CStone Pharmaceuticals Reports 2019 Annual Financial Results

HONG KONG, Mar 26, 2020 – (ACN Newswire) – CStone Pharmaceuticals ("CStone"; Stock Code: 2616.HK), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and molecularly-targeted precision medicines for the treatment of cancer, today released its audited annual financial results for the year ended December 31, 2019.

"2019 was a transformational year for the company as we continued to advance the development of our IO and precision medicine products. Among the multiple critical milestones achieved, we initiated 9 new pivotal studies, for a total of 13 registration studies that are ongoing," said Dr. Frank Jiang, Chairman and Chief Executive Officer of CStone. "In 2019, we presented key data of our three IO backbone assets, which have demonstrated promising safety and efficacy profiles. In particular, CS1001 (anti-PD-L1), our lead IO monoclonal antibody showed efficacy in multiple tumor types, with especially outstanding activity in esophageal cancer and natural killer T-cell lymphoma ("NKTL"), indicating its potential to be a best-in-class drug candidate. We have also made major progress with our precision medicine portfolio, novel IO combinations, and other early phase programs. We have further enhanced our external partnership, including an IO combination collaboration with Bayer Healthcare LLC and a licensing partnership with Numab Therapeutics AG. In addition to the pipeline progress, we have entered into agreement for the construction of our own global R&D headquarters and manufacturing facility in Suzhou, laying the foundation for cutting-edge research and sustainable drug supply in the future. More importantly, we embarked on the journey of commercialization by having Ms. Shirley Zhao (MD, MBA) join us to lead and scale up a full-fledged commercial organization."

Looking forward, we expect to receive New Drug Application ("NDA") approval in Taiwan for TIBSOVO (ivosidenib) in relapsed/refractory acute myeloid leukemia ("R/R AML") this year. We will submit several NDAs / Biologics License Applications in China across multiple indications for our lead assets including CS1001, avapritinib and pralsetinib; and expect data readouts of seven critical clinical studies. We also aspire to establish a Pipeline 2.0 with more first-in-class/best-in-class therapies. Moreover, we anticipate to further scale up our commercialization in 2020 and drive successful launches of our lead assets in the coming years.

FINANCIAL HIGHLIGHTS

Non-International Financial Reporting Standards ("Non-IFRS") Measures:

The research and development expenses excluding the share-based payment expenses increased by RMB461.8 million from RMB726.9 million for the year ended December 31, 2018 to RMB1,188.7 million for the year ended December 31, 2019, primarily attributable to additional trials which increased clinical development costs.

The administrative expenses excluding the share-based payment expenses increased by RMB58.3 million from RMB79.3 million for the year ended December 31, 2018 to RMB137.6 million for the year ended December 31, 2019, primarily attributable to increase in employee costs.

The loss excluding the effect of the fair value changes of the conversion feature of preferred shares and share-based payment expenses increased by RMB468.7 million from RMB672.6 million for the year ended December 31, 2018 to RMB1,141.3 million for the year ended December 31, 2019, primarily due to increase in research and development expenses and administrative expenses, while partially offset by increase in interest income.

International Financial Reporting Standards ("IFRS") Numbers:

– Other income increased by RMB63.5 million from RMB20.5 million for the year ended December 31, 2018 to RMB84.0 million for the year ended December 31, 2019, primarily attributable to increase in interest income from bank deposits and time deposits.
– Other gains and losses decreased by RMB104.6 million from losses of RMB742.0 million for the year ended December 31, 2018 to losses of RMB637.4 million for the year ended December 31, 2019, primarily attributable to a narrowed loss on fair value changes of derivative financial liabilities, which was a non-cash, one-time adjustment upon the listing as required under the IFRS.
– Research and development expenses increased by RMB545.4 million from RMB850.2 million for the year ended December 31, 2018 to RMB1,395.6 million for the year ended December 31, 2019, primarily attributable to additional trials which increased clinical development costs.
– Administrative expenses increased by RMB150.5 million from RMB191.0 million for the year ended December 31, 2018 to RMB341.5 million for the year ended December 31, 2019, primarily attributable to increase in employee costs.
– As a result of the above factors, the loss for the year increased by RMB515.3 million from RMB1,793.1 million for the year ended December 31, 2018 to RMB2,308.4 million for the year ended December 31, 2019, primarily due to increase in research and development expenses and administrative expenses, while partially offset by increase in interest income.

BUSINESS HIGHLIGHTS

On February 26, 2019 (the "Listing Date"), the Company was successfully listed on The Stock Exchange of Hong Kong Limited (the "Stock Exchange"). Over the past year, significant advancement has been made with respect to our product pipeline and business operations:

Late-stage assets:

– CS1001 (PD-L1 antibody) – In 2019, we have made notable progress to advance our lead immuno-oncology ("IO") asset CS1001 in the clinic, qualifying it as a promising anti-PD-L1 with unique advantage and significant differentiation. Data presented at 3 major congresses (Chinese Society of Clinical Oncology ("CSCO"), European Society for Medical Oncology ("ESMO"), and The American Society of Hematology ("ASH") have demonstrated that CS1001 is safe and efficacious in multiple solid tumors and lymphomas, including esophageal, gastric, cholangiocarcinoma/ gall bladder, and microsatellite instability-high ("MSI-H")/mismatch repair deficient ("dMMR") cancer, as well as NKTL. Its outstanding activity in esophageal cancer and NKTL in particular reveals the potential of CS1001 as a best-in-class drug candidate. Based on these proof-of-concept data, we have initiated two additional registrational trials of CS1001 in China for patients with advanced gastric cancer and esophageal cancer, and dosed the first patient in April 2019 and December 2019, respectively. Together with the 4 initiated in 2018 (Stage III non- small cell lung cancer ("NSCLC"), stage IV NSCLC, NKTL and classical Hodgkin lymphoma ("cHL")), we are currently conducting 6 registrational trials for CS1001. We expect top-line results of the Phase III trial of CS1001 in combination with standard-of- care chemotherapies in patients with first-line Stage IV squamous or non-squamous NSCLC to be available in the second half of 2020. Furthermore, we plan to consult with Center for Drug Evaluation ("CDE") on our cHL and NKTL regulatory strategy and expect to submit an NDA in China for cHL and potentially also NKTL in the second half of 2020.

– CS1003 (PD-1 antibody) – Preliminary data of the Phase Ia study of CS1003 monotherapy were presented at the CSCO 2019 annual meeting, which showed that CS1003 was safe and tolerable. Anti-tumor activity of CS1003 was observed in multiple tumor types. We have initiated a global Phase III trial of CS1003 in combination with LENVIMA (lenvatinib), a standard-of-care tyrosine kinase inhibitor ("TKI") in patients with advanced hepatocellular carcinoma ("HCC") and dosed the first patient in December 2019.

– Ivosidenib (CS3010) – In May 2019, an NDA for the isocitrate dehydrogenase-1 inhibitor TIBSOVO (ivosidenib) has been submitted to the Taiwan Food and Drug Administration ("TFDA") for the treatment of adult patients with R/R AML containing an isocitrate dehydrogenase-1 mutation ("IDH1m"); marketing approval is expected in 2020. Two registrational trials in IDH1m AML are ongoing in China: one in IDH1m R/R AML, anticipating trial completion in 2020 and NDA submission in China by the first half of 2021; and another in newly diagnosed IDH1m AML patients who are not eligible for intensive therapy.

– Avapritinib (CS3007) – On January 9, 2020, the KIT/PDGFRA inhibitor AYVAKITTM (avapritinib) received U.S. Food and Drug Administration ("U.S. FDA") approval for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor ("GIST") harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. As a result, we plan to submit an NDA in Taiwan in the first half of 2020 for this indication. Two registration trials for the avapritinib were initiated in China in patients with unresectable or metastatic GIST. One trial is a China pharmacokinetics bridging study for the indication of advanced GIST with a PDGFRA exon 18 mutation. We expect the top-line results from the trial to become available and to submit an NDA in China in the first half of 2020. Another trial is conducted in third-line GIST as part of a global Phase III trial comparing avapritinib with regorafenib. Enrollment has been completed for this study and top-line results from the global trial are expected to be available in the second quarter of 2020 with NDA submission in China in the second half of 2020.

