ABVC BioPharma Inc (ABVC)

[Biorat]

ABVC BioPharma: A High-Potential Return on Investment for Investors Seeking Near-Term Catalysts


 11/04/2023  7:00 P.M.

Top takeaways

• ABVC BioPharma is developing next-generation plant-based therapies for serious diseases in oncology/hematology, CNS disorders, and ophthalmology.

• The company has signed licensing agreements with AiBtl BioPharma and Xinnovation Therapeutics worth millions of dollars for its CNS drugs.

• Vitargus® is ABVC’s flagship product and the first biodegradable hydrogel product used in retinal detachment surgery. Positive results from clinical trials could lead to distribution agreements in Asia and Australia sooner than in the United States.

• Potential to reach $35 per share in the next year due to its strong leadership, strategic partnerships, and multiple near-term catalysts


Developing Next-Generation Plant-Based Therapies for Serious Diseases

ABVC BioPharma, Inc. (NASDAQ: ABVC ), is a clinical-stage biopharmaceutical company with the aim of transforming the oncology/hematology, CNS disorders, and ophthalmology treatment landscape with healthier and innovative therapies with better odds at a positive outcome.


ABVC BioPharma's CNS Drugs Have Definitive Agreements with AiBtl BioPharma and Xinnovation , Worth Millions of Dollars

ABVC Biopharma Inc. has recently gained interest in the investment community. The stock surged by 362.35% and then retreated on Thursday October 26, 2023 following the company's announcement that is signed a legal binding term sheet to license global rights of its CNS drugs, which are used to treat major depressive disorder (MDD) and attention deficit hyperactivity disorder (ADHD), to AiBtl BioPharma. The licensed products, owned by ABVC and its subsidiary BioLite, were valued at $667M by a third-party evaluation. The multi-year licensing deal will cover the drugs’ clinical trial, registration, manufacturing, supply, and distribution rights. ABVC and AiBtl will collaborate on development of the drugs and strengthen their new drug development. ABVC’s licensing revenues will include 46M shares of AiBtl (equating to a 57% interest in the company) and milestone cash payments of $7M with the royalties of 5% of net sales, up to $200 million, after the product’s launch. AiBtl aims to go public and list on Nasdaq in 2024

ABVC and Xinnovation Therapeutics Co., Ltd have also entered into a partnership to develop and commercialize ABV-1504 and ABV-1505, which are innovative treatments for (MDD) and (ADHD), respectively, in the Chinese market. ABVC Biopharma could potentially earn $20 million from the partnership, while Xinnovation Therapeutics Co., Ltd will shoulder the costs associated with clinical trials and product registration in China. ABVC Biopharma can anticipate substantial royalty payments ranging from 5% to 12% based on the projected annual net sales of the licensed drugs in China. This is projected to generate approximately $50 million in annual revenue for ABVC Biopharma, with an astounding estimated revenue of $1 billion during the patent life of these products. Xinnovation will fund the Phase III trials under the agreement and ABVC gets the global market less the Chinese market.

The (MDD) and (ADHD) trials, if successful, will take the company closer to Phase III trials for those products and drive the multi-product biopharma company forward.

 As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032.

ABVC's CNS drugs have been developed into a controlled-release tablet formulation or PDC-1421, the primary active ingredient in its neurological programs. This formulation enables the active ingredient to be absorbed slower over time compared to conventional tablet formulations, thereby reducing the dosage frequency and increasing the bioavailability.

The product is ready for an End-of-Phase II meeting with the FDA to finalize the protocol for Phase III trials. At the same time, ABVC commenced the ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and another five sites in Taiwan. The trials are heading for the interim report, which ABVC expects to complete by the end of 2023.


Vitargus®: The Future of Retinal Detachment Surgery

In ophthalmology, Vitargus® (ABV-1701) is a groundbreaking, advanced-staged and ABVC's flagship product that is expected to be the first biodegradable hydrogel product used in retinal detachment surgery. Vitargus® has completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods Administration (TGA) to initiate the next phase of the trial in two participating sites.

The Science Park Administration in Taiwan approved ABVC’s plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus® and to pursue the process development work for manufacturing optimization. This project is proposed by ABVC’s Taiwan affiliate and co-development partner, BioFirst Corporation.

