美國
證券和交易委員會
華盛頓特區 20549
Form
（標記一）
截至季度結束日期的財務報告
或者
過渡期從 至 .
委託文件號碼：
(根據其章程規定的註冊人準確名稱)
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（國家或其他管轄區的 |
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（IRS僱主 |
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(主要行政辦公室地址) |
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（郵政編碼） |
(
(註冊人電話號碼，包括區號)
財政年度：6月30日
（前名稱、地址及財政年度，如果自上次報告以來有更改）
在法案第12(b)條的規定下注冊的證券：
每種類別的證券 |
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交易標誌 |
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名稱爲每個註冊的交易所: |
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該 |
請在檢查標記處註明註冊人（1）是否已在證券交易法第13或15（d）條所規定的過去12個月（或註冊人需要提交此類報告的較短期間）內提交了所有必須提交的報告，並且（2）自過去90天以來一直受到此類提交要求的限制。
請在以下勾選方框表示註冊人是否已在Regulation S-T Rule 405規定的前12個月(或在註冊人需要提交此類文件的較短期間內)提交了每個互動數據文件。
請勾選標記以說明註冊人是大型快速申報人、加速申報人、非加速申報人、較小的報告公司還是新興成長型公司。請查看《交易所法》第120億.2條中「大型快速申報人」、「加速申報人」、「較小的報告公司」和「新興成長型公司」的定義。
大型加速報告人 |
☐ |
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加速文件提交人 |
☐ |
☑ |
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較小的報告公司 |
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新興成長公司 |
如果是新興成長型公司，在選中複選標記的同時，如果公司已選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期來符合新的或修訂後的財務會計準則，則表明該公司已選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期來符合新的或修訂後的財務會計準則。☐
請用複選標記表示註冊申報人是否爲殼公司(如《交易所法》第120億.2條所定義) 是 ☐ 否
截至2024年11月12日流通的普通股股份數量爲
目錄
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頁碼 |
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項目 1. |
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1 |
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條目2。 |
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項目 3. |
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25 |
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項目4 |
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25 |
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項目1。 |
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項目1A。 |
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項目2。 |
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項目3。 |
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物品 4. |
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項目5。 |
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項目6。 |
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i
說明：
2024年10月18日（「收盤日期」），在截至2024年9月30日的財政季度之後，即本季度報告Form 10-Q（本「報告」）所涉及的財政季度，原名爲kintara therapeutics，Inc.的內華達州公司（「Kintara」）根據2024年4月2日日期的一份特定合併計劃協議（「合併協議」）進行了事先宣佈的合併交易，其中各方爲Kintara、kayak合併有限公司，內華達州公司和Kintara的直接全資子公司（「合併子公司」）以及內華達州公司TuHURA生物科學有限公司（「TuHURA」），根據協議，合併子公司與TuHURA合併，TuHURA作爲Kintara的直接全資子公司和合並的倖存公司（「合併」）。與合併完成同時，Kintara於收盤日期東部時間凌晨12:01實施了1股對35股的股票合併（「反向股票分割」），每股面值爲0.001美元。在收盤日期東部時間凌晨12:03，Kintara完成了合併，而在收盤日期東部時間凌晨12:04，Kintara將其名稱更改爲「TuHURA生物科學有限公司」。
根據合併協議，合併生效時，(i) Kintara向TuHURA股東發行了約40,441,605股普通股，按照0.1789的匯率（考慮到股票合併後）每股Kintara的普通股交換TuHURA普通股，（ii）每個現有的TuHURA股票期權被認定爲和轉換爲購買Kintara普通股的期權，根據合併協議中規定的交換比率進行一定調整，（iii）每個現有的用於購買TuHURA普通股的認股權證被認定爲和轉換爲根據交換比率交換爲一張類似期限的購買Kintara普通股的認股權證。
Kintara的普通股份發行給TuHURA的前股東，已在Kintara的S-4表格註冊聲明文件（文件號333-279368）中登記，該文件已經修改。
Kintara 的普通股在納斯達克資本市場上市，之前的交易標的爲 「KTRA」，於 2024 年 10 月 17 日星期四的收盤業務交易結束後，在 2024 年 10 月 18 日星期五開始在納斯達克資本市場進行反向股票拆分調整後和併購後的交易，標的爲 「HURA」。Kintara 的普通股由新的 CUSIP 號碼 898920 103 代表。
就併購事項，金塔拉與Equiniti Trust Company, LLC簽訂了一份附帶價值權協議（「CVR協議」），根據該協議，截至併購和逆向股份拆分完畢前的股東和股票認股權證持有人，將每持有的普通股獲得一個附帶價值權利（「CVR」）。根據CVR協議，若金塔拉在研究中招募至少十名皮膚轉移性乳腺癌患者，以判斷金塔拉的REm-001低於1.2毫克/千克的劑量是否表現出類似於先前1.2毫克/千克劑量研究中所見的治療效果，且這些患者完成八週的隨訪，時間爲2025年12月31日前（在CVR協議中規定），則CVR持有人有權共計獲得約1,539,918股普通股（已考慮逆向股份拆分的影響）。
除非上下文另有要求，在本報告中，「我們」、「我們的」、「本公司」指的是kintara therapeutics, Inc.，一家內華達州公司合併前及其全資子公司。
除非本報告另有明確規定，否則本報告中的信息不反映併購的完成情況，正如前文所述，此併購發生在此後的期間。
i
第1部分 - 財務206,601
第一條. 財務報表。
kintara therapeutics，公司
基本報表
(未經審計)
截至2024年9月30日的三個月
(以美元表示，除非另有說明)
1
kintara therapeutics，公司
合併資產負債表
（以千爲單位，除每股面值金額外）
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九月， |
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6月30日， |
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Note |
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$ |
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$ |
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(未經審計) |
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資產 |
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流動資產 |
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現金及現金等價物 |
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預付費用、稅款及其他應收款 |
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臨床試驗存入資金 |
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3 |
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總流動資產 |
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物業和設備，淨值 |
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5 |
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總資產 |
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負債 |
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流動負債 |
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應付賬款及應計負債 |
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6 |
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關聯方應付款 |
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7 |
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總流動負債 |
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里程碑支付負債 |
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10 |
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總負債 |
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股東權益 |
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優先股 |
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已授權 |
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已發行未流通股份 |
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8 |
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2024年9月30日的C系列股份（2024年6月30日 – |
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8 |
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— |
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普通股 |
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授權的 |
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已發行和流通 |
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8 |
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額外實收資本 |
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8 |
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累積赤字 |
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( |