– Pralsetinib (CS3009) – As part of a global pivotal Phase I/II trial of pralsetinib, an investigational RET inhibitor, for the treatment of RET-altered NSCLC, medullary thyroid cancer ("MTC"), and other advanced solid tumors, we have completed enrollment in China for the cohort study for the indication of RET fusion-positive NSCLC as a second-line treatment and expect an NDA submission for this indication in China in the second half of 2020. Furthermore, we have initiated an additional registrational cohort for first-line RET fusion-positive NSCLC and expect to dose the first patient in the first half of 2020.

Early-stage assets:

– Novel combinations – With combination therapy as a core strategy and the unique advantage of leveraging our 3 IO backbone agents (anti-PD-L1, anti-PD-1, and anti-CTLA4), a total of six combinations with assets from our internal pipeline and external partners are in development: i) CS1002 (CTLA-4 antibody) plus CS1003 (PD-1 antibody), with the first patient dosed in January 2020; ii) CS1001 with fisogatinib (CS3008; FGFR4 inhibitor) in HCC; iii) CS1001 with regorafenib; iv) CS1003 with regorafenib; all with first-patient- dosed achieved in December 2019; and two other combination studies planned, including v) CS1001 with a PARP inhibitor (IMP4297); and vi) CS1001 with a multi-kinase inhibitor (donafenib).

– Other early-stage assets – We have also made significant headway on other early clinical- stage programs including CS3005 (A2aR antagonist), CS3002 (CDK4/6 inhibitor), CS3003 (HDAC6 inhibitor) and CS3006 (MEK inhibitor). In January 2020, we dosed the first patient for CS3002 and CS3005 in the respective phase I studies.

Business development and other key activities:

– We have continued to enhance our value through external collaborations with global leading biotechs and biopharmaceutical companies.
— In May 2019, we entered into a global clinical collaboration with Bayer HealthCare LLC ("Bayer") to evaluate CS1001 in combination with Bayer's oral multi-kinase inhibitor Stivarga (regorafenib) (targeting VEGFR, KIT, RET, BRAF, FGFR and CSF1R, etc.), as a treatment for multiple types of cancer including gastric cancer. In December 2019, the first patient was dosed in a Phase Ib trial of CS1001 in combination with regorafenib.
— In April 2019, we entered into an exclusive regional licensing agreement with Numab Therapeutics AG ("Numab") for the development and commercialization of NM21-1480 (ND021), a potential best-in-class monovalent, tri-specific antibody- based molecule targeting PD-L1, 4-1BB, and human serum albumin. The agreement provides us exclusive rights to develop and commercialize NM21-1480 in Greater China, South Korea and Singapore and can potentially provide us with access to Numab's novel multi-specific technology platform.

– Moving forward, we will focus on pursuing strategic partnership that will accelerate CStone value creation.

– In March 2019, we appointed four internationally-renowned oncologists: Paul A. Bunn, Jr., MD, Elizabeth M. Jaffee, MD, Weiping Zou, MD, Ph.D. and Richard S. Finn, MD, as members of our Scientific Advisory Board. The addition of these four experts will considerably augment our public profile in the oncology field and provide valuable insights into our R&D strategies and processes.

– In August 2019, we entered into an agreement (with a state-owned enterprise under the Suzhou Industrial Park) to build an approximately 100,000 square meters R&D center and manufacturing facility in the Suzhou Industrial Park for large and small molecule drug development and commercial production. We expect the construction of the facility to commence in the first half of 2020.

– In October 2019, we entered into an agreement with Jiangsu Industrial Technology Research Institute (JITRI) and formed JITRI-CStone Innovation Center to further promote a two-way collaboration with industry partners and innovation centers in China and around the world.

– In December 2019, Ms. Shirley Zhao, MD, MBA, joined us as the General Manager for Greater China and Head of Commercial to lead and scale up a full-fledged commercial organization. Ms. Zhao will be responsible for continuing to scale up the commercial team and infrastructure in preparation for multiple product launches in mainland China, Hong Kong and Taiwan over the next two years. Upon regulatory approval, we expect to launch ivosidenib by the end of 2020 and avapritinib in 2021 in Taiwan, and to launch avapritinib, pralsetinib and CS1001 (PD-L1 antibody) in 2021 in mainland China with well-established local operation.

Since the outbreak of the novel coronavirus ("COVID – 19"), the Company has adopted immediate measures to maintain effective and high-quality level of operation. We are proactively managing the progress of ongoing trials to ensure that study protocols are followed and no significant disruptions will affect delivery of the results. Also, we are actively supporting the nation's battle against the coronavirus with a donation to Suzhou Charity Federation after the outbreak in Suzhou. We will make our best efforts to advance our development, aim to deliver data and launch our products within the expected timeline, while maintaining our commitment to our patients, employees and a broader community.

Conference Call Information

The Company will host a live conference call and webcast at 10AM HKT, March 27, 2020 to present its financial results for the year ended December 31, 2019. The conference call may be accessed by dialing 4001203170 (China Mainland), +852 30082034 (Hong Kong), +18455071610 (US) and +61 283733610 (International) and referring to conference ID / Passcode 8576303 / CStone. A webcast of the conference call will be available in the Investor Relations section of the Company' website at http://www.cstonepharma.com/en/relation/calendar.html (Passcode : CStone).

About CStone
CStone is a biopharmaceutical company focused on developing and commercializing innovative immune-oncology and molecularly-targeted drugs to address unmet medical needs for cancer patients in China and worldwide. Since the Company's inception in 2015, CStone has assembled a world-class management team that has a full spectrum of complementary skillsets from preclinical research to clinical development and commercialization. With combination therapies as a core strategy, the Company has built a rich oncology pipeline of 15 oncology drug candidates. Currently five late-stage drug candidates are at or near pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model, and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative and differentiated oncology therapies to cancer patients worldwide.

For more information about CStone, please visit: www.cstonepharma.com.

Forward-looking Statement
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Azabu Insights: Update on Temperature’s Impact on the Coronavirus

TOKYO, Mar 24, 2020 – (ACN Newswire) – On March 6th Azabu Insights proposed a theory that coronavirus seemed to be spreading faster in cold countries than in warm countries. We followed this up with an update on March 11th showing that at that time the data was showing ninety-eight percent of the cases were all in cold countries.



Chart 1: Percent of Cases in Cold vs. Warm Countries (updated March 23)


Chart 2: Top Twenty-Five Countries by COVID-19 Cases (updated March 23)


Chart 3: Percent of Global Population Living in Countries Cold in July



Since then we have had many comments from different people. One very respected business person who works in life sciences, told us he thought it was a, "multivariate problem," and suggested that, "It's possible, for example, that infection rate would be strongly correlated with people meeting in enclosed areas will less have outside air circulation." He was saying that our analysis might be true but it might not be, "because of the temperature," but because of something that "relates to temperature."

Another doctor said he thought it was because in spring people go outside more and they are less impacted by the dry air of air conditioning systems.

One hospital vice president, whom we highly respect, responded politely, "I do not think that COVID-19 relates to temperature."

Our conclusion on March 11th was: "As previously, we conclude that COVID-19 can spread in warm regions but seems to spread much more quickly in colder regions. We hope that countries and regions around the world will aggressively work to keep the virus at bay until the summer months and hope that the warm temperatures will support further containment."

You can see, then as now, we were certainly not 100% convinced that temperature was the driver or that temperature would save the day. But we do remain optimistic.

As recently as March 21, a virologist, Christian Drosten, who advises the German government in their so-far successful tackling of the coronavirus crisis, expressed some optimism that in the coming months we may have some success beating the virus. When asked about the effect of temperature, he responded: "This effect isn't likely to be particularly pronounced. It won't be able to stop the outbreak, but it may help a bit. And combined with the isolation measures, I strongly expect that we will see an impact in a month." It seems he also was not 100% convinced that higher temperature in summer months would solve things, but he thought it could help and envisioned more success at beating the virus spread in weeks ahead.

Updating Data on Temperature vs. Case Statistics – The Situation Now (March 23rd)

On the other hand, we have had people recently coming to us and saying that they've heard that there are more outbreaks in warm countries, like Malaysia and Brazil recently. They ask, "doesn't this prove the theory wrong?" So, we wanted to take a third look at the data and see what it says now and try to figure out what it means. Here are the results.

