Atossa Therapeutics Announces Second Quarter 2019 Financial Results and Provides Company Update

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics Announces Second Quarter 2019 Financial Results and Provides Company Update
Completes Second Quarter with Cash and Cash Equivalents of $17.1 Million

 

SEATTLE, Aug. 13, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced financial results for the second quarter ended June 30, 2019 and provided an update on recent company developments.

Steven C. Quay, M.D., Ph.D., Atossa Therapeutics’ President and CEO commented, “During the quarter we were very pleased to have achieved our primary endpoint in our Phase 2 trial of topical Endoxifen to reduce mammographic breast density (MBD). We are now focusing our efforts on the oral formulation of Endoxifen and are developing a modified-release oral tablet which is being tested in a Phase 1 study and that we plan to use in a Phase 2 study to reduce MBD. The Phase 2 study is scheduled to start in the fourth quarter and should be completed by mid-2020. We completed the quarter with $17.1 million in cash, which will enable us to continue to make clinical progress with our programs.”

Recent Developments

Recent developments include the following:

  • July 2019 – Provided update on expanded access program, which now allows physicians and patients to visit the company website to obtain information on compassionate use access
  • July 2019 – Initiated a Phase 1 study of our proprietary modified-release oral Endoxifen tablet
  • June 2019 – Successfully reached the primary endpoint of MBD reduction using the topical formulation of Endoxifen in a Phase 2 study

Q2 2019 Financial Results

For the three and six months ended June 30, 2019 and 2018, we have no source of sustainable revenue and no associated cost of revenue.

Total operating expenses were approximately $7,286,000 and $11,350,000 for the three and six months ended June 30, 2019, respectively, consisting of research and development (R&D) expenses of approximately $2,612,000 and $4,063,000 respectively, and general and administrative (G&A) expense of approximately $4,674,000 and $7,287,000, respectively. Total operating expenses were approximately $4,143,000 and $6,017,000 for the three and six months ended June 30, 2018, respectively, consisting of research and development expenses of approximately $1,468,000 and $1,939,000, respectively, and general and administrative expenses of approximately $2,675,000 and $4,078,000, respectively.

R&D expenses for the three months ended June 30, 2019, were approximately $2,612,000, an increase of approximately $1,144,000 or 78% from total R&D expenses for the three months ended June 30, 2018 of approximately $1,468,000. R&D expenses for the six months ended June 30, 2019, were approximately $4,063,000, an increase of approximately $2,124,000 or 110% from total R&D expenses for the six months ended June 30, 2018 of approximately $1,939,000.  The increase in R&D expenses for the period ended June 30, 2019, is mainly attributed to an increase in stock-based compensation expense (non-cash). We expect our R&D expenses to increase throughout 2019 as we commence an additional Phase 2 clinical study of oral Endoxifen, develop and manufacture our modified release tablet form of oral Endoxifen, continue our clinical trial of Fulvestrant administered via our intraductal technology and continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via our intraductal technologies.

G&A expenses were approximately $4,674,000 for the three months ended June 30, 2019, an increase of approximately $1,999,000, or 75% from the total G&A expenses for the three months ended June 30, 2018, of approximately $2,675,000. G&A expenses were approximately $7,287,000 for the six months ended June 30, 2019, an increase of approximately $3,209,000, or 79% from the total G&A expenses for the six months ended June 30, 2018, of approximately $4,078,000. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. The increase in G&A expenses for the period ended June 30, 2019, is mainly attributed to an increase in stock-based compensation expense (non-cash). Additionally, payroll expenses have increased resulting from salary increases over the prior year.

As of June 30, 2019, Atossa had approximately $17.1 million in cash and cash equivalents and working capital of approximately $17.4 million.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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 Form10-K and 10-Q, each as amended and supplemented from time to time.

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

Investor Relations Contact:
Scott Gordon
Core IR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office:(516) 222-2560
scottg@corprominence.com

Source: Atossa Therapeutics Inc.

