Costs

 

Debt issuance costs are recorded as a direct reduction of the carrying amount of the related debt. Debt issuance costs are amortized over the maturity period of the related debt instrument using the effective interest method.

 

Equity-Based Payments to Non-Employees

 

Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting.

 

Fair Value Measurements

 

The Company follows Accounting Standards Codification (“ASC”) Topic 820-10, Fair Value Measurements and Disclosures (“ASC 820”), which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

 

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

 

Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

 

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

 

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.

 

In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument.

 

The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.

 

Foreign Currency Translation

 

The Company’s foreign subsidiary has operations denominated in a foreign currency, and assets and liabilities are translated to U.S. dollars, which is the functional currency, at period end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the periods presented. Gains and losses from translation adjustments are accumulated in a separate component of stockholders’ equity.

 

 
8

Table of Contents

   

Goodwill and Intangible Assets

 

Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company has not recognized any impairment charges through June 30, 2021.

 

Intangible assets subject to amortization consist of in process research and development, license agreements, and patents reported at the fair value at date of the acquisition less accumulated amortization. Amortization expense is provided using the straight-line method over the estimated useful lives of the assets as follows:

   

Patents                                                            7.2 years

 

Impairment of Long-Lived Assets

 

The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment (“ASC 360”). Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has not recognized any impairment charges through June 30, 2021.

 

Income Taxes

 

Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

 

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. On June 30, 2021, and December 31, 2020, the Company does not have any significant uncertain tax positions. All tax years are still open for audit.

 

Leases

 

The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (“ROU”) assets, and lease liability obligations are included in the Company’s balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liability obligations represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company estimates its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The ROU asset also includes any lease payments made and excludes lease incentives and lease direct costs. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. Please refer to Note 15 for additional information.

  

 
9

Table of Contents

 

AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

License Agreements

 

As more fully discussed in Note 14, the Company entered into a license agreement (the “First Wave License Agreement”) with First Wave Bio, Inc. (“First Wave”), pursuant to which First Wave granted the Company an exclusive license to certain patents and patent applications related to a proprietary formulation of niclosamide for use in the fields of ICI-AC and COVID-19 GI infections. The acquisition of intellectual property and patents for the worldwide, exclusive right to develop, manufacture, and commercialize proprietary formulations of niclosamide for the fields of treating ICI-AC and COVID-19 in humans was accounted for as an asset acquisition and initial liabilities of approximately $13.3 million in connection with the license acquisition were recorded as research and development expense, because it was determined to have no alternative future uses and therefore no separate economic value, which included cash payments totaling approximately $10.3 million and the issuance of approximately $3.0 million worth of preferred stock.

 

As more fully discussed in Note 14, the Company entered into a sublicense agreement with TransChem, Inc. (“TransChem”), pursuant to which TransChem granted the Company an exclusive license to certain patents and patent applications. Payments made to TransChem in connection with this sublicense agreement were recorded as research and development expense. The Company terminated the sublicense agreement with TransChem during the year ended December 31, 2020.

 

Research and Development

 

Research and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related to patents. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (CROs), investigative sites, consultants and contractors that conduct or provide other services relating to clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (CDMOs) and third-party contractors relating to chemistry, manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s licenses, amortization of intangible assets related to the acquisition of MS1819 and research and development costs related to niclosamide.

 

Stock-Based Compensation

 

The Company’s board of directors (the “Board”) and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”) which took effect on May 12, 2014, and the 2020 Omnibus Equity Incentive Plan, which took effect on September 11, 2020 (the “2020 Plan”). From the effective date of the 2020 Plan, no new awards have been or will be made under the 2014 Plan. The Company accounts for its stock-based compensation awards to employees and Board members in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees and Board members, including grants of employee stock options, to be recognized in the statements of operations by measuring the fair value of the award on the date of grant and recognizing this fair value as stock-based compensation using a straight-line method over the requisite service period, generally the vesting period.

 

For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable.

 

The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock.

 

Subsequent Events

 

The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements.

 

 
10

Table of Contents

 

AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

Recent Accounting Pronouncements

 

In August 2020, the FASB issued accounting pronouncement (ASU 2020-06) related to the measurement and disclosure requirements for convertible instruments and contracts in an entity’s own equity. The pronouncement simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments and the settlement assessment for contracts in an entity’s own equity. As a smaller reporting company, as defined by the U.S. Securities and Exchange Commission (the “SEC”), this pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2023. The Company is currently evaluating the impact of this ASU on the financial statements.

 

Note 3 - Fair Value Disclosures

 

Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value.

 

The fair value of the Company’s financial instruments are as follows:

 

 

 

 

 

 

Fair Value Measured at Reporting Date Using

 

 

 

 

 

 

Carrying Amount

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Fair Value

 

June 30, 2021:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$ 8,074,491

 

 

$ 4,072,706

 

 

$ 4,001,785

 

 

$ -

 

 

$ 8,074,491

 

Other receivables

 

$ -

 

 

$ -

 

 

$ -

 

 

$ -

 

 

$ -

 

Note payable

 

$ 139,569

 

 

$ -

 

 

$ -

 

 

$ 139,569

 

 

$ 139,569

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2020:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$ 6,062,141

 

 

$ 3,000,184

 

 

$ 3,061,957

 

 

$ -

 

 

$ 6,062,141

 

Other receivables

 

$ 551,489

 

 

$ -

 

 

$ -

 

 

$ 551,489

 

 

$ 551,489

 

Note payable

 

$ 552,405

 

 

$ -

 

 

$ -

 

 

$ 552,405

 

 

$ 552,405

 

 

On June 30, 2021, and December 31, 2020, cash and cash equivalents included approximately $4.1 million, and $3.0 million, respectively, held in high-quality money market funds quoted in an active market and included in level 1 in the table above.

 

The fair value of other receivables approximates carrying value as these consist primarily of French research and development tax credits that are normally received the following year.

 

The fair value of the note payable in connection with the financing of directors and officer’s liability insurance approximates carrying value due to the terms of such instruments and applicable interest rates.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

Note 4 - Other Receivables

 

Other receivables consisted of the following:

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Research and development tax credits

 

$ -

 

 

$ 493,906

 

Other

 

 

-

 

 

 

57,583

 

Total other receivables

 

$ -

 

 

$ 551,489

 

 

On December 31, 2020, research and development tax credits were comprised of the 2020 refundable tax credits (CIR) for research conducted in France and Europe.

 

In April 2021, the Company received payment for the 2020 refundable tax credits for research conducted in France of approximately $550,000.

 

Note 5 - Property, Equipment and Leasehold Improvements

 

Property, equipment, and leasehold improvements consisted of the following:

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Laboratory equipment

 

$ -

 

 

$ 2,410

 

Computer equipment and software

 

 

48,275

 

 

 

19,676

 

Office equipment

 

 

42,193

 

 

 

5,483

 

Leasehold improvements

 

 

-

 

 

 

29,163

 

Total property, plant, and equipment

 

 

90,468

 

 

 

56,732

 

Less accumulated depreciation

 

 

(1,225 )

 

 

(38,403 )

Property, plant and equipment, net

 

$ 89,243

 

 

$ 18,329

 

  

Depreciation expense for the three months ended June 30, 2021 and 2020 was approximately $2,000 and $9,000, respectively. Depreciation expense for the six months ended June 30, 2021 and 2020 was approximately $3,000 and $18,000, respectively.

 

For the six months ended June 30, 2021, approximately $2,000 of depreciation was included in research and development expense and approximately $1,000 of depreciation was included in general and administrative expense.

 

During the six months ended June 30, 2021, approximately $29,000 of leaseholds improvements were written off in connection with closing the Company’s laboratory in France.

 

For the three months ended June 30, 2020, approximately $5,000 of depreciation was included in research and development expense and approximately $4,000 of depreciation is included in general and administrative expense.

 

For the six months ended June 30, 2020, $9,000of depreciation is included in research and development expense and $9,000 of depreciation is included in general and administrative expense.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

Note 6 - Intangible Assets and Goodwill

 

Patents

 

Pursuant to the Mayoly APA entered into in March 2019 (see Note 14), in which the Company purchased all remaining rights, title and interest in and to MS1819 from Mayoly, the Company recorded Patents in the amount of approximately $3.8 million as follows:

 

Common stock issued at signing to Mayoly

 

$ 1,740,959

 

Due to Mayoly at December 31, 2019

 

 

449,280

 

Due to Mayoly at December 31, 2020

 

 

393,120

 

Assumed Mayoly liabilities and forgiveness of Mayoly debt

 

 

1,219,386

 

 

 

$ 3,802,745

 

 

Intangible assets are as follows:

  

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Patents

 

$ 3,802,745

 

 

$ 3,802,745

 

Less accumulated amortization

 

 

(1,186,983 )

 

 

(923,209 )

Patents, net

 

$ 2,615,762

 

 

$ 2,879,536

 

  

Amortization expense was approximately $132,000 and $132,000 for the three months ended June 31, 2021, and 2020, respectively.

 

Amortization expense was approximately $264,000 and $264,000 for the six months ended June 31, 2021, and 2020, respectively.

 

As of June 30, 2021, amortization expense related to patents is expected to be as follows for the next five years (2021 through 2026):

 

2021 (balance of year)

 

$ 263,774

 

2022

 

 

527,548

 

2023

 

 

527,548

 

2024

 

 

527,548

 

2025

 

 

527,548

 

2026

 

 

241,796

 

Total

 

$ 2,615,762

 

 

Goodwill is as follows:

 

 

 

Goodwill

 

Balance on January 1, 2020

 

 

1,886,686

 

Foreign currency translation

 

 

167,362

 

Balance on December 31, 2020

 

 

2,054,048

 

Foreign currency translation

 

 

(62,761 )

Balance on June 30, 2021

 

 

1,991,287

 

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

Note 7 - Accounts Payable and Accrued Expenses

 

Accounts payable and accrued expenses consisted of the following:

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Trade payables

 

$ 4,449,910

 

 

$ 1,558,591

 

Accrued expenses

 

 

193,975

 

 

 

127,012

 

Total accounts payable and accrued expenses

 

$ 4,643,885

 

 

$ 1,685,603

 

 

Note 8 - Note Payable

 

Directors and Officer’s Liability Insurance

 

On November 30, 2020, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of approximately $620,000 that bears interest at an annual rate of 4.250%. Monthly payments, including principal and interest, of approximately $70,000 per month. The balance due under this financing agreement was approximately $140,000 and $552,000 on June 30, 2021 and December 31, 2020, respectively.

 

On December 5, 2019, the Company entered into a 9-month financing agreement for its directors and officer’s liability insurance in the amount of approximately $500,000 that bears interest at an annual rate of 5.461%. Monthly payments, including principal and interest, were approximately $57,000 per month. The balance due under this financing agreement was approximately $113,000 on June 30, 2020.

 

Note 9 – Convertible Debt

 

The ADEC Note Offering

 

On February 14, 2019, the Company entered into a note purchase agreement with ADEC Private Equity Investments, LLC (“ADEC”), pursuant to which the Company issued to ADEC two Senior Convertible Notes (each an “ADEC Note,” and together, the “ADEC Notes”), in the principal amount of $1.0 million per ADEC Note, resulting in gross proceeds to the Company of $2.0 million (the “ADEC Note Offering”).

 

In December 2019, the Company repaid $1,550,000 principal amount of the ADEC Notes and in January 2020, the Company repaid the remaining principal balance of $450,000 plus outstanding accrued interest of approximately $104,000 on the ADEC Notes to ADEC Private Equity Investments, LLC.

 

Senior Convertible Promissory Note Offering

 

On December 20, 2019, the Company began an offering of (i) Senior Convertible Promissory Notes (each a “Promissory Note,” and together, the “Promissory Notes”) in the principal amount of up to $8.0 million to certain accredited investors (the “Note Investors”), and (ii) warrants (“Note Warrants”) to purchase shares of Common Stock, each pursuant to Note Purchase Agreements entered into by and between the Company and each of the Note Investors (the “Promissory NPAs”) (the “Promissory Note Offering”).

 

The Promissory Notes were scheduled to mature on September 20, 2020, accrue interest at a rate of 9% per annum, and were convertible, at the sole option of the holder, into shares of Common Stock (the “Promissory Note Conversion Shares”) at a price of $0.97 per share (the “Conversion Option”). The Promissory Notes could be prepaid by the Company at any time prior to the maturity date in cash without penalty or premium (the “Prepayment Option”).

 

On January 2, 2020, January 3, 2020, and January 9, 2020, the Company issued Promissory Notes to the Note Investors in the aggregate principal amount of approximately $3.5 million.

 

As additional consideration for the execution of the Promissory NPA, each Note Investor also received Note Warrants to purchase that number of shares of Common Stock equal to one-half (50%) of the Promissory Note Conversion Shares issuable upon conversion of the Promissory Notes (the “Note Warrant Shares”). The Note Warrants have an exercise price of $1.07 per share and expire five years from the date of issuance. In July 2020, the Company filed a registration statement covering the Note Warrant Shares in connection with the Series B Private Placement and the Exchange described in Note 11, which was declared effective in September 2020.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

In connection with the three closings in January 2020 of the Promissory Note Offering, the Company paid aggregate placement agent fees of approximately $277,000, which fees were based on (i) 9% of the aggregate principal amount of the Promissory Notes issued to the Note Investors introduced by the placement agent, and (ii) a non-accountable expense allowance of 1% of the gross proceeds from the Promissory Note Offering. In addition, the placement agent was issued warrants (the “Placement Agent Warrants”), to purchase an aggregate of 199,732 shares of Common Stock representing 7% of the Promissory Note Conversion Shares issuable upon conversion of the Promissory Notes issued to the Note Investors. The Placement Agent Warrants expire five years from the date of issuance. 41,495 of these Placement Agent Warrants have an exercise price of $1.21 per share and 158,237 of these Placement Agent Warrants have an exercise price of $1.42 per share.

