On MAY 5, 2022 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, reported its financial results for the quarter ended March 31, 2022 and provided a business update (Press release, INmune Bio, MAY 5, 2022, View Source [SID1234613788]).
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Q1 2022 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro and INB03):
Dosed the first patient in the Phase II trial using XPro to treat patients with mild Alzheimer’s Disease (AD). The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Data is anticipated in the second half of 2023.
Delivered multiple oral and poster presentations at AD/PD 2022 (International Conference on Alzheimer’s and Parkinson’s Disease).
Presented breast cancer data at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which suggested the use of INmune Bio’s DN-TNF candidate, INB03, may help reverse resistance to immunotherapy patients with HER2+ cancers.
INKmune Platform Highlights:
Planned expansion of INKmune program to include AML and new site in EU.
2 of 3 patients with MDS/AML remain stable more than 6 months after the last treatment with INKmune.
INKmune shows best-in-class therapeutic persistence measured by activated tumor killing NK cells (NKG2D+ NK cells) in the peripheral blood or bone marrow more than 100 days after INKmune treatment in the two patients with stable disease
Highlighted the potential of INKmune primed NK cells to treat solid tumors by improving the ability of natural killer (NK) cells to survive hostile tumor microenvironments and by increased avidity, a necessary step for cancer cell killing, compared to NK cells primed with cytokines (IL-2, IL15).
Upcoming Milestones:
Initiate Xpro Phase 2 program for Mild Cognitive Impairment (MCI) in patients 1H 2022.
Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, by 2H 2022.
Continued enrollment and opening of sites for XPro Phase 2 program for mild AD.
Initiate INKmune Phase 1 program in ovarian cancer or solid tumor in 2H 2022.
Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML.
Report top-line data from Phase 2 trial of Xpro in MCI patients in mid-2023.
Report top-line data from Phase 2 trial of XPro in Mild AD patients in 2H 2023.
Report pre-clinical INKmune data in renal cell carcinoma and nasopharyngeal carcinoma.
"Our scientific platforms continue to showcase our unique approach to repairing dysfunction of the innate immune system," stated RJ Tesi, M.D., CEO of INmune Bio. "In April, we announced the dosing of our first patient treated with XPro1595 ("XPro) in the treatment of neuroinflammation as a cause of mild Alzheimer’s disease (AD) in a Phase II clinical trial AD02, a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and in the United States that will assess the cognitive and functional impact of XPro in 201 mild AD patients. A second blinded, randomized, placebo-controlled Phase 2 trial in patients with mild cognitive impairment (MCI) is also planned. It appears that targeting amyloid and tau have little therapeutic benefit. Newer treatment strategies such as targeting glial dysfunction with XPro is supported by pre-clinical and epidemiologic studies. We expect top-line results from both clinical trials in 2023."
"The impact of inflammation and in particular TNF is increasingly apparent as evinced by recent genetic (link) studies," stated CJ Barnum, VP of CNS Development at INmune Bio. "These Phase 2 studies are the first step in determining the extent to which neutralizing solTNF will benefit MCI and AD patients. Our expectations are high, and we look forward to sharing the results next year.
"The clinical and scientific framework around INKmune, our NK cell targeting platform continues to grow. We have already observed that two of the three patients treated with INKmune for MDS/AML remain off therapy with their disease controlled for more than 6 months since their last dose of INKmune," said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "We are demonstrating the effectiveness of INKmune in treatment of hematologic malignancies but believe the most promising application will be using INKmune to treat residual disease in solid tumors."
"Separately, we presented additional pre-clinical breast cancer data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, which further demonstrated the use of our DN-TNF oncology drug candidate, INB03, to potentially help reverse resistance to immunotherapy for women with HER2+ breast cancer. With this robust collection of data in multiple indications, we are optimistic for the coming quarters and look forward to sharing our continued results with shareholders and clinicians alike," stated Dr. Tesi.
"We continue to move forward on our planned three Phase II programs this year and believe we are well positioned to deliver on potential value creating milestones in both our DN-TNF and INKmune platforms," concluded Dr. Tesi.
Financial Results for the Quarter Ended March 31, 2022:
Net loss attributable to common stockholders for the quarter ended March 31, 2022 was approximately $6.9 million, compared to approximately $4.6 million for the quarter ended March 31, 2021.
Revenues totaled approximately $0.2 million for the first quarter 2022 compared to approximately $0.0 million for the first quarter 2021.
Research and development expense totaled approximately $4.3 million for the first quarter 2022 compared to approximately $2.5 million during the first quarter 2021.
General and administrative expense was approximately $2.3 million for the first quarter 2022 compared to approximately $2.1 million during the first quarter 2021.
Other expense was approximately $0.4 million for the first quarter 2022 compared to approximately $0.0 million during the first quarter 2021.
As of March 31, 2022, the Company had cash and cash equivalents of approximately $66.7 million.
During the quarter, RJ Tesi, Mark Lowdell, David Moss and Kelly Ganjei bought 82,900 shares for approximately $700,000 as previously reported in an 8-K filed with the SEC. As of May 5, 2022, 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.
Date: May 5, 2022
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13728543
A live audio webcast of the call can be accessed using this link: View Source
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 12, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728543.
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 akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.