Atossa Therapeutics Inc (ATOS)

[Treehunned]

Good loading zone to make bank again.

[powerwalker]

Glad to see you here, Xena, and your work from last week.

Peace,
Powerwalker

[slugo1]

I get lucky sometimes lol

[Jdanger 2]

You called it

[slugo1]

Nice entry point

[ttottip]

It will bounce back hard!

[ttottip]

What great prices!

[XenaLives]

Yes, this needs to be discussed openly, and not just by ATOS stockholders.

[MuskVoice]

[the_aaardvark]

Why all this old news

[willlbone]

Head and shoulders goes down the drain.

[XenaLives]

Atossa Therapeutics’ Phase 2 Endoxifen Breast Cancer Study Produces Substantially Positive Results Allowing Study to be Halted Early

SEATTLE, Feb. 02, 2021 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announces that based on substantially positive results achieved with the patients enrolled to date in its Australian open-label Phase 2 clinical study of oral Endoxifen administered in the “window of opportunity” between diagnosis of breast cancer and surgery, Atossa has halted the study and is accelerating its Endoxifen program in the United States.

“It is a welcome event to halt an ongoing clinical trial because the results are so overwhelmingly positive,” commented Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “Data from the first six patients in our Australian Phase 2 window of opportunity study shows a 74% average reduction in Ki-67, which is a common measure of tumor cell activity, and that at the time of surgery all patients had Ki-67 levels lower than 25%, which is an important threshold to improve long-term survival as identified in studies by others. We believe that additional enrollment will not alter these positive results so we are terminating the study early. This saves at least a year on the development time line allowing us to accelerate clinical development in the Unites States. We look forward to reporting final data from all patients in the study and sharing our continued progress in the development of oral Endoxifen.”

The study enrolled seven newly-diagnosed patients with ER+ and human epidermal growth factor receptor 2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients received Atossa’s proprietary oral Endoxifen for at least 14 days from the time of diagnosis up to the day of surgery. The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The Phase 2 study was conducted on behalf of Atossa by Avance Clinical, a leading Australian CRO.

The American Cancer Society (ACS) estimates that in 2020, 276,480 women will be diagnosed with breast cancer in the U.S. Every two minutes an American woman is diagnosed with breast cancer and 42,170 die each year.

Atossa is evaluating a number of potential clinical benefits and potential indications for its oral Endoxifen in the window of opportunity setting. These may include avoidance of surgery in some patients, such as older and/or frail patients, allowing for breast conservation surgery, and use of Endoxifen in place of other neoadjuvant therapies such as chemotherapy, aromatase inhibitors and other endocrine therapies like tamoxifen.

https://atossatherapeutics.com/atossa-therapeutics-phase-2-endoxifen-breast-cancer-study-produces-substantially-positive-results-allowing-study-to-be-halted-early/

[XenaLives]

Atossa Therapeutics Receives $21 Million from Recent Exercises of Outstanding Warrants

SEATTLE, Jan. 29, 2021 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, announced that it has received $21 million from the exercise of outstanding warrants. The warrants were issued in financings in December 2020 and January 2021.

“In the past 60 days, we have made great progress in adding substantial cash resources so that we can accelerate development of our COVID-19 and breast cancer therapies,” commented Kyle Guse, CFO and General Counsel. “We completed financings with gross proceeds of approximately $60 million and in the past week have added an additional $21 million to our balance sheet through the exercise of outstanding warrants. We look forward to the speed at which we can now advance our programs in 2021.”

https://atossatherapeutics.com/atossa-therapeutics-receives-21-million-from-recent-exercises-of-outstanding-warrants/

[XenaLives]

Atossa Therapeutics Announces Receipt of FDA Safe to Proceed Letter for Treatment of an Ovarian Cancer Patient with Oral Endoxifen Under Expanded Access Pathway
March 11, 2021 09:30 ET | Source: Atossa Therapeutics, Inc.




...
SEATTLE, March 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases today announced the FDA has issued a “Safe to Proceed” letter under their Expanded Access Pathway, permitting the use of Atossa’s oral Endoxifen as a treatment in an ovarian cancer patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief.