The Phase II trial of Vitargus® is expected to release its results in Q4 2023. If the results are positive, it could lead to distribution agreements in Asia and Australia in early 2024.

ABVC is prioritizing the regulatory approval and commercialization of Vitargus®, its flagship biodegradable hydrogel product for retinal detachment surgery, in Asia and Australia, where the regulatory approval process is typically faster and the demand for innovative medical devices is growing rapidly.

This is in contrast to the United States, where the regulatory approval process is longer and the market for retinal detachment surgery devices is more mature. However, ABVC is also pursuing the US market, where it has already received a feasibility study approval from the Australian Therapeutic Goods Administration (TGA) to proceed with the next phase of trials.

Overall, ABVC is well-positioned to capitalize on the growing demand for a product that can deliver like Vitargus® can in both Asia and Australia, while also pursuing the US market in the long term. Based on all of the data, It's believe that ABVC has a $35 upside per share valuation without the need for the rest of the pipeline. In fact, the stock could actually trade higher than $35 per share if it were able to capitalize on its full potential.

According to iHealthcare Analyst, Inc., the global market for retinal surgery devices is expected to reach $4.3 billion by 2029, driven, in part, by the rising geriatric population worldwide.

Early clinical studies done by the Company indicate Vitargus® has unique properties that could eliminate the need for patients to remain in a face-down position post-surgery, while significantly improving patient comfort and visual acuity during surgical recovery compared to current products available on the market. Vitargus® is believed to be the first biodegradable vitreous substitute to eliminate the need for an additional surgery to remove surgical fluids.Several large pharmaceutical companies are interested in becoming distribution and/or manufacturing partners for Vitargus®. ABVC continues to have active discussions.


FDA Greenlights BLEX 404 Clinical Trial for Advanced Non-Small Cell Lung Cancer

The U.S. FDA has approved the Investigational New Drug (IND) application for the proposed clinical investigation of  BLEX 404, the primary active ingredient in ABV-1519. This treatment is being co-developed by BioKey, Inc. and by the Rgene Corporation, Taiwan. The study is under review at the Taiwan FDA for approval. With three previous INDs approved by the US FDA for combination therapies of triple-negative breast cancer, myelodysplastic syndromes (MDS), and pancreatic cancer, BLEX 404 is a promising new option in the fight against cancer.


ABVC BioPharma: Strong Financial Progress and Promising Pipeline Poised for Growth

ABVC BioPharma's financial outlook has improved significantly since the new CEO joined in June 2023. Dr.Uttam the new CEO of ABVC BioPharma has chosen to forgo a salary and instead opted for stock options as a pivotal component of his compensation package. This move demonstrates the CEO’s confidence in the company’s future and its potential for growth.

ABVC BioPharma is making significant strides in its clinical trials and pipeline development thus creating a more financially sound company going forward under a new and experienced CEO. The company generated $969,783 and $355,797 in revenues for the years ended December 31, 2022 and 2021, respectively, representing an increase of $613,986 or approximately 173%.Despite a net loss of $16,312,374 for the year ended December 31, 2022 compared to $12,035,851 for the year ended December 31, 2021, ABVC BioPharma has received a $3.175 million investment from The Lind Partners to continue clinical trials. This investment will help the company to further develop its pipeline of six drugs and one medical device known as Vitargus®, a biodegradable vitreous substitute that facilitates retina reattachment surgery.

ABVC signed both an agreement with Xinnovation and a term sheet with AiBtl BioPharma to earn licensing fees of up to $20 million from Xinnovation and royalties of 5-12% of net sales from AiBtl BioPharma. The licensed products in the term sheet with AiBtl BioPharma for (MDD) and (ADHD) were valued at $667 million by a third-party evaluation. The future financial outlook looks to be improving dramatically for ABVC BioPharma with the flagship product Vitargus® expected to find cash infusion collaboration deals in the near future.

The CEO has done a fantastic job of turning the company around, and it is now poised for significant growth.


Asia's Biopharma revolution: ABVC Biopharma poised to lead the charge with real FDA-approved natural pharmacological medicines

Asia's biopharma market is on the cusp of a revolution, with natural pharmacological medicines poised to dominate. And ABVC Biopharma is at the forefront of this revolution, with a pipeline of innovative natural drugs that are specifically designed to meet the needs of Asian patients.

