Oncotelic Narrows Losses, Boosts Cash Amid R&D Focus

TL;DR

**OTLC is still burning cash with no revenue, but the reduced net loss and improved cash balance offer a glimmer of hope for this speculative biotech play.**

AI Summary

Oncotelic Therapeutics, Inc. (OTLC) reported a net loss of $1,068,225 for the nine months ended September 30, 2025, a significant improvement from the $3,922,998 net loss in the same period of 2024. This improvement was primarily driven by the absence of a goodwill impairment charge, which was $3,200,000 in 2024. The company generated no revenue in either period. Operating expenses decreased substantially from $3,544,559 in 2024 to $658,039 in 2025, largely due to the lack of goodwill impairment. General and administrative expenses, however, increased from $343,347 in 2024 to $657,019 in 2025. OTLC's cash position improved significantly, rising from $86,128 at December 31, 2024, to $409,000 at September 30, 2025. The company continues to focus on developing immuno-oncology therapeutics, particularly OT-101 through its joint venture with GMP Bio, in which Oncotelic holds a 45% stake. Strategic outlook includes advancing OT-101 into Phase 2 and Phase 3 trials for high-grade glioma and pancreatic cancer, and exploring digital assets for animal health indications.

Why It Matters

Oncotelic's reduced net loss and improved cash position, despite zero revenue, signal a more stable financial footing for investors, primarily due to the absence of a large goodwill impairment. The company's 45% stake in GMP Bio, with a preliminary $1.7 billion drug pipeline valuation, offers significant long-term potential, but this valuation is non-binding and not GAAP-compliant, posing a risk. The increased general and administrative expenses warrant scrutiny, as does the reliance on convertible debt for financing. For employees and customers, the continued advancement of OT-101 for difficult-to-treat cancers and viral respiratory diseases could lead to impactful new therapies, positioning OTLC as a potential player in the competitive biotech landscape.

Risk Assessment

Risk Level: high — The company reported no revenue for the nine months ended September 30, 2025, and 2024, indicating a complete reliance on financing activities. The accumulated deficit reached $39,108,893 as of September 30, 2025, highlighting significant historical losses. Furthermore, the company has substantial current liabilities of $20,079,663, including $10,328,100 in convertible and short-term debt, which could lead to further dilution.

Analyst Insight

Investors should approach OTLC with extreme caution, recognizing its pre-revenue stage and reliance on dilutive financing. Monitor the progress of OT-101 clinical trials and the upcoming ASC-compliant valuation of GMP Bio closely, as these are critical catalysts. Consider this a highly speculative investment, suitable only for those with a high-risk tolerance and a long-term horizon, given the significant R&D phase.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

N/A

total Debt

$10,328,100

net Income

-$1,068,225

eps

N/A

gross Margin

N/A

cash Position

$409,000

revenue Growth

0.0%

Revenue Breakdown

Key Numbers

• $1,068,225 — Net Loss (For the nine months ended September 30, 2025, a significant improvement from $3,922,998 in 2024.)
• $0 — Service Revenue (No revenue generated for the nine months ended September 30, 2025 and 2024.)
• $658,039 — Total Operating Expenses (For the nine months ended September 30, 2025, down from $3,544,559 in 2024 due to no goodwill impairment.)
• $409,000 — Cash (As of September 30, 2025, up from $86,128 at December 31, 2024.)
• $20,079,663 — Total Current Liabilities (As of September 30, 2025, indicating significant short-term obligations.)
• $10,328,100 — Convertible and Short-Term Debt (As of September 30, 2025, a primary source of financing.)
• 45% — Ownership Stake (Oncotelic's ownership in GMP Bio.)
• $1.7 billion — Preliminary Valuation (Estimated potential value of GMP Bio's drug pipeline by Frost & Sullivan (Hong Kong), non-binding.)
• 440,778,404 — Common Stock Outstanding (As of November 13, 2025, indicating potential for dilution.)
• $1,480,848 — Non-Cash Issuance of Shares and Warrants (Issued in connection with debt, equity purchase agreement and services for the nine months ended September 30, 2025.)

