HER2 x IL-12

BRIDGEWATER, NJ, USA and LONDON, UK I September 16, 2024 I Tharimmune, Inc . (NASDAQ:THAR) (“Tharimmune” or the “Company”), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, announced today that it has entered into a definitive agreement with Intract Pharma to exclusively license INT-023/TH023, an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab. This strategic partnership aims to expand Tharimmune’s therapeutic pipeline and reinforce its commitment to pioneering novel treatments for autoimmune diseases. Under the terms of the agreement, Tharimmune licensed global development and commercialization rights (outside of South Korea) to Intract Pharma’s Soteria ® and Phloral ® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Intract Pharma received an upfront payment and is eligible to receive additional payments upon an equity financing of the Company and is eligible for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. The agreement retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial. In addition, Tharimmune has the option to exercise the license to Intract’s platform for up to four additional targets. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit TNF-α. Tumor necrosis factor-alpha is a signaling protein involved in acute phase reactions and systemic inflammation. Infliximab is sold by Janssen Biotech under the Remicade ® brand for numerous indications including Crohn’s disease, ulcerative colitis, rheumatoid diseases and plaque psoriasis. Traditionally administered through intravenous infusions, oral delivery of antibodies such as infliximab is challenging due to the complexity of navigating such large molecules through the gastrointestinal tract. This new partnership aims to overcome these challenges using Intract’s delivery platform, making it possible to administer infliximab in a pill form. An oral route of administration holds potential to improve patient compliance and quality of life, while also reducing the burden on the healthcare system associated with long-term intravenous therapy. “The integration of Intract’s innovative technology, combined with the high-quality infliximab monoclonal antibody provided by their existing supply agreement, holds tremendous potential to accelerate and reinforce our commitment to immunology. This new collaboration not only broadens our therapeutic focus, but also aligns with our mission to improve patient outcomes by developing more convenient and accessible treatment options,” said Randy Milby, CEO of Tharimmune. “An oral form of infliximab represents a significant advancement in the treatment of chronic inflammatory diseases, and the opportunity for Tharimmune to compete in a multibillion-dollar global market.” This partnership enables the targeted delivery of antibody therapeutics directly to the colon or small intestine. By leveraging Intract’s platform, Tharimmune aims to enhance the effectiveness of TNF-α inhibitors such as infliximab through precision delivery that maximizes proteolytic stabilization and tissue permeation. This novel approach offers significant potential for directly addressing inflammatory conditions within the gastrointestinal tract, including inflammatory bowel disease, as well as systemic inflammatory disorders where TNF-α plays a critical role in disease progression. “Safer and orally available biological treatments for long term use in chronic inflammation and immune mediated diseases represents a major area of medical need for millions of patients” said Vipul Yadav, CEO of Intract. “We are delighted to be partnering with Tharimmune and bringing on board their clinical development expertise in immunology to further advance together our oral anti-TNFα antibody into the clinic”. About Intract Pharma Intract is a biopharmaceutical company developing disruptive oral antibody delivery solutions to significantly improve the efficacy and safety of emerging and established protein therapeutics, as well as improve patient experience and outcomes in inflammation and immunology indications. Its platform leverages the advantage of precision targeting of large proteins and antibodies to the colon, while also protecting the biologics from enzymatic breakdown, allowing tissue/systemic uptake to create next-generation oral antibody medicines. For more information, please visit www.intractpharma.com About Tharimmune Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company’s lead clinical-stage asset, TH104, is known to suppress chronic, debilitating pruritus or “uncontrollable itching” in PBC, a rare and orphan liver disease with no known cure. The Company’s early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company’s antibody discovery technology platform against these and other specified targets. For more information, please visit www.tharimmune.com . SOURCE: Tharimmune

