atos20220803_8k.htm
false 0001488039 0001488039 2022-11-07 2022-11-07
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): November 7, 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 November 7, 2022, Atossa Therapeutics, Inc. (the “Company”) issued a press release announcing the quarter ended September 30, 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: November 7, 2022
Atossa Therapeutics, Inc.
 
 
 
By:  
/s/ Kyle Guse 
 
   
Kyle Guse
 
   
Chief Financial Officer, General Counsel and Secretary 
 
 
 
 
 
 
 
 
 
 
ex_441996.htm

EXHIBIT 99.1

 

Atossa Therapeutics Announces Third Quarter 2022 Financial Results and

Provides Corporate Update

 

 

SEATTLE, November 7, 2022 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), today announces financial results for the fiscal quarter ended September 30, 2022, and provides an update on recent company developments. Atossa is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer and lung injury caused by cancer treatments.

 

Key developments from Q3 2022 and to date include:

 

 

Received FDA authorization from FDA to initiate its Phase 2 study of neoadjuvant (Z)-endoxifen in premenopausal women with ER+/HER2- breast cancer.

 

 

Invested in a privately-held Dynamic Cell Therapies, a company focused on CAR-T therapies as an important step in pursuing its strategy to develop CAR-T therapies or adjacent opportunities within the immuno-oncology space.

 

 

Completed dosing in both Part B and Part C (of four parts) of Phase 1/2a Clinical Trial of AT-H201 in healthy volunteers, which the Company is now developing for patients with compromised lung function due to the damaging effects of cancer treatment.

 

“We continue to make progress with our (Z)-endoxifen programs. In particular, our Phase 2 study of neoadjuvant (Z)-endoxifen for pre-menopausal women with ER+/HER2- breast cancer was authorized by FDA to begin in the United States, and we plan to initiate the study during the fourth quarter of this year. We are re-aligning our strategy to address new avenues in the field of oncology.  We have altered our approach to the development of AT-H201 in cancer patients with compromised lung-function resulting from cancer treatment, and are beginning to explore the possibility of pursuing immune-oncology programs. In the meantime, we will continue our current programs and will provide progress updates as they become available,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer.

 

Quarter Ended September 30, 2022 Financial Results (in thousands): 

 

As of September 30, 2022, the Company had cash, cash equivalents and restricted cash of approximately $117,477.

 

Revenue and Cost of Revenue: For the three months ended September 30, 2022 and 2021, we had no source of revenue and no associated cost of revenue.

 

Operating Expenses: Total operating expenses were $8,205 for the three months ended September 30, 2022, which is an increase of $3,047 or 59% from operating expenses for the three months ended September 30, 2021 of $5,158. Operating expenses for the three months ended September 30, 2022 consisted of research and development (R&D) expenses of $5,160 and general and administrative (G&A) expenses of $3,045. Operating expenses for the three months ended September 30, 2021 consisted of R&D expenses of $2,206, and G&A expenses of $2,952. The basis for factors contributing to the increased operating expenses in the three months ended September 30, 2022 are explained below.

 

Research and Development Expenses: R&D expenses for the three months ended September 30, 2022 were $5,160, an increase of $2,954 or 134% from total R&D expenses for the same period in 2021 of $2,206. The increase in R&D expenses was primarily driven by increases in clinical and non-clinical trial costs as well as drug formulation and analysis costs of $2,475. Stock-based compensation expense also increased $62 compared to the prior year period, and other R&D compensation expense increased $85 due to salary, bonus, and benefit increases.

 

General and Administrative Expenses: G&A expenses were $3,045 for the three months ended September 30, 2022, an increase of $93 or 3% from the total G&A expenses of $2,952 for the three months ended September 30, 2021. The increase in G&A expenses was primarily driven by an increase in legal fees, professional fees and other expenses of $159 for the three months ended September 30, 2022. G&A expenses also increased in part due to an increase in salary, bonus, and benefits of $123, which was offset by a decrease in stock-based compensation expense of $190. 

 

Nine Months Ended September 30, 2022 Financial Results (in thousands): 

 

Revenue and Cost of Revenue: For the nine months ended September 30, 2022 and 2021, we had no source of revenue and no associated cost of revenue.

 

Operating Expenses: Total operating expenses were $19,553 for the nine months ended September 30, 2022, which is an increase of $3,860 or 25% from operating expenses for the nine months ended September 30, 2021 of $15,693. Operating expenses for the nine months ended September 30, 2022 consisted of R&D expenses of $10,097 and G&A expenses of $9,456. Operating expenses for the nine months ended September 30, 2021 consisted of R&D expenses of $7,383 and G&A expenses of $8,310. The basis for factors contributing to the increased operating expenses in the nine months ended September 30, 2022 are explained below.

