10 unchanged sentences
dollars, unless otherwise noted.
−Removed: is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation with high unmet need.
−Removed: 3, 2023, we entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc.
−Removed: d/b/a Avior Bio, LLC
−Removed: (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed
−Removed: Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103
−Removed: and to practice the Licensed Technology in connection with the foregoing, throughout the world, each as defined in the Avior License
−Removed: In February 2023, the U.S.
−Removed: Food and Drug Administration (“FDA”) approved an investigational new drug (“IND”)
−Removed: application for TH104.
−Removed: TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating
−Removed: pruritus or “uncontrollable itching.” With respect to TH104, we intend to first seek approval for the treatment of moderate-to-severe
−Removed: chronic pruritus in patients with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known
−Removed: cure in which more than 70% of patients suffer from debilitating chronic pruritic.
−Removed: We expect to obtain topline data from a Phase 2 trial
−Removed: in TH104 in Q4 2025 and with respect to TH103, we intend to develop the product candidate and potentially file an IND.
−Removed: September 11, 2024, we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”),
−Removed: pursuant to which, we exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody
−Removed: Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and
−Removed: human components that inhibit tumor TNF-α.
−Removed: Under the terms of the Intract Agreement, we licensed global development and commercialization
−Removed: rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement
−Removed: for infliximab to be used in the oral product development program.
−Removed: are also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”)
−Removed: targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”)
−Removed: and programmed cell death protein 1 (“PD-1”).
−Removed: We are developing antibodies including bispecific antibodies, antibody drug
−Removed: conjugates (“ADCs”) and small molecular weight bovine-derived Picobodies™ or antibody “knob” domains which
−Removed: have the potential to target and bind more tightly to “undruggable” epitopes better than full sized antibodies.
−Removed: We are advancing
−Removed: HS3215, a bispecific against both HER2 and HER3 antibody which targets a novel “bridging epitope” encompassing multiple domains
−Removed: of the HER2 extracellular domain (“ECD”) as well as ligand-dependent and independent blocking of the ECD of HER3 into IND-enabling
−Removed: studies in 2025.
−Removed: In addition, we anticipate that HS0059, a HER2/HER3 bispecific ADC (“bsADC”), and HS1940, a PD-1 Picobody,
−Removed: will progress to enter IND-enabling studies in 2025.
−Removed: critical components of our business strategy to achieve our goals include:
−Removed: TH104 as a transmucosal buccal film product for the treatment of moderate-to-severe chronic pruritus in PBC and other inflammatory
−Removed: TH023 by obtaining regulatory authorization to initiate a first-in-human bioavailability clinical trial and pursue an IND through
−Removed: a preclinical and clinical path forward for, HS1940, a unique PD-1 knob-domain antibody fragment with unique binding differentiation
−Removed: compared to full length antibodies for IO vulnerable tumors;
−Removed: to advance pre-clinical candidate selection activities against HER2/HER3 receptors with various antibody formats, including HS3215
−Removed: designed for multiple solid tumor types;
−Removed: create a strategy to develop HS0059 as a bispecific ADC specifically targeted to both HER2 and HER3 receptors in high unmet need
−Removed: standard-of-care resistant tumors with a high capacity to metastasize;
−Removed: the discovery of next generation multi-specific (bi- and tri) antibodies with binding capabilities to novel epitopes of combinations
−Removed: of HER2, HER3, PD-1, PD-L1, TROP2 with and without toxin delivery capacity to multiple high unmet need rare cancers and other validated
−Removed: immunology and metabolic targets, including glucose-dependent insulinotropic peptide (GIP);
−Removed: strategic collaboration opportunities including potential M & A transactions to maximize the value of our pipeline to bring novel
−Removed: therapies to patients suffering from high unmet need conditions
−Removed: Biomedical Research Institute Research and Development Collaboration and License Agreement
−Removed: July 5, 2023 (the “ABSI Effective Date”), we entered into a Research and Development Collaboration and License Agreement
−Removed: (the “ABSI Agreement”) with Applied Biomedical Science Institute (“ABSI”) pursuant to which ABSI granted us an
−Removed: exclusive royalty-bearing, sublicensable license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to the
−Removed: ABSI Know-How to Exploit the ABSI Products for the treatment, diagnosis, prediction, detection or prevention of disease in humans and
−Removed: animals worldwide (the “Territory”).
−Removed: Pursuant to the ABSI Agreement, the parties shall form a committee to manage the preclinical,
−Removed: IND- enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product.
−Removed: parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target with a view
−Removed: to identifying or generating suitable Products for our Company to Exploit.
−Removed: “Target” means ErB2 (Her2) and ErbB3.
