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JUPITER, Fla., Nov. 10, 2022 (GLOBE 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 production and unmet clinical needs for effective and affordable biopharmaceutical products for human and animal health, today announced its financial results for the third quarter of 2022, and highlighted recent company developments.
“The approval of our first-in-human clinical trial application with the South African Health Products Regulatory Authority (SAHPRA) to initiate a Phase 1 clinical trial is a significant milestone for Dyadic which further supports the C1-cell protein production platform as a potentially transformational technology for use in developing and manufacturing biopharmaceuticals,” said Mark Emalfarb, President and Chief Executive Officer of Dyadic. “In addition to establishing a safety record with regulatory agencies for proteins produced from C1-cells we continually strive to improve productivity and quality and, in some cases efficacy, of those proteins. These efforts led to several scientific breakthroughs this quarter, including increased protein expression levels through the application of our new genetic approaches in engineering C1- cells.
“In our Alternative Proteins vertical, our Dapibus ™ microbial cell line continues to gain traction in several areas, including the cultured meat industry where we have initiated efforts in the production of media components to support scale up and commercialization in this rapidly growing market. We signed new and expanded animal health collaborations this quarter with top animal health companies. We are accelerating our efforts in the Animal Health vertical based upon recent positive data we received with a livestock antigen in the vaccine market as well as our success in demonstrating the ability for C1-cells to express ferritin nanoparticle antigens. In the Human Health vertical, we are focusing on the initiation of the Phase 1 clinical trial for DYAI-100 and continued progress on programs with our pharmaceutical partners,” Mr. Emalfarb concluded.
Recent Company Developments
Third Quarter 2022 Financial Results
Cash Position: As of September 30, 2022, cash, cash equivalents, and the carrying value of investment grade securities, including accrued interest were approximately $14.2 million compared to $20.4 million as of December 31, 2021. Based on current plans, the Company expects that its existing cash, cash equivalents, and investment securities will be sufficient to enable it to fund Phase 1 clinical trials of DYAI-100 and its operating expenses into 2024.
Revenue: Research and development revenue and license revenue for the quarter ended September 30, 2022, increased to approximately $880,000 compared to $693,000 for the same period a year ago. Research and development revenue and license revenue for the nine months ended September 30, 2022, increased to approximately $2,187,000 compared to $2,091,000 for the same period a year ago.
Cost of Revenue: Cost of research and development revenue for the quarter ended September 30, 2022, increased to approximately $603,000 compared to $393,000 for the same period a year ago. Cost of research and development revenue for the nine months ended September 30, 2022, decreased to approximately $1,419,000 compared to $1,613,000 for the same period a year ago.
R&D Expenses: Research and development expenses for the quarter ended September 30, 2022, decreased to approximately $744,000 compared to $1,902,000 for the same period a year ago. Research and development expenses for the nine months ended September 30, 2022, decreased to approximately $3,917,000 compared to $5,919,000 for the same period a year ago.
The decrease in research and development expenses was due to the winding down of activities of contract research organization and pharmaceutical quality and regulatory consultants to manage and support the pre-clinical and clinical development as well as a decrease in cGMP manufacturing costs as the Company moves towards its anticipated Phase 1 clinical trial of its DYAI-100 RBD COVID-19 booster vaccine candidate.
G&A Expenses: General and administrative expenses for the quarter ended September 30, 2022, decreased to approximately $1,383,000 compared to $1,693,000 for the same period a year ago. General and administrative expenses for the nine months ended September 30, 2022, decreased to approximately $4,753,000 compared to $4,994,000 for the same period a year ago.
Net Loss: Net loss for the quarter ended September 30, 2022, was approximately $1,809,000 or $(0.06) per share compared to $1,715,000 or $(0.06) per share for the same period a year ago. Net loss for the nine months ended September 30, 2022, was approximately $7,589,000 or $(0.27) per share compared to $8,856,000 or $(0.32) per share for the same period a year ago.
Conference Call Information
Date: Thursday, November 10, 2022
Time: 5:00 p.m. Eastern Time
Dial-in numbers: Toll Free 1-877-407-0784 International 1-202-689-8560
Conference ID: 13731917
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1561607&tp_key=84d3d19ead
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 DYAI-100
DYAI-100, also known as C1-SARS-CoV-2 RBD vaccine, is a novel receptor-binding domain (RBD) recombinant booster vaccine candidate, highly expressed in Dyadic’s proprietary C1-cell protein production platform for the prevention of COVID-19. The C1-SARS-CoV-2 RBD vaccine drug product consists of the SARS-CoV-2 RBD-C-tag adjuvanted with alum Alhydrogel 85® 2%. DYAI-100 is expected to start a Phase 1 clinical trial in South Africa in late 2022 to assess the safety, reactogenicity, and immunogenicity of the C1-SARS-CoV-2 RBD vaccine, administered as a booster, in healthy volunteers.
