atos20190327_8k.htm
false 0001488039 0001488039 2022-05-09 2022-05-09
 
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 
WASHINGTON, D.C. 20549 
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of Earliest Event Reported): May 9, 2022 
 
Atossa Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
 
 
 
 
 
 
 
 
 
Delaware
 
001-35610
 
26-4753208
  
 
  
 
 
(State or other jurisdiction of
incorporation)
 
(Commission File Number)
 
(I.R.S. Employer
Identification No.)
 
 
 
 
 
 
107 Spring Street
Seattle, Washington
 
 
98104
  
 
 
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (206325-6086
 
Not Applicable
Former name or former address, if changed since last report
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
 
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. ☐
 
 
 
Securities registered pursuance to Section 12(b) of the Act:
Title of each class
Trading symbol(s)
Name of each exchange on which registered
Common Stock, $0.18 par value
ATOS
The Nasdaq Capital Market 
 
 
 

 
 
 
Item 2.02. Results of Operations and Financial Condition.
 
On May 9, 2022, Atossa Therapeutics, Inc. (the “Company”) issued a press release announcing the quarter ended March 31, 2022 financial results and a Company update. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
 
 
The information in Items 2.02, and 9.01 of this report, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits
 
 
 
Exhibit No.
 
Description
 
     
104   Cover page Interactive Data File (embedded within the Inline XBRL document)
* * *
 
 
 

 
 
 
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 hereunto duly authorized.
 
 
 
 
 
 
Date: May 9, 2022
Atossa Therapeutics, Inc.
 
 
 
By:  
/s/ Kyle Guse 
 
 
 
Kyle Guse
 
 
 
Chief Financial Officer, General Counsel and Secretary 
 
 
  
 
 
ex_372135.htm

 

Exhibit 99.1

 

 

Atossa Therapeutics Announces First Quarter 2022 Financial Results and

Provides Corporate Update

 

SEATTLE, May 09, 2022 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces financial results for the fiscal quarter ended March 31, 2022, and provides an update on recent company developments.

 

Key developments from Q1 2022 and to date include:

 

 

Received issuance of key U.S. patent covering Endoxifen directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen.

 

 

Announced planned U.S. Phase 2 clinical study of Endoxifen in the neoadjuvant setting (prior to surgery) to compare Endoxifen to standard of care in premenopausal women with breast cancer. A CRO has been engaged to work on this study and the Company also intends to retain a leading U.S. research institution to help manage the study. The Company anticipates submitting an IND to the FDA in the second quarter of 2022.

 

 

Completed Part B (second of four parts) of Phase 1b/2a clinical study of AT-H201 in Australia.

 

“We continue to make steady progress with our Endoxifen programs: one to reduce tumor cell activity in breast cancer patients in the neoadjuvant setting; and another to reduce dense breast tissue in women,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Our Phase 2 study in women with measurable breast density continues to enroll participants in Stockholm and we have been preparing to submit a request (IND) to the FDA this quarter to open a Phase 2 study in the neoadjuvant setting here in the Unites States. We began 2022 with significant progress in our COVID-19 program, both initiating and completing key parts of our Phase1b/2a trial in Australia for AT-H201, and we have now completed the first two parts of that study.”

 

Quarter Ended March 31, 2022 Financial Results (in thousands): 

 

For the quarter ended March 31, 2022, Atossa has no source of sustainable revenue and no associated cost of revenue.

 

As of March 31, 2022, the Company had cash, cash equivalents and restricted cash of approximately $131,596.

 

Operating Expenses: Total operating expenses were $4,747 for the three months ended March 31, 2022, which is an increase of $1,216 or 34%, from the three months ended March 31, 2021. Operating expenses for 2022 consisted of research and development (R&D) expenses of $1,499 and general and administrative (G&A) expenses of $3,248. Operating expenses for 2021 consisted of R&D expenses of $1,379, and G&A expenses of $2,152. The basis for the increased operating expenses in 2022 is explained below.

