Niki BioSolutions, Inc 20-F for FY2021

Niki BioSolutions, Inc. (NIKI)

20-F 2022-04-29 For: 2021-12-31

Added on April 06, 2026

About this 20-F

Niki BioSolutions, Inc filed this 20-F on April 29, 2022, covering the fiscal year ended December 31, 2021 (FY2021).

Headline figures

Fiscal year ended December 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $27.11M; compared with net income of $4.92M a year earlier
Diluted EPS: -$0.71; compared with $0.20 a year earlier

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Title of Each Class		Trading Symbol		Name of Each Exchange on Which Registered
Class A Ordinary shares, par value $1.00		APM		NASDAQ Global Market

Large accelerated filer	☐	Accelerated filer	☐	Non-accelerated filer	☒
				Emerging growth company	☒

INTRODUCTION		ii

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
ITEM 4.	INFORMATION ON THE COMPANY	45
ITEM 4A.	UNRESOLVED STAFF COMMENTS	86
ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	86
ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	100
ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	114
ITEM 8.	FINANCIAL INFORMATION	116
ITEM 9.	THE OFFER AND LISTING	117
ITEM 10.	ADDITIONAL INFORMATION	117
ITEM 11.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	123
ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	123

PART II		124
ITEM 13.	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	124
ITEM 14.	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	124
ITEM 15.	CONTROLS AND PROCEDURES	124
ITEM 16	[RESERVED]
ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT	125
ITEM 16B.	CODE OF ETHICS	126
ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	126
ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	126
ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	126
ITEM 16F.	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	126
ITEM 16G.	CORPORATE GOVERNANCE	126
ITEM 16H.	MINE SAFETY DISCLOSURE	126
ITEM 16I.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	126

PART III		127
ITEM 17.	FINANCIAL STATEMENTS	127
ITEM 18.	FINANCIAL STATEMENTS	127
ITEM 19.	EXHIBITS	127

	●	“505(b)(2) Application” refers to an application for which one or more of the investigations relied upon by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C. 355(b)(2)).

	●	“A*STAR” refers to Agency for Science, Technology and Research

	●	“Acticule” refers to Acticule Life Sciences Limited, an 80% owned subsidiary of Aptorum Group.

	●	“Aeneas Group” refers to Aeneas Limited and its subsidiaries. Aeneas Limited is 76.8% owned by Jurchen Investment Corporation. Because Mr. Huen, our CEO, holds 100% equity interest in Jurchen Investment Corporation, we refer Aeneas Group as a fellow subsidiary of Aptorum Group.

	●	“AML” refers to Aptorum Medical Limited, a 91% owned subsidiary of Aptorum Group, as of the date of this report.

	●	“AML Clinic” refers to an outpatient medical clinic operated by AML under the name of Talem Medical.

	●	“Aptorum Group,” “Company,” “we,” “Group” and “us” refer to Aptorum Group Limited, a Cayman Islands exempted company with limited liability whose principal place of business is in Hong Kong.

	●	“Aptorum Non-Therapeutics Group” refers to the Company’s non-therapeutics segment that encompasses: diagnostics projects including the novel molecular-based rapid pathogen identification and detection diagnostics (“RPIDD”) technology, natural supplement products including NativusWell^®, and the AML Clinic.

	●	“Aptorum Therapeutics Group” refers to the Company’s therapeutics segment that is operated through its wholly-owned subsidiary, Aptorum Therapeutics Limited, a Cayman Islands exempted company with limited liability, whose principal place of business is in Hong Kong and its indirect subsidiary companies, whose principal places of business are in the United Kingdom, Singapore and Hong Kong.

	●	“At The Market Offering” or “ATM Offering” refers to the offering and sale of the Company’s Class A Ordinary Shares, offered pursuant to the prospectus supplement and the accompanying prospectus to the registration statement on Form F-3 (File No. 333-235819), in which H.C. Wainwright & Co., LLC (“Wainwright”), acted as the Company’s sales agent in accordance with certain at the market offering agreement (the “Sales Agreement”), dated as of March 26, 2021, by and between the Company and Wainwright.

	●	“Bond” refers to the $15,000,000 convertible bond the Company originally issued to Peace Range Limited in the Bond Offering, but which has since been repurchased by one of the Company’s wholly owned subsidiaries, Aptorum Investment Holding Limited, pursuant to that certain Bond Repurchase Agreement dated April 24, 2019 between the Company, Peace Range Limited and Aptorum Investment Holding Limited, and which has matured and been redeemed on October 25, 2019

	●	“Bond Offering” refers to the Company’s private offering of the Bond that closed on April 25, 2018.

	●	“cGCP” refers to Current Good Clinical Practice as adopted by the applicable regulatory authority.

