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3/29/2023
Good evening and welcome to Dyadic International's Fiscal Year 2022 Financial Results Conference Call. Currently, all participants are on a listen-only mode. Following management's prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded today, March 29, 2023. I would now like to turn the call over to Ms. Ping Rawson, Dyadoc's Chief Financial Officer. Please go ahead.
Thank you, operator. Good evening and welcome everyone to Dyadic International's fiscal year 2022 year-end conference call. I hope you have had the opportunity to review Dyadic's press release announcing financial results for the year-end of December 31st, 2022 and the recent company highlights. You may access our release and form 10-K under the investor section of the company's website at dyadic.com. On today's call, Our president and CEO, Mark Emelfarb, will give a review of our fiscal year 2022 business and corporate highlights, including a brief summary of our recent research and business development efforts. Our chief business officer, Joe Hazleton, will join Mark for the business updates. I will follow with a review of our financial results in more detail. We'll then hold a brief Q&A session. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward-looking statements, which involve risks and uncertainties and other factors that could cause dyadic's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. DADC expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in DADC's report filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Dimafar. Mark?
Thank you, Ping. Hello, everyone, and thank you for joining DIATIC's 2022 year-end conference call. On today's call, we will highlight several of the significant advances we made in our technology and the meaningful progress we made and continue to make in each of our three core verticals, human health, animal health, and alternative proteins. On today's call, Joe and I will discuss our 2023 strategy for growth and revenue. Throughout 2022, we've discussed the company's scientific advancements, focused on our core business in achieving commercial agreements in human health, animal health, and alternative proteins. Today, I would like to focus our key business drivers that we believe will help accelerate product commercialization and licensing. While we continue to drive broader pharmaceutical acceptance of the C1 platform in biopharmaceuticals to maximize your future potential for dyadic, our shareholders, and human health globally. In our Q3 update, I highlighted that the commitment it takes to build a commercially relevant filamentous fungal protein production platform is to support life sciences manufacturing demands, persistence, focus, and determination to see the process through. In addition to persistence, when to enter the biotech space, companies cannot underestimate the patience needed to undertake to painstaking scientific and clinical development plans for both platform technologies and biological products. On average, a traditional vaccine in the influenza market takes roughly five to seven years to develop, conduct clinical trials, receive regulatory approval, and commercialize. For dyadic, we had the additional tasks beyond the clinical development of a product, as we had to undertake the development, engineering, and validation of our C1 protein production platform to transition from industrial to biopharmaceutical applications. For perspective, Chinese hamster ovary or chill cell production systems and baculovirus or insect cells took decades and hundreds of millions, if not billions of dollars invested in the development and engineering of the host cells that get to the stage we are at today with C1 in less than seven years apart upon starting our transition from industrial biotech to biopharmaceuticals. What makes dyadic unique compared to these more standard cell lines in use today is our decades of bioindustrial heritage. We have shown that our C1 platform can be used to develop C1 cell lines to express stable antigens that have been shown to be up to 300 times more productive than baculovirus cells, which are being used in both human and animal health. To put that in perspective, C1 has the ability to produce 300 doses of a particular vaccine to one dose of a baculovirus-produced vaccine, which leads to improved cost and speed efficiencies. With all these outstanding attributes, our C1 platform offers the most common question we get from shareholders is, what is holding back broader and more rapid adoption of the C1 platform for pharmaceutical applications in human and animal health? And the question we do have asked repeatedly from pharmacists, do you have any human safety data from a regulatory body? A little over a year ago, we brought Joe Hazleton in as our chief commercial business officer, who has spent his 25-year career in pharmaceutical commercialization, business development, market access, and pricing to diagnose this very issue and to develop a strategic plan to address gaps in our current business efforts. I will now ask Joe to provide you with his perspective on this issue and to provide a brief update on our Phase I trial. Joe?
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