Purple Biotech Ltd 20-F for FY2024

Purple Biotech Ltd. (PPBT)

20-F 2025-03-10 For: 2024-12-31

Added on April 10, 2026

About this 20-F

Purple Biotech Ltd filed this 20-F on March 10, 2025, covering the fiscal year ended December 31, 2024 (FY2024).

Headline figures

Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $7.24M; compared with a net loss of $19.88M a year earlier
Diluted EPS: $4.99; down 72.2% from $17.96 a year earlier

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Title of each class		Trading Symbol(s)		Name of each exchange on which registered
American Depositary Shares, each representing 200 Ordinary Shares⁽¹⁾		PPBT		NASDAQ Capital Market

ITEM 1.	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS	1
ITEM 2.	OFFER STATISTICS AND EXPECTED TIMETABLE	1
ITEM 3.	KEY INFORMATION	1
ITEM 4.	INFORMATION ON THE COMPANY	46
ITEM 4A.	UNRESOLVED STAFF COMMENTS	80
ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	81
ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	87
ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	106
ITEM 8.	FINANCIAL INFORMATION	109
ITEM 9.	THE OFFER AND LISTING	110
ITEM 10.	ADDITIONAL INFORMATION	110
ITEM 11.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	124
ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	125
ITEM 13.	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	126
ITEM 14.	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	126
ITEM 15.	CONTROLS AND PROCEDURES	126
ITEM 16.	[RESERVED]	126
ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT	126
ITEM 16B.	CODE OF ETHICS	127
ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	127
ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	128
ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	128
ITEM 16F.	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	128
ITEM 16G.	CORPORATE GOVERNANCE	128
ITEM 16H.	MINE SAFETY DISCLOSURE	129
ITEM 16I.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	129
ITEM 16J.	INSIDER TRADING POLICIES	129
ITEM 16K.	CYBERSECURITY	129
ITEM 17.	FINANCIAL STATEMENTS	131
ITEM 18.	FINANCIAL STATEMENTS	131
ITEM 19.	EXHIBITS	131

	●	“TyrNovo” refers to TyrNovo Ltd., the majority owned subsidiary of Purple Biotech,

	●	“FameWave” refers to FameWave Ltd., the wholly owned subsidiary of Purple Biotech,

	●	“Immunorizon” refers to Immunorizon Ltd., the wholly owned subsidiary of Purple Biotech,

	●	“dollar”, “US$” or “$” refer to U.S. dollars, the lawful currency of the United States of America,

	●	“Securities Act” refers to the Securities Act of 1933, as amended,

	●	“SEC” refers to the United States Securities and Exchange Commission,

“API”		Active Pharmaceutical Ingredient – any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production process, becomes an active ingredient in the drug product.

“approved product”		A product that has been approved for marketing by a regulatory authority.

“BLA”		Biologics License Application – An application submitted to the FDA to request approval to market a new biological product in the United States.

“cGMP”		Current Good Manufacturing Practice – minimum requirements of the FDA and other regulatory authorities for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product that is intended for human use to ensure that the product is safe for use and has the ingredients and strength that it claims to have.

“Clinical”		Pertaining to human studies.

“CMC”		Chemistry, manufacturing, and controls.

“Consensi”		An FDA approved fixed-dose combination drug treatment intended for the treatment of osteoarthritis pain and for hypertension, previously developed and commercialized by the Company. During 2021, the Company determined to discontinue operations related to Consensi.

“CROs”		Contract research organizations.

“FDA”		United States Food and Drug Administration.

“Formulation”		All the active and inactive materials contained in a final medical product.

“IND”		Investigational New Drug (Application) – an application to test an experimental drug in human beings and that requires clearance by the FDA for clinical trials to be initiated.

“NDA”		New Drug Application - an application submitted to the FDA to approve marketing a new pharmaceutical drug in the United States.

“PDX”		Patient-derived xenograft - an animal model in which patient-derived tumor tissue at low passage are implanted in animals, used to conserve original tumor characteristics and to provide relevant predictive insights into clinical outcomes when evaluating new cancer therapies.

“Pharmacokinetics”, “PK”		The study of the absorption, distribution, metabolism and excretion of a drug from the body; the pharmacokinetic indices provide, among other things, information on the extent and time of the patient’s exposure to the material. It is the study of how the body affects the drug.

“preclinical”		Drug development studies performed outside of a human living organism or cell, using living cells, or appropriate animal models. The studies begin before trials in humans and assess safety, toxicity, and efficacy. Since drug development is dynamic, preclinical studies are performed throughout the drug development lifecycle.