	●	“cGLP” refers to Current Good Laboratory Practice as adopted by the applicable regulatory authority.

	●	“cGMP” refers to Current Good Manufacturing Practice as adopted by the applicable regulatory authority.

	●	“Class A Ordinary Shares” refers to the Company’s Class A Ordinary Shares, par value $1.00 per share.

	●	“Class B Ordinary Shares” refers to the Company’s Class B Ordinary Shares, par value $1.00 per share.

	●	“CMC” refers to chemical, manufacturing and control.

	●	“Covar” refers to Covar Pharmaceuticals Incorporated, a contract research organization engaged by the Company.

	●	“CROs” refers to contract research organizations.

	●	“CTA” refers to Clinical Trial Application.

	●	“EEA” refers to the European Economic Area.

	●	“EMA” refers to the European Medicines Agency.

	●	“EMEA” refers to Europe, the Middle East and Africa.

	●	“EPO” refers to the European Patent Organization or the European Patent Office operated by it.

	●	“European Patent” refers to patents issuable by the EPO.

	●	“EU” refers to the European Union.

	●	“Exchange Act” refers to the U.S. Securities Exchange Act of 1934, as amended.

	●	“FDA” refers to U.S. Food and Drug Administration.

	●	“FDCA” refers to the U.S. Federal Food, Drug and Cosmetic Act.

	●	“Fiscal year” refers to the period from January 31 of each calendar year to December 31 of the following calendar year.

	●	“HKD” refers to Hong Kong Dollars.

	●	“Hong Kong” or “H.K.” refers to Hong Kong Special Administrative Region of the People’s Republic of China.

	●	“Hong Kong Doctors” refers to the doctors in Hong Kong under the employment of AML Clinic.

	●	“IND” refers to Investigational New Drugs.

	●	“IP” refers to intellectual property.

	●	“IPO” or “Offering” means the initial public offering by the Company of 761,419 Class A Ordinary Shares consummated on December 17, 2018.

	●	“Jurchen” refers to Jurchen Investment Corporation, a company wholly-owned by our CEO, Ian Huen, and a holding company of Aptorum Group.

	●	“Lead Projects” refers to ALS-4, SACT-1 and RPIDD.

	●	“Nativus” refers to Nativus Life Sciences Limited, a wholly-owned subsidiary of Aptorum Group.

	●	“NMPA” refers to China’s National Medical Products Administration and its predecessor, the China Food and Drug Administration.

	●	“NDA” refers to a New Drug Application issued by the FDA.

	●	“Ordinary Shares” refers to the Class A Ordinary Shares and Class B Ordinary Shares collectively.

	●	“PRC” and “China” refer to the People’s Republic of China.

	●	“Registered Direct Offering” means the registered direct offering by the Company of 1,351,350 Class A Ordinary Shares and warrants to purchase up to 1,351,350 Class A Ordinary Share consummated on February 28, 2020.

	●	“Restructure” refers to the Company’s change from an investment fund with management shares and non-voting participating redeemable preference shares to a holding company with operating subsidiaries, effective as of March 1, 2017.

	●	“Registration Statement” refers to the Company’s Registration Statement on Form F-1 (File No. 333-227198) for the sale of up to 3,493,969 Class A Ordinary Shares (including Class A Ordinary Shares underlying certain warrants and a bond, as fully described therein) which initially filed on September 5, 2018 and became effective on December 3, 2018.

	●	“R&D” refers to research and development.

	●	“R&D Center” refers to an in-house pharmaceutical development center located in Hong Kong Science and Technology Park.

	●	“Securities Exchange Commission,” “SEC,” “Commission” or similar terms refer to the Securities Exchange Commission.

	●	“Sarbanes-Oxley Act” refers to the Sarbanes-Oxley Act of 2002.

	●	“Scipio” refers to Scipio Life Sciences Limited, a variable interest entity which we hold 97.93% economic interest and 35.06% voting power.

	●	“Securities Act” refers to the Securities Act of 1933.

	●	“Series A Notes” refers to Series A convertible notes, at a purchase price of $10,000 per note, sold in the Series A Note Offering.

	●	“Series A Note Investors” refers to the investors who purchased Series A Notes.

	●	“Series A Note Offering” refers to the private offering of Series A Notes, pursuant to Regulation S or Regulation D, as promulgated under the Securities Act that closed on May 15, 2018.

	●	“UK” refers to the United Kingdom.

	●	“United States,” “U.S.” and “US” refer to the United States of America.

	●	“Videns” refers to Videns Incorporation Limited, a wholly-owned subsidiary of Aptorum Group.

	●	“US$,” “U.S. dollars,” or “dollars” are to the legal currency of the United States.

