As filed with the Securities and Exchange Commission on June 7, 2023

Registration No. 333-213618333-271416

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

PRE-EFFECTIVE AMENDMENT NO. 53 TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

AMERICAN BRIVISION (HOLDING) CORPORATIONABVC BIOPHARMA, INC.

(Exact name of Registrantregistrant as specified in its charter)

11 Sawyers Peak Drive, Goshen, NY, 10924.44370 Old Warm Springs Blvd.,

(845) 291-1291Fremont, CA 94538

(510) 668-0881

(Address, including zip code, and telephone number,

including area code, of Registrant’sregistrant’s principal executive offices)

Dr. Howard Doong

Chief Executive Officer

44370 Old Warm Springs Blvd.,

Fremont, CA 94538

(510) 668-0881- telephone

(Name, address, including zip code, and telephone number, including area code, of agent for service)

CopiesWith copies to:

Louis E. Taubman, Esq.

Joan Wu, Esq.

Hunter Taubman Fischer & Li LLC

1450 Broadway,950 Third Avenue, 19th Floor 26

New York, NY 10018New York ‌10022

(917) 512-0827- telephone

Louis Taubman, Esq.

Approximate date of commencement of proposed sale of the securities to the public:From time to timeAs soon as practicable after this Registration Statement becomesregistration statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”,filer,” “accelerated filer”filer,” “smaller reporting company” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act.  (Check one):

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

CALCULATION OF REGISTRATION FEE

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrantRegistrant shall file a further amendment whichthat specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in

EXPLANATORY NOTE

ABVC BioPharma, Inc. is filing this prospectus is not complete and may be changed.  We may not sell these securities until the registration statement filed with the Securities and Exchange Commission (“SEC”Amendment No. 3 (this “Amendment No. 3”) is effective.  This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

American BriVision (Holding) Corporation

55,453,224 Shares of Common Stock

This prospectus relates to the resale of up to 55,453,224 shares of common stock of American BriVision (Holding) Corporation, a Nevada corporation (the “Company”)Registration Statement on Form F-1 (Registration No. 333-271416), $0.001 par value (the “Common Stock”). The selling stockholders named herein may sell common stock from time to time in the principal marketoriginally filed on which the stock is traded at the prevailing market price, at prices related to such prevailing market price, in negotiated transactions or a combination of such methods of sale. We will not receive any proceeds from the sales by the selling stockholders.

Our common stock is quoted on the OTC Markets under the symbol ABVC. On September 19, 2017, the closing price of our common stock was $2.00 per share. Prior to January 14, 2016, our common stock was quoted under the symbol MTOO. Prior to December 15, 2015, our common stock was quoted under the symbol ECOC.

The selling stockholders,April 24, 2023 and any broker-dealer executing sell orders on behalf of the selling stockholders, may be deemed to be “underwriters” within the meaning of the Securities Act of 1933, as amended.  Commissions received by any broker-dealer may be deemed underwriting commissions under the Securities Act of 1933, as amended.

THIS INVESTMENT INVOLVES A HIGH DEGREE OF RISK.  YOU SHOULD PURCHASE SHARES ONLY IF YOU CAN AFFORD A COMPLETE LOSS OF YOUR INVESTMENT. 

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES, OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

The date of this prospectus is                     .

TABLE OF CONTENTS

PART 1

RISK FACTORS

You should carefully consider the risks described below as well as other information provided to you in this document, including information in the section of this document entitled “Forward Looking Statements”. If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our common stock could decline, and you may lose all or part of your investment.

Risks Relating to Our Business

We are a pre-revenue biopharmaceutical company and are thus subject to the risks associated with new businesses in that industry.

We acquired the sole licensing rights to develop and commercialize for drug and therapeutic use of the products and have only recently begun to pursue this new business opportunity. As such, we are a clinical stage biopharmaceutical company with no history of revenue-generating operations, and our only assets consist of the intellectual property and related assets licensed to us by BioLite. Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in the development of pharmaceuticals. We still must establish and implement many important functions necessary to operate a business, including the clinical development of theproducts, establishing our managerial and administrative structure and implementing financial systems and controls.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their pre-revenue generating stages, particularly those in the pharmaceutical field. Potential investors should carefully consider the risks and uncertainties that a new company with no operating history will face. In particular, potential investors should consider that there is a significant risk that we will not be able to:

If we cannot execute any one of the foregoing, our business may fail, in which case you may lose the entire amount of your investment in our Company. To date, we are still setting up our pipeline products. We cannot assure that any of our efforts will be successful or result in the development or timely launch of additional products, or ultimately produce any material revenue.

In addition, as a pre-revenue biopharmaceutical company, we expect to encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be able to reach such point of transition or make such a transition, which would have a material adverse effect on our company.

If we fail to raise additional capital, our ability to implement our business model and strategy could be compromised.

We have limited capital resources and operations. To date, our operations have been funded partial from the proceeds from financings or loans from shareholders or our management.

If we do not raise a sufficient amount to fund our ongoing development activities, we will likely be unable to carry out our business. We may not be able to obtain additional financing on terms acceptable to us, or at all. Even if we obtain financing for our near term operations and product development, we may require additional capital beyond the near term. If we are unable to raise capital when needed, our business, financial condition and results of operations would be materially adversely affected, and we could be forced to reduce or discontinue our operations.

We are highly dependent on our license agreement with BioLite and BioFirst who is highly dependent on its license agreements with independent third parties, and the loss of this license would materially impair our business plan and viability.

We have secured sole rights to develop and commercialize the products from BioLite, and those products are currently our only product candidates. As such, our Collaborative Agreement, as amended, and the Addendum with BioLite are critical to our business. Except for BLI-1501, or known as ABV-1503, which is the extract of green tea so that it does not require any kind of licensing to use and to commercialize, the rights to develop and to commercialize the other six products solely licensed to BioLite and BioFirst were from independent third parties. Therefore, independent third parties have licensed the rights to BioLite and BioFirst. Neither Biolite nor BioFirst does own the rights without a valid license. Further, any change to the licensing agreement(s) between the independent third parties and BioLite or BioFirst will have an impact on our business. In the event that either our Collaborative Agreement with BioLite and/ or BioFirst was terminated or any independent third party stopped licensing the rights to BioLite and/or BioFirst, we would lose the ability to develop and commercialize the products, and our business prospects would be materially damaged, which could lead to the loss of your investment.

We have no experience as a company in obtaining regulatory approval for, or commercializing, any product candidate.

As a company, we have never obtained regulatory approval for, or commercialized, any product candidate. It is possible that the Food and Drug Administration (“FDA”) may refuse to accept our planned New Drug Application (or “NDA”) for any of the Products for substantive review, or may conclude after review of our data that our application is insufficient to obtain regulatory approval of the Products or any future product candidates. If the FDA does not accept or approve our planned NDA for our product candidates, it may require that we conduct additional clinical, preclinical or manufacturing validation studies, which may be costly, and submit that data before it will reconsider our applications. Depending on the extent of these or any other FDA required studies, approval of any NDA or application that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Any delay in obtaining, or an inability to obtain, regulatory approvals would prevent us from commercializing the Products, generating revenues and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA we submit. If any of these outcomes occur, we may be forced to abandon our planned NDA for the Products, which would materially adversely affect our business and could potentially cause us to cease operations. We face similar risks for any approval in a foreign jurisdiction.

Dependence on Key Existing and Future Personnel.

Our success will depend, to a large degree, upon the efforts and abilities of our officers and key employees. The loss of the services of one or more of our key employees could have a material adverse effect on our operations. In addition, as our business model is implemented, we will need to recruit and retain additional management and key employees in virtually all phases of our operations. Key employees will require a strong background in our industry. We cannot assure that we will be able to successfully attract and retain key personnel.

Our growth is dependent on our ability to successfully develop, acquire or license new drugs.

Our growth is supported by continuous investment in time, resources and capital to identify and develop new products or new formulations for the market via geographic expansion and market penetration. If we are unable to either develop new products on our own or acquire licenses for new products from third parties, our ability to grow revenues and market share will be adversely affected. In addition, we may not be able to recover our investment in the development of new drugs and medical devices, given that projects may be interrupted, unsuccessful, not as profitable as initially contemplated or we may not be able to obtain necessary financing for such development. Similarly, there is no assurance that we can successfully secure such rights from third parties on an economically feasible basis.

We may not be able to develop our existing licensed compounds and our business plan is entirely dependent on entering into co-development agreements with capable pharmaceutical companies for the development or commercialization of our product candidates.

There is no guarantee that any of our desired results will be realized by any of our licensed product candidates. We do not have the resources to independently develop the licensed compounds and we intend to enter into co-development agreements with capable pharmaceutical companies for the development or commercialization of our product candidates. We do not currently have any co-development agreements with such pharmaceutical companies and there is no guarantee that we will enter into such agreements on terms acceptable to us. Our business and plans to develop and commercialize our existing product candidates are entirely dependent on our ability to enter into such agreements, and such inability would adversely affect our business materially and could potentially cause us to cease operations.

