NASDAQ: ONCO

We are currently focusing our efforts on commercializing
Proclarix.

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.

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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.

We have incurred net losses since inception and expect to continue to incur
net losses in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending in
large part on the timing of our preclinical studies, clinical trials and manufacturing activities, our expenditures on other research
and development activities and commercialization activities. As of December 31, 2025, we had cash of approximately $5.2 million, a working
capital deficit of approximately $3.1 million and an accumulated deficit of approximately $131.2 million. During the year ended December
31, 2025, we used approximately $9.7 million in cash for operating activities. In addition, as of March 11, 2026, our cash balance was
approximately $3.6 million. We believe that our current cash balance is not sufficient to fund its operations for one year from the date
of issuance of the consolidated financial statements for the year. As such, we have entered into Series D and Series E PIPE financings
with certain investors in September 2025 and October 2025, respectively, which provided us additional cash flow to support our near-term
operations. While such capital raises may enable us to sustain current operations and meet existing obligations, we continue to generate
recurring net operating losses and have not yet established sustained positive cash flows to support our strategic growth initiatives.
Such initiatives include the commercialization of Proclarix and our development and commercialization of future product candidates. These
factors raise substantial doubt on our ability to continue as a going concern for one year from the date of issuance of our consolidated
financial statements for the financial year ended December 31, 2025.

Until we generate revenue sufficient to support
self-sustaining cash flows, if ever, we will need to raise additional capital to fund our continued operations, including our product
development and commercialization activities related to our current and future products. There can be no assurance that additional capital
will be available to us on acceptable terms, or at all, or that we will ever generate revenue sufficient to provide self-sustaining cash
flows. These circumstances raise substantial doubt about our ability to continue as a going concern. The accompanying consolidated financial
statements of Onconetix, as of and for the year ended December 31, 2025, included elsewhere in this Report do not include any adjustment
that might be necessary if the Company is unable to continue as a going concern.

Because of the numerous risks and uncertainties
associated with our business, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve
or maintain profitability. Additionally, even if we are able to generate revenue from Proclarix, we may not become profitable. If we
fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations
at planned levels and may be forced to reduce our operations.

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”).

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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.

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”).

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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.

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.

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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.

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.

Management and History

Onconetix, Inc. (formerly Blue Water Vaccines
Inc. and Blue Water Biotech, Inc.) was founded in October 2018. The Company’s initial goal was to develop a transformational universal
flu vaccine to treat and prevent infections in patients globally. After deprioritizing our vaccine programs, the Company subsequently
shifted its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of men’s health and
oncology.

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Karina M. Fedasz had been appointed as our Interim
Chief Executive Officer since April 2025 and Chief Financial Officer since June 2024, respectively. For more than two decades, Ms. Fedasz
has helped companies raise capital, model and forecast business, manage cash flow and conduct mergers and acquisitions. She is a dynamic,
data-driven executive with a bold, high-growth mindset. From January 2023 to June 2024, Ms. Fedasz worked with various clients, including
a not-for-profit and an early-stage artificial intelligence and data-driven health and wellness tracker. From February 2022 to December
2022, Ms. Fedasz served as Head of Business Development for Evofem Biosciences, a Nasdaq-listed public biotech company developing innovative
products for women's health. From August 2019 to October 2021, Ms. Fedasz served in various positions of increasing responsibility, including
Chief Financial Officer, at IDW Media Holdings, a micro-cap media company, where she managed the company's initial public offering. From
April 2018 to August 2019, Ms. Fedasz served as Chief Financial Officer of MOCEAN, an integrated agency for entertainment, gaming, and
brands. Ms. Fedasz's breadth of experience has seen her lead teams in media, technology, services, manufacturing, and education, and
she has worked with companies whose clients and customers include Fortune 500 companies such as Netflix, Disney, Amazon, Apple, Activision,
and EA. Ms. Fedasz received an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los
Angeles (UCLA). She holds an inactive CPA in the state of California.

Additionally, members of our board of directors
(“Board”) have extensive expertise in the fields of life sciences, business and finance. Our directors include Andrew Oakley,
who had held several CFO positions at publicly-traded pharmaceutical companies, Sarah Romano, who has over a decade of experience leading
the finance function of multiple publicly-traded companies, Dr. Thomas Meier, who has over two decades of experience as life-science
and biotech entrepreneur, executive manager, and board member on life-science and biotech companies, and Timothy Ramdeen, who has nearly
a decade of experience in private equity and hedge fund investing, capital markets, and company formation.

Nasdaq Compliance

On January 24, 2025, the Company received a letter
from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company’s Common Stock
from November 25, 2024 to January 10, 2025, the Company is no longer in compliance with the requirement for continued listing on The
Nasdaq Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum
Bid Price Rule”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq provided the Company with 180 calendar days to regain
compliance with the Minimum Bid Price Rule.

On April 14, 2025, Nasdaq issued a further notice
(the “Notice”) to the Company that it determined that the Company’s securities had a closing bid price of $0.10 or
less for ten consecutive trading days. Accordingly, the Company is subject to the provisions under Nasdaq Listing Rule 5810(c)(3)(A)(iii).
As a result, unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”), trading of the
Common Stock would be suspended at the opening of business on April 23, 2025, and a Form 25-NSE would be filed with the SEC, which would
remove the Company’s securities from listing and registration on Nasdaq. On May 27, 2025, the Company appeared before the Nasdaq
Hearings Panel and requested a stay of suspension. The Panel’s decision about the stay request is still pending as of the date
these financials were filed.

On April 24, 2025, the Company received an additional
deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in
Listing Rule 5250(c)(1) (the “Filing Rule”) given the Company’s failure to timely file its Annual Report on Form 10-K
for the fiscal year ended December 31, 2024, and that this matter serves as an additional basis for delisting the Company’s securities
from Nasdaq. As the Company was already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company had seven calendar
days from the date of the Notice, or until May 1, 2025, to request a stay of the suspension, which request would stay the suspension
of the Company’s securities pending the Panel’s decision. The Company submitted a stay request on or before May 1, 2025.

On May 20, 2025, the Company received an additional
deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in
Listing Rule 5250(c)(1) given the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March
31, 2025, and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq. The Company had
seven calendar days from the date of the Notice, or until May 27, 2025, to request a stay of the suspension, which would stay the suspension
of the Company’s securities pending the Panel’s decision. On May 27, 2025, the Company appeared before the Panel and requested
a stay of suspension.

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Following the hearing before the Panel, on June
11, 2025, the Panel issued its decision, whereby it granted the Company’s request for continued listing, ultimately subject to
the Company’s compliance with all applicable continued listing criteria by June 30, 2025.

On June 2, 2025, the Company filed its Annual
Report on Form 10-K for the fiscal year ended December 31, 2024 with the SEC, and on June 12, 2025, its Quarterly Report for the period
ended March 31, 2025. Effective with the open of the market on June 13, 2025, the Company implemented a reverse stock split of its outstanding
shares of Common Stock at a ratio of 1-for-85 shares.

On July 7, 2025, Nasdaq formally notified the
Company that it had regained compliance with both the Filing Rule and the Bid Price Rule and otherwise satisfied all other applicable
criteria for continued listing on The Nasdaq Capital Market. Nasdaq further noted, however, that Onconetix is subject to a Mandatory
Panel Monitor, as defined in Nasdaq Listing Rule 5815(d)(4)(B), through July 7, 2026 (the “Panel Monitor”). If, within the
one-year period, Nasdaq determines that the Company fails to satisfy the Filing Rule or the Bid Price Rule, Nasdaq will issue a delisting
determination, which determination would be stayed upon the Company’s subsequent timely request for a new hearing before the Panel,
rather than providing the Company with the opportunity to present a plan to regain compliance with the Filing Rule for consideration
by Nasdaq Listing Qualifications Staff or a 180-day grace period to regain compliance with the Bid Price Rule as otherwise provided in
the Nasdaq Listing Rules.

Acquisitions

Proteomedix

On December 15,
2023, Onconetix entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among (i) Onconetix,
(ii) Proteomedix, (iii) each of the holders of outstanding capital stock, convertible securities, or stock options of Proteomedix
named therein (collectively, the “Sellers”) and (iv) Thomas Meier, in the capacity as the representative of Sellers
in accordance with the terms and conditions of the Share Exchange Agreement.

Pursuant to the Share
Exchange Agreement, subject to the terms and conditions set forth therein, the Sellers agreed to sell to Onconetix, and Onconetix
agreed to buy, all of the issued and outstanding voting equity interests of Proteomedix in exchange for newly issued shares of Common
Stock and newly issued shares of Series B Preferred Stock (the “Share Exchange”).

The consummation of
the Share Exchange (the “Share Exchange Closing”) was subject to customary closing conditions and the execution of the Subscription
Agreement entered into with Altos Ventures, a shareholder of Proteomedix prior to the closing of the Share Exchange (the “PMX Investor”). The
Share Exchange closed on December 15, 2023 (the “Share Exchange Closing Date”). The closing of the acquisition of Proteomedix
for all stock consideration provided Proteomedix shareholders with an initial 16.4% ownership stake of Onconetix, and Series B Preferred
Stock convertible into 79,315 shares of Onconetix Common Stock, subject to Onconetix stockholder approval of the same (“Stockholder
Approval”). On September 5, 2024, at the annual stockholders’ meeting of the Company, the Company obtained the requisite
Stockholder Approval from Onconetix stockholders. On September 24, 2024, all outstanding shares of Series B Preferred Stock converted
into an aggregate of 79,315 shares of Onconetix Common Stock.

