Atossa Therapeutics, Inc. (ATOS) stock prices were up by a marginal 0.43% as of market close on April 30th, 2021, bringing the price per share up to USD$2.33 at the end of the trading day. Subsequent pre-market fluctuations saw a more significant upswing of 6.44%, putting the stock price up to USD$2.48.
Expedition of Endoxifen Program
In the recent reporting of corporate updates, a key highlight for the fourth quarter of 2020 was the demonstration of positive interim results for the open label Phase 2 clinical study of oral Endoxifen. The treatment program indicated success after being administered in the critical period between diagnosis and surgery of breast cancer. As a result, ATOS has concluded the study ahead of time and has fast-tracked the Endoxifen program in the United States.
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Endoxifen Single-Patient Study
ATOS recently received a “Safe to Proceed” letter from the U.S. Food and Drug Administration which permitted the use of Endoxifen under an expanded access pathway. The oral treatment was administered to an ovarian cancer patient, with a recent announcement made about updated findings following the 24-month single-patient study. As a clear indicator of success, the patient did not suffer any side effects and did not see a recurrence of cancer, with no other safety or tolerability concerns.
Details of Endoxifen Study
The patient with recurrent ovarian cancer did not tolerate the typical ovarian cancer treatment of tamoxifen, hence the compassionate use granted by the FDA. The patient underwent functional molecular genomic testing with 3D tumor organoid cultures that were grown in-lab from the patient’s tumor to help determine potential therapies. Testing indicated a combination of Endoxifen and alpelisib provided an exceptional tumor response.
Success of AT-301
Q4 2020 also saw the company announce final results from a Phase 1 clinical study for the company’s proprietary drug candidate AT-301 administered by a nasal spray. In the double-blinded, randomized, placebo-controlled study, AT-301 was found to be safe and adequately tolerated in healthy participants at two different dose levels over the course of 14 days. The drug candidate is being developed for home-use by patients shortly after being diagnosed with COVID-19.
Solid Financial Position
As of December 31st 2020, ATOS announced cash, cash equivalents, and restricted cash in the amount of USD$39.7 million at the company’s disposal. Despite having neither a source of sustainable revenue nor associated costs of revenue, ATOS completed financing transactions that generated USD$136 million in net proceeds over December 2020 and the first quarter of 2021.
Future Outlook for ATOS
With the world hurtling towards universal immunizations, ATOS is taking the necessary measures to establish their footprint in the booming sector. With many promising developments on various fronts and a consolidated financial position despite not having a commercialized product yet, the company is poised for lucrative upcoming quarters.