UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2025
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number: 001-32513
DYADIC INTERNATIONAL, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
45-0486747
State
or Other Jurisdiction of
Incorporation or Organization
I.R.S.
Employer
Identification No.
1044
North U.S. Highway One , Suite 201
Jupiter , Florida
33477
Address
of Principal Executive Offices
Zip
Code
(561)
743-8333
Registrant’s
Telephone Number, Including Area Code
N/A
Former
Name, Former Address and Former Fiscal Year, if Changed Since Last Report
Securities
registered pursuant to Section 12(b) of the Act:
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
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The
number of shares outstanding of the registrant’s Common Stock as of August 12, 2025 was 36,187,798 .
TABLE
OF CONTENTS
Page
PART I FINANCIAL INFORMATION
3
Item
1.
Financial Statements
3
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item
3.
Quantitative and Qualitative Disclosures about Market Risk
30
Item
4.
Controls and Procedures
30
PART II OTHER INFORMATION
Item
1.
Legal Proceedings
31
Item
1A.
Risk Factors
31
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
31
Item
3.
Defaults Upon Senior Securities
31
Item
4.
Mine Safety Disclosures
31
Item
5.
Other Information
31
Item
6.
Exhibits
32
Signatures
33
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
quarterly report on Form 10-Q (“Quarterly Report”) contains forward-looking statements within the meaning of the federal
securities laws, particularly under Item 2 “Management’s Discussion and Analysis.” All statements other than statements
of historical fact are forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding
industry prospects, future business, future results of operations or financial condition, future liquidity and capital resources, our
ability to implement our agreements with third parties, management strategies, and our competitive position. Forward-looking statements
generally can be identified by use of the words “expect,” “should,” “intend,” “anticipate,”
“will,” “project,” “may,” “might,” “potential,” or “continue”
and other similar terms or variations of them or similar terminology. Dyadic International, Inc., and its subsidiaries caution readers
that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those
contained in the forward-looking information. Such statements reflect the current views of our management with respect to our operations,
results of operations and future financial performance.
Forward-looking
statements involve many risks, uncertainties, or other factors beyond Dyadic’s control. These factors include, but are not limited
to (i) our history of net losses; (ii) market and regulatory acceptance of our microbial protein production platforms and other
technologies; (iii) failure to commercialize our microbial protein production platforms or our other technologies; (iv) competition,
including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) our capital needs;
(vii) changes in global economic and financial conditions; (viii) our reliance on information technology; (ix) our dependence
on third parties; (x) government regulations and environmental, social and governance issues; (x) intellectual property risks;
(xi) our ability to comply with the listing standards of the Nasdaq Stock Market LLC; and (xii) other factors discussed in Dyadic’s
publicly available filings, including information set forth under the caption “Risk Factors” in this Quarterly Report and
in our annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 26, 2025 (the “Annual
Report”). We caution you that the foregoing list of important factors is not exclusive. Any forward-looking statements are based
on our beliefs, assumptions, and expectations of future performance, considering the information currently available to us. Before investing
in our common stock, investors should carefully read the information set forth under the caption “Risk Factors” and elsewhere
in this Quarterly Report, in our Annual Report and in our other SEC filings, which could have a material effect on our business, results
of operations and financial condition. The forward-looking statements contained in this Quarterly Report are made only as of the date
hereof, and except as required by law, we undertake no obligation to publicly update any forward-looking statements for any reason after
the date of this Quarterly Report to conform these statements to actual results or to changes in our expectations.
2
PART
I
Item
1. Financial
Statements
DYADIC
INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
June 30, 2025
December 31, 2024
(Unaudited)
(Audited)
Assets
Current assets:
Cash and cash equivalents
$ 2,140,899
$ 6,506,750
Short-term investment securities
2,842,419
2,756,577
Restricted cash and cash equivalents, current
1,588,384
—
Interest receivable
34,736
24,248
Accounts receivable
715,317
237,027
Prepaid expenses and other current assets
84,984
303,066
Total current assets
7,406,739
9,827,668
Non-current assets:
Long-term investment securities
409,670
—
Restricted cash and cash equivalents, noncurrent
245,147
—
Operating lease right-of-use asset, net
65,961
92,211
Other assets
10,529
10,396
Total assets
$ 8,138,046
$ 9,930,275
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$ 738,794
$ 482,320
Accrued expenses
929,850
970,462
Deferred research and development obligations
1,833,531
833,813
Operating lease liability, current portion
57,577
54,249
Accrued interest
80,000
80,000
Accrued interest- related party
21,800
27,173
Total current liabilities
3,661,552
2,448,017
Non-current liabilities:
Convertible notes, net of issuance costs
3,930,170
3,911,471
Convertible notes, net of issuance costs - related party
1,070,971
1,065,876
Operating lease liability, net of current portion
5,054
34,621
Total liabilities
8,667,747
7,459,985
Commitments and contingencies (Note 5)
-
-
Stockholders’ equity:
Preferred stock, $ .0001 par value:
Authorized shares - 5,000,000 ; none issued and outstanding
—
—
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 - 42,389,300 and 42,089,301 , outstanding shares - 30,135,798 and 29,835,799 as of June 30, 2025, and December 31, 2024, respectively
42,390
42,090
Common stock, $.001 par value:
Authorized shares - 100,000,000; issued shares - 42,389,300 and 42,089,301, outstanding shares - 30,135,798 and 29,835,799 as of June 30, 2025, and December 31, 2024, respectively
42,390
42,090
Additional paid-in capital
108,265,657
107,444,595
Treasury stock, shares held at cost - 12,253,502
( 18,929,915 )
( 18,929,915 )
Accumulated deficit
( 89,907,833 )
( 86,086,480 )
Total stockholders’ equity
( 529,701 )
2,470,290
Total liabilities and stockholders’ equity
$ 8,138,046
$ 9,930,275
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
3
DYADIC
INTERNATIONAL, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2025
2024
2025
2024
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Revenues:
Research and development revenue
$ 213,449
$ 385,896
$ 396,549
$ 720,513
Grant revenue
503,181
—
713,653
—
License and milestone revenue
250,000
—
250,000
—
Total revenue
966,630
385,896
1,360,202
720,513
Costs and expenses:
Costs of research and development revenue
148,457
301,956
274,937
445,911
Costs of grant revenue
465,134
—
636,312
—
Research and development
629,379
515,629
1,124,358
1,038,352
General and administrative
1,436,630
1,607,756
3,032,968
3,396,350
Foreign currency exchange loss
16,098
3,146
23,170
8,049
Total costs and expenses
2,695,698
2,428,487
5,091,745
4,888,662
Loss from operations
( 1,729,068 )
( 2,042,591 )
( 3,731,543 )
( 4,168,149 )
Other income (expense):
Interest income
49,127
138,471
137,585
225,914
Gain on sale of Alphazyme
—
—
—
60,977
Interest expense
( 89,456 )
( 88,634 )
( 178,699 )
( 110,273 )
Interest expense - related party
( 24,377 )
( 52,469 )
( 48,696 )
( 63,288 )
Interest expense
( 24,377 )
( 52,469 )
( 48,696 )
( 63,288 )
Total other income (expense), net
( 64,706 )
( 2,632 )
( 89,810 )
113,330
Net loss
$ ( 1,793,774 )
$ ( 2,045,223 )
$ ( 3,821,353 )
$ ( 4,054,819 )
Basic and diluted net loss per common share
$ ( 0.06 )
$ ( 0.07 )
$ ( 0.13 )
$ ( 0.14 )
Basic and diluted weighted-average common shares outstanding
30,102,324
29,291,259
30,071,285
29,085,696
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
4
DYADIC
INTERNATIONAL, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF STOCKHOLDERS ’ EQUITY
(Unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Six Months Ended June 30, 2025
Common Stock
Treasury Stock
Additional Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
January 1, 2025
42,089,301
$ 42,090
( 12,253,502 )
$ ( 18,929,915 )
$ 107,444,595
$ ( 86,086,480 )
$ 2,470,290
Stock-based compensation expense
—
—
—
—
225,030
—
225,030
Issuance of common stock upon vesting of restricted stock units
250,964
251
—
—
231,370
—
231,621
Issuance of common stock upon exercise of stock options
27,483
27
—
—
24,222
—
24,249
Net loss
—
—
—
—
—
( 2,027,579 )
( 2,027,579 )
March 31, 2025
42,367,748
$ 42,368
( 12,253,502 )
$ ( 18,929,915 )
$ 107,925,217
$ ( 88,114,059 )
$ 923,611
Stock-based compensation expense
—
—
—
—
340,462
—
340,462
Issuance of common stock upon vesting of restricted stock units
21,552
22
—
—
( 22 )
—
—
Net loss
—
—
—
—
—
( 1,793,774 )
( 1,793,774 )
June 30, 2025
42,389,300
$ 42,390
( 12,253,502 )
$ ( 18,929,915 )
$ 108,265,657
$ ( 89,907,833 )
$ ( 529,701 )
Six Months Ended June 30, 2024
Common Stock
Treasury Stock
Additional Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
January 1, 2024
41,064,563
$ 41,065
( 12,253,502 )
$ ( 18,929,915 )
$ 105,044,756
$ ( 80,277,321 )
$ 5,878,585
Stock-based compensation expense
—
—
—
—
306,478
—
306,478
Issuance of common stock upon vesting of restricted stock units
375,753
376
—
—
339,959
—
340,335
Net loss
—
—
—
—
—
( 2,009,596 )
( 2,009,596 )
March 31, 2024
41,440,316
$ 41,441
( 12,253,502 )
$ ( 18,929,915 )
$ 105,691,193
$ ( 82,286,917 )
$ 4,515,802
Balance
41,440,316
$ 41,441
( 12,253,502 )
$ ( 18,929,915 )
$ 105,691,193
$ ( 82,286,917 )
$ 4,515,802
Stock-based compensation expense
—
—
—
—
297,603
—
297,603
Issuance of common stock upon vesting of restricted stock units
61,793
62
—
—
( 62 )
—
—
Issuance of common stock upon exercise of stock options
5,569
6
—
—
( 6 )
—
—
Issuance of common stock upon settlement of convertible debt
223,463
223
—
—
399,777
—
400,000
Net loss
—
—
—
—
—
( 2,045,223 )
( 2,045,223 )
June 30, 2024
41,731,141
$ 41,732
( 12,253,502 )
$ ( 18,929,915 )
$ 106,388,505
$ ( 84,332,140 )
$ 3,168,182
Balance
41,731,141
$ 41,732
( 12,253,502 )
$ ( 18,929,915 )
$ 106,388,505
$ ( 84,332,140 )
$ 3,168,182
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
5
DYADIC
INTERNATIONAL, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2025
2024
Six Months Ended June 30,
2025
2024
Cash flows from operating activities
Net loss
$ ( 3,821,353 )
$ ( 4,054,819 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
565,492
604,081
Amortization of held-to-maturity securities, net
( 15,996 )
( 27,699 )
Amortization of debt issuance costs
23,794
26,717
Gain from the sale of investment in Alphazyme
—
( 60,977 )
Foreign currency exchange loss (gain), net
23,170
8,049
Changes in operating assets and liabilities:
Interest receivable
( 10,488 )
( 18,077 )
Accounts receivable
( 471,860 )
210,725
Prepaid expenses and other current assets
218,050
201,073
Operating lease assets and liabilities
11
870
Accounts payable
224,080
( 224,307 )
Accrued expenses
191,009
152,800
Accrued interest
—
80,000
Accrued interest - related party
( 5,373 )
32,000
Deferred research and development obligation
999,718
( 7,790 )
Net cash used in operating activities
( 2,079,746 )
( 3,077,354 )
Cash flows from investing activities
Purchases of held-to-maturity investment securities
( 4,560,278 )
( 4,734,528 )
Proceeds from maturities of investment securities
4,080,762
1,546,000
Proceeds from the sale of investment in Alphazyme
—
60,977
Net cash used in investing activities
( 479,516 )
( 3,127,551 )
Cash flows from financing activities
Proceeds from exercise of stock
24,249
—
Proceeds from issuance of convertible notes, net of issuance costs
—
3,882,884
Proceeds from issuance of convertible notes, net of issuance costs - related party
—
1,941,442
Net cash provided by financing activities
24,249
5,824,326
Effect of exchange rate changes on cash
2,693
( 1,051 )
Net decrease in cash, cash equivalents, and restricted cash and cash equivalents
( 2,532,320 )
( 381,630 )
Cash, cash equivalents, and restricted cash and cash equivalents at beginning of period
6,506,750
6,515,028
Cash, cash equivalents, and restricted cash and cash equivalents at end of period
$ 3,974,430
$ 6,133,398
Reconciliation of cash, cash equivalents, and restricted cash and cash equivalents to the consolidated balance sheets
Cash and cash equivalents
$ 2,140,899
$ 6,133,398
Restricted cash and cash equivalents, current
1,588,384
—
Restricted cash and cash equivalents, noncurrent
245,147
—
Total cash, cash equivalents, and restricted cash and cash equivalents
$ 3,974,430
$ 6,133,398
Supplemental cash flow information
Vesting of restricted stock units
$ 269,100
$ 439,085
Conversion of convertible notes
$ —
$ 400,000
Cash paid for interest
$ 208,973
$ 34,844
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
6
Notes
to Consolidated Financial Statements
Note
1: Organization and Summary of Significant Accounting Policies
Description
of Business
Dyadic
International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) is a
global biotechnology platform company headquartered in Jupiter, Florida, with operations in the U.S. and the Netherlands. We aim to develop
and commercialize scalable, non-animal protein production platforms to meet growing global demand across the life sciences, food and
nutrition, and bio-industrial markets.