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Terms of the PMX
Transaction

Consideration

Pursuant to the Share
Exchange Agreement, on December 15, 2023, in full payment for the Purchased Shares, Onconetix issued shares (the “Exchange Shares”)
consisting of: (i) 1,081 shares of Common Stock equal to approximately 19.99% of the total issued and outstanding Common Stock prior
to the acquisition and (ii) 2,696,729 shares of Series B Preferred Stock convertible into 79,315 shares of Common
Stock. The parties agreed that the aggregate value of the Exchange Shares at the Share Exchange Closing was equal to approximately Seventy-Five
Million U.S. Dollars ($75,000,000) (the “Exchange Consideration”) less the value of the Proteomedix Shares for which the
Proteomedix Stock Options (as defined below) are exercisable immediately prior to the Share Exchange Closing, subject to adjustment for
indemnification as described below. Following the Share Exchange Closing, 6,718 and 6,566 shares of Common Stock were issued and outstanding,
respectively.

The fair value of the
1,081 shares of Common Stock, was determined using the closing price of the Common Stock as of the Share Exchange Closing Date,
which was $809.88. The fair value of the 2,696,729 shares of Series B Preferred Stock was based on the underlying fair value of
the common shares issuable upon conversion, also based on the closing price of the Common Stock as of the Share Exchange Closing Date.
The aggregate fair value of the common and preferred shares issued as consideration was equal to approximately $65.1 million.

Tungsten Advisors acted
as financial advisor to Proteomedix at Proteomedix’s expense. As part of compensation for services rendered by Tungsten Advisors,
the parties agreed that $7,500,000 in Exchange Shares were issued to certain affiliates of Tungsten Advisors (the “Advisor Parties”)
out of the total Exchange Consideration issued by Onconetix.

As a result of the PMX
Transaction, Proteomedix became a direct, wholly owned subsidiary of Onconetix. Immediately following the Conversion (as defined below)
and closing of the investment pursuant to the Subscription Agreement (as defined below), Sellers owned approximately 87.2% of the outstanding
equity interests of Onconetix, the PMX Investor owned approximately 7.5% of the outstanding equity interests of Onconetix, and the stockholders
of Onconetix immediately prior to the Share Exchange Closing owned approximately 5.3% of the outstanding equity interests of Onconetix.

Each option to purchase
shares of Proteomedix (each, a “Proteomedix Stock Option”) outstanding immediately before the Share Exchange Closing, whether
vested or unvested, remained outstanding until the Conversion unless otherwise terminated in accordance with its terms. At the Conversion,
each outstanding Proteomedix Stock Option, whether vested or unvested, was assumed by Onconetix and converted into the right to receive
(a) an option to acquire shares of Common Stock (each, an “Assumed Option”) or (b) such other derivative security as Onconetix
and Proteomedix agreed, subject in either case to substantially the same terms and conditions as were applicable to such Proteomedix
Stock Option immediately before the Share Exchange Closing. Each Assumed Option: (i) represented the right to acquire a number of shares
of Common Stock equal to the product of (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix
Option immediately prior to the Share Exchange Closing, multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement);
and (ii) had an exercise price (as rounded down to the nearest whole cent) equal to the quotient of (A) the exercise price of the corresponding
Proteomedix Option, divided by (B) the Exchange Ratio.

From and after the Share
Exchange Closing and until the first anniversary of the Share Exchange Closing, Sellers, severally and not jointly, are required to indemnify
Onconetix and its affiliates and their respective representatives (collectively, the “Onconetix Indemnitees”) against (i) any
inaccuracy in or breach of any of the representations or warranties of such Seller contained in the Share Exchange Agreement and (ii) breach
or non-fulfillment of any covenant, agreement or obligation to be performed by such Seller pursuant to the Share Exchange Agreement.
Any payment due from any Seller in respect of an indemnification claim by any Onconetix Indemnitee shall solely be satisfied by recourse
to the Exchange Shares and the shares of Common Stock issuable upon the Conversion, with each share of Common Stock valued at the same
price per share of Common Stock used to determine the Exchange Ratio.

Lock-Up Agreement

Simultaneously with
the execution of the Share Exchange Agreement, the Sellers and the Advisor Parties, as shareholders of Proteomedix, entered into Lock-Up
Agreements (each, a “Lock-Up Agreement”). Pursuant to each Lock-Up Agreement, each signatory thereto will agree not to, during
the period commencing from the Share Exchange Closing Date and ending on the 6-month anniversary of the date of Stockholder Approval: (i)
lend, offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase
any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly,
the Exchange Shares or the Conversion Shares, (ii) enter into any swap or other arrangement that transfers to another, in whole
or in part, any of the economic consequences of ownership of the Exchange Shares or the Conversion Shares, or (iii) publicly disclose
the intention to do any of the foregoing, whether any such transaction described in clauses (i), (ii) or (iii) above is to be settled
by delivery of the Exchange Shares or the Conversion Shares or other securities, in cash or otherwise (subject to certain exceptions).

8

Non-Competition and
Non-Solicitation Agreement

Simultaneously with
the execution of the Share Exchange Agreement, certain executive officers (each, a “Management Shareholder”) of Proteomedix
each entered into a non-competition and non-solicitation agreement (collectively, the “Non-Competition and Non-Solicitation Agreements”)
with Onconetix. Under the Non-Competition and Non-Solicitation Agreements, each Management Shareholder agreed not to compete with Proteomedix,
and after the Share Exchange Closing, Onconetix, and their respective affiliates during the three-year period following the Share Exchange
Closing and, during such three-year restricted period, not to solicit employees or customers of such entities. Each Non-Competition and
Non-Solicitation Agreement also contains customary confidentiality and non-disparagement provisions.

Stockholder Support
Agreement

Simultaneously with
the execution of the Share Exchange Agreement, Onconetix, Proteomedix and certain directors of Onconetix who are stockholders of Onconetix,
entered into a Stockholder Support Agreement (the “Stockholder Support Agreement”), pursuant to which, among other things,
each such stockholder of Onconetix has agreed (a) to support the adoption of the Share Exchange Agreement and the approval of the PMX
Transaction, subject to certain customary conditions, and (b) not to transfer any of their subject shares (or enter into any arrangement
with respect thereto), subject to certain customary conditions.

Stockholder Subscription
Agreement and Debenture

In connection with the PMX Transaction, on December
18, 2023, Onconetix entered into a Subscription Agreement (the “Subscription Agreement”) with the PMX Investor for a private
placement of $5.0 million of units (the “Units”), each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded
warrant (collectively, the “Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $3.40 per share, for
an aggregate purchase price per Unit of $850 (the “Purchase Price”). Additional shares are issuable to the PMX Investor to
the extent the PMX Investor continues to hold Common Stock included in the Units and if the VWAP during the 270 days following the Share
Exchange Closing is less than the Purchase Price, as set forth in the Subscription Agreement.

On January 23, 2024, the Company issued a non-convertible
debenture (the “Altos Debenture”) to the PMX Investor in the principal sum of $5.0 million, the payment of which shall offset
the $5.0 million subscription amount for the Units pursuant to the Subscription Agreement.

The Altos Debenture had an interest rate of 4.0%
per annum, and the principal and accrued interest was originally repayable in full upon the earlier of (i) the closing under the Subscription
Agreement and (ii) June 30, 2024. Additionally, the $5.0 million subscription amount under the Subscription Agreement shall be increased
by the amount of interest payable under the Altos Debenture.

On April 24, 2024, the Altos Debenture was amended
to extend the maturity date to the earlier of (i) the closing under the Subscription Agreement and (ii) October 31, 2024 (the
“Altos Amendment”). On September 24, 2024, upon obtaining stockholder approval and pursuant to the Subscription Agreement,
the Company issued an aggregate of 6,040 units (the “Units”) to Altos, each Unit comprised of (i) one share of Common Stock
and (ii) one pre-funded warrant (collectively, the “Altos Warrants”) to purchase 0.3 shares of Common Stock at an exercise
price of $3.40 per share. The Altos Warrants were immediately exercisable at any time on or after the date of issuance and had a term
of exercise of five (5) years from the date of issuance. The outstanding debt, as per the Altos Debenture agreement, is considered settled
through the unit issuance.

Additional shares are issuable to Altos to the
extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than
$850, as set forth in the Subscription Agreement.

On September 24, 2024, Altos exercised all the
Altos Warrants, and the Company issued to Altos an additional 1,812 shares of Common Stock upon such exercise.

9

On June 24, 2025, the 270-day volume weighted
average price after the closing of the Subscription Agreement was below $850. In accordance with the Make-Whole Provision under the Subscription
Agreement, the Company issued 241,514 shares of common stock (the “Make-Whole Shares”) to Altos Venture AG, following the
determination that the 270-day volume weighted average price (“Issuer VWAP”) was below the $850 threshold. The Company recorded
common stock of $2 and additional paid in capital of $995,036 related to the issuance of the 241,514 shares in the accompanying consolidated
balance sheet as of December 31, 2025.

ENTADFI

On April 19, 2023, the Company entered into
an asset purchase agreement with Veru Inc., a Wisconsin corporation (“Veru”, and the asset purchase agreement, the “Veru
APA”). Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets
related to Veru’s ENTADFI business. The transaction closed on April 19, 2023.

The Company purchased substantially all of Veru’s
assets, rights and property related to ENTADFI for a total possible consideration of $100.0 million (as described below). The acquisition
of ENTADFI capitalizes on the demonstrable success of the FDA-approved drug ENTADFI for treating benign prostatic hyperplasia and
counteracting negative sexual side effects seen in men on alternative BPH therapies.

Pursuant to the terms of the Veru APA, the Company
agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the
transaction, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii)
an additional $10.0 million in the form of two equal (i.e. each for $5.0 million) non-interest bearing notes payable, each due on April
19, 2024 (the “April Veru Note”) and September 30, 2024 (the “September Veru Note,” together with the “April
Veru Note”, the “Veru Notes”).

