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   Biotech / MedicalDyadic


From: Paul Lee5/7/2011 3:49:38 PM
   of 9
 
The Best Growth Stock to Hold Forever (OTC: DYAI)
Money — By Editor on November 18, 2010 6:12 pm

The Best Growth Stock to Hold Forever
If I had to pick a stock that offered indefinite growth potential, I’d bet big on a fungus.

My choice for “The Best Growth Stock to Hold Forever” is a biotech pioneer called Dyadic International (OTC: DYAI). Most people have never heard of this little Florida-based gem, but in the coming years, I think it will rise to prominence as one of the nation’s leading bio-industrial concern, supplying several key sectors of the economy with vital tools to carry out a host of manufacturing tasks.

This maker of specialty enzymes has this lock on the future because it owns a special fungus called C-1. In the hands of genetic engineers — Dyadic CEO Mark Emalfarb calls them “gene jockeys,” C-1 can be programmed to generate vast quantities of enzymes.

One of the key areas that will be effected is the pharmaceutical industry. Many of today’s leading drugs are the result not simply of a certain chemical formula — made by mixing those chemicals together and stamping out pills — but of certain biological processes. That is, the medicine you take, one way or another, is the result of a process involving living things.

To accomplish this, drug manufacturing relies on a technology that, frankly, tends to weird some people out. In fact, I had one Game-Changing Stocks reader send me an email in which he vowed to never again take a drug manufactured this way. The manufacturing process centers on a technology known as CHO.

Now, when I first heard of CHO, I figured it must stand for carbon, hydrogen and oxygen — the building blocks of life, right? Wrong. That’s chemistry-oriented thinking. CHO stands for Chinese Hamster Ovary. Laboratory technicians begin their drug manufacturing process with these cells and introduce other agents to obtain — that is, to organically grow — a certain substance. It could be your blood pressure medication, your treatment for asthma, Parkinson’s, cancer or a host of other maladies. Biotech drugs are a big business — and they are all manufactured the same way.

The process has some drawbacks. For one, it is time-consuming, because the manufacturing process must be proven at different sizes. In other words, just because CHO yields X results for Quantity Y, the output for Quantity Z might be totally different. Each phase of this testing takes weeks in the lab as the eggs cells undertake the necessary biological steps. And while every manufacturer in the world relies on this process, which offers other limitations, every manufacturer is always on the lookout for something different.

That’s why Dyadic partnered with an expert in the drug manufacturing space and launched a new venture called EnGen Bio. Its aim is to deliver enzyme-based manufacturing processes to Big Pharma to reduce their costs, improve purity and decrease production time. Given the proper enzymes, which act as catalysts, what takes weeks in the incubator takes only hours in the test tube. It’s also scalable, yields far purer results — there aren’t any hamster egg byproducts to clean out, and it can be done with less water and at lower temperature, which both deliver substantial additional cost savings.

Think about it: Potentially hundreds of drugs — billions of prescriptions a year — could be made using Dyadic’s enzymes. Several deals are in the works to test the technology. Big Pharma is clearly interested, and as time passes and the concept is continually proven possible, successful and efficient, Dyadic stands to earn significant royalties.

That’s just one area where these enzymes can be used.

Ready for another? Let’s run your car to the filling station.

Once we get there, you’ll likely see a sticker on the pump that notes as much as 10% of the gasoline you pump could be ethanol — pure grain alcohol derived from corn.

That sticker won’t be there much longer. A new EPA rule changes how much ethanol can go into your tank — it’s not less, it’s more. The ceiling was 10%. Now it’s 15%. This means the feds just increased the market for ethanol by +50%.

Now a lot of folks are all sorts of upset out this. Greens in particular like to have a wall-eyed fit over the new ethanol blending rules, which they think will lead to more plants being planted and more land being cultivated for row crops.

That's not right. That's not what the law says, anyway.

You see, federal law passed way back in the Bush years sets a production schedule for biofuels, of which traditional corn-based ethanol is one. Biodiesel is another. A third is a special type of ethanol, derived not by boiling the starch off corn and distilling it into white lightning -- which is all ethanol is -- this type of ethanol is made from the sugar in plants, which can be fermented into ethanol.

This type of biofuel, called cellulosic ethanol because it uses plant sugar or "cellulose," can be made from any plant, be it leftover corn stover, wheat straw, grass, even algae. Anything made from plants that grow contains cellulose that can be turned into fuel. There's even a company that's collecting used office paper from Congress and turning it into biofuel -- probably the only useful thing lawmakers have generated in recent memory!





The upside is that these plants can be grown anywhere. In many cases, the biomass being used for cellulosic ethanol will simply be the leftover plant matter from traditional crops. In other cases, special grasses might be planted. These not only can be planted just about anywhere, but they don't need as much water, bug killer or fertilizer as corn does.

