展示99.1
アトッサセラピューティクスは、2024年第1四半期の財務結果を発表し、企業の最新情報を提供します。
2024年5月13日、シアトル− Atossa Therapeutics, Inc.(ナスダック: ATOS)(以下「Atossa」または「会社」)は、2024年3月31日に終了した財務四半期の財務結果を発表し、最近の企業動向について更新しました。アトサは臨床段階のバイオ製薬会社であり、乳がんを中心とした重要な医療ニーズの領域で革新的な医薬品を開発しています。
2024年第1四半期および今年の主な進展は次のとおりです:
「2024年第1四半期は、アトサの社長兼最高経営責任者であるスティーブン・クェイ博士によると、当社にとって重要な進展の時期でした。新しい組み合わせ研究を開始し、AACRで非常に有望な単剤療法データを発表し、5つの進行中の第2相研究のうち2番目を完全に登録しました。2024年の残りの期間は、(Z)-エンドキシフェン開発プログラムを前進させ、今年後半に予定されている重要なデータの読み取りを準備し、規制当局との対話をさらに進めることを重点とします。
当局および見込みのあるパートナー。四半期におけるすべての重要な成果にもかかわらず、現金残高は強いままで、8400万ドルです。
2024年3月31日終了の3ヶ月と2023年の比較
売上高と売上原価。 2024年3月31日および2023年3月31日の3か月間、売上高の出典はなく、関連する売上原価もありません。
営業費用。 2024年3月31日までの3か月間の総営業費用は700万ドルで、2023年3月31日までの3か月間の総営業費用710万ドルから10万ドル減少した。2024年3月31日までの3か月間の営業費用が減少した要因について以下で説明します。
研究開発費用。 2024年3月31日までの3か月間の研究開発費は370万ドルで、2023年3月31日までの3か月間の研究開発費350万ドルから20万ドル増加しました。
以下の表は、2024年3月31日と2023年のそれぞれの3か月間にわたるR&D経費の主要カテゴリの内訳と、これらのカテゴリのドルでの変化(千ドル単位)を提供しています。
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3月31日に終了した3か月間、 |
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2024 |
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2023 |
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増加 (減少) |
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研究開発経費 |
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臨床試験と非臨床試験 |
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$ |
2,884 |
|
|
$ |
2,336 |
|
|
$ |
548 |
|
|
補償 |
|
|
626 |
|
|
|
1,034 |
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|
|
(408 |
) |
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専門家費用とその他 |
|
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238 |
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|
|
138 |
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|
|
100 |
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研究開発費合計 |
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$ |
3,748 |
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$ |
3,508 |
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$ |
240 |
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• |
研究開発費の増加は、(Z)-エンドキシフェン試験の臨床および非臨床試験へ前年期間と比較して500,000ドルの増加に主に起因しました。これには薬剤開発費も含まれています。 |
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• |
2024年3月31日までの3か月間の研究開発費用の減少は、前年同期比で非現金の株式報酬が40万ドル減少したことに主な要因がありました。非現金の株式報酬は、2024年のアマチュア価値のオプションが期間内に低下したため、前年同期比で減少しました。 |
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2024年3月31日までの3か月間のR&Dプロフェッショナル料金の増加は、前年同期と比較して$100,000増加しました。2024年における当社のエンドキシフェンプログラムに関連するコンサルティング料金の増加が、主な要因でした。 |
一般管理費(G&A)の経費。 2024年3月31日までの3ヶ月間のG&A費用は320万ドルであり、2023年3月31日までの3ヶ月間の合計G&A費用から40万ドル減少しています。この合計は360万ドルでした。
以下の表は、2024年3月31日と2023年の3か月間におけるG&A費用内の主要カテゴリの内訳と、それらのカテゴリのドル変動(千ドル単位)を提供しています。
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For the Three Months Ended March 31, |
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2024 |
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2023 |
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Increase (Decrease) |
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General and Administrative Expense |
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Compensation |
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$ |
1,325 |
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$ |
2,084 |
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$ |
(759 |
) |
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Professional fees and other |
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1,680 |
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|
|
1,164 |
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|
|
516 |
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Insurance |
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227 |
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|
|
342 |
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|
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(115 |
) |
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General and Administrative Expense Total |
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$ |
3,232 |
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$ |
3,590 |
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|
$ |
(358 |
) |
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• |
The decrease in G&A compensation expense of $0.8 million for the three months ended March 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. |
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• |
The increase in G&A professional fees of $0.5 million for the three months ended March 31, 2024 compared to the prior year period was primarily due to an increase in legal fees for higher patent-related activity. |
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• |
The decrease in G&A insurance expense of $0.1 million for the three months ended March 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 $1.1 million for the three months ended March 31, 2024, an increase of $0.2 million from interest income of $0.9 million for the three months ended March 31, 2023. The increase was due to a change in the mix of our money market accounts which yielded a higher rate of return.
