NKGen Biotech Completes Merger, Advances Cell Therapy Pipeline

TL;DR

**NKGen Biotech's post-merger cash infusion is modest, and with $32.9M still in escrow, this speculative biotech play faces significant liquidity and clinical trial risks.**

AI Summary

NKGen Biotech, Inc. (formerly Graf Acquisition Corp. IV) completed its merger with Legacy NKGen on September 29, 2023, becoming a biotechnology company focused on cell therapies for neurodegenerative and oncological diseases. The company's product candidates are based on proprietary SuperNK™ (SNK) cells, which have demonstrated increased activity in vitro. In connection with the Business Combination, Graf stockholders redeemed 3,386,528 shares for approximately $35.4 million. NKGen received approximately $21.9 million in gross proceeds, comprising $1.7 million from the Graf trust account and $20.2 million from warrant subscriptions and a securities purchase agreement. An additional $32.9 million in funds were deposited into escrow accounts, not yet received by the company. As of October 7, 2025, there were 124,376,734 shares of common stock outstanding. The company is developing SNK01, an autologous cell therapy, with initial insights from compassionate use data in five patients with Alzheimer's and Parkinson's disease showing marked improvement in clinical symptoms. NKGen initiated a Phase I trial in Mexico (MX04) for AD patients and received IND clearance in October 2023 for further clinical development.

Why It Matters

NKGen Biotech's successful merger and focus on SuperNK™ cell therapies could be a significant development in the competitive biotechnology landscape, particularly for neurodegenerative and oncological diseases. The initial compassionate use data, while preliminary, suggests potential for SNK01 in Alzheimer's and Parkinson's, which are areas with high unmet medical needs. For investors, the company's ability to secure funding and advance clinical trials will be critical, especially given the $32.9 million in escrowed funds. Employees and customers could benefit from a new, potentially transformative treatment option, but the high-risk nature of drug development means significant hurdles remain before market impact.

Risk Assessment

Risk Level: high — The company explicitly states its 'history of operating losses and expectations of significant expenses and continuing losses for the foreseeable future,' indicating substantial financial risk. Furthermore, the filing highlights the critical need for 'ability to raise financing in the future' and 'ability to service its operations and expenses and other liquidity needs and to address its ability to continue as a going concern,' directly citing going concern risk. The $32.9 million in escrowed funds, not yet received by the company, adds to the financial uncertainty.

Analyst Insight

Investors should approach NKGen Biotech with extreme caution, recognizing it as a highly speculative investment. Monitor closely for updates on the release of the $32.9 million in escrowed funds and the progress and results of its clinical trials, as these will be critical determinants of its future viability and potential for success.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

$10.4M

total Debt

$10.0M

net Income

$-10.4M

eps

$-0.08

gross Margin

N/A

cash Position

$21.9M

revenue Growth

N/A

Key Numbers

• $35.4M — Graf Share Redemptions (Amount of cash paid to Graf stockholders who exercised redemption rights.)
• $21.9M — Gross Proceeds Received (Total funds received by NKGen at the Closing of the Business Combination.)
• $32.9M — Escrowed Funds (Funds deposited into escrow accounts, not yet received by the Company, representing a significant potential liquidity source.)
• 124,376,734 — Common Stock Outstanding (Total shares of common stock issued and outstanding as of October 7, 2025.)
• 0.408 — Exchange Ratio (Ratio at which Legacy NKGen common stock was exchanged for NKGen common stock.)
• 15,595,260 — Shares Issued to Legacy NKGen (Aggregate shares of NKGen common stock issued to former Legacy NKGen stockholders.)
• $10.4415 — Redemption Price Per Share (Price per share at which Graf's common stock was redeemed.)
• $11.50 — Warrant Exercise Price (Exercise price for Public, Private, and Working Capital Warrants.)
• $10,000,000 — Senior Convertible Notes Principal (Aggregate principal amount of 5.0% / 8.0% convertible senior notes issued to NKMAX.)
• 5 — Compassionate Use Patients (Number of patients with AD and PD treated with SNK01 under compassionate use, showing initial positive results.)