Corn hits a ceiling for biofuel production in 2015, when 15 billion gallons of ethanol can be used. But during the same time, and extending through to 2022, cellulosic ethanol production will grow from only a few million gallons today to 16 billion gallons in 2022.

The thing is, the energy to be harvested from plant sugar can't be reached in a cost-effective manner without enzymes. So just as Dyadic likely will be receiving a part of your bill at the pharmacy, it also likely will be getting paid every time you fill up with petro. After all, without the proper mix of enzymes, all that agricultural waste and grass and scrap wood and paper will just be trash.

These two applications are indicative of Dyadic's remarkable potential. But there are others. Emalfarb, in fact, has trademarked the catchphrase "Dyadic Inside." In the near future, you're likely to see this label at the pharmacy, at the gas station and even when you pop the top on an ice-cold brewski or bottle of vino -- Dyadic's enzymes are already used in their production.

Action to Take --> Forever is a long time, but I'm confident that as time passes, these markets for Dyadic's products will develop and new markets will emerge, and this little company will collect a royalty on more things than we can count. Because of this, Dyadic is my pick for the "Best Growth Stock to Hold Forever."



--Andy Obermueller

smarterclicks.com


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To: Paul Lee who wrote (1)5/7/2011 3:50:12 PM
From: Paul Lee
   of 9
 
Dyadic Netherlands Enters into R&D Collaboration with Sanofi Pasteur and EnGen Bio

Sanofi Pasteur to Fund Research Utilizing Dyadic’s C1 Platform Technology For Certain Vaccine Applications

JUPITER, Fla. and WAGENINGEN, The Netherlands

May 02, 2011

Dyadic International, Inc. ("Dyadic") (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products for the biopharmaceutical, biofuels and industrial enzyme industries, announced today that its research and development subsidiary, Dyadic Nederland B.V. (“Dyadic Netherlands”), has entered into a research agreement with Sanofi Pasteur, the vaccines division of sanofi-aventis Group, and EnGen Bio, Inc.

Under the agreement, Sanofi Pasteur will fund collaborative research at Dyadic Netherland’s research and development facility in Wageningen, The Netherlands, which will utilize Dyadic’s proprietary and patented C1 Platform Technology for certain vaccine applications. The research will be conducted under the guidance and direction of Dyadic Netherland’s General Manager, Dr. ir. Wim van der Wilden, with coordination by Dr. Mark Alfenito, the President and CEO of EnGen Bio. The research is anticipated to be completed in six to twelve months. All other terms of the research collaboration are confidential.

Sanofi Pasteur, based in Lyon, France, is the largest company entirely dedicated to vaccines. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

EnGen Bio, based in Redwood City, California, is an early stage biopharmaceutical company that is working to develop biopharmaceutical applications for Dyadic’s proprietary and patented C1 Platform Technology. For more information, please visit: www.engenbio.com.

Dyadic’s President and Chief Executive Officer, Mark Emalfarb, stated, “We are very pleased to have the opportunity to work with Sanofi Pasteur and EnGen Bio to further demonstrate the utility of our C1 technology for certain vaccine applications.”

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To: Paul Lee who wrote (2)5/7/2011 3:51:57 PM
From: Paul Lee
   of 9
 
Dyadic CEO makes a comeback

Company sues prominent legal, accounting firms

Premium content from South Florida Business Journal - by Brian Bandell

Date: Monday, May 4, 2009, 12:00am EDT - Last Modified: Monday, May 4, 2009, 12:00am EDT


Dyadic International founded in 1979 by Mark Emalfarb, went public in 2004 and ventured into biotechnology.

Laboratory technicians Rashida Tharpe and Mikcol Andrews work with biofuels at Dyadic International’s Jupiter headquarters.



Dyadic International CEO Mark Emalfarb has turned from the hunted to the hunter.

Two years after an accounting scandal in Hong Kong led to his ouster, the founder of the Jupiter-based company is back in charge and suing former accountants and attorneys.

The defendants in the Palm Beach County Circuit Court lawsuit include national accounting powerhouse Ernst & Young and legal heavyweight Greenberg Traurig, plus its attorney Robert I. Schwimmer. Dyadic also named the Miami law firms of Moscowitz & Moscowitz and Bilzin Sumberg Baena Price & Axelrod, both of whom did work for the company after the accounting problems were discovered.

According to the complaint, Dyadic (Pink Sheets: DYAI) had $27 million in cash when Emalfarb was ousted at the recommendation of these attorneys in mid-2007, and just $3 million in cash when he returned a year later after winning a legal battle that forced a shareholder board election. It also lost out on potential licensing deals for its biotechnology, according to the complaint.