We may not be able to secure financing needed for future operating needs on acceptable terms, or on any terms at all.

From time to time, we may seek additional financing to provide the capital required to expand our production facilities, Research and development (“R&D”) initiatives and/or working capital, as well as to repay outstanding loans if cash flow from operations is insufficient to do so. We cannot predict with certainty the timing or amount of any such capital requirements. If such financing is not available on satisfactory terms, we may be unable to expand our business or to develop new business at the rate desired. If we are able to incur debt, we may be subject to certain restrictions imposed by the terms of the debt and the repayment of such debt may limit our cash flow and growth. If we are unable to incur debt, we may be forced to issue additional equity, which could have a dilutive effect on our current stockholders.

Expansion of our business may put pressure on our management and the operational infrastructure, which could impede our ability to meet an increased demand for our products.

Our business plan is to develop new drugs and to finish Phase II clinical trials for our drugs. If Phase II clinical trials achieve good results, namely, successful POC, we will then license the new drugs to pharmaceuticals for further development. The advantages of this business plan are:

Growth in our business may place a significant strain on our personnel, management, financial systems and other resources. The evolution of our business also presents numerous risks and challenges that include continued acceptance of our products, sales and market share expansion, costs for expansion, technological evolvement and industrial dynamics.

If we are successful in obtaining rapid market growth of our products, we will be required to deliver large volumes of quality products and services on a timely basis at a reasonable cost to the customers. Meeting any such increased demands will require us to expand our manufacturing facilities, to increase our ability to purchase raw materials, to expand our work force, to expand our quality control capabilities and to increase the scale upon which we provide our products and services.  Such demands would require more capital and working capital than we currently have available and we may be unable to meet the needs of our customers, which could adversely affect our relationship with our customers and reduce our revenues.

Our growth strategy includes the pursuit of acquisitions, and new product development, which could have a materially adverse effect on our business, financial condition, results of operations and growth prospects.

Our business strategy includes growth through strategic acquisitions, and the development of new products, medical devices and technologies, which will involve significant capital expenditure and risks. Innovative pharmaceutical development involves R&D costs, but it may achieve no tangible results and instead may adversely affect our future profitability. In addition, any acquisition or combination that we consummate will likely involve, among other things, the payment of cash, the incurrence of contingent liabilities and the amortization of expenses related to goodwill and other intangible assets, and transaction costs, which may adversely affect our business, financial condition, results of operations and growth prospects. Our ability to integrate and organize any new businesses and/or products, whether internally developed or obtained by acquisition or combination, will likely require significant expansion of our operations. There is no assurance that we will be able to obtain the necessary resources for such expansion, and the failure to do so could have a materially adverse effect on our business, financial condition, results of operations and growth prospects.  In addition, future acquisitions or combinations by us involve risks of, among other things, entering markets or segments in which we have no or limited prior experience, the potential loss of key employees or difficulty, delay or failure in the integration of the operations of any such new business with our current business and operating and financial difficulties of any new or newly combined operations, any of which could have a materially adverse effect on our business, financial condition, results of operations and growth prospects.  Moreover, there can be no assurance that the anticipated benefits of any internally developed new business segment or business combination will be realized.

Our current products have certain side effects.  If the side effects associated with our current or future products are not identified prior to their marketing and sale, we may be required to withdraw such products from the market, perform lengthy additional clinical trials or change the labeling of our products, any of which could adversely impact our growth.

ABV-1501 and ABV-1502

ABV-1501 and ABV-1502 have the same Active Pharmaceutical Ingredient (“API”): “Maitake mushroom extract”. Side effects, or adverse events, associated with ABV-1501 and ABV-1502, “Maitake mushroom extract”, include blood bilirubin increase, lymphocyte count decrease, neutrophil count decrease, platelet count decrease, white blood cell decrease, headache, and hyperglycemia. Serious adverse events (collectively, the “SAE”) associated with this compound may lead to leukocytosis, platelet count decrease, eye disorders, abdominal pain, gastrointestinal disorders, aphonia, lung infection, muscle weakness right-sided, confusion, edema cerebral, stroke, dyspnea, wheezing, and pruritus.

“Blood Bilirubin” means a brownish yellow substance found in bile. It is produced when the liver breaks down old red blood cells. Bilirubin is then removed from the body through the stool (feces) and gives stool its normal color. (according to Web MD).

“Lymphocyte” means a type of white blood cell that is part of the immune system. (according to PubMed Health).

“Neutrophil” means a type of immune cell that is one of the first cell types to travel to the site of an infection. (according to PubMed Health).

“Platelet count” means a lab test to measure how many platelets you have in your blood (according to MedlinePlus).

“Hyperglycemia” means the technical term for high blood glucose (blood sugar) (according to American Diabetes Association).

“Leukocytosis” means an increase in the total number of WBCs due to any cause (according to Medscape).

“Gastrointestinal Disorder” means esophagus, stomach, small intestine, and large intestine diseases (according to MedLine Plus).

“Aphonia” means the inability to produce voiced sound (according to TheFreeDictionary.com-Medical Dictionary Section).

“Edema cerebral” means swelling of the brain caused by the accumulation of fluid in the brain substance (according to TheFreeDictionary.com-Medical Dictionary Section).

“Wheezing” means a high-pitched whistling sound made while breathing and it is resulted from a narrowing of the airways and typically indicates some difficulty breathing (according to Wikipedia).

“Pruritus” means itching (according to WebMD) and is defined as an unpleasant sensation that provokes the desire to scratch (according to Medscape).

According to the MSKCC’s Phase II clinical trial on Myelodysplastic Syndrome (the “MDS Trial”), 3 patients out of 21 participants who completed the MDS Trial experienced adverse effect (the “Three Patients”), and 1 patient out of the Three Patients experienced SAE (the “SAE Patient”).

“Hematopoiesis” is the formation of blood cellular components. All cellular blood components are derived from haematopoietic stem cells. In a healthy adult person, approximately 2 million new blood cells are produced daily in order to maintain steady state levels in the peripheral circulation (according to Wikipedia). “Peripheral” means situated away from the center, as opposed to centrally located (according to Medicinenet.com). “Myelodysplastic” describes patients who have Myelodysplastic syndromes, which are a group of disorders caused by poorly formed or dysfunctional blood cells. Myelodysplastic syndromes occur when something goes wrong in your bone marrow — the spongy material inside your bones where blood cells are made. Treatment for myelodysplastic syndromes usually focuses on reducing or preventing complications of the disease and its treatments. In certain cases, myelodysplastic syndromes are treated with a bone marrow transplant (according to Mayo Clinic).

The Three Patients withdrew the MDS Trial prior to completion due to the following grade I possibly related side effects: one reported nausea and joint swelling; the other withdrew reportedly due to a grade I allergic reaction (rash and pruritus). “Grade I side effects” are transient (those going away after a short time) or mild discomfort, they don’t cause limitation in activity, and there’s no medical intervention and/or therapy required.

The following SAE were observed in 1 out of 21 participants, or at a rate of 4.76%: leukocytosis, platelet count decrease, eye disorders, abdominal pain, gastrointestinal disorders, aphonia, lung infection, muscle weakness right-sided, confusion, edema cerebral, stroke, dyspnea, wheezing, and pruritus. No other SAE were reported, as they were determined not relevant to this product after careful review by the principal investigator.  Adverse events other than SAE: blood bilirubin increase, lymphocyte count decrease, neutrophil count decrease, platelet count decrease, white blood cell decrease, headache, pain in extremity, metabolism and nutrition disorders, and hyperglycemia.

ABV-1503

Side effect, or adverse events, associate with ABV-1503, “Epigallocatechin Gallate” (“EGCG”), the green tea extract, may lead to liver damage in the high dosage or concentration of EGCG extract, and may lead to insomnia and anxiety. It may also inhibit iron absorption. There is no SAE associated with EGCG.

ABV-1504 and ABV-1505

ABV-1504 and ABV-1505 have the same API, “Radix Polygalae”, which is known as Polygala tenuifolia Willd or PDC-1421 Capsule (“Polygala tenuifolia Willd”). Side effects, or adverse events, associated with ABV-1504 and ABV-1505, coming from administration of the trial medicine or examination procedure such as the procedure of taking blood (fainting, pain and/or bruising), may lead to gastrointestinal disorders (abdominal fullness and constipation), nervous system disorders (drowsiness, sleepiness, and oral ulcer). In addition, long-term use may cause miscarriages.

According to the Phase I Trial of Polygala tenuifolia Willd conducted by BioLite, there is no serious adverse effect, but there are adverse events. Nonetheless, such adverse events occurred in the medication Trial or clinical trial do not necessarily result from the use of Polygala tenuifolia Willd. Following is a table representing the result of such trial.

