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Oncotelic Therapeutics, Inc. (OTLC)·Q3 2021 Earnings Summary

Executive Summary

  • Q3 2021 was pre-revenue with improved net loss as PPP loan forgiveness offset lower R&D and reduced G&A versus Q2; net loss attributable to OTLC narrowed to $1.56M and EPS was $(0.00) on 370.4M average shares .
  • Operating expenses fell quarter-over-quarter (Q3 opex $1.81M vs Q2 $3.76M) on lower G&A and R&D; year-over-year, opex rose on higher stock-based comp while R&D declined due to lower personnel and clinical development costs .
  • Pipeline updates: IL-2 combo trial completed safety cohort with escalation underway; COVID-19 study reported top-line efficacy signals; AL-101 505(b)(2) strategy highlighted; JV with GMP advanced and multiple bids for OT-101 noted—key near-term catalysts .
  • Wall Street consensus estimates via S&P Global were unavailable for OTLC; therefore, no beat/miss assessment can be made. Consensus estimates unavailable via S&P Global.
  • Balance sheet tightened: cash declined to $0.08M and current liabilities increased to $14.8M, reinforcing going concern risk and the need for external financing/JV structure .

What Went Well and What Went Wrong

What Went Well

  • PPP loan forgiveness recognized, boosting other income by $0.25M in Q3, contributing to the improved bottom line quarter-over-quarter .
  • IL-2 oncology combo (OT-101/IL-2) cleared its safety cohort; dose escalation ongoing, supporting Phase 2 expansion and clinical momentum .
  • Management sees strategic progress: “We look forward to the completion of our JV so that the OT-101 asset can be fully developed… leverage… 505(b)2 strategy for AL-101” —Amit Shah, CFO .

What Went Wrong

  • Cash decreased to $78k and current liabilities rose to $14.8M; management disclosed substantial doubt about going concern without capital raises .
  • Interest expense remained elevated at $(0.45)M and derivative-related items continued to impact P&L, highlighting financing-related headwinds .
  • No product revenue in Q3 (and across 2021 to date), leaving the company reliant on financing and partnerships while clinical timelines progress .

Financial Results

Quarterly P&L vs Prior Quarters

MetricQ1 2021Q2 2021Q3 2021
Revenue ($USD)$0 $0 $0
R&D Expense ($USD)$1,556,673 $956,814 $621,927
G&A Expense ($USD)$481,209 $2,807,398 $1,187,035
Total Operating Expenses ($USD)$2,037,882 $3,764,212 $1,808,962
Loss from Operations ($USD)$(2,037,882) $(3,764,212) $(1,808,962)
PPP Loan Forgiveness ($USD)$0 $0 $253,347
Change in Fair Value of Derivatives ($USD)$(536,345) $630,174 $145,449
Interest Expense, net ($USD)$(520,906) $(433,979) $(445,363)
Net Loss Attributable to OTLC ($USD)$(2,803,080) $(3,231,280) $(1,562,528)
Basic EPS ($USD)$(0.03) $(0.01) $(0.00)
Basic Weighted Avg Shares94,193,348 369,547,235 370,443,893

Q3 Year-over-Year

MetricQ3 2020Q3 2021
Revenue ($USD)$0 $0
R&D Expense ($USD)$936,196 $621,927
G&A Expense ($USD)$680,077 $1,187,035
Total Operating Expenses ($USD)$1,616,273 $1,808,962
Loss from Operations ($USD)$(1,616,273) $(1,808,962)
PPP Loan Forgiveness ($USD)$0 $253,347
Interest Expense, net ($USD)$(331,459) $(445,363)
Change in Fair Value of Derivatives ($USD)$49,992 $145,449
Net Loss Attributable to OTLC ($USD)$(1,986,557) $(1,562,528)
Basic EPS ($USD)$(0.02) $(0.00)

Balance Sheet / KPIs

MetricQ1 2021Q2 2021Q3 2021
Cash and Equivalents ($USD)$830,719 $461,285 $78,081
Total Current Liabilities ($USD)$13,026,519 $14,125,817 $14,800,715
GMP Convertible Debt for Clinical Trial ($USD)$2,030,356 $2,040,329 $2,050,409
Total Stockholders’ Equity ($USD)$10,960,843 $9,585,433 $8,389,555

Segment breakdown: not applicable—company reports consolidated results and is pre-revenue .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q4 2021None providedNone providedMaintained (no guidance)
Margins/OpExFY/Q4 2021None providedNone providedMaintained (no guidance)
Pipeline timing (clinical)Early 2022Initiate PD-1 combo Phase 2s (mesothelioma, GBM, lung, CRC)Initiation target reaffirmedMaintained
JV/Strategic2021-2022JV formation with GMP, review bids for OT-101JV progressing; multiple bids being reviewedMaintained/Progressing

Earnings Call Themes & Trends

No earnings call transcript was available for Q3 2021; themes below reflect the 8-K release and Q3 10-Q.