−Removed: Upon completion
−Removed: of the Discovery Timeline for a Target, subject to the terms and conditions of ABSI Agreement, we shall exclusively own any ABSI Products
−Removed: against such Target.
−Removed: In the event the committee determines that the discovery activities are unsuccessful with respect to a Target, we
−Removed: may propose an additional target, which, upon approval by ABSI, shall replace a failed Target, each capitalized term as defined in the
−Removed: ABSI Agreement.
−Removed: part of the ABSI Agreement, on July 26, 2023, we issued 1,674 shares of our common stock with a per share value of $149.34, representing
−Removed: total compensation expense of $250,000.
−Removed: March 11, 2024, we entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $50,000 beginning
−Removed: March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter.
−Removed: Patent License Agreement
−Removed: November 3, 2023 (the “Avior Effective Date”), we entered into the Avior Patent License Agreement with Avior pursuant to
−Removed: which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other
−Removed: things, develop, have developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the
−Removed: Licensed Technology in connection with the foregoing, throughout the world.
−Removed: Pursuant to the Avior Patent License Agreement, we paid
−Removed: Avior an up front license fee of $400,000 within ten days of the Avior Effective Date and an additional mid-six digit license fee
−Removed: which shall be paid in four equal installments within ten days of the end of each fiscal quarter following the Avior Effective Date.
−Removed: In addition, we shall pay Avior a high single digit percentage of any upfront payments received by us as a result of the grant of
−Removed: any sublicenses with respect to TH104.
−Removed: We shall also pay Avior milestone payments in the aggregate amount of $24.25 million upon the
−Removed: occurrence of various development milestones (the “Development Milestone Payments”).
−Removed: Furthermore, we shall pay Avior
−Removed: certain fees based upon sales milestones.
−Removed: The payments for such sales milestones range from the low seven digits to the low eight
−Removed: digits with higher sales being subject to higher fees.
−Removed: Finally, we shall pay Avior royalties based on net sales.
−Removed: Such royalties
−Removed: range from low single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages.
−Removed: Avior Patent License Agreement shall expire upon the expiration of the final payment obligation due to Avior as set forth in such
−Removed: Upon the expiration of the Avior Patent License Agreement, we shall have a fully paid-up, irrevocable, freely
−Removed: transferable and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed,
−Removed: make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have
−Removed: commercialized any and all Licensed Products and to practice the Licensed Technology worldwide.
−Removed: Pursuant to the Avior Patent License
−Removed: Agreement, we may terminate the agreement at any time without cause, upon 30 days’ prior written notice to Avior along with
−Removed: payment of the next unpaid Development Milestone Payment, if any.
−Removed: Furthermore, either we or Avior may terminate the Avior Patent
−Removed: License Agreement (i) on written notice to the other party if the other party materially breaches any provision of the Avior Patent
−Removed: License Agreement and fails to cure such breach within 30 days after the breaching party receives written notice thereof or (ii) on
−Removed: written notice in the event that either party (A) becomes insolvent or admits its inability to pay its debts generally as they
−Removed: (B) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or
−Removed: insolvency law, which is not fully dismissed or vacated within 60 days;
−Removed: (C) is dissolved or liquidated or takes any corporate action
−Removed: for such purpose;
−Removed: (D) makes a general assignment for the benefit of creditors;
−Removed: or (E) has a receiver, trustee, custodian or similar
−Removed: agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or
−Removed: Upon termination of the Avior Patent License Agreement, the license granted pursuant to such agreement shall terminate and
−Removed: all rights in the Licensed Patent Rights and Licensed Products shall revert back to Avior.
−Removed: License Agreement
−Removed: June 17, 2024 (the “Enkefalos Effective Date”), we signed a letter of intent (the “Enkefelos LOI”) to enter into
−Removed: the Enkefalos License Agreement with Enkefalos Biosciences Inc.
−Removed: pursuant to which we are licensing the global rights in all fields of
−Removed: use for the products related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier and all associated
−Removed: know-how, technology, intellectual property and related information and constructs, and any associated authorized generic rights and
−Removed: all related assets (collectively, the “Products” referred to in this letter as ENBI-01) from Enkefalos Biosciences, Inc.
−Removed: Pursuant to the Enkefalos License Agreement, we paid Enkefalos an upfront license fee of $150,000 upon signing of the Enkefalos LOI and
−Removed: an additional $150,000 license fee to be paid 6 months after the Enkefalos Effective Date.
−Removed: In addition, we shall pay Enkefalos a $50,000
−Removed: annual license fee and milestone payments in the aggregate amount of up to $8,500,000 upon the occurrence of various development milestones
−Removed: (the “Enkefalos Development Milestone Payments”).
−Removed: Furthermore, we shall pay Enkefalos royalties based on net sales.
