美國
證券交易委員會
華盛頓特區20549
表格
| (標記一個) | |
| | 根據證券交易法案第13或15(d)條條文提交的季度報告 |
截止至本季度結束
| | 根據證券交易法案第13或15(d)條條文提交的過渡報告 |
在從⋯到⋯的過渡期間
委員會檔案編號：
| monopar therapeutics inc | ||
| （依憑章程所載的完整登記名稱） |
| | | |
| (依據所在地或其他管轄區) 的註冊地或組織地點) | (I.R.S. 僱主識別號碼) 1000 Skokie Blvd., Suite 350 |
| | | |
| (總部辦公地址) | 388-0349 |
(
MNPR’(納斯達克資本市場)
根據法案第12(b)條規定註冊的證券：
| 每種類別的名稱 | 交易 標的 | 每個交易所的名稱 註冊在哪裡的 | ||
| | | 輝瑞公司面臨數起分開的訴訟，這些訴訟仍在進行中，需等待第三項索賠條款的裁決。2023年9月，我們與輝瑞公司同意合併2022和2023年的訴訟，並將審判日期從2024年11月推遲至2025年上半年，具體時間將由法院確定。 ☒ 是 ☐ 否 |
☒ 是 ☐ 否
請勾選以下項目，以判定在過去12個月(或更短期間，該註冊人被要求提交報告)內所有根據1934年證券交易法第13條或第15(d)條要求提供報告的報告是否已經提交，並且該註冊人在過去90天中是否受到提交報告的要求。
請在選框內打勾，確認註冊人是否在過去12個月內（或註冊人需要提交此類文件更短的期限內）根據Regulation S-t第405條規定提交了必須提交的所有互動數據文件。
請勾選該申報者是否為大型快速申報者、快速申報者、非快速申報者、小型報告公司或新興成長公司。請參閱交易所法案第1202條中“大型快速申報者”、“快速申報者”、“小型報告公司”和“新興成長公司”的定義。
| 大型加速歸檔人 | ☐ | 加速歸檔人 | ☐ |
| | ☒ | 小型報告公司 | |
| 新興成長型企業 | |
如果一家新興成長型公司，請用勾選標記表示該申報人已選擇不使用根據證交所法案13(a)條款提供的任何新的或修訂過的財務會計準則的延長過渡期。
請勾選是否申報公司為空殼公司（按照法規定義第120億2條）。是
截至2024年10月31日，我們每類普通股的流通股數如下所示:
| Class A普通股 | 流通股數 | |
| 每股普通股，每股面值$0.001 | |
前瞻性陳述
本表格10-Q季度報告包含根據1933年證券法第27A條修訂版（「法案」）和1934年證券交易法第21E條修訂版的「前瞻性陳述」。除本10-Q季度報告中包含的歷史事實陳述外，所有其他陳述均為前瞻性陳述。使用「期望」、「相信」、「預期」、「計劃」、「尋求」、「估計」、「項目」、「期望」、「打算」、「可能」、「可以」、「應該」、「將」、「繼續」等類似表達旨在識別前瞻性陳述。下述不確定性和因素，以及其他因素，可能影響未來業績，並導致實際結果與前瞻性陳述中表述或暗示的事項有實質差異：
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我們為了支持持續進行臨床、監管和商業發展計劃，以及提前付款和未來里程碑支付，需要籌集足夠的資金；我們還需要在未來進一步籌集額外資金，以支持任何現有或未來的產品候選計劃直至完成臨床試驗、獲批過程，以及如適用，商業化。 |
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我們籌集所有基金類型的能力要在可接受的條件下進行。 |
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我們能夠找到合適的藥品合作夥伴或合作夥伴，以進一步推動我們的開發工作，在可接受的財務條件下； |
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與我們或任何開發夥伴的研究和開發活動相關的風險和不確定性，包括臨床前研究、臨床試驗、監管提交、製造業和品質費用。 |
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發展放射藥物治療和影像試劑以及銅螯合治療所涉及的已知和未知風險。 |
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臨床試驗和監管審批期限的不確定性，以及產品上市批准的時間表。 |
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我們有能力應對目前放射藥物項目或未來藥物候選者可能的有限保存期所帶來的履行和物流挑戰。 |
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我們有能力以合理的成本獲得我們目前正在使用或可能納入我們藥物候選者中的放射性同位素供應。 |
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針對我們打算開展的關於ALXN-1840的監管討論及其後果所涉及的不確定性； |
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市場接受率、價格、功效和安全性方面的市場競爭力，對於我們獲得行銷認可的任何產品的市場接受率和競爭力，以及與較大藥品公司相比，我們競爭性地推廣這些產品的能力； |
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商業化、營銷和產品製造以及整體策略的困難； |
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知識產權狀況和策略的不確定性，包括新發現和專利申請。 |
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我們有能力吸引和留住經驗豐富和合格的關鍵人員，或者找到並利用外部的經驗、專業知識以及科學、醫療和商業化知識來完成新產品的產品開發和商業化。 |
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我們對所需支出水平、資本需求和可接受條件下獲得所需額外融資的估計所隱含的風險。 |
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美國總統和國會選舉結果對經濟和未來政府法律法規的影響，包括加強政府對醫療保健和製藥業的控制，導致直接價格控制降低價格，其他政府法規影響出售治療或成像產品的成本要求和結構，以及最近的政府立法影響其他行業，可能間接增加我們獲得商品和服務的成本以及我們的資本成本。 |
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不確定COVID-19再度爆發或另一場大流行可能對我們推進臨床計劃和籌集額外融資的能力造成的影響。 |
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國內和全球通脹的累計影響，金融市場的波動，以及經濟衰退的可能性，都可能使我們獲得商品和服務的成本增加，或者使融資更難於以可接受條件獲得，甚至一點也得不到。 |
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俄羅斯-烏克蘭戰爭、以色列-哈馬斯戰爭或任何潛在未來衝突對我們臨床材料製造業的支出和時間表、以及對一般政治、經濟、貿易和金融市場情況帶來的不確定影響； |
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財務預測和運營時間表的不確定性以及新競爭性產品和技術的發展。 |
儘管我們相信該前瞻性陳述中確定的風險評估是適當的，但我們無法保證這些風險會實現。請謹慎閱讀本季度報告表10-Q中的謹慎性聲明，包括有關前瞻性陳述的“第1A項 - 風險因素”部分的聲明。本文中我們或代表我們採取的任何後續書面或口頭前瞻性陳述都被謹慎聲明徹底限定。我們不承擔任何義務更新本季度報告表10-Q或其他地方發表的任何聲明，包括但不限於任何前瞻性陳述，除非法律要求。
本季度報告中的任何前瞻性陳述反映了我們對未來事件或我們未來財務表現的當前看法，涉及已知和未知的風險、不確定性和其他可能導致我們實際結果、表現或成就與這些前瞻性陳述所暗示的任何未來結果、表現或成就有實質差異的因素。基於估計、預測、預測、市場研究或類似方法論的資訊 inherently受到不確定性的影響，實際事件或情況可能與此信息中預測的事件和情況有實質差異。
風險因素摘要
我們的業務受到許多風險和不確定性的影響，包括在我們於2023年12月31日提交給證券交易委員會的10-k表格的“第1A條 - 風險因素”中突出顯示的風險，以及本季度10-Q報告的“第1A條 - 風險因素”中突出顯示的風險。這些風險包括但不限於以下：
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我們是一家處於臨床階段的生物技術公司，歷史上一直虧損。我們預計在可預見的將來將繼續遭受重大損失，可能永遠無法實現或維持現金自給自足或盈利能力，這可能導致我們普通股市值下降。 |
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| ● | 我們能夠籌集足夠資金，以支持持續進行我們項目的臨床、監管和商業開發，以及支付合同的進度款和未來里程碑款，以及在未來進一步籌集額外資金，以支持現有或未來產品候選項目的進行，直至完成臨床試驗、批准過程並在適當情況下商業化。 | |
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盡管ALXN-1840的關鍵第3期試驗已經完成，並在本報告的其他地方描述了其主要終點，但根據從第2期機械性試驗和與監管機構的討論的結果，Alexion最終終止了在Wilson氏症中基於ALXN-1840計畫。在短期內，我們將重點放在組裝監管文件並與美國食品和藥品管理局（FDA）開展討論。這些討論的結果以及該計畫所需的額外資金存在不確定性。 | |
| ● | 審批過程可能會冗長、昂貴且不確定。美國食品藥品監督管理局和世界各地其他監管機構可能要求我們進行額外的非臨床和/或臨床研究以獲得ALXN-1840批准，我們可能無法籌集到完成這些研究所需的資金或其結果可能未達到FDA和其他監管機構所需的臨床或統計重要性水平。 |
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我們目前沒有且可能永遠不會擁有任何在市場上批准銷售的產品。我們的業務高度依賴於獲得美國和國際各種政府機構的營銷批准，如果我們未獲准製造和銷售我們的產品候選者，將嚴重損害我們的業務。 | |
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我們的臨床試驗可能無法為監管機構批准我們產品的營銷和銷售提供足夠的確定性結果，這將對我們的財務狀況產生不利影響。 |
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如果我們在臨床試驗中病患招募方面遇到延遲或困難，我們獲得必要的監管批准將會延遲或受阻，這可能會大幅延遲我們的計劃進度並對我們的財務狀況產生不利影響。 |
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如果我們或我們的許可證持有人、開發合作夥伴或供應商無法按照規定的質量規格足夠量製造我們的產品，或者無法為製造設施獲得監管批准，我們可能無法開發和/或滿足對產品的需求，同時將失去市場時間和潛在收入。 | |
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我們依賴合格的第三方進行我們的原料藥製造、我們的藥品製造、非臨床研究和我們的臨床試驗。如果這些第三方未能或無法成功履行其合同義務並按照預期的期限或績效目標進行，我們的臨床試驗的啟動或進行將會延遲，我們可能無法取得對我們目前產品候選品或任何未來產品的監管機構批准，或商業化，我們的財務狀況將受不利影響。 |
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放射性藥品技術是一種相對新穎的癌症影像和治療方法，可能為其帶來重大且潛在不可預測的挑戰，包括放射性同位素的供應、對放射性藥品安全性的潛在誤解，以及由於其新穎性而造成的市場接受程度低。對這些挑戰的認知可能會使我們在專注於放射性藥品計畫時更難籌集資金。 |
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俄烏戰爭，導致對俄羅斯和俄羅斯實體實施制裁，以及俄羅斯減少對歐盟和其他盟友的燃料幣供應，都導致燃料成本上升，減少獲取關鍵物資的途徑，並可能導致船期延誤。與此同時，以色列 - 哈馬斯戰爭帶來額外的不確定性。此時對更廣泛的政治、經濟、貿易和金融市場的影響仍不明朗，這可能會增加我們臨床材料的供應成本，延遲臨床材料的製造，限制放射性同位素的供應，增加其他商品和服務的成本，或使籌集額外融資更加困難或昂貴，這些都可能對我們的臨床和臨床前計劃以及我們的財務狀況產生不利影響。 |
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市場變數，如產品成本、勞動力費用、燃料、貨運和能源成本的通脹，以及地緣政治事件可能會導致我們的營運和行政費用大幅增加。 |
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不穩定的市場和經濟狀況，例如市場的波動性，由於對銀行穩定性的擔憂和通脹帶來的經濟挑戰，可能對我們籌集資金的能力造成嚴重不利影響，這可能導致我們延遲、重組或停止營運。 | |
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美國總統和國會選舉結果對經濟和未來政府法律法規的影響，包括潛在增加政府對醫療和藥品的控制，導致直接價格控制壓低價格，其他政府法規影響販售治療或影像產品的成本要求和結構，以及最近的政府立法影響其他行業，這些可能間接增加我們獲取商品和服務的成本和資本成本。 | |
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我們在目標醫療領域面臨來自其他放射藥品、生物技術和藥品公司，以及具有基於研究的學術醫療機構的重大競爭，如果我們無法有效競爭，我們的營運結果將受到不利影響。我們行業中許多競爭對手擁有更強大的組織能力、更高的資本資源，以及在目標市場上已建立的行銷和銷售資源和經驗。競爭和技術變革可能使我們的產品候選者過時或難以競爭。 |
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第三方許可的終止將對我們開發和銷售產品至關重要的化合物或技術的權利造成不利影響。 | |
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如果我們和我們的第三方許可方無法獲得和保護各自的知識產權，我們的競爭對手可能能夠開發和銷售競爭性藥物，這將對我們的財務狀況產生不利影響。 |
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如果我們失去關鍵管理領導人員，和/或我們科學人員的專業知識和經驗，且我們無法招募合格的員工或其他高素質和有經驗的人員滿足未來需求，我們將面臨重大計劃延遲和增加的運營和補償成本風險，我們的業務將受到重大干擾。 |
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| ● | COVID-19或其他疫情的未來或長期影響仍不確定，其範圍和影響可能對我們的業務、財務狀況、營運成果、股價和籌集額外基金的能力產生重大負面影響。 |
財務信息
縮編合併
資產負債表
(未經查核)
| 2024年9月30日 | 2023年12月31日* | |||||||
| 資產 | ||||||||
| 流動資產: | ||||||||
| 現金及現金等價物 | $ | $ | ||||||
| 其他流動資產 | ||||||||
| 全部流動資產 | ||||||||
| 經營租賃權使用資產 | ||||||||
| 資產總額 | $ | $ | ||||||
| 550,714 | ||||||||
| 流動負債： | ||||||||
| 應付帳款、應計費用及其他流動負債 | $ | $ | ||||||
