Kiora Pharmaceuticals Reports Third Quarter Results; Retinal Disease Pipeline Advancing Two Phase 2 Studies
Kiora Pharmaceuticals Reports Third Quarter Results; Retinal Disease Pipeline Advancing Two Phase 2 Studies
Ended the quarter with $29.0 million in cash, cash equivalents and short-term investments plus $1.8 million in collaboration receivables related to the Company's Théa Open Innovation (TOI or Théa) partnership.Encinitas, California--(Newsfile Corp. - November 8, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced third quarter 2024 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key third quarter and recent corporate highlights include:
加州Encinitas - （Newsfile corp. - 2024年11月8日）- Kiora Pharmaceuticals，Inc.（納斯達克：KPRX）（"Kiora"或"公司"）今天宣佈了2024年第三季度的財務業績，並就其治療視網膜疾病的療法管線提供了更新。 第三季度和最近的公司要點包括：
Investigational new drug application approval to initiate ABACUS-2, the Phase 2 study of KIO-301, a novel molecular photoswitch, for the treatment of retinitis pigmentosa.
Finalized the design of the Phase 2 KLARITY trial of KIO-104, a small molecule targeting the treatment of multiple retinal inflammatory diseases, with submission for trial approval on track for Q4 2024.
Ended the quarter with $29.0 million in cash, cash equivalents and short-term investments plus $1.8 million in collaboration receivables related to the Company's Théa Open Innovation (TOI or Théa) partnership.
Expected runway into 2027, excluding any potential partnership milestones.
調查性新藥申請已獲批，啓動ABACUS-2，KIO-301的2期研究，這是一種用於治療視網膜色素性視網膜炎的新型分子光開關。
確定了KIO-104的2期KLARITY試驗設計，這是一種小分子，針對治療多種視網膜炎症性疾病，已提交試驗批准申請，計劃於2024年第4季度按時展開。
季度末，現金、現金等價物和短期投資合計2900萬美元，加上180萬美元的與公司Théa Open Innovation（TOI或Théa）合作伙伴關係相關的協作應收款項。
Expected runway into 2027, excluding any potential partnership milestones.
"Kiora remains in a strong position with two compelling and innovative drug candidates entering Phase 2 clinical trials and a strong balance sheet to fund development and operations beyond anticipated readouts for both studies," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "During the third quarter, we worked diligently to prepare for these trials, which will increase their likelihood of success.
「Kiora仍然處於強勢地位，有兩個引人注目和創新的藥物候選品進入第2期臨床試驗，並擁有強勁的資產負債表，以資助開發和運營超出這兩項研究預期結果的時間點，」 Kiora總裁兼首席執行官Brian M. Strem博士表示。 "在第三季度，我們努力準備這些試驗，以增加它們成功的可能性。
"Regarding KIO-301, we recently received approval to initiate ABACUS-2, a 36-patient, multi-center, double-masked, randomized, controlled, multi-dose study in patients with ultra-low vision or no light perception due to retinitis pigmentosa. Based on KIO-301's differentiated mechanism of action as a small molecule, we will enroll patients with any of the known 150-plus underlying gene mutations associated with retinitis pigmentosa. Dosing of the first patient with KIO-301 will begin next year following the completion of the ongoing validation work around functional vision endpoints.
“關於KIO-301，我們最近獲得批准啓動ABACUS-2，該研究是一個包括36名患者的多中心，雙盲，隨機，對照，多劑量研究，針對具有視網膜色素變性所致超低視覺或無光感的患者。 基於KIO-301作爲一種小分子的不同的作用機制，我們將招募患有與視網膜色素變性相關的任何已知150多種基因突變的患者。 第一名接受KIO-301治療的患者的給藥將在明年開始，此前將完成圍繞功能視力終點的進行中的驗證工作。
"Following multiple interactions with the FDA and European regulators, retinal specialists, and patient advocacy groups, it's clear that demonstrating improvement in functional vision is essential for marketing authorization as well as reimbursement. Thus, throughout the third quarter and continuing into the fourth, we've invested time to validate functional vision endpoints, increasing the probability of success of ABACUS-2 and a potential Phase 3 study in the US and Europe. This validation work is being performed in collaboration with our partner Théa, with additional support from the Choroideremia Research Foundation.