) |
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( |
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累計其他綜合收益 |
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股東權益總額 |
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總負債和股東權益 |
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運營性質、公司歷史、持續經營和管理計劃 (註釋 1) |
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後續事件(備註10) |
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附註是這些未經審計的簡明合併中期財務報表的一個組成部分。
2
kintara therapeutics，公司
簡明合併中期運營報表
(未經審計)
（以千爲單位，每股金額除外）
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截至三個月 |
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備註 |
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2024 |
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2023 |
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費用 |
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研發 |
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$ |
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$ |
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一般和行政 |
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( |
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( |
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其他收入（損失） |
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外匯 |
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( |
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( |
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利息淨額 |
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本期淨虧損 |
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( |
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( |
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基本每股虧損的計算 |
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本期淨虧損 |
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( |
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( |
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A輪優先股現金股利 |
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8 |
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( |
) |
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( |
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C輪優先股股利 |
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8 |
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( |
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( |
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本期淨虧損歸屬於普通股股東 |
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$ |
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( |
) |
$ |
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( |
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基本和完全攤薄每股虧損 |
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$ |
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( |
) |
$ |
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( |
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基本和完全攤薄加權平均股數 |
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附註是這些未經審計的簡明合併中期財務報表的一個組成部分。
3
kintara therapeutics，公司
股東權益（不足）的簡明綜合中期報表
(未經審計)
截至2024年9月30日的三個月
(以千爲單位)
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數字 |
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普通 |
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額外的 |
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累計 |
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優先股 |
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累計 |
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總股東 |
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截至2024年6月30日的餘額 |
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( |
) |
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限制性股票單位歸屬時發行股票 |
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— |
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— |
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— |
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— |
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— |
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— |
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C系列優先股轉換爲普通股 |
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— |
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— |
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( |
) |
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— |
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— |
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股票期權費用 |
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— |
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— |
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— |
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— |
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— |
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限制性股票單位費用 |
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— |
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— |
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— |
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— |
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— |
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A輪優先股現金股利 |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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C輪優先股股利 |
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— |
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— |
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— |
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( |
) |
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— |
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本期虧損 |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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2024年9月30日的餘額 |
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( |
) |
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附註是這些未經審計的簡明合併中期財務報表的一個組成部分。
4
kintara therapeutics，公司
濃縮合並的股東權益 interim 報表
(未經審計)
2023年9月30日結束的九個月內的合同餘額
(以千爲單位)
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數字 |
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普通 |
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額外的 |
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累計 |
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優先股 |
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累計 |
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總股東 |