Following is a table showing the trial outcomes:

Serious Adverse Events

Other Adverse Events

If significant side effects of our medicines are identified after they are marketed and sold:

The occurrence of any of those events would harm our sales of these medicines and substantially increase the costs and expenses of marketing these medicines, which in turn could cause our revenues and net income to decline. In addition, the reputation and sales of our medicines could be adversely affected due to the severe side effects discovered.

Maitake Combination Therapy

Maitake Combination Therapy is for indications including but not limited to the following: breast cancer, brain tumor, hepatocellular carcinoma, pancreatic cancer, renal cell carcinoma, nasopharyngeal carcinoma, prostate cancer, cervix cancer, oral/ pharynx/larynx cancer, lung cancer, leukemia, myeloma, lymphoma, gastric cancer, thyroid cancer, esophageal cancer, small intestine cancer, large intestine/colon/rectal cancer, ovary, skin cancer, head and neck, soft tissue sarcoma, bone tumor, bladder cancer, and cholangiocarcinoma.”

Hepatocellular carcinoma, Renal cell carcinoma means a kidney cancer (according to Wikipedia).

Nasopharyngeal carcinoma means a type of cancer that occurs in the nasopharynx, which is located behind our nose and above the back of throat (according to Mayo Clinic).

Myeloma means a blood cancer related to lymphoma and leukemia where a type of white blood cell called plasma cell multiplies unusually. They release too much protein into the bones and blood, building up in the body and causing organ damage (according to Web MD).

Lymphoma means a cancer that begins in infection-fighting cells of the immune system, called lymphocytes. These cells are in the lymph nodes, spleen, thymus, bone marrow, and other parts of the body. When you have lymphoma, lymphocytes change and grow out of control (according to Web MD).

Soft tissue sarcoma means a type of cancer that begins in the soft tissues of the human body that connect, support and surround other body structures (according to Mayo Clinic).

Cholangiocarcinoma means a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile. Also known as “bile duct cancer.” (according to Mayo Clinic).

Since this product shares the same API of ABV-1501 AND abv-1502, its side effects, or adverse events, and SAE are substantially disclosed in detail above under ABV-1501 and ABV-1502.

We may be subject to product liability claims in the future, which could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

We face an inherent business risk of exposure to product liability claims in the event that the uses of our products are alleged to have caused adverse side effects. Side effects or marketing or manufacturing problems pertaining to any of our products could result in product liability claims or adverse publicity. These risks will exist for those products in clinical development and with respect to those products that receive regulatory approval for commercial sale.  Furthermore, although we have not historically experienced any problems associated with claims by users of our products, we do not currently maintain product liability insurance and there could be no assurance that we are able to acquire product liability insurance with terms that are commercially feasible.

We face an inherent risk of product liability claims as a result of the clinical testing of our products and potentially commercially selling any products that we may develop. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidate. Regardless of the merits or eventual outcome, liability claims may result in:

We currently do not maintain general liability insurance; and even if we have a general liability insurance in the future, this insurance may not fully cover potential liabilities that we may incur. The cost of any product liability litigation or other proceeding, even if resolved in our favor, could be substantial. We would need to increase our insurance coverage if and when we begin selling any product candidate that receives marketing approval. In addition, insurance coverage is becoming increasingly expensive. If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate, which could adversely affect our business, financial condition, results of operations and prospects.

If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.

We are engaged in a rapidly changing field. Other products that will compete directly with the products that we are seeking to develop and market currently exist or are being developed. Competition from fully integrated pharmaceutical companies and more established biotechnology companies is intense and is expected to increase. Most of these companies have significantly greater financial resources and expertise in discovery and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing than us. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established biopharmaceutical or biotechnology companies. Many of these competitors have significant products that have been approved or are in development and operate large, well-funded discovery and development programs. Academic institutions, governmental agencies and other public and private research organizations also conduct research, seek patent protection and establish collaborative arrangements for therapeutic products and clinical development and marketing. These companies and institutions compete with us in recruiting and retaining highly qualified scientific and management personnel. In addition to the above factors, we will face competition based on product efficacy and safety, the timing and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage, price and patent position. There is no assurance that our competitors will not develop more effective or more affordable products, or achieve earlier patent protection or product commercialization, than our own.

Other companies may succeed in developing POC earlier than ourselves, obtaining FDA approvals for such products more rapidly than we will, or in developing products that are more effective than products we propose to develop. While we will seek to expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop, or that any therapy we develop will be preferred to any existing or newly developed technologies.

We have conducted, and may in the future conduct, clinical trials for certain of our product candidate at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.

We have conducted and may in the future choose to conduct one or more of our clinical trials outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. Generally, the patient population for any clinical trials conducted outside of the United States must be representative of the population for whom we intend to seek approval in the United States. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the United States. If the FDA does not accept the data from any of our clinical trials that we determine to conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and delay or permanently halt our development of the product candidate.

In addition, the conduct of clinical trials outside the United States could have a significant impact on us. Risks inherent in conducting international clinical trials include:

If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our product candidate.

We are not permitted to commercialize market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Comparable non-U.S. regulatory authorities impose similar restrictions. We may never receive such approvals. We must complete extensive preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidate in humans before we will be able to obtain these approvals.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. Any inability to successfully complete preclinical and clinical development could result in additional costs to us and impair our ability to generate revenues from product sales, regulatory and commercialization milestones and royalties. In addition, if (1) we are required to conduct additional clinical trials or other testing of our product candidate beyond the trials and testing that we contemplate, (2) we are unable to successfully complete clinical trials of our product candidate or other testing, (3) the results of these trials or tests are unfavorable, uncertain or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition to incurring additional costs, may:

Even if our product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third party payors and others in the medical community necessary for commercial success and the market opportunity for the product candidate may be smaller than we estimate.

We have never commercialized a product. Even if our products are approved by the appropriate regulatory authorities for marketing and sale, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third party payors and others in the medical community. For example, physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market. Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch therapies due to lack of reimbursement for existing therapies.

Efforts to educate the medical community and third party payors on the benefits of our product candidate may require significant resources and may not be successful. If our product candidates are approved but do not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance of our products, if approved for commercial sale, will depend on a number of factors, including:

The potential market opportunities for our products are difficult to estimate precisely. Our estimates of the potential market opportunities are predicated on many assumptions, including industry knowledge and publications, third party research reports and other surveys. While we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source. If any of the assumptions proves to be inaccurate, the actual markets for our products could be smaller than our estimates of the potential market opportunities.

We rely on a limited number of suppliers and the loss of any of our suppliers, or delays or problems in the supply of materials used in our products, could materially and adversely affect our operations and growth.

We generally rely on a limited number of suppliers for most of the primary materials used in our products.  Our suppliers may not be able to supply the necessary materials without interruption and we may not have adequate remedies for such failure, which could result in a shortage of our products.  If one of our suppliers fails or refuses to supply us for any reason, it could take time and expense to obtain a new supplier.  In addition, our failure to maintain existing relationships with our suppliers or to establish new relationships in the future could negatively affect our ability to obtain the materials used in our products in a timely manner.  The search for new suppliers could potentially delay the manufacture of our products, resulting in shortages in the marketplace and may cause us to incur additional expense.  Failure to comply with applicable legal requirements subjects our suppliers to possible legal or regulatory action, including shutdown, which may adversely affect their ability to supply us with the materials we need for our products.  Any delay in supplying, or failure to supply, materials for our products by any of our suppliers could result in our inability to meet the commercial demand for our products, and could adversely affect our business, financial condition, results of operations and growth prospects.

We may seek to enter into collaborations with third parties for the development and commercialization of our product candidate. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our product candidate.

We may seek third-party collaborators for development and commercialization of our products. Our likely collaborators for any marketing, distribution, development, licensing or broader collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies, non-profit organizations, government agencies, and biotechnology companies. Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.

Collaborations involving our products will pose, the following risks to us:

Collaborative Agreements may not lead to development or commercialization of our product candidate in the most efficient manner or at all. If a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

We are dependent on obtaining certain patents and protecting our proprietary rights.

Our success will depend, in part, on our ability to obtain patents, maintain trade secret protection and operate without infringing on the proprietary rights of third parties or having third parties circumvent our rights. We are licensing in patented technologies for our products. The patent positions of biotechnology, biopharmaceutical and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. Thus, there can be no assurance that any of our patent applications will result in the issuance of patents, that we will develop additional proprietary products that are patentable, that any patents issued to us or those that already have been issued will provide us with any competitive advantages or will not be challenged by any third parties, that the patents of others will not impede our ability to do business or that third parties will not be able to circumvent our patents. Furthermore, there can be no assurance that others will not independently develop similar products, duplicate any of our products not under patent protection, or, if patents are issued to us, design around the patented products we developed or will develop.

