ACCESS Newswire
14 Aug 2019, 01:31 GMT+10
JUPITER, FL / ACCESSWIRE / August 13, 2019 / Dyadic International, Inc. ("Dyadic") (NASDAQ: DYAI), a global biotechnology company focused on further improving and applying its proprietary C1 gene expression platform to accelerate development, lower production costs and improve the performance of biologic vaccines, drugs, and other biologic products, at flexible commercial scales, today announced its financial results for the quarter ended June 30, 2019, and recent developments.
"I am pleased to report that we maintained our momentum in the second quarter by signing several agreements with highly experienced, value-added partners, including the Serum Institute of India (''Serum''). Serum is one of the world's largest vaccine manufacturers and our collaboration provides for the development and manufacture up to twelve antibodies and vaccines using Dyadic's C1 gene expression platform. We expect these relationships, along with those we signed in the first quarter and the recent agreement we signed earlier this week with a top tier pharmaceutical company, will further the development of our C1 technology platform and expand the breadth of potential commercial opportunities for human and animal health applications," said Mark Emalfarb, Dyadic's Chief Executive Officer.
Mr. Emalfarb also commented, "We achieved several milestones in the quarter, including up-listing to the Nasdaq and joining the Russell Microcap Index® reinforcing the continued growth of our Company. As a result, we are well positioned to enhance our visibility in the investment community, broaden our shareholder base and further build long-term shareholder value. In the fall, our management team will continue to be very active at both investor and industry conferences. Our management team is lean but highly experienced and energized, supported by best in-class scientific partners. Finally, our balance sheet remains a source of strength with approximately $38.8 million in cash and investment grade securities, no debt and complemented by partner funded on-going R&D collaborations."
"We continue to make progress executing on our vision of creating more efficient and commercially cost-effective healthcare solutions for society globally. Based on the number of additional non-disclosure agreements we have signed year to date and our ongoing discussions with several pharma and biotech companies, we look forward to sharing additional new developments as the second half of the year unfolds," concluded Mr. Emalfarb.
RECENT DEVELOPMENTS
FINANCIAL RESULTS
For the Three Months Ended June 30, 2019
Research and development revenue for the three months ended June 30, 2019, increased to approximately $391,000 compared to $161,000 for the same period a year ago. Cost of research and development revenue for the three months ended June 30, 2019, increased to approximately $322,000 compared to $129,000 for the same period a year ago. The increase in revenue and cost of research and development revenue reflect four on-going research collaborations for the three months ended June 30, 2019 compared to two collaborations in 2018 for the same period.
Research and development expenses for the three months ended June 30, 2019, increased to approximately $818,000 compared to $601,000 for the same period a year ago. This increase reflects the costs of additional internal research activities with third-party contract research organizations.
Research and development expenses - related party, for the three months ended June 30, 2019, was approximately $336,000 compared to $341,000 for the same period a year ago. These expenses reflect the research and development costs related to the Research Services Agreement and the Service Framework Agreement ("R&D Agreements") between Dyadic and Biotechnology Developments for Industry in Pharmaceuticals, S.L.U. ("BDI"), which started in July 2017.
General and administrative expenses for the three months ended June 30, 2019, increased 102.9% to approximately $1,871,000 compared to $922,000 for the same period a year ago. The increase principally includes increases in noncash share-based compensation expenses of $501,000 related to stock options granted in 2019 and options vested upon the April 2019 up-listing to the NASDAQ, the Securities and Exchange Commission (the "SEC") registration and up-listing expenses of $176,000, accrued annual bonuses and incentives for employees of $149,000 and business development and investor relations costs of $86,000.
Interest income for the three months ended June 30, 2019, increased 20.9% to approximately $266,000 compared to $220,000 for the same period a year ago. The increase in interest income reflects higher yield on Dyadic's investments in held-to-maturity, investment grade securities.
