BRCA1

Company to Host Conference Call Today, March 28, at 4:30pm ETBOCA RATON, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the year ended December 31, 2023 and provides a business update. Q4 2023 and Recent Corporate Highlights DN-TNF Platform Highlights (XPro™): The AD02 randomized, blinded program for patients with Early Alzheimer's Disease remains on schedule to reach its final enrollment target by mid-2024, with top-line data expected to be presented approximately six months after the last patient is enrolled. The trial is currently active in North America, UK, EU, and the Pacific Rim.INmune Bio and Cumulus Bioscience issued a joint press release highlighting seven AD patients who received weekly XPro™ treatment for four weeks experienced a statistically significant increase in Alpha wave frequency and power (p<0.05). Reduced Alpha power is associated with cognitive decline and the progression of Alzheimer's Disease. EEG, which is widely considered a gold standard for objectively measuring brain activity, offers valuable insights into neural connectivity. Neurological research has consistently shown a progressive decline in alpha band power and frequency in individuals with MCI and Alzheimer's disease.INB03 cancer platform – poster was submitted to the 46th annual San Antionio Breast Cancer Symposium and associated data presented by Roxana Schillaci, Ph.D., of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina that shows that INB03 improves the potency of T-DXd in a model of immunotherapy resistant HER2+ breast cancer. INKmune™ Platform: The first patient was enrolled in the Phase I/II open label trial of INKmune™ in metastatic castration-resistant prostate cancer (mCRPC) in the final week of 2023. Enrollment of 3 patients in cohort 1 is complete and cohort 2 will open for enrolment after review of the first cohort by the Data Safety Monitoring Committee in mid-April. Phase I patient enrollment at all three dose levels is expected to be completed by September. and then roll directly into the phase 2 program. Patients receive three infusions of INKmune™ as out-patient treatment over two weeks and are monitored for four months for immunological and clinical responses. Three dose levels of INKmune™ are being tested in a modified Bayesian Phase I/II trial.We continue to assess other solid tumors as clinical targets for INKmune™. Currently IND enabling pre-clinical data are being generated to support a clinical trial in patients with renal cell cancer. Initiation of a clinical trial in this indication is dependent of receipt of non-dilutive grant or similar type funding.Mark Lowdell and team are investigating the role of NK cell dysfunction as a mechanism of carcinogenesis. Most recently we have shown that healthy individuals with the BRCA1 mutation, a marker of high risk of ovarian cancer, have dysfunctional NK cells compared to matched healthy, BRCA1 negative (BRCA1-ve) controls. These data support the concept of tumor immune surveillance by NK cells and its failure as a contribution to carcinogenesis. (Cancers 2024, 16, 1186. https://doi.org/10.3390/cancers16061186).The third patient for the INKmune™ AML program in UK and EU has been enrolled and subsequent to their completion of follow-up, the company will wind down the AML program to focus resources on the prostate-cancer program and other solid tumors. Upcoming Events and Milestones: Full enrollment in the Phase II XPro™ trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease are expected mid-2024 followed by top-line data approximately 6 months from the last patient enrolled.Initiate a Phase II trial of XPro™ in patients with Treatment-Resistant Depression 2H 2024.Webinar on using XPro™ on the role of demyelination and myelin repair in AD in Q2, 2024.Expect to complete enrollment in the Phase I portion of the mCRPC trial by end of Q3 2024 with data in Q4 2024. The Phase II portion is expected to complete enrollment in Q2, 2025 with data Q4, 2025.Mark Lowdell, PhD, found and CSO has been awarded the prestigious 2024 ISCT Career Achievement Award in Cell & Gene Therapy by the International Society of Cell and Gene Therapy. This distinction is awarded to an individual who has made a significant impact during their career, advancing the field of cell and gene therapy through their longstanding service in the Society’s Three Pillars of Value: Academia, Regulatory/Quality Operations, and Commercialization. Prof. Lowdell will receive the award at the 2024 annual meeting of the