Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the
“Company”) (NASDAQ: DYAI), a global biotechnology company focused
on building innovative microbial platforms to develop and produce
biopharmaceuticals and alternative proteins for human and animal
health, today announced its financial results for the second
quarter of 2023, and highlighted recent company developments.
“As announced last month, we are excited to
report the interim analysis of Day 29 data from our first in human
Phase 1 clinical trial, in which no major vaccine related safety
issues were observed. DYAI-100, the vaccine candidate produced from
our proprietary and patented C1-cell protein production platform
has been shown to produce an immune response at both the low and
high dosing levels,” said Mark Emalfarb, President and Chief
Executive Officer of Dyadic. “We believe this important milestone
is a pivotal point in the evolution from our commercial success in
industrial biotech to broadening our capability as a life-science
biotechnology company. As demonstrated by our recently announced
fully funded collaboration with a top five pharmaceutical company
in a large infectious disease segment, we believe that our Phase 1
data will provide the biopharmaceutical industry, academia, and
governmental agencies with the confidence that our C1-cell
microbial protein production platform offers the safety, speed,
cost, and quality needed to gain market share in the competitive
industry,” concluded Mr. Emalfarb.
Joe Hazelton, Chief Business Officer of Dyadic,
also commented, “In addition to the expansion of our pharmaceutical
licensing programs, Dyadic is working toward the development of
near-term commercialization opportunities such as our non-animal
derived serum albumin projects, where we recently reported positive
results from third party analytical testing of the company’s
animal-free recombinant bovine serum albumin. We believe
demonstrating that Dyadic’s recombinant albumin is comparable to
currently marketed products has brought us a step closer to
commercialization opportunities in the rapidly expanding global
serum albumin market as well as helping us to initiate several
other projects for non-pharmaceutical enzyme and protein
applications. We believe the successful expression of a stable
casein protein in our Dapibus™ expression system further
demonstrates the broad applicability of our technology in large and
growing segments such as non-animal dairy proteins.” Mr. Hazelton
continued, “We are expanding both our C1 licensing and DapibusTM
programs for strain engineering and production services with a
focus on customers interested in creating high performance
microbial strains for their vaccine antigens, monoclonal
antibodies, other therapeutic proteins, as well as enzymes and
proteins for food, nutrition, and wellness.”
Recent Company Progress
DYAI-100 SARS-CoV-2 RBD (Receptor Binding Domain)
Booster Vaccine Candidate
- No major vaccine-related safety
concerns based on the interim analysis of the Day 29 data for both
low and high dose groups reviewed by the Data Safety Monitoring
Board (DSMB).
- To date, no serious adverse events
or local and systemic side effects have been observed.
- Booster vaccine
produced immune response at both dose levels.
- The Last Patient
Last Visit (LPLV) is scheduled for August 25, 2023, and the full
clinical study report (CSR) is expected in Q4 2023.
Vaccine Collaborations
- Essential Drugs Company
Limited (EDCL) in Bangladesh – On June 21, 2023, the
Company announced that it entered a Memorandum of Understanding
with EDCL, the state-owned pharmaceutical company under the
Ministry of Health and Family Welfare of Bangladesh, to facilitate
biopharmaceutical research, pre-clinical development, cGMP
production, and clinical development for the prevention and control
of diseases and improvement of public health programs in
Bangladesh.
- Top
5 Pharma – In April 2023, the
Company entered a new fully funded research collaboration, with a
top 5 pharmaceutical company, to express a vaccine antigen from C1
for human health in a large infectious disease segment. The
agreement also grants an option for a future commercialization
license in the designated field.
- Rubic
One Health
(“Rubic”) – On April 12, 2023, the Company
expanded its initial 2021 license agreement with Rubic to include
vaccines and therapeutic proteins beyond COVID-19 vaccines, for
both human animal health markets. The expanded license agreement
will help Rubic prepare for the development and manufacture of
affordable vaccines and drugs for the African continent.
- Virovax
Bio (“Virovax”) – Currently, four new animal studies are
ongoing with C1 produced ferritin nanoparticle antigens combined
with Virovax’s adjuvants for influenza (H5N1/Bird Flu), West Nile
and Powassan, to protect against encephalitis and meningitis.
- Uvax Bio
(“Uvax”) – In June 2023, the Company has renewed and
expanded its research collaboration with Uvax, a spin-off vaccine
company from Scripps Research. Uvax is developing prophylactic
vaccines for the most challenging infectious diseases, and our
research collaboration is expected to help Uvax overcome gene
expression challenges using the Company’s C1-cell protein
production platform.
Antibody Collaborations
- NIIMBL – During
the NIIMBL annual meeting in June 2023, the Company presented data
and research results generated from the NIIMBL Grant received
by the Company under the previously announced White House’s
American Rescue Plan, which ended successfully.
