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Qualigen Therapeutics, Inc. (QLGN)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 revenue fell to $0.72M from $1.90M in Q1 2021, driven by Sekisui Diagnostics’ inventory sell-down ahead of the 3/31/22 distribution termination; management expects revenue to increase in subsequent quarters as QLGN now retains 100% of FastPack revenue from April 1, 2022 .
  • Net loss improved year over year to $(4.32)M vs $(5.24)M, with EPS of $(0.12) vs $(0.19) in Q1 2021; operating expenses fell vs Q1 2021 on lower R&D tied to the deprioritized QN‑165 program, partially offset by higher QN‑302 and QN‑247 spend .
  • Strategic repositioning advanced: QLGN resumed worldwide FastPack sales/marketing, closed a majority stake in NanoSynex (AST platform), and advanced QN‑302 (G‑Quadruplex selective inhibitor) with IND‑enabling studies targeted in 2022 .
  • Liquidity remained adequate with $13.61M in cash at 3/31/22 and stated ability to fund operations into mid‑2023; management sees FastPack growth as a nearer‑term revenue lever while therapeutics progress continues .
  • Potential stock catalysts: proof of FastPack revenue acceleration post‑April, NanoSynex integration milestones, and QN‑302 IND‑enabling progress in 2022 .

What Went Well and What Went Wrong

  • What Went Well

    • Resumed full FastPack control: “As of April 1, 2022, we will be entitled to 100% of the revenue from FastPack sales… We expect to demonstrate increased revenues in upcoming quarters.”
    • Pipeline focus on QN‑302: exclusive worldwide license secured from UCL; QN‑302 became the lead program with IND‑enabling studies on track in 2022; AACR data momentum and TD2 CRO engaged .
    • Diagnostics expansion: definitive agreements (May) and closing (June) to acquire a majority stake in NanoSynex’s rapid AST platform; management highlighted synergies with FastPack and commercialization expertise .

  • What Went Wrong

    • Revenue volatility: Q1 revenue declined due to Sekisui reducing purchases ahead of distribution termination (one‑time effect), depressing quarterly sales .
    • R&D reprioritization: QN‑165 COVID program deprioritized in 2021 after FDA requested additional preclinical work; Q1 2022 R&D mix shifted to oncology (QN‑302, QN‑247), with prior COVID expenses a headwind to recent periods .
    • Listing pressure: received Nasdaq minimum bid price deficiency notice in March 2022, introducing a compliance overhang if the share price does not recover within grace periods .

Financial Results

Income Statement Comparison (oldest → newest)

MetricQ1 2021Q3 2021Q1 2022
Total Revenues ($)$1,899,496 $1,155,065 $722,029
Net Product Sales ($)$1,420,842 $1,155,065 $722,029
License Revenue ($)$478,654 $0 $0
Cost of Product Sales ($)$1,202,479 $993,120 $828,848
Total Expenses ($)$7,712,378 $5,962,976 $5,730,667
Net Loss ($)$(5,242,719) $(2,858,518) $(4,319,787)
Diluted EPS ($)$(0.19) $(0.10) $(0.12)

Notes:

  • Year over year: revenue down due to Sekisui’s one‑time inventory sell‑down; net loss improved on lower QN‑165 spend and operating cost control .
  • Sequential (prior quarter) comparison: Q4 2021 quarter data not furnished in filings; Q3 2021 shown for trend context .

Revenue Mix (Segment/Type)

Revenue TypeQ1 2021Q3 2021Q1 2022
Net Product Sales ($)$1,420,842 $1,155,065 $722,029
License/Other Revenue ($)$478,654 (Yi Xin) $0 $0
Total Revenues ($)$1,899,496 $1,155,065 $722,029

Operating Expense Detail and Liquidity (Q1 2022 vs prior year)

MetricQ1 2021Q1 2022
Research & Development ($)$3,499,373 $1,864,745
General & Administrative ($)$2,873,939 $2,898,751
Sales & Marketing ($)$136,587 $138,323
Cash & Equivalents (period-end) ($)—$13,610,894

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FastPack revenue captureFrom April 1, 2022 onwardShared with Sekisui under distribution pactQLGN receives 100% of FastPack revenue; expects increased revenues in upcoming quarters Raised (qualitative)
Diagnostics strategy2022+Sekisui as global distributor through 3/31/22QLGN resumes worldwide FastPack sales/marketing; added NanoSynex AST platform Strategic expansion
QN‑302 timeline2022—IND‑enabling studies on track in 2022 New timeline affirmed
Cash runwayThrough mid‑2023—Company states ability to fund operations into mid‑2023 New disclosure

No formal numeric revenue/EPS guidance provided; commentary remains directional/qualitative .

