- Fully enrolled two Phase 2 studies with data from both expected in the second half of 2024
- First patient dosed in new Phase 2 breast cancer prevention study
- Data from ongoing Phase 2 EVANGELINE study scheduled to be presented at 2024 AACR Annual Meeting
- Ended 2023 with
$88.5 million of cash and cash equivalents and no debt
Key developments from Q4 2023 and the year to date include:
- Full enrollment of Phase 2 Karisma-Endoxifen Clinical Trial – the study is investigating (Z)-endoxifen in premenopausal women with measurable breast density. Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in breast density. Full enrollment was achieved in
November 2023 and data is expected in the second half of 2024. - Full enrollment of Phase 2 I-SPY 2 Clinical Trial – (Z)-endoxifen is being evaluated as a neoadjuvant treatment in a study arm of the ongoing I-SPY 2 clinical trial. The study arm targets patients with newly diagnosed estrogen receptor-positive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. Full enrollment was achieved in
February 2024 and data is expected in the second half of 2024. - First patient dosed with (Z)-endoxifen in RECAST DCIS study – the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) study is an ongoing Phase 2 platform study designed to offer women diagnosed with DCIS six months of neoadjuvant endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.
- Expanded access patient concluded five-years of (Z)-endoxifen treatment – the pre-menopausal, Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-), breast cancer patient who received neoadjuvant and adjuvant (Z)-endoxifen therapy under an FDA-approved "expanded access" program completed five years of successful treatment.
- Data from ongoing EVANGELINE study scheduled to be presented at the AACR Annual Meeting – safety and efficacy data from the 40mg pharmacokinetic run-in cohort of the ongoing Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study is scheduled to be presented on
April 9, 2024 at theAmerican Association for Cancer Research (AACR) Annual Meeting. The data is scheduled to be presented by Dr.Matthew Goetz , deputy director of translational research for theMayo Clinic Comprehensive Cancer Center and co-leader of theMayo Clinic Women's Cancer Program.Dr. Goetz is also the primary investigator of the EVANGELINE study. - Appointment of
Tessa Cigler , M.D., M.P.H andJonathan Finn , CFA to Atossa’s Board of Directors –Dr. Cigler is a medical oncologist and clinical investigator at the Weill Cornell Breast Center inNew York City . As a member of the Weill Cornell Breast Center research team, she heads several clinical trials designed to provide her patients with access to the new promising options for therapy and supportive care.Mr. Finn has more than 25 years of experience in the financial industry with a focus on early to mid-stage biotech and technology companies. He currently serves as Executive Vice President and Chief Investment Officer atVantage Consulting Group , an investment advisory firm.
"I am very proud of the progress we made in Q4 2023 and the momentum we have continued to generate in 2024,” said
Comparison of the Year Ended
Operating Expenses.Total operating expenses were
The following table provides a breakdown of major categories within R&D expense for the years ended
Year Ended 2023 | Year Ended 2022 | Increase (decrease) | ||||||||
Research and Development Expense | ||||||||||
Clinical and non-clinical trials | $ | 12,722 | $ | 10,225 | $ | 2,497 | ||||
Compensation | $ | 3,474 | 4,268 | (794 | ) | |||||
Professional fees and other | $ | 1,138 | 590 | 548 | ||||||
Research and Development Expense Total | $ | 17,334 | $ | 15,083 | $ | 2,251 |
R&D Expenses. R&D expenses for the year ended
- The increase in R&D expense was in part due to increased spending on clinical and non-clinical trials of
$1.1 million compared to the prior year due to increased spending on (Z)-endoxifen trials, including drug development costs. The additional increase of$1.4 million was due to a change in estimate of the amount that no longer met the reasonably assured threshold to be sustained under a potential ATO audit related to R&D expenditures under the Australian R&D tax incentive program as a result of recentAustralian Taxation Office guidance. - The decrease in R&D compensation expense for the year ended
December 31, 2023 compared to the prior year was primarily due to a decrease in non-cash stock-based compensation of$0.8 million . Non-cash stock-based compensation decreased compared to the prior year due to the weighted average fair value of options amortizing in the year endedDecember 31, 2023 being lower year over year. - The increase in R&D professional fees and other was due in part to the refund in the prior year of
$1.0 million from a research institution with which we had an exclusive right to negotiate for the acquisition of worldwide rights of two oncology programs. No exclusivity payments were made or refunded during the year endedDecember 31, 2023 .
