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.（纳斯达克：KPRX）（"Kiora"或"公司"）今天宣布了2024年第三季度的财务业绩，并就其治疗视网膜疾病的疗法管线提供了更新。 第三季度和最近的公司要点包括：
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.
调查性新药申请已获批，启动ABACUS-2，KIO-301的2期研究，这是一种用于治疗视网膜色素性视网膜炎的新型分子光开关。
确定了KIO-104的2期KLARITY试验设计，这是一种小分子，针对治疗多种视网膜炎症性疾病，已提交试验批准申请，计划于2024年第4季度按时展开。
季度末，现金、现金等价物和短期投资合计2900万美元，加上180万美元的与公司Théa Open Innovation（TOI或Théa）合作伙伴关系相关的协作应收款项。
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仍然处于强势地位，有两个引人注目和创新的药物候选品进入第2期临床试验，并拥有强劲的资产负债表，以资助开发和运营超出这两项研究预期结果的时间点，” Kiora总裁兼首席执行官Brian M. Strem博士表示。 "在第三季度，我们努力准备这些试验，以增加它们成功的可能性。
"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.
“关于KIO-301，我们最近获得批准启动ABACUS-2，该研究是一个包括36名患者的多中心，双盲，随机，对照，多剂量研究，针对具有视网膜色素变性所致超低视觉或无光感的患者。 基于KIO-301作为一种小分子的不同的作用机制，我们将招募患有与视网膜色素变性相关的任何已知150多种基因突变的患者。 第一名接受KIO-301治疗的患者的给药将在明年开始，此前将完成围绕功能视力终点的进行中的验证工作。
"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.
通过与FDA和欧洲监管机构、视网膜专家以及患者倡导团体的多次互动，明显地显示，证明在功能视力方面取得改进对于获得营销授权和报销至关重要。因此，在第三季度和第四季度继续投入时间，以验证功能视力终点，增加ABACUS-2和在美国和欧洲进行潜在的第三期研究成功的可能性。此验证工作是与我们的合作伙伴Théa以及Choroideremia研究基金会的额外支持一起进行的。
"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."
我们的另一个活跃项目是KIO-104，这是一种有效的局部给药小分子，我们正在开发以治疗炎症性视网膜疾病。我们的目标是为患者和医护人员提供一种替代慢性类固醇使用或全身抗炎药物的选择，这两者往往会导致并发症。 KIO-104通过抑制特定类型的T细胞及其导致有害炎症的生物分子（细胞因子）发挥作用。在之前成功的首次人体研究之后，我们计划在明年上半年开始KLARITY项目。该研究将是一个探索炎症性视网膜疾病患者中KIO-104多个剂量的第二期临床试验，包括后部非感染性葡萄膜炎和糖尿病性黄斑水肿。研究结果将为一个或多个特定适应症的剂量扩大试验提供信息。
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的首席财务官Melissa Tosca补充说："我们继续高效管理我们的现金，并通过投资我们的产品线来创造价值。我们的Théa合作通过报销我们的KIO-301研发活动，促进了我们整体产品线的进展，从而使我们能够进一步投资于KIO-104。展望未来，随着我们在KLARITY试验中开始招募患者，我们预计研发费用将增加。但是，在任何潜在合作伙伴里程碑以及ABACUS-2和KLARITY预期数据披露之前，我们将维持至2027年及更远的现金储备。"
Third Quarter Financial Highlights
第三季度财务亮点
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2900万美元的现金及现金等价物和短期投资收官，并记录了180万美元的合作回款，用于补偿TOI的研发费用，以及40万美元的研发激励税收抵免。上一季度现金位置增加主要是由于收到150万美元的研发激励税收抵免。
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年第三季度的研究与开发费用为220万美元，在承认Théa提供的90万美元报销前。这导致2024年第三季度的净研究与开发费用为130万美元，而在2013年第三季度的研发费用为110万美元，当时没有与合作伙伴有关的报销信用。同比增加主要是由于与KIO-301和KIO-104相关的研究活动。
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，管理和行政支出为140万美元，与2023年第三季度的支出140万美元相比没有变化。
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年第三季度的净亏损为340万美元，而2013年第三季度的净亏损为580万美元。净亏损的减少主要归因于非现金部分——在2024年第三季度与聚焦于KIO-301和KIO-104并停止任何KIO-201持续发展和许可活动的战略决策相关的未来考虑公允价值变动为-110万美元。
About Kiora Pharmaceuticals
Kiora Pharmaceuticals是一家临床阶段的生物技术公司，专注于开发和销售用于治疗孤儿性视网膜疾病的产品。KIO-301正在开发用于治疗RP、脉络膜萎缩和Stargardt病的药物。这是一种分子光开关，有可能恢复遗传性和/或老年相关视网膜变性患者的视力。KIO-104正在开发用于治疗后段非细菌性葡萄膜炎的药物。它是一种新一代，非类固醇，免疫调节，小分子脱氢酶抑制剂。除新闻发布和证券交易委员会的备案外，我们还计划在我们的网站 (www.kiorapharma.com) 和社交媒体账户上发布可能与投资者相关的信息。我们鼓励投资者关注我们的Twitter和LinkedIn账户，以及访问我们的网站和/或订阅电子邮件提醒。
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是一家临床阶段的生物技术公司，致力于开发和商业化治疗孤儿性视网膜疾病的产品。KIO-301正在开发用于治疗视网膜色素变性病、脉络膜萎缩症和Stargardt病的产品。这是一种分子光开关，有望恢复患有遗传性和/或年龄相关性视网膜退行性疾病的患者的视力。KIO-104正在开发用于治疗视网膜炎症的产品。这是一种下一代、非类固醇、免疫调节和小分子二氢乳酸脱氢酶抑制剂。除了新闻发布和证券交易委员会的备案外，我们计划在我们的网站 和社交媒体账户上发布可能对投资者有关的信息。我们鼓励投资者关注我们的Twitter和LinkedIn账户，以及访问我们的网站和/或订阅电子邮件提醒。
Forward-Looking Statements
前瞻性声明
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.