	●	developing a sustainable and scalable manufacturing process for our drug candidates and any approved products, including establishing and maintaining commercially viable supply relationships with third parties;

	●	launching and commercializing drug candidates following regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor;

	●	obtaining market acceptance of our drug candidates as viable treatment options;

	●	addressing any competing technological and market developments;

	●	negotiating and maintaining favorable terms in any collaboration, licensing or other arrangement into which we may enter to commercialize drug candidates for which we have obtained required approvals and marketing authorizations; and

	●	maintaining, protecting and expanding our portfolio of IP rights, including patents, trade secrets and know-how.

	●	the size and nature of the patient population;

	●	patient eligibility criteria defined in the clinical protocol;

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

	●	the proximity of patients to trial sites;

	●	the design of the trial and changes to 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 exist and will reduce the number and types of patients available to us;

	●	clinicians’ and patients’ perceptions as to the potential advantages and side effects of the drug 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;

	●	patients enrolled in clinical trials may not complete a clinical trial; and

	●	the availability of approved therapies that are similar to our drug candidates.

	●	regulators, institutional review boards (“IRBs”) or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

	●	clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs;

	●	the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out at a higher rate than we anticipate;

	●	our contractors and investigators may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

	●	we might have to suspend or terminate clinical trials of our drug candidates for various reasons, including a lack of clinical response or a determination that participants are being exposed to unacceptable health risks;

	●	regulators, IRBs or ethics committees may require that we or our investigators suspend or terminate clinical research for various reasons, including non-compliance with regulatory requirements;

	●	the cost of clinical trials of our drug candidates may be greater than we anticipate;

	●	the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; and

	●	our drug candidates may cause adverse events, have undesirable side effects or other unexpected characteristics, causing us, our investigators, or regulators to suspend or terminate the trials.

	●	be delayed in obtaining regulatory approval for our drug candidates;

	●	not obtain regulatory approval at all;

	●	obtain approval for indications that are not as broad as intended;

	●	have a drug removed from the market after obtaining regulatory approval;

	●	be subject to additional post-marketing testing requirements;

	●	be subject to restrictions on how a drug is distributed or used; or

	●	be unable to obtain reimbursement for use of a drug.

	●	disagreement with regulators regarding the design or implementation of our clinical trials;

	●	failure to demonstrate that a drug candidate is safe and effective or safe, pure and potent for its proposed indication;

	●	failure of clinical trial results to meet the level of statistical significance required for approval;

	●	failure to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks;

	●	disagreement with regulators regarding our interpretation of data from studies in animals or clinical trials;

	●	insufficiency of data collected from clinical trials of our drug candidates to support the submission and filing of a New Drug Application (“NDA”), or other submission or to obtain marketing approval;

	●	the FDA, NMPA, EMA, Health Canada or a comparable regulatory authority’s finding of deficiencies related to the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies; and

	●	changes in approval policies or regulations that render our preclinical studies and clinical data insufficient for approval.

	●	our inability to obtain sufficient funds required to conduct or continue a trial, including lack of funding due to unforeseen costs or other business decisions;

	●	regulatory reports for additional analysts, reports, data, preclinical studies and clinical trials;

	●	failure to reach agreement with, or inability to comply with conditions imposed by the FDA, NMPA, EMA, Health Canada or other regulators regarding the scope or design of our clinical trials;

	●	regulatory questions regarding interpretations of data and results and the emergence of new information regarding our drug candidates or other products;

	●	delay or failure in obtaining authorization to commence a clinical trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;

	●	withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials;

	●	unfavorable or inconclusive results of clinical trials and supportive non-clinical studies, including unfavorable results regarding effectiveness of drug candidates during clinical trials;

	●	difficulty in maintaining contact with patients during or after treatment, resulting in incomplete data;

	●	our inability to obtain approval from IRBs or ethics committees to conduct clinical trials at their respective sites;

	●	our inability to enroll and retain a sufficient number of patients who meet the inclusion and exclusion criteria in a clinical trial;

	●	clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, withdrawing from or dropping out of a trial, or becoming ineligible to participate in a trial;

	●	failure of our clinical trial managers to satisfy their contractual duties or meet expected deadlines;

	●	manufacturing issues, including problems with manufacturing or timely obtaining from third parties sufficient quantities of a drug candidate for use in a clinical trial;

	●	ambiguous or negative interim results, or results that are inconsistent with earlier results;

	●	feedback from the FDA, NMPA, EMA, Health Canada, an IRB, data safety monitoring boards, or comparable entities, or results from earlier stage or concurrent studies in animals and clinical trials, regarding our drug candidates, including which might require modification of a trial protocol;

	●	unacceptable risk-benefit profile or unforeseen safety issues or adverse side effects; and

	●	a decision by the FDA, NMPA, EMA, Health Canada, an IRB, comparable entities, or the Company, or recommendation by a data safety monitoring board or comparable regulatory entity, to suspend or terminate clinical trials at any time for safety issues or for any other reason.

