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 March 31, 2026
OR
☐ 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: 001-41294
Onconetix,
Inc.
(Exact
name of registrant as specified in its charter)
Delaware 83-2262816
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
201 E. Fifth Street , Suite 1900
Cincinnati , OH 45202
(Address of principal executive offices) (Zip Code)
(513)
620-4101
(Registrant’s
telephone number, including area code)
Not
Applicable
(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 exchange on which registered
Common stock, $0.00001 par value ONCO 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 ☒
As
of May 12, 2026, the registrant had 11,464,572 shares of common stock, $0.00001 par value per share, outstanding.
TABLE
OF CONTENTS
Page
Cautionary
Note Regarding Forward-Looking Statements
ii
PART I.
FINANCIAL
INFORMATION
1
Item 1.
Condensed
Consolidated Financial Statements (unaudited)
1
Condensed
Consolidated Balance Sheets
1
Condensed
Consolidated Statements of Operations and Comprehensive Loss
2
Condensed
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
3
Condensed
Consolidated Statements of Cash Flows
4
Notes
to Unaudited Condensed Financial Statements
5
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
23
Item 3.
Quantitative
and Qualitative Disclosures About Market Risk.
37
Item 4.
Controls
and Procedures.
37
PART II.
OTHER
INFORMATION
39
Item 1.
Legal
Proceedings.
39
Item 1A.
Risk
Factors.
39
Item 2.
Unregistered
Sales of Equity Securities and Use of Proceeds.
44
Item 3.
Defaults
Upon Senior Securities.
44
Item 4.
Mine
Safety Disclosures.
44
Item 5.
Other
Information.
44
Item 6.
Exhibits.
45
Signatures
46
i
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q (this “Report”) contains forward-looking statements that reflect our current expectations and
views of future events. The forward-looking statements are contained principally in the sections entitled “Risk Factors”
and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Readers are cautioned
that known and unknown risks, uncertainties and other factors, including those over which we may have no control and others listed in
the “Risk Factors” section of this Report, may cause our actual results, performance or achievements to be materially different
from those expressed or implied by the forward-looking statements.
In
some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”
“believe,” “estimate,” “predict,” “project,” “potential,” “continue”
and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the
future, although not all forward-looking statements contain these words. These statements relate to future events or our future financial
performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels
of activity, performance, or achievement to differ materially from those expressed or implied by these forward-looking statements. These
forward-looking statements include, but are not limited to, statements about:
●
our projected financial
position and estimated cash burn rate;
●
our estimates regarding
expenses, future revenues and capital requirements;
●
our ability to continue
as a going concern;
●
our need to raise substantial
additional capital to fund our operations and repay indebtness;
●
our ability to commercialize
or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix AG (“Proteomedix”);
●
our reliance on third parties,
including Laboratory Corporation of America (“LabCorp”), to develop, market, distribute and sell Proclarix;
●
the successful development
of our commercialization capabilities, including sales and marketing capabilities;
●
our ability to consummate
the transaction on a timely basis as contemplated by the Share Exchange Agreement with Realbotix, LLC (“Realbotix” and
the “Share Exchange Agreement” and the transactions contemplated therein, the “Realbotix Transaction”) and
the anticipated benefits of the Realbotix Transaction;
●
our ability to maintain
the necessary regulatory approvals to market and commercialize our product;
●
the results of market research
conducted by us or others;
●
our ability to obtain and
maintain intellectual property protection for our current product;
●
our ability to protect
our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual
property rights;
●
the possibility that a
third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their intellectual property
rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us;
ii
●
our reliance on third parties,
including manufacturers and logistics companies;
●
the success of competing
therapies or diagnostics and products that are or become available;
●
our ability to successfully
compete against current and future competitors;
●
our ability to expand our
organization to accommodate potential growth and our ability to attract, motivate and retain key personnel;
●
the potential for us to
incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits
to cause us to limit our commercialization of our product;
●
market acceptance of our
product, the size and growth of the potential markets for our current product, and our ability to serve those markets; and
●
disruptions in the business
of Onconetix or Proteomedix, which could have an adverse effect on their respective businesses and financial results.
These
forward-looking statements involve numerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking
statements are reasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other
matters that we anticipate herein could be materially different from our expectations. Important risks and factors that could cause our
actual results to be materially different from our expectations are generally set forth in “Risk Factors,” “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” and other sections in this Report. You should thoroughly
read this Report and the documents that we refer to with the understanding that our actual future results may be materially different
from and worse than what we expect. We qualify all our forward-looking statements by these cautionary statements.
The
forward-looking statements made in this Report relate only to events or information as of the date on which the statements are made in
this Report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence
of unanticipated events. You should read this Report and the documents that we refer to in this Report and have filed as exhibits to
this Report, completely and with the understanding that our actual future results may be materially different from what we expect.
iii
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
ONCONETIX,
INC.
Condensed Consolidated Balance Sheets
March 31,
December 31,
2026
2025
(Unaudited)
ASSETS
Current assets
Cash
$ 3,716,072
$ 5,220,654
Accounts receivable, net
43,725
296,866
Inventories
137,642
149,961
Investor receivable
—
50,000
Prepaid
expenses and other current assets
431,915
349,293
Total current assets
4,329,354
6,066,774
Property
and equipment, net
31,533
37,085
Deferred
offering costs
225,000
225,000
Operating
right of use asset
42,726
48,774
Goodwill
10,203,473
18,549,005
Total
assets
$ 14,832,086
$ 24,926,638
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current
liabilities
Accounts payable
$ 1,532,885
$ 1,757,695
Accrued expenses
279,121
341,881
Notes
payable
247,196
—
Operating lease liability,
current
24,415
24,412
Contingent warrant liabilities
24,978
26,590
Derivative
liabilities
956,979
6,985,347
Total current liabilities
3,065,574
9,135,925
Operating
lease liability, net of current portion
18,311
24,362
Total
liabilities
$ 3,083,885
9,160,287
Commitments
and Contingencies
Series C Redeemable Preferred Stock, $ 0.00001 par value, 10,000 shares authorized, 7 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively
1,724
1,724
Stockholders’
equity
Common stock, $ 0.00001 par value, 250,000,000 shares authorized at March 31, 2026 and December 31, 2025; 2,755,184 and 312,028 shares issued at March 31, 2026 and December 31, 2025, respectively; 2,755,154 and 311,998 shares outstanding at March 31, 2026 and December 31, 2025, respectively
27
3
Series D Preferred Stock, $ 0.00001 par value, 32,000 shares authorized at March 31, 2026 and December 31, 2025; 9,952 and 16,325 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively.
—
—
Series E Preferred Stock, $ 0.00001 par value, 10,000 shares authorized at March 31, 2026 and December 31, 2025; 7,581 and 7,813 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively.
—
—
Additional
paid-in capital
148,242,874
147,836,001
Treasury stock, at cost; 30 shares of common stock at March 31, 2026 and December 31, 2025
( 625,791 )
( 625,791 )
Accumulated
deficit
( 135,429,433 )
( 131,214,558 )
Accumulated
other comprehensive loss
( 441,200 )
( 231,028 )
Total
stockholders’ equity
11,746,477
15,764,627
Total
liabilities, convertible preferred stock, and stockholders’ equity
$ 14,832,086
$ 24,926,638
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
ONCONETIX,
INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
For
the three months ended
March
31,
2026
March
31,
2025
Revenue
$
21,457
$
101,630
Cost
of revenue
23,112
55,798
Gross
profit
( 1,655
)
45,832
Operating
expenses
Selling,
general, and administrative
2,039,328
1,674,206
Research
and development
50,818
24,455
Impairment
of goodwill
8,134,000
10,918,000
Total
operating expenses
10,224,146
12,616,661
Loss
from operations
( 10,225,801
)
( 12,570,829
)
Other
(expense) income
Interest expense
( 2,244
)
( 223,592
)
Change in fair value of subscription
agreement liability – related party
—
3,319,000
Change in fair value of contingent
warrant liabilities
1,612
( 9,795
)
Change in fair value of Series
D Derivative Liability
3,955,778
—
Change in fair value of Series
E Derivative Liability
2,072,590
—
Gain on forgiveness of accounts
payable
—
944,694
Other
income (loss)
( 16,810
)
( 5,363
)
Total
other income (loss)
6,010,926
4,024,944
Loss
before income taxes
( 4,214,875
)
( 8,545,885
)
Income
tax benefit
—
—
Net
loss
$
( 4,214,875
)
$
( 8,545,885
)
Deemed dividend Series
C preferred stock
—
( 1,170,091
)
Net
loss applicable to common stockholders
( 4,214,875
)
( 9,715,976
)
Net loss
per share, basic and diluted
$
( 6.71
)
$
( 227.25
)
Weighted
average number of common shares outstanding, basic and diluted
628,528
42,755
Other
comprehensive income (loss)
Net loss
$
( 4,214,875
)
$
( 8,545,885
)
Foreign currency translation
( 210,172
)
141,048
Change
in pension benefit obligation
—
( 30,779
)
Total
comprehensive loss
$
( 4,425,047
)
$
( 8,435,616
)
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ONCONETIX,
INC.
Condensed
Consolidated Statements of Convertible Preferred Stock and
Stockholders’
Equity (Deficit)
(Unaudited)
Series
A
Preferred Stock
Common
Stock
Additional
Paid-in
Treasury
Stock
Accumulated
Accumulated
Other
Comprehensive
Due
from
Total
Onconetix
Equity
Total
Stockholders’
Equity
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Income
Shareholders
(Deficit)
(Deficit)
Balance
at December 31, 2024
-
$ -
27,684
$ —
$ 127,825,744
( 30 )
$ ( 625,791 )
$ ( 115,683,621 )
$ ( 2,723,397 )
( 250,308 )
$ 8,542,627
$ 8,542,627
Issuance
of common stock in connection with the ELOC
—
—
58,838
1
4,776,308
—
—
—
—
250,308
5,026,617
5,026,617
Stock-based
compensation expense
—
—
—
—
29,256
—
—
—
—
—
29,256
29,256
Redemption
of Series C Preferred Stock
—
—
—
—
—
—
—
( 1,170,091 )
—
—
( 1,170,091 )
( 1,170,091 )
Foreign
currency translation adjustment
—
—
—
—
—
—
—
—
141,048
—
141,048
141,048
Change
in pension benefit obligation
—
—
—
—
—
—
—
—
( 30,779 )
—
( 30,779 )
( 30,779 )
Net
loss
—
—
—
—
—
—
—
( 8,545,885 )
—
—
( 8,545,885 )
( 8,545,885 )
Balance
at March 31, 2025
—
$ —
86,522
$ 1
$ 132,631,308
( 30 )
$ ( 625,791 )
$ ( 125,399,597 )
$ ( 2,613,128 )
—
$ 3,992,793
$ 3,992,793
Series
D
Series
E
Accumulated
Preferred
Preferred
Additional
Other
Total
Stock
Stock
Common
Stock
Paid-in
Treasury
Stock
Accumulated
Comprehensive
Stockholders’
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Income
Equity (Deficit)
Balance
at December 31, 2025
16,325
$ -
7,813
$ -
312,028
3
$ 147,836,001
( 30 )
$ ( 625,791 )
$ ( 131,214,558 )
$ ( 231,028 )
$ 15,764,627
Stock-based
compensation expense
—
—
—
—
—
—
22,305
—
—
—
—
22,305
Conversion
of Series E Preferred Stock to Common Stock
—
—
( 232 )
—
76,555
1
( 1 )
—
—
—
—
—
Conversion
of Series D Preferred Stock to Common Stock
( 6,373 )
—
—
—
2,222,656
22
( 22 )
—
—
—
—
—
Issuance
of Common Stock for Warrant Exercise
—
—
—
—
144,087
1
384,841
—
—
—
—
384,842
Cancellation
of restricted common stock
—
—
—
—
( 131 )
—
—
—
—
—
—
—
Cash in
lieu of shares
—
—
—
—
( 11 )
—
( 250 )
—
—
—
—
( 250 )
Foreign
currency translation adjustment
—
—
—
—
—
—
—
—
—
—
( 210,172 )
( 210,172 )
Net
loss
—
—
—
—
—
—
—
—
—
( 4,214,875
)
—
( 4,214,875
)
Balance
at March 31, 2026
9,952
$ —
7,581
$ —
2,755,184
27
$ 148,242,874
( 30 )
$ ( 625,791 )
$ ( 135,429,433 )
$ ( 441,200 )
$ 11,746,477
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ONCONETIX,
INC.
Consolidated Statements of Cash Flows
(Unaudited)
Three
Months
Ended
March 31,
2026
Three
Months
Ended
March 31,
2025
Cash flows from operating activities
Net
loss
$ ( 4,214,875
)
$ ( 8,545,885 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Loss
on impairment of goodwill
8,134,000
10,918,000
Amortization
of debt discounts
—
4,966
Depreciation
and amortization
5,398
4,748
Change
in fair value of subscription agreement liability – related party
—
( 3,319,000 )
Net periodic
pension benefit
—
( 89,827 )
Stock-based
compensation
22,305
29,256
Gain
on forgiveness of accounts payable
—
( 944,694 )
Change
in fair value of contingent warrant liability
( 1,612 )
9,795
Change
in fair value of Series D derivative liability
( 3,955,778
)
—
Change
in fair value of Series E derivative liability
( 2,072,590
)
—
Disposal
of property and equipment
—
2,472
Changes
in operating assets and liabilities:
Accounts
receivable
270,735
9,453
Inventories
11,654
( 91,019 )
Investor
receivable
50,000
—
Prepaid
expenses and other current assets
( 83,396 )
3,638
Accounts
payable
( 224,779 )
( 261,362 )
Accrued
expenses
( 62,543 )
269,779
Net
cash used in operating activities
( 2,121,481 )
( 1,999,680 )
Cash
flows from investing activities
Net
cash Provided by (used in) investing activities
—
—
Cash
flows from financing activities
Proceeds
from issuance of note payable
247,196
100,000
Principal
payments of notes payable
—
( 937,550 )
Payment
for redemption of Series C Preferred Stock
—
( 1,318,813 )
Proceeds from exercise
of warrants
384,842
—
Cash in lieu of shares
( 250 )
—
Proceeds
from issuance of common stock in connection with the ELOC
—
5,026,617
Net
cash provided by financing activities
631,788
2,870,254
Effect
of exchange rate changes on cash
( 14,889 )
60,119
Net increase
(decrease) in cash
( 1,504,582 )
930,693
Cash,
beginning of period
5,220,654
646,500
Cash,
end of period
$ 3,716,072
$ 1,577,193
Supplemental
disclosure of cash flow information:
Cash
paid for interest
$ —
$ 21,162
Noncash
investing and financing activities:
D&O
insurance premium financed
$ —
$ 460,875
Conversion
of Series D preferred stock to common stock
$ 22
$ —
Conversion
of Series E preferred stock to common stock
$ 1
$ —
Deemed
dividend owed to Series C preferred stock shareholders
$ —
$ 394,757
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 1
— Organization and Basis of Presentation
Organization
and Nature of Operations
Onconetix,
Inc. (formerly known as Blue Water Biotech, Inc. and Blue Water Vaccines Inc.) (the “Company” or “Onconetix”)
was formed on October 26, 2018, and is a commercial stage biotechnology company focused on the research, development, and commercialization
of innovative solutions for oncology.
On
December 15, 2023, Onconetix acquired 100 % of the issued and outstanding voting equity interests in Proteomedix AG, a Swiss company
(“Proteomedix” or “PMX”), and its related diagnostic product Proclarix. As a result of this transaction, Proteomedix
became a wholly owned subsidiary of Onconetix. Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis.
Proteomedix has identified novel biomarker signatures with utility in prostate cancer diagnosis, prognosis and therapy management.
In
April 2023, the Company acquired ENTADFI, a Food and Drug Administration (“FDA”)-approved, once daily pill that combines
finasteride and tadalafil for the treatment of benign prostatic hyperplasia.
Historically,
the Company’s focus was on the research and development of transformational vaccines to prevent infectious diseases worldwide,
until the third quarter of 2023, at which time the Company halted its efforts on vaccine development activities to focus on commercialization
activities for ENTADFI and pursue other potential acquisitions. However, in light of (i) the time and resources needed to continue pursuing
commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company abandoned commercialization of ENTADFI
and the ENTADFI assets were fully impaired at June 30, 2024 (see Notes 4 and 5).
