第99.1展示文本
INmune生物公司宣佈2024年第三季度業績並提供業務更新
佛羅里達博卡拉頓，2024年10月31日（全球新聞通訊社） -- INmune Bio公司。（納斯達克：INMB）（以下簡稱「公司」），一家臨床階段的炎症和免疫公司，專注於開發利用患者固有免疫系統來對抗疾病的治療方法，今天宣佈截至2024年9月30日的季度財務業績並提供業務更新。
Q3 2024 和最近 企業 亮點
DN-TNF平台亮點（XPro™）：
| ● | 公佈於9月27日星期五完成了第2期阿爾茨海默病（AD）試驗的招募。這個全球貨幣的盲測、隨機的第2期試驗（即AD02試驗）着重於早期AD患者和具有高神經炎症標誌物的患者。公司確定目前正在篩選中的患者已足夠滿足試驗的目標201名患者後，決定結束向試驗招募新患者。目前正在篩選流程中的所有患者仍有資格參與AD02，這可能導致輕微過度招募。 |
| ● | 宣佈AD02試驗盲數據中間分析結果顯示，新型認知測量工具EMACC表現出色，EMACC與臨床癡呆評分盒子總和（CDR-SB）之間具有高度顯著的相關性，這是AD試驗的一項認可終點。分析的關鍵發現包括： |
| ● | 統計 相關性：獨立審查證實，在AD02試驗中，EMACC基線評分與CDR-Sb之間存在極顯著相關性（p<0.001）。 CDR-Sb是最常在AD註冊研究中使用的臨床評分量表。 |
| ● | 可靠性： 在篩查過程中測量的EMACC相關性再次出現在治療前的第一次研究訪問中爲0.93。更高的精度產生更爲穩健且可複製的結果，且樣本量更小。 |
| ● | 不同化能力: 具有CDR全球評級爲0.5（AD前期）和評級爲1.0（輕度癡呆）的患者之間，在EMACC表現方面存在顯著差異，效果量（cohen's d）爲0.87（p<.0001）。這表明EMACC能夠準確區分疾病階段，突出其敏感性和精準性。 |
| ● | 已宣佈 發表在《Cell Reports》, “小膠質細胞通過ΤNFR1依賴的表型極化調節皮質再髓鞘形成.” 髓鞘對神經元之間的快速和高效通信至關重要。失去髓鞘會損害神經元功能和通信，是許多中樞神經系統疾病，包括阿爾茨海默病的神經退行性過程中的關鍵步驟。來自該出版物的數據確定可溶性TNF作爲一個關鍵的細胞因子檢查點，將小膠質細胞從修復性、再髓鞘細胞轉變爲有害的、脫髓鞘細胞。這些數據表明，阻斷可溶性TNF是治療脫髓鞘性疾病的一個有前景的策略。 |
| ● | 將於2024年11月7日美東時間下午1點舉行，宣佈使用EMACC和CSD-Sb進行認知測試的網絡研討會。點擊這裏註冊 |
INKmune™平台：
| ● | 宣佈，在第一劑量隊列的 INKmune™ 在一項第 I/II 期試驗（「CaRePC」 試驗）中展示出卓越的安全性和增強的 NK 電芯活性，針對轉移性去勢耐藥前列腺癌（mCRPC）的男性。從首三名患者的監測血樣的盲分析顯示，患者的 NK 電芯表型和功能發生了改變。儘管這是最低劑量隊列，但其中 3 名患者中有 2 名顯示出循環激活的 NK 電芯增加，所有三名患者顯示出增強的 NK 電芯功能，在最後一次 INKmune™ 輸注後持續超過 40 天。一名患者伴隨 NK 電芯活性和功能增加顯示了暫時 21% 的 PSA 下降。 |
| ● | 在門診基礎上，INKmune™ 在mCRPC研究中已進行了21次管理，沒有發生顯著不良事件，包括零例細胞因子釋放綜合徵(CRS)。結合從MDS/AML和mCRPC試驗中對INKmune™ 的經驗，已安全使用了超過30次INKmune™ 輸注，無需進行調理療法、預處理或細胞因子支持。 |
| ● | CaRe PC試驗最近爲最高劑量組的第一位患者施用了劑量，併爲中間劑量組的受試者開放了第II期招募。中間劑量組和高劑量組中INKmune™的劑量是第一組中INKmune™的3倍和5倍。所有八個臨床試驗點現在已經開放，隨着更多的高劑量組結果變得可用，該試驗將發佈進一步的結果。 |
