17 unchanged sentences
addition, unless the context otherwise requires and for the purposes of this Report only:
−Removed: “ Exchange Act ”
−Removed: refers to the Securities Exchange Act of 1934, as amended;
+Added: Act ” refers to the Securities Exchange Act of 1934, as amended;
Act ” refers to the Securities Act of 1933, as amended.
9 unchanged sentences
Results of Operations .
−Removed: An analysis of our financial results comparing the three months ended March 31, 2026 and 2025.
+Added: An analysis of our financial results comparing the three and six months ended June 30, 2026 and 2025.
Critical Accounting
1 unchanged sentence
in our reported financial results and forecasts.
−Removed: July 25, 2024, we acquired a wholly-owned subsidiary, Scienture LLC.
−Removed: Scienture LLC is a specialty pharmaceutical company focused on the
−Removed: commercialization and development of products for the treatment of Cardiovascular (“ CVS ”) and Central Nervous
−Removed: System (“ CNS ”) diseases.
−Removed: Scienture LLC launched its first commercial product for hypertension and is in the process
−Removed: of commercializing its second product for the treatment of opioid overdose.
−Removed: Its development pipeline consists of a broad range of novel
−Removed: product candidates including new potential treatments for migraine, thrombosis, pain and other related disorders.
−Removed: Scienture LLC’s
−Removed: mission is to bring to market innovative technology-based products to address unmet medical needs.
−Removed: Its targeted portfolio consists of
−Removed: short term and long-term opportunities with efficient development, regulatory, and go to market strategies.
−Removed: our acquisition of Scienture, we existed as a holding company owning all equity interests of Softell Inc.
−Removed: (f/k/a Trxade Inc.) (“ Softell ”),
−Removed: Integra Pharma Solutions, LLC d.b.a.
−Removed: Trxade Prime (“ IPS ”), Bonum Health, LLC, Bonum Health Inc., and Scienture.
−Removed: October 4, 2024, the Company and Softell entered into IPS Assignment Agreement, pursuant to which the Company transferred, and Softell
−Removed: accepted, 100% of the membership interests of IPS.
−Removed: As a result, IPS became a wholly-owned subsidiary of Softell.
−Removed: During the year ended
−Removed: December 31, 2023 and a portion of the quarter ended March 31, 2024, Softell, operated a web-based market platform that enabled commerce
−Removed: among healthcare buyers and sellers of pharmaceuticals, accessories and services.
−Removed: Softell’s current primary operations are conducted
−Removed: IPS is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to customers.
−Removed: IPS’ customers
−Removed: include all healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide.
−Removed: September 20, 2024, the Company fil changed its legal name from “TRxADE HEALTH, Inc.” to “Scienture Holdings, Inc.”
−Removed: Bonum Health, LLC was formed to hold certain telehealth assets acquired in October 2019.
−Removed: The “Bonum Health Hub” was launched
−Removed: in February 2020;
−Removed: however, the Company does not anticipate installations moving forward.
−Removed: On April 30, 2025, the Company completed the
−Removed: sale of Bonum Health, Inc.
−Removed: and Bonum Health, LLC.
−Removed: of Legacy Subsidiaries
−Removed: April 8, 2025, the Company entered into a Membership Interest Purchase Agreement (the “ IPS MIPA ”) with Tollo
−Removed: Health, LLC (“ Tollo ”), pursuant to which Tollo agreed to purchase and the Company agreed to sell all of the
−Removed: Company’s membership interests in IPS.
−Removed: April 8, 2025, the Company also entered into a Stock Purchase Agreement (the “ Bonum and Softell SPA ” and together
−Removed: with the IPS MIPA, the “ Agreements ”) with Tollo, pursuant to which Tollo agreed to purchase and the Company
−Removed: agreed to sell all issued and outstanding shares of common stock of Bonum Health, Inc.
−Removed: Suren Ajjarapu, the Company’s
−Removed: former Chief Executive Officer, and Prashant Patel, the Company’s former President and Chief Operating Officer, each had a beneficial
−Removed: interest in Tollo at the time the Company entered into the each of the Agreements.
−Removed: connection with each of the Agreements, the Company agreed to retain certain excluded liabilities of IPS, Softell and Bonum Health, Inc.