“Dr. Goff recently contacted Atossa with an interest in gaining access to our Endoxifen under the FDA’s expanded access, or compassionate use, program for one of her patients,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “The patient has recurrent ovarian cancer and recently underwent functional molecular genomic testing, using 3D tumor organoid cultures grown in the laboratory from the patient’s tumor. The organoid testing revealed that the combination of Endoxifen and alpelisib produced an exceptional tumor response. We are gratified to be able to help this patient and are anxious to follow her response to this drug combination. If the drug combination shows promise in this patient, Atossa will consider doing additional clinical studies in patients with ovarian cancer.”

Under the FDA expanded access program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient. Approval from the Institutional Review Board (IRB) must be obtained prior to providing oral Endoxifen to this patient.

About FDA Expanded Access

Sometimes called "compassionate use," expanded access is a potential pathway for a patient with serious disease or condition, or an immediately life-threatening condition, to gain access to 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 more information about this process, please see the FDA website: FDA Expanded Use Website

https://www.globenewswire.com/news-release/2021/03/11/2191501/0/en/Atossa-Therapeutics-Announces-Receipt-of-FDA-Safe-to-Proceed-Letter-for-Treatment-of-an-Ovarian-Cancer-Patient-with-Oral-Endoxifen-Under-Expanded-Access-Pathway.html

[XenaLives]

About Atossa's Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen, which is an FDA-approved drug to treat ovarian and breast cancer. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. In third party preclinical studies, endocrine-sensitive and letrozole-resistant breast tumors, Z-endoxifen resulted in robust antitumor and antiestrogenic activity compared to tamoxifen and aromatase inhibitor monotherapy.

Atossa has been developing its proprietary oral Endoxifen for breast cancer and other breast conditions and has successfully completed five clinical studies with this drug, including an expanded access study of a female breast cancer patient who has been taking oral Endoxifen for over two years, with no recurrence to date.

About Ovarian Cancer

In 2021 ovarian cancer will be diagnosed in about 21,400 women in the United States and about 13,770 women will die from the disease. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

About Alpelisib

Alpelisib was approved in the United States in 2019 for use in combination with the endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. PIK3 is a family of lipid kinases and one of them, PIK3CA, has mutations or gene amplification detected in 30.5% of all ovarian cancers and 45% of the endometrioid and clear cell subtypes. Alpelisib is marketed by Novartis under the brand name of Piqray.

About Atossa Therapeutics

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com

https://www.globenewswire.com/news-release/2021/03/11/2191501/0/en/Atossa-Therapeutics-Announces-Receipt-of-FDA-Safe-to-Proceed-Letter-for-Treatment-of-an-Ovarian-Cancer-Patient-with-Oral-Endoxifen-Under-Expanded-Access-Pathway.html

[XenaLives]

AG-1001-AU-02: AN OPEN LABEL, PILOT AND EXPANSION PHARMACODYNAMIC STUDY OF (Z)-ENDOXIFEN IN PATIENTS WITH INVASIVE BREAST CANCER PRIOR TO UNDERGOING MASTECTOMY OR LUMPECTOMY.
This study is designed to determine if Oral Endoxifen “turns’ down” or reduces tumor cell activity in patients with newly diagnosed estrogen receptor positive breast cancer. Participating patients will receive Oral Endoxifen for at least 21 days prior to surgery, or during the “Window of Opportunity.” Tissue samples obtained from the initial biopsy and again at surgery will be analyzed and results compared to determine if cancer cell activity is lower following Oral Endoxifen administration. If a reduction in tumor cell activity is reduced in at least two of the first eight patients, then the study will be expanded to enroll an additional 17 patients.

This study is being conducted by Dr. Vinod Ganju, Peninsula & South Eastern Haematology & Oncology Group, Franksten, Victoria, Australia.



