PharmaCyte Swings to $8.4M Loss Amid FDA Hold, Strategic Review

TL;DR

**PMCB is burning cash and stuck in FDA limbo, making it a high-risk bet with no clear path to market for its core therapy.**

AI Summary

PharmaCyte Biotech, Inc. (PMCB) reported a net loss of $8,360,096 for the three months ended July 31, 2025, a significant decline from the net income of $23,421,355 in the same period of 2024. This shift was primarily driven by a substantial decrease in 'Total other income (loss), net,' which plummeted from $24,690,242 in 2024 to a loss of $7,511,791 in 2025, largely due to a $21,395,734 gain on related party investment in TNF in 2024 that did not recur in 2025, and a $4,832,000 change in fair value of warrants - TNF in 2025. The company's cash and cash equivalents decreased from $15,172,163 at April 30, 2025, to $13,178,305 at July 31, 2025. Operating expenses also decreased by 33.2% to $848,305 from $1,268,887 year-over-year, mainly due to reduced general and administrative costs. PMCB is currently under an FDA clinical hold for its LAPC treatment IND, and spending on development programs is curtailed pending a review by its Business Review Committee and Board, which is also evaluating its relationship with SG Austria. The company recently secured $7 million in gross proceeds from a private placement of Series C convertible preferred stock and warrants in August 2025, bolstering its liquidity to an expected $15.7 million, sufficient for at least the next twelve months.

Why It Matters

This filing reveals PharmaCyte's precarious financial and operational state, marked by a significant net loss and an ongoing FDA clinical hold for its lead pancreatic cancer therapy. For investors, the lack of recurring 'other income' and the continued R&D delays due to the clinical hold and internal strategic review signal heightened risk and uncertainty regarding future revenue generation. Employees face potential instability as spending on programs is curtailed. Customers and patients awaiting the LAPC treatment will experience further delays. Competitively, this prolonged stagnation could allow rivals to advance their own therapies, further eroding PMCB's market position in the highly competitive biotechnology sector.

Risk Assessment

Risk Level: high — The company reported a net loss of $8,360,096 for the three months ended July 31, 2025, a stark contrast to the $23,421,355 net income in the prior year, primarily due to the absence of a $21,395,734 gain on related party investment. Furthermore, its core product candidate for LAPC remains under an FDA clinical hold since October 2020, with spending curtailed on development programs, indicating significant regulatory and operational hurdles.

Analyst Insight

Investors should exercise extreme caution and consider avoiding PMCB stock given the substantial net loss, ongoing FDA clinical hold, and internal strategic review that has curtailed R&D spending. The recent $7 million private placement provides short-term liquidity but doesn't address the fundamental lack of progress on its core therapeutic pipeline or the significant regulatory challenges.

Financial Highlights

debt To Equity

0.03

revenue

$–

operating Margin

N/A

total Assets

$45,110,453

total Debt

$1,518,865

net Income

$ (8,360,096)

eps

$ (1.23)

gross Margin

N/A

cash Position

$13,178,305

revenue Growth

N/A

Key Numbers

• $8,360,096 — Net Loss (for the three months ended July 31, 2025, compared to $23,421,355 net income in 2024)
• $13,178,305 — Cash and Cash Equivalents (as of July 31, 2025, down from $15,172,163 at April 30, 2025)
• $7,511,791 — Total Other Income (Loss), Net (a loss for the three months ended July 31, 2025, compared to a gain of $24,690,242 in 2024)
• $21,395,734 — Gain on Related Party Investment - TNF (recorded in 2024 but not in 2025, significantly impacting net income)
• $848,305 — Total Operating Expenses (for the three months ended July 31, 2025, a decrease from $1,268,887 in 2024)
• $1.23 — Basic and Diluted Loss Per Share (for the three months ended July 31, 2025, compared to $1.90 income per share in 2024)
• 6,795,779 — Weighted Average Shares Outstanding (for the three months ended July 31, 2025)
• $7,000,000 — Gross Proceeds from Private Placement (secured in August 2025 from Series C convertible preferred stock and warrants)

Key Players & Entities

• PharmaCyte Biotech, Inc. (company) — registrant
• FDA (regulator) — U.S. Food and Drug Administration
• SG Austria Pte. Ltd. (company) — licensor of Cell-in-a-Box technology
• Iroquois Master Fund Ltd. (company) — party in Cooperation Agreement
• Business Review Committee (company) — evaluating company's business and strategy
• Nasdaq Stock Market LLC (company) — exchange where PMCB common stock is registered
• Femasys (company) — convertible note receivable and warrant asset counterparty
• TNF (company) — warrant asset and investment counterparty
• Nevada (regulator) — state of incorporation