On
April 21, 2023, the Company filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of
Delaware to change its corporate name from “Blue Water Vaccines Inc.” to “Blue Water Biotech, Inc.” The name
change was effective as of April 21, 2023. On December 15, 2023, the Company filed an amendment to its Amended and Restated Certificate
of Incorporation with the Secretary of State of Delaware to change its corporate name from “Blue Water Biotech, Inc.” to
“Onconetix, Inc.” In connection with each of the name changes, the Company also amended the Company’s bylaws to reflect
the new corporate name.
Reverse
Stock Split
On
June 13, 2025, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-eighty-five
(1:85). The Company accounted for the reverse stock split on a retrospective basis pursuant to ASC
260, Earnings Per Share . All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise
prices and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect
the reverse stock split for all periods presented. The number of authorized shares and par value of the preferred
stock and common stock were not adjusted because of the reverse stock split.
On
March 25, 2026, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-five
(1:5). The Company accounted for the reverse stock split on a retrospective basis pursuant to ASC
260, Earnings Per Share . All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise
prices and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect
the reverse stock split for all periods presented. The number of authorized shares and par value of the preferred
stock and common stock were not adjusted because of the reverse stock split.
5
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 1
— Organization and Basis of Presentation (cont.)
Basis
of Presentation and Principles of Consolidation
The
Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted
in the United States of America (“U.S. GAAP”) and include the accounts of Onconetix and its 100 % wholly owned subsidiary,
Proteomedix, since the acquisition date of December 15, 2023. All significant intercompany balances and transactions have been eliminated
in consolidation.
Unaudited
Interim Consolidated Financial Statements
The
accompanying condensed consolidated balance sheet as of March 31, 2026, and the condensed consolidated statements of operations and comprehensive
loss and the condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three
months ended March 31, 2026 and 2025, and the condensed consolidated statements of cash flows for the three months ended March 31, 2026
and 2025 are unaudited. These unaudited interim consolidated financial statements have been prepared on the same basis as the audited
consolidated financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments,
necessary for the fair statement of the Company’s financial position as of March 31, 2026 and its results of operations and comprehensive
loss for the three months ended March 31, 2026 and 2025, and its cash flows for the three months ended March 31, 2026 and 2025. The financial
data and the other financial information disclosed in the notes to these condensed consolidated financial statements related to the three-month periods
are also unaudited. Operating results for the three months ended March 31, 2026, are not necessarily indicative of the results that may
be expected for the year ended December 31, 2026, any other interim periods, or any future year or period. The unaudited condensed
consolidated financial statements included in this Report should be read in conjunction with the audited consolidated financial statements
and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which includes a broader
discussion of the Company’s business and the risks inherent therein.
Note 2
— Going Concern and Management’s Plans
The
Company’s operating activities to date have been devoted to seeking licenses, engaging in research and development activities,
potential asset and business acquisitions, expenditures associated with the previously planned commercial launch of ENTADFI, and the
commercialization of Proclarix.
The
Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the
foreseeable future.
As of March 31, 2026, the Company had cash of approximately $ 3.7 million, a working capital surplus of approximately $ 1.3 million and an accumulated deficit of approximately $ 135.4 million. During the three months ended March 31, 2026, the Company used approximately $ 2.1 million in cash for operating activities. In addition, as of May 11, 2026, the Company’s cash balance was approximately $ 4.1 million.
The
Company successfully closed a Series D financing and a Series E financing in September 2025
and October 2025, respectively. These financings provided the Company with additional cash
flow to support near-term operations. While these capital raises may enable the Company to
sustain current operations and meet existing obligations, the Company continues to generate
recurring net operating losses and has not yet established sustained positive cash flows
to support its strategic growth initiatives, which includes the commercialization of Proclarix,
and participation in strategic transactions and investments, including its involvement with
Realbotix. These factors raise substantial doubt about the Company’s ability to continue
as a going concern within one year from the date of the issuance of these consolidated financial
statements.
Management’s
plans for funding the Company’s operations include advancing its strategic initiatives, including commercialization efforts related
to Proclarix, and execution of recent and potential strategic transactions. Management also intends to pursue additional equity or debt
financing to support operations and strategic initiatives. However, there are currently no committed sources of financing, and there
is no assurance that additional funding will be available on favorable terms, if at all. This uncertainty raises significant concern
about the Company’s ability to sustain operations and execute its strategic initiatives. If additional capital is not secured,
the Company may need to curtail clinical trials, development, and commercialization efforts, and take further measures to reduce expenses
to conserve cash.
Because
of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s
ability to continue as a going concern for one year from the issuance of the unaudited condensed consolidated financial statements, which
is not alleviated by management’s plans. The unaudited condensed consolidated financial statements have been prepared under the
going concern basis of accounting. These unaudited condensed consolidated financial statements do not include any adjustments that might
be necessary from the outcome of this uncertainty.
6
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 3
— Summary of Significant Accounting Policies
During
the three months ended March 31, 2026, there were no changes to the Company’s significant accounting policies described in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2025. Selected significant accounting policies are discussed
in further detail below:
Fair
Value Measurements
Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
●
Level 1, defined as observable
inputs such as quoted prices (unadjusted) for identical instruments in active markets;
●
Level 2, defined as inputs
other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments
in active markets or quoted prices for identical or similar instruments in markets that are not active; and
●
Level 3, defined as unobservable
inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations
derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
In
some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In
those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input
that is significant to the fair value measurement. Financial instruments, including cash, inventory, accounts receivable, accounts payable,
accrued liabilities, operating lease liabilities, and notes payable are carried at cost, which management believes approximates fair
value due to the short-term nature of these instruments.
The
fair value of the contingent warrant liability and the related party subscription agreement liability are valued using significant unobservable
measures and other fair value inputs and are therefore classified as Level 3 financial instruments.
The
fair value of financial instruments measured on a recurring basis is as follows as of March 31, 2026 and December 31, 2025:
As
of March 31, 2026
Description
Total
Level 1
Level 2
Level
3
Liabilities:
Contingent warrant liability
$
24,978
—
—
$
24,978
Series D and E derivative
liabilities
$
956,979
—
—
$
956,979
Total
$
981,957
$
—
$
—
$
981,957
As
of December 31, 2025
Description
Total
Level
1
Level
2
Level
3
Liabilities:
Contingent warrant liability
$ 26,590
—
—
$ 26,590
Series D and E derivative
liabilities
$ 6,985,347
—
—
$ 6,985,347
Total
$ 7,011,937
$ —
$ —
$ 7,011,937
7
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 3
— Summary of Significant Accounting Policies (cont.)
These
non-financial assets had been valued using significant unobservable measures and other fair value inputs and were classified as Level
3 measurements.
None
of the Company’s other non-financial assets or liabilities are recorded at fair value on a non-recurring basis as
of March 31, 2026 and December 31, 2025. There were no transfers between levels during the periods presented.
Revenue
Recognition
The
following is a description of principal activities from which the Company generates its revenue:
Development
Services
Proteomedix
provides a range of services to life sciences customers referred to as “Development Services” including testing for biomarker
discovery, assay design and development. These Development Services are performed under individual statement of work (“SOW”)
arrangements with specific deliverables defined by the customer. Development Services are generally performed on a time and materials
basis. During the performance and through completion of the service to the customer in accordance with the SOW, the Company has the right
to bill the customer for the agreed upon price and recognizes the Development Services revenue over the period estimated to complete
the SOW. The Company generally identifies each SOW as a single performance obligation.
Completion
of the service and satisfaction of the performance obligation under a SOW is typically evidenced by access to the data or test made available
to the customer or any other form or applicable manner of delivery defined in the SOW. However, for certain SOWs under which work is
performed pursuant to the customer’s highly customized specifications, the Company has the enforceable right to bill the customer
for work completed, rather than upon completion of the SOW. For those SOWs, the Company recognizes revenue over a period of time during
which the work is performed based on the expended efforts (inputs). As the performance obligation under the SOW is satisfied, any amounts
earned as revenue and billed to the customer are included in accounts receivable.
Product
Sales
The
Company derives revenue through sales of its products, which includes Proclarix, its diagnostic product, directly to end users, including
laboratories, hospitals, and medical centers, and to distributors. The Company considers customer purchase orders, which in some cases
are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. For each contract, the
Company considers the promise to transfer products, each of which is distinct, to be the identified performance obligations. In determining
the transaction price, the Company evaluates whether the price is subject to refund or adjustment to determine the net consideration
to which it expects to be entitled. The Company fulfills its performance obligation applicable to product sales once the product is transferred
to the customer.
Other
Revenue
The
Company generates other revenue including license revenue through agreements that grant third parties rights to use its intellectual
property and proprietary materials. In September 2025, the Company entered into a license agreement with Immunovia AB, under which it
granted exclusive rights to certain intellectual property and transferred biological materials related to the PancreaSure™ test.
The agreement included two non-refundable payments of $ 0.3 million. Based on the terms of the agreement and the nature of the license,
the Company determined that the performance obligations were satisfied upon the transfer of the licensed rights. Accordingly, the Company
recognized $ 0.6 million as license revenue during the year ended December 31, 2025. The license agreement also states that the Company
shall earn a 3 % royalty on any sales Immunovia has from products developed using the licensed intellectual property. Further, Immunovia
agreed to pay the Company $ 0.1 million for the delivery of the biological materials. As of March 31, 2026, the Company had not recognized
any revenue due to the royalties or due to the biological materials.
During
the three months ended March 31, 2026 and 2025, the Company recognized revenue of approximately $0.02 million and $ 0.1 million, respectively.
Any
revenues earned but not yet billed to the customer as of the date of the condensed consolidated financial statements are recorded as
contract assets and are included in prepaid expenses and other current assets in the accompanying condensed consolidated financial statements.
The Company had no unbilled accounts receivable as of March 31, 2026 and December 31, 2025. Amounts recorded in contract assets are reclassified
to accounts receivable in our condensed consolidated financial statements when the customer is invoiced according to the billing schedule
in the contract. Accounts receivable was approximately $ 0.04 million and $ 0.3 million as of March 31, 2026 and December 31, 2025, respectively.
8
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 3
— Summary of Significant Accounting Policies (cont.)
In
relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs
to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred.
New
Accounting Pronouncement s
There
were no new accounting pronouncements issued since the Company’s filing of the Annual Report on Form 10-K for the year ended December
31, 2025, which could have a significant effect on the accompanying condensed consolidated financial statements.
Note 4
— Balance Sheet Details
Inventories
Inventories,
which primarily relate to Proclarix product as of March 31, 2026 and Proclarix products as of December 31, 2025, consisted of the
following:
March
31,
2026
December 31,
2025
Raw
materials
$ 95,570
$ 103,431
Finished
goods
42,072
46,530
Total
$ 137,642
$ 149,961
Prepaid
Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following as of March 31, 2026, and December 31, 2025:
March
31,
2026
December 31,
2025
Prepaid insurance
$ 296,475
$ 136,739
VAT taxes receivable
46,352
31,955
Prepaid other
79,102
170,552
Other receivable
9,986
10,047
Total
$ 431,915
$ 349,293
Goodwill
Goodwill
consisted of the following as of March 31, 2026 and December 31, 2025:
Balance as of December 31, 2024
27,048,973
Impairment loss
( 11,512,000 )
Foreign currency translation
3,012,032
Balance as of December
31, 2025
$ 18,549,005
Impairment loss
( 8,134,000 )
Foreign currency translation
( 211,532 )
Balance as of March 31,
2026
$ 10,203,473
9
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 4
— Balance Sheet Details (cont.)
Impairments
for three months ended March 31, 2026 and 2025
During
the three months ended March 31, 2026 and 2025, the Company’s stock price and market capitalization declined, and the Company determined
that this was an indicator of a potential impairment of its goodwill. Accordingly, as of March 31, 2026 and 2025, the Company performed
quantitative analysis to identify and measure the amount of impairment losses to be recognized. The Company recognized goodwill impairment
losses of approximately $ 8.1 million and $ 10.9 million for the three months ended March 31, 2026 and 2025, respectively.
Under
the income approach, the Company estimated the fair value of the reporting unit based on the present value of estimated future cash flows,
which the Company considers to be a Level 3 unobservable input in the fair value hierarchy. The Company prepared cash flow projections
based on management’s estimates of future revenue and operating costs, taking into consideration the historical performance and
the current macroeconomic, industry, and market conditions. The Company based the discount rate on the weighted-average cost of capital
considering Company-specific characteristics and changes in the reporting unit’s projected cash flows. Under the market approach,
the Company estimated the fair value of the reporting unit based on revenue market multiples derived from comparable companies with similar
characteristics as the reporting unit, as well as an estimated control premium.
Accrued
Expenses
Accrued
expenses consisted of the following as of March 31, 2026 and December 31, 2025:
March
31,
2026
December 31,
2025
Accrued compensation
$ 41,663
$ 42,228
Accrued professional fees
139,004
201,208
Other accrued expenses
16,750
18,445
Accrued franchise taxes
80,000
80,000
Accrued interest
1,704
—
Total
$ 279,121
$ 341,881
Note 5
— Significant Agreements
Immunovia
AB
On
September 17, 2025, Proteomedix entered into a license agreement with Immunovia AB, pursuant to which Immunovia obtained exclusive rights
to certain intellectual property and proprietary biological materials related to the PancreaSure™ test. In exchange for these rights,
Immunovia paid Proteomedix a non-refundable upfront license fee of $ 0.3 million. Based on the terms of the agreement and the nature of
the license, the Company determined that the performance obligations were satisfied upon the transfer of the licensed rights. Accordingly,
the Company recognized the $ 0.6 million as license revenue during the year ended December 31, 2025. Additionally, the agreement
provided for a second payment of $ 0.3 million due by March 31, 2026, which was received during the three months ended March 31, 2026,
and is no longer shown as a part of Accounts receivable, net on the consolidated balance sheet as of March 31, 2026.
10
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Notes
6 — Notes Payable
Insurance
Financing
During
the three months ended March 31, 2026, the Company obtained financing for certain Director & Officer liability insurance policy premiums.
The agreement assigns the lender a first priority lien on and security interest in the financed policies and any additional
premium required in the financed policies.
The
total premiums, taxes and fees financed are approximately $ 0.3 million, with an annual interest rate of 8.5 %. In consideration
of the premium payment by the lender to the insurance companies or the agent or broker, the Company unconditionally promised to pay the
lender the amount financed plus interest and other charges permitted under the agreement. At March 31, 2026, the Company recognized approximately
$ 0.2 million as an insurance financing note payable, which is included in the current portion of notes payable in the accompanying
condensed consolidated balance sheets. The Company will pay the insurance financing through monthly installment payments of approximately
$ 25,693 , with the last payment for the note due on December 17, 2026 .
During
the three months ended March 31, 2026, the Company recorded approximately $ 2,000 of interest expense. As of March 31, 2026 and December
31, 2025, the Company has recorded accrued interest of approximately $ 2,000 and $ 0 , respectively, which is included in accrued expenses
in the accompanying condensed consolidated balance sheets.
Note
7 — Subscription Agreement
On
December 18, 2023, the Company entered into a subscription agreement (the “Subscription Agreement”) with the PMX Investor,
who became a stockholder of Onconetix at the closing of the PMX Transaction, for the sale of 1,176 units, each comprised of 1 share of
common stock and 0.30 pre-funded warrants (the “Units”) at $ 4,250 per Unit. The Subscription Agreement includes a make-whole
provision (the “Make-Whole Provision”) which requires the issuance of additional shares of common stock in the event that
the 270-day volume weighted average price after the closing of the Subscription Agreement, is below $ 4,250 , and the PMX Investor still
holds the common shares acquired upon closing of the Subscription Agreement 270 days after such closing. The Subscription Agreement would
only close upon obtaining stockholder approval for certain transactions involving the Company’s Series B Preferred Stock. The Subscription
Agreement was amended on January 23, 2024 to include a provision for interest on the $ 5 million debenture, accruing at a rate of 4 %,
to be included in the calculation of the units to be issued upon the conversion. Stockholder approval was obtained on September 5, 2024,
and as a result, the conversion and the issuance of 1,176 units, attributable to the Subscription Agreement, and 32 units, attributable
to additional accrued interest under the debenture to the PMX Investor took place on September 24, 2024.
