Executive Summary

Q2 2022 revenue rose 28% year over year to $1.43M as Qualigen took full control of FastPack distribution post-Sekisui; net loss narrowed 24% YoY to $4.12M, or $0.11 per share .
Diagnostics execution improved: FastPack gross profit on product sales increased ~64% YoY to ~$0.3M, and management highlighted sales traction after insourcing sales/marketing in April .
Therapeutics on track: QN-302 IND‑enabling studies targeted for completion in Q3–Q4 2022; QN‑247 showed in vivo efficacy signal with no safety issues; RAS-F program advanced preclinical work .
Balance sheet: $9.7M cash at June 30, 2022; management believes cash funds anticipated operations into 2023, with flexibility to raise capital as markets improve .
Stock catalysts: near-term QN‑302 IND-enabling readouts (2H22), diagnostics revenue ramp post-sales transition, and integration/progress of NanoSynex AST platform acquired in June .

What Went Well and What Went Wrong

What Went Well
- “In the first full quarter since assuming full responsibility for sales and marketing of FastPack … sales increased approximately 28% year-over-year … with gross profit up 64%” .
- Management hit or was ahead of projected milestones in both therapeutics and diagnostics; QN‑302 IND‑enabling on track for Q3–Q4 2022 .
- NanoSynex majority stake strengthens diagnostics portfolio; structured with milestone-based funding and staged financial commitment .
What Went Wrong
- Net loss remains large relative to revenue; Q2 net loss of $4.12M vs revenue of $1.43M, implying a ~−288% net margin despite YoY improvement (calculated from ).
- Gross margin still modest (approx. 23%) despite YoY improvement; prior quarter (Q1) gross margin was negative due to distribution transition dynamics (calculated from ).
- Continued dependency on external capital: company acknowledged intention to raise capital as needed, and expects R&D costs to increase during clinical phases .

Financial Results

Income statement comparisons (oldest → newest)

Metric	Q2 2021	Q1 2022	Q2 2022
Revenue ($)	$1,117,935	$722,029	$1,430,534
Cost of Product Sales ($)	$916,624	$828,848	$1,099,677
Gross Profit ($)	$201,311 (calc. from )	$(106,819) (calc. from )	$330,857 (calc. from )
Gross Margin (%)	18.0% (calc. from )	−14.8% (calc. from )	23.1% (calc. from )
Operating Expenses ($)	$8,512,733	$5,730,667	$5,571,864
Net Loss ($)	$(5,398,077)	$(4,319,787)	$(4,127,520)
Diluted EPS ($)	$(0.19)	$(0.12)	$(0.11)
Net Loss Margin (%)	−482.7% (calc. from )	−598.4% (calc. from )	−288.2% (calc. from )

R&D mix (Q2 2022):
- Therapeutics: $1.1M (73% of R&D)
- Diagnostics: $0.4M (27% of R&D)
Balance sheet and liquidity

Metric	Q4 2021 (12/31)	Q1 2022 (3/31)	Q2 2022 (6/30)
Cash and Equivalents ($)	$17,538,272	$13,610,894	$9,746,257
Total Assets ($)	$22,835,705	$18,708,453	$26,348,851
Total Liabilities ($)	$6,270,971	$5,191,624	$7,878,708
Stockholders’ Equity ($)	$16,564,734	$13,516,829	$18,470,143
Cash Runway Commentary	—	“had $13.6M in cash” (Q1)	“$9.7M in cash; sufficient to fund anticipated operations into 2023” (Q2)

KPIs and other items
- FastPack YoY performance in Q2: sales +28% and gross profit +64% vs Q2 2021 .
- Warrant liabilities at quarter-end: $987,300 .
- Weighted-average shares Q2 2022: 36,680,156 .

Notes: Margins are calculated from cited revenue and cost figures.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
QN‑302 IND‑enabling studies	2022	On track for IND‑enabling in 2022 (Q1 update)	On track to complete IND‑enabling studies in Q3–Q4 2022	Narrowed timing window
QN‑247 development focus	2022	Advancing preclinical; AML focus (Q1)	Identified potential initial indication in triple‑negative breast cancer; in vivo efficacy signal, no safety issues	Clarified initial indication and data
Diagnostics sales outlook	2022	Expect increased sales as Qualigen receives 100% of FastPack revenue post‑Sekisui	Sales met expectations in Q2; looking for continued successful results	Maintained positive outlook
Cash runway	2022–2023	Ability to fund operations into mid‑2023 (Q1)	Cash sufficient to fund anticipated operations “into 2023”; positioned to raise capital as needed	Reaffirmed runway; added capital flexibility

The company did not issue quantitative revenue/EPS/OpEx guidance. Guidance reflects milestone timing and qualitative outlook.