| 總負債 | ||||||||
| 承諾事項和或附帶條件（注8） | ||||||||
| 股東權益： | ||||||||
| 每股普通股面額$ 每份股份， 股份已授權 和 分於2024年9月30日和2023年12月31日分別發行和尚未售出的股份 ** | ||||||||
| 資本公積額額外增資 | ||||||||
| 累積其他全面損失 | ( | ) | ( | ) | ||||
| 累積虧損 | ( | ) | ( | ) | ||||
| 股東權益總額 | ||||||||
| 負債和股東權益總額 | $ | $ | ||||||
* 源自公司經過審計的綜合基本報表。
** 與股份發行數量相關的資訊具有追溯效應，這是一項於2024年8月12日生效的1比5逆向股票合併。
附註是這些簡明合併財務報表不可或缺的一部分。
縮編合併
損益及全面損益表
(未經查核)
| 截至9月30日的三個月 | 截至9月30日的九個月 | |||||||||||||||
| 2024 |
2023 |
2024 |
2023 |
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| 營業費用： |
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| 研發費用 |
$ | $ | $ | $ | ||||||||||||
| 總務與行政 |
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| 營業費用總計 |
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| 營運虧損 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| 其他收入 |
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| 利息收入 |
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| 淨損失 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| 其他綜合損益： |
||||||||||||||||
| 外匯翻譯收益（損失） |
( |
) | ||||||||||||||
| 投資未實現收益（損失） |
( |
) | ( |
) | ( |
) | ||||||||||
| 全面損失 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| 每股淨損失： |
||||||||||||||||
| 基本和稀釋的 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| 加權平均股本數: |
||||||||||||||||
| 基本和稀釋的** |
||||||||||||||||
**有關流通股數和每股數據的資訊，將對一項在2024年8月12日生效的1比5的股票逆向分拆產生追溯效應。
相關附註是這些基本報表的一個不可或缺的部分。
股東權益的縮編合併財務報表’ 股本
截至2024年9月30日的三個和九個月結束了。
(未經查核)
| 累計 | ||||||||||||||||||||||||
| 額外的 | 其他 | 總計 | ||||||||||||||||||||||
| 普通股** | 已付款 | 綜合 | 累計 | 股東权益 | ||||||||||||||||||||
| 股份 | 金額 | 股本中的資本金** | 收入（損失） | 赤字累計 | 股權 | |||||||||||||||||||
| 2024 年 1 月 1 日結存 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| 根據即時需求發行普通股TM 與JonesTrading Institutional Services, LLC簽訂銷售協議，扣除佣金、費用和發行成本$ | ||||||||||||||||||||||||
| 根據授予的限制性股份單位給員工發行普通股，扣除稅款後 | ( | ) | ( | ) | ||||||||||||||||||||
| 以股份為基礎的報酬（非現金） | — | |||||||||||||||||||||||
| 淨損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 其他綜合收益，淨額 | — | |||||||||||||||||||||||
| 2024年3月31日止結餘 | ( | ) | ||||||||||||||||||||||
| 對已取得限制性股票單位的員工發行普通股股份，扣除稅款後 | ( | ) | ( | ) | ||||||||||||||||||||
| 行使股票期權 | ||||||||||||||||||||||||
| 以股份為基礎的補償（非現金） | — | |||||||||||||||||||||||
| 淨損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 其他綜合收益，淨額 | — | |||||||||||||||||||||||
| 2024年6月30日餘額 | ( | ) | ||||||||||||||||||||||
| 對已取得限制性股票單位的員工發行普通股股份，扣除稅款後 | ( | ) | ( | ) | ||||||||||||||||||||
| 以股份為基礎的補償（非現金） | — | |||||||||||||||||||||||
| 逆向股票合併對分數股股份的损害 | ||||||||||||||||||||||||
| 與市場認購採購費用有關的發售成本 | — | ( | ) | ( | ) | |||||||||||||||||||
| 淨損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 其他綜合損失，淨額 | — | ( | ) | ( | ) | |||||||||||||||||||
| 2024年9月30日結餘 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
** 關於股份總量的資訊，其包含對一宗於2024年8月12日生效的1比5股票合併所產生的追溯效應。
相關附註是這些基本報表的一個不可或缺的部分。
monopar therapeutics inc。
股東權益的縮編合併財務報表’ 股權
截至2023年9月30日的三個月和九個月
(未經查核)
| 累計 | ||||||||||||||||||||||||
| 額外的 | 其他 | 總計 | ||||||||||||||||||||||
| 普通股** | 已付款 | 綜合 | 累計 | 股東权益 | ||||||||||||||||||||
| 股份 | 金額 | 股本中的資本金** | 收入（損失） | 赤字累計 | 股權 | |||||||||||||||||||
| 2023 年 1 月 1 日結存 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||
| 根據需求發行普通股TM 與JonesTrading Institutional Services, LLC的銷售協議，扣除佣金、費用和發行成本$ | ||||||||||||||||||||||||
| 發行普通股給非僱員董事，根據已發行的限制性股票單位 | ( | ) | ||||||||||||||||||||||
| 發行普通股給員工，根據已發行的限制性股票單位，扣除稅款 | ( | ) | ( | ) | ||||||||||||||||||||
| 以股份為基礎的報酬（非現金） | — | |||||||||||||||||||||||
| 淨損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 其他綜合收益 | — | |||||||||||||||||||||||
| 2023年3月31日結束餘額 | ( | ) | ||||||||||||||||||||||
| 根據需求資金進行普通股發行Tm 與JonesTrading機構服務有限責任公司的銷售協議，扣除$ 的佣金、費用和發行成本 | ||||||||||||||||||||||||
| 按照已發行的受限制股份單位給非雇員董事進行普通股發行 | ( | ) | ||||||||||||||||||||||
| 按照已發行的受限制股份單位給員工進行普通股發行，扣除稅款 | ( | ) | ( | ) | ||||||||||||||||||||
| 股票基於償償（非現金） | — | |||||||||||||||||||||||
| 淨損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 其他全面損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 2023年6月30日結餘 | ( | ) | ||||||||||||||||||||||
| 按已實現限制股單位向非員工董事發行普通股 | ||||||||||||||||||||||||
| 按已實現限制股單位向員工發行普通股，扣除稅款後 | ( | ) | ||||||||||||||||||||||
| 行使股票期權獲發的普通股份 | ( | ) | ( | ) | ||||||||||||||||||||
| 與股票控股相關的補償（非現金） | — | |||||||||||||||||||||||
| 淨損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 其他全面損失 | — | ( | ) | ( | ) | |||||||||||||||||||
| 截至2023年9月30日的結餘 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||
** 與股份發行數量相關的資訊具有追溯效應，這是一項於2024年8月12日生效的1比5逆向股票合併。
相關附註是這些基本報表的一個不可或缺的部分。
縮編合併
Statements of Cash Flows (未經查核)
| 截至年終前九個月 |
||||||||
| 九月三十日， |
||||||||
| 2024 |
2023 |
|||||||
| 經營活動現金流量： |
||||||||
| 淨損失 |
$ | ( |
) | $ | ( |
) | ||
| 調整為使淨虧損轉化為經營活動所使用現金： |
||||||||
| 以股票為基礎的薪酬支出（非現金） |
||||||||
| 營運資產和負債的變動，淨額 |
||||||||
| 其他流動資產 |
( |
) | ||||||
| 應付帳款、應計費用及其他流動負債 |
( |
) | ( |
) | ||||
| 營運租賃權益資產和負債，淨額 |
||||||||
| 經營活動所使用之淨現金流量 |
( |
) | ( |
) | ||||
| 投資活動之現金流量: |
||||||||
| 購買短期投資 |
( |
) | ( |
) | ||||
| 短期投資到期 |
||||||||
| 投資活動產生的淨現金流量 |
||||||||
| 來自籌資活動的現金流量: |
||||||||
| 普通股股份在隨需資本下的出售所獲得的現金收益Tm 銷售協議 |
||||||||
| 行使股票期權 |
||||||||
| 與凈股份結算的授予限制性股票單位相關的支付的稅金 |
( |
) | ( |
) | ||||
| 融資活動提供的淨現金 |
||||||||
| 匯率之影響 |
( |
) | ||||||
| 現金及現金等價物淨減少額 |
( |
) | ( |
) | ||||
| 期初現金及現金等價物餘額 |
||||||||
| 期末現金及現金等價物 |
$ | $ | ||||||
相關附註是這些基本報表的一個不可或缺的部分。
業務性質
monopar therapeutics inc（「Monopar」或「公司」）是一家臨床階段的生物技術公司，專注於晚期ALXN-1840 用於威爾森氏症的及放射藥物節目，包括第 1階段MNPR-101-Zr，用於影像診斷愛文思控股 1a第101-Lu和已晚期前臨床階段的MNPR-101-Ac225，用於治療愛文思控股 的技術。
流動性
該公司已經累積虧損約 $
持續經營評估
公司採用會計準則編碼。 205-40 (ASC 205-40”), 揭露有關實體之不確定性的信息’公司能否持續經營存疑，這是財務會計準則委員會（FASB）發布的，用於指導上市公司在何時以及如何披露其基本報表中之持續經營不確定性的指南。ASC 205-40 要求管理層對實體持續作為持續經營的評估，須於該實體基本報表發布日期後的一年之內進行中間及年度評估。 一年。 年（或在 一年。 基本報表可供發布之日起一年後（如適用）。此外，如果企業存在「對實體能否持續作為營運實體存在重大疑慮」，則公司必須提供某些披露。 2024年10月， 公司至少分析了其現金需求，至少到2025年12月31日為止。 公司分析了其現金需求，至少需到2025年12月31日。 並已確定，基於公司當前可用現金，公司對其能否持續作為營運實體存在重大疑慮。 無 對其能否持續作為營運實體存在重大疑慮。
風險與不確定因素
與公司財務狀況和資本需求相關的風險
很多，如果 不 大多數生物技術公司永遠不會獲利，而且在成功開發任何從商業銷售中產生收入的產品，並且在成功開發任何從商業銷售產生收入的產品以促進盈利能力之前，都被收購、合併本公司自成立以來一直遭受虧損，預計未來幾年將繼續承受重大的營運損失。這些損失源於本公司目前和未來的授權及/或購買產品候選產品的臨床發展，並在可預見的未來將繼續進行。因此，本公司預計未來將尋求籌集額外資本 12 數月來為我們未來的營運提供資金。本公司能夠籌集足夠的資金，以支持持續的臨床、監管和商業發展，並進行合約未來里程碑付款，以及在未來進一步籌集額外資金，以支持任何現有或未來的產品候選計劃，通過完成臨床試驗，批准程序和（如適用）商業化為不確定。
公司未來虧損金額以及何時（如果有可能）公司會變得有利可圖，都是不確定的。公司能否產生營業收入並實現盈利將取決於許多因素，包括其產品候選品開發的成功完成；從美國FDA和國際監管機構獲得必要的監管批准；建立製造/品質、銷售、市場營銷和經銷安排等。 第三方 第三方支付者的賠償足夠；以及籌集足夠的資金來資助其活動。如果公司在這些事業中的一些或全部方面不成功，其業務、財務狀況和營運結果預計將受到重大不利影響。 第三方如果公司在這些任務中的一些或全部失敗，預計將對其業務、財務狀況和營運結果造成重大且不利影響。
請參閱注釋 2 – 重大會計政策
報告基礎
這些綜合經營的基本報表包括了monopar therapeutics inc的財務結果，其全資法國子公司monopar therapeutics, SARL，以及其全資澳洲子公司monopar therapeutics australia pty ltd，並已按照美國普遍公認的會計原則（“GAAP”）編製，包括財務報告所需的所有GAAP披露資料。所有公司內部帳戶已被取消。在編製這些綜合經營的基本報表時採用的主要會計政策如下所述，並且在所列的所有期間中均已一致應用。公司主要從事研究活動、開發產品候選者，並籌集資金來支持和擴大這些活動。
The accompanying interim unaudited condensed consolidated financial statements contain all normal, recurring adjustments necessary to present fairly the Company’s condensed consolidated financial position as of September 30, 2024, and the Company’s condensed consolidated results of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, and the Company’s condensed consolidated cash flows for the nine months ended September 30, 2024 and 2023.