“Dyadic was led to the brink of ruin by the very professionals it relied upon to protect it,” the lawsuit states.

The lawsuit charges E&Y, the law firms and the lawyers with breach of fiduciary duty, professional negligence, constructive fraud and civil conspiracy. Greenberg Traurig and a spokeswoman for Schwimmer said Dyadic’s claims are baseless and they plan to put up a vigorous defense.

Jane Moscowitlso ...

Dyadic International CEO Mark Emalfarb has turned from the hunted to the hunter.

Two years after an accounting scandal in Hong Kong led to his ouster, the founder of the Jupiter-based company is back in charge and suing former accountants and attorneys.

The defendants in the Palm Beach County Circuit Court lawsuit include national accounting powerhouse Ernst & Young and legal heavyweight Greenberg Traurig, plus its attorney Robert I. Schwimmer. Dyadic also named the Miami law firms of Moscowitz & Moscowitz and Bilzin Sumberg Baena Price & Axelrod, both of whom did work for the company after the accounting problems were discovered.

According to the complaint, Dyadic (Pink Sheets: DYAI) had $27 million in cash when Emalfarb was ousted at the recommendation of these attorneys in mid-2007, and just $3 million in cash when he returned a year later after winning a legal battle that forced a shareholder board election. It also lost out on potential licensing deals for its biotechnology, according to the complaint.

“Dyadic was led to the brink of ruin by the very professionals it relied upon to protect it,” the lawsuit states.

The lawsuit charges E&Y, the law firms and the lawyers with breach of fiduciary duty, professional negligence, constructive fraud and civil conspiracy. Greenberg Traurig and a spokeswoman for Schwimmer said Dyadic’s claims are baseless and they plan to put up a vigorous defense.

Jane Moscowitz also said the claims were baseless and that her firm’s investigation was independent, diligent and unbiased.

E&Y and Bilzin Sumberg declined comment.

E&Y and Schwimmer, who was an attorney for co-defendant Jenkins and Gilchrist at the time, should have detected accounting problems in Puridet, Dyadic’s Hong Kong-based subsidiary, when they helped Dyadic acquire Puridet in 2003 and go public the following year, the lawsuit complaint says.

E&Y also gave Puridet clean audits in 2003 through 2005, although an investigation Moscowitz conducted in 2007 found improper transactions occurring at the company during those years, the complaint says.

The complaint says Emalfarb had no formal business training or accounting experience, so he relied on his lawyers and accountants for due diligence.

“Jenkins’, Schwimmer’s and E&Y’s advice to include the Asian subsidiaries within the public company was not in Dyadic’s best interest or that of its investors, but instead was crafted to further their own financial interest,” Dyadic’s complaint says. “Their representation of Dyadic as a public company, which included Asian subsidiaries, would produce much higher fees than representing Dyadic without these subsidiaries.”

Anonymous whistle-blower e-mails

The problems at Puridet were disclosed to investors in April 2007, when Emalfarb received anonymous whistle-blower e-mails about the activities in Hong Kong. After Emalfarb forwarded the e-mails to Dyadic CFO Wayne Moor, the company’s board started an investigation under the advisement of Schwimmer and Greenberg Traurig, the complaint says.

The board hired Moscowitz and Moscowitz to conduct the investigation, which featured Greenberg Traurig as special counsel. According to Dyadic’s complaint and documentation provided with it, the board told Moscowitz not to investigate E&Y’s accounting or auditing of Puridet in exchange for E&Y’s cooperation.

Ultimately, the Moscowitz report preceded the board’s firing of Emalfarb, who was the company’s largest shareholder.

The report said Emalfarb did not take strong-enough action to stop the accounting violations at Puridet after getting whistle-blower e-mails in 2003 and 2004. It showed an e-mail from Emalfarb, telling Puridet officials to stop doing business with one of the suspicious companies.

While the report did not present direct evidence that Emalfarb knew suspicious dealings at Puridet continued, it concluded that it was “reasonable to infer” Emalfarb knew about them, based on his frequent contacts with Puridet management.

Dyadic’s lawsuit said the investigation by Greenberg Traurig, E&Y and Moor ignored their roles in supervising Puridet and focused on Emalfarb. It said Greenberg was also representing E&Y in an unrelated banking case.

“Due to this undisclosed conflict and despite its duty to render corporate governance advice to the board as Dyadic’s lawyers, Greenberg and Schwimmer did not advise the board to include E&Y, the party most responsible for causing Dyadic’s problems with its Asian subsidiaries and the party with the singular ability to correct those same problems, as a focus of the investigation,” Dyadic says in its complaint.

The complaint also faulted Schwimmer and Greenberg Traurig for recommending that Dyadic retain E&Y as its accounting firm, even though it would not sign off on the company’s financial reports because of the issues at Puridet. Dyadic was delisted from AMEX for not filing its SEC reports. Its share price plummeted from $5.30 when the accounting scandal was revealed in April 2007 to 50 cents last month.

