- Three new research collaborations
- Positive results in our initial glycoengineering
modifications of C1 strains
- Achieving high levels of productivity for therapeutic
proteins
- Board approved a reverse stock split subject to shareholder
approval
- Recognized industry thought leader joins board
- New Chief Accounting Officer appointed
- $47.7 million of cash, cash equivalents and investment
securities at March 31, 2018
JUPITER, Fla., May 10, 2018 (GLOBE NEWSWIRE) --
Dyadic International, Inc. (“Dyadic”) (OTCQX:DYAI), a global
biotechnology company focused on further improving and applying its
proprietary C1 gene expression platform to speed up the development
and production of biologic vaccines and drugs at flexible
commercial scales, announced its financial results for the quarter
ended March 31, 2018.
“Based on the encouraging data we generated to
date in our research programs, we are seeing increased interest in
our C1 Gene Expression Platform and gaining traction in our
business development efforts,” said Mark Emalfarb, President and
CEO of Dyadic. “We continue to see additional positive data that we
anticipate will expedite our entering into a number of further, but
just as important, additional research collaborations throughout
the remainder of the year.”
BUSINESS HIGHLIGHTS AND RECENT
DEVELOPMENTS
- Entered into three research collaborations, including
Mitsubishi Tanabe Pharma Corp. and the Israel Institute for
Biological Research.
- Data generated from research collaborations with two top-tier
pharmaceutical companies continues to show encouraging results on
FC-Fusion proteins and monoclonal antibody productivity and
manufacturing process development.
- Reached productivity levels as high as 1.71 grams per liter per
day for monoclonal antibodies and 1.31 grams per liter per day for
FC-Fusion proteins.
- Achieved positive results in our initial glycoengineering
modifications of C1 strains, moving ahead with our research
programs to develop C1 strains that produce mAbs with
mammalian-like glycosylation.
- In March 2018, the Board approved a proposal to vote on a
reverse stock split at the annual shareholder meeting to be held on
June 6, 2018.
- Barry Buckland, Ph.D., a recognized industry thought leader,
including 29 years at Merck, joined the Board of Directors in
January 2018.
- Promoted to Chief Accounting Officer, Ping W. Rawson, who has
replaced Tom Dubinski, our former Chief Financial Officer, to serve
as the Company's principal financial officer and assume
responsibility for finance, tax and treasury.
FINANCIAL RESULTS FOR THE QUARTER ENDED
MARCH 31, 2018
At March 31, 2018, cash and cash
equivalents were approximately $4.6 million compared to $5.8
million at December 31, 2017. The carrying value of
investment-grade securities, including interest receivable as of
March 31, 2018, was approximately $43.1 million compared to
$43.3 million at December 31, 2017.
Research and development revenue for the three
months ended March 31, 2018, increased to approximately
$184,000 compared to $122,000 for the same period a year ago. Cost
of research and development revenue for the three months ended
March 31, 2018, increased to approximately $147,000 compared
to $122,000 for the same period a year ago. The increases in
revenue and cost of research and development revenue are
attributable to new research collaborations in 2018.
Provision for contract losses for the three
months ended March 31, 2018, was $0 compared to approximately
$211,000 for the same period a year ago. The provision for contract
losses recorded in 2017 was associated with the Company's extended
involvement in the ZAPI program and another research collaboration
completed in 2017.
Research and development expenses for the three
months ended March 31, 2018, increased to approximately
$577,000 compared to $320,000 for the same period a year ago. The
increase principally reflects the costs of additional internal
research activities with third-party contract research
organizations and personnel related costs.
Research and development expenses - related
party, for the three months ended March 31, 2018, increased to
approximately $393,000 compared to $0 for the same period a year
ago. The increase reflects the research and development costs
associated with the Company’s R&D Agreements with BDI, which
started in July 2017.
General and administrative expenses for the
three months ended March 31, 2018, decreased to approximately
$1,293,000 compared to $1,790,000 for the same period a year ago.