通過與FDA和歐洲監管機構、視網膜專家以及患者倡導團體的多次互動，明顯地顯示，證明在功能視力方面取得改進對於獲得營銷授權和報銷至關重要。因此，在第三季度和第四季度繼續投入時間，以驗證功能視力終點，增加ABACUS-2和在美國和歐洲進行潛在的第三期研究成功的可能性。此驗證工作是與我們的合作伙伴Théa以及Choroideremia研究基金會的額外支持一起進行的。
"Our other active program is KIO-104, a potent, locally delivered small molecule that we are developing to treat inflammatory retinal diseases. The goal is to offer patients and providers an alternative to chronic steroid use or systemic anti-inflammatory drugs, both of which often lead to complications. KIO-104 acts by suppressing specific types of T cells and their resulting biomolecules (cytokines) that underlie damaging inflammation. Following a previously successful first-in-man study, we now plan to initiate KLARITY in the first half of next year. This study will be a Phase 2 clinical trial to explore multiple doses of KIO-104 in patients with inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. Findings in the study will inform a dose expansion trial in one or more specific indications."
我們的另一個活躍項目是KIO-104，這是一種有效的局部給藥小分子，我們正在開發以治療炎症性視網膜疾病。我們的目標是爲患者和醫護人員提供一種替代慢性類固醇使用或全身抗炎藥物的選擇，這兩者往往會導致併發症。 KIO-104通過抑制特定類型的T細胞及其導致有害炎症的生物分子（細胞因子）發揮作用。在之前成功的首次人體研究之後，我們計劃在明年上半年開始KLARITY項目。該研究將是一個探索炎症性視網膜疾病患者中KIO-104多個劑量的第二期臨床試驗，包括後部非感染性葡萄膜炎和糖尿病性黃斑水腫。研究結果將爲一個或多個特定適應症的劑量擴大試驗提供信息。
Kiora's Chief Financial Officer, Melissa Tosca, added, "We continue to efficiently manage our cash while creating value by investing in our pipeline. Our Théa partnership enables our overall pipeline progress through their reimbursement of our KIO-301 R&D activities, allowing us to invest further in KIO-104. Going forward, we anticipate R&D expenses will increase as we begin patient enrollment in the KLARITY trial. However, we maintain a cash runway into 2027, before any potential partnership milestones, and beyond the expected data readouts from ABACUS-2 and KLARITY."
Kiora的首席財務官Melissa Tosca補充說："我們繼續高效管理我們的現金，並通過投資我們的產品線來創造價值。我們的Théa合作通過報銷我們的KIO-301研發活動，促進了我們整體產品線的進展，從而使我們能夠進一步投資於KIO-104。展望未來，隨着我們在KLARITY試驗中開始招募患者，我們預計研發費用將增加。但是，在任何潛在合作伙伴里程碑以及ABACUS-2和KLARITY預期數據披露之前，我們將維持至2027年及更遠的現金儲備。"
Third Quarter Financial Highlights
第三季度財務亮點
Kiora ended the third quarter of 2024 with $29.0 million in cash and cash equivalents and short-term investments. In addition, the Company recorded $1.8 million in collaboration receivables from TOI for reimbursed R&D expenses and $0.4 million R&D incentive tax credits. The increase in cash position from the prior quarter was due primarily to the receipt of $1.5 million in R&D incentive tax credits.
Kiora在2024年第三季度以2900萬美元的現金及現金等價物和短期投資收官，並記錄了180萬美元的合作回款，用於補償TOI的研發費用，以及40萬美元的研發激勵稅收抵免。上一季度現金位置增加主要是由於收到150萬美元的研發激勵稅收抵免。
Research and development expenses for the third quarter of 2024 were $2.2 million, before recognizing $0.9 million in reimbursement from Théa. This resulted in net research and development expenses for the third quarter of 2024 of $1.3 million compared to $1.1 million in R&D expenses in the third quarter of 2023, during which time there were no partnership-related reimbursement credits. The year-over-year increase was primarily due to research activities related to KIO-301 and KIO-104.
2024年第三季度的研究與開發費用爲220萬美元，在承認Théa提供的90萬美元報銷前。這導致2024年第三季度的淨研究與開發費用爲130萬美元，而在2013年第三季度的研發費用爲110萬美元，當時沒有與合作伙伴有關的報銷信用。同比增加主要是由於與KIO-301和KIO-104相關的研究活動。
General and administrative expenses were $1.4 million for the third quarter of 2024, no change from the $1.4 million spent in the third quarter of 2023.
