- Presented data from EVANGELINE study showing 100% disease control rate at 24-weeks
- Initiated study evaluating (Z)-endoxifen in combination with abemaciclib (VERZENIO®)
- Ended first quarter 2024 with
$84.0 million of cash and cash equivalents and no debt
Key developments from Q1 2024 and the year to date include:
- Presented data from 40mg pharmacokinetic run-in cohort of ongoing EVANGELINE study at the AACR annual meeting – data showed 100% disease control rate, 37% average MRI-based lesion size decrease and a 92% reduction in Ki-67, at 24 weeks. Treatment related toxicities included grade 3 headache (one patient), grade 2 amenorrhea (one patient), and grade 2 hot flashes (one patient). There were no grade 4 or 5 treatment related toxicities.
- Initiated study evaluating (Z)-endoxifen in combination with abemaciclib (VERZENIO®) – the study will enroll 20 women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) invasive breast cancer. Participants will receive (Z)-endoxifen daily in combination with abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, twice daily for a total of 24 weeks prior to surgery.
- Expanded access patient concluded five-years of (Z)-endoxifen treatment – the pre-menopausal, ER+ / 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. The patient remains cancer-free and reported no significant safety or tolerability issues over the course of her treatment.
- Fully enrolled 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.
- Appointed
Tessa Cigler , M.D., M.P.H 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.
“The first quarter of 2024 was a period of significant progress for our Company,” said
Comparison of Three Months Ended
Revenue and Cost of Revenue. For the three months ended
Operating Expenses. Total operating expenses were
R&D Expenses. R&D expenses for the three months ended
The following table provides a breakdown of major categories within R&D expense for the three months ended
For the Three Months Ended | |||||||||||||
2024 | 2023 | Increase (Decrease) | |||||||||||
Research and Development Expense | |||||||||||||
Clinical and non-clinical trials | $ | 2,884 | $ | 2,336 | $ | 548 | |||||||
Compensation | 626 | 1,034 | (408 | ) | |||||||||
Professional fees and other | 238 | 138 | 100 | ||||||||||
Research and Development Expense Total | $ | 3,748 | $ | 3,508 | $ | 240 | |||||||
- The increase in R&D expense was primarily due to increased spending on clinical and non-clinical trials of
$0.5 million compared to the prior year period for (Z)-endoxifen trials, including drug development costs. - The decrease in R&D compensation expense for the three months ended
March 31, 2024 compared to the prior year period was primarily due to a decrease in non-cash stock-based compensation of$0.4 million . Non-cash stock-based compensation decreased compared to the prior year period due to the weighted average fair value of options amortizing in 2024 being lower period over period. - The increase in R&D professional fees of
$0.1 million for the three months endedMarch 31, 2024 compared to the prior year period was primarily attributable to higher consulting fees in 2024 related to our endoxifen program.
General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2024 were
The following table provides a breakdown of major categories within G&A expenses for the three months ended
For the Three Months Ended | |||||||||||||
2024 | 2023 | Increase (Decrease) | |||||||||||
General and Administrative Expense | |||||||||||||
Compensation | $ | 1,325 | $ | 2,084 | $ | (759 | ) | ||||||
Professional fees and other | 1,680 | 1,164 | 516 | ||||||||||
Insurance | 227 | 342 | (115 | ) | |||||||||
General and Administrative Expense Total | $ | 3,232 | $ | 3,590 | $ | (358 | ) | ||||||
- The decrease in G&A compensation expense of
$0.8 million for the three months endedMarch 31, 2024 compared to the prior year period was 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 period due to the weighted average fair value of options amortizing in 2024 being lower period over period. - The increase in G&A professional fees of
$0.5 million for the three months endedMarch 31, 2024 compared to the prior year period was primarily due to an increase in legal fees for higher patent-related activity. - The decrease in G&A insurance expense of
$0.1 million for the three months endedMarch 31, 2024 compared to the prior year period was due to lower negotiated insurance premiums for the same or better coverage period over period.
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 five 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) | ||||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 83,960 | $ | 88,460 | ||||
Restricted cash | 110 | 110 | ||||||
Prepaid materials | 1,372 | 1,487 | ||||||
Prepaid expenses and other current assets | 1,613 | 2,162 | ||||||
Total current assets | 87,055 | 92,219 | ||||||
Investment in equity securities | 1,710 | 1,710 | ||||||
Other assets | 2,322 | 2,323 | ||||||
Total assets | $ | 91,087 | $ | 96,252 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 1,230 | $ | 806 | ||||
Accrued expenses | 1,613 | 973 | ||||||
Payroll liabilities | 659 | 1,654 | ||||||
Other current liabilities | 1,826 | 1,803 | ||||||
Total current liabilities | 5,328 | 5,236 | ||||||
Total liabilities | 5,328 | 5,236 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity | ||||||||
Convertible preferred stock - 582 shares issued and outstanding as of | — | — | ||||||
Common stock - | 22,829 | 22,792 | ||||||
Additional paid-in capital | 256,571 | 255,987 | ||||||
(1,475 | ) | (1,475 | ) | |||||
Accumulated deficit | (192,166 | ) | (186,288 | ) | ||||
Total stockholders' equity | 85,759 | 91,016 | ||||||
Total liabilities and stockholders' equity | $ | 91,087 | $ | 96,252 |
ATOSSA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands, except share and per share data) | ||||||||
For the Three Months Ended | ||||||||
2024 | 2023 | |||||||
Operating expenses | ||||||||
Research and development | $ | 3,748 | $ | 3,508 | ||||
General and administrative | 3,232 | 3,590 | ||||||
Total operating expenses | 6,980 | 7,098 | ||||||
Operating loss | (6,980 | ) | (7,098 | ) | ||||
Interest income | 1,138 | 850 | ||||||
Other expense, net | (36 | ) | (33 | ) | ||||
Loss before income taxes | (5,878 | ) | (6,281 | ) | ||||
Income tax benefit | — | — | ||||||
Net loss | (5,878 | ) | (6,281 | ) | ||||
Net loss per share of common stock - basic and diluted | $ | (0.05 | ) | $ | (0.05 | ) | ||
Weighted average shares outstanding used to compute net loss per share - basic and diluted | 125,319,778 | 126,624,110 |
Source:
2024 GlobeNewswire, Inc., source