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Press Release

SyneuRx Reaches Target Enrollment in Phase 2 Clinical Trial of COVID-19 Oral Antiviral Candidate Pentarlandir® (SNB01)

Early research suggests Pentarlandir is safe to use against COVID-19; Phase 3 trial evaluating effectiveness against both COVID-19 and influenza is expected in the coming months

LOS ANGELES and NEW TAIPEI CITY, Taiwan, April 13, 2022 -- SyneuRx™ International (TPEX:6575), a global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system disorders, today announced it has completed enrollment for its phase 2 clinical trial evaluating the efficacy and safety of SNB01 ('Pentarlandir’), a novel COVID-19 oral antiviral candidate. In preclinical studies, Pentarlandir demonstrated preliminary efficacy and an excellent safety profile against Omicron, Delta, and previously identified variants of concern in addition to several influenza viruses.

“COVID-19 continues to plague many parts of the world, including individuals who are immunocompromised, unvaccinated or not up to date on vaccines, or who experience breakthrough infection even when vaccinations are up to date,” said Emil Tsai, M.D.-Ph.D., M.A.S., founder and CEO of SyneuRx. “Antivirals that can potentially address multiple variants are much-needed, new tools to combat COVID-19 at a crucial time as new outbreaks continue to emerge.”

In the phase 2 study, 89 participants suffering from unvaccinated or early-stage breakthrough cases of COVID-19 were randomized evenly into high-dose, low-dose, and placebo groups. For the phase 3 study expected to begin in the coming months, an optimal dose will be selected and the scope will expand to evaluate Pentarlandir’s broad-spectrum antiviral activity in inhibiting SARS-CoV-2 as well as influenza viruses, including rigorous safety assessments.

Tsai continued, “Our goal from the start has been to introduce a safe, effective and accessible therapeutic with multiple use cases, including the ability to work against most COVID-19 variants and treat certain influenza strains in order to keep high-risk patients from hospitalization due to the potential ‘twindemic’ caused by COVID-19 and/or influenza.”

To learn more about the Pentarlandir phase 2 clinical trial, visit clinicaltrials.gov (clinicaltrials.gov identifier: NCT04911777).

To learn more about SyneuRx, visit syneurx.com.

About Pentarlandir

Working through years of research into how several debilitating central nervous system diseases operate, SyneuRx scientists arrived at the theory that regulatory enzymes such as protease would be a critically-important ‘drug target’ for these types of illnesses, which coincidentally is also a target for several virally-caused diseases such as HIV and hepatitis. Researchers decided to test all of the compounds in the company’s patent portfolio against protease and discovered that several SyneuRx-developed compounds were potent protease blockers, of which the compound that became Pentarlandir proved to be the most safe and efficacious in preclinical tests. SyneuRx confirmed its ability to block coronavirus replication in multiple, rigorous cellular studies and it also proved to maintain an excellent safety profile, which made Pentarlandir an ideal candidate to go into clinical development. SyneuRx has found Pentarlandir also may block replication of several influenza viruses in cellular assay. The company continues to test the efficacy of Pentarlandir against other potentially lethal viral strains.

About SyneuRx

SyneuRx International (TPEX:6575) is a clinical-stage global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system (CNS) disease conditions. Founded in 2013, SyneuRx is poised to bring change-making pharmaceuticals to market with a robust, promising pipeline of seven investigational drugs for CNS disorders and two for COVID-19 – eight of which are currently in phase 2 and phase 3 clinical trials with the U.S. Food and Drug Administration. The company’s mission is to infuse a scientific and humanistic approach into its research and development of safe, effective, and accessible therapies for patients suffering from disorders such as schizophrenia, dementia, depression, as well as COVID-19 and other RNA-encoded viruses. Dedicated to taking a safety-first approach with its research and development by focusing on well-established lead compounds as well as natural sources and plant substances to treat or prevent illness, SyneuRx has received Breakthrough Therapy Designations and Orphan Drug Designations from the FDA for two of its novel CNS therapeutics. To learn more, visit syneurx.com.

Media Contact

SyneuRx Press Office

(818) 696-8800

media@syneurx.com

Disclosure Notice

The information contained in this release is as of April 13, 2022. SyneuRx assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about SyneuRx' efforts to combat COVID-19 as well as flu and the company's investigational oral antiviral candidate Pentarlandir® (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advanced purchase agreements, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for Pentarlandir may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any such applications for Pentarlandir, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pentarlandir, including development of products or therapies by other companies; risks related to the availability of raw materials for Pentarlandir; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of Pentarlandir within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRx's business, operations and financial results; and competitive developments.

Recent News

Q&A with SyneuRx Chief Scientist and CEO., Emil Tsai, M.D.–Ph.D., M.A.S.: What are the top Symptoms of the BA.2 Variant and is it a Major Cause for Concern?

Since the beginning of the COVID-19 pandemic two years ago, the public has been told that new variants should be expected as part of the evolution of the virus. At the beginning of 2022, researchers began keeping an eye on a new subvariant known as BA.2.

While many epidemiologists doubt BA.2 will cause a large-scale spike in cases, it is highly transmissible. We sat down with SyneuRx Chief Scientist and CEO., Dr. Emil Tsai, to learn if and how the symptoms of BA.2 differ from previous variants and if there is cause for major concern by the public.

What is the BA.2 variant?