First off, the cold countries have moved more to the top of the cases list. The top fifteen countries are now all cold countries, as are twenty-two of the top twenty-five countries by case count.

On a percentage basis, today still ninety-six percent of cases have been in cold countries with only four percent in warm countries.

Our definition of cold countries remains unchanged, with a February temperature below fifteen degrees Celsius defining a cold country and above fifteen degrees delineating a warm country. This is because we found the average temperature in Okinawa in February was sixteen degrees Celsius. At this temperature you can go out wearing shorts during the days but need a light jacket or sweatshirt in the evening.

On the other hand, what the people have said to us is certainly true. Some warm countries have seen outbreaks that are hard to ignore. Brazil (1,546 cases), Australia (1,353 cases), Malaysia (1,306 cases) are the leaders in the warm countries right now. Still this is much lower than the leaders in cold countries, China (81,054 cases), Italy (59,138 cases), and USA (32,783 cases).

Please refer to the charts which illustrate this information.


Chart #1: Percent of Cases in Cold vs. Warm Countries (updated March 23, 2020)

Chart #2: Top Twenty-Five Countries by COVID-19 Cases (updated March 23, 2020)


Countries and Regions That Have Beaten The Virus

The warm countries of Singapore and Hong Kong, had initially had high case counts, ranking number 17 and 18 for most cases as of March 8th. Countries like these have shown that the virus can essentially be stopped. Singapore now has the 40th most cases and Hong Kong has the 50th most cases. But we feel that they probably beat the virus as much because they dealt very aggressively with it as because of the warm weather there.

After all, China and Korea are cold countries and they've shown that by dealing aggressively with COVID-19, they could slow or stop the virus too. China has shown very few cases recently despite it seeming out of control at one point. Korea, which does have a high case count, (probably influenced by aggressive testing), has shown a very low death rate.

The Effect of Testing

What about the effect of testing? There is some thinking that the second order things we?ve talked about are also important. For instance, it might be possible that there is more testing in cold countries than warm countries. We haven't found reliable data on this for all countries, which would be required, but it is a reasonable thing to consider. Note that we did show a consideration for this by doing a per capita GDP analysis, below.

Cold vs. Warm Country Populations

One reader told us they thought there might be more cold countries in the world or more people living in cold countries. We looked at that but concluded that there are only forty-seven percent of the people living in cold countries, whereas fifty-three percent of the people live in warm countries. So, if anything, this should have counteracted the high percentage of cases in cold countries.

Northern Hemisphere vs. Southern Hemisphere Populations

Another reader asked us about what will happen to the Southern hemisphere in July and August. So, we decided to do that analysis as well. Australia concerns us a lot because it has 1,353 cases and will be heading into winter shortly. In Australia most of the population lives in areas where the temperature will be below our fifteen-degree threshold in its coldest month of July.

However, on a further analysis we found that much of the rest of the southern hemisphere population will actually be defined as warm even in the months of July and August. To wit, only nine southern hemisphere countries, representing 2.7% of the world's population will be colder than fifteen degrees, and classified as a cold country in the month of July. July is typically the coldest month of the year in the Southern Hemisphere. If we were to include northern hemisphere countries that will still be below fifteen degrees in July, such as Russia and Iceland, then we can see that 6.9 percent of the world's population will be cold in July.

Chart #3: Percent of Global Population Living in Countries that will be Cold in July


The Effect of Per Capita GDP on Case Counts

Further thinking about "second order considerations" we wanted to look at GDP to see if maybe the colder countries had higher per capita GDP and this was leading to higher COVID-19 case counts. One might argue that this would have led to more travelers to the cold countries, a situation where better healthcare exists, and a situation where more tests have been conducted.

All of these are certainly possible and would push against the idea that temperature itself, or some corollary of temperature is supporting the lower case counts in warm countries.

We looked at GDP in cold and warm countries and found that cold countries have a higher average per capita GDP. In fact, sixty-seven percent of the world's per capita GDP is in cold countries and thirty-three percent is in warm countries. So, this GDP factor is certainly one that cannot be completely ignored.

It is indeed a possibility that the virus simply spread "first" in cold countries and it will spread in warm countries next.

Still, we feel that 96.0% of all cases being in cold countries can't be seen as insignificant at this point.

Conclusions

So, what does all of this mean? Does it show that the virus only spreads in cold countries? Does it show that the summer will stop the spread in Europe and North America? Is anything conclusive?

We think that the numbers are telling us four things
A. The spread seems to be faster in colder weather (for whatever reason),
B. The virus can spread in warm countries but seems to spread slower (for whatever reason),
C. The virus can be "beaten" in both warm and cold countries with the right intervention,
D. The summer months are likely to "help" the slow of the spread at least for a few months in Europe and North America, but it will certainly help if Europe and North America continue to take aggressive containment measures.

Separately we think that data is showing that countries that test and treat coronavirus patients in separate "coronavirus only" facilities do much better at containment. Protecting elderly in hospitals and in retirement homes is vitally important to success. This is a topic for another article.

Comments about our analysis are welcome at the email below.

About Azabu Insights

Azabu Insights is a boutique strategic consulting company based in Azabu Juban, Tokyo, Japan. Our teams work collaboratively with clients to build strategies that lead to positive change. Our multilingual team members have top tier academic backgrounds and deep industry experience that we leverage to provide first class, fully engaged, strategic consulting. Core specializations include life sciences, finance, electronics, automotive, aerospace and other industries. For more information contact: info@azabuinsights.com.


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Blockchain Holdings to Acquire COVID-19 Quarantine Management Product TRACEsafe

VANCOUVER, BC / ACCESSWIRE, Mar 21, 2020 – (ACN Newswire) – Blockchain Holdings Ltd. ("Blockchain") (CSE:BCX), a public company listed on the Canadian Securities Exchange under the symbol "BCX", today announced that effective March 13, 2020, it entered into a binding letter of intent (the "Transaction") to acquire 100% of the rights and interests in a self-quarantine monitoring technology suite known collectively as "IMSafe" from WiSilica, Inc. ("WiSilica"). TRACEsafe is a global health monitoring product that may be deployed by governments and corporations as they fight the global COVID-19 pandemic.

TRACEsafe is an innovative suite of patent-protected health and safety products, including a flagship identification bracelet and software solution used in a variety of applications, including to administer quarantine guidelines set out by governments. In addition to quarantine applications, TRACEsafe products are being used in hospitals for infant monitoring in maternity wards and visitor monitoring to elder care facilities.

Already, TRACEsafe disposable bracelets are being deployed and in active use by the Hong Kong government manage and enforce their quarantine program for foreign visitors with initial deliveries completed. Based on the success of the program in Hong Kong, and confirmed orders in excess of 65,000 units, TRACEsafe expects to roll out in multiple countries in the coming weeks and months. TRACEsafe expects to make its next deliver of bracelets within the next 60 days, and estimates its working capital requirements for such deliveries to be approximately $300,000.

COVID-19 is widely expected to change how people shop, travel, and work for the foreseeable future, and TRACEsafe could play an important part in implementing new safety and health policies.

The Transaction

Blockchain has entered into a binding letter of intent ("the Transaction") to acquire 100% of the TRACEsafe assets. Under the terms of the Transaction, Blockchain will pay total consideration of USD$1,574,188, comprised of two cash payments of US$100,000 and US$150,000, respectively, and US$1,324,188 payable in 6,000,000 common shares of Blockchain at a deemed price of CAD$0.305 per share in exchange for all of the business assets related to the TRACEsafe Self-Quarantine Monitoring System.

In addition, under the terms of the Transaction, WiSilica and key personnel may be entitled to certain share performance bonuses. Upon achievement of specified milestones, each performance bonus consists of a one-time payment of CAD$1,200,000 in common shares of Blockchain at a deemed price of CAD$0.305 per share and 2,000,000 performance share warrants of Blockchain. Each such performance share warrant entitles WiSilica or its nominee(s) to acquire one (1) common share of Blockchain at a price of CAD$0.305 per share for a period of two years. The following business milestones will trigger a performance bonus:

1. achievement of $500,000 in gross revenue by June 30, 2020;
2. securing material contracts in at least six international countries with total volume reaching to pro rata 100,000 units per year by July 30, 2020; and
3. a software management platform for monitoring and tracking quarantine patients is set up that is purchased or otherwise subscribed to and monetized by an Organisation for Economic Cooperation and Development or G20 country by no later than August 31, 2020.