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2023年6月30日的餘額 |
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( |
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C輪優先股轉換爲普通股 |
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— |
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— |
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— |
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( |
) |
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— |
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— |
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股票期權費用 |
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— |
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— |
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— |
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— |
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— |
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限制性股票單位費用 |
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— |
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— |
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— |
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— |
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— |
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A輪優先股現金股利 |
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— |
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— |
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— |
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— |
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— |
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( |
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C輪優先股股利 |
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— |
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— |
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本期虧損 |
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— |
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— |
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( |
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2023年9月30日的資產負債表 |
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( |
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( |
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附註是這些未經審計的簡明合併中期財務報表的一個組成部分。
5
kintara therapeutics，公司
精簡合併中期現金流量表
(未經審計)
(以千爲單位)
|
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截至三個月 |
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2024 |
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2023 |
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備註 |
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$ |
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$ |
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經營活動現金流量 |
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本期虧損 |
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調整淨虧損爲經營活動使用的現金淨額 |
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財產和設備的折舊 |
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里程碑責任的公允價值變動 |
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股票期權費用 |
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限制性股票單位費用 |
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營運資產和負債的變化 |
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預付費用、稅款及其他應收款 |
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臨床試驗存入資金 |
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用於經營活動的淨現金 |
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A輪優先股現金股利 |
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融資活動提供的淨現金 |
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現金及現金等價物減少 |
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現金及現金等價物期初餘額 |
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補充信息（備註9） |
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附註是這些未經審計的簡明合併中期財務報表的一個組成部分。
6
kintara therapeutics，公司
基本報表附註
(未經審計)
2024年9月30日
(以美元和千爲單位表示，除面值和每股金額外，除非另有說明)
1 運營性質、公司歷史以及持續經營能力和管理計劃
業務性質
Kintara therapeutics, Inc. 是一家內華達州公司（簡稱「Kintara」或「公司」），是一家臨床階段的藥物開發公司，專注於爲滿足未滿足醫療需求的患者開發新型癌症療法。公司正在開發一種晚期治療藥物 - REm-001，用於皮膚轉移性乳腺癌（「CMBC」）。爲了加快公司的開發時間表，它利用來自廣泛來源的現有臨床前和臨床數據。公司可能會尋求營銷合作伙伴，以潛在抵消臨床成本，並從其當前和未來產品候選的批准適應症中產生未來的特許權使用費營業收入。
與TuHURA生物科學公司合併
2024年4月2日，公司與德拉瓦州公司TuHURA生物科學公司（「TuHURA」）及其全資子公司Kayak Mergeco, Inc.（「Merger Sub」）簽訂了合併協議及計劃（「合併」），進行一項全股票合併交易（「合併協議」），成立一傢俱有專業知識和資源的公司，以推進風險多樣化的晚期腫瘤管線（「合併協議」）。合併協議規定，合併完成後，前TuHURA股東將擁有公司的大部分股份。根據合併協議設想的合併及其他事務於2024年10月18日完成（見註釋10）。除非上下文另有要求，報告中使用的「我們」、「我們的」和「公司」均指Kintara therapeutics, Inc.，一家公司在合併前的內華達州公司及其全資子公司。
公司歷史
公司是一家於2009年6月24日在內華達州成立的公司，原名Berry Only, Inc.。2013年1月25日，公司與Del Mar Pharmaceuticals (BC) Ltd.（「Del Mar (BC)」）、9594540億.C. Ltd.（「Callco」）以及9594560億.C. Ltd.（「Exchangeco」）及Del Mar (BC)的證券持有人簽訂並完成了一項交換協議（「交換協議」）。交換協議完成後，Del Mar (BC)成爲公司的全資子公司（「反向收購」）。
2020年8月19日，公司完成了與德拉瓦州公司Adgero Biopharmaceuticals Holdings, Inc.（「Adgero」）的合併，Adgero在德拉瓦州法律下繼續存在，併成爲公司的直接全資子公司。合併完成後，公司將名稱從DelMar Pharmaceuticals, Inc.更改爲Kintara therapeutics, Inc.，並開始在納斯達克資本市場以「KTRA」標的交易。
Kintara therapeutics, Inc.是Del Mar（BC）的母公司，該公司是加拿大不列顛哥倫比亞省的一家企業，以及Adgero，這些都是專注於癌症治療藥物開發的臨床階段公司。公司還是Callco和Exchangeco的母公司，這兩家公司也是加拿大不列顛哥倫比亞省的公司。Callco和Exchangeco的成立是爲了促進反向收購。與Adgero的合併相關，公司還成爲Adgero Biopharmaceuticals, Inc.（「Adgero Bio」）的母公司，後者曾是Adgero的全資子公司。
2024年10月18日，公司根據合併協議的條款與TuHURA及合併子公司完成合並。在合併相關過程中，合併子公司與TuHURA合併，TuHURA作爲公司的全資子公司存續。合併完成後，公司將其公司名稱改爲「TuHURA Biosciences, Inc.」。
提及「公司」指的是公司及其全資子公司。
持續經營和管理計劃
這些簡明合併中期基本報表是基於持續經營情況編制的，這意味着公司預計將繼續運營在可預見的未來，並考慮到資產的實現和負債的正常業務結算。
截至2024年9月30日的三個月，公司報告了損失$
7
九月 2024年6月30日。公司目前處於臨床階段，尚未產生任何收入。公司在其產品候選品商業化或與合作伙伴合作之前，不具有實現收入的前景，這可能永遠不會發生。2022年8月2日，公司簽署了一份股票購買協議，根據該協議，公司已發行了截至2024年9月30日，公司已籌集
這些情況表明，關於公司能否正常運營存在重大疑慮，在提交這些簡明綜合中期財務報表之日起，
在2024年10月18日，公司完成了與TuHURA的合併，根據合併協議的條款（附註11）。
因此，管理層正在追求各種融資方案，以爲公司的運營提供基金，以便其作爲持續經營的一部分繼續下去。管理層計劃繼續尋找通過發行新股權（包括債務）、簽訂戰略合作伙伴關係和/或進行額外戰略交易來獲得必要融資的機會。然而，公司籌集額外資金的能力可能會受到各種風險和不確定性的影響，包括但不限於全球動盪。公司可能無法籌集足夠的額外資金，並且可能需要根據公司今後能夠籌集的資金量調整其藥物候選開發計劃。儘管如此，不能保證這些舉措會取得成功。
這些簡明的合併中期財務報表未對資產和負債的金額和分類進行任何調整，如果公司無法繼續作爲持續經營的一部分，可能需要進行調整，這可能或可能不對這些簡明的合併中期財務報表具有實質影響。
2 重要會計政策
股票拆分
2022年11月10日，公司提交了對公司章程的變更證明，以實施1:
做法的基礎
公司的簡要合併中期基本報表已經根據美國公認會計原則（「U.S. GAAP」）編制，並以美元呈現。公司的功能貨幣及其所有子公司的功能貨幣均爲美元。
隨附的簡要合併中期基本報表包含公司的帳戶及其全資子公司，包括Adgero、Adgero Bio、Del Mar (BC)、Callco 和 Exchangeco。所有的公司內餘額和交易在合併時均已被消除。
在編制這些簡要合併中期基本報表時應用的主要會計政策如下所列，並已一致適用於所有報告期。
未經審計的中期財務數據