The interim condensed consolidated results of operations and comprehensive loss and condensed consolidated cash flows for the periods presented are not necessarily indicative of the condensed consolidated results of operations or cash flows which may be reported for the remainder of 2024 or for any future period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 28, 2024.
Functional Currency
The Company’s consolidated functional currency is the U.S. Dollar. The Company’s Australian subsidiary and French subsidiary use the Australian Dollar and European Euro, respectively, as their functional currency. At each quarter-end, each foreign subsidiary’s balance sheets are translated into U.S. Dollars based upon the quarter-end exchange rate, while their statements of operations and comprehensive loss and statements of cash flows are translated into U.S. Dollars based upon an average exchange rate during the period.
Comprehensive Loss
Comprehensive loss represents net loss plus any income or losses not reported in the condensed consolidated statements of operations and comprehensive loss, such as foreign currency translations gains and losses and unrealized gains and losses on debt security investments that are reflected on the Company’s condensed consolidated statements of stockholders’ equity.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and reported amounts of expenses in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
Cash Equivalents
The Company considers all highly liquid investments purchased with a maturity of three months or less on the date of purchase to be cash equivalents. Cash equivalents as of September 30, 2024 and December 31, 2023, consisted of two money market accounts and U.S. Treasury Bills.
Investments
The Company considers all of its investments in debt securities (U.S. Government or Agencies), with maturities at the date of purchase from over three months to one year to be available-for-sale securities. These investments are recorded at fair value with the unrealized gains and losses reflected in accumulated other comprehensive income (loss) on the Company’s condensed consolidated balance sheets. Realized gains and losses from the sale of investments, if any are determined, are recorded net in the condensed consolidated statements of operations and comprehensive loss. The investments selected by the Company have a low level of inherent credit risk given they are issued by the U.S. government and any changes in their fair value are primarily attributable to changes in interest rates and market liquidity. Investments as of September 30, 2024 consisted of U.S. Treasury Bills with maturities of less than three months.
Prepaid Expenses
Prepayments are expenditures for goods or services before the goods are used or the services are received and are charged to operations as the benefits are realized. Prepaid expenses may include payments to development collaborators in excess of actual expenses incurred by the collaborator measured at the end of each reporting period. Prepayments also include insurance premiums, dues and subscriptions and software costs of $
Leases
Lease agreements are evaluated to determine whether an arrangement is or contains a lease in accordance with ASC 842, Leases. Right-of-use lease assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The right-of-use lease asset on the Company’s condensed consolidated balance sheets includes any lease payments made and excludes lease incentives. The incremental borrowing taking into consideration the Company’s credit quality and borrowing rate for similar assets is used in determining the present value of future payments. Lease expense is recorded as general and administrative expenses on the Company’s condensed consolidated statements of operations and comprehensive loss.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. The Company maintains cash and cash equivalents at two reputable financial institutions. As of September 30, 2024, the balance at one financial institution was in excess of the $
Fair Value of Financial Instruments
For financial instruments consisting of cash and cash equivalents, investments, accounts payable, accrued expenses, and other current liabilities, the carrying amounts are reasonable estimates of fair value due to their relatively short maturities.
The Company adopted ASC 820, Fair Value Measurements and Disclosures, as amended, which addresses the measurement of the fair value of financial assets and financial liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date.
The standard establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources. Unobservable inputs reflect a reporting entity’s pricing an asset or liability developed based on the best information available under the circumstances. The fair value hierarchy consists of the following three levels:
Level 1 - instrument valuations are obtained from real-time quotes for transactions in active exchange markets involving identical assets.
Level 2 - instrument valuations are obtained from readily available pricing sources for comparable instruments.
Level 3 - instrument valuations are obtained without observable market values and require a high-level of judgment to determine the fair value.
Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. There were no transfers between Level 1, 2 or 3 of the fair value hierarchy during the three and nine months ended September 30, 2024 and 2023. The following table presents the assets that are reported at fair value on the Company's condensed consolidated balance sheets on a recurring basis. No values were recorded in Level 2 or Level 3 as of September 30, 2024 and December 31, 2023. The Company has no liabilities reported at fair value on a recurring basis
Assets Measured at Fair Value on a Recurring Basis
| September 30, 2024 | Level 1 | Total | ||||||
| Assets: | ||||||||
| Cash equivalents(1) | $ | $ | ||||||
| Total | $ | $ |
| |||||
| December 31 2023 | Level 1 | Total | ||||||
| Assets: | ||||||||
| Cash equivalents(1) | $ | $ | ||||||
| Total | $ | $ | ||||||
| (1) | Cash equivalents as of September 30, 2024 and December 31, 2023, represent the fair value of the Company’s investment in two money market accounts and U.S. Treasury Bills with maturities at the date of purchase of three months or less. | |
Net Loss per Share
Net loss per share for the three and nine months ended September 30, 2024 and 2023, is calculated by dividing net loss by the weighted-average shares of common stock outstanding during the periods. Diluted net loss per share for the three and nine months ended September 30, 2024 and 2023, is calculated by dividing net loss by the weighted-average shares of the sum of a) weighted average common stock outstanding (
Research and Development Expenses
Research and development (“R&D”) costs are expensed as incurred. Major components of R&D expenses include salaries and benefits paid to the Company’s R&D staff, compensation expenses of G&A personnel performing R&D, fees paid to consultants and to the entities that conduct certain R&D activities on the Company’s behalf and costs of materials and supplies which were used in R&D activities during the reporting period.