Our
proprietary platforms—Dapibus™ and C1—are designed for rapid, cost-effective, and flexible production of high-value
proteins, enabling partners to reduce development timelines and manufacturing costs. While Dyadic’s primary focus is on non-therapeutic
applications, both platforms retain the capability to produce biologics, such as vaccines and therapeutic proteins, for external partners.
DBA
Name Change Update
Effective on August 1, 2025, we are doing business as Dyadic Applied BioSolutions
(as previously announced on July 2, 2025). This rebranding initiative marks a strategic transition from a research-driven organization
to a commercially focused enterprise. The new name and visual identity better reflect the emphasis on delivering applied biotechnology
solutions through our patented and proprietary C1 and Dapibus™ gene expression platforms.
This
underscores our focus on commercializing high-value, non-therapeutic proteins in the life sciences, food, nutrition and industrial bioprocessing
sectors. These proteins avoid the regulatory complexity and high costs associated with therapeutic biologics, enabling faster time to
revenue, broader market reach, and long-term supply agreements. Our recent significant milestones across both food and nutrition as well
as fully funded legacy collaborations, such as with the Gates Foundation, underscore our strategic shift to revenue-focused bioprocessing
protein platforms from therapeutic and vaccine development.
Liquidity
and Capital Resources
In
accordance with FASB Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements – Going
Concern (“Topic 205-40”), management is required to evaluate whether there are conditions and events, considered in the aggregate
that raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the issuance
date of the Company’s condensed interim financial statements. This evaluation does not take into consideration the potential mitigating
effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the financial
statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its
plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect
of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within
one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate
the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within
one year after the date that the financial statements are issued.
The Company expects to incur losses and have negative net cash flows from
operating activities as it continues developing its C1 and Dapibus TM microbial protein production platforms and related products,
and as it expands its pipelines and engages in further research and development activities for internal products as well as for its third-party
collaborators and licensees. The success of the Company depends on its ability to develop its technologies and products to the point of
regulatory approval, commercialization, and subsequent revenue generation or through the sublicensing of the Company’s technologies
and products, and its ability to raise capital to finance these developmental efforts.
On
March 8, 2024, the Company issued an aggregate principal amount of $ 6.0 million of its 8.0 % Senior Secured Convertible Promissory Notes
due March 8, 2027 (the “Convertible Notes”) in a private placement. The purchasers of the Convertible Notes included immediate
family members and family trusts related to Mark Emalfarb, our President and Chief Executive Officer and a member of our Board of Directors,
including The Francisco Trust, an existing holder of more than 5% of the Company’s outstanding common stock, (collectively, the
“Purchasers”). The net proceeds from the sale of the Convertible Notes, after deducting offering expenses, were $ 5,824,326 .
The Company intends to use the net proceeds from the offering of the Convertible Notes for working capital and general corporate purposes.
The
Convertible Notes are senior, secured obligations of Dyadic and its affiliates, and interest is payable quarterly in cash on the principal
amount equal to 8 % per annum. The Convertible Notes will mature on March 8, 2027 (the “Maturity Date”), unless earlier converted,
repurchased, or redeemed in accordance with the terms of the Convertible Notes. The Convertible Notes can be converted into shares of
Dyadic’s common stock, par value $ 0.001 per share (the “Common Stock”), at the option of the holders of the Convertible Notes (the “Noteholders”)
at any time prior to the Maturity Date.
7
On
October 4, 2024, the Company entered into an amendment (the “Amendment”) to the Convertible Notes. Pursuant to the Amendment,
(i) the conversion price upon which the Convertible Notes will be convertible into shares of the Company’s common stock is $ 1.40
per share of common stock, and (ii) the Redemption Date (as defined in the Amendment) will fall on any of the 26, 29 and 32-month anniversaries
of the original issue date of the Convertible Notes.
During
the year ended December 31, 2024, $ 910,000 of the Convertible Notes were converted into 556,623 shares of Common Stock. For more information
regarding the Convertible Notes, including the covenants related thereto, see Note 4 to the Consolidated Financial Statements.
On May 1, 2025, the Company entered
into a second amendment (the “Second Amendment”) to the Convertible Notes. Pursuant to the Second Amendment, the Redemption
Date (as defined in the Second Amendment) will now fall on December 1, 2026.
The
Convertible Notes contain customary covenants, and the Securities Purchase Agreement relating to the Convertible Notes also contains
certain affirmative and negative covenants (including, without limitation, restrictions on our ability to incur indebtedness, permit
liens, make dividends or certain debt payments or consummate certain affiliate transactions). The Company was in compliance with its
covenants with respect to the Convertible Notes as of June 30, 2025.
On
November 16, 2024, Dyadic entered into an agreement with the Gates Foundation (the “Gates Foundation”, formerly known as the Bill
& Melinda Gates Foundation) relating to a grant in the amount of $ 3,092,136 awarded from the Gates Foundation for the cell line development
of monoclonal antibodies targeting respiratory syncytial virus and malaria utilizing the Company’s C1 platform to provide globally
accessible treatment options for underserved populations (the “Gates Foundation Grant”). Funds received in advance that have
not been spent are recorded as restricted cash and cash equivalents in the Company’s consolidated balance sheets.
On
March 20, 2025, the Company received a funding award from Coalition for Epidemic Preparedness (“CEPI”) to advance Dyadic’s
C1 platform through a $ 4.5 million grant through Fondazione Biotecnopolo di Siena (“FBS”) to accelerate recombinant protein
vaccine development and manufacturing. The funding will support antigen design, cell line development, optimization, characterization,
and scale-up to cGMP manufacturing. If successful, the next phase will focus on selecting a CEPI-priority pathogen antigen. Dyadic,
as a subcontractor, will receive up to $ 2.4 million of the total grant funding.
On
July 30, 2025, the Company entered into an underwriting agreement with Craig-Hallum Capital Group LLC, in its capacity as
underwriter, relating to the issuance and sale (the “Offering”) of 6,052,000 shares
of the Company’s Common Stock. The public offering price in the Offering was $ 0.95 per
share of Common Stock. The closing of the Offering occurred on August 1, 2025. The net proceeds
to the Company from the Offering were approximately $ 5.3 million, after deducting underwriting discounts and commissions and estimated
offering expenses payable by the Company. The Company intends to use the net proceeds of the Offering for working capital and general
corporate purposes, such as product development, sales and marketing.
The Company expects its existing cash, cash equivalents, restricted cash
and cash equivalents and its short term investment securities, totaling approximately $ 6.9 million as of June 30, 2025, together with the capital raised from the
Offering of approximately $ 5.3 million, will be sufficient to meet its operational, business, and other
liquidity requirements for at least the next twelve (12) months from the date of issuance of the financial statements contained in this
Quarterly Report. However, the Company has based this estimate on assumptions that may prove to be wrong, and its operating plan may change
as a result of many factors currently unknown to it. In the event our financing needs are not able to be met by our existing cash, cash
equivalents and investments, we would seek to raise additional capital through strategic financial opportunities that could include, but
are not limited to, future public or private equity offerings, collaboration agreements, convertible notes or other debt instruments,
and/or other means. Any amount raised may be used for the further development and commercialization of product candidates, and for other
working capital purposes. There is no guarantee that any of these strategic or financing opportunities will be executed or realized on
favorable terms, if at all, and some could be dilutive to existing shareholders.
Summary
of Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements, including the accounts of the Company and its wholly owned subsidiaries,
have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) as found in the Accounting Standards
Codification (“ASC”), Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”)
and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting.
Certain information and footnote disclosures normally included in consolidated financial statements have been condensed or omitted pursuant
to such rules and regulations. All significant intra-entity transactions and balances have been eliminated in consolidation. The information
included in this Quarterly Report should be read in conjunction with the audited consolidated financial statements and footnotes as of
and for the year ended December 31, 2024, included in our Annual Report.
8
In
the opinion of management, the accompanying unaudited interim consolidated financial statements reflect all adjustments, which are of
a normal recurring nature, considered necessary for a fair presentation of all periods presented. The results of the Company’s
operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for a
full fiscal year.
Segment
Information
Operating
segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief
operating decision maker, or CODM, in deciding how to allocate resources and in assessing performance. The CODM is the
Company’s senior management team that includes the Chief Executive Officer, President & Chief Operating Officer, and Chief
Financial Officer. The Company views its operations as and manages its business in one operating segment, which is the business of
developing and commercializing recombinant protein products using the Company’s proprietary microbial platforms, including C1
and Dapibus™. Segment information is further described in Note 8 to the consolidated financial statements included in this
Quarterly Report on Form 10-Q.
Use
of Estimates
The
preparation of these consolidated financial statements in accordance with GAAP requires management to make estimates and judgments that
affect the reported amount of assets and liabilities and related disclosure of contingent assets and liabilities at the date of our consolidated
financial statements and the reported amounts of revenues and expenses during the applicable period. Estimates inherent in the preparation
of these consolidated financial statements include, but are not limited to, estimates related to revenue recognition, accrued expenses,
stock-based compensation expense, and income taxes. The Company bases its estimates on historical experience and other market specific
or other relevant assumptions it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates
as there are changes in circumstances, facts, and experience. Actual results may differ from these estimates under different assumptions
or conditions. Such differences could be material to the consolidated financial statements.
Concentrations
and Credit Risk
The
Company’s financial instruments that are potentially subject to concentrations of credit risk consist primarily of cash and cash
equivalents, investment securities, and accounts receivable. At times, the Company has cash, cash equivalents, and investment securities
at financial institutions exceeding the Federal Depository Insurance Company (“FDIC”) and the Securities Investor Protection
Corporation (“SIPC”) insured limit on domestic currency and the Netherlands’ FDIC counterpart for foreign currency.
The Company currently deals with four reputable financial institutions and has not experienced any losses in those accounts.
For
the three months ended June 30, 2025 and 2024, the Company’s revenue was generated from eight
and ten
customers, respectively. For the six months ended June 30,
2025 and 2024, the Company’s revenue was generated from ten
and thirteen
customers, respectively. Significant customers are those that
account for greater than 10% of the Company’s revenues. For the three months ended June 30, 2025 and 2024, three and four significant
customers accounted for $ 794,615
or 58.4 %
and $ 284,594
or 73.7 %
of revenue, respectively. For the six months ended June 30, 2025 and 2024, four and five significant customers accounted for $ 1,101,653
or 80.9 %
and $ 506,379
or 70.3 %
of revenue, respectively.
As of June 30, 2025 and December 31, 2024, accounts receivable was from
seven and nine customers, of which, four and three customers accounted for $ 658,005 or 92.0 % and $ 158,416 or 66.9 % of total accounts receivable,
respectively. The loss of business from one or a combination of the Company’s customers could adversely affect its operations.
The
Company conducts operations in the Netherlands through its foreign subsidiary and generates a portion of its revenues from customers
that are located outside of the United States. For the three months ended June 30, 2025 and 2024, the Company had three and four customers
outside of the United States (i.e., European customers) that accounted for $ 63,560
or 6.6 %
and $ 105,932
or 27.5 %
of revenue, respectively. For the six months ended June 30, 2025 and 2024, the Company had three and seven customers outside of the United
States (i.e., European customers) that accounted for $ 111,893
or 8.2 %
and $ 304,001
or 42.2 %
of revenue, respectively.
As
of June 30, 2025 and December 31, 2024, the Company had three and four customers outside of the United States (i.e., European customers)
that accounted for $ 304,548 or 42.6 % and $ 145,603 or 61.5 % of accounts receivable, respectively.
The
Company uses several contract research organizations (“CROs”) to conduct its research projects. For the three months ended
June 30, 2025 and 2024, two CROs accounted for $ 880,020 or 91.1 % and $ 597,696 or 96.5 % of total research services we purchased, respectively.
For the six months ended June 30, 2025 and 2024, two CROs accounted for $ 1,363,447 or 85.9 % and $ 957,040 or 90.2 % of total research services
we purchased, respectively. As of June 30, 2025 and December 31, 2024, two CROs accounted for $ 638,908 or 86.5 % and $ 284,166 or 58.9 %
of accounts payable, respectively. The loss of one CRO or a combination of the Company’s CROs could adversely affect its operations.
Cash
and Cash Equivalents
We
treat highly liquid investments with original maturities of three months or less when purchased as cash equivalents, including money
market funds, which are unrestricted for withdrawal or use.
Investment
Securities
The
Company’s investment policy requires investment securities to be investment grade and held to maturity with the primary objective
to maintain a high degree of liquidity while maximizing yield. The Company invests excess cash balances in short-term and long-term investment
grade securities. Short-term investment securities mature within twelve (12) months or less, and long-term investment securities mature
over twelve (12) months from the applicable reporting date. Management determines the appropriate classification of each investment at
the time of purchase and reevaluates the classifications at each balance sheet date.
The
Company classifies its investments in debt securities as held-to-maturity. Held-to-maturity securities are those securities that the
Company has the ability and intent to hold until maturity. Held-to-maturity securities are recorded at amortized cost, net of allowance
for credit losses if applicable, and adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are
amortized over the life of the related held-to-maturity security. When a debt security is purchased at a premium, both the face value
of the debt and premium amount are reflected as investing outflow.
When
evaluating an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which
fair value has been below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates,
and whether it is more likely than not the Company will be required to sell the investment before recovery of the investment’s
cost basis. The Company measures expected credit losses on held to maturity debt securities on an individual security basis. The estimate
of expected credit losses considers historical credit information from external sources. The impairment of the investment that is related
to the credit loss, if any, is expensed in the period in which the event or change occurred.
9
The
Company classifies its investments in money market funds as available-for-sale securities and presented as cash equivalents on the consolidated
balance sheets. As of June 30, 2025 and December 31, 2024, all our money market funds were invested in U.S. Government money market funds,
for which the risk of loss is minimal.
As
of June 30, 2025, and December 31, 2024, the Company did not have any investment securities classified as trading.
