PharmaCyte Swings to $15.8M Loss Amidst Warrant Revaluation, FDA Hold
Ticker: PMCB · Form: 10-Q · Filed: Dec 18, 2025 · CIK: 1157075
| Field | Detail |
|---|---|
| Company | Pharmacyte Biotech, Inc. (PMCB) |
| Form Type | 10-Q |
| Filed Date | Dec 18, 2025 |
| Risk Level | high |
| Pages | 16 |
| Reading Time | 19 min |
| Key Dollar Amounts | $0.0001, $20.9 m, $5 million, $1,000 |
| Sentiment | bearish |
Sentiment: bearish
Topics: Biotechnology, FDA Clinical Hold, Net Loss, Warrant Liabilities, Pancreatic Cancer, Cell-in-a-Box Technology, Strategic Review
TL;DR
**PMCB is bleeding cash and stuck in FDA limbo, making it a high-risk bet until they sort out their core tech and clinical path.**
AI Summary
PharmaCyte Biotech, Inc. (PMCB) reported a significant net loss of $15,778,071 for the six months ended October 31, 2025, a stark contrast to the net income of $21,951,795 in the prior year period. This substantial loss was primarily driven by a $10,231,000 negative change in the fair value of warrant liabilities and a $5,210,000 negative change in the fair value of investment in QCLS. Operating expenses decreased slightly to $2,224,356 from $2,374,947 year-over-year, with general and administrative costs falling to $1,988,114 from $2,181,461. The company's cash and cash equivalents increased to $15,406,017 as of October 31, 2025, from $15,172,163 at April 30, 2025, largely due to $6,207,616 in net proceeds from the issuance of Series C convertible preferred stock. PMCB continues to face a clinical hold from the FDA on its Investigational New Drug Application (IND) for pancreatic cancer, requiring additional preclinical studies and manufacturing information. A key strategic change involves a Business Review Committee evaluating the company's relationship with SG Austria, which holds the know-how for its core Cell-in-a-Box technology, potentially impacting future development programs.
Why It Matters
This 10-Q reveals a critical financial downturn for PharmaCyte Biotech, with a significant net loss driven by non-cash warrant revaluations, which could concern investors about valuation volatility. The ongoing FDA clinical hold on its pancreatic cancer IND, coupled with a strategic review of its relationship with key technology partner SG Austria, casts a long shadow over its core drug development pipeline. For employees, this uncertainty could impact job security and future project scope. Customers and the broader market, particularly those awaiting advancements in pancreatic cancer treatment, face further delays. Competitively, this prolonged development stall could allow rivals to gain ground in the oncology space, making PMCB's path to market even more challenging.
Risk Assessment
Risk Level: high — The company reported a net loss of $15,778,071 for the six months ended October 31, 2025, a significant deterioration from the prior year's net income. Furthermore, the FDA has placed a clinical hold on its IND for pancreatic cancer, requiring additional preclinical studies and manufacturing information, indicating substantial regulatory hurdles and delays in its primary development program.
Analyst Insight
Investors should exercise extreme caution and consider avoiding PMCB until the FDA clinical hold is lifted and the strategic review of its relationship with SG Austria provides a clear, viable path forward for its Cell-in-a-Box technology. The significant non-cash losses from warrant revaluations also highlight high financial volatility.
Financial Highlights
- debt To Equity
- 0.55
- revenue
- $0
- operating Margin
- N/A
- total Assets
- $55,976,469
- total Debt
- $19,422,384
- net Income
- ($15,778,071)
- eps
- ($2.47)
- gross Margin
- N/A
- cash Position
- $15,406,017
- revenue Growth
- N/A
Key Numbers
- $15.8M — Net Loss (For the six months ended October 31, 2025, a significant swing from prior year's net income.)
- $10.2M — Change in Fair Value of Warrant Liability (A major contributor to the net loss for the six months ended October 31, 2025.)
- $5.2M — Change in Fair Value of Investment - QCLS (Another significant factor in the reported net loss for the six months ended October 31, 2025.)
- $6.2M — Net Proceeds from Series C Preferred Stock (Helped increase cash and cash equivalents despite operating losses.)
