CollPlant Faces Going Concern Doubt Amidst R&D-Heavy Strategy

Ticker: CLGN · Form: 20-F · Filed: Mar 26, 2026 · CIK: 0001631487

Complexity: moderate

Sentiment: bearish

Topics: Biotechnology, Regenerative Medicine, 3D Bioprinting, Going Concern, Clinical Trials, Medical Aesthetics, R&D Risk

Related Tickers: CLGN, ABBV

TL;DR

**CLGN is a high-risk bet on unproven tech with a 'going concern' warning; avoid until they secure serious funding or show clear path to profitability.**

AI Summary

CollPlant Biotechnologies Ltd. (CLGN) reported significant losses for the fiscal year ended December 31, 2025, and anticipates continued losses, raising substantial doubt about its ability to continue as a going concern. The company's financial viability hinges on its ability to secure additional funding, which may not be available on acceptable terms. Revenue generation is heavily dependent on the successful development, regulatory approval, and commercialization of its medical aesthetics and 3D bioprinting product candidates, including 3D-bioprinted breast implants and bioinks, which are based on its novel recombinant human collagen (rhCollagen) technology. A key strategic development is the ongoing development and global commercialization agreement for dermal and soft tissue filler products with Allergan, an AbbVie company, initiated in February 2021. The company faces risks related to limited clinical data, challenges in scaling rhCollagen production, and intense competition in a rapidly changing technological landscape. Its strategic outlook focuses on advancing its rhCollagen-based products through clinical trials and establishing robust sales and marketing capabilities, potentially through third-party collaborations.

Why It Matters

CollPlant's financial instability, highlighted by the 'going concern' warning, directly impacts investor confidence and the company's ability to fund critical R&D. For employees, this uncertainty could affect job security and future growth opportunities. Customers and the broader medical market, particularly in regenerative and aesthetic medicine, stand to lose out on potentially innovative rhCollagen-based products if CollPlant fails to secure necessary capital. In a competitive landscape dominated by larger pharmaceutical and biotech firms, CollPlant's unique 3D bioprinting and medical aesthetics technologies, if successfully commercialized, could offer significant advancements, but its current financial state poses a substantial hurdle.

Risk Assessment

Risk Level: high — The filing explicitly states, "Management has concluded that there is substantial doubt about our ability to continue as a going concern," and notes that the independent registered public accounting firm's report contains an explanatory paragraph to this effect. This indicates a severe financial risk, as the company has incurred "significant losses since our inception" and will need to "raise additional funding" to continue operations, with no guarantee of obtaining it on acceptable terms.

Analyst Insight

Investors should exercise extreme caution and consider this a highly speculative investment. Await clear evidence of successful non-dilutive financing or significant progress in clinical trials and regulatory approvals for key products, especially the Allergan collaboration, before considering an investment.

Key Numbers

Key Players & Entities

Forward-Looking Statements

FAQ

What are the primary financial concerns for CollPlant Biotechnologies Ltd. (CLGN) as of its 2025 20-F filing?

CollPlant Biotechnologies Ltd. (CLGN) has incurred significant losses since its inception and anticipates continued losses for the foreseeable future. Management has concluded there is substantial doubt about its ability to continue as a going concern, and the company will need to raise additional funding, which may not be available on acceptable terms.

What is CollPlant's core technology and how does it relate to its product pipeline?

CollPlant's core technology is based on recombinant human collagen (rhCollagen) produced in genetically engineered tobacco plants. This technology underpins its product candidates in medical aesthetics and 3D bioprinting, including 3D-bioprinted breast implants and bioinks.

Who is CollPlant's CEO and what is their contact information?

Yehiel Tal is the Chief Executive Officer of CollPlant Biotechnologies Ltd. He can be reached at +972 73 232 5600 or Yehiel@CollPlant.com, with the principal executive offices located at 4 Oppenheimer, Weizmann Science Park, Rehovot 7670104, Israel.

What is the significance of CollPlant's agreement with Allergan, an AbbVie company?

In February 2021, CollPlant entered into a development and global commercialization agreement with Allergan, an AbbVie company, for dermal and soft tissue filler products. This partnership is crucial for the potential commercial success and market penetration of CollPlant's rhCollagen-based products.

What are the main risks associated with investing in CollPlant's ordinary shares?

Key risks include a history of significant losses, the need for additional funding, the 'going concern' warning, limited clinical data, challenges in scaling rhCollagen production, intense competition, and reliance on third parties for manufacturing and sales. These factors could substantially impact the price of CLGN ordinary shares.

How many ordinary shares of CollPlant were outstanding as of December 31, 2025?