As
of March 31, 2026 and December 31, 2025, the fair value of the related party subscription agreement liability was $ 0 . The change in fair
value of the related party subscription agreement liability for the three months ended March 31, 2026 and 2025 was $ 0 and a decrease
of $ 3,319,000 , respectively.
11
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 8
— Warrant and derivative liabilities
Contingent
warrant liabilities
The
following table summarizes the activity for the contingent warrant liabilities, using unobservable Level 3 inputs, for the three months
ended March 31, 2026:
Contingent
Warrant
Liability
Balance at December 31, 2025
26,590
Change in fair value
( 1,612 )
Balance at March 31, 2026
$ 24,978
Series
D derivative liabilities and warrant liabilities
On
September 22, 2025, the Company completed a private placement transaction with institutional investors, resulting in the issuance of
Series D convertible preferred stock and accompanying warrants to purchase shares of common stock. In connection with the Series D PIPE
Financing, the Company recorded warrant liabilities related to the Series D Warrants and derivative liabilities associated with certain
embedded features in the Series D Preferred Stock. These instruments were classified as liabilities and measured at fair value in accordance
with ASC 815 due to their settlement provisions and other contractual terms. Refer to Note 9 for further details on the private placement
transaction.
The
Company measured its bifurcated embedded derivative liabilities and warrant liabilities as of March 31, 2026, December 31, 2025 and September
22, 2025, at fair value on a recurring basis using level 3 inputs. These financial instruments are measured using management’s
best estimate of fair value, where the inputs into the determination of fair value require significant management judgment to estimation.
The derivative liabilities and warrant liabilities were both measured using Monte Carlo valuation models. Valuations based on unobservable
inputs are highly subjective and require significant judgments. Changes in such judgments could have a material impact on fair value
estimates.
As
of December 11, 2025, the Company had entered a letter of intent with Realbotix (“LOI”), which contemplates a change of control
transaction. A closing condition of the LOI is that no convertible securities of the Company will be outstanding prior to, or upon, closing
(subject to approval of the preferred shareholders) which creates two distinct timing scenarios for the settlement of the preferred securities:
prior to, or at closing, pursuant to the terms of the LOI or after closing in the event the transaction proposed by the LOI is not completed.
Given the disparate timing conditions, the valuation included two scenarios in the Monte Carlo valuation analysis as of March 31, 2026
and December 31, 2025: Closing and No Closing. The Closing scenario includes settlement logic for the preferred securities based on the
profit-maximizing outcome of the preferred shareholder at the hypothetical closing date. The No Closing scenario models the embedded
derivatives as if there was no forced conversion event (similar to valuation analyses of the embedded derivatives as of their original
issuance and September 30, 2025).
The
table below shows the inputs used to determine the fair value of the derivative liabilities:
As
of
March
31,
March
31,
December
31,
December
31,
2026
2026
2025
2025
Closing
Scenario
Non-closing
Scenario
Closing
Scenario
Non-closing
Scenario
Expected term (years)
2.48
2.48
2.75
2.73
Expected volatility
150.00 %
150.00 %
150.00 %
150.00 %
Expected dividend yield
0.00 %
0.00 %
0.00 %
0.00 %
Risk-free interest rate
3.78 %
3.78 %
3.50 %
3.50 %
Probability
40.00 %
60.00 %
40.00 %
60.00 %
The
Limited Waiver Agreement executed on December 23, 2025 resulted in reclassification of the warrants to equity, the warrant liability
was remeasured using inputs as of December 23, 2025, and no subsequent liability remeasurement was required through December 31, 2025.
12
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 8
— Warrant and derivative liabilities (cont.)
The
following table presents information about the Company’s derivative liabilities that are measured at fair value on a recurring
basis as of March 31, 2026 and December 31, 2025, and indicates the fair value hierarchy of the valuation inputs the Company utilized
to determine such fair value:
Valuation
Level
March
31,
2026
December 31,
2025
Derivative
liabilities
Level
3
625,555
4,581,333
$ 625,555
$ 4,581,333
The
following table sets forth a summary of the change in the fair value of the derivative liabilities that are measured at fair value on
a recurring basis for the three months ended March 31, 2026:
Derivative
Liabilities
Balance, as of December 31,
2025
4,581,333
Change
in fair value
( 3,955,778 )
Balance, as of March
31, 2026
$ 625,555
Series
E derivative liabilities and warrant liabilities
On
October 1, 2025, the Company completed a private placement transaction with institutional investors, resulting in the issuance of Series
E convertible preferred stock and accompanying warrants to purchase shares of common stock. In connection with the Series E PIPE financing,
the Company recorded warrant liabilities related to the Series E Warrants and derivative liabilities associated with certain embedded
features in the Series E Preferred Stock. These instruments were classified as liabilities and measured at fair value in accordance with
ASC 815 due to their settlement provisions and other contractual terms. Refer to Note 9 for further detail on the private placement transaction.
The
Company measures its bifurcated embedded derivative liability and warrant liability as of March 31, 2026, December 31, 2025 and issuance,
at fair value on a recurring basis using level 3 inputs. These financial instruments are measured using management’s best estimate
of fair value, where the inputs into the determination of fair value require significant management judgment to estimation. The derivative
liability and warrant liability were both measured using Monte Carlo valuation models. Valuations based on unobservable inputs are highly
subjective and require significant judgments. Changes in such judgments could have a material impact on fair value estimates.
As
of December 11, 2025, the Company had entered a letter of intent with Realbotix (“LOI”), which contemplates a change of control
transaction. A closing condition of the LOI is that no convertible securities of the Company will be outstanding prior to, or upon, closing
(subject to approval of the preferred shareholders) which creates two distinct timing scenarios for the settlement of the preferred securities:
prior to, or at closing, pursuant to the terms of the LOI or after closing in the event the transaction proposed by the LOI is not completed.
Given the disparate timing conditions, the valuation included two scenarios in the Monte Carlo valuation analysis as of March 31, 2026
and December 31, 2025: Closing and No Closing. The Closing scenario includes settlement logic for the preferred securities based on the
profit-maximizing outcome of the preferred shareholder at the hypothetical closing date. The No Closing scenario models the embedded
derivatives as if there was no forced conversion event (similar to valuation analyses of the embedded derivatives as of their original
issuance and September 30, 2025).
13
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 8
— Warrant and derivative liabilities (cont.)
The
table below shows the inputs used to determine the fair value of the derivative liabilities:
As
of
March 31,
March 31,
December 31,
December 31,
2026
2026
2025
2025
Closing
Scenario
Non-closing
Scenario
Closing
Scenario
Non-closing
Scenario
Expected term (years)
2.5
2.5
2.73
2.75
Expected volatility
150.00 %
150.00 %
150.00 %
150.00 %
Expected dividend yield
0.00 %
0.00 %
0.00 %
0.00 %
Risk-free interest rate
3.78 %
3.78 %
3.50 %
3.50 %
Probability
40.00 %
60.00 %
40.00 %
60.00 %
The
Limited Waiver Agreement executed on December 23, 2025 resulted in reclassification of the warrants to equity, the warrant liability
was remeasured using inputs as of December 23, 2025, and no subsequent liability remeasurement was required through December 31, 2025.
The
following table presents information about the Company’s derivative liabilities that are measured at fair value on a recurring
basis as of March 31, 2026 and December 31, 2025, and indicates the fair value hierarchy of the valuation inputs the Company utilized
to determine such fair value:
Valuation
Level
March
31,
2026
December
31,
2025
Derivative
liabilities
Level
3
331,424
2,404,014
$ 331,424
$ 2,404,014
The
following table sets forth a summary of the change in the fair value of the derivative liabilities that are measured at fair value on
a recurring basis for the three months ended March 31, 2026:
Derivative
Liabilities
Balance, as of December 31,
2025
2,404,014
Change
in fair value
( 2,072,590
)
Balance, as of March
31, 2026
$ 331,424
Note 9
— Convertible Preferred Stock and Stockholders’ Equity
Authorized
Capital
As
of March 31, 2026 and December 31, 2025, the Company is authorized to issue 250,000,000 shares and 10,000,000 shares of common stock
and preferred stock, respectively, with a par value of $ 0.00001 for both common stock and preferred stock.
At
March 31, 2026 and December 31, 2025, the Company had designated 1,150,000 shares, 10,000 shares, 2,700,000 shares, 10,000 shares, 32,000
shares, and 10,000 shares of Series Seed Preferred Stock, Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock,
Series D Preferred Stock, and Series E Preferred Stock, respectively.
14
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 9
— Convertible Preferred Stock and Stockholders’ Equity (cont.)
Preferred
Stock
Series
Seed Convertible Preferred Stock
The
Company has 1,150,000 shares of preferred stock designated as Series Seed Preferred Stock (“Series Seed”) and there are no
shares of Series Seed outstanding as of March 31, 2026 and December 31, 2025.
Series
A Convertible Preferred Stock
On
September 29, 2023, the Company filed a Certificate of Designations of Rights and Preferences of Series A Preferred Stock of the Company
(the “Series A Certificate of Designations”) with the State of Delaware to designate and authorize the issuance of up to
10,000 shares of Series A Preferred Stock.
On
October 3, 2023, the Company issued 3,000 shares of Series A Convertible Preferred Stock in exchange for the settlement of $ 3.0 million
in notes payable due to Veru, Inc.
On
September 24, 2024, Veru converted all 3,000 shares of Series A Convertible Preferred Stock into 335 shares of the Company’s common
stock per the stated conversion ratio. There were 0 shares of Series A Convertible Stock outstanding as of March 31, 2026 and December
31, 2025.
Series
B Convertible Preferred Stock
In
connection with the PMX acquisition on December 15, 2023, the Company issued 2,696,729 shares of Series B Convertible Preferred Stock,
which were initially convertible into approximately 15,863 shares of common stock, subject to stockholder approval on September 5, 2024.
All Series B Preferred Stock was fully converted into common stock on September 24, 2024. As of March 31, 2026 and December 31, 2025,
no Series B Preferred Stock remains outstanding.
Series
C Convertible Preferred Stock
On
October 1, 2024, the Board of Directors authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series
C Convertible Preferred Stock”, with a par value of $ 0.00001 , pursuant to the certificate of designations. At any time after the
initial issuance date of Series C convertible Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid
and non-assessable shares of Common Stock. The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis,
equal to and in the same form as dividends actually paid on shares of Common Stock, when and if actually paid. In addition, from and
after the occurrence and during the continuance of any Triggering Event, dividends (“Default Dividends”) will accrue on the
Stated Value of each Preferred Share at a rate of fifteen percent ( 15.0 %) (the “Default Rate”) per annum. Each holder is
entitled to convert any portion of the outstanding Preferred Shares held by such holder into validly issued, fully paid and non-assessable
Conversion shares at the Conversion Rate, which can be determined by dividing (x) the Conversion Amount of such Preferred Share by (y)
the Conversion Price, $ 22.528 , subject to adjustment as provided in the Certificate of Designations.
On
July 16, 2025, the Company exercised its voluntary Series C Preferred Stock adjustment right to lower the conversion price of the Series
C Preferred Stock to $ 17.50 , and holders of 1,920 shares of Series C Preferred Stock agreed to convert their shares into shares of Common
Stock. During the year ended December 31, 2025, 1,369 shares of Series C Preferred Stock were redeemed for an aggregate amount of $ 1.71
million, 1,920 shares of Series C Preferred Stock were converted into common stock and 203 shares of Series C Preferred Stock were exchanged
into 244 shares of Series D Preferred Stock (as defined below). As of March 31, 2026 and December 31, 2025, 7 shares of Series C Preferred
Stock remain outstanding, with a carrying value of $ 1.7 thousand, as reflected in the accompanying consolidated balance sheet.
15
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 9
— Convertible Preferred Stock and Stockholders’ Equity (cont.)
Series
D Preferred Stock
On
September 22, 2025, the Company entered into a securities purchase agreement (the “Series D Securities Purchase Agreement”
and the financing contemplated therein, the “Series D PIPE Financing”) with eleven institutional investors, and sold or exchanged
debt, to such investors (collectively, the “Series D PIPE Investors”) an aggregate of 16,099 shares of Series D convertible
preferred stock, par value $ 0.00001 per share (“Series D Preferred Stock”), which includes an issuance of 500 shares of Series
D Preferred Stock to the lead investor in consideration for the Series D PIPE Investors’ irrevocable commitment to purchase shares
of the Series D Preferred Stock, and warrants (the “Series D Warrants”) to purchase 872,565 shares of Common Stock, (the
Series D Preferred Stock together with the Series D Warrants, the “Series D PIPE Securities”), for an aggregate purchase
price of approximately $ 12.9 million and net cash proceeds of $ 9.3 million. The exercise price of the Series D Warrants is $ 18.448 , and
the Series D Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.
The
Series D Preferred Stock was determined to be more akin to an equity-like host than a debt-like host and was classified as permanent
equity as it was not redeemable in any manner that would require classification outside of permanent equity pursuant to ASC 480-10-S99.
The Series D Preferred Stock was recorded on the accompanying consolidated balance sheet at its par value. Certain embedded share-settled
redemption features within the Series D Preferred Stock were bifurcated and accounted for separately a derivative liability.
The
Series D Warrants and certain embedded share-settled redemption features of the Series D Preferred Stock issued were determined to be
liability-classified instruments pursuant to ASC 480 and ASC 815. The embedded features of the Series D Preferred Stock were bifurcated
and accounted for separately as derivative liabilities. The Company measured the warrant liabilities and bifurcated derivative liabilities
at fair value on a recurring basis using Level 3 inputs as of September 22, 2025 (the issuance date), December 23, 2025 (amended warrants
date), December 31, 2025 (derivative liabilities fair value date) and March 31, 2026, respectively. See Note 8 for further information
regarding the valuation methodology and assumptions used in determining the fair value of the warrant and derivative liabilities.
The
Series D Preferred Stock has no voting rights. The Series D Preferred Stock are convertible into common stock at the election of the
holders of the Series D Preferred Stock at any time at an initial conversion price of $ 18.448 per share. The conversion price is subject
to customary adjustments for stock dividends, stock splits, reclassifications, stock combinations and the like (subject to certain exceptions),
anti-dilution provisions, and a floor price of $ 0.5322 .
The
Series D Preferred Stock is not redeemable by the holder except in the event of 1) a liquidation, dissolution, or winding up, or 2) the
Series D Preferred Stock is redeemable for common stock of the Company upon the occurrence of a change in control. Holders of the Series
D Preferred Stock shall be entitled to receive dividends as authorized and declared by the Company’s Board of Directors, payable
in cash, securities, or in other assets as determined by the Company’s Board of Directors.
In
the event of the Company’s liquidation, dissolution, or winding up, holders of the Series D Preferred Stock will be entitled to
receive out of the assets, whether capital or surplus, an amount equal to the stated value of the Series D Preferred Stock, plus any
accrued and unpaid dividends thereon and any other fees or liquidated damages owed before any distribution or payment shall be made to
the holders of any junior securities.
During
the three months ended March 31, 2026, holders of Series D Preferred Stock converted 6,373 shares into 2,222,656 shares of common stock.
As of March 31, 2026 and December 31, 2025, 9,952 and 16,325 shares of Series D Preferred Stock remain outstanding, respectively.
Series
E Preferred Stock
On
October 1, 2025, Onconetix entered into, and sold to institutional investor(s) (collectively, the “PIPE Investors”), pursuant
to a securities purchase agreement (the “Securities Purchase Agreement”) an aggregate of 7,813 shares of Series E convertible
preferred stock, par value $ 0.00001 per share (“Series E Preferred Stock”), which are convertible into common stock of the
Company, $ 0.00001 par value per share (the “Common Stock”) and warrants to purchase 405,045 shares of Common Stock (the “Warrants”
and, together with the Series E Preferred Stock, the “PIPE Securities”), for an aggregate purchase price of approximately
$ 6.25 million and net cash proceeds of $ 6.2 million. Such investment is referred to as the “PIPE Financing”. The exercise
price of the Series E Warrants is $ 19.288 , and the Series E Warrants are exercisable beginning on the issuance date and expire on the
third anniversary of the issuance date.
16
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 9
— Convertible Preferred Stock and Stockholders’ Equity (cont.)
The
Series E Preferred Stock was determined to be more akin to an equity-like host than a debt-like host and was classified as permanent
equity as it was not redeemable in any manner that would require classification outside of permanent equity pursuant to ASC 480-10-S99.