ABVC Biopharma's natural drugs are based on traditional Chinese medicine principles, but they are also backed by cutting-edge science. The company's lead drug, ABV-1701, is a natural injectable gel that is used to treat retinal detachment. ABV-1701 has already shown promising results in clinical trials, and it is expected to be launched in China in the near future.

ABVC Biopharma is also developing a pipeline of other natural drugs for the treatment of a variety of diseases, including cancer, dementia, and Alzheimer's disease. The company's drugs are all designed to be more gentle and effective than synthetic drugs, and they are also more in line with Asian cultural preferences for natural medicines.

ABVC Biopharma is well-positioned to lead the biopharma revolution in Asia. The company has a strong track record of innovation, and it has a deep understanding of the Asian market. With its pipeline of innovative natural drugs, ABVC Biopharma is poised to capture a significant share of the growing Asian biopharma market.


WHO International Standard Terminologies on traditional Chinese medicine undoubtedly makes the case for ABVC's real FDA-approved drugs
Overview

ABVC Biopharma is developing a new generation of FDA-approved drugs that are based on natural pharmacological compounds. This is a significant development, as it means that people will have access to safe and effective drugs that are based on natural compounds that have been used for centuries in traditional Chinese medicine (TCM).

The World Health Organization (WHO) has recently recognized TCM and developed international standard terminologies for it. This is a positive development for ABVC, as it suggests that there is a growing awareness of the potential of natural medicines to improve human health. It also means that concerns about the safety and efficacy of TCM products are being alleviated.

ABVC's drugs are a bridge between East and West. They are based on natural compounds that have been used for centuries in TCM, but they have been rigorously tested and approved by the FDA. This means that people can be confident that they are safe and effective.

In a world where people are increasingly looking for natural ways to improve their health, ABVC's drugs are a breath of fresh air. They offer people a safe and effective way to experience the benefits of TCM, without having to worry about the risks associated with unregulated products.


Forging Strategic Partnerships to Accelerate Growth and Unlock New Markets

1) BioKey, Inc.,  Business relations

ABVC BioPharma owns BioKey, a contract research organization (CRO) that provides drug discovery and development services. This allows ABVC BioPharma to control its own drug development process and be more efficient and effective in developing new drugs.

.2) MerDury BioPharma 1) Video 2) Business relations

ABVC BioPharma and MerDury BioPharma are working together to develop new drugs using MerDury's 3D printing technology. This could lead to drugs that are absorbed into the body more quickly or that are targeted to specific organs or tissues. The collaboration is beneficial for both companies, as ABVC gains access to MerDury's technology and MerDury gains access to ABVC's pipeline of drug candidates.

3) Ramathibidi Hospital Business relations

ABVC BioPharma is conducting Phase II clinical trials of its novel vitreous substitute, Vitargus®, at two leading medical institutions in Thailand: Srinagarind Hospital and Ramathibodi Hospital. These relationships are mutually beneficial, providing ABVC with access to qualified clinical research teams and well-equipped clinical research facilities, and the hospitals with the opportunity to participate in cutting-edge clinical research and to potentially offer their patients new and innovative treatments. Overall, these relationships have the potential to help ABVC bring Vitargus® to market more quickly and to make a real difference in the lives of patients with retinal diseases.

4) Srinagarind Hospital Business relations

ABVC BioPharma and Srinagarind Hospital have a relationship in the form of a Phase II clinical trial of Vitargus®, ABVC's novel vitreous substitute, for the treatment of retinal detachment and vitreous hemorrhage. The trial is being conducted at Srinagarind Hospital, a leading medical institution in Thailand with a reputation for excellence in clinical care and research. The relationship is mutually beneficial, providing ABVC with access to a qualified clinical research team and a well-equipped clinical research facility, and Srinagarind Hospital with the opportunity to participate in cutting-edge clinical research and to potentially offer its patients new and innovative treatments. Overall, the relationship has the potential to help ABVC bring Vitargus® to market more quickly and to make a real difference in the lives of patients with retinal diseases.

5) Sydney Eye Hospital Business relations

ABVC BioPharma and Sydney Eye Hospital are collaborating on a clinical research study to evaluate Vitargus®, a novel tamponade agent for the treatment of retinal detachment and vitreous hemorrhage. The study is being conducted at Sydney Eye Hospital and has the potential to lead to new and effective treatments for patients with retinal diseases.