	●	We are a clinical stage biotechnology company with a history of operating losses. We expect to incur significant additional losses in the future and may never be profitable;

	●	Our limited operating history as a biotechnology research and development company makes it difficult to evaluate our business and prospects, and we depend on the success of a limited portfolio of therapeutic candidates for our future revenue, which could impair our ability to achieve profitability;

	●	We will need to raise additional capital to achieve our strategic objectives of developing and commercializing our therapeutic candidates, and to develop, acquire and/or in-license additional therapeutic candidates, and our failure to raise sufficient capital would significantly impair our ability to fund our future operations, develop our current or future therapeutic candidates, seek regulatory approval that is a prerequisite to selling any product, attract development or commercial partners, and retain key personnel;

	●	Our long-term capital requirements are uncertain and subject to numerous risks;

	●	Our clinical trials may fail to demonstrate adequately the safety and efficacy of our therapeutic candidates, which would prevent or delay regulatory approval and commercialization;

	●	Regulations are constantly changing, and in the future our business may be subject to additional regulations that could increase our compliance costs or delay our ability to market our product candidates, if at all;

	●	Our therapeutic candidates may cause undesirable side effects or have other properties that could halt clinical development, prevent regulatory approval, limit commercial potential, or result in significant negative consequences;

	●	If we and/or our potential commercialization partners are unable to obtain FDA and/or other foreign regulatory authority approval for our therapeutic candidates, we and/or our potential commercialization partners, will be unable to commercialize our therapeutic candidates;

	●	Preclinical studies, CMC, and clinical trials may involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future results. We and/or our potential commercialization partners will not be able to commercialize our therapeutic candidates without developing CMC satisfactorily to regulatory authorities, completing preclinical and clinical studies, and then seeking to obtain regulatory approval, if such trials show that our therapeutic candidates are safe and effective;

	●	If we do not establish collaborations for our oncology therapeutic candidates or any other therapeutic candidates that we may develop or acquire in the future and/or commercialize such therapeutic candidates, or otherwise raise substantial additional capital, we will likely need to alter our development and any commercialization plans;

	●	Any collaborative arrangements that we establish may not be successful or we may otherwise not realize the anticipated benefits from these collaborations. We do not control third parties with whom we have or may have collaborative arrangements, and we rely on them to achieve results which may be significant to us. In addition, any future collaboration arrangements may place the development, manufacturing and commercialization of our oncology therapeutic candidates or any other therapeutic candidates that we may develop or acquire in the future, outside our control, and may require us to relinquish important rights or may otherwise be on terms unfavorable to us;

	●	Our current business model is based largely upon the development or acquisition and commercialization of new combination products and new therapeutic candidates that may have not yet been administered to humans or have limited history of treatment with humans. Unexpected difficulties or delays in successfully developing, acquiring or commercializing such combination and new drugs could have an adverse effect on our business, financial condition and results of operations;

	●	We rely mainly on third parties to conduct our CMC, research and development, preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including, but not limited to, failing to conform with quality standards for our therapeutic candidates, which may endanger our clinical trial participants and/or fail to meet established deadlines for the completion of such studies and trials;

	●	If third parties do not manufacture our current therapeutic candidates or any other therapeutic candidate that we may develop or acquire in the future in sufficient quantities in the required timeframe, at the required quality standards and at an acceptable cost, preclinical, clinical development and commercialization of our therapeutic candidates could be delayed;

	●	We rely on third-party contract vendors to manufacture and supply us with API that is compliant with the International Conference of Harmonization Q7 guidance and other applicable laws and regulations, in the quality and quantities we require on a timely basis;

	●	We anticipate continued reliance on third-party manufacturers if we are successful in obtaining marketing approval from the FDA and/or other regulatory agencies for NT219, CM24, our CAPTN-3 tribody platform’s leading therapeutic candidate IM1240 or any other therapeutic candidates we may develop or acquire in the future;

	●	We and our third-party manufacturers are, and will be, subject to regulations of the FDA and other foreign regulatory authorities;

	●	Our oncology therapeutic candidates and/or any other therapeutic candidate that we may develop or acquire in the future, if approved, will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and applicable foreign laws, regulations and guidelines, we could lose the FDA and/or other regulatory agencies’ approval(s) we will obtain (if any), and our business would be seriously harmed;

	●	The manufacture of our therapeutic candidates is complex, and we may encounter difficulties in production, particularly with respect to process development or scaling-up of our manufacturing capabilities. If we, or any of our third-party manufacturers, encounter such difficulties, our ability to supply drugs for clinical trials or our products (if approved) for patients on a timely basis could be materially delayed or adversely affected. In addition, this may cause an increase in costs that could result in our inability to maintain a commercially viable cost structure;

	●	Because each of CM24, NT219 and CAPTN-3, our tribody platform with its leading therapeutic candidate, IM1240, represents a novel approach to the treatment of disease, there are many uncertainties regarding the development, the market acceptance, third-party reimbursement coverage and the commercial potential of these therapeutic candidates;