−Removed: royalties range from low-single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages.
−Removed: The Enkefalos License Agreement shall expire upon the expiration of the final payment obligation due to Enkefalos as set forth in such
−Removed: Upon the expiration of the Enkefalos Patent License Agreement, we shall have a fully paid, irrevocable, freely transferable
−Removed: and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made,
−Removed: use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have commercialized any
−Removed: and all Licensed Products and to practice the Licensed Technology worldwide.
−Removed: Pursuant to the Enkefalos License Agreement, either the
−Removed: Company or Enkefalos may terminate the Enkefalos License Agreement on written notice to the other party.
−Removed: Upon termination of the Enkefalos
−Removed: License Agreement, the license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed
−Removed: Products shall revert back to Enkefalos.
−Removed: Patent License Agreement
−Removed: September 11, 2024 (the “Intract Effective Date”), we entered into a Patent License Agreement (the “Intract
−Removed: Agreement”) with Intract Pharma Limited, (“Intract”), pursuant to which the Company exclusively licensed
−Removed: INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab.
−Removed: Under the terms of the Intract
−Removed: Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and
−Removed: Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development
−Removed: Pursuant to the Intract Agreement, Intract recieved an upfront license fee of $400,000 and is eligible to receive
−Removed: additional payments upon an equity financing of the Company and for future development, regulatory and commercial
−Removed: milestones, as well as mid-single digit royalties based on net product sales.
−Removed: Under the terms of the Intract Agreement, we retain a
−Removed: right of first refusal to continue development and commercialization after a Phase 2 clinical trial and have the option to exercise
−Removed: the license to Intract’s platform for up to four additional targets.
−Removed: The term of the Intract Agreement expires upon the final
−Removed: payment obligation of the Company under the Intract Agreement.
−Removed: In addition, the Intract Agreement may be terminated by us at any
−Removed: time upon 90 days written notice to Intract.
−Removed: Either party may terminate the Intract Agreement if the other party materially breaches
−Removed: any provision of the Intract Agreement and fails to cure such breach within thirty (30) days after the breaching party receives
−Removed: written notice thereof.
−Removed: In addition, either party may terminate the Intract Agreement on written notice in the event that either
−Removed: party declare:
−Removed: (a) becomes insolvent or admits inability to pay its debts generally as they become due;
−Removed: (b) becomes subject,
−Removed: voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully
−Removed: dismissed or vacated within sixty (60) days;
−Removed: (c) is dissolved or liquidated or takes any corporate action for such purpose;
−Removed: makes a general assignment for the benefit of creditors;
−Removed: or (e) has a receiver, trustee, custodian or similar agent appointed by
−Removed: order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
−Removed: June 7, 2024, we entered into an at-the-market offering agreement (the “ATM Agreement”) with Rodman & Renshaw LLC
−Removed: (the “ATM Sales Manager”) under which we may sell, from time to time through the ATM Sales Manager, shares of common stock
−Removed: in one or more offerings up to a total dollar amount of $1.65 million.
−Removed: Sales of shares of our common stock through the ATM Sales Manager,
−Removed: if any, will be made by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415(a)(4)
−Removed: under the Securities Act of 1933, as amended (the “Securities Act”), including without limitation sales made directly on
−Removed: the Nasdaq Stock Market LLC or any other existing trading market for the common shares.
−Removed: Our common stock is being offered and sold pursuant
−Removed: to the effective shelf registration statement on Form S-3 and an accompanying prospectus declared effective by the U.S.
−Removed: Securities and
−Removed: Exchange Commission (the “SEC”) on March 24, 2023, and pursuant to a prospectus supplement dated June 7, 2024.
−Removed: June 10, 2024, we reported positive results from our Phase 1 clinical trial with TH104.
−Removed: Results from healthy subjects demonstrated consistent
−Removed: pharmacokinetic (PK) profiles across buccal and intravenous routes of administration with a comparable safety and tolerability profile
−Removed: between routes of administration.
−Removed: This Phase 1 trial was a single-dose, single-center, open-label, randomized 2-way crossover study comparing
−Removed: 16 mg of TH104 with 1 mg intravenous nalmefene administered under fasting conditions, with a 7-day washout period between doses.
−Removed: healthy subjects were enrolled to complete both doses of the crossover design.
−Removed: All 20 subjects completed TH104 buccal dosing, while 19
−Removed: of 20 subjects also completed the intravenous dosing.
−Removed: The primary objective was to evaluate the absolute bioavailability of TH104, as
−Removed: well as to assess safety and tolerability.