The BA.2 variant is a mutation or subvariant of the BA.1 variant commonly known as Omicron. Omicron was a mutation of the original COVID-19 virus and BA.2 is a mutation of Omicron or BA1.

What do we know about BA.2 so far?
Currently, the BA.2 variant is responsible for the surge in Europe and some East Coast cities. Approximately 30% of cases in the U.S. are the BA.2 variant, but it is gaining momentum. BA.2 is much more infectious than Omnicom. However, it does not have increased severity of illness or death. It is predicted that BA.2 will become the dominant COVID-19 strain within weeks or months in the U.S.

Could Europe’s rise in cases be a signal of what’s to come for the U.S.?

Yes, Europe is a leading indicator of what will happen in the U.S. based on what has happened in the past with COVID-19. It is currently the dominant variant in Europe and is predicted to be the predominant strain in the U.S. in the near future.

How much should you worry about B.A.2 if you’re vaccinated?

Your level of risk is dependent on the date of your last vaccination as well as other factors, such as if you are moderately or severely immunocompromised. If you were vaccinated in the last few months, you would most likely be fine. You will probably have little to no symptoms, or you may have flu-like symptoms. If your vaccination was longer than six months ago, you are elderly, or you have an underlying medical condition such as obesity, cardiovascular disorder, respiratory disorder, etc., then you are at higher risk and should take precautionary measures based on your own medical circumstances and tolerance of risk.

What are the BA.2 variant symptoms?

Again, this is dependent on how recently you were vaccinated, your age and any underlying medical conditions that you may have. If you are vaccinated, young, and do not have any medical conditions, your symptoms could range from no symptoms to flu-like symptoms. If you were vaccinated longer than six months ago, are elderly, or have an underlying medical condition, your symptoms could be much more severe. BA.2 symptoms are similar to those seen with the other variants of COVID-19 and depend on the person and their risk factors.

What order do they appear in?

The symptoms and the order they appear can differ for each infected person. Half of those infected may be asymptomatic, meaning they have no symptoms, while others may have flu-like symptoms or lose their sense of taste or smell. The exact symptoms or the order in which they appear can range drastically. That is why it is essential to be tested if you encounter someone infected with COVID-19 or have any symptoms. Testing is not just for your protection but also for the protection of those you encounter daily.

How severe are BA.2 variant symptoms?

There isn’t an easy answer to this question because it’s dependent on several factors. COVID-19 symptoms and their severity can range from being asymptomatic to death. If your vaccination isn’t up-to-date or you fall into specific categories, symptoms can be very severe. It is well known that symptoms progress in severity depending on your age, underlying medical conditions and vaccination status.

How can we stay safe?

We don’t live in isolation, so we must take precautions. Even if you don’t have symptoms, you could be infected and pass it on to people around you. As individuals, we can stay safe by following the C.D.C. guidelines and getting vaccinated. Still, we must think of others by getting vaccinated, keeping our distance from those who can’t get vaccinated, the elderly and those with underlying medical conditions. We must also get tested whenever we are in direct contact with someone who has tested positive for COVID-19 or are experiencing symptoms, do our part to avoid large crowds, and wear high-quality masks (N95, KN95 or KF94) in indoor spaces because of this very contagious coronavirus strain.

Press Release

SyneuRx Announces Oral COVID-19 Antiviral Drug Candidate Pentarlandir® Is Showing

Effectiveness Against Both the Omicron and Delta COVID-19 Variants

Acting as Both a Dual Protease and TMPRSS2 Inhibitor,

Pentarlandir® is About to Enter FDA Phase III Trial

January 6, 2022 – Los Angeles, US and New Taipei City, Taiwan – SyneuRx™ International, (Taipei Exchange, ticker ID TT6575, www.syneurx.com), a pioneering developer of novel CNS (Central Nervous System) and anti-viral pharmaceuticals, today announced that its investigational oral SARS-CoV-2 (COVID-19) anti-viral drug candidate Pentarlandir® has successfully demonstrated effectiveness against both the Omicron and Delta variants of the virus in its preclinical studies. Pentarlandir® is currently in the final stage of a Phase II US-FDA trial (Phase III is scheduled to begin in 2022).

Designed as an early-stage COVID-19 treatment, Pentarlandir® is given by mouth to patients suffering either from early-stage ‘breakthrough’ cases of COVID-19 (for those who have been previously vaccinated or infected) or potentially as a first-line treatment pathway for the unvaccinated who might otherwise face potential hospitalization and death.

Pentarlandir® is indicated for the majority of COVID-19 patients – people who are in general good health with little risk of progressing to severe COVID-19 (that would result in hospitalization and death). In contrast, the Pfizer drug Paxlovid is designed for those who are at high risk of developing serious COVID-19 complications, (those aged 65 and older, or patients with comorbidities such as diabetes, obesity, heart or respiratory disorders).

Given the natural origins of Pentarlandir®’s active chemical component, costs for the drug are expected to be significantly lower than for Paxlovid. As such, Pentarlandir® will be more accessible and affordable to less wealthy nations and as such represents an ideal solution to addressing the large worldwide population infected with the variant COVID-19 viruses.

How do Pentarlandir® and its competitor drugs stop COVID-19?

The Merck antiviral molnupiravir is considered a polymerase inhibitor, since it targets ribonucleic acid polymerase and inhibits COVID-19 as the RNA polymerase duplicates and introduces fatal errors into viral replication. The drug has a roughly 30% efficacy rate in preventing hospitalizations as demonstrated in early tests and as such is no longer considered a potential first-line treatment.