該 隨附的未經審計的簡要合併中期基本報表是根據證券交易委員會（「SEC」）對中期財務信息的規則和規定編制的。因此，這些報表不包括完整財務報表所需的所有信息和註釋。這些未經審計的簡要合併中期基本報表應與2024年6月30日的經審計合併基本報表一起閱讀，該報表包含在公司於2024年10月7日向SEC提交的10-k表格中。 我個人認爲
8
管理， 未經審計的簡明合併中期基本報表反映了所有必要的正常和經常性調整，以確保公平的呈現。截至2024年9月30日的三個月的結果並不一定代表截至2025年6月30日的財政年度或其他任何未來年度或中期期間的結果。
估計的使用
根據美國通用會計準則編制基本報表要求管理層對可能影響報告期間資產、負債、費用、或有資產和或有負債的未來事件作出估計和假設。實際結果可能與這些估計有顯著差異。管理層需作出估計的重要領域包括爲服務而發行的股權工具的評估、里程碑支付負債和臨床試驗應計費用的計提。有關這些假設和條件的性質的進一步細節可在這些簡明合併中期基本報表的相關附註中找到。
每股虧損
每股虧損是根據已發行普通股的加權平均數計算的。對於截至2024年和2023年9月30日的三個月期間，稀釋後每股虧損與基礎每股虧損沒有差異，因爲公司的warrants、期權、限制性股票單位和可轉換優先股的影響是反稀釋的。截至2024年9月30日，潛在的普通股股份爲
政府援助
政府補助，包括來自類似機構的補助，只有在合理保證公司已滿足批准補助計劃的要求，並且合理保證補助將被收到時，才會被確認。用於補償公司已發生費用的補助將在確認費用的同一期間，作爲收入或損失的減少而被確認。公司採用淨呈現基礎，以補助抵消研究和開發費用，因爲它是在補助計劃下被回收的。
最近發佈的會計準則
管理層認爲，任何最近發佈但尚未生效的會計準則，如果目前被採納，將不會對公司的簡明合併中期基本報表產生重大影響。
3 臨床試驗存入資金
2020年10月，公司宣佈已與一家合同研究機構（"CRO"）達成最終協議，管理VAL-083用於膠質母細胞瘤的註冊研究。根據協議，公司提供了研究用藥物，而CRO管理了研究的所有運營方面，包括現場激活和患者招募。公司根據與患者招募里程碑相關的協議規定需支付一定款項。截至2024年9月30日的三個月，公司已確認該研究的費用爲$ (2023 - $
2023年10月31日，公司宣佈VAL-083的這一註冊研究的初步上線結果未達到膠質母細胞瘤當前的治療標準。因此，公司宣佈終止了VAL-083的開發。截至2024年6月30日，$
截至2024年6月30日和9月30日，公司已記錄$
4 臨床試驗資助
自2023年7月1日起，公司獲得了$
9
到 公司作爲支出報銷。截至2024年9月30日的三個月，公司收到了$
該贈款受各種績效條件和資金風險的限制，NIH的財務狀況可能不時發生變化。公司僅在有充分保證贈款將撥款給公司的情況下承認該贈款。
5 不動產和設備，淨值
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截至2024年9月30日，資本化成本總額爲 不動產和設備爲 $
6 應付賬款和應計負債
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7 關聯交易
Valent Technologies, LLC 協議
2023年11月20日，公司因成本削減措施而解除了布朗博士的首席科學官職務；他仍然是公司的顧問。 布朗博士是Valent Technologies, LLC（「Valent」）的負責人，因此Valent是公司的關聯方。
2010年9月12日，公司與Valent簽署了專利轉讓協議（「Valent轉讓協議」），根據該協議，Valent將VAL-083的專利的所有權、所有權和利益全部轉讓給公司。 公司現在擁有VAL-083的所有權和所有權，並負責進一步開發和商業化。 根據Valent轉讓協議的條款，Valent有權獲得從VAL-083的開發和商業化中獲得的所有收入的未來版稅。 如果公司終止協議，根據Valent轉讓協議的終止前公司已達到的開發里程碑，公司可能有權從Valent隨後的VAL-083開發中獲得版稅。
2014年9月30日，公司與Valent和Del Mar（BC）簽署了交換協議（「Valent交換協議」）。 根據Valent交換協議，Valent將其拖欠的借款（截至2014年9月30日尚未清償的金額爲$
2024年2月13日，公司根據Valent分配協議向Valent發送了選擇退出通知，根據該協議，公司轉讓了VAL-83萬億專利的全部權利、所有權和利益給Valent。因此，公司向Valent授予了一項非獨佔的、完全支付的、免版稅的、永久的、全球性的、不可轉讓的許可，受到有限例外的限制。公司有權從Valent對VAL-083後續商業化的淨銷售額中獲得的版稅爲。 Valent淨銷售額的%（如Valent分配協議中定義）。
10
關聯方應付款
截至2024年9月30日，公司應付給董事和高管的費用、支出及其他負債總額爲$
8
優先股
Series C優先股
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Series C優先股 |
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2024年6月30日餘額 |
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C系列優先股轉換爲普通股 |
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餘額 - 2024年9月30日 |
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在2020年8月，公司發行了
系列C優先股分紅派息不需要董事會的聲明，並在分紅派息產生的日期按年度計提，金額等於公司普通股在支付相應分紅派息日期的公允價值。2024年8月19日支付的系列C優先股分紅派息的公允價值是通過將支付的分紅派息乘以
系列C優先股在發生清算時，關於資產和權利的分配方面（i）比公司普通股優先（ii）比今後創建的任何其他類別或系列的資本股優先。xpressly 與系列C優先股平等或優於系列C優先股。系列C優先股在清算時與公司的系列A優先股平等。至2024年9月30日，系列C優先股的清算價值爲聲稱的價值$ （2024年6月30日 - $
截至2024年9月30日，公司的系列C優先股累計分紅如下：
系列C分紅 |
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Dividend Shares |
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10% - 2021年8月19日（實際） |
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15% - 2022年8月19日（實際） |
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20% - 2023年8月19日（實際） |
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25% - 2024年8月19日（實際） |
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A系列優先股
自2014年9月30日起，公司向內華達州國務卿提交了系列A優先股的設計證明（「系列A設計證明」）。根據系列A設計證明，公司指定
11
the 公司持有的A類優先股股東有權在公司可供分配給股東的任何資產中，優先於普通股股東獲得所持有的A類優先股的規定價值，以及任何應計但未支付的股利，在進行與普通股相關的支付前進行支付。Valent持有A類優先股（附註7）。
A類優先股在資產和權利分配發生清算時，（i）優先於公司的普通股，（ii）優先於公司此後創建的任何其他不明文規定與A類優先股等額或更高的資本股種類或系列。A類優先股在清算中與公司C類優先股等額。2024年9月30日，A類優先股的清算價值爲其規定價值。 $
有
普通股
2024年9月30日結束的三個月期間普通股發行
在2024年9月30日結束的三個月內，公司發行了
2023年9月30日結束的三個月期間普通股發行
在截至2023年9月30日的三個月期間，公司發行
2017年全員激勵計劃
後來在2018年4月11日公司股東年度股東大會上得到批准，公司董事會批准通過了公司的2017年全權股權激勵計劃（「2017計劃」），並進行了修改。董事會還批准了一種績效股單位獎勵協議的形式，用於授予績效股單位（「PSU」），以及在2017計劃下授予的受限制股單位（"RSU"）獎勵。根據公司股東批准的公司 於2022年6月21日，截至2024年9月30日，2017計劃下可用的普通股數量爲
以下表格列出了截至2024年9月30日的所有股權補償計劃的總體信息：
計劃（以千爲單位，除每股金額外） |
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未行使尚待行使的普通股期權和權利所指發行的股份數量 |
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普通股期權和權利的加權平均行使價格 |
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未來根據股權激勵計劃發行的普通股數量（不包括列（a）中反映的證券）(2) |
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董事會批准的2017年股權激勵計劃(1) |
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未經股東批准的股權激勵計劃 - Del Mar（BC）2013年修訂和重訂股票期權計劃 |
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總計 |
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(1) Del Mar（BC）2013年修訂和重訂股票期權計劃是指公司之前的股權激勵計劃
(2) 資產的餘額
在任何一個日曆年度內，任何一名參與者可以被授予公司普通股股票的最大數量是
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股 根據2017計劃和/或遺留計劃發行的普通股，或根據2017計劃和/或遺留計劃授予的未決獎勵，未授予任何獎勵。2017計劃將在2027年7月7日或之後停止授予。
股票期權
截至2024年9月30日的三個月內，期權沒有變化。
下面的表格總結了截至2024年9月30日所有板塊中未行使和可行使的期權：
行使價格 |
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加權 |
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公司已將以下金額作爲期權費用確認，涉及的期間（單位：千）:
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截至三個月 |
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2024 |
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2023 |
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研發 |
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一般和行政 |
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截至2024年和2023年9月30日的所有期權費用均已被確認作爲額外的實收資本。未結股票期權的總內在價值，以及可行使的股票期權爲
下表列出了所有板塊下未成熟股票期權的變動：
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數量 |
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加權 |
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2024年6月30日未解除限制的 |
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歸屬 |
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2024年9月30日前尚未獲授的股份 |
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截至2024年9月30日，未歸屬股票期權的總內在價值爲
限制性股票單位
在截至2024年9月30日的三個月期間，公司確認總額爲$
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數量 |
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2024年6月30日餘額 |
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限制性股票單位的認股權發放 |
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餘額 - 2024年9月30日 |
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普通股認股權證
以下表格列出了優先股認股權的變化：
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數量 |
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加權 |
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2024年6月30日餘額 |
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服務發行的認股權證期滿 |
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餘額 - 2024年9月30日 |