Key Players & Entities

• NKGen Biotech, Inc. (company) — registrant after merger
• Graf Acquisition Corp. IV (company) — former name of registrant
• Legacy NKGen (company) — merged subsidiary
• Merger Sub (company) — former wholly-owned subsidiary of Graf
• NKMAX Co., Ltd. (company) — former parent of Legacy NKGen and recipient of Senior Convertible Notes
• Graf Acquisition Partners IV LLC (company) — Sponsor
• $35.4 million (dollar_amount) — aggregate redemption amount for Graf shares
• $21.9 million (dollar_amount) — gross proceeds received by the Company at Closing
• $32.9 million (dollar_amount) — funds deposited into escrow accounts, not yet received by the Company
• U.S. Securities and Exchange Commission (regulator) — regulates filings

FAQ

Risk Factors

• Dependence on Future Financing [high — financial]: The company has a history of losses and has not generated significant revenue. It anticipates incurring substantial operating losses and negative cash flows for the foreseeable future, necessitating significant future financing. Failure to secure additional funding could jeopardize its ability to continue as a going concern.
• Uncertainty of Regulatory Approval [high — regulatory]: The development of cell therapies is subject to stringent regulatory oversight by agencies like the FDA and Health Canada. Obtaining approval for product candidates like SNK01 requires extensive and costly clinical trials to demonstrate safety and efficacy. Delays or failure to obtain regulatory approval will prevent commercialization.
• Manufacturing and Scalability Challenges [medium — operational]: The company's proprietary manufacturing process for SuperNK™ (SNK) cells needs to be scaled to meet potential commercial demand. Any disruptions or failures in manufacturing, quality control, or the ability to scale production could significantly impact the company's ability to deliver its therapies.
• Competition in Cell Therapy Market [medium — market]: The biotechnology sector, particularly in cell therapies for neurodegenerative and oncological diseases, is highly competitive. The company faces competition from established pharmaceutical companies and emerging biotech firms, some of which may have greater financial resources and established market presence.
• Significant Stockholder Redemptions [medium — financial]: During the business combination, Graf stockholders redeemed 3,386,528 shares for approximately $35.4 million. This significantly reduced the capital available to the company from the SPAC transaction, impacting its initial cash position.
• Intellectual Property Risks [low — legal]: The company's success depends on its ability to protect its proprietary technology and intellectual property. Challenges to its patents or the inability to secure new patents could weaken its competitive position and impact future revenue streams.

Industry Context

NKGen operates in the highly competitive and rapidly evolving biotechnology sector, specifically focusing on cell therapies for neurodegenerative and oncological diseases. The industry is characterized by significant investment in research and development, long development timelines, and stringent regulatory hurdles. Key trends include the increasing focus on immunotherapy, personalized medicine, and the development of novel cell-based treatments.

Regulatory Implications

The company's product candidates, particularly SNK01, are subject to rigorous review by regulatory bodies like the FDA and Health Canada. Obtaining approval requires demonstrating robust safety and efficacy through extensive clinical trials. The Fast Track designation for SNK01 by the FDA indicates potential for expedited review but does not guarantee approval.

What Investors Should Do

1. Monitor clinical trial progress and data readouts for SNK01.
2. Assess the company's ability to secure future funding.
3. Evaluate the competitive landscape and differentiation of SNK technology.
4. Track regulatory milestones and FDA/Health Canada interactions.

Key Dates

• 2023-09-29: Business Combination Completion — NKGen Biotech, Inc. (formerly Graf Acquisition Corp. IV) completed its merger with Legacy NKGen, officially becoming a publicly traded biotechnology company focused on cell therapies.
• 2023-10: FDA IND Clearance for SNK01 — Received clearance from the FDA for a Phase I/IIa trial in the United States for SNK01, enabling further clinical development in neurodegenerative diseases.
• 2023-12: Health Canada CTA Clearance for SNK01 — Received clearance from Health Canada for a Clinical Trial Application (CTA) for SNK01, allowing for clinical development in Canada.
• 2023-12: First US Patient Initiated in SNK01 Trial — The first patient in the United States was enrolled in the SNK01 Phase I/IIa trial, marking a significant step in the clinical development program.
• 2025-02: FDA Fast Track Designation for SNK01 — Received Fast Track designation from the FDA for the investigation of SNK01, which is intended to expedite the development and review of drugs for serious conditions.

