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PALISADE BIO, INC. (PALI)·Q3 2020 Earnings Summary

Executive Summary

  • Q3 2020 remained a pre-revenue quarter with revenue of $2,500 and net loss of $2.32M (EPS -$0.13); net loss widened year over year (vs. $1.76M, EPS -$0.59 in Q3 2019) and increased versus Q2 2020 ($1.95M, EPS -$0.15) .
  • Operating loss was $2.34M, up modestly year over year; G&A increased as the company built an enhanced management structure, while R&D declined as clinical programs were wound down .
  • Cash was $12.7M at quarter-end, down from $15.8M in Q2, reflecting spend and working capital timing; YTD net loss was elevated by a non-cash $5.6M warrant inducement expense recorded in January 2020 .
  • Strategic updates included completion of last subject follow-up in the non-GCP Phase II stroke trial, FDA feedback supporting Phase 3 for ALS, and completion of the Suzhou stem cell manufacturing facility; these items frame clinical catalysts rather than financial ones .
  • A forward-looking corporate catalyst emerged post-quarter: Seneca agreed to merge with Leading BioSciences to form Palisade Bio; management outlined LB1148’s Phase III plans and financing, positioning the combined company ahead of 2021 milestones .

What Went Well and What Went Wrong

What Went Well

  • Completed last subject follow-up in the non-GCP Phase II stroke study, advancing toward data readout and strengthening the clinical narrative .
  • FDA feedback indicated Phase 1/2 results support moving into a Phase 3 clinical study for ALS, a meaningful regulatory step forward .
  • Management additions and organizational build-out to support corporate objectives; “With Matt and Dane joining the management team we are focused on executing on the strategy of acquiring new therapeutic products for development while seeking partners for our promising neural stem cell therapeutic NSI-566” — Dr. Kenneth Carter, Executive Chairman .

What Went Wrong

  • Net loss widened year over year to $2.32M and EPS fell to -$0.13 versus -$0.59 in Q3 2019, underscoring the cost structure versus minimal revenue base .
  • G&A expenses increased as the company enhanced management infrastructure, pressuring operating loss despite lower R&D .
  • Revenue remained de minimis at $2,500, offering little offset to operating expenses in the period .

Financial Results

MetricQ3 2019Q1 2020Q2 2020Q3 2020
Revenue ($USD)$11,020 $6,020 $2,500 $2,500
Operating Loss ($USD)$(2,124,175) $(1,990,464) $(1,947,354) $(2,343,636)
Net Loss ($USD)$(1,763,134) $(7,575,218) $(1,950,941) $(2,321,822)
Diluted EPS ($USD)$(0.59) $(0.93) $(0.15) $(0.13)
Weighted Avg Shares (basic & diluted)2,975,779 8,139,159 12,642,972 17,306,672

Operating Expense Breakdown

MetricQ3 2019Q1 2020Q2 2020Q3 2020
R&D Expense ($USD)$825,486 $696,889 $446,032 $466,014
G&A Expense ($USD)$1,301,189 $1,299,595 $1,503,822 $1,880,122
Total Operating Expenses ($USD)$2,126,675 $1,996,484 $1,949,854 $2,346,136

Balance Sheet KPIs

MetricQ1 2020Q2 2020Q3 2020
Cash and Cash Equivalents ($USD)$10,030,024 $15,834,832 $12,651,728
Total Assets ($USD)$11,360,549 $17,101,662 $15,169,547
Total Liabilities ($USD)$1,382,592 $867,369 $1,047,074
Total Stockholders’ Equity ($USD)$9,977,957 $16,234,293 $14,122,473
Warrant Liabilities (fair value) ($USD)$59,971 $62,623 $44,954
Accounts Payable & Accrued Expenses ($USD)$961,026 $542,976 $577,558

Notes:

  • YTD net loss was materially impacted by a non-cash $5.6M warrant inducement expense recorded in January 2020 .
  • Cash declined sequentially in Q3 as spend normalized post Q2 financings .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial Guidance (Revenue, EPS, OpEx)FY 2020N/AN/ANo formal financial guidance provided in Q3 2020 press release

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q1)Current Period (Q3)Trend
R&D executionWinding down clinical programs; affirmed stroke Phase II data readout in 2H20 Completed last subject follow-up in non-GCP stroke Phase II Continued progress
Regulatory/legal (ALS)FDA feedback supports moving to Phase 3 ALS Reiterated FDA feedback supports Phase 3 ALS Consistent regulatory momentum
Manufacturing/supplyCompletion of Suzhou stem cell manufacturing facility Suzhou facility completion reiterated Operational readiness maintained
In-licensing/out-licensing strategyActive on out-licensing NSI-566/NSI-189 and in-licensing novel therapeutics Continued focus on partnering and acquiring new science Ongoing strategic pursuit
Corporate transformation/M&AN/A in Q1–Q2 earnings releasesPost-quarter: merger to form Palisade Bio; LB1148 Phase III plans outlined Transformational shift underway

Management Commentary

  • “With Matt and Dane joining the management team we are focused on executing on the strategy of acquiring new therapeutic products for development while seeking partners for our promising neural stem cell therapeutic NSI-566.” — Dr. Kenneth Carter, Executive Chairman (Q1 2020) .
  • “We expect to close the merger by Q2 2021…Concurrent financing led by Altium Growth Fund provides sufficient cash runway to achieve key clinical and regulatory milestones.” — Thomas Hallam, CEO of Leading BioSciences (Dec 17, 2020 M&A call) .
  • “We achieved the primary endpoint with a highly statistically significant p-value of <0.001…median time to bowel recovery was 32 hours for LB1148 vs. 45 hours placebo.” — Thomas Hallam on LB1148 Phase II cardiac surgery study (M&A call) .
  • Management reiterated R&D focus areas and the strategic plan to out-license legacy assets while in-licensing/acquiring new therapeutics throughout 2020 .

Q&A Highlights

  • No Q3 2020 earnings call transcript was available in the company document catalog; as such, Q&A highlights and call-based guidance clarifications are not available from primary sources.

Estimates Context

  • S&P Global consensus estimates for Q1–Q3 2020 (revenue and EPS) were unavailable in our data pull; therefore, comparisons to Wall Street consensus cannot be made for this recap. We attempted retrieval but encountered access-limit errors (no estimates provided).
  • Where estimate comparisons are required for future recaps, we will anchor on S&P Global consensus and highlight beats/misses accordingly.

Key Takeaways for Investors

  • Operating structure still reflects a pre-revenue biotech with minimal reported revenue ($2,500) and rising G&A tied to organizational build-out; loss levels remain primarily a function of OpEx rather than top-line variability .
  • R&D spend moderated as programs were wound down, while regulatory momentum (ALS Phase 3 support) and clinical progress in stroke could catalyze asset value conversations with potential partners .
  • Balance sheet shows sufficient cash for near-term objectives ($12.7M), but cash declined sequentially vs. Q2; financing execution and disciplined OpEx will remain central to runway management .
  • The non-cash $5.6M warrant inducement significantly distorted YTD loss metrics; investors should normalize this in trend assessments when comparing year-to-date performance .
  • Post-quarter merger to form Palisade Bio and LB1148’s Phase III plans introduce a new clinical-commercial narrative and potential 2021–2022 milestones, reshaping the medium-term thesis .
  • Near-term trading may hinge more on corporate updates and clinical timelines than quarterly financials, given the de minimis revenue base and the strategic pivot to Palisade Bio .
  • Watch for guidance on clinical trial initiations, financing close, and any out-licensing transactions of legacy assets to inform valuation re-rating potential .