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 U.S. patents and numerous pending patent applications.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on using (Z)-endoxifen to prevent and treat breast cancer. For more information, please visit www.atossatherapeutics.com.
Contact
Eric Van Zanten
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 Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
ATOSSA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
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March 31, 2024 |
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December 31, 2023 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
83,960 |
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$ |
88,460 |
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Restricted cash |
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|
110 |
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110 |
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Prepaid materials |
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1,372 |
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|
1,487 |
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Prepaid expenses and other current assets |
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1,613 |
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|
2,162 |
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Total current assets |
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87,055 |
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92,219 |
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Investment in equity securities |
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1,710 |
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1,710 |
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Other assets |
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2,322 |
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2,323 |
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Total assets |
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$ |
91,087 |
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$ |
96,252 |
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Liabilities and stockholders' equity |
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Current liabilities |
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Accounts payable |
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$ |
1,230 |
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$ |
806 |
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Accrued expenses |
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1,613 |
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|
973 |
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Payroll liabilities |
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659 |
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1,654 |
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Other current liabilities |
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1,826 |
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1,803 |
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Total current liabilities |
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5,328 |
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|
5,236 |
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Total liabilities |
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5,328 |
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5,236 |
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Commitments and contingencies |
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Stockholders' equity |
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Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized; |
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— |
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— |
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Common stock - $0.18 par value; 175,000,000 shares authorized; 125,507,814 and 125,304,064 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively |
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22,829 |
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22,792 |
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Additional paid-in capital |
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256,571 |
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|
255,987 |
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Treasury stock, at cost; 1,320,046 shares of common stock at March 31, 2024 and December 31, 2023 |
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(1,475 |
) |
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(1,475 |
) |
Accumulated deficit |
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(192,166 |
) |
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(186,288 |
) |
Total stockholders' equity |
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85,759 |
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|
91,016 |
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Total liabilities and stockholders' equity |
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$ |
91,087 |
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$ |
96,252 |
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ATOSSA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
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For the Three Months Ended March 31, |
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2024 |
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2023 |
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Operating expenses |
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Research and development |
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$ |
3,748 |
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$ |
3,508 |
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General and administrative |
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|
3,232 |
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|
|
3,590 |
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Total operating expenses |
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|
6,980 |
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|
7,098 |
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Operating loss |
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(6,980 |
) |
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|
(7,098 |
) |
Interest income |
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|
1,138 |
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|
850 |
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Other expense, net |
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(36 |
) |
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(33 |
) |
Loss before income taxes |
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(5,878 |
) |
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(6,281 |
) |
Income tax benefit |
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— |
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— |
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Net loss |
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(5,878 |
) |
|
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(6,281 |
) |
Net loss per share of common stock - basic and diluted |
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$ |
(0.05 |
) |
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$ |
(0.05 |
) |
Weighted average shares outstanding used to compute net loss per share - basic and diluted |
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125,319,778 |
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126,624,110 |
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