DYAI: MoUs Highlight C1 Vaccine Potential
NASDAQ:DYAI
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Second Quarter 2023 Operational & Financial Results
Dyadic International Inc. (NASDAQ:DYAI) provided 2Q:23 operational and financial results in a press release on August 9, 2023, filed its Form 10-Q with the SEC and held a conference call with investors.1 Dyadic announced several new collaborations and expanded agreements since its first quarter report. 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 was provided in June.
A few new collaborations were announced including Uvax Bio for an infectious disease vaccine, Fondazione Fondazione Biotecnopolo di Siena to develop epidemic related vaccines and antibodies and an unidentified animal health company in a fully funded livestock antigen program. A memorandum of understanding was signed with the Bangladesh state-owned pharmaceutical company which is seeking to develop a biopharmaceutical program to support improvement of public health. Work on the Janssen monoclonal antibody and bispecific continues.
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
➢ MoU with Bangladesh State-Owned Pharmaceutical Company – June 2023
Financial results for the quarter ending June 30, 2023, compared to the same prior year period:
➢ Revenues were $0.8 million, up 27% from $0.7 million and cost of revenues was $0.8 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 $0.9 million, down 50% from $1.8 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 $1.4 million, down 18% over prior year period amounts. Lower incentives, insurance expenses, business development, investor relation and legal expenses contributed to the change;
➢ Interest income increased to $109,000 from $30,000 due to higher yields on securities held;
➢ Other income was $28,000 compared to $0 and reflected true-ups related to the Alphazyme sale;
➢ Net loss amounted to ($2.2) million compared to ($3.3) million. On a per share basis, net loss was ($0.07) vs. ($0.12).
As of June 30, 2023, cash, equivalents and short-term securities totaled $10.1 million compared to $12.6 million at the end of 2022. 2Q:23 cash burn was ($1.6) million compared with ($1.8) million in 2Q:22. Financing cash flows were zero. Dyadic holds no debt on its balance sheet. Cash burn guidance for 2023 is maintained at $6 to $7 million.
Bangladesh Memorandum of Understanding
Dyadic has entered into a Memorandum of Understanding (MoU) with Essential Drugs Company Limited (EDCL) the state-owned pharmaceutical company in Bangladesh. Details were provided in a June 21 press release. The purpose of the MoU is to help build the infrastructure to increase access and affordability of biomanufactured vaccines and drugs for underserved diseases. Dyadic hopes a collaboration will enable the acceleration of adoption of its microbial platform to manufacture vaccines and biologics faster. The government of Bangladesh seeks to expand collaborations with global partners in an effort to innovate critical therapies. The collaboration with Dyadic is intended to advance research, develop drugs and vaccines, facilitate current good manufacturing practices (cGMP) production and conduct clinical trials.
The relationship traces back to 2021, when Dyadic and Bangladesh began to work on a strategic plan to address the country’s bio-security interests and to promote research training and dissemination of knowledge of health technology. This effort is particularly important as Bangladesh recently reported over 1,600 cases of dengue fever in a day and a 2023 total of almost 20,000 cases as of mid-July. More than 170 people have died. There is only one vaccine in the US and it is recommended only for people who have had dengue in the past. The vaccine does not work in all types of the fever and new medicines are needed. For those with severe disease, hospitalization is required; however, there is no antiviral treatment for dengue. The prevalence of the mosquito-transmitted disease in Bangladesh highlights the need for internal development of vaccines and treatment.
Serum Albumin
Dyadic announced continued progress toward commercialization of animal-free recombinant serum albumin in an August 7th press release. The results of third-party clinical testing showed that C1 produced serum albumin is structurally equivalent to commercial animal derived product. C1 produced serum albumin has the additional advantage of providing more consistent product that does not include any animal-related contaminants and can be produced efficiently and at low-cost relative to the alternative now in use.
Dyadic is developing bovine and human animal-free serum albumin and has identified a market size of $5.7 billion in 2022 that is growing at a high single digit rate per annum. The product has both pharmaceutical and non-pharmaceutical applications. These include use of albumin to increase blood volume to treat various conditions such as surgical blood loss, hemorrhage, or trauma. Additionally, recombinant serum albumin is being used as an alternative to plasma-derived albumin in human therapeutics, cell culture media, diagnostic test kits and research & development. Serum albumin also has non-pharmaceutical applications as a component of cell culture media in the alternative protein segment. Bovine serum albumin is frequently used as a component of the cell culture media to grow animal cells for the production of cultivated meat.
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1. A transcript is also available here.