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以下表格總結了截至2024年9月30日公司尚未行使的普通股認股權證：
認股權證的描述 |
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行使 |
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到期日 |
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2022年4月投資者認股權證 |
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2022年投資者認股權證 |
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2022年4月代理人認股權證 |
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C輪優先股權證
關於C輪優先股定向增發，公司發行了
以下表格列出了C輪代理人權證的未行使變更情況：
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餘額 |
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數量 |
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餘額， |
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轉換 |
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優先C-1系列代理商權證 |
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優先C-2系列代理商權證 |
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優先C-3系列代理人認股權證 |
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補充現金流量信息表
公司發生以下非現金投融資交易（以千美元計）：
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截至三個月 |
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2024 |
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2023 |
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C輪優先股普通股股息（附註8） |
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A輪優先股現金股息在應付賬款和應計負債中 |
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C輪優先股轉換爲普通股（附註8） |
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所得稅已付款項 |
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支付的利息 |
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10
公司的財務工具是根據公允價值進行衡量的，使用公允價值層次結構來確定輸入，該結構最大化使用可觀察輸入並最小化使用不可觀察輸入，要求在可用時使用最可觀察的輸入。可觀察的輸入是市場參與者用於對資產或負債進行估值的輸入，並且是根據從獨立來源獲取的市場數據制定的。不可觀察的輸入是基於對市場參與者用於對資產或負債進行估值的因素的假設。可能用於衡量公允價值的三個級別的輸入如下所示：
一級 - 輸入利用活躍市場上相同資產或負債的報價（未調整）；
二級 - 是不包括在一級中的報價的輸入，這些輸入對資產或負債是可觀察的，可以是直接或間接的，例如利率期貨，匯率期貨和可在通常引用間隔內觀察到的收益曲線；以及
三級 - 使用估計和假設開發的不可觀察的輸入，這些輸入是由報告實體開發的，反映了市場參與者將使用的假設。
資產和負債的分類基於對公允價值衡量具有重要意義的最低級別的輸入。估值輸入的可觀察性變化可能導致在公允價值層次結構內對某些證券的級別進行重新分類。
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2024年9月30日 |
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負債 |
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一級 |
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二級 |
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三級 |
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里程碑支付負債 |
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$ |
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2024年6月30日餘額 |
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估值預估變動 |
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餘額 - 2024年9月30日 |
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公司的金融工具包括現金及現金等價物、其他應收款、應付賬款和關聯方應付款。由於這些金融工具的即時或短期到期性質，現金及現金等價物、其他應收款、應付賬款和關聯方應付款的賬面價值大致等於其公允價值。
11 後續事件
公司已評估自2024年9月30日至本壓縮合並中期基本報表發佈之日期間的後續事件，並確定除了下面提到的事項外，沒有需要在這些壓縮合並中期基本報表中披露的後續事件。
對霍夫曼僱傭協議的修訂
羅伯特·霍夫曼，前首席執行官及臨時首席財務官，與公司是2021年11月8日簽署的一份執行僱傭協議（「霍夫曼僱傭協議」）的當事方。2024年10月4日，公司與霍夫曼先生就霍夫曼僱傭協議簽署了修訂協議（「霍夫曼修訂」）。根據霍夫曼修訂，2024年10月4日之前公司授予霍夫曼先生的所有未到期期權將全部歸屬，條件是霍夫曼先生同意將霍夫曼僱傭協議的競業限制延長至其與公司終止僱傭關係後的十二個月。
與TuHURA生物科學公司合併
2024年10月4日，在公司的股東特別會議上，公司的股東批准了必要的提案以完成根據合併協議進行的合併，其中合併子公司與TuHURA合併，而TuHURA在合併中存續併成爲公司的直接全資子公司。2024年10月18日美國東部時間凌晨12:01生效， 公司實施了反向拆股，每一股已發行和流通的普通股轉換爲一股普通股。
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十月 2024 年 18 月 18 日，公司完成合並，自美國東部時間2024年10月18日凌晨 12:04 起，公司更名爲 「TuHura Biosciences, Inc.」
根據合併協議的條款和條件，在合併生效時（「生效時間」），(i) 當時每股流通的TuHura普通股，面值美元
合併後，截至合併前的TuHura股東立即擁有的總股東在完全攤薄的基礎上擁有的總資產約爲
2024 年 10 月 18 日，公司完成了 「一對一」 協議，在合併完成前立即生效
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項目2。 管理層對財務狀況和業務結果的討論和分析 財務狀況及經營結果探討與分析。
本管理層的討論與分析（「MD&A」）包含根據1995年《私人證券訴訟改革法》的定義的「前瞻性聲明」，這些聲明代表我們的預測、估計、期望或信念，涉及管理層未來計劃或目標及我們未來經濟和財務表現等財務事項。在某些情況下，您可以通過術語如「可能」、「應該」、「計劃」、「相信」、「將」、「預期」、「估計」、「期待」、「項目」或「打算」來識別這些聲明，包括它們的反義詞或類似短語或表達。您應該意識到，這些聲明是關於未來事件的預測或估計，並受到多種因素的影響，這些因素可能影響聲明的準確性。這些前瞻性聲明不應被視爲我們或任何其他人對我們的事件或計劃將會實現的表述。您不應過度依賴這些前瞻性聲明，這些聲明僅在本報告日期有效。除非適用證券法可能要求，否則我們沒有義務公開修訂任何前瞻性聲明，以反映本報告日期後的情況或事件，或以反映意外事件的發生。
您應當查看我們在截至2024年6月30日的年度報告（表格10-K）和我們向證券交易委員會（「SEC」）的其他文件中描述的「風險因素」和風險，這些內容可以在www.sec.gov找到。實際結果可能與任何前瞻性聲明有重大差異。
所有金額均以美元和千美元表示，除非另有說明，股份面值和每股金額除外。
背景
kintara therapeutics，Inc.，一家內華達州公司（「金塔拉」或「公司」），是一家專注於新癌症治療開發和商業化的臨床階段生物製藥公司。
我們是Del Mar（BC）的母公司，這是一家位於加拿大不列顛哥倫比亞省的公司，也是Adgero生物製藥控股有限公司的母公司，後者是一家特拉華州的公司（以下簡稱「Adgero」）。 我們還是9594540億.C. 有限公司（以下簡稱「Callco」）和9594560億.C. 有限公司（以下簡稱「Exchangeco」）的母公司，這兩家公司也都位於加拿大不列顛哥倫比亞省。 Callco和Exchangeco是爲促成2013年發生的反向收購而設立的。
「我們」、「我們的」提到時，指的是Kintara及我們的全資子公司Del Mar Pharmaceuticals（BC）有限公司（「Del Mar（BC）」）、Adgero、Adgero生物製藥公司（「Adgero Bio」）、Callco和Exchangeco。
我們致力於爲存在醫療需求的患者開發新型癌症療法。 我們的使命是通過爲固體腫瘤表現出使其對當前可用療法具抗性或不太可能對其作出反應的患者開發和商業化抗癌療法，重點關注孤兒癌症指標，從而造福患者。
我們的首選候選藥物是REm-001，一種用於治療皮膚轉移性乳腺癌（「CMBC」）的晚期光動力療法（「PDT」）。光動力療法是一種使用光敏化合物或光敏劑的治療方式，當暴露在特定波長的光線下時，光敏劑會充當催化劑產生一種形式的活性氧，誘導局部腫瘤細胞死亡。
最近事件
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即將到來的臨床里程碑
自2023年7月1日起，我們獲得了來自美國國立衛生研究院（「NIH」）的2,000美元資助，將在兩年內按照發生的費用接收。來自NIH的資助將資助與REm-001 CMBC 15名患者臨床研究（「REm-001研究」）相關的大部分費用。由於獲得了NIH的資助，我們重新啓動了REm-001項目，並已在紀念斯隆·凱特琳癌症中心開展了招募工作，截至2024年11月14日，我們已在四名患者中開始了治療。我們預計在2024年第四季度完成REm-001研究的患者招募。
REm-001
背景
通過REm-001，我們正在開發光動力療法（「PDT」）用於治療罕見、未滿足的醫療需求。PDT是一種治療方法，使用光敏化合物或光敏劑，在特定波長的光照射下，作爲催化劑產生一種誘導局部腫瘤細胞死亡的氧的形式。REm-001由三部分組成：激光光源、光傳遞裝置和REm-001藥品產品（統稱爲「REm-001療法」）。REm-001由一個原料藥（API）和脂質配方組成。REm-001的API是SnET2（「二乙基氯苯恩卟啉錫」）是第二代PDT光敏劑藥物。我們相信REm-001相較於早期一代PDT化合物具有多重優勢。
我們的REm-001的主要適應症是CMBC，這是一種可能影響患有晚期乳腺癌的患者的疾病，有效的治療期權有限。在四個CMBC患者的2期和/或3期臨床研究中，主要針對此前接受化療並未能通過放射治療的患者，REm-001療法能夠減少或消除大部分接受治療的CMBC腫瘤。具體而言，我們對從這些研究中收集的數據進行的分析表明，在接受REm-001療法治療的大約80%可評估的腫瘤部位中，存在完全有效反應；即隨訪臨床評估顯示未發現餘留的腫瘤跡象。我們相信臨床數據表明，REm-001療法有望成爲一種治療手段，可以在這種難治患者人群中局部消除或減緩治療的皮膚癌腫瘤的生長。
已經採用了多種方法治療CMBC患者，包括各種形式的化療、放療、手術切除、熱療、冷凍療法、電化療、局部藥物和病竈內化療注射。然而，我們大多數時候認爲這些療法往往效果有限、毒性大和/或副作用。我們認爲我們的REm-001療法對於這種情況有幾個優勢：它可以高度定向到腫瘤部位，對全身性影響或正常組織毒性很小，可以與其他療法結合使用，並可以定期重複。
Our REM-001 Therapy product consists of three parts: the DD series laser light source (or equivalent), the ML2-0400 light delivery device (or equivalent) and the drug REM-001. In use, REM-001 is first administered by intravenous infusion and allowed to distribute within the body and be taken up by the tumors. Tumors are then illuminated with light using the light delivery device, which is attached to the laser light source, so that the accumulated REM-001 can be activated for the desired clinical effect.