Additionally, the terms of the Veru APA required
the Company to pay Veru up to an additional $80.0 million based on the Company’s net sales from the ENTADFI business after
closing. The Milestone Payments were to be payable as follows: (i) $10.0 million is payable if the Company’s annual net sales
from the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company’s annual net sales
from the ENTADFI business equal or exceed $200.0 million, and (3) $50.0 million is payable if annual net sales from the ENTADFI business
equal or exceed $500.0 million. No more than one Milestone Payment shall be made for the achievement of each net sales milestone. There
can be no assurance that the net sales milestones for payment of any of the Milestone Payments will be reached.

Furthermore, in connection with the transaction,
the Company assumed royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered
into by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017. The Camargo Obligations assumed by the Company include a
6% royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million as follows: (i) $5.0 million
is payable upon the first time the Company achieves net sales from ENTADFI of $100.0 million during a calendar year, (ii) $7.5 million
is payable upon the first time the Company achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $10.0 million
is payable upon the first time the Company achieves net sales from ENTADFI of $300.0 million during a calendar year.

On September 29, 2023, the Company entered into
an amendment (the “Veru Amendment”) of the Veru APA. Pursuant to the Veru Amendment, the $4.0 million note payable originally
due on September 30, 2023 was deemed paid and fully satisfied upon (1) the payment to Veru of $1.0 million in immediately available funds
on September 29, 2023, and (2) the issuance to Veru by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company, which
converted in to 1,679 shares of Common Stock on September 24, 2024.

In 2024 and 2025, the Company and Veru modified and extended the payment
terms under the Veru Notes on various occasions. Subsequently, on August 28, 2025, Veru and the Company agreed to amend and restate
the September Veru Note (as amended and restated, the “Second A&R September Veru Note”). Pursuant to the Second A&R
September Veru Note, the principal amount owed to Veru was increased by $100,000 to an aggregate principal amount of $5.2 million, and
the maturity date was amended to September 19, 2025. All other terms of the September Veru Note remained the same. On August 28, 2025,
Veru and the Company also entered into a waiver agreement (the “August 2025 Veru Waiver”) pursuant to which Veru agreed to
waive and extend the date for payment of the April Veru Note to September 19, 2025.

10

As of September 22, 2025, approximately $8.8
million was payable to Veru under the Veru Notes and related amendments. On September 22, 2025, the Company and Veru entered into a Settlement
Agreement and Release (the “Veru Settlement Agreement”), pursuant to which Veru agreed to accept a cash payment of approximately
$6.3 million (including interest accrued through receipt of the Settlement Amounts (as defined herein), 3,125 shares of Series D Preferred
Stock (as defined below) and 846,975 Series D Warrants (as defined below and such cash payment, shares of Series D Preferred Stock and
Series D Warrants, collectively, the “Settlement Amounts”) in full satisfaction of all amounts due under the Veru Notes,
as amended by all preceding amendments, forbearance agreements, and waivers, and Veru agreed that such acceptance constituted complete
discharge of all obligations thereunder. The Settlement Agreement contains customary release provisions that upon timely delivery of
the Settlement Amounts, Veru shall release all claims or actions against the Company.

As of September 24, 2025, Veru confirmed receipt
of all Settlement Amounts in satisfaction of all outstanding amounts, and all Veru Notes and related amendments were deemed cancelled
and terminated, respectively, and of no further force or effect.

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 has abandoned
commercialization of ENTADFI and no longer holds inventory of ENTADFI. There is currently no plan to resume commercialization of ENTADFI.
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. At December 31, 2024 and 2025, the ENTADFI assets were fully impaired.

Business of the Company

Business Model

Founded in 2010, Proteomedix develops, markets
and sells non-invasive diagnostic tests accompanied by decision support systems to detect and assess the prognosis of cancer. Proteomedix’s
lead product, Proclarix®, is an in vitro diagnostic test for prostate cancer. Proteomedix is working to address all stages
in cancer management by developing tools for both more accurate detection and more efficient treatment of cancer including (i) diagnostic
tests to early detect and define the stage of cancer; (ii) prognostic tools for the identification of patients with aggressive disease;
and (iii) stratification biomarkers to match patients with therapies that are more likely to be safe and effective.

Currently, prostate cancer stands as the most
prevalent and second most fatal cancer type affecting men. The widespread utilization of PSA screening since it became broadly available
in the 1980s helped reduce the occurrence of metastatic prostate cancers by over half, but also led to a notable increase in overdiagnosis,
sometimes resulting in excessive treatment, severe complications, and potential psychological distress. There exists a considerable population
of men each year who are notified of their heightened risk for prostate cancer based on elevated PSA levels, with limited options beyond
invasive needle biopsies for managing their cancer risk.

Proclarix addresses the unsolved problem of prostate
cancer overdiagnosis, which can lead to excessive use of MRI and negative prostate biopsies that increase costs for the healthcare system
and uncertainty for patients. Proclarix is approved for sale in the European Union under the IVDR. Proclarix was first CE marked under
the IVD Directive in Europe on January 31, 2019. On October 7, 2022, Proclarix gained CE marking under the IVD Regulation (IVDR) and
was registered in the United Kingdom and Switzerland under applicable regulations. Clinical studies have confirmed that Proclarix accurately
identifies clinically significant prostate cancer through a risk score derived from a clinical decision support system and can help avoid
many unneeded biopsies. Proclarix as a clinical support system is designed to aggregate multimodal information in an effort to develop
a patient-centric diagnostic approach. We intend to add more information to the risk score in the future, such as other biomarkers or
magnetic resonance imaging data, to provide an even more powerful tool to guide the patient’s diagnostic journey. The markers and
the bioinformatics algorithm used are patent-protected.

11

The guidelines of the European Association of
Urology (“EAU”) and of the American Urological Association/Society of Urologic Oncology (“AUA/SUO”) both recommend
the use of blood-based biomarker tests, such as Proclarix, to aid in the early detection and evaluation of prostate cancer. Proclarix
can be performed in any laboratory using standard equipment. Proteomedix announced commercial availability of Proclarix in Europe on
February 26, 2020 and began marketing Proclarix to selected pilot laboratories offering Proclarix in Switzerland, Germany, Italy and
the United Kingdom. Proclarix is currently not reimbursed in Europe, and therefore patients pay for Proclarix out of pocket. The number
of sold Proclarix tests currently corresponds to the market development stage and selected laboratories are offering Proclarix. In 2025,
we had revenues of $23,091 from sales of Proclarix. Prior to being acquired by Onconetix in 2023, Proteomedix had $67,380 from sales
of Proclarix. In the United States, the development and commercialization of Proclarix is being pursued by Laboratory Corporation of
America Holdings, more commonly called LabCorp, pursuant to an exclusive license agreement entered into between Proteomedix and LabCorp
in 2023.

Proteomedix was founded by a multi-disciplinary
group of scientists and clinicians that include Prof. Emeritus Dr. med. Thomas Cerny, president of the Swiss Cancer Research Foundation,
Prof. Ruedi Aebersold, a pioneer in proteomics technology development, and the late Prof. Dr. Wilhelm Krek, a leader in cancer research.
Proteomedix’s management consists of Dr. Ralph Schiess (Chief Executive Officer), who developed the biomarker technology, and Christian
Brühlmann (Chief Business Officer), with seasoned experience in finance, business development and product management. On February
18, 2025, Christian Brühlmann resigned from his position as Chief Strategy Officer of the Company. Mr. Brühlmann will remain
in his position as Chief Business Officer of Proteomedix. On February 24, 2025, Dr. Schiess resigned from his positions as the Interim
Chief Executive Officer of the Company and Chief Science Officer of Proteomedix, effective immediately, and from his position as Chief
Executive Officer of Proteomedix, effective May 31, 2025.

Proclarix

Proteomedix is seeking to develop diagnostic,
prognostic and predictive tools to enable more efficient cancer management at all stages of disease progression. Proteomedix’s
tests use proprietary protein biomarkers to address the limitations in current cancer detection, prognosis, and therapy prediction. In
addition, Decision Support Systems support the clinical decision-making by integrating different inputs in a risk score (see Figure 1).

Figure 1: Product Pipeline

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Proclarix

Proclarix is used to indicate the risk of clinically
significant prostate cancer through a risk score derived from a clinical decision support system (Figure 2). On the reagent side it is
comprised of two quantitative Enzyme-linked Immunosorbent Assays (“ELISA”) that measure the concentration of thrombospondin
1 (“THBS1”) and cathepsin D (“CTSD”) in human serum. The clinical decision support system is a web-based software
running a proprietary algorithm that integrates the values for THBS1 and CTSD, the patient’s age and total and free PSA levels
from third party providers (e.g., Roche Diagnostics, Siemens Healthineers) to calculate a risk score.

Figure 2: Proclarix: Assays and software algorithm for risk
score calculation.

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Proclarix is used as an aid in prostate cancer
diagnosis as a second-line test after PSA and DRE testing. It enables a personalized decision for each patient based on objective risk
parameters (4 serum glycoproteins + age) to triage between biopsy or a monitoring approach. Proclarix has been validated and approved
for use in men with elevated total PSA (2.0 to 10.0 ng/mL), a normal DRE not suspicious for cancer and an elevated prostate volume (≥35
mL) (Figure 3). The Proclarix decision support tool returns a risk score that can be used as an aid in discriminating between clinically
significant (grade group 2 or higher [GG2+]) and insignificant prostate cancer or benign prostate disease. The risk score of Proclarix
gives the physician and patient actionable information to confidently make decisions when considering the necessity of a prostate biopsy
which is required for diagnosis of prostate cancer.

Figure 3: Proclarix: Finding clinically significant prostate
cancer in the diagnostic “grey zone.”

