Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ:DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines, drugs and other commercial products at flexible commercial scales, today announced its financial results for 2020 and recent business highlights.
"We are very pleased with substantial progress made thus far in 2021 and over the course of 2020. With the ongoing challenges of the COVID-19 pandemic, we have been working tirelessly to identify ways to apply our C1 technology to help speed the development, increase availability, and lower the cost of COVID-19 vaccines and treatments to make them affordable and available worldwide. We and our collaborators worked conscientiously to introduce the C1 technology to the world to enable as many COVID-19 programs as possible and we are continuing to do so as COVID-19 variants continue to emerge. Due to our success in several animal studies where rapidly engineered C1-cells have achieved high levels of antigen productivity and were shown to be safe, effective, and protective, our C1 technology has gained the attention of a growing number of infectious disease and other scientists in industry and government. This momentum has begun to accelerate after our announcement that our proprietary COVID-19 vaccine candidate, DYAI-100, is advancing into a first-in-human Phase 1 clinical trial, which is expected to begin in the second half of 2021. As SARS-CoV-2 continues to mutate into different variants, we have already begun the engineering of novel C1 cell lines to enable the development of next-generation multivalent COVID-19 vaccine candidates," stated Mark Emalfarb, Dyadic's Founder and Chief Executive Officer.
Mr. Emalfarb continued, "Additionally, we expanded our fully funded vaccine development partnership with Medytox to accelerate the development of multivalent COVID-19 vaccine candidates and/or boosters to immunize people against multiple existing or future SARS-CoV-2 variants. Dr. Gi-Hyeok Yang, Sr. Executive Vice President and Head of Research and Development at Medytox recently stated, "Based on our experience and comparing the C1 technology platform against several other expression platforms, such as CHO and insect cells, we believe that the fungi-derived C1 expression system is the most realistic technology to develop and manufacture multi-valent (i.e., tri-valent, and tetra-valent) vaccines, rapidly and affordably, against COVID-19 mutant viruses, without the need for a large-scale bioreactor facility. Medytox has confidence that the C1 technology platform can play a critical role in helping combat COVID-19, which may continue to persist as a seasonal influenza and necessitate COVID-19 variant vaccine shots every year. We look forward to gaining additional experience with the C1 technology as it has potential for use in developing and producing a growing number of vaccines, drugs, and other biological products in addition to COVID-19."
"Beyond our COVID-19 initiatives, in 2020, we commenced five, new funded collaborations with top pharmaceutical companies to produce therapeutics of commercial interest for human health applications. Additionally, our fully funded collaboration with TurtleTree Scientific to develop human growth factors, enables us to enter a new and significant commercial opportunity that includes regenerative therapies. We believe these collaborations, as well as others currently in various stages of discussion, will help accelerate our C1 platform towards the commercialization of numerous products to improve animal and human health, globally. We look forward to evaluating new opportunities to maximize the value of our C1 technology and expand its commercial potential with the goal of driving further value for our shareholders." concluded Mr. Emalfarb.
Recent Company Progress
COVID-19 Initiatives:
Human Health (Non-COVID) Collaborations:
Animal Health Collaborations:
Research License:
Financial Highlights
Cash Position: At December 31, 2020, cash, cash equivalents, and the carrying value of investment grade securities, including accrued interest were approximately $29.2 million compared to $36.0 million at December 31, 2019.
Revenues: Research and development revenue for the year ended December 31, 2020, decreased slightly to approximately $1,602,000 compared to $1,681,000 for the year ended December 31, 2019.
Cost of Revenues: Cost of research and development revenue for the year ended December 31, 2020, decreased slightly to approximately $1,425,000 compared to $1,460,000 for the year ended December 31, 2019. For the year ended December 31, 2020, the Company reported a provision for contract losses of approximately $187,000 from one research collaboration, compared to zero for the year ended December 31, 2019.
The slight decreases in revenue and cost of research and development revenue for the year ended December 31, 2020 reflected a growing number of research collaborations to fourteen, compared to ten research collaborations for the year ended December 31, 2019, however, with smaller dollar amounts for each project.
R&D Expenses: Research and development expenses for the year ended December 31, 2020 increased to approximately $3,868,000 compared to $3,088,000 for the year ended December 31, 2019. The increase primarily reflected the costs of COVID-19 projects and additional internal research projects.
Research and development expenses - related party, for the year ended December 31, 2020, were none compared to approximately $869,000 for the year ended December 31, 2019. The decrease was due to the completion of research service agreement with BDI in June 2019.
G&A Expenses: General and administrative expenses for the year ended December 31, 2020, increased by 10.2% to approximately $6,085,000 compared to $5,520,000 for the year ended December 31, 2019. The increase principally reflected increases in noncash share-based compensation expenses of $397,000, insurance premiums and other outside services of $216,000, legal and SEC registration expenses of $193,000, business development and investor relations costs of $191,000, offset by reductions in executive compensation costs and accrued incentives of $216,000, trade show and travel expenses of $143,000 and other decreases of $73,000.
Interest Income: Interest income for the year ended December 31, 2020, was approximately $447,000 compared to $985,000 for the year ended December 31, 2019. The decrease was primarily due to a decrease in interest rate and yield on the Company's investment grade securities, which are classified as held-to-maturity.