−Removed: Findings from the study indicated that the primary endpoint of the study which was absolute
−Removed: bioavailability (F) of TH104, or fraction (or percentage) of the administered dose absorbed into the systemic circulation compared to
−Removed: an equivalent intravenous dose of nalmefene, was 0.459 (45.9%).
−Removed: The median time to maximum concentration (C max ) of TH104 was
−Removed: 2.0 hours, and mean half-life (T 1/2 ) as measured in the blood of subjects was 14 hours after a single buccal administration
−Removed: of TH104, compared to 9 hours for the 1mg intravenous dose of nalmefene.
−Removed: These data were consistent and within range of previous findings
−Removed: of nalmefene in the literature and the Company believes PK results from this Phase 1 trial show proportional kinetics consistent with
−Removed: published findings of oral and intravenous formulations, suggesting TH104 could be developed for once-daily dosing in a target population
−Removed: of moderate-to-severe chronic pruritus in PBC patients.
−Removed: The Phase 1 trial also demonstrated that a 16mg dose of TH104 had a comparable
−Removed: safety and tolerability profile to the FDA-approved 1mg dose of nalmefene intravenous formulation.
−Removed: Treatment emergent adverse events
−Removed: (TEAEs) in this study were reported in 8 subjects (40.0%) in the TH104 group and 7 subjects (36.8%) in the intravenous group.
−Removed: TEAEs were considered mild in severity.
−Removed: The most frequently reported TEAE for both TH104 and intravenous treatments was dizziness (4
−Removed: subjects in the TH104 group;
−Removed: 7 subjects in the intravenous group).
−Removed: TEAEs reported in at least 2 subjects in any treatment group were
−Removed: nausea (3 subjects in each group) and somnolence (3 subjects in each group).
−Removed: There were no serious adverse events reported during this
−Removed: No subjects discontinued the study due to adverse events.
−Removed: No subjects exhibited abnormal results for the visual examinations of
−Removed: the buccal mucosa pre- or post-dosing with TH104 buccal film.
−Removed: June 17, 2024, we reported positive Type C meeting feedback from the U.S.
−Removed: Food and Drug Administration (FDA) for our Phase 2
−Removed: clinical trial with TH104, confirming our plan to pursue a 505(b)(2) approval pathway, which permits inclusion of data from external
−Removed: studies when the active ingredient is already approved in the United States.
−Removed: The FDA also agreed that the nonclinical studies
−Removed: submitted to the FDA in advance of the meeting appear sufficient to support the proposed Phase 2 clinical trial.
−Removed: In addition, the
−Removed: FDA provided feedback on study design and certain recommendations regarding PBC patient inclusion, the primary endpoint to assess
−Removed: pruritus in these patients, and considerations for monitoring for adverse events in this patient population.
−Removed: Based on this
−Removed: interaction, in early 2025, we began start up activities in preparation for the Phase 2 trial with TH104 in moderate-to-severe chronic pruritus
−Removed: in PBC patients.
−Removed: We plan to plan to initiate a hepatic impairment study prior to launching the Phase 2 study.
−Removed: On June 7, 2024, we entered into an at-the-market offering agreement (the
−Removed: “ATM Agreement”) with Rodman & Renshaw LLC (the “Manager”), pursuant to which we may offer and sell, from
−Removed: time to time, shares of our common stock having an aggregate offering price of up to $1,650,000 through the Manager.
−Removed: Any shares sold under
−Removed: the ATM Agreement will be issued pursuant to our effective shelf registration statement on Form S-3 and the related prospectus supplement.
−Removed: We will pay the Manager a commission of 3.0% of the aggregate gross proceeds from the sales of shares of our common stock sold through
−Removed: the Manager pursuant to the ATM Agreement.
−Removed: During the year ended December 31, 2024, we raised gross proceeds of $83,568 pursuant to the
−Removed: ATM Agreement from the sale of 40,000 shares of our common stock at an average price of $ 2.0892
−Removed: per share (the “ATM Sale”).
−Removed: The net proceeds from the ATM Sale during the year ended December 31, 2024 were $ 73,189,
−Removed: after deducting sales agent commissions of $2,507 and other fees of $7,992.
−Removed: June 21, 2024, we closed a private placement offering (the “June 2024 PIPE Offering”) with certain accredited investors of
−Removed: $2.08 million of our securities consisting of shares of our common stock and/or pre-funded warrants to acquire shares of our common stock
−Removed: and warrants to acquire shares of our common stock.
−Removed: Net proceeds from the June 2024 PIPE Offering were approximately $1.8 million.
−Removed: signed a development agreement for TH1014 Phase 2A clinical trial manufacturing on July 25, 2024.
−Removed: In the study, our CMO will manufacture
−Removed: four increasing strengths of TH104 active material and their corresponding placebos.