Clinical Trials Accruals
The Company accrues and expenses the costs for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with contract research organizations, service providers, and clinical trial sites. The Company estimates the amounts to accrue based upon discussions with internal clinical personnel and external service providers as to progress or stage of completion of trials or services and the agreed upon fees to be paid for such services. Costs of setting up clinical trial sites for participation in the trials are expensed immediately as R&D expenses. Clinical trial site costs related to patient screening and enrollment are accrued as patients are screened/entered into the trial.
Collaborative Agreements
The Company and its collaborative partners are active participants in collaborative agreements and all parties would be exposed to significant risks and rewards depending on the technical and commercial success of the activities. Contractual payments to the other parties in collaboration agreements and costs incurred by the Company when the Company is deemed to be the principal participant for a given transaction are recognized on a gross basis in R&D expenses. Royalties and license payments are recorded as earned.
During the three and nine months ended September 30, 2024 and 2023, no milestones were met, and no royalties were earned; therefore, the Company did not pay or accrue/expense any license or royalty payments.
Licensing Agreements
The Company has various agreements licensing technology utilized in the development of its product or technology programs. The licenses contain success milestone obligations and royalties on future sales. During the three and nine months ended September 30, 2024 and 2023, no milestones were met, and no royalties were earned; therefore, the Company did not pay or accrue/expense any license or royalty payments under any of its license agreements.
See Note 8 for additional discussion regarding the Company’s Licensing Agreements.
Patent Costs
The Company expenses costs relating to issued patents and patent applications, including costs relating to legal, renewal and application fees, as a component of general and administrative expenses in its condensed consolidated statements of operations and comprehensive loss.
Income Taxes
The Company uses an asset and liability approach for accounting for deferred income taxes, which requires recognition of deferred income tax assets and liabilities for the expected future tax consequences of events that have been recognized in its financial statements but have not been reflected in its taxable income. Estimates and judgments are required in the calculation of certain tax liabilities and in the determination of the recoverability of certain deferred income tax assets, which arise from temporary differences and carryforwards. Deferred income tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those tax assets and liabilities are expected to be realized or settled.
The Company regularly assesses the likelihood that its deferred income tax assets will be realized from recoverable income taxes or recovered from future taxable income. To the extent that the Company believes any amounts are not “more likely than not” to be realized, the Company records a valuation allowance to reduce the deferred income tax assets. In the event the Company determines that all or part of the net deferred tax assets are not realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period such determination is made. Similarly, if the Company subsequently determines deferred income tax assets that were previously determined to be unrealizable are now realizable, the respective valuation allowance would be reversed, resulting in an adjustment to earnings in the period such determination is made.
Internal Revenue Code Sections 382 and 383 (“Sections 382 and 383”) limit the use of net operating loss (“NOL”) carryforwards and R&D credits, after an ownership change. To date, the Company has not conducted a Section 382 or 383 study, however, because the Company will continue to raise significant amounts of equity in the coming years, the Company expects that Sections 382 and 383 will limit the Company’s usage of NOLs and R&D credits in the future.
ASC 740, Income Taxes, requires that the tax benefit of net operating losses, temporary differences, and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. The Company has reviewed the positive and negative evidence relating to the realizability of the deferred tax assets and has concluded that the deferred tax assets are not “more likely than not” to be realized. As a result, the Company recorded a full valuation allowance as of September 30, 2024 and December 31, 2023. U.S. Federal R&D tax credits from 2016 to 2019 were utilized to reduce payroll taxes in future periods and were recorded as other current assets (anticipated to be received within 12 months), on the Company’s condensed consolidated balance sheets. The Company intends to maintain the valuation allowance until sufficient evidence exists to support its reversal. The Company regularly reviews its tax positions. For a tax benefit to be recognized, the related tax position must be “more likely than not” to be sustained upon examination. Any amount recognized is generally the largest benefit that is “more likely than not” to be realized upon settlement. The Company’s policy is to recognize interest and penalties related to income tax matters as an income tax expense. For the three and nine months ended September 30, 2024 and 2023, the Company did not have any interest or penalties associated with unrecognized tax benefits.
The Company is subject to U.S. Federal, Illinois and California state income taxes. In addition, the Company is subject to local tax laws of France and Australia. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. Monopar was originally formed as an LLC in December 2014, then incorporated on December 16, 2015. The Company is subject to U.S. Federal, state and local tax examinations by tax authorities for the tax years 2015 through 2023. The Company does not anticipate significant changes to its current uncertain tax positions through September 30, 2024.
Stock-Based Compensation
The Company accounts for stock-based compensation arrangements with employees, non-employee directors and consultants using a fair value method, which requires the recognition of compensation expense for costs related to all stock-based awards, including stock option and restricted stock unit (“RSU”) grants. The fair value method requires the Company to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model or the closing stock price on the date of grant in the case of RSUs.
Stock-based compensation expense for awards granted to employees, non-employee directors and consultants are based on the fair value of the underlying instrument calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. Determining the appropriate fair value model and related assumptions requires judgment, including estimating the future stock price volatility and expected terms. For stock options granted in 2023, the expected volatility rates are estimated based on the Company’s historical actual volatility over the three-year period from its initial public offering on December 18, 2019 through December 31, 2022. For awards granted during the three months ended September 30, 2024, the expected volatility rates were estimated based on the Company’s historical actual volatility over the four-year period from its initial public offering on December 18, 2019, through December 31, 2023. The expected term for options granted to date is estimated using the simplified method. Forfeitures only include known forfeitures to-date as the Company accounts for forfeitures as they occur due to a limited history of forfeitures. The Company has not paid dividends and does not anticipate paying a cash dividend in the future vesting period and, accordingly, uses an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.
Recent Accounting Pronouncements
In October 2023, the FASB issued Accounting Standards Update ("ASU") 2023-06, Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The ASU incorporates certain U.S. Securities and Exchange Commission (SEC) disclosure requirements and are expected to clarify or improve disclosure and presentation requirements of a variety of Codification Topics, allow users to more easily compare entities subject to the SEC's existing disclosures with those entities that were not previously subject to the requirements, and align the requirements in the Codification with the SEC's regulations. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective with early adoption prohibited. For all other entities, the amendments will be effective two years later. In accordance with ASU 2023-06, the Company has added Note 7 – Net Loss per Share.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The purpose of the amendment is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect the amendments in ASU 2023-07 will have on its segment disclosures.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU improves income tax disclosure requirements and will require more detailed information on several income tax disclosures, such as income taxes paid and the income tax rate reconciliation table. The standard is effective for public business entities with annual periods beginning after December 15, 2024, and early adoption is permitted. The Company is currently evaluating the impact of this new standard on its condensed consolidated financial statements and related disclosures. The Company does not expect a material impact to its condensed consolidated financial statements based on adoption of this ASU.
Note 3 - Investments
As of September 30, 2024, the Company had two money market accounts and available-for-sale investments with contractual maturities of three months or less categorized as cash and cash equivalents as follows:
| As of September 30, 2024 |
Cost Basis |
Unrealized Gains | Aggregate Fair Value |
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| U.S. Treasury Bills |
$ | $ | $ | |||||||||
| Money Market Accounts |
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| Total |
$ | $ | $ | |||||||||
As of September 30, 2024, there were
As of December 31, 2023 the Company had two money market accounts and available-for-sale investments with contractual maturities of three months or less categorized as cash and cash equivalents as follows:
| As of December 31, 2023 |
Cost Basis |
Unrealized Gains | Aggregate Fair Value |
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| U.S. Treasury Bills |
$ | $ | $ | |||||||||
| Money Market Accounts |
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| Total |
$ | $ | $ | |||||||||
As of December 31, 2023, there were
See Note 2 for additional discussion regarding the Company’s fair value measurements.
Note 4 - Capital Stock
Holders of the common stock are entitled to receive such dividends as may be declared by the Board of Directors out of funds legally available therefor. To date no dividends have been declared. Upon dissolution and liquidation of the Company, holders of the common stock are entitled to a ratable share of the net assets of the Company remaining after payments to creditors of the Company. The holders of shares of common stock are entitled to one vote per share for the election of each director nominated to the Board and one vote per share on all other matters submitted to a vote of stockholders.