As a result of our review of the historical data, we submitted questions to the U.S. Food and Drug Administration (“FDA”) under a Type C format to review the technology and results and determine the anticipated requirements for regulatory approval. On March 3, 2017, we received the FDA’s written response to these questions. Based on that response, we have successfully
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manufactured REM-001 and developed light delivery devices for our planned 15-patient Phase 2 study. We received a Study May Proceed letter from the FDA for our 15-patient study on August 9, 2022.
On October 19, 2022, we announced that the REM-001 program in CMBC was paused to conserve cash which will be used to support the funding of the GBM AGILE Study. Effective July 1, 2023, we were awarded a two-year $2,000 Small Business Innovation Research grant from the National Institutes of Health to support the clinical development of REM-001 for the treatment of CMBC. The grant will be received in tranches of approximately $1,250 for the period July 1, 2023, to June 30, 2024, and approximately $750 for the period July 1, 2024, to June 30, 2025. As a result of receiving the grant, we re-initiated our REM-001 program and have opened enrollment at Memorial Sloan Kettering Cancer Center, where we have initiated treatment in a total of 4 patients as of November 14, 2024. We expect to complete enrollment of patients in the REM-001 Study in the fourth calendar quarter of 2024.
REM-001 Regulatory Filings
On August 9, 2022, we announced that we received a Study May Proceed letter from the FDA to begin our 15-patient study evaluating REM-001 PDT for the treatment of CMBC. The FDA has granted us Fast Track Designation (“FTD”) for REM-001 in CMBC.
VAL-083
On October 31, 2023, we announced preliminary topline results for VAL-083 from the GBM AGILE study. VAL-083 did not perform better than the current standards of care in glioblastoma and the preliminary safety data was similar to that of the current standards of care used to treat glioblastoma. As a result, we terminated the development of VAL-083. On February 13, 2024, we sent an Opt-Out Notice to Valent under the Valent Assignment Agreement whereby we assigned all rights, title, and interest in and to the patents for VAL-083 to Valent. As a result, we granted Valent a non-exclusive, fully-paid, royalty-free, perpetual, worldwide and non-transferable license, subject to limited exceptions. We are entitled to receive royalties from Valent’s subsequent commercialization of VAL-083 equal to 5% of Valent Net Sales (as defined in the Valent Assignment Agreement).
Merger Agreement
See “Recent Events” above for a description of the Merger Agreement and transactions consummated thereby.
Compensation Matters
Robert E. Hoffman, former Chief Executive Officer and Interim Chief Financial Officer of the Company, and the Company are parties to the Hoffman Employment Agreement, and on October 4, 2024, the Company and Mr. Hoffman entered into the Hoffman Amendment pursuant to the which, all outstanding stock options previously granted to Mr. Hoffman by the Company vested in full on October 4, 2024 in exchange for Mr. Hoffman agreeing to extend the non-competition restrictions of the Hoffman Employment Agreement for a period of twelve months following the date that his employment terminates with the Company.
Corporate History
We are a Nevada corporation formed on June 24, 2009, under the name Berry Only Inc. On January 25, 2013, we entered into and closed an exchange agreement (the “Exchange Agreement”), with Del Mar (BC), Callco, and Exchangeco and the security holders of Del Mar (BC). Upon completion of the Exchange Agreement, Del Mar (BC) became a wholly-owned subsidiary of ours (the “Reverse Acquisition”).
On August 19, 2020, we acquired Adgero and changed our name from DelMar Pharmaceuticals, Inc. to Kintara Therapeutics, Inc. We are the parent company to the following entities:
Del Mar (BC), a British Columbia, Canada corporation incorporated on April 6, 2010, which is a clinical stage company with a focus on the development of drugs for the treatment of cancer;
Adgero, a Delaware corporation incorporated on October 26, 2015, which is a clinical stage company with a focus on the development of photodynamic therapy for the treatment of rare, unmet medical needs, specifically orphan cancer indications;
Adgero Biopharmaceuticals, Inc. a Delaware corporation incorporated on November 16, 2007; and
Callco and Exchangeco which are British Columbia, Canada corporations. Callco and Exchangeco were formed to facilitate the Reverse Acquisition.
On October 18, 2024, we completed the Merger with TuHURA, and following the consummation of the Merger, changed our name from Kintara Therapeutics, Inc. to TuHURA Biosciences, Inc.
19
Outstanding Securities
As of November 12, 2024, we had 42,284,524 shares of common stock issued and outstanding.
Selected Quarterly Information
The financial information reported herein has been prepared in accordance with accounting principles generally accepted in the United States. Our functional currency at September 30, 2024, and June 30, 2024, is the US dollar. The following tables represent selected financial information for us for the periods presented.
