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AP

Ayala Pharmaceuticals, Inc. (ADXS)·Q1 2021 Earnings Summary

Executive Summary

  • Q1 FY2021 revenue was $1.615M driven by OS Therapies funding milestone recognition, versus $0.003M in Q1 FY2020; net loss narrowed to $(3.98)M and diluted EPS improved to $(0.05) from $(0.15) year over year .
  • Management emphasized continued prioritization of the ADXS-503 HOT program in NSCLC, citing disease control rate of 67% and overall response rate of 17% in early Part B patients previously progressing on KEYTRUDA; cash balance rose to $33.3M, with runway into at least March 2022 .
  • The company executed a headquarters relocation and terminated the prior lease, introducing expected cost savings of ~$1.692M per year, strengthening OpEx efficiency .
  • No Q1 FY2021 earnings call transcript was available; estimates from S&P Global were unavailable for ADXS, so beats/misses versus Street cannot be assessed at this time.

What Went Well and What Went Wrong

What Went Well

  • ADXS-503 clinical momentum: “growing body of evidence” for enhancing/restoring sensitivity to checkpoint inhibitors; Part B combination arm showed DCR 67% and ORR 17% in first six evaluable patients with prior progression on KEYTRUDA, including two patients with durable disease control on treatment for 10 and 8 months .
  • Strengthened liquidity: cash and cash equivalents increased to $33.3M, supported by an $8.5M net public offering and $2.6M from warrant exercises during the quarter, extending runway into at least March 2022 .
  • Operating discipline: R&D expenses fell to $2.57M from $4.86M and total OpEx declined to $5.58M from $7.89M YoY, reflecting wind-down of discontinued studies and focus on core programs .

What Went Wrong

  • Revenue quality is non-recurring: the $1.615M recognized relates to OS Therapies’ funding milestone and associated IP transfer, not product sales; sustainability depends on future milestones/royalties .
  • Continued losses: net loss was $(3.98)M despite OpEx reductions; absent recurring revenue, the path to operating breakeven remains uncertain .
  • Clinical/program rationalization: HPV and personalized neoantigen programs remain in wind-down; strategy relies heavily on ADXS-503/504 execution and external partnerships to drive value .

Financial Results

Metric (USD)Q1 FY2020 (Three months ended Jan 31, 2020)Q1 FY2021 (Three months ended Jan 31, 2021)
Revenue$0.003M $1.615M
Net Loss$(7.857)M $(3.977)M
Diluted EPS$(0.15) $(0.05)
Research & Development$4.859M $2.570M
General & Administrative$3.030M $3.008M
Total Operating Expenses$7.889M $5.578M

Balance sheet highlights (sequential liquidity):

Metric (USD)Oct 31, 2020Jan 31, 2021
Cash & Cash Equivalents$25.178M $33.318M

Revenue source detail:

Revenue ComponentQ1 FY2021 Amount
OS Therapies milestone/license transfer (ADXS-HER2)$1.615M recognized upon funding milestone and IP/IND transfer

KPIs (clinical):

ProgramKPICurrent Period Detail
ADXS-503 (NSCLC, Part B combo with KEYTRUDA)Disease Control Rate67% in first six evaluable patients with prior progression on KEYTRUDA
ADXS-503 (NSCLC, Part B combo with KEYTRUDA)Overall Response Rate17% in first six evaluable patients
ADXS-503 (NSCLC, Part B combo with KEYTRUDA)DurabilityTwo patients remained on treatment 10 and 8 months
SafetyTolerabilityAppeared safe/well tolerated as mono and combo; no added toxicities in combo

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough FY2022“Cash runway currently anticipated to take the Company into fiscal second quarter of 2022” (issued Jan 25, 2021) “Sufficient capital… until at least March 2022” (filed Mar 16, 2021) Maintained (timing aligned)
OpEx/Facilities Savings2021–2025Not previously specifiedEarly termination of HQ lease and relocation expected to realize ~$1,692,000 per year savings through original expiration (Nov 30, 2025) New, Raised clarity on savings

Earnings Call Themes & Trends

Note: No Q1 FY2021 earnings call transcript was available; themes derived from press releases and 10‑Q.

TopicPrevious Mentions (Q2 FY2020 10‑Q; FY2020 PR)Current Period (Q1 FY2021 PR/10‑Q)Trend
R&D execution – ADXS-503 HOT programCompleted Part A/B dose levels; early signs of activity; program prioritized Expanded ADXS-503; DCR 67%, ORR 17%; on‑mechanism biomarker activation; AACR presentation planned Improving
Program rationalization (HPV/NEO wind‑down)AIM2CERV and ADXS‑NEO closed/winding down; focus on HOT and PSA Continued focus on HOT; leveraging OS Therapies for HER2 Stable (execution on focused pipeline)
Liquidity/financingCash $23.8M (Jul 31, 2020); ATM/Lincoln Park lines disclosed Cash $33.3M; net offering $8.5M; warrants $2.6M; runway into at least Mar 2022 Improving
Cost efficiency/real estateN/ALease termination and relocation to smaller lab/office; ~$1.692M annual savings Improving
Regulatory/legalRoutine disclosures; Stendhal arbitration resolved (prior periods) No material legal changes disclosed in Q1 10‑Q Stable

Management Commentary

  • “We are encouraged by the growing body of evidence that suggest ADXS‑503 has the potential to synergistically enhance and/or restore sensitivity to checkpoint inhibitors…Our strengthened balance sheet leaves us well positioned to continue progress with our off‑the‑shelf neoantigen immunotherapy ADXS‑HOT program” — Kenneth A. Berlin, President & CEO, Interim CFO (Mar 16, 2021) .
  • “Fiscal year 2020 was transformative…we have prioritized [ADXS‑503]…our strengthened balance sheet ensures continued momentum…advance our Lm‑technology to expand the reach of checkpoint inhibitors” (Jan 25, 2021) .

Q&A Highlights

  • No earnings call transcript was found for Q1 FY2021; therefore, Q&A themes and any real‑time guidance clarifications are unavailable in the source set for this period.

Estimates Context

  • S&P Global/Capital IQ consensus estimates were unavailable for ADXS due to missing mapping; as a result, we cannot assess revenue or EPS versus Street for Q1 FY2021 at this time. Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

  • Clinical signal in NSCLC: Early ADXS‑503 combo data (DCR 67%, ORR 17%) in KEYTRUDA‑refractory patients supports the checkpoint‑sensitization thesis; upcoming AACR presentation may serve as a catalyst .
  • Strengthened liquidity and reduced burn: Cash rose to $33.3M and runway extends into at least March 2022; facility savings (~$1.692M/yr) further support OpEx discipline .
  • Revenue is milestone‑based: The $1.615M recognized from OS Therapies is non‑recurring; watch for further BD milestones and clinical progress to sustain cash inflows .
  • Focused pipeline: Execution centers on ADXS‑503 (NSCLC) and ADXS‑504 (prostate) with discontinued programs reducing spend; partnership optionality remains a strategic lever .
  • Risk‑reward hinges on clinical durability and expansion: Additional responders/duration and biomarker corroboration in larger NSCLC cohorts will be critical for de‑risking .
  • Near‑term watch items: AACR data readouts, site additions/enrollment pace post‑COVID impacts, and any further cost actions or financing updates .

Sources

  • Q1 FY2021 press release and 8‑K 2.02 (Mar 16, 2021): .
  • Q1 FY2021 10‑Q (filed Mar 16, 2021): .
  • FY2020 results press release 8‑K (Jan 25, 2021): .
  • 8‑K (Mar 30, 2021): lease agreement, termination, relocation and savings: .