Dennis Kwan, the CTO of WiSilica, is expected to be appointed as CEO of a new subsidiary of Blockchain that will hold the TRACESafe assets.

Financing

Blockchain also announced today a non-brokered private placement offering of up to 3,333,333 units (the "Units") at a price of C$0.30 per Unit for gross proceeds of up to C$1,000,000 (the "Financing").

Each Unit is comprised of one common share in the capital of Blockchain (a "Common Share") and one-half of one Common Share purchase warrant (a "Warrant"). Each whole Warrant will entitle the holder thereof to acquire one Common Share at a price of C$0.50 for a period of two years from the date of issuance of such Warrant.

Blockchain intends to use the proceeds of the Financing towards partial payment of the purchase price of the Transaction and working capital and general corporate purposes.

About TRACEsafe

TRACEsafe, is a proprietary self-quarantine management monitoring system which registers a user through a wrist tag. The tag can log time stamps and locations of the user through a single application used by both the user and administrators to a central monitoring system. TRACEsafe allows a user to declare once they have entered quarantine, and subsequently prompts periodic check-in acknowledgements. The application will alert administrators if the user fails to acknowledge a check-in, the tag is unreachable through the user's phone or if the tag has been tampered with.

TRACEsafe was developed by WiSilica, Inc., a California-based private company in the business of creating intelligent Internet of Things (IoT) solutions to enable human centric lighting, real time tracking, intelligent wireless controls, and customized IoT Solutions. It helps customers manage space, energy, and gain access to insightful reports and dashboards.

Executive Quotes

"We are delighted to play a role in expanding TRACEsafe, which we believe will play a critical role in assisting governments with the mitigation of the COVID-19 pandemic. The acquisition of the TRACEsafe business assets further advances Blockchain Holdings' technology and data aggregation business. Following the 2019 acquisition of a strategic minority equity stake in Airbeam Wireless Technologies, a 5G semiconductor manufacturer and small cell network innovator, the transaction with WiSilica further highlights Blockchain's role as a value-added investor in disruptive technology startups," stated Wayne Lloyd, CEO of Blockchain.

"TRACEsafe family of products represent the culmination of years of innovation in low-power wireless technology from WiSilica, and have been proven in many demanding applications in the health and safety market. We are humbled by the recognition by BCX through their acquisition of this part of WiSilica's business, and we look forward to much greater possibilities with the support of BCX to launch TRACEsafe into the next stage of growth," explained Dennis Kwan. "I couldn't be more excited to be a part of this cutting-edge opportunity," he continued.

About Blockchain Holdings

Blockchain provides investors and fund managers with unique insights into the growing ecosystem of crypto-assets. BCXdata.com captures and aggregates data from different blockchains for use and analysis with a clean and approachable API. With a portfolio of proprietary tools, Blockchain is giving users an institutional-grade analysis package that forms the basis for an extended suite of product offerings in the future.

This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

For further information, please contact:
Malcolm Burke
+1-604-220-2000
mpb@primarycapital.net

Alan Tam, CFO
+1-604-377-7575
alantamca@gmail.com

Wayne Lloyd
+1-604-629-9975
wayne@blockchainholdingsltd.com

This press release was prepared by management of Blockchain, which takes full responsibility for its contents. The Canadian Securities Exchange has in no way passed upon the merits of the proposed transaction and has neither approved or disapproved the contents of this press release.

Statements in this news release may contain forward-looking statements that are based on Blockchain's expectations, estimates and projections regarding its business and the economic environment in which it operates, including with respect to expectations regarding the TRACEsafe assets, the appointment of Dennis Kwan to a leadership role with respect to the TRACEsafe assets, the entering into and completion of a definitive agreement regarding the Transaction and the expected use of proceeds from the Financing. Although Blockchain believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and involve risks and uncertainties that are difficult to control or predict. Therefore, outcomes and results may differ materially from those expressed in these forward-looking statements and readers should not place undue reliance on such statements. These forward-looking statements speak only as of the date on which they are made, and Blockchain undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law.

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Startup by Silicon Valley Nobel Protege Invents Compact Home Device with Blockchain Technology Capable of Detecting Coronavirus

SAN JOSE, CA, Mar 21, 2020 – (ACN Newswire) – Silicon Valley entrepreneur and Nobel Laureate Protege Dr. Ned Saleh announced today that the compact blood-testing device invented by his startup Synsal Inc. could have detected the Coronavirus outbreak and saved lives had it been deployed in the mass market. Saleh stated Synsal's technology has been verified on a similar infectious pathogen using a method called Reverse-Transcription Loop-mediated isothermal AMPlifications or RT-LAMP.

The new programmable technology — comparable in cost to a cell phone — is an innovative compact device that detects a wide range of wellness panels and human relevant biomarkers from a few drops of blood or bodily fluids. When deployed within a decentralized data-sharing network, the device can detect emerging outbreaks like the COVID-19, "for as little as $20 per test at high volume", Saleh indicated.

This technology is designed as a comprehensive quantified wellness solution and can also detect infectious outbreaks. "If you can measure it, you can improve it," Saleh said. "Powered by artificial intelligence (AI) and analytics, our device generates actionable data that engages users in an innovative rapid behavior changing process encompassing gamification and reward, it is truly Medicine 2.0 " he added. Saleh confirmed Synsal has a global presence and engaged with partners to roll out this technology worldwide including in China. The value of the exclusively user-owned and cryptographically secure data generated in Synsal's blockchain network positions the device to pay back its cost of ownership, and generate personal revenue from this new class of digital assets.

Synsal is developing an interoperable decentralized quantified wellness network on emerging blockchain platforms like BurstIQ and Harmony. Saleh stated, "this is a horizontally disruptive technology designed to bring the blockchain to every household and accelerate its adoption similar to the way email brought the internet to every household. This could shift the economic burden of healthcare cost from treatment to prevention in a global market worth over 2 Trillion dollars ($2T). Our network's quantified data sets us up to create proprietary models critical to smart epidemiological mapping and early detection, which given the rapid spread of the COVID-19 pandemic, holds potential to save lives. This extends to future inevitable outbreaks."

Saleh added, "On the financial front, our data becomes particularly relevant in today's global algorithmic trading markets. We have the capability to pre-create financial risk models to feed in data from our proprietary network to create risk assessment reports that can be shared with financial market analysts and decision makers in real-time, thus avoiding massive market sell-offs and possible recession."

Saleh started developing this technology as a graduate student at the University of Michigan in the nation's most prestigious program in nuclear engineering. He calls it "micro-plasma" and confirmed it does not occur naturally. Saleh co-built a micro-plasma laser-based machine cited in the Guinness Book of World Records which helped, in part, land his advisor Gerard Mourou the 2018 Physics Nobel Prize. Saleh declared he developed a compact next generation of this technology, now used by Synsal, based on "Van Allen electron beam micro-plasma."

Saleh, who worked at top Silicon Valley micro-electronics companies including Intel, IBM and KLA, became fascinated by miniaturization of devices and later invented a miniaturized microfluidics test lab. "Unlike past attempts to mainstream micro-sampled human diagnostics — which lacked scientific rigor and transparency — ours has been validated, and eventually will be judged by the global base of users who will adopt this technology and monetize the valuable data it generates."

When asked why Synsal technology has unique positioning and world-changing potential, Saleh said "We believe our technology has an absolute insurmountable differential advantage. We state this confidently based on borrowed knowledge from Moore's Law in the semiconductor industry. We have transformed the principles of selective patterning into microfluidics and assay preparation, and as such set the theoretical limit on progressive densification of surface functionality, which we think is superior until competitive technologies prove otherwise."