The Series E Preferred Stock was recorded on the accompanying consolidated balance sheet at its par value. Certain embedded share-settled
redemption features within the Series E Preferred Stock were bifurcated and accounted for separately a derivative liability.
The
Series E Warrants and certain embedded share-settled redemption features of the Series E Preferred Stock issued were determined to be
liability-classified instruments pursuant to ASC 480 and ASC 815. The embedded features of the Series E Preferred Stock were bifurcated
and accounted for separately as derivative liabilities. The Company measured the warrant liabilities and bifurcated derivative liabilities
at fair value on a recurring basis using Level 3 inputs as of October 1, 2025 (the issuance date), December 23, 2025 (amended warrants
date) and December 31, 2025 (derivative liabilities fair value date), and March 31, 2026. See Note 8 for further information regarding
the valuation methodology and assumptions used in determining the fair value of the warrant and derivative liabilities.
The
Series E Preferred Stock has no voting rights. The Series E Preferred Stock are convertible into common stock at the election of the
holders of the Series E Preferred Stock at any time at an initial conversion price of $ 19.288 per share. The conversion price is subject
to customary adjustments for stock dividends, stock splits, reclassifications, stock combinations and the like (subject to certain exceptions),
anti-dilution provisions, and a floor price of $ 0.298 .
The
Series E Preferred Stock is not redeemable by the holder except in the event of 1) a liquidation, dissolution, or winding up, or 2) the
Series E Preferred Stock is redeemable for common stock of the Company upon the occurrence of a change in control. Holders of the Series
E Preferred Stock shall be entitled to receive dividends as authorized and declared by the Company’s Board of Directors, payable
in cash, securities, or in other assets as determined by the Company’s Board of Directors.
In
the event of the Company’s liquidation, dissolution, or winding up, holders of the Series E Preferred Stock will be entitled to
receive out of the assets, whether capital or surplus, an amount equal to the stated value of the Series E Preferred Stock, plus any
accrued and unpaid dividends thereon and any other fees or liquidated damages owed before any distribution or payment shall be made to
the holders of any junior securities.
During
the three months ended March 31, 2026, holders of Series E Preferred Stock converted 232 shares into 76,555 shares of common stock. As
of March 31, 2026 and December 31, 2025, 7,581 and 7,813 shares of Series E Preferred Stock remain outstanding, respectively.
October
2024 ELOC
Concurrently,
on October 2, 2024, the Company entered into a Common Stock Equity Line of Credit Purchase Agreement (the “ELOC Purchase Agreement”)
with an institutional investor, whereby the Company may sell up to $ 25,000,000 of the Company’s new issued Common Stock. Pursuant
to the ELOC Purchase Agreement, the investor shall purchase from the Company up to the lesser of (i) $ 25.0 million in shares of our Common
Stock and (ii) 3,902 shares, representing 19.99 % of the total number of shares of Common Stock outstanding immediately prior to the execution
of the ELOC Purchase Agreement. Pursuant to the ELOC Purchase Agreement, 30 % of the gross proceeds to the Company from any sale of common
stock thereunder must be applied towards the redemption of the Series C Redeemable Preferred Stock.
During
the three months ended March 31, 2026 and 2025, the Company received proceeds of $ 0 and $ 4.8 million under the ELOC, respectively.
Common
Stock
As
of March 31, 2026 and December 31, 2025 there were 2,755,184 and 312,028 shares of common stock issued, respectively, and 2,755,154 and
311,998 shares of common stock outstanding, respectively.
17
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 9
— Convertible Preferred Stock and Stockholders’ Equity (cont.)
Treasury
Stock
On
November 10, 2022, the Board approved a stock repurchase program (the “Repurchase Program”) to allow the Company to repurchase
up to 125,000 shares of common stock with a maximum price of $ 1.00 per share, with discretion to management to make purchases subject
to market conditions. On November 18, 2022, the Board approved an increase to the maximum price to $ 2.00 per share. There was no expiration
date for this program and prices are not adjusted for the reverse stock split to comply with the program.
There
were no repurchases of common stock during the three months ended March 31, 2026 and 2025.
On
November 13, 2024, the Board terminated the Repurchase Program.
Warrants
The
following summarizes the Company’s outstanding warrants, excluding contingent warrants issuable upon exercise of the outstanding
warrants as of March 31, 2026:
Number of
Shares WA
Average
Exercise
Price WA
Remaining
Contractual
Life
(in years)
Outstanding as of December 31, 2025 1,280,375 $ 24.85 2.73
Granted — — —
Exercised ( 144,087 ) — —
Cancelled — — —
Outstanding as of March 31, 2026 1,136,288 26.26 2.49
Warrants vested and exercisable as of March 31, 2026 1,136,288 $ 26.26 2.49
As
of March 31, 2026, the Company had outstanding warrants, which are exercisable into 1,136,288 shares of common stock. The shares of common
stock underlying the warrants outstanding had an exercise price of $ 26.26 per share, based on the closing trading price on March 31,
2026.
Contingent
Warrant Liabilities
As
of March 31, 2026, the fair value of contingent warrant labilities includes the Series C PIPE warrants of $ 4,700 and those issuable upon
exercise of the Inducement PIOs of approximately $ 20,278 totaling $ 24,978 included as contingent warrant liabilities in the accompanying
condensed consolidated balance sheets.
As
of December 31, 2025, the fair value of contingent warrant labilities includes the Series C Warrants of $ 6,300 and those issuable upon
exercise of the Inducement PIOs of approximately $ 20,290 totaling $ 26,590 included as contingent warrant liabilities in the accompanying
consolidated balance sheets.
Onconetix
Equity Incentive Plans
The
Company’s 2019 Equity Incentive Plan (the “2019 Plan”) was adopted by its board of directors and by its stockholders
on July 1, 2019. On February 23, 2022 the Company’s board of directors adopted the Company’s 2022 Equity Incentive Plan (the
“2022 Plan”), which is the successor and continuation of the Company’s 2019 Plan. Under the 2022 Plan, the Company
may grant stock options, restricted stock, restricted stock units, stock appreciation rights, and other forms of awards to employees,
directors, and consultants of the Company. In May 2023, the number of shares of common stock reserved for issuance under the 2022 Plan
was increased to 185 , and in September 2024, the number of shares of common stock reserved for issuance under the 2022 Plan was increased
to 3,411 . Stock-based awards granted during the three months ended March 31, 2026 and 2025 were all granted under the 2022 Plan. As of
March 31, 2026, there are 1,752 shares available for issuance under the 2022 Plan.
18
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 9
— Convertible Preferred Stock and Stockholders’ Equity (cont.)
Stock
Options
The
following summarizes activity related to the Company’s stock options under the 2019 Plan and the 2022 Plan for the three months
ended March 31, 2026:
Weighted
Average
Weighted Remaining
Average Contractual
Number of Exercise Life
Shares Price (in years)
Outstanding as of December 31, 2025 5 $ 28,504.73 6.8
Granted — — —
Forfeited / cancelled ( 3 ) 8,109.00
—
Exercised — — —
Outstanding as of March 31, 2026 2 31,875.00 6.5
Options vested and exercisable as of March 31, 2026 2 $ 31,875.00 6.5
There
were no stock options granted during the three months ended March 31, 2026 and 2025.
The
aggregate fair value of stock options that vested during the three months ended March 31, 2026 and 2025 was approximately $ 0 and $ 46,000 ,
respectively.
Restricted
Stock
On
May 9, 2023, the Board’s Compensation Committee approved the issuance of restricted stock, granted under the Company’s 2022
Plan, to the Company’s executive officers, employees, and certain of the Company’s consultants. The restricted shares granted
totaled 28 , of which 8 , 4 , and 8 were granted to the Company’s former CEO, former CFO, and former CBO, respectively. All of the
restricted shares granted vest as follows: 50 % in January 2024, 25 % in August 2024, and 25 % in August 2025. In addition, on May 31, 2023,
the Board’s Compensation Committee approved the issuance of 1 share of restricted stock, granted to the Company’s non-executive
Board members, with full vesting on May 31, 2024. Furthermore, on September 26, 2024, the Company issued its Board members a total of
39 restricted stock, with full vesting August 31, 2025. On February 24, 2025, in connection with the appointment of an executive Board
member, the Company issued 4 shares of restricted stock with full vesting August 31, 2025. Subsequently, the Company modified the vesting
date of 27 shares previously issued to the Board members to provide for full vesting August 31, 2026. On August 15, 2025, the Company
issued its Board members a total of 494 restricted stock, with full vesting August 16, 2026.
The
following summarizes activity related to the Company’s restricted stock awards granted under the 2022 Plan for the three months
ended March 31, 2026:
Weighted
Average
Number of
Grant Date
Shares
Fair Value
Nonvested as of December 31, 2025
390
$ 71.55
Granted
—
—
Vested
—
—
Forfeited
( 127 )
98.62
Nonvested as of March 31, 2026
263
$ 57.92
Proteomedix
Stock Option Plan
Proteomedix
sponsors a stock option plan (the “PMX Option Plan”) which provides common stock option grants to be granted to certain employees
and consultants, as was determined by the board of directors of Proteomedix. In connection with the PMX Transaction, the Company assumed
the PMX Option Plan.
Generally,
options issued under the PMX Option Plan have a term of not more than 11 years and provide for a four-year vesting period. Stock options
issued under the PMX Option Plan are measured at fair value using the Black-Scholes option pricing model.
19
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 9
— Convertible Preferred Stock and Stockholders’ Equity (cont.)
There
was no activity under the PMX Option Plan for the three months ended March 31, 2026 and 2025. As of March 31, 2026 and December 31, 2025,
there were no outstanding stock options.
Stock-Based
Compensation
Stock-based
compensation expense related to stock options and restricted stock, for the three months ended March 31, 2026 and 2025 was as follows:
For
the Three Months Ended
March 31,
2026
2025
Selling,
general and administrative
$ 22,305
$ 29,256
Research
and development
—
—
Total
$ 22,305
$ 29,256
Note 10
— Commitments and Contingencies
Office
Lease
Proteomedix
leases office and lab space in Zurich Switzerland. In May 2025, Proteomedix entered into a lease amendment to reduce its leased premises.
Effective June 30, 2025, the Company terminated the April 2024 lease amendment, which included office space and laboratory space. Additionally,
a partial termination of a prior lease amendment further reduced the office space.
This
lease expired on December 31, 2025 , and was renewed for a successive two-year term, resulting in an additional right-of-use asset and
lease liability of approximately $ 49,000 . The lease, as renewed, requires payments of approximately $ 24,000 over the next twelve months.
The lease will automatically renew for successive two-year terms, unless terminated. Either party may terminate the lease with twelve
months’ written notice.
Litigation
From
time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities.
As of March 31, 2026, the Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims.
Indemnification
In
the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties
and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that
may be made against the Company in the future but have not yet been made. To date, the Company has not been required to defend any action
related to its indemnification obligations. The maximum potential amount of future payments the Company could be required to make under
these indemnification agreements is not estimable at this time.
20
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note 11
— Related Party Transactions
On
June 17, 2025, the Company entered into a separate consulting agreement with a firm affiliated with Dr. Meier. The agreement provides
for the payment of certain success fees and reimbursement of related expenses. Under its terms, Dr. Meier is entitled to earn up to 10 %
of success fees for transactions greater than $ 9 million earned by the affiliated firm, payable only upon receipt of such proceeds. The
Company recorded approximately $ 0 in related expenses during the three months ended March 31, 2026 and 2025. As of March 31, 2026 and
December 31, approximately $ 16,500 related to this agreement was included in accounts payable.
Note 12
— Net Loss Per Share
Basic
net loss per share is computed by dividing the net income or loss applicable to common shares by the weighted average number of common
shares outstanding during the period. The weighted average number of shares of common stock outstanding includes pre-funded warrants
because their exercise requires only nominal consideration for delivery of shares; it does not include any potentially dilutive securities
or any unvested restricted shares of common stock. Certain restricted shares, although classified as issued and outstanding at March
31, 2026, are considered contingently returnable until the restrictions lapse and will not be included in the basic net loss per share
calculation until the shares are vested. Unvested shares of the Company’s restricted stock do not contain non-forfeitable rights
to dividends and dividend equivalents.
The
two-class method is used to determine earnings per share based on participation rights of participating securities in any undistributed
earnings. Each share of preferred stock that includes rights to participate in distributed earnings is considered a participating security
and the Company uses the two-class method to calculate net income available to the Company’s common stockholders per common share
— basic and diluted.
The
following securities were excluded from the computation of diluted shares outstanding due to the losses incurred in the periods presented,
as they would have had an anti-dilutive impact on the Company’s net loss:
Three
months Ended
March 31,
2026
2025
Options to purchase shares of common
stock
2
32
Warrants
1,136,288
2,765
Unvested shares of restricted stock
263
46
Common stock issuable upon conversion of Series
C Redeemable Preferred Stock
379
1,112
Common stock issuable upon conversion of Series
D Redeemable Preferred Stock
539,462
—
Common stock issuable
upon conversion of Series E Redeemable Preferred Stock
393,042
—
Total
2,069,436
3,955
21
ONCONETIX,
INC.
Notes to Condensed Consolidated Financial Statements
March
31, 2026
(Unaudited)
Note
13 – Segment Information
The
Company conducts its business activities and reports financial results as one business segment. The presentation of financial results
as one reportable segment is consistent with the way the Company operates its business and is consistent with the manner in which the
Chief Operating Decision Maker (“CODM”) evaluates performance and makes resource and operating decisions for the business.
The Company’s CODM is the Chief Executive Officer . Furthermore, the Company notes that monitoring financial results as one reportable
segment helps the CODM manage costs on a consolidated basis, consistent with the integrated nature of the operations. The CODM uses net
loss, as reported on the Consolidated Statements of Operations and Comprehensive Loss, in evaluating performance of the Company and determining
how to allocate resources of the Company as a whole. As the CODM evaluates performance on a consolidated basis, all required financial
segment information is included in the consolidated financial statements.
Geographic
Information
The
distribution of revenue by geographical area was as follows:
Three
Months Ended
March 31,
2026
2025
United States
$ —
$ —
United Kingdom
21,457
7,246
Switzerland
—
94,384
Total
$ 21,457
$ 101,630
Note 14
— Subsequent Events
Resignation
of Andrew Oakley and Thomas Meier as Directors; Elections of Sammy Dorf as Chairman of the Board:
Effective
on April 20, 2026, Andrew Oakley and Thomas Meier notified the Board of their resignation from the Board. As a result of their resignation
from the Board and effective as of the date mentioned herein, Mr. Oakley has also resigned from his position as Chairman of the Board
and his service on the Audit Committee, Compensation Committee and the Nominating and Corporate Governance Committee, and Mr. Meier has
also resigned from his service on the Compensation Committee.
Effective
on April 23, 2026, the Board has appointed Sammy Dorf, an existing member of the Board, as Chairman of the Board. In connection with
Mr. Dorf’s election as Chairman, the Compensation Committee of the Board has agreed to compensate Mr. Dorf $ 20,000 per year, with
$ 5,000 payable on a quarterly basis, commencing on the date of his election.
Election
of Josh Epstein:
Effective
as of April 23, 2026, the Board elected Josh Epstein to serve as a member of the Board and a member of the Audit Committee, Compensation
Committee and as the chair of the Nominating and Corporate Governance Committee. Mr. Epstein, a Class II director, will serve for a term
expiring at the Company’s 2026 annual meeting of stockholders.
For
his service on the Board, Mr. Epstein will receive compensation consistent with that of other non-employee directors.
Result
of the Special Meeting of Stockholders of the Company held on April 30, 2026:
On
April 30, 2026, the Company held a special meeting of stockholders (the “ April 2026 Special Meeting ”). At the April
2026 Special Meeting, the stockholders of the Company approved the stockholder proposal to grant discretionary authority to Board to
amend the Amended and Restated Certificate of Incorporation of the Company to effect one or more reverse stock splits of the Common Stock,
at a ratio in the range of 1-for-2 to 1-for-10, provided that, (i) the Company shall not effect the aforementioned reverse stock splits
that, in the aggregate, exceed 1-for-100 , and (ii) any such reverse stock split is completed no later than the one year anniversary date
of the April 2026 Special Meeting.