- EU 87G7
COVID-19 Antibody
Collaboration – In June 2023, a
manuscript was submitted to a peer-reviewed scientific journal
titled “Filamentous Fungus-Produced Human Monoclonal Antibody
Provides SARS-CoV-2 Protection in Hamster and Non-Human Primate
Models” in collaboration with Dr. Albert Osterhaus and several
other authors. The manuscript describes the safety and efficacy
results with a C1-cell produced monoclonal antibody obtained from
studies in hamsters and non-human primates.
-
Fondazione Biotecnopolo di Siena (“FBS”) – On May
24, 2023, the Company entered a Memorandum of Understanding with
the FBS, which performs the functions of an anti-pandemic
hub with a particular focus on the development and production
of vaccines and monoclonal antibodies for the
treatment of emerging epidemic-pandemic
pathologies. We expect FBS to conduct research and
development, clinical study, regulatory approval, manufacture and
commercialization of vaccines and therapeutic proteins using the
Company’s C1 protein production platform.
Animal Health
- New
Animal Health Partner – In June 2023, the Company entered
a fully funded collaboration with a new animal health company to
develop an antigen for livestock animals.
-
Rubic One Health
(“Rubic”) – On April 12, 2023, the Company
expanded its initial 2021 license agreement with Rubic to include
vaccines and therapeutic proteins beyond COVID-19 vaccines for both
human animal health markets. The expanded license agreement is
expected to help Rubic prepare for the development and manufacture
of affordable vaccines and drugs for the African continent.
- Phibro
Animal Health/Abic Biological Laboratories – In the first
quarter of 2023, the Company extended its research collaboration
with Abic Biological Laboratories Ltd. (“Abic”), an affiliate of
Phibro Animal Health Corporation (“Phibro”) to apply newly
developed techniques and methods to further increase the expression
level of a recombinant livestock antigen using C1. The Company and
Abic have expanded the collaboration to include the development of
additional antigens for use in livestock animal health
applications.
Alternative Proteins and Dapibus™ Platform
- Commercial
Product Portfolio Pipeline – On
August 7, 2023, the Company announced that it has successfully
developed stable cell lines to produce recombinant serum albumin
products. The Company initiated animal-free recombinant serum
albumin projects in late 2022 for use in potential therapeutic,
product development, research, and/or diagnostic human and animal
pharmaceutical applications. We have started sampling potential
customers who have expressed interest in Dyadic’s C1 serum albumin
products. Initial independent analytical assessment of the
Company’s recombinant bovine serum albumin demonstrated that it is
structurally equivalent to the commercially available animal
derived product. In non-pharmaceutical applications, the Company
initiated the development of non-animal derived recombinant dairy
proteins and enzymes for use in food and nutrition to support its
Dapibus™ platform.
- Fermbox
Bio (“Fermbox”) – On May 7, 2023,
the Company entered a fully funded co-development and marketing
agreement with Fermbox to help accelerate our ability to exploit
the Dapibus™ platform and expand Dyadic’s product offerings for
non-pharmaceutical alternative proteins applications, such as food,
nutrition, wellness and other bioproducts.
Other Events
-
BARDA and FDA
Workshop – On April 27, 2023, the Company
presented at Recombinant Protein-Based COVID-19 Vaccines Workshop,
a virtual event hosted by the Biomedical Advanced Research and
Development Authority (BARDA) and FDA. The goals of the workshop
were to provide: 1) a forum for product sponsors to discuss
progress and technical challenges in the manufacturing when
changing strain composition to currently circulating variants of
SARS-CoV-2; and 2) an open forum for collaborative discussions to
facilitate advancement of recombinant protein-based COVID-19
vaccines.
-
Patent Update – On April 18,
2023, the Company announced the receipt of a notice of allowance
from the U.S. Patent and Trademark Office for patent application
16/640,483, titled “Production of Flu Vaccine in Myceliophthora
thermophila”, which will cover claims for the development and
manufacture of seasonal and pandemic influenza vaccines from the
Company’s C1 protein production platform. The Company has developed
several influenza antigens and in collaboration with scientists in
the EU and USA various animal studies have been completed, with
both hemagglutinin (HA) and neuraminidase (NA) antigens expressed
from the Company’s C1 protein production platform. Additional
pandemic influenza (H5N1/bird flu) animal trials are currently in
process.
Financial Highlights
Cash Position:
As of June 30, 2023, cash, cash equivalents, and the carrying value
of investment grade securities, including accrued interest, were
approximately $10.2 million compared to $12.7 million as of
December 31, 2022.
Revenue: Research and
development revenue and license revenue for the quarter ended June
30, 2023, increased to approximately $837,000 compared to $659,000
for the same period a year ago. Research and development revenue
and license revenue for the six months ended June 30, 2023,
increased to approximately $1,815,000 compared to $1,307,000 for
the same period a year ago. The increase is primarily attributed to
higher individual contract amounts on certain research funding
compared to the same period a year ago.