 

The Company determined the Prepayment Option feature represents a contingent call option. The Company evaluated the Prepayment Option in accordance with ASC 815-15-25. The Company determined that the Prepayment Option feature is clearly and closely related to the debt host instrument and is not an embedded derivative requiring bifurcation. Additionally, the Company determined the Conversion Option represents an embedded call option. The Company evaluated the Conversion Option in accordance with ASC 815-15-25. The Company determined that the Conversion Option feature meets the scope exception from ASC 815 and is not an embedded derivative requiring bifurcation.

 

The Company evaluated the Promissory Notes for a beneficial conversion feature in accordance with ASC 470-20. The Company determined that at each commitment date the effective conversion price was below the closing stock price (market value), and the Convertible Notes contained a beneficial conversion feature.

 

Pursuant to the January 2020 closings of the Promissory Note Offering, the principal amount of approximately $3.5 million was first allocated based on the relative fair value of the Promissory Notes and the Note Warrants. The fair value of the Note Warrants amounted to approximately $2.4 million. Then the beneficial conversion feature was calculated, which amounted to approximately $1.8 million. The Company incurred debt issuance costs of approximately $0.5 million related to the offering. The initial carrying value of the Promissory Notes issued amounted to approximately $0.1 million.

 

On June 1, 2020, the Company entered into an amendment to a certain Promissory Note in the principal amount of $100,000 issued on December 20, 2019, to Edward J. Borkowski, the chairman of the Board, to increase the Conversion Price to $1.07 per share (the “Note Amendment”). The Company evaluated the Note Amendment transaction in accordance with ASC 470-50 and determined the Note Amendment did not constitute a substantive modification of the Promissory Note and that the transaction should be accounted for as a debt modification with no accounting treatment required.

 

During the three months ended June 30, 2020, the Company recognized approximately $2.3 million of interest expense related to these Promissory Notes, including amortization of debt discount related to the value of the Note Warrants of approximately $0.7 million, amortization of the beneficial conversion feature of approximately $1.1 million, amortization of debt discount related to debt issuance costs of approximately $0.3 million, and accrued interest expense of approximately $0.2 million.

 

During the six months ended June 30, 2020, the Company recognized approximately $4.5 million of interest expense related to these Promissory Notes, including amortization of debt discount related to the value of the Note Warrants of approximately $1.3 million, amortization of the beneficial conversion feature of approximately $2.2 million, amortization of debt discount related to debt issuance costs of approximately $0.7 million and accrued interest expense of approximately $0.3 million.

 

 
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AZURRX BIOPHARMA, INC.

 Notes to Unaudited Consolidated Financial Statements

 

Note 10 – Other Liabilities

 

Other liabilities consisted of the following:

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Current

 

 

 

 

 

 

Lease liabilities

 

$ 118,486

 

 

$ 57,417

 

Other liabilities

 

 

71,139

 

 

 

-

 

 

 

$ 189,625

 

 

$ 57,417

 

Long-term

 

 

 

 

 

 

 

 

Lease liabilities

 

$ 285,753

 

 

$ 19,123

 

 

 

$ 285,753

 

 

$ 19,123

 

 

Note 11 – Equity

 

Our certificate of incorporation, as amended and restated on December 20, 2019 and February 24, 2021 (the “Charter”) authorizes the issuance of up to 250,000,000 shares of Common Stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.

 

On February 24, 2021 the Company held a Special Meeting of Stockholders (the “2021 Special Meeting”), whereby, the shareholders approved, among others, the following proposals: (i) amending the Company’s Certificate of Incorporation to increase the authorized shares of its Common Stock to 250,000,000 shares from 150,000,000 shares, and (ii) amending the Company’s Charter to authorize the Board to effect a reverse stock split of both the issued and outstanding and authorized shares of Common Stock, at a specific ratio, ranging from one-for-five (1:5) to one-for-ten (1:10), any time prior to the one-year anniversary date of the 2021 Special Meeting, with the exact ratio to be determined by the Board (the “Reverse Split”). As of the date hereof, the Board had not elected to effect a Reverse Split. The authorization for the Reverse Split will expire on February 24, 2022.

 

Common Stock

 

The Company had 82,585,075 and 31,150,309 shares of its Common Stock issued and outstanding on June 30, 2021, and December 31, 2020, respectively.

 

Each holder of Common Stock is entitled to one vote for each share of Common Stock held on all matters submitted to a vote of the stockholders. The Company’s Charter and Amended and Restated Bylaws (the “Bylaws”) do not provide for cumulative voting rights.

 

In addition, the holders of Common Stock will be entitled to receive ratably such dividends, if any, as may be declared by the Board out of legally available funds; however, the current policy of the Board is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of Common Stock will be entitled to share ratably in all assets that are legally available for distribution.

 

Holders of Common Stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences, and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s preferred stock that the Company may designate and issue in the future.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

Preferred Stock

 

We have 10,000,000 shares of preferred stock, par value $0.0001 per share, authorized and available for issuance in one or more series. The Board is authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The Board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance.

 

On July 16, 2020, we authorized 5,194.805195 shares as Series B Preferred Stock. Shares of Series B Preferred Stock that are converted into shares of Common Stock shall be retired and may not be reissued as Series B Preferred Stock but may be reissued as all or part of another series of Preferred Stock. On June 30, 2021, 676.05 shares of Series B Preferred Stock were issued and outstanding, with approximately 2,168.14 shares of Series B Preferred Stock remaining authorized but unissued.

 

On January 5, 2021, we authorized 75,000 shares as Series C Preferred Stock. Shares of Series C Preferred Stock converted into Common Stock (or Prefunded Warrants, as applicable) or redeemed shall be canceled and shall not be reissued. On June 30, 2021, 0 shares of Series C Preferred Stock were issued and outstanding, with approximately 41,902.90 shares of Series C Preferred Stock remaining authorized but unissued.

 

On June 30, 2021, the Company had approximately 676.05 shares of preferred stock issued and outstanding with approximately 9,919,805.19 shares of preferred stock remaining authorized but unissued.

 

Series B Convertible Preferred Stock

 

Pursuant to the Certificate of Designation of Rights and Preferences of the Series B Preferred Stock (the “Series B Certificate of Designation”), the terms of the Series B Preferred Stock are as follows:

 

Ranking

 

The Series B Preferred Stock will rank senior to the Common Stock with respect to distributions of assets upon the liquidation, dissolution or winding up of the Company.

 

Stated Value

 

Each share of Series B Preferred Stock has a stated value of $7,700, subject to adjustment for stock splits, combinations, and similar events (the “Series B Stated Value”).

 

Dividends

 

Each holder of shares of Series B Preferred Stock, in preference and priority to the holders of all other classes or series of stock of the Company, is entitled to receive dividends, commencing from the date of issuance. Such dividends may be paid by the Company only when, as and if declared by the Board, out of assets legally available therefor, semiannually in arrears on the last day of June and December in each year, commencing December 31, 2020, at the dividend rate of 9.0% per year, which is cumulative and continues to accrue on a daily basis whether or not declared and whether or not the Company has assets legally available therefor. The Company may pay such dividends at its option either in cash or in kind in additional shares of Series B Preferred Stock (rounded down to the nearest whole share), provided the Company must pay in cash the fair value of any such fractional shares in excess of $100.00. On June 30, 2021, aggregate dividends payable amounted to approximately $231,000.

 

Liquidation Preference; Liquidation Rights

 

Under the Certificate of Designations, each share of Series B Preferred Stock carries a liquidation preference equal to the Series B Stated Value (as adjusted thereunder) plus accrued and unpaid dividends thereon (the “Liquidation Preference”).

 

 
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If the Company voluntarily or involuntarily liquidates, dissolves or winds up its affairs, each holder of the Series B Preferred Stock will be entitled to receive out of the Company’s assets available for distribution to stockholders, after satisfaction of liabilities to creditors, if any, but before any distribution of assets is made on the Common Stock or any of the Company’s shares of stock ranking junior as to such a distribution to the Series B Preferred Stock, a liquidating distribution in the amount of the Stated Value of all such holder’s Series B Preferred Stock plus all accrued and unpaid dividends thereon. On June 30, 2021, the value of the liquidation preference of the Series B Preferred Stock aggregated to approximately $5.4 million.

 

Conversion

 

Each share of Series B Preferred Stock will be convertible at the holder’s option at any time, into Common Stock at a conversion rate equal to the quotient of (i) the Series B Stated Value divided by (ii) the initial conversion price of $0.77, subject to specified adjustments for stock splits, cash or stock dividends, reorganizations, reclassifications other similar events as set forth in the Series B Certificate of Designations. In addition, at any time after the six month anniversary of the Series B Closing Date, if the closing sale price per share of Common Stock exceeds 250% of the initial conversion price, or $1.925, for 20 consecutive trading days, then all of the outstanding shares of Series B Preferred Stock will automatically convert (the “Automatic Conversion”) into such number of shares of Common Stock as is obtained by multiplying the number of shares of Series B Preferred Stock to be so converted, plus the amount of any accrued and unpaid dividends thereon, by the Series B Stated Value per share and dividing the result by the then applicable conversion price. The Series B Preferred Stock contains limitations that prevent the holder thereof from acquiring shares of Common Stock upon conversion (including pursuant to the Automatic Conversion) that would result in the number of shares beneficially owned by such holder and its affiliates exceeding9.99% of the total number of shares of Common Stock outstanding immediately after giving effect to the conversion, which percentage may be increased or decreased at the holder’s election not to exceed 19.99%.

 

Most Favored Nations (MFN) Exchange Right

 

In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “Subsequent Financing”), each holder of the Series B Preferred Stock has the right, subject to certain exceptions set forth in the Series B Certificate of Designations, at its option, to exchange (in lieu of cash subscription payments) all or some of the Series B Preferred Stock then held (with a value per share of Series B Preferred Stock equal to the stated value, plus accrued and unpaid dividends thereon, of the Series B Preferred Stock (the “Series B Exchange Amount”)) for any securities or units issued in a Subsequent Financing on dollar-for-dollar basis (the “Series B Exchange Right”).

 

As of June 30, 2021, holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Series B Exchange Amount of approximately $14.4 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 19,140,240 shares of Common Stock (which conversion the Company elected to make in full), and additional January 2021 Investor Warrants exercisable for up to an aggregate of 19,140,140 shares of Common Stock.

 

As a result, as of June 30, 2021, any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right in connection with up to 676.05 shares of Series B Preferred Stock plus accrued dividends of approximately $231,000 may require the Company to issue up to 7,248.85 additional shares of Series C Preferred Stock that are currently convertible up to7,248,846 underlying shares of Common Stock, together with January 2021 Investor Warrants to purchase up to an additional 7,248,846 shares of Common Stock, to any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right into the January 2021 Offerings. Any shares of Series C Preferred Stock to be issued pursuant to the Series B Exchange Right into the January 2021 Offerings would, upon issuance, be immediately converted into underlying shares of Common Stock.

  

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

Voting

 

The holders of the Series B Preferred Stock, voting as a separate class, have customary consent rights with respect to certain corporate actions of the Company. The Company may not take the following actions without the prior consent of the holders of at least a majority of the Series B Preferred Stock then outstanding: (a) authorize, create, designate, establish, issue or sell an increased number of shares of Series B Preferred Stock or any other class or series of capital stock ranking senior to or on parity with the Series B Preferred Stock as to dividends or upon liquidation; (b) reclassify any shares of Common Stock or any other class or series of capital stock into shares having any preference or priority as to dividends or upon liquidation superior to or on parity with any such preference or priority of Series B Preferred Stock; (c) amend, alter or repeal the Certificate of Incorporation or Bylaws of the Company and the powers, preferences, privileges, relative, participating, optional and other special rights and qualifications, limitations and restrictions thereof, which would adversely affect any right, preference, privilege or voting power of the Series B Preferred Stock; (d) issue any indebtedness or debt security, other than trade accounts payable, insurance premium financings and/or letters of credit, performance bonds or other similar credit support incurred in the ordinary course of business, or amend, renew, increase, or otherwise alter in any material respect the terms of any such indebtedness existing as of the date of first issuance of shares of Series B Preferred Stock; (e) redeem, purchase, or otherwise acquire or pay or declare any dividend or other distribution on (or pay into or set aside for a sinking fund for any such purpose) any capital stock of the Company; (f) declare bankruptcy, dissolve, liquidate, or wind up the affairs of the Company; (g) effect, or enter into any agreement to effect, a Change of Control (as defined in the Certificate of Designations); or (h) materially modify or change the nature of the Company’s business.

 

2014 Equity Incentive Plan

 

The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”), which took effect on May 12, 2014. Upon adoption of the 2020 Plan on September 11, 2020, the Company ceased making grants under the 2014 Plan.

 

The Company issued an aggregate of 795,006 stock options, during the six months ended June 30, 2020, under the 2014 Plan (see Note 13).