The Company’s amended and restated certificate of incorporation authorizes the Company to issue
Reverse Stock Split
On August 5, 2024, the Company conducted its Annual Meeting of Stockholders in which the stockholders approved among other items, a proposal to amend the Company's Second Amended and Restated Certificate of Incorporation to effect a reverse stock split of the outstanding shares, which provided the Board of Directors with authority to effect a reverse split within a specified range of ratios. Subsequently, the Board of Directors approved a reverse stock split of 1 for
Furthermore, at the Annual Meeting of Stockholders, a proposal to amend the 2016 Stock Incentive Plan was approved. As a result, the total number of shares reserved for issuance under the Amended 2016 Plan would increase from
The reverse stock split reduced the number of shares of the Company's common stock outstanding on August 12, 2024 from
The par value of the Company's common stock was unchanged at $
The reverse stock split did not modify the rights or preferences of the underlying common stock. The Company's stockholders' equity reflects the par value for all shares of common stock at $
On April 20, 2022, the Company entered into a Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”), pursuant to which Monopar may offer and sell, from time to time, through or to JonesTrading, as sales agent or principal, shares of Monopar’s common stock. On January 4, 2023, the Company filed a a prospectus related to the offer and sale of shares of common stock under this agreement of up to an aggregate amount of $
Note 5 - Stock Incentive Plan
In April 2016, the Company’s Board of Directors and stockholders representing a majority of the Company’s outstanding stock at that time, approved the Monopar Therapeutics Inc. 2016 Stock Incentive Plan, as amended (the “Plan”), allowing the Company to grant up to an aggregate
During the nine months ended September 30, 2024, the Board of Directors granted to a consultant aggregate stock options for the purchase of
Under the Plan, the per share exercise price for the shares to be issued upon exercise of an option shall be determined by the Plan Administrator, except that the per share exercise price shall be
Stock option activity under the Plan was as follows:
| Options Outstanding |
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| Number of Shares Subject to Options |
Weighted-Average Exercise Price |
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| Balances at December 31, 2023 |
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| Granted(1) |
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| Forfeited(2) |
( |
) | ||||||
| Exercised |
( |
) | ||||||
| Balances at September 30, 2024 |
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| Unvested options outstanding expected to vest(3) |
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| (1) |
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| (2) |
Forfeited options represent unvested shares and vested, unexercised and expired shares related to employee terminations. |
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| (3) |
Forfeitures only include known forfeitures to-date as the Company accounts for forfeitures as they occur due to a limited history of forfeitures. |
A summary of options outstanding as of September 30, 2024, is shown below:
| Exercise Prices | Number of Shares Subject to Options Outstanding | Weighted-Average Remaining Contractual Term in Years | Number of Shares Subject to Options Fully Vested and Exercisable | Weighted-Average Remaining Contractual Term in Years | ||||||||||||
| $0.00 - $25.00 | ||||||||||||||||
| $25.01 - $50.00 | ||||||||||||||||
| $50.01 - $75.00 | ||||||||||||||||
| $75.01 - $100.00 | ||||||||||||||||
Restricted stock unit activity under the Plan was as follows:
| Weighted- Average | ||||||||
| Restricted |
Grant Date |
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| Stock Units |
Fair Value |
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| (#) |
per Unit ($) |
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| Unvested balance at December 31, 2023 |
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| Granted(1) |
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| Vested |
( |
) | |
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| Forfieted |
( |
) | ||||||
| Unvested Balance at September 30, 2024 |
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(1) There were
Stock option grants and fair values under the Plan were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 |
2023 |
2024 |
2023 |
|||||||||||||
| Stock options granted |
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| Weighted-average grant date fair value per share |
$ | $ | $ | $ | ||||||||||||
| Fair value of shares vested |
$ | $ | $ | $ | ||||||||||||
As of September 30, 2024, the aggregate intrinsic value of outstanding vested and unvested stock options was approximately $
During the three months ended September 30, 2024 and 2023, the Company recognized $
Note 6 - Related Party Transactions
As of September 30, 2024, Tactic Pharma, LLC (“Tactic Pharma”), the Company’s initial investor, beneficially owned
None of the related parties discussed in this paragraph received compensation other than market-based salary, market-based stock-based compensation and benefits and performance-based incentive bonus or in the case of non-employee directors, market-rate Board fees and market-rate stock-based compensation. The Company considers the following individuals as related parties: Two of the Company’s board members were also Managing Members of Tactic Pharma as of September 30, 2024. Chandler D. Robinson is a Company Co-Founder, Chief Executive Officer, common stockholder, Managing Member of Tactic Pharma, former Manager of the predecessor LLC, Manager of CDR Pharma, LLC and Board member of Monopar as a C Corporation. Michael Brown is a Managing Member of Tactic Pharma (as of February 1, 2019, with no voting power as it relates to Monopar), a previous managing member of Monopar as an LLC, common stockholder and Board member of Monopar as a C Corporation.
Basic and diluted net loss per common share was calculated as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands, except for net loss per share) |
2024 |
2023 |
2024 |
2023 |
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| Numerator: |
||||||||||||||||
| Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Denominator: |
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| Weighted-average common shares outstanding, basic and diluted** |
||||||||||||||||
| Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share |
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| Stock options to purchase common stock** |
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| Unvested restricted stock units** |
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** Information pertaining to number of shares outstanding gives retroactive effect to a 1 for
Note 8 – Commitments and Contingencies
License, Development and Collaboration Agreements
XOMA Ltd.
Pursuant to a non-exclusive license agreement with XOMA Ltd. for the humanization technology used in the development of MNPR-101, the Company is obligated to pay XOMA Ltd. clinical, regulatory and sales milestones which could reach up to $
NorthStar Medical Radioisotopes, LLC ("NorthStar")
In June 2024, the Company entered into a long-term, non-exclusive master supply agreement for NorthStar to provide Monopar with the therapeutic radioisotope actinium-225 ("Ac-225"). The original collaboration agreement was amended at that time to clarify certain economic terms and those related to jointly developed intellectual property rights for Monopar’s MNPR-101 for radiopharmaceutical use. Monopar has acquired those rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving Monopar full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Both companies will share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown with MNPR-101 superior binding and yield with Ac-225 over the current industry-leading linker, DOTA.
Legal Contingencies
The Company may be subject to claims and assessments from time to time in the ordinary course of business. No claims have been asserted to date.
Indemnification
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but that have not yet been made. To date, the Company has not paid any claims nor been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of future claims against these indemnification obligations.
In accordance with its second amended and restated certificate of incorporation, amended and restated bylaws and the indemnification agreements entered into with each officer and non-employee director, the Company has indemnification obligations to its officers and non-employee directors for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacities. There have been no indemnification claims to date.
Note 9 – Subsequent Events
On October 23, 2024, the Company executed a License Agreement effective October 23, 2024 with Alexion Pharmaceuticals, Inc. (“Alexion, AstraZeneca Rare Disease” or “Alexion”), pursuant to which Alexion, AstraZeneca Rare Disease granted the Company an exclusive worldwide license for the development and commercialization of ALXN-1840, a drug candidate for Wilson disease that has progressed through a Phase 3 clinical trial that met its primary endpoint.
As initial upfront consideration for the License Agreement, the Company issued Alexion
Additionally, pursuant to the license agreement, Alexion is eligible to receive milestones and royalties, as further described below.
The shares issued to Alexion were issued pursuant to a separate Common Stock Investment Agreement, also dated October 23, 2024, between the Company and Alexion (the “Equity Agreement”). Pursuant to the Equity Agreement, the Company agreed to anti-dilution provisions that entitle Alexion to additional shares of common stock so that the total number of shares issued thereunder continue to represent
As additional consideration, the Company will be obligated to pay Alexion aggregate milestone payments of up to $
Subsequent to September 30, 2024, the Company sold
On October 28, 2024, the Company entered into and executed a placement agent agreement with Rodman & Renshaw LLC in connection with registered public offering of
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes contained in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis are set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing activities, includes forward-looking statements that involve risks and uncertainties.
Overview
We are a clinical-stage biotechnology company with late-stage ALXN-1840 for Wilson disease, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers.
Financial Status
Our cash, cash equivalents and investments as of September 30, 2024, were $6 million. Our primary funding source over the past three years was sales of shares of our common stock under at-the-market sales programs through Capital on Demand™ Sales Agreements with JonesTrading Institutional Services LLC (“Jones Trading”). As of October 31, 2024 we sold 557,761 shares of our common stock this year at an average gross price per share of $7.73 for net proceeds of $4,202,244 after fees and commissions of $107,806. On October 28, 2024, we entered into and executed a placement agent agreement with Rodman & Renshaw LLC in connection with a registered public offering of 1,181,540 shares of our common stock, par value $0.001 per share, at an offering price of $16.25 per Share. The offering closed on October 30, 2024 and yielded net proceeds from the offering of approximately $17.7 million, after deducting placement agent fees and other estimated offering expenses.
As discussed further below and elsewhere in this Quarterly Report, we expect that our current funds will be sufficient at least into the first half of 2026 for us to: (1) assemble a regulatory package and initiate discussions with the FDA for the in-licensed ALXN-1840 investigational drug candidate for Wilson disease; (2) continue to conduct and conclude our first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr; (3) continue to conduct our first-in-human therapeutic clinical trial of MNPR-101-Lu; (4) advance our preclinical MNPR-101-Ac program into the clinic; and (5) invest in internal R&D projects to expand our radiopharma pipeline. We will require additional funding to further advance our clinical and preclinical programs and we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations.
Our Product Pipeline
Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised. It affects one in 30,000 live births in the US. Over time this results in the build-up of toxic copper levels in the liver, brain, and other organs, leading to damage that greatly impacts a patient’s life. Patients can develop a wide range of symptoms, including liver disease and/or psychiatric or neurological symptoms, such as personality changes, tremors and difficulty walking, swallowing or talking. In some cases, the damage and loss of function may be irreversible.
ALXN-1840 (bis-choline tetrathiomolybdate) is an investigational once-daily, oral medicine in development for the treatment of Wilson disease. This novel molecule is designed to selectively and tightly bind and remove copper from the body’s tissues and blood. ALXN-1840 has been granted Orphan Drug Designation in the United States and orphan designation in the European Union for Wilson disease.
A pivotal Phase 3 trial with ALXN-1840 has been completed, which met its primary endpoint. The primary endpoint assessed copper mobilization over 48 weeks, defined as daily mean AUEC (Area Under the Effect Curve) for dNCC (directly measured non-ceruloplasmin-bound copper). In the trial, 214 patients were enrolled, and the trial was randomized, rater-blinded, and multi-centered, designed to evaluate the efficacy and safety of ALXN-1840 versus standard-of-care (SoC) in patients with Wilson disease aged 12 years and older. In the trial, people taking ALXN-1840 experienced rapid copper mobilization, with a response at four weeks and sustained through the 48 weeks. The primary endpoint demonstrated three-times greater copper mobilization from tissues compared to the SoC arm (Least Square Mean Difference [LSM Diff] 2.18 µmol/L; p< 0.0001), including in patients who had been treated previously for an average of 10 years.