We may be required to obtain licenses from third parties to avoid infringing patents or other proprietary rights. No assurance can be given that any licenses required under any such patents or proprietary rights would be made available, if at all, on terms we find acceptable. If we do not obtain such licenses, we could encounter delays in the introduction of products or could find that the development, manufacture or sale of products requiring such licenses could be prohibited.

A number of pharmaceutical, biopharmaceutical and biotechnology companies and research and academic institutions have developed technologies, filed patent applications or received patents on various technologies that may be related to or affect our business. Some of these technologies, applications or patents may conflict with our technologies or patent applications. Such conflict could limit the scope of the patents, if any, that we may be able to obtain or result in the denial of our patent applications. In addition, if patents that cover our activities are issued to other companies, there can be no assurance that we would be able to obtain licenses to these patents at a reasonable cost or be able to develop or obtain alternative technology. If we do not obtain such licenses, we could encounter delays in the introduction of products, or could find that the development, manufacture or sale of products requiring such licenses could be prohibited. In addition, we could incur substantial costs in defending ourselves in suits brought against us on patents it might infringe or in filing suits against others to have such patents declared invalid.

We are subject to various government regulations.

The manufacture and sale of human therapeutic and diagnostic products in the U.S. and foreign jurisdictions are governed by a variety of statutes and regulations. These laws require approval of manufacturing facilities, controlled research and testing of products and government review and approval of a submission containing manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the safety and efficacy of the product for each use sought, including adherence to current PIC/S Guide to Good Manufacturing Practice for Medicinal products during production and storage, and control of marketing activities, including advertising and labeling.

The product we are currently developing will require significant development, preclinical and clinical testing and investment of substantial funds prior to its commercialization. The process of obtaining required approvals can be costly and time-consuming, and there can be no assurance that future products will be successfully developed and will prove to be safe and effective in clinical trials or receive applicable regulatory approvals. Markets other than the U.S. have similar restrictions. Potential investors and shareholders should be aware of the risks, problems, delays, expenses and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.

Our existing indebtedness may adversely affect our ability to obtain additional funds and may increase our vulnerability to economic or business downturns.We are subject to a number of risks associated with our indebtedness, including: 1) we must dedicate a portion of our cash flows from operations to pay debt service costs, and therefore we have less funds available for operations and other purposes; 2) it may be more difficult and expensive to obtain additional funds through financings, if available at all; 3) we are more vulnerable to economic downturns and fluctuations in interest rates, less able to withstand competitive pressures and less flexible in reacting to changes in our industry and general economic conditions; and 4) if we default under any of our existing credit facilities or if our creditors demand payment of a portion or all of our indebtedness, we may not have sufficient funds to make such payments. As of June 30, 2016, our outstanding debt was $2,050,000 which was a short term loan. This loan was subsequently paid off on August 9, 2016.

We have recurring losses from operations and a significant accumulated deficit. In addition, we continue to experience negative cash flows from operations. These factors raise substantial doubt about our ability to continue as a going concern. If we do not generate revenues, do not achieve profitability and do not have other sources of financing for our business, we may have to curtail or cease our development plans and operations, which could cause investors to lose the entire amount of their investment. With the doubt about our ability to continue as a going concern, we may also face difficulties to raise additional funds.

We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively.

The development and commercialization of new drug products is highly competitive. We expect that we will face significant competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to our products that we may seek to develop or commercialize in the future. Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective, have fewer or more tolerable side effects or are less costly than any product candidates that we are currently developing or that we may develop, which could render our product candidates obsolete and noncompetitive.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other marketing approval for their products before we are able to obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Many of our existing and potential future competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

If we are unable to establish appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations, result in the restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our Common Stock.

Effective internal controls are necessary for us to provide reliable financial reports and effectively prevent fraud. We maintain a system of internal control over financial reporting, which is defined as a process designed by, or under the supervision of, our principal executive officer and principal financial officer, or persons performing similar functions, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

As a public company, we will have significant additional requirements for enhanced financial reporting and internal controls.  We will be required to document and test our internal control procedures in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, which requires annual management assessments of the effectiveness of our internal controls over financial reporting. The process of designing and implementing effective internal controls is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain a system of internal controls that is adequate to satisfy our reporting obligations as a public company.

We cannot assure you that we will not, in the future, identify areas requiring improvement in our internal control over financial reporting.  We cannot assure you that the measures we will take to remediate any areas in need of improvement will be successful or that we will implement and maintain adequate controls over our financial processes and reporting in the future as we continue our growth.  If we are unable to establish appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations, result in the restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our Common Stock.

The audit report included in the financial reports of this Registration was prepared by auditors who are not inspected by the Public Company Accounting Oversight Board and, as a result, you are deprived of the benefits of such inspection

Because our auditors are located in Hong Kong, Special Administrative Region of the People’s Republic of China (“PRC”), a jurisdiction where Public Company Accounting Oversight Board (United States), or the PCAOB, is currently unable to conduct inspections without the approval of the PRC authorities, our auditors are not currently inspected by the PCAOB.

Inspections of other firms that the PCAOB has conducted outside PRC have identified deficiencies in those firms' audit procedures and quality control procedures, which may be addressed as part of the inspection process to improve future audit quality. The inability of the PCAOB to conduct inspections in PRC prevents the PCAOB from regularly evaluating our auditor's statements, audits and quality control procedures. As a result, investors may be deprived of the benefits of PCAOB inspections.

The inability of the PCAOB to conduct inspections of auditors in PRC makes it more difficult to evaluate the effectiveness of our auditor's quality control and audit procedures as compared to auditors outside of PRC that are subject to PCAOB inspections. Investors may lose confidence in our reported financial information and procedures and the quality of our financial statements.

Risks Relating to Our Securities

Insiders have substantial control over us, and they could delay or prevent a change in our corporate control even if our other stockholders wanted it to occur.

Our executive officers, directors, and principal stockholders own, in the aggregate, approximately 70.86% of our outstanding Common Stock. As a result of their stockholdings, these stockholders are able to assert substantial control over matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. This could delay or prevent an outside party from acquiring or merging with us even if our other stockholders wanted it to occur.

The market price of our Common Stock may be volatile and there may not be sufficient liquidity in the market for our securities in order for investors to sell their securities.

The market price of our Common Stock has been and will likely continue to be highly volatile, as is the stock market in general. Factors that may materially affect the market price of our Common Stock are beyond our control, these factors may materially adversely affect the market price of our Common Stock, regardless of our performance.  In addition, the public stock markets have experienced extreme price and trading volume volatility. These broad market fluctuations may influence the market price of our Common Stock. There is currently only a limited public market for our Common Stock, which is listed on the OTCQB Market, and there can be no assurance that a trading market will develop further or be maintained in the future.

Our articles of incorporation allow for our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.

Our Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock without stockholder approval. As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock. In addition, our Board of Directors could authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our existing stockholders. Although we have no present intention to issue any additional shares of preferred stock or to create any additional series of preferred stock, we may issue such shares in the future.

Our independent auditors have issued an audit opinion for our company, which includes a statement describing our going concern status. Our financial status creates a doubt whether we will continue as a going concern.

Our auditors have issued a going concern opinion regarding our company. This means there is substantial doubt we can continue as an ongoing business for the next twelve months. The financial statements do not include any adjustments that might result from the uncertainty regarding our ability to continue in business. As such we may have to cease operations and investors could lose part or all of their investment in our company.

The audit report included in this Annual Report was prepared by auditors who may not be inspected by the Public Company Accounting Oversight Board and, as a result, you are deprived of the benefits of such inspection

The independent registered public accounting firm that issues the audit reports included in our financial reports filed with the SEC, as auditors of companies that are traded publicly in the United States and a firm registered with the PCAOB, is required by the laws of the United States to undergo regular inspections by the PCAOB to assess its compliance with the laws of the United States and professional standards. Because our auditors are located in Hong Kong, SAR, a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of the Peoples’ Republic of China (PRC) authorities, our auditors are not currently inspected by the PCAOB.

Inspections of other firms that the PCAOB has conducted outside PRC have identified deficiencies in those firms' audit procedures and quality control procedures, which may be addressed as part of the inspection process to improve future audit quality. The inability of the PCAOB to conduct inspections in PRC prevents the PCAOB from regularly evaluating our auditor's statements, audits and quality control procedures. As a result, investors may be deprived of the benefits of PCAOB inspections.

