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AIM ImmunoTech Inc. (AIM)·Q1 2020 Earnings Summary

Executive Summary

  • AIM ImmunoTech reported minimal operating revenue ($0.045M) and a net loss of $3.81M ($0.22 EPS) in Q1 2020, while materially strengthening liquidity to ~$31.1M in cash, cash equivalents and marketable securities .
  • Operating expenses rose year over year on higher G&A tied to compensation and legal/professional costs; production costs and R&D were broadly stable to slightly down versus prior year .
  • The quarter’s primary catalyst was FDA authorization for the first human Ampligen trial in COVID-19 cancer patients, alongside expanded COVID-19 initiatives (NIID-Japan testing; material transfer agreement with Smoore for inhalation device studies) .
  • No formal financial guidance was issued and no earnings call transcript was available; AIM furnished an 8‑K corporate presentation and issued a business update press release as primary investor communications .

What Went Well and What Went Wrong

What Went Well

  • Liquidity runway improved: cash, cash equivalents and marketable securities reached ~$31.1M as of March 31, 2020, supported by ATM equity issuance and warrant exercises .
  • Accelerated COVID-19 program momentum: FDA authorization for a Phase 1/2a Ampligen + IFN α‑2b study in cancer patients with mild/moderate COVID‑19; NIID‑Japan in vitro/animal testing commenced; multiple outsourcing NDAs for manufacturing and regulatory work initiated .
  • Management focus and strategy: “AIM is committed to a focused business plan oriented toward finding senior co‑development partners… and to access the public equity markets” (prepared remarks), underscoring capital-light partnering to advance Ampligen/Alferon .

What Went Wrong

  • No product sales scale: revenues remained de minimis ($0.045M) from cost-recovery programs; Alferon commercial production remains on hold pending revalidation and FDA pre‑approval inspection with an estimated ~$10M funding need .
  • Persistent losses and expense pressure: net loss ($3.81M) increased YoY, with G&A up 22% driven by salaries/bonuses and legal/professional fees; interest/finance costs rose on long‑term debt .
  • Manufacturing constraints: Alferon facility status requires reaffirmation via FDA inspection; risk disclosures emphasize uncertainty of timelines and potential adverse impacts if approvals are not obtained .

Financial Results

MetricQ2 2019Q3 2019Q1 2020
Revenue ($USD Thousands)$29 $61 $45
Net Loss ($USD Thousands)$(2,029) $(2,948) $(3,808)
Diluted EPS ($USD)$(1.07) $(1.12) $(0.22)
Production Costs ($USD Thousands)$215 $230 $204
R&D Expenses ($USD Thousands)$1,096 $1,190 $898
G&A Expenses ($USD Thousands)$1,942 $1,846 $2,268
Cash & Equivalents (end of period, $USD Thousands)$959 $9,616 $27,590
Cash + Marketable Securities (end of period, $USD Thousands)~$31,101

KPIs

KPIQ2 2019Q3 2019Q1 2020
Weighted Avg Shares (basic & diluted)1,898,703 2,603,854 17,490,322
Redeemable Warrants Liability ($USD Thousands)$874 $82 $239

Notes:

  • Cash + Marketable Securities explicitly disclosed for Q1 2020; not disclosed as a combined figure in prior quarters above .
  • No segment reporting applicable; revenues are from cost-recovery programs .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial GuidanceFY/Q1 2020None issuedNone issuedMaintained (no guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2019 and Q3 2019)Current Period (Q1 2020)Trend
COVID-19 InitiativesNo COVID-19 program; focus on Argentina launch, oncology EAP, ATM financing FDA IND authorization for Ampligen + IFN α‑2b in cancer patients with COVID‑19; NIID‑Japan testing initiated; NDAs for outsourcing; provisional patent filings Rapid acceleration into COVID-19 (new program)
Manufacturing/AlferonRevalidation and FDA pre‑approval inspection required; production on hold; ~$10M estimated to recommence Status reiterated; facility reaffirmation and funding need highlighted Maintained (awaiting funding/regulatory)
Argentina Ampligen CommercializationFDA clearance to ship; GP Pharm responsible for market access strategy Lots manufactured (Dec’19/Jan’20); launch preparations continue Incremental progress
Oncology Trials (Ampligen + checkpoint inhibitors)Multiple Phase 2 programs at Roswell/UPMC in TNBC, colorectal, ovarian; early enrollment progress Continued planning and recruitment; COVID-19 may delay enrollments Steady with potential COVID headwinds
Capital StrategyATM program and public offerings executed to bolster liquidity Further capital raised (ATM, warrants exercised) leading to $31.1M liquidity Strengthened balance sheet

Management Commentary

  • “AIM is committed to a focused business plan oriented toward finding senior co‑development partners with the capital and expertise needed to commercialize… Ampligen… and… Alferon N Injection. Lastly, the Company plans to access the public equity markets to raise further capital.”
  • “On May 11, 2020, the Company received notice that the FDA sent an approval of an IND to Roswell Park Cancer Institute to conduct a Phase 1/2A study of Ampligen and IFN alpha Regimen in Cancer patients with mild or moderate COVID‑19 infections.”
  • “We are working with the National Institute of Infectious Diseases (NIID) in Japan to test Ampligen as a potential treatment for COVID‑19… in vitro tests… underway and animal experimentation… planned…” .

Q&A Highlights

  • No Q1 2020 earnings call transcript available; AIM furnished an 8‑K corporate presentation and issued a Q1 business update press release in lieu of a call .

Estimates Context

  • Wall Street consensus estimates (S&P Global Capital IQ) were unavailable for AIM’s Q1 2020 EPS and revenue. Values retrieved from S&P Global unavailable due to coverage/limit.
  • Given the absence of published consensus, we benchmark performance to prior quarters and internal disclosures .

Key Takeaways for Investors

  • Liquidity is materially improved (~$31.1M cash, cash equivalents and marketable securities), providing runway to prosecute COVID-19 and oncology programs without immediate dependence on grants .
  • Near-term catalysts include initial data flow from the Roswell COVID-19 cancer patient study and NIID‑Japan preclinical work; these events are likely to drive stock sentiment .
  • Operating model remains R&D‑stage with minimal revenue ($0.045M) and ongoing losses; expect continued G&A/R&D spend as programs advance .
  • Alferon commercial restart is contingent on ~$10M revalidation funding and FDA pre‑approval inspection, representing both upside optionality and execution risk .
  • Equity markets and warrant exercises have been effective financing levers; dilution risk persists but is balanced by program momentum and balance sheet strength .
  • The absence of formal guidance and sell‑side coverage highlights the importance of clinical readouts and regulatory milestones for valuation and trading .

Additional Relevant Q1 2020 Disclosures

  • Corporate presentation “Ampligen Overview COVID‑19 and Cancer” furnished via 8‑K; estimated cash/marketable securities $31.1M as of March 31, 2020 .
  • Material Transfer Agreement with Shenzhen Smoore Technology for inhalation studies; NDAs for potential manufacturing/regulatory outsourcing; PPP loan obtained and repaid in May 2020 .
  • Ampligen lots manufactured Dec 2019/Jan 2020; ready for Argentina launch and trials .

Citations: All financial and operational data are sourced from company filings and documents as cited in brackets.