Exhibit 99.1
Dyadic Announces Third Quarter 2023 Financial Results and Highlights Recent Company Progress
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Received an upfront payment of $0.6 million in October for product development and licensing of our Dapibus™ platform for animal-free dairy enzyme products |
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DYAI-100 Phase 1 clinical trial top-line results expected in December 2023 |
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New research collaboration with Vaccine and Immunotherapy Center at Massachusetts General Hospital as part of US $5.88 million awards from the Department of Defense (“DoD”) |
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New development and commercialization agreement with bYoRNA to develop cost-effective messenger RNA (mRNA) |
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Ongoing preclinical animal studies showing positive results with high neutralizing antibody levels for seasonal and pandemic flu and other infectious diseases |
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Expanded leadership team to support increased business development activities |
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Entered multiple new research collaborations and product development agreements |
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Advanced pharmaceutical and non-pharmaceutical product pipeline, including animal-free recombinant serum albumin and other cell culture proteins and enzymes |
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Cash and investment grade securities of $8.2 million as of September 30, 2023 |
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Financial results and business update conference call scheduled for 5:00 pm ET today |
JUPITER, FL / November 8, 2023, (GLOBAL NEWSWIRE) Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), 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, today announced its financial results for the third quarter of 2023, and highlighted recent company developments.
“Dyadic’s business strategy to focus on near term applications for our proprietary and patented C1 and Dapibus™ protein production platforms and pipeline product opportunities is showing significant increased interest and inbound new projects”, said Mr. Mark Emalfarb, President and CEO of Dyadic. “Launching our Dapibus™ platform for non-pharmaceutical applications less than 10 months ago, we have already signed a number of agreements, including with Fermbox Bio in the second quarter and with an enzyme development company in the third quarter where in October we received $600,000 for the development and commercialization of select animal-free recombinant products. The progress we have made with our recombinant serum albumin product pipeline demonstrates our continued focus on products with near-term commercial potential, shorter development timelines and lower production costs. We have developed stable cell lines for the production of recombinant serum albumin at high productivity levels that in initial testing has shown analytical comparability to reference standard samples of currently marketed products. These products, and other projects in development align with our strategy to improve our revenue outlook while we continue to increase the adoption of C1 for the higher margin applications of human preventative and therapeutic biological vaccines and drugs to combat infectious and other diseases.”
Mr. Emalfarb continued, “We are continuing to engage with large pharmaceutical and biotech companies, academic institutions, and governmental agencies, and other commercial organizations. We are very pleased to see increased interest in our proprietary and patented C1-cell protein production platform to develop vaccines and drugs, such as monoclonal antibodies for commercialization. Examples of this include the funded research and development project with a top 5 pharmaceutical company to express a vaccine antigen from C1 for human health in a large infectious disease segment, as well as our collaboration with the Vaccine and Immunotherapy Center at Massachusetts General Hospital as part of US $5.88 Million Department of Defense grant.”
“We are continuing our pursuit of additional vaccine and drug development opportunities. We believe the safety data being generated in our DYAI-100 phase 1 clinical trial, coupled with our non-human primate study, are pivotal points in the Company’s evolution from a commercial success in industrial biotech to realizing our capability as a life-science biotechnology company,” concluded Mr. Emalfarb.
Exhibit 99.1
Recent Company Progress
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DYAI-100 SARS-CoV-2 RBD (Receptor Binding Domain) Booster Vaccine Candidate |
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Phase 1 clinical trial, last patient last visit occurred in September, data lock achieved on November 1, 2023 and top-line results are expected in December 2023 with full study report to follow. |
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No major vaccine-related safety concerns for both low and high dose groups reviewed by the Data Safety Monitoring Board (DSMB). |
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To date, no serious adverse events or adverse events of special interest have been observed. |
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Interim phase 1 clinical trial safety results are helping to accelerate the adoption of our C1 protein production platform in use for manufacturing human vaccines. |
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VIC at Massachusetts General Hospital – On October 25, 2023, the Company announced that it has entered into a new research collaboration with Vaccine and Immunotherapy Center (“VIC”) at Massachusetts General Hospital to express vaccine antigens for influenza A and other infectious diseases, as part of US $5.88 million awards from the Department of Defense (“DoD”). |
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bYoRNA SAS (“bYoRNA”) – On September 26, 2023, the Company entered into a development and commercialization agreement with bYoRNA combining bYoRNA’s novel eukaryotic “bio” RNA platform with Dyadic’s industrially proven C1 protein production platform to provide the pharmaceutical industry with a potentially more cost-efficient platform for manufacturing large quantities of lower cost mRNA, enabling access to mRNA vaccines and drugs to a broader global population. |
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Animal-free Dairy Enzymes – On September 18, 2023, the Company signed a development and license agreement to develop and commercialize certain non-animal dairy enzymes used in the production of food products using Dapibus™. In October 2023, the Company received an upfront payment of $0.6 million for product development. Dyadic is also eligible to receive certain potential success fees, milestones, and royalties. |
