DYAI: Abundant Opportunities in Products and Animal & Human Health
NASDAQ:DYAI
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First Quarter 2023 Operational & Financial Results
Dyadic International Inc. (NASDAQ:DYAI) provided 2022 operational and financial results in a press release on May 10, 2023, filed its Form 10-Q with the SEC and held a conference call with investors. Dyadic announced several new collaborations and expanded agreements since its prior financial update. It has also completed its first in-human trial where DYAI-100 was used as a booster vaccine. No serious adverse events were reported and a safety assessment is expected in June. Revenues provided an upside surprise, increasing 51% over 1Q:22 on greater research and development revenues. Funds were also received from the sale of the Alphazyme interest in January and a milestone was received in April from the food company collaboration. Additionally, several grants are being pursued in a variety of infectious diseases which should provide responses as the year progresses.
Management emphasizes the orientation of its efforts towards three core verticals including Human Health, Animal Health and Alternative Proteins. The goal for each is to identify opportunities that can drive near-term revenues. Ongoing collaborations include strategic partnerships to produce animal free ingredients, opportunities for enzymes, growth factors and cell culture media in the food industry as well as production of metabolites and cannabinoids in the health and wellness space among other initiatives.
Salient efforts include those by partner Virovax which is working with Dyadic on the next generation of vaccine candidates sharing its experience in vaccines and adjuvants in a variety of infectious diseases. Epygen is moving forward on a C1-produced bivalent COVID vaccine in India offering the capacity to provide all parts of the vaccine manufacturing and distribution process. Other collaborations continue including those with Janssen, Phibro, university partners and others. We also note the sale of the Alphazyme interest provides $1.3 million in cash to the balance sheet in 1Q:23 while maintaining exposure to payments from C1 related Alphazyme sales.
Highlights for 2023 to date include:
➢ Sale of Alphazyme interest – January 2023
➢ Dosing initiated in DYAI-100 COVID trial – January 2023
➢ Dosing completed in DYAI-100 COVID trial – February 2023
➢ Participation in FDA Vaccine Workshop – April 2023
➢ Presentation at World Vaccine Congress – April 2023
➢ Patent Notice of Allowance awarded from USPTO – April 2023
➢ Fermbox Bio animal free protein collaboration – May 2023
Financial results for the year ending December 31, 2022, compared to the same prior year period:
➢ Revenues were $1.0 million, up 51% from $0.6 million and cost of revenues was $0.7 million vs. $0.4 million. The revenue and cost of research increase was attributable to activity related to the Janssen license agreements and other collaboration programs in the pipeline;
➢ Research and development expenses totaled $0.8 million, down 40% from $1.3 million. The decrease was attributable to the reduction in contract research organization activities and cost of pharmaceutical quality and regulatory consultants to manage and support the pre-clinical and clinical development. A decrease in current good manufacturing practice (cGMP) manufacturing costs also contributed to the change;
➢ General and administrative expenses were $1.5 million, down 11% over prior year period amounts. Lower incentives,
insurance expenses, business development and investor relation expenses were partially offset by higher legal expenses;
➢ Interest income increased to $105,000 from $3,000 due to higher invested balances and a higher yield on securities held;
➢ Other income of $1.0 million captured the sale of equity interest in Alphazyme;
➢ Net loss amounted to ($1.0) million compared to ($2.5) million. On a per share basis, net loss was ($0.03) vs. ($0.09).
As of March 31, 2023, cash, equivalents and short-term securities totaled $11.7 million compared to $12.6 million at the end of 2022. 1Q:23 cash burn was ($0.9) million compared with ($2.9) million in 1Q:22. Financing cash flows were zero. Dyadic holds no debt on its balance sheet. Cash burn guidance for 2023 is $6 to $7 million.
Dyadic Presentation at FDA Vaccines Workshop
On April 27th, CEO Mark Emalfarb presented at the FDA Vaccines Workshop to present the C1 platform and discussed the expression system’s relative speed, productivity, sustainability and affordability. The Phase I COVID study in South Africa was highlighted as was the expected vaccine trial in India. Mark discussed the background behind Dyadic’s efforts to develop the vaccine and addressed concerns such as storage temperature, ability to address new COVID variants and production of sufficient antibodies in animal models using multiple forms of administration.
Patent Notice of Allowance
On April 18th, 2023, Dyadic announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for patent application 16/640,483. The title of the patent is Production of flu vaccine in myceliophthora thermophila which is expected to be valid through 2038. The invention relates to the production of recombinant influenza virus surface proteins in C1. The recombinant proteins are for use in influenza vaccine compositions.
Collaboration with Fermbox Bio
Dyadic will be collaborating with Fermbox Bio Inc. to design, develop and commercialize innovative animal free alternative proteins and biomaterials. The arrangement is a fully funded, co-development collaboration that will employ the Dapibus filamentous fungal based microbial protein production platform and Fermbox’s product development capabilities. The deal promises to offer near-term commercialization opportunities in bio-alternate development and microbial precision fermentation. This may produce product offerings for non-pharmaceutical alternative proteins applications, such as those in the food, nutrition, wellness and other bioproduct categories.
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1. Source: Dyadic April 27 Presentation at FDA Vaccine Workshop