ISCT meeting in Vancouver, Canada in May. Financial Results for the Year Ended December 31, 2023: Net loss attributable to common stockholders for the year ended December 31, 2023, was approximately $30.0 million, compared to approximately $27.3 million during the year ended December 31, 2022.Research and development expenses totaled approximately $20.3 million for the year ended December 31, 2023, compared to approximately $17.1 million during the year ended December 31, 2022.General and administrative expenses were approximately $9.6 million for the year ended December 31, 2023, compared to approximately $9.3 million during the year ended December 31, 2022.Other expense, net was approximately $0.3 million for the year ended December 31, 2023, compared to approximately $1.3 million during the year ended December 31, 2022.As of December 31, 2023, the Company had cash and cash equivalents of approximately $35.8 million.As of March 28, 2024, the Company had approximately 18.0 million common shares outstanding. Earnings Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter Conference Call when reaching an operator. Date: March 28, 2024Time: 4:30 PM Eastern TimeParticipant Dial-in 1-877-407-0784Participant Dial-in (international): 1-201-689-8560Conference ID: 13744427 A live audio webcast of the call can be accessed by clicking here or using this link:https://callme.viavid.com/viavid/?callme=true&passcode=13739436&h=true&info=company&r=true&B=6 A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through April 3 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13744427. 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 persist for more than 100 days and function in the hypoxic TME because due to upregulated nutrient and mitochondrial survival proteins. INKmune™ is a patient friendly that does not require pre-medication, conditioning or additional cytokine therapy 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 trial in high-MDS/AML in the UK and Europe. The company plans 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. Forward Looking Statements Clinical trials are in the 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. INmune Bio Contact:David Moss, CFO (858) 964-3720info@inmunebio.com Investor Contact:Jason NelsonCore IR(516) 842-9614 x-823 The following tables summarize our results of operations for the periods indicated: INMUNE BIO INC. CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share amounts) December 31,2023 December 31,2022 ASSETS CURRENT ASSETS Cash and cash equivalents $35,848 $52,153 Research and development tax credit receivable 1,905 8,099 Other tax receivable 537 362 Prepaid expenses and other current assets 1,510 4,027 Prepaid expenses – related party 142 34 TOTAL CURRENT ASSETS 39,942 64,675 Operating lease – right of use asset 414 507 Other assets 131 99 Acquired in-process research and development intangible assets 16,514 16,514 TOTAL ASSETS $57,001 $81,795 LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $7,901 $5,206 Accounts payable and accrued liabilities – related parties 35 9 Deferred liabilities 489 616 Current portion of long-term debt, net 9,921 5,000 Operating lease, current liability 119 87 TOTAL CURRENT LIABILITIES 18,465 10,918 Long-term debt, net - 9,697 Long-term operating lease liability 397 526 Accrued liability – long-term - 550 TOTAL LIABILITIES 18,862 21,691 COMMITMENTS AND CONTINGENCIES Redeemable common stock, $0.001 par value; 75,697 and 0 shares issued and outstanding, respectively 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,17,950,776 and 17,945,995 shares issued and outstanding, respectively 18 18 Additional paid-in capital 159,143 151,799 Accumulated other comprehensive loss (799) (699)Accumulated deficit (121,022) (91,014)TOTAL STOCKHOLDERS’ EQUITY 37,340 60,104 TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY $57,001 $81,795 INMUNE BIO INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSSFOR THE YEARS ENDED DECEMBER 31, 2023 AND 2022(In thousands, except share and per share amounts) 2023 2022 REVENUE $155 $374 OPERATING EXPENSES General and administrative 9,623 9,258 Research and development 20,273 17,067 Total operating expenses 29,896 26,325 LOSS FROM OPERATIONS (29,741) (25,951) OTHER EXPENSE, NET Other expense, net (267) (1,348)Total other expense, net (267) (1,348) NET LOSS $(30,008) $(27,299) Net loss per common share – basic and diluted $(1.67) $(1.52) Weighted average number of common shares outstanding – basic and diluted 