JUPITER, FL / ACCESSWIRE / March 30, 2020 / Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ:DYAI), a global biotechnology company focused on further improving and applying its proprietary C1 gene expression platform to speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced its financial results for the year ended December 31, 2019, and recent developments.
"I am pleased to report that 2019 was another successful year for Dyadic as we achieved several important scientific and business milestones and expanded our global presence. While still early in 2020, we are seeing continued momentum. During 2019, we entered into six new proof of concept research collaborations to express different types of biologic vaccines and drugs for both human and animal health and entered into two research licenses. As a result, Dyadic's pipeline of opportunities is getting larger and more diverse. Last week, we entered into a nonexclusive research license with WuXi Biologics, a leading global Contract Development Manufacturing Organization ("CDMO") and another fully funded feasibility study with a leading animal health company. We are now working with three of the top four animal health companies," said Mark Emalfarb, Dyadic's Chief Executive Officer.
He further commented, "To assist in the global fight against the COVID-19 pandemic, we are working with the Israel Institute for Biological Research ("IIBR"), Ufovax, a spin-off vaccine company of Scripps Research, as well as a group of coronavirus experts from Erasmus Medical Center, Utrecht University, and the University of Veterinary Medicine Hannover (TiHo) along with a clinical contract research organization, CR20. We expect to use C1 to express a growing number of potential coronavirus vaccine and antibody candidates for a number of different parties. Our involvement in these COVID-19 initiatives further highlights the broad application potential of our C1 technology by helping to immediately address the coronavirus outbreak, be better prepared for future infectious diseases, pandemic and epidemic outbreaks, and advance biopharmaceutical manufacturing to help speed up development, lower the cost and improve the performance of biologic vaccines and drugs to make healthcare more accessible and affordable to patients globally."
"Supporting our growth strategy is our robust scientific data, solid financial position with approximately $36 million in cash and investment grade securities, and on-going R&D collaborations funded by our partners. Our visibility in the investment community has significantly increased as well. In 2019, our shares were up-listed to the Nasdaq and we joined the Russell Microcap Index® further reinforcing the continued growth of our Company. We look forward to sharing additional new developments throughout the year as we remain confident in our vision of creating more efficient and commercially cost-effective healthcare solutions," concluded Mr. Emalfarb.
RECENT DEVELOPMENTS
SCIENTIFIC ACHIEVEMENTS
2019 BUSINESS DEVELOPMENT HIGHLIGHTS
In 2019, we entered into six new proof of concept research collaborations including the Serum Institute of India, two leading animal health companies, and three top tier human health companies, as well as an expanded collaboration with ZAPI. In addition, we signed two sublicensing agreements and two non-exclusive research license agreements.
CORPORATE DEVELOPMENT
RESULTS FOR THE YEAR ENDED DECEMBER 31, 2019
At December 31, 2019, cash and cash equivalents were approximately $4.8 million compared to $2.4 million at December 31, 2018. The carrying value of investment grade securities, including accrued interest at December 31, 2019 was $31.2 million compared to $39.1 million at December 31, 2018.
Research and development revenue for the year ended December 31, 2019, increased to approximately $1,681,000 compared to $1,295,000 for the year ended December 31, 2018.
Cost of research and development revenue for the year ended December 31, 2019, increased to approximately $1,460,000 compared to $1,027,000 for the year ended December 31, 2018.
The increases in revenue and cost of research and development revenue for the year ended December 31, 2019 reflects ten research collaborations compared to six research collaborations for the year ended December 31, 2018.
Interest income for the year ended December 31, 2019, increased 10.1% to approximately $985,000 compared to $895,000 for the year ended December 31, 2018. The increase in interest income reflects the higher yield on the Company's investment grade securities, which are classified as held-to-maturity.
Research and development expenses for the year ended December 31, 2019 increased to approximately $3,088,000 compared to $2,102,000 for the year ended December 31, 2018. The increase primarily reflects the costs of additional internal research projects.
Research and development expenses - related party, for the year ended December 31, 2019, decreased to approximately $869,000 compared to $1,216,000 for the year ended December 31, 2018. The decrease is primarily due to the completion of the research service agreement with BDI in June 2019.
General and administrative expenses for the year ended December 31, 2019, increased 22.0% to approximately $5,520,000 compared to $4,523,000 for the year ended December 31, 2018. The increase principally reflects increases in noncash share-based compensation expenses of $717,000 related to 2019 stock options awards and options vested upon the April 2019 uplisting to the NASDAQ, business development and investor relations costs of $186,000, and insurance costs of $138,000, legal cost and NASDAQ uplisting expenses of $125,000, offset by reductions in executive compensation costs, including the separation of the Company's former CFO, of $168,000, which was a one-time expense in 2018.