The Pfizer EUA drug Paxlovid combines two protease inhibitors for its viral attack vectors. Ritonavir is an existing drug used to combat HIV, while Nirmatrelvir is the brand name given to the experimental molecule PF-07321332, which was developed to specifically attack the protease of the COVID-19 virus. Protease is an integral enzyme within the virus that is necessary for proper replication. While Nirmatrelvir attacks the protease of COVID-19, ritonavir attacks the enzymes that would take on Nirmatrelvir, with both drugs operating in tandem to slow the replication of the virus.

Pentarlandir® is efficacious against COVID-19 and its variants by relying on a dual methodology to stop the virus – first acting as a protease inhibitor like Nirmatrelvir, but also acting as a TMPRSS2 inhibitor which acts to prevent the virus from infecting/entering cells in the first place. Unlike Paxlovid, Pentarlandir® is a single chemical with minimal documented side effects and is purified from natural sources, making it far less expensive to manufacture.

SyneuRx and Pentarlandir® Trials:

If successfully developed, SyneuRx intends to make Pentarlandir® available to the world’s developing nations as part of the United Nations-backed Medicines Patent Pool. More information about the Pentarlandir® Phase II trial can be found here: www.clinicaltrials.gov/ct2/show/NCT04911777

Quotes:

“Given the worldwide onslaught of the Omicron variant of COVID-19 plus its ability to substantially evade current vaccines and its proclivity to manifest as a less-lethal endemic virus than its predecessors, the need for an inexpensive and highly-effective oral antiviral has never been greater, regardless of whether the pandemic is transitioning to endemic” said Dr. Guochuan ‘Emil’ Tsai MD PhD MAS, founder and CEO of SyneuRx. “We are very pleased that Pentarlandir® shows strong effectiveness against Omicron, and our hope is that it will become a drug of choice for home treatment of COVID-19 throughout the world in the future.”

About SyneuRx

SyneuRx is publicly traded in Taipei Exchange (ticker ID TT6575); it was founded in 2013 with the goal of using scientific breakthroughs to develop novel CNS drugs for patients suffering from severe mental health disorders. The multi-national team is located in the U.S. and Taiwan. Prior to starting SyneuRx, Dr. Guochuan (Emil) Tsai, MD, PhD was a member of the faculty at Harvard Medical School and is now at the UCLA School of Medicine, Department of Psychiatry and Biobehavioral Sciences.

SyneurRx and Pentarlandir are trademarks and registered trademarks, respectively, of SyneuRx International. All previous trademarks and registered trademarks previously cited are hereby recognized and acknowledged.

Disclosure Notice

The information contained in this release is as of January 6, 2022. SyneuRx assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about SyneuRx’s efforts to combat COVID-19 as well as flu and the company’s investigational oral antiviral candidate Pentarlandir® (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advanced purchase agreements, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for Pentarlandir® may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any such applications for Pentarlandir®, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pentarlandir®, including development of products or therapies by other companies; risks related to the availability of raw materials for Pentarlandir®; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of Pentarlandir® within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRx’s business, operations and financial results; and competitive developments.

Press Release

German

French

中文

SyneuRx Announces Oral COVID-19 Twindemic Antiviral Drug Candidate Pentarlandir®
Has Entered Final Portion of FDA Phase II Testing

Based on Highly-Purified Isomers of Tannic Acid and Acting as a Dual Protease and TMPRSS2 Inhibitor, Pentarlandir Has Shown Significant Anti-Viral Properties
with Minimal Observed Side Effects

November 19, 2021 – Los Angeles, CA – SyneuRx™ International, (www.syneurx.com), a pioneering developer of novel CNS (Central Nervous System) and anti-viral pharmaceuticals, today announced that its investigational oral SARS-CoV-2 (COVID-19) anti-viral drug candidate Pentarlandir® has successfully been in Phase II US-FDA trial for several months and is nearing Phase III in 2022.

Designed as an early-stage COVID-19 treatment, Pentarlandir® is given by mouth to patients suffering either from ‘breakthrough’ cases of COVID-19 (for those who have been previously vaccinated or infected) or potentially as a first-line treatment pathway for the unvaccinated who might otherwise face potential hospitalization and death. SyneuRx has previously received ‘Breakthrough Therapy Designation and Orphan Drug Designation’ grants by the FDA for its CNS drug candidates.

Pentarlandir® is based on highly-purified isomers of tannic acid and is derived from a botanical origin (just like Tamiflu®, which is itself purified from a chemical found in Star Anise). Pentarlandir® specifically targets main protease, or 3CL-protease, which turns baseline viral protein into the necessary building blocks that enable the replication of new viral particles and also inhibits TMPRSS2 for viral entry. Pentarlandir acts on not just the serine protease TMPRSS2, but also HAT (both of which are critical for the entry of influenza-type viruses into cells). Therefore, it holds promise as a therapeutic tool for ‘twindemic’ scenarios (treatment of both COVID-19 and Influenza endemics).

If successfully developed, SyneuRx intends to make Pentarlandir® available to the world’s developing nations as part of the United Nations-backed Medicines Patent Pool. Pentarlandir® is projected to be widely-available worldwide within 12-24 months following phase III under current factory availability.

More information about the Pentarlandir Phase II trial can be found here: https://www.clinicaltrials.gov/ct2/show/NCT04911777

How was Pentarlandir® Discovered?