6) Cedars-Sinai Medical Center Business relations

ABVC BioPharma and Cedars-Sinai Medical Center are collaborating on the development and evaluation of ABVC's new drugs for cancer patients, including ABV-1601, a new medication for treating depression in cancer patients. The two companies are also working on other research projects to develop new biomarkers for depression in cancer patients. This collaboration is helping to advance the development of new and effective treatments for cancer patients.

7) Rgene Corporation Business relations

ABVC Biopharma and Rgene Corporation have a collaboration agreement that gives ABVC access to Rgene's gene editing technology platform. This could help ABVC to develop new drugs more quickly.

8) AiBtl BioPharma Business relations

ABVC BioPharma and AiBtl BioPharma have entered into a global licensing agreement for ABVC's CNS drugs for MDD and ADHD. AiBtl will receive exclusive global rights to develop, register, manufacture, supply, and distribute the licensed products. In return, ABVC will receive 46 million shares of AiBtl stock, milestone cash payments of $7M, and royalties of 5% of net sales up to $200M. The two companies are also working to strengthen their new drug development and business collaboration. This relationship is significant for both companies as it allows ABVC to monetize its CNS drug portfolio and focus on developing its other proprietary products, while giving AiBtl access to a promising new pipeline of drugs for two large and underserved markets.

9) Xinnovation Licensing agreement Business relations

ABVC BioPharma has licensed its drug candidates for MDD and ADHD to Xinnovation Therapeutics Co., Ltd. for development and commercialization in China. ABVC will receive royalty payments on the sales of the drugs.

10) Science Park Administration Business relations

This relationship is significant because it gives ABVC BioPharma access to the Science Park Administration's expertise and resources. The Science Park Administration is a government agency that promotes the development of science and technology in Taiwan. It has a strong track record of supporting innovative companies, such as ABVC BioPharma.

11) Zhonghui United Technology (Chengdu) Group Co., Ltd Business relations.

Overall, this agreement is a positive development for ABVC as it will provide the company with access to valuable real estate assets and a partner to help it develop its healthcare business in China.

ABVC's list of strategic partnerships is just the beginning. The company's extensive network of partners is constantly growing and evolving, which positions ABVC for a bright future for investors and customers.


ABVC Technical Indicators and Analysis

On October 26th, 2023, the share price of ABVC stock increased by 362.35% from $0.85 to a high of $3.93. However, the stock price fell sharply after a short attack and profit-taking in the afternoon on the 26th while buying volume was at its lowest point on the day, closing at $1.28, a decrease of 67.66% from the high of the day pre-market.

On October 31st, 2023, the ABVC share price continued to decline, dropping to a low of $1.01, a decrease of 21.2% from the close on October 26th. This represents a total decline of 74.3% from the high of $3.93 on October 26th.  The drop down to $1.01 is .04 cents from the high of the day on the 25th which is equivalent to 100% of the gains from the high of the day on the 26th being returned. .98 cents being the high on the 25th. This is a refund of $2.92, It’s worth noting that an oversold condition exists. Oversold means that the price of a stock has fallen below its fair value.

ABVC stock fell sharply on October 26th from the gap-up open, likely due to a short attack and profit-taking. This is because ABVC has a small share pool, which made it easier for short sellers to drive the price down, especially in the early afternoon. Investors and swing traders needed time to digest the news and decide whether to buy or sell ABVC stock. Longs were selling to lock in profits before the news could be digested. That selling aided the shorts and was further exacerbated by a lack of buying in the early afternoon.

The stock price of ABVC is likely to go up in the future because the recent good news and upcoming catalysts are likely to have a positive impact on the company and have not yet been taken into account in the stock price. However, it is important to remember that there is no guarantee that the stock price will go up, and investors should always do their own research before making any investment decisions.

In addition to the above, here is a more concise summary:

ABVC stock increased by 362.35% on October 26th, but fell by 67.66% after a short attack and profit-taking.

The stock price continued to decline on October 31st, dropping to a low of $1.01, a decrease of 74.3% from the high on October 26th.

The oversold condition is likely due to the small share pool of ABVC stock.