−Removed: including all liabilities:
−Removed: (i) related to, in connection with or arising out of any claims, charges, complaints, actions, suits, settlements,
−Removed: hearings, investigations, proceedings, or governmental or regulatory inquiries with respect to IPS, Softell or Bonum Health, Inc., respectively,
−Removed: prior to the closing under the applicable Agreement;
−Removed: (ii) related to, in connection with or arising out of any breach by the Company
−Removed: of the applicable Agreement or any other agreements and documents required to be delivered by the Company;
−Removed: (iii) not disclosed by the
−Removed: Company in accordance with each Agreement;
−Removed: (iv) related to any actions threatened or initiated by a governmental entity against IPS,
−Removed: Softell, or Bonum Health, Inc., respectively;
−Removed: and (v) related to tax returns or tax matters of the Company, IPS, Softell, or Bonum Health,
−Removed: Inc., respectively, for any periods prior to closing under the applicable Agreement.
−Removed: Company and Tollo consummated the closing of each of the Agreements on April 30, 2025.
−Removed: As consideration for acquiring IPS, Softell, and
−Removed: Bonum Health, Inc., Tollo agreed to pay the Company $5 million, with that consideration delivered in the form of a promissory note bearing
−Removed: interest at the prime rate.
−Removed: The promissory note matures on June 30, 2030.
−Removed: However, Tollo is required to pay 20% of the proceeds of a
−Removed: future equity financing toward repayment of the principal and accrued but unpaid interest owed under the promissory note.
−Removed: 2025, the promissory note was assigned to Integral Health, Inc., which (at the time of the assignment) was owned by Suren Ajjarapu, the
−Removed: Company’s former Chief Executive Officer, and Prashant Patel, the Company’s former President and Chief Operating Officer.
−Removed: divestitures are part of a broader strategic realignment at the Company designed to sharpen operational focus and unlock long-term value.
−Removed: It is aligned with the Company’s commitment to streamline its core operations, optimize its portfolio, and accelerate growth in
+Added: with our wholly-owned subsidiary, Scienture, LLC, which we acquired on July 25, 2024, we are a Commack, New York based specialty
+Added: pharmaceutical company focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to
+Added: market, and distributing novel specialty pharmaceutical products to satisfy unmet market needs.
+Added: We are particularly focused on the
+Added: commercialization and development of products for the treatment of Cardiovascular (“ CVS ”) and Central
+Added: Nervous System (“ CNS ”) diseases as well as a broad range of novel product candidates including new
+Added: potential treatments for hypertension, migraine, pain and thrombosis and other related disorders.
+Added: To date, we have launched
+Added: ARBLI™, a commercial product for the treatment of hypertension, and we are in the process of commercializing a second product,
+Added: REZENOPY™, for the treatment of opioid overdose.
+Added: Our development pipeline consists of a broad range of novel product
+Added: candidates including new potential treatments for migraine, thrombosis, pain and other related disorders.
+Added: Our mission is to bring to
+Added: market innovative technology-based products to address unmet medical needs.
+Added: We target a diversified portfolio of short- and
+Added: long-term opportunities with efficient development, regulatory, and go to market strategies.
+Added: connection with our $11 million financing facility with Streeterville that we established in April 2026, we formed a wholly owned subsidiary—SCNX
+Added: Holdings, LLC (“ SCNX Sub ”).
+Added: SCNX Sub exists solely in connection with the financing facility and has no operations.
+Added: At closing of the financing facility, Streeterville paid deposited $3 million into a bank account held by SCNX Sub, which is secured
+Added: pursuant to a deposit account control agreement among SCNX Sub, Streeterville, and the bank.
+Added: the year ended December 31, We previously were known as TRxADE HEALTH, Inc.
+Added: and operated a web-based market platform focused on enhancing
+Added: commerce among healthcare participants, a licensed pharmaceutical wholesaler, and a digital telehealth company, through our ownership
+Added: of Softell Inc.
+Added: (f/k/a Trxade Inc.) (“ Softell ”), Integra Pharma Solutions, LLC d.b.a.
+Added: Trxade Prime (“ IPS ”),
+Added: Bonum Health, LLC, and Bonum Health Inc.
+Added: In April 2025, we sold Softell, IPS, and Bonum Health Inc.
+Added: We dissolved Bonum Health Inc.
+Added: November 2025.