−Removed: The manufacturing operation is a 5-month program,
−Removed: where each of the strengths will be released for clinical packaging by the end of the year.
−Removed: We are pleased to state that the developmental
−Removed: activities are on track and within budget.
−Removed: Updates to the developmental activities are provided biweekly, and we currently see no risks
−Removed: to the timely completion of the activities and procurement of the clinical trial materials in the proposed timeframe.
−Removed: December 9, 2024, we closed a private placement offering (the “December 2024 PIPE Offering”) with certain accredited investors
−Removed: of $2.02 million of our securities consisting of shares of our common stock and/or pre-funded warrants to acquire shares of our common
−Removed: stock and warrants to acquire shares of our common stock.
−Removed: Net proceeds from the December 2024 PIPE Offering were approximately $1.8 million.
+Added: the year ended December 31, 2025, we began a strategic shift in our business to prioritize digital asset treasury management and investment
+Added: in the digital asset ecosystem, specifically the Canton Network.
+Added: As described in Item 1, from 2022 through late 2025, we primarily operated
+Added: as a biotechnology company developing therapeutic candidates in inflammatory and immunologic conditions.
+Added: In November 2025, we undertook
+Added: a strategic shift to prioritize a disciplined digital asset treasury strategy.
+Added: connection with this shift, in November 2025 we completed a private placement offering, strengthening our liquidity and supporting our
+Added: digital asset treasury strategy.
+Added: Concurrently, we entered into an at-the-market equity program and established a shelf registration statement.
+Added: In January 2026, we completed a registered direct offering of common stock and pre-funded warrants, further strengthening our capital
+Added: digital asset treasury strategy is centered on acquiring, holding and deploying Canton Coin (“CC”) and supporting the Canton
+Added: Network through validator operations, application support and ecosystem participation.
+Added: results of operations for the year ended December 31, 2025 reflect our two reportable segments:
+Added: legacy biotechnology operations, and
+Added: our digital asset treasury strategy initiated in November 2025.
+Added: See Note 10 to our consolidated financial statements included elsewhere
+Added: in this Annual Report on Form 10-K for additional segment financial performance information.
of Results of Operations
43 unchanged sentences
travel expenses and other operating costs that are not specifically attributable to research activities.
+Added: General and administrative
+Added: expenses also include expenses related to our canton-centric digital asset treasury strategy.
expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support our
−Removed: continued research activities and development of our product candidates.
−Removed: We also incur expenses associated with being a public company,
−Removed: including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, directors and officers insurance expenses,
−Removed: corporate governance expenses, investor relations activities and other administrative and professional services.
+Added: digital asset treasury strategy and continued research activities and development of our product candidates.
+Added: We also incur expenses associated
+Added: with being a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, directors
+Added: and officers insurance expenses, corporate governance expenses, investor relations activities and other administrative and professional
income consists of interest income from funds held in our cash accounts.
+Added: Loss from Digital Asset Holdings
+Added: unrealized gain (loss) from digital assets holdings represents the change in fair value of our digital assets.
+Added: We use a USD/CC reference
+Added: price from a crypto market data provider for purposes of periodic fair value remeasurement.
of Operations
1 unchanged sentence
following table sets forth key components of our results of operations for the years ended December 31, 2025 and 2024.
−Removed: Consolidated Statements
−Removed: of Operations Data:
−Removed: Operating expenses:
−Removed: and administrative
+Added: Consolidated Statements of Operations Data:
Operating expenses:
+Added: Research and development
+Added: $ (3,318,133 )
+Added: General and administrative
+Added: Total operating expenses
Other income (expense):
Interest expense
−Removed: other income (expense)
+Added: Interest income
+Added: Unrealized loss from digital assets holdings
(22,010,362 )
(22,010,362 )
+Added: Total other income (expense)
(21,997,297 )
+Added: (22,233,521 )
+Added: Total loss before income taxes
+Added: $ (42,103,363 )
+Added: $ (12,197,568 )
+Added: $ (29,905,795 )
and Development Expenses
−Removed: and development expenses increased by $2.8 million, or 80%, to $6.4 million for the year ended December 31, 2024 from $3.6 million for
+Added: table below summarizes by program our research and development expenses for the periods presented:
Year Ended December 31,
−Removed: The increase was primarily the result of an increase in clinical trial expenses of approximately $1.6 million
−Removed: due to completion of our Phase 1 clinical trial and start-up costs related to our Phase 2 clinical trial in TH104, an increase of $1.8
−Removed: million in license fees, and an increase of $0.2 million in regulatory fees.