As of December 31, 2025, CollPlant Biotechnologies Ltd. had 12,803,006 ordinary shares outstanding.

What accounting standards does CollPlant use for its financial statements?

CollPlant Biotechnologies Ltd. reports its financial information under generally accepted accounting principles in the United States of America (U.S. GAAP).

Where are CollPlant's ordinary shares traded?

CollPlant's ordinary shares, with a par value of NIS 1.50 per share, are traded on the Nasdaq Capital Market under the trading symbol CLGN.

What are the regulatory challenges CollPlant faces for its rhCollagen-based products?

CollPlant faces challenges in obtaining favorable pre-clinical and clinical trial results, securing regulatory action for marketing authorization, and achieving approval for its rhCollagen-based products in medical aesthetics and 3D bioprinting. Even if approved, products will remain subject to ongoing regulatory scrutiny.

How does CollPlant's reliance on tobacco plants for rhCollagen production pose a risk?

CollPlant's development and production of rhCollagen relies upon the continued availability of tobacco plants. Any interruption in the availability or supply of these plants could delay production and adversely affect the commercial utilization of its rhCollagen-based products.

Risk Factors

Industry Context

The medical aesthetics and regenerative medicine industries are characterized by rapid technological advancements and significant investment. Companies are increasingly focusing on biomaterials and 3D printing to develop innovative solutions for tissue repair and aesthetic enhancement. CollPlant operates within this dynamic landscape, facing competition from established players and emerging biotech firms.

Regulatory Implications

CollPlant's product candidates, particularly in medical aesthetics and tissue repair, are subject to stringent regulatory review processes by bodies like the FDA and EMA. Failure to obtain regulatory approval or significant delays in the approval process pose a major risk to commercialization and revenue generation.

What Investors Should Do

  1. Monitor funding rounds and cash burn rate closely.
  2. Evaluate progress on the Allergan partnership and other collaborations.
  3. Assess clinical trial results and regulatory submission timelines.

Key Dates

Glossary

recombinant human collagen (rhCollagen)
A type of collagen produced using genetic engineering techniques to mimic human collagen. It is CollPlant's core technology for its product candidates. (This is the foundational technology for CollPlant's product pipeline, including medical aesthetics and 3D bioprinting applications.)
going concern
A business's ability to continue operating for the foreseeable future without the threat of liquidation. A 'going concern' doubt means there are significant uncertainties about the company's ability to survive. (The company's financial condition raises substantial doubt about its ability to continue as a going concern, indicating a high level of financial risk for investors.)
bioinks
Specialized materials used in 3D bioprinting that contain living cells and biomaterials, enabling the creation of biological structures. (CollPlant is developing bioinks based on its rhCollagen technology, which are crucial for its 3D bioprinting product candidates.)

Year-Over-Year Comparison

Specific comparative financial data for revenue growth, margin changes, and new risks compared to the previous filing are not detailed in the provided text. However, the persistent mention of significant losses and doubt about going concern suggests a continued challenging financial environment. The core risks related to product development, regulatory approval, and funding remain central themes.

Filing Stats: 4,470 words · 18 min read · ~15 pages · Grade level 14 · Accepted 2026-03-26 08:47:35

Key Financial Figures

Filing Documents

Item 18

Item 17 Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company. Yes No TABLE OF CONTENTS Page INTRODUCTION iii CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS iv EXPLANATORY NOTE vi PART I 1 ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 1 ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 A. Reserved 1 B. Capitalization and Indebtedness 1 C. Reasons for the Offer and Use of Proceeds 1 D.

Risk Factors

Risk Factors 1 ITEM 4. INFORMATION ON THE COMPANY 46 A. History and Development of the Company 46 B. Business Overview 47 C. Organizational Structure 86 D. Property, Plants and Equipment 86 ITEM 4A. UNRESOLVED STAFF COMMENTS 86 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 87 A. Operating Results 89 B. Liquidity and Capital Resources 91 C. Research and Development, Patents and Licenses 94 D. Trend Information 95 E. Critical Accounting Estimates 95 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 96 A. Directors and Senior Management 96 B. Compensation 99 C. Board Practices 101 D. Employees 112 E. Share Ownership 112 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 114 A. Major Shareholders 114 B. Related Party Transactions 117 C. Interests of Experts and Counsel 119 ITEM 8. FINANCIAL INFORMATION 120 A. Consolidated Statements and Other Financial Information 120 B. Significant Changes 120 i ITEM 9. THE OFFER AND LISTING 120 A. Offer and Listing Details 120 B. Plan of Distribution 121 C. Markets 121 D. Selling Shareholders 121 E.