Brigitte Piniewski, M.D. is a primary care physician, researcher, author and digital health start-up advisor including Synsal. Dr. Piniewski stated that the community strongly needs a personally relevant biomarker testing service which cannot be provided through traditional healthcare. "When open access to stand-alone, biomarker testing becomes the norm, human health intelligence will advance in leaps and bounds. In parallel, the Synsal blockchain-based record management solution provides a data-as-financial-asset service laying the foundation for the human-centric societies of tomorrow." [linkedin.com/in/brigittepiniewski/]

Kapil Amarasinghe is a British medical doctor, blockchain promoter and influencer. His daily practice in emergency-room medicine puts him at the forefront of immediate critical medical decision-making. Dr. Amarasinghe believes the Synsal technology provides powerful predictive value from AI and analytics that helps understand broad wellness trends, an urgent and unmet need today from the large but siloed clinical databases. [linkedin.com/in/kapil-amarasinghe-97a71965/]

Yev Muchnik is a technology attorney, influencer and thought leader in the blockchain space. She works with emerging growth companies across various industries incorporating blockchain technology and was recently on the Blockchain Advisory Group to the Colorado Department of Agriculture. She too is a Synsal advisor and believes a provenance for capturing quantified self-data is critical in today's world of data manipulation and critical need for ethical data governance. "Synsal's model is very promising in bringing back ownership of data to their originators, especially in the wellness and health domain, thanks to the capability of blockchain technology." [linkedin.com/in/yevmuchnik/]

Synsal is partnering with Harmony (https://harmony.one/), a fast and secure blockchain company whose mission is to scale trust for billions of people, in order to build and scale the Synsal health data monetization platform. Stephen Tse, the Founder & CEO of Harmony and a serial entrepreneur from Silicon Valley, stated "We are building Harmony as the infrastructure layer for applications with global reach and are excited to work with Synsal to help everyone secure their personal health data."

Please visit: https://synsal.com or email: info@synsal.com.
Dr. Ned Saleh is on https://www.linkedin.com/in/ned-saleh-phd-3224293/.

Contact:
Synsal, Inc.
5407 Silver Vista Way, San Jose, CA. 95138
Gideon Nweze: www.linkedin.com/in/gideon-nweze-b6281488/
Dr. Ned Saleh, CEO, www.linkedin.com/in/ned-saleh-phd-3224293/
Web: https://synsal.com, Telegram: https://t.me/SynsalToken

Source: Synsal, Inc.

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

The Impact of Hospitals on Accelerating the Spread of Coronavirus

TOKYO, Mar 21, 2020 – (ACN Newswire) – Consultants at Azabu Insights wanted to understand the stark differences between mortality rates in Korea (currently 1.1%) and Italy (8.3%). We felt that current explanations suggested by virologists, while making a number of valid points, have ultimately been unsatisfactory.

Azabu Insights presents the hypothesis that hospitals may have been one of the breeding grounds for virus infection in Italy and this may have been one of the causes of the high mortality rates. This is a major concern, going forward, for other countries including the United States.

Azabu Insights recommends that policy experts and hospital management carefully consider existing practices to ensure that potential carriers of coronavirus can access to testing and appropriate treatment without spreading the virus to other persons in the healthcare facility. We think that the highly contagious nature of COVID-19 suggests a need for more isolated facilities and stricter measures than have been implemented, in many cases, thus far.

We urge that the successful policies implemented to curb the early outbreaks in China and Korea, including those around hospital isolation and safe testing, should be examined and implemented when appropriate.

Exploring Macro Drivers Behind Infection and Mortality

Previous articles have noted that many of those who died in Italy were older, male, and often smokers. Experts agree that these traits are key risk factors in severe COVID-19 infections (as they are for many other respiratory diseases). It has been argued that these attributes are reflective of broader Italian society, particularly citing Italy's age profile, and by extension proving why Italy's outbreak has been so deadly. We contrasted this with Japan and Korea, which share Italy's characteristics of aging populations with high smoking rates and have also seen coronavirus outbreaks in recent weeks.

Firstly, we examined the key macro data. According to the World Bank, 23% of Italians are over the age of 65, making it the oldest nation in Europe. Note however, there are 16 European countries where at least 20% of the population is over 65, so Italy is by no means a large outlier. Compared with Italy, Korea is a little younger with 18% of its citizens over 65 however Japan is significantly older with 27% of its populace 65 or older. Digging a little further we see that in Cremona, one of the areas hit hard by the northern Italy outbreak, almost 33% of people were over the age of 60 compared with 38% over 60 in Japans Kitami, the site of Japans main outbeak. With regards to smoking, overall smoking rates are higher in Korea (24%) and Italy (22%) than in Japan (18%). However in Korea, men's smoking rates are much higher at 34% than the 27% of Japanese males and the 23% of Italian men who currently smoke.

These numbers suggest that Japan and Korea, at best, both share similar risk factors to Italy and arguably look much poorer than their European counterpart. Given this, Azabu Insights asserts there are other factors that are driving the speed and intensity of the Italian outbreak.

Partly Result of Tested Populations

Part of the effect of the disparity can be accounted for by the disparity in tested populations. Korea has tested aggressively, with over 286 thousand people (second only to China's 320 thousand) tested and 3% testing positive. They tested broadly across all age groups with 28% of test subjects 20-29 years old and 58% under the age of 50. In turn many of the younger Koreans tested positive for COVID-19. It should come as no surprise that the mortality rate would be lower amongst this group of younger people because younger people have a lower mortality risk from the outset.

Italians have conversely seen a high 21% of those tested, return positive COVID-19 results (seven times higher than Korea). This says to us that the people who received the tests may have been chosen differently. Perhaps, in Italy, they prioritized (as would make sense) testing of the old, those at risk and those with severe symptoms. We know that the survival rates decrease significantly over 70 and further after 80, so the widespread reports that most people who died were over 70 did not surprise us.

To state it simply: if you find a large number of positive cases among young people, who are not at risk, you would expect few of them to die. If you find a large number of positive cases amongst older at-risk people, you would expect more of them to die. It is an example of Bayess theorem.

But testing differences alone, likely do not account for the sheer numbers of deaths in Italy, which have now surpassed those in China.

Risk of Infection at Hospitals

At Azabu Insights we have interviewed hundreds of doctors face to face over the last five years. We travel to all corners of Japan to meet directly with doctors in their hospitals. A key observation, something that nearly everyone who visits a hospital should know by gut intuition: the primary demographic in a hospital is the elderly. Confirming the data we see that in Japan, 73% of all people in hospitals are 65 or above and 53% are 75 or above. We are confident that these percentages are likely similar in demographically comparable Italy and in many other parts of the world.

This leads to examination of testing procedures for highly infectious diseases. Korea's testing regime, discussed earlier, has seen a number of novel and innovative solutions. It is possible to be tested for coronavirus in a drive through in just a few minutes. Other than the obvious convenience, this has the core benefit of not needing to walk through a hospital waiting room and risk infecting the other patients and the hospital staff.

In Japan interviews with the president and vice president of two major Japanese hospitals highlighted similar concerns. The first doctor was actively sending people with symptoms away from the hospital to get treated elsewhere. The second doctor had temporarily refused to see measles patients at his hospital. Both of these health practitioners did this to protect their own patients from in hospital spread.

In contrast we see that 10% of healthcare workers in the Lombardy region of Italy have contracted coronavirus. In one region, 20% of all GPs are confirmed to have coronavirus. In both cases, many of them are continuing to work given the well documented shortage of healthcare workers in Italy right now. On top of this, a study of 138 patients in Wuhan, China, suggests 41% of patients may have been victims of hospital-related transmission. This further suggests to us that hospitals are perhaps the worst place to be during a viral epidemic. Yet hospitals are hard to avoid for people in need of medical care. This is especially challenging for the elderly (age 75) who are 6.5 times more likely to be in a hospital than younger adults (age 35).

The SARS Effect on Treatment Patterns

We have extensively reviewed published data and studies, looked at various government recommendations, as well as examining popular published media outlets. In past outbreaks such as SARS, cases of asymptomatic spread were low and in-hospital spread was considered controllable through the use of masks and other standard procedures. In the case of coronavirus however we see clear evidence of both asymptomatic spread and spread from within the hospital system. However we believe that the role of asymptomatic spread and from within the hospital system remains significantly underestimated.

