JUPITER, Fla., Aug. 09, 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 lower the cost of biologic vaccines and drugs at flexible
commercial scales, announced its financial results for the second
quarter and six months ended June 30, 2018. It also
announced that on August 6, 2018, the Company’s Board of Directors
authorized an extension of the Company’s existing stock repurchase
program through August 15, 2019.
“Since the beginning of this year, we have
achieved numerous corporate and research milestones in our
third-party collaborations and internal research programs and
continue to be encouraged by the progress we are making,” said Mark
Emalfarb, President and CEO of Dyadic. Mr. Emalfarb also commented
that “we have generated data that demonstrate a potential for C1 to
help manufacture biologics rapidly, at lower cost, and with
potentially new properties and productivity levels that are
superior when compared to Chinese Hamster Ovary (“CHO”) cells,
which are commonly used for biomanufacturing. Research programs to
develop C1 strains that produce mAbs with mammalian-like
glycosylation are also progressing well. In the next six months, we
expect to enter into additional funded research collaborations with
top-tier biopharmaceutical companies in an effort to apply C1 for
use in both animal and human health applications.”
BUSINESS HIGHLIGHTS AND RECENT
ACHIEVEMENTS/ DEVELOPMENTS
- Entered into an additional research collaboration with a
biotech company to test the feasibility of using C1 to produce
seven different molecular biology enzymes as pharmaceutical
products. We have secured a total of four collaborations since the
beginning of this year.
- Data generated indicated C1 can express a variety of
different types of vaccines and therapeutic proteins,
including monoclonal antibodies (mAbs), Fab antibody fragments,
FC-Fusion proteins, and difficult-to-express genes such, as
virus-like particles (VLPs), Bi-Specific antibodies, and antigens,
at a higher productivity level than other gene expression
platforms.
- Achieved record C1 productivity levels as high as 2.4 grams per
liter per day (9 g/l in 90 hours) for monoclonal antibodies and 1.9
grams per liter per day for Fabs.
- Through process and media optimization, achieved 50% C1
fermentation process improvement accompanied by a corresponding
drop in the defined media cost.
- Created C1 protease expression library and improved protein
stability and productivity by eliminating targeted C1 protease
genes.
- On June 6, 2018, the Company’s shareholders approved a proposal
to amend Dyadic’s Restated Certificate of Incorporation to effect a
reverse stock split of the Company's issued and outstanding shares
of common stock at a ratio of up to 1-for-4, if and when the
Company’s Board of Directors determines it is in the Company’s best
interest to do so.
FINANCIAL RESULTS FOR THE QUARTER AND
SIX MONTHS ENDED JUNE 30, 2018
At June 30, 2018, cash and cash equivalents
were approximately $3.2 million compared to $5.8 million at
December 31, 2017. The carrying value of investment grade
securities, including interest receivable as of June 30, 2018,
was approximately $42.6 million compared to $43.3 million at
December 31, 2017.
As of June 30, 2018, there were
approximately 28.1 million shares outstanding and 10.9 million
shares held in treasury.
Research and development revenue for the three
months ended June 30, 2018, decreased to approximately
$161,000 compared to $207,000 for the same period a year ago.
Research and development revenue for the six months ended
June 30, 2018, increased to approximately $346,000 compared to
$329,000 for the same period a year ago.
Cost of research and development revenue for the
three months ended June 30, 2018, decreased to approximately
$129,000 compared to $200,000 for the same period a year ago. Cost
of research and development revenue for the six months ended
June 30, 2018, decreased to approximately $276,000 compared to
$321,000 for the same period a year ago.
The changes in revenue and cost of research and
development revenue reflect different research collaborations
completed in 2017 and new research collaborations started in
2018.
Interest income for the three months ended
June 30, 2018 increased 69.2% to approximately $220,000
compared to $130,000 for the same period a year ago. Interest
income for the six months ended June 30, 2018 increased 65.0%
to approximately $406,000 compared to $246,000 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.