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New Fully Funded Collaborations - In the third quarter, the Company entered into a number of new fully funded research collaborations in the follow areas: |
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Development of an enzyme for dispersion and absorption of injected drugs to reduce tissue damage; |
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Development and commercialization agreement with a multinational pharmaceutical company to develop multiple C1 cell lines to produce monoclonal antibodies targeting infectious diseases; |
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Development of a C1 cell line for a monoclonal antibody against Filoviruses such as Ebola and Marburg. |
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Multiple Preclinical Animal Studies |
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C1 expressed adjuvanted ferritin nanoparticle H5N1 antigen targeting pandemic influenza (H5N1/Bird Flu) showed high neutralizing antibody and hemagglutinin inhibition (HI) levels. |
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C1 expressed adjuvanted MHCII H1N1 antigen targeting seasonal influenza showed high neutralizing antibody levels. |
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C1 expressed adjuvanted Full Spike SARS-CoV-2 antigen showed high neutralizing antibody levels after single dose. |
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On-going Research and Development Collaborations |
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The Company signed MoUs with Essential Drugs Company Limited (EDCL) in Bangladesh and Fondazione Biotecnopolo di Siena (“FBS”) in Italy and are currently negotiating for formal contracts. |
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The Company continues to develop C1 expressed vaccine antigens for human health in a large infectious disease segment with a Top 5 pharmaceutical company, and other research collaborations with Uvax Bio and Virovax Bio. |
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The Company has on-going collaborations with Phibro animal health/Abic Biological Laboratories, Rubic One Health and entered a fully funded research and development project with a new animal health company for livestock animals. |
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The Company is continuing its development of innovative animal free alternative proteins, including cellulosic enzymes for renewable biofuels with Fermbox Bio and pulp and paper processing. |
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Advancement of Pharmaceutical and Non-pharmaceutical Product Pipeline |
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The Company is making progress in developing animal-free recombinant serum albumin with initial positive analytical results towards commercialization and prospective licensing opportunities. |
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The Company is continuing its development cell culture media and other proteins and enzymes for multiple applications. |
Corporate Development
The Company expanded its leadership team and appointed Doug Pace as its Executive Vice President for Business Development to support its increased business development activities and accelerated timeline.
Exhibit 99.1
Financial Highlights
Cash Position: As of September 30, 2023, cash, cash equivalents, and the carrying value of investment grade securities, including accrued interest, were approximately $8.2 million compared to $12.7 million as of December 31, 2022.
Revenue: Research and development revenue and license revenue for the three months ended September 30, 2023, decreased to approximately $397,000 compared to $880,000 for the same period a year ago. The decrease in research and development revenue was due to several research projects winding down or on hold as a result of a laboratory relocation at a major contract research organization. Research and development revenue and license revenue for the nine months ended September 30, 2023, slightly increased to approximately $2,212,000 compared to $2,187,000 for the same period a year ago.
Cost of Revenue: Cost of research and development revenue for the three months ended September 30, 2023, decreased to approximately $106,000 compared to $603,000 for the same period a year ago. The decrease in cost of research and development revenue was due to several research projects winding down or on hold as a result of a laboratory relocation at a major contract research organization. Cost of research and development revenue for the nine months ended September 30, 2023, increased to approximately $1,626,000 compared to $1,419,000 for the same period a year ago.
R&D Expenses: Research and development expenses for the three months ended September 30, 2023, decreased to approximately $716,000 compared to $744,000 for the same period a year ago. Research and development expenses for the nine months ended September 30, 2023, decreased to approximately $2,444,000 compared to $3,917,000 for the same period a year ago. The decrease primarily reflected the winding down of activities related to the Company’s Phase 1 clinical trial of DYAI-100 COVID-19 vaccine candidate as patient dosing was completed in February 2023.
G&A Expenses: General and administrative expenses for the three months ended September 30, 2023, decreased by 7.3% to approximately $1,282,000 compared to $1,383,000 for the same period a year ago. The decrease principally reflected decreases in business development and investor relations expenses of approximately $55,000, insurance expenses of $41,000, and legal expenses of $27,000, offset by other increases of $22,000.
General and administrative expenses for the nine months ended September 30, 2023, decreased by 12.4% to approximately $4,165,000 compared to $4,753,000 for the same period a year ago. The decrease principally reflected decreases in business development and investor relations expenses of approximately $192,000, accrued expenses related to management incentives of $172,000, insurance expenses of $113,000, legal expenses of $75,000 and other decreases of $36,000.
Net Loss: Net loss for the three months ended September 30, 2023, was approximately $1,614,000 or $(0.06) per share compared to $1,809,000 or $(0.06) per share for the same period a year ago. Net loss for the nine months ended September 30, 2023, was approximately $4,724,000 or $(0.16) per share compared to $7,589,000 or $(0.27) per share for the same period a year ago.