Restricted
Cash and Cash Equivalents
Restricted cash and
cash equivalents represent amounts subject to restrictions under an agreement with the Gates Foundation. These funds may need to be refunded
and are limited to use as specified in the agreement. The restriction on these funds lapses as the Company fulfills its obligations under
the agreement. Amounts expected to be used within the next twelve (12) months are classified as current.
Accounts
Receivable
Accounts
receivable consist of billed receivables currently due from customers and unbilled receivables. Unbilled receivables represent the excess
of contract revenue (or amounts reimbursable under contracts) over billings to date. Such amounts become billable in accordance with
the contract terms, which usually consider the passage of time, achievement of certain milestones or completion of the project.
Accounts
receivable are stated net of an allowance for credit losses, if deemed necessary based on the Company’s evaluation of collectability
and potential credit losses. Management assesses the collectability of its accounts receivable using the specific identification of account
balances and considers the credit quality and financial condition of its significant customers, historical information regarding credit
losses and the Company’s evaluation of current and expected future economic conditions and changes in our customer collection trends.
If necessary, an allowance for credit losses is recorded against accounts receivable such that the carrying value of accounts receivable
reflects the net amount expected to be collected. Accounts receivable balances are written off against the allowance for credit losses
when the potential for collectability is considered remote. Substantially all of our accounts receivable were current and include unbilled
amounts that will be billed and collected over the next twelve (12) months. Management determined that no allowance for credit losses
was required as of June 30, 2025, and December 31, 2024.
Accounts
receivable consist of the following:
Schedule
of Accounts Receivables
June 30, 2025
December 31, 2024
(Unaudited)
(Audited)
Billed receivable
$ 455,152
$ 173,993
Unbilled receivable
260,165
63,034
Accounts receivable
$ 715,317
$ 237,027
Accounts
Payable
Accounts
payable consist of the following:
Schedule
of Accounts Payable
June 30, 2025
December 31, 2024
(Unaudited)
(Audited)
Research and development expenses
$ 654,571
$ 340,698
Legal expenses
—
68,420
Other
84,223
73,202
Accounts payable
$ 738,794
$ 482,320
Accrued
Expenses
Accrued
expenses consist of the following:
Schedule
of Accrued Expenses
June 30, 2025
December 31, 2024
(Unaudited)
(Audited)
Employee wages and benefits
$ 349,187
$ 496,906
Research and development expenses
452,970
437,196
Legal expenses
110,833
25,000
Other
16,860
11,360
Accrued expenses
$ 929,850
$ 970,462
Deferred
Financing Costs
Deferred
financing costs represent costs incurred in connection with the issuance of debt instruments and equity financings. Deferred financing
costs related to the issuance of debt are amortized over the term of the financing instrument using the effective interest method and
are presented in the consolidated balance sheets as an offset against the related debt. Offering costs from equity financings are netted
against the gross proceeds received from the equity financings. See Note 4 for the amortization amount.
Revenue
Recognition
The
Company has no products approved for sale. All our revenue to date has been research revenue from third-party collaborations and grants, as well as revenue from sublicensing agreements and collaborative arrangements, which may include upfront payments, options to
obtain a license, payment for research and development services, milestone payments and royalties, in the form of cash or non-cash considerations
(e.g., minority equity interest).
Revenue
related to research collaborations and agreements: The Company typically performs research and development services as specified
in each respective agreement on a best-efforts basis, and recognizes revenue from research funding under collaboration agreements in
accordance with the 5-step process outlined in ASC Topic 606 (“Topic 606”): (i) identify the contract(s) with a customer;
(ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) a locate the transaction
price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance
obligation. We recognize revenue when we satisfy a performance obligation by transferring control of the service to a customer in an
amount that reflects the consideration that we expect to receive. Depending on how the performance obligation under our license and collaboration
agreements is satisfied, we recognize the revenue either at a point in time or over time by using the input method under Topic 606 to
measure the progress toward complete satisfaction of a performance obligation.
10
Under
the input method, revenue will be recognized based on the entity’s efforts or inputs to the satisfaction of a performance obligation
(e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction
of that performance obligation. The Company believes that the cost-based input method is the best measure of progress to reflect how
the Company transfers its performance obligation to a customer. In applying the cost-based input method of revenue recognition, the Company
uses actual costs incurred relative to budgeted costs to fulfil the performance obligation. These costs consist primarily of full-time
equivalent effort and third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total
budgeted costs as the Company completes its performance obligations.
A
cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance
obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative
effect of revisions to estimated costs to complete the Company’s performance obligations will be recorded in the period in which
changes are identified, and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a
material impact on the timing and amount of revenue recognized in future periods.
Revenue
related to grants: The Company receives grants from governments, agencies, and other private and not-for-profit organizations. These
grants are intended to be used to partially or fully fund the Company’s research collaborations. However, most, if not all, of
such grant revenues, is expected to be earmarked for third parties to advance the research required, including preclinical and clinical
trials. Revenue related to grants is presented on a gross basis on the Consolidated Statements of Operations.
Revenue
related to sublicensing agreements: If the sublicense to the Company’s intellectual property is determined to be distinct from
the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when technology
is transferred to the customer and the customer can use and benefit from the license.
Customer
options: If the sublicensing agreement includes customer options to purchase additional goods or services, the Company will evaluate
if such options are considered material rights to be deemed as separate performance obligations at the inception of each arrangement.
Milestone
payments : At the inception of each arrangement that includes development, commercialization, and regulatory milestone payments,
the Company evaluates whether the achievement of the milestones is considered probable and estimates the amount to be included in
the transaction price. If the milestone payment is in exchange for a sublicense and is based on the sublicensee’s subsequent
sale of the product, the Company recognizes milestone payment by applying the accounting guidance for royalties.
Royalties:
With respect to licenses deemed to be the predominant item to which the sales-based royalties relate, including milestone payments
based on the level of sales, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance
obligation to which some or a the royalty has been a located has been satisfied (or partially satisfied). To date, the Company has not
recognized any royalty revenue resulting from any of its sublicensing arrangements.
We
invoice customers based on our contractual arrangements with each customer, which may not be consistent with the period that revenues
are recognized. When there is a timing difference between when we invoice customers and when revenues are recognized, we record either
a contract asset (unbilled accounts receivable) or a contract liability (deferred research and development obligations), as appropriate.
If upfront fees or considerations related to a sublicensing agreement are received prior to the technology transfer,
the Company will record the amount received as deferred revenue from the licensing agreement.
Research
and Development Costs
Research
and development (“R&D”) costs are expensed as incurred. R&D costs are for the Company’s internally funded pharmaceutical
programs and other governmental and commercial projects.
Research
and development costs consist of personnel-related costs, facilities, research-related overhead, services from independent contract research
organizations, and other external costs. Research and development costs, including related party, for the three and six months ended
June 30, 2025 and 2024 were as follows:
Schedule
of Research and Development Costs
2025
2024
2025
2024
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Outside contracted services
$ 486,585
$ 395,188
$ 842,841
$ 783,434
Personnel related costs
124,669
106,889
246,385
213,216
Facilities, overhead and other
18,125
13,552
35,132
41,702
Research and development
costs
$ 629,379
$ 515,629
$ 1,124,358
$ 1,038,352
11
Foreign
Currency Transaction Gain or Loss
The
Company and its foreign subsidiary use the U.S. dollar as its functional currency and initially measure the foreign currency denominated
assets and liabilities at the transaction date. Monetary assets and liabilities are then re-measured at exchange rates in effect at the
end of each period, and property and non-monetary assets and liabilities are carried at historical rates.
Fair
Value Measurements
The
Company applies fair value accounting for certain financial instruments that are recognized or disclosed at fair value in the financial
statements. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability
in an orderly transaction between market participants at the measurement date. Fair value is estimated by applying the following hierarchy,
which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the
lowest level of input that is available and significant to the fair value measurement:
● Level
1 – Quoted prices in active markets for identical assets or liabilities.
● Level
2 – Observable inputs other than quoted prices in active markets for identical
assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive
markets, or other inputs that are observable or can be corroborated by observable market
data for substantially the full term of the assets or liabilities.
● Level
3 – Inputs that are generally unobservable and typically reflect management’s
estimate of assumptions that market participants would use in pricing the asset or liability.
The
Company’s financial instruments included cash, cash equivalents,
restricted cash and cash equivalents, investment in debt securities, accounts receivable, accounts
payable and accrued expenses, accrued payroll and related liabilities, deferred research and development obligations, deposits, and the
Company’s 8% Senior Secured Convertible Promissory Notes (the “Convertible Notes”), due March 2027. The carrying amount
of these financial instruments, except for investment in debt securities and Convertible Notes, approximates fair value due to the short-term
maturities of these instruments. The Company’s short-term and long-term investments in debt securities are recorded at amortized
cost, and their estimated fair value amounts are provided by the third-party broker service for disclosure purposes. See Note 4 for additional
information related to the Convertible Notes.
Income
Taxes
For
the six months ended June 30, 2025, there was no provision for income taxes or unrecognized tax benefits recorded. As of June 30, 2025
and December 31, 2024, deferred tax assets were $ 18.8 million and $ 17.6 million, respectively. Due to the Company’s history of
operating losses and the uncertainty regarding our ability to generate taxable income in the future, the Company has established a 100 %
valuation allowance against deferred tax assets as of June 30, 2025 and December 31, 2024.
Stock-Based
Compensation
We
recognize all share-based payments to employees, consultants, and our Board of Directors (the “Board”), as non-cash compensation
expense, in research and development expenses or general and administrative expenses in the consolidated statement of operations based
on the grant date fair values of such payments. Stock-based compensation expense recognized each period is based on the value of the
portion of share-based payment awards that is ultimately expected to vest during the period. Forfeitures are recorded as they occur.
For
performance-based awards, the Company recognizes related stock-based compensation expenses based upon its determination of the potential
likelihood of achievement of the specified performance conditions at each reporting date.
Net
Loss Per Share
Basic
net loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common stock shares
outstanding during the reporting period. Diluted net loss per share adjusts the weighted average number of common stock shares outstanding
for the potential dilution that could occur if common stock equivalents, such as stock options, were exercised and converted into common
stock, calculated by applying the treasury stock method.
For the three and six
months ended June 30, 2025, a total of 6,064,253 shares of potentially dilutive securities, including 64,656 shares of unvested
restricted stock units and options to purchase 5,999,597 shares of common stock, were excluded from the computation of diluted net
loss per share as their effect would have been anti-dilutive. For the three and six months ended June 30, 2024, a total of 5,948,147
shares of potentially dilutive securities, including 117,925 shares of unvested restricted stock units and options to purchase
5,830,22 shares of common stock, were excluded from the computation of diluted net loss per share as their effect would have been
anti-dilutive.
New Accounting Pronouncements as of June 30, 2025
In
December 2023, the FASB issued ASU 2023-09 – Income Taxes (Topic ASC 740) Income Taxes. The ASU improves the transparency of income
tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income
taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures.
The amendments in ASU 2023-09 will become effective for our annual disclosures for the fiscal year ending December
31, 2025. We do not expect that this guidance will have a material impact on our financial position and our results of operations.
In November 2024, the FASB issued ASU 2024-03 – Income Statement
– Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). The guidance enhances the disclosures
about an entity’s expenses by requiring more detailed information about the types of expenses in commonly presented expense captions. This
guidance is effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. We are
currently evaluating the impact of adopting this guidance.
On July 4, 2025, the U.S. government enacted the One Big Beautiful Bill
Act (“OBBBA”) of 2025 which includes, among other provisions, changes to the U.S. corporate income tax system, including
the allowance of 100% expensing of qualified asset expenditures, immediate expensing of qualifying domestic research and development expenses
and permanent extensions of certain other provisions within the Tax Cuts and Jobs Act. Certain provisions are effective for 2025,
beginning January 19, 2025. We are evaluating the impact of these tax law changes on our consolidated financial statements.
Other
recent authoritative guidance issued by the FASB (including technical corrections to the Accounting Standards Codification (“ASC”))
and the SEC did not or are not expected to have a material effect on our consolidated financial statements.
12
Note
2: Cash, Cash Equivalents, and Investments
The
Company’s investments in debt securities are classified as held-to-maturity and are recorded at amortized cost, net of
allowance for credit losses, and its investments in money market funds are classified as available-for-sale securities and presented
as cash equivalents or restricted cash equivalents on the consolidated balance sheets. The following table shows the Company’s
cash, available-for-sale securities, and investment securities by major security type as of June 30, 2025, and December 31,
2024:
Schedule
of Cash and Cash Equivalents and Investments
June 30, 2025 (Unaudited)
Level (1)
Fair Value
Allowance for Credit Losses
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Adjusted Cost
Assets:
Cash deposit
1
$ 1,878,460
$ —
$ —
$ —
$ 1,878,460
Money market funds (2)
1
2,095,970
—
—
—
2,095,970
Short-term investment in corporate bonds (3)(5)(6)
2
2,841,103
—
—
( 1,316 )
2,842,419
Long-term investment in corporate bonds (4)(5)(6)
2
410,323
653
—
409,670
Total financial assets
$ 6,815,533
$ —
$ —
$ ( 1,316 )
$ 7,226,519
Reconciliation to cash, cash equivalents and investments on the
condensed consolidated balance sheet
Minus: Restricted cash and cash equivalents, current and noncurrent
( 1,833,531 )
Total cash, cash, cash equivalents and investments
$ 5,392,988
December 31, 2024 (Audited)
Level (1)
Fair Value
Allowance for Credit Losses
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Adjusted Cost
Assets:
Cash deposit
1
$ 926,287
$ —
$ —
$ —
$ 926,287
Money market funds (2)
1
5,580,463
—
—
—
5,580,463
Short-term investment in corporate bonds (3)(5)(6)
2
2,756,428
—
—
( 149 )
2,756,577
Total financial assets
$ 9,263,178
$ —
$ —
$ ( 149 )
$ 9,263,327
Notes:
(1) Definition of the
three-level fair value hierarchy:
● Level
1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities
● Level
2 - Other inputs that are directly or indirectly observable in the markets
● Level
3 - Inputs that are generally unobservable
(2) All our money market
funds were invested in U.S. Government money market funds.