We believe that public policy and messaging in many countries is still largely based on previous outbreaks such as SARS and has failed to keep pace with the reality of how the coronavirus is spread. In contrast, China and Korea have adapted quickly and changed how they approach the management of this pandemic. In particular, they have shown that aggressive isolation of patients from the regular hospital system, including preventing congregation at test centers and separating coronavirus patients from regular patients in completely separate hospitals, can be an effective tool in controlling the spread of the coronavirus. We encourage policy makers in other countries, such as the US, to look to their example for ways to update their approach to better manage the current crisis.

Available Beds and Isolated Treatment Facilities

For patients that require treatment due to more severe coronavirus symptoms, the availability of physically separated treatment or in hospital isolation facilities is key to limit the hospital related transmission alluded to in the above paragraphs. We believe that China for example, did this very effectively by building two hospitals and acquiring gyms just to treat COVID-19 patients.

We examined available hospital capacity, with a focus on the ability to isolate and treat infectious disease. For standard hospital treatment, research shows that Japan is the most equipped globally with 13.4 beds per thousand people, followed by Korea with 11.5 beds per thousand people. This contrasts with most other developed countries which typically have anywhere from two to eight beds (2.9 in USA, 2.8 in UK, 3.4 in Italy) per thousand people. The real concern however is the number of beds that are available to treat highly infectious diseases. Taking conservative Japan as our baseline, we found that only 0.12% of all of Japan's beds are set up for infectious diseases and 0.32% are tuberculosis certified.

We know from reports that 16% of people in Lombardy hospitals had coronavirus. We believe that its very likely that small hospitals in the countryside of Italy were over run with too many people that had the virus. Despite reports of operating rooms being turned into seclusion units on a best effort basis, we have serious concerns about the ability of the hospitals to limit the spread of coronavirus within their institutions. This can lead to the worst case scenario where the infected patients spread the disease both to healthcare workers and to other patients resulting in the deaths of the already at-risk patients. From this perspective we think that the typical concern of running out of respirators, though important, the earlier measures of keeping the patients from spreading the virus may be more important.

Next Steps and Best Practices

We believe that the risk of testing and of treating people in regular hospitals is being fully underestimated. We feel that hospitals overestimate their ability to keep the virus from spreading in their hospitals.

Our suggestion is that as the United States begins its testing and particularly as it ramps up, they should be extremely careful and learn from the experience of countries such as China and Korea. All testing should be conducted at designated locations that are not physically connected to hospitals where there are other patients. No patients should be allowed to congregate or wait.

An ideal situation would be one in which coronavirus patients could be treated in their own, completely separate hospitals, as has begun to happen in Northern Italy, and in parts of the United States, but, we feel, not broadly enough.

Further, the major hospitals must immediately decrease the number of people they treat. This goes for Japan as well, no longer should hospitals allow large waiting rooms filled with people. All non-essential procedures should be delayed. Again we have heard anecdotal reports of this occurring in the US and other countries already, but not universally.

In addition we recommend that any worker at a major hospital should be tested, at least for temperature, before going into hospitals and aged care facilities. Visitation, by people who may be asymptomatic carriers, should be severely limited. Everyone who goes into hospitals should wear masks, minimize touching and speaking, and should not be waiting in centers together.

Azabu Insights believes that these best practices should be implemented in conjunction with existing recommendations for limiting community spread including, but not limited to, hygiene and hand washing, wearing masks in public places if available, avoiding crowded places and working from home where possible.

About Azabu Insights

Azabu Insights is a boutique strategic consulting company based in Azabu Juban, Tokyo, Japan. Our teams work collaboratively with clients to build strategies that lead to positive change. Our multilingual team members have top tier academic backgrounds and deep industry experience that we leverage to provide first class, fully engaged, strategic consulting. Core specializations include life sciences, finance, electronics, automotive, aerospace and other industries. For more information contact: info@azabuinsights.com


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Novotech CRO Tapped for Two Informa Citeline Awards for Excellence in Asia-Pacific Clinical Trials

SYDNEY, Mar 20, 2020 – (ACN Newswire) – Asia-Pacific's largest specialist biotech CRO Novotech has been selected as a finalist in two categories for the Citeline Awards 2020 (formerly CARE Awards), hosted by Informa Pharma Intelligence, scheduled this year on September 17th. The categories are Clinical Research Team of the Year, and Medidata Clinical Partnership of the Year.





Dr John Moller, Novotech CEO, said, "These are major milestones for the company, and further recognition of Novotech as the premier CRO in Asia-Pacific. We are particularly thrilled that the Medidata Clinical Partnership of the Year recognizes Novotech and its Chinese partner PPC, for excellence in clinical trial services in the Asia region."

Karen Currie, Citeline Executive Director of Editorial, said: "We had a highly competitive pool of entries this year. Nominations were received from a variety of organizations, from large and small CROs to young biotechs and well-established pharmas, to specialized vendors who provide indispensable services to the clinical research industry. Attaining a position on a shortlist is a tremendous achievement and we extend our congratulations to all the finalists."

Now in their fifth year, the Citeline Awards honor the accomplishments of those working behind the scenes in Clinical R&D, improving healthcare worldwide through the discovery and development of new drugs. The Citeline Awards focus on the people and companies inspiring the biopharm industry through tireless work, innovative thinking, and advances across Clinical R&D.

Currie said "Drug development is a challenging endeavor, and we are pleased and honored to celebrate the accomplishments of this distinguished group of R&D professionals at the upcoming awards ceremony."

The winners will be chosen by a distinguished panel of independent judges.
View the full Citeline Awards shortlist here: https://tinyurl.com/rppo9hv.

About Informa Pharma Intelligence
Informa Pharma Intelligence powers a full suite of analysis products – Datamonitor Healthcare, Sitetrove, Trialtrove, Pharmaprojects, Medtrack, Biomedtracker, Scrip, Pink Sheet and In Vivo – to deliver the data needed by the pharmaceutical and biomedical industry to make decisions and create real-world opportunities for growth.

With more than 500 analysts keeping their fingers on the pulse of the industry, every key disease, clinical trial, drug approval and R&D project is covered by the breadth and depth of data available to customers. For more information visit pharmaintelligence.informa.com.

About Informa PLC
Informa operates at the heart of the Knowledge and Information Economy. It is one of the world's leading business intelligence, academic publishing, knowledge, and events businesses. With more than 6,500 employees globally, it has a presence in all major geographies, including North America, South America, Asia, Europe, the Middle East and Africa.

About Novotech
Novotech, established in 1996, is internationally recognized as the leading full-service contract research organization (CRO) in Asia-Pacific. Novotech provides clinical development services across all clinical trial phases and therapeutic areas and has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotech companies.

Novotech obtained the ISO 27001, the best-known standard in the ISO family, providing the requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. Visit http://novotech-cro.com.

For RFP enquiries, please fill in the form available at https://novotech-cro.com/talk-to-an-expert.

Media Contact
Kate Johnson
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

GeoMap Platform Sees Renewed Focus on China and South Korea Patient Recruitment as COVID-19 Cases Drop

San Francisco, Mar 20, 2020 – (ACN Newswire) – The award-winning global leader in digital patient recruitment, GeoMap Clinical said it was seeing more demand for clinical trial patient recruitment in China and South Korea as the two regions reported a drop in COVID-19 infections.



(Image credit the Johns Hopkins COVID-19 heat map https://coronavirus.jhu.edu/map.html )



GeoMap is working closely with biotechs and CROs around the world to keep screening patients and connecting them with study coordinators online to support important ongoing clinical research amid the COVID-19 crisis. The Platform recruits for clinical trials in North America, Latin America, Australia, New Zealand, China, South Korea, Singapore, Thailand, and the EU.

The company said, "GeoMap has seen a surge in demand for clinical trial patient recruitment in China and South Korea, which is further indication that the region is recovering from the crisis. The international biotech community, which is facing trial delays in many parts of the world, is now looking at reactivating sites or opening studies in Asia as the COVID-19 crisis eases in the region.

"For all studies now it is important for patients to be screened online and then get to talk to a study coordinator about next steps, because there are many alternatives to clinic visits that are now being offered. Home visits, telemedicine, apps and wearables like smart watches are being rapidly introduced into the mix as sponsors innovate to keep studies running."

The GeoMap Platform is a 3-step process:
1. Find the right patients online using advanced algorithms across country specific social and news media, as well as video and online search
2. Screen them using the Proprietary AI Patient Screener Funnel of more than 300+ possible questions
3. Connect them to sites via direct, secure encrypted email to the study coordinator/s for a phone call.