Exhibit 99.1
Conference Call Information
Date: Wednesday. November 08, 2023
Time: 5:00 p.m. Eastern Time
Dial-in numbers: Toll Free: 844-826-3033; International +1-412-317-5185
Conference ID: 10183803
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1593556&tp_key=ec162fd8d6
Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer Phone: (561) 743-8333
Email: ir@dyadic.com
Exhibit 99.1
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2023 |
2022 |
2023 |
2022 |
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Revenues: |
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Research and development revenue |
$ | 352,942 | $ | 835,480 | $ | 2,079,918 | $ | 1,983,636 | ||||
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License revenue |
44,118 | 44,117 | 132,353 | 202,941 | ||||||||
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Total revenue |
397,060 | 879,597 | 2,212,271 | 2,186,577 | ||||||||
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Costs and expenses: |
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Costs of research and development revenue |
105,869 | 602,847 | 1,625,731 | 1,418,702 | ||||||||
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Research and development |
716,351 | 743,585 | 2,444,469 | 3,917,245 | ||||||||
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General and administrative |
1,282,361 | 1,383,433 | 4,164,970 | 4,753,162 | ||||||||
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Foreign currency exchange loss |
12,600 | 13,205 | 38,143 | 23,578 | ||||||||
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Total costs and expenses |
2,117,181 | 2,743,070 | 8,273,313 | 10,112,687 | ||||||||
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Loss from operations |
(1,720,121 | ) | (1,863,473 | ) | (6,061,042 | ) | (7,926,110 | ) | ||||
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Other income: |
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Interest income |
105,862 | 54,300 | 319,787 | 87,277 | ||||||||
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Other income |
— | — | 1,017,592 | 250,000 | ||||||||
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Total other income |
105,862 | 54,300 | 1,337,379 | 337,277 | ||||||||
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Net loss |
$ | (1,614,259 | ) | $ | (1,809,173 | ) | $ | (4,723,663 | ) | $ | (7,588,833 | ) |
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Basic and diluted net loss per common share |
$ | (0.06 | ) | $ | (0.06 | ) | $ | (0.16 | ) | $ | (0.27 | ) |
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Basic and diluted weighted-average common shares outstanding |
28,811,061 | 28,391,894 | 28,794,712 | 28,302,332 | ||||||||
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 November 8, 2023.
Exhibit 99.1
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
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September 30, 2023 |
December 31, 2022 |
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(Unaudited) |
(Audited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 7,403,176 | $ | 5,794,272 | ||||
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Short-term investment securities |
772,804 | 6,847,270 | ||||||
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Interest receivable |
9,822 | 58,285 | ||||||
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Accounts receivable |
417,878 | 330,001 | ||||||
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Prepaid expenses and other current assets |
484,188 | 392,236 | ||||||
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Total current assets |
9,087,868 | 13,422,064 | ||||||
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Non-current assets: |
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Operating lease right-of-use asset, net |
153,112 | — | ||||||
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Investment in Alphazyme |
— | 284,709 | ||||||
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Other assets |
14,586 | 6,045 | ||||||
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Total assets |
$ | 9,255,566 | $ | 13,712,818 | ||||
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
$ | 600,148 | $ | 1,276,313 | ||||
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Accrued expenses |
620,242 | 955,081 | ||||||
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Deferred research and development obligations |
13,897 | 40,743 | ||||||
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Deferred license revenue, current portion |
176,471 | 176,471 | ||||||
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Operating lease liability, current portion |
46,599 | — | ||||||
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Total current liabilities |
1,457,357 | 2,448,608 | ||||||
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Deferred license revenue, net of current portion |
44,118 | 176,471 | ||||||
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Operating lease liability, net of current portion |
101,567 | — | ||||||
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Total liabilities |
1,603,042 | 2,625,079 | ||||||
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Commitments and contingencies (Note 4) |
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Stockholders’ equity: |
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Preferred stock, $.0001 par value: |
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Authorized shares - 5,000,000; none issued and outstanding |
— | — | ||||||
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Common stock, $.001 par value: |
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Authorized shares - 100,000,000; issued shares - 41,064,563 and 40,816,602, outstanding shares - 28,811,061 and 28,563,100 as of September 30, 2023, and December 31, 2022, respectively |
41,065 | 40,817 | ||||||
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Additional paid-in capital |
104,746,897 | 103,458,697 | ||||||
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Treasury stock, shares held at cost - 12,253,502 |
(18,929,915 | ) | (18,929,915 | ) | ||||
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Accumulated deficit |
(78,205,523 | ) | (73,481,860 | ) | ||||
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Total stockholders’ equity |
7,652,524 | 11,087,739 | ||||||
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Total liabilities and stockholders’ equity |
$ | 9,255,566 | $ | 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 November 8, 2023.