It’s time to discuss Atossa Therapeutics (ATOS) again without so much negativity. I know there was the nonsense about a short squeeze/gamma squeeze, but this is a longer term hold. Now that the dust has settled, I am revisiting this play. Especially now with all the variants this could be a covid play as well.
- Received authorization from Swedish regulators to initiate a Phase 2 clinical study of Endoxifen to reduce mammographic breast density (MBD).
- Received authorization from Australian regulators to initiate a clinical study of AT-H201 which is being developed for the treatment of patients with COVID-19 and “long haul” respiratory illness.
- Announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19.
- “The intended mechanism of action of AT-301 is to prevent virus entry into human cells by inhibiting the obligatory Spike Protein activation. The activation is performed by three human cell surface enzymes, ACE2, furin, and TMPRSS2, and is therefore unaffected by mutations and variants in SARS-CoV-2.”
- “We continue to experience encouraging progress in our MBD and COVID-19 programs, with new regulatory approvals being granted in Sweden for a Phase 2 trial in MBD and authorization in Australia to commence a Phase 2 study of AT-H201 for respiratory illness associated with COVID-19,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer.
- ” Scheduled a special stockholder meeting for September 7, 2023 for the purpose of approving an increase in authorized shares of common stock. If the proposal is approved by the stockholders, Atossa does not intend to issue any of the newly authorized shares of common stock for the purpose of raising capital in the nine months following approval of the proposal at a price less than $10 per share. The newly authorized shares of common stock are intended to be used at any time to complete and/or support acquisitions, collaborations, partnerships and licensing transactions.”
- The fact they’re requesting authorization of common stock like this means there’s obviously something big happening in the backend.
- “Through the completion of capital raising transactions and the exercise of warrants, Atossa has grown its cash balances quarter over quarter for the past three quarters, ending the second quarter 2023 with $142.4 million in cash and cash equivalents.”
- The latest corporate presentation PDF.
Expenses
Total operating expenses were approximately $10,534,000 for the six months ended June 30, 2023
R&D expenses for the six months ended June 30, 2023, were approximately $5,177,000G&A expenses for the six months ended June 30, 2023, were approximately $5,357,000Cash burn rate is at $21,068,000 every 6 months.
So they have enough cash on hand for a minimum of 3 years without any dilution or funding.
Look at all the institutions that opened up or added to their positions. A lot of new reports this month. Here are a few large names and buys.
New Positions Reported:
- Group One Trade – 1,644,488 Shares
- Nuveen Asset Management, – 1,097,131 Shares
- Millennium Management 1,666,911 Shares
- Bank of Nova Scotia – 348,698 Shares
Increased Positions Reported:
- Northern Trust Corp – 1,1231,852 Shares
- Vanguard Group Inc – 5,762,626 Shares
- Geode Capital Management – 1,968,745 Shares
- BlackRock Inc – 8.954,293 Shares
- Bank of New York Mellon Corp – 465,572 Shares
To those saying the Blackrock investments aren’t substantial, they literally own over 10% of the company now. They have been buying Atossa before the Russell inclusion.
Let’s talk about the timeline on Phase 3 for Endoxifen. FDA 505(b)(2) may bring Endoxifen to market without the need of Phase 3.
As discussed in this video:
[Interviewer]can you shed some colour on what maybe a phase 3 study may look like … since the FDA is already familiar with Tamoxifen and it’s outcomes…?
[Dr Quay] .. first of all it’s very hard to answer that, but I think one of the things we have talked about in the past is that there’s a pathway called 505(b)(2) which allows you to submit applications for metabolites of drugs that are already approved. There are some special aspects of that package … you’re allowed to reference the data with the primary drug, you’re typically allowed to do one instead of two controlled clinical trials, and you typically get 7 years of market exclusivity independent of your patent situation. So it’s a nice model and we’ve publicly said that this is our target. We’ve obviously not had conversations with the FDA about all of the aspects of our programs qualifying for 505(b)(2), but I mean I think that’s how I would answer that question.
What is 505(b)(2) ?
The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for which the applicant has not obtained right of reference. In other words, the 505(b)(2) pathway enables investigators and/or manufacturers to apply for approval without having to repeat all the drug development work done for an innovator drug.
This article was written by u/youwishh.