The decrease principally reflects reductions in legal and
litigation costs of approximately $561,000 and share-based
compensation expenses related to stock options granted in 2018 of
approximately $92,000, offset by separation costs associated with
our former CFO of approximately $97,000, increase in business
development costs of approximately $55,000, and other increases of
approximately $4,000.
Foreign currency exchange loss for the three
months ended March 31, 2018, was approximately $5,000 compared
to a gain of $28,000 for the same period a year ago. The change
represents the currency fluctuation of the Euro in comparison to
U.S. dollar.
Interest income for the three months ended
March 31, 2018, increased to approximately $186,000 compared
to $116,000 for the same period a year ago. The increase in
interest income reflects the higher yield on the Company’s
investment grade securities, which are classified as
held-to-maturity.
Net loss for the quarter ended March 31,
2018, was approximately $(2.0) million, or $(0.07) per basic and
diluted share, compared to net income of $2.1 million, or $0.07 per
basic and diluted share, for the same period a year ago. Net income
in the first quarter of 2017 was primarily due to the receipt of a
litigation settlement of approximately $4.4 million.
As of March 31, 2018, there were
approximately 28.1 million shares of common stock outstanding and
approximately 10.9 million shares held in treasury, after the
Company purchased 267,000 shares at a weighted average price of
$1.40 per share in open market transactions in the first quarter of
2018.
CONFERENCE CALL INFORMATION
Dyadic management will host a conference call
today, Thursday, May 10,
2018, at 5:00 p.m. to discuss the financial results for
the quarter ended March 31, 2018. In order to participate in
the conference call, please dial 800-839-7875 for U.S./Canada
callers and +719-325-4891 for International callers, using access
code 7239777.
A replay of the conference call will be
available on Dyadic’s website (www.dyadic.com) 24 hours after the
live event.
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 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,
monoclonal antibodies, biosimilars/biobetters, and other
therapeutic proteins. 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 drugs to market
faster, in greater volumes, at lower cost, and with new properties
to drug developers and manufacturers and, hopefully, improve access
and cost to patients and the healthcare system, but 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.
Dyadic trades on the OTCQX tier of the OTC
marketplace. Investors can find real-time quotes, market
information and financial reports for Dyadic in the Company’s
annual and quarterly reports which are filed with the OTC markets.
Please visit the OTC markets website at
www.otcmarkets.com/stock/DYAI/quote.
Safe Harbor Regarding Forward-Looking
Statements
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “look forward to,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” “would” and similar
expressions. Forward-looking statements are based on management’s
beliefs and assumptions and on information available to management
only as of the date of this press release. These forward-looking
statements involve risks, uncertainties and other factors that
could cause Dyadic’s actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Investors are urged to consider these factors carefully
in evaluating the forward-looking statements and are cautioned not
to place undue reliance on such forward-looking statements. Dyadic
expressly disclaims any intent or obligation to update or revise
any forward-looking statements to reflect actual results, any
changes in expectations or any change in events. Factors that could
cause results to differ materially include, but are not limited to:
(1) general economic, political and market conditions; (2) our
ability to carry out and implement our biopharmaceutical research
and business plans and strategic initiatives; (3) our ability to
retain and attract employees, consultants, directors and advisors;
(4) our ability to implement and successfully carry out Dyadic’s
and third parties research and development efforts; (5) our ability
to obtain new license and research agreements; (6) our ability to
maintain our existing access to, and/or expand access to third
party contract research organizations in order to carry out our
research projects for ourselves and third parties; (7) competitive
pressures and reliance on key customers and collaborators; and (8)
other factors discussed in Dyadic’s publicly available filings,
including information set forth under the caption “Risk Factors” in
our December 31, 2017 Annual Report filed with the OTC
Markets on March 27, 2018, and our March 31, 2017 Quarterly
Report filed with the OTC Markets on May 10, 2018. New risks
and uncertainties arise from time to time, and it is impossible for
us to predict these events or how they may affect us.
Important Information about the Reverse Stock Split
Proposal
This communication may be deemed to be
solicitation material in connection with the proposal to be
submitted to Dyadic’s shareholders at its annual meeting seeking
approval to authorize a reverse stock split (the “Reverse Stock
Split Proposal”).