−Removed: These increases were offset by a decrease of $0.7 million
−Removed: in pre-clinical vendor expenses and a decrease of $0.1 million in stock-based compensation expense related to our research and development
+Added: Other research and development
+Added: Total research and development expenses
+Added: $ (3,318,133 )
+Added: and development expenses decreased by $3.3 million, or 52%, to $3.1 million for the year ended December 31, 2025 from $6.4 million for
+Added: year ended December 31, 2024.
+Added: The decrease was primarily the result of decreases in (i) clinical trial expenses of approximately $1.6
+Added: million due to completion of our Phase 1 clinical trial and offset by start-up costs related to our Phase 2 clinical trial in GV104,
+Added: (ii) license fees of $1.5 million, (iii) pre-clinical expenses of $0.9 million.
+Added: These decreases were offset by an increase of $0.3 million
+Added: in CMC expenses and an increase of $0.1 million in stock-based compensation expense and $0.2 million in wages related to our research
+Added: and development personnel.
and Administrative Expenses
1 unchanged sentence
for the year ended December 31, 2024.
−Removed: The change in general and administrative expenses was primarily due to a decrease of $0.2 million
−Removed: in investor relations, a decrease of $0.4 million in insurance, and a decrease of $0.1 million in stock-based compensation expense related
−Removed: to our general and administrative personnel.
−Removed: These decreases were offset by an increase in wages of $0.4 million, an increase in $0.1
−Removed: million in general corporate, and an increase of $0.1 million in director remuneration.
−Removed: expense decreased by $2,821, or 17%, to $13,684 for the year ended December 31, 2024 from $16,505 for the year ended December 31, 2023.
−Removed: The decrease in interest expense was primarily related to the decrease in D&O insurance premium financing liability.
−Removed: income increased by $97,277, or 64%, to $249,908 for the year ended December 31, 2024 from $152,631 for year ended December 31, 2023.
−Removed: The increase in interest income was primarily due to the increase in cash from the June 2024 and December 2024 PIPE Offerings as well
−Removed: as a higher balance toward the end of 2023 which existed for most of 2024
+Added: The change in general and administrative expenses was primarily due to increases of (i) $7.3 million
+Added: in general and administrative personnel expenses including bonuses, (ii) $1.5 million in investor relations, (iii) $2.0 million in stock-based
+Added: compensation expense related to our general and administrative personnel (iv) $0.2 million in public company expenses, and (v) $0.1 million
+Added: in other general corporate.
+Added: These increases were offset by a decrease in professional fees of $0.2 million.
+Added: expense increased by $14,661, or 107%, to $28,345 for the year ended December 31, 2025 from $13,684 for the year ended December 31, 2024.
+Added: The increase in interest expense was primarily related to the director and officer insurance premium financing liability as well as a
+Added: note payable which was fully paid as of December 31, 2025.
+Added: income decreased by approximately $0.2 million, or 83%, to less than $0.1 million for the year ended December 31, 2025 from $0.3 million
+Added: for year ended December 31, 2024.
+Added: The decrease in interest income was primarily due to the decrease in cash during 2025 and a decrease
+Added: in interest rates.
+Added: Loss from Digital Assets Holdings
+Added: loss from digital assets holdings increased to $22.0 million for the year ended December 31, 2025 from $0 for year ended December 31,
+Added: This was the result of the contribution of digital assets from the Cryptocurrency Offering in November 2025 and subsequent digital
+Added: asset purchases, where the reference price of CC as of December 31, 2025 was less than the weighted average cost of our CC holdings.
and Capital Resources
4 unchanged sentences
net cash used in operating activities, and had an accumulated deficit of approximately $72.8 million as of December 31, 2025.
−Removed: December 31, 2024, we have primarily financed our operations through public and private offerings of our equity securities.
−Removed: net proceeds from our initial public offering (“IPO”) on January 14, 2022 of approximately $12.5 million.
−Removed: Additionally, we
−Removed: closed the May 2023 Offering and November 2023 Offering, public offerings with net proceeds of approximately $2.1 million and $8.7 million,
−Removed: respectively.
−Removed: the year ended December 31, 2024, we raised gross proceeds of $83,688 pursuant to the ATM Agreement from the sale of 40,000 shares of
−Removed: our common stock at an average price of $2.0892 per share.
−Removed: The net proceeds from the ATM Sale during the year ended December 31, 2024
−Removed: were $73,189, after deducting sales agent commissions of $2,507 and other fees of $7,992.
−Removed: Further, on June 17, 2024 and December 9, 2024, we closed private placement offerings (the “June 2024 PIPE Offering”
−Removed: and “December 2024 PIPE Offering”) with certain accredited investors, consisting of offerings of shares of our common stock
−Removed: and/or pre-funded warrants to acquire shares of our common stock and warrants to acquire shares of our common stock, with combined net
−Removed: proceeds of approximately $3.6 million.
