INmune Bio Inc

INmune Bio, Inc. Is a clinical stage biotechnology company, which engages in developing new immunotherapies that reprograms the immune system to fight cancer and Alzheimer’s disease. Its products include pipeline, INKMUNE-Cancer, INB03-Cancer, XPRO1595-Alzheimer and TRD, and LIVNate. The company was founded by Mark Lowdell in September 2015 and is headquartered in Boca Raton, FL.

Earnings data Q1 2021

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Earnings data Q1 2024

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Earnings data Q3 2024

Earnings data Q4 2024

INmune Bio reports stable financials, eyes growth in diversified programs

INmune Bio's financials remain stable, with a strategic focus on advancing key programs and achieving upcoming milestones.
The company's strengths lie in efficient trial consolidation, diversification into solid tumors, and patient-centric treatment approaches.
Challenges include operational complexities, FDA holds, and the need for successful international site enrollments.
Opportunities for growth include new program launches, expansion into different therapeutic areas, and exploring combination therapies.

INmune Bio advances Alzheimer's and cancer treatments amidst financial strength

INmune Bio's Q1 2023 performance reflects a focus on advancing treatments for Alzheimer's, cancer, and other diseases, supported by a strong financial position.
While facing challenges such as FDA clinical hold and resource allocation, the company's commitment to innovation and diversification presents growth opportunities.
With upcoming milestones and a promising pipeline, INmune Bio is poised to make significant strides in addressing critical medical needs and expanding its therapeutic reach.

INmune Bio reports Q2 loss, progresses in Alzheimer's and solid tumors

INmune Bio's Q2 2023 earnings call highlighted progress in Alzheimer's and solid tumor treatments, with positive effects observed on gray matter microstructure.
The company's financials showed a net loss but with sufficient cash reserves for operations, while upcoming milestones signal growth potential.
Challenges include managing losses, regulatory progress, and market strategies, but opportunities lie in therapeutic advancements and diversification.

INmune Bio advances Alzheimer's and cancer trials amidst financial challenges

INmune Bio made progress in patient enrollment for Alzheimer's and prostate cancer trials, with a focus on regulatory milestones. Financially, the company reported a net loss but maintains a healthy cash position. Challenges include regulatory hurdles and competition, while opportunities exist in upcoming milestones and market expansion.

INmune Bio advances Alzheimer's and prostate cancer trials amid financial challenges

INmune Bio's Q4 2023 Earnings Call highlighted progress in Alzheimer's and prostate cancer trials, with positive regulatory developments. Financially, the company reported a net loss but maintains a healthy cash position. Analyst questions focused on trial specifics and market comparisons.

INmune Bio Inc advances Alzheimer's trials and secures funding for growth

INmune Bio Inc's Q2 2024 showcased progress in Alzheimer's trials, successful fundraising, and strategic milestones ahead
The company's leadership, financial stability, and upcoming trials position it well for growth and market recognition
While facing competitive challenges and operational complexities, INmune Bio Inc remains focused on innovation and market expansion

INmune Bio excels in clinical trials, secures funding for growth

INmune Bio's Q3 2024 earnings call highlighted strong clinical progress, financial growth, and a focus on data-driven decision-making for future success.
The company's emphasis on quality standards, innovative drug delivery, and promising trial results positions them well for upcoming milestones and market impact.
While facing inquiries and challenges, INmune Bio remains confident in its programs, signaling a resilient approach to addressing industry complexities and driving growth.

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Boca Raton, Florida, April 25, 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 announced today that it has entered into definitive agreements for the sale and purchase of 986,000 shares of its common stock and warrants to purchase up to an aggregate of 986,000 shares of its common stock at an offering price of $9.84 per share of common stock and accompanying warrant. The warrants include an acceleration clause upon positive top-line data in the Company's Phase 2 Alzheimer's Disease program (as further described  below).  The offering was priced at-the-market under Nasdaq rules based on the average of the previous 5-days' closing prices, or $9.84 per share which includes $0.125 per warrant. The warrants terminate on the earlier of (1) the two (2) year anniversary of the initial exercise date of the warrant or (2) thirty (30) trading days following the reporting of positive top-line data (EMACC) in the Phase 2 Alzheimer's program of XPro1595, (the “Termination Date”). The gross proceeds of this offering are approximately $9.7 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about April 29, 2024, subject to the satisfaction of customary closing conditions.

INmune Bio Inc. Announces $9.7 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Boca Raton, Florida, April 23, 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, is delighted to announce the successful completion of the extended stability validation for XProTM continuous storage in solution at 2-8C. The 24 and 30-month stability test samples passed all chemistry and potency assays; allowing the Company to make a conservative claim of 24-month stability. The 24-month stability claim is consistent with other pegylated cytokines, such as alpha-interferon, and allows the Company to design a global supply chain using proven and established systems. With this data, the company can benefit from such existing systems that use temperature controlled and monitored shipment of liquid-formulation drugs at 2-8C, which is routine across the pharmaceutical industry. The 24-month stability data confirms that XProTM can mirror these established supply chain strategies.