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| ● | 已出版 由inMune首席科學官馬克·洛德爾博士領導的《癌症免疫療法》雜誌上具有里程碑意義的論文，標題爲：蛋白質組學 以及用於癌症免疫療法的記憶樣自然殺傷細胞的表型特徵。該研究表明，這就像記憶一樣 自然殺傷 (mLNK) 細胞，由細胞因子或 inkMune 產生TM引發，顯示對多發性細胞的毒性增加 腫瘤類型，爲癌症免疫療法提供了廣闊的潛力。重要的是，雖然大多數研究都是針對健康的Nk細胞進行的 志願者，這項研究表明，來自癌症患者的mLNK與健康志願者產生的mLNK同樣有效 支持 InkMune 的體內治療方法。該研究還爲新陳代謝和生理學提供了新的見解 Nk 細胞記憶的潛在機制，爲血液系統惡性腫瘤和實體瘤的創新治療鋪平了道路。 |
| ● | 宣佈 INKmune™的新配方支持最高試驗劑量的單袋管理，並擴大生物反應器容量，爲可擴展的製造業做準備。已經提交了一份帶有改進配方的IND修訂版給FDA，其中還包括支持INKmune™製造中使用的另一種臨界試劑的其他驗證數據，改善供應鏈冗餘度。 |
企業：
| ● | 與新的和現有的機構投資者以及公司的某些董事、高管和員工簽訂了證券購買協議，募集了約1300萬美元的全部收益。 |
| ● | 在2024年羅素美國指數年度重構結束時，被添加到廣泛市場的羅素3000®指數，於7月1日星期一生效21世紀醫療改革法案, 2024. |
| ● | 7月份從澳洲獲得了250萬美元的研發補貼。 |
即將到來的活動和里程碑:
| ● | 預計阿爾茨海默病2期臨床試驗的一線數據將於2025年第二季度發佈。 |
| ● | 在2024年下半年對患有治療抵抗性抑鬱症的患者進行XPro™的II期臨床試驗。 |
| ● | 預計在年底完成INKmune™在轉移性去勢抵抗性前列腺癌試驗的I期招募。預計II期招募將在2025年第二季度完成，但隨着數據的不斷更新，我們預計會提供關於INKmune™的免疫學和治療反應的定期更新。 |
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Financial 結果 為了 第三季度截止於2024年9月30日：
| ● | 2024年9月30日結束的本季度歸屬於普通股股東的淨虧損約為1210萬美元，相較於2023年9月30日結束的本季度約為860萬美元。 |
| ● | 截至2024年9月30日的季度，研發費用總計約1,010萬美元，相較於2023年9月30日的季度，約為600萬美元。 |
| ● | 截至2024年9月30日的季度，總務及行政開支約為220萬美元，而截至2023年9月30日的季度則約為260萬。 |
| ● | 截至2024年9月30日，公司現金及現金等價物約為3360萬美元。 |
| ● | 截至2024年10月31日，該公司約有2220萬股普通股尚未流通。 |
業績會資訊
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.
Date: October 31, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): 1-203-518-9843
Conference ID: INMUNE
A live audio webcast of the call can be accessed by clicking here or using this link: INmune Bio, Inc. Third Quarter 2024 Earnings Call - 1692115
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11156467.
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About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About INKmune™
INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.
INKmune™ is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™ is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.