- $15.4M — Cash and Cash Equivalents (As of October 31, 2025, showing a slight increase from April 30, 2025.)
- $2.2M — Total Operating Expenses (For the six months ended October 31, 2025, a slight decrease from the prior year.)
- $1.24 — Basic and Diluted Loss Per Share (For the three months ended October 31, 2025, indicating increased losses per share.)
- $2.47 — Basic and Diluted Loss Per Share (For the six months ended October 31, 2025, a significant increase in loss per share from prior year's income.)
Key Players & Entities
- PharmaCyte Biotech, Inc. (company) — registrant
- U.S. Food and Drug Administration (regulator) — regulatory body for IND
- SG Austria Pte. Ltd. (company) — licensor of Cell-in-a-Box technology
- Iroquois Master Fund Ltd. (company) — party to Cooperation Agreement
- Femasys (company) — issuer of convertible note receivable and warrant asset
- QCLS (company) — issuer of warrant asset and investment in preferred stock
- $15,778,071 (dollar_amount) — net loss for six months ended October 31, 2025
- $21,951,795 (dollar_amount) — net income for six months ended October 31, 2024
- $10,231,000 (dollar_amount) — negative change in fair value of warrant liability
- $5,210,000 (dollar_amount) — negative change in fair value of investment - QCLS
FAQ
What caused PharmaCyte Biotech's significant net loss for the six months ended October 31, 2025?
PharmaCyte Biotech reported a net loss of $15,778,071 for the six months ended October 31, 2025, primarily due to a $10,231,000 negative change in the fair value of warrant liabilities and a $5,210,000 negative change in the fair value of investment in QCLS.
What is the current status of PharmaCyte Biotech's Investigational New Drug Application (IND) for pancreatic cancer?
The FDA placed PharmaCyte Biotech's IND for pancreatic cancer on clinical hold on October 1, 2020. The company is still in the process of conducting additional preclinical studies and gathering manufacturing information requested by the FDA to lift this hold.
How has PharmaCyte Biotech's cash position changed in the last six months?
PharmaCyte Biotech's cash and cash equivalents increased to $15,406,017 as of October 31, 2025, from $15,172,163 at April 30, 2025. This increase was largely driven by $6,207,616 in net proceeds from the issuance of Series C convertible preferred stock.
What strategic review is PharmaCyte Biotech's Board of Directors undertaking?
The Board has formed a Business Review Committee to evaluate the company's business, strategy, and operations, including its relationship with SG Austria. This review is critical because all licensed patents have expired, and the know-how for the Cell-in-a-Box technology solely resides with SG Austria.
What are the implications of the expired patents and reliance on SG Austria for PharmaCyte Biotech?
The expiration of licensed patents and the sole reliance on SG Austria for Cell-in-a-Box technology know-how pose significant risks. If PharmaCyte is unsuccessful in seeking an acceptable new framework with SG Austria, it may reevaluate or terminate development programs dependent on this technology, including its LAPC program.
How did operating expenses change for PharmaCyte Biotech in the recent period?
Total operating expenses for PharmaCyte Biotech decreased slightly to $2,224,356 for the six months ended October 31, 2025, compared to $2,374,947 for the same period in 2024. General and administrative expenses specifically decreased to $1,988,114 from $2,181,461.
What is PharmaCyte Biotech's core technology and its intended use?
PharmaCyte Biotech's core technology is the proprietary cellulose-based live cell encapsulation technology known as "Cell-in-a-Box." It is intended as a platform for developing cellular therapies for various cancers, including locally advanced, inoperable pancreatic cancer (LAPC), by encapsulating genetically engineered live human cells.
What specific items did the FDA request from PharmaCyte Biotech to lift the clinical hold?
The FDA requested additional sequencing data and genetic stability studies, a stability study on the final formulated product and Master Cell Bank cells, evaluation of delivery device compatibility, a detailed description of the manufacturing process, and additional product release specifications for the encapsulated cells.
How has PharmaCyte Biotech's stock performance been impacted by these developments?