Selected Balance Sheet Data
|
|
September 30, |
|
|
June 30, |
|
||
|
|
(in thousands) |
|
|||||
Cash and cash equivalents |
|
|
3,020 |
|
|
|
4,909 |
|
Working capital |
|
|
1,226 |
|
|
|
3,269 |
|
Total assets |
|
|
4,140 |
|
|
|
6,202 |
|
Total stockholders’ equity |
|
|
1,695 |
|
|
|
3,757 |
|
Selected Statement of Operations Data
For the three months ended
|
|
September 30, |
|
|
September 30, |
|
||
|
|
$ |
|
|
$ |
|
||
|
|
(in thousands, except per share data) |
|
|||||
Expenses |
|
|
|
|
|
|
||
Research and development |
|
|
252 |
|
|
|
1,859 |
|
General and administrative |
|
|
1,957 |
|
|
|
1,103 |
|
|
|
|
(2,209 |
) |
|
|
(2,962 |
) |
Other income |
|
|
|
|
|
|
||
Foreign exchange |
|
|
(1 |
) |
|
|
(2 |
) |
Interest, net |
|
|
49 |
|
|
|
2 |
|
|
|
|
48 |
|
|
|
— |
|
Net loss for the period |
|
|
(2,161 |
) |
|
|
(2,962 |
) |
Series A Preferred cash dividend |
|
|
(2 |
) |
|
|
(2 |
) |
Series C Preferred stock dividend |
|
|
(13 |
) |
|
|
(173 |
) |
Net loss for the period attributable to common stockholders |
|
|
(2,176 |
) |
|
|
(3,137 |
) |
Basic and fully diluted weighted average number of shares |
|
|
1,586 |
|
|
|
49 |
|
Basic and fully diluted loss per share |
|
|
(1.37 |
) |
|
|
(63.92 |
) |
Expenses, net of non-cash, share-based compensation expense – non-GAAP
The following table discloses research and development, and general and administrative expenses net of non-cash, share-based compensation payment expense. The disclosure has been provided to reconcile the total operational expenses on a GAAP basis and the non-GAAP operational expenses net of non-cash stock-based compensation in order to provide an estimate of cash used in research and development, and general and administrative expense. Management uses the cash basis of expenses for forecasting and budget purposes to determine the allocation of resources and to plan for future financing opportunities.
20
For the three months ended
|
|
September 30, |
|
|
September 30, |
|
||
|
|
$ |
|
|
$ |
|
||
|
|
(in thousands) |
|
|||||
Research and development – GAAP |
|
|
252 |
|
|
|
1,859 |
|
Less: non-cash, share-based compensation expense |
|
|
(38 |
) |
|
|
(86 |
) |
Research and development net of non-cash, share-based, compensation expense – Non-GAAP |
|
|
214 |
|
|
|
1,773 |
|
General and administrative – GAAP |
|
|
1,957 |
|
|
|
1,103 |
|
Less: non-cash, share-based compensation expense |
|
|
(63 |
) |
|
|
(121 |
) |
General and administrative net of non-cash, share-based, compensation expense – Non-GAAP |
|
|
1,894 |
|
|
|
982 |
|
Results of Operations
Comparison of the three months ended September 30, 2024, and September 30, 2023
|
|
Three months ended |
|
|
|
|
|
|
|
|||||||
|
|
September 30, |
|
|
September 30, |
|
|
Change $ |
|
|
Change % |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
252 |
|
|
|
1,859 |
|
|
|
(1,607 |
) |
|
|
(86 |
) |
General and administrative |
|
|
1,957 |
|
|
|
1,103 |
|
|
|
854 |
|
|
|
77 |
|
|
|
|
(2,209 |
) |
|
|
(2,962 |
) |
|
|
753 |
|
|
|
|
|
Other income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Foreign exchange |
|
|
(1 |
) |
|
|
(2 |
) |
|
|
1 |
|
|
|
(50 |
) |
Interest, net |
|
|
49 |
|
|
|
2 |
|
|
|
47 |
|
|
|
2,350 |
|
|
|
|
48 |
|
|
|
— |
|
|
|
48 |
|
|
|
|
|
Net loss |
|
|
(2,161 |
) |
|
|
(2,962 |
) |
|
|
801 |
|
|
|
|
|
Research and Development
Research and development expenses decreased to $252 for the three months ended September 30, 2024, from $1,859 for the three months ended September 30, 2023. The decrease was largely attributable to lower clinical development costs and related decreases in personnel and patent costs incurred during the three months ended September 30, 2024, compared to the three months ended September 30, 2023, primarily due to termination of the development of VAL-083 in October of 2023. Non-cash, share-based compensation expense decreased to $38 for the three months ended September 30, 2024, from $86 for the three months ended September 30, 2023, due to the recognition of higher compensation expense recognized during the three months ended September 30, 2023, for stock options granted in August 2023.
General and Administrative
General and administrative expenses were $1,957 for the three months ended September 30, 2024, compared to $1,103 for the three months ended September 30, 2023. A significant portion of the increase was a result of higher professional fees and special meeting fees incurred in relation to the transaction with TuHURA, offset by lower non-cash, share-based compensation expenses and a reduction in travel costs in the current three months compared to the same period in the prior fiscal year. Non-cash, share-based compensation expense decreased to $63 for the three months ended September 30, 2024, from $121 for the three months ended September 30, 2023, due to the recognition of higher compensation expense recognized during the three months ended September 30, 2023, for stock options granted in August 2023. Personnel, facilities, office and sundry costs have increased primarily due to special meeting costs, filing fees, and shareholder communication costs related to the transaction with TuHURA.
Preferred Share Dividends
For each of the three months ended September 30, 2024, and 2023, we recorded $2 related to the cash dividend payable to Valent on the Series A Preferred Stock. The dividend has been recorded as a direct increase in accumulated deficit for both periods. In addition, for the three months ended September 30, 2024, we recorded $13 (2023 - $173) related to the stock dividend payable to investors on the Series C Preferred Stock. The dividends have been recorded as a direct increase in accumulated deficit for both periods.
21
Liquidity and Capital Resources
Three months ended September 30, 2024, compared to the three months ended September 30, 2023
|
|
September 30, |
|
|
September 30, |
|
|
Change |
|
|
Change |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Cash flows from operating activities |
|
|
(1,889 |
) |
|
|
(1,317 |
) |
|
|
(572 |
) |
|
|
43 |
|
Cash flows from investing activities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
100 |
|
Cash flows from financing activities |
|
|
— |
|
|
|
(2 |
) |
|
|
2 |
|
|
|
(100 |
) |
Operating Activities
Net cash used in operating activities was $1,889 for the three months ended September 30, 2024, compared to $1,317 for the three months ended September 30, 2023. During the three months ended September 30, 2024, and 2023, we reported net losses of $2,161 and $2,962, respectively. Adjustments to reconcile net loss to net cash used in operating activities for the three months ended September 30, 2024, included stock option expense of $98 and restricted stock unit expense of $3 being recognized during the current period compared to $160 and $47, respectively, in the same period in the prior fiscal year.
The most significant change in working capital for the three months ended September 30, 2024, was related to a decrease in prepaid expenses, taxes and other receivables of $156. The most significant changes in working capital for the three months ended September 30, 2023, were related to the use of clinical trial deposit to settle clinical trial expenses of $1,075 and settlement of accounts payable and accrued liabilities of $214.
Investing Activities
There was no investing activity during the three months ended September 30, 2024 and 2023.