The GeoMap Platform is the fastest and most accurate targeting tool available that doesn't require IRB/EC approval, and it can start recruiting in under 24 hours. The Platform has strict verification and email encryption so PHI is managed in accordance with state and country regulatory guidelines.

For a full briefing on the new recruitment support tools, please see:
https://www.geomap-clinicaltrialfinder.com/patient-recruitment-covid-19/

About GeoMap

The GeoMap Clinical Platform is the world's most advanced geo-location/targeting and AI platform powered by specialist algorithms that find and screen the right people living or working near sites. The Platform is a sophisticated location and health profile search service that sends only highly eligible people to their nearest site.

GeoMap has been designed to end pain points across the clinical trials sector saving time and money at every stage, while ensuring patient privacy and regulatory compliance. The GeoMap Clinical Platform is not a database builder. Patient ID is redacted instantly and the focus is instead on finding only motivated patients to support enrolment and retention. For a tour of the platform, visit: https://www.trial-wire.com/.

Media Contact
Chris Thompson
team@dmgpr.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Australian CRO, Avance Clinical is Uniquely Positioned for COVID-19 Vaccines and Therapies Clinical Trials

Adelaide, AUS, Mar 20, 2020 – (ACN Newswire) – Australian CRO Avance Clinical said today that Australia's fast regulatory approval environment, key opinion leader expertise and high-quality clinical research sites, as well as the attractive 40% Government rebate on clinical trial spend, means Avance is uniquely positioned to deliver rapid results for urgent COVID-19 trials.





Avance Clinical offers 20-years of experience in the CRO sector, and has conducted vaccine and infectious diseases trials in the past 5 years. Avance is clearly the CRO of choice for trials targeting COVID-19.

"Importantly, the more than 40% R&D cash rebate from the Australian Government and the attractive current exchange rate, makes Australia one the most cost-effective destinations for conducting clinical trials," said Avance Clinical CEO Yvonne Lungershausen.

Australia's reputation for scientific and research excellence, its advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment further reinforces its advantage as a destination for current COVID-19 trials.

"Our depth of expertise and knowledge in the area makes us the CRO of choice for any biotech looking to develop treatments for COVID-19," said Ben Edwards, Avance's Chief Strategy Officer.

"It is also very important to emphasise that based on current trends, Australia is likely to be one of the countries least affected by COVID-19.

We anticipate that this sets the scene for the least amount of disruption to clinical trial activities over the period in which the world adjusts to the situation created by COVID-19."

Ms Lungershausen said in general terms, we do not anticipate significant disruption to the progress and timelines for the projects we are currently managing across all therapeutics indications. "Our team's experience in working with remotely based clients and clinical service providers and our virtual communication systems and processes place us in a clear position of strength in maintaining the momentum for our current projects," she said.

"Our team is very much accustomed to remote communication and management of projects," said Mr Edwards.

Clinical research sites in Australia have already responded to the challenges of the COVID-19 pandemic, putting measures and systems in place which aim to safeguard the interests of their patients and the general public, while also seeking to minimise disruption to clinical research activities.

The Avance Clinical operations team maintains constant communication with trial sites, receiving the latest information on ongoing changes in procedures and effectively managing the activities relating to the projects being managed by Avance.

"Avance Clinical has a range of tools available to support the sites and our clients to successfully complete their trials during this challenging time. These will be carefully managed to ensure study compliance," said Ms Lungershausen.

For more information about the benefits of running your next study in Australia contact us: https://www.avancecro.com/contact-us/

About Avance Clinical

Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organisations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.

Avance Clinical offers high quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialised patient groups. Other benefits include:

– Access to independent Phase 1 facilities across Australia including hospital-based units for critical care
– Dedicated Investigators committed to clinical research
– Major hospitals with world class infrastructures and dedicated Clinical Trial Units
– Expedited clinical trial start-up timeframes

Media Contact:
Media@AvanceCRO.com
Chris Thompson

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Impact BioMedical’s Linebacker and Equivir inhibit SARS-CoV-2, virus responsible for the COVID-19 outbreak

SINGAPORE, Mar 18, 2020 – (ACN Newswire) – SGX-listed Singapore eDevelopment Ltd (SeD; SGX:40V) has announced that its wholly-owned U.S. biomedical subsidiary Impact BioMedical, Inc. has through its scientific research partner GRDG Sciences, LLC. conducted molecular docking studies utilizing advanced computational models, indicating that its Linebacker and Equivir compounds successfully inhibit infection by SARS-CoV-2, the virus responsible for the COVID-19 outbreak. The results indicate that the two compounds block 3 integral viral mechanisms for SARS-CoV-2 replication and infection: the viral spike interaction point, helicase, and protease.





Equivir and Linebacker are undergoing accelerated testing against the SARS-CoV-2 virus and data is expected to confirm efficacy based on previous work against other coronaviruses such as SARS and MERS. This research is part of a program conducted by GRDG to adhere to the principles and initiatives established by Project Bioshield and the Biomedical Advanced Research and Development Authority (BARDA) directives from the U.S. Department of Health and Human Services (HHS).

On 11 March 2020, the World Health Organisation Director-General, Dr. Tedros Adhanom Ghebreyesus stated that there are more than 118,000 cases of COVID-19 in 114 countries and 4,291 people have lost their lives to COVID-19. The World Health Organisation has therefore made the assessment that COVID-19 can be characterised as a pandemic and this is the first pandemic caused by a coronavirus, he added.

"Recent studies and analyses indicate that Angiotensin converting enzyme 2 ("ACE2") could be the host receptor for the novel coronavirus 2019-nCoV/SARS-CoV-2," says Dr. David Ostrov, PhD, a structural biologist / immunologist in the Department of Pathology, Immunology and Laboratory Medicine at the University of Florida, who previously discovered compounds that bind to ACE2, blocking interactions with SARS. "These new compounds with the potential to bind ACE2 and block coronavirus entry into cells were identified by simulation of structural interactions. New drug candidates will be evaluated for effects on coronavirus with GRDG."

Identifying ACE2 as the host receptor for SARS-CoV-2 is significant, however, inhibiting ACE2 is problematic as ACE2 is required to regulate cardiovascular system. Therefore, the intention is to modulate ACE2 through a conformational change to prevent interaction with the virus while simultaneously inhibiting the helicase and protease sites of the ACE2 which are necessary for viral replication.

The research is headed by Mr. Daryl Thompson, GRDG's Director of Scientific Initiatives. "The coronavirus presents a unique challenge in that it appears to exploit a 'hand shake' docking site to human cellular membranes that is atypical of Influenza and Rhinovirus. Influenza attaches to human membranes through the use of ICAM or intercellular adhesion molecules to download its genetic material.

"It's now becoming clear that the present strain of coronavirus is hijacking the ACE2 or Angiotensin Converting Enzyme pathway to accomplish the same goal. The issue is that ACE2 is essential for maintaining the health of the pulmonary system and may not be a straightforward target for inhibition. Instead, we are utilizing both Linebacker and Equivir therapeutics as molecular probes to identify methods to make the ACE2 resistant and less accessible to coronavirus infection," says Mr. Thompson.

"We are constantly pushing to stay ahead of this virus and look to provide meaningful solutions to the current pandemic situation at the soonest," said Mr. Chan Heng Fai, Executive Chairman and Executive Director of SeD.

GRDG's Chief Scientific Advisor, Dr. Roscoe M. Moore, Jr., the former United States Assistant Surgeon General and the former Epidemic Intelligence Service Officer at Centers for Disease Control and Prevention or CDC, said, "These results are encouraging and signal the potential of Linebacker and Equivir to be important solutions to the coronavirus pandemic."

GRDG is also advised by Lieutenant Colonel William H. Lyerly Jr., retired U.S. Army Medical Service Corps Officer, and retired Career Senior Executive / Scientific Professional at the U.S. Department of Homeland Security. Lieutenant Colonel Lyerly also served as senior official in the U.S. Department of Health and Human Services, the U.S. Agency for International Development, and U.S. Executive Office of the President (White House). Lieutenant Colonel Lyerly states, "the importance of technologies such as Linebacker and Equivir cannot be understated as the global spread of the virus continues to accelerate."