The filing indicates a basic and diluted loss per share attributable to common stockholders of $(2.47) for the six months ended October 31, 2025, compared to income of $1.83 in the prior year, reflecting a significant negative impact on shareholder value.
What is the company's current approach to spending on its development programs?
PharmaCyte Biotech's Board has curtailed spending on the company's programs, including pre-clinical and clinical activities, until the review by the Business Review Committee and the Board is complete and new actions and plans are determined.
Risk Factors
- FDA Clinical Hold on IND Application [high — regulatory]: The FDA has placed a clinical hold on PharmaCyte's Investigational New Drug Application (IND) for pancreatic cancer. To lift the hold, the company must conduct additional preclinical studies and provide further information on DNA sequencing, manufacturing, and product release specifications. This significantly delays the potential for clinical trials and product development.
- Dependence on SG Austria for Core Technology [high — operational]: PharmaCyte's core Cell-in-a-Box technology know-how is held by SG Austria. A Business Review Committee is evaluating the company's relationship with SG Austria, indicating potential disruptions or changes to access to this critical technology, which could impact future development programs.
- Significant Net Loss Driven by Fair Value Changes [medium — financial]: For the six months ended October 31, 2025, the company reported a net loss of $15,778,071. This was heavily influenced by a negative change in the fair value of warrant liabilities ($10,231,000) and a negative change in the fair value of its investment in QCLS ($5,210,000).
- Volatility in Financial Instruments [medium — financial]: The company's financial results are significantly impacted by fluctuations in the fair value of various financial instruments, including warrant liabilities, derivative liabilities, and investments. For the six months ended October 31, 2025, these changes contributed substantially to the net loss.
- Reliance on External Partnerships [medium — operational]: The company's development of its Cell-in-a-Box technology relies on licenses and know-how from SG Austria and Austrianova Singapore. Any disputes or changes in these agreements could severely impact operations.
Industry Context
The biotechnology sector, particularly in oncology, is characterized by high R&D costs, long development timelines, and significant regulatory hurdles. Companies like PharmaCyte face intense competition and the need for substantial capital to advance drug candidates through clinical trials. Success is often dependent on achieving regulatory approval and demonstrating clinical efficacy, with many early-stage companies relying on partnerships or significant funding rounds.
Regulatory Implications
The FDA's clinical hold on PharmaCyte's IND application represents a major regulatory hurdle. The company must address the FDA's concerns regarding preclinical studies and manufacturing data. Failure to do so could indefinitely delay or halt the development of its lead product candidate, impacting its future viability.
What Investors Should Do
- Monitor FDA communication regarding the clinical hold.
- Track the Business Review Committee's findings on the SG Austria relationship.
- Analyze the impact of fair value changes on financial results.
- Evaluate cash burn rate and future funding needs.
Key Dates
- 2025-10-31: End of Six-Month Reporting Period — Company reported a net loss of $15.8M, a significant swing from the prior year's net income, largely due to fair value adjustments of liabilities and investments.
- 2025-04-30: End of Prior Six-Month Reporting Period — Company had $15.17M in cash and cash equivalents, and reported net income in the prior year period.
- 2020-10-01: FDA places IND on clinical hold — This event initiated the requirement for additional preclinical studies and information, delaying the company's progress in clinical development for pancreatic cancer.
- 2020-09-01: Submission of IND to FDA — The initial step towards seeking approval for clinical trials for the pancreatic cancer therapy.
Glossary
- Cell-in-a-Box technology
- A proprietary cellulose-based live cell encapsulation technology developed by PharmaCyte Biotech. (This is the core technology platform the company is developing for cancer therapies, particularly for pancreatic cancer.)
- Investigational New Drug Application (IND)
- An application filed with the FDA to seek approval to conduct clinical trials in humans. (PharmaCyte's IND for pancreatic cancer is currently on clinical hold, preventing further clinical development.)
- Clinical Hold
- A status imposed by the FDA on an IND application, halting all clinical trials until specific requirements are met. (The company must satisfy FDA requirements to lift the clinical hold and proceed with its planned clinical trials.)