ELOC
Draws and Series D & E Preferred Stock Conversions:
In
the period between March 31, 2026, and May 12, 2026, the Company issued a total of 8,710,353 shares of common stock through conversions
of preferred stock and a sale on the ELOC. The total shares of Series D Preferred Stock converted during this period were 1,796 in exchange
for 1,537,118 shares of common stock. The total shares of Series E Preferred Stock converted during this period were 7,581 in exchange
for 6,603,654 shares of common stock. The remaining outstanding shares of preferred stock as of May 12, 2026 are 8,156 for Series D Preferred
Stock and 0 for Series E Preferred stock. Additionally, the Company received proceeds of approximately $ 994 thousand on the sale of 569,581
shares under the ELOC.
22
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial
statements and the related notes to those statements included elsewhere in this Report and with the audited financial statements and
the related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC, on March
13, 2026. In addition to historical financial information, the following discussion and analysis contains forward-looking statements
that involve risks, uncertainties, and assumptions. Some of the numbers included herein have been rounded for the convenience of presentation.
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. See
“Cautionary Note Regarding Forward-Looking Statements.”
Overview
We
are a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for
oncology. Through our acquisition of Proteomedix, which closed on December 15, 2023, we own Proclarix, an in vitro diagnostic test for
prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation
(“IVDR”), which we anticipate will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp.
Since
our inception in October 2018 until April 2023, when we acquired ENTADFI, we devoted substantially all of our resources to performing
research and development, undertaking preclinical studies and enabling manufacturing activities in support of our product development
efforts, hiring personnel, acquiring and developing our technology and now halted vaccine candidates, organizing and staffing our company,
performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such activities.
ENTADFI
is an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate. However,
in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway
and indebtedness, the Company abandoned commercialization of ENTADFI and no longer holds remaining inventory of the product as of December
31, 2025. In addition, as part of cost reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated
three employees involved with the ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company
on an as-needed, consulting basis. Based on the circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired.
Proclarix
is an easy-to-use next generation protein-based blood test that can be done with the same sample as a patient’s regular Prostate-Specific
Antigen (“PSA”) test. The PSA test is a well-established prostate specific marker that measures the concentration of PSA
molecules in a blood sample. A high level of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many
other reasons including infections, prostate stimulation, vigorous exercise or even certain medications. PSA results can be confusing
for many patients and even physicians. It is estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant
resulting in an overdiagnosis and overtreatment that impacts the physician’s routine, our healthcare system, and the quality of
patients’ lives. Approximately 10% of all men have elevated PSA levels., commonly referred to as the diagnostic “grey zone”,
of which only 20 - 40% present clinically with cancer. Proclarix is intended for use in diagnosing these patients where it is difficult
to decide if a biopsy is necessary to verify a potential clinically significant cancer diagnosis. Proclarix helps doctors and patients
with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic support
for further treatment decisions. No additional intervention is required, and results are available quickly. Local diagnostic laboratories
can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay
(ELISA) standard, which most diagnostic laboratories are already equipped to process.
Proclarix
is CE-marked and for sale in Europe. We continue our sales efforts and expect growing revenues from sales of Proclarix in 2026 and beyond.
We anticipate these sales to offset some expenses relating to commercial scale up and development, we expect our expenses also to increase
in connection with our ongoing activities, as we:
●
commercialize Proclarix;
●
hire additional personnel;
●
operate as a public company;
●
obtain, maintain, expand,
and protect our intellectual property portfolio; and
●
perform product validation
studies in connection with a license agreement.
23
We
rely and will continue to rely on third parties for the manufacturing of Proclarix. We have no internal manufacturing capabilities, and
we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for commercial product.
We
do not have any products approved for sale, aside from Proclarix. We have abandoned commercialization of ENTADFI and have destroyed our
inventory of the product.
To
date, we have financed our operations primarily with proceeds from our sale of preferred securities to seed investors, the initial public
offering (“IPO”), and subsequent offerings of debt and equity securities. We will continue to require significant additional
capital to commercialize Proclarix, and to fund operations for the foreseeable future. Accordingly, until such time as we can generate
significant revenue, if ever, we expect to finance our cash needs through public or private equity or debt financings, third-party (including
government) funding and to rely on third-party resources for marketing and distribution arrangements, as well as other collaborations,
strategic alliances and licensing arrangements, or any combination of these approaches, to support our operations.
Some
recent key developments affecting our business include the following:
Realbotix
Corp. Share Exchange Agreement
On
February 11, 2026, we entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among (i) Onconetix,
(ii) Realbotix Corp., a company existing under the laws of the Province of Ontario (“Parent”), (iii) Simulacra Corporation,
a Delaware corporation and a wholly-owned subsidiary of Parent (the “Seller”) and (iv) Realbotix, LLC, a Delaware limited
liability company and wholly owned subsidiary of the Seller (the “Realbotix”).
Pursuant
to the Share Exchange Agreement, subject to the terms and conditions set forth therein, the Seller agreed to contribute and transfer
to us, and we agreed to acquire and accept, all of the issued and outstanding equity interests of Realbotix (the “Realbotix Interests”)
in exchange for newly issued shares of Common Stock. (the “Share Exchange” and the other transactions contemplated by the
Share Exchange Agreement, the “Realbotix Transactions”).
Unless
otherwise defined herein, the capitalized terms used below are defined in the Share Exchange Agreement.
Consideration
In
full consideration for the contribution of the Realbotix Interests, we will issue shares of Common Stock to the Seller (the “Exchange
Shares”), such that, immediately following the Closing and after giving effect to such issuance, the Seller will own a percentage
of our fully diluted shares (the “Fully Diluted Shares”) that will be adjusted based on Net Cash (as defined below) as follows:
(i) if Net Cash is greater than or equal to $12.5 million, but less than $15.0 million, Seller will own 90% of the Fully Diluted Shares,
(ii) if Net Cash is greater than or equal to $15.0 million, but less than $18.0 million, Seller will own 85% of the Fully Diluted Shares,
(iii) if Net Cash is greater than or equal to $18.0 million, but less than $20.0 million, Seller will own 80% of the Fully Diluted Shares
and (iv) if Net Cash is greater than or equal to $20.0 million, Seller will own 75% of the Fully Diluted Shares. “Net Cash”
means the amount of cash and cash equivalents held by us upon the Closing, whether received by Realbotix or us in connection with the
Realbotix Transactions, net of D&O tail insurance costs; change-of-control or other payments owed to our officers and director of
as a result of the Realbotix Transactions; all our indebtedness; certain of our liabilities and our transaction expenses.
Conversion
of Company Convertible Securities
Prior
to the consummation of the Share Exchange, the holders of Realbotix Convertible Securities will exercise their rights to receive Realbotix
Interests pursuant to the terms of such Realbotix Convertible Securities (as defined below) at the applicable conversion ratio as set
forth in the Realbotix Convertible Securities (the “Realbotix Convertible Securities Conversion”). Upon completion of the
Realbotix Convertible Securities Conversion and prior to Closing, all Realbotix Convertible Securities will be canceled or terminated,
as applicable, will no longer be outstanding and will cease to exist and no payment or distribution will be made with respect thereto.
Each holder of Realbotix Convertible Securities thereafter will cease to have any rights with respect to such securities.
24
Closing
Conditions
The
consummation of the Share Exchange is subject to customary closing conditions, including (i) the accuracy of the representations and
warranties of the parties (subject to customary materiality qualifiers); (ii) compliance in all material respects by the parties with
their respective covenants and agreements under the Share Exchange Agreement; (iii) delivery of customary closing certificates and good
standing certificates; (iv) receipt by Board of a fairness opinion; (v) the absence of any law, order or injunction prohibiting the consummation
of the Realbotix Transactions and (vi) receipt of any required third-party and regulatory approvals and consents.
The
obligation of the Realbotix, Parent and Seller to complete the Closing is subject to the condition that, at Closing, we shall have an
aggregate of at least $12.5 million in Net Cash (the “Net Cash Condition”).
Additionally,
the obligation of Realbotix, Parent and us to complete the Closing are subject to the conditions that (i) we have entered into an agreement
with an investor, reasonably acceptable to us and Realbotix, providing for an equity line of credit pursuant to which such investor would
commit to purchase up to an aggregate of $125.0 million of Common Stock and (ii) the conversion of our Preferred Stock into Common Stock
and the termination of or certain amendments to of all Onconetix Options and Onconetix Warrants (the “Convertible Securities Condition”).
Termination
In
addition to termination by mutual written agreement, for the other party’s uncured breach or if a governmental order permanently
prohibits the Closing, the Share Exchange Agreement provides for termination:
●
By either party if the
Closing has not been consummated on or before November 30, 2026, provided the terminating party is not in breach in a manner that
caused the failure to close by such date. The date is automatically extended to December 20, 2026 if all conditions to Closing other
than the Net Cash Condition have been satisfied.
●
By either party if our
stockholder approval is not obtained at the stockholder meeting (including any adjournment or postponement thereof).
●
By Realbotix if a Buyer
Adverse Recommendation Change (as defined in the Share Exchange Agreement) occurs prior to receipt of Buyer stockholder approval.
●
By us in connection with
entering into a definitive agreement for a Buyer Superior Proposal (as define in the Share Exchange Agreement).
●
By us if the audited Realbotix
financial statements have not been delivered by April 30, 2026.
Each
party will bear its own fees and expenses incurred in connection with the negotiation, execution and performance of the Share Exchange
Agreement and the Realbotix Transactions. However, the Share Exchange Agreement provides for the payment of termination fees and reimbursement
of transaction expenses in the following termination scenarios:
●
In the event of a termination
of the Share Exchange Agreement as a result of a material breach by either party, the breaching party will be required to pay a termination
fee to the non-breaching party of $500,000 plus transaction expenses, with such transaction expenses not to exceed $500,000.
●
In the event of a termination
of the Share Exchange Agreement (i) by the Company as the result of a Buyer Adverse Recommendation Change or (ii) by Buyer upon entering
into an agreement in respect of a Buyer Superior Proposal as a result of a Buyer Adverse Recommendation Change, Buyer must pay a
termination fee of (A) $500,000 plus all Seller transaction expenses plus (B) if the transaction in respect of a Buyer Superior Proposal
closes, an additional $1,500,000 upon closing of such transaction. If the transaction contemplated by the Buyer Superior Proposal
doesn’t close, Buyer is only obligated to pay $500,000 plus all Seller transaction expenses.
●
In the event of a termination
of the Share Exchange Agreement by Realbotix for failure to satisfy the Net Cash Condition, if Net Cash at the time of termination
would be greater than $5.0 million (assuming the consummation of any Transaction Financing pursuant to Financing Agreements), we
are obligated to pay Realbotix’s transaction expenses, with such transaction expenses not to exceed $500,000.
25
Representations
and Warranties
We,
Realbotix, and the Seller have made customary representations and warranties in the Share Exchange Agreement. The representations and
warranties of us, Realbotix, and the Seller will not survive the Closing.
Covenants
of the Parties
Each
party to the Share Exchange Agreement agreed to use its commercially reasonable efforts to consummate the Realbotix Transaction.
The
Share Exchange Agreement contains certain covenants by each of the parties, to be observed during the period between the execution of
the Share Exchange Agreement and Closing, including covenants regarding: (1) the provision of access to information, properties, books,
records and personnel; (2) delivery of audited financial statements of the Company; (3) litigation support; (4) the preparation and filing
of a registration statement, SEC reports and related disclosure documents and compliance with Nasdaq listing and reporting requirements;
(5) no insider trading; (6) further assurances; (7) public announcements; (8) confidentiality; (9) indemnification of directors and officers
and tail insurance; and (10) transfer taxes.
The
parties have agreed to take all necessary actions to cause our Board, immediately after closing, to consist of five directors, including:
(i) one person who is designated by us and reasonably acceptable to Realbotix and (ii) four persons who are designated by Realbotix and
reasonably acceptable to us.
We
have also agreed to prepare and file with the Securities and Exchange Commission (“SEC”) a registration statement on Form
S-4 in connection with the registration under the Securities Act of 1933, as amended (the “Securities Act”), of the issuance
of the Exchange Shares to be issued under the Share Exchange Agreement and containing a proxy statement (a “Proxy Statement”)
for the purpose of soliciting proxies from our stockholders for the matters to be acted on at the special meeting of our stockholders.
We have also agreed to use reasonable best efforts to maintain its listing on the Nasdaq and to enable the listing on Nasdaq of the Exchange
Shares.
During
the time between the execution of the Share Exchange Agreement and the Closing, Realbotix agreed to conduct its business in the ordinary
course of business in all material respects and to comply with certain covenants regarding the operation of its business, including covenants
related to (i) amendments to the Realbotix’s organizational documents; (ii) recapitalization of the Realbotix’s equity interests;
(iii) issuance of additional securities; (iv) incurrence of additional indebtedness; (v) material changes to tax elections; (vi) amendments
to or termination of material contracts; (vii) maintenance of books and records; (viii) establishment of any subsidiary or entry into
a new line of business; (ix) maintenance of insurance policies; (x) revaluation of material assets or material changes in accounting
methods, principles or policies, except as required to comply with U.S. GAAP; (xi) waiver, settlement or compromise of material claims,
actions or proceedings, subject to specified thresholds; (xii) acquisition of equity interests or assets, or any other form of business
combination, outside of the ordinary course of business; (xiii) capital expenditures in excess of specified thresholds; (xiv) adoption
of a plan of liquidation, dissolution, merger, consolidation, restructuring, recapitalization or other reorganization; (xv) voluntary
incurrence of liabilities or obligations in excess of specified thresholds other than pursuant to contracts in existence as of the date
of the Share Exchange Agreement or entered into in the ordinary course of business; (xvi) sale, lease, license or other disposition of
any material portion of the Realbotix’s assets, properties or rights; (xvii) entry into any agreement, understanding or arrangement
relating to the voting of the Realbotix’s equity interests; (xviii) taking any action that would reasonably be expected to materially
delay or impair the obtaining of any required governmental or regulatory consents in connection with the Share Exchange Agreement; or
(xix) authorization or agreement to take any of the foregoing actions.
26
During
the same period, we also agreed to conduct its business in the ordinary course of business in all material respects and to comply with
certain interim operating covenants, including covenants restricting our ability, without Realbotix’s prior written consent (subject
to specified exceptions), to (i) amend its organizational documents; (ii) effect mergers, consolidations, acquisitions, liquidations,
restructurings or other business combinations; (iii) issue, repurchase, redeem or otherwise modify its equity securities or declare dividends
or other distributions; (iv) incur additional indebtedness or guarantee obligations of third parties; (v) dispose of material assets
or subsidiaries; (vi) make material loans, advances or capital contributions; (vii) make material tax elections or changes in accounting
methods, principles or practices, except as required by applicable law, GAAP or Regulation S-K; (viii) amend, terminate, waive or assign
material contracts other than in the ordinary course of business; (ix) fail to maintain books, records or insurance coverage in the ordinary
course of business; (x) establish subsidiaries or enter into new lines of business; (xi) settle material litigation or other proceedings
other than within specified thresholds; (xii) make capital expenditures or incur liabilities in excess of specified thresholds; (xiii)
enter into arrangements relating to the voting of Common Stock; (xiv) take actions that would reasonably be expected to materially delay
or impair the receipt of required governmental or regulatory approvals; or (xv) authorize, commit or publicly propose any of the foregoing
actions.
Governing
Law
The Share
Exchange Agreement is governed by the laws of the State of Delaware.
February
2026 Special Meeting of Stockholders
On
February 3, 2026, the Company held a special meeting of stockholders (the “Special Meeting”), whereby its stockholders approved
an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding
shares of Common Stock at a ratio in the range of 1-for-2 to 1-for-50, at any time prior to the one-year anniversary date of the Special
Meeting.
On
March 6, 2026, the Board determined to fix a reverse stock split ratio of its Common Stock of 1-to-5 (the “Reverse Stock Split”).
On March 24, 2026, the Company filed the Amendment to its Charter with the Secretary of State of the State of Delaware to effect the
Reverse Stock Split. The Reverse Stock Split became effective in accordance with the terms of the Amendment at 12:01 a.m. Eastern Time
on March 25, 2026 (the “Effective Time”). The Company’s Common Stock continues to trade on The Nasdaq Capital Market
under the symbol ONCO and has been trading on a split-adjusted basis since the market opened on March 25, 2026. At the Effective Time,
every 5 (five) shares of the Company’s issued and outstanding Common Stock had converted automatically into one (1) issued and
outstanding share of Common Stock, with no corresponding reduction in the number of authorized shares of Common Stock, and without any
change in the par value per share.