Company to Host Conference Call Today, August 7, at 4:30pm ETBOCA RATON, Fla., Aug. 07, 2023 (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 quarter ended June 30, 2023 and provides a business update. Q2 2023 Corporate Highlights: DN-TNF Platform Highlights (XPro™ and INB03™): AD02 blinded randomized program in patients with Early Alzheimer’s Disease (AD) continues to enroll in Australia and Canada. The company is actively pursuing other regulatory venues to expand the clinical trial footprint. Discussions with the FDA have provided a clear pathway to lifting the clinical hold before the end-of-year.Announced expansion of novel MRI biomarker data to include gray matter. Gray matter, the portion of the brain containing nerve cell bodies, has historically been the focus of Alzheimer’s disease research and drug development. Previous MRI biomarker analysis from patients receiving XPro™ for treatment of AD has demonstrated early changes in white matter that predict presence of neuroinflammation and response to XPro™ therapy. The new data, reported at the annual Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands in July, demonstrates improvement in gray matter in patients with AD. The results demonstrate a dose dependent enhancement in gray matter measures in the brain in AD patients treated with XPro™. The data confirm that neuroinflammation affects white and gray matter of the brain. Treatment with XPro™ resulted in improvements in both white and gray matter microstructural elements that may predict improvements in cognition. The data further validate the biomarker package associated with the on-going Phase II trial in patients with Early AD. Presented data in early July at the 16th European Meeting on Glial Cells in Health and Disease in Berlin that show that XPro™ promotes remyelination by affecting astroglial and microglial biology. Myelin is a specialized lipid produced by oligodendrocytes that forms the myelin sheath of axons. Axons are the projections that allow neurons to communicate with each other and with other tissues such as muscle, skin, retina, nose, and the ear for sight, smell, and hearing respectively. An intact and healthy myelin sheath is necessary for axons to allow neurons to communicate with each other and work properly. Drug therapies to prevent demyelination are available, but there are no therapies that promote remyelination. Therapies that promote remyelination will be needed to effectively treat many neurodegenerative diseases and is increasingly recognized as part of the pathology associated with Alzheimer’s disease. The Company plans a webinar on highlighting the importance of remyelination therapy in patients with MS and AD before the end-of-year.Presented additional data on combination of INB03™ with trastuzumab-deruxtecan (Enhertu™, TDxd) at the American Association for Cancer Research (AACR) annual scientific meeting in April showing that triple negative breast cancer (TNBC) often express MUC4. MUC4-expressing cancers, breast cancer, HER2+ breast cancer, TNBC, gastric, and pancreatic cancer, are candidates for combination therapy with DN-TNF. In pre-clinical models, INB03™ reduced MUC4 expression to decrease resistance to immunotherapy including tyrosine kinase inhibitors (TKI), trastuzumab and TDxd. A pSar DN-TNF compound with new composition-of-matter IP is in animal testing in preparation for a strategic partnering program in oncology. The polysarcosine (pSar) DN-TNF program converts XPro™ from a single drug into a DN-TNF drug platform. Polysarcosine is a novel half-life extender that effectively replaces the PEG half-life extender used in XPro™. The pSar program is an essential part of INmune Bio’s business development efforts. XPro™ has been designated for the CNS programs, including AD, TRD, ALS and other neurological diseases. The pSar program provides at least three new DN-TNF biologics that are eligible for composition-of-matter IP and have unique biologic characteristics that allow partnering DN-TNF opportunities beyond CNS, such as oncology (INB03™), Duchenne’s Muscular Dystrophy (DMD), and other disease indications. Each drug is a novel DN-TNF compound that will require a unique development program. INKmune™ Platform: IND cleared by the Food & Drug Administration (FDA) in May for INKmune™ for a Phase I/II open label trial in metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial is expected to enroll the first of 30 patients in the final quarter of 2023. Patients will receive three infusions of INKmune™ as out-patient treatment during the six-month trial. Three doses of INKmune™ are being tested in a modified Bayesian Phase I/II trial to answer four questions: Is INKmune™ safe in patients with mCRPC?What dose of INKmune™ should be used