E&Y resigned as Dyadic’s auditor in June 2008 – the same month Emalfarb won back his position as Dyadic’s CEO after a proxy and legal fight.

“If Mark Emalfarb didn’t sue and get control of Dyadic, they probably would have gotten away with it,” said Dyadic’s Boca Raton-based attorney, Steven M. Katzman. “Emalfarb will pursue these claims vigorously and hold the responsible parties accountable."

KEY PLAYERS:

Dyadic International’s complaint has allegations about the roles of attorney Robert Schwimmer, accounting firm Ernst & Young and the law firms of Greenberg Traurig, Moscowitz and Moscowitz and Bilzin Sumberg. (Schwimmer, Greenberg Traurig and Moscowitz and Moscowitz say the legal claims are baseless, while Ernst & Young and Bilzin Sumberg declined comment.) According to the complaint:

In 1979, Mark Emalfarb founded Jupiter-based Dyadic International as a producer of enzymes for industrial and apparel products. It went public in 2004 and ventured into biotechnology.
Puridet, of Hong Kong, sold Dyadic’s enzymes to Asian customers. It was bought by Dyadic in 2003.
South Dragon Detergent Co. was a large Puridet customer in 2003 and 2004, but when allegations surfaced that Puridet’s management controlled its checkbook, Emalfarb told Puridet’s management to stop dealing with the company.
Pui Shing Detergent Co. became Puridet’s largest customer in 2005 and 2006, but it eventually became clear after a Dyadic investigation in 2007 that it had the same address as South Dragon and was also controlled by Puridet’s management. This meant Dyadic’s publicly filed financials were misstated and Puridet avoided paying some Chinese taxes, an investigation by Moscowitz and Moscowitz concluded.
Robert I. Schwimmer, an attorney with Greenberg Traurig in Chicago, helped Dyadic acquire Puridet and go public. He advised the company during its investigation.
Ernst & Young was the accountant and auditor for Dyadic as it bought Puridet, went public and made public filings. Its Hong Kong arm audited Puridet’s books and gave it a clean bill of health in 2004 and 2005.
Miami law firm Moscowitz and Moscowitz (with partners Jane and Norman Moscowitz) conducted an investigation into the accounting issues at Puridet at the request of Dyadic’s board. The report placed blame on Emalfarb. (Jane Moscowitz said her firm’s investigation on behalf of Dyadic was independent, diligent and unbiased.)
Miami law firm Bilzin Sumberg was hired by Dyadic’s board to advise it during the investigation, while Emalfarb was on a leave of absence.
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Read more: Dyadic CEO makes a comeback | South Florida Business Journal

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From: Paul Lee6/27/2011 9:41:50 AM
   of 9
 
DYADIC INTERNATIONAL ENTERS INTO RESEARCH AND LICENSE AGREEMENT

WITH MAJOR PLAYER IN THE ANIMAL FEED INDUSTRY



JUPITER, Fla., June 27, 2011 - Dyadic International, Inc. ("Dyadic") (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products for the industrial enzyme, bioenergy, and biopharmaceutical industries, announced today that it has entered into a long-term research, development and license agreement with a key provider of animal nutritional solutions throughout the world (the “Commercial Partner”), to develop, manufacture and commercialize animal feed enzyme products.



Under the agreement, the Commercial Partner will continue its successful research cooperation with Dyadic’s R&D subsidiary, Dyadic Netherlands, and utilize Dyadic’s patented and proprietary C1 platform technology to develop fungal strains that will produce high levels of enzymes for feed applications.



As part of this agreement, Dyadic has granted the Commercial Partner a worldwide license to use the developed C1 fungal strains to manufacture and sell animal feed enzyme products. Dyadic will receive an upfront access fee and will be eligible to receive a commercial milestone payment as well as royalties based on the Commercial Partner’s worldwide sales of products which utilize the C1 technology platform.



In accordance with Dyadic’s confidentiality obligations under the agreement, no additional information on the identity of the Commercial Partner or the terms of the agreement can be disclosed.



Dyadic’s President and Chief Executive Officer, Mark Emalfarb, stated, “We are very fortunate to partner with a global player in the animal feed industry to grow our respective businesses in one of the largest and fastest growing enzyme markets. Through our growing relationship with this party, Dyadic has demonstrated and expects to continue to show the benefits of using Dyadic’s C1 technology for the development of novel highly productive and efficient animal feed enzyme products. This transaction is a prime example of Dyadic’s ability to leverage its technologies in a variety of industries by providing its partners with solutions that contribute to better performing products at higher productivity, lower costs and higher margins.”

