On March 3, 2023 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, its financial results for the year ended December 31, 2022 and provides a business update (Press release, INmune Bio, MAR 3, 2023, View Source [SID1234628138]).
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Q4 2022 and 2022 Corporate Highlights:
DN-TNF Platform Highlights (XPro and INB03):
· Consolidating the Mild Cognitive Impairment (MCI) Phase 2 trial into the Mild Alzheimer’s Disease Phase 2 study which will become a single Phase 2 AD trial. The combined trials should improve our ability to demonstrate a clinical benefit in patients receiving XPro, accelerate enrollment, and reduce costs. Including patients with MCI in the Phase 2 AD trial does not significantly increase the trial size and should shorten the time to last patient enrolled. Patients that complete the six-month Phase 2 AD study are eligible to enroll into a 12-month Open Label Extension trial (OLE). The OLE study is a 12-month study where long-term safety and efficacy of XPro treatment in patients with early AD are evaluated. Topline readout of Phase 2 AD trial is expected in 2H 2024.
· Phase 2 AD Trial open in Canada following receipt of No Objection Letter from Health Canada in November.
· Received research and development rebates from Australia and the United Kingdom in early 2023 that totaled approximately $6.4 million USD. The Company will reinvest the cash rebate in increasing recruitment and enrollment in Australia where we expect to continue to receive future rebates associated with research and development spend, in Canada to expand the Phase 2 AD program and in other foreign jurisdictions to allow the enrollment of early AD patients into the ongoing Phase 2 AD trial.
· Announced pre-clinical data that support a pioneering approach to treating Duchenne Muscular Dystrophy (DMD) targeting soluble TNF (sTNF) using a Dominant-Negative TNF (DN-TNF) biologic significantly decreased muscle damage and inflammation and promote muscle growth in the mouse mdx model of DMD. The company formed a wholly owned subsidiary, DN02, Inc., which will hold all the intellectual property to facilitate partnering and business development activities for DMD without impacting the Company’s CNS programs. There are currently no approved drugs that promote muscle regeneration in DMD patients.
· FDA review of Chemistry Manufacturing and Controls (CMC) associated with a clinical hold on XPro AD trial in the U.S. is ongoing. The Company continues to have dialog with the FDA to address the FDA’s clinical hold questions. We plan to open US Phase 2 trials sites for XPro in AD when the current hold is lifted. The Company continues to enroll patients in AUS and CAN and is working to open additional international regulatory venues. We will inform investors when each new country opens. We expect the US will open in plenty of time to include Phase 2 patients, however there are no negative consequences to the development program if all or most of the Phase 2 patients are enrolled outside of the US.
· 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 3 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, DMD and other diseases. Each drug is a novel DN-TNF compound that will require a unique development program. DMD and oncology are the first two pSar programs that are targeted for partnering.
· MUC4 expressing cancers include breast cancer, HER2+ breast cancer, triple negative breast cancer, gastric and pancreatic cancer which are candidates for DN-TNF therapy. In pre-clinical models, INB03 DN-TNF reduces MUC4 expression to decrease resistance to immunotherapy. A pSar DN-TNF compound with new composition-of-matter IP is in animal testing and if positive, this unique DN-TNF drug will be moved into a strategic partnering program in oncology. Data on combination of DN-TNF with trastuzumab-deruxtecan (Enhertu) was presented at SABCS in November 2022. Additional data will be presented at AACR (Free AACR Whitepaper) in April 2023
INKmune Platform:
· IND to be filed this month for the use of INKmune to treat patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. Excluding skin cancer, prostate cancer is the most common cancer in men. "Despite advances in the treatment of men with metastatic castration-resistant prostate cancer, the lethal form of the disease, median survival remains short and novel treatment approaches are urgently needed," said Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer who will be Principal Investigator (PI) of the INKmune trial. "Current treatment paradigms, including chemotherapy, second generation androgen receptor signaling inhibitors, and others have largely been maximized for therapeutic benefit. Although immunotherapy has shown activity and promise in other solid tumors, immunotherapeutic approaches for prostate cancer such as checkpoint inhibitors have been unsuccessful to date. Given the promise of immunotherapy, establishing the efficacy of an ‘off-the-shelf" immuno-therapeutic approach for mCRPC would be practice changing and could profoundly impact the care and quality of life for mCRPC patients. Harnessing the innate anti-tumor activity of NK cells represents a golden opportunity to advance immunotherapy to effectively and safely treat mCRPC. Now is the time to pursue such an approach." The Phase I/II design will enroll patients at several medical centers in the US.