INmune Bio Inc. Announces 24-Month Stability Validation of XPro™ for Phase III Readiness and Commercial Supply Chain Modeling & Development of Novel Immunogenicity Assay

Boca Raton, Florida, April 22, 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 announced today that it has entered into definitive agreements for the sale and purchase of 571,592 shares of its common stock with above market warrant exercise price  that include an acceleration clause upon positive top-line data in the Company's Phase 2 Alzhzimer's Disease program (as further described  below).  The warrants give the investor the right to purchase 571,592 additional shares of its common stock in a registered direct offering. The offering was priced at the market based on the Friday, April 19th Nasdaq consolidated closing bid price of $8.32 per share. The exercise price of the warrants is $9.152, which represents a 10% premium to the price at which the common shares were offered. The warrants terminate on the earlier of (1) the two (2) year anniversary of the initial exercise date of the warrant or (2) thirty (30) trading days following the reporting of top line data (EMACC) in the Phase 2 Alzheimer's program of XPro1595, (the “Termination Date”). The gross proceeds of this offering are approximately $4.8 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about April 24, 2024, subject to the satisfaction of customary closing conditions. Members of management and the Company's board of directors and certain key employees participated in the offering and will pay a combined offering price for the common stock and warrants of $8.445 per share and warrant, and  in the case of officers and directors that participated in the offering, if the warrant termination date is on a blackout date then the officers and directors will have an additional 60 days from the termination of the blackout date to exercise the warrant.

INmune Bio Inc. Raises Approximately $4.8 Million in Gross Proceeds Through Registered Direct Offering with Officers, Employees and Directors Purchasing Approximately 20% of the Offering

INmune Bio is focused on developing drugs for neurology and cancer medicine. The company's most advanced product candidate is XPro 1595, which is being developed for Alzheimer's disease. INMB's financial situation may require a cash raise by the end of 2024, but there is potential for significant upside if their clinical platforms show positive results.

INmune Bio: An Opportunity In The Freefall (Rating Upgrade)

Novel Immunotherapy Approach Targets Soluble Tumor Necrosis Factor to Overcome Resistance and Enhance Therapeutic Outcome in High-Risk Breast Cancer

INmune Bio Inc. Presents Data on INB03's Role as an Immune Check Point Modulator in the Treatment of High-Risk Breast Cancer at AACR 2024

INmune Bio, Inc. (INMB) Q4 2023 Earnings Call Transcript

BOCA 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.

INmune Bio Inc. Announces Year End 2023 Results and Provides a Q4 Business Update

Management to host conference call and webcast at 4:30 pm ET on that day Boca Raton, Florida, March 26, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology and inflammation company focused on developing treatments that harness a patient's innate immune system to fight disease, today announced that it will host a conference call on Thursday, March 28, 2024 at 4:30 PM Eastern Time to discuss results for its fourth quarter ended December 31, 2023 and to provide a corporate update. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

INmune Bio Inc. to Report Fourth Quarter 2023 Financial Results and Provide a Corporate Update on Thursday, March 28

International Society for Cell & Gene Therapy (ISCT)  Names Dr. Lowdell with the Career Achievement Award in Cell and Gene Therapy Recognizing Exceptional Contributions and Achievements in the Field Boca Raton, Florida, March 13, 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, announces its Chief Scientific Officer and Co-Founder Mark Lowdell, Ph.D. has been awarded the Career Achievement Award in Cell and Gene Therapy by the International Society of Cell & Gene Therapy (ISCT), which the organization considers its highest honor.

INmune Bio CSO and Co-Founder Mark Lowdell, Ph.D. Receives The ISCT Career Achievement Award in Cell and Gene Therapy

Patients with Alzheimer's Disease show improvement in brainwaves following 4 weeks of XPro™ therapy.

INmune Bio Reports Significant EEG Improvement in Alzheimer's Patients Treated with XPro™

Boca Raton, Florida, Feb. 12, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc.   (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer's disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, announced today that RJ Tesi, M.D., Chief Executive Officer, and David Moss, Chief Financial Officer, will present a corporate update at the Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually from February 13-14, 2024.

INmune Bio to Participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference

Boca Raton, Florida, Feb. 06, 2024 (GLOBE NEWSWIRE) --   INmune Bio, Inc.   (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer's disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, announces its management will be participating in Baird's Biotech Discovery Series webcast on Tuesday, February 13, 2024 at 10:30AM EST.  The webcast will feature RJ Tesi, MD, CEO, CJ Barnum, PhD, head of Neuroscience, and Malu Tansey, PhD, Professor of Neuroscience and Neurology, Norman and Susan Fixel Chair in Parkinson's Disease, Director, Parkinson's Foundation Research Center of Excellence, University of Florida.