本新闻稿中的某些声明属于"前瞻性声明"，并根据《1995年私人证券诉讼改革法案》的安全港条款进行了声明。这些"前瞻性"声明包括与Kiora的开发和商业化努力以及其他与Kiora的开发阶段产品（包括KIO-104和KIO-301）相关的监管或营销批准努力有关的声明，以及这些批准或成功可能无法及时获得或实现，现有现金储备的充足性可以支持特定时期的运营，预期的现金储备，及时完成2024年计划举措的能力，包括KIO-301和KIO-104的2期临床发展，KIO-301有望成为治疗类似RP这类遗传性退行性疾病患者的首个治疗选择的潜力，Kiora计划进一步资助KIO-104的发展，KIO-104有降低炎症的潜力，KIO-104临床试验顶线结果的时间安排，KIO-104适用于其他视网膜炎症性疾病的潜力，Kiora临床试验结果的预期披露日期及其成功的可能性，以及2024年研发、一般和行政开支的预期趋势。这些声明涉及可能导致与本新闻稿中所述不符的风险和不确定性，例如及时进行临床试验的能力，市场等条件以及Kiora的年度报告提交给SEC的2024年3月25日提交的表格10-k中包含的某些风险因素等因素，或是在Kiora的其他公开文件（包括2024年11月8日提交给SEC的表格10-Q）中描述的风险因素。Kiora的结果也可能受到Kiora目前不知晓的因素的影响。本新闻稿中的前瞻性声明仅适用于本新闻稿日期。Kiora明确声明不承担任何义务或责任，以公开发布任何对这些声明的更新或修订，以反映其对于此类声明基于的期望的任何变化，或在任何此类声明的基础上相关事件、情况或环境的变化，法律的要求除外。
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Contact:
investors@kiorapharma.com
Brian Siegel，IRC，MBA-高级管理董事，Hayden IR，电话：（346）396-8696，ir@zedge.net
investors@kiorapharma.com
CONDENSED CONSOLIDATED BALANCE SHEETS
简明合并资产负债表
| 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（未经审计） | 2023年12月31日 | |||||
| 资产 | ||||||
| 流动资产： | ||||||
| 现金及现金等价物 | $ | 5,637,019 | $ | 2,454,684 | ||
| 短期投资 | 23,398,016 | - | ||||
| 预付款项及其他流动资产 | 470,424 | 233,382 | ||||
| 合作应收款 | 1,783,472 | - | ||||
| 税项和其他应收款 | 363,706 | 2,049,965 | ||||
| 流动资产合计 | 31,652,637 | 4,738,031 | ||||
| 非流动资产： | ||||||
| 固定资产，净值 | 62,609 | 8,065 | ||||
| 限制性现金 | 4,520 | 4,267 | ||||
| 无形资产和在研研发项目，净额 | 6,687,100 | 8,813,850 | ||||
| 带有使用权的运营租赁资产 | 72,637 | 106,890 | ||||
| 其他资产 | 29,851 | 40,767 | ||||
| 总资产 | $ | 38,509,354 | $ | 13,711,870 | ||
| 负债和股东权益 | ||||||
| 流动负债: | ||||||
| 应付账款 | $ | 660,415 | $ | 206,260 | ||
| 应计费用 | 1,714,211 | 1,380,666 | ||||
| 应计合作贷款 | 1,119,591 | - | ||||
| 经营租赁负债 | 33,447 | 47,069 | ||||
| 总流动负债 | 3,527,664 | 1,633,995 | ||||
| 非流动负债： | ||||||
| 待定对价 | 4,133,008 | 5,128,959 | ||||
| 递延所得税负债 | 779,440 | 779,440 | ||||
| 营运租赁负债 | 39,190 | 59,822 | ||||
| 总非流动负债 | 4,951,638 | 5,968,221 | ||||
| 总负债 | 8,479,302 | 7,602,216 | ||||
| 承诺和事项（注8） | ||||||
| 股东权益： | ||||||
| 普通股，每股面值$0.01：共有10,000,000股授权；其中3,750股指定为A系列，未发行股份；10,000股指定为B系列，未发行股份；10,000股指定为C系列，未发行股份；20,000股指定为D系列，7股已发行股份；1,280股指定为E系列，未发行股份；3,908股指定为F系列，其中于2024年9月30日和2023年12月31日分别发行并流通420股。 | 4 | 4 | ||||
| 普通股，每股面值$0.01：共有15,000,000股和5,000,000股授权；其中于2024年9月30日和2023年12月31日分别发行和流通3,000,788股和856,182股。 | 267,679 | 77,078 | ||||