Dilution

Dilution 121 F. Expenses of the Issue 121 ITEM 10. ADDITIONAL INFORMATION 121 A. Share Capital 121 B. Articles of Association 121 C. Material Contracts 121 D. Exchange Controls 121 E. Taxation 121 F. Dividends and Paying Agents 132 G. 133 H. Documents on Display 133 I. Subsidiary Information 133 ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 133 ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 134 A. Debt Securities 134 B. Warrants and rights 134 C. Other Securities 134 D. American Depositary Shares 134 PART II 135 ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 135 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 135 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 135 ITEM 16. [RESERVED] 136 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 136 ITEM 16B. CODE OF ETHICS 136 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 136 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 137 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 137 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 137 ITEM 16G. CORPORATE GOVERNANCE 137 ITEM 16H. MINE SAFETY DISCLOSURE 139 ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 139 ITEM 16J. INSIDER TRADING POLICIES 139 ITEM 16K. CYBERSECURITY 139 PART III 140 ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 140 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 140 ITEM 19. EXHIBITS 140

SIGNATURES

SIGNATURES 142 ii INTRODUCTION We are a regenerative and aesthetic medicine company focused on medical aesthetics and 3D bioprinting of tissues and organs. Our products are based on our recombinant human collagen (rhCollagen) produced in genetically engineered tobacco plants using our proprietary technology. These products address indications for the diverse fields of tissue repair and aesthetics, and are ushering in a new era in regenerative and aesthetic medicine. In February 2021, we entered into a development and global commercialization agreement for dermal and soft tissue filler products with Allergan, an AbbVie company. Unless the context requires otherwise, the terms "CollPlant," "we," "us," "our," "the Company," and similar designations refer to CollPlant Biotechnologies Ltd. and its subsidiaries, CollPlant Ltd. and CollPlant Inc. References to "ordinary shares," "warrants" and "share capital" refer to our ordinary shares, warrants and share capital, respectively, of CollPlant Biotechnologies Ltd. Unless the context requires otherwise, references to "our products" refer also to products being developed by any strategic partner. References to "U.S. dollars" and "$" are to currency of the United States of America, and references to "NIS" are to New Israeli Shekels. References to "ordinary shares" or "our ordinary shares" are to the ordinary shares of CollPlant Biotechnologies Ltd., par value NIS 1.50 per share. We report financial information under generally accepted accounting principles in the United States of America or U.S. GAAP. The functional and presentation currency of the Company in this annual report on Form 20-F, or the Annual Report, is the U.S. dollar. iii CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain information included or incorporated by reference in this Annual Report on Form 20-F may be deemed to be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and othe

Forward-looking statements

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: our history of significant losses, our ability to remain as a going concern, and our need to raise additional capital and our inability to obtain additional capital on acceptable terms, or at all, including uncertainties surrounding the methods of fundraising and our preferences regarding such methods, and including our ability to conclude a non-dilutive financing transaction; our expectations regarding the timing and cost of commencing pre-clinical and clinical trials with respect to rhCollagen based products in medical aesthetics and 3D bioprinting; ours or our strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based products in medical aesthetics and 3D bioprinting, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of rhCollagen based products in medical aesthetics and 3D bioprinting; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers; our ability to establish and maintain strategic partnerships and other business collaborations; iv our reliance on third parties to conduct some or all aspects of our pro

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable.

OFFER STATISTICS AND EXPECTED TIMETABLE

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable.

KEY INFORMATION

ITEM 3. KEY INFORMATION A. Reserved. B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors You should carefully consider the risks described below, together with all of the other information in this Annual Report on Form 20-F. The risks and uncertainties described below are those significant risk factors, currently known and specific to us, that we believe are relevant to an investment in our securities. Additional risks and uncertainties not currently known to us or that we now deem immaterial may also harm us. If any of these risks materialize, our business, results of operations or financial condition could suffer, and the price of our ordinary shares could decline substantially. Summary Risk Factors Investing in our ordinary shares involves a high degree of risk, as fully described below. The principal factors and uncertainties that make investing in our ordinary shares risky, include, among others: Risks Related to Our Financial Position and Capital Requirements We have generally incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain additional capital when needed may force us to delay, limit, or terminate our product development efforts or other operations. Management has concluded that there is substantial doubt about our ability to continue as a going concern, and the report of our independent registered public accounting firm contains an explanatory paragraph as to our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms or at all. Risks Related to Commercialization of Our Products The commercial success of any current or future product, if approved, will depend upon the degree of market acceptance by physicians

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