This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
8/13/2020
Good evening, ladies and gentlemen, and thank you for holding. Welcome to the Dyadic International's second quarter 2020 financial results conference call. Currently, all participants are in listen-only mode. My name is Jerry, and I will be your conference coordinator for today. As a reminder, please note that this call is being recorded. At this point, I would like to turn the call over to Ping Rawson, Dyadic's chief financial officer. Please go ahead, Ms. Rawson.
Thank you, Jerry. Good evening, everyone, and welcome to our second quarter 2020 earnings call. A press release with Dyadic International's second quarter 2020 financial results was issued earlier today. The press release on Form 8K and Dyadic's quarterly report on Form 10Q have been posted to the SEC and Dyadic's website. On today's call, our President and CEO, Mark Emalfarb, will give a review of the business and corporate accomplishments for our second quarter of 2020, including a brief summary of our research and business development efforts. I will follow with a review of our financial results in more detail. We will then provide you with an opportunity to ask questions. Matthew Jones and Ronen Chalet will join Mark and I to answer your questions. 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. Dyadic expressly disclaims any intent or obligation to update any forward-looking statements, except as required by law. For more information about factors that may cause actual results to be materially different from forward-looking statements, please refer to the repressed lease we issued today, as well as risks described in our annual report on Form 10-K for the year-ended December 31, 2019 and our quarterly report on Form 10-Q for the quarter-ended June 30, 2020, particularly in the section titled Risk Factors. This information can be found in our other filings with the SEC when available. With that, I'd like to turn the call over to Mark. Mark?
Thank you, Ping. Welcome, everyone, and thank you for joining our second quarter conference call. I hope that you and your family are safe during these difficult times. I am pleased to report that we have made terrific progress on multiple fronts in the second quarter, further advancing and strengthening our diverse and growing portfolio of opportunities by adding new top-tier collaborations in both the animal and human health fields. We are expanding our commercial reach in large and growing addressable markets while continuing to report exciting and new scientific data and progress. We are involved in a number of collaborations helping combat the COVID-19 pandemic. These developments reinforce the broad application potential of our C1 technology, as well as some of its key attributes, including high productivity and low cost of goods. The continued growth of our company has added to our visibility in the investment community. With our recent inclusion in the Russell 2000 and 3000 indices, providing us the opportunity to further broaden our shareholder base. Our management team remains highly energized by the significant number of opportunities available to us, supported by best-in-class scientific partners and our ongoing R&D collaborations funded partially or fully by our partners and our objective and diverse pipeline of potentially high-return projects. In response to COVID-19, we've taken the necessary health and safety measures to protect our employees, lab teams, and partners around the world who, for the most part, have been working remotely. We are fortunate that beyond those changes in the way we conduct our daily work, COVID-19 has had minimal impact on a company's ability to continue our progress. Tonight, I would like to provide some additional color on some of our most recent business and development and scientific accomplishments and conclude with comments on the S3 registration statement we filed today. We continue to advance and grow our diverse portfolio of business opportunities as we further develop and improve our C1 technology platform to meet the different needs of the markets we are serving. We entered into a number of fully funded and Joseph Hazelton. Thank you very much. Global Animal Health Companies, as well as another global animal health company. We entered the animal health market in 2019 and have been on a steep growth trajectory over the past 18 months. Human health. We entered into a fully funded R&D collaboration with another one of the top five global pharmaceutical companies for human health. Under this agreement, Dyadic will be expressing two different types of therapeutic compounds. In addition, We were in discussion with a number of other pharmaceutical and biotech companies, including continuing our discussions with Sanofi to fund follow-on or new research collaborations. Infectious diseases, in the ZAPI program, we were successful in expressing an additional antigen, the RVFV antigen, at high levels, which were approximately 1,200 milligrams per liter. Zappi reported that Baclavirus was unable to express this antigen stably. This is another example of C1 potential hyperproductivity to express certain difficult to express antigens that may be needed to combat the current and future pandemics and other biological threats. In addition, we have successfully stably expressed the HA protein in our influenza collaboration