Glossary

SuperNK™ (SNK) cells

Proprietary activated natural killer (NK) cells manufactured using a specific process that aims to enhance their activity, such as cytotoxicity and cytokine production. (These are the core of NKGen's product candidates, forming the basis of their cell therapy platform for neurodegenerative and oncological diseases.)

Autologous cell therapy

A type of cell therapy where the patient's own cells are collected, modified or processed, and then re-infused back into the same patient. (SNK01 is an autologous cell therapy, meaning it uses the patient's own NK cells, which can reduce the risk of immune rejection.)

Compassionate use

The use of an investigational medical product outside of a clinical trial for patients with a serious or life-threatening condition who cannot be treated satisfactorily by approved therapies. (Initial insights into SNK01's potential in neurodegenerative diseases were derived from compassionate use data in five patients, providing early, albeit non-conclusive, evidence.)

Investigational New Drug (IND) application

A submission to the FDA that requests permission to administer an investigational drug or biologic to humans. It includes data from preclinical studies and information about the manufacturing process. (The FDA's clearance of the IND for SNK01 is a critical step that allows the company to proceed with formal clinical trials in the United States.)

Clinical Trial Application (CTA)

A submission to regulatory authorities in Canada (and other countries) to seek authorization to conduct a clinical trial with a new drug or biologic. (Health Canada's clearance of the CTA for SNK01 permits the company to initiate clinical trials in Canada.)

Natural Killer (NK) cells

A type of white blood cell that is part of the innate immune system and plays a role in killing tumor cells and virally infected cells. (NKGen's therapies are based on leveraging the natural cytotoxic capabilities of NK cells, aiming to enhance their effectiveness through proprietary processes.)

Year-Over-Year Comparison

As this is the first 10-K filing following the business combination, a direct year-over-year comparison of financial metrics like revenue and net income is not applicable. However, the filing details the significant capital raised ($21.9M gross proceeds received, with $32.9M in escrow) and the substantial redemptions ($35.4M) that occurred during the business combination, setting the stage for future operational and financial performance.

Key Financial Figures

• $0.0001 — he principal U.S. market Common Stock, $0.0001 par value per share NKGN OTC Expert Mar
• $11.50 — of Common Stock at an exercise price of $11.50 per share NKGNW OTC Expert Market Sec
• $10.4415 — at a redemption price of approximately $10.4415 per share, for an aggregate redemption
• $35.4 million — gate redemption amount of approximately $35.4 million. Upon the Closing, the Company received
• $21.9 million — ing, the Company received approximately $21.9 million in gross proceeds, comprising approxima
• $1.7 million — ross proceeds, comprising approximately $1.7 million from the Graf trust account and approxi
• $20.2 million — he Graf trust account and approximately $20.2 million from the transactions in relation to th
• $32.9 million — ments (as defined below), approximately $32.9 million in funds were deposited into escrow acc
• $10.00 — through the sale of 17,161,500 units at $10.00 per unit. " Legacy NKGen " means NKGen
• $11 — is exercisable, at an exercise price of $11.50, for one share of NKGen Common Stock
• $10,000,000 — " Senior Convertible Notes " means the $10,000,000 aggregate principal amount of 5.0% / 8.
• $1.00 — of common stock at a purchase price of $1.00 per warrant, resulting in an aggregate
• $10,209,994 — lting in an aggregate purchase price of $10,209,994. " Warrants " means the Private Warran
• $1.5 million — e Sponsor with a principal amount up to $1.5 million on May 15, 2023. " Working Capital War