ATOSSA Therapeutics INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

As of
June 30,
As of  
2019 December 31,
Assets (Unaudited) 2018
Current assets
Cash and cash equivalents $ 17,058,527 $ 10,380,493
Restricted cash 110,000 110,000
Prepaid expenses 813,168 509,833
Research and development tax rebate receivable 406,306 518,098
Other current assets 140 30,942
Total current assets 18,388,141 11,549,366
Furniture and equipment, net 44,174 54,487
Intangible assets, net 83,958 99,375
Right-of-use asset 75,822
Other assets 17,218 17,218
Total Assets $ 18,609,313 $ 11,720,446
Liabilities and Stockholders’ Equity            
Current liabilities
Accounts payable $ 318,266 $ 353,328
Accrued expenses 53,485 177,074
Payroll liabilities 589,445 935,070
Stock-based compensation liability 1,410,025
Lease liability 51,795
Other current liabilities 19,838 39,939
Total current liabilities 1,032,829 2,915,436
Long term liabilities
Lease liability long term 24,027
Total Liabilities 1,056,856 2,915,436
Commitments and contingencies
Stockholders’ equity
Preferred stock – $0.001 par value; 10,000,000 shares authorized; 676 and 2,379
shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
1 2
Additional paid-in capital- Series B convertible preferred stock 675,999 2,378,997
Common stock – $0.18 par value; 175,000,000 shares authorized, and 9,129,563 and
5,846,552 shares issued and outstanding, as of June 30, 2019 and December 31, 2018, respectively
1,643,309 1,052,372
Additional paid-in capital 103,400,247 82,204,902
Accumulated deficit (88,167,099 ) (76,831,263 )
Total Stockholders’ Equity 17,552,457 8,805,010
Total Liabilities and Stockholders’ Equity $ 18,609,313 $ 11,720,446


ATOSSA Therapeutics INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)

For the Three Months
Ended June 30,
For the Six Months
Ended June 30,
2018 2018
2019 (as restated) 2019 (as restated)
Operating expenses
Research and development $ 2,611,948 $ 1,467,736 $ 4,063,184 $ 1,938,712
General and administrative 4,674,121 2,674,920 7,287,214 4,078,385
Total operating expenses 7,286,069 4,142,656 11,350,398 6,017,097
Operating loss (7,286,069 ) (4,142,656 ) (11,350,398 ) (6,017,097 )
Other income 23,540 79 14,562 138
Loss before income taxes (7,262,529 ) (4,142,577 ) (11,335,836 ) (6,016,959 )
Income taxes
Net loss $ (7,262,529 ) $ (4,142,577 ) $ (11,335,836 ) $ (6,016,959 )
Deemed dividends attributable to preferred stock (11,479,308 ) (11,479,308 )
Net loss applicable to common shareholders $ (7,262,529 ) $ (15,621,885 ) $ (11,335,836 ) $ (17,496,267 )
Loss per common share – basic and diluted $ (0.80 ) $ (5.08 ) $ (1.44 ) $ (6.11 )
Weighted average shares outstanding – basic and diluted 9,126,153 3,073,803 7,852,907 2,864,033

 

Aug 13, 2019

Atossa Therapeutics CEO Steven Quay Gives Tedx Talk At University of Washington Regarding the the Relationship of Dense Breast Tissue and Breast Cancer Risk

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics CEO Steven Quay Gives Tedx Talk At University of Washington Regarding the the Relationship of Dense Breast Tissue and Breast Cancer Risk

 

 

SEATTLE, July 30, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced the online launch of company CEO Steven Quay’s Tedx UofW Talk, “How to Be Smart When You’re Dense: Preventing Breast Cancer by 2030.”

In the Tedx UofW talk, Steven Quay, M.D., Ph.D., Atossa’s Chief Executive Officer outlines the journey of Atossa Therapeutics in identifying improved ways to identify women at high risk of breast cancer, using mammography to identify dense breast tissue.  Dr. Quay also details his experience with triumph, failure and perseverance while trying to prevent one of the world’s most common diseases: breast cancer. He emphasizes the need for unshaken efforts to solve such complex problems, and ways that he and his team are doing so in breast cancer research.

The talk has been posted online at https://www.youtube.com/watch?v=hK4PlbYE_5M&list=PLsRNoUx8w3rNCo4uCVXiNDFZLiKrIOQ1J&index=5 and can also be accessed via the company’s website at www.atossaTherapeutics.com.