The inability of the PCAOB to conduct inspections of auditors in PRC makes it more difficult to evaluate the effectiveness of our auditor's quality control and audit procedures as compared to auditors outside of PRC that are subject to PCAOB inspections. Investors may lose confidence in our reported financial information and procedures and the quality of our financial statements.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report contains forward-looking statements and information that are based on the beliefs of our management as well as assumptions made by and information currently available to us.  Such statements should not be unduly relied upon.  When used in this report, forward-looking statements include, but are not limited to, the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan” and similar expressions, as well as statements regarding new and existing products, technologies and opportunities, statements regarding market and industry segment growth and demand and acceptance of new and existing products, any projections of sales, earnings, revenue, margins or other financial items, any statements of the plans, strategies and objectives of management for future operations, any statements regarding future economic conditions or performance, uncertainties related to conducting business in China, any statements of belief or intention, and any statements or assumptions underlying any of the foregoing.  These statements reflect our current view concerning future events and are subject to risks, uncertainties and assumptions.  There are important factors that could cause actual results to vary materially from those described in this report as anticipated, estimated or expected, including, but not limited to: competition in the industry in which we operate and the impact of such competition on pricing, revenues and margins, volatility in the securities market due to the general economic downturn; Securities and Exchange Commission (the “SEC”) regulations which affect trading in the securities of “penny stocks,” and other risks and uncertainties.  Except as required by law, we assume no obligation to update any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward- looking statements, even if new information becomes available in the future.  Depending on the market for our stock and other conditional tests, a specific safe harbor under the Private Securities Litigation Reform Act of 1995 may be available.  Notwithstanding the above, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) expressly state that the safe harbor for forward-looking statements does not apply to companies that issue penny stock.  Because we may from time to time be considered to be an issuer of penny stock, the safe harbor for forward-looking statements may not apply to us at certain times.

USE OF PROCEEDS

We will not receive any proceeds from the sale of shares by the selling stockholders named in this prospectus. All proceeds from the sale of the common stock will be paid directly to the selling stockholders.

DETERMINATION OF OFFERING PRICE

The selling stockholders may sell these shares in the over-the-counter market or otherwise, at market prices prevailing at the time of sale, at prices related to the prevailing market price, or at negotiated prices. We will not receive any proceeds from the sale of shares by the selling stockholders. 

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

The following discussion provides information which management believes is relevant to an assessment and understanding of our results of operations and financial condition. The discussion should be read along with our condensed consolidated financial statements for the year ended September 30, 2016, and notes thereto contained elsewhere in this Report,and our annual report on Form 10--K for the period from July 21, 2015 (inception) to September 30, 2015 including the consolidated financial statements and notes thereto. The following discussion and analysis contains forward-looking statements, which involve risks and uncertainties. Our actual results may differ significantly from the results, expectations and plans discussed in these forward-looking statements. See “Cautionary Note Concerning Forward-Looking Statements.”

As used in this Report, the terms “we”, “us”, “our”, and “our Company” and “the Company” refer to American BriVision (Holding) Corporation (formerly known as Metu Brands, Inc.) and its subsidiaries, unless otherwise indicated.

Introduction

Currently, we are a holding company operating through our wholly owned subsidiary, BriVision. BriVision was incorporated in 2015 in the State of Delaware. It is a biotechnology company focused on the development of new drugs and innovative medical devices to fulfill unmet medical needs.  Following the Share Exchange (as described herein below), we have abandoned our prior business plan and we are now pursuing BriVision’s historical businesses and proposed businesses, which focus on the development of new drugs and innovative medical devices to fulfill unmet medical needs.  The business model of the Company is to integrate research achievements from world-famous institutions, conduct clinical trials of translational medicine for POC, out-license to international pharmaceutical companies, and exploit global markets.

Overview

Prior to the Share Exchange, we were a company operating a web site for the sale of women's apparel.

We have had limited operations and have been issued a "going concern" opinion by our auditor, based upon our reliance on the sale of our common stock as the sole source of funds for our future operations.

On February 8, 2016, a Share Exchange Agreement (“Share Exchange Agreement”) was entered into by and among American BriVision (Holding) Corporation (the “Company”), BriVision, a Delaware Corporation, Euro-Asia Investment & Finance Corp. Limited, a company incorporated under the laws of Hong Kong Special Administrative Region of the People's Republic of China (“Euro-Asia”), being the owners of record of 164,387,376 (52,336,000 pre-stock split) shares of common stock of the Company, and the persons listed in Exhibit A thereof (the “BriVision Shareholders”), being the owners of record of all of the issued share capital of BriVision (the “BriVision Stock”).

Pursuant to the Share Exchange Agreement, upon surrender by the BriVision Shareholders and the cancellation by BriVision of the certificates evidencing the BriVision Stock as registered in the name of each BriVision Shareholder, and pursuant to the registration of the Company in the register of members maintained by BriVision as the new holder of the BriVision Stock and the issuance of the certificates evidencing the aforementioned registration of the BriVision Stock in the name of the Company, the Company should issue 166,273,921(52,936,583 pre-stock split) shares (the “Acquisition Stock”) (subject to adjustment for fractionalized shares as set forth below) of the Company’s common stock to the BriVision Shareholders (or their designees), and 163,159,952 (51,945,225 pre-stock split) shares of the Company’s common stock owned by Euro-Asia should be cancelled and retired to treasury.

The Acquisition Stock collectively should represent 79.70% of the issued and outstanding common stock of the Company immediately after the Closing, in exchange for the BriVision Stock, representing 100% of the issued share capital of BriVision in a reverse merger, or the Merger. Pursuant to the Merger, all of the issued and outstanding shares of BriVision’s common stock were converted, at an exchange ratio of 0.2536-for-1, into an aggregate of 166,273,921(52,936,583 pre-stock split) shares of Company’s common stock and BriVision became a wholly owned subsidiary, of the Company. The holders of Company’s common stock as of immediately prior to the Merger held an aggregate of 205,519,223 (65,431,144 pre-stock split) shares of Company’s common stock, Because of the exchange of the BriVision Stock for the Acquisition Stock (the “Share Exchange”), BriVision became a wholly owned subsidiary (the “Subsidiary”) of the Company and there was a change of control of the Company following the closing.  There were no warrants, options or other equity instruments issued in connection with the share exchange agreement.

As a result of the consummation of the Share Exchange, BriVision is now our wholly-owned subsidiary and its shareholders own approximately 79.70% of our issued and outstanding common stock.

All references to the “Combined Company” refer to American BriVision (Holding) Corporation and its wholly owned subsidiary, BriVision.

Accounting Treatment of the Merger

For financial reporting purposes, the Share Exchange represents a “reverse merger” rather than a business combination and BriVision is deemed the accounting acquirer in the transaction. The Share Exchange is being accounted for as a reverse-merger and recapitalization. BriVision is the acquirer for financial reporting purposes and the Company is the acquired company. Consequently, the assets and liabilities and the operations that will be reflected in the historical financial statements prior to the Share Exchange will be those of BriVision and will be recorded at the historical cost basis of BriVision, and the consolidated financial statements after completion of the Share Exchange will include the assets and liabilities of the Company and BriVision, and the historical operations of BriVision and operations of the combined entities (American Brivision (Holding) Corporation and its wholly owned subsidiary Brivision) from the closing date of the Share Exchange.

For more information about the Share Exchange, please refer to the current report on Form 8-K we filed to SEC which was accepted on February 12, 2016 and displaced on February 16, 2016.

Following the Share Exchange, we have abandoned our prior business plan and we are now pursuing BriVision’s historical businesses and proposed businesses. BriVision is a biotechnology company focused on the development of new drugs to fulfill unmet medical needs.  Our business model is to integrate research achievements from world-famous institutions, such as MSKCC and MD Anderson Cancer Center (“MDACC”), conduct clinical trials for POC, out-license to international pharmaceutical companies, and exploit global markets.

We currently have six products (collectively, the “Products”) that are licensed to us:

The first five products all are ready to go into phase II clinical study. ABV-1504 already starts phase II clinical study in Taiwan and we expect it will start in the States this year.  ABV-1505 got IND (Investigational New Drug Application) by US FDA on January 25, 2016.  ABV-1501 Phase II IND will be filed on February 2016.  ABV-1502 and ABV-1503 are preparing IND package now.

With regard to the sixth product, Maitake Combination Therapy, we license it out and collect license fees or co-develop with other biotechnology company. On May 26, 2017, we entered into a co-development agreement (the “Co-Dev Agreement”) with Rgene Corporation (“Rgene”), a corporation incorporated under the laws of Taiwan, to co-develop and commercialize certain products that are included in the Maitake Combination Therapy. Under the terms of the Co-Dev Agreement, Rgene will pay us $3,000,000 in cash or stock by August 15, 2017 in three installments. We are entitled to receive 50% of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared between Rgene and us. As of the date of this registration statement, no clinic trials of any phase and/or part have occurred; no net licensing income and/or net sales profit has occurred; and we have received $240,000 in cash including $90,000 of income recognized upon signing of the agreement by both parties, and $150,000 of installment received in July 2017. We are still in discussion with Rgene with respect to the schedule of the outstanding balance. The Company is entitled to receive 50% of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared by both Parties.