in a blinded randomized pivotal trial in men with mCRPC?How long can the effects of INKmune™ be sustained, (Determined by measuring tumor killing NK cells in the blood called memory like NK cells).Is there a tumor response to INKmune™ therapy? Measures of tumor response include blood PSA and tumor DNA levels in the patient’s blood and PMSA PET scan. The results of the open label study should allow the Company to design a pivotable trial. LAUREL, the INKmune™ trial in high risk MDS and AML has opened a third clinical site in Athens, Greece. The site is screening patients and expects to enroll patients soon. Changing management of high risk MDS patients in the UK has resulted in screen failures. The cause of these screen failures has been identified and addressed to help increase recruiting of patient into LAUREL. The Company is seeking to modify the trial enrollment criteria to increase the pool of potential patients to drive recruitment.CSO Dr. Mark Lowdell gave the opening plenary presentation in the Presidential Session at the annual International Society of Cell & Gene Therapy (ISCT) where he presented the scientific discovery of INKmune™ and development to clinical trials. His talk highlighted that NK cells primed by INKmune™ have the ability to alter their phenotype to a cancer-killing population of memory-like NK cells that differ from single-cytokine or multiple-cytokine (IL-12, IL-15, IL-18) primed NK cells. This innovation avoids the cost and complications associated with cytokine therapy and produces NK cells ideally suited for attacking cancer. Upcoming Events and Milestones: Top-line results for the Phase II XPro™ trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease are expected towards the end of 2024.Initiate a Phase II trial of XPro™ in patients with Treatment-Resistant Depression upon resolution of the ongoing FDA manufacturing review.Webinar on using XPro™ to promote remyelination in AD and MS before end-of-year.Additional open-label Phase I trial data of INKmune™ in high-risk MDS/AML in 2023.Opening of a Phase I/II trial in a prostate cancer in the second half of 2023. Financial Results for the Quarter Ended June 30, 2023: Net loss attributable to common stockholders for the quarter ended June 30, 2023, was approximately $6.5 million, compared to approximately $6.8 million during the quarter ended June 30, 2022.Research and development expenses totaled approximately $4.1 million for the quarter ended June 30, 2023, compared to approximately $4.2 million during the quarter ended June 30, 2022.General and administrative expense were approximately $2.3 million for the quarter ended June 30, 2023, compared to approximately $2.2 million during the quarter ended June 30, 2022.Other expense was approximately $0.1 million for the quarter ended June 30, 2023, compared to approximately $0.5 million during the quarter ended June 30, 2022.As of June 30, 2023, the Company had cash and cash equivalents of approximately $47.8 million.As of August 7, 2023, 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 First Quarter Conference Call when reaching an operator. Date: August 7, 2023Time: 4:30 PM Eastern TimeParticipant Dial-in: 1-877-404-0784 Participant Dial-in (international): 1-201-689-8560 Conference ID: 13739436 A live audio webcast of the call can be accessed using this link or clicking here: https://viavid.webcasts.com/starthere.jsp?ei=1621197&tp_key=3e16bba085 A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 14 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13739436. 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 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)(Unaudited) June 30,2023 December 31,2022 ASSETS CURRENT ASSETS Cash and cash equivalents $47,825 $52,153 Research and development tax credit receivable 1,934 8,099 Other tax receivable 112 362 Prepaid expenses and other current assets 2,707 4,027 Prepaid expenses – related party 30 34 TOTAL CURRENT ASSETS 52,608 64,675 Operating lease – right of use asset 468 507 Other assets 130 99 Acquired in-process research and development intangible assets 16,514 16,514 TOTAL ASSETS $69,720 $81,795 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $2,385 $5,206 Accounts payable and accrued liabilities – related parties 9 9 Deferred liabilities 560 616 Current portion of long-term debt 10,000 5,000 Operating lease, current liabilities 101 87 TOTAL CURRENT LIABILITIES 13,055 10,918 Long-term debt, net 4,822 9,697 Long-term operating lease liabilities 463 526 Accrued liability – long-term 726 550 TOTAL LIABILITIES 19,066 21,691 COMMITMENTS AND CONTINGENCIES 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, 17,945,995 shares issued and outstanding 18 18 Additional paid-in capital 155,399 151,799 Accumulated other comprehensive loss (712) (699)Accumulated