Earnings Call Themes & Trends (no Q1 call transcript furnished)

TopicPrevious Mentions (Q‑2 and Q‑1 proxies)Current Period (Q1 2022)Trend
Diagnostics distribution/strategySekisui distribution taper and coming termination; manufacturing equipment issues restrained supply in 2021 QLGN resumed full FastPack distribution control from 4/1/22; expects revenue growth Improving control; revenue tailwind expected
Pipeline focusQN‑165 COVID deprioritized after FDA feedback (Aug 2021); shift to oncology QN‑302 becomes lead program; IND‑enabling in 2022; AACR posters; TD2 engaged Oncology focus intensifying
Inorganic expansion—Majority stake in NanoSynex (AST platform) signed (May) and closed (June) Portfolio expansion
Macro/operationalCOVID impacted prior demand; equipment constraints in 2021 One‑off distributor inventory unwind depressed Q1 sales; direct control post‑April Near‑term recovery setup
Regulatory/compliance—Nasdaq minimum bid price notice (Mar 2022) Compliance item to monitor

Management Commentary

  • “We are pleased with all that we accomplished in the first quarter of 2022… QN‑302 is a G‑Quadruplex… lead therapeutics program… We are on track with IND‑enabling studies this year.” — Michael Poirier, Chairman & CEO .
  • “As of April 1, 2022, we will be entitled to 100% of the revenue from FastPack sales… The decrease in first quarter revenue represented a one‑time event… We expect to demonstrate increased revenues in upcoming quarters.” — Michael Poirier .
  • On NanoSynex: “Potentially game‑changing… rapid, accurate and personalized test for bacterial infections… we aim to make a meaningful impact in the global fight against antibiotic resistant ‘superbugs’.” — Michael Poirier ; closing announced June 2, 2022 .

Q&A Highlights

  • No Q1 2022 earnings call transcript was available in the company document set. The company held a June 2, 2022 conference call regarding the NanoSynex acquisition and corporate update (dial‑in and webcast details provided) .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2022 revenue and EPS was unavailable via our data source at time of analysis. Values retrieved from S&P Global could not be accessed due to API limits; therefore, no estimate vs. actual comparison is presented.

Key Takeaways for Investors

  • Near‑term revenue setup improves: Q1’s revenue dip was a one‑off distributor inventory unwind; QLGN now captures 100% of FastPack revenue and expects growth in coming quarters .
  • Oncology pipeline clarity: QN‑302 is the lead program with 2022 IND‑enabling activities; QN‑165 COVID deprioritization reduces program risk and spend variability .
  • Diagnostics optionality expands: Majority stake in NanoSynex’s AST platform adds a new infectious disease diagnostic vector with potential synergies to FastPack .
  • Liquidity runway: $13.61M cash and company statement of funding into mid‑2023 provide time to execute on FastPack revenue ramp and QN‑302 milestones .
  • Monitor compliance: Nasdaq minimum bid price notice introduces a non‑fundamental overhang; potential corporate actions (e.g., split) are typical remedies if needed .
  • What to watch next: evidence of FastPack revenue acceleration in Q2/Q3, NanoSynex development funding milestones, and concrete QN‑302 IND‑enabling progress updates .
Sources:
- Q1 2022 8-K press release and exhibits, including full unaudited financial statements **[1460702_0001493152-22-013145_ex99-1.htm:0]** **[1460702_0001493152-22-013145_ex99-1.htm:1]** **[1460702_0001493152-22-013145_ex99-1.htm:2]** **[1460702_0001493152-22-013145_ex99-1.htm:3]** **[1460702_0001493152-22-013145_ex99-1.htm:5]** **[1460702_0001493152-22-013145_form8-k.htm:1]** **[1460702_0001493152-22-013145_form8-k.htm:2]**
- Q3 2021 10-Q for prior-quarter trend and MD&A **[1460702_0001493152-21-028354_form10-q.htm:2]** **[1460702_0001493152-21-028354_form10-q.htm:36]** **[1460702_0001493152-21-028354_form10-q.htm:37]**
- May 4, 2022 8-K and press release: NanoSynex definitive agreements **[1460702_0001493152-22-012075_ex99-1.htm:0]** **[1460702_0001493152-22-012075_form8-k.htm:1]** **[1460702_0001493152-22-012075_form8-k.htm:3]**
- June 2, 2022 8-K and press release: NanoSynex closing and call details **[1460702_0001493152-22-015663_ex99-1.htm:1]** **[1460702_0001493152-22-015663_ex99-1.htm:2]**
- March 4, 2022 Nasdaq bid price notice 8-K **[1460702_0001493152-22-006117_form8-k.htm:1]**