As of this registration statement, together with Rgene, Rgene has prepared the IND package for pancreatic cancer combination therapy and filed Phase II IND application to FDA on July 27, 2017, and on August 25, 2017, Rgene has received a “study may proceed” letter from FDA.

The IND packages for breast cancer combination therapy and for ovary cancer combination therapy are still being prepared and yet completed.

Recent Developments

Forward Stock Split

On March 21, 2016, our Board approved an amendment to Articles of Incorporation to effect a forward split at a ratio of 1 to 3.141 and increase the number of our authorized shares of common stock, par value $0.001 per share, to 360,000,000, which went effective on April 8, 2016. The amendment to Articles of Incorporation was approved by the majority of the shareholders of the Company.

Collaborative Agreement with Biolite

On December 29, 2015, BriVision, a Delaware corporation and our wholly-owned subsidiary, entered into a Collaborative Agreement with BioLite, of which our sole director, Eugene Jiang, is a director. Pursuant to the Collaborative Agreement, BioLite granted BriVision sole licensing rights for drug and therapeutic use of the five products (the “Five Products”): BLI-1005 CNS-Major Depressive Disorder; BLI-1008 CNS-Attention Deficit Hyperactivity Disorder; BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1; BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer; and BLI-1501 Hematology-Chronic Lymphocytic Leukemia, in the U.S. and Canada.

Except for BLI-1501, or known as ABV-1503, which is the extract of green tea so that it does not require any grant of any right to use and to commercialize, the rights to develop and to commercialize the rest of Five Products were licensed to BioLite from independent third parties. As a result, BioLite and the Company (indirectly) are dependent on the license agreements with independent third parties with regards to the four of the Five Products.

This Collaborative Agreement has a term of fifteen years from the first commercial sales of the Five Products in the U.S. or Canada and automatically renews for five more years unless either party gives the other party six month written notice of termination prior to the expiration date of the term. 

Pursuant to the Collaborative Agreement, an upfront payment of $3,500,000 (the “Milestone Payment”), which is 3.5% of total payments due under the Collaborative Agreement, was to be paid upon execution of that agreement.

Under the Collaborative Agreement, BriVision should pay a total of $100,000,000 in cash or stock of BriVision with equivalent value, according to the following schedule:

On May 6, 2016, we and BioLite entered into Milestone Payment Agreement in order to amend the Collaborative Agreement, whereby BriVision has agreed to pay the Milestone Payment to BioLite $2,600,000 in cash and $900,000 in newly issued shares of our common stock, at the price of $1.60 per share, for an aggregate number of 562,500 shares. 

Under the Collaborative Agreement, BioLite is also entitled to 5% of net sales of the Five Products. There have not been any commercial sales since the Collaborative Agreement became effective.

As our collaboration with BioLite continues under the Collaborative Agreement, we intend to work together to select potential drug candidates (including but not limited to botanical drugs) from different research institutes, start to develop it from pre-clinical stage (including all Chemistry Manufacturing and Controls, or CMC process and animal study) to clinical study stage. When the phase II clinical trial is finished and the efficacy is approved, we will have reached the “POC” stage. We then plan to out license our drugs to big pharmaceutical companies, coordinate with them to develop and enhance the drugs and exploit global markets. 

Second Payment

As of date of this registration statement, Biolite has submitted the first IND submission and we have made the Second Payment to BioLite with $650,000 in cash and $5,850,000 in the form of newly issued shares of our common stock, at the price of $2.0 per share, for an aggregate number of 2,925,000 shares. The shares were issued pursuant to Section 4(a)(2) of the 1933 Securities Act, as amended.

Addendum to the Collaborative Agreement

On January 12, 2017, BriVision entered into an Addendum to the Collaborative Agreement which was previously entered into with BioLite on December 29, 2015, as amended on May 6, 2016. Pursuant to the Collaborative Agreement, BioLite granted BriVision sole licensing rights for drug and therapeutic use of the Five Products in USA and Canada.  

Pursuant to the Addendum, BioLite and BriVision agreed to: 

1)       Include one more product, namely, “Maitake Combination Therapy” as one of the Products (the “Sixth Product” and along with the “Five Products’, the “Products”);

2)       Define the Territory of the Sixth Product to be worldwide and restate the Territory of the Five Products to be USA and Canada;

3)       For Five Products, we own the clinical trial data and intellectual property developed in North America, and such ownership for the Sixth Product shall be worldwide. We shall pay for all clinical trials and other expenses associated with all clinical trial charges and shall have the right to sublicense the Five Products in the USA and Canada and the Sixth Product globally;

4)       Confirm there is no additional Milestone Payments as defined in paragraph 3 of the Collaborative Agreement will be made with respect to the Sixth Product;

5)       In the case that BioLite is obligated to pay its licensor in excess of 3% of the net sales, BioLite and we shall renegotiate and increase the Royalty Charge to a percentage to be later agreed from its original amount of 5% of the net sales as defined in paragraph 4 of the Collaborative Agreement.

BioFirst Collaborative Agreement

On July 24, 2017, we entered into BioFirst Collaborative Agreement with BioFirst, pursuant to which BioFirst granted us the global license for medical use of Vitargus. According to the BioFirst Collaborative Agreement, we will co-develop and commercialize Vitargus with BioFirst and pay BioFirst $3,000,000 in cash or stock by September 30, 2018 in two installments. The first payment of $300,000, representing 10% of the Total Payment due under the BioFirst Collaborative Agreement, was paid by us upon signing of the BioFirst Collaborative Agreement. No other payment has incurred as of this registration statement. As of this registration statement, no net licensing income and/or net sales profit has occurred. 

We are entitled to receive 50% of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared by both parties.

Eugene Jiang, our sole director and former CEO until September 15, 2017, is one of the directors and common stock shareholders of BioFirst. 

Revenue Generation

Most of our licensed products are still under development and trial stage. Therefore, no revenue is expected in near term.

Research and Development

During the year ended September 30, 2016, we have spent approximately $10,000,000 on research and development.

During the three months ended June 30, 2017, we have spent approximately $17,500 on research and development. 

Critical Accounting Policies and Estimates

We believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating this “Management’s Discussion and Analysis of Financial Condition and Results of Operation.”

Basis of Presentation

The accompanying audited financial statements and related notes have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP). This basis of accounting involves the application of accrual accounting and consequently, revenues and gains are recognized when earned, and expenses and losses are recognized when incurred. The Company’s financial statements are expressed in U.S. dollars.

Forward Stock split

On March 21, 2016, the Board of Directors of the Company approved an amendment to Articles of Incorporation to effect a forward split at a ratio of 1 to 3.141 and increase the number of our authorized shares of common stock, par value $0.001 per share, to 360,000,000, which was effective on April 8, 2016. The majority of the shareholders of the Company approved the amendment to Articles of Incorporation. See Note 4 for more details.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the amount of revenues and expenses during the reporting periods. Actual results could differ materially from those results.

Fair Value Measurements

The Company applies the provisions of ASC Subtopic 820-10, “Fair Value Measurements”, for fair value measurements of financial assets and financial liabilities and for fair value measurements of nonfinancial items that are recognized or disclosed at fair value in the financial statements.  ASC 820 also establishes a framework for measuring fair value and expands disclosures about fair value measurements.

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.  When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and it considers assumptions that market participants would use when pricing the asset or liability.

ASC 820 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 establishes three levels of inputs to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows:

There were no assets or liabilities measured at fair value on a recurring basis subject to the disclosure requirements of ASC 820 as of September 30, 2016.

Cash and Cash Equivalents

We consider highly liquid investments with maturities of three months or less, when purchased, to be cash equivalents. As of September 30, 2016 and September 30, 2015, our cash and cash equivalents amounted $173,537 and $994,830, respectively. All of our cash deposit is held in a financial institution located in Taiwan where there is currently regulation mandated on obligatory insurance of bank accounts. We believe this financial institution is of high credit quality.

Income Taxes

We account for income taxes using the asset and liability approach which allows the recognition and measurement of deferred tax assets to be based upon the likelihood of realization of tax benefits in future years. Under the asset and liability approach, deferred taxes are provided for the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A valuation allowance is provided for deferred tax assets if it is more-likely-than-not that these items will expire before we are able to realize their benefits, or that future deductibility is uncertain.

Under ASC 740, a tax position is recognized as a benefit only if it is “more likely than not” that the tax position would be sustained in a tax examination, with a tax examination being presumed to occur. The evaluation of a tax position is a two-step process. The first step is to determine whether it is more-likely-than-not that a tax position will be sustained upon examination, including the resolution of any related appeals or litigations based on the technical merits of that position. The second step is to measure a tax position that meets the more-likely-than-not threshold to determine the amount of benefit to be recognized in the financial statements. A tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. Tax positions that previously failed to meet the more-likely-than-not recognition threshold should be recognized in the first subsequent period in which the threshold is satisfied. Previously recognized tax positions that no longer meet the more-likely-than-not criteria should be de-recognized in the first subsequent financial reporting period in which the threshold is no longer satisfied. Penalties and interest incurred related to underpayment of income tax are classified as income tax expense in the year incurred. No significant penalty or interest relating to income taxes has been incurred during the period from July 21, 2015 (inception) to September 30, 2016. GAAP also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures and transition.