Alexion ended up terminating the ALXN-1840 program in Wilson disease based on review of results from Phase 2 mechanistic trials and discussions with regulatory authorities. The Phase 2 mechanism of action studies failed to meet their primary objectives of demonstrating net-negative copper balance in Wilson disease patients during short-term treatment with ALXN-1840 and reducing hepatic copper concentration after treatment with ALXN-1840. The decision not to progress the ALXN-1840 program in Wilson disease was not related to any safety signals.
In the near term, we will be focusing on assembling a regulatory package and initiating discussions with the FDA. These activities will provide clarity on the additional capital needed for the program. As a result, the costs beyond the $4.0 million due at signing and within ninety (90) days pursuant to the license agreement, will largely be consultant time along with patent maintenance. These near-term expenses are estimated to be less than $1.0 million to assemble the detailed regulatory package and maintain the patent portfolio.
The regulatory approval process can be lengthy, expensive and uncertain. The FDA and other regulatory agencies around the world could require us to perform additional nonclinical and/or clinical studies to obtain ALXN-1840 approval, which we may not be able to raise the capital to complete or the results of which may not meet the level of clinical or statistical significance required by the FDA and other regulatory agencies. What the FDA and other regulatory agencies require for approval could have a material impact on the timelines and/or capital required to get ALXN-1840 approved. Even if approved, market adoption could be slower or lower than expected, especially given competition from existing therapies or new ones that get approved. We are planning to initially focus on Wilson disease patients with more severe symptoms, and this population could end up being smaller than we are anticipating. This population could be further reduced in size if the FDA or other regulatory agencies give us a more narrow label than anticipated. Being an orphan indication, this could result in a very small eligible patient population. Additionally, if the currently filed patents do not end up providing sufficient protection, we will be heavily reliant on the orphan drug designation protections in the US and EU.
MNPR-101 for Radiopharmaceutical Use, Development Update
The radiopharma space has had numerous positive recent developments and announcements, from acquisitions to clinical data to reimbursement rates to commercial demand. Since this past December alone, four significant acquisitions have been publicly announced or completed which have had upfront payments ranging from approximately $1 billion to over $4 billion (BMS/RayzeBio, AstraZeneca/Fusion Pharma, Eli Lilly/POINT BioPharma, and Novartis/Mariana Oncology).
Monopar has a proprietary first-in-class humanized monoclonal antibody, MNPR-101, that targets the urokinase plasminogen activator receptor ("uPAR"). uPAR is expressed on several of the more aggressive, deadly cancers including pancreatic, breast, ovarian, colorectal, and bladder cancers. Monopar has conjugated MNPR-101 to imaging and therapeutic radioisotopes for the purpose of creating highly precise radiopharmaceutical agents that have the potential to image and treat tumors expressing uPAR while reducing exposure to healthy tissues. In February 2024, we received regulatory clearance in Australia to commence a first-in-human Phase 1 imaging and dosimetry clinical trial with our novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) in patients with advanced cancers, and in April, we launched the Phase 1 trial. In July 2024, we announced the enrollment of our first patient and in September 2024, we announced positive early clinical data validating the tumor-targeting ability of MNPR-101-Zr. In August 2024, we received regulatory clearance in Australia to commence a first-in-human Phase 1a clinical trial of our novel uPAR-targeted radiopharmaceutical therapy MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) in patients with advanced solid cancers. We launched the trial in October 2024, and it is now active and open for patient enrollment.
We are also actively exploring opportunities to expand our radiopharmaceutical pipeline primarily through internal development efforts. In October 2024, we announced the filing of a provisional patent application for new radiopharmaceutical compounds and a family of linkers used to connect radioisotopes with targeting agents, including our uPAR-targeting antibody MNPR-101.
Our Strategy
Our management team has extensive experience in developing therapeutics and medical technologies through global regulatory approval and commercialization. In aggregate, companies they co-founded have achieved four drug approvals and three diagnostic medical imaging device approvals in the U.S. and the EU, successfully sold an asset developed by management which subsequently had a positive Phase 3 clinical trial, sold two oncology-focused diagnostic imaging businesses to Fortune Global 1000 firms, and completed the clinical and commercial development and ultimately the sale of a commercial biopharmaceutical company for over $800 million in cash. In addition, the team has supported multiple regulatory submissions with the FDA and the European Medicines Agency (EMA) and launched multiple drugs in the U.S and the EU. Understanding the preclinical, clinical, regulatory and commercial development processes and hurdles are key factors in successful drug development and the expertise demonstrated by our management team across all of these areas increases the probability of success in advancing the product candidates in our product pipeline.
| ● | Assemble a regulatory package for ALXN-1840 and initiate discussions with the FDA. We are planning to assemble a regulatory package to support a New Drug Application (NDA) approval for ALXN-1840 in Wilson disease patients with more severe symptoms. | |
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Expand the development of MNPR-101 for radiopharmaceutical use as a therapeutic as well as a diagnostic imaging agent. Based on promising preclinical data from our imaging and efficacy animal model studies in multiple cancers including triple-negative breast and pancreatic cancers and human clinical data from our MNPR-101-Zr Phase 1 trial validating the tumor-targeting ability of MNPR-101, we have prioritized significant resources and funds toward the development of our radiopharmaceutical programs. We have two open and active human clinical trials for our MNPR-101 radiopharmaceutical program; a Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr in patients with advanced cancers and a Phase 1a therapeutic clinical trial of MNPR-101-Lu also in patients with advanced cancers. In addition, we are continuing our preclinical development of MNPR-101-Ac, using the alpha-emitter actinium-225 conjugated to MNPR-101. |
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Expand our drug development pipeline through internal efforts, in-licensing and acquisition of product candidates. We plan to continue the expansion of our drug development pipeline through internal research and development, acquiring or in-licensing additional product candidates, particularly those that leverage existing scientific and clinical data that helps reduce the risks of the next steps in clinical development. The focus on this front will include identifying both novel and established targets and candidates complementing our radiopharmaceutical and rare disease programs. | |
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Utilize the expertise and prior experience of our team in the areas of asset acquisition, drug development and commercialization to establish ourselves as a leading biotechnology company. Our senior executive team has relevant experience in biopharmaceutical in-licensing and acquisitions as well as developing product candidates through approval and commercialization. In aggregate, our team has co-founded BioMarin Pharmaceutical (Nasdaq: BMRN), Sensant Corp (acquired by Siemens), American BioOptics (assets acquired by Olympus), Raptor Pharmaceuticals ($800 million sale to Horizon Therapeutics), and Tactic Pharma, LLC (“Tactic Pharma”) (sale of lead asset, bis-choline tetrathiomolybdate, was ultimately acquired by Alexion in June 2018 for $764 million; Alexion was subsequently acquired by AstraZeneca). In October 2024, we in-licensed, ALXN-1840 from Alexion, AstraZeneca Rare Disease and plan to pursue regulatory approval and commercialization of this late-stage drug candidate for Wilson disease. |
Revenues
We are an emerging growth company. We have no approved drugs and have not generated any revenues. To date, we have engaged in acquiring or in-licensing drug product candidates, and in entering into collaboration agreements for the preclinical testing and clinical development of our drug product candidates along with providing the infrastructure to support the clinical development of our drug product candidates. We do not anticipate revenues from operations until we complete testing and development of one of our drug product candidates and obtain marketing approval, or until we sell, enter into a collaborative marketing arrangement, or out-license one of our drug product candidates to another party. See “Liquidity and Capital Resources”.
Recently Issued and Adopted Accounting Pronouncements
During the three months ended September 30, 2024, there were three recently issued accounting pronouncements that are described in more detail in Note 2 of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Critical Accounting Policies and Use of Estimates
While our significant accounting policies are described in more detail in Note 2 of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our condensed consolidated financial statements.
Going Concern Assessment
We apply Accounting Standards Codification 205-40 ("ASC 205-40"), Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern, which the Financial Accounting Standards Board ("FASB") issued to provide guidance on determining when and how reporting companies must disclose going concern uncertainties in their financial statements. ASC-205-40 requires management to perform interim and annual assessments of an entity's ability to continue as a going concern within one year of the date of issuance of the entity's financial statements (or within one year after the date on which the financial statements are available to be issued when applicable). Further, a company must provide certain disclosures if there is "substantial doubt about the entity's ability to continue as a going concern." In October 2024, we analyzed our cash requirements at least through December 31, 2025 and we have determined that, based upon our current available cash, we have no substantial doubt about our ability to continue as a going concern.
Clinical Trials Accruals
We accrue and expense the costs for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with contract research organizations, service providers, and clinical trial sites. We estimate the amounts to accrue based upon discussions with internal clinical personnel and external service providers as to progress or stage of completion of trials or services and the agreed upon fees to be paid for such services. Costs of setting up clinical trial sites for participation in the trials are expensed immediately as research and development expenses. Clinical trial site costs related to patient screening and enrollment are accrued as patients are screened/entered into the trial.
We account for stock-based compensation arrangements with employees, non-employee directors and consultants using a fair value method, which requires the recognition of compensation expense for costs related to all stock-based compensation grants, including stock option and restricted stock unit (“RSU”) grants. The fair value method requires us to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model or the closing stock price on the date of grant in the case of RSUs.
Stock-based compensation costs for stock awards granted to our employees, non-employee directors and consultants are based on the fair value of the underlying instruments calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. Determining the appropriate fair value model and related assumptions requires judgment, including selecting methods for estimating our future stock price volatility and expected holding term. During the nine months ended September 30, 2024, we granted 2,000 options to purchase shares of our common stock to a consultant, 30,001 options to purchase shares of our common stock to officers and 11,522 options to purchase shares of our common stock to non-officer employees. For awards granted during the three and nine months ended September 30, 2024, the expected volatility rates are estimated based on our actual historical volatility over the four-year period from our initial public offering on December 18, 2019, through December 31, 2023. For awards granted during the three and nine months ended September 30, 2023, the expected volatility rates are estimated based on our actual historical volatility over the three-year period from our initial public offering on December 18, 2019, through December 31, 2022. The expected term for stock options granted during the three and nine months ended September 30, 2024, and 2023, was estimated using the simplified method. Forfeitures only include actual forfeitures to-date as we account for forfeitures as they occur due to a limited history of forfeitures. We have not paid dividends and do not anticipate paying a cash dividend in future vesting periods and, accordingly, use an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.