Earnings Call Themes & Trends

Note: No Q2 2022 earnings call transcript located in our document set; insights drawn from press releases and 10‑Q and ListDocuments returned no Q2 2022 transcript. Key themes across periods:

Topic	Previous Mentions (Q4 2021)	Previous Mentions (Q1 2022)	Current Period (Q2 2022)	Trend
Diagnostics go‑to‑market	—	Resumed worldwide FastPack sales/marketing post‑Sekisui; expect meaningful sales growth	First full quarter insourced; +28% YoY sales, +64% gross profit; appoint COO to lead diagnostics	Improving execution
QN‑302 (G4 inhibitor)	—	Secured license; engaged TD2 CRO; IND‑enabling this year	IND‑enabling on track Q3–Q4 2022; manufacturing scale‑up with Hande Sciences	On schedule
QN‑247 (nucleolin)	—	Advanced preclinical program	In vivo efficacy signal; potential TNBC initial indication; no safety issues	Positive preclinical data
RAS‑F program	—	Extended ULRF research collaboration	Presented program updates (ASCO abstracts); preclinical spend increased	Active preclinical
Portfolio expansion	—	Announced intent to acquire NanoSynex	Closed NanoSynex majority stake; AST platform focus; staged funding	Strategic broadening
Cash/liquidity	—	$13.6M cash; outlook into mid‑2023	$9.7M cash; sufficient into 2023; positioned for capital raise as needed	Adequate near‑term

Management Commentary

“The second quarter of 2022 has been dynamic for both therapeutics and diagnostics, as we have hit our projected milestones either on time or ahead of schedule. We are very pleased with the results of our FastPack sales … Sales results for the quarter met our expectations” — Michael Poirier, Chairman & CEO .
“We remain on track to complete our IND‑enabling studies for QN‑302 in the third and fourth quarters of 2022… we have identified a potential initial indication of triple negative breast cancer for QN‑247” — Michael Poirier .
“Our majority interest in NanoSynex provides potential for us in a large, underserved … diagnostics sector … at this time, there is measured and focused financial commitment on our part, and we continue to carefully manage our cash” — Michael Poirier .
Prior quarter on diagnostics transition: “As of April 1, 2022, we will be entitled to 100% of the revenue from FastPack sales … we assumed experienced sales professionals from Sekisui and our outlook … continues to show sales growth” — Michael Poirier .

Q&A Highlights

No Q2 2022 earnings call transcript was found in our document set; company did host a June 2 call regarding the NanoSynex transaction . No Q&A from a Q2 results call to summarize.

Estimates Context

Wall Street consensus estimates (S&P Global) for Q2 2022 and prior two quarters were not retrievable due to access limits during this session; therefore, we cannot provide revenue/EPS vs-consensus comparisons for this quarter. Values would normally be sourced from S&P Global (Capital IQ).

Key Takeaways for Investors

Diagnostics inflection is underway: insourced FastPack sales/marketing drove +28% YoY revenue and +64% gross profit; watch for sustained QoQ growth and margin expansion in H2 as the salesforce ramps .
Therapeutics execution remains the primary long-term value driver; near-term catalysts include QN‑302 IND‑enabling completion (Q3–Q4) and continued QN‑247 preclinical validation in TNBC .
The NanoSynex AST platform adds optionality in a large infectious disease testing market, but funding commitments are milestone-based; monitor cash usage and progress against milestones .
Liquidity is adequate into 2023, but additional capital likely before pivotal clinical work; potential dilution is a risk as R&D spend escalates entering clinical phases .
Near-term trading setup: pipeline readouts and evidence of diagnostics revenue/margin traction are the key stock catalysts; absence of earnings consensus makes the narrative more event-driven this quarter.
Risk factors include continued operating losses vs. small revenue base, execution risk integrating NanoSynex, and dependence on capital markets .

Citations:

Q2 2022 press release and 8‑K:
Q2 2022 10‑Q and MD&A:
Q1 2022 press release and 8‑K:
NanoSynex acquisition 8‑K and press release:

Qualigen Therapeutics, Inc. (QLGN)·Q2 2022 Earnings Summary