(3) Short-term investment
securities will mature within 12 months or less, from the applicable reporting date.
(4) Long-term investment securities will mature between 12 months and 18 months from the applicable reporting date.
(5) For the three months ended June 30, 2025 and 2024, the Company received discounts of $ 9,618 and $ 31,357 to purchase held-to-maturity investment securities, respectively. For the six months ended June 30, 2025 and 2024 , the Company received discounts of $ 15,722 and $ 61,472 to purchase held-to-maturity investment securities, respectively.
For the year ended December 31, 2024, the Company received discounts of $ 78,770 to purchase held-to-maturity investment securities.
(6) The
Company considers the decline in the market value of its investment portfolio to be temporary in nature. As of June 30, 2025 and
December 31, 2024, the Company did not consider any of its investments to be other-than-temporarily impaired and no allowance for
credit losses was recorded.
Note
3: Research and Collaboration Agreements, Sublicense Agreements, and Investments in Privately Held Companies
Gates
Foundation Grant
In November 2024, the Gates Foundation
(the “Gates Foundation”, formerly known as the Bill & Melinda Gates Foundation) awarded the Company a grant in the amount
of $ 3,092,136 for the cell line development of monoclonal antibodies targeting respiratory syncytial virus and malaria utilizing the Company’s
C1 platform to provide globally accessible treatment options for underserved populations (the “Gates Foundation Grant”).
As of June 30, 2025, the Company has received approximately $ 2.3
million of the Gates Foundation Grant. The
remaining award of approximately $ 0.7 million is expected to be received later in 2026, subject to potential modifications of timing and
amounts.
The Company is required to apply the funds it receives under the agreements
solely toward direct costs for the applicable funded projects, other than less than 15% of such funds, which it may apply
toward general overhead and administrative expenses that support the entire operations of the Company. The Company receives funding
in advance and tracks and reports eligible expenses incurred to the Gates Foundation. Funds received in advance that have not been
spent are recorded as restricted cash and cash equivalents and as deferred research and development obligations in the Company’s
consolidated balance sheets. As the Company incurs costs associated with research and development related to the project, on a monthly
basis, the Company reclasses amounts from the grant to recognize grant revenue and cost of grant revenue. The deferred research and development
obligations also include grant funds spent but not yet expensed in accordance with GAAP. The grant agreements include the Gates Foundation’s
discretionary termination provisions. Any grant funds that have not been used or committed to the funded project must be returned
promptly to the Gates Foundation upon expiration or termination of the agreement.
For the three and six months ended June 30, 2025, the Company recognized grant
revenue of $ 361,759 and $ 538,107 , respectively, in connection with the Gates Foundation Grant. For the three and six months ended June
30, 2025, the Company recognized cost of grant revenue of $ 349,558 and $ 492,849 , respectively, in connection with the Gates Foundation
Grant.
As of June 30, 2025,
the Company had restricted cash and cash equivalents, current of $ 1,588,384 ,
restricted cash and cash equivalents, noncurrent of $ 245,147 ,
and deferred research and development obligations of $ 1,833,531
related to the Gates Foundation Grant.
Coalition
for Epidemic Preparedness Innovations (CEPI) Grant
On
March 20, 2025, the Company received a funding award from CEPI to advance Dyadic’s C1 platform through a $ 4.5
million grant through Fondazione Biotecnopolo di Siena (“FBS”) to accelerate recombinant protein vaccine development and
manufacturing. The funding will support antigen design, cell line development, optimization, characterization, and scale-up to cGMP
manufacturing. If successful, the next phase will focus on selecting a CEPI-priority pathogen antigen. Dyadic, as a subcontractor,
will receive up to $ 2.4
million of the total grant funding. The Company will be reimbursed for research and development expenses in arrears on a quarterly basis.
For the three and six months ended June 30, 2025, the Company recognized grant
revenue of $ 141,422 and $ 175,545 , respectively, in connection with the CEPI Grant. For the six months ended June 30, 2025, the Company
recognized cost of grant revenue of $ 115,576 and $ 143,463 , respectively, in connection with the CEPI Grant.
13
Proliant
On
June 27, 2024 , the Company entered into a License and Development Agreement (the “Proliant Agreement”) with
Proliant Biologicals, LLC d/b/a Proliant Health and Biologicals (“Proliant”), pursuant to which, Proliant will license
Dyadic’s proprietary fungal microbial expression and production platforms and microbial strains for the production of
recombinant serum albumin, for an initial period of 10
years with an option to extend for an additional 3
years under certain circumstances. Under the terms of the Proliant Agreement, Dyadic has received an initial upfront payment of
$ 500,000
and a second payment of $ 500,000
upon the completion of the transfer of a Production Strain (as defined in the Proliant Agreement.) for the year ended December 31,
2024. The Company expects to receive a final payment of $ 500,000
in the third quarter of 2025 upon meeting a certain productivity threshold. For the three and six months ended June 30, 2025,
the Company did not receive any additional payments under the Proliant Agreement. Upon commencing commercial sales of animal-free
recombinant serum albumin products produced pursuant to the Proliant Agreement, the Company will receive royalties based on a
certain percentage of the gross margin received by Proliant, as defined in the Proliant Agreement.
Inzymes
ApS
On
September 18, 2023, Dyadic International (USA) Inc., a subsidiary of the Company, signed a Development and Exclusive License Agreement
(the “Inzymes Agreement”) with Inzymes ApS (“Inzymes”), a Denmark corporation, to develop and commercialize certain
non-animal dairy enzymes used in the production of food products using Dyadic’s proprietary Dapibus™ platform. In October
2023, the Company received an upfront payment of $ 0.6 million in accordance with the terms of the Inzymes Agreement.
On
October 11, 2024, the Inzymes Agreement was amended (“the Amended Inzymes Agreement”) to change the scope of research and
development services required under the agreement as well as adjust the success fees upon the achievement of certain target yields, milestone
payments upon first commercial sale of each product and royalties.
For
the year ended December 31, 2024, the Company has completed all product research and development services and satisfied all related
performance obligations under the Amended Inzymes Agreement, and recognized $ 890,169
in license revenues, including success fees upon the achievement of target yield of one related product. For the year ended December
31, 2024, the Company also recognized research and development revenues of $ 25,000
related to the Amended Inzymes Agreement.
For the three and six months ended June 30, 2025, the Company recognized
milestone revenue of $ 250,000 upon the achievement of commercially viable target yield related to the Inzymes Agreement.
The
Company will continue evaluating the achievement of milestones related to target yields and product commercialization of each product
when they are considered probable and estimable under the Inzymes Agreement.
Alphazyme
In
2019 the Company entered into a sub-licensing agreement with Alphazyme, LLC (“Alphazyme”) that was subsequently amended (the
“Amended Alphazyme LLC Agreement”). Under the Amended Alphazyme LLC Agreement, Alphazyme obtained additional capital contribution
and Dyadic’s ownership was diluted to 1.99 %.
The
Company evaluated the nature of its equity interest investment in Alphazyme and determined that Alphazyme is a VIE due to the capital
structure of the entity. However, the Company is not the primary beneficiary of Alphazyme as Dyadic does not have the power to control
or direct the activities of Alphazyme that most significantly impact the VIE. As a result, the Company does not consolidate its investment
in Alphazyme. The Company reports its investment in Alphazyme under the cost method of accounting, given that it does not have the ability
to exercise significant influence or control over Alphazyme.
On
January 18, 2023, the Company entered into a Securities Purchase Agreement, under which the Company agreed to sell its equity interest
in Alphazyme, LLC (the “Alphazyme Sale Agreement”). The Company continues to have the potential to receive additional payments
based on the future sales of Alphazyme’s existing products, pursuant to the Alphazyme Sale Agreement.
The
Amended Sublicense Agreement between Dyadic and Alphazyme, which was previously entered on June 24, 2020, remains in effect. Under the
Amended Alphazyme Sub-License Agreement, Dyadic is entitled to potential milestone and royalty payments upon the commercialization of
Alphazyme products using Dyadic’s proprietary C1-cell protein production platform.
For
the year ended December 31, 2024, the Company received a total cash payment of $ 1.3
million from the sale of its equity interest in Alphazyme, LLC. In the first quarter of 2024, the Company received an additional
cash payment of $ 60,977 ,
which was recorded as gain on sale of Alphazyme in the consolidated statement of operations. There was no
revenue recognized related to Alphazyme in 2025.
Note
4: Convertible Notes Payable
On
March 8, 2024, the Company issued senior secured convertible promissory notes (the “Convertible Notes”) with an aggregate
principal amount of $ 6.0
million, of which, $ 2.0
million were sold to related parties, including immediate family
members and family trusts related to Mark Emalfarb, our Chief Executive Officer and a member of our Board of Directors.
The
Convertible Notes are senior, secured obligations of the Company and its affiliates, and interest is payable quarterly in cash on the
principal amount equal to 8 % per annum, and guaranteed by its subsidiary, Dyadic International (USA), Inc. under a subsidiary guarantee
for the benefit of the holders of the Convertible Notes (each such holder, a “Holder”).
The
Convertible Notes mature on March 8, 2027, unless earlier converted or redeemed in accordance with the terms of the Convertible Notes.
The Convertible Notes are secured by a first priority lien on substantially all assets of the Company and Dyadic International (USA),
Inc.
The
Convertible Notes are accounted for in accordance with ASC 470-20, Debt with Conversion and Other Options and ASC 815-15, Derivatives
and Hedging . Under ASC 815, contracts that are both indexed to its own stock and classified in stockholders’ equity in its
statement of financial position are not considered to be derivative instruments. Based on the Company’s analysis, it is determined
that the Convertible Notes contain embedded features that are indexed to the Company’s own stock and are classified in stockholders’
equity in the Company’s statement of financial position, but do not meet the requirements for bifurcation and recognition as derivatives,
and therefore, do not need to be accounted for separately. Accordingly, the proceeds received from the issuance of the Convertible Notes
were recorded as a single liability in accordance with ASC 470 on the Company’s consolidated balance sheets.
14
The
Company incurred $ 175,674 of
debt issuance costs associated with the Convertible Notes, which were recorded as a reduction of the Convertible Notes on the
consolidated balance sheets. The debt issuance costs are being amortized and recognized as additional interest expense over the
expected life of the Convertible Notes using the effective interest method. We determined that the expected life of the debt is
equal to the three 5 -year
term of the Convertible Notes.
On
October 4, 2024, the Company entered into an amendment (the “Amendment”) to the Convertible Notes. Under the Amendment,
(i) the conversion price upon which the Convertible Notes will be convertible into shares of the Company’s common stock is
$ 1.40
per share of common stock, and (ii) the Redemption Date (as defined in the Amendment) will fall on any of the 26, 29 and 32-month
anniversaries of the original issue date of the Convertible Notes.
On May 1, 2025, the Company entered into a second amendment (the “Second
Amendment”) to the Convertible Notes. Pursuant to the Second Amendment, the Redemption Date (as defined in the Second Amendment)
will now fall on December 1, 2026.
The
Company assessed the Amendment and Second Amendment for a debt extinguishment or modification in accordance with ASC 470-50. As both
the change in the present value of future cash flows of the modified Convertible Notes to that of the original Convertible Notes (including
callable features) and the change in fair value of the embedded conversion option to that of the carrying value of the Convertible Notes
immediately before modification resulted in a less than 10% change, neither Amendments was deemed substantial and they are regarded as
a note modifications. The Company did not incur any gain or loss relating to the modifications and any incremental costs related to the
Amendments were expensed.
For
the three and six months ended June 30, 2025, $ 101,800
and $ 208,973 of interest were paid, and debt issuance costs of $ 12,032
and $ 23,795 were amortized and recorded in interest expenses in the consolidated statements of operations, respectively.
For
the three and six months ended June 30, 2024, $ 34,844
and $34,844 of interest were paid, and debt issuance costs of $ 23,591
and $26,716 were amortized and recorded in interest expenses in the consolidated statements of operations, respectively.
As of June 30, 2025, the accrued interest on the Convertible Notes to related
parties and other third parties was $ 21,800 and $ 80,000 , respectively. As of June 30, 2024, the accrued
interest on the Convertible Notes to related parties and other third parties was $ 32,000
and $ 80,000 ,
respectively.
As of June 30, 2025 and 2024, accumulated amortized debt issuance costs are
$ 60,171 and $ 26,716 , respectively.
During
the year ended December 31, 2024, $ 910,000
of the Convertible Notes were converted into 556,623
shares of the Company’s common stock. As of June 30,
2025, convertible notes payable consisted of the following:
Schedule
of Convertible Notes Payable
Holder
Issuance Date
Due Date
Interest Rate
Convertible Note Principal
Principal Repayments
Conversion to
Common Stock
Principal Outstanding
Francisco Trust dated 2/28/1996 (1)
03/08/24
03/08/27
8 %
$ 1,000,000
$ —
$ —
$ 1,000,000
Bradley Emalfarb (2)
03/08/24
03/08/27
8 %
500,000
—
( 500,000 )
-
Bradley Scott Emalfarb Irrevocable Trust (2)
03/08/24
03/08/27
8 %
410,000
—
( 410,000 )
-
Emalfarb Descendent Trust (3)
03/08/24
03/08/27
8 %
90,000
—
—
90,000
Convertible Notes - Related Party
$ 2,000,000
$ —
$ ( 910,000 )
1,090,000
Unamortized Debt Issuance Costs - Related Party
( 19,029 )
Net Carrying Amount
$ 1,070,971
Convertible Notes - Third Party
03/08/24
03/08/27
8 %
$ 4,000,000
$ —
$ —
4,000,000
Unamortized Debt Issuance Costs - Third Party
( 69,830 )
Net Carrying Amount
$ 3,930,170
Notes:
(1) Mr. Thomas Emalfarb,
nephew of Mr. Mark A. Emalfarb, our Chief Executive Officer, is the Trustee
of the Francisco Trust. Mr. Thomas Emalfarb may be deemed to have voting, dispositive and investment power with respect to the shares
of common stock held by the Francisco Trust and disclaims any such beneficial ownership other than to the extent of any pecuniary interest
he may have therein, directly or indirectly. The amount of accrued interest as of June 30, 2025, is $ 20,000 .