Results of Operations
Comparison of the Three and Nine Months Ended September 30, 2024 and 2023
The following table summarizes the results of our operations for the three and nine months ended September 30, 2024 and 2023:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
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| (Unaudited) |
(Unaudited) |
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| (in thousands) |
2024 |
2023 |
Variance |
2024 |
2023 |
Variance |
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| Research and development expenses |
$ | 984 | $ | 1,317 | $ | (333 | ) | $ | 3,081 | $ | 4,564 | $ | (1,483 | ) | ||||||||||
| General and administrative expenses |
591 | 749 | (158 | ) | 2,006 | 2,355 | (349 | ) | ||||||||||||||||
| Total operating expenses |
1,575 | 2,066 | (491 | ) | 5,087 | 6,919 | (1,832 | ) | ||||||||||||||||
| Operating loss |
(1,575 | ) | (2,066 | ) | 491 | (5,087 | ) | (6,919 | ) | 1,832 | ||||||||||||||
| Other income | 171 | — | 171 | 171 | — | 171 | ||||||||||||||||||
| Interest income |
99 | 112 | (13 | ) | 255 | 331 | (76 | ) | ||||||||||||||||
| Net loss |
$ | (1,305 | ) | $ | (1,954 | ) | $ | 649 | $ | (4,661 | ) | $ | (6,588 | ) | $ | 1,927 | ||||||||
Research and Development (“R&D”) Expenses
R&D expenses for the three months ended September 30, 2024 were $984,000, compared to $1,317,000 for the three months ended September 30, 2023. This represents a decrease of $333,000 attributed to (1) a decrease in camsirubicin manufacturing costs of $301,000 due to our decision to wind down that program, and (2) a decrease of $218,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023. These decreases were partially offset by a net increase of $186,000 due to other R&D expenses attributable to MNPR-101 for radiopharma use.
R&D expenses for the nine months ended September 30, 2024 were $3,081,000 compared to $4,564,000 for the nine months ended September 30, 2023. This represents a decrease of $1,483,000 attributed to (1) a decrease of $1,572,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, and (2) a net decrease of $366,000 due to other R&D expenses. These decreases were partially offset by an increase of $455,000 in expenses for MNPR-101 for radiopharma use.
General and Administrative (“G&A”) Expenses
G&A expenses for the three months ended September 30, 2024 were $591,000, compared to $749,000 for the three months ended September 30, 2023. This represents a decrease of $158,000 primarily attributed to (1) a reduction of stock based compensation expenses of $146,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, and (2) a decrease in stock-based compensation to the CEO and the board of directors of $64,000 as no equity awards have been issued to the CEO and the board of directors to date in 2024 partially offset by a net increase in consulting and other G&A expenses of $52,000.
G&A expenses for the nine months ended September 30, 2024 were $2,006,000, compared to $2,355,000 for the nine months ended September 30, 2023. This represents a decrease of $349,000 primarily attributed to (1) a reduction of stock based compensation expenses of $197,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, and (2) a decrease in stock-based compensation to the CEO and the board of directors of $197,000 as no equity awards were issued to the CEO and the board of directors to date in 2024 partially offset by a net increase in consulting, tax services and other G&A expenses of $45,000.
Other Income
Interest Income
Interest income for the three months ended September 30, 2024, decreased by $13,000 versus the three months ended September 30, 2023. The reduction in the amount of interest received is a reflection of the lower daily average cash balance in the third quarter of 2024 versus the third quarter of 2023.
Interest income for the nine months ended September 30, 2024, decreased by $76,000 versus the nine months ended September 30, 2023, due to lower interest received due to a lower daily average cash balance in the nine months ended September 30, 2024 versus the nine months ended September 30, 2023.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred losses and cumulative negative cash flows from operations since we commenced operations resulting in an accumulated deficit of approximately $64.9 million as of September 30, 2024. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and G&A expenses will increase to enable the execution of our strategic plan. As a result, we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations. We will seek to obtain needed capital through a variety of methods including and not limited to marketed offerings, rights offerings, debt financing, strategic partnerships or other sources of capital that may be available.
We invest our cash equivalents in two money market accounts and U.S. Treasury Bills and may consider expanding the instruments to include U.S Treasury Notes and U.S. Treasury bonds.
Cash Flows
The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023.
| Nine Months Ended September 30, |
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| (Unaudited) |
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| (in thousands) |
2024 |
2023 |
Variance |
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| Net cash used in operating activities |
$ | (4,405 | ) | $ | (6,312 | ) | $ | 1,907 | ||||
| Net cash provided by investing activities |
— | 1,957 | (1,957 | ) | ||||||||
| Net cash provided by financing activities |
3,155 | 1,692 | 1,463 | |||||||||
| Effect of exchange rates |
4 | (8 | ) | 12 | ||||||||
| Net decrease in cash and cash equivalents |
$ | (1,246 | ) | $ | (2,671 | ) | $ | 1,425 | ||||
During the nine months ended September 30, 2024 and 2023 we had a net cash outflow of $1,246,000 and $2,671,000, respectively. During the nine months ended September 30, 2024, versus the nine months ended September 30, 2023, the decrease in net cash outflow of $1,425,000 primarily consisted of a decrease in net cash provided by investing activities of $1,957,000 due to the purchases of investments versus certain investments maturities in 2023, partially offset by (1) a decrease in net cash used in operating activities of $1,907,000, (2) an increase in net cash provided by financing activities of $1,463,000 due to the increased sales of shares of our common stock under at-the-market sales programs and (3) an increase due to effect of foreign exchange rates.
Cash Flow Used in Operating Activities
The decrease of $1,907,000 in cash flow used in operating activities during the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily a result of lower net loss due to a reduction in research and development expenses.
Cash Flow Provided by Investing Activities
The cash provided by investing activities during the nine months ended September 30, 2024 and the cash provided by investing activities during the nine months ended September 30, 2023 represent our net investment in U.S. Treasury Bills maturing or invested in during the periods reported.
Cash Flow Provided by Financing Activities
The increase in cash flow provided by financing activities during the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 of $1,463,000 was primarily due to higher net proceeds from sales of our common stock under at-the-market sales programs during the nine months ended September 30, 2024 when compared to the sales of our common stock during the nine months ended September 30, 2023.
Future Funding Requirements
To date, we have not generated any revenue from product sales. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate any revenue from product sales or royalties unless and until we obtain regulatory approval of and commercialize any of our current or future drug product candidates or we out-license or sell a drug product candidate to another party. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development, future preclinical studies and clinical trials of, and seek regulatory approval for, our current and future drug product candidates. We will need substantial additional funding for clinical development prior to seeking regulatory approval. If we obtain regulatory approval of any of our current or future drug product candidates, we will need substantial additional funding for commercialization requirements and our continuing drug product development operations.
As a company, we have not completed development through marketing approvals of any therapeutic or imaging products. We expect to continue to incur significant increases in expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially as we:
| ● | develop our ALXN-1840 investigational drug candidate as a treatment for Wilson disease; | |
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progress our MNPR-101-Zr imaging and dosimetry clinical trial in advanced cancer patients; | |
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| ● | progress our MNPR-101-Lu therapeutic clinical trial in advanced cancer patients; | |
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continue the preclinical activities and potentially advance MNPR-101-Ac into the clinic as a therapeutic in advanced cancer patients; |
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support intellectual property initiatives for our Wilson disease and radiopharmaceutical programs; |
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| ● | identify and potentially invent or license novel targets and drug candidates complementing our radiopharmaceutical programs, and pursue the future preclinical and clinical development and regulatory requirements of such drug product candidates; |
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seek regulatory approvals for any of our current and future drug product candidates that successfully complete registration clinical trials; |
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establish or purchase the services of a sales, marketing and distribution infrastructure to commercialize any products for which we obtain marketing approval; |
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develop, or contract for, manufacturing/quality capabilities in order to establish a reliable, high quality supply chain sufficient to support our clinical and specialized radiopharmaceutical requirements and to provide sufficient capacity to launch and supply the market for any product for which we obtain marketing approval; and |
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add or contract for required operational, financial, human resources and management information systems and capabilities and other specialized expert personnel to support our drug product candidate development and planned commercialization efforts. |
We anticipate that the funds available as of October 31, 2024 will fund our obligations at least into the first half of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug product candidates, and the extent to which we enter into collaborations with third parties to participate in the development and commercialization of our drug product candidates, we are unable to accurately estimate with high reliability the amounts and timing required for increased capital outlays and operating expenditures associated with our current and anticipated drug product candidate development programs.
Our future capital requirements will depend on many factors, including:
| ● | the development program for ALXN-1840 in Wilson disease; | |
| ● | the clinical development progress of MNPR-101-Zr in imaging advanced cancers; | |
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the clinical development progress of MNPR-101-Lu as a therapeutic agent in advanced cancers; |
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| ● | the progress of preclinical and clinical development of MNPR-101-Ac (the radioisotope actinium-225 conjugated to MNPR-101); | |
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the progress of preclinical activities towards identifying novel targets and candidates to complement our radiopharmaceutical programs; |
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the number and characteristics of other drug product candidates that we may invent, license, acquire, or otherwise pursue; |
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the scope, progress, timing, cost and results of research, preclinical development and clinical trials and regulatory requirements for future drug product candidates; |
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| ● | the costs, timing and outcomes of seeking, obtaining, and maintaining FDA and international regulatory approvals; | |
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the costs associated with establishing or contracting for manufacturing/quality requirements and establishing or contracting for sales, marketing and distribution capabilities; |
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our ability and related costs to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights; |
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our need and ability to hire or contract for additional management, administrative, scientific, medical, sales and marketing, and manufacturing/quality and other specialized personnel or external expertise; |
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the effect and timing of entry of competing products or new therapies that may limit market penetration or prevent the introduction of our drug product candidates or reduce the commercial potential of our product portfolio; |
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our need to implement additional required internal management, operational, record keeping, and other systems and infrastructure; and |
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the economic and other terms, timing and success of our existing collaboration and licensing arrangements and any collaboration, licensing or other arrangements into which we may enter into in the future, including the timing of receipt of or payment to or from others of any license, milestone or royalty payments under these arrangements. |
We intend to continue evaluating drug product candidates for the purpose of growing our pipeline. Identifying and securing high-quality compounds usually takes time and related expenses. Our spending could be significantly accelerated in the future if additional drug product candidates are acquired and enter clinical development. In this event, we may be required to expand our management team, and pay higher contract manufacturing costs, contract research organization fees, other clinical development costs and insurance costs that are not currently projected. Beyond our current funds, substantial additional long-term funding is needed to further develop our radiopharmaceutical and rare disease programs.