Other Non-Operating Items: For the year ended December 31, 2020, the Company recorded a gain related to its investment in Alphazyme resulting from a third-party capital contribution. As of December 31, 2020, the fair market value of the Company's investment in Alphazyme was approximately $285,000.
Net Loss: Net loss for the year ended December 31, 2020 was approximately $9.3 million, or $(0.34) per share, compared to a net loss of $8.3 million, or $(0.31) per share, for the year ended December 31, 2019. The change was primarily due to increases in general and administrative expenses of approximately $0.6 million, provision for contract losses of approximately $0.2 million, reduction in interest income of $0.5 million, offset by an unrealized gain from our investment in Alphazyme of approximately $0.3 million.
Conference Call Information
Date: Tuesday, March 30, 2021
Time: 5:00 p.m. Eastern Time
Dial-in numbers: Toll Free: 877-407-8033 International: 201-689-8033
Webcast Link: https://www.webcaster4.com/Webcast/Page/2031/40394
An archive of the webcast will be available within 24 hours after completion of the live event and will be accessible on the Investor Relations section of the Company's website at www.dyadic.com for a limited time. To access the replay of the webcast, please follow the webcast link above. A dial-in replay of the call will also be available to those interested. To access the replay, please dial Toll Free: 877-481-4010 (U.S. or Canada) or International: 919-882-2331 (International) and enter replay pass code: 40394.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. As the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs, and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.
Please visit Dyadic's website at http://www.dyadic.com for additional information, including details regarding Dyadic's plans for its biopharmaceutical business.
Safe Harbor Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International's expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including those described in the Company's most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled "Risk Factors" in Dyadic's annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic's periodic filings with the SEC, which are accessible on the SEC's website and at http://www.dyadic.com.
Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| Years Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
Revenues: | ||||||||
Research and development revenue | $ | 1,601,921 | $ | 1,681,076 | ||||
Costs and expenses: | ||||||||
Costs of research and development revenue | 1,424,931 | 1,459,701 | ||||||
Provision for contract losses | 187,388 | - | ||||||
Research and development | 3,868,121 | 3,087,597 | ||||||
Research and development - related party | - | 868,720 | ||||||
General and administrative | 6,084,799 | 5,519,922 | ||||||
Foreign currency exchange loss (gain), net | 62,345 | 27,725 | ||||||
Total costs and expenses | 11,627,584 | 10,963,665 | ||||||
Loss from operations | (10,025,663) | (9,282,589) | ||||||
Interest income | 446,999 | 984,930 | ||||||
Unrealized gain from investment in Alphazyme | 284,709 | - | ||||||
Loss before income taxes | (9,293,955) | (8,297,659) | ||||||
Provision for (benefit from) income taxes | 31,318 | 10,306 | ||||||
Net loss | $ | (9,325,273) | $ | (8,307,965) | ||||
Basic and diluted net loss per common share | $ | (0.34) | $ | (0.31) | ||||
Basic and diluted weighted-average common shares outstanding | 27,471,587 | 27,003,695 | ||||||
See Notes to Consolidated Financial Statements in Part I of Dyadic's Annual Report on Form 10-K filed with Securities and Exchange Commission on March 30, 2021.
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, | ||||||||
| 2020 | 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 20,637,045 | $ | 4,823,544 | ||||
Short-term investment securities | 8,457,452 | 29,399,146 | ||||||
Interest receivable | 112,247 | 329,711 | ||||||
Accounts receivable | 294,199 | 558,530 | ||||||
Income tax receivable | - | 250,308 | ||||||
Prepaid expenses and other current assets | 280,555 | 277,999 | ||||||
Total current assets | 29,781,498 | 35,639,238 | ||||||
Non-current assets: | ||||||||
Long-term investment securities | - | 1,511,636 | ||||||
Long-term income tax receivable | - | 250,308 | ||||||
Investment in Alphazyme | 284,709 | - | ||||||
Other assets | 6,225 | 51,314 | ||||||
Total assets | $ | 30,072,432 | $ | 37,452,496 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,013,099 | $ | 943,378 | ||||
Accrued expenses | 489,756 | 566,003 | ||||||
Deferred research and development obligations | 123,016 | 78,644 | ||||||
Total current liabilities | 1,625,871 | 1,588,025 | ||||||
Commitments and contingencies (Note 5) | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, $.0001 par value: | ||||||||
Authorized shares - 5,000,000; none issued and outstanding | - | - | ||||||
Common stock, $.001 par value: | ||||||||
Authorized shares - 100,000,000; issued shares - 39,747,659 and 39,612,659, outstanding shares - 27,494,157 and 27,359,157 as of December 31, 2020 and 2019, respectively | 39,748 | 39,613 | ||||||
Additional paid-in capital | 98,013,079 | 96,105,851 | ||||||
Treasury stock, shares held at cost - 12,253,502 | (18,929,915) | (18,929,915) | ||||||
Accumulated deficit | (50,676,351) | (41,351,078) | ||||||
Total stockholders' equity | 28,446,561 | 35,864,471 | ||||||
Total liabilities and stockholders' equity | $ | 30,072,432 | $ | 37,452,496 | ||||
See Notes to Consolidated Financial Statements in Part I of Dyadic's Annual Report on Form 10-K filed with Securities and Exchange Commission on March 30, 2021.
| Last Trade: | US$1.75 |
| Daily Change: | -0.16 -8.14 |
| Daily Volume: | 265,579 |
| Market Cap: | US$51.780M |
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