Provision for contract losses for the three
months ended June 30, 2018 was $0 compared to approximately
$10,000 for the same period a year ago. Provision for contract
losses for the six months ended June 30, 2018 was $0 compared
to approximately $221,000 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 June 30, 2018 was approximately $601,000 compared
to $420,000 for the same period a year ago. Research and
development expenses for the six months ended June 30, 2018
was approximately $1,178,000 compared to $739,000 for the same
period a year ago. The increase primarily reflects the costs of
additional internal research activities with third-party contract
research organizations and personnel related costs.
Research and development expenses - related
party, for the three months ended June 30, 2018, increased to
approximately $341,000 compared to $0 for the same period a year
ago. Research and development expenses - related party, for the six
months ended June 30, 2018 increased to approximately $733,000
compared to $0 for the same period a year ago. The increase
reflects the research and development costs related to the
Company’s R&D agreements with BDI, which started in July
2017.
General and administrative expenses for the
three months ended June 30, 2018 decreased 25.3% to
approximately $922,000 compared to $1,234,000 for the same period a
year ago. The decrease primarily reflects reductions in legal and
litigation costs of approximately $137,000, compensation costs
associated with our former CFO of approximately $86,000,
share-based compensation expenses related to stock options granted
in 2018 of approximately $55,000, and other cost reductions of
approximately $34,000.
General and administrative expenses for the six
months ended June 30, 2018 decreased 26.8% to approximately
$2,215,000 compared to $3,024,000 for the same period a year ago.
The decrease primarily reflects reductions in legal and litigation
costs of approximately $699,000, share-based compensation expenses
related to stock options granted in 2018 of approximately $146,000,
and other cost reductions of approximately $29,000, offset by
increases in business development costs of approximately $54,000
and separation costs (including stock option modification costs),
net of compensation cost reduction, associated with our former CFO
of approximately $11,000.
Foreign currency exchange gain for the three
months ended June 30, 2018 was approximately $15,000 compared
to $178,000 for the same period a year ago. Foreign currency
exchange gain for the six months ended June 30, 2018 was
approximately $10,000 compared to $206,000 for the same period a
year ago. The change reflects the reduction in cash balance carried
in Euro and the currency fluctuation of the Euro in comparison to
the U.S. dollar.
Net loss for the three months ended
June 30, 2018 was approximately $(1.6) million, or $(0.06) per
basic and diluted share, compared to $(1.3) million, or $(0.05) per
basic and diluted share, for the same period a year ago. The
increase in net loss was primarily due to the higher research and
development expenses in 2018.
Net loss for the six months ended June 30,
2018 was approximately$(3.6) million, or $(0.13) per basic and
diluted share, compared to a net income of $0.7 million, or $0.03
per basic and diluted share, for the same period a year ago. Net
income for the six months ended June 30, 2017 was primarily due to
the receipt of a litigation settlement of $4.4 million.
EXTENSION OF STOCK REPURCHASE
PROGRAM
Under the Company’s existing stock repurchase
program, Dyadic may repurchase up to $5 million of the Company’s
common stock in accordance with all applicable securities laws and
regulations, including Rule 10b-18 of the Securities Exchange Act
of 1934, as amended. The extent to which Dyadic repurchases its
stock, and the timing of such repurchases, will depend upon a
variety of factors, including market conditions, regulatory
requirements and other corporate considerations, as determined by
Dyadic’s management. The repurchase program may be extended,
suspended or discontinued at any time. Since August 2017, the
Company has repurchased $0.9 million of its common stock under this
program, leaving it with additional authorization of up to $4.1
million under the program as a result of this extension. The
Company expects to finance the program from existing cash
resources.
CONFERENCE CALL INFORMATION
Dyadic management will host a conference call
today, Thursday, August 9, 2018, at 5:00 PM
ET to discuss the financial results for the quarter ended
June 30, 2018. In order to participate in the conference call,
please dial 800-967-7164 for U.S./Canada callers and +323-994-2131
for International callers, using access code 9709316.