After years of research into how several debilitating CNS diseases operate, SyneuRx scientists arrived at the theory that metabolizing/regulating enzymes such as protease were in fact a critically-important ‘drug target’ for these types of illnesses, which coincidentally have proven to be a critical mechanism of action for several virally-caused diseases such as HIV and Hepatitis.

Researchers decided to test all the compounds in the company’s patent portfolio against the SARS-CoV-2 protease and found to their surprise that several SyneuRx-developed compounds were potent protease blockers for both SARS-CoV-2 and H1N1 influenza viruses, of which the compound that became Pentarlandir proved to be the most efficacious.

Further studies confirmed Pentarlandir®’s ability to block coronavirus replication in multiple, rigorous cellular studies and it also proved to maintain an excellent safety profile, which made it the best candidate to go into clinical development.

“The importance of finding a safe, inexpensive and highly-efficacious oral drug capable of treating COVID-19 for people regardless of their risk of progression cannot be overstated,” said Dr. Guochuan ‘Emil’ Tsai MD PhD MAS, founder and CEO of SyneuRx. “Our researchers have devoted several years to the discovery, isolation and development of Pentarlandir and we are very pleased with the progress of the Phase II trial. We are actively developing this candidate drug and remain hopeful that we will continue our positive track record to date.”

About SyneuRx

Disclosure Notice

The information contained in this release is as of November 18, 2021. SyneuRx assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about SyneuRx’s efforts to combat COVID-19 as well as flu and the company’s investigational oral antiviral candidate Pentarlandir® (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advanced purchase agreements, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for Pentarlandir may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any such applications for Pentarlandir, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pentarlandir, including development of products or therapies by other companies; risks related to the availability of raw materials for Pentarlandir; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of Pentarlandir within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRx’s business, operations and financial results; and competitive developments.

Press Release Frequently Asked Questions

About SyneuRx

What are the origins of SyneuRx as a company?

In the early 2000’s, SyneuRx founder and CEO Dr. Guochuan (Emil) Tsai, MD, PhD, MAS was evaluating a series of prominent new neurological pathways he had discovered while at Harvard and UCLA that showed a profound impact on patients suffering from depression, dementia and schizophrenia.

After several years of research into pharmacologically-active chemicals that might impact these novel regulatory pathways, several biologically-active agents proved to be very promising drug candidates affecting these newly-found pathways, producing very positive results in early animal and human trials.

In 2013, Dr. Tsai founded SyneuRx in Taipei, Taiwan to facilitate commercial development of these and other Central Nervous System (CNS) pharmaceuticals he was developing - the company was listed on the Taiwan Stock Exchange shortly thereafter.

What are the company founder’s milestone academic and research achievements?

Prior to starting SyneuRx, Dr. Guochuan (Emil) Tsai, MD, PhD, MAS was a member of the faculty at Harvard Medical School - he is now at the UCLA School of Medicine, Department of Psychiatry and Biobehavioral Sciences. His expertise in brain science, psychiatry and management began with a rigorous academic background, including his education at National Yang-Ming University, Taiwan, Johns Hopkins Medical School and Carey School of Business (both of Baltimore, Maryland).

Dr. Tsai trained in his formative clinician years at Massachusetts General Hospital, McLean Hospital, and the teaching hospitals of Harvard. He has received advanced degrees in general psychiatry and child / adolescent psychiatry as well as neuroscience, and is a diplomate of the American Board of Psychiatry and Neurology in both adult and child psychiatry. He has been elected to receive the title of ‘Fellow’ at the esteemed American College of Neuropsychopharmacology and is a member of the Society for Neuroscience.

He has published more than 100 scientific articles, with more than 14,000 citations as well as holding more than 100 granted patents. His pioneering research opened up the field of glutamatergic treatments for brain disorders; he was the first to report the therapeutic efficacy of NMDA modulation for a wide variety of CNS disorders.

The new therapeutic classes he has validated includes: full and partial agonists of NMDA receptor, inhibitors for glycine transporter and D-amino acid oxidase inhibitor. These discoveries are the cornerstone that led to the establishment of the pharmaceutical venture SyneuRx (TT6575) - founded by Dr. Tsai in 2013, and which has a diverse pipeline of CNS and anti-viral therapeutics.

Most recently, Dr. Tsai has discovered an array of novel chemicals that are inhibitors of 3CL protease, a pathway that is absolutely needed for the processing of SARS-CoV-2 (COVID-19) viral proteins during viral replication, and inhibitors of TMPRSS2 for viral entry. In other words, it was found that the most promising of these new drug candidates stops the COVID-19 virus from multiplying as well as entering human cells.

Is SyneuRx a public company – if yes, on what exchange?

SyneuRx is currently traded on the Taipei Exchange, with a ticker ID of TT6575. A complete 5-year stock history of the company since December 01, 2016 may be found at https://finance.yahoo.com/quote/6575.TWO/

Where are the company’s primary offices located?

Ongoing R&D is undertaken in Taipei at 20F-10, No.99, Sec.1, Xintai 5th Rd, Xizhi Dist., New Taipei City 22175, Taiwan, while the United States operation is responsible for clinical trials, sales and marketing and is based at 411 Amapola Ave. Torrance, CA 90501.

What are the total number of employees worldwide?

SyneuRx employs 53 people worldwide.

How many drugs does SyneuRx currently have under development?