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From: Paul Lee2/29/2012 9:42:53 AM
   of 9
 
DYADIC INTERNATIONAL PARTNERS WITH LEADING PROVIDER OF NUTRITIONAL INGREDIENT SOLUTIONS FOR PRODUCTION OF FOOD ENZYMES



JUPITER, Fla., February 29, 2012 - Dyadic International, Inc. ("Dyadic") (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products for the industrial enzyme, bioenergy, and biopharmaceutical industries, announced today that it has entered into a research, development and license agreement with a leading global provider of nutritional ingredient solutions to use Dyadic’s patented and proprietary C1 platform technology to develop, manufacture and commercialize key enzyme products for food applications.



Dyadic’s President and Chief Executive Officer, Mark Emalfarb, stated, “We are very fortunate to partner with a company that has such a long history of providing innovative and effective products. Dyadic looks forward to utilizing its C1 technology for the expression of next generation enzyme products for food applications. This collaboration is yet another example of Dyadic’s ability to continue leveraging its technologies in a variety of industries by providing its partners with the pathway towards greater profitability through better performing products at lower costs and higher yields.”



Under this agreement, Dyadic’s partner will fund research at Dyadic’s research and development center in the Netherlands to develop customized C1 fungal strains that can produce high levels of key enzymes for food applications. Dyadic has granted its partner a worldwide license to use these developed C1 fungal strains to manufacture and sell these key ingredients used in manufacturing certain foods.



In addition to research funding, if the research is successful and Dyadic’s partner commercializes enzyme products derived from Dyadic’s C1 technology, Dyadic will be eligible to receive commercial milestone payments as well as ongoing royalties based on the production of these enzyme products. Additionally, if Dyadic is successful in achieving the desired enzyme yields in this project, both parties agree that it will lead to collaboration on additional development projects for the food industry.



At the request of Dyadic’s partner, Dyadic has agreed to keep the identity of its partner confidential until further notice.



About Dyadic



Dyadic International, Inc. is a global biotechnology company that uses its patented and proprietary technologies to conduct research, development and commercial activities for the discovery, development, manufacture and sale of enzyme and protein products for the bioenergy, industrial enzyme and biopharmaceutical industries. Dyadic utilizes an integrated technology platform based on its patented and proprietary C1 fungus which enables the development and large scale manufacture of low cost proteins and enzymes for diverse market opportunities. The C1 platform technology can also be used to screen for the discovery of novel genes and proteins. Dyadic actively pursues licensing arrangements and other commercial opportunities to leverage the value of these technologies by providing its partners and collaborators with the benefits of manufacturing and/or utilizing the enzymes which these technologies help produce. Please visit Dyadic’s website at www.dyadic.com.

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From: Paul Lee7/16/2012 9:53:41 AM
   of 9
 
DYADIC DEMONSTRATES INDUSTRY-LEADING BIOFUELS ENZYME PERFORMANCE



AlternaFuel® CMAX3™ performance equals and surpasses leading biofuels enzymes



JUPITER, Fla., July 16, 2012 - Dyadic International, Inc. ("Dyadic") (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and others proteins for the bioenergy, bio-based chemical, biopharmaceutical and industrial enzyme industries, today unveiled its latest biofuels enzyme advancement, AlternaFuel® CMAX3™. This next generation product enables the production of cellulosic biofuels and bio-based chemicals from a wide range of renewable non-food feedstocks under broad operating conditions.



Dyadic’s President and CEO, Mark Emalfarb, stated “The data supporting this product clearly demonstrates Dyadic’s scientific capabilities to leverage our C1 technology platform to create enzyme mixtures whose performance rivals the leading biofuels enzyme product on the market. This is largely due to the inherent robustness and versatility of the C1 genome and expression system, both of which have considerable untapped potential. The results obtained with AlternaFuel® CMAX3™ are not only relevant for the production of biofuels but also for bio-based chemicals and biogas. Dyadic and its licensees are continuing to develop better performing enzymes to further reduce the total cost of producing advanced biofuels and other bio-based products.”



Jan Wery, Science Director at Dyadic Netherlands, added, “AlternaFuel® CMAX3™ achieved a similar saccharification yield at pH 5.0 and substantially better results at pH 6.0 than those achieved by the current leading competitive biofuels enzyme product. Saccharification yield is defined as the relative amount of fermentable sugars released through enzymatic hydrolysis from lignocellulosic biomass such as agricultural feedstock and waste. This important parameter demonstrates the level of progress being made across the entire industrial enzyme industry in developing enzymes necessary for lignocellulosic biomass to replace petroleum in fuel and chemical production.”