Interim Results: The open-label study was designed to permit an interim analysis of the Ki-67 change. The requirement was to achieve a meaningful Ki-67 change in at least two of eight patients. Interim results are as follows: All patients (N=6) experienced a significant reduction in Ki-67. A summary of these results includes:

--Ki-67 was reduced by more than 50% in every patient in the window of opportunity between initial biopsy and surgery, with an overall reduction of 74%.
--All six patients had a Ki-67 below 25% after treatment. In a paper entitled, “Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients,” Ki-67 was an independent prognostic value for predicting overall survival in ER+ breast cancer patients. Ki-67 levels below 25% were associated with the lowest risk of death in this systematic review and meta-analysis.
--Treatment ranged from 16-40 days with an average of 22 days.
--There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats, which are often a tolerability challenge for patients on tamoxifen.

https://atossatherapeutics.com/clinical-trials/

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number

ACTRN12618001561279
Ethics application status

Approved
Date submitted

11/09/2018
Date registered

18/09/2018
Date last updated

9/10/2018
Type of registration

Prospectively registered

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375802

[XenaLives]

Ownership info:

 
 File Date	Form	Security		Prev 
 Shares	Current 
 Shares	Change 
 (Percent)	Ownership 
 (Percent)	Change 
 (Percent) 
 2021-01-15	13G	INTRACOASTAL CAPITAL, LLC			3,749,923		4.99	 
 2021-01-15	13G	CVI Investments, Inc.			3,800,000		5.30	 
 2021-01-14	13G	Empery Asset Management, LP			3,800,000		5.32	

More recent filings..

 
 2021-05-13	13F	Renaissance Technologies Llc			1.53	3,304,140	570.48	6,972	1,389.74				 
 2021-05-14	13F	Vanguard Group Inc			1.53	3,180,565	513.88	6,711	1,264.02				 
 2021-06-01	NP	VTSMX - Vanguard Total Stock Market Index Fund Investor Shares [click for advisory]				2,080,920		4,391					 
 2021-05-07	13F	BlackRock Inc.			1.80	1,532,282	228,940.66	3,233	323,200.00				 
 2021-06-01	NP	VEXMX - Vanguard Extended Market Index Fund Investor Shares [click for advisory]				1,000,089		2,110					 
 2021-05-12	13F	Geode Capital Management, Llc			1.53	488,114	442.93	1,029	1,110.59				 
 2021-05-17	13F	Cvi Holdings, Llc				432,305		912					 
 2021-07-22	NP	FSMAX - Fidelity Extended Market Index Fund [click for advisory]				362,917		1,169					 
 2021-05-19	13F	Virtu Financial LLC			1.53	271,937	-1.22	574	119.08				 
 2021-05-17	13F	Sabby Management, Llc				242,237		511					 
 2021-05-17	13F	Morgan Stanley			1.06	197,733	732,244.44	418					 
 2021-05-12	13F	Northern Trust Corp			1.52	145,648	1,258.53	307	2,970.00				 
 2021-05-18	13F	Jane Street Group, Llc				94,810		200					 
 2021-07-22	NP	FSKAX - Fidelity Total Market Index Fund [click for advisory]				88,019		283					 
 2021-07-19	13F	Cutler Group LP			4.20	72,179	63.94	456	395.65				 
 2021-05-13	13F	Barclays Plc			1.52	65,694	455.69	139	1,163.64				 
 2021-05-17	13F	Goldman Sachs Group Inc				63,770		135					 
 2021-06-01	NP	VITNX - Vanguard Institutional Total Stock Market Index Fund Institutional Shares [click for advisory]				60,800		128					 
 2021-07-22	NP	FNCMX - Fidelity Nasdaq Composite Index Fund [click for advisory]				60,434		195					 
 2021-07-22	NP	FCFMX - Fidelity Series Total Market Index Fund [click for advisory]				58,337		188					 
 2021-05-14	13F	Sculptor Capital LP				53,500		113					 
 2021-05-17	13F	Capstone Investment Advisors, Llc				51,257		108					 
 2021-05-17	13F	Edmond De Rothschild Holding S.a.				50,000		106					 
 2021-05-17	13F	Susquehanna International Group, Llp			1.53	49,256	-54.16	104	1.96				 
 2021-04-30	13F	Creative Planning				48,666		103					 
 2021-05-17	13F	Two Sigma Advisers, Lp			1.52	48,400	348.15	102	920.00				 
 2021-07-26	13F	Spire Wealth Management			4.55	48,000	6.67	335	252.63				 
 2021-05-13	13F	Bank of New York Mellon Corp				35,927		76					 
 2021-05-21	13F/A	Citadel Advisors Llc			1.54	34,070	-22.12	72	71.43				 
 2021-05-04	13F	Commonwealth Equity Services, Llc				31,383		66					 
 2021-05-06	13F	Meitav Dash Investments Ltd				30,000		63					 
 2021-05-17	13F	Bienville Capital Management, LLC				28,379	

https://fintel.io/so/us/atos

[XenaLives]

Atossa Therapeutics Announces Pricing of $20.0 Million Underwritten Public Offering
December 08, 2020 21:45 ET | Source: Atossa Therapeutics, Inc.