Clinical Studies

Proteomedix’s biomarkers have been tested
in clinical studies including a total of more than 2,000 patient samples from multiple clinical sites, and results have been published
in peer-reviewed journals. We believe these results demonstrate that Proclarix is a valuable test identifying clinically significant
prostate cancer thereby facilitating informed decision making for patients considering a prostate biopsy.

Validation Study. The study leading to
the granting of regulatory approval in Europe included 955 samples collected at two clinical sites, a screening center in Innsbruck,
Austria, as well as a referral center in Hamburg, Germany. The results of this study demonstrated that by using the Proclarix test the
burden of unneeded biopsies could have been lowered by approximately 43% — twice as much compared to clinical comparators percent
free PSA (“%fPSA”) or PSA density. High sensitivity of 90% and a negative predictive value of 95% for clinically significant
prostate cancer indicated that the diagnosis of very few cancers would have been delayed.

PROPOSe Study. The PROPOSe study evaluated
the accuracy of Proclarix in prostate biopsy decision making. Ten clinical sites in Germany, Denmark and Austria prospectively enrolled
457 men presenting for prostate biopsy. Proclarix detected clinically significant cancer with high sensitivity above 90% and reliably
ruled out patients with no or indolent cancer with a negative predictive value greater than 90%. When the biopsy performed was guided
by magnetic resonance imaging (“MRI”), both sensitivity (97%) and negative predictive value (96%) were even higher. Importantly,
Proclarix was significantly superior to the current clinical standard, %fPSA, in ruling out unneeded biopsies (22% vs. 14%) and the primary
study endpoint was met (p-value < 0.005).

Naples Study. A two-center study evaluated
Proclarix and the Prostate Health Index (phi) test from Beckman Coulter, Inc. for predicting clinically significant prostate cancer in
a total of 344 men. Both Proclarix and the phi test accurately predicted clinically significant cancer. When using predefined cut-offs
recommended by the manufacturers, Proclarix (cut-off 10) outperformed phi (cut-off 27) in terms of specificity and positive predictive
value (p < 0.002) at similar sensitivities.

14

Clinical evaluation of Proclarix. Results
of multiple clinical evaluations using Proclarix together with MRI for prostate cancer diagnosis showed that Proclarix can be used in
a broad range of patients without the need for prostate volume restriction. The aim of one such evaluation was the assessment of the
diagnostic performance of Proclarix in combination with MRI. Blood samples from 721 men undergoing MRI followed by biopsy at two clinical
centers were analyzed. The combined Proclarix-MRI score’s specificity (68%) was significantly (p<0.001) better compared to Proclarix
(27%) or MRI (28%) alone for diagnosing clinically significant prostate cancer. Importantly, Proclarix by itself was found to be useful
in men with indetermined imaging results by outperforming PSA density in terms of specificity (25% vs 13%, p=0.004) at 100% sensitivity.
In another evaluation of a study of 517 men with suspected prostate cancer, Proclarix performed well in accurately diagnosing prostate
cancer in the overall study population and in a subset of men with elevated PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and normal
DRE (n=281). In addition, a sub-analysis of was performed specifically analyzing 169 men with an indeterminate MRI result and Proclarix
was more accurate in selecting appropriate candidates for prostate biopsy when compared to PSA density and online risk calculators. A
third evaluation describes which patients with suspected prostate cancer can benefit from Proclarix after MRI and concluded that Proclarix
outperformed PSA density in the selection of candidates for prostate biopsy, especially in men with PI-RADS 1-3. In these studies, Proclarix
proved to be effective before, after, and together with MRI assessment to identify men at risk of clinically significant prostate cancer
and those who can safely avoid biopsy. Proclarix in combination with MRI reliably predicted clinically significant prostate cancer and
ruled out men with no or indolent cancer.

Clinical Guidelines

Guidelines assist clinicians in making informed
treatment decisions, taking into account the available scientific data. To reduce the number of negative biopsies in asymptomatic men
with a PSA level between 3–10 ng/mL and a normal DRE, the EAU guidelines recommend using an online risk-calculator that is correctly
calibrated to the population prevalence, MRI of the prostate or an additional biomarker test such as Proclarix. The EAU guidelines specifically
state that Proclarix has been correlated with the detection of significant prostate cancer, notably in case of equivocal MRI results.

Proclarix was also included in the 2023 AUA/SUO
clinical practice guideline. The AUA/SUO guideline covers recommendations on the early detection of prostate cancer and provides a framework
to facilitate clinical decision-making in the implementation of prostate cancer screening, biopsy, and follow-up. The AUA/SUO guideline
concludes that the evaluation of prostate cancer risk should be focused on the detection of clinically significant prostate cancer (GG2+).
The AUA/SUO guidelines advice that use of laboratory biomarkers such as Proclarix, prostate MRI, and biopsy techniques may improve detection
and safety when a prostate biopsy is deemed necessary following prostate cancer screening.

The inclusion of Proclarix in the European and
U.S. guidelines is an important recognition of the clinical value of Proclarix. It serves as a validation for the clinical utility and
importance of using Proclarix in the detection of prostate cancer and we believe it will lead to broader acceptance of Proclarix and
accelerate payor adoption.

Product Quality and Safety

Proteomedix’s quality management system
is ISO (International Organization for Standardization) 13485:2016 certified for the “Design and development, production and distribution
of in-vitro diagnostic reagents and stand-alone software for prostate cancer management”. Proteomedix is annually audited by TÜV
SÜD Product Service GmbH, an internationally recognized notified body headquartered in Germany. ISO certification is a prerequisite
for obtaining CE-mark, the regulatory clearance requirement for market access, recognized by the European Commission (“EC”)
in the IVDR. Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low
risk) to class D (highest risk). Proclarix, as class C device, was assessed by TÜV SÜD for conformity resulting in IVDR certification.
The certification of Proclarix under the new IVDR demonstrates compliance to the highest quality standard currently in force for tests
used in screening, diagnosis, or staging of cancer. Proteomedix is marketing Proclarix as one of the first IVDR compliant cancer tests
demonstrating the commitment to highest analytical and clinical performance.

Prosgard

Prosgard as a clinical support system is designed to aggregate multimodal
information in an effort to develop a patient centric diagnostic approach. The vision for Prosgard is to add more information to the
existing Proclarix risk score in the future such as other biomarkers, clinical information, or MRI imaging data to provide an even more
powerful tool to guide the patient’s diagnostic journey.

15

Prognosis (Px)

A subset of Proteomedix’s protein biomarkers
also correlate with prostate cancer prognosis. Radical prostatectomy provides excellent cancer control of clinically localized prostate
cancer. However, approximately 30% of surgically treated men will experience cancer recurrence within 10 years of surgery. Several clinical
parameters and the combination thereof (e.g., the Cancer of the Prostate Risk Assessment (“CAPRA”) score) have been shown
to be reliable predictors of treatment failure. Still, there is a compelling need to identify novel markers that are specifically linked
to the presence of biologically aggressive prostate cancer for improved prediction of outcome in populations with moderately elevated
PSA levels.

A novel serum biomarker quintet that improves disease prognosis
in men with confirmed prostate cancer

A clinical evaluation of a multivariable model
comprising fibronectin 1, galectin-3-binding protein, lumican, matrix metalloprotease 9, thrombospondin-1 and PSA together with clinical
Grade Group (GG) and clinical stage (cT) was performed. The prognostic utility of the proposed marker combination was assessed in serum
samples from 557 men with confirmed localized prostate cancer. The analysis showed that the proposed model had a better prediction for
disease progression and thus prostate cancer aggressiveness compared to the “CAPRA” score. This novel biomarker test has the
potential to improve prostate cancer patient management by indicating who needs active treatment. In contrast to the existing biomarker
tests from competitors that all need tissue specimens, the test is non-invasive and can be directly measured in patients’ blood
samples.

Prediction (Rx)

Proteomedix’s protein biomarkers further
have the potential to predict the response of patients treated with drugs that inhibit the PI3K signaling pathway. Proteomedix analyzed
the blood of patients participating in a Phase II trial (SAKK 08/08). The patients were treated with Novartis AG’s Everolimus, a
drug inhibiting the PI3K pathway signaling by blocking mTOR. A subset of 8 serum biomarkers could individually predict reaching the primary
endpoint (progression free survival at 12 weeks) with an accuracy of at least 75%.

Decision Support Systems

Recent initiatives are incorporating as well as
interpreting clinical information from various sources (e.g., biomarker information and other patient data) enabling physicians to have
more comprehensive biochemical insight into each patient’s disease in order to determine the optimal treatment plan for the patient.
Collating multiple data sources in clinical workflows allows precision-medicine resulting in cost-effective diagnostics and therapies.
Proclarix already consists of a decision support system integrating different values in a risk score. In the future, additional clinical
information like the results of an MRI scan could be integrated in the report to provide a complete picture of the diagnostic situation
of the patient to enable effective patient management.

Commercialization Strategy

Proclarix

Proclarix is currently not reimbursed in Europe,
and therefore patients pay for Proclarix out of pocket. We intend to pursue reimbursement from public and private payors in key European
markets to secure broad adoption in the longer term. The market introduction of Proclarix has followed a two-phased approach: first a
market preparation phase in which we reach out to key opinion leaders in selected European countries to solicit their support for Proclarix,
followed by a market development phase where we begin commercializing Proclarix in those markets with focused marketing and sales activities
to urologists and general practitioners. We intend to secure access to testing through partnerships with reference diagnostic labs. We
have initiated outreach to commercial laboratories and hospital laboratories that are routinely serving study sites and academic collaboration
partners, and have established pilots with laboratories in Switzerland, Germany, Italy, and the United Kingdom.

