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Panbela Therapeutics, Inc. (PBLA)·Q4 2023 Earnings Summary

Executive Summary

  • Q4 2023 focused on clinical execution with ASPIRE (Phase III PDAC) surpassing 50% enrollment in January and DSMB recommending continuation without changes; management now expects to update the interim OS analysis timing due to fewer-than-expected events, reflecting longer patient survival dynamics .
  • Operating spend was concentrated in R&D for ASPIRE; Q4 R&D was $6.12M and G&A $0.93M, driving a net loss of $6.49M ($65.90 per share); cash rose sequentially to $2.58M, aided by a subsequent $9.0M gross equity raise in January 2024 .
  • Strategic catalysts are lining up: interim OS analysis for ASPIRE (timing under evaluation), STK11 NSCLC Phase I data targeted by year-end 2024, ovarian cancer Phase I initiation in 1H24, and neoadjuvant pancreatic trial initiation in 1H24; FAP global registration feedback targeted in 2H24 .
  • Balance sheet and listing remain key watch items: current liabilities materially exceed current assets; the stock is trading on OTCPink and management is pursuing a national exchange uplisting (evaluating CBOE and NYSE American) .

What Went Well and What Went Wrong

  • What Went Well
    • ASPIRE momentum: DSMB twice recommended continuation without modification; enrollment surpassed 50% (January) with full ~600 patient enrollment anticipated by Q1 2025 .
    • External validation: Onivyde’s first-line PDAC approval (NALIRIFOX) with 1.9-month OS benefit supports ASPIRE’s control-arm survival assumptions and underscores unmet need, potentially contextualizing ASPIRE’s opportunity set .
    • Pipeline breadth supported by partners: Multiple Phase II/III programs (PACES, FAP, T1D, mCRPC) and translational initiatives with MD Anderson and Johns Hopkins advance largely with external funding, focusing internal cash on ASPIRE .
  • What Went Wrong
    • Timeline slippage: ASPIRE interim OS analysis moved from “early 2024” (Q2 call) to “mid-2024” (Q3) and now “evaluating timing” given fewer events; ovarian and neoadjuvant pancreatic trials also shifted into 1H24 .
    • Cash/burn profile: Quarterly cash burn projected around $6–$6.5M, with added working capital required for chemotherapy supply deposits; current liabilities ($12.32M) exceed current assets ($3.06M) at year-end .
    • Listing overhang: Shares trade on OTCPink; management is working toward a national exchange listing, evaluating options, but timing/requirements are not finalized .

Financial Results

MetricQ2 2023Q3 2023Q4 2023
General & Administrative ($M)$1.64 $1.11 $0.93
Research & Development ($M)$4.23 $6.74 $6.12
Net Loss ($M)$5.83 $7.83 $6.49
Diluted EPS ($)$(7.95) $(2.69) $(65.90)
Cash & Equivalents ($M)$7.21 $0.91 $2.58
Current Assets ($M)$10.81 $1.89 $3.06
Current Liabilities ($M)$10.55 $8.92 $12.32
Debt – Current Portion ($M)$1.00 $1.00 $1.00
Debt – Non-current ($M)$4.19 $4.19 $4.19
Shares Outstanding (period-end)2,612,038 2,996,334 480,025
Revenue ($M)n/a (no revenue reported) n/a (no revenue reported) n/a (no revenue reported)

Notes:

  • Q4 YoY: G&A down 44% to $0.93M; R&D up 77% to $6.12M; net loss $6.49M vs $4.73M in Q4 2022 .
  • Post-quarter financing: $9.0M gross equity raise closed Jan 31, 2024; net proceeds approx. $8.2M .

No segment revenues or gross/EBITDA margins were disclosed; the company is a clinical-stage biotech without reported product revenue in the presented periods .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ASPIRE interim OS analysis timing2024Early 2024 (Q2 call); then mid-2024 (Q3 call) Timing under evaluation due to insufficient events; update forthcoming Lowered/pushed later
ASPIRE full enrollment (~600 pts)Through Q1 2025Enrollment robust; ~36 months total; interim as early as early 2024 >50% enrolled (Jan); full enrollment anticipated by Q1 2025 Clarified timeline
STK11 NSCLC Phase I data2024By year-end 2023; then “early next year” (Q3) By end of 2024, contingent on enrollment Lowered/pushed later
Ovarian cancer Phase I start1H 2024“Begin this year” (2023); then year-end/early 2024 Initiation in 1H 2024 Maintained (later window)
Neoadj. pancreatic investigator trial1H 2024By end of 2023 Initiation in 1H 2024 Lowered/pushed later
FAP global registration feedback2H 2024Seek FDA/EMA harmonization; timing not specified Anticipated in 2H 2024 Clarified timeline