...
SEATTLE, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, announced today the pricing of an underwritten public offering with expected total gross proceeds of $20.0 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company.

The securities offered by the Company consist of (i) 14,575,000 Units, each consisting of one share of common stock (the “Common Stock”), and 0.75 Warrants (“Warrants”) to purchase one share of Common Stock at a price of $1.00 per Unit and (ii) 5,425 Units, each consisting of one share of Series C Convertible Preferred Stock (the “Preferred Stock”) with a stated value of $1,000 per share and convertible into 1,000 shares of Common Stock together with Warrants to purchase 750 shares of Common Stock at a purchase price of $1,000 per Unit. The Warrants will have an exercise price of $1.00 per share, will be immediately exercisable and will expire four years from the date of issuance.

The shares of Common Stock, Preferred Stock and the accompanying Warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about December 11, 2020, subject to customary closing conditions.

Maxim Group LLC is acting as the sole book-running manager in connection with the offering.

Atossa Therapeutics has granted to Maxim Group LLC a 45-day option to purchase up to an additional 3,000,000 shares of Common Stock and/or Warrants to purchase up to an additional 2,250,000 shares of Common Stock, at the public offering price less discounts and commissions.

The offering is being conducted pursuant to the Company's registration statement on Form S-1 (File No. 333- 250820), as amended, previously filed with and subsequently declared effective by the Securities and Exchange Commission (“SEC”). A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at [phone].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

https://www.globenewswire.com/news-release/2020/12/09/2141850/0/en/Atossa-Therapeutics-Announces-Pricing-of-20-0-Million-Underwritten-Public-Offering.html

[XenaLives]

Atossa Therapeutics Announces Second COVID-19 Therapeutic Development Program, AT-301 Nasal Spray: Summit Biosciences Retained to Develop and Supply AT-301 Nasal Spray for Clinical Study

AT-301 Intended to Prevent COVID-19 and Treat Early Cases Via Nasal Delivery
SEATTLE, May 28, 2020 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, announced that it has begun the development of a second COVID-19 program using its proprietary drug candidate AT-301, to be administered by nasal spray.

AT-301 is Atossa’s proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person’s immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2, with the goal that it could become a “bridge to the vaccine” and be useful in the next phase of the coronavirus pandemic.

“In April we launched our AT-H201 COVID-19 HOPE program for the most severely ill COVID-19 patients,” commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. “By contrast, our new AT-301 nasal spray program is being developed for the relatively healthier COVID-19 patients who have not been hospitalized. We are developing AT-301 with a nasal spray delivery mechanism because many COVID-19 patients are infected via the nasal passage. The mechanism of action is intended to inhibit essential human host proteases, which are found in abundance in the nasal mucosa, from activating the SARS-CoV-2 Spike Protein, the known first and obligatory step that must be taken before the virus can enter the body.”

“This may eventually be useful as a prophylactic, to be used before leaving the home. In that setting it would be intended to create a barrier inside the nose to prevent virus entry – sort of a short-term vaccine-like treatment that could be helpful before a true vaccine is available. Our goal with the two COVID-19 programs is to ultimately commercialize therapies for patients on both ends of the spectrum – from the healthier patients who will be treated at home and the sicker patients who require mechanical ventilation in the hospital,” concluded Dr. Quay.

Atossa has retained Summit Biosciences, Inc., a pharmaceutical company with a proven track record in nasal spray medicines, to develop and produce a clinical supply of pre-filled nasal spray products in multi-dose devices containing AT-301 with the goal of commencing initial human clinical trials in the third quarter 2020.