SyneuRx currently has two schizophrenia drug candidates under FDA evaluation (two Breakthrough Therapy Designations granted by US-FDA for adult and treatment-resistant schizophrenia); two drug candidates under FDA evaluation for depression and suicide, two drug candidates under FDA evaluation for dementia, and two for COVID-19 treatments (the COVID drug Pentarlandir® has both oral and inhaler formulations for this modality).

How many of these drugs have been approved by the FDA? How many are still in trials?

Currently, SyneuRx has not received FDA approval for its pharmacological products in the pipeline, as they are all in Phase II or III testing at the moment. It is worth noting that the FDA approves only 20-60 new drugs a year for all diseases combined and the process is understandably painstaking to protect public health.

What kind of experts does SyneuRx have working on research and development and how does the company’s drug development methodology operate?

The company currently employs 10 PHD’s/MD’s in biochemistry, molecular biology, neuroscience, pharmacology, veterinary medicine, medicine, and health economics.

From a methodology standpoint, SyneuRx starts with compound discovery (invention) of novel mechanisms for therapeutic treatments satisfying both CNS and anti-virologic use-cases, then goes on to validation of these novel mechanisms, to involvement in a wide range of preclinical studies all the way through to clinical studies, manufacturing, marketing and distribution.

Why have I never heard of SyneuRx?

Unless you are involved in any of our FDA trials or are a clinical / research mental health scientist, there is no reason to be familiar with our company as SyneuRx has no consumer-available drugs for sale at the moment.

Is there any FDA-related documentation or study information data available at this stage for review?

SyneuRx has received several ‘Breakthrough Therapy Designations and Orphan Drug Designations’ granted by the FDA. However, that dossier has not yet been made public by the Agency.

Are there any other drugs SyneuRx is currently developing outside of COVID-19 treatments?

There are 7 other investigational drugs, see the drug pipeline on www.syneurx.com for more information about our potential therapies for depression, dementia and schizophrenia.

Have any of the company’s stable of CNS pharmaceuticals passed FDA certification?

We have two Breakthrough Therapy Designations by the FDA. They are now in late-phase clinical development, but are not approved as of yet.

About Pentarlandir®

How was Pentarlandir® discovered as being effective against COVID-19?

Working through years of research into how several debilitating CNS diseases operate, SyneuRx scientists arrived at the theory that regulatory enzymes such as protease would be a critically-important ‘drug target’ for these types of illnesses, which coincidentally is also a target for several virally-caused diseases such as HIV and hepatitis.

Researchers decided to test all the compounds in the company’s patent portfolio against protease and found to their shock that several SyneuRx-developed compounds were potent protease blockers, of which the compound that became Pentarlandir® proved to be the most safe and efficacious.

We confirmed its ability to block coronavirus replication in multiple, rigorous cellular studies and it also proved to maintain an excellent safety profile, which made Pentarlandir® the best candidate to go into clinical development.

What is the primary organic ingredient that Pentarlandir® is derived from?

Pentarlandir® is based on isomers of tannic acid, which are derived from a botanical origin (Tamiflu®, by way of comparison, is itself purified from Star Anise) - SyneuRx purifies the specific isomers of tannic acid to ~99% from a high-content source plant.

Being a highly-purified form of tannic acid, does that mean a patient could self-treat themselves with massive amounts of tea or red wine instead of Pentarlandir®?

No, there is a huge difference between tannins and tannic acid. Tannic acid is not present in tea or red wine at all, these contain tannins OTHER than tannic acid. Tannins are a broad class of compounds that are present in foods and beverages alike. Tannic acids, however, are a diverse group of compounds with wildly-divergent potencies vis a vis stopping the COVID-19 virus replication.

How can you claim such a commonly-found natural ingredient as tannic acid is an efficacious anti-viral against the scourge of COVID-19, when so many other drugs have failed to be approved or meet minimum therapeutic efficacy claims against coronavirus?

Drug development is about identifying the ‘right’ target (mechanism of action) and finding the safest and most effective compounds to address that specific target. Protease proved to be the right target to prevent the COVID-19 virus from replicating in cells or animals, so the next step was to find the right compound at the right dose that was most efficacious for human patients.

Many promising COVID-19 drugs are essentially ‘fishing expeditions’ trying to find the right path to safety and efficacy - virtually all of these types of drugs fail to be approved. Untenable side effects and failure to show categoric proof of efficacy via statistical norms are other reasons why so many previous drug candidates have failed even in Phase II or III FDA drug trials.

Is Pentarlandir effective against other virally-caused illnesses besides COVID-19?

SyneuRx has found Pentarlandir® also blocks replication of the H1N1 influenza virus in cellular assay – we continue to test the efficacy of Pentarlandir® against H1N1 and other potentially lethal viral strains.

What are the target biologic areas being addressed by Pentarlandir® that make it effective against COVID?

Pentarlandir® specifically targets the Main protease, or named 3CL-protease, which turns baseline viral proteins into the necessary building blocks that enable the virus to replicate new viral particles.

Is Pentarlandir® a vaccine?

No. Vaccines induce the body to create antibodies which prevent people from getting sick in the first place. Pentarlandir® is indicated for use in already infected COVID-19 patients and acts to inhibit viral reproduction - it is therefore a treatment, not a preventive vaccine.

Is Pentarlandir® a substitute for getting vaccinated?

ABSOLUTELY NOT - vaccines are for prevention, while Pentarlandir® is designed solely for treatment of existing COVID-19 illness. If effectiveness is satisfactory, vaccination is always preferable to treatment in non-infected individuals, without exception!