2024年第三季度，管理和行政支出爲140萬美元，與2023年第三季度的支出140萬美元相比沒有變化。
Net loss was $3.4 million for the third quarter of 2024 compared to a net loss of $5.8 million for the third quarter of 2023. The decrease in net loss is primarily attributed to a non-cash component, the change in fair value of contingent consideration, of -$1.1 million in the third quarter of 2024 related to the strategic decision to focus on KIO-301 and KIO-104 and halt any continuing development and licensing activities for KIO-201.
2024年第三季度的淨虧損爲340萬美元，而2013年第三季度的淨虧損爲580萬美元。淨虧損的減少主要歸因於非現金部分——在2024年第三季度與聚焦於KIO-301和KIO-104並停止任何KIO-201持續發展和許可活動的戰略決策相關的未來考慮公允價值變動爲-110萬美元。
About Kiora Pharmaceuticals
Kiora Pharmaceuticals是一家臨床階段的生物技術公司，專注於開發和銷售用於治療孤兒性視網膜疾病的產品。KIO-301正在開發用於治療RP、脈絡膜萎縮和Stargardt病的藥物。這是一種分子光開關，有可能恢復遺傳性和/或老年相關視網膜變性患者的視力。KIO-104正在開發用於治療後段非細菌性葡萄膜炎的藥物。它是一種新一代，非類固醇，免疫調節，小分子脫氫酶抑制劑。除新聞發佈和證券交易委員會的備案外，我們還計劃在我們的網站 (www.kiorapharma.com) 和社交媒體帳戶上發佈可能與投資者相關的信息。我們鼓勵投資者關注我們的Twitter和LinkedIn帳戶，以及訪問我們的網站和/或訂閱電子郵件提醒。
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase. In addition to news releases and SEC filings, we expect to post information on our website, , and social media accounts that could be relevant to investors. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts.
Kiora Pharmaceuticals是一家臨床階段的生物技術公司，致力於開發和商業化治療孤兒性視網膜疾病的產品。KIO-301正在開發用於治療視網膜色素變性病、脈絡膜萎縮症和Stargardt病的產品。這是一種分子光開關，有望恢復患有遺傳性和/或年齡相關性視網膜退行性疾病的患者的視力。KIO-104正在開發用於治療視網膜炎症的產品。這是一種下一代、非類固醇、免疫調節和小分子二氫乳酸脫氫酶抑制劑。除了新聞發佈和證券交易委員會的備案外，我們計劃在我們的網站 和社交媒體帳戶上發佈可能對投資者有關的信息。我們鼓勵投資者關注我們的Twitter和LinkedIn帳戶，以及訪問我們的網站和/或訂閱電子郵件提醒。
Forward-Looking Statements
前瞻性聲明
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash on hand to fund operations for specific periods, the projected cash runway, the ability to timely complete planned initiatives for 2024, including phase 2 clinical development of KIO-301 and KIO-104, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, Kiora's plans to further fund development of KIO-104, the potential for KIO-104 to reduce inflammation, the timing of topline results from clinical trials of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, the anticipated readout dates for Kiora's clinical trials and their likelihood of success, and expected trends for research and development and general and administrative spending in 2024. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2024 or described in Kiora's other public filings including on Form 10-Q filed with the SEC on November 8, 2024. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.