(2) Mark A. Emalfarb,
our Chief Executive Officer, is the Trustee of the Irrevocable Trust and
the brother of Mr. Bradley S. Emalfarb, who is the sole beneficiary of the Irrevocable Trust. Mr. Bradley S. Emalfarb, as sole beneficiary
of the Irrevocable Trust, therefore, may be deemed to have voting, dispositive and investment power with respect to the shares of common
stock held by the Irrevocable Trust and disclaims any such beneficial ownership other than to the extent of any pecuniary interest he
may have therein, directly or indirectly. In 2024, $500,000 of the Convertible Notes held by Mr. Bradley S. Emalfarb were converted into
294,891 shares of the Company’s common stock and $410,000 of the Convertible Notes held by Bradley Scott Emalfarb Irrevocable Trust
were converted into 261,732 shares of the Company’s common stock. As of June 30, 2025, there is no accrued interest for Bradley
Emalfarb and Bradley Scott Emalfarb Irrevocable Trust.
(3) Messrs. Thomas
Emalfarb, Scott Emalfarb and Michael Emalfarb, nephews of Mr. Mark A. Emalfarb, our
Chief Executive Officer, are co-trustees of the Descendant Trust and may therefore be deemed to have shared voting, dispositive and investment
power over the shares of common stock held by the Descendant Trust. The amount of accrued interest as of June 30, 2025, is $1,800.
15
Note
5: Commitments and Contingencies
Legal
Proceedings
We
are not currently involved in any litigation that we believe could have a materially adverse effect in our financial condition or results
of operations. From time to time, the Company is subject to legal proceedings, asserted claims and investigations in the ordinary course
of business, including commercial claims, employment and other matters, which management considers immaterial, individually and in the
aggregate. The Company makes a provision for a liability when it is both probable that a liability has been incurred and the amount of
the loss can be reasonably estimated. The requirement for these provisions is reviewed at least quarterly and adjusted to reflect the
impact of negotiations, settlements, rulings, advice of legal counsel and other information and events pertaining to a particular case.
Litigation is inherently unpredictable and costly. Protracted litigation and/or an unfavorable resolution of one or more of proceedings,
claims or investigations against the Company could have a material adverse effect on the Company’s consolidated financial position,
cash flows or results of operations.
VTT
Research Contract
On July 1, 2025, the Company entered into a Fifth Amendment to the commission
contract concerning VTT Technical Research Centre of Finland Ltd. (“VTT”) to continue developing Dyadic’s C1 fungal
expression system (the “Fifth Amendment”). The original contract was entered on June 28, 2019, and subsequently amended by
the First Amendment on June 21, 2022, the Second Amendment on September 9, 2022, the Third Amendment on January 31, 2024, and the Fourth
Amendment on February 19, 2025. Under the terms of the Fifth Amendment, the contract duration was extended to September 30, 2025, and
Dyadic will pay VTT a total of approximately EUR104,000.
Note
6: Share-Based Compensation
Description
of Equity Plans
The
2021 Equity Incentive Award Plan (the “2021 Plan”) was adopted by the Company’s Board of Directors on April 9, 2021
and approved by the Company’s Annual Meeting of Shareholders (the “Annual Meeting”) on June 11, 2021. The 2021 Plan
serves as a successor to the Company’s 2011 Equity Incentive Plan (the “2011 Plan”). Since the adoption of the 2021
Plan, all equity awards were made from the 2021 Plan and no additional awards will be granted under the 2011 Plan. The 2021 Plan provides
for the issuance of a variety of share-based compensation awards, including stock options, restricted stock awards, restricted stock
unit awards, performance awards, dividend equivalents awards, deferred stock awards, stock payment awards and stock appreciation rights.
As of April 16, 2021, the 2021 Plan increased the number of shares available for grant by 3,000,000 in addition to the number of shares
remaining available for the grant of new awards under the 2011 Plan.
As
of June 30, 2025, the Company had 5,999,597 stock options outstanding and 64,656 unvested restricted stock units in addition to 1,571,382
shares of common stock available for grant under the 2021 Plan. As of December 31, 2024, the Company had 5,788,597 stock options outstanding
and 117,925 unvested restricted stock units in addition to 2,056,629 shares of common stock available for grant under the 2021 Plan.
Stock
Options
Options
are granted to purchase common stock at prices that are equal to the fair value of the common stock on the date the option is
granted. Vesting is determined by the Board of Directors at the time of grant. The term of any stock option awards under the
Company’s 2011 Plan and 2021 Plan is ten
years , except for certain options granted to
the contractors, which are two 2 to five
years .
The
grant-date fair value of each option grant is estimated using the Black-Scholes option pricing model and amortized on a straight-line
basis over the requisite service period, which is generally the vesting period, for each separately vesting portion of the award as if
the award was, in substance, multiple awards. Use of a valuation model requires management to make certain assumptions with respect to
selected model inputs, including the following.
Risk-free
interest rate . The risk-free interest rate is based on U.S. Treasury rates with securities approximating the expected lives of options
at the date of grant.
Expected
dividend yield . The expected dividend yield is zero, as the Company has never paid dividends to common shareholders and does not
currently anticipate paying any in the foreseeable future.
Expected
stock price volatility. The expected stock price volatility was calculated based on the Company’s own volatility. The Company reviews its volatility assumption on an annual
basis and has used the Company’s historical volatilities since 2016.
16
Expected
life of option. The expected life of option was based on the contractual term of the option and expected employee exercise and post-vesting
employment termination behavior. The Company uses the weighted average vesting period and contractual term of the option as the best
estimate of the expected life of a new option.
The
assumptions used in the Black-Scholes option pricing model for stock options granted for the six months ended June 30, 2025, are as follows:
Schedule
of Stock Options
Risk-Free interest rate
4.1 % - 4.4 %
Expected dividend yield
— %
Expected stock price volatility
65.1 - 65.4 %
Expected life of options (in years)
0.8 - 6.3
The
following table summarizes the stock option activities for the six months ended June 30, 2025:
Schedule
of Stock Option Activities
Weighted-Average
Weighted-Average
Remaining Contractual
Aggregate Intrinsic
Shares
Exercise Price
Term (Years)
Value
Outstanding at December 31, 2024
5,788,597
$ 2.97
5.34
$ 655,578
Granted (1)
698,500
1.71
Exercised (2)
( 55,000 )
1.17
Canceled (3)
( 432,500 )
3.13
Outstanding at June 30, 2025
5,999,597
$ 2.83
5.60
$ —
Exercisable at June 30, 2025
4,768,372
$ 3.09
4.77
$ —
Notes:
(1) Represents the
following options granted:
●
Annual
share-based compensation awards on January 2, 2025, with an exercise price of $ 1.74 , including: (a) 356,500 stock options granted
to executives and key personnel, vesting upon one year anniversary, or annually in equal installments over four years , (b) 277,500
stock options granted to members of the Board of Directors, vesting upon one year anniversary, (c) 19,500 stock options granted to
employees, vesting annually in equal installments over four years , and (d) 20,000 stock options granted to a consultant, vesting
upon one year anniversary.
●
One time share-based compensation award on May 30, 2025, with an exercise
price of $ 1.04 , of 25,000 stock options granted to an executive, vesting annually in equal installments over four years.
(2) Represents the
following options exercised:
(a)
25,000 stock options with an exercise price of $ 0.97 per share exercised by a board member (b) 30,000 stock options with an exercise
price of $ 1.33 per share exercised by a board member.
(3) Represents the
following options canceled:
(a)
55,000
stock options with an exercise price of $ 1.75
per share granted to a consultant, (b) 75,000
stock options with an exercise price of $ 4.10
per share granted to key personnel, (c) 37,500 stock options
with an exercise price of $2.23 per share granted to a consultant, and (d) 265,000 stock options with a weighted average exercise price of $3.28 per share granted to a former board member.
Restricted
Stock Units
Restricted
stock units (the “RSUs”) are granted subject to certain restrictions. Vesting conditions are determined at the discretion
of the Board of Directors. The fair market value of RSUs is generally determined based on the closing market price of the stock on the
grant date.
The
following table summarizes the restricted stock award activity for the six months ended June 30, 2025:
Schedule
of Restricted Stock Award Activity
Weighted-Average
Grant Date
Shares
Fair Value
Outstanding at December 31, 2024
117,925
$ 1.59
Granted (1)
230,023
1.74
Vested (2)
( 272,516 )
1.67
Forfeited (3)
( 10,776 )
1.74
Outstanding at June 30, 2025
64,656
$ 1.74
Notes:
(1)
On
January 2, 2025, the Company granted 96,984 restricted stock units, vesting upon one year anniversary, to the Board of Directors
as a result of reduction in director cash compensation of 2025, and an aggregate of 133,039 restricted stock units, vested in full,
to executives and key personnel in lieu of cash bonus earned for the year ended December 31, 2024.
(2)
Represents
the vesting 133,039 RSUs granted to executives and key personnel, and 139,477 RSUs granted to the Board of Directors.
(3)
Represents
the cancellation of unvested RSUs granted to a former member of the Board of Directors.
17
Compensation
Expenses
We
recognize all share-based payments to employees and our Board of Directors, as non-cash compensation expense, in research and development
expenses or general and administrative expenses in the consolidated statement of operations, and these charges had no impact on the Company’s
reported cash flows. Stock-based compensation expense is calculated on the grant date fair values of such awards, and recognized each
period based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period. Forfeitures
are recorded as they occur. For the three and six months ended June 30, 2025, there were forfeitures of $ 0 and $ 16,880 , respectively.
For
performance-based awards, the Company recognizes related stock-based compensation expenses based upon its determination of the potential
likelihood of achievement of the specified performance conditions at each reporting date.
Total
non-cash share-based compensation expense was allocated among the following expense categories:
Schedule
of Non-cash Share-based Compensation Expense
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
General and administrative
$ 323,321
$ 285,372
$ 531,317
$ 579,406
Research and development
17,141
12,231
34,175
24,675
Total
$ 340,462
$ 297,603
$ 565,492
$ 604,081
The
following table summarizes the Company’s non-cash share-based compensation expense allocation between options and restricted stock
units:
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Share based compensation expense - stock option
$ 304,861
$ 243,538
$ 482,155
$ 433,807
Share based compensation expense - restricted stock units
35,601
54,065
83,337
170,274
Total
$ 340,462
$ 297,603
$ 565,492
$ 604,081
Note
7: Shareholders’ Equity
Issuances
of Common Stock
For the six months ended June 30, 2025, there were 272,516 shares issued
from the vesting of restricted stock units with a weighted average issue price of $ 1.68 per share and 55,000 shares issued from the exercise
of stock options. For the six months ended June 30, 2024, there were 666,578 shares of the Company’s common stock issued with a
weighted average issue price of $ 1.61 per share, including 223,463 shares from the conversion of the Convertible Notes, 61,793 shares
from the vesting of restricted stock units, and 5,569 shares from the exercise of stock options.
Treasury
Stock
As
of June 30, 2025, there were 12,253,502 shares of common stock held in treasury, at a cost of $ 18.9 million, representing the purchase
price on the date the shares were surrendered to the Company.
18
Note
8: Segment
The
Company operates and manages its business as one reportable
segment and one operating
segment, which is the business of developing and commercializing synthetic protein products using the Company’s proprietary
microbial platforms, including C1 and Dapibus TM . The Company’s chief operating decision maker, or CODM, is the
Company’s senior management team that includes the Chief Executive Officer, President & Chief Operating Officer and Chief
Financial Officer. The CODM assesses performance for the segment and decides how to allocate resources based on consolidated net
loss that is also reported on the consolidated statements of operations.
The
measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. The Company operates in the U.S.
and Europe. All material long-lived assets of the Company reside in the U.S. For geographic information about the Company’s product
revenues, see Note 1, Concentration . Long-lived assets primarily consist of operating lease right-of-use assets.
The
CODM uses consolidated net loss to evaluate the Company’s spending and monitor budget versus actual results. The monitoring of
budgeted versus actual results is used in assessing the performance of segment and in establishing resource allocation across the organization.
Factors used in determining the reportable segment include the nature of the Company’s operating activities, the organizational
and reporting structure and the type of information reviewed by the CODM to allocate resources and evaluate financial performance. The
accounting policies of the segment are the same as those described in Note 1 of the notes to the consolidated financial statements included
in this Annual Report on Form 10-K.
The
CODM reviews cash, cash equivalents and investment securities as a measure of segment assets. As of June 30, 2025 and December 31, 2024,
the Company’s cash, cash equivalents and investment securities were $ 7.3
million and $ 9.3
million,
respectively.