Key Players & Entities

• Oncotelic Therapeutics, Inc. (company) — registrant
• GMP Bio (company) — joint venture partner, 45% owned
• OT-101 (product) — immuno-oncology therapeutic in development
• Dragon Overseas Capital Limited (company) — affiliate of Golden Mountain Partners
• Golden Mountain Partners (company) — affiliate of GMP Bio
• Peak One Opportunity Fund, L.P. (company) — equity purchase agreement counterparty
• Fourth Man (company) — convertible note holder
• Mast (company) — convertible note holder and equity purchase agreement counterparty
• Jefferson Capital Ventures, LLC (company) — independent contractor for consulting services
• Valor Nation, Inc. (company) — independent contractor for consulting services

FAQ

Risk Factors

• Substantial Net Losses and Negative Cash Flows [high — financial]: The company reported a net loss of $1,068,225 for the nine months ended September 30, 2025, and no revenue. This indicates a continued reliance on external financing to fund operations and development activities.
• Significant Current Liabilities [high — financial]: As of September 30, 2025, total current liabilities were $20,079,663, a substantial amount relative to the company's cash position of $409,000. This highlights potential short-term liquidity challenges.
• Dependence on Convertible and Short-Term Debt [medium — financial]: The company has $10,328,100 in convertible and short-term debt as of September 30, 2025. This financing structure can lead to future dilution through conversion or require significant cash outflows for repayment.
• Reliance on Joint Venture for Key Drug Development [high — operational]: Oncotelic's primary focus is on developing OT-101 through its joint venture with GMP Bio, in which it holds a 45% stake. The success of this venture is critical, and its performance directly impacts Oncotelic's future prospects.
• Uncertainty of Strategic Partnerships [medium — operational]: The term sheet with Mosaic ImmunoEngineering, Inc. has been extended multiple times, with definitive agreements not yet signed as of December 2024. Delays or failure to finalize this partnership could impact development timelines.
• Drug Development and Approval Risks [high — regulatory]: The company's strategy relies on advancing OT-101 through Phase 2 and Phase 3 trials. Clinical trial failures, regulatory hurdles, and the lengthy drug approval process pose significant risks to commercialization.
• Potential for Stock Dilution [medium — financial]: With 440,778,404 common shares outstanding as of November 13, 2025, and the issuance of shares and warrants for debt and services ($1,480,848 in non-cash issuance), there is a significant risk of further dilution for existing shareholders.
• Valuation of GMP Bio Pipeline [medium — market]: While Frost & Sullivan provided a preliminary, non-binding valuation of $1.7 billion for GMP Bio's drug pipeline, this is an estimate and not a guarantee of future value. Actual realization depends on successful development and market acceptance.

Industry Context

The immuno-oncology sector is a rapidly evolving and highly competitive field within the broader biotechnology and pharmaceutical industry. Companies are focused on developing novel therapies that leverage the immune system to treat cancer. Key trends include the development of personalized medicine, combination therapies, and advancements in understanding the tumor microenvironment. Oncotelic operates in this dynamic landscape, aiming to advance its lead candidate, OT-101, through clinical trials.

Regulatory Implications

Oncotelic's drug development pipeline, particularly OT-101, is subject to stringent regulatory oversight by agencies like the FDA. The success of clinical trials and the subsequent approval process are critical. Any delays, adverse findings, or changes in regulatory requirements could significantly impact the company's ability to bring its therapies to market.

What Investors Should Do

1. Monitor cash burn and future financing needs.
2. Closely follow the progress of OT-101 clinical trials.
3. Assess the outcome of the Mosaic ImmunoEngineering partnership discussions.
4. Evaluate the potential impact of convertible debt and warrants.

