AIM ImmunoTech Inc. (AIM)·Q2 2017 Earnings Summary

Executive Summary

• Revenue accelerated to $0.213M in Q2 2017 from $0.015M in Q2 2016 and $0.084M in Q1 2017, driven by initial Ampligen sales via European Early Access Programs (EAP), notably pancreatic cancer in the Netherlands .
• Operating loss narrowed sequentially to $(2.73)M from $(3.24)M in Q1; net loss improved to $(2.19)M (vs $(2.82)M in Q1), though loss increased year over year (Q2 2016: $(1.30)M) .
• Strategic progress: completed intranasal Ampligen (AMP-600) human safety study (generally well-tolerated); advancing immuno-oncology with 12 pancreatic cancer patients on therapy under EAP; pursuing Canadian pathway for ME/CFS with Millions Missing Canada .
• Liquidity remains tight: cash and marketable securities were $3.21M at 6/30; $0.52M note payable outstanding; June warrant exercises added ~$1.06M net, but Alferon manufacturing remains on hold pending funding and FDA revalidation, and management disclosed a material weakness related to warrant exercise accounting .
• No formal financial guidance; stock catalysts skew to clinical and regulatory updates (EAP outcomes, immuno-oncology studies, and Canadian ME/CFS path) rather than near-term earnings .

What Went Well and What Went Wrong

• What Went Well

  • Revenue inflection from EAP: Q2 revenues rose to $0.213M (+1,320% YoY) as Netherlands pancreatic EAP began contributing; management highlighted first Ampligen sales in Europe .
  • Clinical execution: AMP-600 intranasal Ampligen + FluMist safety study completed with “generally well tolerated” profile, supporting vaccine adjuvant strategy; CEO emphasized repurposing Ampligen beyond ME/CFS into oncology and as an adjuvant .
  • Immuno-oncology momentum: 12 pancreatic cancer patients on single‑agent Ampligen under EAP; eight metastatic patients on drug ≥12 weeks at Erasmus MC, signaling real‑world uptake .

• What Went Wrong

  • Persistent losses: Net loss increased YoY to $(2.19)M in Q2 (from $(1.30)M in Q2 2016)), with R&D up YoY; although sequentially better, profitability remains distant .
  • Manufacturing/commercialization delay: Alferon manufacturing still on hold; FDA pre‑approval inspection and additional funds needed to revalidate facility and resume production, creating execution and funding risk .
  • Controls and capital structure: Material weakness in internal control over accounting for warrant exercises; continued reliance on equity/warrants and a 12% bridge facility underscore financing risk and dilution .

Financial Results

Expense detail (Opex mix):

KPIs and balance sheet snapshots:

Note: No Wall Street consensus estimates were available from S&P Global for Q2 2017 at retrieval time; estimate comparisons are therefore omitted .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The most overarching [event] is our decision to repurpose Ampligen beyond the single indication of ME/CFS… We have taken Ampligen now into pancreatic cancer and we’re looking closely at opportunities for Ampligen as a vaccine adjuvant.”
• “The intranasal human safety study of Ampligen plus FluMist known as AMP‑600 indicates that intranasal Ampligen is generally well‑tolerated.”
• “The net loss for the six months ended June 30, 2017 was approximately $5,014,000 or $0.19 per share… Cash, cash equivalents and marketable securities were approximately $3,211,000 at June 30, 2017.”
• “We have generated the first sales of Ampligen through our early access programs in Europe.”
• “We have dramatically cut costs across the board from a few years ago and yet with a fraction of the resources we’re delivering a spectacular number of tangible results.”

Q&A Highlights

• No separate analyst Q&A was recorded; management indicated they incorporated stockholder questions into prepared remarks and invited questions via email for the call .
• Clarifications provided included: repurposing strategy (oncology and adjuvant) ; Canadian regulatory approach for ME/CFS ; EAP progress and early sales ; and financial discipline/austerity .

Estimates Context

• S&P Global consensus estimates for Q2 2017 revenue and EPS were not available at retrieval time; consequently, no beat/miss analysis versus Wall Street is included .
• Given low absolute revenues and early EAP commercialization, future estimates will be sensitive to patient accrual and pricing under EAPs rather than traditional product launches .

Key Takeaways for Investors

• EAP traction is beginning to translate into reported revenue; watch quarterly patient counts and EAP geographies for leading indicators of topline momentum .
• Clinical catalysts center on immuno‑oncology data flow and potential vaccine‑adjuvant development steps post AMP‑600 safety completion; regulatory progress in Canada for ME/CFS could provide incremental optionality .
• Sequential improvement in operating loss and EPS signals cost control; sustaining this trend will depend on R&D cadence and manufacturing spend timing .
• Liquidity remains constrained despite June warrant proceeds and a 12% bridge line; further equity or partnering is likely, implying dilution and financing risk until larger revenue streams or partnerships emerge .
• Manufacturing risk persists: Alferon resumption requires revalidation and FDA pre‑approval inspection; timelines are funding‑dependent and uncertain .
• Governance/controls: remedial actions are underway following a material weakness tied to warrant exercise accounting; monitor remediation progress in subsequent filings .
• Trading setup: Near‑term stock moves likely tied to clinical/regulatory headlines (EAP outcomes, oncology program updates, Canada pathway) rather than earnings per se; risk/reward remains event‑driven with financing overhang .