 

Research and Development Expenses: R&D expenses for the nine months ended September 30, 2022 were $10,097, an increase of $2,714 or 37% from total R&D expenses for the same period in 2021 of $7,383. R&D expenses increased due to an increase in spending on clinical and non-clinical trials of $2,910. Compared to the prior year period, stock-based compensation expense also increased $763, and other R&D compensation expense increased $288 due to salary, bonus, and benefit increases in the nine months ended September 30, 2022. Professional expenses also increased $430 during the nine months ended September 30, 2022, as compared to the same period in 2021. The increases in R&D expenses were offset in part by a refund of $1,000 from the research institution with which 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. In the nine months ended September 30, 2021, R&D expenses included $1,000 attributable the same one-time fee, which was paid in June 2021. Finally, on June 27, 2022, we paid $300 for the exclusive right to negotiate with a CAR-T Company.

 

General and Administrative Expenses: G&A expenses were $9,456 for the nine months ended September 30, 2022, an increase of $1,146 or 14% from the total G&A expenses for the nine months ended September 30, 2021 of $8,310. The increase in G&A expenses for the nine months ended September 30, 2022 was primarily due to the increase in stock-based compensation expense of $832. Compensation expense also increased $554 due to salary, bonus, and benefit increases related to the addition of employees in the nine months ended September 30, 2022. Legal fees also increased $321 compared to the prior year period due to increased patent prosecution activity. These increases are offset in part by a decrease in professional fees and other expenses of $562 due primarily to the reduction of proxy solicitation costs compared to the prior year period. 

 

 

 

About Atossa Therapeutics

 

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer and lung injury caused by cancer treatments. 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 and (Z)-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 breast density, Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for (Z)-endoxifen, whether Atossa can complete acquisitions, 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 September 30,

         
   

2022

   

As of December 31,

 
   

(Unaudited)

   

2021

 

Assets

               

Current assets

               

Cash and cash equivalents

  $ 117,367     $ 136,377  

Restricted cash

    110       110  

Prepaid expenses

    5,107       2,488  

Research and development rebate receivable

    610       1,072  

Other current assets

    201       1,193  

Total current assets

    123,395       141,240  
                 

Deposit on investment in equity securities

    2,700       -  

Other assets

    629       22  

Total Assets

  $ 126,724     $ 141,262  
                 

Liabilities and Stockholders' Equity

               

Current liabilities

               

Accounts payable

  $ 1,653     $ 1,717  

Accrued expenses

    117       204  

Payroll liabilities

    1,071       1,184  

Other current liabilities

    27       21  

Total current liabilities

    2,868       3,126  
                 

Total Liabilities

    2,868       3,126  
                 

Commitments and contingencies

               
                 

Stockholders' equity

               

Series B convertible preferred stock - $0.001 par value; 10,000 shares authorized; 1 share issued and outstanding as of September 30, 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 September 30, 2022 and December 31, 2021

    22,792       22,792  

Additional paid-in capital - common stock

    249,239       243,996  

Accumulated deficit

    (148,703

)

    (129,234

)

Accumulated other comprehensive loss

    (54

)

    -  

Total Stockholders' Equity

    123,856       138,136  

Total Liabilities and Stockholders' Equity

  $ 126,724     $ 141,262  

 

 

 

 

ATOSSA THERAPEUTICS, INC. 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(amounts in thousands, except for per share amounts)

 

 

 

   

For the Three Months Ended September 30,

   

For the Nine Months Ended September 30,

 
   

2022

   

2021

   

2022

   

2021

 
                                 

Operating expenses

                               

Research and development

 

$

5,160

   

$

2,206

   

$

10,097

   

$

7,383

 

General and administrative

   

3,045

     

2,952

     

9,456

     

8,310

 

Total operating expenses

   

8,205

     

5,158

     

19,553

     

15,693

 

Operating loss

   

(8,205

)

   

(5,158

)

   

(19,553

)

   

(15,693

)

Other income (expense), net

   

194

     

(39

)

   

84

     

(81

)

Loss before income taxes

   

(8,011

)

   

(5,197

)

   

(19,469

)

   

(15,774

)

Income taxes

   

-

     

-

     

-

     

-

 

Net loss

   

(8,011

)

   

(5,197

)

   

(19,469

)

   

(15,774

)

Foreign currency translation adjustment

   

(54

)

   

-

     

(54

)

   

-

 

Comprehensive loss

 

$

(8,065

)

 

$

(5,197

)

 

$

(19,523

)

 

$

(15,774

)

Loss per share of common stock - basic and diluted

 

$

(0.06

)

 

$

(0.04

)

 

$

(0.15

)

 

$

(0.14

)

Weighted average shares outstanding - basic and diluted

   

126,624

     

126,538

     

126,624

     

113,690