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In the United States, Proteomedix entered into
an exclusive partnership with LabCorp in 2023 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 for
identification, screening, staging, predisposition, diagnosis, prognosis, monitoring, prevention or treatment selection with respect to
prostate cancer. In consideration for granting LabCorp an exclusive license, Proteomedix received an upfront license fee and is entitled
to royalty and milestone payments based upon sales of licensed products or services in the United States. LabCorp is wholly responsible
for the cost of research, development and commercialization of licensed products or services in the United States but has the right to
offset a portion of those costs against future royalty and milestone payments otherwise due to Proteomedix. Additionally, in December
2025, Proteomedix and LabCorp entered into an amendment to the exclusive partnership whereby LabCorp would conduct a new validation study
starting in 2026.

Sales, Distribution, Marketing and Advertising

In clinical diagnostics high throughput assay
parameters like PSA typically are performed on closed, fully integrated systems that use proprietary reagents. Integrated systems are
provided by a few mid-sized to large diagnostic companies (e.g., Roche Diagnostics, Abbott Laboratories, Siemens Healthineers AG, DiaSorin
S.p.A.) with a worldwide distribution network. Reagents are provided in a closed-system approach, access is through collaboration agreements
only. Business development discussions with multiple diagnostic companies have already started.

Lower volume parameters are run on smaller, open
systems that are used in laboratories for tests with lower throughput to complement the test menu. Access to these open systems presents
an option for direct commercialization in selected markets during market introduction. First, the goal is to establish commercial proof
of concept and drive initial market adoption.

Market adoption of a new test is driven by KOLs
and clinical urology centers. Publication of clinical studies proving the medical benefit of the test and KOLs advocating it at scientific
conferences will trigger the usage by other physicians. Additionally, demand is created through urology centers specialized in prostate
cancer that cover a large geographical area. Their influence on other urologists and general practitioners in the region will lead to
multiplier effects. Diagnostic testing in clinical urology centers is provided either by an in-house hospital laboratory or a commercial
laboratory where Proclarix will be implemented.

General practitioners recruit patients for screening
and decide whether to refer a patient to a specialist. They have an important gatekeeper role and Proclarix is a helpful tool for this
triage. Marketing outreach of commercial laboratory networks (e.g., Unilabs, Switzerland; Sonic Healthcare, Australia; LabCorp, U.S.A.)
provides an opportunity to directly address the large number of general practitioners and urologists in private practices through their
specialized sales force.

Market Opportunity

Proclarix, the first diagnostic product of Proteomedix,
is addressing unmet medical needs related to the early detection of prostate cancer, which is the second most frequently diagnosed cancer
in men. There were 1,467,854 new cases of prostate cancer and 397,430 prostate cancer related deaths worldwide in 2022 according
to World Cancer Research Fund International.

The PSA test represents the current standard of
care in prostate cancer diagnosis. It accurately identifies individuals with no sign of disease. 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. The high unmet need for improved patient stratification or diagnostic triage in this segment is addressed
only by a few tests. Compared to those tests Proclarix has important competitive advantages: (i) it shows comparable or often superior
clinical performance, (ii) it is blood-based and therefore minimally invasive and (iii) it is highly reproducible in comparison to e.g.,
urine-based tests. The use of Proclarix does not require prior prostate massage. Samples are stable and can be shipped at ambient temperature.
Proclarix has a high accuracy and negative predictive value (NPV) and is easy to automate on equipment readily available as well as adaptable
to current laboratory practice and thus clinical routine.

The worldwide market for in vitro diagnostic (“IVD”)
products was valued at $109 billion in 2025. Europe and North America are the largest markets, followed by Asia, mainly Japan and China,
according to MarketsandMarkets.

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About two-thirds of prostate cancer diagnoses
occur in countries ranking very high in the Human Development Index, where only 18% of the world’s male population resides, according
to the American Cancer Society. This underscores a significant market demand for improved diagnostic tools, especially in regions with
robust healthcare infrastructure where early detection and treatment are paramount. Our innovative test aims to meet this demand by offering
enhanced accuracy, accessibility, and efficiency, positioning it as a valuable asset in the fight against prostate cancer while also presenting
lucrative commercial opportunities for stakeholders.

Currently, standard prostate cancer screening
combines a digital rectal exam (“DRE”) with the measurement of PSA. PSA is not a highly cancer specific marker, meaning it
picks up many benign conditions of raised PSA levels in the blood—such as clinically not significant enlargement of the prostate
or inflammation. The consequences are prostate cancer overdiagnosis, leading to unnecessary prostate biopsies. It is currently estimated
that more than 60% of men that undergo a biopsy have no clinically significant prostate cancer, but due to the biopsy become exposed to
potential side effects such as infections, bleeding and incontinence.

The use of MRI for the diagnosis of prostate cancer
has been rapidly adopted during the last decade. There is clinical evidence that MRI allows clinicians to verify diagnosis and improve
localization, risk stratification and staging of clinically significant prostate cancer over other methods. MRI-guided biopsy has a higher
accuracy than ultrasound-guided biopsy. However, MRI-based diagnosis of prostate cancer is hampered by the relatively high costs of US$415
– US$900 and limited availability. Still, up to one-third of MRIs are inconclusive. Thus, there is a clear need for an improved
non-invasive diagnostic test with higher specificity for clinically significant prostate cancer to aid in selecting patients undergoing
MRI, MRI-guided biopsy, and biopsy. Proper classification in clinically significant cancer and non-significant type or non-cancer conditions
such as benign prostate hyperplasia is important to prevent overtreatment and its associated side-effects and costs. Proteomedix is developing
diagnostic tools for disease prognosis and monitoring that are essential for reliable, patient-friendly, and cost-effective disease management.
Proteomedix’s biomarkers have shown the potential to distinguish between those prostate cancer patients who are more likely to respond
to certain drug-based interventions. With this information, better choices for drug therapies can be made to maximize the likelihood of
efficacious treatment. Proteomedix’s biomarkers could also aid in clinical drug development.

Competition

Proclarix Competition Analysis

The molecular diagnostics field is intensely competitive
and characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition,
evolving industry standards, reimbursement uncertainty and price competition. Moreover, recent consolidation in the industry permits larger
clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more intense competition.

The market for assessing men at risk for prostate
cancer is large, with many competitors some of which possess substantially greater financial, selling, logistical and laboratory resources,
more experience in dealing with third-party payors, and greater market penetration, purchasing power and marketing budgets, as well as
more experience in providing diagnostic services. Some companies and institutions are developing liquid biopsy (blood and urine)-based
tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids, or the presence of fragments of mutated genes that
are associated with prostate cancer. These competitors could have technological, financial, reputational, and market access advantages
over us.

There are a number of tests already on the market
or in clinical testing or commercial development that are also intended to triage diagnostics in men with moderately elevated PSA levels.
Of these tests the majority also target solely PSA as a biomarker. Certain isoforms of PSA are differentiated, or transcript levels (mRNA)
are determined in addition to protein levels. Of these tests the best established is %fPSA, which is also available from all suppliers
of the PSA test, including market leaders Abbott Laboratories, Roche Diagnostics, Siemens Healthineers AG and Beckman Coulter, Inc. However,
the sensitivity and specificity improvements are very modest.

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The 4Kscore from OPKO Health, Inc. (Nasdaq: OPK)
and the phi score from Beckman Coulter, Inc. measure additional forms of PSA and related proteins but they do not include additional biomarkers
either. The 4Kscore test is a blood based 4-plex test which combines the results of the blood test with clinical information in an algorithm
that calculates a patient’s percent risk for aggressive prostate cancer prior to an initial or repeat biopsy (no previous diagnosis
of prostate cancer). The 4Kscore test received marketing approval from the FDA in December 2021. The phi score combines the results of
three blood tests to provide information about what elevated PSA levels might mean and the probability of finding prostate cancer on biopsy.
The IsoPSA test of Cleveland Diagnostics, Inc. analyzes structural changes of PSA to detect underlying cancer biology.

Over the last decade, gene-based testing in urine
targeting additional biomarkers became available. The PCA3 test from Gen-Probe Inc. (now a part of Hologic, Inc.) was the first genetic
assay to be introduced to the market. The SelectMDx test from MdxHealth SA measures a combination of two genes and integrates them together
with PSA value, prostate volume, patient age and digital rectal exam to a risk score. The assay targets mRNA transcripts in the patient’s
urine. mRNA is normally not sufficiently shed into urine to allow for direct analysis. Therefore, this test method requires prostate massage
prior to sample collection and the urine samples will be collected in a specialized practice. The ExoDx IntelliScore from Exosome Diagnostics,
Inc., a subsidiary of Bio-Techne Corporation, measures PCA3 as well as other gene transcripts in exosomes harvested from urine. The method
does not require prostate massage, however, because mRNA is relatively unstable, the samples require cold storage in shipment and relatively
rapid testing turn-around.

The Stockholm3 test is part of an academic initiative,
OncoWatch, led by the Karolinska Institute, Sweden and funded by the European Institute of Innovation and Technology Health program. Established
in 2020, A3P Biomedical AB (publ) is commercializing the Stockholm3 test. It is a blood-based test that predicts the risk for aggressive
prostate cancer at biopsy by analyzing five protein markers, more than 100 genetic markers and clinical data.

Except for PCA3, Prostate Health Index and 4Kscore,
all of the above-mentioned tests are only available as a testing service through specialized reference laboratories, they are not offered
as commercial products. Testing is performed centrally as a laboratory developed test (“LDT”) by a single diagnostic laboratory.
Uptake of LDTs in the United States has been limited, and in Europe they are mostly not known to urologists.

In recent years, MRI-based diagnosis followed
by targeted biopsy is becoming the standard of choice in specialized centers. As MRI instrumentation is costly and its availability is
still limited, there is a need for diagnostics supporting the decision to perform MRI that Proclarix can fulfill. MRI is not regarded
as competitive to the Proclarix positioning, but complementary.