Until we can generate a sufficient amount of product revenue to finance our cash requirements, we expect to finance our future cash needs primarily through a combination of equity offerings, debt financings, strategic collaborations and grant funding. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our current stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our current stockholders’ rights. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with other parties, we likely will have to share or relinquish valuable rights to our technologies, future revenue streams, research programs or drug product candidates or grant licenses on terms that may not be favorable to us, which will reduce our future returns and affect our future operating flexibility. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our pipeline product development or commercialization efforts or grant rights to others to develop and market drug product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
License, Development and Collaboration Agreements
Alexion, AstraZeneca Rare Disease
On October 23, 2024, we executed a License Agreement with Alexion Pharmaceuticals, Inc., pursuant to which Alexion granted us an exclusive worldwide license for the development and commercialization of ALXN-1840, a drug candidate for Wilson disease. As initial upfront consideration for the License Agreement, we issued Alexion 387,329 shares (representing 9.9% of our outstanding shares) of our common stock and agreed to make an upfront cash payment of $4.0 million. We agreed to an anti-dilution provision that entitles Alexion to receive additional shares at no cost to maintain their 9.9% ownership until we raise the next $25.0 million of common equity capital, subject to a maximum of 705,015 Shares unless we obtain stockholder approval. We have given customary registration rights to Alexion and agreed to file a resale registration statement within forty-five (45) days of October 23, 2024. To date, we have issued an aggregate of 522,501 shares of our common stock to Alexion.
A cash payment of $1.0 million was paid at the time of signing and the remaining $3.0 million is due to be paid within ninety (90) days. Additionally, we are obligated to milestone payments of up to $94.0 million for achievement of regulatory approval and sales related milestones. In addition, we are obligated to pay tiered royalties based on net sales in the low to mid-double digit range. We have also given Alexion the right of first negotiation regarding any rights should we intend to sublicense ALXN-1840. Furthermore, we will have to pay Alexion a percentage in the mid-double digits of any sublicensing income received by us. As part of this license agreement, we will also owe a third-party single digit millions cash milestone payment upon regulatory approval in Europe and a single digit percentage royalty on net sales in Europe.
NorthStar Medical Radioisotopes, LLC ("NorthStar")
In June 2024, we entered into a long-term, non-exclusive master supply agreement with NorthStar underwhich Northstar will provide us with the therapeutic radioisotope actinium-225 ("Ac-225"). The original collaboration agreement was amended at that time to clarify certain economic terms and those related to jointly developed intellectual property rights for our MNPR-101 for radiopharmaceutical use. We have acquired these rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving us full ownership and title to our lead MNPR-101 radiopharmaceutical platform. We will jointly share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown that MNPR-101 has superior binding and yield with Ac-225 over the current industry-leading linker, DOTA.
XOMA Ltd.
Pursuant to a non-exclusive license agreement with XOMA Ltd. for the humanization technology used in the development of MNPR-101, we are obligated to pay XOMA Ltd. clinical, regulatory and sales milestones which could reach up to $14.925 million if we achieve all milestones for MNPR-101. The agreement does not require the payment of sales royalties. There can be no assurance that we will achieve any milestones. As of October 31, 2024, we had not reached any milestones and had not been required to pay XOMA Ltd. any funds under this license agreement. The first milestone payment is payable upon first dosing of a human patient in a Phase 2 clinical trial. We are currently conducting a Phase 1 clinical trial and cannot reliably predict when we will be able to commence a Phase 2 clinical trial, if at all.
Service Providers
In the normal course of business, we contract with service providers to assist in the performance of R&D, including drug product manufacturing, process development, clinical and preclinical development, and G&A including financial strategy, audit, tax and legal support. We can elect to discontinue the work under these agreements at any time. We could also enter into collaborative research and development, contract research, manufacturing and supplier agreements in the future, which may require upfront payments and/or long-term commitments of cash.
Office Lease
We are currently leasing on a month-to-month basis office space for our executive headquarters at 1000 Skokie Blvd., in the Village of Wilmette, Illinois for $4,238 per month.
Legal Contingencies
We are currently not, and to date have never been, a party to any adverse material legal proceedings.
Indemnification
In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. Our exposure under these agreements is unknown because it involves claims that may be made against us in the future, but that have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations.
In accordance with our Second Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws and the indemnification agreements entered into with each officer and non-employee director, we have indemnification obligations to our officers and non-employee directors for certain events or occurrences, subject to certain limits, while they are serving at our request in such capacity. There have been no claims to date.
Item 4. Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer have provided certifications filed as Exhibits 31.1 and 31.2, respectively, and Exhibit 32.1. Such certifications should be read in conjunction with the information contained in this Item 4 for a more complete understanding of the matters covered by those certifications.
(a) Disclosure Controls and Procedures
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures as of September 30, 2024, pursuant to Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures, as of such date, were effective.
(b) Changes in Internal Control over Financial Reporting
We have concluded that the condensed consolidated financial statements and other financial information included in this Quarterly Report on Form 10-Q fairly present in all material respects our financial condition, results of operations and comprehensive loss and cash flows as of, and for, the periods presented.
There have been no changes in our internal control over financial reporting during the three months ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Other than the additional risk factors below, there have been no material changes in information regarding our risk factors as described in Item 1A of our Annual Report on Form 10-K as filed with the SEC on March 28, 2024.
Our strategic focus on our radiopharmaceutical program could subject to us to concentrated risks.
As a result of our strategic decision to focus our efforts on our radiopharmaceutical program, a relatively novel approach to cancer imaging and treatment, and wind-down our camsirubicin and MNPR-202 programs, we face concentrated risks. Although the nature of the risks associated with our radiopharmaceutical program as described in Item 1A of our Annual Report on Form 10-K have not materially changed, the impacts from those risks should they be realized, or from perceptions of those risks in the market, could be more acute. In addition, our decision to wind-down our camsirubicin and MNPR-202 programs could adversely impact our stock price. Following our decision to wind-down our Validive program in 2023, our stock price suffered significant declines. We cannot predict what impact our decision to focus on our radiopharmaceutical program and wind-down our other programs will have on our stock price or financing prospects.
There are risks and uncertainties associated with our newly-acquired ALXN-1840 program.
Although a pivotal Phase 3 trial with ALXN-1840 has been completed, which met its primary endpoint as described elsewhere in this report, Alexion ended up terminating the ALXN-1840 program in Wilson disease based on review of results from Phase 2 mechanistic trials and discussions with regulatory authorities. The Phase 2 mechanism of action studies failed to meet their primary objectives of demonstrating net-negative copper balance in Wilson disease patients during short-term treatment with ALXN-1840 and reducing hepatic copper concentration after treatment with ALXN-1840. The decision not to progress the ALXN-1840 program in Wilson disease was not related to any safety signals.
In the near term, Monopar will be focusing on assembling a regulatory package and initiating discussions with the FDA. These activities will provide clarity on the additional capital needed for the program.
The regulatory approval process can be lengthy, expensive and uncertain. The FDA and other regulatory agencies around the world could require us to perform additional nonclinical and/or clinical studies to obtain ALXN-1840 approval, which we may not be able to raise the capital to complete or the results of which may not meet the level of clinical or statistical significance required by the FDA and other regulatory agencies. What the FDA and other regulatory agencies require for approval could have a material impact on the timelines and/or capital required to get ALXN-1840 approved. Even if approved, market adoption could be slower or lower than expected, especially given competition from existing therapies or new ones that get approved. We are planning to initially focus on Wilson disease patients with more severe symptoms, and this population could end up being smaller than we are anticipating. This population could be further be reduced in size if the FDA or other regulatory agencies give us a more narrow label than anticipated. Being an orphan indication, this could result in a very small eligible patient population. Additionally, if the currently filed patents do not end up providing sufficient protection, we will be heavily reliant on the orphan drug designation protections in the US and EU.
During the quarter ended September 30, 2024, director or officer of the Company adopted or terminated a “Rule 10b5- 1 trading arrangement” or “non-Rule 10b5- 1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
The following exhibits are filed as part of this Quarterly Report on Form 10-Q.
| Exhibit |
Document |
Incorporated by Reference From: |
||
| 3.1 | Second Amended and Restated Certificate of Incorporation | Form 10-K filed on March 26, 2018 | ||
| 3.2 | Certificate of Amendment | Form 8-K filed on August 9, 2024 | ||
| 10.1* | License Agreement between Alexion and Monopar | Form 8-K filed on October 24, 2024 | ||
| 10.2 | Common Stock Investment Agreement | Form 8-K filed on October 24, 2024 | ||
| 10.2 | Placement Agency Agreement | Form 8-K filed on October 30, 2024 | ||
| 10.4 | Form of Securities Purchase Agreement | Form 8-K filed on October 30, 2024 | ||
| Certification of Chandler D. Robinson, Chief Executive Officer |
Filed herewith |
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| Certification of Karthik Radhakrishnan, Chief Financial Officer |
Filed herewith |
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| Filed herewith |
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| 101.INS |
Inline XBRL Instance Document |
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| 101.SCH |
Inline XBRL Taxonomy Extension Schema |
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| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase |
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| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase |
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| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase |
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| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase |
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| 104 |
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
* Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).
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.
| MONOPAR THERAPEUTICS INC. |
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| Dated: November 8, 2024 |
By: |
/s/ Chandler D. Robinson |
|
| Name: |
Chandler D. Robinson |
||
| Title: |
Chief Executive Officer and Director (Principal Executive Officer) |
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| MONOPAR THERAPEUTICS INC. |
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| Dated: November 8, 2024 |
By: |
/s/ Karthik Radhakrishnan |
|
| Name: |
Karthik Radhakrishnan | ||
| Title: |
Chief Financial Officer (Principal Financial Officer) |
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