Dyadic International is a development-stage biotech trading at $1.85 when it sits on $1.60 in cash. The cash remains from the sale to Dupont in 2015 of rights to their C1 fungus-based biological manufacturing platform for industrial applications. Dyadic retained rights for non-industrial applications and for the last three years has been developing the C1 fungus platform for manufacture of biological drugs and vaccines. The company is 40% owned by ceo Mark Emalfarb who has managed the cash like it was his own. Stock buybacks have totaled $22 million while the company has spent just $10 million of their own money on C1 development. Most R&D has been funded by pharmaceutical partners including seven active partnerships in 2018. Dyadic projects to still have at least $1.40 in cash on June 30, the date the retirement-aged ceo has long promised to begin technology monetization efforts. Purchasing Dyadic shares is a bet that the C1 technology is worth more than the $0.45 a share by which the current stock price exceeds the projected cash balance. The company is uplisting to Nasdaq in Q1 2019 to attract more investors to make that bet.
There are only a limited number (about 11) biological drugs approved by the FDA. Only about 2% of the population in the United States take one but 40% of prescription drug costs are tied to biologics. They’re mostly new, still on patent, very expensive, and expected to be the fastest growing class of drug spending going forward. Trends in medicine are toward biologically manufactured therapeutics like monoclonal antibodies ,bispecifics, virus-like particles, biosimilars, enzymes, and other proteins. Many cancer immunotherapy drugs are biologics. The biologic manufacturing of these therapeutics is often very expensive. Most commonly drug manufacturers modify the DNA of Chinese hamster ovary cells (CHO) such that they produce the desired drug. These cells are then grown in a factory full of huge 12,000 liter tanks to produce the drugs. Such factories with carefully controlled systems to feed the CHO cells, circulate oxygen, and remove toxins from the tanks can cost as much as $1 billion to build. Numerous large tanks are required to produce sufficient quantities of the drug because the CHO cells produce only a limited amount. It’s literally a drug factory that is the size of an industrial factory.
Dyadic historically used a specific fungus, the C1 fungus, to produce the enzymes for industrial applications. The company started in 1979 producing pumice used to stone wash blue jeans. When the industry switched to using enzymes to produce the stonewashed look, Dyadic switched from producing pumice to producing enzymes. The C1 fungus was used as it has a unique morphology that makes it highly productive and relatively inexpensive. It’s relatively easy to grow in massive quantities as it tolerates wider ranges of pH and temperature than CHO cells. Its morphology results in low viscosity mixtures so transfer of oxygen and nutrients are not hampered. Importantly, the C1 fermentation cycle of 5-7 days is less than half the time required for CHO. This makes it a quick development platform that can also be used as the production platform. Over about 15 years, mutations of this fungus were discovered that made it more and more productive. Particularly significant was the discovery of the “white strain” followed by development that increased the productivity of this strain 12-fold from 2011 to 2014. This increased the value for industrial enzyme production, but it also opened up pharmaceutical applications. In 2015, the rights to the C1 technology were sold to Dupont for $75 million. Dyadic held on to pharmaceutical rights in humans and animals as Emalfarb wanted to explore whether the C1 fungus could be used to produce vaccines and biological drugs.
After three years of development the answer is yes, the C1 fungus can produce a great variety of biological drugs. If you look at the company’s investor presentations you’ll see they’ve produced many of the currently approved multi-billion dollar biologics like Certolizumab, Keytruda and Remicade. The C1-produced drugs seem to bind identical to ones produced by CHO cells and show no adverse reactions in mice. In partnership with Sanofi-Pasteur they’ve produced flu vaccines which seem to work in mice too. Most importantly, the high productivity of C1 in industrial applications seems to be present with biological drugs too. The investor presentation shows two 12,000 liter tanks of CHO cells being replaced with one 2,000 liter tank of C1 with equivalent productivity. Since C1 is easier to grow too, a $1 billion dollar CHO cell factory might be replaced with a C1 factory costing half as much or less.