About AlternaFuel® CMAX3™



AlternaFuel® CMAX3™is the latest generation of a cellulase and hemicellulase complex based on Dyadic’s C1 platform technology which enables efficient conversion of multiple forms of non-food biomass into fermentable sugars at broad pH and temperature ranges that can be used to produce biofuels, bio-based chemicals, biogas and other bio-based products.



For more information on AlternaFuel® CMAX3™, please visit Dyadic’s recently remodeled website at www.dyadic.com.


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From: Paul Lee9/7/2016 9:30:03 AM
   of 9
 
Dyadic International, Inc. Announces Research and Development Agreement to Further Advance Its Proprietary C1 Fungal Strain for Biopharmaceutical Development & Production JUPITER, FL – September 7, 2016 (GLOBE NEWSWIRE) - Dyadic International, Inc. ("Dyadic") (OTCQX: DYAI), a global biotechnology company focused on the development and large scale manufacture of low cost, better performing biologic vaccines and drugs at flexible commercial scales, today announced they have entered into a research and development agreement to further advance its proprietary C1 fungal strain for biopharmaceutical development & production. The collaboration is targeting the development of highly productive C1 strains & fermentation processes, and the accompanying associated molecular tools to produce a number of targeted therapeutic proteins for Dyadic as well as those specified by third party biotech and pharmaceutical companies.

"We are excited to be further advancing C1's capabilities for the development and production of lower cost therapeutic proteins," said Mark A. Emalfarb, Founder and CEO, Dyadic. "In order to reach our ambitious goals and to incentivize the scientists carrying out this project, the agreement provides for potential milestone payments for achieving specified productivity levels and glycosylation properties within specified timelines."

"The research & development program will encompass the entire spectrum of strain development through fermentation optimization, applying proven scientific and genetic techniques and principles, executed by some of the most skilled filamentous fungal researchers to re-engineer the highly productive industrially proven C1 expression system for therapeutic uses," said Ronen Tchelet, PhD, Dyadic's VP of Research & Business Development. "What we are setting out to accomplish in this development program has the potential to help bring biologic vaccines & drugs to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers and, hopefully, improve access and reduce cost to patients and the healthcare system, but most importantly saving lives."

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical protein production system based on the fungus Myceliopthora thermophila, nicknamed C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, production and performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines, monoclonal antibodies, biosimilars and/or biobetters, and other therapeutic proteins. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in developing and manufacturing biopharmaceuticals which these technologies help produce. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic drugs to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers and, hopefully, improve access and cost to patients and the healthcare system, but most importantly saving lives. Please visit Dyadic's website at www.dyadic.com for additional information, including details regarding Dyadic's plans for its biopharmaceutical business.

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To: Paul Lee who wrote (7)2/27/2018 8:46:56 AM
From: Paul Lee
   of 9
 
Dyadic International, Inc. Announces Research and Development Collaboration with Mitsubishi Tanabe Pharma Corporation To Produce Two Target Proteins in C1
GlobeNewswire•February 27, 2018
JUPITER, Fla., Feb. 27, 2018 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”) ( DYAI), a global biotechnology company focused on further improving and applying its proprietary C1 gene expression platform to speed up the development and production of biologic products at commercial scales, today announced that it has entered into a funded proof of concept research collaboration to explore the potential of its C1 technology to produce two vital therapeutic proteins for human health indications with Mitsubishi Tanabe Pharma Corp., one of the World’s top tier pharmaceutical companies.

“We are very pleased to have the opportunity to collaborate with Mitsubishi Tanabe Pharma Corp. to express two of its important therapeutic compounds using our C1 production platform”, said Mark Emalfarb, Dyadic’s CEO. “This research and development program is aiming to help Mitsubishi Tanabe overcome specific gene expression challenges and to further demonstrate the potential of C1 to become a platform of choice for manufacturing protein-based biologics because of its speed of development and low cost of goods.”

“In this research collaboration, we will be using our proprietary synthetic biology and genome engineering techniques to further modify our C1 host production organism to produce the desired therapeutic proteins”, said Ronen Tchelet, Ph.D., Dyadic’s Head of Research. “We have already proved that our C1 technology is capable of speeding up the development process and producing certain monoclonal antibodies (mAbs) at commercially important levels. We expect this project to generate additional data and to enlarge the diversity of the types of proteins that our C1 platform can potentially produce at higher yields and with lower cost.”

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Myceliophthora thermophila, nicknamed C1. The C1 microorganism, which enables the development and large-scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines, monoclonal antibodies, biosimilars and/or biobetters, and other therapeutic proteins. Additionally, the Company has entered into a proof of concept research project to explore the potential of its C1 technology to produce an important active moiety for a third party. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of using these technologies in the development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines & drugs to market faster, in greater volumes, at lower cost, and potentially with new properties to drug developers and manufacturers and, hopefully, improve access and cost to patients and the healthcare system, but most importantly save lives.