FAQ

Risk Factors

• FDA Clinical Hold on LAPC Treatment [high — regulatory]: The company's Investigational New Drug (IND) application for its locally advanced, inoperable pancreatic cancer (LAPC) treatment has been on clinical hold by the FDA since October 1, 2020. To lift the hold, the FDA requires additional preclinical studies and information regarding DNA sequencing, manufacturing, and product release specifications. This ongoing hold significantly impedes the advancement of a key product candidate.
• Review of Relationship with SG Austria [medium — operational]: The company's Business Review Committee and Board are evaluating its relationship with SG Austria, a key licensor of its proprietary technology. This review, alongside the clinical hold, suggests potential operational uncertainties and strategic re-evaluations that could impact future development and operations.
• Significant Decline in Other Income [high — financial]: The company experienced a substantial shift in 'Total other income (loss), net' from a gain of $24,690,242 in Q2 2024 to a loss of $7,511,791 in Q2 2025. This was primarily due to a non-recurring $21,395,734 gain on a related party investment in TNF in 2024 and a $4,832,000 change in fair value of warrants - TNF in 2025, impacting overall profitability.
• Decreasing Cash Position [medium — financial]: Cash and cash equivalents decreased from $15,172,163 as of April 30, 2025, to $13,178,305 as of July 31, 2025. While a recent private placement is expected to bolster liquidity to approximately $15.7 million, the net cash used in operating activities was $1,993,981 for the quarter.
• Dependence on FDA Approval [high — regulatory]: The company's core business strategy relies heavily on the successful development and FDA approval of its LAPC treatment. The current clinical hold highlights the significant regulatory hurdles and the lengthy, uncertain process involved in bringing a novel therapy to market.

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 Biotech operate in a competitive landscape where innovation is key, but success is contingent on navigating complex clinical trials and FDA approvals. The focus on niche areas like LAPC requires specialized expertise and substantial capital investment.

Regulatory Implications

The ongoing FDA clinical hold on PharmaCyte's LAPC treatment IND represents a critical regulatory risk. The need for additional preclinical studies and data submission indicates potential deficiencies that must be addressed before clinical development can resume. Failure to satisfy FDA requirements could lead to further delays or abandonment of the program.

What Investors Should Do

1. Monitor FDA communication regarding the clinical hold.
2. Assess the impact of the SG Austria relationship review.
3. Evaluate the sustainability of cash burn post-private placement.
4. Track changes in fair value of investments and warrants.

Key Dates

• 2020-10-01: FDA places IND on clinical hold for LAPC treatment. — This date marks the beginning of a significant regulatory hurdle that continues to impact the company's primary development program.
• 2025-07-31: End of Q2 2025 reporting period. — The 10-Q filing reflects the financial and operational status as of this date, showing a net loss and reduced cash reserves.
• 2025-08-01: Start of Q3 2025. — The period following the reporting date, during which the company secured $7 million in gross proceeds from a private placement.

Glossary

IND

Investigational New Drug application. A submission to the FDA to seek approval to start clinical trials in humans. (The company's IND for its LAPC treatment is currently on clinical hold, preventing further human trials.)

Clinical Hold

A status imposed by the FDA on an IND application, halting all clinical trials for the drug or biologic. (PharmaCyte's LAPC treatment IND is under clinical hold, requiring specific actions to be lifted.)

Cell-in-a-Box

PharmaCyte's proprietary cellulose-based live cell encapsulation technology. (This is the core technology platform upon which the company is developing its cancer therapies.)

LAPC

Locally Advanced, Inoperable Pancreatic Cancer. (This is the specific type of cancer PharmaCyte is targeting with its lead product candidate.)

Warrant Asset

An asset representing the right to purchase shares of stock at a specified price, often received as part of a financing or investment. (Changes in the fair value of warrant assets, particularly related to TNF, significantly impacted the company's other income/loss.)

Convertible Preferred Stock

A class of preferred stock that can be converted into a specified number of common stock shares. (The company recently completed a private placement of Series C convertible preferred stock and warrants.)