+Added: In connection with the acquisition of Scienture, LLC, we changed our legal name to “Scienture Holdings, Inc.”
+Added: The divestiture of these legacy subsidiaries was part of a broader strategic realignment designed to sharpen operational focus and unlock
+Added: long-term value.
+Added: It is aligned with our commitment to streamline our core operations, optimize our portfolio, and accelerate growth in
the Branded and Specialty Pharma markets.
−Removed: The Company intends to use the proceeds obtained from the divestment to facilitate the high-growth
−Removed: commercial and strategic product development activities at its Scienture subsidiary.
−Removed: Company believes that the key benefits of the divestitures include:
−Removed: Operational Efficiency :
−Removed: Streamlining the Company’s structure aimed at strengthening its balance sheet, providing
−Removed: for leaner operations and a more agile decision-making framework.
−Removed: Consolidating overlapping functions and eliminating redundancies intended to cause annualized cost savings.
−Removed: Affording the full focus and deployment of resources to the commercial products and the high value product pipeline
−Removed: in development at its Scienture subsidiary.
−Removed: to the disposition of IPS, Softell, and Bonum Health, Inc.
−Removed: we now exist as a holding company for existing and planned pharmaceutical
−Removed: operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market,
−Removed: and distributing novel specialty pharmaceutical products to satisfy unmet market needs.
−Removed: We are in the process of winding down our Bonum
−Removed: Health, LLC subsidiary.
−Removed: since 2019, Scienture, located in Commack, New York, is a specialty pharmaceutical company focused providing enhanced value to
−Removed: patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs.
−Removed: In this regard, Scienture is
−Removed: in the process of developing and commercializing products for the treatment of CNS and CVS diseases as well as a broad range of novel product candidates including new potential treatments
−Removed: for hypertension, migraine, pain and thrombosis and other related disorders.
−Removed: vision is to be a leader in the industry by developing and commercializing new medicines for the treatment of CNS and CVS diseases and
+Added: vision is to be a leader in the industry by developing and commercializing new branded pharmaceutical products for the treatment of CNS and CVS diseases and
across other therapeutic areas.
−Removed: Key elements of Scienture’s strategy to achieve this vision include:
−Removed: product candidates through clinical studies and toward commercialization.
−Removed: Scienture is in various stages of clinical development
−Removed: for the product candidates in its pipeline, and it intends to move these programs efficiently toward being commercially available
−Removed: to patients, subject to approval by the U.S.
+Added: Key elements of our strategy to achieve this vision include:
+Added: Advance product candidates
+Added: through clinical studies and toward commercialization.
+Added: The product candidates in our pipeline are at various stages of clinical development.
+Added: We intend to move these programs efficiently toward being commercially available to patients, subject
+Added: to approval by the U.S.
Food and Drug Administration (the “ FDA ”).
−Removed: growth and profitability.
−Removed: Using dedicated sales and marketing resources in the U.S., which Scienture is in the process of building,
−Removed: Scienture will seek to begin to generate revenues and then drive the revenue growth of its product candidates approved for marketing
+Added: Drive growth and profitability.
+Added: Using dedicated sales and marketing resources in the U.S., which we are in the process of building, we will seek to
+Added: begin to generate revenues and then drive the revenue growth of our product candidates approved for marketing by the FDA.
to grow pipeline.
−Removed: Scienture will continue to evaluate and seek to develop additional product candidates that it believes have significant
−Removed: commercial potential through Scienture’s internal research and development efforts.
−Removed: strategic business development opportunities.
−Removed: Scienture is exploring a broad range of strategic opportunities.
−Removed: This may include in-licensing
−Removed: products and entering into co-promotion and co-development partnerships for Scienture’s product candidates, although no agreements
−Removed: have been reached.
−Removed: currently has four primary product candidates in its development pipeline, summarized below, and is engaged in a variety of research
+Added: We will continue to evaluate commercial product acquisition opportunities and seek to develop additional
+Added: product candidates that we believe have significant commercial potential through our internal research and
+Added: development efforts.
+Added: Target strategic business
+Added: development opportunities.
+Added: We are exploring a broad range of strategic opportunities.
+Added: This may include in-licensing products
+Added: and entering into co-promotion and co-development partnerships for our product candidates, although no agreements have
+Added: been reached.