“I am grateful for having had the opportunity to address our approach to breast cancer as something that, like cervical cancer, has the potential to be completely eradicated over time.  It was an honor to participate in this University of Washington program and I hope the information provided helps those who participated in the event, as well as those who view it online,” commented Dr. Quay.

Steven Quay is the founder of Seattle-based Atossa Therapeutics, Inc., dedicated to breast cancer prevention. He received a Ph.D. in Biological Chemistry and a M.D. from the University of Michigan, a postdoc at MIT and Harvard, and he was a faculty member at Stanford Medical School.  His contributions to medicine, cancer, and biochemistry have been cited more than 9,300 times, putting him in the top 1% of the world’s scientists.  Since entering the biotech industry in 1983, he has founded six startups, invented seven FDA-approved pharmaceuticals, and holds 87 U.S. patents.  Over 80 million people have benefited from the medicines he invented.  His current passion involves the prevention of the two million yearly breast cancer cases worldwide.  This talk was given at a TEDx event using the TED conference format but independently organized by a local community.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.  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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.

Atossa Therapeutics Company Contact:

Atossa Therapeutics, Inc.
Kyle Guse
CFO and General Counsel
(O) 866-893-4927
kyle.guse@atossaTherapeutics.com

Investor Relations Contact:

Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
scottg@CoreIR.com

 

Jul 30, 2019

 

Atossa Therapeutics Provides Information on FDA Expanded Access Policy and Requests

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics Provides Information on FDA Expanded Access Policy and Requests

 

SEATTLE, July 17, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today reported that patients and their doctors can now visit the company’s website to obtain information about gaining access to the company’s proprietary Endoxifen pursuant to the FDA’s “Expanded Access” guidelines. The company’s website includes its  Expanded Access policy as well as an automated form that can be used by physicians to request that their patients be considered for this program: http://www.atossaTherapeutics.com/clinical-trials/ – ea-form.

Sometimes called “compassionate use”, Expanded Access is a potential pathway for a physician to access an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available for their patient with a serious disease or condition, or an immediately life-threatening condition. For more information about this process, please see the FDA website: FDA Expanded Use Website.

In December 2018, Atossa began providing its oral Endoxifen to a pre-menopausal, estrogen-receptor positive (ER+), lacking CYP2D6 function, breast cancer patient under an FDA-approved “Single-Patient Expanded Access” IND. The purpose of this therapeutic approach was to reduce activity of the cancer cells prior to surgery. The patient received daily doses of Atossa’s oral Endoxifen for approximately three weeks prior to surgery. There were no safety or tolerability issues and her surgery was successfully completed. The cancer cell biological activity was reduced, based on the estrogen receptor activity of the tumor cells and a 50 percent reduction in Ki-67. The FDA subsequently approved the use of Atossa’s oral Endoxifen for this patient following her surgery under the same program.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.

Atossa Therapeutics Company Contact:

Atossa Therapeutics, Inc.
Kyle Guse
CFO and General Counsel
(O) 866-893-4927
kyle.guse@atossaTherapeutics.com

Investor Relations Contact:

Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
scottg@CoreIR.com

 

Jul 17, 2019

Atossa Therapeutics Announces New Proprietary Modified-Release Oral Endoxifen Tablet; Phase 1 Clinical Trial Initiated

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics Announces New Proprietary Modified-Release Oral Endoxifen Tablet; Phase 1 Clinical Trial Initiated

 

SEATTLE, July 11, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced that it is developing a new proprietary modified-release oral tablet form of its Endoxifen, which is the form of the drug that the company intends for future clinical studies and commercialization. This is the next generation of oral Endoxifen following the successful clinical studies of the capsule form of the company’s oral Endoxifen. A patent application covering the new table has also been filed with the U.S. Patent and Trademark Office.

Steven C. Quay, Ph.D., M.D., CEO and president of Atossa, commented: “We are excited to take this next step in our oral Endoxifen product development. Based on the abundance of information from our previous clinical studies, we strongly believe in the potential efficacy of oral dosing and intend for this modified-release tablet to be the commercial form of our oral Endoxifen. The goal of the modified-release aspect of the drug is to create more even uptake of the drug which we believe may reduce side effects and improve efficacy.”