Next steps with this program include the design and manufacturing of the clinical trial materials and the active pharmaceutical ingredients in AT-301 followed by adequate and well-controlled studies to demonstrate safety and efficacy. These studies must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray and intends to apply to the FDA as soon as possible so that human clinical trials may be commenced in the third quarter 2020.

https://atossatherapeutics.com/atossa-therapeutics-announces-second-covid-19-therapeutic-development-program-at-301-nasal-spray-summit-biosciences-retained-to-develop-and-supply-at-301-nasal-spray-for-clinical-study/

[XenaLives]

Candidate: AT-H201

Type: Combination of two undisclosed “drugs that have been previously approved by the FDA for other diseases,” designed to act in the manner of a mucosal vaccine by binding to the surface of SARS-CoV-2 and blocking viral entry gene proteins in nasal epithelial cells. The chemical vaccine is designed to interfere with spike protein activation by host proteases, to mask receptor binding domains (RBD) via electrostatic mechanisms, and to provide a generalized mucoadhesive epithelial barrier.

Status: Atossa on June 11 announced positive results from in vitro testing of AT-H201 showing that it inhibited SARS-CoV-2 infectivity of VERO cells in a laboratory culture, as measured by microscopy and SARS-CoV-2 N-protein immunostaining. AT-H201 components were found to be at least four times more potent than Gilead Sciences’ Veklury™ (remdesivir) and at least 20 times more potent than hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

In May, Atossa announced positive in vitro test results showing AT-H201 inhibited SARS-CoV-2 infectivity of VERO cells in a laboratory culture. AT-H201 is the first submicromolar inhibitor of SARS-CoV-2 identified to date in published literature, according to the company.

The components of AT-H201 were found to be at least four times more potent than Gilead Sciences’ remdesivir, and at least 20 times more potent than generic hydroxychloroquine, Atossa said. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

“These results support the continued development of AT-H201 for COVID-19 patients and beginning studies in the clinical setting,” stated Steven Quay, MD, PhD, Atossa’s President and CEO.

In April, Atossa said it contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study, designed to assess AT-H201 administered via inhalation in COVID-19 patients on ventilators, with the goal of reducing the amount of time on ventilators. The company has applied for FDA approval for NY HOPE under the Coronavirus Treatment Acceleration Program.

In the study, 39 patients will be enrolled in the active treatment group and compared to the outcomes of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to standard of care, while on mechanical ventilation for up to seven days, and will be followed up during hospitalization and for 28 days after discharge. Atossa said the primary objectives are to determine the number of ventilator-free days after patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates. Secondary efficacy endpoints include a variety of lung function parameters and time in ICU. Secondary safety endpoints include markers of coagulation and system function.

Atossa announced the drug development program April 16. The company has filed provisional patent applications with the U.S. Patent and Trademark Office directed to the formulation, manufacturing, and methods of use of AT-H201.

https://www.genengnews.com/covid-19-candidates/covid-19-too-soon-to-tell/atossa-therapeutics/

Atossa Therapeutics Announces Availability of Manuscript on Results from In vitro Testing of COVID-19 Drug, AT-H201

SEATTLE, June 11, 2020 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, announced that the manuscript of the results from in vitro testing of AT-H201, Atossa’s proprietary COVID-19 drug candidate, titled: “AT-H201 constituents collectively are the most potent inhibitors of SARS-CoV-2 infectivity in VERO cells identified and mechanistically act as a chemical vaccine: Human safety data support rapid clinical development as inhaled therapy for COVID-19,” S. Quay, S. Chen, J. Rea and H. L. Remmel is now available at: ResearchGate Preprint AT-H201 laboratory testing against SARS-CoV-2.

The preliminary study results show that AT-H201 inhibits SARS-CoV-2 infectivity of VERO cells in a laboratory culture, which is a standard cell type being used to study infectivity of the coronavirus. Significant findings from the testing include:

AT-H201 components inhibited SARS-CoV-2 from infecting VERO cells in a laboratory culture as measured by microscopy and SARS-CoV-2 N-protein immunostaining.
AT-H201 appears to be the most potent inhibitor of SARS-CoV-2, defined as the ratio of the expected pulmonary dose to the in vitro effective dose, identified to date from published literature.
Testing was also performed on remdesivir, an anti-viral medication being studied by others for use in COVID-19 patients, and the generic anti-malaria drug hydroxychloroquine, which is also being studied by others in COVID-19 patients. The AT-H201 components were found to be at least four times more potent than remdesivir and at least 20 times more potent than hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.
The testing was conducted on behalf of Atossa by a leading academic research institute. Successful in vitro tests do not guarantee similar results in in vivo studies, including in human clinical trials. Additional safety and efficacy studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. Atossa has filed provisional patent applications on AT-H201 to treat COVID-19.

https://atossatherapeutics.com/atossa-therapeutics-announces-availability-of-manuscript-on-results-from-in-vitro-testing-of-covid-19-drug-at-h201/

[XenaLives]

COVID-19 Programs
Atossa has two programs to develop therapies to treat COVID-19: One called the COVID-19 HOPE Program which uses AT-H201 for severely ill patients to improve lung function and reduce the amount of time that COVID-19 patients are on ventilators and another called AT-301 Nasal Spray for at-home use immediately following diagnosis of COVID-19 to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person’s immune system can more effectively fight the virus.

https://atossatherapeutics.com/

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

NEBULIZED FORMULATION BEING DEVELOPED TO IMPROVE LUNG FUNCTION IN BOTH ACTIVE-DISEASE COVID-19 PATIENTS AND “LONG HAUL” PATIENTS WITH POST-INFECTION PULMONARY DISEASE

SEATTLE, July 07, 2021 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announces it has received regulatory approval from HREC (Human Research Ethics Committee) to open a clinical study of AT-H201 in Australia. The nebulized formulation, AT-H201, is being developed as an inhalation therapy for moderately to severely-ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease.

“The COVID-19 pandemic continues to be an urgent health crisis with many regions reporting low vaccination rates combined with new SARS-CoV-2 variants proving more infectious and more deadly,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “If the initial parts of the study are successful we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer. Our goal in developing nebulized AT-H201 is to improve lung function in patients with active disease, which may reduce the number of patients requiring ventilators and in “long-haul” patients who have residual pulmonary function damage. Up to one third of hospitalized patients have pulmonary function changes 60 days or more after recovering from COVID. The portability of nebulizers, already routinely used for other chronic lung disease, allows for treatment at home.”

The Phase 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients. The study has 4 parts: a single ascending dose part, a multiple ascending dose part, a combination part in healthy individuals and a combination in COVID-19 infected patients and will be conducted with Avance Clinical Pty Ltd., a leading Australian clinical research organization.

AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes. AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. In May 2020, we completed in vitro testing of AT-H201 which showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The AT-H201 components were found to be at least four times more potent than Remdesivir and at least 20 times more potent than Hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. No assurance can be given than studies will be successful or that regulatory approvals will be obtained.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need 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 DISCLAIMER STATEMENT

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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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: [phone]
[e-mail]

INVESTOR RELATIONS CONTACT:
Core IR
Office: [phone]
[e-mail]

https://atossatherapeutics.com/approval-to-open-clinical-study-of-at-h201-in-australia/

[XenaLives]

Historic short interest:

You can go to this link to check short interest in a stock:
http://nasdaqtrader.com/Trader.aspx?id=ShortInterest

Publication schedule is here:
http://nasdaqtrader.com/Trader.aspx?id=ShortIntPubSch