Net loss for the three months ended June 30, 2019, was approximately $2.7 million, or $(0.10) per diluted share, compared to a net loss of $1.6 million, or $(0.06) per diluted share, for the same period a year ago.
For the Six Months Ended June 30, 2019
Research and development revenue for the six months ended June 30, 2019, increased to approximately $793,000 compared to $346,000 for the same period a year ago revenue. Cost of research and development revenue for the six months ended June 30, 2019, increased to approximately $650,000 compared to $276,000 for the same period a year ago. The increase in revenue and cost of research and development revenue for the six months ended June 30, 2019 reflect seven on-going research collaborations compared to three collaborations for the same period a year ago.
Research and development expenses for the six months ended June 30, 2019 increased to approximately $1,511,000 compared to $1,178,000 for the same period a year ago. The increase primarily reflects the costs of additional internal research activities with third-party contract research organizations.
Research and development expenses - related party, for the six months ended June 30, 2019, was approximately $726,000 compared to $733,000 for the same period a year ago. These expenses reflect the research and development costs related to the R&D Agreements with BDI, which started in July 2017.
General and administrative expenses for the six months ended June 30, 2019, increased 48.9% to approximately $3,299,000 compared to $2,215,000 for the same period a year ago. The increase principally includes increases in noncash share-based compensation expenses of $574,000 related to stock options granted in 2019 and options vested upon the April 2019 up-listing to the NASDAQ, SEC registration and up-listing expenses of $273,000, accrued annual bonuses and incentives for employees of $264,000 and business development and investor relations costs of $131,000, offset by reductions in compensation costs associated with Dyadic's former CFO of $183,000.
Interest income for the six months ended June 30, 2019, increased 31.3% to approximately $533,000 compared to $406,000 for the same period a year ago. The increase reflects higher yield on Dyadic's investments in held-to-maturity, investment grade securities.
Net loss for the six months ended June 30, 2019 was approximately $4.9 million, or $(0.18) per diluted share, compared to a net loss of $3.6 million, or $(0.13) per diluted share, for the same period a year ago.
BALANCE SHEET
At June 30, 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 June 30, 2019 was $34.0 million compared to $39.1 million at December 31,2018.
CONFERENCE CALL INFORMATION
Date: Tuesday, August 13, 2019
Time: 5:00 p.m. Eastern Time
Dial-in numbers: 844-369-8770 (U.S. or Canada) or + 862-298-0840 (International) No pass code is needed
Webcast Link: https://www.investornetwork.com/event/presentation/50926.
An archive of the webcast will be available approximately three hours after completion of the live event and will be accessible on the "Investors" section of Dyadic's website at www.dyadic.com for a limited time. To access the replay of the webcast, please use the webcast link above. A dial-in replay of the call will also be available to those interested until August 20, 2019. To access the teleconference replay, please dial 877-481-4010 or 919-882-2331 #50926.
About Dyadic International
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 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. Recently, Dyadic has also begun exploring the use of its C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of Adeno-associated viral vectors (AAV), certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to create synergy by leveraging Dyadic's 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 as a result improve access and cost to patients and the healthcare system, and most importantly, save lives.
Please visit Dyadic's website at 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'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 Dyadic's most recent filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. 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 at www.dyadic.com.
Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: [email protected]
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenues: | ||||||||||||||||
Research and development revenue | $ | 390,874 | $ | 161,286 | $ | 793,401 | $ | 345,616 | ||||||||
Costs and expenses: | ||||||||||||||||
Costs of research and development revenue | 322,228 | 129,116 | 650,131 | 275,925 | ||||||||||||
Research and development | 818,240 | 601,199 | 1,510,610 | 1,178,083 | ||||||||||||
Research and development - related party | 336,310 | 340,849 | 725,783 | 733,398 | ||||||||||||
General and administrative | 1,870,678 | 921,542 | 3,298,745 | 2,214,539 | ||||||||||||
Foreign currency exchange loss (gain), net | 4,932 | (15,198 | ) | 10,966 | (10,358 | ) | ||||||||||
Total costs and expenses | 3,352,388 | 1,977,508 | 6,196,235 | 4,391,587 | ||||||||||||
Loss from operations | (2,961,514 | ) | (1,816,222 | ) | (5,402,834 | ) | (4,045,971 | ) | ||||||||
Interest income | 265,722 | 219,585 | 532,684 | 406,042 | ||||||||||||
Loss before income taxes | (2,695,792 | ) | (1,596,637 | ) | (4,870,150 | ) | (3,639,929 | ) | ||||||||
Provision for income taxes | - | - | 900 | - | ||||||||||||
Net loss | $ | (2,695,792 | ) | $ | (1,596,637 | ) | $ | (4,871,050 | ) | $ | (3,639,929 | ) | ||||
Basic and diluted net loss per common share | $ | (0.10 | ) | $ | (0.06 | ) | $ | (0.18 | ) | $ | (0.13 | ) | ||||
Basic and diluted weighted-average common shares outstanding | 26,828,754 | 28,060,811 | 26,771,439 | 28,109,756 | ||||||||||||
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2019 | December 31, 2018 | |||||||
(Unaudited) | (Audited) | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,781,520 | $ | 2,386,314 | ||||
Short-term investment securities | 32,104,149 | 38,816,441 | ||||||
Interest receivable | 399,242 | 294,240 | ||||||
Accounts receivable | 504,510 | 318,744 | ||||||
Income tax receivable | - | 506,866 | ||||||
Prepaid research and development |
Shares
Watch latest videosSubscribe and FollowGet a daily dose of Albuquerque Express news through our daily email, its complimentary and keeps you fully up to date with world and business news as well. News RELEASESPublish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Albuquerque Express. More Information
null in null
InternationalSectionFox faces $787 million lawsuit from Newsom over Trump phone callDOVER, Delaware: California Governor Gavin Newsom has taken legal aim at Fox News, accusing the network of deliberately distorting... DeepSeek faces app store ban in Germany over data transfer fearsFRANKFURT, Germany: Germany has become the latest country to challenge Chinese AI firm DeepSeek over its data practices, as pressure... Canadian option offered to Harvard graduates facing US visa issuesTORONTO, Canada: Harvard University and the University of Toronto have created a backup plan to ensure Harvard graduate students continue... Israel should act fast on new peace deals, Netanyahu saysJERUSALEM, Israel: Israeli Prime Minister Benjamin Netanyahu says that Israel's success in the war with Iran could open the door to... UN offer rejected in Dreamliner crash investigationNEW DELHI, India: India has decided not to allow a United Nations (UN) investigator to join the investigation into the recent Air India... UN climate agency gets 10 percent boost amid global budget cutsBONN, Germany: Despite widespread belt-tightening across the United Nations, nearly 200 countries agreed this week to increase the... BusinessSectionWall Street extends rally, Standard and Poor's 500 hits new highNEW YORK, New York - U.S. stock markets closed firmly in positive territory to start the week Monday, with the S&P 500 and Dow Jones... Canadian tax on US tech giants dropped after Trump furyWASHINGTON, D.C.: On Friday, President Donald Trump announced that he was halting trade discussions with Canada due to its decision... Trump-backed crypto project gets $100 million boost from UAE fundLONDON, U.K.: A little-known investment fund based in the United Arab Emirates has emerged as the most prominent public backer of U.S.... DIY weight-loss drug trend surges amid high prices, low accessSAN FRANCISCO, California: Across the U.S., a growing number of people are taking obesity treatment into their own hands — literally.... Apple allows outside payment links under EU pressureSAN FRANCISCO, California: Under pressure from European regulators, Apple has revamped its App Store policies in the EU, introducing... Euro, pound surge as U.S. rate cut odds grow after Powell hintNEW YORK CITY, New York: The U.S. dollar tumbled this week, hitting its lowest levels since 2021 against the euro, British pound, and... Movie Review |