10-Q: INmune Bio Inc. Reports Q1 2025 Financial Results, CORDStrom Advances Toward BLA Submission

INmune Bio Inc. reports a net loss of $9.7 million for Q1 2025 and is advancing its CORDStrom product towards a BLA submission while facing going concern uncertainties.

Summary

• INmune Bio Inc. reported a net loss of $9.7 million for the three months ended March 31, 2025, compared to a net loss of $11.0 million for the same period in 2024.
• The company's cash and cash equivalents decreased to $19.3 million as of March 31, 2025, from $20.9 million at the end of 2024.
• The company is projecting insufficient liquidity to sustain operations through one year following the issuance of the financial statements, raising substantial doubt about its ability to continue as a going concern.
• INmune Bio is developing product candidates including XPro for Alzheimer's disease and treatment-resistant depression, CORDStrom for recessive dystrophic epidermolysis bullosa (RDEB), and INKmune for cancer.
• The company anticipates submitting a Biologics License Application (BLA) for CORDStrom in the US in the first half of 2026 and plans to file Marketing Authorization Applications (MAAs) in the United Kingdom and EU.
• A Phase II trial for XPro in Alzheimer's disease has completed enrollment with 208 patients, and data is expected in June.
• The company has a $2.0 million award from the National Institute of Mental Health (NIMH) to treat TRD with XPro, with a Phase II trial expected to start enrollment in 2025 once NIMH funds are released.
• The company sold 649,860 shares of common stock at an average price of $8.37 per share under the ATM program during the three months ended March 31, 2025, generating net proceeds of approximately $5.3 million.
• The company entered into a collaboration agreement in April 2025 for manufacturing space in the United Kingdom, requiring a deposit of approximately $0.5 million, an upfront payment of approximately $0.2 million, and additional minimum payments of approximately $1.3 million in the first year and approximately $2.6 million in the second year.

Sentiment

Score: 4

Explanation: The sentiment is neutral to slightly negative. While there's progress in clinical trials and regulatory designations, the going concern uncertainty and financial losses weigh heavily.

Positives

• The net loss decreased from $11.0 million in Q1 2024 to $9.7 million in Q1 2025.
• The Phase II trial for XPro in Alzheimer's disease has completed enrollment.
• CORDStrom received Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA.
• The company secured $5.3 million in net proceeds from the sale of common stock under the ATM program.
• The company has a $2.0 million award from the National Institute of Mental Health (NIMH) to treat TRD with XPro.

Negatives

• The company reported a net loss of $9.7 million for Q1 2025.
• The company has concerns about its ability to continue as a going concern due to insufficient liquidity.
• Operating activities used $6.8 million of cash during the three months ended March 31, 2025.
• The company has an ongoing dispute with a vendor involving approximately $1.6 million in outstanding invoices.

Risks

• The company faces substantial doubt about its ability to continue as a going concern due to insufficient liquidity.
• The development of product candidates is subject to numerous risks and uncertainties.
• The company may not be able to secure additional financing on favorable terms or at all.
• Fluctuations in foreign exchange rates could adversely affect financial results.
• The company is involved in a dispute with a vendor, which could result in additional expenses.

Future Outlook

The company expects to continue to incur significant losses and increasing operating losses for the foreseeable future. They plan to submit a BLA for CORDStrom in the first half of 2026 and MAAs in the UK and EU. The company also anticipates data from the Phase II trial for XPro in Alzheimer's disease in June and plans an end-of-phase II meeting with the FDA to finalize plans for the pivotal Phase III trial.

Management Comments

• The primary focus continues to be treatment of cancer with INKmune and treatment of Alzheimers Disease (AD) and Treatment Resistant Depression (TRD) with XPro1595.
• We believe our DN-TNF platform can be used as a CNS (central nervous system) therapy to target glial activation to prevent progression of Alzheimers disease (AD); to target neuroinflammation in treatment resistant depression (TRD).
• We believe INKmune improves the ability of the patients own NK cells to attack their tumor.

Industry Context

The company operates in the competitive biotechnology industry, focusing on developing therapies for diseases with unmet needs, such as Alzheimer's disease, treatment-resistant depression, recessive dystrophic epidermolysis bullosa, and various cancers. The company's approach involves precision medicine and targeting the innate immune system.

Comparison to Industry Standards

• The company's focus on Alzheimer's disease aligns with the industry's pursuit of effective treatments for neurodegenerative diseases, with companies like Biogen and Eli Lilly also heavily invested in this area.
• The development of CORDStrom for RDEB addresses a rare disease with limited treatment options, similar to efforts by companies like Abeona Therapeutics and Castle Creek Biosciences.
• The INKmune program targets cancer by enhancing NK cell activity, a strategy also being explored by companies like Fate Therapeutics and Nkarta Therapeutics.
• The company's financial situation, with recurring losses and reliance on external funding, is common among early-stage biotechnology companies, as seen with companies like Cassava Sciences and Anavex Life Sciences.

Legal Proceedings

• The Company has an ongoing dispute with a vendor in which the Company believes that the vendor did not properly provide services for which they have invoiced the Company.

Related Party Transactions

• The Company recorded a payable to UCL of $52,000 for medical research performed on behalf of the Company.
• The Company recorded a payable to AmplifyBio of $26,000 for medical research performed on behalf of the Company.
• The Company recorded $25,000 payable to Immune Ventures within accounts payable and accrued liabilities related parties in the consolidated balance sheet.

Stakeholder Impact

• Shareholders face potential dilution from future equity offerings.
• Employees face uncertainty due to the company's going concern status.
• Patients with RDEB may benefit from the potential approval of CORDStrom.
• Suppliers and creditors face increased risk due to the company's financial challenges.

Next Steps

• Analyze data from the Phase II AD trial expected in June.
• Hold an end-of-phase II meeting with the FDA to finalize plans for the pivotal Phase III trial.
• Start enrollment in the Phase II TRD trial during 2025 once NIMH funds have been released.
• Prepare for and hold a pre-BLA meeting to discuss particulars of its planned BLA submission for CORDStrom.
• Submit a BLA seeking approval of CORDStrom for treatment of RDEB.
• Seek to submit MAAs to the EU and United Kingdom in 2026.

Key Dates

Keywords

CORDStrom, INKmune, XPro, RDEB, Alzheimer's disease, Treatment resistant depression, Clinical trials, Financial results, Biotechnology, Going concern, BLA, MAA