| 资本公积金 | 168,996,195 | 153,192,228 | ||||
| 累计赤字 | (139,158,620) | (146,976,855) | ||||
| 累计其他综合损失 | (75,206) | (182,801) | ||||
| 股东权益总计 | 30,030,052 | 6,109,654 | ||||
| 负债和股东权益总计 | $ | 38,509,354 | $ | 13,711,870 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)
(unaudited)
经简化合并利润及综合亏损表（未经审计）
综合收益（亏损）
（未经审计）
| 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日的三个月 | 九个月截至9月30日 | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| 营业收入： | ||||||||||||
| 合作收入 | $ | - | $ | - | $ | 16,000,000 | $ | - | ||||
| 授予收入 | - | - | 20,000 | - | ||||||||
| 总收入 | - | - | 16,020,000股普通股于2023年5月9日（最近实际日期）为发行和流通的股份。 | - | ||||||||
| 营业费用： | ||||||||||||
| 一般和行政 | 1,380,997 | 1,415,844 | 4,215,411 | 3,782,596 | ||||||||
| 迄今为止，我们的研究和开发费用与AV-101的开发有关。研究和开发费用按照发生的原则确认，并将在收到将用于研究和开发的货物或服务之前支付的款项资本化，直至收到这些货物或服务。 | 1,317,231 | 1,085,010 | 3,717,570 | 2,915,392 | ||||||||
| 研发过程中的减值 | 2,008,000 | 1,904,314 | 2,008,000 | 1,904,314 | ||||||||
| 2024年6月30日结束的六个月内，与待定代偿的公允价值变动有关。 | (1,103,991) | 1,513,400 | (995,951) | 1,865,945 | ||||||||
| 总营业费用 | 3,602,237 | 5,918,568 | 8,945,030 | 10,468,247 | ||||||||
| 营业收入（亏损） | (3,602,237) | (5,918,568) | 7,074,970 | (10,468,247) | ||||||||
| 其他收入（费用），净： | ||||||||||||
| 利息收入( 净额 ) | 248,840 | 49,912 | 813,989 | 128,464 | ||||||||
| 其他收入（费用），净额 | (59,929) | 105,715 | (70,724) | 94,493 | ||||||||
| 其他收入，净额 | 188,911 | 155,627 | 743,265 | 222,957 | ||||||||
| 净利润（损失） | $ | (3,413,326) | $ | (5,762,941) | $ | 7,818,235 | $ | (10,245,290) | ||||
| 根据认股权重设条款视为派息 | - | (530,985) | - | (530,985) | ||||||||
| 归属于普通股股东的净亏损 | $ | (3,413,326) | $ | (6,293,926) | $ | 7,818,235 | $ | (10,776,275) | ||||
| 每股普通股的净收益（基本） | $ | (0.81) | $ | (7.30) | $ | 2.08 | $ | (23.35) | ||||
| 基本每股加权平均值 | 4,214,950 | 789,656 | 3,757,467 | 438,687 | ||||||||
| 每股普通股的净收益（摊薄） | $ | (0.81) | $ | (7.30) | $ | 1.91 | $ | (23.35) | ||||
| 摊薄每股加权平均值 | 4,214,950 | 789,656 | 4,092,880 | 438,687 | ||||||||
| 其他全面收益（亏损）： | ||||||||||||
| 净利润（损失） | $ | (3,413,326) | $ | (5,762,941) | $ | 7,818,235 | $ | (10,245,290) | ||||
| 可交易证券未实现收益 | 76,435 | - | 73607 | - | ||||||||
| 外币翻译调整 | 94,094 | (40,310) | 33,988 | (83,430) | ||||||||
| 综合收益（损失） | $ | (3,242,797) | $ | (5,803,251) | $ | 7,925,830 | $ | (10,328,720) | ||||