As of September 30, 2016 and September 30, 2015, our income tax expense amounted $836 and $0, respectively.

Recent Accounting Pronouncements

From time to time, new accounting standards issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. The recent accounting standards are not expected to have a material impact on the consolidated financial statements upon adoption.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that is material to investors.

Limited Operating History; Need for Additional Capital

There is no historical financial information about us upon which to base an evaluation of our performance.  As of the date of this filing, we have not generated any revenues from operations. We cannot guarantee we will be successful in our business operations.  Our business is subject to risks inherent in the establishment of a new business enterprise, including limited capital resources, possible delays in the launching of our games and market or wider economic downturns. We do not believe we have sufficient funds to operate our business for the next 12 months.

We have no assurance that future financing will be available to us on acceptable terms, or at all.  If financing is not available on satisfactory terms, we may be unable to continue, develop or expand our operations.  Equity financing could result in additional dilution to existing shareholders.

If we are unable to raise additional capital to maintain our operations in the future, we may be unable to carry out our full business plan or we may be forced to cease operations.

The following discussion and analysis should be read in conjunction with our audited financial statements for the period ended September 30, 2016 and accompanying notes that appear in 1) our Annual Report on Form 10-K as filed with the SEC on January 12, 2017; 2) Form 10-K/A Amendment No.1 as filed with the SEC on February 22, 2017; 3) Form 10-K/A Amendment No.2 as filed with the SEC on May 22, 2017, 4) Form 10-K/A Amendment No. 3 as filed with the SEC on September 22, 2017, and 5) the financial statements included in this Report.

Results of Operation

Our financial statements have been prepared assuming that we will continue as a going concern and, accordingly, do not include adjustments relating to the recoverability and realization of assets and classification of liabilities that might be necessary should we be unable to continue in operation. We expect we will require additional capital to meet our long term operating requirements. We expect to raise additional capital through, among other things, the sale of equity or debt securities, but we cannot guarantee that we will be able to achieve the same.

Results of Operations — Fiscal Year Ended September 30, 2016 Compared to The Period from July 21, 2015 (Inception) to September 30, 2015.

The following table presents, for the period indicated, our consolidated statements of operations information.

Revenues.   We generated zero and zero in revenues and $32 and zero in cost of sales for the year ended September 30, 2016 and the period from July 21, 2015 (inception) to September 30, 2015.

Operating Expenses.   Our operating expenses were $10,997,263 for the year ended September 30, 2016 as compared to $315,602 for the period from July 21, 2015 (inception) to September 30, 2015. The increase of $10,681,661 in the current year was the result of more professional fees, as well as the $10,000,000 for the Milestone payment for royalty fee.

Interest Expense. The interest expense was $10,170 for the year ended September 30, 2016 as compared to $0 for the period from July 21, 2015 (inception) to September 30, 2015 

Net Loss. The net loss was $11,007,799 for the year ended September 30, 2016 compared to a loss of $315,602 for the period from July 21, 2015 (inception) to September 30, 2015. The result of increase of net loss in the current year was due to the increased professional fees and the Milestone payment incurred during the year ended September 30, 2016.

Results of Operations — Three Months Ended June 30, 2017 Compared to June 30, 2016.

The following table presents, for the three months indicated, our consolidated statements of operations information.

Revenues. We generated $90,000 and zero in revenues and zero and zero in cost of sales for the three months ended June 30, 2017 and 2016, respectively. Revenue of $90,000 was from the co-development with related party, Rgene, and such agreement was signed in May 2017. There was no agreement signed during the three months ended June 30, 2017.

Operating Expenses. Our operating expenses were $189,479 in the three months ended June 30, 2017 as compared to $289,098 in the three months ended June 30, 2016. The decrease of $99,619 in the current period was mainly due to $119,671 decrease in selling, general and administrative expenses caused by fewer professional fees during this period, offset by $17,500 increase in research and development expenses and $2,552 increase in stock based compensation related to stocks granted to the consultant, Kazunori Kameyama, during the three months ended June 30, 2017.

Interest Expense. The interest expense was $28,500 in the three months ended June 30, 2017 as compared to $3,753 in the three months ended June 30, 2016. The increase is due to the interest related to a non-secured financing acquired from a related party at the end of January 2017.

Net Loss. The net loss was $127,879 for the three months ended June 30, 2017 compared to $293,237 for the three months ended June 30, 2016. The result of decrease of net loss in current period was mainly due to decrease in research and development expenses, offset by increased in selling, general and administrative expense and stock based compensation and the increase in revenue as compared against the three months ended June 30, 2016.

Results of Operations — Nine Months Ended June 30, 2017 Compared to June 30, 2016.

The following table presents, for the six months indicated, our consolidated statements of operations information.

Revenues. We generated $160,000 and zero in revenues and zero and $32 in cost of sales for the nine months ended June 30, 2017 and 2016, respectively.  

Operating Expenses. Our operating expenses were $636,706 in the nine months ended June 30, 2017 as compared to $10,349,486 in the nine months ended June 30, 2016. The decrease of $ 9,712,780 in the current period was mainly due to a decrease of $9,932,152 in research and development expenses since no milestone was met under collaborative agreement with Biolite during the current period, offset by $213,444 increase in selling, general and administrative expenses due to more professional fees incurred during the current period; and by $5,928 increase in stock based compensation.

Interest Expense. The interest expense was $47,500 in the nine months ended June 30, 2017 as compared to $3,753 in the nine months ended June 30, 2016.  The increase is mainly due to the interest expense related to a non-secured financing acquired from a related party in January 2017.

Net Loss. The net loss was $524,887 for the nine months ended June 30, 2017 compared to $10,353,105 for the nine months ended June 30, 2016. The result of decrease of net loss in current period was mainly due to the decrease in research and development expenses, offset by increase in selling, general and administrative expenses and stock based compensation and the increase in revenues as compared against the nine months ended June 30, 2017.

Balance Sheet Data

For The Year Ended September 30, 2016

During the year ended September 30, 2016, we did not generate any revenue and incurred operating expenses of $10,997,263, and resulted in a net loss of $11,007,799. The expenses were mainly expense related to daily operation costs and the professional fees, as well as the Milestone payment.

For The Period from July 21, 2015 (Inception) to September 30, 2015

During the period from July 21, 2015 (inception) through September 30, 2015, we did not generate any revenue and incurred operating expenses of $315,602, and resulted in a net loss of $315,602. The expenses were mainly expense related to daily operation costs and the professional fees.

Balance Sheet Data

For The Nine Months Period Ended June 30, 2017

During the nine months period ended June 30, 2017, we generated revenue of $160,000 and incurred operating expenses of $476,706, and resulted in a net loss of $524,887. The expenses were mainly expense related to daily operation costs and the professional fees, as well as the research and development expenses.

For The Year Ended September 30, 2016

During the year ended September 30, 2016, we did not generate any revenue and incurred operating expenses of $10,997,263, and resulted in a net loss of $11,007,799. The expenses were mainly expense related to daily operation costs and the professional fees, as well as the Milestone payment.

Liquidity and Capital Resources as of September 30, 2016

Working Capital

Cash Flows

Cash Flow from Operating Activities

During the year ended September 30, 2016 and the period from July 21, 2015 (inception) to September 30, 2015, the net cash used in operating activities were $3,474,707 and $715 respectively. There was increase in due to related parties during the year ended September 30, 2016.

Cash Flow from Investing Activities

During the year ended September 30, 2016 and the period from July 21, 2015 (inception) to September 30, 2015, there were no net cash used in or generated from investing activities.

Cash Flow from Financing Activities

During the year ended September 30, 2016 and the period from July 21, 2015 (inception) to September 30, 2015, the net cash generated from financing activities were $2,653,414 and $995,545 respectively. Shares were issued during the year ended September 30, 2016.

Liquidity and Capital Resources As of June 30, 2017

Working Capital

Cash Flows

Cash Flow from Operating Activities

During the nine months ended June 30, 2017 and 2016, the net cash used in operating activities were $1,115,484 and $3,263,340 respectively. The decrease is primarily due to the significant decrease of net loss of $10.4 million incurred in prior period to $0.5 million incurred in current period, albeit the increase in due to related party, Biolite, by $6.5 million in prior period and then cash payment of $650,000 to BioLite in the current period pursuant to the Collaborative Agreement, and more issuance of common stocks for compensation with $897,521 in prior period compared to $5,928 in current period.

Cash Flow from Investing Activities

During the nine months ended June 30, 2017 and 2016, there were no net cash used in or generated from investing activities.