	●	If we fail to comply with any obligations under our in-license agreements with Yissum Research and Development Company (“Yissum”) and/or Tel Hashomer – Medical Research Infrastructure and Services Ltd. (“THM”) or any future license agreement, or disputes arise with respect to those agreements, it could have a negative impact on our intellectual property rights and we could lose our rights to NT219 and/or CM24 or any further therapeutic candidates, which could have a material adverse effect on our business, financial condition and results of operations;

	●	Our shareholders may not realize a benefit from our acquisitions of therapeutic candidates commensurate with the ownership dilution they experienced in connection with the transactions;

	●	The markets for our oncology therapeutic candidates are rapidly changing and competitive, and new drug delivery mechanisms, drug delivery technologies, new drugs and new treatments which may be developed by others could impair our ability to maintain and grow our business and remain competitive.

	●	Our business and operations may be materially adversely affected in the event of computer system failures or security or breaches due to cyber-attacks or cyber intrusions, including ransomware, phishing attacks and other malicious intrusions;

	●	Third-party claims of intellectual property infringement and other legal challenges may require us to spend substantial time and money and could prevent us from, or delay us in, developing or commercializing our therapeutic candidates. An adverse result in any infringement claims or other legal challenges could have a material adverse effect on our business, results of operations and on our financial condition;

	●	We may be unable to adequately protect or enforce our rights to intellectual property, causing us to lose valuable rights. Loss of any of our intellectual property rights may lead us to lose market share and could have an adverse effect on our business, results of operations and financial condition;

	●	We conduct our operations in Israel, and therefore, political, economic and military instability in Israel and its region may adversely affect our business, results of operations, and financial condition; and

	●	We may not meet the continued listing requirements of NASDAQ, which could result in a delisting of the ADSs from NASDAQ;

	●	our ability to successfully out-license and/or commercialize our oncology therapeutic candidates, or any other therapeutic candidates that we may acquire, in-license, or develop in the future, including securing commercialization agreements with third parties and favorable pricing and market share;

	●	the progress, success, and cost of our preclinical and/or clinical trials and research and development programs;

	●	our ability to successfully complete the required CMC development for our oncology therapeutic candidates or any other therapeutic candidates that we may acquire, in-license, or develop in the future;

	●	the costs, timing and outcome of regulatory review and obtaining and maintaining regulatory approval of our oncology therapeutic candidates or any other therapeutic candidates that we may acquire, in-license, or develop in the future, and addressing regulatory and other issues that may arise post-approval for such oncology therapeutic candidates;

	●	the costs of obtaining new patents and enforcing our issued patents and defending intellectual property-related claims;

	●	the costs of developing and maintaining our third parties’ cGMP manufacturing standards;

	●	our consumption of available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated;

	●	our ability to obtain recommendations and publish studies regarding the efficacy and/or safety of our oncology therapeutic candidates or any other therapeutic candidates that we may acquire or develop in the future that may be published by government agencies, professional organizations, academic or medical journals or other key opinion leaders;

	●	sufficient coverage and reimbursement by third-party payers for our therapeutic candidates; and

	●	the costs of seeking out and acquiring or engaging in-licensing or similar transactions for other oncological candidates.

	●	delays in conducting preclinical studies;

	●	delays in manufacturing the drug substance and drug product for preclinical studies and clinical trials;

	●	delays in manufacturing the drug substance and drug product following NDA or BLA approval, if we receive such approval at all;

	●	delays in receiving import or other government approvals to ensure appropriate drug supply, and shortages of combination drugs used in our clinical studies;

	●	delays in obtaining institutional review board (human ethics committee) and other regulatory approvals to commence a clinical trial;

	●	negative or inconclusive results from preclinical and/or clinical trials;

	●	the FDA or other foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical studies and may not approve initiation of certain clinical trials;

	●	the clinical trials may be delayed or not completed due to the failure to recruit suitable candidates or if there is a lower rate of suitable candidates than anticipated or if there is a delay in recruiting suitable candidates;

	●	an inability to monitor patients adequately during or after treatment;

	●	problems with investigator or patient compliance with the trial protocols;

	●	a therapeutic candidate may not prove safe or efficacious;

	●	there may be unexpected or even serious adverse events and side effects from the use of a therapeutic candidate;

	●	the results with respect to any therapeutic candidate may not confirm the positive results from earlier preclinical studies or clinical trials;

	●	the results will leave only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of the therapeutic candidate;

	●	our therapeutic candidates may not be reimbursed under different healthcare programs such as Medicare, Medicaid or private health insurance programs;