ABVC's stock price is likely to trend higher in the future because it should be trading higher given the recent news, with a potential gain of 362% or more from wherever the stock is trading in one day the next time the company has a positive press release. This is because ABVC has a small share pool and low float, which makes it easier for the stock price to move sharply. Additionally, strong hands now own the majority of the stock, and the recent good news about ABVC has not yet been factored into the stock price at all.. A positive catalyst, such as the announcement of a new drug approval or partnership, could trigger a significant jump in the stock price.

In other words, ABVC Biopharma has a growth oriented view and is showing a lot of upside potential. If the company has good news in the future, its stock price could go up significantly.

Short interest data for ABVC is not updated as frequently as investors would like. Fintel and Nasdaq report short interest data, but it is important to note that short volume is not the same as a short position held. Both long and short positions can be traded daily for ABVC.

According to Yahoo Finance, as of October 26, 2023, ABVC Biopharma has 3.95 million shares outstanding and a float of 2.68 million shares. marketbeat.com also reports that ABVC Biopharma has a free float of 2.41 million shares so there is a slight difference in count.

This video is dated, but investors should still watch it for ABVC analysis in addition to the analysis provided here. video


Insider ownership and institutions

According to a press release by ABVC BioPharma, Inc. on May 12, 2022, the company entered into securities purchase agreements with certain institutional investors for the issuance and sale of 2,000,000 shares of common stock and warrants to purchase up to 2,000,000 shares of common stock, at a purchase price of $2.11 per share and accompanying warrant in a registered direct offering. The warrants were to be immediately exercisable at an exercise price of $2.45 per share of common stock and will expire five years from the date of issuance. The closing of the offering occurred on or about May 16, 2022, and were subject to the satisfaction of customary closing conditions.

As for insider ownership and institution transaction, insiders stock buying and selling can be found here. Insiders hold 38.99% of the shares and 10 institutions are holding shares in ABVC. 3.28% of the float is held by institutions. Source.

Note: Institutions have to file Form 4 or Form 13F with the SEC within the following timeframe after the last news report on ABVC: within 45 days of the end of the quarter in which the news report was published. For this reason the current number of shares held by institutions is unknown.


The ultimate verdict

ABVC Biopharma Inc. is a promising investment with multiple near-term catalysts. The company’s strategic partnerships in neurological and mental health treatments create a promising future. ABVC’s CNS drugs targeting MDD and ADHD have definitive agreements with Xinnovation for ABV-1504, ABV-1505, and ABV-1601. The definitive agreement carries a possible aggregate income of $20 million for ABVC. There is also a licensing deal with AiBtl BioPharma for a valuation of $667 million. As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032. ABVC’s CNS drug has been developed into a controlled-release tablet formulation or PDC-1421, the primary active ingredient in its neurological programs. This formulation enables the active ingredient to be absorbed slower over time compared to conventional tablet formulations, thereby reducing the dosage frequency and increasing the bioavailability.

Investors should keep an eye on ABVC’s major depressive disorder (MDD) and adult attention-deficit/hyperactivity disorder (ADHD) trials, which, if successful, will take the company closer to Phase III trials for those products and drive its multi-product biopharma company forward. The product is ready for an End-of-Phase II meeting with the FDA to finalize the protocol for Phase III trials. At the same time, ABVC has commenced ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and another five sites in Taiwan. With all these developments in place, ABVC Biopharma Inc. is poised to make a significant impact in the biopharmaceutical industry. ABVC Biopharma shares could revalue upwards of $35 in the next year, given the transformational leadership of the current CEO and his team. Note that the $35 price per share projection is based on current analysis and supported by older projections.


More information:

According to CNN Money, one analyst has a 12-month price target of $20.20 for ABVC Biopharma Inc. This represents a significant increase from the current stock price, which is oversold. The high and low estimates for the stock price are also $20.20, indicating a strong conviction this analyst holds that ABVC has substantial upside potential. Zacks confirmation $20.20.

Zacks had already placed a $9.50 valuation on ABVC well before the recent developments reported above and in the news.

Recent bullish mentions for ABVC share direction were also given by Benzinga's 'Stock Whisper' and the Marketing Sentinel.com.

Maxim Group Llc.,  Zacks and other analysts may come out with updated projections at any time.


Disclaimer: I enjoy searching for undervalued micro caps (Invested in ABVC, it fits the profile). Over the years, I have become a biotech fanatic & studying biotech is my passion. All posts are to initiate discussion, definitely not financial advice.