As part of the development of this new oral tablet, Atossa has commenced a Phase 1 study in Australia to ascertain the pharmacokinetics of the tablet. The study is randomized, double-blinded and placebo-controlled with both single and multiple-doses in 2 groups with a total of 24 healthy female volunteers who will be dosed for 14 days. Atossa’s oral Endoxifen capsule, which has been used in previous clinical studies, will serve as the comparator. The first group of the study has now been enrolled and dosed.

Dr. Quay continued: “This new study builds on the success of our Phase 1 studies of the oral capsule and topical forms of our Endoxifen, our recent successful Phase 2 study of topical Endoxifen, which demonstrated significant efficacy in reducing breast density, and our single-patient compassionate use study of oral Endoxifen. Following completion of this Phase 1 trial, we will continue to use this proprietary modified-release formulation for future clinical studies — including a Phase 2 trial that we have already indicated is in development — and ultimately regulatory approval. We look forward to completing the study in the next quarter.”

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.

Atossa Therapeutics Company Contact:

Atossa Therapeutics, Inc.
Kyle Guse
CFO and General Counsel
(O) 866-893-4927
kyle.guse@atossaTherapeutics.com

Investor Relations Contact:

Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
scottg@CoreIR.com

 

Jul 11, 2019

 

Atossa Therapeutics to Present at the 9th Annual LD Micro Invitational on June 4, 2019

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics to Present at the 9th Annual LD Micro Invitational on June 4, 2019

 

SEATTLE, May 30, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions,  today announced that Kyle Guse, CFO, will be a featured presenter at the LD Micro Invitational Conference on June 4, 2019 at 11:40 am PDT, at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.

Management will also be available for one-on-one meetings on June 5th, 2019.

For those interested in attending or for registered attendees who wish to request meetings, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.

Atossa Therapeutics Company Contact:

Atossa Therapeutics, Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
kyle.guse@atossaTherapeutics.com

Investor Relations Contact:

Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
scottg@CoreIR.com

 

May 30, 2019

 

Atossa Therapeutics Announces First Quarter 2019 Financial Results and Provides Company Update

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics Announces First Quarter 2019 Financial Results and Provides Company Update
Completes First Quarter with Cash and Cash Equivalents of $19.6 Million

 

SEATTLE, May 13, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced financial results for the quarter ended March 31, 2019 and provided an update on recent company developments.

Steven C. Quay, M.D., Ph.D., Atossa Therapeutics’ President and CEO commented, “As we anticipated, we completed dosing in the topical Endoxifen breast density study in April and we look forward to announcing initial top-line results later this quarter. Further, as previously reported, the FDA approved an ‘Expanded Access’ program for use of our oral Endoxifen to treat a breast cancer patient prior to her surgery and in March 2019 we received a second approval for this patient to continue treatment post-surgery. We are planning a Phase 2 clinical study using our oral Endoxifen to reduce breast density and we look forward to providing updates on the launch of that study and progress with our other programs.”

Q1 2019 Corporate Developments

Developments during the first quarter include the following:

  • April 2019 – Completed dosing of Phase 2 topical Endoxifen breast density trial
  • April 2019 – Completed the first phase of a preclinical study using proprietary intraductal delivery technology. The company is now advancing to the next preclinical phase, which involves the intraductal administration of immune modulating formulations. These results will form the basis for advancing the intraductal delivery program into humans and to ultimately deliver immunotherapy to treat breast cancer using Atossa’s proprietary intraductal delivery technology
  • March 2019 – FDA approval of oral Endoxifen for expanded access as post-mastectomy treatment for a U.S. breast cancer patient
  • March 2019 – Atossa received $11.3 million from the exercise of warrants that were previously outstanding
  • February 2019 – Atossa provided breast cancer prevention recommendations to the United States Preventative Services Task Force
  • February 2019 – Atossa reports results from expanded access program for a U.S. breast cancer patient taking oral Endoxifen: sizeable reduction in cancer cell biological activity; no safety or tolerability issues
  • January 2019 – Successfully completed and provided final results from male Phase 1 study of topical Endoxifen; no clinically significant safety nor tolerability issues and acceptable pharmacokinetics

Q1 2019 Financial Results

For the quarter ended March 31, 2019 the company reported no revenue and no associated cost of revenue.