- Fair Value of Warrant Liability
- The estimated market value of the company's outstanding warrants, which can fluctuate based on market conditions and the company's stock price. (A significant negative change in fair value of warrant liabilities contributed substantially to the company's net loss in the current period.)
- Series C convertible preferred stock
- A class of preferred stock that can be converted into common stock, with specific terms and liquidation preferences. (The issuance of Series C preferred stock provided significant proceeds, increasing the company's cash position.)
- Warrant Asset
- An asset representing the value of warrants held by the company, which can also fluctuate in fair value. (Changes in the fair value of warrant assets, such as those related to QCLS and Femasys, impact the company's other income/expenses.)
Year-Over-Year Comparison
Compared to the six months ended October 31, 2024, PharmaCyte Biotech, Inc. has experienced a dramatic shift from net income of $21,951,795 to a net loss of $15,778,071. This reversal is primarily driven by a substantial negative change in the fair value of warrant liabilities and investment in QCLS, which were positive in the prior year. Operating expenses have seen a slight decrease from $2,374,947 to $2,224,356, but this improvement is overshadowed by the significant non-operating losses. Cash and cash equivalents have increased slightly, bolstered by proceeds from Series C preferred stock issuance, but the overall financial picture is considerably more bearish due to the net loss and increased loss per share.
Filing Stats: 4,699 words · 19 min read · ~16 pages · Grade level 18.5 · Accepted 2025-12-18 17:04:23
Key Financial Figures
- $0.0001 — ch registered Common Stock, Par Value $0.0001 Per Share PMCB The Nasdaq Stock Mar
- $20.9 m — h and cash equivalents of approximately $20.9 million, inclusive of the $5 million rece
- $5 million — imately $20.9 million, inclusive of the $5 million received on the maturity of the Femasys
- $1,000 — preferred stock with a stated value of $1,000 per share and warrants to purchase up t
Filing Documents
- pharmacyte_i10q-103125.htm (10-Q) — 1201KB
- pharmacyte_ex3101.htm (EX-31.1) — 9KB
- pharmacyte_ex3102.htm (EX-31.2) — 9KB
- pharmacyte_ex3201.htm (EX-32.1) — 4KB
- pharmacyte_ex3202.htm (EX-32.2) — 4KB
- 0001683168-25-009259.txt ( ) — 6057KB
- pmcb-20251031.xsd (EX-101.SCH) — 53KB
- pmcb-20251031_cal.xml (EX-101.CAL) — 55KB
- pmcb-20251031_def.xml (EX-101.DEF) — 261KB
- pmcb-20251031_lab.xml (EX-101.LAB) — 383KB
- pmcb-20251031_pre.xml (EX-101.PRE) — 360KB
- pharmacyte_i10q-103125_htm.xml (XML) — 824KB
Management's Discussion and Analysis of Financial Condition and Results of Operations
Management's Discussion and Analysis of Financial Condition and Results of Operations 29 Item 3.
Quantitative and Qualitative Disclosures About Market Risk
Quantitative and Qualitative Disclosures About Market Risk 38 Item 4.
Controls and Procedures
Controls and Procedures 38 PART II. OTHER INFORMATION 39 Item 1.
Legal Proceedings
Legal Proceedings 40 Item 1A.