 

As of June 30, 2021, there were 2,720,500 shares issued and outstanding under the 2014 Plan and 387,000 shares are reserved subject to issuance of restricted stock and restricted stock unit awards (“RSUs”).

 

2020 Equity Incentive Plan

 

The Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “2020 Plan”), which took effect on September 11, 2020. The initial number of shares of Common Stock available for issuance under the 2020 Plan is 10,000,000 shares, which will, on January 1 of each calendar year, unless the Board decides otherwise, automatically increase to equal ten percent (10%) of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, calculated on an As Converted Basis. As Converted Shares include all outstanding shares of Common Stock and all shares of Common Stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but will not include any shares of Common Stock issuable upon the exercise of options and other convertible securities issued pursuant to either the 2014 Plan or the 2020 Plan. The number of shares permitted to be issued as “incentive stock options” (“ISOs”) is 15,000,000 under the 2020 Plan.

 

The Company issued an aggregate of 1,564,691 stock options during the six months ended June 30, 2021, under the 2020 Plan (see Note 13).

 

As of June 30, 2021, 10,000,000 total shares were available under the 2020 Plan, of which 1,574,691 were issued and outstanding and 8,425,309 shares were available for potential issuances.

 

Equity Line with Lincoln Park

 

In November 2019, the Company entered into a purchase agreement (the “Equity Line Agreement”), together with a registration rights agreement (the “Lincoln Park Registration Rights Agreement”), with Lincoln Park. Under the terms of the Equity Line Agreement, Lincoln Park has committed to purchase up to $15,000,000 of Common Stock (the “Equity Line”). Upon execution of the Equity Line Agreement, the Company issued Lincoln Park 487,168 shares of Common Stock (the “Commitment Shares”) as a fee for its commitment to purchase shares of Common Stock under the Equity Line Agreement, which had a grant date fair value of approximately $297,000 and had no effect on expenses or stockholders’ equity.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

   

The remaining shares of Common Stock that may be issued under the Equity Line Agreement may be sold by the Company to Lincoln Park at the Company’s discretion from time-to-time over a 30-month period commencing after the satisfaction of certain conditions set forth in the Equity Line Agreement, subject to the continued effectiveness of a registration statement covering such shares of Common Stock sold to Lincoln Park by the Company. The registration statement was filed with the SEC on December 31, 2019 and was declared effective on January 14, 2020.

 

There is approximately $14.0 million of availability left for issuance pursuant to the Equity Line Agreement. The Company issued an aggregate of 0, and 1,495,199shares of Common Stock, during the six months ended June 30, 2021 and 2020, respectively, in connection with the Equity Line Agreement, resulting in net proceeds to the Company of approximately $0, and $988,000, respectively.

 

At The Market Agreement with H.C. Wainwright

 

On May 26, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Wainwright, shares of its Common Stock, and pursuant to which Wainwright may sell its Common Stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Wainwright a commission of 3.0% of the aggregate gross proceeds from each sale of Common Stock. As of May 26, 2021, the Company was authorized to offer and sell up to $50 million of its Common Stock pursuant to the ATM Agreement. During the three months ended June 30, 2021, the Company issued and sold 1,495,645 shares of its common stock under the ATM Agreement for which the Company received gross proceeds of approximately $1.3 million, less issuance costs incurred of approximately $46,000.

 

Common Stock Issuances

 

2021 Issuances

 

During the three months ended June 30, 2021, the Company issued an aggregate of 195,000 shares of its Common Stock to consultants with a grant date fair value of approximately $147,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.

 

During the three months ended June 30, 2021, the Company issued an aggregate of 5,639,153 shares of Common Stock upon the conversion of an aggregate of 5,639.15 shares of Series C Preferred Stock with a stated value of approximately $4.1 million plus accrued dividends of approximately $122,000.

 

During the three months ended June 30, 2021, the Company issued an aggregate of 328,375 shares of Common Stock upon the exercise of an aggregate of 328,375 investor warrants (See Note 12).

 

During the six months ended June 30, 2021, the Company issued an aggregate of 770,301 shares of its Common Stock to consultants with a grant date fair value of approximately $1.1 million for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.

 

During the six months ended June 30, 2021, the Company issued an aggregate 75,000 shares of its Common Stock with a grant date fair value of approximately $94,000 in connection with the settlement with the Company’s former investment bank, which was recorded as stock-based compensation and included as part of general and administrative expense.

 

During the six months ended June 30, 2021, the Company issued an aggregate of 31,254,595 shares of Common Stock upon the conversion of an aggregate of 33,097.10 shares of Series C Preferred Stock with a stated value of approximately $24.7 million plus accrued dividends of approximately $198,000.

 

During the six months ended June 30, 2021, the Company issued an aggregate of 9,456,443 shares of Common Stock upon the exercise of an aggregate of 9,526,209 investor warrants, including an aggregate of 3,991,882 pre-funded warrants (See Note 12).

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

During the six months ended June 30, 2021, the Company issued an aggregate of 2,582,782 shares of Common Stock upon the conversion of an aggregate of 258.08 shares of Series B Preferred Stock with a stated value of approximately $2.0 million plus accrued dividends of approximately $3,000.

 

During the six months ended June 30, 2021, the Company issued an aggregate of 5,800,000 shares of Common Stock in connection with the March 2021 Offering as detailed below.

 

2020 Issuances

 

During the three months ended June 30, 2020, the Company did not issue any shares of its Common Stock to consultants or outside Board members.

 

During the six months ended June 30, 2020, the Company issued an aggregate of 101,195 shares of its Common Stock to consultants with a total grant date fair value of approximately $87,000 for services provided, that was recorded was recorded as stock-based compensation, included as part of general and administrative expense.

 

During the six months ended June 30, 2020, the Company issued an aggregate of 105,937 shares of its Common Stock to outside Board members as payment of Board fees with an aggregate grant date fair value of approximately $131,000 that was recorded as stock-based compensation, included as part of general and administrative expense. The aggregate effective settlement price was $1.24 per share, and each individual stock issuance was based on the closing stock price of the Common Stock on the initial date the payable was accrued.

 

Restricted Stock and Restricted Stock Units

 

Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock unit awards refer to an award under the 2014 Plan or 2020 Plan, which constitutes a promise to grant shares of Common Stock at the end of a specified restriction period.

 

During the three and six months ended June 30, 2021, there was no vesting of restricted shares of Common Stock or RSUs.

 

During the three months ended June 30, 2020, an aggregate of 2,917 unvested restricted shares of Common Stock, subject to service conditions, vested with a total grant date fair value of approximately $10,500 and was recorded as stock-based compensation, included as part of general and administrative expense.

 

During the six months ended June 30, 2020, an aggregate of 8,334 unvested restricted shares of Common Stock, subject to service conditions, vested with a total grant date fair value of approximately $30,008 and was recorded as stock-based compensation, included as part of general and administrative expense.

 

As of June 30, 2021, the Company had unrecognized restricted common stock expense of approximately $394,000. Approximately $197,000 of this unrecognized expense vests upon the first commercial sale in the United States of MS1819 and approximately $197,000 of this unrecognized expense vests upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days. These milestones were not considered probable on June 30, 2021.

 

As of June 30, 2020, the Company had unrecognized restricted common stock expense of approximately $400,000. Approximately $6,000 of this unrecognized expense will be recognized over the average remaining vesting term of 0.15 years. Approximately $197,000 of this unrecognized expense vests upon the first commercial sale in the United States of MS1819 and approximately $197,000 of this unrecognized expense vests upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days. These milestones were not considered probable at June 30, 2020.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

The Series B Private Placement and the Exchange

 

On July 16, 2020 (the “Series B Closing Date”), the Company consummated a private placement offering (the “Series B Private Placement”) whereby the Company entered into a Convertible Preferred Stock and Warrant Securities Purchase Agreement (the “Series B Purchase Agreement”) with certain accredited and institutional investors (the “Series B Investors”). Pursuant to the Series B Purchase Agreement, the Company issued an aggregate of 2,912.583005 shares of Series B Convertible Preferred Stock, par value $0.0001 per share (the “Series B Preferred Stock”), at a price of $7,700.00 per share, initially convertible into an aggregate of 29,125,756 shares of Common Stock at $0.77 per share, together with warrants (the “Series B Warrants”) to purchase an aggregate of 14,562,826 shares of Common Stock at an exercise price of $0.85 per share. The amount of the Series B Warrants is equal to 50% of the shares of Common Stock into which the Series B Preferred Stock is initially convertible.

 

In connection with the Series B Private Placement, an aggregate of approximately 1,975.58 shares of Series B Preferred Stock initially convertible into 19,755,748 shares of Common Stock and related 9,877,835 Series B Warrants were issued for cash consideration, resulting in aggregate gross proceeds of approximately $15.2 million and aggregate net proceeds to the Company of approximately $13.2 million after deducting placement agent compensation and offering expenses.

 

An aggregate of approximately 937.00 shares of Series B Preferred Stock initially convertible into 9,370,008 shares of Common Stock and related Series B Warrants to purchase 4,684,991 shares of Common Stock were issued to certain Series B Investors (the “Exchange Investors”) in exchange for consideration consisting of approximately $6.9 million aggregate outstanding principal amount, together with accrued and unpaid interest thereon through the Series B Closing Date of approximately $0.3 million, of certain Senior Convertible Promissory Notes (the “Promissory Notes”) issued between December 20, 2019 and January 9, 2020 (the “Exchange”), pursuant to an Exchange Addendum (the “Exchange Addendum”) executed by the Company and the Exchange Investors. As additional consideration to the Exchange Investors, the Company also issued certain additional warrants (the “Exchange Warrants”) to purchase an aggregate of 1,772,937 shares of Common Stock at an exercise price of $0.85 per share. The amount of the Exchange Warrants is equal to 25% of the shares of Common Stock into which such Promissory Notes were originally convertible upon the initial issuance thereof.

 

Pursuant to the Series B Private Placement and the Series B Purchase Agreement, for purposes of complying with Nasdaq Listing Rule 5635(c) and 5635(d), the Company was required to hold a meeting of its stockholders not later than 60 days following the Series B Closing Date to seek approval (the “2020 Stockholder Approval”) for, among other things, the issuance of shares of Common Stock upon (i) full conversion of the Series B Preferred Stock; and (ii) full exercise of the Series B Warrants and the Exchange Warrants. In the event the 2020 Stockholder Approval was not received on or prior to the 90th day following the Series B Closing Date, subject to extension upon the prior written approval of the holders of at least a majority of the Series B Preferred Stock then outstanding, the Company would have been required to repurchase all of the then outstanding shares of Series B Preferred Stock at a price equal to 150% of the stated value thereof plus accrued and unpaid dividends thereon, in cash. On September 11, 2020, the Company received the 2020 Stockholder Approval.

 

The Company prepaid the remaining outstanding balance of $25,000 aggregate principal amount of Promissory Notes, together with accrued and unpaid interest thereon through the prepayment date of approximately $1,000, held by those holders who did not participate in the Exchange. Following these transactions, no Promissory Notes remain outstanding.

 

January 2021 Offerings

 

On December 31, 2020, the Company entered into a securities purchase agreement (the “Series C Purchase Agreement”), pursuant to which the Company agreed to sell in a registered direct offering 5,333.333 shares of Series C Preferred Stock, at a price of $750.00 per share, initially convertible into an aggregate of 5,333,334 shares of Common Stock, at an initial stated value of $750.00 per share and a conversion price of $0.75 per share (the “January 2021 Registered Direct Offering”).

 

Concurrently with the Registered Direct Offering, in a private placement offering pursuant to the Series C Purchase Agreement (the “January 2021 Private Placement,” and together with the January 2021 Registered Direct Offering, the “January 2021 Offerings”), the Company agreed to sell an additional 5,333.3333 shares of Series C Preferred Stock at the same price as the Series C Preferred Stock offered in the January 2021 Registered Direct Offering and convertible on the same terms and warrants (the “January 2021 Investor Warrants”) to purchase up to an aggregate of 10,666,668 shares of Common Stock, with an exercise price of $0.80 per share and a maturity date of July 6, 2026.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

In connection with the January 2021 Private Placement, we entered into a registration rights agreement, dated as of December 31, 2020, pursuant to which we filed a registration statement on Form S-1 (File No. 333-252087) to register the shares of Common Stock issuable upon the conversion of the Series C Preferred Stock sold in the January 2021 Private Placement and the exercise of the January 2021 Investor Warrants. The registration statement was declared effective by the SEC on January 21, 2021.

 

On January 6, 2021, the January 2021 Offerings closed, and the Company received aggregate gross proceeds of approximately $8.0 million, excluding the net proceeds. The net proceeds to the Company from the January 2021 Offerings, after deducting the placement agent’s fees and expenses, was approximately $7.1 million. The Company used the net proceeds to fund the payment of cash consideration to First Wave under the First Wave License Agreement, and for other general corporate purposes.

 

The Company paid the placement agent a cash fee equal to 8.0% and a management fee equal to 1.0% of the aggregate gross proceeds received by the Company in the January 2021 Offerings, or approximately $700,000. The Company also agreed to issue to the placement agent or its designees warrants (the “January 2021 Placement Agent Warrants”) exercisable for up to 746,667 shares of Common Stock, which is equal to 7.0% of the amount determined by dividing the gross proceeds of the January 2021 Offerings by the offering price per share of Common Stock, or $0.75. The January 2021 Placement Agent Warrants have substantially the same terms as the January 2021 Investor Warrants, except they are exercisable at $0.9375 per share, or 125% of the effective purchase price per share of the Series C Preferred Stock issued. The Company also reimbursed the placement agent $35,000 for non-accountable expenses, $125,000 for legal fees and expenses and other out-of-pocket expenses and $12,900 for clearing fees.