Competitive Advantages of Proclarix

We believe Proclarix has important competitive
advantages:

●
Blood-based test
-
Minimally invasive, high reproducibility, no prostate massage required, suitably stable for shipment, the most common sample type in clinical laboratories and therefore fitting in current lab workflow

●
Immunoassay-based
-
Compatible with existing laboratory instrumentation in local laboratory

●
Easy to automate
-
Adaptable to clinical routine, fast time to result

●
Objective result generation
-
Comparable results independent of operator

●
Genetics-guided discovery
-
Cancer-related, highly plausible biomarkers

Proclarix can be applied in any diagnostic laboratory,
using readily available immunoassay technology platforms. Furthermore, Proclarix fits very well into the current laboratory workflow,
which is important for laboratories that are driven by efficiency and cost.

The stakeholders benefit in various ways from
Proclarix:

Patients: Gain more certainty whether
a biopsy is really needed through a minimally invasive procedure with a fast time to result. This results in reduced anxiety about prostate
cancer diagnosis and less complications and side effects from biopsies.

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Physicians: Focus on relevant patients
with clinically significant cancer and increased patient satisfaction by significantly reducing unneeded prostate biopsies and its accompanying
complications. No need for additional training or new logistic processes: Standard blood-drawing equipment can be used, and the blood
sample sent to the current laboratory.

Laboratory: Increase revenue with
no additional investment for new equipment because Proclarix is readily applicable in most laboratories.

Payer (insurance company): Increase
profits by saving costs for avoided biopsies (accompanied by risk of complications, discomfort) and resulting overtreatment.

Government Regulation

The FDA and other regulatory authorities at federal,
state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing,
manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval,
advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and diagnostics.

Foreign Regulation

In order to market any product outside of the
United States, we need to comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and
governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our product candidates.
For example, in the EU, we must obtain authorization of a clinical trial application, or CTA, in each member state in which we intend
to conduct a clinical trial. Whether or not we obtain FDA approval for a drug, we would need to obtain the necessary approvals by the
comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those countries.
The approval process varies from country to country and can involve additional product testing and additional administrative review periods.
The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory
approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one
country may negatively impact the regulatory process in others.

Further, some countries outside of the United
States, including the EU member states, Switzerland and the United Kingdom, have also adopted data protection laws and regulations, which
impose significant compliance obligations. In the EU, the collection and use of personal health data is governed by the provisions of
the General Data Protection Regulation, or GDPR. The GDPR became effective on May 25, 2018, repealing its predecessor directive and increasing
responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects. The GDPR, together
with the national legislation of the EU member states governing the processing of personal data, impose strict obligations and restrictions
on the ability to process personal data, including health data from clinical trials and adverse event reporting. In particular, these
obligations and restrictions concern potentially burdensome documentation requirements, granting certain rights to individuals to control
how we collect, use, disclose, retain and process information about them, the information provided to the individuals, the transfer of
personal data out of the EU, security breach notifications, and security and confidentiality of the personal data. The processing of sensitive
personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest
among foreign regulators. In addition, the GDPR provides for more robust regulatory enforcement and fines of up to €20 million or
4% of the annual global revenue of the noncompliant company, whichever is greater. Data protection authorities from the different EU member
states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing
personal data in the EU. Guidance on implementation and compliance practices are often updated or otherwise revised.

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European Union

European Union Coverage Reimbursement and Pricing

In the European Union, pricing and reimbursement
schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug
candidate to currently available therapies, or so-called health technology assessments, in order to obtain reimbursement or pricing approval.
For example, the European Union provides options for its member states to restrict the range of drug products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union member states
may approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the
company.

EU Drug regulation

In order to market any product outside of the
United States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
of our product. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable
foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions
such as in China and Japan. Although many of the issues discussed above with respect to the United States apply similarly in the context
of the EU, the approval process varies between countries and jurisdictions and can involve additional product testing and additional administrative
review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required
to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure
or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others. Failure
to comply with applicable foreign regulatory requirements may be subject to, among other things, fines, suspension or withdrawal of regulatory
approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Non-clinical studies and clinical trials

Similarly to the United States, the various phases
of non-clinical and clinical research in the EU are subject to significant regulatory controls.

Non-clinical studies are performed to demonstrate
the health or environmental safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with
the principles of good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC. In particular, non-clinical studies, both in
vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which
define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These
GLP standards reflect the Organization for Economic Co-operation and Development requirements.

Clinical trials of medicinal products in the EU
must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on
good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the
Declaration of Helsinki. Additional GCP guidelines from the European Commission, focusing in particular on traceability, apply to clinical
trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint
an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU
member states, the sponsor is liable to provide ‘no fault’ compensation to any study subject injured in the clinical trial.

Certain countries outside of the United States,
including the EU, have a similar process that requires the submission of a clinical study application (CTA) much like the IND prior to
the commencement of human clinical studies. A CTA must be submitted to each country’s national health authority and an independent
ethics committee, much like the FDA and the Institutional Review Board (“IRB”), respectively. Once the CTA is approved by
the national health authority and the ethics committee has granted a positive opinion in relation to the conduct of the trial in the relevant
member state(s), in accordance with a country’s requirements, clinical study development may proceed.

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The CTA must include, among other things, a copy
of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the
medicinal product under investigation. Currently, CTAs must be submitted to the competent authority in each EU member state in which the
trial will be conducted. Under the new Regulation on Clinical Trials, which is currently expected to become applicable by early 2022,
there will be a centralized application procedure where one national authority takes the lead in reviewing the application and the other
national authorities have only a limited involvement. Any substantial changes to the trial protocol or other information submitted with
the CTA must be notified to or approved by the relevant competent authorities and ethics committees. Medicines used in clinical trials
must be manufactured in accordance with good manufacturing practice (GMP). Other national and EU-wide regulatory requirements also apply.

Marketing Authorizations

To market a medicinal product in the EU and in
many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EU, medicinal product candidates
can only be commercialized after obtaining a Marketing Authorization (MA). To obtain regulatory approval of an investigational medicinal
product under EU regulatory systems, we must submit a marketing authorization application (“MAA”). The process for doing this
depends, among other things, on the nature of the medicinal product. There are two types of Mas:

●
the “Union MA”, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (“EMA”) and which is valid throughout the entire territory of the EU. The Centralized Procedure is mandatory for certain types of products, such as (i) medicinal products derived from biotechnology medicinal products, (ii) designated orphan medicinal products, (iii) advanced therapy products (such as gene therapy, somatic cell therapy or tissue-engineered medicines), and (iv) medicinal products containing a new active substance indicated for the treatment certain diseases, such as HIV/AIDS, cancer, neurodegenerative diseases, diabetes, other auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or that the granting of authorization would be in the interest of public health in the EU; and

●
“National Mas”, which are issued by the competent authorities of the EU member states and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in an EU member state, this National MA can be recognized in another member state through the Mutual Recognition Procedure. If the product has not received a National MA in any member state at the time of application, it can be approved simultaneously in various member states through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the Reference member state.

Under the above-described procedures, in order
to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product
on the basis of scientific criteria concerning its quality, safety and efficacy.

Under the Centralized Procedure, the maximum timeframe
for the evaluation of a MAA by the EMA is 210 days. Where there is a major public health interest and an unmet medical need for a product,
the CHMP may perform an accelerated review of a MA in no more than 150 days (not including clock stops). Innovative products that target
an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and
review programs, such as the PRIME scheme, which provides incentives similar to the breakthrough therapy designation in the US PRIME is
a voluntary scheme aimed at enhancing the EMA’s support for the development of medicines that target unmet medical needs. It is
based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development
plans and speed up their evaluation to help them reach patients earlier. Product developers that benefit from PRIME designation can expect
to be eligible for accelerated assessment, but this is not guaranteed. The benefits of a PRIME designation include the appointment of
a CHMP rapporteur before submission of a MAA, early dialogue and scientific advice at key development milestones, and the potential to
qualify products for accelerated review earlier in the application process.

Mas have an initial duration of five years. After
these five years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit balance,
unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period.

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Data and marketing exclusivity

The EU also provides opportunities for market
exclusivity. Upon receiving MA, new chemical entity, or reference product candidates, generally receive eight years of data exclusivity
and an additional two years of market exclusivity. If granted, the data exclusivity period prevents generic or biosimilar applicants from
relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar
MA in the EU during a period of eight years from the date on which the reference product was first authorized in the EU. The market exclusivity
period prevents a successful generic or biosimilar applicant from commercializing its product in the EU until 10 years have elapsed from
the initial authorization of the reference product in the EU. The overall 10-year market exclusivity period can be extended to a maximum
of eleven years if, during the first eight years of those 10 years, the MA holder obtains an authorization for one or more new therapeutic
indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in
comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities
to be a new chemical entity, and products may not qualify for data exclusivity.

Pediatric Development

In the EU, MAAs for new medicinal products candidates
have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (PIP) agreed
with the EMA’s Pediatric Committee (PDCO). The PIP sets out the timing and measures proposed to generate data to support a pediatric
indication of the drug for which MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures
of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to
provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely
to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations,
or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA
is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible
for six months’ supplementary protection certificate extension (if any is in effect at the time of authorization).

Post-Approval Requirements

Similar to the United States, both MA holders
and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the
competent regulatory authorities of the member states. The holder of a MA must establish and maintain a pharmacovigilance system and appoint
an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited
reporting of suspected serious adverse reactions and submission of periodic safety update reports (PSURs).

All new MAA must include a risk management plan
(RMP) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks
associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA. Such risk-minimization
measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct
of additional clinical trials or post-authorization safety studies.

The advertising and promotion of medicinal products
is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
is also prohibited in the EU. Although general requirements for advertising and promotion of medicinal products are established under
EU directives, the details are governed by regulations in each member state and can differ from one country to another.