Risk Factors
Risk Factors 40 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 41 Item 3. Defaults Upon Senior Securities 41 Item 4. Mine Safety Disclosures 41 Item 5. Other Information 41 Item 6. Exhibits 42
– FINANCIAL INFORMATION
PART I – FINANCIAL INFORMATION
Financial Information
Item 1. Financial Information. PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) October 31, 2025 April 30, 2025 ASSETS Current assets: Cash and cash equivalents $ 15,406,017 $ 15,172,163 Marketable equity securities 201,190 366,316 Warrant asset – QCLS - current 1,912,000 2,917,000 Convertible Note receivable – Femasys - current 5,000,000 3,696,000 Prepaid expenses and other current assets 503,147 223,759 Total current assets 23,022,354 22,375,238 Other assets: Intangible asset 1,549,427 1,549,427 Investment in preferred stock – QCLS 20,747,000 22,474,000 Warrant asset – QCLS - non current 9,530,000 5,701,000 Warrant asset – Femasys 1,120,000 3,061,000 Other assets 7,688 7,688 Total other assets 32,954,115 32,793,115 Total Assets $ 55,976,469 $ 55,168,353 LIABILITIES, TEMPORARY EQUITY AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,021,339 $ 399,204 Accrued expenses 520,656 2,515,080 Accrued Series C dividends 35,389 – Total current liabilities 1,577,384 2,914,284 Other liabilities: Long-term portion of accrued expenses – 25,000 Warrant liabilities 16,152,000 338,000 Derivative liabilities 1,693,000 – Total other liabilities 17,845,000 363,000 Total Liabilities 19,422,384 3,277,284 Commitments and Contingencies (Note 8) – Temporary Equity: Series B convertible preferred stock: authorized 35,000 shares, $ 0.0001 par value and $ 1,000 face value, 0 shares issued and outstanding as of October 31, 2025 and April 30, 2025, respectively – – Series C convertible preferred stock: authorized 7,000 shares, $ 0.0001 par value and $ 1,000 face value, 7,000 and 0 shares issued and outstanding as of October 31, 2025 and April 30, 2025, respectively. Liquidation preference of $ 7,000,000 as of October 31, 2025. 901,996 – Contingently redeemable warrants 417,000 – Total temporary equity 1,318,996 – St
Financial Statements
Financial Statements. 3 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three Months Ended October 31, Six Months Ended October 31, 2025 2024 2025 2024 Revenue $ – $ – $ – $ – Operating expenses: Research and development costs 141,085 97,470 236,242 193,486 General and administrative 1,234,966 1,008,590 1,988,114 2,181,461 Total operating expenses 1,376,051 1,106,060 2,224,356 2,374,947 Loss from operations ( 1,376,051 ) ( 1,106,060 ) ( 2,224,356 ) ( 2,374,947 ) Other income (expenses): Interest income 206,387 382,562 424,180 929,994 Change in fair value of warrant liability ( 10,474,000 ) 1,829,000 ( 10,231,000 ) 3,913,000 Change in fair value of derivative liability 302,000 980,000 302,000 2,184,000 Change in fair value of convertible note receivable - Femasys 392,000 435,000 1,304,000 680,000 Change in fair value of warrant asset - Femasys ( 726,000 ) 276,000 ( 1,941,000 ) ( 1,234,000 ) Change in fair value of investment - QCLS ( 2,371,000 ) ( 4,265,000 ) ( 5,210,000 ) ( 3,540,734 ) Change in fair value of warrants - QCLS 6,050,000 – 1,218,000 – Gain on legal settlement – re-fair value of warrants – – 106,000 – Gain on related party investment - QCLS 2,089,000 – 2,089,000 21,395,734 Issuance costs – Series C convertible preferred stock and warrants ( 1,234,553 ) – ( 1,234,553 ) – Loss on issuance of Series C convertible preferred stock ( 215,000 ) – ( 215,000 ) – Unrealized loss on marketable securities ( 60,663 ) – ( 165,126 ) – Other expense ( 95 ) ( 1,062 ) ( 216 ) ( 1,252 ) Total other income and (expense), net ( 6,041,924 ) ( 363,500 ) ( 13,553,715 ) 24,326,742 Net income (loss) ( 7,417,975 ) ( 1,469,560 ) ( 15,778,071 ) 21,951,795 Preferred stock dividends ( 96,639 ) ( 443,958 ) ( 96,639 ) ( 1,129,759 ) Preferred stock accretion ( 901,996 ) ( 1,045,357 ) ( 901,996 ) ( 3,
Financial Statements