 

Pursuant to the January 2021 Private Placement and the Series C Purchase Agreement, the Company was required to hold a meeting of its stockholders not later than March 31, 2021 to seek approval (the “2021 Stockholder Approval”) for, among other things, the issuance of shares of Common Stock upon (i) full conversion of the Series C Preferred Stock; and (ii) full exercise of the January 2021 Investors Warrants and the January 2021 Placement Agent Warrants, and to increase the authorized shares to 250,000,000 from 150,000,000.

 

On February 24, 2021, the Company received the 2021 Stockholder Approval, and all outstanding shares of Series C Preferred Stock were converted to Common Stock.

 

Accounting for the January 2021 Offerings

 

Upon receiving the 2021 Stockholder Approval on February 24, 2021, the Company classified the Series C Preferred Stock as permanent equity because no features provide for redemption by the holders of the Series C Preferred Stock or conditional redemption, which is not solely within the Company’s control, and there are no unconditional obligations in that (1) the Company must or may settle in a variable number of its equity shares and (2) the monetary value is predominantly fixed, varying with something other than the fair value of the Company’s equity shares or varying inversely in relation to the Company’s equity shares.

 

Because the Series C Preferred Stock contains certain embedded features that could affect the ultimate settlement of the Series C Preferred Stock, the Company analyzed the instrument for embedded derivatives that require bifurcation. The Company’s analysis began with determining whether the Series C Preferred Stock is more akin to equity or debt. The Company evaluated the following criteria/features in this determination: redemption, voting rights, collateral requirements, covenant provisions, creditor and liquidation rights, dividends, and conversion rights. The Company determined that the Series C Preferred Stock was more akin to equity than to debt when evaluating the economic characteristics and risks of the entire Series C Preferred Stock, including the embedded features. The Company then evaluated the embedded features to determine whether their economic characteristics and risks were clearly and closely related to the economic characteristics and risks of the Series C Preferred Stock. Since the Series C Preferred Stock was determined to be more akin to equity than debt, and the underlying that causes the value of the embedded features to fluctuate would be the value of the Company’s common stock, the embedded features were considered clearly and closely related to the Series C Preferred Stock. As a result, the embedded features would not need to be bifurcated from the Series C Preferred Stock.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

The Company concluded the freestanding January 2021 Investor Warrants did not contain any provision that would require liability classification and therefore should be classified in stockholder’s equity, based on their relative fair value.

 

The proceeds from the January 2021 Offerings were allocated to the Series C Preferred Stock and the January 2021 Investor Warrants based on their relative fair values. The total proceeds of approximately $7.1 million, net of $0.9 million offering costs, were allocated as follows: approximately $4.6 million to the Series C Preferred Stock and approximately $3.4 million to the January 2021 Investor Warrants. After allocation of the proceeds, the effective conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of approximately $4.3 million equal to the intrinsic value of the beneficial conversion feature and recognized on the closing date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share. The total offering costs of approximately $0.9 million were recognized in equity.

 

Series B Most Favored Nations (MFN) Exchanges into the January 2021 Offerings

 

Subject to the consummating the January 2021 Offerings, the holders of the Series B Preferred Stock became entitled to exercise their Series B Exchange Right to exchange their Series B Preferred Stock at the Series B Exchange Amount into the Series C Preferred Stock and related January 2021 Investor Warrants.

 

During the three months ended June 30, 2021, holders of approximately 533.47 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $4.2 million had elected to exercise their Series B Exchange Rights into 5,639.15 shares of Series C Preferred Stock, convertible into an aggregate of 5,639,153 shares of Common Stock and additional January 2021 Investor Warrants exercisable for up to an aggregate of 5,639,153 shares of Common Stock. Immediately upon issuance of the Series C Preferred Stock pursuant to the Series B Exchange Right, all shares of Series C Preferred Stock were converted into 5,639,153 shares of Common Stock.

 

During the six months ended June 30, 2021, holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $14.4 million had elected to exercise their Series B Exchange Rights into 19,140.14 shares of Series C Preferred Stock, convertible into an aggregate of 19,140,240 shares of Common Stock and additional January 2021 Investor Warrants exercisable for up to an aggregate of 19,140,240 shares of Common Stock. Immediately upon issuance of the Series C Preferred Stock pursuant to the Series B Exchange Right prior to February 24, 2021, an aggregate of 13,166.62 shares of Series C Preferred Stock were converted into 13,166,624 shares of Common Stock, at an effective conversion price of $0.77 per share, and an aggregate of 334.46 shares of Series C Preferred Stock, convertible into 334,463 shares of Common Stock, remained unconverted pending stockholder approval. Upon receiving the 2021 Stockholder Approval on February 24, 2021, the Company elected to convert all 334.46 remaining shares of Series C Preferred Stock issued pursuant to the Series B Exchange Right, plus accrued dividends thereon of approximately $2,000 into 336,994 shares of Common Stock.

 

As a result, as of June 30, 2021, the Company may be required to issue up to 7,248.85 additional shares of Series C Preferred Stock that are currently convertible up to 7,248,846 underlying shares of Common Stock, together with January 2021 Investor Warrants to purchase up to an additional 7,248,846 shares of Common Stock, to any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right into the January 2021 Offerings. Any shares of Series C Preferred Stock to be issued pursuant to the Series B Exchange Right would, upon issuance, be immediately converted into underlying shares of Common Stock.

 

Accounting for the Series B Exchanges into the January 2021 Offerings

 

During the three months ended June 30, 2021, pursuant to the Series B Exchange Right, the Company issued an aggregate of 5,639.15 shares of Series C Preferred Stock and warrants to purchase an aggregate of 5,639,153 shares of Common Stock in connection with the exchange of approximately 533.47 shares of Series B Preferred Stock. The Company analyzed the exchanges pursuant to the Series B Exchange Right from preferred stock to preferred stock qualitatively and determined that the exchanges result in a substantive change and should be accounted for as an extinguishment. As such, for the three months ended June 30, 2021, the Company recognized an aggregate deemed dividend of approximately $3.4 million as calculated by the difference in the carrying value of the Series B Preferred Stock exchanged and the fair value of the Series C Preferred Stock and January 2021 Investor Warrants issued on each exchange date.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

      

During the six months ended June 30, 2021, pursuant to the Series B Exchange Right, the Company issued an aggregate of 19,140.14 shares of Series C Preferred Stock and warrants to purchase an aggregate of 19,140,140 shares of Common Stock in connection with the exchange of approximately 1,839.76 shares of Series B Preferred Stock. The exercise of all of these warrants and the conversion of a portion of these shares of Series C Preferred Stock were prohibited until the Company received stockholder approval on February 24, 2021. The Company analyzed the exchanges pursuant to the Series B Exchange Right from preferred stock to preferred stock qualitatively and determined that the exchanges result in a substantive change and should be accounted for as an extinguishment. As such, for the six months ended June 30, 2021, the Company recognized an aggregate deemed dividend of approximately $21.0 million as calculated by the difference in the carrying value of the Series B Preferred Stock exchanged and the fair value of the Series C Preferred Stock and January 2021 Investor Warrants issued on each exchange date.

 

March 2021 Offering

 

On March 7, 2021, the Company entered into a securities purchase agreement (the “March 2021 Purchase Agreement”), pursuant to which the Company agreed to sell, in a registered direct offering (the “March 2021 Offering”) priced at the market under Nasdaq rules, (i) 5,800,000 shares of Common Stock, (ii) pre-funded warrants (the “March 2021 Pre-Funded Warrants”) to purchase up to 2,058,548 shares of Common Stock, with an exercise price of $0.01 per share and no expiration term and (iii) warrants (the “March 2021 Warrants”) to purchase an aggregate of 3,929,274 shares of Common Stock with an exercise price of $1.21 per share and an expiration term of five years from the date of issuance. The price per share of March 2021 Offering was $1.2725.

 

On March 10, 2021, the March 2021 Offering closed and the Company received aggregate gross proceeds of approximately $10.0 million, excluding the net proceeds, if any, from the exercise of the March 2021 Warrants. The net proceeds to the Company from the March 2021 Offering were approximately $9.1 million, after deducting the placement agent’s fees and expenses.

 

The Company paid the placement agent a cash fee equal to 8.0% of the aggregate gross proceeds received by the Company, or approximately $800,000. The Company also agreed to issue the placement agent or its designees warrants (the “March 2021 Placement Agent Warrants”) exercisable for up to 550,099 shares of Common Stock, which is equal to 7.0% of the amount determined by dividing the gross proceeds of the March 2021 Offering by the offering price per share of Common Stock, or $1.2725. The March 2021 Placement Agent Warrants have substantially the same terms as the March 2021 Warrants, except they are exercisable at $1.5906 per share, or 125% of the effective purchase price per share of Common Stock issued. The Company also reimbursed the placement agent $35,000 for non-accountable expenses, $50,000 for legal fees and expenses and other out-of-pocket expenses and approximately $16,000 for clearing fees.

 

The March 2021 Offering was made pursuant to the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-231954) originally filed with the SEC on June 21, 2019, and declared effective on June 25, 2019. The Company filed a prospectus supplement with the SEC in connection with the sale of such securities in the March 2021 Offering.

 

The Company concluded the freestanding March 2021 Warrants and the March 2021 Placement Agent Warrants did not contain any provisions that would require liability classification and therefore should be classified in stockholder’s equity.

 

Note 12 - Warrants

 

During the three months ended June 30, 2021, the Company issued January 2021 Investor Warrants to purchase an aggregate of 5,639,153 shares of Common Stock to holders of Series B Preferred Stock elected to exercise their Series B Exchange Rights into Series C Preferred Stock and related warrants, as referenced in Note 11. These January 2021 Investor Warrants were issued between April 1, 2021 and June 9, 2021, are exercisable at $0.80 per share and expire on July 6, 2026. The total grant date fair value of these warrants was determined to be approximately $3.4 million, as calculated using the Black-Scholes model, and were recorded as a deemed dividend and recognized on the exchange date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

During the six months ended June 30, 2021, in connection with the January 2021 Offerings, the Company issued January 2021 Investor Warrants to the investor to purchase an aggregate of 10,666,668 shares of Common Stock, as referenced in Note 11. These January 2021 Investor Warrants were issued on January 6, 2021, are exercisable at $0.80 per share and expire on July 6, 2026. The exercise of the January 2021 Investor Warrants was prohibited until the Company received stockholder approval on February 24, 2021. The total grant date fair value of these warrants was determined to be approximately $6.0 million, as calculated using the Black-Scholes model, and were recorded as additional paid in capital based on their relative fair value of approximately $3.4 million (See Note 11).

 

During the six months ended June 30, 2021, in connection with the conversion of the Series C Preferred Stock issued in the January 2021 Offerings, the Company issued pre-funded warrants to the investor to purchase an aggregate of 1,933,334 shares of Common Stock as referenced in Note 11. These pre-funded warrants were issued on January 6, 2021, are exercisable at $0.001 per share and do not expire. The total grant date fair value of these pre-funded was determined to be approximately $1.6 million and was recorded as additional paid in capital (See Note 11).

 

During the six months ended June 30, 2021, in connection with the January 2021 Offerings, the Company issued January 2021 Placement Agent Warrants to the placement agent and/or their designees to purchase an aggregate of 746,667 shares of Common Stock, as referenced in Note 11. These January 2021 Placement Agent Warrants were issued on January 6, 2021, are exercisable at $0.9375 per share and expire on July 6, 2026. The total grant date fair value of these warrants was determined to be approximately $392,000, as calculated using the Black-Scholes model, and had no effect on shareholders’ equity (See Note 11).

 

During the six months ended June 30, 2021, the Company issued January 2021 Investor Warrants to purchase an aggregate of 19,140,240 shares of Common Stock to holders of Series B Preferred Stock elected to exercise their Series B Exchange Rights into Series C Preferred Stock and related warrants, as referenced in Note 11. These January 2021 Investor Warrants were issued between January 13, 2021 and June 9, 2021, are exercisable at $0.80 per share and expire on July 6, 2026. The exercise of 13,501,087 of these warrants was prohibited until the Company received stockholder approval on February 24, 2021. The total grant date fair value of these warrants was determined to be approximately $21.0 million, as calculated using the Black-Scholes model, and were recorded as a deemed dividend and recognized on the exchange date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share.

 

During the six months ended June 30, 2021, in connection with the March 2021 Offering, the Company issued March 2021 Warrants to the investor to purchase an aggregate of3,929,274 shares of Common Stock, as referenced in Note 11. These March 2021 Warrants were issued on March 10, 2021, are exercisable at $1.21 per share and expire five years from the date of issuance. The total grant date fair value of these warrants was determined to be approximately $3.5 million, as calculated using the Black-Scholes model, and were recorded as additional paid in capital (See Note 11).

 

During the six months ended June 30, 2021, in connection with March 2021 Offering, the Company issued pre-funded warrants to the investor to purchase an aggregate of 2,058,548 shares of Common Stock, as referenced in Note 11. These pre-funded warrants were issued on March 10, 2021, are exercisable at $0.01 per share and do not expire. The total grant date fair value of these pre-funded was determined to be approximately $2.6 million and was recorded as additional paid in capital (See Note 11).