deficit (104,051) (91,014)TOTAL STOCKHOLDERS’ EQUITY 50,654 60,104 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $69,720 $81,795 INMUNE BIO INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share and per share amounts)(Unaudited) For the Three Months EndedJune 30, For the Six Months EndedJune 30, 2023 2022 2023 2022 REVENUE $46 $16 $84 $179 OPERATING EXPENSES General and administrative 2,309 2,215 4,637 4,547 Research and development 4,148 4,189 8,281 8,498 Total operating expenses 6,457 6,404 12,918 13,045 LOSS FROM OPERATIONS (6,411) (6,388) (12,834) (12,866) OTHER EXPENSE, NET (90) (450) (203) (875) NET LOSS $(6,501) $(6,838) $(13,037) $(13,741) Net loss per common share – basic and diluted $(0.36) $(0.38) $(0.73) $(0.77) Weighted average common shares outstanding – basic and diluted 17,945,995 17,945,995 17,945,995 17,908,349 COMPREHENSIVE LOSS Net loss $(6,501) $(6,838) $(13,037) $(13,741)Other comprehensive loss – foreign currency translation (4) (757) (13) (702)Total comprehensive loss $(6,505) $(7,595) $(13,050) $(14,443) INMUNE BIO INC.CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands) (Unaudited) For the Six Months EndedJune 30, 2023 2022 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(13,037) $(13,741)Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 3,600 3,422 Accretion of debt discount 125 113 Changes in operating assets and liabilities: Research and development tax credit receivable 6,165 (13)Other tax receivable 250 457 Prepaid expenses 1,320 (1,944)Prepaid expenses – related party 4 (37)Other assets (31) - Accounts payable and accrued liabilities (2,821) (2,046)Accounts payable and accrued liabilities – related parties - (71)Deferred liabilities (56) 2 Accrued liability – long-term 176 176 Operating lease liabilities (10) 58 Net cash used in operating activities (4,315) (13,624) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from sale of common stock - 699 Net proceeds from the exercise of warrants - 30 Net cash provided by financing activities - 729 Impact on cash from foreign currency translation (13) (702) NET DECREASE IN CASH AND CASH EQUIVALENTS (4,328) (13,597)CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 52,153 74,810 CASH AND CASH EQUIVALENTS AT END OF PERIOD $47,825 $61,213 SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: Cash paid for income taxes $- $- Cash paid for interest expense $930 $601

BOCA RATON, Fla., Aug. 07, 2023 (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 quarter ended June 30, 2023 and provides a business update. Q2 2023 Corporate Highlights: DN-TNF Platform Highlights (XPro™ and INB03™): AD02 blinded randomized program in patients with Early Alzheimer’s Disease (AD) continues to enroll in Australia and Canada. The company is actively pursuing other regulatory venues to expand the clinical trial footprint. Discussions with the FDA have provided a clear pathway to lifting the clinical hold before the end-of-year. Announced expansion of novel MRI biomarker data to include gray matter. Gray matter, the portion of the brain containing nerve cell bodies, has historically been the focus of Alzheimer’s disease research and drug development. Previous MRI biomarker analysis from patients receiving XPro™ for treatment of AD has demonstrated early changes in white matter that predict presence of neuroinflammation and response to XPro™ therapy. The new data, reported at the annual Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands in July, demonstrates improvement in gray matter in patients with AD. The results demonstrate a dose dependent enhancement in gray matter measures in the brain in AD patients treated with XPro™. The data confirm that neuroinflammation affects white and gray matter of the brain. Treatment with XPro™ resulted in improvements in both white and gray matter microstructural elements that may predict improvements in cognition. The data further validate the biomarker package associated with the on-going Phase II trial in patients with Early AD. Presented data in early July at the 16th European Meeting on Glial Cells in Health and Disease in Berlin that show that XPro™ promotes remyelination by affecting astroglial and microglial biology. Myelin is a specialized lipid produced by oligodendrocytes that forms the myelin sheath of axons. Axons are the projections that allow neurons to communicate with each other and with other tissues such as muscle, skin, retina, nose, and the ear for sight, smell, and hearing respectively. An intact and healthy myelin sheath is necessary for axons to allow neurons to communicate with each other and work properly. Drug therapies to prevent demyelination are available, but there are no therapies that promote remyelination. Therapies that promote remyelination will be needed to effectively