Financial Statements. 4 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three Months Ended October 31, Six Months Ended October 31, 2025 2024 2025 2024 Net income (loss) $ ( 7,417,975 ) $ ( 1,469,560 ) $ ( 15,778,071 ) $ 21,951,795 Other comprehensive income (loss): Foreign currency translation ( 381 ) 61 ( 258 ) 244 Other comprehensive income (loss) ( 381 ) 61 ( 258 ) 244 Comprehensive income (loss) $ ( 7,418,356 ) $ ( 1,469,499 ) $ ( 15,778,329 ) $ 21,952,039 See accompanying Notes to Condensed Consolidated
Financial Statements
Financial Statements. 5 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN TEMPORARY EQUITY AND STOCKHOLDERS' EQUITY THREE AND SIX MONTHS ENDED OCTOBER 31, 2025 AND 2024 (UNAUDITED) Preferred Stock Series B Preferred Stock Series C Contingently Redeemable Warrants Common Stock Additional Paid-in Treasury Stock Accumulated Accumulated Other Comprehensive Total Stockholders' Shares Amount Shares Amount Amount Shares Amount Capital Shares Amount Deficit Loss Equity Balance, April 30, 2024 14,646 $ 11,867,016 – $ – $ – 21,672,078 $ 2,167 $ 185,334,173 ( 13,634,454 ) $ ( 42,040,216 ) $ ( 115,625,010 ) $ ( 23,511 ) $ 27,647,603 Stock-based compensation options – – – – – – – 222,677 – – – – 222,677 Preferred stock accretion – 2,148,047 – – – – – ( 2,148,047 ) – – – – ( 2,148,047 ) Series B preferred stock redemption ( 2,917 ) ( 2,893,144 ) – – – – – – – – – – – Series B preferred stock subject to redemption ( 5,833 ) ( 5,788,805 ) – – – – – – – – – – – Preferred stock dividends – – – – – – – ( 685,801 ) – – – – ( 685,801 ) Foreign currency translation adjustment – – – – – – – – – – – 183 183 Net income – – – – – – – – – – 23,421,355 – 23,421,355 Repurchase of common stock – – – – – – – – ( 320,346 ) ( 749,600 ) – – ( 749,600 ) Balance, July 31, 2024 5,896 5,333,114 – – – 21,672,078 2,167 182,723,002 ( 13,954,800 ) ( 42,789,816 ) ( 92,203,655 ) ( 23,328 ) 47,708,370 Fractional shares adjustment – – – – – 17 – – – – – – – Stock-based compensation options – – – – – – – 119,155 – – – – 119,155 Preferred stock accretion – 1,045,357 – – – – – ( 1,045,357 ) – – – – ( 1,045,357 ) Series B preferred stock redemption ( 2,917 ) ( 2,868,607 ) – – – – – – – – – – – Series B preferred stock subject to rede
Financial Statements
Financial Statements. 7 PHARMACYTE BIOTECH, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) NOTE 1 – NATURE OF BUSINESS PharmaCyte Biotech, Inc. (the "Company") is a biotechnology company focused on developing cellular therapies for cancer based upon a proprietary cellulose-based live cell encapsulation technology known as "Cell-in-a-Box ." The Cell-in-a-Box technology is intended to be used as a platform upon which therapies for several types of cancer, including locally advanced, inoperable pancreatic cancer ("LAPC") will be developed. The current generation of the Company's product candidate is referred to as "CypCaps." The Company is a Nevada corporation incorporated in 1996. In 2013, the Company restructured its operations to focus on biotechnology. The Company acquired licenses from SG Austria Pte. Ltd., a Singapore corporation ("SG Austria") and its wholly owned subsidiary, Austrianova Singapore Pte. Ltd., a Singapore corporation ("Austrianova Singapore") using the Cell-in-the-Box technology to treat cancer. The restructuring resulted in the Company focusing all its efforts upon the development of a novel, effective and safe way to treat cancer. In January 2015, the Company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to reflect the nature of its current business. In October 2021, the Company moved its headquarters from Laguna Hills, California to Las Vegas, Nevada. On September 1, 2020, the Company submitted an Investigational New Drug Application ("IND") to the U.S. Food and Drug Administration ("FDA") for a planned clinical trial in LAPC. On October 1, 2020, the Company received notice from the FDA that it had placed the IND on clinical hold. On October 30, 2020, the FDA sent a letter to the Company setting forth the reasons for the clinical hold and specific guidance on what the Company must do to have the clinical hold lifted. To lift the clinical hold, the FDA informed the Company that it needs to c