Key Dates

• 2024-04-15: Filing of 2024 Annual Report on Form 10-K — Provides audited financial statements and detailed company information for the fiscal year ended December 31, 2024.
• 2025-09-30: End of Nine-Month Reporting Period — Date for which the unaudited condensed consolidated financial statements in the 10-Q are presented.
• 2025-12-31: Original Expiration of Mosaic Term Sheet — This date was the initial expiration for definitive agreements with Mosaic ImmunoEngineering, Inc., highlighting ongoing partnership discussions.
• 2025-06-30: Extended Expiration of Mosaic Term Sheet — Further extension of the term sheet with Mosaic, indicating continued negotiations and due diligence.
• 2025-11-13: Common Stock Outstanding Record Date — Indicates the number of common shares outstanding as of this date, relevant for calculating potential dilution.

Glossary

DAO

Decentralized Autonomous Organization, a type of entity governed by smart contracts on a blockchain. (Oncotelic formed a wholly owned subsidiary, Pet2DAO LLC, in November 2022, indicating an exploration into decentralized business models.)

Term Sheet

A non-binding agreement outlining the basic terms and conditions of a potential business deal. (Oncotelic entered into a binding term sheet with Mosaic ImmunoEngineering, Inc. in April 2024, which has been subject to extensions, indicating ongoing partnership discussions.)

Consolidated Financial Statements

Financial statements that combine the accounts of a parent company and its subsidiaries, presenting them as a single economic entity. (The 10-Q includes unaudited consolidated financial statements for Oncotelic and its subsidiaries.)

Going Concern

An assumption that a company will continue to operate for the foreseeable future, typically at least 12 months from the reporting date. (The financial statements are prepared under the assumption that Oncotelic will continue as a going concern, despite its net losses and cash position.)

Non-controlling Interest

The portion of equity in a subsidiary that is not attributable to the parent company. (The consolidated financial statements include entities in which Oncotelic has non-controlling interests.)

Goodwill Impairment Charge

A charge taken when the carrying value of goodwill on a company's balance sheet exceeds its fair value. (The absence of a goodwill impairment charge of $3,200,000 in 2025 was a primary driver for the improved net loss compared to 2024.)

Immuno-oncology

A type of cancer treatment that harnesses the body's own immune system to fight cancer. (Oncotelic's core business focus is on developing immuno-oncology therapeutics, such as OT-101.)

Minority Investment

An investment in another company where the investor owns less than 50% of the voting stock. (Oncotelic's investment in GMP Bio is recorded as a minority investment in equity securities.)

Year-Over-Year Comparison

Compared to the nine months ended September 30, 2024, Oncotelic Therapeutics, Inc. has significantly reduced its net loss from $3,922,998 to $1,068,225. This improvement is primarily due to the absence of a $3,200,000 goodwill impairment charge in the current period. Operating expenses also saw a substantial decrease from $3,544,559 to $658,039, largely attributable to the same factor. However, general and administrative expenses increased from $343,347 to $657,019. The company's cash position has improved from $86,128 at December 31, 2024, to $409,000 at September 30, 2025, though current liabilities remain high at $20,079,663.

Key Financial Figures

• $25 million — tion, to direct Mast, to purchase up to $25 million (the "Maximum Commitment Amount") in sh

Filing Documents

• form10-q.htm (10-Q) — 1442KB
• ex10-8.htm (EX-10.8) — 75KB
• ex31-1.htm (EX-31.1) — 20KB
• ex31-2.htm (EX-31.2) — 20KB
• ex32-1.htm (EX-32.1) — 7KB
• ex32-2.htm (EX-32.2) — 7KB
• 0001493152-25-023834.txt ( ) — 7864KB
• otlc-20250930.xsd (EX-101.SCH) — 67KB
• otlc-20250930_cal.xml (EX-101.CAL) — 46KB
• otlc-20250930_def.xml (EX-101.DEF) — 318KB
• otlc-20250930_lab.xml (EX-101.LAB) — 442KB
• otlc-20250930_pre.xml (EX-101.PRE) — 379KB
• form10-q_htm.xml (XML) — 1192KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION 3 ITEM 1.

Financial Statements (unaudited)

Financial Statements (unaudited) 3 Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 3 Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2025 and 2024 4 Consolidated Statements of Changes in Stockholders' Equity for the Three Months and Nine Months Ended September 30, 2025 and 2024 5 Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024 7

Notes to Consolidated Financial Statements

Notes to Consolidated Financial Statements 8 ITEM 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 35 ITEM 3.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 49 ITEM 4.