treat many neurodegenerative diseases and is increasingly recognized as part of the pathology associated with Alzheimer’s disease. The Company plans a webinar on highlighting the importance of remyelination therapy in patients with MS and AD before the end-of-year. Presented additional data on combination of INB03™ with trastuzumab-deruxtecan (Enhertu™, TDxd) at the American Association for Cancer Research (AACR) annual scientific meeting in April showing that triple negative breast cancer (TNBC) often express MUC4. MUC4-expressing cancers, breast cancer, HER2+ breast cancer, TNBC, gastric, and pancreatic cancer, are candidates for combination therapy with DN-TNF. In pre-clinical models, INB03™ reduced MUC4 expression to decrease resistance to immunotherapy including tyrosine kinase inhibitors (TKI), trastuzumab and TDxd. A pSar DN-TNF compound with new composition-of-matter IP is in animal testing in preparation for a strategic partnering program in oncology. The polysarcosine (pSar) DN-TNF program converts XPro™ from a single drug into a DN-TNF drug platform. Polysarcosine is a novel half-life extender that effectively replaces the PEG half-life extender used in XPro™. The pSar program is an essential part of INmune Bio’s business development efforts. XPro™ has been designated for the CNS programs, including AD, TRD, ALS and other neurological diseases. The pSar program provides at least three new DN-TNF biologics that are eligible for composition-of-matter IP and have unique biologic characteristics that allow partnering DN-TNF opportunities beyond CNS, such as oncology (INB03™), Duchenne’s Muscular Dystrophy (DMD), and other disease indications. Each drug is a novel DN-TNF compound that will require a unique development program. INKmune™ Platform: IND cleared by the Food & Drug Administration (FDA) in May for INKmune™ for a Phase I/II open label trial in metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial is expected to enroll the first of 30 patients in the final quarter of 2023. Patients will receive three infusions of INKmune™ as out-patient treatment during the six-month trial. Three doses of INKmune™ are being tested in a modified Bayesian Phase I/II trial to answer four questions: Is INKmune™ safe in patients with mCRPC? What dose of INKmune™ should be used in a blinded randomized pivotal trial in men with mCRPC? How long can the effects of INKmune™ be sustained, (Determined by measuring tumor killing NK cells in the blood called memory like NK cells). Is there a tumor response to INKmune™ therapy? Measures of tumor response include blood PSA and tumor DNA levels in the patient’s blood and PMSA PET scan. The results of the open label study should allow the Company to design a pivotable trial. LAUREL, the INKmune™ trial in high risk MDS and AML has opened a third clinical site in Athens, Greece. The site is screening patients and expects to enroll patients soon. Changing management of high risk MDS patients in the UK has resulted in screen failures. The cause of these screen failures has been identified and addressed to help increase recruiting of patient into LAUREL. The Company is seeking to modify the trial enrollment criteria to increase the pool of potential patients to drive recruitment. CSO Dr. Mark Lowdell gave the opening plenary presentation in the Presidential Session at the annual International Society of Cell & Gene Therapy (ISCT) where he presented the scientific discovery of INKmune™ and development to clinical trials. His talk highlighted that NK cells primed by INKmune™ have the ability to alter their phenotype to a cancer-killing population of memory-like NK cells that differ from single-cytokine or multiple-cytokine (IL-12, IL-15, IL-18) primed NK cells. This innovation avoids the cost and complications associated with cytokine therapy and produces NK cells ideally suited for attacking cancer. Upcoming Events and Milestones: Top-line results for the Phase II XPro™ trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease are expected towards the end of 2024. Initiate a Phase II trial of XPro™ in patients with Treatment-Resistant Depression upon resolution of the ongoing FDA manufacturing review. Webinar on using XPro™ to promote remyelination in AD and MS before end-of-year. Additional open-label Phase I trial data of INKmune™ in high-risk MDS/AML in 2023. Opening of a Phase I/II trial in a prostate cancer in the second half of 2023. Financial Results for the Quarter Ended June 30, 2023: Net loss attributable to common stockholders for the quarter ended June 30, 2023, was approximately $6.5 million, compared to approximately $6.8 million during the quarter ended June 30, 2022. Research and development expenses totaled approximately $4.1 million for the quarter ended June 30, 2023, compared to