本新聞稿中的某些聲明屬於"前瞻性聲明"，並根據《1995年私人證券訴訟改革法案》的安全港條款進行了聲明。這些"前瞻性"聲明包括與Kiora的開發和商業化努力以及其他與Kiora的開發階段產品（包括KIO-104和KIO-301）相關的監管或營銷批准努力有關的聲明，以及這些批准或成功可能無法及時獲得或實現，現有現金儲備的充足性可以支持特定時期的運營，預期的現金儲備，及時完成2024年計劃舉措的能力，包括KIO-301和KIO-104的2期臨床發展，KIO-301有望成爲治療類似RP這類遺傳性退行性疾病患者的首個治療選擇的潛力，Kiora計劃進一步資助KIO-104的發展，KIO-104有降低炎症的潛力，KIO-104臨床試驗頂線結果的時間安排，KIO-104適用於其他視網膜炎症性疾病的潛力，Kiora臨床試驗結果的預期披露日期及其成功的可能性，以及2024年研發、一般和行政開支的預期趨勢。這些聲明涉及可能導致與本新聞稿中所述不符的風險和不確定性，例如及時進行臨床試驗的能力，市場等條件以及Kiora的年度報告提交給SEC的2024年3月25日提交的表格10-k中包含的某些風險因素等因素，或是在Kiora的其他公開文件（包括2024年11月8日提交給SEC的表格10-Q）中描述的風險因素。Kiora的結果也可能受到Kiora目前不知曉的因素的影響。本新聞稿中的前瞻性聲明僅適用於本新聞稿日期。Kiora明確聲明不承擔任何義務或責任，以公開發布任何對這些聲明的更新或修訂，以反映其對於此類聲明基於的期望的任何變化，或在任何此類聲明的基礎上相關事件、情況或環境的變化，法律的要求除外。
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Contact:
investors@kiorapharma.com
Brian Siegel，IRC，MBA-高級管理董事，Hayden IR，電話：（346）396-8696，ir@zedge.net
investors@kiorapharma.com
CONDENSED CONSOLIDATED BALANCE SHEETS
簡明合併資產負債表
| September 30, 2024 (unaudited) | December 31, 2023 | |||||
| ASSETS | ||||||
| Current Assets: | ||||||
| Cash and Cash Equivalents | $ | 5,637,019 | $ | 2,454,684 | ||
| Short-Term Investments | 23,398,016 | - | ||||
| Prepaid Expenses and Other Current Assets | 470,424 | 233,382 | ||||
| Collaboration Receivables | 1,783,472 | - | ||||
| Tax and Other Receivables | 363,706 | 2,049,965 | ||||
| Total Current Assets | 31,652,637 | 4,738,031 | ||||
| Non-Current Assets: | ||||||
| Property and Equipment, Net | 62,609 | 8,065 | ||||
| Restricted Cash | 4,520 | 4,267 | ||||
| Intangible Assets and In-Process R&D, Net | 6,687,100 | 8,813,850 | ||||
| Operating Lease Assets with Right-of-Use | 72,637 | 106,890 | ||||
| Other Assets | 29,851 | 40,767 | ||||
| Total Assets | $ | 38,509,354 | $ | 13,711,870 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current Liabilities: | ||||||
| Accounts Payable | $ | 660,415 | $ | 206,260 | ||
| Accrued Expenses | 1,714,211 | 1,380,666 | ||||
| Accrued Collaboration Credit | 1,119,591 | - | ||||
| Operating Lease Liabilities | 33,447 | 47,069 | ||||
| Total Current Liabilities | 3,527,664 | 1,633,995 | ||||
| Non-Current Liabilities: | ||||||
| Contingent Consideration | 4,133,008 | 5,128,959 | ||||
| Deferred Tax Liability | 779,440 | 779,440 | ||||
| Operating Lease Liabilities | 39,190 | 59,822 | ||||
| Total Non-Current Liabilities | 4,951,638 | 5,968,221 | ||||
| Total Liabilities | 8,479,302 | 7,602,216 | ||||
| Commitments and Contingencies (Note 8) | ||||||
| Stockholders' Equity: | ||||||
| Preferred Stock, $0.01 Par Value: 10,000,000 shares authorized; 3,750 designated Series A, 0 shares issued and outstanding; 10,000 designated Series B, 0 shares issued and outstanding; 10,000 shares designated Series C, 0 shares issued and outstanding; 20,000 shares designated Series D, 7 shares issued and outstanding; 1,280 shares designated Series E, 0 shares issued and outstanding; 3,908 shares designated Series F, 420 issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 4 | 4 | ||||
| Common Stock, $0.01 Par Value: 150,000,000 and 50,000,000 shares authorized; 3,000,788 and 856,182 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 267,679 | 77,078 | ||||