−Removed: The shares of our common stock began trading on The Nasdaq Capital Market on January 12, 2022
−Removed: under the ticker symbol “HILS” and effective as of September 25, 2023, are traded under the ticker symbol “THAR.”
−Removed: on our limited operating history, recurring negative cash flows from operations, current plans and available resources, we will need
−Removed: substantial additional funding to support future operating activities.
−Removed: We have concluded that the prevailing conditions and ongoing liquidity
−Removed: risks faced by us raise substantial doubt about our ability to continue as a going concern for at least one year following the date these
−Removed: consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued.
−Removed: The accompanying consolidated financial
−Removed: statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.
−Removed: may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships, grants
−Removed: or other arrangements or a combination of the foregoing to support our future operations;
−Removed: however, there can be no assurance that we
−Removed: will be able to obtain additional capital on terms acceptable to us, on a timely basis, or at all.
−Removed: The failure to obtain sufficient additional
−Removed: funding could adversely affect our ability to achieve our business objectives and product development timelines and may result in delaying
−Removed: or terminating clinical trial activities which could have a material adverse effect on our results of operations.
+Added: December 31, 2025, we have primarily financed operations through public and private offerings of equity securities.
+Added: the year ended December 31, 2024, we sold 203,359 shares of our common stock pursuant to the 2024 ATM Agreement for net proceeds of approximately
+Added: $0.3 million, after deducting commissions of $15,506 and other offering fees of $41,952.
+Added: During the year ended December 31, 2025, we
+Added: sold 1,657,799 shares of our common stock pursuant to the 2025 ATM Agreement for net proceeds of approximately $5.1 million, after deducting
+Added: commissions of approximately $0.1 million.
+Added: on June 17, 2024, December 9, 2024, June 13, 2025, and July 25, 2025, we closed private placement offerings (the “June 2024 PIPE
+Added: Offering,” “December 2024 PIPE Offering,” “June 2025 PIPE Offering,” and the “July 2025 PIPE Offering,”
+Added: respectively) with certain accredited investors, consisting of shares of our common stock and/or pre-funded warrants to acquire shares
+Added: of our common stock and common warrants to acquire shares of our common stock.
+Added: The combined net proceeds received from these offerings
+Added: was approximately $7.0 million.
+Added: addition, on July 23, 2025 and August 26, 2025, we closed registered direct public offerings (the “July 2025 Direct Offering”
+Added: and the “August 2025 Direct Offering”) with certain investors, consisting of shares of our common stock and/or pre-funded
+Added: warrants to acquire shares of our common stock and common warrants to acquire shares of our common stock, with combined net proceeds
+Added: of approximately $6.3 million.
+Added: November 2025, we closed the Cash Offering for net proceeds of approximately $90.9 million in cash and the Cryptocurrency Offering for
+Added: net proceeds of approximately $446.2 million in cryptocurrency.
+Added: the prior reporting period, we identified certain conditions that raised substantial doubt about our ability to continue as a going concern.
+Added: These conditions included our limited operating history, recurring operating losses, and recurring negative cash flows from operations
+Added: as described above.
+Added: However, on November 3, 2025, we raised net proceeds of over $537 million through a private placement offering.
+Added: a result, we believe we now have sufficient liquidity to fund anticipated cash requirements for operations and working capital purposes
+Added: through at least March 2027.
+Added: As a result, the previously disclosed going concern uncertainty language has been removed as substantial
+Added: doubt no longer exists regarding our ability to continue as a going concern.
Flow Activities for the Years Ended December 31, 2025 and 2024
following table sets forth a summary of our cash flows for the periods presented.
−Removed: Ended December 31,
+Added: Year Ended December 31,
Net cash used in operating activities
1 unchanged sentence
$ (10,901,991 )
+Added: Net cash used in investing activities
+Added: (77,572,567 )
Net cash provided by financing activities
−Removed: Net (decrease) increase in cash
+Added: Net increase (decrease) in cash
$ (7,375,991 )
1 unchanged sentence
used in operating activities for the year ended December 31, 2025 was $16.0 million which consisted of net loss of $42.1 million, partially
−Removed: offset by non-cash stock-based compensation of approximately $0.7 million, non-cash stock issuance pursuant to a services agreement of
−Removed: less than $0.1 million, and net changes in operating assets and liabilities of approximately $0.6 million.
+Added: offset by non-cash stock-based compensation of approximately $2.9 million, unrealized loss from digital asset holdings of approximately
+Added: $22.0 million, write-off of deferred offering costs of $0.1 million, and net changes in operating assets and liabilities of approximately
+Added: $1.1 million.
used in operating activities for the year ended December 31, 2024 was $10.9 million which consisted of net loss of $12.2 million, partially
offset by non-cash stock-based compensation of approximately $0.7 million, non-cash stock issuance pursuant to a services agreement of
−Removed: approximately $0.4 million, and net changes in operating assets and liabilities of approximately $0.8 million.