The aforementioned EU rules are generally applicable
in the European Economic Area (“EEA”) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.

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For other countries outside of the EU, such as
countries in Latin America or Asia (e.g., China and Japan), the requirements governing the conduct of clinical studies, product licensing,
pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with GCP
and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail
to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of
regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Privacy and data protection laws

We are also subject to laws and regulations in
non-US countries covering data privacy and the protection of health-related and other personal information. For instance, EU member states
and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. Laws and regulations
in these jurisdictions apply broadly to the collection, use, storage, disclosure, processing, and security of personal information that
identifies or may be used to identify an individual, such as names, contact information and sensitive personal data such as health data.
These laws and regulations are subject to frequent revisions and differing interpretations,

As of May 2018, the General Data Protection Regulation
(GDPR) replaced the Data Protection Directive with respect to the processing of personal data in the European Union. The GDPR imposes
many requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent from
individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, shortened
timelines for data breach notifications, limitations on retention and secondary use of information, increased requirements pertaining
to health data and pseudonymized (i.e., key-coded) data and additional obligations when we contract third-party processors in connection
with the processing of the personal data. The GDPR allows EU member states to make additional laws and regulations further limiting the
processing of genetic, biometric or health data. Failure to comply with the requirements of GDPR and the applicable national data protection
laws of the EU member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding
financial year, whichever is higher, and other administrative penalties.

EU Medical device legislation

Medical device legislation is harmonized in the
European Union (EU) through the European Commission’s New Legislative Framework. The new regulatory framework for medical devices,
published in April 2017, is based on the Medical Devices Regulation (MDR) (EU) 2017/745 applicable for medical devices and active implantable
medical devices and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 applicable for in vitro diagnostic medical
devices (IVDs). The dates of application of the MDR were May 26, 2021 (Article 123(2) as amended by Regulation (EU) 2020/561 and Regulation
2023/607) and May 26, 2022 (Article 113(2)), respectively. As regulations, the legislation applies to all the EU Member States as drafted
and is applicable in the European Economic Area (EEA) which consists of the 27 EU Member States plus Norway, Liechtenstein, and Iceland.

The new regulatory framework in EU was triggered
by the breast implant scandal (2012) and various similar case scenarios, where the cause identified significant gaps in the market surveillance
and supply chain oversight as well as insufficient controls and compliance to state-of-the-art standards and documentation. Europe’s
new regulatory framework for IVDs introduced significant changes for IVD manufacturers; the most important is the up-classification of
IVDs (introduction of 7 classification rules and four risk classes A to D harmonized with the international classification system), which
require independent conformity assessments for most IVD Classes by independent regulatory compliance assessors (Notified Bodies, NB).
Other changes under the IVDR are the increased NB-involvement, a new risk-based classification system and classification rules, increased
elements and compliance to General Safety and Performance Requirements (GSPR), stricter demands on clinical evidence (scientific validity,
analytical and clinical performance), stronger focus for post-market surveillance (PMS) and post-market performance follow-up (PMPF),
stricter regulatory responsibilities throughout the supply chain for economic operators (like importers or distributors) and traceability
through Unique Device Information (UDI, labelling). Overall, the IVDR is a significant expansion of the previous EU-Directive 98/79/EC
(IVDD), which has been effective for IVDs since 1998.

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Since 2022, due to different reasons, the European
Commission issued various updates to the IVDR to introduce transitional provisions for certain IVDs, which are already on the EU market
prior to the Date of Application (legacy devices) and which are not to be substantially changed by function and design (Regulation (EU)
2022/112 and Regulation (EU) 2023/6074). The current accepted transitional periods provided for in IVDR Article 120 will end on either
December 31, 2027, or December 31, 2028. Currently a new proposal (2024/0021 (COD)) is even proposing extended transitional periods up
to December 31, 2029, for some devices (Class B and Class A sterile) and December 31, 2028, for medium risk IVDs (Class C). Due to these
extended transition timelines for legacy devices, many IVD manufacturers are not yet setting compliance to IVDR on their highest priority.
As of the date of this Report, Proteomedix transitioned from IVDD to IVDR and the Proclarix devices are certified under the new legislation
and fully compliant with IVDR.

For the Proclarix IVDs (Assays and Risk Calculator
software), which are class C devices under IVDR, Proteomedix has already CE marked them in 2019 under IVDD and since then started to comply
with IVDR. This includes the performance and safety of the device, specifically clinical performance testing and addressing the clinical
evidence for Proclarix.

Irrespective of the amendments for extended transition
timelines to IVDR published since 2022 by the European Commission – Proteomedix AG has selected and streamlined the interaction
with a NB (TÜV SÜD) for a conformity assessment under IVDR and passed this NB conformity assessment for their Technical Documentation
and Quality Management System according to international standard ISO 13485:2016 (“Design and development, production and distribution
of in-vitro diagnostic reagents and stand-alone software for prostate cancer management”) in July 2022.

Proteomedix AG has agreements signed with Emergo
Europe B.V. acting as their EU Authorized Representative (EU AR, also referred as EC REP).

The IVDR-compliance of Proclarix devices makes
them as one the first IVDs under the new EU regime and this will have several advantages to other devices marketed under IVDD or without
CE mark yet. Because of the mentioned significant changes introduced with the IVDR, other competitors might face problems and delays when
trying to get to this stage of IVDR compliance. As mentioned before, every new device or substantially changed device would not be able
to use the amended timelines and must fully comply with IVDR before placing them on the EU market. Second, clients (users, laboratories)
might expect compliance with the IVDR at some degree as the new normal (of state-of-the-art quality). Third, for the Proclarix devices
marketed since 2019 in EU, there is automatically systematic post market surveillance data collected from the field, which further can
support the clinical evidence (validity) of the Proclarix devices.

Proteomedix AG also has an appointed Data Protection
Officer (DPO) for data safety in line to requirements from General Data Protection Regulation (EU) 2016/679 (GDPR) and Swiss Data Protection
Act although there are no personnel data included or affected in the Proclarix IVDs.

Switzerland and United Kingdom (UK) Medical
Device Regulation

Switzerland and United Kingdom (UK) are not part
of the EU market and in principle, become third countries with different jurisdictions and differing product regulations. However, these
two countries still align to a certain degree on the European CE Mark and CE marked devices currently can be marketed without significant
additional approval in Switzerland and UK.

For Switzerland, the new EU Regulations (MDR/IVDR)
required an update of the Mutual Recognition Agreements to include the EU Regulations, which has so far not been negotiated by the Switzerland–EU
Joint Committee for Switzerland and the EU at international treaty level. Therefore, trading of devices can no longer move freely between
the Swiss market and the EU market and the sharing of information between authorities (incl. EUDAMED) or the mutual recognition of certificates
of conformity are not possible and must be regulated through Swiss law separately in Switzerland. The new Swiss law for medical devices,
the Medical Devices Ordinance (MedDO) was introduced in 2020 together with certain obligations for Swiss manufacturers such as registration
with Swissmedic. As a consequence, Swiss manufacturers must appoint an EU-based AR and/or importer in line with Article 11 and Article
13 of the IVDR.

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For UK, IVD manufacturers must comply with the
UK MDR 2002 (Medical device Regulation), which has been revised several times with new guidelines addressed in the Guidance on the Regulation
of In Vitro Diagnostic Medical Devices in Great Britain. Similar to EU, IVD manufacturers must identify the appropriate conformity assessment
procedure for their device and demonstrate compliance with relevant requirements of the applicable legislation for IVDs in the UK for
the purpose of affixing the UKCA mark to their device (UK MDR 2002 Part IV). UKCA marking (UK Conformity Assessed marking) is the UK product
marking requirement that will be needed for devices being placed on the market in UK, substituting the EU requirements for CE Marking
(CE marking will continue to be accepted in Northern Ireland). Most of these IVDs will then require a designated UK Authorized Body (UKAB)-issued
certificate (similar to an EU CE Marking Certificate). EN ISO 13485:2016 is the designated standard under the UK MDR 2002 that covers
QMS requirements for medical device manufacturers. In the UK, device manufacturers must further appoint a single “UK Responsible
Person” for all of their devices, who will act on the manufacturer’s behalf to perform tasks, including product registration.
However, for medical devices with a valid CE marking placed on the UK-market, there was a transition time until 1 July 2023 (no requirement
to re-label the device with a UKCA mark), and the UK government recently has extended acceptance of CE marked devices in UK beyond 30
June 2023 (MDR 2002, SI 2002 No 618, as amended).

Therefore, Proteomedix AG with a valid CE mark
for EU (IVDR) and appointed EU-AR, and local registration in Switzerland (Swissmedic) is in full compliance to the current changed requirements
on the EU, Swiss and UK markets. Proteomedix AG has agreements signed with Emergo Consulting (UK) Ltd. acting as their UK Responsible
Person. The requirement to comply with UKCA marking would apply after 30 June 2030.

EU – Impact and market opportunities
on other non-EU markets

With the overall intend from regulators to harmonize
regulation, the CE marking and compliance to European IVDR for the Proclarix can be considered as a state-of-the-art regulatory compliance
with high potential to enter other markets. Some of these like Australia, New Zealand or Singapore and other markets recognize the CE
mark and – though they might have separate approval procedures – are expected to mainly rely on the CE Certificate. For example,
Australia and New Zealand have a Trans-Tasman Mutual Recognition Arrangement (TTMRA), which means that CE mark can be recognized and sold
without additional regulatory processes. Brazil’s medical device market regulator, ANVISA, recently announced updates to the IVD
legislation as Resolution (RDC) 830/2023 similar to the EU definition and classification of IVD under IVDR. For US, the FDA recently in
January 2024 amended their title of their Quality System regulation part 820 (QSR), and integrated elements and concepts from ISO 13485:2016
into their new Quality Management System Regulation (QMSR).