 

During the six months ended June 30, 2021, in connection with the March 2021 Offering, the Company issued March 2021 Placement Agent Warrants to the placement agent and/or their designees to purchase an aggregate of 550,099 shares of Common Stock, as referenced in Note 11. These March 2021 Placement Agent Warrants were issued on March 10, 2021, are exercisable at $1.5906 per share and expire five years from the date of issuance. The total grant date fair value of these warrants was determined to be approximately $453,000, as calculated using the Black-Scholes model, and had no effect on shareholders’ equity (See Note 11).

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

During the six months ended June 30, 2021, the Company issued warrants to a consultant to purchase an aggregate of 200,000 shares of Common Stock that are subject to service-based milestone vesting conditions for investor relations services. These warrants were issued on February 8, 2021, are exercisable at $1.69 per share and expire four years from the date of issuance. The total grant date fair value of these warrants was determined to be approximately $214,000, as calculated using the Black-Scholes model. For the three months ended June 30, 2021, warrants to purchase a total of 150,000 shares of Common Stock vested, with a grant date fair value of approximately $161,000, which was recorded as stock-based compensation and was included as part of general and administrative expense. For the six months ended June 30, 2021, warrants to purchase a total of 200,000 shares of Common Stock vested, with a grant date fair value of approximately $214,000, which was recorded as stock-based compensation and was included as part of general and administrative expense.

 

During the three months ended June 30, 2021, warrants to purchase an aggregate of 328,375 shares of Common Stock were exercised for cash proceeds of approximately $264,000.

 

During the six months ended June 30, 2021, warrants to purchase an aggregate of 9,526,209 shares of Common Stock, including the pre-funded warrants issued in January 2021 and March 2021, were exercised for 9,456,443 shares of Common Stock resulting in cash proceeds of approximately $4.9 million.

 

During the six months ended June 30, 2020, in connection with the January 2020 closings of the Promissory Note Offering, the Company issued Note Warrants to investors to purchase an aggregate of 1,813,257 shares of Common Stock with the issuance of the Promissory Notes as referenced in Note 9. These Note Warrants were issued between January 2, 2020 and January 9, 2020, and became exercisable commencing six (6) months following the issuance date at $1.07per share and expire five years from issuance. The total grant date fair value of these warrants was determined to be approximately $1.6 million, as calculated using the Black-Scholes model, and were recorded as a debt discount based on their relative fair value.

 

During the six months ended June 30, 2020, in connection with the January 2020 closings of the Promissory Note Offering, the Company issued placement agent warrants to purchase an aggregate of 199,732 shares of Common Stock. These placement agent warrants were issued between January 2, 2020 and January 9, 2020, vested immediately, and expire five years from issuance. 41,495 of these Placement Agent Warrants are exercisable at $1.21 per share and 158,237 are exercisable at $1.42 per share. The total grant date fair value of these placement agent warrants was determined to be approximately $174,000, as calculated using the Black-Scholes model, and was charged to debt discount that will be amortized over the life of the debt.

 

Warrant transactions for the six months ended June 30, 2021 and 2020 were as follows:

 

 

 

 

 

 

Exercise

 

 

Weighted

 

 

 

 

 

Price Per

 

 

Average

 

 

 

Warrants

 

 

Share

 

 

Price

 

 

 

 

 

 

 

 

 

 

 

Warrants outstanding and exercisable on January 1, 2020

 

 

5,378,288

 

 

$

1.07- 7.37

 

 

$ 2.53

 

Granted during the period

 

 

2,012,989

 

 

1.07- 1.42

 

 

$ 1.10

 

Expired during the period

 

 

(30,096 )

 

4.76 - 7.37

 

 

$ 4.92

 

Exercised during the period

 

 

-

 

 

 

-

 

 

 

-

 

Warrants outstanding and exercisable on June 30, 2020

 

 

7,361,181

 

 

$

1.07- 7.37

 

 

$ 2.13

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrants outstanding and exercisable on January 1, 2021

 

 

25,179,192

 

 

$

0.85- 7.37

 

 

$ 1.22

 

Granted during the period

 

 

39,224,830

 

 

$

0.001-1.69

 

 

$ 0.78

 

Expired during the period

 

 

(321,193 )

 

 

-

 

 

 

-

 

Exercised during the period

 

 

(9,526,209 )

 

 

-

 

 

 

-

 

Warrants outstanding and exercisable on June 30, 2021

 

 

54,556,620

 

 

$

0.80– 6.60

 

 

$ 1.02

 

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

Warrants exercisable on June 30, 2021, were as follows:

 

 

 

Exercise Price

 

Number of Shares

Under Warrants

 

 

Weighted Average Remaining Contract Life in Years

 

 

Weighted Average

Exercise Price

 

 

 

 $

0.00 - 0.99

 

 

44,098,268

 

 

 

4.64

 

 

 

 

 

 

 $

1.00 - 1.99

 

 

8,407,884

 

 

 

3.88

 

 

 

 

 

 

 $

2.00 - 2.99

 

 

320,063

 

 

 

2.07

 

 

 

 

 

 

 $

3.00 - 3.99

 

 

611,683

 

 

 

0.86

 

 

 

 

 

 

 $

4.00 - 4.99

 

 

164,256

 

 

 

0.78

 

 

 

 

 

 

 $

5.00 - 5.99

 

 

766,716

 

 

 

0.70

 

 

 

 

 

 

 $

6.00 - 6.99

 

 

187,750

 

 

 

0.26

 

 

 

 

Totals

 

 

 

 

 

54,556,620

 

 

 

4.38

 

 

$ 1.02

 

 

The weighted average fair value of warrants granted during the six months ended June 30, 2021, and 2020, was $0.90 and $1.10 per share, respectively. The grant date fair values were calculated using the Black-Scholes model with the following weighted average assumptions:

  

 

 

June 30,

 

 

 

2021

 

Expected life (in years)

 

 

4.38

 

Volatility

 

83.8- 90.8

%

Risk-free interest rate

 

0.36- 0.90

%

Dividend yield

 

-

%

  

Note 13 - Stock Options

 

Under the 2014 Plan and the 2020 Plan, the fair value of options granted is estimated on the grant date using the Black-Scholes option valuation model. This valuation model for stock-based compensation expense requires the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the volatility of the common stock price and the assumed risk-free interest rate. The Company recognizes stock-based compensation expense for only those shares expected to vest over the requisite service period of the award. No compensation cost is recorded for options that do not vest and the compensation cost from vested options, whether forfeited or not, is not reversed.

 

On June 30, 2021, the Board rescinded and cancelled certain stock option awards previously made under the 2014 Plan (the “Prior Awards”) to James Sapirstein, the Company’s President, Chief Executive Officer and Chairman of the Board, and Daniel Schneiderman, the Company’s Chief Financial Officer, and issued new stock options awards (the “New Awards”) under the 2020 Plan in an equivalent amount and with equivalent exercise price, vesting and expiration terms to the Prior Awards. This action was approved by the Board following the recommendation of a special committee of the Board upon review of certain matters raised in a stockholder litigation demand letter received by the Company on or about July 27, 2020, as previously disclosed in the Company’s definitive proxy statement, dated August 11, 2020, in connection with stockholder approval of the 2020 Plan.

 

The terms of the New Awards to Mr. Sapirstein (the “New Sapirstein Awards”) covering 900,000 shares of the Common Stock at an exercise price of $0.85 per share comprised of (i) stock options to purchase 300,000 shares of Common Stock that vest over a term of 18 months in 18 equal monthly installments starting with the first monthly installment on February 16, 2022, (ii) stock options to purchase 200,000 shares of Common Stock that vested immediately upon the grant of such stock options, and (iii) stock options to purchase 400,000 shares of Common Stock subject to milestone-based vesting based upon the achievement of certain strategic milestones specified by the Board. The Company determined the cancellation and reissue of the New Sapirstein Awards did not result in modification accounting under ASC 718 as there was no change between the fair value of the original stock options immediately prior to the modification and the grant date fair value of the replacement stock options and no change to vesting conditions.. The Company will recognize a total of approximately $492,000, representing the original unexpensed amount over the remaining requisite service periods of the New Sapirstein Awards.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

The terms of the New Awards to Mr. Schneiderman (the “New Schneiderman Awards”) covering an aggregate of 285,006 shares of Common Stock at an exercise price of $0.85 per share comprised of (i) stock options to purchase 250,000 shares of Common Stock, of which stock options to purchase 79,860 shares of Common Stock vested immediately upon the grant of such stock options and the remaining stock options to purchase 170,140 shares of Common Stock will vest over a term of 2 years and 1 month in 25 equal monthly installments, and (ii) stock options to purchase 35,006 shares of Common Stock, of which stock options to purchase 17,502 shares of Common Stock vested immediately upon the grant of such stock options and the remaining options to purchase 17,504 shares of Common Stock vest over a term of 19 months in 19 equal monthly installments. The Company determined the cancellation and reissue of the New Schneiderman Awards did not result in modification accounting under ASC 718 as there was no change between the fair value of the original stock options immediately prior to the modification and the grant date fair value of the replacement stock options and no change to vesting conditions. The Company will recognize a total of $192,000 over the remaining requisite service periods of the New Schneiderman Awards, which amounts to the unexpensed amount of the original stock option grants.

 

During the three months ended June 30, 2021, the Company issued stock options under the 2020 Plan to new employees to purchase an aggregate of 36,000 shares of Common Stock with a strike price of $0.78 per share and a term of ten years that vest in equal monthly installments over three years. These options had a total fair value of approximately $24,000, as calculated using the Black-Scholes model.

 

During the three months ended June 30, 2021, excluding the Prior Awards described above, stock options to purchase an aggregate of 19,264 shares of Common Stock under the 2014 Plan were cancelled with strike prices ranging between $0.85 and $3.60 per share.

 

During the six months ended June 30, 2021, the Company issued stock options under the 2020 Plan to new employees to purchase an aggregate of 379,685 shares of Common Stock with strike prices ranging from $0.78 to $1.54 per share and a term of ten years that vest in equal monthly installments over three years. These options had a total fair value of approximately $300,000, as calculated using the Black-Scholes model.

 

During the six months ended June 30, 2021, excluding the Prior Awards described above, stock options to purchase an aggregate of 154,778 shares of Common Stock under the 2014 Plan were cancelled with strike prices ranging between $0.85 and $3.60 per share.

 

During the six months ended June 30, 2021, stock options to purchase an aggregate of 416,142 shares of Common Stock, subject to service-based milestone vesting conditions, vested with a total grant date fair value of approximately 305,000 which was recorded as stock-based compensation, of which approximately $245,000 was included as part of general and administrative expense and approximately $60,000 was included as part of research and development expense.

 

During the six months ended June 30, 2021, stock options to purchase an aggregate of 755,000 shares of Common Stock, subject to performance-based milestone vesting conditions, vested due to the Company achieving certain clinical milestones, with a total grant date fair value of approximately $623,000 which was recorded as stock-based compensation, of which approximately $253,000 was included as part of general and administrative expense and approximately $370,000 was included as part of research and development expense. Stock options to purchase an aggregate of 437,500 shares of Common Stock, with a total grant date fair value of approximately $427,000, vested due to the Company completing enrollment of the Phase 2 OPTION 2 clinical trial. Stock options to purchase an aggregate of 210,000 shares of Common Stock, with a total grant date fair value of approximately $148,000, vested due to the Company’s public announcement of topline data for the Phase 2 OPTION 2 clinical trial. Stock options to purchase an aggregate of 7,500 shares of Common Stock, with a total grant date fair value of approximately $8,000, vested due to the Company completing enrollment of the Phase 2 Combination Trial in Europe. Stock options to purchase an aggregate of 100,000 shares of Common Stock, with a total grant date fair value of approximately $40,000, vested due to the Company determining that initiating a U.S. Phase 1 clinical trial for any product other than MS1819 became probable in connection with the initiation of the COVID-19 niclosamide trial.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

     

During the six months ended June 30, 2020, stock options to purchase an aggregate of 200,000 shares of Common Stock were cancelled with strike prices ranging between $0.97 and $3.60 per share.

 

During the six months ended June 30, 2020, stock options to purchase an aggregate of 315,834 shares of Common Stock, subject to service conditions, vested with a total grant date fair value of approximately $200,977 and were recorded as stock-based compensation, and included as part of general and administrative expense.

 

During the three and six months ended June 30, 2020, stock options to purchase an aggregate of 50,000 shares of Common Stock, subject to performance conditions vesting, vested with a total grant date fair value of approximately $20,150 and were recorded as stock-based compensation, and included as part of general and administrative expense due to the Company determining the probability of initiating the Option 2 Clinical Trial was greater than 75% at June 30, 2020.

 

The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions:

 

 

 

June 30,

 

2021

 

Contractual term (in years)

 

 

10

 

Volatility

 

83.8 - 90.6

Risk-free interest rate

 

0.93 - 1.69

%

Dividend yield

 

-

%

 

The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of the Company’s Common Stock if available or of several public entities that are similar to the Company. The Company bases volatility this way because it may not have sufficient historical transactions in its own shares on which to solely base expected volatility. The risk-free interest rate is based on the U.S. Treasury rates at the date of grant with maturity dates approximately equal to the expected term at the grant date. The Company has not historically declared any dividends and does not expect to in the future.