Until the entire world has been vaccinated, there is a huge need for an antiviral drug like Pentarlandir® - and even after 95%+ world vaccination rates, the virus has been continuing to mutate at an unpredictable rate. As such, current vaccines may prove to be tragically and immediately ineffective if facing a major mutation (called immune evasion) as in the case of Omicron variant, at least until a new version of the vaccine can be created and approved for use. This process alone can take several months (at the least) and thus a convenient, safe and effective treatment for cases involving the new mutation is warranted for stockpiling and eventual distribution.

Is Airnecflu® the same as Pentarlandir®?

Though Airnecflu® has the same active ingredient as Pentarlandir®, it is designed for inhalation use only.

Since Pentarlandir® was originally developed as a CNS (Central Nervous System) drug, will SyneuRx still pursue FDA certification for it in this capacity?

Due to the immediate urgency of the COVID catastrophic pandemic, the CNS label will be sought after the initial indication of efficacy against COVID-19.

About Pentarlandir® Phase II Trial

I’m interested in signing up to become a part of the FDA trials of Pentarlandir®, how can I do that?

Please refer to NCT04911777 at clinictrials.gov.

What are the minimum requirements for a patient to be considered as part of the trial?

For the ongoing Phase II study, the study individuals need to have symptomatic and documented mild COVID-19 disease. The purpose of the study is to determine Pentarlandir®’s efficacy in resolving the symptoms and slowing down or stopping the progression of mild to moderate COVID-19 into a severe illness in a range of test subjects.

How long has the FDA been evaluating Pentarlandir® and in what stage are the current trials?

Pentarlandir® is currently in Phase II trials as of January, 2022. The FDA approved the study to proceed in the early summer of 2021.

Have any non-U.S. equivalent governmental body to the FDA approved Pentarlandir® for COVID-19 treatments?

Not as of yet.

How long does a patient have to take Pentarlandir® to achieve maximum efficacy?

In the Phase II study, the drug is administered for 14 days – that number could move down in Phase III if it is determined to be safe and effective to lower the dosage period.

I think I was exposed to COVID-19, how soon would I need to begin Pentarlandir® treatment?

Final guidelines on Pentarlandir® treatments will be provided by your physician if the drug is approved for treating COVID.

Where are the primary Pentarlandir® clinical trials currently underway?

Please refer to the public information regarding the trial at NCT04911777 in clinicaltrials.gov.

How can I get more information about SyneuRx, Pentarlandir® or Airnecflu®?

Please visit the SyneuRx website at www.syneurx.com.

What are the documented side effects of taking Pentarlandir® or Airnecflu®?

There have been no serious side effects observed to date as part of the Phase II Pentarlandir® clinical trial. We continue to monitor the safety of our test subjects throughout the clinical studies. For Airnecflu®, we are now conducting a GLP animal toxicity study for potential inhalation side effects. It will be completed by Q2, 2022.

Pentarlandir® vs Other COVID Treatment

Is Pentarlandir® a similar drug to Ivermectin and Hydroxychloroquine?

No, they have completely different mechanisms of action and neither of these drugs is in fact proven to work against COVID-19 at all.

The initial report touting Ivermectin as an effective COVID-19 cure was found to be fraudulent. There is also no scientifically-valid evidence supporting the efficacy of hydroxychloroquine as a COVID-19 treatment or cure.

How does Pentarlandir® compare to other COVID antiviral treatments available in the market, such as Pfizer’s new drug Paxlovid or Merck’s Molnupiravir?

Pentarlandir® serves a different population than Pfizer’s Paxlovid™ or Merck’s Molnupiravir™. Pentarlandir is indicated for the majority of COVID-19 patients – people who are in general good health[BU1] [ET2] with little risk of progressing to severe COVID-19 (that would result in hospitalization and death). In contrast, the Pfizer® drug Paxlovid is designed for those who are at high risk of developing serious COVID-19 complications,(those aged 65 and older, or patients with cormorbidities such as diabetes, obesity, heart or respiratory disorders).Paxlovid and Molnupiravir both are found to reduce the risks of hospitalization or death (89% by Paxlovid and 50% by Molnupiravir). Officials at the FDA has given authorization for Paxlovid™ to be given to adults and children over the age of 12 who face a high risk of hospitalization. FDA panel narrowly votes to recommend Molnupiravir™ for COVID-19. The panel voted that the pill should only be given to people with symptomatic infections and people who have a high risk of developing severe symptoms.

While these two new drugs are effective to high-risk COVID patients, there is still no approved treatment for those who are not high-risks.

Our investigational drug Pentarlandir® is aimed to treat everyone, vaccinated or not, early in the process with mild-to-moderate symptoms and without high risks of developing severe COVID. This is a much wider indication and will be applicable to most COVID patients in the worldwide general population.

Pentarlandir® has 3 pathways to suppress COVID virus infection. The main mechanism of action is the same as the more effective Pfizer’s Paxlovid™, which is to inhibit the main-protease of SARS-CoV-2 from producing the necessary building blocks for the virus to replicate. In addition, Pentarlandir® can also inhibit TMPRSS2 and blocks the viral entry to human cells. Last but not least, it can also work to suppress inflammatory response to the infection to reduce serious complications such as a cytokine storm from COVID.