Cost of
Revenue: Cost of research and development revenue
for the quarter ended June 30, 2023, increased to approximately
$793,000 compared to $411,000 for the same period a year ago. Cost
of research and development revenue for the six months ended June
30, 2023, increased to approximately $1,520,000 compared
to $815,000 for the same period a year ago.
R&D
Expenses: Research and development expenses for
the quarter ended June 30, 2023, decreased by 49.9% to
approximately $918,000 compared to $1,831,000 for the same period a
year ago. Research and development expenses for the six months
ended June 30, 2023, decreased by 45.6% to approximately $1,728,000
compared to $3,174,000 for the same period a year ago.
The decrease in research and development
expenses for the quarter and six months ended June 30, 2023 versus
the same periods in 2022 was due to the winding down of activities
of contract research organization and consultants to manage and
support the pre-clinical and clinical development as well as a
decrease in cGMP manufacturing costs as the Company completed the
dosing of Phase 1 clinical trial of its DYAI-100 RBD COVID-19
booster vaccine candidate in February 2023.
G&A
Expenses: General and administrative expenses for
the quarter ended June 30, 2023, decreased by 18.1% to
approximately $1,403,000 compared to $1,714,000 for the same period
a year ago. The decrease in G&A expenses for the quarter ended
June 30, 2023 compared to the same period in 2022 includes
decreases in legal expenses of $103,000, incentives of
approximately $81,000, business development and investor relations
expenses of $75,000, insurance expenses of $37,000, and other
decreases of $15,000. General and administrative expenses for the
six months ended June 30, 2023, decreased by 14.5% to approximately
$2,883,000 compared to $3,370,000 for the same period a year ago.
The decrease in G&A expenses for the six months ended June 30,
2023 compared to the same period in 2022 includes decreases in
incentives of approximately $215,000, business development and
investor relations expenses of $137,000, insurance expenses of
$72,000, legal expenses of $48,000 and other decreases of
$15,000.
Other Income: Other income for
the three and six months ended June 30, 2023, was primarily from
the sale of the equity interest in Alphazyme, LLC.
Net Loss: Net
loss for the quarter ended June 30, 2023, was approximately
$2,153,000 or $(0.07) per share compared to $3,288,000 or $(0.12)
per share for the same period a year ago. Net loss for the six
months ended June 30, 2023, was approximately $3,109,000 or $(0.11)
per share compared to $5,780,000 or $(0.20) per share for the same
period a year ago.
Conference Call
Information
Date: Wednesday, August 9, 2023
Time: 5:00 p.m. Eastern Time
Dial-in numbers: Toll Free: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13735362
Webcast
Link: https://viavid.webcasts.com/starthere.jsp?ei=1593531&tp_key=0b0ed46180
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. To access the replay of the webcast, please follow
the webcast link above.
About Dyadic International,
Inc.
Dyadic International, Inc. is a global biotechnology company
focused on building innovative microbial platforms to address the
growing demand for global protein bioproduction and unmet clinical
needs for effective, affordable, and accessible biopharmaceutical
products and alternative proteins for human and animal health.
Dyadic’s gene expression and protein production
platforms are based on the highly productive and scalable fungus
Thermothelomyces heterothallica (formerly Myceliophthora
thermophila). Our lead technology, C1-cell protein production
platform, is based on an industrially proven microorganism (named
C1), which is currently used to speed development, lower production
costs, and improve performance of biologic vaccines and drugs at
flexible commercial scales for the human and animal health markets.
Dyadic has also developed the DapibusTM filamentous fungal based
microbial protein production platform to enable the rapid
development and large-scale manufacture of low-cost proteins,
metabolites, and other biologic products for use in
non-pharmaceutical applications, such as food, nutrition, and
wellness.
With a passion to enable our partners and
collaborators to develop effective preventative and therapeutic
treatments in both developed and emerging countries, Dyadic is
building an active pipeline by advancing its proprietary microbial
platform technologies, including our lead asset DYAI-100 COVID-19
vaccine candidate, as well as other biologic vaccines, antibodies,
and other biological products.
To learn more about Dyadic and our commitment to
helping bring vaccines and other biologic products to market
faster, in greater volumes and at lower cost, please visit
http://www.dyadic.com.
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, such as the success of our clinical
trial and interest in our protein production platforms, our
research projects and third-party collaborations, as well as the
availability of necessary funding. 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 www.dyadic.com.