Resignation
of Andrew Oakley and Thomas Meier as Directors; Elections of Sammy Dorf as Chairman of the Board
Effective
on April 20, 2026, Andrew Oakley and Thomas Meier notified the Board of their resignation from the Board. As a result of their resignation
from the Board and effective as of the date mentioned herein, Mr. Oakley has also resigned from his position as Chairman of the Board
and his service on the Audit Committee, Compensation Committee and the Nominating and Corporate Governance Committee, and Mr. Meier has
also resigned from his service on the Compensation Committee.
Effective
on April 23, 2026, the Board has appointed Sammy Dorf, an existing member of the Board, as Chairman of the Board. In connection with
Mr. Dorf’s election as Chairman, the Compensation Committee of the Board has agreed to compensate Mr. Dorf $20,000 per year, with
$5,000 payable on a quarterly basis, commencing on the date of his election.
Election
of Josh Epstein
Effective
as of April 23, 2026, the Board elected Josh Epstein to serve as a member of the Board and a member of the Audit Committee, Compensation
Committee and as the chair of the Nominating and Corporate Governance Committee. Mr. Epstein, a Class II director, will serve for a term
expiring at the Company’s 2026 annual meeting of stockholders.
For
his service on the Board, Mr. Epstein will receive compensation consistent with that of other non-employee directors.
27
Result
of the Special Meeting of Stockholders of the Company held on April 30, 2026
On
April 30, 2026, the Company held a special meeting of stockholders (the “ April 2026 Special Meeting ”). At the April
2026 Special Meeting, the stockholders of the Company approved the stockholder proposal to grant discretionary authority to Board to
amend the Amended and Restated Certificate of Incorporation of the Company to effect one or more reverse stock splits of the Common Stock,
at a ratio in the range of 1-for-2 to 1-for-10, provided that, (X) the Company shall not effect the aforementioned reverse stock splits
that, in the aggregate, exceed 1-for-100, and (Y) any such reverse stock split is completed no later than the one year anniversary date
of the April 2026 Special Meeting.
Series
E PIPE Financing
On
October 1, 2025, the Company entered into a securities purchase agreement (the “Series E Securities Purchase Agreement”)
with institutional investor(s) and sold to such institutional investors(s)(collectively, the “Series E PIPE Investors”),
an aggregate of 7,813 shares of Series E convertible preferred stock, par value $0.00001 per share (“Series E Preferred Stock”),
which are convertible into common stock of the Company, $0.00001 par value per share and warrants (the “Series E Warrants”)
to purchase 405,045 shares of Common Stock, for an aggregate purchase price of approximately $6.25 million, which was also equal to the
net cash proceeds. The exercise price of the Series E Warrants is $19.288, and the Series E Warrants are exercisable beginning on the
issuance date and expire on the third anniversary of the issuance date.
Concurrently
with entering into the Series E Securities Purchase Agreement, the Company also entered into a registration rights agreement with the
Series E PIPE Investors, pursuant to which it has agreed to provide the Series E PIPE Investors with certain registration rights related
to the shares of Common Stock underlying the shares of Series E Preferred Stock and Series E Warrants.
During
the three months ended March 31, 2026, the holders converted 232 shares of Series E Preferred Stock into 76,555 shares of Common Stock.
As of March 31, 2026, there are 7,581 shares of Series E Preferred Stock outstanding.
Series
D PIPE Financing
On
September 22, 2025, the Company entered into a securities purchase agreement (the “Series D Securities Purchase Agreement”)
with eleven institutional investors, and sold or exchanged debt, to such investors (collectively, the “Series D PIPE Investors”)
an aggregate of 16,099 shares of Series D convertible preferred stock, par value $0.00001 per share (“Series D Preferred Stock”),
which includes an issuance of 500 shares of Series D Preferred Stock to the lead investor in consideration for the Series D PIPE Investors’
irrevocable commitment to purchase shares of the Series D Preferred Stock, and warrants (the “Series D Warrants”) to purchase
872,565 shares of Common Stock, for an aggregate purchase price of approximately $12.9 million and net cash proceeds of $9.3 million.
The exercise price of the Series D Warrants is $18.448, and the Series D Warrants are exercisable beginning on the issuance date and
expire on the third anniversary of the issuance date.
Concurrently
with entering into the Series D Securities Purchase Agreement, the Company also entered into a registration rights agreement with the
Series D PIPE Investors, pursuant to which it has agreed to provide the Series D PIPE Investors with certain registration rights related
to the shares of Common Stock underlying the shares of Series D Preferred Stock and Series D Warrants.
During
the three months ended March 31, 2026, the holders converted 6,373 shares of Series D Preferred Stock into 2,222,656 shares of Common
Stock. Additionally, the holders exercised 144,087 warrants for shares of Common Stock, resulting in net proceeds of $384,842. As of
March 31, 2026, there are 9,952 shares of Series D Preferred Stock outstanding.
Reverse
Stock Split
On
June 13, 2025, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-eighty-five
(1:85). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification (“ASC”)
260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise prices
and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock
split for all periods presented. The number of authorized shares and par value of the preferred stock and common stock were not adjusted
because of the reverse stock split.
On
March 25, 2026, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-five
(1:5). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification (“ASC”)
260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise prices
and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock
split for all periods presented. The number of authorized shares and par value of the preferred stock and common stock were not adjusted
because of the reverse stock split.
28
Certain
Significant Relationships
We
have entered into grant, license and collaboration arrangements with various third parties as summarized below. For further details regarding
these and other agreements, see Notes 5 to each of our audited financial statements included in the Form 10-K and unaudited financial
statements included elsewhere in this Report.
Laboratory
Corporation of America
On
March 23, 2023, Proteomedix entered into a license agreement with LabCorp pursuant to which LabCorp has the exclusive right to develop
and commercialize Proclarix and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license,
in the United States (“Licensed Products” and the agreement, the “LabCorp Agreement”). In consideration for granting
LabCorp an exclusive license, Proteomedix received an initial license fee in the mid-six figures upon signing of the contract. Additionally,
Proteomedix is entitled to royalty payments between 5% and 10% on the net sales recognized by LabCorp of any Licensed Products plus milestone
payments as follows:
●
after the first sale of
Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures;
●
after LabCorp achieves
a certain amount in the low seven figures in net sales of the Licensed Products, LabCorp will pay Proteomedix an amount in the low
seven figures; and
●
after a certain amount
in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures.
A
total of $2.5 million in milestone payments are payable under the license agreement. An additional $0.5 million was paid to Proteomedix
as an initial license fee in 2023.
LabCorp
is wholly responsible for the cost, if any, of research, development and commercialization of Licensed Products in the United States
but has the right to offset a portion of those costs against future royalty and milestone payments. Additionally, LabCorp may deduct
royalties or other payments made to third parties related to the manufacture or sale of Licensed Products up to a maximum amount of any
royalty payments due to Proteomedix.
The
license agreement and related royalty payment provisions expire during 2038, which approximates the expiration of the last patent covered
by the license agreement. LabCorp has the right to terminate the license agreement for any reason by providing 90 days written notice
to Proteomedix. Either party may terminate the license agreement due to a material breach of the terms of the license agreement with
30 days’ notice, provided such breach is not cured within the foregoing 30-day period. Finally, Proteomedix may terminate the license
agreement with 60 days’ notice in the event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit
the payment within the foregoing 60-day period.
29
On
December 6, 2025, Proteomedix and LabCorp entered into an amendment (the “LabCorp Amendment”) of the LabCorp License Agreement.
The Amendment provides for a new validation study to be conducted by LabCorp for Proclarix, titled Prostate Cancer Risk Identification
in a Multi-Ethnic Cohort: A Prospective U.S.-Based Multi-Center Validation Study of Proclarix (the “PRIME Study”). Pursuant
to the LabCorp Amendment, LabCorp will not be required to pay any royalties or milestone payments in connection with its use of the risk
calculator for purposes of the PRIME Study. The Company will compensate LabCorp with specified milestone-based payments for conducting
the PRIME Study of up to $300,000 in the aggregate and will bear all associated costs and expenses. Mid-five figure milestone payments
will be made as subjects are enrolled, commencing on the effective date of the PRIME Study and to be paid for every additional batch
of subjects enrolled. If the final milestone tier is not reached, the Company must pay Labcorp a fixed amount per subject enrolled beyond
the last milestone tier that was paid. All payments are due within thirty (30) days of each invoice.
Pursuant
to the LabCorp Amendment, LabCorp is also required to provide the Company with the results of each clinical study conducted by LabCorp
upon completion; however, the Company may not use or disclose such results to any third party without LabCorp’s prior consent.
Immunovia-Proteomedix
Licensing Agreement
On
September 17, 2025, Proteomedix entered into a licensing agreement (the “Immunovia Agreement”) with Immunovia, Inc. (“Immunovia”),
a pancreatic cancer diagnostics company based in Lund, Sweden. Under the Agreement, Proteomedix will provide Immunovia with master cell
lines required to produce antibodies for three of the five biomarkers used in the PancreaSure test, as well as a license to key intellectual
property related to the manufacturing of associated reagents.
In
return, Immunovia will make total payments of $0.6 million over two payments of $0.3 million each to Proteomedix, due on September 30,
2025 (“Initial Up Front Payment”), and March 31, 2026 (“Second Up Front Payment”). Based on the terms of the
agreement and the nature of the license, the Company determined that the performance obligations were satisfied upon the transfer of
the licensed rights which occurred during 2025. Accordingly, the Company recognized $0.6 million as license revenue during the year ended
December 31, 2025.
Additionally,
Immunovia will make a $0.1 million payment for materials and pay a 3% royalty on net sales of PancreaSure and any other products incorporating
the licensed intellectual property from January 1, 2026, through December 31, 2032.
Services
Agreement
On
July 21, 2023, the Company, entered into a Licensing and Services Master Agreement (“Master Services Agreement”) and a related
statement of work with IQVIA, pursuant to which IQVIA was to provide to the Company commercialization services for the Company’s
products, including recruiting, managing, supervising and evaluating sales personnel and providing sales-related services for such products,
for fees totaling up to $29.1 million over the term of the statement of work. The statement of work had a term through September 6, 2026,
unless earlier terminated in accordance with the Master Services Agreement and the statement of work. On July 29, 2023, a second statement
of work was entered into with IQVIA for certain subscription services providing prescription market data access to the Company. The fees
under the second statement of work totaled approximately $800,000, and the term was through July 14, 2025. On October 12, 2023, the Company
terminated the Master Services Agreement and the statements of work. The Company recorded net credits of approximately $0 and $0.9 million
related to this contract during the three months ended March 31, 2026 and 2025, respectively, which is included in selling, general and
administrative expense in the accompanying consolidated statements of operations and comprehensive loss. The Company had approximately
$0 recorded in related accounts payable as of March 31, 2026 and December 31, 2025, respectively, which includes amounts due for early
termination of the contract.
30
On
January 15, 2025, the Company and IQVIA entered into a Settlement Agreement (the “IQVIA Settlement Agreement”) concerning
potential termination payments under the Master Services Agreement and statements of work. Pursuant to the IQVIA Settlement Agreement,
the Company agreed to pay to IQVIA an aggregate of $150,000 in exchange for a mutual release of all claims in connection with the Master
Services Agreement. As of December 31, 2025, the Company paid IQVIA the agreed upon amount of $150,000 and recorded a gain of approximately
$(0.9) million on settlement of accounts payable.
Components
of Results of Operations
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses consist principally of commercialization activities, and personnel expenses, including salaries and
bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, information
technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.
We
anticipate that our selling, general and administrative expenses related to Proteomedix will increase when compared to historical levels
as a result of efforts to commercialize Proclarix, and costs associated with integration of Proteomedix’s operations.
Research
and Development Expenses
Historically,
substantially all of our research and development expenses consist of expenses incurred in connection with the development of our product
candidates. These expenses historically have included fees paid to third parties to conduct certain research and development activities
on our behalf, consulting costs, costs for laboratory supplies, product acquisition and license costs, certain payroll, and personnel-related
expenses, including salaries and bonuses, employee benefit costs and stock-based compensation expenses for our research and product development
employees. We expense both internal and external research and development expenses as they are incurred.
We
do not allocate our costs by product candidate, as a significant amount of research and development expenses include internal costs,
such as payroll and other personnel expenses, laboratory supplies, and external costs, such as fees paid to third parties to conduct
research and development activities on our behalf, that are not tracked by product candidate.
As
discussed above, we have terminated the vaccine programs that substantially all of our research and development historically related
to. We do not anticipate incurring significant research and development expenses in the near future, unless we are able to resume such
activities. Predicting the timing or cost to complete our clinical programs for future product candidates, or validation of our commercial
manufacturing and supply processes is difficult and delays may occur because of many factors, including factors outside of our control,
such as regulatory approvals. Furthermore, we are unable to predict when or if our future product candidates will receive regulatory
approval with any certainty.
Other
Income (Expense)
Other
income (expense) is comprised of interest expense on notes payable, the change in fair value of financial instruments that are recorded
as liabilities, which includes the related party subscription agreement liability, the contingent warrant liability, derivative liabilities,
and other financing-related costs.
31
Results
of Operations
Comparison
of the Three Months Ended March 31, 2026 and 2025
The
following table summarizes our statements of operations for the periods indicated:
Three
Months
Ended
March 31,
2026
Three
Months
Ended
March 31,
2025
$
Change
%
Change
Revenue
$ 21,457
$ 101,630
$ (80,173 )
(78.9 )%
Cost of revenue
23,112
55,798
(32,686 )
(58.6 )%
Gross profit
(1,655 )
45,832
(47,487 )
(103.6 )%
Operating expenses
Selling, general and administrative
$ 2,039,328
$ 1,674,206
365,122
21.8 %
Research and development
50,818
24,455
26,363
107.8 %
Impairment of goodwill
8,134,000
10,918,000
(2,784,000 )
(25.5 )%
Total operating expenses
10,224,146
12,616,661
(2,392,515 )
(19.0 )%
Loss from operations
(10,225,801 )
(12,570,829 )
2,345,028
18.7 %
Other income (expense)
Interest expense
(2,244 )
(223,592 )
221,348
99.0 %
Change in fair value of subscription agreement
liability – related party
—
3,319,000
(3,319,000 )
(100.0 )%
Change in fair value of contingent warrant
liability
1,612
(9,795 )
11,407
116.5 %
Change in fair value of Series D derivative
liability
3,955,778
—
3,955,778
100.0 %
Change in fair value of Series E derivative
liability
2,072,590
—
2,072,590
100.0 %
Gain on forgiveness of accounts payable
—
944,694
(944,694 )
(100.0 )%
Other - net
(16,810 )
(5,363 )
(11,447 )
(213.4 )%
Total other income
6,010,926
4,024,944
1,985,982
49.3 %
Loss before income taxes
(4,214,875 )
(8,545,885 )
4,331,010
50.7 %
Income tax benefit
—
—
—
— %
Net loss
$ (4,214,875 )
$ (8,545,885 )
4,331,010
50.7 %
Deemed dividend Series
C preferred stock
—
(1,170,091 )
1,170,091
100 %
Net loss applicable
to common stockholders’
$ (4,214,875 )
$ (9,715,976 )
5,501,101
56.6 %
Revenue,
Cost of Revenue, and Gross Margin
For
the three months ended March 31, 2026, the Company generated approximately $21 thousand of revenue, compared to approximately $102 thousand
for the same period in 2025. The decrease in revenue was primarily attributable to lower product sales generated by Proteomedix during
the current period, reflecting reduced customer demand and timing of orders compared to the prior year period. Cost of revenue for the
three months ended March 31, 2026 was approximately $23 thousand, compared to approximately $56 thousand for the same period in 2025,
and was primarily attributable to costs incurred related to Proteomedix product sales. The Company reported a gross loss for the three
months ended March 31, 2026 as cost of revenue exceeded revenue, primarily due to lower sales volumes during the period, while certain
production and fulfillment costs remained relatively fixed.
Selling,
General and Administrative Expenses
For
the three months ended March 31, 2026, selling, general and administrative expenses increased by $0.4 million compared to the same
period in 2025. The change is largely due to the increase in professional fees including accounting, legal, and regulatory fees, which
were related to the additional filings and transactions during the current period.