+Added: less than $0.1 million, and net changes in operating assets and liabilities of approximately $0.6 million.
+Added: Flows from Investing Activities
+Added: used in investing activities for the year ended December 31, 2025 was $77.6 million, representing the purchase of digital assets.
+Added: were no cash flows from investing activities during the year ended December 31, 2024.
Flows from Financing Activities
1 unchanged sentence
The net increase in financing activities was
−Removed: due to proceeds from the PIPE Offerings of $4.1 million, proceeds from the ATM Sale of $0.1 million and insurance premium financing
−Removed: liability of $0.4 million, offset by payments of deferred offering costs of $0.7 million and repayments of insurance premium financing
−Removed: liability of $0.4 million.
+Added: due to proceeds from the Cash Offering of $99.4 million, proceeds from the PIPE offerings of $3.7 million, proceeds from the registered
+Added: direct public offerings of $7.1 million, proceeds from the ATM offerings of $5.5 million, proceeds from the exercise of warrants of $1.5
+Added: million and proceeds from option exercises of $0.2 million.
+Added: These increases were offset by payments of deferred offering and other issuance
+Added: costs of $10.0 million and repayment of note payable of $0.2 million.
provided by financing activities for the year ended December 31, 2024 was $3.5 million.
The net increase in financing activities was
−Removed: from net cash proceeds of $12.2 million from the issuance of our common stock in connection with public offerings and $0.7 million in
−Removed: proceeds received from insurance premium financing liability offset by deferred offering costs of $0.5 million and $0.7 million in repayments
−Removed: of insurance premium financing liability.
+Added: due to proceeds from the PIPE Offerings of $4.1 million, proceeds from the ATM Sale of $0.1 million and insurance premium financing liability
+Added: of $0.4 million, offset by payments of deferred offering costs of $0.7 million and repayments of insurance premium financing liability
+Added: of $0.4 million.
May 24, 2024, the Company effectuated an additional reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an
14 unchanged sentences
and management must select an amount that falls within that range of reasonable estimates.
−Removed: Estimates are used in the following areas,
−Removed: among others:
−Removed: research and development expense recognition, stock-based compensation, allowances of deferred tax assets, and cash flow
−Removed: assumptions regarding going concern considerations.
−Removed: Although management believes the estimates that have been used are reasonable, actual
−Removed: results could vary from the estimates that were used.
+Added: We consider the following areas to be our
+Added: critical accounting estimate:
+Added: fair value of digital assets, research and development expense recognition, stock-based compensation, allowances
+Added: of deferred tax assets, and cash flow assumptions regarding going concern considerations.
+Added: Although management believes the estimates
+Added: that have been used are reasonable, actual results could vary from the estimates that were used.
Accounting Policies
+Added: account for digital assets, which are comprised of CC, as indefinite-lived intangible assets in accordance with Financial Accounting
+Added: Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 350-60, Intangibles—Goodwill and
+Added: Other-Crypto Assets .
+Added: Our digital assets are initially recorded at cost.
+Added: Subsequently, they are measured at fair value with the gain
+Added: or loss associated with remeasurement of the digital assets recognized in net income (loss) during each reporting period.
+Added: Upon disposal
+Added: of a digital asset (e.g., by sale, exchange or transfer), we derecognize the asset and recognize a realized gain or loss in net income,
+Added: calculated as the difference between the sale proceeds and the asset’s carrying amount.
+Added: fair value of the digital assets is determined based on the quoted price in its principal market at the time of measurement.
+Added: its principal market as the market that it has access to and has the greatest volume and level or orderly transactions in accordance
+Added: with FASB ASC 820, Fair Value Measurement .
+Added: We track the cost of its digital assets using the first-in-first-out (FIFO) method.
and development
11 unchanged sentences
recognize compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense
−Removed: in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each
−Removed: stock-based award.
−Removed: The fair value of each option grant to employees, non-employees and directors is estimated as of the date of grant
−Removed: using the Black-Scholes option-pricing model, net of actual forfeitures.
−Removed: The fair value is amortized as compensation cost on a straight-line
−Removed: basis over the requisite service period of the awards, which is generally the vesting period.
+Added: in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock-based
+Added: The fair value of each option grant to employees, non-employees and directors is estimated as of the date of grant using the Black-Scholes
+Added: option-pricing model, net of actual forfeitures.
+Added: The fair value is amortized as compensation cost on a straight-line basis over the requisite
+Added: service period of the awards, which is generally the vesting period.
fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model.
35 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.