 

During the six months ended June 30, 2021 and 2020, stock option activity under the 2014 Plan and 2020 Plan was as follows:

 

 

 

 

 

Average

 

 

Remaining

 

 

 

 

 

Number

 

 

Exercise

 

 

Contract

 

 

Intrinsic

 

 

 

of Shares

 

 

Price

 

 

Life (Years)

 

 

Value

 

Stock options outstanding on January 1, 2020

 

 

1,677,500

 

 

$ 2.17

 

 

 

5.37

 

 

$ -

 

Granted during the period

 

 

795,006

 

 

$ 1.00

 

 

 

10.00

 

 

 

-

 

Canceled during the period

 

 

(200,000 )

 

$ 2.10

 

 

 

3.28

 

 

 

-

 

Stock options outstanding on June 30, 2020

 

 

2,272,506

 

 

$ 1.86

 

 

 

6.52

 

 

$ -

 

Exercisable on June 30, 2020

 

 

1,084,834

 

 

$ 2.59

 

 

 

5.6

 

 

$ -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-vested stock options outstanding on January 1, 2020

 

 

883,500

 

 

$ 1.33

 

 

 

6.26

 

 

$ -

 

Granted during the period

 

 

795,006

 

 

$ 1.03

 

 

 

10.00

 

 

 

-

 

Vested during the period

 

 

(365,834 )

 

$ 2.59

 

 

 

6.88

 

 

 

-

 

Canceled during the period

 

 

(125,000 )

 

$ 2.10

 

 

 

2.82

 

 

 

-

 

Non-vested stock options outstanding on June 30, 2020

 

 

1,187,672

 

 

$ 1.24

 

 

 

7.06

 

 

$ -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

 

 

 

 

 

Number

 

 

Exercise

 

 

Contract

 

 

Intrinsic

 

 

 

of Shares

 

 

Price

 

 

Life (Years)

 

 

Value

 

Stock options outstanding on January 1, 2021

 

 

4,070,284

 

 

$ 1.38

 

 

 

7.94

 

 

$ -

 

Granted during the period

 

 

1,564,691

 

 

$ 0.88

 

 

 

10.00

 

 

 

-

 

Canceled during the period

 

 

(1,339,784 )

 

$ 1.05

 

 

 

2.87

 

 

 

-

 

Stock options outstanding on June 30, 2021

 

 

4,295,191

 

 

$ 1.18

 

 

 

7.72

 

 

$ 79,440

 

Exercisable on June 30, 2021

 

 

2,413,727

 

 

$ 1.41

 

 

 

6.70

 

 

$ 52,120

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-vested stock options outstanding on January 1, 2021

 

 

2,740,657

 

 

$ 0.99

 

 

 

8.42

 

 

 

-

 

Granted during the period

 

 

1,564,691

 

 

$ 0.88

 

 

 

10.00

 

 

 

-

 

Vested during the period

 

 

(1,468,504 )

 

$ -

 

 

 

-

 

 

 

-

 

Canceled during the period

 

 

(955,380 )

 

$ -

 

 

 

-

 

 

 

-

 

Non-vested stock options outstanding on June 30, 2021

 

 

1,881,464

 

 

$ 0.87

 

 

 

9.04

 

 

$ -

 

 

 
30

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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

As of June 30, 2021, the Company had unrecognized stock-based compensation expense of approximately $1.1 million. Approximately $0.8 million of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 1.93 years. Approximately $40,000 of this unrecognized expense will vest upon initiating a Phase 3 clinical trial in the U.S. for MS1819. Approximately, $140,000 of this unrecognized expense will vest upon the public release of topline data of the complete Combination Trial results. Approximately, $140,000 of this unrecognized expense will vest upon signing of a definitive term sheet with Board approval for either (i) a strategic licensing, distribution, or commercialization agreement for MS1819 with a bona fide partner, or (ii) the substantial sale of the Company or the MS1819 asset, on or before December 31, 2021. The Company will recognize the expense related to these milestones when the milestones become probable.

 

As of June 30, 2020, the Company had unrecognized stock-based compensation expense of approximately $0.9 million. Approximately $327,000 of this unrecognized expense will be recognized over the average remaining vesting term of the options of 9.62 years. Approximately $440,000 of this unrecognized expense will vest upon enrollment completion of the next MS1819 Phase II clinical trial in the U.S. for CF (the OPTION 2 Trial). Approximately $41,000 of this unrecognized expense will vest upon enrollment completion of the ongoing Combination Trial in Europe. Approximately $20,000 of this unrecognized expense will vest upon trial completion of the next MS1819 Phase II clinical trial in the U.S. for CF (the OPTION 2 Trial). Approximately $40,000 of this unrecognized expense vests upon the Company initiating a Phase III clinical trial in the U.S. for MS1819. Approximately $40,000 of this unrecognized expense vests upon initiating a U.S. Phase I clinical trial for any product other than MS1819. The Company will recognize the expense related to these milestones when the milestones become probable.

 

Note 14 - Agreements

 

License Agreement with First Wave Bio, Inc.

 

On December 31, 2020, we entered into the First Wave License Agreement, pursuant to which First Wave granted us a worldwide, exclusive right to develop, manufacture, and commercialize First Wave’s proprietary immediate release and enema formulations of niclosamide (the “Niclosamide Product”) for the fields of treating ICI-AC and COVID-19 in humans.

 

In consideration of the license and other rights granted by First Wave, we agreed to pay First Wave a $9.0 million upfront cash payment due within 10 days, which was paid in January 2021 and are obligated to make an additional payment of $1.25 million due on June 30, 2021. In addition, we are obligated to pay potential milestone payments to First Wave totaling up to $37.0 million for each indication, based upon the achievement of specified development and regulatory milestones. As of June 30, 2021, the Company achieved a milestone related to clinical development of niclosamide in the COVID-19 field and has expensed $1.0 million in research and development and accrued $1.0 million in accounts payable. Under the First Wave License Agreement we are obligated to pay First Wave royalties as a mid-single digit percentage of net sales of the Niclosamide Product, subject to specified reductions. We were also obligated to issue to First Wave junior convertible preferred stock, initially convertible into $3.0 million worth of Common Stock based upon the volume weighted average price of the Common Stock for the five-day period immediately preceding the date of the First Wave License Agreement, or $0.9118 per share, convertible into an aggregate of 3,290,196 shares of Common Stock. As of December 31, 2020, this was initially classified as a liability in the consolidated balance sheet because of certain NASDAQ restrictions and the requirement to obtain stockholder approval.

 

 
31

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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

On January 8, 2021, in connection with the securities purchase agreement with First Wave (the “First Wave Purchase Agreement”) pursuant to which we issued to First Wave 3,290.1960 shares of Series C Preferred Stock, which were convertible into an aggregate of 3,290,196 shares of Common Stock based on a conversion price of $0.75 per share, and with a grant date fair value of approximately $2.5 million. The First Wave Purchase Agreement contains demand and piggyback registration rights with respect to the Common Stock issuable upon conversion of the Series C Preferred Stock.

 

The conversion price of the Series C Preferred Stock was determined to be beneficial and, as a result, the Company recorded a deemed dividend of approximately $230,000 equal to the intrinsic value of the beneficial conversion feature and recognized on the issuance date and recorded as a reduction of income available to common stockholders in computing basic and diluted loss per share.

 

Upon the 2021 Stockholder Approval on February 24, 2021, the Company recognized a change in fair value of approximately $0.5 million based on the difference in fair value of the $3.0 million liability initially recorded pursuant to the First Wave License Agreement as of December 31, 2020 and the fair value of approximately $2.5 million of Series C Preferred Stock issued pursuant to the First Wave Purchase Agreement to settle the liability.

 

Following the 2021 Stockholder Approval, the shares of Series C Preferred Stock were automatically converted into Common Stock.

 

The Company is solely responsible, and has agreed to use commercially reasonable efforts, for all development, regulatory and commercial activities related to the Niclosamide Products in the ICI-AC and COVID-19 fields. The Company may sublicense its rights under the First Wave License Agreement and, if it does so, will be obligated to pay milestone payments and royalties to First Wave based on the sublicensee’s development and commercialization of the licensed Niclosamide Products.

 

Pursuant to the First Wave License Agreement, First Wave retains rights to develop and commercialize the licensed niclosamide formulations outside the ICI-AC and COVID-19 fields, and to develop and commercialize other niclosamide formulations that are not licensed to Company. Pursuant to the First Wave License Agreement, the Company grants First Wave a worldwide, non-exclusive, royalty-free, perpetual, irrevocable license for use outside the ICI-AC and COVID-19 fields, with the right to grant sublicenses, under any Program IP and other intellectual property owned by the Company and incorporated into the Niclosamide Product.

 

The First Wave License Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on date of expiration of the last to expire royalty term with respect to the country. The First Wave License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the First Wave License Agreement by either party, termination by the Company in specified circumstances, termination by First Wave in specified circumstances, termination by the Company for convenience with advance notice, and termination upon a party’s insolvency or bankruptcy. After expiration of the royalty term, the Company shall have a non-exclusive, fully-paid, perpetual, royalty-free right and irrevocable license with respect to any Product in any country within the territory.

 

The First Wave License Agreement also contains customary representations, warranties, and covenants by both parties, as well as customary provisions relating to indemnification, confidentiality, and other matters.

 

 
32

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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

Mayoly Agreement

 

In March 2019, the Company and Laboratories Mayoly Spinder (“Mayoly”) entered into an Asset Purchase Agreement (the “Mayoly APA”), pursuant to which the Company purchased substantially all remaining rights, title, and interest in and to MS1819. Further, upon execution of the Mayoly APA, the Joint Development and License Agreement (the “JDLA”) previously executed by AzurRx SAS and Mayoly was assumed by the Company. In addition, the Company granted to Mayoly an exclusive, royalty-bearing right to revenue received from commercialization of MS1819 within certain territories.

 

TransChem Sublicense

 

In August 2017, the Company entered into a sublicense agreement with TransChem, pursuant to which TransChem granted the Company an exclusive license to patents and patent applications relating to Helicobacter pylori 5’methylthioadenosine nucleosidase inhibitors (the “TransChem Licensed Patents”) currently held by TransChem (the “TransChem Sublicense Agreement”). In March 2020, the Company provided TransChem with sixty (60) days prior written notice of its intent to terminate the TransChem Sublicense Agreement, which as of June 30, 2021 has been terminated.

 

Note 15 - Leases

 

The Company leases its offices and research facilities under operating leases which are subject to various rent provisions and escalation clauses.

 

Effective June 1, 2021, the Company commenced a sixty-three-month lease agreement for its corporate headquarters located in approximately 3,472 square feet of office space at 777 Yamato Road, Suite 502, Boca Raton, FL 33431.

 

The Company’s leases expire at various dates through 2026. The escalation clauses are indeterminable and considered not material and have been excluded from minimum future annual rental payments.

 

Lease expense amounted to approximately $57,000 and $40,000, respectively, for the three months ended June 30, 2021, and 2020.

 

Lease expense amounted to approximately $110,000 and $77,000, respectively, for the six months ended June 30, 2021, and 2020.

 

The weighted-average remaining lease term and weighted-average discount rate under operating leases on June 30, 2021, are:

 

 

 

June 30,

 

 

 

2021

 

Lease term and discount rate

 

 

Weighted-average remaining lease term

 

4.5 years

 

Weighted-average discount rate

 

 

6.86 %

 

Approximately $118,000 of short-term lease liability is included in other current liabilities and approximately $286,000 of long-term lease liability is included in other liabilities (See Note 10).

 

 
33

Table of Contents

 

AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

Maturities of operating lease liabilities on June 30, 2021, were as follows:

 

2021

 

$ 61,642

 

2022

 

 

104,629

 

2023

 

 

83,691

 

2024

 

 

86,202

 

2025

 

 

88,788

 

Thereafter

 

 

60,593

 

Total lease payments

 

 

485,545

 

Less imputed interest

 

 

(81,306 )

Present value of lease liabilities

 

$ 404,239

 

 

Note 16 - Income Taxes

 

The Company is subject to taxation at the federal level in both the United States and France and at the state level in the United States. On June 30, 2021, and December 31, 2020, the Company had no tax provision for either jurisdiction.

 

On June 30, 2021, and December 31, 2020, the Company had gross deferred tax assets of approximately $27.3 million and $26.1 million, respectively. As the Company cannot determine that it is more likely than not that the Company will realize the benefit of the deferred tax asset, a valuation allowance of approximately $27.3 million and $26.1 million, respectively, has been established on June 30, 2021, and December 31, 2020. The change in the valuation allowance in the six months ended June 30, 2021 and 2020 was approximately $(1.2) million and $(0.4) million, respectively.

 

On June 30, 2021, the Company has gross net operating loss (“NOL”) carryforwards for U.S. federal and state income tax purposes of approximately $65.1 million and $22.6 million, respectively. The NOL’s expire between the years 2034 and 2039. The Company’s ability to use its NOL carryforwards may be limited if it experiences an “ownership change” as defined in Section 382 (“Section 382”) of the Internal Revenue Code of 1986, as amended. An ownership change generally occurs if certain stockholders increase their aggregate percentage ownership of a corporation’s stock by more than 50 percentage points over their lowest percentage ownership at any time during the testing period, which is generally the three-year period preceding any potential ownership change.

 

On June 30, 2021, and December 31, 2020, the Company had approximately $27.0 million and $23.0 million, respectively, in net operating losses which it can carryforward indefinitely to offset against future French income.