The following table provides a breakdown of major categories within General and Administrative (G&A) expenses for the years ended
Year Ended 2023 | Year Ended 2022 | Increase (decrease) | ||||||||
General and Administrative Expense | ||||||||||
Compensation | $ | 7,388 | $ | 7,429 | $ | (41 | ) | |||
Professional fees and other | $ | 5,367 | 3,539 | 1,828 | ||||||
Insurance | $ | 1,288 | 1,640 | (352 | ) | |||||
General and Administrative Expense Total | $ | 14,043 | $ | 12,608 | $ | 1,435 |
G&A Expenses. G&A expenses for the year ended December 31, 2023 were
- The decrease in G&A compensation expense of
$41 thousand for the year ended December 31, 2023 compared to the prior year was partially due to an increase in cash compensation expense of$1.3 million , offset by a decrease in non-cash stock-based compensation of$1.4 million . The increase in cash compensation expense compared to the prior year was primarily driven by salary and bonus severance costs for former executives of$0.6 million , an increase of$0.4 million due to compensation for new employees as well as an overall increase in salaries, bonuses and benefits of$0.3 million . Non-cash stock-based compensation decreased by$1.4 million due to the weighted average fair value of options amortizing in 2023 being lower year over year.
- The increase in G&A professional fees of
$1.8 million for the year ended December 31, 2023 compared to the prior year was primarily due to an increase in legal fees for higher patent-related activity of$0.7 million and an increase in professional fees of$0.8 million primarily due to higher investor relations costs and accounting fees. The additional increase of$0.4 million was due to a change in estimate related to the Australian R&D tax incentive program. - The decrease in G&A insurance expense of
$0.4 million for the year endedDecember 31, 2023 compared to the prior year was due to lower negotiated insurance premiums for the same or better coverage year over year.
Impairment Charge on Investment in
Interest Income. Interest income was
About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.
Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. (Z)-endoxifen is currently being studied in four Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued
About
Contact
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com
FORWARD-LOOKING STATEMENTS
This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or other comparable words. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, such as data related to the (Z)-endoxifen program and the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, to differ materially from those projected or anticipated, including risks and uncertainties associated with: macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim and final clinical results; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to remain compliant with the continued listing requirements of the
CONSOLIDATED BALANCE SHEETS (amounts in thousands, except share and per share data) | |||||||
As of | |||||||
2023 | 2022 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 88,460 | $ | 110,890 | |||
Restricted cash | 110 | 110 | |||||
Prepaid materials | 1,487 | 5,247 | |||||
Prepaid expenses and other current assets | 2,162 | 1,207 | |||||
Research and development tax rebate receivable | — | 743 | |||||
Total current assets | 92,219 | 118,197 | |||||
Investment in equity securities | 1,710 | 4,700 | |||||
Other assets | 2,323 | 635 | |||||
Total assets | $ | 96,252 | $ | 123,532 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities | |||||||
Accounts payable | $ | 806 | $ | 2,965 | |||
Accrued expenses | 973 | 1,059 | |||||
Payroll liabilities | 1,654 | 1,525 | |||||
Other current liabilities | 1,803 | 19 | |||||
Total current liabilities | 5,236 | 5,568 | |||||
Total liabilities | 5,236 | 5,568 | |||||
Commitments and contingencies | |||||||
Stockholders' equity | |||||||
Convertible preferred stock - 582 shares issued and outstanding as of | — | — | |||||
Common stock - | 22,792 | 22,792 | |||||
Additional paid-in capital | 255,987 | 251,366 | |||||
(1,475 | ) | — | |||||
Accumulated deficit | (186,288 | ) | (156,194 | ) | |||
Total stockholders' equity | 91,016 | 117,964 | |||||
Total liabilities and stockholders' equity | $ | 96,252 | $ | 123,532 |
CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands, except share and per share data) | |||||||
For the Year Ended | |||||||
2023 | 2022 | ||||||
Operating expenses | |||||||
Research and development | $ | 17,334 | $ | 15,083 | |||
General and administrative | 14,043 | 12,608 | |||||
Total operating expenses | 31,377 | 27,691 | |||||
Operating loss | (31,377 | ) | (27,691 | ) | |||
Impairment charge on investment in equity securities | (2,990 | ) | — | ||||
Interest income | 877 | ||||||
Other expense, net | (70 | ) | (146 | ) | |||
Loss before income taxes | (34,437 | ) | (26,960 | ) | |||
Income tax benefit | — | — | |||||
Net loss | (34,437 | ) | (26,960 | ) | |||
Net loss per share of common stock - basic and diluted | $ | (0.24 | ) | $ | (0.21 | ) | |
Weighted average shares outstanding used to compute net loss per share - basic and diluted | 126,081,602 | 126,624,110 |
Source:
2024 GlobeNewswire, Inc., source