17,980,791 17,927,327 COMPREHENSIVE LOSS Net loss $(30,008) $(27,299)Other comprehensive loss – foreign currency translation (100) (700)Total comprehensive loss $(30,108) $(27,999) CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE YEARS ENDED DECEMBER 31, 2023 AND 2022(In thousands) 2023 2022 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(30,008) $(27,299)Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 7,368 7,149 Impairment of right of use asset - 89 Accretion of debt discount 224 239 Changes in operating assets and liabilities: Research and development tax credit receivable 6,194 (3,186)Other tax receivable (175) 229 Prepaid expenses and other current assets 2,517 (1,749)Prepaid expenses – related party (108) (20)Other assets (32) - Accounts payable and accrued liabilities 2,695 1,473 Accounts payable and accrued liabilities – related parties 26 (71)Deferred liabilities (127) 142 Accrued liability – long-term (550) 351 Operating lease liability (4) (33)Net cash used in operating activities (11,980) (22,686) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from sale of common stock 775 699 Repayment of debt (5,000) - Net proceeds from the exercise of warrants - 30 Net cash (used in) provided by financing activities (4,225) 729 Impact on cash from foreign currency translation (100) (700) NET DECREASE IN CASH (16,305) (22,657)CASH AT BEGINNING OF YEAR 52,153 74,810 CASH AT END OF YEAR $35,848 $52,153 SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: Cash paid for income taxes $- $- Cash paid for interest expense $1,778 $1,372

People carrying BRCA1 and BRCA2 gene mutations are at high risk of developing breast and ovarian cancer. Researchers have found that changes occur in the immune cells of breast tissue in carriers of BRCA1 and BRCA2 mutations long before breast cancer develops. This raises the possibility of early intervention to prevent the disease, as an alternative to risk-reduction surgery. Drugs already approved for late-stage breast cancer treatment could reactivate the faulty immune cells and keep the breast cells healthy. If successful in mouse models, this preventative therapeutic approach could pave the way for clinical trials in human carriers of BRCA1 and BRCA2 mutations. People carrying BRCA1 and BRCA2 gene mutations are at high risk of developing breast and ovarian cancer. Researchers have found that changes occur in the immune cells of breast tissue in carriers of BRCA1 and BRCA2 mutations long before breast cancer develops. This raises the possibility of early intervention to prevent the disease, as an alternative to risk-reduction surgery. Drugs already approved for late-stage breast cancer treatment could reactivate the faulty immune cells and keep the breast cells healthy. If successful in mouse models, this preventative therapeutic approach could pave the way for clinical trials in human carriers of BRCA1 and BRCA2 mutations. Researchers at the University of Cambridge have created the world's largest catalogue of human breast cells, which has revealed early cell changes in healthy carriers of BRCA1 and BRCA2 gene mutations. Everyone has BRCA1 and BRCA2 genes, but mutations in these genes -- which can be inherited -- increase the risk of breast and ovarian cancer. The study found that the immune cells in breast tissue of healthy women carrying BRCA1 or BRCA2 gene mutations show signs of malfunction known as 'exhaustion'. This suggests that the immune cells can't clear out damaged breast cells, which can eventually develop into breast cancer. This is the first time that 'exhausted' immune cells have been reported in non-cancerous breast tissues at such scale -- normally these cells are only found in late-stage tumours. The results raise the possibility of using existing immunotherapy drugs as early intervention to prevent breast cancer developing, in carriers of BRCA1 and BRCA2 gene mutations. The researchers have received a 'Biology to Prevention Award' from Cancer Research UK to trial this preventative approach in mice. Existing drugs have serious side effects, so testing in mice is necessary to find the right safe dosage. If effective, this will pave the way to a pilot clinical trial in women carrying BRCA gene mutations. "Our results suggest that in carriers of BRCA mutations, the immune system is failing to kill off damaged breast cells -- which in turn seem to be working to keep these immune cells at bay," said Professor Walid Khaled in the University of Cambridge's Department of Pharmacology