	●	changes to the current regulatory requirements related to clinical trials which can delay, hinder or lead to unexpected costs in connection with our receiving the applicable regulatory approvals; and

	●	we may not be able to control the amount and timing of resources that our collaborators may devote to our drug product or therapeutic candidates;

	●	we may be held liable should a collaborator fail to comply with applicable laws, rules, or regulations when performing services for us;

	●	our collaborators may experience financial difficulties or changes in business focus;

	●	our collaborators may experience quality or regulatory issues that negatively affect our therapeutic candidates;

	●	our collaborators may fail to secure adequate commercial supplies in a timely manner for our drug products upon marketing approval, if at all;

	●	we may suffer losses due to our collaborators’ failure to perform their duties and we may not be able to be reimbursed by our collaborators for such losses;

	●	our collaborators may have a shortage of qualified personnel;

	●	we may be required to relinquish important rights, such as local trademark, marketing and distribution rights;

	●	business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;

	●	under certain circumstances, a collaborator could move forward with a competing therapeutic candidate developed either independently or in collaboration with others, including our competitors; and

	●	collaborative arrangements are often terminated or allowed to expire, which could delay and increase the cost of development of our therapeutic candidates, or our collaborators may not deliver assignments on schedule, which could delay the development of our therapeutic candidates.

	●	refusal to approve pending applications or supplements to approved applications that we or our potential commercialization partners submit;

	●	voluntary or mandatory recall;

	●	refusal to permit the import or export of our therapeutic candidates;

	●	product seizure or detentions;

	●	injunctions or the imposition of civil or criminal penalties and fines; or

	●	adverse publicity or changes to the drug’s labeling.

	●	delays in reaching a consensus with regulatory agencies on study design;

	●	delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites;

	●	the shortage of staff in clinical sites;

	●	imposition of a temporary or permanent clinical hold by regulatory agencies;

	●	delays in recruiting suitable patients to participate in clinical studies for CM24, NT219 or future therapeutic candidates;

	●	failure by us or our CROs, or third parties, to adhere to clinical study requirements;

	●	failure to perform in accordance with the FDA’s cGCPs, requirements, or applicable regulatory guidelines in other countries;

	●	patients dropping out of a study;

	●	occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

	●	changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

	●	changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;

	●	the cost of clinical studies of CM24 and NT219 and/or future therapeutic candidates being greater than we anticipate;

	●	management’s decision to allocate internal resources to other projects;

	●	clinical studies of CM24, NT219 and/or future therapeutic candidates producing negative or inconclusive results, which may result in us deciding, or regulators requiring, conduct of additional clinical studies or abandon product development programs; and

	●	delays in manufacturing, testing, release, validating, or import/export of sufficient stable quantities of CM24, NT219, and/or future therapeutic candidates or approved drugs for use in clinical studies or the inability to do any of the foregoing, including any quality issues associated with contract manufacturers.

	●	the size and nature of the patient population;

	●	the patient eligibility criteria defined in the protocol;

	●	the size of the study population required for analysis of the trial’s endpoints;

	●	the proximity of patients to trial sites;

	●	the design of the trial;

	●	our ability to recruit clinical trial investigators with the appropriate competencies and experience;

	●	competing clinical trials for similar therapies or other new therapeutics;

	●	clinicians’ and patients’ perceptions of the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating;

	●	our ability to obtain and maintain patient consents;

	●	the risk that patients enrolled in clinical trials will not complete a clinical trial, will withdraw from a clinical trial, or will withdraw from one arm of the study, which could cause an imbalance between study arms and result in informative censoring, causing the results of a study arm to be uninterpretable; and

	●	the effect of epidemics, endemics or pandemics on the ability of patients to visit the testing sites and the effect of the disease on potential patients who contracted the disease.

	●	collaboration partners have significant discretion in determining the efforts and resources that they will apply to these partnerships;

	●	collaboration partners may have limited supply of products, such as a PD-1 antibody, which we require for the development of our therapeutic candidates;

	●	collaboration partners may not perform their obligations as expected;

	●	collaboration partners may not pursue development of our therapeutic candidates or may elect not to continue or renew development programs, based on clinical trial results, changes in the collaboration partners’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;

	●	collaboration partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

	●	collaboration partners may have or could independently develop, or develop with third parties, products that compete directly or indirectly with our out-licensed therapeutic candidates;

	●	collaboration partners may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and

	●	collaboration agreements may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable therapeutic candidates.

	●	the scope of rights granted under the license agreement and other interpretation-related issues;

	●	the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

	●	the sublicensing of patent and other rights;

	●	our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

	●	the ownership of inventions and know-how resulting from the creation or use of intellectual property by us, alone or with our licensors and collaborators;