# EDGAR Filing Document

**Accession Number:** 0001213809
**File Stem:** 0001437749-23-001640
**Filing Date:** 2023-1
**Character Count:** 11914
**Document Hash:** 80537090652abf17500a98fe58131a53
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-23-001640.hdr.sgml**: 20230124

**ACCESSION NUMBER**: 0001437749-23-001640

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230124

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230124

**DATE AS OF CHANGE**: 20230124

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** DYADIC INTERNATIONAL INC
- **CENTRAL INDEX KEY:** 0001213809
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 450486747
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-32513
- **FILM NUMBER:** 23545938

**BUSINESS ADDRESS:**
- **STREET 1:** 140 INTRACOASTAL POINTE DRIVE
- **STREET 2:** SUITE 404
- **CITY:** JUPITER
- **STATE:** FL
- **ZIP:** 33477
- **BUSINESS PHONE:** 561-743-8333

**MAIL ADDRESS:**
- **STREET 1:** 140 INTRACOASTAL POINTE DRIVE
- **STREET 2:** SUITE 404
- **CITY:** JUPITER
- **STATE:** FL
- **ZIP:** 33477

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CCP WORLDWIDE INC
- **DATE OF NAME CHANGE:** 20030110

dyai20230123_8k.htm

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM **8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the**

**Securities Exchange Act of 1934**

**Date of Report (date of earliest event reported): **<u>January 24, 2023</u>**

**Dyadic International, Inc.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware**<br> (State or other jurisdiction of incorporation or organization) | **000-55264**<br> (Commission File Number) | **45-0486747**<br> (I.R.S. Employer Identification Number) |
| **140 Intracoastal Pointe Drive, Suite 404**<br> **Jupiter, **FL 33477** | **140 Intracoastal Pointe Drive, Suite 404**<br> **Jupiter, **FL 33477** | **140 Intracoastal Pointe Drive, Suite 404**<br> **Jupiter, **FL 33477** |
| (Address of principal executive offices and zip code) | (Address of principal executive offices and zip code) | (Address of principal executive offices and zip code) |
| **(**561**) **743-8333** | **(**561**) **743-8333** | **(**561**) **743-8333** |
| (Registrant's telephone number, including area code) | (Registrant's telephone number, including area code) | (Registrant's telephone number, including area code) |
| **N/A**<br> **(Former Name or Former Address, if Changed Since Last Report)** | **N/A**<br> **(Former Name or Former Address, if Changed Since Last Report)** | **N/A**<br> **(Former Name or Former Address, if Changed Since Last Report)** |

---

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

---

| |
|:---|
| Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). |
| Emerging growth company ☐ |
| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ |

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Securities registered pursuant to Section 12(b) of the Act

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | DYAI | The NASDAQ Stock Market LLC |

---

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**Item 8.01 Other Events**

On January 24, 2023, Dyadic International, Inc. ("Dyadic" or the "Company") issued a press release announcing that it has initiated dosing in its Phase 1 clinical trial to demonstrate clinical safety and antibody response in humans for the DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference, other than the fourth paragraph of the press release.

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| | |
|:---|:---|
| **Item 9.01 Financial Statements and Exhibits** | **Item 9.01 Financial Statements and Exhibits** |
| (d) Exhibits |  |
| The following exhibit is being filed herein: | The following exhibit is being filed herein: |
| **Exhibit**<br> <u>**Number**</u> | <u>**Description**</u> |
| 99.1 | [Press Release Dated January 24, 2023](ex_466666.htm) |
| 104 | Cover page Interactive Data File (embedded within the Inline XBRL document) |

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**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 24, 2023

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| | |
|:---|:---|
| **Dyadic International, Inc.** | **Dyadic International, Inc.** |
| **By:** | /s/ Mark A. Emalfarb |
| **Name:** | Mark A. Emalfarb |
| **Title:** | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![image01.jpg](image01.jpg)

**Dyadic Announces Initiation of Dosing of First-In-Human Phase 1 Trial to Demonstrate Clinical Safety and Antibody Response in Humans** **for DYAI-100 COVID-19 Recombinant Protein RBD Booster Vaccine Candidate**

**JUPITER, FL / January 24, 2023,** Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms today announced that, in line with the timing announced during management's Q3 earnings call, it has initiated dosing in its Phase 1 clinical trial to demonstrate clinical safety and antibody response in humans for the DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate.

The Phase 1 randomized, double blind, placebo-controlled trial is designed as a first-in-human trial to assess the clinical safety and antibody response of DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine, produced using the C1 platform, administered as a booster vaccine at two single dose levels in healthy volunteers. Following the regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) in late 2022, site preparations and patient recruitment was commenced in South Africa for initiation of the Phase 1 clinical trial and the first dosing for eligible patients began during the week of January 9th.

The trial will include healthy patients ages 18-55 in a randomization scheme of 4:1 with 15 subjects per cohort. Following the screening period there are 8 scheduled clinic visits with the first 6 visits occurring within the first 29 days and two follow up visits on Days 90 and 180. Safety data will be collected throughout the trial and immunogenicity assessments are scheduled on patient visits 1, 4, 5, 6 and the two follow up visits on Days 90 and 180. Dosing for the trial is expected to be completed within the first quarter of 2023, with a full study report being available later this year.

"Dyadic and our South African partner, Rubic One Health, are very pleased that dosing has begun for the DYAI-100 COVID-19 booster vaccine candidate," commented Mark Emalfarb, President and Chief Executive Officer of Dyadic. "With the initiation of the Phase 1 clinical trial, this is the first time a vaccine or treatment manufactured from our C1 protein production platform is being tested in humans. Importantly, this study is expected to demonstrate clinical safety and antibody response in humans to help further combat the COVID-19 pandemic. The results from this first in human clinical trial are expected to accelerate the adoption of the C-1 protein production platform for both vaccine and therapeutic candidates. We continue to believe that the use of our industrially proven, highly productive C1 protein production platform to manufacture the recombinant protein antigen used in DYAI-100 represents a novel, highly efficient and economical approach to rapidly manufacture large quantities of vaccines," Mr. Emalfarb concluded.

**About Dyadic International, Inc.** 

Dyadic International, Inc. is a global biotechnology company committed to building innovative 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 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 Dapibus<sup>TM</sup> 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 https://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

Phone: (561) 743-8333

Email:<u> </u><u>ir@dyadic.com</u>