Pentarlandir® acts on not only the serine protease TMPRSS2 (transmembrane protease serine 2) but also HAT (human trypsin-like protease), both of which are critical for the entry of influenza-type viruses into cells. Therefore, Pentarlandir® and its next generation product Airnecflu® (for inhalation use) hold promise to be the therapeutic tool for ‘twindemic’ scenarios (treatment of both COVID-19 and Influenza endemics, which has been call “flurona” recently).

Roche-Atea’s oral antiviral drug candidate AT-527 failed its phase 2 trial in Oct 2021. It’s also for mild-to-moderate COVID-19 patients. Why do you think SyneuRx’s Pentarlandir® will succeed?

While Roche’s antiviral targets the same patient population (mild-to-moderate COVID patients), it has completely different mechanisms of action: AT-527 inhibits viral replication via RdRp chain termination and NiRAN inhibition. If anything, At-527 is closer to Remdesivir than to our candidate drug Pentarlandir®. Cumulative evidence from clinical studies to date have shown little-to-no benefit of Remdisivir for hospitalized patients with COVID (review article in NEJM Aug 3, 2021) and the WHO has recommended against the use of Remdesivir due to limited clinical benefits.

How does Pentarlandir® compare to the recent discovery that an inexpensive antidepressant known as Fluvoxamine is an effective treatment for COVID-19?

Fluvoxamine reduces production of inflammatory cytokines in animal studies. The effect is not directly on the virus. Current tests around fluvoxamine are still inconclusive at best, but we are watching its progress carefully and hope that it does prove to be an effective COVID-19 treatment in addition to Pentarlandir®.

Is Airnecflu® the same as Tamiflu?

No, Tamiflu acts on neuraminidase – Airnecflu® operates via serine protease inhibition. Tamiflu is totally ineffective against COVID-19 because of the type of pathways this virus uses for entry of the cell and replication.

Is Pentarlandir® the same as Tamiflu?

No, Pentarlandir® acts on the serine proteases TMPRSS2 and HAT, which are critical for the entry of influenza-type viruses and SARS-coronavirus into cells. Tamiflu does not and is thus ineffective against COVID-19. Both Pentarlandir® and Airnecflu® do share one important similarity to Tamiflu – all three originally are derived exclusively from common organic sources.

Product Approval/Availability

Will SyneuRx make Pentarlandir® available to the world’s developing nations as part of the United Nations-backed Medicines Patent Pool?

Absolutely! The world is in a pandemic catastrophe and profits must never replace human lives, in the opinion of SyneuRx management.

What countries are expected to receive access to Pentarlandir® first upon FDA approval?

Availability will be determined by the approval of national regulatory agencies such as the U.S. FDA. The FDA is the world’s gold standard for drug approvals - most countries are expected to swiftly follow suit if the FDA approves Pentarlandir®.

How many full-course patient doses of Pentarlandir does SyneuRx expect to be able to make per month?

At our current single factory capacity – 2,000,000. Should large pharmaceutical companies with multiple factories worldwide choose to partner with SyneuRx, that number could easily increase to 100X that number.

Has any retail price for Pentarlandir® been established as of yet?

No, but it will be affordable - Pentarlandir® was created to save humanity from viral catastrophe, not for business gain. We will make Pentarlandir® as accessible and affordable to less wealthy nations and as such represents an ideal solution to addressing the large worldwide population infected with the variant COVID-19 viruses.

Has SyneuRx decided whether to partner with a tier-1 pharmaceutical company to distribute or manufacture any of its drugs under license?

We are keenly interested in forming partnership to maximize availability of our investigational COVID-19 treatment to the world.

What are the specific patient circumstances that would necessitate prescribing Airnecflu® instead of Pentarlandir®?

Airnecflu® is indicated for patients with primary respiratory infections, which is how most COVID patients present before hospitalization. There is no restriction for using either version of the drug, but if patients have infections in other organ systems outside of the lungs, we would recommend the oral Pentarlandir® instead. The final instructions will be from your physician once the drugs are approved.

Are there any manufacturing-specific challenges that would hamper initial supplies of any SyneuRx COVID-19 formulations?

SyneuRx has a proprietary manufacturing process. Other than the badly-broken worldwide supply chain experienced by any company beginning in 2021 requiring raw materials or finished goods from another part of the world, the answer is no.

What distribution channels does SyneuRx plan to utilize for worldwide distribution?

We are still determining the best way to move forward for this.

When does SyneuRx expect to receive notification of the final FDA trial results and begin selling Airnecflu® and/or Pentarlandir®?

After Phase II has been marked as completed by the FDA, the next step is to progress to a Phase III FDA study and final review by a Board of specialist physicians and scientists who will make their recommendations to the Agency for final decision.

If everything goes forward in a positive manner, Pentarlandir® is projected to be widely available worldwide within 12-24 months, while Airnecflu® is projected to be widely available in 2023-2024. Should a major pharmacology company partner with SyneuRx to speed up the clinical development, manufacture and distribution, those times-to-market would be massively reduced.

Others

Why should I believe that Pentarlandir® is effective, isn’t this just another example of junk science trying to pass off a ‘miracle cure’?

Protease inhibitors have proven themselves over decades of use to become the main therapeutic agent treating infections caused by other single strand RNA viruses. Proven science - not hype - drives our potential COVID-19 efficacy claims.

What material impact on the SyneuRx stock is expected if the FDA approves Airneflu® and/or Pentarlandir®?

As a publicly-traded company, we cannot make any comment in regards to forward-looking statements outside of officially-sanctioned analyst calls.

What assurances does the public have that SyneuRx is a legitimate company?