Filing Documents

• nkgn-20241231.htm (10-K) — 3398KB
• nkgenbiotechinc-exhibit3114.htm (EX-31.1) — 8KB
• nkgenbiotechinc-exhibit3124.htm (EX-31.2) — 8KB
• nkgenbiotechinc-exhibit3213.htm (EX-32.1) — 6KB
• nkgn-20241231_g1.jpg (GRAPHIC) — 102KB
• nkgn-20241231_g10.jpg (GRAPHIC) — 87KB
• nkgn-20241231_g2.jpg (GRAPHIC) — 121KB
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• nkgn-20241231_g7.jpg (GRAPHIC) — 46KB
• nkgn-20241231_g8.jpg (GRAPHIC) — 72KB
• nkgn-20241231_g9.jpg (GRAPHIC) — 59KB
• 0001845459-25-000004.txt ( ) — 17152KB
• nkgn-20241231.xsd (EX-101.SCH) — 120KB
• nkgn-20241231_cal.xml (EX-101.CAL) — 96KB
• nkgn-20241231_def.xml (EX-101.DEF) — 740KB
• nkgn-20241231_lab.xml (EX-101.LAB) — 1108KB
• nkgn-20241231_pre.xml (EX-101.PRE) — 960KB
• nkgn-20241231_htm.xml (XML) — 2007KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 37 Item 1B. Unresolved Staff Comments 83 Item 1C. Cybersecurity 84 Item 2.

Properties

Properties 84 Item 3.

Legal Proceedings

Legal Proceedings 84 Item 4. Mine Safety Disclosures 84 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 85 Item 6. [Reserved] 86 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 87 Item 7A . Quantitative and Qualitative Disclosure About Market Risk 111 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 112 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures 165 Item 9A .

Controls and Procedures

Controls and Procedures 166 Item 9B . Other Information 167 Item 9C . Disclosure Regarding Foreign Jurisdiction that Prevent Inspection 167 Part III Item 10. Directors, Executive Officers and Corporate Governance 168 Item 11.

Executive Compensation

Executive Compensation 176 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 180 Item 13. Certain Relationships and Related Transactions, and Director Independence 182 Item 14. Principle Accountant Fees and Services 187 Part IV Item 15. Exhibits and Financial Statements 189 Item 16. Form 10-K Summary 195

Signatures

Signatures 196 1 Table of Contents PART I SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. The Company's forward-looking statements include, but are not limited to, statements regarding the Company's or its management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including the Company's expectations regarding the plans and strategy for our business, future financial performance, expense levels and liquidity sources. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would," "goal" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this Annual Report on Form 10-K and in documents incorporated herein are based on the Company's current expectations and beliefs concerning future developments and their potential effects on us taking into account information currently available to the Company. There can be no assurance that future developments affecting the Company will be those that the Company has anticipated. These forward-looking statements involve a number of risks, uncertainties (many of which are difficult to predict and beyond the Company's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. As a result of a number of known and unknown risks and uncertainties, the Company's actual re

Business

Item 1. Business Our Mission and Vision Our mission is to improve patient outcomes in the areas of neurodegenerative and oncological diseases by developing safe and effective cellular therapies that leverage the power of a patient's immune system. Our vision is to become the global leader in natural killer (" NK ") cell therapies. Overview We are a biotechnology company developing cell therapies for neurodegenerative and oncological diseases based on activated NK cells. NK cells are part of the human innate immune response system that can selectively identify and destroy abnormal or diseased cells. Our product candidates are based on a proprietary manufacturing and cryopreservation process which produces SuperNK TM (" SNK ") cells that have shown increased activity as compared to the starting population of NK cells, based on the results of in vitro experiments performed by NKMAX, as defined by parameters such as cytotoxicity, cytokine production and activating receptor expression. SNK cells can be produced in large quantities and cryopreserved, while maintaining high levels of cytotoxicity and activating receptor expression after thawing and reconstitution. We believe that SNK cells have the potential to deliver transformational benefits to patients with both neurodegenerative diseases, such as Alzheimer's Disease (" AD ") and Parkinson's disease (" PD "), and oncological diseases. Our initial insights into the potential of SNK01, an autologous cell therapy candidate, in neurodegenerative disease is derived from compassionate use data from three patients with AD and two patients with PD. Compassionate use refers to the use outside of a clinical trial of an investigational, or unapproved, medical product (drug, biologic or medical device) in patients with a chronically or seriously debilitating disease who cannot be treated satisfactorily by an authorized medicinal product. Treatment of these five patients with SNK01 was associated with marked improvement in c

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