32
Research
and Development Expenses
For
the three months ended March 31, 2026 research and development expenses increased by $26 thousand to $51 thousand compared to the same
period in 2025. This change was due to the new clinical study agreement with LabCorp where the Company agreed to pay for research and
development costs.
Impairments
The
Company recorded an impairment of goodwill related to the PMX acquisition during the three months ended March 31, 2026 totaling $8.1
million, compared to $10.9 million during the three months ended March 31, 2025.
Other
Income
Other
income for the three months ended March 31, 2026, increased by approximately $2.0 million
compared to the same period in 2025. The increase was primarily driven by a $4.0 million
decrease in the change in fair value of Series D derivative liability, a $2.1 million decrease
in the change in fair value of Series E derivative liability, partially offset by a $3.3
million decrease in the change in fair value of the subscription agreement liability –
related party, a $0.9 million decrease to gain on forgiveness of accounts payable related
to the settlement of IQVIA balances, and smaller changes in interest expense and other items.
Income
Tax Benefit
The
Company did not record any income tax benefit or expense during the three months ended March 31, 2026 and 2025.
Liquidity
and Capital Resources
The
Company’s operating activities to date have been primarily devoted to seeking licenses, engaging in research and development activities,
potential asset and business acquisitions, and expenditures associated with the now halted commercial launch of ENTADFI and the commercialization
of Proclarix.
The
Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the
foreseeable future.
As
of March 31, 2026, the Company had cash of approximately $3.7 million, a working capital
surplus of approximately $1.3 million and an accumulated deficit of approximately $135.4
million. During the three months ended March 31, 2026, the Company used approximately $2.1
million in cash for operating activities. In addition, as of May 11, 2026, the Company’s
cash balance was approximately $4.1 million. The Company’s current cash balance
is not sufficient to fund its operations through the end of December 2026.
During
the financial year ended December 31, 2025, the Company closed a Series D Preferred Stock financing in September 2025 and a Series E
Preferred Stock financing in October 2025. Such financings provided the Company with additional cash flow to support near-term
operations. While these capital raises may enable the Company to sustain current operations and meet existing obligations, the
Company continues to generate recurring net operating losses and has not yet established sustained positive cash flows to support
its strategic growth initiatives, which includes the commercialization of Proclarix and the closing of the Realbotix Transactions.
These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date
of issuance of these consolidated financial statements.
Management’s
plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to
further successful commercialization activities within certain jurisdictions. Management also intends to secure additional funding through
equity or debt financings if available, and to utilize the ELOC entered into in October 2024 on an as-needed basis to fund current operating
needs, including future expenses incurred in connection with closing the Realbotix Transactions, subject to certain restrictions and
beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management determined
that the funds readily available under the ELOC will not be sufficient to sustain operations. In addition, there are currently no other
commitments in place for further financing nor is there any assurance that such financing will be available to sustain its operations
and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required to curtail any future
clinical trials, development and/or commercialization of Proclarix and any future product candidates, or it may be unable to close the
Realbotix Transactions on a timely basis as contemplated in the Share Exchange Agreement. As such, the Company may take additional measures
to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it is required
to, file for bankruptcy.
33
Because
of historical and expected operating losses, net operating cash flow deficits, and debts due within one year, there is substantial doubt
about the Company’s ability to continue as a going concern for one year from the issuance of the consolidated financial statements,
which is not alleviated by management’s plans. The consolidated financial statements have been prepared assuming the Company will
continue as a going concern. These consolidated financial statements do not include any adjustments that might be necessary from the
outcome of this uncertainty.
Future
Funding Requirements
We
anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to commercialize Proclarix and
to close the Realbotix Transactions as contemplated in the Share Exchange Agreement.
We
will require significant amounts of additional capital in the short-term, to continue to fund our continuing operations, to close the
Realbotix Transactions, to satisfy existing and future obligations and liabilities contracts entered into in support of the Company’s
commercialization plans, in addition to funds needed to support our working capital needs and business activities, including the development
and commercialization of Proclarix, and the development and commercialization of our future product candidates. Until we can generate
a sufficient amount of revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private
equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic
alliances and licensing arrangements, or any combination of these approaches.
While
the Company closed the Series D and E Preferred Stock financings during the financial year ended December 31, 2025, there are currently
no other commitments in place for further financing nor is there any assurance that such financing will be available to the Company on
favorable terms, if at all. This creates significant uncertainty whether the Company will have the funds available to be able to sustain
its operations and expand commercialization of Proclarix, or to close the Realbotix Transactions on a timely basis as contemplated in
the Share Exchange Agreement. If the Company is unable to secure additional capital, it may be required to curtail any future clinical
trials, development and/or commercialization of future product candidates, delay the closing of or terminate the proposed Realbotix Transactions
as contemplated in the Share Exchange Agreement, and it may take additional measures to reduce expenses in order to conserve its cash
in amounts sufficient to sustain operations and meet its obligations, or, if it’s required to, file for bankruptcy.
Our
future capital requirements will depend on many factors, including:
●
fees paid to financial,
legal, accounting and other advisors in connection with negotiating and completing the Realbotix Transactions;
●
the costs of future commercialization
activities, including product manufacturing, marketing, sales, royalties, and distribution, for Proclarix, and other products for
which we may receive marketing approval;
●
the timing, scope, progress,
results and costs of research and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical
trials;
●
the outcome, timing and
cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential
for such authorities to require that we perform field efficacy studies, require more studies than those that we currently expect
or change their requirements regarding the data required to support a marketing application;
34
●
our ability to maintain
existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements,
including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
●
any product liability or
other lawsuits related to our product;
●
the expenses needed to
attract, hire and retain skilled personnel;
●
the revenue, if any, received
from commercial sales of Proclarix, or other products for which we may have received or will receive marketing approval;
●
the costs to establish,
maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments
we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing
our patents or other intellectual property rights; and
●
the costs of operating
as a public company.
A
change in the outcome of any of these or other variables could significantly change the costs and timing associated with our business
activities. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and
capital requirements associated with such change.
Cash
Flows
The
following table summarizes our cash flows for the periods indicated:
Three
months
Ended
March 31,
2026
Three
months
Ended
March 31,
2025
Net cash used in operating activities
$ (2,121,481 )
$ (1,999,680 )
Net cash provided by investing activities
—
—
Net cash provided by financing activities
631,788
2,870,254
Effect of exchange rate
changes on cash
(14,889 )
60,119
Net increase (decrease)
in cash
$ (1,504,582 )
$ 930,693
Cash
Flows from Operating Activities
Net
cash used in operating activities for the three months ended March 31, 2026, was approximately
$2.1 million, which was primarily driven by a net loss of approximately $4.2 million and
gain on change in fair value of derivative liabilities of approximately $6 million, which
were offset by a non-cash stock-based compensation expense of approximately $0.02 million,
loss on impairment of goodwill of approximately $8.1 million, and net changes in our operating
assets and liabilities of $0.04 million.
Net
cash used in operating activities for the three months ended March 31, 2025, was approximately $2.0 million, which was primarily driven
by a net loss of approximately $8.5 million, a non-cash change in fair value of subscription liability of approximately $3.3 million,
a gain on forgiveness of accounts payable of approximately $0.9 million, and net changes in our operating assets and liabilities of $0.07
million. These items were offset by several non-cash items, which primarily include impairment of goodwill of approximately $10.9 million.
35
Cash
Flows from Financing Activities
Net
cash provided by financing activities for the three months ended March 31, 2026, was approximately $0.6 million, and resulted primarily
from proceeds of approximately $0.4 million from exercise of warrants.
Net
cash provided by financing activities for the three months ended March 31, 2025, was approximately $2.9 million, and resulted primarily
from proceeds of approximately $5.0 million from the purchase of common stock in connection with the ELOC and $0.1 million from the issuance
of notes payable. These proceeds were offset by payments on notes payable of approximately $0.9 million and a payment of approximately
$1.3 million related to redemption of the Series C Preferred Stock.
Legal
Contingencies
From
time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such
matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated.
Off-Balance
Sheet Arrangements
During
the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined in the rules and regulations
of the SEC.
Recent
Accounting Pronouncements Not Yet Adopted
See
Note 3 to our condensed consolidated financial statements included elsewhere in this Report for more information.
Critical
Accounting Policies and Estimates
Our
consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).
The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts
of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements.
On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience, known trends and events
and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ
from these estimates under different assumptions or conditions.
As
of March 31, 2026, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s
Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates,” included
in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 13, 2026.
JOBS
Act
Section 107
of the Jumpstart Our Business Startups Act (“JOBS”) Act provides that an “emerging growth company” can take advantage
of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting
standards. In other words, an “emerging growth company” can delay the adoption of new or revised accounting standards until
those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period.
For
as long as we remain an “emerging growth company” under the JOBS Act, we will, among other things:
●
be exempt from the provisions
of Section 404(b) of the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide
an attestation report on the effectiveness of our internal control over financial reporting;
●
be permitted to omit the
detailed compensation discussion and analysis from proxy statements and reports filed under the Securities and Exchange Act
of 1934, as amended (the “Exchange Act”), and instead provide a reduced level of disclosure concerning executive compensation;
and
●
be exempt from any rules
that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the
auditor’s report on the financial statements.
36
We
currently intend to take advantage of some or all of the reduced regulatory and reporting requirements that will be available to us so
long as we qualify as an “emerging growth company,” including the extension of time to comply with new or revised financial
accounting standards available under Section 102(b) of the JOBS Act. Among other things, this means that our independent registered
public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial
reporting so long as we qualify as an emerging growth company, which may increase the risk that weaknesses or deficiencies in our internal
control over financial reporting go undetected. Likewise, so long as we qualify as an emerging growth company, we may elect not to provide
you with certain information, including certain financial information and certain information regarding compensation of our executive
officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult for
investors and securities analysts to evaluate our company. As a result, investor confidence in our company and the market price of our
common stock may be materially and adversely affected.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a smaller reporting company, we are not required to provide the information required by this Item.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
The
Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e)) that are designed to ensure that information required to be disclosed by us in reports we file or submit under the Securities
Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the appropriate time periods, and that such
information is accumulated and communicated to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely
discussions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer has evaluated the effectiveness of our disclosure controls and procedures. Management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily
applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer has concluded that the Company’s disclosure controls and procedures were not effective
as of March 31, 2026, as a result of the material weaknesses described below.
Material
Weaknesses in Internal Control Over Financial Reporting
A
material weakness in internal control is a deficiency in internal control, or combination of control deficiencies, that adversely affects
the Company’s ability to initiate, authorize, record, process, or report external financial data reliably in accordance with GAAP
such that there is more than a remote likelihood that a material misstatement of the Company’s annual or interim financial statements
will not be prevented or detected.
We
have identified the following internal control deficiencies, which we believe to be material weaknesses as of March 31, 2026:
●
We did not maintain an
effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements.
●
We do not have an effective
risk assessment process and effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate
a sufficient level of precision in the application of our controls.
●
Our controls over the approval
and reporting of expense payments were not designed and maintained to achieve the Company’s objectives.
●
We do not yet have adequate
internal controls in place for the timely identification, approval or reporting of related party transactions.”
●
We have insufficient accounting
resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries,
and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for
complex, non-routine transactions, and prepare financial statements.
●
The Company did not design,
implement and maintain effective controls to ensure information technology (“IT”) policies and procedures set the tone
at the top, to mitigate the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer
operations domains. Specifically, the design and implementation of user authentication, user access privileges, data backup and data
recovery controls as well as the monitoring controls of excessive user access and elevated privileged access to financial applications
and data were not appropriately designed and maintained. In addition, these inadequate ITGC controls combined with the use of personal
devices to conduct business, can lead to an IT control environment vulnerable to breaches and social engineering persuasion.
37
The
above material weaknesses did not result in a material misstatement of our previously issued financial statements but could have resulted
in material misstatements of our account balances or disclosures of our annual or interim financial statements that would not be prevented
or detected. We have developed a remediation plan for these material weaknesses which is described below in Remediation of Material
Weaknesses .
Remediation
of Material Weaknesses
As
of the date of this Quarterly Report on Form 10-Q, management is re-assessing the design of controls and modifying processes designed
to improve our internal control over financial reporting and remediate the control deficiencies that led to the material weaknesses,
including but not limited to (a) improving consistency in change management supported by standard operating procedures to govern the
authorization, testing and approval of changes to information technology systems supporting all of the Company’s internal control
processes, (b) enhancing design and implementation of our control environment, including the expansion of formal accounting and IT policies
and procedures and financial reporting controls, (c) continuing to identify and design and implement effective review and approval controls,
and (d) implementing appropriate timely review and oversight responsibilities within the accounting and financial reporting functions
and ensuring appropriate segregation of duties.
We
will consider the material weaknesses remediated after the applicable controls operate for a sufficient period of time, and management
has concluded, through testing, that the controls are operating effectively.
The
process of designing and implementing an effective accounting and financial reporting system is a continuous effort that requires us
to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to
maintain an accounting and financial reporting system that is adequate to satisfy our reporting obligations. As we continue to evaluate
and take actions to improve our internal control over financial reporting, we may determine to take additional actions to address control
deficiencies or determine to modify certain of the remediation measures described above. We cannot assure you that the measures we have
taken to date, or any measures we may take in the future, will be sufficient to remediate the material weakness we have identified or
avoid potential future material weaknesses.
Inherent
Limitation on the Effectiveness of Internal Control Processes
Our
Chief Executive Officer does not expect that our disclosure controls or our internal control over financial reporting will prevent all
errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. 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, 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.
Changes
in Internal Control over Financial Reporting
During
the fiscal quarter ended March 31, 2026, there were no changes in our internal control over financial reporting (as such term is defined
in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
38
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
We
are not currently subject to any material legal proceedings, nor, to our knowledge, is any material legal proceeding threatened against
us or any of our officers or directors in their corporate capacity.
Item
1A. Risk Factors
In
addition to the following risk factors, you should carefully consider the risk factors included in our Annual Report on Form 10-K, filed
with the SEC on March 13, 2026, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and Current Reports on Form
8-K that we have filed or will file with the SEC. Any of these factors could result in a significant or material adverse effect on our
results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial
may also impair our business or results of operations.
Risks
Related to our Financial Position and Need for Capital
We
have incurred significant net losses since inception, have only generated minimal revenue, and anticipate that we will continue to incur
substantial net losses for the foreseeable future and may never achieve profitability. Our stock is a highly speculative investment.
We
are a commercial-stage biotechnology company that was incorporated in October 2018. Our net
loss was $4.2 million for the three months ended March 31, 2026. As of March 31, 2026, we
had an accumulated deficit of $135.4 million. We also generated negative operating cash flows
of $2.1 million for the three months ended March 31, 2026.
We
expect to continue to spend significant resources to commercialize our product. We expect to incur substantial and increasing operating
losses over the next several years. As a result, our accumulated deficit will also increase significantly. Additionally, there can be
no assurance that our current product or those that may be under development by us in the future will be commercially viable. If we are
unable to achieve profitability or raise sufficient working capital, we may be unable to continue our operations.
There
is substantial doubt about our ability to continue as a “going concern,” and we will require substantial additional funding
to finance our long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or
terminate our product or other operations.
The
Company has incurred substantial operating losses since inception and expects to continue
to incur significant operating losses for the foreseeable future. As of March 31, 2026, the
Company had cash of approximately $3.7 million, a working capital surplus of approximately
$1.3 million and an accumulated deficit of approximately $135.4 million. In addition, as
of May 12, 2026, the Company’s cash balance was approximately $4.1 million, and the
Company has approximately $0.02 million of debt due within the next 12 months.
We
believe that we will need to raise substantial additional capital to fund our continuing operations, satisfy existing and future obligations
and liabilities, and otherwise support the Company’s working capital needs and business activities, including completing the Realbotix
Transactions on a timely basis and the commercialization of Proclarix, which is still subject to further successful development and commercialization
activities within certain jurisdictions.
39
Management
also intends to secure additional required funding through equity or debt financings if available. In December 2024, the Company began
utilizing the ELOC entered into in October 2024 (see Note 9) on an as-needed basis to fund current operating needs, subject to certain
restrictions and beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management
determined that the funds readily available under the ELOC will not be sufficient to sustain operations, close the Realbotix Transactions
on a timely basis and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required
to curtail any future clinical trials, development and/or commercialization of future product candidates, delay the closing of the Realbotix
Transactions on a timely basis as contemplated in the Share Exchange Agreement, and it may take additional measures to reduce expenses
in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it is required to, file for
bankruptcy.