Contact:
Dyadic International, Inc.Ping W. RawsonChief
Financial OfficerPhone: 561-743-8333Email: ir@dyadic.com
|
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES |
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
Research and development revenue |
$ |
793,042 |
|
$ |
614,435 |
|
$ |
1,726,976 |
|
$ |
1,148,156 |
|
License revenue |
|
44,117 |
|
|
44,118 |
|
|
88,235 |
|
|
158,824 |
|
Total revenue |
|
837,159 |
|
|
658,553 |
|
|
1,815,211 |
|
|
1,306,980 |
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
Costs of research and development revenue |
|
792,944 |
|
|
411,109 |
|
|
1,519,862 |
|
|
815,855 |
|
Research and development |
|
917,552 |
|
|
1,830,798 |
|
|
1,728,118 |
|
|
3,173,660 |
|
General and administrative |
|
1,402,569 |
|
|
1,714,029 |
|
|
2,882,609 |
|
|
3,369,729 |
|
Foreign currency exchange loss |
|
14,521 |
|
|
20,621 |
|
|
25,543 |
|
|
10,373 |
|
Total costs and
expenses |
|
3,127,586 |
|
|
3,976,557 |
|
|
6,156,132 |
|
|
7,369,617 |
|
|
|
|
|
|
Loss from operations |
|
(2,290,427 |
) |
|
(3,318,004 |
) |
|
(4,340,921 |
) |
|
(6,062,637 |
) |
|
|
|
|
|
Other income: |
|
|
|
|
Interest income |
|
109,194 |
|
|
30,009 |
|
|
213,925 |
|
|
32,977 |
|
Other income |
|
28,273 |
|
|
— |
|
|
1,017,592 |
|
|
250,000 |
|
Total other income |
|
137,467 |
|
|
30,009 |
|
|
1,231,517 |
|
|
282,977 |
|
|
|
|
|
|
Net loss |
$ |
(2,152,960 |
) |
$ |
(3,287,995 |
) |
$ |
(3,109,404 |
) |
$ |
(5,779,660 |
) |
|
|
|
|
|
Basic
and diluted net loss per common share |
$ |
(0.07 |
) |
$ |
(0.12 |
) |
$ |
(0.11 |
) |
$ |
(0.20 |
) |
|
|
|
|
|
Basic
and diluted weighted-average common shares outstanding |
|
28,811,061 |
|
|
28,264,157 |
|
|
28,786,402 |
|
|
28,257,776 |
|
See Notes to Consolidated Financial Statements in
Item 1 of Dyadic’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August 9, 2023.
|
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES |
CONSOLIDATED BALANCE SHEETS |
|
|
June 30,
2023 |
|
December 31,
2022 |
|
(Unaudited) |
|
(Audited) |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
5,841,591 |
|
|
$ |
5,794,272 |
|
Short-term investment securities |
|
4,287,325 |
|
|
|
6,847,270 |
|
Interest receivable |
|
36,053 |
|
|
|
58,285 |
|
Accounts receivable |
|
767,597 |
|
|
|
330,001 |
|
Prepaid expenses and other current assets |
|
136,152 |
|
|
|
392,236 |
|
Total current assets |
|
11,068,718 |
|
|
|
13,422,064 |
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
Investment in Alphazyme |
|
— |
|
|
|
284,709 |
|
Other assets |
|
5,822 |
|
|
|
6,045 |
|
Total
assets |
$ |
11,074,540 |
|
|
$ |
13,712,818 |
|
|
|
|
|
|
|
Liabilities
and stockholders’
equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
905,876 |
|
|
$ |
1,276,313 |
|
Accrued expenses |
|
909,482 |
|
|
|
955,081 |
|
Deferred research and development obligations |
|
9,000 |
|
|
|
40,743 |
|
Deferred license revenue, current portion |
|
176,471 |
|
|
|
176,471 |
|
Total current liabilities |
|
2,000,829 |
|
|
|
2,448,608 |
|
|
|
|
|
|
|
|
Deferred license revenue, net of current portion |
|
88,235 |
|
|
|
176,471 |
|
Total liabilities |
|
2,089,064 |
|
|
|
2,625,079 |
|
|
|
|
|
|
|
|
Commitments and contingencies
(Note 4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 - 41,064,563 and
40,816,602, outstanding shares - 28,811,061 and28,563,100 as of
June 30, 2023, and December 31, 2022, respectively |
|
41,065 |
|
|
|
40,817 |
|
Additional paid-in capital |
|
104,465,590 |
|
|
|
103,458,697 |
|
Treasury stock, shares held at cost - 12,253,502 |
|
(18,929,915 |
) |
|
|
(18,929,915 |
) |
Accumulated deficit |
|
(76,591,264 |
) |
|
|
(73,481,860 |
) |
Total
stockholders’ equity |
|
8,985,476 |
|
|
|
11,087,739 |
|
Total liabilities
and stockholders’
equity |
$ |
11,074,540 |
|
|
$ |
13,712,818 |
|
See Notes to Consolidated Financial Statements in
Item 1 of Dyadic’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August 9, 2023.
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