 

On June 30, 2021, and December 31, 2020, the Company had taken no uncertain tax positions that would require disclosure under ASC 740, Accounting for Income Taxes.

 

Note 17 - Net Loss per Common Share

 

Basic net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options and warrants is computed using the treasury stock method.

 

On June 30, 2021, diluted net loss per share did not include the effect of 7,060,539 shares of Common Stock issuable upon the conversion of Series B preferred stock, including accrued and unpaid dividends through June 30, 2021, 54,556,620 shares of Common Stock issuable upon the exercise of outstanding warrants, 112,000 shares of restricted stock not yet issued, 275,000 unearned shares of restricted stock and RSUs, and 4,295,191 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion. Also excluded from the diluted net loss per are the potentially dilutive effect of up to 188,307 shares of Common Stock and 7,248,846 shares of Common Stock issuable upon exercise of January 2021 Investor Warrants potentially issuable pursuant the Series B Exchange Right.

 

 
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AZURRX BIOPHARMA, INC.

Notes to Unaudited Consolidated Financial Statements

    

At June 30, 2020, diluted net loss per share did not include the effect of 7,427,032 shares of Common Stock issuable upon the conversion of convertible debt, 7,361,181 shares of Common Stock issuable upon the exercise of outstanding warrants, 387,000 shares of Common Stock pursuant to unearned and unissued restricted stock and RSUs, and 2,272,506 shares of Common Stock issuable upon the exercise of outstanding options as their effect would be antidilutive during the periods prior to conversion.

 

Note 18 - Employee Benefit Plans

 

401(k) Plan

 

Since 2015, the Company has sponsored a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company.

 

All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit-sharing contributions.

 

Employer contributions under this 401(k) plan amounted to approximately $23,000 and $40,000 for the three months ended June 30, 2021 and 2020, respectively.

 

Employer contributions under this 401(k) plan amounted to approximately $55,000 and $62,000 for the six months ended June 30, 2021 and 2020, respectively.

 

Note 19 – Subsequent Events

 

July 2021 Offering

 

On July 22, 2021, the Company entered into an underwriting agreement with Wainwright pursuant to which the Company agreed to sell, in an upsized firm commitment offering, 9,090,910 shares of Common Stock to Wainwright at an offering price to the public of $0.55 per share, less underwriting discounts and commissions. On July 27, 2021, pursuant to the terms of the underwriting agreement, Wainwright exercised its 30-day over-allotment option in full to purchase an additional 1,363,636 shares of Common Stock at the same offering price to the public, less underwriting discounts and commissions. The offering closed on July 27, 2021.

 

The Company received net proceeds from the offering of approximately $5.1 million. The Company intends to use the net proceeds from the offering for milestone payments due under the Company’s license agreements and for other general corporate purposes.

 

The Company paid Wainwright an underwriting discount equal to 8.0% of the gross proceeds of the offering, and reimbursed Wainwright for a non-accountable expense allowance of $35,000, $125,000 in legal fees and $15,950 for clearing expenses. Additionally, as partial compensation for Wainwright’s services as underwriter in the offering, the Company issued to Wainwright (or its designees) warrants to purchase 731,819 shares of Common Stock equal to 7.0% of the aggregate number of shares of Common Stock sold in the offering (the “Wainwright Warrants”). The Wainwright Warrants have a term of five (5) years from the date of the offering and an exercise price of $0.6875 per share (equal to 125% of the offering price per share), subject to adjustments as provided in the terms of the Wainwright Warrants. The Wainwright Warrants provide for liquidated damages and compensation for buy-ins, if the Company fails to timely deliver the underlying Common Stock within specified timeframes from exercise. The Wainwright Warrants do not provide for any Black Scholes payout in the event of a fundamental transaction relating to the Company.

 

Most Favored Nations (MFN) Exchange Right

 

As of August 13, 2021, any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right in connection with up to 676.05 shares of Series B Preferred Stock plus accrued dividends of approximately $288,000 may require the Company to issue either: (i) up to 7,324,125 additional shares of Series C Preferred Stock that are currently convertible up to 7,324,125 underlying shares of Common Stock, together with January 2021 Investor Warrants to purchase up to an additional 7,324,125 shares of Common Stock, to any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right into the January 2021 Offerings, or (ii) up to 9,987,571 additional shares of Common Stock at a price of $0.55 per share, with no warrants, to any holders of Series B Preferred Stock who elect to exercise their Series B Exchange Right into the July 2021 Offering. Any shares of Series C Preferred Stock to be issued pursuant to the Series B Exchange Right into the January 2021 Offerings would, upon issuance, be immediately converted into underlying shares of Common Stock.

 

Appointment of New Director

 

On August 11, 2021, the Board approved, effective immediately, an increase in the size of the Board from six directors to seven directors and appointed Terry Coelho, age 60, to serve as a member of the Board to fill the newly-created vacancy. Ms. Coelho will hold this position until the next annual meeting of the Company’s stockholders or until her successor is elected and qualified, subject to her earlier resignation or removal. Ms. Coelho will also serve as a member of the Audit Committee and the Compensation Committee of the Board.

 

 
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

References in this report to “AzurRx,” “Company,” “we,” “us,” “our,” or similar references mean AzurRx BioPharma, Inc. and its subsidiaries on a consolidated basis. References to “AzurRx BioPharma” refer to AzurRx BioPharma, Inc. on an unconsolidated basis. References to “AzurRx SAS” refer to AzurRx BioPharma’s wholly owned subsidiary through which we conduct our European operations. References to the “SEC” refer to the U.S. Securities and Exchange Commission.

 

Forward-Looking Statements

 

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes included elsewhere in this interim report. Our consolidated financial statements have been prepared in accordance with U.S. GAAP. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,” “intend,” “believe,” or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading “Risk Factors” included in our Annual Report filed on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021. Readers are cautioned not to place undue reliance on these forward-looking statements.

 

Overview

 

We are engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. We are focused on developing our pipeline of gut-restricted GI clinical drug candidates, including MS1819 and niclosamide.

 

MS1819, our lead drug candidate, is a recombinant lipase for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”) and chronic pancreatitis, currently in two Phase 2 clinical trials for CF. In March 2021, we announced topline results from our Phase 2b OPTION 2 monotherapy trial, and in May 2021, we announced positive interim results from the first 18 patients in our Phase 2 combination trial in Europe.

  

In 2021, we are launching two new clinical programs using proprietary formulations of niclosamide, a small molecule with anthelminthic, anti-viral and anti-inflammatory properties. The first, FW-1022, is for Severe Acute Respiratory Syndrome Coronavirus 2 (“COVID-19”) gastrointestinal infections.  In April 2021, we launched the Phase 2 RESERVOIR COVID-19 GI clinical trial using a proprietary oral immediate-release tablet formulation of micronized niclosamide. The second, FW-420, is for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-Associated Colitis (“ICI-AC”) and diarrhea in advanced stage oncology patients. We are preparing to initiate our Phase 1b/2a PASSPORT ICI-AC trial using both an oral immediate-release tablet and a topical rectal enema foam formulations of niclosamide in the second half of 2021.

 

COVID-19 Update

 

In March 2020, the World Health Organization declared the novel coronavirus disease, or COVID-19, outbreak a global pandemic. To limit the spread of COVID-19, governments have taken various actions including the issuance of stay-at-home orders and physical distancing guidelines. Accordingly, businesses have adjusted, reduced or suspended operating activities. Beginning in March 2020, the majority of our workforce began working from home. Disruptions caused by the COVID-19 pandemic, including the effects of the stay-at-home orders and work-from-home policies, have impacted productivity, including delayed enrollment of new patients at certain of our clinical trial sites, and may further disrupt our business and delay our development programs and regulatory timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct business in the ordinary course. As a result, our expenses may vary significantly if there is an increased impact from COVID-19 on the costs and timing associated with the conduct of our clinical trials and other related business activities.

 

 
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We have implemented business continuity plans designed to address and mitigate the impact of the ongoing COVID-19 pandemic on our employees and our business. We continue to operate normally with the exception of enabling all of our employees to work productively at home and abiding by travel restrictions issued by federal, state and local governments. Our current plans to return to the office remain fluid as federal, state and local guidelines, rules and regulations continue to evolve.

 

Liquidity and Capital Resources

 

To date, we have not generated any revenues and have experienced net losses and negative cash flows from our activities.

 

As of June 30, 2021, we had cash and cash equivalents of approximately $8.1 million, and had sustained cumulative losses attributable to common stockholders of approximately $112.3 million. We have not yet achieved profitability and anticipate that we will continue to incur net losses for the foreseeable future. We expect that our expenses will continue to grow and, as a result, we will need to generate significant product revenues to achieve profitability. We may never achieve profitability. As such, we are dependent on obtaining, and are continuing to pursue, the necessary funding from outside sources, including obtaining additional funding from the sale of securities in order to continue our operations. Without adequate funding, we may not be able to meet our obligations. We believe these conditions may raise substantial doubt about our ability to continue as a going concern.

 

Our primary sources of liquidity come from capital raises through additional equity and/or debt financings. This may be impacted by the COVID-19 pandemic, which is evolving and could negatively impact our ability to raise additional capital in the future.

 

We have funded our operations to date primarily through the issuance of debt, convertible debt securities, preferred stock, as well as the issuance of Common Stock in various public offerings and private placement transactions. We expect to incur substantial expenditures in the foreseeable future for the development of MS1819, niclosamide and any other drug candidates. We will require additional financing to develop our drug candidates, run clinical trials, prepare regulatory filings and obtain regulatory approvals, fund operating losses, and, if deemed appropriate, establish manufacturing, sales and marketing capabilities. Our current financial condition raises substantial doubt about our ability to continue as a going concern. Our failure to raise capital as and when needed would have a material adverse impact on our financial condition, our ability to meet our obligations, and our ability to pursue our business strategies. We will seek funds through additional equity and/or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing.

 

Although, we are primarily focused on the development of our drug candidates, including MS1819 and niclosamide, we are also opportunely focused on expanding our product pipeline of clinical assets through collaborations, and also through acquisitions of products and companies. We are continually evaluating potential asset acquisitions business combinations, and other partnership opportunities. To finance such acquisitions, we might raise additional equity capital, incur additional debt, or both.

 

Currently, we have approximately $94.3 million of securities available to be sold under the shelf registration statement filed on May 26, 2021, which was declared effective on June 2, 2021 and will expire on June 2, 2024, and approximately $48.7 million of our Common Stock available for issuance pursuant to an ATM Agreement with H.C. Wainwright & Co., LLC. We may sell the remaining shares of Common Stock that may be issued under the ATM Agreement at our discretion from time to time until June 1, 2024, subject to the continued effectiveness of a registration statement covering such shares of Common Stock sold by us.

 

Additionally, we have approximately $30.0 million of securities available to be sold under the shelf registration statement filed on June 5, 2019, which was declared effective on June 25, 2019 and will expire on June 25, 2022, and

approximately $14.0 million of our Common Stock available for issuance pursuant to a purchase agreement with Lincoln Park Capital Fund, LLC. We may sell the remaining shares of Common Stock that may be issued under the purchase agreement at our discretion from time to time until July 2022, subject to the continued effectiveness of a registration statement covering such shares of Common Stock sold to Lincoln Park Capital Fund, LLC by us.

 

Our ability to issue securities is subject to market conditions. Each issuance under the shelf registration statements will require the filing of a prospectus supplement identifying the amount and terms of the securities to be issued.

 

 
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Consolidated Results of Operations for the Three Months Ended June 30, 2021 and 2020

 

The following table summarizes our consolidated results of operations for the periods indicated:

 

 

 

Three Months Ended

 

 

 

 

 

 

June 30,

 

 

Increase

 

 

 

2021

 

 

2020

 

 

(decrease)

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$ 5,647,798

 

 

$ 1,089,177

 

 

$ 4,558,621

 

General and administrative expenses

 

 

3,629,090

 

 

 

1,304,527

 

 

 

2,324,563

 

Total operating expenses

 

 

9,276,888

 

 

 

2,393,704

 

 

 

6,883,184

 

Other expenses (income)

 

 

2,056

 

 

 

2,302,174

 

 

 

(2,300,118 )

Net loss

 

$ 9,278,944

 

 

$ 4,695,878

 

 

$ 4,583,066

 

 

Research and Development Expense

 

Research and development expenses include cash and non-cash expenses primarily relating to the development of our lead drug candidate, MS1819 and our in-licensed niclosamide drug candidates.

 

Non-cash research and development expenses, including stock-based compensation, and depreciation and amortization totaled approximately $0.2 million for the three months ended June 30, 2021 and approximately $0.1 million recorded for the three months ended June 30, 2020. Cash research and development expenses for the three months ended June 30, 2021 totaled approximately $4.5 million, an increase of approximately $3.6 million, or 414% over the approximately $0.9 million recorded for the three months ended June 30, 2020.

 

The increase in total research and development expenses was primarily attributable increases of approximately $2.7 million in clinical related expenses in connection with conducting two Phase 2 clinical trials for MS1819, and one clinical trial for niclosamide during the three months ended June 30, 2021, as compared to one Phase 2 clinical trial for MS1819 during the three months ended June 30, 2020, approximately $1.0 million milestone payment pursuant to the First Wave License Agreement related to niclosamide clinical development, approximately $0.7 million in CMC related activates for MS1819, and approximately $0.1 million in personnel related expenses.

