Executive Summary

Q2 FY2021 (quarter ended April 30, 2021) showed revenue of $1.38M, up sharply year over year from $0.25M but down sequentially from $1.62M; net loss was $(5.11)M versus $(6.32)M YoY and $(3.98)M QoQ; EPS was $(0.04) vs $(0.10) YoY and $(0.05) QoQ .
Operating expenses rose YoY on higher R&D and G&A (R&D $4.34M vs $3.92M; G&A $3.35M vs $2.65M), with management citing winding down legacy studies, research-related asset disposals, sub-license/legal fees, and settlement of shareholder demand letters as drivers .
Liquidity strengthened: cash and cash equivalents ended the quarter at $48.1M and the company extended its cash runway “into fiscal 3rd quarter of 2023” (vs Q1 guidance of funding “until May 2022”)—a clear positive guidance change .
Clinical update remains the key potential catalyst: at ASCO 2021, ADXS-503 + pembrolizumab in NSCLC showed a 44% disease control rate with durability in post-KEYTRUDA progressors; ADXS-504 in early prostate cancer was advanced with a planned Phase 1 (since initiated in Q3) .

What Went Well and What Went Wrong

What Went Well
- Strengthened balance sheet and meaningfully extended cash runway into fiscal Q3 2023, lowering near-term financing risk .
- Positive clinical signal: ADXS-503 combo arm at ASCO reported 44% DCR, including durable PR/SD beyond one year in NSCLC patients progressing on KEYTRUDA; management emphasized potential to enhance/restore CPI sensitivity: “Achieving clinical benefit in patients with immediate prior progression on KEYTRUDA® is particularly meaningful…” — Kenneth A. Berlin .
- Revenue improved YoY to $1.38M (from $0.25M), aided by collaboration/other revenue line items in the period .
What Went Wrong
- Sequential revenue declined to $1.38M from $1.62M in Q1, and net loss widened sequentially to $(5.11)M from $(3.98)M, reflecting higher OpEx in the quarter .
- R&D expenses increased YoY due to legacy study wind-down costs and disposal losses, signaling some non-recurring but elevated spend; G&A rose YoY on legal/sub-license fees and settlements—pressuring opex efficiency .
- No earnings call transcript available for Q2 2021 in our document set, limiting visibility into management’s detailed Q&A and near-term operational cadence (company furnished only an 8‑K with press release) .

Financial Results

Metric	Q2 2020	Q1 2021	Q2 2021
Revenue ($USD Millions)	$0.25	$1.62	$1.38
R&D Expense ($USD Millions)	$3.92	$2.57	$4.34
G&A Expense ($USD Millions)	$2.65	$3.01	$3.35
Total Operating Expenses ($USD Millions)	$6.57	$5.58	$7.70
Loss from Operations ($USD Millions)	$(6.32)	$(3.96)	$(6.32)
Net Loss ($USD Millions)	$(6.32)	$(3.98)	$(5.11)
EPS (Basic & Diluted, $)	$(0.10)	$(0.05)	$(0.04)
Cash & Cash Equivalents (Period-End, $USD Millions)	N/A	$33.32	$48.11

Notes:

YoY highlights: Revenue +$1.13M; EPS improved from $(0.10) to $(0.04) .
QoQ highlights: Revenue declined $0.24M; net loss widened by $1.13M; cash position improved $14.79M .

Segment breakdown and KPI comments:

No reportable segments disclosed; KPIs are primarily clinical milestones and cash runway. The company reiterated cash runway sufficiency into fiscal Q3 2023 .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Liquidity Horizon	Sufficient capital “until May 2022” (Q1 FY21 update)	Anticipated cash runway “into fiscal 3rd quarter of 2023” (Q2 FY21)	Raised / Extended

No quantitative guidance provided for revenue, margins, OpEx, OI&E, or tax rate in Q2 materials .

Earnings Call Themes & Trends

Note: No Q2 FY2021 earnings call transcript available in our corpus; themes are derived from company releases.