	●	suspending the marketing of the drug;

	●	having regulatory authorities withdraw approvals of the drug;

	●	adding warnings on the label;

	●	developing a REMS for the drug or, if a REMS is already in place, incorporating additional requirements under the REMS, or to develop a similar strategy as required by a comparable regulatory authority;

	●	conducting post-market studies;

	●	being sued and held liable for harm caused to subjects or patients; and

	●	damage to our reputation.

	●	fines, untitled or warning letters, or holds on clinical trials;

	●	refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;

	●	product seizure or detention, or refusal to permit the import or export of our drug candidates; and

	●	injunctions or the imposition of civil or criminal penalties.

	●	physicians, hospitals, and patients considering our drug candidates as a safe and effective treatment;

	●	the potential and perceived advantages of our drug candidates over alternative treatments;

	●	the prevalence and severity of any side effects;

	●	product labeling or product insert requirements of the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities;

	●	limitations or warnings contained in the labeling approved by the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities;

	●	the timing of market introduction of our drug candidates as well as competitive drugs;

	●	the cost of treatment in relation to alternative treatments and their relative benefits;

	●	the availability of adequate coverage, reimbursement and pricing by third-party payors and government authorities;

	●	lack of experience and financial and other limitations on our ability to create and sustain effective sales and marketing efforts or ineffectiveness of our sales and marketing partners; and

	●	changes in legislative and regulatory requirements that could prevent or delay regulatory approval of our drug candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any drug candidates for which we obtain regulatory approval.

	●	successful enrollment in, and completion of, studies in animals and clinical trials;

	●	other parties’ ability in conducting our clinical trials safely, efficiently and according to the agreed protocol;

	●	receipt of regulatory approvals from the FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities for our drug candidates;

	●	our ability to establish commercial manufacturing capabilities by making arrangements with third-party manufacturers;

	●	reliance on other parties to conduct our clinical trials swiftly and effectively;

	●	launch of commercial sales of our drug candidates, if and when approved;

	●	obtaining and maintaining patents, trade secrets and other IP protection and regulatory exclusivity, as well as protecting our rights in our own IP;

	●	ensuring that we do not infringe, misappropriate or otherwise violate patents, trade secrets or other IP rights of other parties;

	●	obtaining acceptance of our drug candidates by doctors and patients;

	●	obtaining reimbursement from third-party payors for our drug candidates, if and when approved;

	●	our ability to compete with other drug candidates and drugs; and

	●	maintenance of an acceptable safety profile for our drug candidates following regulatory approval, if and when received.

	●	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 under our collaborative development relationships;

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

	●	the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and

	●	the priority of invention of patented technology.

	●	we might be unable to identify manufacturers on acceptable terms or at all because the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities must approve any manufacturers we determine to use and any potential manufacturer may be unable to satisfy federal, state or international regulatory standards;

	●	although we would be choosing manufacturers with the type of experience most suitable for our drug candidates, it is possible that our contract manufacturers may not be able to execute unique manufacturing procedures and other logistical support requirements we have developed and they might require a significant amount of support from us to implement and maintain the infrastructure and processes required to manufacture our particular drug candidates;

	●	our contract manufacturers might be unable to reproduce the quantity and quality of the drugs we need to meet our clinical and commercial needs within the time frames when we require those drugs;

	●	our contract manufacturers may breach their contracts with us, including by not performing as agreed or not devoting sufficient resources to our drug candidates, or they may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products;

	●	even if initially accepted by regulatory authorities, a manufacturer remains subject to ongoing periodic unannounced inspection by regulatory authorities to ensure strict compliance with cGMP and other government regulations, and our contract manufacturers may fail to comply with these regulations and requirements, resulting in rescission of cGMP licenses and our inability to continue using their services, requiring us to find a replacement manufacturer;

	●	depending on the terms of our agreement with a manufacturer, we may not own, or may have to share, the IP rights to any improvements made by the manufacturer in the manufacturing process for our drug candidates; and

	●	our contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.

	●	identifying, recruiting, integrating, maintaining and motivating additional employees;

	●	managing our internal development efforts effectively, including clinical, the FDA or other comparable regulatory authority review process for our drug and diagnostics technology candidates, while complying with our contractual obligations to contractors and others; and

	●	improving our operational, financial and management controls, reporting systems and procedures.