approximately $4.2 million during the quarter ended June 30, 2022. General and administrative expense were approximately $2.3 million for the quarter ended June 30, 2023, compared to approximately $2.2 million during the quarter ended June 30, 2022. Other expense was approximately $0.1 million for the quarter ended June 30, 2023, compared to approximately $0.5 million during the quarter ended June 30, 2022. As of June 30, 2023, the Company had cash and cash equivalents of approximately $47.8 million. As of August 7, 2023, 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 First Quarter Conference Call when reaching an operator. Date: August 7, 2023 Time: 4:30 PM Eastern Time Participant Dial-in: 1-877-404-0784 Participant Dial-in (international): 1-201-689-8560 Conference ID: 13739436 A live audio webcast of the call can be accessed using this link or clicking here: A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 14 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13739436. 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 . 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. INmune Bio Contact: David Moss, CFO (858) 964-3720 info@inmunebio.com Investor Contact: Jason Nelson Core 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) (Unaudited) June 30, 2023 December 31, 2022 ASSETS CURRENT ASSETS Cash and cash equivalents $ 47,825 $ 52,153 Research and development tax credit receivable 1,934 8,099 Other tax receivable 112 362 Prepaid expenses and other current assets 2,707 4,027 Prepaid expenses – related party 30 34 TOTAL CURRENT ASSETS 52,608 64,675 Operating lease – right of use asset 468 507 Other assets 130 99 Acquired in-process research and development intangible assets 16,514 16,514 TOTAL ASSETS $ 69,720 $ 81,795 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $ 2,385 $ 5,206 Accounts payable and accrued liabilities – related parties 9 9 Deferred liabilities 560 616 Current portion of long-term debt 10,000 5,000 Operating lease, current liabilities 101 87 TOTAL CURRENT LIABILITIES 13,055 10,918 Long-term debt, net 4,822 9,697 Long-term operating lease liabilities 463 526 Accrued liability – long-term 726 550 TOTAL LIABILITIES 19,066 21,691 COMMITMENTS AND CONTINGENCIES 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, 17,945,995 shares issued and outstanding 18 18 Additional paid-in capital 155,399 151,799 Accumulated other comprehensive loss (712 ) (699 ) Accumulated deficit (104,051 ) (91,014 ) TOTAL STOCKHOLDERS’ EQUITY 50,654 60,104 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 69,720 $ 81,795 INMUNE BIO INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, 2023 2022 2023 2022 REVENUE $ 46 $ 16 $ 84 $ 179 OPERATING EXPENSES General and administrative 2,309 2,215 4,637 4,547 Research and development 4,148 4,189 8,281 8,498 Total operating expenses 6,457 6,404 12,918 13,045 LOSS FROM OPERATIONS (6,411 ) (6,388 ) (12,834 ) (12,866 ) OTHER EXPENSE, NET (90 ) (450 ) (203 ) (875 ) NET LOSS $ (6,501 ) $ (6,838 ) $ (13,037 ) $ (13,741 ) Net loss per common share – basic and diluted $ (0.36 ) $ (0.38 ) $ (0.73 ) $ (0.77 ) Weighted average common shares outstanding – basic and diluted 17,945,995 17,945,995 17,945,995 17,908,349 COMPREHENSIVE LOSS Net loss $ (6,501 ) $ (6,838 ) $ (13,037 ) $ (13,741 ) Other comprehensive loss – foreign currency translation (4 ) (757 ) (13 ) (702 ) Total comprehensive loss $ (6,505 ) $ (7,595 ) $ (13,050 ) $ (14,443 ) INMUNE BIO INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) For the Six Months Ended June 30, 2023 2022 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (13,037 ) $ (13,741 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 3,600 3,422 Accretion of debt discount 125 113 Changes in operating assets and liabilities: Research and development tax credit receivable 6,165 (13 ) Other tax receivable 250 457 Prepaid expenses 1,320 (1,944 ) Prepaid expenses – related party 4 (37 ) Other assets (31 ) - Accounts payable and accrued liabilities (2,821 ) (2,046 ) Accounts payable and accrued liabilities – related parties - (71 ) Deferred liabilities (56 ) 2 Accrued liability – long-term 176 176 Operating lease liabilities (10 ) 58 Net cash used in operating activities (4,315 ) (13,624 ) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from sale of common stock - 699 Net proceeds from the exercise of warrants - 30 Net cash provided by financing activities - 729 Impact on cash from foreign currency translation (13 ) (702 ) NET DECREASE IN CASH AND CASH EQUIVALENTS (4,328 ) (13,597 ) CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 52,153 74,810 CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 47,825 $ 61,213 SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: Cash paid for income taxes $ - $ - Cash paid for interest expense $ 930 $ 601