About C1-cell Protein Production Platform
C1-cell protein production platform is Dyadic’s platform technology, which is based on an industrially proven microorganism (named C1). The C1-cell protein production platform is a robust and versatile thermophilic filamentous fungal expression system for the development and production of biologic products, including enzymes, antigens, antibodies, and other therapeutic proteins. The C1 technology 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.
About Dapibus™ Protein Production Platform
Dapibus™ is Dyadic’s newly developed filamentous fungal based microbial gene expression and protein production platform, which is being further designed and customized to enable the rapid development and large-scale manufacture of low-cost enzymes, proteins, metabolites, and other biologic products for use in non- pharmaceutical applications, such as food, nutrition, and wellness.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company committed to building disruptive microbial platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health.
Dyadic’s lead technology, its C1-cell gene expression and protein production platform, C1 gene expression and protein production platform is based on the highly productive and scalable industrially proven fungus Thermothelomyces heterothallica ( formerly Myceliophthora thermophila). 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 is also developing the Dapibus™ 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 product 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 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 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. Rawson
Chief Financial Officer
561-743-8333
Email: ir@dyadic.com
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended September 30,Nine Months Ended September 30, 2022202120222021Revenues: Research and development revenue$835,480 $692,929 $1,983,636 $2,090,541 License revenue 44,117 — 202,941 — Total revenue 879,597 692,929 2,186,577 2,090,541 Costs and expenses: Costs of research and development revenue 602,847 392,544 1,418,702 1,612,810 Research and development 743,585 1,901,548 3,917,245 5,918,888 General and administrative 1,383,433 1,692,837 4,753,162 4,994,458 Foreign currency exchange loss, net 13,205 30,002 23,578 76,080 Total costs and expenses 2,743,070 4,016,931 10,112,687 12,602,236 Loss from operations (1,863,473) (3,324,002) (7,926,110) (10,511,695) Other income: Interest income 54,300 3,202 87,277 49,772 Other income — 1,605,532 250,000 1,605,532 Total other income 54,300 1,608,734 337,277 1,655,304 Net loss$(1,809,173)$(1,715,268)$(7,588,833)$(8,856,391) Basic and diluted net loss per common share$(0.06)$(0.06)$(0.27)$(0.32) Basic and diluted weighted-average common shares outstanding 28,391,894 28,079,157 28,302,332 27,754,597
See Notes to Consolidated Financial Statements in Item 1 of Dyadic’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2022.
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS September 30, 2022 December 31, 2021
(Unaudited) (Audited)Assets Current assets: Cash and cash equivalents$ 6,739,117 $ 15,748,480 Short-term investment securities 7,461,884 4,511,780 Interest receivable 43,873 94,375 Accounts receivable 235,368 277,831 Prepaid expenses and other current assets 448,208 375,830 Total current assets 14,928,450 21,008,296 Non-current assets: Investment in Alphazyme 284,709 284,709 Other assets 6,003 6,117 Total assets$ 15,219,162 $ 21,299,122 Liabilities and stockholders’ equity Current liabilities: Accounts payable$ 777,238 $ 1,547,953 Accrued expenses 987,891 709,560 Deferred research and development obligations 445,044 151,147 Deferred license revenue, current portion 176,471 147,059 Total current liabilities 2,386,644 2,555,719 Deferred license revenue, net of current portion 220,588 352,941 Total liabilities 2,607,232 2,908,660 Commitments and contingencies (Note 4) Stockholders’ equity: Preferred stock, $.0001 par value: Authorized shares - 5,000,000; none issued and outstanding — — Common stock, $.001 par value: Authorized shares - 100,000,000; issued shares - 40,716,602 and 40,482,659, outstanding shares - 28,463,100 and 28,229,157 as of September 30, 2022, and December 31, 2021, respectively 40,717 40,483 Additional paid-in capital 102,836,563 101,026,496 Treasury stock, shares held at cost - 12,253,502 (18,929,915) (18,929,915)Accumulated deficit (71,335,435) (63,746,602)Total stockholders’ equity 12,611,930 18,390,462 Total liabilities and stockholders’ equity$ 15,219,162 $ 21,299,122
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 10, 2022.