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From: Paul Lee6/4/2019 6:06:27 PM
   of 9
 
14:01 04 Jun 2019

The biotechnology platform company helps drug makers negotiate the cost curve from discovery to large-scale manufacturing of low-cost enzymes and proteins that can ultimately lower the cost of healthcare



When Mark A Emalfarb started Dyadic International Inc ( NASDAQ:DYAI), it was cashing in on a 1980s trend — supplying pumice stones to denim makers to help make stonewashed jeans more fashionable and comfortable. Forty years later, Dyadic is a sought-after biotechnology platform company listed on the tech-laden Nasdaq.

Founded in 1979, the Jupiter, Florida, biotechnology platform company, sold a variety of industrial enzymes worldwide for more than two decades to the biofuel, animal nutrition, pulp and paper, food and beverage and textile industries.

Dyadic leverages its proprietary C1 technology — an industrially proven fungal gene expression technology for producing large amounts of low cost biologic products — to help bring biologic vaccines, therapeutic enzymes, proteins, biosimilars, drugs and potentially other types of biologics such as metabolites and viral vectors such as AAV to market faster and at a lower cost.

The company has patented its proprietary filamentous fungus, Myceliophthora thermophila, nicknamed C1 and the associated molecular tools used to engineer the C1 cells to express and manufacture large volumes of low-cost biologic products such as enzymes and proteins.

The C1 fungus, is a living cell that has been bioengineered by Dyadic scientists for more than two decades. Through a series of serendipitous mutations, the C1 cells morphed into what the company calls microscopic propagules — this change in the shape and form of the C1 cells led to both hyper productivity and robust and reproducible growth characteristics. This scientific anomaly improved C1’s productivity several hundred-fold and allowed for the large industrial scale production of enzymes and other proteins.

Dyadic, which started trading on the Nasdaq on April 17 this year, is ripe with opportunities. Proactive Investors sat down with Dyadic International’s founder and CEO Mark Emalfarb to learn more about those opportunities.

Emalfarb is a named inventor on over 25 US and international biotech patents and patent applications linked to the patented and proprietary C1 microorganism.

How did you end up in the biotechnology industry and what is the genesis of Dyadic International?

I was a journalism major and a member of the University of Iowa NCAA championship wrestling team coached by Dan Gable. I started out helping to pioneer the stonewash jeans industry by supplying pumice stones to soften and fade denim to Levi Strauss & Co ( NYSE:LEVI), Guess Jeans, Wrangler, Lee as well as many other jean manufacturers and garment wet processers. Sales of pumice grew to around $15 million per year by the mid 80’s which yielded a profit of nearly $5 million.

In the 80’s cellulase enzymes were coming on the scene as a more environmentally friendly alternative to the use of pumice in the stone wash process. Since Dyadic had the customer relationships with the laundries performing the stone wash services for the blue jean manufactures Dyadic began to offer the cellulase enzymes to its customers to supplement and/or replace the pumice.

As the enzyme manufacturers began to open up additional distributors our margins were contracting, so I embarked on a search to find scientists who could help us develop our own cellulase enzyme products. The next step in Dyadic’s evolution “from jeans to genes” was to become a biotech company, to develop and manufacture our own line of enzymes.

We found top scientists at Moscow State University that had been carrying out research on cellulases since the 1970’s. We worked with both Russian and American scientists and launched our first commercial cellulase product, ACE, in 1994 and followed that quickly in the Fall of 1996 with a neutral cellulase enzyme (NCE) which was produced from C1. We obtained our first of over two dozen patents on C1 in the Fall of 1998.

We then embarked on a two-plus decade-long R&D effort which takes us to where we are today, with a potentially significant biopharmaceutical gene expression platform based on the fungus Myceliophthora thermophila, named C1.

How would you explain the C1 expression technology to investors who may not be familiar with the science behind it?

C1 is a novel industrially proven fungus, a living cell that has been engineered to produce large volumes of low-cost enzymes and other proteins. The first breakthrough moment came in the process of developing C1 when we bred the natural C1 isolate, a fungus which was isolated from Russia’s alkaline soil, to make more and more of what we wanted.

After several rounds of UV & chemical mutagenesis we had a serendipitous mutation that micronized the C1 fungus, which meant it could be cultivated industrially with greater productivity, under lower viscosity to produce the desired C1 neutral cellulases at a very low cost.

How can the C1 gene expression platform disrupt the status quo in bio-manufacturing, and potentially help bring biologic vaccines and drugs to market faster at lower cost to drug developers?

The C1 microorganism, which enables the development and large-scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. We have already demonstrated C1’s potential for use in helping to speed the development and lower the cost of biologic vaccines and drugs by demonstrating high productivity in several internal and externally funded research programs with many different types and classes of pharmaceutical proteins of interest to both animal and human pharmaceutical companies.