TopicPrevious Mentions (Q1 & Q2 2021)Current Period (Q3 2021)Trend
OT-101 + PD-1 oncologyPlans for combinations; PD-1 combos under development Multiple Phase 2 PD-1 combos planned early 2022; AI-driven biomarker strategy Advancing
OT-101 + IL-2 oncologyTrial initiated; ongoing Safety cohort completed; dose escalation ongoing; Phase 2 expansion enabled Positive progress
OT-101 COVID-19 (C001)Enrollment discontinued in June; awaiting topline results Top-line signals: safety met; Day-7 mortality 4.5% OT-101 vs 20% placebo; >96% viral load knockdown incidence 89% vs 67%; survival improved Data disclosed
Artemisinin/PulmoHeal (ARTIVeda/ArtiShield)ARTI-19 India trial topline positive; commercialization framework with Windlas Deployed PulmoHeal™; positioning for pharmaceutics; awaiting WHO trial read-through Building validation
AL-101 505(b)(2) strategy (PD/ED/FSD)Strategy outlined Phase 3-ready; 6 trials completed; targeting PD, ED (PDE5 non-responders), FSD/HSDD Reiterated
AI/Edgepoint (ArtiHealth)Telehealth and CGMP blockchain initiatives described Continued AI-driven development; supports PulmoHeal package Ongoing
Capital/JV (GMP)GMP note; JV term sheet; equity purchase facility GMP invested further; JV advancing; multiple bids for OT-101 Progressing
Going concernSubstantial doubt disclosed Continued substantial doubt without financing Persistent

Management Commentary

  • “We look forward to the completion of our JV so that the OT-101 asset can be fully developed… At the same time, we are leveraging… 505(b)2 strategy for the development of AL-101 as our lead fast to market drug candidate.” —Amit Shah, CFO .
  • Operating expense drivers: R&D decreased due to lower personnel and clinical development costs; G&A increased on higher stock comp (+$0.6M) offset by lower legal/professional (−$0.1M) .
  • Strategic update: “Multiple bids for OT-101… being reviewed by the Company and the Board.” JV financing of $1.5M (Sept) and $0.5M (Oct) noted; aggregate GMP investment of $5.2M in OT-101 .
  • Clinical data: OT-101/IL-2 safety cohort cleared; dose escalation to 190 mg/m2 ongoing; historical MTD not reached even at 330 mg/m2 in prior P001 trial .
  • COVID-19 signals: Day-7 mortality 4.5% OT-101 vs 20% placebo; >96% viral load knockdown incidence 89% vs 67%; improved overall survival in critically ill patients .

Q&A Highlights

No Q3 2021 earnings call transcript available; no Q&A disclosures were found.

Estimates Context

  • Wall Street consensus EPS and revenue estimates via S&P Global were unavailable for OTLC for Q3 2021 and the prior two quarters. Consensus estimates unavailable via S&P Global.
  • As a result, no beat/miss assessment can be made; any future revisions would likely focus on cash runway, JV milestones, and clinical timelines rather than financial metrics.

Key Takeaways for Investors

  • Cash is critically low ($78k) and current liabilities high ($14.8M); financing/JV execution is essential to sustain operations and clinical progress .
  • Near-term catalysts: JV finalization and potential OT-101 transaction, PD-1 Phase 2 starts, IL-2 program dose escalation/Phase 2 expansion, and potential regulatory steps for AL-101 505(b)(2) .
  • Q3 P&L improved quarter-over-quarter due to PPP forgiveness and lower opex; underlying interest and derivative-related items remain a drag, reflecting the capital structure .
  • Clinical narrative strengthened: OT-101 COVID-19 signals and oncology combo progress de-risk mechanisms while remaining early-stage; validation from external trials (e.g., WHO artesunate) could be impactful .
  • Dilution risk persists given equity-based financing history and warrant issuances; investors should monitor future equity lines/convertible notes and their terms .
  • Management’s focus on 505(b)(2) AL-101 may offer a faster-to-market pathway versus de novo approvals, but robust funding and execution are prerequisites .
  • Trading implications: headlines around JV, bids for OT-101, and Phase 2 initiations are likely to drive stock movement in the near term; downside risk tied to financing delays or negative data readouts .