These examples demonstrate that Proclarix with
established CE mark (IVDR) and ISO 13485:2016 QMS has high potential to get faster market access in other non-EU countries, too. It can
be expected that more non-EU country legislations will further adapt their approval or acceptance process to the level of IVDR or ISO
13485 in the forthcoming years.

Intellectual Property

Proteomedix’s biomarkers were discovered
using a genetics-guided discovery approach focusing on the PI3K/PTEN cancer pathway that plays a dominant role in prostate cancer development.
Applying proteomics technology to a disease-relevant mouse model allowed the identification of proteins specifically linked to the molecular
cause of prostate cancer. The biomarkers and the bioinformatics algorithm used in Proclarix are protected by issued and pending patents
in Europe, the United States, and other countries.

Cancer arises from different genetic mutations
that can be linked to specific signaling pathways often referred to as cancer pathways. Depending on what pathway is affected in a patient,
results in different cancer subtypes that are more or less aggressive and further determines if a patient responds to a certain drug treatment
or not.

Proteomedix’s biomarkers were discovered
by a group of researchers at ETH Zurich using a genetics-guided discovery approach focusing on the PI3K/PTEN cancer pathway that plays
a dominant role in prostate cancer development. Using a mouse model and mass-spectrometry based proteomics technology including a glycoprotein
enrichment technology led to the identification of proteins directly linked to the molecular cause of cancer and therefore correlating
to the disease status in the prostate. Different serum glycoproteins were combined to form multiplexed biomarker signatures predictive
for tissue PI3K/PTEN status as well as diagnosis and prognosis of prostate cancer (Figure 5). The genetic-guided proteomics approach enabled
the fast discovery and validation of several biomarkers which in different combinations correspond to diagnosis, prognosis and potentially
to therapy response.

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Figure 5: Proteomedix’s approach to improve prostate cancer
disease management.

The biomarker assays were transferred from a mass
spectrometry-based to an immunoassay-based platform. Immunoassay-based measurement offers several advantages compared to other analytical
methods. In general, immunoassays provide a rapid, sensitive, reproducible, cost effective and easily manageable analysis. The reagents
used are stable and the method is established in routine diagnostic laboratories guaranteeing broad compatibility of Proteomedix’s
tests on established automated clinical platforms and thus rapid adoption rates and platform flexibility of the diagnostic tests. The
deep knowledge in selecting novel biomarkers, assay development and clinical development enabled Proteomedix to enable several R&D
partnerships.

In 2021, Proteomedix entered into a research and
development partnership with New Horizon Health Limited, Grand Cayman, Cayman Islands. The partnership builds on complimentary platform
and biomarker developments with utility in cancer patient management.

In 2022, Immunovia AB (Sweden) (“Immunovia”)
partnered with Proteomedix to leverage Proteomedix’s research and development capabilities and advances their research and development
efforts. With this partnership, Immunovia gained a more flexible research and development organization, increased its research and development
productivity, and refocused internal resources on commercial build up, thus further accelerating the roll-out of their proprietary IMMrayTM
PanCan-d test. The partnership capitalizes on the combined expertise of two leading innovators in proteomics-based diagnostics, who have
both launched innovative oncology tests, Immunovia with IMMrayTM PanCan-d in the U.S. and Proteomedix with Proclarix® in
Europe.

In September 2025, Proteomedix and Immunovia furthered
their relationship by entering into a separate licensing agreement. Under the licensing agreement, Proteomedix will produce master cell
lines for three of the five biomarkers used in PancreaSure, a Immunovia pancreatic cancer diagnostic test, and license key intellectual
property related to the manufacturing of associated reagents to Immunovia in consideration for two payments of $300,000 each to Proteomedix,
due on September 30, 2025, and March 31, 2026. Additionally, Immunovia will make a $100,000 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.

Patents

Proteomedix has exclusively licensed worldwide
rights to one patent family from ETH Zurich and the State Hospital of St. Gallen, which describes and protects the use of the proprietary
biomarkers for diagnosing and monitoring prostate cancer. The parent international patent application WO 2009138392 A1 was filed on May
12, 2009, claims a priority date of May 14, 2008 (priority date) and was granted in China (CN201027373B), Europe (EP2281201B1), Japan
(JP6025607B) and the United States (US10151755B2/ US9377463B2).

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Proteomedix also obtained a non-exclusive license from ETH Zurich for certain
patents pertaining to specific enrichment of glycoproteins, including EP1514107 (expired June 3, 2023) and US7183118 (expired May 3, 2024),
that ETH Zurich licensed from the Institute for Systems Biology (ISB), Seattle. The license enabled Proteomedix to use the glycoprotein
technology for the development of new diagnostic products. The license was terminated in connection with the expiration of the patent
and no further license payments are required.

In addition, a new patent covering the latest
development and clinical results was filed by Proteomedix on July 11, 2017, claiming a priority of July 15, 2016. The patent covers the
specific test format and algorithm contained in Proteomedix’s first product (Proclarix) for the improved diagnosis of prostate cancer.
An international application (WO2018011212A1) was filed, and the patent was granted in Europe (EP3270163B1), Japan (JP6979712B2), South
Korea (KR102408276B1), Australia (AU2017294979B2), United States (US11320435B2, with term extension of 377 days) and China (CN109477836B)
with the application still pending in Canada (CA3028874A1).

A patent application describing and claiming a
method combining Proclarix and magnetic resonance imaging to diagnose prostate cancer was filed by Proteomedix on June 29, 2021. The patent
was originally filed in Switzerland and subsequently as PCT application (WO2023274742A1) and as national applications in the United States
and China.

A patent application describing and claiming a
method measuring a blood-based protein combination with prognostic utility in prostate cancer patients was filed by Proteomedix on June
29, 2021. The patent was originally filed in Switzerland followed by an international application (WO2018011212A1). National applications
were filed in Europe, United States and China.

Trademarks

The brand “Proteomedix” was filed
on June 4, 2010, and registered under no. 602190 in Switzerland on June 22, 2010. This application served as the basis for the international
trademark application. The product name “Proclarix” was filed on July 1, 2019, and registered under no. 733974 in Switzerland
on July 22, 2019. This application served as the basis for the international trademark application. The product name “Prosgard”
was filed on July 1, 2019, and registered under no. 733975 in Switzerland on July 22, 2019.

Manufacturing and Supply

We currently do not own or operate any manufacturing
facilities. For Proclarix, we outsource manufacturing to a CMO in Germany. All of the key reagents used in Proteomedix’s IVD kits
(i.e., antigens and antibodies) are proprietary and owned exclusively by Proteomedix. These reagents are produced by an independent supplier
in Germany and shipped to the CMO for manufacturing of the IVD kits. The development and production of the Proclarix risk calculator software
and the hosting of the Proclarix risk calculator software are performed by external suppliers.

Employees

As of March 10, 2026,
we had 2 full-time and 6 subcontracted employees. None of our employees are represented by a collective bargaining agreement, and we
have never experienced any work stoppage. We believe we have good relations with our employees.

Properties and Facilities

We currently lease an office located at 201 E
Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.

Additionally, Proteomedix leases office and lab space located at Wagistrasse
23, 8952 Schlieren, Switzerland. This lease expired on December 31, 2025 and was renewed for a two-year term with a monthly rent of $2,000
per month. The lease will automatically renew for successive two-year terms, unless terminated. Either party may terminate the lease with
twelve months’ written notice.

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Corporate Information

We were incorporated on October 22, 2018 under
the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202,
and our telephone number is (513) 620-4101. Our corporate website address is www.onconetix.com. We make available free of charge
on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy
statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act
as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the SEC. Alternatively, you may
also access our reports at the SEC’s website at www.sec.gov.

Fundraising Activities

On October 1, 2024, the Board authorized the Company
to create a series of 10,000 shares of preferred stock designated as “Series C Preferred Stock”, with a par value of $0.00001,
pursuant to the Certificate of Designations of Series C Preferred Stock. At any time after the initial issuance date of Series C Preferred
Stock, each Series C Preferred Stock shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. On
October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “Series C PIPE Investors”),
pursuant to a securities purchase agreement, an aggregate of 3,499 shares of Series C Preferred Stock, which includes an issuance of 840
shares of Series C Preferred Stock to the lead investor in consideration for the Series C PIPE Investors’ irrevocable commitment
to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock, for aggregate net cash proceeds
to the Company of $1.9 million.

On October 2, 2024, the Company entered into a
Common Stock ELOC Purchase Agreement relating to a Committed Equity Facility with an institutional investor (the “ELOC Purchaser”),
whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase,
up to $25.0 million of the Company’s newly issued Common Stock, subject to certain limitations. As of December 31, 2025, the Company
has sold approximately 661,762 shares under the ELOC Purchase Agreement for gross proceeds of approximately $7.1 million.

On July 16, 2025, the Company exercised its voluntary
adjustment right under the Certificate of Designation of the Series C Preferred Stock to lower the conversion price of the Series C Preferred
Stock to $3.50, and holders of 1,920 shares Series C Preferred Stock agreed to convert their shares into shares of Common Stock.

As of December 31, 2025, 7 shares of Series C
Preferred Stock were outstanding from the original issuance of 3,499, after the redemption of 1,369 shares of Series C Preferred Stock
for an aggregate consideration of $1.71 million, the conversion of 1,920 shares of Series C Preferred Stock into common stock, and the
exchange of 203 shares of Series C Preferred Stock into 244 shares of Series D Preferred Stock.

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 4,362,827 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 $3.6896, and the Series D Warrants are exercisable beginning on the issuance date and expire on the third
anniversary of the issuance date.

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 shares of common stock
and warrants (the “Series E Warrants”) to purchase 2,025,223 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 $3.8576, and the Series E
Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.

Legal Proceedings

From time to time we may be involved in various
disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.

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