| Additional Paid-In Capital | 168,996,195 | 153,192,228 | ||||
| Accumulated Deficit | (139,158,620) | (146,976,855) | ||||
| Accumulated Other Comprehensive Loss | (75,206) | (182,801) | ||||
| Total Stockholders' Equity | 30,030,052 | 6,109,654 | ||||
| Total Liabilities and Stockholders' Equity | $ | 38,509,354 | $ | 13,711,870 |
| 2024年9月30日（未經審計） | 2023年12月31日 | |||||
| 資產 | ||||||
| 流動資產： | ||||||
| 現金及現金等價物 | $ | 5,637,019 | $ | 2,454,684 | ||
| 短期投資 | 23,398,016 | - | ||||
| 預付款項及其他流動資產 | 470,424 | 233,382 | ||||
| 合作應收款 | 1,783,472 | - | ||||
| 稅項和其他應收款 | 363,706 | 2,049,965 | ||||
| 流動資產合計 | 31,652,637 | 4,738,031 | ||||
| 非流動資產： | ||||||
| 固定資產，淨值 | 62,609 | 8,065 | ||||
| 限制性現金 | 4,520 | 4,267 | ||||
| 無形資產和在研研發項目，淨額 | 6,687,100 | 8,813,850 | ||||
| 帶有使用權的運營租賃資產 | 72,637 | 106,890 | ||||
| 其他資產 | 29,851 | 40,767 | ||||
| 總資產 | $ | 38,509,354 | $ | 13,711,870 | ||
| 負債和股東權益 | ||||||
| 流動負債: | ||||||
| 應付賬款 | $ | 660,415 | $ | 206,260 | ||
| 應計費用 | 1,714,211 | 1,380,666 | ||||
| 應計合作貸款 | 1,119,591 | - | ||||
| 經營租賃負債 | 33,447 | 47,069 | ||||
| 總流動負債 | 3,527,664 | 1,633,995 | ||||
| 非流動負債： | ||||||
| 待定對價 | 4,133,008 | 5,128,959 | ||||
| 遞延所得稅負債 | 779,440 | 779,440 | ||||
| 經營租賃負債 | 39,190 | 59,822 | ||||
| 總非流動負債 | 4,951,638 | 5,968,221 | ||||
| 總負債 | 8,479,302 | 7,602,216 | ||||
| 承諾和事項（注8） | ||||||
| 股東權益： | ||||||
| 普通股，每股面值$0.01：共有10,000,000股授權；其中3,750股指定爲A系列，未發行股份；10,000股指定爲B系列，未發行股份；10,000股指定爲C系列，未發行股份；20,000股指定爲D系列，7股已發行股份；1,280股指定爲E系列，未發行股份；3,908股指定爲F系列，其中於2024年9月30日和2023年12月31日分別發行並流通420股。 | 4 | 4 | ||||
| 普通股，每股面值$0.01：共有15,000,000股和5,000,000股授權；其中於2024年9月30日和2023年12月31日分別發行和流通3,000,788股和856,182股。 | 267,679 | 77,078 | ||||
| 資本公積金 | 168,996,195 | 153,192,228 | ||||
| 累計赤字 | (139,158,620) | (146,976,855) | ||||
| 累計其他綜合損失 | (75,206) | (182,801) | ||||
| 股東權益總計 | 30,030,052 | 6,109,654 | ||||
| 負債和股東權益總計 | $ | 38,509,354 | $ | 13,711,870 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)
(unaudited)
經簡化合並利潤及綜合虧損表（未經審計）
綜合收益（虧損）
(未經審計)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue: | ||||||||||||
| Collaboration Revenue | $ | - | $ | - | $ | 16,000,000 | $ | - | ||||
| Grant Revenue | - | - | 20,000 | - | ||||||||
| Total Revenue | - | - | 16,020,000 | - | ||||||||
| Operating Expenses: | ||||||||||||
| General and Administrative | 1,380,997 | 1,415,844 | 4,215,411 | 3,782,596 | ||||||||
| Research and Development | 1,317,231 | 1,085,010 | 3,717,570 | 2,915,392 | ||||||||
| In-Process R&D Impairment | 2,008,000 | 1,904,314 | 2,008,000 | 1,904,314 | ||||||||
| Change in Fair Value of Contingent Consideration | (1,103,991) | 1,513,400 | (995,951) | 1,865,945 | ||||||||
| Total Operating Expenses | 3,602,237 | 5,918,568 | 8,945,030 | 10,468,247 | ||||||||
| Operating Income (Loss) | (3,602,237) | (5,918,568) | 7,074,970 | (10,468,247) | ||||||||
| Other Income (Expense), Net: | ||||||||||||
| Interest Income, Net | 248,840 | 49,912 | 813,989 | 128,464 | ||||||||
| Other Income (Expense), Net | (59,929) | 105,715 | (70,724) | 94,493 | ||||||||