INmune Bio to Participate in Baird's Biotech Discovery Series Webcast on February 13, 2024

The Phase II clinical trial in patients with Alzheimer's disease with neuroinflammation is on track to complete enrollment mid-2024 with top line data expected approximately six months after the final patient is enrolled.

INmune Bio Announces FDA Removal of Clinical Hold for Alzheimer's Disease Program

Boca Raton, Florida, Jan. 02, 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, dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023. INKmune™ is a biologic therapy given as out-patient therapy without the need for pre-medication or cytokine support.

INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune™ in Patients with Metastatic Castration-Resistant Prostate Cancer

Enrollment in the Company's Phase II study using XPro TM to treat patients with Alzheimer's Disease with neuroinflammation is accelerating in sites outside the US and the Company is maintaining its timeline to successfully conclude the trial.

INmune Bio Provides Update Regarding Global Alzheimer's Phase II Clinical Trial and Clinical Hold Issued by the United States FDA

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Investing in most current Alzheimer's drug companies is not recommended because they are not likely to modify the disease. Compounds that inhibit oxidative stress may only slow down the progression of Alzheimer's disease over the short term. Anavex's blarcamesine, Cyclo Therapeutics Trappsol Cyclo, Green Valley's GV-971, aromatherapy, and panax ginseng not only inhibit the formation of oxidants but scavenge them and reverse part of their damage.

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INB03 increases uptake of deruxtecan, the immunotoxin associated with trastuzumab deruxtecan (T-DXd, ENHERTU®), in models of resistant MUC4 expressing HER2 positive breast cancer and increases the tumor killing immunology of the tumor microenvironment.

INmune Bio Inc. Demonstrates that INB03 Enhances the Uptake of Trastuzumab Deruxtecan in HER2+ Breast Cancer with MUC4 Expression in Poster Presented at San Antonio Breast Cancer Symposium

Boca Raton, Florida, Nov. 27, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments that leverage the patient's innate immune system to combat disease, announced today it has received European Medicines Agency's (EMA) Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) in France and the Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS) in Spain to initiate a Phase II trial in Early Alzheimer's Disease (AD) with XPro™.

INmune Bio Receives EMA's Authorization in France and Spain for Phase II Clinical Trial of XPro™ for Early Alzheimer's Disease

The Company received regulatory approval to extend its Phase II trial of XPro™ in individuals with early Alzheimer's disease in Poland, with additional European Union (EU) countries expected to open soon. The Company received regulatory approval to extend its Phase II trial of XPro™ in individuals with early Alzheimer's disease in Poland, with additional European Union (EU) countries expected to open soon.

INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer's Disease in Europe

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INmune Bio, Inc. (NASDAQ:INMB ) Q3 2023 Earnings Conference Call November 1, 2023 4:30 PM ET Company Participants David Moss - Chief Financial Officer RJ Tesi - Chief Executive Officer Mark Lowdell - Chief Scientific Officer Conference Call Participants Joel Beatty - Baird Tom Shrader - BTIG Daniel Carlson - Tailwinds Research Operator Greetings and welcome to the INmune Bio Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode.

INmune Bio, Inc. (INMB) Q3 2023 Earnings Call Transcript

BOCA RATON, Fla., Nov. 01, 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 September 30, 2023 and provides a business update.

INmune Bio Inc. Announces Third Quarter 2023 Results and Provides Business Update

INmune Bio receives International Search Report and Written Opinion communicating possession of novelty, inventive step, and industrial applicability in all claims pending in an international patent application covering, among other things, its proprietary cell line, INB16, and the INKmune™ therapeutic composition.

INmune Bio Inc. Patent Claims Covering INB16 Cell Line and INKmune™ Therapeutic Composition given Favorable Patentability Opinion by International Search Authority

SIRP-CD47 is an innate immune checkpoint known as the “don't eat me” signal. INB03 downregulates expression of SIRPα on macrophages promote increased cancer cell death by antibody dependent cellular phagocytosis (ADCP).

INmune Bio Inc. Presents Preclinical Data at SITC 2023 Showing INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα

INmune Bio is a phase 2 stage biotech company focusing on Alzheimer's and other diseases with its lead asset, XPro, and its endogenous NK cell activator, INKmune. INmune's XPro has shown promising results in stabilizing Alzheimer's disease and improving cognition in early-stage trials. The company's pipeline includes potential treatments for treatment-resistant depression and various cancers, with a focus on activating the innate immune system.

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