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Forward Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
David Moss
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
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The following tables summarize our results of operations for the periods indicated:
INMUNE BIO INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
| September 30, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 33,552 | $ | 35,848 | ||||
| Research and development tax credit receivable | 1,109 | 1,905 | ||||||
| Other tax receivable | 311 | 537 | ||||||
| Prepaid expenses and other current assets | 864 | 1,510 | ||||||
| Prepaid expenses – related party | 15 | 142 | ||||||
| TOTAL CURRENT ASSETS | 35,851 | 39,942 | ||||||
| Operating lease – right of use asset | 335 | 414 | ||||||
| Other assets | 82 | 131 | ||||||
| Acquired in-process research and development intangible assets | 16,514 | 16,514 | ||||||
| TOTAL ASSETS | $ | 52,782 | $ | 57,001 | ||||
| LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 10,590 | $ | 7,901 | ||||
| Accounts payable and accrued liabilities – related parties | 55 | 35 | ||||||
| Deferred liabilities | 549 | 489 | ||||||
| Current portion of long-term debt | 2,494 | 9,921 | ||||||
| Operating lease, current liability | 135 | 119 | ||||||
| TOTAL CURRENT LIABILITIES | 13,823 | 18,465 | ||||||
| Long-term operating lease liability | 284 | 397 | ||||||
| TOTAL LIABILITIES | 14,107 | 18,862 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| Redeemable common stock, $0.001 par value; no shares and 75,697 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively (Note 9) | - | 799 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, and 22,172,451 and 17,950,776 shares issued and outstanding, respectively | 22 | 18 | ||||||
| Additional paid-in capital | 193,575 | 159,143 | ||||||
| Accumulated other comprehensive loss | (1,036 | ) | (799 | ) | ||||
| Accumulated deficit | (153,886 | ) | (121,022 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 38,675 | 37,340 | ||||||
| TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY | $ | 52,782 | $ | 57,001 | ||||
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INMUNE BIO INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| REVENUE | $ | - | $ | 43 | $ | 14 | $ | 127 | ||||||||
| OPERATING EXPENSES | ||||||||||||||||
| General and administrative | 2,219 | 2,586 | 7,369 | 7,223 | ||||||||||||
| Research and development | 10,067 | 5,985 | 25,813 | 14,266 | ||||||||||||
| Total operating expenses | 12,286 | 8,571 | 33,182 | 21,489 | ||||||||||||
| LOSS FROM OPERATIONS | (12,286 | ) | (8,528 | ) | (33,168 | ) | (21,362 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET | 193 | (35 | ) | 304 | (238 | ) | ||||||||||
| NET LOSS | $ | (12,093 | ) | $ | (8,563 | ) | $ | (32,864 | ) | $ | (21,600 | ) | ||||
| Net loss per common share – basic and diluted | $ | (0.60 | ) | $ | (0.48 | ) | $ | (1.71 | ) | $ | (1.20 | ) | ||||
| Weighted average common shares outstanding – basic and diluted | 20,185,676 | 18,008,295 | 19,176,853 | 17,966,990 | ||||||||||||
| COMPREHENSIVE LOSS | ||||||||||||||||
| Net loss | $ | (12,093 | ) | $ | (8,563 | ) | $ | (32,864 | ) | $ | (21,600 | ) | ||||
| Other comprehensive loss – foreign currency translation | (323 | ) | (23 | ) | (237 | ) | (36 | ) | ||||||||
| Total comprehensive loss | $ | (12,416 | ) | $ | (8,586 | ) | $ | (33,101 | ) | $ | (21,636 | ) | ||||
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INMUNE BIO INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| For the Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (32,864 | ) | $ | (21,600 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 5,848 | 5,489 | ||||||
| Accretion of debt discount | 73 | 179 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 796 | 6,012 | ||||||
| Other tax receivable | 226 | 186 | ||||||
| Prepaid expenses | 646 | 2,492 | ||||||
| Prepaid expenses – related party | 127 | 34 | ||||||
| Other assets | 49 | (30 | ) | |||||
| Accounts payable and accrued liabilities | 2,689 | (1,531 | ) | |||||
| Accounts payable and accrued liabilities – related parties | 20 | 70 | ||||||
| Deferred liabilities | 60 | (120 | ) | |||||
| Accrued liability – long-term | - | 254 | ||||||
| Operating lease liabilities | (18 | ) | (14 | ) | ||||
| Net cash used in operating activities | (22,348 | ) | (8,579 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock and warrants | 27,789 | 775 | ||||||
| Repayments of debt | (7,500 | ) | (2,500 | ) | ||||
| Net cash provided by financing activities | 20,289 | (1,725 | ) | |||||
| Impact on cash from foreign currency translation | (237 | ) | (36 | ) | ||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (2,296 | ) | (10,340 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 35,848 | 52,153 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 33,552 | $ | 41,813 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | 661 | $ | 1,394 | ||||
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