Revenue

100% decline (from $28k to $0k)

Q4 2024 revenue dropped to zero compared to $28k in Q4 2023 because the company did not record any sales in Q4 2024, likely reflecting a complete absence of Mesenchymal stem cell transactions during that period, in contrast to Q4 2023 where such sales generated modest revenue. " "

R&D Expenses

+22% increase (from $6,007k to $7,353k)

R&D expenses rose significantly as the company increased spending on clinical programs, such as its Alzheimer's program and other research initiatives, expanding its clinical trial activities relative to Q4 2023, and driving the expense increase from $6,007k to $7,353k. " "

Total Operating Expenses

13% increase (from $8,407k to $9,467k)

Operating costs escalated due to the higher R&D spending along with increased general and administrative costs; this led to a greater operating loss, worsening from ($8,379k) to ($9,467k) compared to Q4 2023, reflecting intensified overall investment in ongoing clinical programs and operational activities. " "

Operating Cash Flow

Worsened from ($3,401k) to ($11,013k)

Worsening operating cash flow is attributed to larger operating losses, higher cash usage in clinical and R&D expenditures, and less favorable changes in working capital compared to Q4 2023—exacerbating the cash outflow from ($3,401k) to ($11,013k). " "

Cash & Cash Equivalents

-41% decline (from $35,848k to $20,922k)

Cash declined sharply due to significant cash being used in operations, as seen in much higher operating cash outflows in Q4 2024, along with reduced financing inflows relative to Q4 2023, reducing the cash balance from $35,848k to $20,922k. " "

Total Assets

31% decrease (from $57,001k to $39,562k)

Total assets fell primarily as a result of decreased cash and reductions in other current asset items (e.g., R&D tax credit receivable, prepaid expenses), which were impacted by the increased operating cash outflows compared to Q4 2023, leading to a drop from $57,001k to $39,562k. " "

Total Liabilities

60% decrease (from $18,862k to $7,465k)

Liabilities were reduced sharply largely due to significant debt repayments during Q4 2024, which drastically lowered the current portion of long-term debt and other liabilities compared to Q4 2023, cutting total liabilities from $18,862k to $7,465k. " "

Cash Runway

Q3 2025

"$33.6M in cash as of September 30, 2024 – sufficient to fund operations into Q3 2025 " "

"Cash is sufficient to fund operations through Q3 2025 " "

no change

Additional Capital

Overall

"Approximately 3.9M warrants outstanding could raise over $30 million if exercised " "

"Raised $5.4M through the ATM since year-end 2024; potential to raise approximately $30 million through warrant exercises " "

no change

Alzheimer's Clinical Trial Strategy and Endpoint Innovation

Q1–Q2 discussions centered on designing the AD02 trial using dual endpoints (CDR and EMACC) with enrichment based on inflammation biomarkers, positioning the program as a precision medicine approach " " "

Q3–Q4 continue emphasizing the novel trial design and the potential to redefine Alzheimer’s treatment by halting cognitive decline rather than just slowing it, with robust plans for top‐line data " " "

Consistent focus with continued optimism and refinement of endpoints; the narrative has strengthened around a paradigm shift.

Patient Enrollment Challenges and Biomarker‐Based Selection

Early calls (Q1) mentioned enrollment progress with biomarker-based selection, while Q2 provided detailed figures (e.g. 40–55% enrichment) and rationale for stringent criteria " " "

Q3–Q4 provided more granular data on screening failures (e.g. 72% failure rate) and operational challenges, highlighting rigorous patient selection and compliance factors " " "

A consistent focus with increasing quantitative detail and operational transparency over time.

Regulatory Uncertainty and Fast‐Track Potential

Q1 and Q2 discussions highlighted reliance on established endpoints (CDR) plus innovative measures (EMACC) and acknowledged FDA uncertainties regarding novel biomarkers and shorter trial durations " " "

Q3 and Q4 reaffirm the hope for accelerated regulatory pathways, with caveats about FDA feedback and additional data needs, maintaining an upbeat but cautious stance " " "

Steady emphasis on regulatory challenges with persistent optimism for fast-track possibilities; risk remains acknowledged.

INKmune Platform Efficacy, Safety, and Mechanism Uncertainty

Q1 and Q2 communications stressed promising efficacy (conversion of NK cells), a robust safety profile, and noted unresolved mechanistic complexities, supported by preclinical and early clinical data " " "

Q3 reiterated strong safety and encouraging immunological signals while still noting mechanistic questions, and Q4 provided less in-depth discussion yet maintained the positive safety profile " "

The baseline optimism about safety and efficacy remains, although mechanistic uncertainties persist without new resolution—discussion appears to be stabilizing.

Diversified Pipeline Expansion

Q1 and Q2 detailed multiple programs—XPro for Alzheimer’s (with AD02 trial), planned trial in treatment-resistant depression, and INKmune in mCRPC—emphasizing a broad approach " " "

Q3 and Q4 expanded on the pipeline by including detailed updates on CORDStrom (with orphan designations), continued progress on XPro, and ongoing INKmune trials, integrating strategic plans for commercialization " " "

Consistent expansion with growing emphasis on a multi-platform strategy; the narrative shifts toward readiness for commercialization.

External Partnership and Commercialization Dependencies

Not mentioned in earlier periods (Q1 and Q2)

Q3 and Q4 explicitly note a reliance on external partners for market access—highlighting interest from partners is data dependent and that commercialization will likely be pursued via partnerships " "

A new focus emerging in Q3 and Q4; the topic is now a key dependency for future market access.

Operational Efficiency and Burn Reduction Initiatives

Q1 mentioned cost prudence and adjustments in the open-label extension to reduce expenses; Q2 added details on R&D rebates and cash positions to extend funding into 2025 " "

Q3 and Q4 provided further specifics (e.g. detailed R&D rebates from Australia/U.K., debt payoff plans, ATM proceeds) that underscore concrete burn reduction efforts " "

A consistently prioritized area with increasing detail and measurable improvements, underscoring tighter cost control over time.

Innovative Drug Delivery Systems and Scalable Manufacturing

Q1 highlighted outpatient-ready INKmune infusions and early plans for efficient production; Q2 discussed a new formulation and bioreactor capacity expansion, along with supply chain redundancy measures " "

Q3 maintained focus with detailed scale-up efforts and streamlined infusion protocols, but Q4 did not mention this topic

Once a consistent focus in early quarters, the discussion appears to have been de-emphasized in Q4, suggesting successful integration or shifting priorities.

De-emphasis on Open-Label Extension Data Challenges

Q1 expressed significant concern about analyzing open-label extension data and associated cost issues, with remarks on difficulty in interpreting blinded results " "

Q2 and Q3 did not revisit these challenges, and Q4 made no mention of open-label extension data pitfalls

An initially important concern in Q1 that has been de-emphasized in later quarters, perhaps reflecting a strategic shift away from that program.

Data Dependency and Clinical Outcome Risks

Q1 and Q2 raised issues around the reliance on pivotal interim data—recognizing risks in translating early signals and uncertainties in endpoints and regulatory expectations " " "

Q3 reiterated dependence on robust data to drive partnerships and clinical decisions, while Q4 alluded indirectly to challenges without major new risk statements

A constant theme, with acknowledgement of inherent uncertainties that continue to shape strategic planning; the tone remains cautiously optimistic.