Topic	Previous Mentions (Q1 FY2021)	Current Period (Q2 FY2021)	Trend
ADXS-503 clinical data (NSCLC)	SITC data: DCR 67%, ORR 17% in first six evaluable patients; on‑mechanism immune activation; well tolerated	ASCO data: DCR 44% with durable PR/SD beyond one year in post-KEYTRUDA progressors; translational data consistent with mechanism	Continued signal; focusing on CPI-refractory population
ADXS-HOT platform expansion	Planning expansion into prostate cancer with ADXS‑504	Announced funding agreement with Columbia Univ. Irving Medical Center to run Phase 1 in early prostate cancer with biochemical recurrence	Execution progressing
Liquidity/Runway	Cash $33.3M; funding “until May 2022”	Cash $48.1M; runway “into fiscal Q3 2023”	Improved/extended
R&D execution & OpEx	R&D down YoY on discontinued studies	R&D up YoY due to wind‑down costs and asset disposals; G&A up on legal/sub-license fees and settlements	Mixed; some non‑recurring pressures
Regulatory/Legal	Not highlighted	G&A noted settlement of shareholder demand letters	One‑off cost pressure

Management Commentary

“Achieving clinical benefit in patients with immediate prior progression on KEYTRUDA® is particularly meaningful, suggesting that ADXS-503 has the potential to enhance and/or restore sensitivity to checkpoint inhibitors.” — Kenneth A. Berlin, President & CEO .
“These encouraging data… leave us confident that our off-the-shelf neoantigen immunotherapy may be an important new treatment option… We will continue our progress with ADXS-503 in NSCLC and will expand our ADXS-HOT program to additional indications….” — Kenneth A. Berlin .

Q&A Highlights

No Q2 FY2021 earnings call transcript was available in our document set; the company furnished an 8‑K with press release (Item 2.02), but no call/Q&A was provided .

Estimates Context

Wall Street consensus (S&P Global) for Q2 FY2021 revenue and EPS was unavailable for ADXS; comparisons to consensus could not be made.

Additional Documents Reviewed

Q1 FY2021 results (quarter ended January 31, 2021) with financials and business update, used for sequential comparisons .
Q3 FY2021 results (quarter ended July 31, 2021) reviewed for subsequent context, including initiation of ADXS‑504 Phase 1 and merger announcement with Biosight (outside the Q2 window, not used for Q2 comps) .
No separate press releases beyond the furnished 8‑K/Exhibit 99.1 were found for Q2 FY2021 .

Key Takeaways for Investors

Liquidity reset: materially extended cash runway into fiscal Q3 2023 reduces near‑term financing overhang and provides execution runway across NSCLC/prostate programs .
Clinical narrative intact: ADXS-503 shows durable disease control in CPI‑exposed NSCLC with mechanistic biomarker support, a potential differentiator in a hard‑to‑treat setting .
Sequential softness but YoY improvement: revenue down QoQ and net loss widened sequentially; however, YoY EPS and net loss improved, suggesting some operating leverage potential as one‑time expenses normalize .
Watch OpEx mix: near‑term R&D and G&A gets influenced by legacy wind‑downs, asset disposals, and legal items; normalization could aid loss trajectory in coming quarters .
Near‑term catalysts: further ADXS‑503 combo data updates and execution in ADXS‑504 prostate study are likely stock drivers; any partnership or regulatory milestones would also be impactful .

Appendix: Detailed Financial Statements (Source Excerpts)

Condensed Balance Sheet and P&L details for Q2 FY2021 and YoY comps are provided in the company’s press release furnished with the 8‑K .
Q1 FY2021 sequential comparison data sourced from the company’s March 16, 2021 8‑K and Exhibit 99.1 .

All figures are as reported by the company in its filings and press releases. Where comparisons to consensus would typically appear, S&P Global consensus data were unavailable for this period/ticker.

Ayala Pharmaceuticals, Inc. (ADXS)·Q2 2021 Earnings Summary