These
conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of time within one year
following the date of this Report. Our future capital requirements will depend on many factors, including:
●
fees paid to financial,
legal, accounting and other advisors in connection with negotiating and completing the Realbotix Transactions;
●
the costs of future development
and commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for Proclarix, and
other products for which we have received or will receive marketing approval;
●
our ability to maintain
existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements,
including the timing and amount of any future milestone, royalty, or other payments due under any such agreement;
●
any product liability or
other lawsuits related to our product;
●
the expenses needed to
attract, hire, and retain skilled personnel;
●
the revenue, if any, received
from commercial sales of Proclarix or other products for which we may receive marketing approval;
●
the costs to establish,
maintain, expand, enforce, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments
we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending, and
enforcing our patents or other intellectual property rights; and
●
the costs of operating
as a public company.
Our
ability to raise additional funds will depend on financial, economic, and other factors, many of which are beyond our control. We cannot
be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital
and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce
or terminate our business activities.
40
Our
current liabilities are significant, and if those to whom we owe accounts payable, such as Veru or other vendors, were to demand payment,
we would be unable to pay.
As
of March 31, 2026, we had total current liabilities of approximately $3.1 million, including
accounts payable of approximately $1.5 million, accrued expenses of approximately $0.3 million,
derivative liabilities of $1.0 million, and approximately $0.2 million related to the notes
payable. As of the same date, we had cash of only $3.7 million. We plan to seek funding to
support our operations. However, the level of our current liabilities may make it more difficult
for us to obtain adequate financing on favorable terms, if at all. If those to whom these
payments are due were to demand immediate payment, as they are entitled to do, and we are
not able to make the required payments, we would be subject to liability if our creditors
chose to enforce their rights, which could result in our bankruptcy and insolvency. Under
such a scenario, our assets would be distributed to our creditors leaving nothing to be distributed
to our stockholders.
Risks
Related to Pending Share Exchange
We
could fail to complete the Realbotix Transactions, or the Realbotix Transactions may be completed on different terms.
There
can be no assurance that the Realbotix Transactions will be completed, or if completed, that they will be completed on the same or similar
terms to those set out in our previous disclosure. The Realbotix Transactions are subject to the satisfaction of a number of conditions
precedent, some of which are outside our control, which include, among others, performance by Simulacra and Realbotix of their respective
obligations and covenants in the Share Exchange Agreement. If these conditions are not satisfied (or waived) or the Realbotix Transactions
are not completed for any other reason, our stockholders will not receive the consideration contemplated in the Share Exchange Agreement.
If
the Realbotix Transactions are not completed, our ongoing business may be adversely affected as a result of the costs (including opportunity
costs) incurred in respect of pursuing the Realbotix Transactions, and we could experience negative reactions from the financial markets,
which could cause a decrease in the market price of our Common Stock, particularly if the current market price reflects market assumptions
that the Realbotix Transactions will be completed or completed on certain terms. We may also experience negative reactions from our employees
and there could be negative impact our ability to attract future business opportunities. Failure to complete the Realbotix Transactions
or a change in the terms of the Realbotix Transactions could each have a material adverse effect on our business, financial condition
and results of operations.
We
may pay a transaction fee to Realbotix if we fail to complete the Realbotix Transactions and could significantly harm the market price
of our common stock and negatively affect our future business and operations.
If
the Realbotix Transactions is not completed and the Share Exchange Agreement is terminated under certain circumstances, we may be required
to pay Realbotix a termination fee as follows:
●
In the event of a termination
of the Share Exchange Agreement as a result of a material breach by either party, the breaching party will be required to pay a termination
fee to the non-breaching party of $500,000 plus transaction expenses, with such transaction expenses not to exceed $500,000.
●
In the event of a termination
of the Share Exchange Agreement if (i) our Board deems a third-party offer to acquire our assets to be superior than the Share Exchange
Agreement and is therefore in the best interest of our stockholders (the “Buyer Superior Proposal”) and/or (ii) enters
into an agreement with a third-party to effectuate a Buyer Superior Proposal, we must pay a termination fee of (A) $500,000 plus
all Realbotix transaction expenses plus (B) if the transaction in respect of a Buyer Superior Proposal closes, an additional $1,500,000
upon closing of such transaction. If the transaction contemplated by the Buyer Superior Proposal does not close, we are only obligated
to pay $500,000 plus all Realbotix transaction expenses.
41
●
In the event of a termination
of the Share Exchange Agreement by Realbotix for failure to satisfy the Net Cash Condition (as defined in the Share Exchange Agreement),
if Net Cash (as defined in the Share Exchange Agreement) at the time of termination would be greater than $5.0 million (assuming
the consummation of any transactions for financing), we are obligated to pay Realbotix’s transaction expenses, with such transaction
expenses not to exceed $500,000.
Even
if a termination fee is not payable in connection with a termination of the Share Exchange Agreement, we will have incurred significant
fees and expenses, which must be paid whether or not the Realbotix Transactions is completed. Further, if the Realbotix Transactions
is not completed, it could significantly harm the market price of our common stock.
In
addition, if the Share Exchange Agreement is terminated and we determine to seek another business combination, there can be no assurance
that we will be able to find a partner and close an alternative transaction on terms that are as favorable as or more favorable to us
than the terms set forth in the Share Exchange Agreement.
The
closing of the Realbotix Transactions is subject to approval by our stockholders.. Failure to obtain these other required approvals would
prevent the closing of the Realbotix Transactions.
The
closing of the Realbotix Transactions is subject to certain approvals by our stockholders.. Failure to obtain the required stockholder
approvals may result in a material delay in, or the abandonment of, the Realbotix Transactions. Any delay in completing the Realbotix
Transactions may materially adversely affect the timing and benefits that are expected to be achieved from the Realbotix Transactions.
If
the Realbotix Transactions is not completed, the Board may decide to pursue our dissolution and liquidation. In such an event, the amount
of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of
cash that will need to be reserved for commitments and contingent liabilities.
There
can be no assurance that the Realbotix Transactions will be completed. If the Realbotix Transactions is not completed, our Board may
decide to pursue our dissolution and liquidation. In such an event, the amount of cash available for distribution to our stockholders
will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will
be reduced we continue to fund our operations. In addition, if our Board were to approve and recommend, and our stockholders were to
approve, our dissolution and liquidation, we would be required under Delaware corporate law to pay its outstanding obligations, as well
as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders.
As a result of this requirement, a portion of our remaining cash assets may need to be reserved pending the resolution of such obligations.
In addition, we may be subject to litigation or other claims related to a dissolution and liquidation. If a dissolution and liquidation
were pursued, our Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable
amount to reserve. Accordingly, holders of our common stock could lose all or a significant portion of their investment in the event
of pir liquidation, dissolution or winding up.
The
issuance of securities would result in significant dilution in the equity interest of existing stockholders and adversely affect the
marketplace of our Common Stock.
The
issuance or conversion of Common Stock or other securities convertible into Realbotix Common Stock in connection with the Realbotix Transactions
would result in significant dilution in the equity interest of our existing stockholders and adversely affect the market price of our
Common Stock. In addition, future issuances of, or conversions of, securities may result in significant dilution to our existing stockholders,
which could adversely impact your investment.
42
Our
stockholders may not realize a benefit from the acquisition of Realbotix commensurate with the ownership dilution they will experience
in connection with the Realbotix Transactions contemplated by the Share Exchange Agreement.
If
we are unable to realize the full strategic and financial benefits currently anticipated from the Realbotix Transactions, our stockholders
may experience a dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate
benefit to the extent we are able to realize only part of the strategic and financial benefits currently anticipated from the Realbotix
Transactions. The Realbotix Transactions may pose integration challenges which could result in management and business disruptions, any
of which could harm our results of operation, business prospects, and impair the value of the Realbotix Transactions to our stockholders.
The
failure to successfully integrate the businesses of us and Realbotix in the expected timeframe would adversely affect our future results.
Our
ability to successfully integrate our operations and those of Realbotix will depend, in part, on our ability to realize the anticipated
benefits from the Realbotix Transactions. If we are not able to achieve the stated objectives, the anticipated benefits of the Realbotix
Transactions may not be realized fully, or at all, or may take longer to realize than expected, and the value of our Common Stock may
be adversely affected. In addition, the integration of our and Realbotix’s respective businesses will be a time-consuming and expensive
process. Proper planning and effective and timely implementation will be critical to avoid any significant disruption to our operations.
It is possible that the integration process could result in the loss of key employees, the disruption of our business or the identification
of inconsistencies in standards, controls, procedures and policies that adversely affect our ability to maintain relationships with customers,
suppliers, distributors, creditors or lessors, or to achieve the anticipated benefits of the Realbotix Transactions. Delays encountered
in the integration process could have a material adverse effect on our operating results and financial condition, including the value
of our Common Stock.
The
pending Realbotix Transactions may divert the attention of our management.
The
pending Realbotix Transactions could cause the attention of our management to be diverted from the day-to-day operations. These disruptions
could be exacerbated by a delay in the completion of the Realbotix Transactions and could have an adverse effect on our business, operating
results or prospects regardless of whether the Realbotix Transactions are ultimately completed.
Unexpected
market disruptions may cause major losses for us not anticipated under the Share Exchange Agreement.
We
may incur major losses in the event of disrupted markets and other extraordinary events in which market behavior diverges significantly
from historically recognized patterns, which may offset any potential benefits achieved under the Share Exchange Agreement. The risk
of loss in such events may be compounded by the fact that, in disrupted markets, many positions become illiquid, making it difficult
or impossible to close out positions against which markets are moving. Market disruptions caused by unexpected political, military and
terrorist events, or other factors, may from time to time cause dramatic losses for us.
Risks
associated with changes in the technology industry.
Realbotix
operates in a competitive industry characterized by rapid technological change and evolving industry standards. Realbotix’s ability
to attract new customers to its business, and generate revenue from existing customers will depend largely on its ability to anticipate
industry standards and trends, respond to technological advances in its industry, and keep pace with technological developments and customers’
increasingly sophisticated needs. The success of any enhancement of Realbotix’s products or new related applications will depend
on several factors, including the timely completion and market acceptance of the products.
Realbotix’s
services are expected to embody complex technology that may not meet those standards, changes and preferences. Realbotix’s ability
to design, develop and commercially launch products depends on a number of factors, including, but not limited to, its ability to design
and implement solutions and services at an acceptable cost and quality, its ability to attract and retain skilled technical employees,
the availability of critical components from third parties, and its ability to successfully complete the development of the products
in a timely manner. There is no guarantee that Realbotix will be able to respond to market demands. If Realbotix is unable to effectively
respond to technological changes or fails or delays to develop services in a timely and cost-effective manner, Realbotix may be unable
to recover our development expenses which could negatively impact sales, profitability and the continued viability of its business.
43
We
may be unable to protect Realbotix’s intellectual property.
Realbotix’s
commercial success depends to a significant degree upon its ability to develop new or improved technologies, instruments, and services,
and to obtain patents, where appropriate, or other intellectual property rights or statutory protection for these technologies and products
in Canada and the United States. Despite devoting resources to the research and development of proprietary technology, Realbotix, may
not be able to develop new technology that is patentable or protectable. Further, patents issued to Realbotix, if any, could be challenged,
held invalid or unenforceable, or be circumvented and may not provide Realbotix with necessary or sufficient protection or a competitive
advantage. Competitors and other third parties may be able to design around Realbotix’s intellectual property or develop technology
similar to Realbotix’s products that is not within the scope of such intellectual property. Realbotix’s inability to secure
its indirectly owned, intellectual property rights may have a materially adverse effect on its business and results of operations.
The
business of Realbotix is exposed to cybersecurity risks.
Cyber
incidents can result from deliberate attacks or unintentional events, and may arise from internal sources (e.g., employees, contractors,
suppliers and operational risks) or external sources (e.g., nation states, terrorists, hacktivists, competitors and acts of nature).
Cyber incidents include unauthorized access to information systems and data (e.g., through hacking or malicious software) for purposes
of misappropriating or corrupting data or causing operational disruption. Cyber incidents also may be caused in a manner that does not
require unauthorized access, such as causing denial-of-service attacks on websites (e.g., efforts to make network services unavailable
to intended users). A cyber incident that affects Realbotix might cause disruptions and adversely affect their respective business operations
and might also result in violations of applicable law (e.g., personal information protection laws), each of which might result in potentially
significant financial losses and liabilities, regulatory fines and penalties, reputational harm, and reimbursement and other compensation
costs to Realbotix. In addition, substantial costs might be incurred to investigate, remediate, and prevent cyber incidents.
We
expect to incur significant transaction costs in connection with the Realbotix Transactions.
We
expect to incur a number of non-recurring costs associated with negotiating and completing the Realbotix Transaction. These fees and
costs have been, and will continue to be, substantial and, in many cases, will be borne by us whether or not the Realbotix Transaction
is completed. A substantial majority of our non-recurring expenses will consist of transaction costs related to the Realbotix Transactions
and include, among others, fees paid to financial, legal, accounting and other advisors. We will continue to assess the magnitude of
theses costs, and we may incur additional unanticipated costs. The costs described above and any unanticipated costs and expenses, many
of which will be borne by us even if the Realbotix Transaction is not completed, could have an adverse effect on our financial condition
and operating results.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
There
are no transactions that have not been previously included in a Current Report on Form 8-K.
Issuer
Purchases of Equity Securities
None.
Item
3. Default Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None
44
Item
6. Exhibits
The
following documents are filed as exhibits to this Report.
EXHIBIT
INDEX
Incorporated
by Reference
Exhibit
No.
Description
Form
Exhibit
Filing
Date
2.1
Share
Exchange Agreement, dated February 11, 2026, by and among Onconetix, Inc., Realbotix, LLC, Realbotix Corp, and Simulacra Corporation.†
8-K
2.1
February 12, 2026
3.1
Amended
and Restated Certificate of Incorporation filed with Delaware Secretary of State dated February 23, 2022
8-K
3.1
February 24,
2022
3.2
Certificate
of Amendment to the Company’s Second Amended and Restated Certificate of Incorporation, dated April 24, 2023
8-K
3.1
April 24, 2023
3.3
Certificate
of Amendment to the Company’s Second Amended and Restated Certificate of Incorporation, dated December 21, 2023
8-K
3.1
December 21, 2023
3.4
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation, as amended, of Onconetix, Inc., dated September 24, 2024
8-K
3.1
September 24, 2024
3.5
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation, as amended, of Onconetix, Inc., dated June 11, 2025
8-K
3.1
June 11, 2025
3.6
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation, as amended, of Onconetix, Inc. dated March 25, 2026
8-K
3.1
March 27, 2026
3.7
Certificate
of Designations authorizing the issuance of the Series C Preferred Stock
8-K
3.1
October 3, 2024
3.8
Certificate
of Correction to Certificate of Designations authorizing the issuance of the Series C Preferred Stock
10-Q
3.7
June 12, 2025
3.9
Fourth
Amended and Restated Bylaws of the Company
8-K
3.2
December 21, 2023
3.10
Form
of Warrant (Series E)
8-K
4.1
October 3, 2025
3.11
Certification
of Designation of Series C Preferred Stock.
8-K
3.1
October 3, 2024
3.12
Certification
of Designation of Series D Preferred Stock.
8-K
3.1
September 26, 2025
4.1
Form
of Inducement PIO
8-K
4.1
July 11, 2024
4.2
Form
of Warrant (Series C)
8-K
4.1
October 3, 2024
4.3
Form
of Warrant (Series D)
8-K
4.1
September 26, 2025
31.1*
Certification
of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification
of the Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification
of the Principal Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification
of the Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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
Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension
Presentation Linkbase Document.
104*
Cover Page Interactive
Data File (formatted as Inline XBRL and contained in Exhibit 101).
*
Filed herewith.
**
Furnished herewith.
† Certain
of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation
S-K Item 601(a)(5). The Company agrees to furnish a copy of all omitted exhibits and schedules
to the SEC upon its request.
45
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.
Onconetix, Inc.
Date: May 13, 2026
/s/ David
A. White
David A. White
Chief Executive Officer
(principal executive officer)
46
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.