with Oslo University. Samples of this protein will be sent to Oslo University for their evaluation and further characterization. COVID-19. The company has a number of ongoing COVID-19 vaccine collaborations globally, which have resulted in certain opportunities, which are at various stages of development, including a newly fully funded vaccine research collaboration entered into earlier this week. As announced, on February 25th, we joined the global fight against the coronavirus outbreak by expanding our collaboration with the Israel Institute for Biological Research, the IIBR, to explore the potential of dyadic's industrially proven C1 gene expression platform to express gene sequences in the recombinant vaccine candidates. I'm proud to say that in approximately two months from when we received COVID-19 gene sequences, we successfully expressed a number of high-producing stable C1 cell lines that efficiently expressed the receptor-binding domain, the RBD, of the SARS-CoV-2 spike protein, which are being used to express the vaccine candidates for both the IIBR and the European COVID-19 vaccine programs. The IIBR has reported that they started their mice trials with the C1 Express RBD plus an adjuvant about a month ago. And as reported to Dyadic by the IIBR, the C1 vaccine candidate generated high neutralizing antibody titers. Accordingly, we anticipate that the IIBR will start hamster studies earlier than originally forecasted. The second animal trial, in an established Syrian golden hamster model using the C1 Express RBD of the SARS-CoV-2 spike protein in collaboration with the EU scientists and institutes we've been working with from University of Utrecht, Erasmus Medical Center, University of Veterinary Medicine, Hanover, CHIHO, and CR20, a global CRO, is expected to start shortly. They're waiting for certain regulatory approvals to begin this annual study. As reported previously, we are also working with Ufovex, Case Scripps Research Spinout, and the company was selected by the Frederick National Laboratory to engineer dietics-patented and proprietary C1 cell lines to produce a number of COVID-19 vaccine candidates, which will be utilized by the Vaccine Research Center of the National Institute of Allergy and Infectious Disease, NIAID, at the National Institute of Health. Both the EUFAVax and the Frederick National Laboratory research programs are in earlier stages of development. Based on the excellent expression and stability results to date, as well as the initial but promising in vitro and in vivo data, we provided samples of the C1 expressed RBD SARS-CoV-2 spike protein antigens to the Frederick National Laboratory for their evaluation and a variety of other interested potential opportunities. Earlier this week, the company entered into another fully funded SARS-CoV-2 vaccine research collaboration with a small but well-respected biotech company that has promising biomanufacturing technology that may help to enable the production of vaccines and drugs regionally or even in country, potentially making access to vaccines and drugs in certain remote areas of the world more available and affordable. This collaboration, along with certain others, has the potential to expand beyond COVID-19, where C1 may be beneficially used to develop and manufacture and other vaccines and drugs to help combat infectious diseases and for other human health applications. We are in discussions with several other companies that could potentially lead to opportunities for partnerships globally related to COVID-19, future infectious diseases, pandemics, epidemics and other biological outbreaks. Glycoengineering program. For a self-funded glycoengineering program, we have generated C1 cell lines to produce monoclonal antibodies and other proteins with human-like glycoforms, such as G0, G2, G0F, and G2F. We are now working on leveraging the 14X protease deletion work in the non-glycoengineered C1 strains. We've generated with 50-fold lower protease activity than the 4X C1 strain by reducing the extracellular protease background in one or more of the glycogen-generated C1 strains. We have developed in order to further generate C1 cell lines leading to production of higher amounts of more stable vaccines and drugs, providing us with additional prospects for collaboration, drug development, and eventual commercialization. Shelf Registration Statement on the Form S-3. Today, Dyadic filed a Shelf Registration Statement on a Form S-3 with the Securities Exchange Commission for future offerings of up to $50 million of Dyadic's common stock. In addition, Dyadic established an at-the-market offering, ATM offering program, under which it may sell, from time to time, shares of its common stock for aggregate price grossing to $50 million. The shares will be offered to Jefferies LLC, which will act in its capacity as sales agent. The company's balance sheet and cash position are very strong, with adequate financial resources to continue our near and longer-term business plans. However, management believes it's prudent to have an effective registration statement in place which will provide the company with quick access to the capital markets in order to respond quickly to future business opportunities should they arise. With that, I will turn the call over to Ping to review our financial results.
You're reading a preview of the DYAI Q2 2020 earnings call.
Free account.