The
following table presents information about segment revenue, significant segment expenses and segment operating loss for the three and
six months ended June 30, 2025 and 2024:
Schedule
of Segment Revenue, Significant Segment Expenses and Segment Operating Loss
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Total revenues
$ 966,630
$ 385,896
$ 1,360,202
$ 720,513
Total cost of revenues
613,591
301,956
911,249
445,911
Research and development expenses:
Outside contracted services
486,585
395,188
842,841
783,434
Personnel related costs
107,528
94,658
212,210
188,541
Facilities, overhead, and other
18,125
13,552
35,132
41,702
General and administrative expenses:
—
—
—
—
Compensation and related expenses
581,276
583,423
1,213,798
1,249,903
Business consulting expenses
71,100
210,980
252,327
417,352
Legal and professional services
209,579
224,906
540,676
590,065
Other G&A expenses
251,379
303,076
494,850
559,874
Share-based compensation expenses
340,462
297,602
565,492
604,081
Foreign currency exchange loss
16,098
3,146
23,170
8,049
Other Income (expenses), net
64,706
2,632
89,810
( 113,330 )
Net loss
$ 1,793,774
$ 2,045,223
$ 3,821,353
$ 4,055,069
Note
9: Subsequent Event
For
the purpose of disclosure in the consolidated financial statements, the Company has evaluated subsequent events through August 13,
2025, the date the consolidated financial statements were available to be issued. Except for items mentioned in the notes,
management is not aware of any material events that have occurred subsequent to the balance sheet date that would require adjustment
to, or disclosure in the accompanying financial statements.
On July 30, 2025, the Company entered into an Underwriting Agreement, which
closed on August 1, 2025 for net proceeds of $ 5.3 million. See Note 1 for additional details.
19
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of financial condition and results of operations should be read in conjunction with the financial statements
and the notes to those statements appearing in this Quarterly Report. Some of the information contained in this discussion and analysis
or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes
forward-looking statements that involve risks, assumptions and uncertainties. Important factors that could cause actual results to differ
materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis
include, but are not limited to, those set forth in “ Item 1A. Risk Factors ” in this Quarterly Report. All forward-looking statements included in this Quarterly Report are based on information available to us as of the time we file this Quarterly Report
and, except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements.
Overview
Description
of Business
Dyadic
International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) is a
global biotechnology platform company headquartered in Jupiter, Florida, with operations in the U.S. and the Netherlands. We aim to develop
and commercialize scalable, non-animal protein production platforms to meet growing global demand across the life sciences, food and
nutrition, and bio-industrial markets.
Our
proprietary platforms—Dapibus™ and C1—are designed for rapid, cost-effective, and flexible production of high-value
proteins, enabling partners to reduce development timelines and manufacturing costs. While Dyadic’s primary focus is on non-therapeutic
applications, both platforms retain the capability to produce biologics, such as vaccines and therapeutic proteins, for external partners.
Platform
Capabilities
Dyadic’s
Dapibus™ and C1 platforms are engineered microbial expression systems optimized for high-yield, low-cost, and scalable protein
production. Built on decades of industrial experience, these platforms support applications in:
● Cell
culture media (e.g., albumin, transferrin, fibroblast growth factor (“FGF”))
● Diagnostics
and research reagents
● Functional
food ingredients (e.g., alpha-lactalbumin, caseins, lactoferrin)
● Sustainable
industrial enzymes (e.g., biomass and dairy enzymes)
By
targeting high-value proteins in expanding non-pharmaceutical markets, Dyadic is building a commercial pipeline that aligns with global
trends in sustainability, animal-free manufacturing, and bio-based innovation. Simultaneously, we continue to explore partnering opportunities
for the use of our platforms in pharmaceutical development where appropriate.
Dapibus™
Protein Production Platform
To
accelerate commercialization and reduce regulatory risk, Dyadic developed the Dapibus™ platform—a proprietary expression
system designed to produce high-value, non-animal proteins and enzymes for non-pharmaceutical markets including life sciences, food and
nutrition, and bio-industrial sectors.
Dapibus™
is expected to enable faster development, lower production costs, and simplified regulatory pathways compared to therapeutic biologics,
which Dyadic believes will allow it to address growing demand for sustainable, functional ingredients across a range of industries. The
platform supports applications in bioprocessing, product formulation, diagnostics, and nutrition.
Dyadic
expects to commercialize multiple Dapibus™-enabled products starting in 2025 through a combination of strategic partnerships and
internal manufacturing initiatives.
20
C1
Protein Production Platform
Dyadic’s
proprietary C1 expression system is a patented, thermophilic fungal platform ( Thermothelomyces heterothallica fungus) developed
for the cost-effective, large-scale production of proteins. Originally used to manufacture industrial enzymes, Dyadic has engineered
C1 into a high-yield, scalable platform for both biopharmaceutical and non-pharmaceutical applications.
Following
the 2015 sale of its industrial enzyme business to Danisco USA (a DuPont subsidiary), Dyadic retained co-exclusive rights to the C1 platform
for human and animal pharmaceutical use, including the exclusive ability to sub-license C1 for human and animal pharmaceutical use (subject
to specific conditions). Danisco holds certain retained rights but is obligated to pay Dyadic royalties on any future pharmaceutical
commercialization. Dyadic may owe downstream royalties to Danisco or its licensors depending on specific patent usage.
Food
and Nutrition Applications
Dyadic
is applying Dapibus™ to develop and commercialize animal-free proteins for dairy alternatives and functional nutrition. Key programs
include:
● Dairy
Enzyme Program: Under a development and exclusive license agreement signed in 2023, Dyadic
received a $600,000 upfront payment and an additional $425,000 milestone payment in September
2024 for achieving target yield. Commercial launch by the partner is expected in late 2025.
● Recombinant
Bovine Alpha-Lactalbumin: An improved production strain was developed in 2024. The product
shows comparability to commercial benchmarks and is being actively sampled and characterized
for use in dairy alternatives.
● Recombinant
Human Alpha-Lactalbumin: Development was initiated in 2024 for applications in infant formula,
medical nutrition, nutraceuticals, and pharmaceuticals.
● Recombinant
Human Lactoferrin: A cell line was developed in 2024 for potential use in immune-supportive
and antimicrobial products. Sampling is expected to begin in Q3 2025.
● Casein
Proteins: Four casein variants have been produced, and Dyadic is engaged in discussions with
prospective commercial partners.
21
Life
Sciences
Our
C1 platform is a robust and versatile gene expression system designed for the efficient production of high-value input proteins that
power the life sciences sector, such as cell culture media components, molecular biology reagents, and other critical bioprocessing inputs.
Cell
Culture Media
Dyadic
seeks to leverage its microbial platforms to produce high-value, animal-free growth media components for the biopharma and alternative
protein markets. Key developments include:
● Recombinant
Serum Albumin: In partnership with Proliant Health and Biologicals, Dyadic is advancing toward
a 2025 commercial launch of animal-free serum albumin for cell culture, diagnostics, and
vaccine stabilization. Dyadic has received $1.0 million in milestone payments to date, with
additional payments and royalties tied to commercial success. Early data show strong comparability
to industry standards and efficacy in cultured meat applications. Additionally, the Company anticipates achieving a third milestone payment of $500,000 in Q3 2025 related to productivity
improvements and future revenue sharing payments for commercial sales.
● Recombinant
Transferrin: Dyadic’s animal-free transferrin demonstrated equivalent performance to
leading recombinant standards. Samples are being evaluated for research, diagnostics, and
commercial bioprocessing.
● Recombinant Fibroblast Growth Factor (FGF): Critical for cell proliferation,
Dyadic’s bovine FGF candidate has shown promising results in early testing for biopharma and cultivated meat applications. Efforts
are underway to improve productivity, with additional characterization and validation ongoing. Sampling to cell culture, diagnostic and
research markets is underway.
● Strategic
Co-Promotion: Dyadic has partnered with Biftek Co. to jointly promote growth media supplements
for cell culture markets.
DNA/RNA
Technologies
Dyadic
is expanding into molecular tools for diagnostics and life sciences, with several enzyme products in development:
● DNase-1 (RNase-free): We completed development; production validation ongoing
with a European Contract Development and Manufacturing Organization (“CDMO”). A research-grade product is expected by the
end of 2025. Sampling is active, with ongoing discussions for potential partnerships and agreements across multiple markets
● RNA/DNA
Toolkit: Development is underway for RNase Inhibitors, T7 RNA Polymerase, DNA Ligase, and
Polymerases. Prototype enzymes have been produced, with optimization continuing into late
2025 and into 2026.
Bio-Industrial
Applications
Dyadic
seeks to leverage its Dapibus™ platform to develop and commercialize cost-effective, scalable enzyme solutions for bio-industrial
markets, supporting the global shift toward a more sustainable bioeconomy.
● Strategic Partnership with Fermbox Bio: In 2023, Dyadic partnered with Fermbox Bio to develop EN3ZYME, a proprietary
enzyme cocktail launched in May 2024 for converting agri-residues into fermentable cellulosic sugars. Fermbox
received an initial large purchase order in Q1 2025 with initial enzyme delivery completed in Q2 2025. Dyadic is expected to receive a
50/50 revenue profit share from commercial sales.
● Sustainable Enzyme Portfolio: Dyadic is advancing enzymes applicable to multiple sectors, including nutrition, pulp
and paper, biogas, and biofuels. Sampling to potential commercial partners is ongoing.
● Hyaluronidase
Development: Initiated in 2024, this enzyme targets high-value markets including medical,
cosmetic, and reproductive health. Sampling and commercial engagement are underway.
Pharmaceutical
Applications
While
Dyadic is focused on non-therapeutic markets, the C1 platform remains a validated solution for biopharmaceutical manufacturing and continues
to attract interest from pharma, CDMOs, academic institutions, and government agencies.
C1
addresses key bottlenecks in biologics manufacturing—reducing cost, shortening development cycles, and enabling higher yields—positioning
it as a competitive alternative to CHO, yeast, and insect cell systems.
Strategic
opportunities include:
● Recombinant
vaccines and therapeutics (human and animal)
● Biobetters
and biosimilars
● Drug
formulation and diagnostic reagents
● Cost-effective
production of difficult-to-express proteins
Dyadic
continues to evaluate licensing, collaboration, and commercialization opportunities to unlock C1’s full potential in the biologics
sector.
22
Legacy
Biopharma Programs Support Strategic Growth and Platform Validation
Dyadic’s
legacy pharmaceutical initiatives continue to drive platform validation, unlock non-dilutive funding, and support strategic collaborations
without diverting focus from its core commercial goals.
Fully
Funded Global Health Collaborations
● Gates
Foundation: We were awarded a grant in November 2024 to develop C1-based mAbs targeting RSV
and malaria for underserved populations.
● Israel
Institute for Biological Research: We are in an ongoing collaboration to co-develop vaccines
and biologics for emerging diseases and biothreats.
● Fondazione
Biotecnopolo di Siena / CEPI: Beginning March 2025, we are part of a $4.5 million CEPI-funded
project, eligible for $2.4 million, to accelerate development of C1-produced recombinant
vaccines for global pandemic preparedness.
● Dyadic participated in the inaugural European Vaccines Hub for Pandemic Readiness (“EVH”) meeting, May
22–23, 2025. Led by Dr. Rino Rappuoli, Scientific Director of Fondazione Biotecnopolo di Siena, the EVH aims to establish a centralized
EU hub for vaccine innovation, integrating R&D, clinical trials, and scalable manufacturing. Backed by approximately €100 million
in EU funding over four years, the initiative brings together leading public and private developers. Dyadic’s C1 microbial expression
technology is expected to be among the platform technologies evaluated, highlighting its potential to accelerate development and reducing
the cost of manufacturing vaccines and antibodies at scale.
● On March 23, 2025, CEPI announced a grant of $2.6 million to Uvax Bio. A portion of this funding will support the
development of a MERS vaccine and research to assess the capability of the C1 platform to speed vaccine production and lower manufacturing
costs.
Advancing
C1 Vaccine Capabilities
● Ferritin
Nanoparticle Vaccine Candidates (with ViroVax):
○ H5
Avian Influenza: Demonstrated cross-protection in early trials; commercial interest in poultry,
cattle, and human markets.
○ Mpox:
Early-stage preclinical development reinforcing C1’s rapid response and low-cost manufacturing
potential.
Diagnostics
and Animal Health Expansion
● C1-produced
H5 antigens show strong neutralizing antibody response in poultry and promising cross-protection
in cattle — with the potential to open new opportunities in animal health and diagnostics.
Strategic
Platform Partnerships
● Cygnus
Technologies® (Maravai LifeSciences®): C1 Host Cell Protein (HCP) ELISA Kit to support
C1/Dapibus™ regulatory workflows commercially launched.
● Rabian
BV: We are awaiting funding from the Eurostars program for a rabies vaccine project using the
C1 platform; Dyadic is expected to receive equity in Rabian BV, certain milestone payments, and royalties
on commercial sales.
23
Peer-Reviewed
Validation and Clinical Progress
● Nature
Communications: C1-produced mAb showed protection against Omicron and Delta variants in non-human
primates.
● DYAI-100
Vaccine Candidate: Phase 1 clinical trial met safety and immunogenicity endpoints. Future
development paused to focus on emerging variants in collaboration with Rubic One Health (“Rubic”).
These
legacy programs provide critical third-party validation of the C1 platform’s biopharmaceutical potential while generating non-dilutive
capital and enabling future commercial opportunities.
Licensing
and Strategic Collaborations
In
April 2023, Dyadic expanded its license agreement with Rubic to include vaccines and therapeutic proteins for both human and animal health
in underserved African markets. The C1 platform tech transfer is complete. Dyadic is eligible to receive milestone payments, royalties,
and marketing rights under the agreement. In 2024, Rubic initiated development of several livestock vaccines.
Dyadic
entered an exclusive sublicense agreement with Abic, an affiliate of Phibro Animal Health Corporation, in February 2022. The agreement
was expanded in March 2024 to include additional vaccines and treatments for livestock diseases.