A replay of the conference call will be
available on Dyadic’s website (www.dyadic.com) within 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 (such as
virus like particles (VLPs) and antigens), monoclonal antibodies,
Fab antibody fragments, FC-Fusion proteins, biosimilars and/or
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
http://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 generate the required productivity, stability, purity,
performance, cost, safety and other data necessary 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; (8) the pharmaceutical
and biotech industry, governmental regulatory and other agencies'
willingness to adopt, utilize and approve the use of the C1 gene
expression platform; and (9) 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, 2018 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.
Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Accounting Officer
Phone: (561) 743-8333
Email: prawson@dyadic.com
DYADIC INTERNATIONAL, INC. AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
Research
and development revenue |
|
$ |
161,286 |
|
|
$ |
207,402 |
|
|
$ |
345,616 |
|
|
$ |
328,929 |
|
|
|
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
Costs of
research and development revenue |
|
129,116 |
|
|
199,794 |
|
|
275,925 |
|
|
321,322 |
|
Provision
for contract losses |
|
— |
|
|
10,175 |
|
|
— |
|
|
220,715 |
|
Research
and development |
|
601,199 |
|
|
419,750 |
|
|
1,178,083 |
|
|
739,274 |
|
Research
and development - related party |
|
340,849 |
|
|
— |
|
|
733,398 |
|
|
— |
|
General
and administrative |
|
921,542 |
|
|
1,233,801 |
|
|
2,214,539 |
|
|
3,024,092 |
|
Foreign
currency exchange gain, net |
|
(15,198 |
) |
|
(178,277 |
) |
|
(10,358 |
) |
|
(206,113 |
) |
Total costs and
expenses |
|
1,977,508 |
|
|
1,685,243 |
|
|
4,391,587 |
|
|
4,099,290 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(1,816,222 |
) |
|
(1,477,841 |
) |
|
(4,045,971 |
) |
|
(3,770,361 |
) |
|
|
|
|
|
|
|
|
|
Other
income: |
|
|
|
|
|
|
|
|
Settlement of litigation, net |
|
— |
|
|
— |
|
|
— |
|
|
4,358,223 |
|
Interest
income, net |
|
219,585 |
|
|
130,236 |
|
|
406,042 |
|
|
246,429 |
|
Total other
income |
|
219,585 |
|
|
130,236 |
|
|
406,042 |
|
|
4,604,652 |
|
|
|
|
|
|
|
|
|
|
(Loss) income
before income taxes |
|
(1,596,637 |
) |
|
(1,347,605 |
) |
|
(3,639,929 |
) |
|
834,291 |
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes |
|
— |
|
|
1,901 |
|
|
— |
|
|
87,457 |
|
|
|
|
|
|
|
|
|
|
Net (loss)
income |
|
$ |
(1,596,637 |
) |
|
$ |
(1,349,506 |
) |
|
$ |
(3,639,929 |
) |
|
$ |
746,834 |
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
common share |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.13 |
) |
|
$ |
0.03 |
|
Diluted |
|
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.13 |
) |
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding |
|
|
|
|
|
|
|
|
Basic |
|
28,060,811 |
|
|
28,707,289 |
|
|
28,109,756 |
|
|
29,159,363 |
|
Diluted |
|
28,060,811 |
|
|
28,707,289 |
|
|
28,109,756 |
|
|
29,220,108 |
|
|
|
|
|
Balance sheet
information: |
June 30, 2018 |
|
December 31, 2017* |
|
(Unaudited) |
|
(Audited) |
|
|
|
|
Cash and cash
equivalents |
$ |
3,218,820 |
|
|
$ |
5,786,348 |
|
Investment securities,
short-term, long-term and interest receivable |
42,602,190 |
|
|
43,311,243 |
|
Prepaid research and
development (current and non-current) |
718,654 |
|
|
1,167,439 |
|
Total assets |
46,769,982 |
|
|
50,744,159 |
|
Accumulated
deficit |
(30,991,286 |
) |
|
(27,351,357 |
) |
Stockholders'
equity |
$ |
46,303,536 |
|
|
$ |
49,975,264 |
|
|
|
|
|
*Condensed from audited
financial statements |
|
|
|
Dyadic (NASDAQ:DYAI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Dyadic (NASDAQ:DYAI)
Historical Stock Chart
From Apr 2023 to Apr 2024