Year-Over-Year Comparison

Compared to the prior year's comparable period, PharmaCyte Biotech has shifted from a net income of $23,421,355 to a net loss of $8,360,096. This dramatic change was driven by a significant decrease in 'Total other income (loss), net,' which swung from a substantial gain of $24,690,242 to a loss of $7,511,791, largely due to the non-recurrence of a gain on a related party investment. While operating expenses decreased by 33.2% to $848,305, the absence of the prior year's one-time income significantly impacted profitability. Cash and cash equivalents also saw a decrease, though a recent financing aims to improve liquidity.

Key Financial Figures

• $0.0001 — ch registered Common Stock, Par Value $0.0001 Per Share PMCB The Nasdaq Stock Mar
• $15.7 million — h and cash equivalents of approximately $15.7 million as of the filing of this Quarterly Repo

Filing Documents

• pharmacyte_i10q-073125.htm (10-Q) — 714KB
• 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
• 0001683168-25-006991.txt ( ) — 4464KB
• pmcb-20250731.xsd (EX-101.SCH) — 38KB
• pmcb-20250731_cal.xml (EX-101.CAL) — 49KB
• pmcb-20250731_def.xml (EX-101.DEF) — 197KB
• pmcb-20250731_lab.xml (EX-101.LAB) — 330KB
• pmcb-20250731_pre.xml (EX-101.PRE) — 296KB
• pharmacyte_i10q-073125_htm.xml (XML) — 500KB

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 22 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 29 Item 4.

Controls and Procedures

Controls and Procedures 29 PART II. OTHER INFORMATION 30 Item 1.

Legal Proceedings

Legal Proceedings 30 Item 1A.

Risk Factors

Risk Factors 30 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 30 Item 3. Defaults Upon Senior Securities 30 Item 4. Mine Safety Disclosures 30 Item 5. Other Information 30 Item 6. Exhibits 36

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION

Financial Information

Item 1. Financial Information. PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) July 31, 2025 April 30, 2025 ASSETS Current assets: Cash and cash equivalents $ 13,178,305 $ 15,172,163 Marketable equity securities 261,853 366,316 Warrant asset – TNF - current 820,000 2,917,000 Convertible Note receivable – Femasys - current 4,608,000 3,696,000 Prepaid expenses and other current assets 238,180 223,759 Total current assets 19,106,338 22,375,238 Other assets: Intangible asset 1,549,427 1,549,427 Investment in preferred stock – TNF 19,635,000 22,474,000 Warrant asset – TNF - non current 2,966,000 5,701,000 Warrant asset – Femasys 1,846,000 3,061,000 Other assets 7,688 7,688 Total other assets 26,004,115 32,793,115 Total Assets $ 45,110,453 $ 55,168,353 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 465,209 $ 399,204 Accrued expenses 595,656 2,515,080 Total current liabilities 1,060,865 2,914,284 Other liabilities: Long-term portion of accrued expenses – 25,000 Warrant liabilities 458,000 338,000 Total other liabilities 458,000 363,000 Total Liabilities 1,518,865 3,277,284 Commitments and Contingencies (Note 8) – – Convertible Preferred Stock: 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 July 31, 2025 and April 30, 2025, respectively – – Stockholders' equity: Preferred stock, authorized 10,000,000 Series A preferred stock: authorized 1 share, $ 0.0001 par value and 0 shares issued and outstanding as of July 31, 2025 and April 30, 2025 – – Common stock: authorized 200,000,000 shares, $ 0.0001 par value; 21,672,095 shares issued and 6,795,779 shares outstanding as of July 31, 2025 and April 30, 2025, respectively. 2,167 2,167 Additional paid-in capital 181,550,139 1