Total operating expenses were approximately $4,064,000 for the three months ended March 31, 2019, which is an increase of approximately $2,190,000 or 117 percent, from the three months ended March 31, 2018. Operating expenses for the three months ended March 31, 2019 consisted of research and development (R&D) expenses of approximately $1,451,000 and general and administrative (G&A) expenses of approximately $2,613,000. Operating expenses for the same period in 2018 consisted of R&D expenses of approximately $471,000, and G&A expenses of approximately $1,403,000.

R&D expenses for the three months ended March 31, 2019, were approximately $1,451,000, an increase of approximately $980,000 or 208 percent from total R&D expenses for the three months ended March 31, 2018 of approximately $471,000. The increase in R&D expense is attributed to salaries, stock-based compensation, and clinical trial expenses associated with our Endoxifen program. Stock-based compensation expense increased approximately $668,000 in 2019 resulting from the cancellation of stock options. There were no option cancellations in the comparable period in 2018. We expect our R&D expenses to increase throughout 2019 as we commence additional Phase 2 clinical studies of Endoxifen, continue the clinical trial of Fulvestrant administered via our intraductal technology and continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via our intraductal technologies.

G&A expenses were approximately $2,613,000 for the three months ended March 31, 2019, an increase of approximately $1,210,000, or 86 percent from the total G&A expenses for the three months ended March 31, 2018, of approximately $1,403,000. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. The increase in G&A expenses for the quarter ended March 31, 2019, is mainly attributed to an increase in stock-based compensation expense due to the cancellation of 2018 options of approximately $1,074,000, payroll expenses resulting from salary increases, and increased legal and professional consulting expenses over the prior year.

As of March 31, 2019, Atossa had approximately $19.6 million in cash and cash equivalents and working capital of approximately $19.3 million.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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 Form10-K and 10-Q, each as amended and supplemented from time to time.

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

Investor Relations Contact:
Scott Gordon
Core IR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office:(516) 222-2560
scottg@corprominence.com

Source: Atossa Therapeutics Inc.

 

ATOSSA Therapeutics INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

As of March 31, As of December 31,
2019 2018
Assets (Unaudited)      
Current assets
Cash and cash equivalents $ 19,568,247 $ 10,380,493
Restricted cash 110,000 110,000
Prepaid expenses 835,468 509,833
Research and development tax rebate receivable 237,856 518,098
Other current assets 27,957 30,942
Total current assets 20,779,528 11,549,366
Furniture and equipment, net 48,212 54,487
Intangible assets, net 91,667 99,375
Right-of-use asset 88,103
Other assets 17,218 17,218
Total Assets $ 21,024,728 $ 11,720,446
Liabilities and Stockholders’ Equity            
Current liabilities
Accounts payable $ 463,970 $ 353,328
Accrued expenses 74,844 177,074
Payroll liabilities 891,758 935,070
Stock-based compensation liability 1,410,025
Lease liability 50,706
Other current liabilities 9,863 39,939
Total current liabilities 1,491,141 2,915,436
Long term liabilities
Lease liability long term 37,397
Total Liabilities 1,528,538 2,915,436
Commitments and contingencies (note 11)
Stockholders’ equity
Preferred stock – $0.001 par value; 10,000,000 shares authorized, consisting of Series B convertible preferred stock- $0.001 par value; 702 and 2,379 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively 1 2
Additional paid-in capital- Series B convertible preferred stock 701,999 2,378,997
Common stock – $0.18 par value; 175,000,000 shares authorized, and 9,122,171 and 5,846,552 shares issued and outstanding, as of March 31, 2019 and December 31, 2018, respectively 1,641,979 1,052,372
Additional paid-in capital 98,056,781 82,204,902
Accumulated deficit (80,904,570 ) (76,831,263 )
Total Stockholders’ Equity 19,496,190 8,805,010
Total Liabilities and Stockholders’ Equity $ 21,024,728 $ 11,720,446

 

ATOSSA Therapeutics INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)

For the Three Months Ended March 31,
2019 2018
Operating expenses
Research and development $ 1,451,236 $ 470,976
General and administrative 2,613,093 1,403,465
Total operating expenses 4,064,329 1,874,441
Operating loss (4,064,329 ) (1,874,441 )
Other income (expense) (8,978 ) 59
Loss before income taxes (4,073,307 ) (1,874,382 )
Income taxes
Net loss $ (4,073,307 ) $ (1,874,382 )
Loss per common share – basic and diluted $ (0.62 ) $ (8.48 )
Weighted average shares outstanding – basic and diluted 6,565,514 220,996