Financing Activities
Net cash used in financing activities was $nil for the three months ended September 30, 2024, compared to $2 for the three months ended September 30, 2023 for the payment of the quarterly Series A Preferred Share dividend, which was in accounts payable and accrued liabilities at September 30, 2024.
Going Concern and Capital Expenditure Requirements
Going Concern and Management Plans
(See note 1 to the condensed consolidated interim financial statements)
The condensed consolidated financial statements have been prepared on a going concern basis, which assumes that we will continue our operations for the foreseeable future and contemplates the realization of assets and the settlement of liabilities in the normal course of business.
For the three months ended September 30, 2024, we reported a loss of $2,161 and a negative cash flow from operations of $1,889. We had an accumulated deficit of $162,052 and had cash and cash equivalents of $3,020 as of September 30, 2024. We are in the clinical stage and have not generated any revenues to date. We do not have the prospect of achieving revenues until such time that our product candidate is commercialized, or partnered, which may not ever occur. On August 2, 2022, we entered into the Purchase Agreement under which we received approximately $2,008 in net proceeds as of September 30, 2024, for the issuance of an aggregate of 19 shares of common stock under the Purchase Agreement. On October 9, 2023, we received stockholder approval to issue 20% or more of our outstanding shares as of the date we entered into the Purchase Agreement with Lincoln Park. On February 22, 2024, we determined that we have concluded utilization of the equity facility pursuant to the terms of the Purchase Agreement. In addition, on June 28, 2023, we announced that we had been awarded approximately $2,000 in grant funding for our REM-001 project.
On September 19, 2023, we entered into a Sales Agreement, (the “Sales Agreement”) with AGP pursuant to which we may offer and sell, from time to time, through AGP, as sales agent and/or principal, shares of common stock having an aggregate offering price of up to $10,900 (the “ATM Facility”). From October 31, 2023, until September 30, 2024, we raised $10,471 in net proceeds from the sale of 1,519 shares of our common stock under the ATM Facility. On February 22, 2024, we determined that we have concluded utilization of the ATM facility.
Even with the proceeds from the grant funding, the stock purchase financing, and the ATM sales, we will require significant additional funding to maintain our clinical trials, research and development projects, and for general operations. These circumstances
22
indicate substantial doubt exists about our ability to continue as a going concern within one year from the date of filing of these condensed consolidated financial statements.
Consequently, management began pursuing various financing alternatives to fund our operations in the short and long term and so we can continue as a going concern. In addition, we initiated a process to explore and review a range of strategic alternatives focused on maximizing shareholder value, and as a result, entered into the Merger Agreement for the Merger with TuHURA, which closed on October 18, 2024. Our ability to raise additional capital is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence. We may not be able to raise sufficient additional capital and may tailor our drug candidate development program based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
The condensed consolidated financial statements do not give effect to any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Such adjustments could be material.
Our future funding requirements will depend on many factors, including but not limited to:
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, or strategic collaborations. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our shares of capital stock. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. Economic conditions may affect the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan, file for bankruptcy protection or pursue a dissolution of the Company and liquidation of all of our remaining assets. In such an event, the amount of cash available for distribution to our shareholders, if any, will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations. We cannot provide assurance as to the amount of cash that will be available to distribute to shareholders, if any, after paying our debts and other obligations and setting aside funds for reserves, nor as to the timing of any such distribution, if any.
Critical Accounting Policies and Estimates
The preparation of financial statements, in conformity with generally accepted accounting principles in the United States, requires companies to establish accounting policies and to make estimates that affect both the amount and timing of the recording of assets, liabilities, revenues and expenses. Some of these estimates require judgments about matters that are inherently uncertain and therefore actual results may differ from those estimates.
A detailed presentation of all of our significant accounting policies and the estimates derived therefrom is included in Note 2 to our consolidated financial statements for the year ended June 30, 2024, contained in our Annual Report on Form 10-K filed with the SEC on October 7, 2024. While all of the significant accounting policies are important to our consolidated financial statements, the following accounting policies and the estimates derived therefrom are critical:
Fair value of financial instruments
Accruals for research and development expenses and clinical trials
23
Fair value of financial instruments
We recognize compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. Prior to our adoption of Accounting Standards Update 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), stock options granted to non-employee consultants were revalued at the end of each reporting period until vested using the Black-Scholes option-pricing model and the changes in their fair value were recorded as adjustments to expense over the related vesting period. For the three months ended September 30, 2024, and 2023, the determination of grant-date fair value for stock option awards was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, the anticipated exercise behavior of its grantee, interest rates, and dividend yields. For the three months ended September 30, 2024, and 2023, we utilized the plain vanilla method to determine the expected life of stock options. These variables are projected based on our historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of actual forfeitures, using the accelerated attribution method. We recognize forfeitures as they occur. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results, or updated estimates, differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised.
For the three months ended September 30, 2024, and 2023, we issued stock options to our officers. The determination of grant-date fair value for options granted was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, interest rates, dividend yields, and the term of the option.
Accruals for research and development expenses and clinical trials
As part of the process of preparing our financial statements, we are required to estimate our expenses resulting from our obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. Our objective is to reflect the appropriate expenses in our financial statements by matching those expenses with the period in which services are performed and efforts are expended. We account for these expenses according to the timing of various aspects of the expenses. We determine accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period. For the three months ended September 30, 2024, and 2023, there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
24
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not required for a smaller reporting company.
Item 4. Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Form 10-Q, has concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the quarter ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
25
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
There are no legal proceedings the Company is party to or any of its property is subject to.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully consider the factors discussed in (i) Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended June 30, 2024 filed with the SEC on October 7, 2024, and (ii) the section entitled “Risk Factors” in our proxy statement/prospectus filed with the SEC on August 19, 2024 (the “Proxy Statement”) in connection with our Registration Statement on S-4 related to the Merger, which are incorporate herein by reference and could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K and Proxy Statement may not be the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.
There were no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K and Proxy Statement.
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
26
Item 6. Exhibits.
The exhibits listed below are filed or furnished as part of this Quarterly Report on Form 10-Q.
EXHIBIT INDEX
Exhibit Number |
|
Description |
|
|
|
31.1 |
|
|
|
|
|
31.2 |
|
|
|
|
|
32.1 |
|
|
|
|
|
32.2 |
|
|
|
|
|
EX-101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document* |
|
|
|
EX-101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document* |
|
|
|
EX-101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document* |
|
|
|
EX-101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document* |
|
|
|
EX-101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document* |
|
|
|
EX-101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document* |
|
|
|
104 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
||
* Filed herewith
** The certification furnished in Exhibit 32.1 and Exhibit 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference.
27
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
Kintara Therapeutics, Inc. |
|
|
|
|
Date: November 14, 2024 |
By: |
/s/ James A. Bianco |
|
|
James A. Bianco |
|
|
Chief Executive Officer (Principal Executive Officer) |
|
Kintara Therapeutics, Inc. |
|
|
|
|
Date: November 14, 2024 |
By: |
/s/ Dan Dearborn |
|
|
Dan Dearborn |
|
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
28