 

We expect cash research and development expense to increase during the remainder of this fiscal year as we initiate and conduct two clinical trials for niclosamide, additional milestone payments pursuant to the First Wave License Agreement in connection with clinical development of niclosamide, pursue additional CMC activities in connection with formulation development for MS1819, and personnel related costs in connection with new hires.

 

General and Administrative Expense

 

General and administrative expenses include cash and non-cash expenses primarily relating to our overall operations and being a public company, including personnel, legal and financial professional services, insurance, corporate communication and investor relations, listing and compliance related costs, rent, and expenses associated with obtaining and maintaining intellectual property and patents, among others.

 

Non-cash general and administrative expenses, including stock-based compensation, stock expense and depreciation and amortization totaled approximately $0.5 million for the three months ended June 30, 2021, and approximately $0.2 million recorded for the three months ended June 30, 2020. Cash general and administrative expenses for the three months ended June 30, 2021 totaled approximately $3.2 million, an increase of approximately $2.0 million, or 183% over the approximately $1.1 million recorded for the three months ended June 30, 2020.

 

 
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The increase in total general and administrative was due primarily to increases of approximately $1.4 million in public company costs, including investor relations, corporate communications in connection with market awareness campaigns and compliance related fees, approximately $0.4 million of legal expenses primarily related to increased financing activity and corporate governance, approximately, approximately $0.1 million in personnel costs, approximately $0.1 million in director fees, and approximately $0.1 million in insurance costs, offset by aggregate decreases of approximately $0.1 million in consulting costs and travel and entertainment.

 

We expect cash general and administrative expenses to increase during the remainder of this fiscal year to support our research and development efforts and growing operations.

 

Other Expense (Income)

 

Other expense for the three months ended June 30, 2021 was about $2,000, a decrease of approximately $2.3 million, or 100% compared to the approximately $2.3 million of other expense recorded for the three months ended June 30, 2020. Interest expense was approximately $0 and $2.3 million for the three months ended June 30, 2021 and 2020, respectively. The decreased interest expense was primarily due to amortization of debt discount and accrued interest related to the convertible debt issued in December 2019 and January 2020 for the three months ended June 30, 2020, which was not present for the three months ended June 30, 2021.

 

Net Loss

 

As a result of the factors above, our net loss for the three months ended June 30, 2021 totaled approximately $9.3 million, an increase of approximately $4.6 million, or 98% over the approximately $4.7 million recorded for the three months ended June 30, 2020.

 

Consolidated Results of Operations for the Six Months Ended June 30, 2021 and 2020

 

The following table summarizes our consolidated results of operations for the periods indicated:

 

 

 

Six Months Ended

 

 

 

 

 

 

June 30,

 

 

Increase

 

 

 

2021

 

 

2020

 

 

(decrease)

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$ 8,163,825

 

 

$ 2,642,537

 

 

$ 5,521,288

 

General and administrative expenses

 

 

9,326,604

 

 

 

2,679,618

 

 

 

6,646,986

 

Total operating expenses

 

 

17,490,429

 

 

 

5,322,155

 

 

 

12,168,274

 

Other expenses (income)

 

 

(525,856 )

 

 

4,635,013

 

 

 

(5,160,869 )

Net loss

 

$ 16,964,573

 

 

$ 9,957,168

 

 

$ 7,007,405

 

 

 
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Research and Development Expense

 

Research and development expenses include cash and non-cash expenses primarily relating to the development of our lead drug candidate, MS1819 and our in-licensed niclosamide drug candidates.

 

Non-cash research and development expenses, including stock-based compensation, and depreciation and amortization totaled approximately $0.7 million for the six months ended June 30, 2021 and approximately $0.3 million recorded for the six months ended June 30, 2020. Cash research and development expenses for the six months ended June 30, 2021 totaled approximately $7.5 million, an increase of approximately $5.2 million, or 228% over the approximately $2.3 million recorded for the six months ended June 30, 2020.

 

The increase in total research and development expenses was primarily attributable increases of approximately $3.0 million in clinical related expenses in connection with conducting two Phase 2 clinical trials for MS1819, and one clinical trial for niclosamide during the six months ended June 30, 2021, as compared to one Phase 2 clinical trial for MS1819 during the six months ended June 30, 2020, approximately $1.0 million in CMC related activates primarily for MS1819, approximately $1.0 million milestone payment pursuant to the First Wave License Agreement related to niclosamide clinical development, approximately $0.4 million in non-cash stock option expense, approximately $0.3 million in non-cash amortization, and approximately $0.2 million in regulatory and consulting expenses.

 

We expect cash research and development expense to increase during the remainder of this fiscal year as we initiate and conduct two clinical trials for niclosamide, additional milestone payments pursuant to the First Wave License Agreement in connection with clinical development of niclosamide, pursue additional CMC activities and non-clinical studies in connection with formulation development for MS1819, and personnel related costs in connection with new hires.

 

General and Administrative Expense

 

General and administrative expenses include cash and non-cash expenses primarily relating to our overall operations and being a public company, including personnel, legal and financial professional services, insurance, corporate communication and investor relations, listing and compliance related costs, rent, and expenses associated with obtaining and maintaining intellectual property and patents, among others.

 

Non-cash expenses, including stock-based compensation, stock expense and depreciation and amortization totaled approximately $1.9 million for the six months ended June 30, 2021, and approximately $0.3 million recorded for the six months ended June 30, 2020. Cash general and administrative expenses for the six months ended June 30, 2021 totaled approximately $7.5 million, an increase of approximately $5.2 million, or 223% over the approximately $2.3 million recorded for the six months ended June 30, 2020.

 

The increase in total general and administrative was due primarily to increases of approximately $3.3 million in public company costs, including investor relations, corporate communications, in connection with market awareness campaigns, including a special meeting of the shareholders, and compliance related fees, approximately $0.8 million of legal expenses primarily related to increased financing activity and corporate governance, approximately $0.3 million of business development costs primarily related to fees for the First Wave License Agreement, approximately $0.3 million of other costs related to the settlement with our former investment bank, approximately $0.2 million in personnel costs, and approximately $0.1 million in insurance costs, offset by aggregate decreases of approximately $0.1 million in consulting costs and travel and entertainment.

 

We expect cash general and administrative expenses to increase during the remainder of this fiscal year to support our research and development efforts and growing operations.

 

Other Expense (Income)

 

Other income for the six months ended June 30, 2021 totaled approximately $0.5 million, a decrease in expense of approximately $5.2 million, or 111% over the approximately $4.6 million of other expense recorded for the six months ended June 30, 2020. Interest expense was approximately $0 and $4.6 million for the six months ended June 30, 2021 and 2020, respectively. The decreased interest expense was primarily due to amortization of debt discount and accrued interest related to the convertible debt issued in December 2019 and January 2020 for the six months ended June 30, 2020, which was not present for the six months ended June 30, 2021. The change in fair value was approximately $0.5 million and $0 for the six months ended June 30, 2021 and 2020, respectively. The increased change in fair value related to the extinguishment of the $3.0 million liability in connection with First Wave License Agreement pursuant to the issuance of Series C Preferred Stock with a fair value of approximately $0.5 million for the six months ended June 30, 2021, which was not present for the six months ended June 30, 2020.

 

 
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Net Loss

 

As a result of the factors above, our net loss for the six months ended June 30, 2021 totaled approximately $17.0 million, an increase of approximately $7.0 million, or 71% over the approximately $10.0 million recorded for the six months ended June 30, 2020.

 

Cash Flows for the Six Months Ended June 30, 2021 and 2020

 

The following table summarizes our cash flows for the periods indicated:

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2021

 

 

2020

 

Net cash and cash equivalents provided by (used in):

 

 

 

 

 

 

Operating activities

 

$ (10,696,128 )

 

$ (2,634,733 )

Investing activities

 

 

(9,073,928 )

 

 

(2,808 )

Financing activities

 

 

21,832,600

 

 

 

3,433,595

 

Net increase (decrease) in cash and cash equivalents

 

$ 2,062,544

 

 

$ 796,054

 

 

Operating Activities

 

Net cash used in operating activities during the six months ended June 30, 2021 of approximately $10.7 million was primarily attributable to our net loss of approximately $17.0 million adjusted for addbacks of non-cash expenses of approximately $2.0 million, mostly related to common stock and warrants issued to consultants of approximately $1.2 million, depreciation and amortization of approximately $0.3 million, and stock-based compensation of approximately $1.0 million partially offset by a change in the fair value of liability $0.5 million and a net increase of working capital of approximately $4.3 million.

 

Net cash used in operating activities during the six months ended June 30, 2020 of approximately $2.6 million was primarily attributable to our net loss of approximately $10.0 million adjusted for addbacks of non-cash expenses of approximately $5.3 million, which includes depreciation and amortization of approximately $0.3 million, stock-based compensation of approximately $0.2 million, accretion of debt discount of approximately $4.2 million, interest on convertible debt of approximately $0.3 million and stock expense to settle accounts payable of approximately $0.1 million and a net decrease of working capital of approximately $1.3 million.

 

Investing Activities

 

Net cash used in investing activities during the six months ended June 30, 2021 was approximately $9.1 million, consisting of $9.0 million in cash payments related to the First Wave License Agreement and approximately $74,000 related to the purchase of office furniture and equipment.

 

Net cash used in investing activities for the six months ended June 30, 2020 was approximately $3,000, which consisted of the purchase of equipment.

 

Financing Activities

 

Net cash provided by financing activities of approximately $21.8 million for the six months ended June 30, 2021 was primarily due to the issuance of the Series C Preferred Stock and warrants of approximately $7.1 million from the January 2021 Offerings, the issuance of the Common Stock and warrants of approximately $9.1 million from the March 2021 Offering, the issuance of the Common Stock of approximately $1.2 million from ATM Agreement sales and the cash proceeds from warrant exercises of approximately $4.9 million, offset by repayments of approximately $0.4 million related to the note payable.

 

Net cash provided by financing activities of approximately $3.4 million for the six months ended June 31, 2020 was primarily due to the issuance of the convertible debt of approximately $3.2 million from the Promissory Note Offering, approximately $1.0 million from the proceeds of the Equity Line Agreement, and approximately $0.2 million from the issuance of a note payable in connection with the Payment Protection Program (“PPP”) loan offset by repayments of convertible debt and interest of approximately $0.5 million related to the ADEC Notes and approximately $0.5 million related to the repayment of notes payable, which included the repayment of the PPP loan.

 

 
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Critical Accounting Policies and Estimates

 

Our accounting policies are essential to understanding and interpreting the financial results reported on the consolidated financial statements. The significant accounting policies used in the preparation of our consolidated financial statements are summarized in Note 2 to the consolidated financial statements and notes thereto found in our Annual Report on Form 10-K for the year ended December 31, 2020. Certain of those policies are considered to be particularly important to the presentation of our financial results because they require us to make difficult, complex or subjective judgments, often as a result of matters that are inherently uncertain.

 

During the six months ended June 30, 2021, there were no material changes to matters discussed under the heading “Critical Accounting Policies and Estimates” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended, (the ”Exchange Act”) our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”) conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our CEO and our CFO each concluded that our disclosure controls and procedures are effective to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act, (i) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and (ii) is accumulated and communicated to our management, including our CEO and our CFO, as appropriate to allow timely decisions regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

  

 
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PART II

 

OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

None.

 

ITEM 1A. RISK FACTORS

 

Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for our fiscal year ended December 31, 2020, filed on March 31, 2021. You should carefully consider these risk factors in conjunction with the other information contained in this Quarterly Report. Should any of these risks materialize our business, financial condition and future prospects could be negatively impacted. As of August 13, 2021, there have been no material changes to the disclosures made in the above referenced Form 10-K.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

During the three months ended June 30, 2021, we issued to a non-executive employee stock options to purchase an aggregate of 36,000 shares of Common Stock with a strike price of $0.78 per share, subject to time-based vesting, under the AzurRx BioPharma, Inc. 2020 Omnibus Equity Incentive Plan, as amended and restated, as payment for services rendered. Such issuance was exempt from registration under 4(a)(2) of the Securities Act of 1933, as amended.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

 
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ITEM 6. EXHIBITS

 

(b)

Exhibits

 

Exhibit No.

 

Description

10.1

 

At The Market Offering Agreement, dated May 26, 2021, by and between AzurRx BioPharma, Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 1.2 of the Company’s Registration Statement on Form S-3 filed with the SEC on May 26, 2021).

31.1*

 

Certification of the Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*

 

Certification of the Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**

 

Certification of the Principal Executive Officer and Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

101.INS*

 

XBRL Instance Document

101.SCH*

 

XBRL Taxonomy Extension Schema

101.CAL*

 

XBRL Taxonomy Extension Calculation Linkbase

101.DEF*

 

XBRL Taxonomy Extension Definition Linkbase

101.LAB*

 

XBRL Taxonomy Extension Label Linkbase

101.PRE*

 

XBRL Taxonomy Extension Presentation Linkbase

104*

 

The cover page from the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021 is formatted in iXBRL.

_________________ 

* filed herewith

** furnished, not filed

 

 
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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

AZURRX BIOPHARMA, INC.

 

 

 

 

 

 

By

/s/ James Sapirstein

 

 

 

James Sapirstein

President, Chief Executive Officer and Chairman

(Principal Executive Officer)

 

 

 

By

/s/ Daniel Schneiderman

 

Date: August 16, 2021

 

Daniel Schneiderman

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 
45

 

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