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2023)Trend
ASPIRE (PDAC) enrollment/DSMBAll planned countries open; DSMB continuation; interim expected early/mid-2024 >50% enrolled in Jan; DSMB twice recommended continuation; interim OS timing under evaluation due to fewer events Execution strong; timing pushed
External validation (Onivyde)Not discussed in Q2/Q3Onivyde 1L PDAC approval with 1.9-mo OS benefit; supports control assumptions Positive validation
FAP (Flynpovi) pathRegained NA rights; seeking FDA/EMA harmonization Plan to obtain FDA/EMA feedback in 2H24; pursue value-maximizing paths Advancing regulatory path
PACES (CRC risk reduction)Passed futility; continues Enrollment complete; data expected 2H26 On track
STK11 NSCLC (Phase I/II)Phase I data by YE23, then “early next year” First patient expected 1H24; data targeted by YE24 Timing slipped
Ovarian cancer (Phase I)Planned start 2H23 Initiation 1H24; could be Phase II depending on design Timing slipped
Partnerships/milestonesUS WorldMeds DFMO pediatric divestiture $0.4M upfront + up to $9.1M Expect initial milestones of ~$0.5–$1.0M starting late 2024/early 2025 Monetization path forming
Balance sheet/listingCash through Q3 2023; public offerings in 2023 $9M raise in Jan; pursuing national exchange listing (CBOE/NYSE American) Liquidity improved; listing plan

Management Commentary

  • “ASPIRE ... assess ivospemin (SBP-101) in conjunction with gemcitabine and nab-paclitaxel... DSMB completed its second prespecified review... recommended that the study continue without modification... surpassed 50% enrollment... expecting full enrollment... by the first quarter of 2025.”
  • “We are looking forward to the interim data analysis based on overall survival... We originally projected this to occur in mid-2024. However, we have not seen enough [events] at this time... working to update the expected timing.”
  • “Based on the NAPOLI-3 trial, Onivyde was approved in February... 1.9-month median overall survival benefit... This approval is significant to Panbela... helps to validate the assumed median survival of the control arm.”
  • CFO: “General and administrative expenses were $0.9 million... R&D expenses were $6.1 million... Net loss... $6.5 million... Total cash was approximately $2.6 million as of December 31, 2023... Gross proceeds from the January offering were approximately $9 million.”
  • Burn and financing: “Projecting [total burn] between $6 and $6.5 [million] per quarter... primary driver is the ASPIRE trial... we are fortunate to have funding for almost all other programs from other sources.”

Q&A Highlights

  • Monetization of DFMO pediatric program: $0.4M upfront already received; additional non-dilutive milestones up to $9.1M tied to approvals/commercial sales; initial milestone inflows estimated ~$0.5–$1.0M starting late 2024/early 2025 .
  • Burn/runway: Management guided to total burn of roughly $6–$6.5M per quarter, with variability from chemotherapy supply procurement; ASPIRE is the dominant cash driver .
  • Listing: Considering national exchange uplisting paths, noting CBOE liquidity comparable to Nasdaq; alternatives include NYSE American .
  • Clinical timing clarifications: STK11 Phase I data targeted by year-end 2024 subject to enrollment; ovarian program initiation expected 1H24 (design could enable Phase II) .

Estimates Context

  • Wall Street consensus estimates via S&P Global for PBLA Q4 2023 (revenue, EPS) were unavailable in our system due to a missing CIQ mapping for PBLA; as a result, we cannot benchmark results versus consensus this quarter. We attempted retrieval but the mapping was not present (SpgiEstimatesError) [GetEstimates error].
  • Given the company’s clinical-stage profile and lack of reported product revenue, formal sell-side estimate coverage may be limited; we will update if mapping becomes available.

Key Takeaways for Investors

  • ASPIRE momentum is intact (DSMB green lights, >50% enrolled) and remains the primary value driver; the interim OS analysis timing push reflects a lower-than-expected event rate, not operational delays—this could be a constructive signal for overall survival dynamics in the control arm benchmarked by Onivyde’s recent approval .
  • The near-term stock reaction is likely to hinge on clinical timing updates (ASPIRE interim OS window), incremental enrollment disclosures, and any early data from the STK11 Phase I program in late 2024 .
  • Liquidity improved sequentially and was bolstered by the January raise, but the burn rate (~$6–$6.5M/qtr) and working capital needs (chemo supply deposits) remain meaningful; liability stack (current liabilities > current assets) warrants continued monitoring .
  • Uplisting progress (e.g., CBOE/NYSE American) could broaden the shareholder base and improve liquidity, serving as a tactical catalyst independent of clinical data .
  • Non-dilutive monetization from DFMO pediatric neuroblastoma (US WorldMeds) could begin contributing milestone cash flows in late 2024/early 2025, partially offsetting burn while validating the polyamine platform .
  • Pipeline breadth (PACES, FAP, T1D, mCRPC, ovarian, neoadjuvant PDAC) is largely partner- or externally funded, keeping internal capital prioritized on ASPIRE; any positive readthroughs could diversify future catalysts beyond PDAC .