| Total Other Income, Net | 188,911 | 155,627 | 743,265 | 222,957 | ||||||||
| Net Income (Loss) | $ | (3,413,326) | $ | (5,762,941) | $ | 7,818,235 | $ | (10,245,290) | ||||
| Deemed Dividends from Warrant Reset Provision | - | (530,985) | - | (530,985) | ||||||||
| Net Loss Attributable to Common Shareholders | $ | (3,413,326) | $ | (6,293,926) | $ | 7,818,235 | $ | (10,776,275) | ||||
| Net Income (Loss) per Common Share - Basic | $ | (0.81) | $ | (7.30) | $ | 2.08 | $ | (23.35) | ||||
| Weighted Average Shares Outstanding - Basic | 4,214,950 | 789,656 | 3,757,467 | 438,687 | ||||||||
| Net Income (Loss) per Common Share - Diluted | $ | (0.81) | $ | (7.30) | $ | 1.91 | $ | (23.35) | ||||
| Weighted Average Shares Outstanding - Diluted | 4,214,950 | 789,656 | 4,092,880 | 438,687 | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||
| Net Income (Loss) | $ | (3,413,326) | $ | (5,762,941) | $ | 7,818,235 | $ | (10,245,290) | ||||
| Unrealized Gain on Marketable Securities | 76,435 | - | 73,607 | - | ||||||||
| Foreign Currency Translation Adjustments | 94,094 | (40,310) | 33,988 | (83,430) | ||||||||
| Comprehensive Income (Loss) | $ | (3,242,797) | $ | (5,803,251) | $ | 7,925,830 | $ | (10,328,720) | ||||
| 截至9月30日的三個月 | 九個月截至9月30日 | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| 營業收入： | ||||||||||||
| 合作收入 | $ | - | $ | - | $ | 16,000,000 | $ | - | ||||
| 授予收入 | - | - | 20,000 | - | ||||||||
| 總收入 | - | - | 16,020,000股普通股於2023年5月9日（最近實際日期）爲發行和流通的股份。 | - | ||||||||
| 營業費用： | ||||||||||||
| 一般和行政 | 1,380,997 | 1,415,844 | 4,215,411 | 3,782,596 | ||||||||
| 迄今爲止，我們的研究和開發費用與AV-101的開發有關。研究和開發費用按照發生的原則確認，並將在收到將用於研究和開發的貨物或服務之前支付的款項資本化，直至收到這些貨物或服務。 | 1,317,231 | 1,085,010 | 3,717,570 | 2,915,392 | ||||||||
| 研發過程中的減值 | 2,008,000 | 1,904,314 | 2,008,000 | 1,904,314 | ||||||||
| 2024年6月30日結束的六個月內，與待定代償的公允價值變動有關。 | (1,103,991) | 1,513,400 | (995,951) | 1,865,945 | ||||||||
| 總營業費用 | 3,602,237 | 5,918,568 | 8,945,030 | 10,468,247 | ||||||||
| 營業收入（虧損） | (3,602,237) | (5,918,568) | 7,074,970 | (10,468,247) | ||||||||
| 其他收入（費用），淨： | ||||||||||||
| 利息收入( 淨額 ) | 248,840 | 49,912 | 813,989 | 128,464 | ||||||||
| 其他收入（費用），淨額 | (59,929) | 105,715 | (70,724) | 94,493 | ||||||||
| 其他收入，淨額 | 188,911 | 155,627 | 743,265 | 222,957 | ||||||||
| 淨利潤（損失） | $ | (3,413,326) | $ | (5,762,941) | $ | 7,818,235 | $ | (10,245,290) | ||||
| 根據認股權重設條款視爲派息 | - | (530,985) | - | (530,985) | ||||||||
| 歸屬於普通股股東的淨虧損 | $ | (3,413,326) | $ | (6,293,926) | $ | 7,818,235 | $ | (10,776,275) | ||||
| 每股普通股的淨收益（基本） | $ | (0.81) | $ | (7.30) | $ | 2.08 | $ | (23.35) | ||||
| 基本每股加權平均值 | 4,214,950 | 789,656 | 3,757,467 | 438,687 | ||||||||
| 每股普通股的淨收益（攤薄） | $ | (0.81) | $ | (7.30) | $ | 1.91 | $ | (23.35) | ||||
| 攤薄每股加權平均值 | 4,214,950 | 789,656 | 4,092,880 | 438,687 | ||||||||
| 其他全面收益（虧損）： | ||||||||||||
| 淨利潤（損失） | $ | (3,413,326) | $ | (5,762,941) | $ | 7,818,235 | $ | (10,245,290) | ||||
| 可交易證券未實現收益 | 76,435 | - | 73607 | - | ||||||||
| 外幣翻譯調整 | 94,094 | (40,310) | 33,988 | (83,430) | ||||||||
| 綜合收益（損失） | $ | (3,242,797) | $ | (5,803,251) | $ | 7,925,830 | $ | (10,328,720) | ||||
譯文內容由第三人軟體翻譯。