Atossa Therapeutics, Inc. - Common Stock

Settlement Date	Short Interest	Percent Change	Average Daily Share Volume	Days to Cover 
 07/15/2021	25,729,365	25.31	20,330,195	1.27 
 06/30/2021	20,532,136	24.26	36,128,916	1.00 
 06/15/2021	16,523,650	20.03	27,619,820	1.00 
 05/28/2021	13,765,817	2.87	10,436,082	1.32 
 05/14/2021	13,381,483	0.67	11,522,063	1.16 
 04/30/2021	13,292,748	26.75	9,374,881	1.42 
 04/15/2021	10,486,999	4.48	5,015,580	2.09 
 03/31/2021	10,037,034	52.30	8,531,313	1.18 
 03/15/2021	6,590,306	(6.59)	14,933,780	1.00 
 02/26/2021	7,055,498	22.46	10,501,992	1.00 
 02/12/2021	5,761,507	(37.38)	40,406,319	1.00 
 01/29/2021	9,201,421	9.08	52,079,171	1.00 
 01/15/2021	8,435,454	1171.72	17,990,182	1.00 
 12/31/2020	663,310	(76.33)	9,289,131	1.00 
 12/15/2020	2,802,309	530.23	5,018,860	1.00 
 11/30/2020	444,647	53.10	178,025	2.50 
 11/13/2020	290,424	45.16	124,415	2.33 
 10/30/2020	200,075	15.88	156,253	1.28 
 10/15/2020	172,652	(15.19)	111,688	1.55 
 09/30/2020	203,587	53.67	356,207	1.00 
 09/15/2020	132,481	(34.95)	315,663	1.00 
 08/31/2020	203,648	(20.30)	397,498	1.00 
 08/14/2020	255,528	43.43	761,281	1.00 
 07/31/2020	178,159	5.36	1,323,803	1.00 
 

[XenaLives]

I like the CEO already...

Physician-Scientist Steven Quay: Forensic examination of Wuhan Institute of Virology COVID-19 patient specimens from December 2019 reveals extensive laboratory contamination, including evidence of genetic manipulation of the Nipah Virus, a BSL-4 pathoge...

https://ih.advfn.com/stock-market/NASDAQ/atossa-therapeutics-ATOS/stock-news/85666236/physician-scientist-steven-quay-forensic-examinat

[XenaLives]

That is a myth - there is no penalty to the broker for selling shares with a sell order, or even shares in a non margined account. If your order is not in the money they will use those shares at will.

[ttottip]

Great prices to jump in!

[DR. EVIL]

Loaded calls today

[eb0783]

Thank you shorts! I've added quite a few thousands of shares today. I've been doing that with 300 share orders @the market to watch what is happening...... of course that is less than a drop in the ocean of that 24,000,000 shares that sold in the first hour and a half today.

[Double-Trouble]

With opinions expiration tomorrow 16th and there is volume should be seeing large squeeze starting to happen.
This is great long hold and some very interesting news will start hitting wire pretty steadily.
Stock has be manipulated for long time and that game is over!

[eb0783]

It may go without saying and I assume most on this board are somewhat experienced with biotechs, but I thougth I would repeat this. All longs here should do two things to keep the shorts (and we do have a high SI) from getting our shares. 1) Never put in stops losses because they will see them and easily take them out.....your loss. 2) Put all of your shares in a sell order, good until cancelled, limit at $300 or $400 so they can't be loaned to be sold short (since they are committed by your order).

[oxnous]

Biotechs are usually driven by news

[Treehunned]

Chill week in the 5's hoping this is a new bottom.

[seventhcircle]

pull back incoming

[seventhcircle]

nice move today $ATOS

[alchemytrader]

5.58 not looking good

[maximumgriff]

Gap filled! Thank you very much

[Treehunned]

For this week it has been. Hoping Friday we get a good idea since people wont be able to punch around the price on pre/post market sessions due to holiday.

[ttottip]

The $8's today?

[maximumgriff]

Keep thinking that!

[ttottip]

No need for that. These "gap fills" have no meaning.

[maximumgriff]

Gotta fill that $5.68 gap first

[ttottip]

Tomorrow the 8's.

[ttottip]

Great prices to make money!

[powerwalker]

Thanks, Tree. I saw the drop on Friday, too, but nowhere was there any info on why the steep drop.

Do you see it falling back below $6?

TIA

[Treehunned]

It went down to 7's Friday postmarket and Monday premarket. Alot of trades too almost half of it's outstanding shares traded in the past 10 days. If people are expecting it to hit the teens it's probably healthy for some pull back before it runs cause ATOS loves running the level 2 when that happens is such a amazing site to see.

[powerwalker]

So, Tree, why is ATOS down yesterday and today?

[Treehunned]

Looking forward to Phase 3 results/updates for Endoxifen. Although any news pumps this ticker like when Dr. Steven C. Quay doubted the covid numbers at the Wuhan institute.

[RyRob68]

Let’s go!

[alchemytrader]

8s

[Treehunned]

These big dumps just keep getting bought out by Institutional investors. Don't know who else has this kind of money.

[da_stock_analyst]

Thanks