Controls and Procedures

Controls and Procedures 49

OTHER INFORMATION

PART II. OTHER INFORMATION 51 ITEM 1.

Legal Proceedings

Legal Proceedings 51 ITEM 1A.

Risk Factors

Risk Factors 51 ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 51 ITEM 3. Defaults Upon Senior Securities 51 ITEM 4. Mine Safety Disclosures 51 ITEM 5. Other Information 51 ITEM 6. Exhibits, Financial Statement Schedules 52

SIGNATURES

SIGNATURES 53 2 PART I – FINANCIAL INFORMATION Item 1. Financial Statements ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (Unaudited) September 30, December 31, 2025 2024 ASSETS Current assets: Cash $ 409,000 $ 86,128 Restricted cash 20,000 $ 20,000 Accounts receivable 3,976 18,976 Prepaid & other current assets 1,179,972 9,107 Total current assets 1,612,948 134,211 In process R&D 1,101,760 1,101,760 Goodwill, net of impairment 2,788,230 2,788,230 Investment in GMP Bio at fair value 22,653,225 22,653,225 Total assets $ 28,156,163 $ 26,677,426 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 2,565,877 $ 2,437,167 Accounts payable - related party 347,598 346,057 Contingent consideration 2,625,000 2,625,000 Derivative liability on notes 670,844 703,616 Convertible and short-term debt, net of costs 10,328,100 9,790,866 Convertible debt and short-term debt - related party, net of costs 3,542,244 3,297,208 Convertible debt 3,542,244 3,297,208 Total current liabilities 20,079,663 19,199,914 Total liabilities 20,079,663 19,199,914 Commitments and contingencies (Note 13) - - Stockholders' equity: Common stock, $ .01 par value; 750,000,000 shares authorized; 439,446,318 and 407,289,618 issued and outstanding, respectively (Note 11) 4,394,463 4,072,899 Additional paid-in capital 43,765,008 42,219,400 Accumulated deficit ( 39,108,893 ) ( 38,040,668 ) Total Oncotelic Therapeutics, Inc. stockholders' equity 9,050,578 8,251,631 Non-controlling interests ( 974,078 ) ( 774,119 ) Total stockholders' equity 8,076,500 7,477,512 Total liabilities and stockholders' equity $ 28,156,163 $ 26,677,426 The accompanying footnotes are an integral part of these unaudited consolidated financial statements. 3 ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED

Financial Statements

Financial Statements. Pet2DAO In November 2022, the Company formed a Decentralized autonomous organization (" DAO ") entity, Pet2DAO LLC (" Pet2DAO "), as a wholly owned subsidiary. For more information on Pet2DAO, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024. Mosaic ImmunoEngineering, Inc. Term Sheet In April 2024, the Company entered into a binding term sheet (the "Term Sheet") with Mosaic ImmunoEngineering, Inc. (" Mosaic "). For more information on the Term Sheet, refer to the Current Report on Form 8-K filed with the SEC on April 29, 2024. In August 2024, Mosaic and the Company mutually agreed to extend the date of the Term Sheet to expire at the earlier of (1) the signing of definitive agreements or (2) December 31, 2024. In December 2024, the Company and Mosaic further extended the term of the term-sheet to expire at the earlier of (1) the signing of definitive agreements or (2) June 30, 2025. Currently, both parties are in discussions to extend the timeline to complete the due diligence and finalize the signing of definitive agreements to a date mutually acceptable to both. Principles of Consolidation The consolidated financial statements include the accounts of Oncotelic, its wholly owned subsidiaries, Oncotelic Inc. and PointR; and Edgepoint our non-controlled interest entity. Intercompany accounts and transactions have been eliminated in consolidation. The Company's investment in GMB Bio is recorded and reported as a minority investment in equity securities. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared pursuant to the rules of the SEC for quarterly reports on Form 10-Q and do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America. The accompanying unaudited condensed consolidated financial statements should therefore be read in conjunction with the consolidate

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