Net loss for the year ended December 31, 2019 was approximately $8.3 million, or $(0.31) per share, compared to a net loss of $5.7 million, or $(0.21) per share, for the year ended December 31, 2018. The change was primarily due to the increases in general and administrative expenses of approximately $1.0 million and research and development expense of approximately $0.6 million in 2019, as well as the income tax benefit of approximately $1.0 million in 2018.
CONFERENCE CALL INFORMATION
Dyadic management will host a conference call today, Monday, March 30, 2020, at 5:00 PM ET to discuss the financial results for the year ended December 31, 2019. In order to participate in the conference call, please dial (877) 407-8033 for U.S./Canada callers and +(201) 689-8033 for International callers or use webcast link: https://www.webcaster4.com/Webcast/Page/2031/33572.
An archive of the webcast will be available approximately three 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 this link: https://www.webcaster4.com/Webcast/Page/2031/33572. A dial-in replay of the call will also be available to those interested until April 30, 2020. To access the replay, dial (877) 481-4010 for U.S./Canada callers and +(919) 882-2331 for International callers and enter replay pass code: 33572.
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. In particular, 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 as a result 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 as a result 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: mailto:[email protected]
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31, | ||||||||
2019 | 2018 | |||||||
Revenues: | ||||||||
Research and development revenue | $ | 1,681,076 | $ | 1,295,451 | ||||
Costs and expenses: | ||||||||
Costs of research and development revenue | 1,459,701 | 1,027,278 | ||||||
Provision for contract losses | - | |||||||
Research and development | 3,087,597 | 2,101,628 | ||||||
Research and development - related party | 868,720 | 1,215,536 | ||||||
General and administrative | 5,519,922 | 4,522,676 | ||||||
Foreign currency exchange loss (gain), net | 27,725 | 20,778 | ||||||
Total costs and expenses | 10,963,665 | 8,887,896 | ||||||
Loss from operations | (9,282,589 | ) | (7,592,445 | ) | ||||
Interest income | 984,930 | 894,532 | ||||||
Loss before income taxes | (8,297,659 | ) | (6,697,913 | ) | ||||
Provision for (benefit from) income taxes | 10,306 | (1,006,157 | ) | |||||
Net loss | $ | (8,307,965 | ) | $ | (5,691,756 | ) | ||
Basic and diluted net loss per common share | $ | (0.31 | ) | $ | (0.21 | ) | ||
Basic and diluted weighted-average common shares outstanding | 27,003,695 | 27,673,300 | ||||||
See Notes to Condensed Consolidated Financial Statements in Part I of Dyadic's Annual Report on Form 10-K filed with Securities and Exchange Commission on March 30, 2020.
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, | ||||||||
2019 | 2018 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,823,544 | $ | 2,386,314 | ||||
Short-term investment securities | 29,399,146 | 38,816,441 | ||||||
Interest receivable | 329,711 | 294,240 | ||||||
Accounts receivable | 558,530 | 318,744 | ||||||
Income tax receivable | 250,308 | 506,866 | ||||||
Prepaid research and development | - | 253,446 | ||||||
Prepaid expenses and other current assets | 277,999 | 172,001 | ||||||
Total current assets | 35,639,238 | 42,748,052 | ||||||
Non-current assets: | ||||||||
Long-term investment securities | 1,511,636 | - | ||||||
Long-term income tax receivables | 250,308 | 500,616 | ||||||
Other assets | 51,314 | 52,139 | ||||||
Total assets | $ | 37,452,496 | $ | 43,300,807 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 943,378 | $ | 309,060 | ||||
Accrued expenses | 566,003 | 399,576 | ||||||
Deferred research and development obligations | 78,644 | 141,002 | ||||||
Total current liabilities | 1,588,025 | 849,638 | ||||||
Commitments and contingencies | ||||||||
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 - 39,612,659 and 38,996,988, outstanding shares - 27,359,157 and 26,713,486 as of December 31, 2019 and 2018, respectively | 39,613 | 38,967 | ||||||
Additional paid-in capital | 96,105,851 | 94,385,230 | ||||||
Treasury stock, shares held at cost - 12,253,502 | (18,929,915 | ) | (18,929,915 | ) | ||||
Accumulated deficit | (41,351,078 | ) | (33,043,113 | ) | ||||
Total stockholders' equity | 35,864,471 | 42,451,169 | ||||||
Total liabilities and stockholders' equity | $ | 37,452,496 | $ | 43,300,807 | ||||
See Notes to Condensed Consolidated Financial Statements in Part I of Dyadic's Annual Report on Form 10-K filed with Securities and Exchange Commission on March 30, 2020.
SOURCE: Dyadic International, Inc.