Cash Flow from Financing Activities

During the nine months ended June 30, 2017 and 2016, the net cash generated from financing activities were 950,000 and $2,353,414 respectively. The decrease is mainly because there were smaller amount of financing activities during the nine months ended June 30, 2017. There was a borrowing from related party with $950,000 in current period compared to the proceeds from short term loan and subscription receivable with $2,050,000 and $350,000, respectively in prior period.

Critical Accounting Policy and Estimates

We believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating this “Management’s Discussion and Analysis of Financial Condition and Results of Operation.”

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that is material to investors.

BUSINESS

The Industry

Biotechnology industry provides breakthrough products and technologies to combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing process.

The biotechnology industry is an extremely important sector in the developed world's economies and human health. Biotechnology companies need to spend large research budgets during the R&D period.  Usually it will take 12-16 years to develop a new drug and a new medical device.  Not only is a small biotechnology company’s R&D budget smaller than a large, well-known biotechnology company or an international company, but the larger companies are typically more attractive to researchers or employers and maintains better R&D resources. However, at this early stage, we are developing our products, which are licensed from a related party which substantially reduces our R&D cost.

Business Overview

We are a clinical stage biopharmaceutical company focused on utilizing our licensed technology to (i) enhance the development of pre-existing pharmaceutical products for the treatment of various cancer indications and other diseases, (ii) prospectively identify patients that may respond to such pharmaceutical products and (iii) commercialize such pharmaceutical products for license in various markets. Our business strategy is to integrate research achievements from medical research institutions (such as MSKCC and MDACC), by engaging them to conduct clinical trials of translational medicine for POC while we retain ownership of the Products, and then out-license the Products to pharmaceutical companies. We currently have no revenue generated from our principal operations in clinical product development through research and development efforts. Currently, our only operation is the research and development of five compound licensed to us by BioLite Inc. (“BioLite”), a company formed in Taiwan who is one of our principal shareholders.

Collaborative Agreement with BioLite

On December 29, 2015, BriVision, a Delaware corporation and our wholly owned subsidiary, entered into a Collaborative Agreement with BioLite.

Pursuant to the Collaborative Agreement, Biolite granted BriVision sole licensing rights for drug and therapeutic use of the five products (the “Five Products”): BLI-1005 CNS-Major Depressive Disorder; BLI-1008 CNS-Attention Deficit Hyperactivity Disorder; BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1; BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer; and BLI-1501 Hematology-Chronic Lymphocytic Leukemia, in the U.S. and Canada.

Except for BLI-1501, or known as ABV-1503, which is the extract of green tea so that it does not require any grant of any right to use and to commercialize, the rights to develop and to commercialize other products were licensed to BioLite by independent third parties. As a result, BioLite and the Company are dependent on license agreements with independent third parties with regards to those four of Five Products.

BioLite is considered a related party to us as our sole director and former CEO, Eugene Jiang, is also a director of BioLite. Eugene was our CEO until September 15, 2017.

The material terms of the Collaborative Agreement are as follows:

BioFirst Collaborative Agreement

On July 24, 2017, we entered into the BioFirst Collaborative Agreement with BioFirst, pursuant to which BioFirst granted us the global license for medical use of Vitargus. According to the BioFirst Collaborative Agreement, we will co-develop and commercialize Vitargus with BioFirst and pay BioFirst $3,000,000 in cash or stock by September 30, 2018 in two installments. The first payment of $300,000, representing 10% of the Total Payment due under the BioFirst Collaborative Agreement, was paid by us upon signing of the BioFirst Collaborative Agreement. No other payment has incurred as of this registration statement. As of this registration statement, no net licensing income and/or net sales profit has occurred.

We are entitled to receive 50% of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared by both parties.

Eugene Jiang, our sole director and former CEO, is one of the directors and common stock shareholders of BioFirst. 

Our Products

We have renamed our Products for our purpose. Below is a brief description of each of the Products.

ABV-1501 and ABV-1502 have the same API: “Maitake mushroom extract”. Generally, for non-cancer patients, Phase I clinical trials are performed with healthy subjects to determine safety only, but Phase II clinical trials are performed with patient subjects for both safety and efficacy. However, it is necessary to involve subjects with cancer in trials of cancer drugs; therefore, both Phase I and Phase II trials involving cancer patients include primary endpoints relating to both safety and tolerability and secondary endpoint relating to efficacy.

The SAE in connection to ABV-1501 and ABV-1502 may lead to leukocytosis, platelet count decrease, eye disorders, abdominal pain, gastrointestinal disorders, aphonia, lung infection, muscle weakness right-sided, confusion, edema cerebral, stroke, dyspnea, wheezing, and pruritus.

Following are the details of the endpoints of MSKCC Trials:

1. Survivors who orally administered “Maitake mushroom extract” over a 3-week period are well tolerated (Safety).

2. No DLT was experienced up to 10 mg/kg per day (Safety).

3. The intermediate dose (5–7 mg/kg per day) was associated with the most prominent functional changes, such as increased production of IL-2, IL-10, TNF-α and IFN-γ by subsets of T cells (Efficacy-increase of immune function).

There is no SAE in connection to ABV-1504 and ABV-1505. More details of ABV-1504 and ABV-1505 Clinical Trials are as follows:

Phase I Trial (defined hereinafter):

The endpoint of ABV-1504 Phase I Trial in healthy volunteers is safety and FDA approved to proceed to Phase II Trial. Since ABV-1504 and ABV 1505 have the same API, such endpoint and approval for Phase I Trial of ABV-1504 are applicable, allowed by FDA, to Phase I Trial of ABV-1505 as cross reference (collectively “Phase I Trial”).

Phase I Trial was conducted at five clinical sites in Taiwan: Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, Taipei City Hospital (Songde Branch), Tri-Service General Hospital, and Wan Fang Hospital.

Following are the additional key facts of the Phase I Trial:

Trial Name: A Dose Escalation Phase I Trial of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers.

IND Number: 112567

Trial period:11/13/2012-7/5/2013, Final Report Date 11/12/2013

Total 30 Trial subjects were enrolled. The test drug was orally administered. The primary endpoint is to assess the safety profile of PDC-1421 Capsule in healthy volunteers.

Sponsor: BioLite, Inc.

Phase II Trial of ABV-1504

Phase II Trial of ABV-1504 is conducted in MDD patients. FDA requires such Trial to be divided into two parts, namely, Phase II Part I and Phase II Part II. Phase II Part I evaluates the safety on MDD patients as primary endpoint. Phase II Part II evaluates efficacy as secondary endpoint. Phase II Part I has been completed and Data and Safety Monitoring Board (“DSMB”) has approved to proceed to Phase II Part II Trial. Phase II Part II Trial is currently being conducted and the primary endpoint of Phase II will not be evaluated until Phase II Part II of the clinical trialRegistration Statement, the signature page to the Registration Statement and the filed exhibits. The remainder of the Registration Statement is completed.

Phase II Part I Trial of ABV-1504

Phase II Part I Trial of ABV-1504 was conducted at five clinical sites in Taiwan: Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, Taipei City Hospital (Songde Branch), Tri-Service General Hospitalunchanged and Wan Fang Hospital.

Following are the additional key facts of Phase II Part I Trial of ABV-1504:

has therefore been omitted.

FollowingNo additional securities are the test results of Phase II Part I Trial of ABV-1504:

Phase II Part II Trial of ABV-1504

Phase II Part II Trial of ABV-1504 started in Q3 of 2016 and is now being conducted at five clinical sites in Taiwan- Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, Taipei City Hospital (Songde Branch), Tri-Service General Hospital and Wan Fang Hospital-and will be conducted at Stanford University in the United States (IRB approved and clinical trial agreement signed by both parties on Sep 11, 2017).registered under this Pre-Effective Amendment No. 3. All applicable registration fees were previously paid.

Phase II Trial of ABV-1505

Phase II Trial of ABV- 1505 has not started and will be conducted in ADHD patients. Similarly, FDA requires such Trial to be divided into two parts, namely, Phase II Part I and Phase II Part II.

We have received the IND approval, and we are in the process of negotiating the clinical trial agreement with various clinical sites for Phase II Part I Trial and following by Phase II Part II Trial of ABV-1505.

Following are the additional key facts of both parts of the Phase II Trial of ABV-1504 and ABV-1505:

IND Number: 112567

Primary Trial Objective: To assess the efficacy profile of PDC-1421 Capsule in major depressive disorder with Montgomery-Asberg Depression Rating Scale (“MADRS”).

Secondary Trial Objective: To evaluate the efficacy and safety profile

Trial period: 2 years.

Total 72 Trial subjects will be enrolled.

Trial site: Five sites in Taiwan and one site at Stanford University in the U.S. (IRB approved and Clinical Trial Agreement signed by both parties on Sep. 11, 2017).

Sponsor: BioLite, Inc.