As a public company for several years that has been listed in Taipei, SyneuRx (like other public companies) regularly undergoes official regulation and exhaustive auditing by both the Exchange and the Taiwanese governmental agencies. The founder/CEO of the company is an internationally-recognized scientist and physician with impeccable academic and medical credentials.

Is today’s announcement a way for major stockholders to ‘pump and dump’ their shares?

Our announcement is all about communicating that a potential COVID therapy with solid MOA (mechanism of action) is under development that can save lives in a global pandemic catastrophe. A pandemic that desperately needs treatments for a potential lethal disease possessed of high transmissibility - the idea of using this announcement for personal gain is repugnant to the company founders, the Board of Directors and all the major stockholders.

Further, the stock market in Taipei is under constant scrutiny by government agencies and ‘insiders’ cannot trade stock around the time of any major announcement until an appropriate window of delay after the news has passed.

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Press Release Frequently Asked Questions

About SyneuRx

What are the origins of SyneuRx as a company?

What are the company founder’s milestone academic and research achievements?

Is SyneuRx a public company – if yes, on what exchange?

Where are the company’s primary offices located?

What are the total number of employees worldwide?

How many drugs does SyneuRx currently have under development?

How many of these drugs have been approved by the FDA? How many are still in trials?

What kind of experts does SyneuRx have working on research and development and how does the company’s drug development methodology operate?

Why have I never heard of SyneuRx?

Is there any FDA-related documentation or study information data available at this stage for review?

Are there any other drugs SyneuRx is currently developing outside of COVID-19 treatments?

Have any of the company’s stable of CNS pharmaceuticals passed FDA certification?

About Pentarlandir®

How was Pentarlandir® discovered as being effective against COVID-19?

What is the primary organic ingredient that Pentarlandir® is derived from?

Being a highly-purified form of tannic acid, does that mean a patient could self-treat themselves with massive amounts of tea or red wine instead of Pentarlandir®?

How can you claim such a commonly-found natural ingredient as tannic acid is an efficacious anti-viral against the scourge of COVID-19, when so many other drugs have failed to be approved or meet minimum therapeutic efficacy claims against coronavirus?

Is Pentarlandir effective against other virally-caused illnesses besides COVID-19?

What are the target biologic areas being addressed by Pentarlandir® that make it effective against COVID?

Is Pentarlandir® a vaccine?

Is Pentarlandir® a substitute for getting vaccinated?

Is Airnecflu® the same as Pentarlandir®?

Since Pentarlandir® was originally developed as a CNS (Central Nervous System) drug, will SyneuRx still pursue FDA certification for it in this capacity?

About Pentarlandir® Phase II Trial

I’m interested in signing up to become a part of the FDA trials of Pentarlandir®, how can I do that?

What are the minimum requirements for a patient to be considered as part of the trial?

How long has the FDA been evaluating Pentarlandir® and in what stage are the current trials?

Have any non-U.S. equivalent governmental body to the FDA approved Pentarlandir® for COVID-19 treatments?

How long does a patient have to take Pentarlandir® to achieve maximum efficacy?

I think I was exposed to COVID-19, how soon would I need to begin Pentarlandir® treatment?

Where are the primary Pentarlandir® clinical trials currently underway?

How can I get more information about SyneuRx, Pentarlandir® or Airnecflu®?

What are the documented side effects of taking Pentarlandir® or Airnecflu®?

Pentarlandir® vs Other COVID Treatment

Is Pentarlandir® a similar drug to Ivermectin and Hydroxychloroquine?

How does Pentarlandir® compare to other COVID antiviral treatments available in the market, such as Pfizer’s new drug Paxlovid or Merck’s Molnupiravir?

Roche-Atea’s oral antiviral drug candidate AT-527 failed its phase 2 trial in Oct 2021. It’s also for mild-to-moderate COVID-19 patients. Why do you think SyneuRx’s Pentarlandir® will succeed?

How does Pentarlandir® compare to the recent discovery that an inexpensive antidepressant known as Fluvoxamine is an effective treatment for COVID-19?

Is Airnecflu® the same as Tamiflu?

Is Pentarlandir® the same as Tamiflu?

Product Approval/Availability

Will SyneuRx make Pentarlandir® available to the world’s developing nations as part of the United Nations-backed Medicines Patent Pool?

What countries are expected to receive access to Pentarlandir® first upon FDA approval?

How many full-course patient doses of Pentarlandir does SyneuRx expect to be able to make per month?

Has any retail price for Pentarlandir® been established as of yet?

Has SyneuRx decided whether to partner with a tier-1 pharmaceutical company to distribute or manufacture any of its drugs under license?

What are the specific patient circumstances that would necessitate prescribing Airnecflu® instead of Pentarlandir®?

Are there any manufacturing-specific challenges that would hamper initial supplies of any SyneuRx COVID-19 formulations?

What distribution channels does SyneuRx plan to utilize for worldwide distribution?

When does SyneuRx expect to receive notification of the final FDA trial results and begin selling Airnecflu® and/or Pentarlandir®?

Others

Why should I believe that Pentarlandir® is effective, isn’t this just another example of junk science trying to pass off a ‘miracle cure’?

What material impact on the SyneuRx stock is expected if the FDA approves Airneflu® and/or Pentarlandir®?

What assurances does the public have that SyneuRx is a legitimate company?

Is today’s announcement a way for major stockholders to ‘pump and dump’ their shares?

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