About Singapore eDevelopment Limited
Incorporated on 9 September 2009 and listed on the Singapore Exchange in July 2010, Singapore eDevelopment Limited is involved in (i) property development and investments primarily in the United States and Western Australia; (ii) information technology-related businesses; (iii) development, research, testing, manufacturing, licensing and distribution of biomedical products; and (iv) investment activities. For more information, please visit: www.SeD.com.sg or email contact@sed.com.sg.

About Impact BioMedical, Inc.
Impact BioMedical, Inc. is a wholly-owned direct subsidiary of Global BioMedical Pte. Ltd., a wholly-owned direct subsidiary of Singapore eDevelopment Limited, listed on the SGX. Impact BioMedical strives to leverage its scientific know-how and intellectual property rights to provide solutions that have been plaguing the biomedical field for decades. By tapping into the scientific expertise of GRDG Sciences, LLC. and ASX-listed Holista CollTech Ltd, Impact BioMedical pledges a concerted effort in R&D, drug discovery and development for the prevention, inhibition, and treatment of neurological, oncological and immuno related diseases.

About GRDG Sciences, LLC.
GRDG Sciences, LLC is an advanced research team formed in Florida by natural products discovery drug research scientist, Daryl Thompson. For more information, please visit: http://www.globalrdg.com.

Shareholders and potential investors of SeD should note that there is no certainty or assurance as at the date of this Press Release that Equivir will be licensed or close to monetisation. Shareholders and potential investors of SeD are advised to read this Press Release and any further announcements made by SeD carefully. Shareholders and potential investors of SeD are advised to refrain from taking any action with respect to their securities in SeD which may be prejudicial to their interests, and to exercise caution when dealing in the securities of SeD. Shareholders and potential investors of SeD should consult their stockbrokers, bank managers, solicitors or other professional advisers if they have any doubt about the actions they should take.


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

TOT BIOPHARM Announces 2019 Annual Results

HONG KONG, Mar 18, 2020 – (ACN Newswire) – TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company"; stock code: 1875.HK), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its audited annual results for the year ended 31 December 2019.

Mr. Fu, Shan, Chairman of TOT BIOPHARM, said "TOT BIOPHARM was listed on the Main Board of The Stock Exchange of Hong Kong Limited on 8 November, 2019, officially entering a new stage of internationalization and rapid development. We have gained access to more financing channels which are conducive to the acceleration of various operations of the Company. Leveraging its leading technological innovation capability, the Company's Research and development (R&D) projects are progressing as scheduled during the year. Highlights here include completion of patient enrolment for the Phase III clinical trial of TAB008 (a bevacizumab biosimilar for the treatment of non-squamous non-small-cell lung cancer). In addition, Phase I clinical data of TAA013 (HER2+ breast cancer), our self-developed ADC drug, was published during the year, the first T-DM1 ADC product to release this data in the Chinese market. We are encouraged that our TAB014 (An anti-VEGF Monoclonal Antibody for the Treatment of wet age-related macular degeneration) was recognized as a special major project for technologies of "innovative manufacturing of major new drugs" of China. Moreover, we have commenced diversified strategic cooperation with domestic and international companies, to accelerate the progress of major R&D projects and achieve income growth."

FINANCIAL HIGHLIGHTS (as at 31 December 2019)
Hong Kong Financial Reporting Standards Measures:

– Revenue amounted to RMB45.3 million, representing a 16% year-on-year increase, mainly attributable to diversified revenue sources such as CMO and CDMO service fees as well as commissions for marketing services provided.
– Research and development expenses amounted to RMB191.1 million, representing a 1% year-on-year increase.
– Net loss amounted to RMB299.3 million, representing a 12% year-on-year increase mainly due to listing expenses.

BUSINESS HIGHLIGHTS
Since its inception in 2009, the Company has built and established a "two-chain four-platform" system: Two-chains: a complete industrial value chain as well as a high-quality and diversified product chain; Four-platforms: Innovative technology platform, high-standard commercial production platform, clinical research platform, marketing and business platform. The integrated operation of each value chain and platform exhibits the greatest synergy. The Company's comprehensive product pipeline consists of seven biological and five chemical drug candidates, 11 of which are self-developed.

The operations of the Company's various R&D pipelines proceeded hand-in-hand during the year and achieved smooth progress with the following major milestones.

Regulatory Application:

– TOZ309: A generic drug candidate of temozolomide capsules, which is a chemical drug for the treatment of malignant brain gliomas. ANDA was submitted in July 2019. It is expected to be filed in 2020.

– TOM218: ANDA was submitted and accepted for filing.

The progress of clinical stage products

– TAB008 (a bevacizumab biosimilar for the treatment of non-squamous non-small-cell lung cancer): The Company's most advanced biological drug candidate. Patient enrollment for Phase III clinical trial of the drug was completed in 2019 as scheduled. It is currently preparing the NDA submission. The drug is expected to be approved for launch at the end of 2020 or early 2021.

– TAA013: An ADC candidate containing trastuzumabemtansine (Trastuzumab-MCC-DM1) aiming to become an affordable alternative of Kadcyla, is used for the treatment of breast cancer. The Phase I clinical data was published in 2019, which was also the first T-DM1 ADC product in the Chinese market to release this data. The Company plans to carry out Phase III clinical study in 2020 and expects to complete the Phase III clinical trial by the end of 2022 and launch the drug in 2023.

– TAB014: (A drug developed based on bevacizumab) For the treatment of disease related to retinal neovascularization, such as wet age-related macular degeneration (wAMD). It was recognized as a special major project for technologies of "innovative manufacturing of major new drugs" of China. TAB014 is in Phase I clinical trial. It is expected to complete Phase III clinical trial by 2022 and launch in 2023. The US FDA pre-IND regulatory consultation was completed during the year.

The R&D of other drugs continues to result in product launches as scheduled.

Commercialization and production
Recently, TOT BIOPHARM has been increasing investments and has established an antibody drug production base with a designed production capacity of 16,000L, thereby forming a comprehensive and high-quality drug and product chain. The Company has also developed Perfusion-Batch Hybrid Technology ("PB-Hybrid Technology"), and was the first to apply this technology to commercial-scale production in China and completed production and validation of various products and batches, thus creating a mature technology for its own utilization. The technology has disrupted the traditional processes of large-scale monoclonal antibody cell expansion. It can be expanded from 25L to 2000L directly without going through the 10L, 50L, 200L and 500L expansion steps, thereby streamlining process flows, optimizing product quality, shortening production cycles and reducing capital expenditures. This brings remarkable advantages to our production.

The Company has been engaged in the technology of antibody drug conjugates (ADC) for few years. It has already completed the R&D and trial production of ADC product TAA013, published the data of Phase I clinical trials and finished CDMO/ CMO of innovative ADC drugs with several partners. The Company is constructing the ADC drug production facility, and will be one of the few companies in China with a GMP-compliant ADCs commercial production plant, laying the foundation for the development of the ADC field. Through this experience the Company can have the advantage of quick entry into a market.

Diversified strategic cooperation
The Company takes advantage of its open platform to exploring collaborative opportunities internationally, thereby continuously enriching the Company's product pipeline and enhancing innovation capabilities. The Company will continue to extend new indications of its drug candidates and to expand its market opportunities. The Company will also proactively seek for international strategic collaboration to jointly develop innovative products. In addition, by utilizing its exclusive advantages in production and technology, the Company has conducted new cooperation for CMO, CDMO with companies such as Miracogen, Kintor and NewBio.

Future Development
Ms. Yeh-Huang, Chun-Ying, General Manager of TOT BIOPHARM, said, "Antibody-based drugs in the China market represent an enormous potential and we are ready to seize the huge market opportunities. We will continue to focus on the anti-tumour drugs segment and accelerate our R&D activities, focus on advancing the clinical research of drugs such as TAB008, TAA013 and TAB014, continue to launch products and further open up our businesses and platform and introduce different cooperative partners, thereby enriching our product pipeline and achieving diversified revenue sources. We will always adhere to our business philosophy of "Balance of Humanity and Technology". We are committed to developing new anti-tumour drug products with high technological barriers and economic value, providing a suitable and affordable product portfolio, and creating value for our shareholders and society".


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