Research
and Development
Dyadic
conducts internal and collaborative R&D to advance its microbial platforms across both pharmaceutical and non-pharmaceutical applications.
VTT
Technical Research Centre of Finland
Since
2016, Dyadic has partnered with VTT, a leading European research institute, to enhance C1’s safety, productivity, and efficiency.
VTT supports critical initiatives including glycoengineering, protease deletion, and therapeutic protein expression. Many projects at
VTT are co-funded by Dyadic’s third-party collaborators.
Other
CRO and CDMO Partnerships
Dyadic
works with a global network of research providers and manufacturers, including 53Biologics (Spain), Fermbox Bio (India), and Eleszto
Genetika (Hungary). These partners support the Company’s R&D and scale-up activities across its platforms. While typically
structured as work-for-hire engagements, disruptions to these collaborations could impact timelines or development outcomes.
24
Other
Recent Developments
DBA
Name Change Update
On
July 2, 2025, we announced that, effective on August 1, 2025, we are doing business as Dyadic Applied BioSolutions. This
rebranding initiative marks a strategic transition from a research-driven organization to a commercially focused enterprise. The new
name and visual identity better reflect the emphasis on delivering applied biotechnology solutions through our patented and
proprietary C1 and Dapibus™ gene expression platforms.
Nasdaq
Deficiency Notices
As
previously disclosed, on June 23, 2025, the Company received a deficiency notice (the “MVLS Notice”) from the Nasdaq Listing
Qualifications staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the
last 30 consecutive business days the Company’s securities had not maintained the minimum Market Value of Listed Securities (“MVLS”)
of $35 million required by the continued listing requirements of Nasdaq Listing Rule 5550(b)(2). In addition and as previously disclosed,
on July 17, 2025, the Company received a deficiency notice (the “Minimum Bid Price Notice”) from the Staff of Nasdaq notifying
the Company that for the last 30 consecutive business days the Company’s common stock had not maintained the minimum bid price
of at least $1.00 per share required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid
Price Requirement”). The MVLS Notice and the Minimum Bid Price Notice have no immediate effect on the listing of the Company’s
common stock on the Nasdaq Capital Market, and the Company is currently subject to compliance periods during which it may regain compliance
with the applicable rules. The Company intends to actively monitor the MVLS and the bid price of its common stock between now and the
relevant compliance deadlines and, as appropriate, plans to evaluate available options to resolve the deficiencies and regain compliance
with the requirements. For more information, see “ Item 1A. Risk Factors – We have in the past, and may in the future,
be unable to comply with the listing standards of the Nasdaq Stock Market LLC (“Nasdaq”). If we fail to comply with listing
standards in the future, our common stock may be delisted. Delisting could adversely affect the liquidity of our common stock, and the
market price of our common stock could decrease, and our ability to obtain sufficient additional capital to fund our operations and to
continue to operate as a going concern would be substantially impaired.”
Critical
Accounting Estimates
The
preparation of these consolidated financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”)
requires management to make estimates that affect the reported amount of assets and liabilities and related disclosure of contingent
assets and liabilities at the date of our consolidated financial statements and the reported amounts of revenues and expenses during
the applicable period. Actual results may differ from these estimates under different assumptions or conditions. Such differences could
be material to the consolidated financial statements.
25
We
define critical accounting estimates as those that are reflective of significant judgments and uncertainties and which may potentially
result in materially different results under different assumptions and conditions. In applying these critical accounting estimates, our
management uses its judgment to determine the appropriate assumptions to be used in making certain estimates. These estimates are subject
to an inherent degree of uncertainty. Our critical accounting estimates include the following:
Revenue
Recognition
The
Company has no products approved for sale. All our revenue to date has been research revenue from third-party collaborations and grants, as well as revenue from sublicensing agreements and collaborative arrangements, which may include upfront payments, options to
obtain a license, payment for research and development services, milestone payments and royalties, in the form of cash or non-cash considerations
(e.g., minority equity interest).
Revenue
related to research collaborations and agreements: The Company typically performs research and development services as specified
in each respective agreement on a best-efforts basis, and recognizes revenue from research funding under collaboration agreements in
accordance with the 5-step process outlined in ASC Topic 606 (“Topic 606”): (i) identify the contract(s) with a
customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv)
allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the
entity satisfies a performance obligation. We recognize revenue when we satisfy a performance obligation by transferring control of
the service to a customer in an amount that reflects the consideration that we expect to receive. Depending on how the performance
obligation under our license and collaboration agreements is satisfied, we recognize the revenue either at a point in time or over
time by using the input method under Topic 606 to measure the progress toward complete satisfaction of a performance obligation.
Under
the input method, revenue will be recognized based on the entity’s efforts or inputs to the satisfaction of a performance obligation
(e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction
of that performance obligation. The Company believes that the cost-based input method is the best measure of progress to reflect how
the Company transfers its performance obligation to a customer. In applying the cost-based input method of revenue recognition, the Company
uses actual costs incurred relative to budgeted costs to fulfill the performance obligation. These costs consist primarily of full-time
equivalent effort and third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total
budgeted costs as the Company completes its performance obligations.
26
A
cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance
obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative
effect of revisions to estimated costs to complete the Company’s performance obligations will be recorded in the period in which
changes are identified, and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a
material impact on the timing and amount of revenue recognized in future periods.
Revenue
related to grants: The Company receives grants from governments, agencies, and other private and not-for-profit organizations. These
grants are intended to be used to fund the Company’s research collaborations partially or fully, including opportunities and projects
that the Company is pursuing with certain collaborators. However, most, if not all, of such potential grant revenues, is expected to
be earmarked for third parties to advance the research required, including preclinical and clinical trials for vaccines and/or antibodies
candidates. Revenue related to grants are presented on a gross basis on the Consolidated Statements of Operations.
Revenue
related to sublicensing agreements: If the sublicense to the Company’s intellectual property is determined to be distinct from
the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when technology
is transferred to the customer and the customer can use and benefit from the license.
Customer
options: If the sublicensing agreement includes customer options to purchase additional goods or services, the Company will evaluate
if such options are considered material rights to be deemed as separate performance obligations at the inception of each arrangement.
Milestone
payments: At the inception of each arrangement that includes development, commercialization, and regulatory milestone payments, the
Company evaluates whether the achievement of the milestones is considered probable and estimates the amount to be included in the transaction
price. If the milestone payment is in exchange for a sublicense and is based on the sublicensee’s subsequent sale of product, the
Company recognizes milestone payment by applying the accounting guidance for royalties.
Royalties:
With respect to licenses deemed to be the predominant item to which the sales-based royalties relate, including milestone payments
based on the level of sales, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance
obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has
not recognized any royalty revenue resulting from any of its sublicensing arrangements.
We
invoice customers based on our contractual arrangements with each customer, which may not be consistent with the period that revenues
are recognized. When there is a timing difference between when we invoice customers and when revenues are recognized, we record either
a contract asset (unbilled accounts receivable) or a contract liability (deferred research and development obligations), as appropriate.
If upfront fees or considerations related to a sublicensing agreement are received prior to the technology transfer,
the Company will record the amount received as deferred revenue from the licensing agreement.
We
are not required to disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one
year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed.
The
Company adopted a practical expedient to expense sales commissions when incurred because the amortization period would be one year or
less.
Accrued
Research and Development Expenses
In
order to properly record services that have been rendered but not yet billed to the Company, we review open contracts and purchase orders,
communicate with our personnel and we estimate the level of service performed and the associated cost incurred for the service when we
have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly or quarterly
in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance
sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm
the accuracy of our estimates with the service providers and adjust if necessary. Examples of accrued research and development expenses
include amounts owed to contract research organizations, to service providers in connection with research and development activities.
Stock-Based
Compensation
We
have granted stock options to employees, directors, and consultants. The fair value of each option award is estimated on the date of
grant using the Black-Scholes option-pricing model. The Black-Scholes model considers volatility in the price of our stock, the risk-free
interest rate, the estimated life of the option, the closing market price of our stock and the exercise price. For purposes of the calculation,
we assumed that no dividends would be paid during the life of the options. We also used the weighted-average vesting period and contractual
term of the option as the best estimate of the expected life of a new option, except for the options granted to the CEO (i.e., 5 or 10
years) and certain contractors (i.e., 2 to 5 years). The expected stock price volatility was calculated based
on the Company’s own volatility. The Company reviews its volatility assumption on an annual basis and has used the Company’s
historical volatilities since 2016.
The
estimates utilized in the Black-Scholes calculation involve inherent uncertainties and the application of management judgment. These
estimates are neither predictive nor indicative of the future performance of our stock. As a result, if other assumptions had been used,
our recorded share-based compensation expense could have been materially different from that reported. In addition, because some of the
performance-based options issued to employees, consultants, and other third-parties vest upon the achievement of certain milestones,
the total ultimate expense of share-based compensation is uncertain.
27
Accounting
for Income Taxes
The
Company accounts for income taxes under the asset and liability method in accordance with ASC Topic 740, “Income Taxes”.
Under this method, income tax expense /(benefit) is recognized for: (i) taxes payable or refundable for the current year and (ii) deferred
tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements
or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a
change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance
is provided to reduce the deferred tax assets reported if based on the weight of the available positive and negative evidence, it is
more likely than not some portion or all the deferred tax assets will not be realized.
In
determining taxable income for the Company’s consolidated financial statements, we are required to estimate income taxes in each
of the jurisdictions in which we operate. This process requires the Company to make certain estimates of our actual current tax exposure
and assessment of temporary differences between the tax and financial statement recognition of revenue and expense. In evaluating the
Company’s ability to recover its deferred tax assets, the Company must consider all available positive and negative evidence including
its past operating results, the existence of cumulative losses in the most recent years and its forecast of future taxable income. Significant
management judgment is required in determining our provision for income taxes, deferred tax assets and liabilities and any valuation
allowance recorded against our net deferred tax assets.
The
Company is required to evaluate the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in a company’s
financial statements. ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions
that the company has taken or expects to take in its tax return. For those benefits to be recognized, a tax position must be more-likely-than-not
to be sustained upon examination by taxing authorities. Differences between tax positions taken or expected to be taken in a tax return
and the net benefit recognized and measured pursuant to the interpretation are referred to as “unrecognized benefits.” A
liability should be recognized (or amount of net operating loss carry forward or amount of tax refundable is reduced) for unrecognized
tax benefits, because it represents a company’s potential future obligation to the taxing authority for a tax position that was
not recognized because of applying the provision of ASC 740.
The
Company classifies accrued interest and penalties related to its tax positions as a component of income tax expense. The Company currently
is not subject to U.S. federal, state, and local tax examinations by tax authorities for the years before 2021.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements.
Recent
Accounting Pronouncements
See
Note 1 to the Consolidated Financial Statements for information about recent accounting pronouncements .
Results
of Operations
Three
and Six Months Ended June 30, 2025 Compared to the Same Periods in 2024
Revenue
and Cost of Revenue
The
following table summarizes the Company’s revenue and cost of revenue for the three and six months ended June 30, 2025 and 2024:
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Research and development revenue
$ 213,449
$ 385,896
$ 396,549
$ 720,513
Grant revenue
503,181
—
713,653
—
License and milestone revenue
250,000
—
250,000
—
Costs of research and development revenue
148,457
301,956
274,937
445,911
Cost of grant revenue
465,134
—
636,312
—
For the three months ended June 30, 2025, the decrease in research and
development revenue and cost of research and development revenue was due to a reduction in the number of active collaborations to eight
compared to ten for the same period a year ago.
For the six months ended June 30, 2025, the decrease in research and development
revenue and cost of research and development revenue was due to a reduction in the number of active collaborations to ten compared to
thirteen for the same period a year ago.
The grant revenue and cost of grant revenue for the three and six months
ended June 30, 2025, were related to the Gates Foundation and CEPI grants. There was no grant revenue for the three and six months ended
June 30, 2024.
For the three and six months ended June 30, 2025, the license and milestone
revenue of $250,000 was related to the Inzymes Agreement.
Research
and Development Expenses
Research and development costs
are expensed as incurred and include salary and benefits of research personnel, third-party contract research organization services and
supply costs.
Research and development expenses
for the three months ended June 30, 2025, increased to $629,000 compared to $516,000 for the same period a year ago. The increase was
driven by a rise in the number of active internal research initiatives undertaken to expedite product development.
Research and development expenses
for the six months ended June 30, 2025, increased to $1,124,000 compared to $1,038,000 for the same period a year ago.
The increase was driven by a rise in the number of active internal research initiatives undertaken to expedite product development.
28
General
and Administrative Expenses
General and administrative expenses
for the three months ended June 30, 2025, decreased by 10.6% to $1,437,000 compared to $1,608,000 for the same period a year ago. The
decrease reflected reductions in business development and investor relations expenses of $82,000, accounting and legal expenses of $41,000,
insurance expenses of $28,000, and management incentives of $22,000, partially offset by
other expense increases of $2,000.
General and administrative expenses
for the six months ended June 30, 2025, decreased by 10.7% to $3,033,000 compared to $3,396,000 for the same period a year ago. The decrease
reflected reductions in business development and investor relations expenses of $180,000, management incentives of $100,000, accounting
and legal expenses of $82,000, and insurance expenses of $37,000, partially offset by other expense increases of $35,000.
Loss
from Operations
Loss from operations for the three
months ended June 30, 2025, decreased to $1,729,000 compared to $2,043,000 for the same period a year ago. The decrease in loss from operations
was largely attributable to an increase in total revenue of $581,000 and a reduction in general and administrative expenses of $171,000,
partially offset by increases in cost of revenue of $311,000 and research and development expenses of $113,000.