Financial Statements

Financial Statements. 3 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three Months Ended July 31, 2025 2024 Revenue $ – $ – Operating expenses: Research and development costs 95,157 96,016 General and administrative 753,148 1,172,871 Total operating expenses 848,305 1,268,887 Loss from operations ( 848,305 ) ( 1,268,887 ) Other income (expenses): Interest income 217,793 547,432 Change in fair value of warrant liabilities 243,000 2,084,000 Change in fair value of derivative liability – 1,204,000 Change in fair value of convertible note receivable - Femasys 912,000 245,000 Change in fair value of warrant asset - Femasys ( 1,215,000 ) ( 1,510,000 ) Change in fair value of investment - TNF ( 2,839,000 ) 966,950 Change in fair value of warrants - TNF ( 4,832,000 ) ( 242,684 ) Gain on legal settlement - re-fair value of warrants 106,000 – Gain on related party investment - TNF – 21,395,734 Unrealized loss on marketable securities ( 104,463 ) – Other expense ( 121 ) ( 190 ) Total other income (loss), net ( 7,511,791 ) 24,690,242 Net income (loss) ( 8,360,096 ) 23,421,355 Preferred stock dividends – ( 685,801 ) Preferred stock accretion – ( 2,148,047 ) Net income (loss) attributable to common stockholders $ ( 8,360,096 ) $ 20,587,507 Basic and diluted income (loss) per share attributable to common stockholders $ ( 1.23 ) $ 1.90 Weighted average shares outstanding basic and diluted 6,795,779 7,866,387 See accompanying Notes to Condensed Consolidated

Financial Statements

Financial Statements. 4 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three Months Ended July 31, 2025 2024 Net income (loss) $ ( 8,360,096 ) $ 23,421,355 Other comprehensive income: Foreign currency translation 123 183 Other comprehensive income 123 183 Comprehensive income (loss) $ ( 8,359,973 ) $ 23,421,538 See accompanying Notes to Condensed Consolidated

Financial Statements

Financial Statements. 5 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY THREE MONTHS ENDED JULY 31, 2025 AND 2024 (UNAUDITED) Preferred stock Additional Accumulated Other Total Series B Common stock Paid in Treasury stock Accumulated Comprehensive Stockholders' Shares Amount Shares Amount Capital Shares Amount Deficit Income (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 redeemed ( 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 Balance, April 30, 2025 – $ – 21,672,095 $ 2,167 $ 181,489,647 ( 14,876,316 ) $ ( 44,607,916 ) $ ( 84,968,960 ) $ ( 23,869 ) $ 51,891,069 Stock-based compensation - options – – – – 60,492 – – – – 60,492 Foreign currency translation adjustment – – – – – – – – 123 123 Net loss – – – – – – – ( 8,360,096 ) – ( 8,360,096 ) Balance, July 31, 2025 – $ – 21,672,095 $ 2,167 $ 181,550,139 ( 14,876,316 ) $ ( 44,607,916 ) $ ( 93,329,056 ) $ ( 23,746 ) $ 43,591,588 See accompanying Notes to Condensed Consoli

Financial Statements

Financial Statements. 6 PHARMACYTE BIOTECH, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) Three Months Ended July 31, 2025 2024 Cash flows from operating activities: Net income (loss) $ ( 8,360,096 ) $ 23,421,355 Adjustments to reconcile net income (loss) to net cash used in operating activities: Gain on related party investment – TNF – ( 21,395,734 ) Adjustment from accrued liabilities to warrant liabilities ( 469,000 ) – Gain on re-fair value of warrants ( 106,000 ) – Stock-based compensation 60,492 222,677 Unrealized loss on marketable equity securities 104,463 – Change in fair value of warrant liabilities ( 243,000 ) ( 2,084,000 ) Change in fair value of derivative liability – ( 1,204,000 ) Change in fair value of convertible note receivable - Femasys ( 912,000 ) ( 245,000 ) Change in fair value of warrant asset – Femasys 1,215,000 1,510,000 Change in fair value of investment – TNF 2,839,000 ( 966,950 ) Change in fair value of warrants - TNF 4,832,000 242,684 Change in assets and liabilities: (Increase) decrease in prepaid expenses and other current assets ( 14,421 ) 19,573 Increase in accounts payable 66,005 164,582 Decrease in accrued expenses ( 1,006,424 ) ( 58,484 ) Net cash and cash equivalents used in operating activities ( 1,993,981 ) ( 373,297 ) Cash flows from investing activities: Investment in preferred stock and warrants – ( 7,000,000 ) Net cash and cash equivalents used in investing activities – ( 7,000,000 ) Cash flows from financing activities: Repurchase of common stock, net – ( 742,179 ) Redemption of preferred stock – ( 9,429,583 ) Net cash and cash equivalents used in financing activities – ( 10,171,762 ) Effect of currency rate exchange on cash and cash equivalents 123 183 Net decrease in cash and cash equivalents ( 1,993,858 ) ( 17,544,876 ) Cash and cash equivalents at beginning of the period 15,172,163 50

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

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View this 10-Q filing on SEC EDGAR