and Wellcome-MRC Cambridge Stem Cell Institute, senior author of the report. He added: "We're very excited about this discovery, because it opens up potential for a preventative treatment other than surgery for carriers of BRCA breast cancer gene mutations. "Drugs already exist that can overcome this block in immune cell function, but so far, they've only been approved for late-stage disease. No-one has really considered using them in a preventative way before." The results are published today in the journal Nature Genetics. Risk-reducing surgery, in which the breasts are removed, is offered to those at increased risk of breast cancer. This can be a difficult decision for young women to make and can have a significant effect on body image and sexual relationships. "The best way to prevent breast cancer is to really understand how it develops in the first place. Then we can identify these early changes and intervene," said Khaled. He added: "Late-stage breast cancer tends to be very unpredictable and hard to manage. As we make better and better drugs, the tumours just seem to find a way around it." Using samples of healthy breast tissue collected from 55 women across a range of ages, the researchers catalogued over 800,000 cells -- including all the different types of breast cell. The resulting Human Breast Cell Atlas is now available as a resource for other researchers to use and add to. It contains huge amounts of information on other risk factors for breast cancer including Body Mass Index (BMI), menopausal status, contraceptive use and alcohol consumption. "We've found that there are multiple breast cell types that change with pregnancy, and with age, and it's the combination of these effects -- and others -- that drives the overall risk of breast cancer," said Austin Reed, a PhD student in the University of Cambridge's Department of Pharmacology and joint first author of the report. He added: "As we collect more of this type of information from samples around the world, we can learn more about how breast cancer develops and the impact of different risk factors -- with the aim of improving treatment." One of the biggest challenges in treating breast cancer is that it is not just one disease, but many. Many different genetic variations can lead to breast cancer, and genetic risk interacts with other risk factors in complicated ways. For example, it is known that the likelihood of breast cancer increases with age, but this risk is greatly reduced by pregnancy early in life. And age-associated risk is greatly increased in carriers of the breast cancer genes BRCA1 and BRCA2. The new study aimed to understand how some of these risk factors interact, by characterising the different cell types in the human breast under many different physiological states. The researchers used a technique called 'single cell RNA-sequencing' to characterise the many different breast cell types and states. Almost all cells in the body have the same set of genes, but only a subset of these are switched on in each cell -- and these determine the cell's identity and function. Single cell RNA-sequencing reveals which genes are switched on in individual cells. "Breast cancer occurs around the world, but social inequalities mean not everyone has access to treatment. Prevention is the most cost-effective approach. It not only tackles inequality, which mostly affects low-income countries, but also improves disease outcome in high-income countries," said Dr Sara Pensa, Senior Research Associate in the University of Cambridge's Department of Pharmacology and joint first author of the study.

3月25日，CDE官网显示，罗氏的1类新药GDC-0077拟纳入突破性治疗药物程序，拟定适应症为：与哌柏西利和内分泌疗法联合用药适用于治疗PIK3CA突变、激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性、局部晚期或转移性乳腺癌成人患者。恒瑞医药申报的氟唑帕利胶囊和甲磺酸阿帕替尼片拟纳入突破性治疗品种，拟定适应症为：氟唑帕利单药或联合阿帕替尼治疗gBRCA突变的HER2阴性乳腺癌。GDC-0077是一款PI3Kα特异性抑制剂。它对PI3Kα的选择性更强，并且可以导致突变PI3Kα的降解，从而产生更强力，更持久的抑制效果。 据药物临床试验登记与信息公示平台显示，罗氏登记有一项GDC-0077的临床试验，试验通俗题目：评估GDC-0077或安慰剂联合哌柏西利和氟维司群治疗局部晚期或转移性乳腺癌的随机双盲研究，登记号：CTR20202249，适应症为乳腺癌。1、试验目的本研究计划在辅助内分泌治疗期间或治疗完成后12个月内发生疾病进展，且既往针对局部晚期或转移性疾病未接受过系统治疗的PIK3CA突变、激素受体（HR）阳性、HER2阴性的局部晚期或转移性乳腺癌患者中，评价GDC-0077联合哌柏西利和氟维司群对比安慰剂联合哌柏西利和氟维司群治疗的有效性、安全性和药代动力学特征。氟唑帕利是恒瑞医药研发的1类创新药，为一种新型口服PARP抑制剂。该药已经在中国获批用于胚系BRCA1/2（gBRCA1/2）突变的铂敏感复发性卵巢癌治疗，以及铂类敏感复发性卵巢癌维持治疗，无论胚系BRCA1/2突变状态如何。阿帕替尼是恒瑞医药研发一种高选择性的靶向血管内皮细胞生长因子受体2（VEGFR2）的抗血管生成药物，已经在中国获批单药治疗晚期胃腺癌或胃-食管结合部腺癌、晚期肝细胞癌，以及联合卡瑞利珠单抗治疗不可切除或转移性肝细胞癌。根据中国药物临床试验登记与信息公示平台官网，一项氟唑帕利或氟唑帕利联合阿帕替尼治疗乳腺癌的3期研究正在进行中。该研究第一阶段主要目的为评价联合疗法在转移性乳腺癌中的耐受性，以及相比于研究者选择的化疗的优效性。