 

May 13, 2019

 

Atossa Therapeutics Provides Clinical Update at the 4th Annual Precision: Breast Cancer World R&D Summit

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics Provides Clinical Update at the 4th Annual Precision: Breast Cancer World R&D Summit

 

SEATTLE, April 25, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced that today Steven C. Quay, M.D., Ph.D., Atossa’s President and CEO, is providing an update on the Company’s clinical programs at the Precision: Breast Cancer World R&D Summit at 2:00 pm ET.

Dr. Quay’s presentation is titled, “A Twenty-First Century Approach: From Primary Prevention to Intraductal Immunotherapy,” and will include the following updates:

Ongoing Phase 2 Study: Dosing has been completed in Atossa’s Phase 2 clinical study of topical Endoxifen to reduce mammographic breast density.  Analysis of the results is underway and expected to be announced this quarter.

Expanded Access Program: The first safety end point has been successfully achieved in the FDA-approved expanded access program using Atossa’s proprietary oral Endoxifen to treat a single patient following breast cancer surgery. The patient in this study continues to experience few side effects from Endoxifen.

Intraductal Immunotherapy Program: Atossa recently completed the first phase of a preclinical study using Atossa’s proprietary intraductal delivery technology. Imaging of the mammary ducts of mice showed that dye was successfully dispersed throughout the mammary duct system. Based on these encouraging results, Atossa is advancing to the next preclinical phase which involves the intraductal administration of immune modulating formulations. This preclinical work will form the basis for advancing the intraductal delivery program into humans and to ultimately deliver immunotherapy to treat breast cancer using Atossa’s proprietary intraductal delivery technology.

About Precision: Breast Cancer World R&D Summit

The Precision Breast Cancer World R&D Summit is an exclusive, annual biopharma summit providing insights into the research and development of cutting-edge treatments for Breast Cancer and a networking forum for precision medicine leaders in this space. From therapeutics to diagnostics, the summit brings together scientists and business leaders from pharma, biotech and academia, using extensive networking sessions to forge meaningful collaborations. The discussion and presentations are based around the latest trends in personalized medicine, using case studies covering early discovery to clinical development.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.

Atossa Therapeutics Company Contact:

Atossa Therapeutics Inc.
Kyle Guse
CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossaTherapeutics.com

Investor Relations Contact:

Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516 222-2560
scottg@CoreIR.com

 

Apr 25, 2019

Atossa Therapeutics to Present at the 4th Annual Precision: Breast Cancer World R&D Summit April 25, 2019

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

 

 PDF version   Printer friendly     View All News
Atossa Therapeutics to Present at the 4th Annual Precision: Breast Cancer World R&D Summit April 25, 2019

 

SEATTLE, April 22, 2019 (GLOBE NEWSWIRE) — Atossa Therapeutics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced that  Steven C. Quay, M.D., Ph.D., Atossa’s President and CEO, will present at the Precision: Breast Cancer World R&D Summit at 2:00 pm ET on April 25th. The conference will be held at the Courtyard by Marriott Boston Downtown from April 24 – 25, 2019.

Dr. Quay’s presentation is titled “A Twenty-First Century Approach: From Primary Prevention to Intraductal Immunotherapy,” and will be given during the Novel Approaches in Breast Cancer Drug R&D portion of the conference.

About Precision: Breast Cancer World R&D Summit

The Precision Breast Cancer World R&D Summit is an exclusive, annual biopharma summit providing insights into the research and development of cutting-edge treatments for Breast Cancer and a networking forum for precision medicine leaders in this space. From therapeutics to diagnostics, the summit brings together scientists and business leaders from pharma, biotech and academia, using extensive networking sessions to forge meaningful collaborations. The discussion and presentations are based around the latest trends in personalized medicine, using case studies covering early discovery to clinical development.

About Atossa Therapeutics

Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. 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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.

Atossa Therapeutics Company Contact:

Atossa Therapeutics Inc.
Kyle Guse
CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossaTherapeutics.com

Investor Relations Contact:

Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516 222-2560
scottg@CoreIR.com

 

Apr 22, 2019