Has your C1 technology platform gained traction in the biotech industry after Dyadic sold its industrial enzyme business to DuPont for $75 million?

After selling our industrial enzyme business three years ago to DuPont for $75 million, we developed a newly focused strategy to apply the industrially proven C1 cell line for use in the animal and human health biopharmaceutical industries to lower the COGS and speed up drug development and manufacturing.

C1 has and continues to show great potential to manufacture biologic vaccines and drugs in larger amounts with less capital required and at lower costs than existing production systems.

Dyadic has co-exclusive rights to the C1 technology for use in human and animal pharmaceutical applications, with the exclusive ability to enter into current sub-license agreements. DuPont enjoys rights to utilize the C1 technology for use in pharma applications, but it will make royalty payments to Dyadic on commercialization.

One attraction of the biopharma industry towards C1 are its attributes over the existing platforms of ‘standard’ choice like, for example, the CHO cell lines.





We ended 2018 with nine funded proof-of-concept research collaborations and two new collaborations this year. It was another year of continued progress with many favorable milestones. We have a research collaboration with Mitsubishi Tanabe Pharma Corp where we have expressed and provided Mitsubishi with their protein of interest for further analysis which we hope will be moved into clinical trials and commercialized by Mitsubishi in the future. We also have an ongoing research collaboration with Sanofi-Aventis Deutschland GmbH, to explore the potential of our C1 technology to produce various types of therapeutic compounds for manufacturing protein-based vaccine and biologic drugs.

In 2018, the company also inked a proof of concept research collaboration to produce biologic vaccines for human and animal health with the Israel Institute of Biologic Research (IIBR), a top 20 pharmaceutical company and two top tier academic institutions, including the Structural Genomics Consortium, which is part of the University of Oxford and the Fraunhofer USA Center for Molecular Biotechnology.

We ended 2018 entering into another research collaboration with a top twenty biopharmaceutical company and we are continuing to gain momentum and awareness within both the animal health and human biopharmaceutical industry regarding the potential for our C1 gene expression platform to disrupt the status quo in manufacturing biologic vaccines and drugs.

How is the year going for Dyadic?

In the first quarter of 2019, we signed two new research collaboration agreements — both with top 25 drug companies. One of the world's largest vaccine makers, Serum Institute of India Private Limited will collaborate with Dyadic on up to 12 antibodies and vaccines (8 MABs and 4 rVaccines) using Dyadic's proprietary C1 gene expression platform. We also inked a sub-licensing agreement with Alphazyme LLC, a developer, manufacturer and global distributor of molecular biology enzymes.

We inked a worldwide sub-licensing pact with Luina Bio Pty Ltd, one of Australia's most experienced biopharma contract manufacturing organizations, for the development of targeted antigen, and biological products for pets. These programs demonstrate that the market and the industry are taking notice of Dyadic and the perceived capability of our C1 gene expression platform.

Our R&D revenue for the year ended December 31, 2018, increased to $1,295,000 compared to $758,000 for the previous year. These results demonstrate that our business development efforts are bearing fruit.

We had several corporate achievements which include:

Uplisting to NASDAQ and initiated trading on April 17 Form 10 effective on February 12, 2019 Two Sublicensing Agreements

Luina Bio/Novovet: with equity stake and royalties to use C1 to develop biologic vaccines and drugs for companion animals Alphazyme: with equity stake, milestone payments, and royalties upon the commercialization of C1 Serum Institute of India

esearch and commercialization collaboration to develop and manufacture up to 12 antibodies and vaccines using C1. Our business model is to apply C1 by sublicensing it as widely and broadly as we can to help bring more accessible and affordable cures and treatments for disease to patients globally.

dditionally, we continue to update the pharmaceutical industry on how and where our C1 technology may be used by them potentially even earlier in their discovery and development programs to help them overcome gene expression challenges they may be facing. We have been able to demonstrate expression levels of up to 1 milligram per 4 milliliter in microtiter wells.

We believe the yields of protein expressed that C1 offers in microtiter wells may provide pharma companies with sufficient quantities of protein to identify and characterize promising new vaccine and drug candidates using the same host production organism from discovery through manufacturing.

The pharma industry is beginning to recognize the potential productivity advantages of our C1 technology versus CHO, E.coli, baculovirus and yeast from the various classes and types of proteins which have been expressed from C1 to date. Our fully programmable C1 gene expression platform is robust, and flexible and has been used industrially for over two decades to produce products in some of the largest fermenters used in the biotechnology industry.

The industry is also encouraged by our progress on both the protein stability and glyco-engineering research that is ongoing. However, with proper government support and assistance we can all do a whole lot more a lot quicker.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 888





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