· Additional sites have opened to support the ongoing phase I trial in high risk MDS/AML. A second site in the UK, The Royal Hallamshire Hospital at Sheffield University Medical School enrolled a patient this week with treatment scheduled for March 9th. A third site in Europe, Attikon University Hospital in Athens, Greece, will open shortly.
· The first four patients treated with INKmune were presented at the American Society for Hematology in December. INKmune treatment was associated with the rapid and sustained generation of cancer killing memory-like NK cells in the blood of 3 of 4 patients treated. The INKmune primed NK cells developed the ability to kill NK-resistant tumor cells in-vitro which was absent before treatment. INKmune also initiated increases in important systemic cytokines TNF-a, IL-15, MIP1-a, MIP1-b and IL2Ra which are associated with increased NK cell function and survival.
· The ASH (Free ASH Whitepaper) 2023 presentation included bioinformatics data showing that INKmune primed NK cells, in contrast to IL-15 primed NK cells, upregulates 30 mitochondrial survival proteins and more than 40 nutrient receptors on the NK cell; increasing survival potential in the TME. These data, when combined with the therapeutic persistence data presented in the INKmume treated patients and data on the function of INKmune primed NK cells presented at the Innate Killer Symposia 2022 supports the use of INKmune therapy to treat patients with solid tumors.
· The Company announced positive pre-clinical data in prostate cancer, renal cell carcinoma, ovarian cancer and nasopharyngeal cancer tumor cell lines resistant to natural killer killing. These pre-clinical studies are essential steps in bridging INKmune from the bench to the bedside and guide the INKmune solid tumor development program.
Upcoming Events and Milestones:
· Top-line results for the Phase 2 XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected in 2H 2024.
· We will initiate a Phase 2 trial of XPro in patients with Treatment Resistant Depression that is partially funded by a $2.9 million NIH grant upon resolution of the FDA manufacturing review.
· Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML in 2023.
· Initiation of a Phase I/II program in a prostate cancer upon the acceptance of the IND by the FDA.
Financial Results for the Year Ended December 31, 2022:
Net loss attributable to common stockholders for the year ended December 31, 2022 was approximately $27.3 million, compared to approximately $ 30.3 million for the year ended December 31, 2021.
Research and development expense totaled approximately $17.1 million for the year ended December 31, 2022 to approximately $20.5 million during the year ended December 31, 2021.
General and administrative expense was approximately $9.3 million for the year ended December 31, 2022 compared to approximately $8.8 million during the year ended December 31, 2021.
Other expense was approximately $1.3 million for the year ended December 31, 2022 compared to approximately $1.2 million during the year ended December 31, 2021.
As of December 31, 2022, the Company had cash and cash equivalents of approximately $52.2 million.
As of March 2, 2023, the Company had approximately 17.9 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 2, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13735978
A live audio webcast of the call can be accessed using this link or clicking here:
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A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 9 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13735978
About Metastatic Castration-Resistant Prostate Cancer (mCPRC
Prostate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men globally, with an incidence of 1.4 million and 375,000 deaths in 2020. In the United States, it is estimated that there were 268,490 new cases and 34,500 deaths in 2022. Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. In patients with mCRPC, the prostate cancer grows and spreads to other parts of the body, despite the use of androgen deprivation therapy (ADT) to block the action of male sex hormones. Approximately 10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at least 84% of these patients presenting with metastases at the time of CRPC diagnosis. Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years
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.