A notice of the annual meeting and a proxy
statement to solicit the votes of Dyadic stockholders to approve
the Reverse Split Proposal (the “Proxy Statement”) was posted to
Dyadic’s website (www.dyadic.com) and the OTC Marketplace Portal
(http://www.otcmarkets.com/stock/DYAI/filings) on April 18, 2018
and subsequently mailed to Dyadic stockholders. Shareholders of
Dyadic are urged to read the proxy statement and all other relevant
documents filed with the OTC Markets, because they may contain
important information about the Reverse Stock Split Proposal and
Dyadic.
Dyadic and its Board of Directors and executive
officers may be deemed to be participants in the solicitation of
proxies from the holders of Dyadic common stock in respect of the
Reverse Stock Split Proposal. Information about the directors and
executive officers of Dyadic is set forth in the Proxy Statement.
Investors may obtain additional information regarding the interest
of Dyadic and its directors and executive officers in the Reverse
Stock Split Proposal by reading the proxy statement relating to the
special meeting.
Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Accounting Officer
Phone: +1 (561) 743-8333
Email: prawson@dyadic.com
DYADIC INTERNATIONAL, INC. AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
Three Months Ended March 31, |
|
|
2018 |
|
2017 |
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
Research
and development revenue |
|
$ |
184,330 |
|
|
$ |
121,527 |
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
Costs of
research and development revenue |
|
146,809 |
|
|
121,528 |
|
Provision
for contract losses |
|
— |
|
|
210,540 |
|
Research
and development |
|
576,884 |
|
|
319,524 |
|
Research
and development - related party |
|
392,549 |
|
|
— |
|
General
and administrative |
|
1,292,997 |
|
|
1,790,291 |
|
Foreign
currency exchange loss (gain), net |
|
4,840 |
|
|
(27,836 |
) |
Total costs and
expenses |
|
2,414,079 |
|
|
2,414,047 |
|
|
|
|
|
|
Loss from
operations |
|
(2,229,749 |
) |
|
(2,292,520 |
) |
|
|
|
|
|
Other
income: |
|
|
|
|
Settlement of litigation, net |
|
— |
|
|
4,358,223 |
|
Interest
income, net |
|
186,457 |
|
|
116,193 |
|
Total other
income |
|
186,457 |
|
|
4,474,416 |
|
|
|
|
|
|
(Loss) income
before income taxes |
|
(2,043,292 |
) |
|
2,181,896 |
|
|
|
|
|
|
Provision for income
taxes |
|
— |
|
|
85,556 |
|
|
|
|
|
|
Net (loss)
income |
|
$ |
(2,043,292 |
) |
|
$ |
2,096,340 |
|
|
|
|
|
|
Net (loss) income per
common share |
|
|
|
|
Basic |
|
$ |
(0.07 |
) |
|
$ |
0.07 |
|
Diluted |
|
$ |
(0.07 |
) |
|
$ |
0.07 |
|
|
|
|
|
|
Weighted-average common
shares outstanding |
|
|
|
|
Basic |
|
28,159,244 |
|
|
29,616,461 |
|
Diluted |
|
28,159,244 |
|
|
29,686,676 |
|
Balance sheet
information: |
March 31, 2018 |
|
December 31, 2017* |
|
(Unaudited) |
|
(Audited) |
|
|
|
|
Cash and
cash equivalents |
$ |
4,631,312 |
|
|
$ |
5,786,348 |
|
Investment securities, short-term, long-term and interest
receivable |
43,128,468 |
|
|
43,311,243 |
|
Prepaid
research and development (current and non-current) |
806,728 |
|
|
1,167,439 |
|
Total
assets |
48,822,103 |
|
|
50,744,159 |
|
Accumulated deficit |
(29,394,649 |
) |
|
(27,351,357 |
) |
Stockholders' equity |
$ |
47,826,748 |
|
|
$ |
49,975,264 |
|
|
|
|
|
*Condensed from audited
financial statements |
|
|
|
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