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InMed Pharmaceuticals Inc. (INM)·Q1 2021 Earnings Summary

Executive Summary

  • Pre-revenue quarter; net loss narrowed year-over-year as R&D and G&A declined, while cash fell sequentially ahead of a Nasdaq IPO that closed post-quarter and extended runway into fiscal 2022 .
  • Clinical execution progressed: INM-755 Study 101 demonstrated the cream was safe and well-tolerated on intact skin; Study 102 on small epidermal wounds completed treatment with results anticipated in early Q1 calendar 2021 .
  • Operational update: conference call was cancelled due to expected financing close; subsequent U.S. IPO raised ~$8.0M gross and included warrants, improving liquidity and capital access .
  • Risks surfaced: material weakness in internal controls and potential contingent liability from inadvertent pre-IPO disclosures; neither affected Q1 financial statements, but they heighten governance and legal risk .
  • Near-term stock catalysts: Phase 1 Study 102 results, EB trial filings across multiple jurisdictions, and continued progress on IntegraSyn manufacturing scale-up .

What Went Well and What Went Wrong

  • What Went Well

    • INM-755 Phase 1 Study 101 showed the cream was “safe and well-tolerated on intact skin” with very low systemic exposure and no serious adverse effects; local reactions were mostly mild/moderate and resolved without intervention .
    • Management reiterated minimal COVID-19 impact and maintained timelines with only modest delays; EB filings expected across jurisdictions in late Q4 2020/early Q1 2021 and biosynthesis targeted to be GMP-batch ready by end of calendar 2020 .
    • Liquidity strengthened post-quarter via U.S. IPO/Nasdaq listing, with net proceeds expected at ~$6.9M, supporting operations into fiscal Q2 2022 and improving capital flexibility .
  • What Went Wrong

    • Cash declined during the quarter as operating outflows continued ($4.50M at 9/30 vs $5.81M at 6/30); conference call for Q1 was cancelled due to financing logistics .
    • Internal control material weakness disclosed (finance function resources; warrant valuation error previously identified); remediation underway but not yet completed .
    • Potential contingent liability from inadvertent pre-IPO electronic communications; magnitude and likelihood not determinable, but possible rescission rights and regulatory sanctions pose risk .

Financial Results

US GAAP (USD) – Income statement and key cash metrics

MetricQ1 FY2020 (Sep 30, 2019)Q1 FY2021 (Sep 30, 2020)
Research and development and patents ($USD)$1,961,912 $911,156
General and administrative ($USD)$887,511 $624,788
Amortization and depreciation ($USD)$30,227 $27,981
Total operating expenses ($USD)$2,879,650 $1,563,925
Interest income ($USD)$58,406 $4,345
Net loss ($USD)$(2,805,312) $(1,599,079)
Diluted EPS ($USD)$(0.54) $(0.31)
Cash and cash equivalents end of period ($USD)$11,007,231 $4,497,296

Balance sheet comparison (USD)

MetricJun 30, 2020Sep 30, 2020
Cash and cash equivalents ($USD)$5,805,809 $4,497,296
Total assets ($USD)$7,802,597 $6,603,674
Total shareholders’ equity ($USD)$5,878,318 $4,494,046

IFRS (CAD) – Press release figures (quarter ended Sep 30, 2020)

MetricQ1 FY2020 (Sep 30, 2019)Q1 FY2021 (Sep 30, 2020)
Research and development (C$)$2,331,788 $1,163,721
General and administrative (C$)$958,331 $740,929
Share-based payments (C$)$151,567 $130,298
Net loss (C$)$(3,386,815) $(2,140,553)
Basic/diluted loss per share (C$)$(0.65) $(0.41)
Cash, cash equivalents & short-term investments (C$)$14,708,963 $6,056,517

Notes:

  • No product revenues were generated; company remains pre-revenue and reports only interest income .
  • Margins not meaningful in a pre-revenue biotech context .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
INM-755 Study 102 (wounded skin) resultsEarly Q1 CY2021Study treatment to complete then analyze; timeline aligned with summer start “Anticipates reporting the results… in early first quarter of calendar 2021” Maintained (specific timing reaffirmed)
EB clinical trial applications (multi-country)Late Q4 CY2020 – Q1 CY2021“Clinical trial applications… filed in several jurisdictions in late Q4 2020 or in the first quarter of 2021” No change indicated in Q1 docs; remains the plan Maintained
IntegraSyn™ biosynthesis (GMP-batch readiness)By end CY2020“Primary goal… GMP-batch ready by end of calendar 2020” Continue scale-up and development; 10-Q highlights ongoing advancement Maintained (progressing)
Cash runwayThrough fiscal Q2 2022Prior call: into Q3 CY2021 based on operating adjustments “Cash… together with net IPO proceeds… sufficient… into the second quarter of fiscal 2022” Raised runway (extended)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 FY2020)Current Period (Q1 FY2021)Trend
COVID-19 impactMinimal impact; ~2-month delay to certain activities; proactive vendor management Conference call cancelled due to financing; operations continued; positive Study 101 results Stable execution with minor delays
EB program (INM-755)Phase I intact skin completed; wounded skin study to start; EB CTAs late Q4/Q1 Study 101 positive; Study 102 completed treatment; results early Q1 CY2021 Advancing on plan
INM-088 (glaucoma)Delivery formulation testing completed; IND-enabling targeted H2 CY2020/H1 CY2021 Ongoing preclinical/IND-enabling path reiterated in 10-Q overview Progressing
Biosynthesis/IntegraSynAlmac collaboration; GMP-batch goal by end CY2020 10-Q emphasizes continued scale-up and manufacturing readiness Progressing
Capital/ListingCash sufficient into Q3 CY2021 (pre-IPO) IPO/Nasdaq listing; ~$8.0M gross; net proceeds ~$6.9M; runway to fiscal Q2 2022 Improved liquidity
Controls & legalNot highlightedMaterial weakness remediation; potential contingent liability from inadvertent disclosures Elevated governance/legal focus

Management Commentary

  • “Results of Study 101 indicate that INM-755 was safe and well-tolerated on intact skin, caused no systemic or serious adverse effects” (press release summary of Phase 1) .
  • “The second, 755-102-HV Phase 1 trial… recently completed subject treatment… anticipates reporting the results… in early first quarter of calendar 2021” .
  • COVID-19: “minimal impact… anticipate INM-755 milestones to be pushed out by approximately 2 months” (CEO) .
  • Manufacturing: “primary goal… GMP-batch ready by the end of calendar 2020” and collaboration with Almac to scale an integrated approach (CEO/SVP R&D) .
  • Capital: “The Offering is expected to close on November 16, 2020… net proceeds… approximately US$6.9 million” (IPO 8-K) .
  • Cash runway: “sufficient… into the second quarter of fiscal 2022” (10-Q) .

Q&A Highlights

  • EB filing and NDA timing: Management emphasized patient enrollment rate as key limiter; too early to project NDA filing timing; EB clinical trial applications targeted late Q4 CY2020/Q1 CY2021 .
  • Study readouts: 755-101 intact skin results in summer 2020; 755-102 wounded skin results within months of start, targeting calendar 2020 (subsequently updated to early Q1 CY2021) .
  • Biosynthesis usage: Plan to crossover to internally produced CBN at Phase III, ensuring security of supply via external GMP sources in earlier phases .
  • R&D spend trajectory: Sequential declines driven by preclinical work winding down; management expects R&D not to increase in coming quarters .
  • COVID scenario planning: Low-risk topical study design, small sample, non-hospital sites to mitigate delays; aim to complete in vivo portions during summer .

Estimates Context

  • Wall Street consensus estimates (EPS, revenue) via S&P Global were unavailable for Q1 FY2021 at the time of retrieval; results should be interpreted without an estimates comparison. We attempted to fetch “Primary EPS Consensus Mean” and “Revenue Consensus Mean” using S&P Global data, but data access limits prevented retrieval (Values retrieved from S&P Global).

Key Takeaways for Investors

  • Clinical momentum: Positive safety/tolerability from Study 101 and near-term Study 102 readout are pivotal de-risking steps for INM-755 in EB; watch for data in early Q1 CY2021 .
  • Capital runway extended: IPO proceeds plus cash on hand fund operations into fiscal Q2 2022, reducing financing overhang in the near term .
  • Execution discipline: R&D and G&A declined year-over-year, narrowing net loss; lean spend supports runway while clinical programs advance .
  • Manufacturing optionality: IntegraSyn scale-up continues with Almac, offering long-term CBN supply flexibility; near-term clinical supply secured via external GMP vendors .
  • Risk monitoring: Internal control remediation and inadvertent disclosure contingent liability bear watching; governance improvements are an execution priority .
  • Trading setup: Near-term catalysts (Phase 1 results, EB filings) plus improved liquidity could drive sentiment; absence of revenue means outcomes hinge on clinical and regulatory milestones .
  • Medium-term thesis: If Phase 1/2 EB outcomes are supportive and manufacturing advances, InMed can progress toward pivotal design and partnership options; financing cadence likely tied to clinical progress .