 

Research and Development Expenses: R&D expenses for the three months ended March 31, 2022, were $1,499, an increase of $120 or 9% from total R&D expenses for the same period in 2021 of $1,379. The increase in R&D expense is attributed to increased spending on clinical and non-clinical trials of $584 over 2021 due to additional drug manufactuing costs. Stock-based compensation, which is a non-cash charge, also increased $433 quarter over quarter, and other R&D compensation was up $79 due to salary bonus and benefit increases quarter over quarter. The increase in R&D was offset by a refund of $1,000 from the research institution that the Company had an exclusive right to negotiate for the acquisition of the world-wide rights to two oncology R&D programs. In February 2022, the other party did not honor its obligation to negotiate with us which lead to a cancellation of the agreement and refund of the $1,000 we paid them. 

 

General and Administrative Expenses: G&A expenses were $3,248 for the three months ended March 31, 2022, an increase of $1,096, or 51% from the total G&A expenses for the three months ended March 31, 2021, of $2,152. The increase in G&A expenses for the three months ended March 31, 2022, is primarily attributable to non-cash stock-based compensation expense of $734. Other compensation also increased $264 due to the addition of a new employee quarter over quarter as well as salary, bonus and benefit increases. Legal fees also increased $124 quarter over quarter due to increased patent activity. 

 

About Atossa Therapeutics

 

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

 

Forward-Looking Statements

 

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

 

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse CFO and General Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

 

Investor Relations Contact:
Core IR

Office: (516) 222-2560

ir@atossainc.com

 

Source: Atossa Therapeutics, Inc.

 

 

 

 

 

 

 

 

ATOSSA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands, except for par value)

 

 

   

As of March 31,

         
   

2022

   

As of December 31,

 

Assets

 

(Unaudited)

   

2021

 

Current assets

               

Cash and cash equivalents

 

$

131,486

   

$

136,377

 

Restricted cash

   

110

     

110

 

Prepaid expenses

   

3,874

     

2,488

 

Research and development rebate receivable

   

668

     

1,072

 

Other current assets

   

710

     

1,193

 

Total current assets

   

136,848

     

141,240

 
                 

Other assets

   

630

     

22

 

Total Assets

 

$

137,478

   

$

141,262

 
                 

Liabilities and Stockholders' Equity

               

Current liabilities

               

Accounts payable

 

$

1,596

   

$

1,717

 

Accrued expenses

   

120

     

204

 

Payroll liabilities

   

593

     

1,184

 

Other current liabilities

   

13

     

21

 

Total current liabilities

   

2,322

     

3,126

 
                 

Total Liabilities

   

2,322

     

3,126

 
                 

Commitments and contingencies

               
                 

Stockholders' equity

               

Preferred stock - $0.001 par value; 10,000 shares authorized; 1 share issued and outstanding as of March 31, 2022 and December 31, 2021

   

-

     

-

 

Additional paid-in capital - Series B convertible preferred stock

   

582

     

582

 

Common stock - $0.18 par value; 175,000 shares authorized; 126,624 shares issued and outstanding as of March 31, 2022 and December 31, 2021

   

22,792

     

22,792

 

Additional paid-in capital - common stock

   

245,802

     

243,996

 

Accumulated deficit

   

(134,020

)

   

(129,234

)

Total Stockholders' Equity

   

135,156

     

138,136

 

Total Liabilities and Stockholders' Equity

 

$

137,478

   

$

141,262

 

 

 

 

 

 

 

 

 

 

 

ATOSSA THERAPEUTICS, INC. 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(amounts in thousands, except for per share amounts)

 

 

   

For the Three Months Ended March 31,

 
                 
   

2022

   

2021

 
                 

Operating expenses

               

Research and development

 

$

1,499

   

$

1,379

 

General and administrative

   

3,248

     

2,152

 

Total operating expenses

   

4,747

     

3,531

 

Operating loss

   

(4,747

)

   

(3,531

)

Other expense, net

   

(39

)

   

(7

)

Loss before income taxes

   

(4,786

)

   

(3,538

)

Income taxes

   

-

     

-

 

Net loss

 

$

(4,786

)

 

$

(3,538

)

Loss per common share - basic and diluted

 

$

(0.04

)

 

$

(0.04

)

Weighted average shares outstanding - basic and diluted

   

126,624

     

92,587