Loss from operations for the six
months ended June 30, 2025, decreased to $3,732,000 compared to $4,168,000 for the same period a year ago. The decrease in loss from operations
was largely attributable to an increase in total revenue of $639,000 and a reduction in general and administrative expenses of $363,000,
partially offset by increases in cost of revenue of $465,000 and research and development expenses of $86,000.
Other
Income (Expenses), Net
For the three months ended June 30, 2025, total other income (expenses),
net, was an expense of $65,000 compared to an income of $3,000 for the same period a year ago. The decrease in other income was largely
due to a reduction of $89,000 in interest income, partially offset by a decrease in interest expenses of $28,000 related to the Convertible
Notes.
For the six months ended June 30, 2025, total other income (expenses),
net, was an expense of $90,000 compared to an income of $113,000 for the same period a year ago. The decrease in other income was largely
due to gain on sale of Alphazyme of $61,000 in 2024, decrease in interest income of $88,000 and $55,000 increase in interest expenses
related to the Convertible Notes.
Net
Loss
Net loss for the three months ended June 30, 2025, was $1,794,000 compared
to $2,045,000 for the same period a year ago. The decrease reflected a reduction of $314,000 in
loss from operations and by an increase in interest income of $89,000, partially offset
by a decrease in other expenses of $28,000.
Net loss for the six months ended June 30, 2025, was $3,821,000 compared
to $4,055,000 for the same period a year ago. The decrease reflected a reduction of $436,000 in loss from operations, partially offset
by an increase in other expenses of $55,000.
Liquidity
and Capital Resources
The
Company expects to incur losses and have negative net cash flows from operating activities as it continues developing its microbial platforms
and related products, and as it expands its pipelines and engages in further research and development activities for internal products
as well as for its third-party collaborators and licensees. The success of the Company depends on its ability to develop its technologies
and products to the point of regulatory approval and subsequent revenue generation or through the sublicensing of the Company’s
technologies and products, and its ability to raise capital to finance these developmental efforts.
On
March 8, 2024, the Company issued an aggregate principal amount of $6.0 million of its 8.0% Senior Secured Convertible Promissory Notes
due March 8, 2027 (the “Convertible Notes”) in a private placement. The purchasers of the Convertible Notes included immediate
family members and family trusts related to Mark Emalfarb, our Chief Executive Officer and a member of our Board of Directors,
including The Francisco Trust, an existing holder of more than 5% of the Company’s outstanding common stock, (collectively, the
“Purchasers”). The net proceeds from the sale of the Convertible Notes, after deducting offering expenses, were $5,824,000.
The Company intends to use the net proceeds from the offering of the Convertible Notes for working capital and general corporate purposes.
This private placement funding is expected to support our near-term revenue growth and accelerate our strategic objective of commercialization
opportunities for pharmaceutical and non-pharmaceutical applications.
The
Convertible Notes are senior, secured obligations of Dyadic and its affiliates, and interest is payable quarterly in cash on the principal
amount equal to 8% per annum. The Convertible Notes will mature on March 8, 2027 (the “Maturity Date”), unless earlier converted,
repurchased, or redeemed in accordance with the terms of the Convertible Notes.
29
The Convertible Notes can be converted into shares of Dyadic’s common
stock, par value $0.001 per share (the “Common Stock”), at the option of the holders of the Convertible Notes (the “Noteholders”)
at any time prior to the Maturity Date. On October 4, 2024, the Company entered into an amendment (the “Amendment”) to the
Convertible Notes. Pursuant to the Amendment, (i) the conversion price upon which the Convertible Notes will be convertible into shares
of the Company’s common stock is $1.40 per share of common stock, and (ii) the Redemption Date (as defined in the Amendment) will
fall on any of the 26, 29 and 32-month anniversaries of the original issue date of the Convertible Notes.
On
May 1, 2025, the Company entered into a second amendment (the “Second Amendment”) to the Convertible Notes. Pursuant to
the Second Amendment, the Redemption Date (as defined in the Second Amendment) will now fall on December 1, 2026.
During the year ended December
31, 2024, $910,000 of Convertible Notes were converted into 556,623 shares of Common Stock. For more information regarding the Convertible
Notes, including the covenants related thereto, see Note 4 to the Consolidated Financial Statements.
On July 30, 2025, the Company entered into an underwriting agreement with
Craig-Hallum Capital Group LLC, in its capacity as underwriter, relating to the issuance and sale (the “Offering”) of 6,052,000
shares of the Company’s Common Stock. The public offering price in the Offering was $0.95 per share of Common Stock.
The closing of the Offering occurred on August 1, 2025. The net proceeds
to the Company from the Offering were approximately $5.3 million, after deducting underwriting discounts and commissions and estimated
offering expenses payable by the Company. The Company intends to use the net proceeds of the Offering for working capital and general
corporate purposes, such as product development, sales and marketing
The Company expects its existing cash and cash equivalents, and cash raised
from the Convertible Notes and the Offering on August 1, 2025, investments in debt securities,
and operating cash flows will be sufficient to meet its operational, business, and other liquidity requirements for at least the next
twelve (12) months from the date of issuance of the financial statements contained in this Quarterly Report. However, the Company has
based this estimate on assumptions that may prove to be wrong, and its operating plan may change as a result of many factors currently
unknown to it. In the event our financing needs are not able to be met by our existing cash, cash equivalents and investments, we would
seek to raise additional capital through strategic financial opportunities that could include, but are not limited to, future public or
private equity offerings, collaboration agreements, and/or other means. Any amounts raised may be used for the further development and
commercialization of product candidates, and for other working capital purposes. There is no guarantee that any of these strategic or
financing opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing shareholders.
As of June 30, 2025, cash, cash
equivalents, and restricted cash and cash equivalents were $4.0 million compared to $6.5 million as of December 31, 2024. The carrying
value of investment grade securities, including accrued interest as of June 30, 2025, was $3.3 million compared to $2.8 million as of
December 31, 2024. Additional $5.3 million was received from the net proceeds of the Offering
on August 1, 2025
Net
cash used in operating activities for the six months ended June 30, 2025 was $2.1 million, which was principally attributable to a net
loss of $3.8 million, partially offset by changes in operating assets and liabilities of $1.1 million and share-based compensation expenses
of $0.6 million.
Net
cash used in operating activities for the six months ended June 30, 2024 was $3.1 million, which was principally attributable to a net
loss of $4.0 million, partially offset by changes in operating assets and liabilities of $0.4 million and share-based compensation expenses
of $0.6 million.
Net cash used in investing activities for the six months ended June 30,
2025 was $0.5 million, compared to the net cash used in investing activities of $3.1 million
for the six months ended June 30, 2024. The change in investing activities was attributable to a reduction in purchases of investment
securities of $0.2 million, an increase in proceeds received from maturities of investment
securities of $2.5 million and proceeds from the sale of investment in Alphazyme in 2024 of $0.1
million.
Net cash provided by financing
activities for the six months ended June 30, 2025 was approximately $24,000, which was related to net proceeds from exercise
of stock, compared to the net cash provided by financing activity of $5.8 million for the six months ended June 30, 2024, which was related
to net proceeds from the issuance of Convertible Notes.
Item
3. Quantitative
and Qualitative Disclosures about Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required
under this item.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our
disclosure controls and procedures as of the end of the period covered by this report. The term “disclosure controls and procedures,”
as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls
and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that
it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC
rules and forms. Based on the evaluation of our disclosure controls and procedures as of the end of the period covered by this report,
our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were
effective.
Changes
in Internal Controls Over Financial Reporting
There
were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d)
and 15d-15(d) of the Exchange Act that occurred during the three months ended June 30, 2025, that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
Inherent
Limitation on Effectiveness of Controls
A
control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of
the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because
of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two
or more people, or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under
all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance
with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due
to error or fraud may occur and not be detected.
30
PART
II
Item
1. Legal
Proceedings
We
are not currently involved in any litigation that we believe could have a materially adverse effect in our financial condition or results
of operations. From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course
of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to
time that may harm our business. See Note 5 to the Consolidated Financial Statements for commitments and contingencies.
Item
1A. Risk
Factors
Other
than as set forth below, there have been no changes to our risk factors from those disclosed in our Annual Report for the 2024 fiscal
year filed on March 26, 2025.
We
have in the past, and may in the future, be unable to comply with the listing standards of the Nasdaq Stock Market LLC (“Nasdaq”).
If we fail to comply with listing standards in the future, our common stock may be delisted. Delisting could adversely affect the liquidity
of our common stock, and the market price of our common stock could decrease, and our ability to obtain sufficient additional capital
to fund our operations and to continue to operate as a going concern would be substantially impaired.
Our
common stock is currently listed on the Nasdaq Capital Market, which has minimum requirements that a company must meet in order to remain
listed. These requirements include maintaining a minimum Market Value of Listed Securities (“MVLS”) of $35 million, which
MVLS cannot fall below $35 million for a period of more than 30 consecutive trading days, or the “MVLS Requirement.” On June
23, 2025, we received a deficiency notice from the Staff of Nasdaq, notifying us that, for the last 30 consecutive business days, the
Company’s securities have not maintained the minimum MVLS of $35 million required by the continued listing requirements of Nasdaq
Listing Rule 5550(b)(2). The MVLS Notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital
Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days, or until December 20, 2025, to regain
compliance with the minimum MVLS requirement by having the Company’s MVLS close at $35 million or more for a minimum of 10 consecutive
business days before the MVLS Compliance Date (subject to the Staff’s discretion to extend this period under Nasdaq Listing Rule
5810(c)(3)(H)). On July 17, 2025, we received a separate deficiency notice from the Staff of Nasdaq notifying the Company that for the
last 30 consecutive business days the Company’s securities have not maintained the minimum bid price of at least $1 per share required
by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The Minimum Bid Price Notice has no immediate effect on the
listing of the Company’s common stock on the Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company
has 180 calendar days, or until January 13, 2026 to regain compliance with the minimum bid price requirement by having the Company’s
bid price close at $1 per share or more for a minimum of 10 consecutive business days before the Minimum Bid Price Compliance Date (subject
to the Staff’s discretion to extend this period under Nasdaq Listing Rule 5810(c)(3)(H)).
If
the Company does not regain compliance by the MVLS Compliance Date or the Minimum Bid Price Compliance Date, the Staff will provide written
notification that the Company’s common stock is subject to delisting. At that time, the Company may appeal the delisting determination
to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq listing rules. However, there can be no assurance that,
if the Company receives a delisting notice and appeals the delisting determination by Nasdaq to the panel, such appeal would be successful.
In the event we fail to comply with listing standards in the future, and we do not regain compliance with the MVLS Requirement or the
Minimum Bid Price Requirement prior to the expiration of the applicable compliance period, unless Nasdaq exercises its discretion to
extend this period, our common stock may be subject to a delisting action by Nasdaq.
In
the event that our common stock is delisted from Nasdaq as a result of our failure to comply with the MVLS Requirement or the Minimum
Bid Price Requirement, as a result of Nasdaq not granting us an extension or the panel not granting us a favorable decision or due to
our failure to continue to comply with any other requirement for continued listing on Nasdaq, trading of our common stock could be conducted
in the over-the-counter market established for unlisted securities such as the OTCQX, the OTCQB, the OTCID Basic Market or the Pink Limited
Market, but there can be no assurance that our common stock will be eligible for trading on any such alternative market.
Additionally,
if our common stock is delisted from Nasdaq, the liquidity of our common stock would be adversely affected, the market price of our common
stock could decrease, our ability to obtain sufficient additional capital to fund our operations and to continue to operate as a going
concern would be substantially impaired and transactions in our common stock could lose federal preemption of state securities laws.
Furthermore, there could also be a reduction in our coverage by securities analysts, and the news media and broker-dealers may be deterred
from making a market in or otherwise seeking or generating interest in our common stock, which could cause the price of our common stock
to decline further. Moreover, delisting may also negatively affect our collaborators’, vendors’, suppliers’ and employees’
confidence in us and employee morale.
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults
Upon Senior Securities
Not
applicable.
Item
4. Mine
Safety Disclosures
Not
applicable.
Item
5. Other
Information
(a)
None.
(b)
None.
(c)
For the quarter ended June 30, 2025, none of our directors
or officers (as defined in Section 16 of the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a
“non-Rule 10b5-1 trading arrangement” (each as defined in Item 408(a) and (c), respectively, of Regulation S-K).
31
Item
6. Exhibits
The
following Exhibits are filed as part of this report pursuant to Item 601 of Regulation S- K:
Incorporated
by Reference
Exhibit
No.
Description
of Exhibit
Form
Original
No.
Date
Filed
Filed
Herewith
3.1
Restated Certificate of Incorporation dated November 1, 2004
10- 12G
3.1
January
14, 2019
3.3
Fourth
Amended and Restated Bylaws of Dyadic International, Inc., effective May 29, 2025
8- K
3.1
June
2, 2025
4.1
Second Amendment to Form of Senior Secured Convertible Promissory Note due March 8,2027
8- K
4.1
May
5, 2025
31.1
Certification of Principal Executive Officer of Dyadic Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
x
31.2
Certification of Principal Financial Officer of Dyadic Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
x
32.1
Certification of Principal Executive Officer of Dyadic Pursuant to18 U.S.C Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (1)
32.2
Certification of Principal Financial Officer of Dyadic Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (1)
101.INS
Inline
XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline
XBRL Taxonomy Extension Labels Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (embedded within the Inline XBRL and contained in
Exhibit
101)
(1)
Furnished herewith.
32
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
DYADIC
INTERNATIONAL, INC.
August
13, 2025
By:
/s/
Mark A. Emalfarb
Mark
A. Emalfarb
Chief Executive Officer
(Principal
Executive Officer)
August
13, 2025
By:
/s/
Ping W. Rawson
Ping
W. Rawson
Chief
Financial Officer
(Principal
Financial Officer and Principal Accounting Officer)
33
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.