+Added: currently has two commercial products that have been launched and three primary product candidates in our development pipeline, summarized below, and are engaged in a variety of research
and development efforts to develop novel product candidates for the treatment of various disease conditions.
−Removed: To date, Scienture has
−Removed: generated limited revenue from product sales and will not generate meaningful revenues until it fully commercializes its
−Removed: FDA-approved product candidate (SCN-102) and successfully obtains regulatory approval for, and commercializes, its other product
−Removed: The progress of Scienture products its development pipeline to date is represented by the green bars shown
−Removed: has devoted and will continue to devote significant resources to research and development activities, and expects to incur significant
−Removed: expenses as Scienture continues advancing its product candidates towards FDA approval and expanding product indications for approved
−Removed: products and its intellectual property portfolio.
−Removed: Scienture’s expectations regarding its research and development programs are
−Removed: subject to risks, including the risk that Scienture’s financial condition and results of operations may be materially and adversely
−Removed: affected by delays and failures in the completion of clinical development of its product candidates, which could increase its costs or
−Removed: delay or limit our ability to generate revenues.
−Removed: currently depends on third-party commercial manufacturing organizations (“ CMOs ”) for its manufacturing operations,
−Removed: including the production of raw materials, finished dosage form product, and product packaging for both its planned product commercialization
−Removed: and for use in its preclinical and clinical research.
−Removed: Scienture does not own or operate manufacturing facilities for the production of
−Removed: any of its product candidates nor does Scienture have plans to develop its own manufacturing operations in the foreseeable future to
+Added: To date, we have generated
+Added: limited revenue from product sales and will not generate meaningful revenues until we fully commercializes our FDA-approved product candidates
+Added: (Arbli ™ and REZENOPY ™ ) and successfully obtain regulatory approval for, and commercialize, our other product candidates.
+Added: The progress of our
+Added: products in our development pipeline to date is represented by the green bars shown below.
+Added: have devoted and will continue to devote significant resources to sales and marketing of our commercial products and research and
+Added: development activities, and expects to incur significant expenses as we continue advancing our product candidates
+Added: towards FDA approval and expanding product indications for approved products and our intellectual property portfolio.
+Added: Our expectations regarding our research and development programs are subject to risks, including the risk that
+Added: our financial condition and results of operations may be materially and adversely affected by delays and failures in
+Added: the completion of clinical development of our product candidates, which could increase costs or delay or limit our ability to
+Added: generate revenues.
+Added: currently depend on third-party commercial manufacturing organizations (“ CMOs ”) for our manufacturing operations,
+Added: including the production of raw materials, finished dosage form product, and product packaging for both our planned product commercialization
+Added: and for use in our preclinical and clinical research.
+Added: We do not own or operate manufacturing facilities for the production of
+Added: any of our product candidates nor do we have plans to develop such manufacturing operations in the foreseeable future to
support clinical trials or commercial production.
−Removed: Scienture currently employs internal resources to manage its manufacturing contractors.
−Removed: is in discussion with CMOs headquartered in North America, Europe and Asia for its pipeline product candidates.
+Added: We currently employs internal resources to manage our manufacturing contractors.
+Added: We are in discussion with CMOs headquartered in North America, Europe and Asia for our pipeline product candidates.
These CMOs offer a comprehensive
range of commercial contract manufacturing and packaging services.
−Removed: Scienture fails to produce its products and product candidates in the volumes that it requires on a timely basis, or fails to comply
−Removed: with stringent regulations applicable to pharmaceutical drug manufacturers, Scienture may face delays in the development and commercialization
−Removed: of its products and product candidates or be required to withdraw its products from the market for risks associated with
−Removed: manufacturing and supply of its products and product candidates.
−Removed: (ARBLI TM - Losartan Oral Suspension)
−Removed: with the brand name Arbli TM , is an oral liquid formulation of losartan potassium for (i) treatment of hypertension, to lower
+Added: we fail to produce our products and product candidates in the volumes that we require on a timely basis, or fail to comply
+Added: with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization
+Added: of our products and product candidates or be required to withdraw our products from the market for risks associated with
+Added: manufacturing and supply of our products and product candidates.
+Added: (ARBLI ™ - Losartan Oral Suspension)
+Added: with the brand name Arbli ™ , is an oral liquid formulation of losartan potassium for (i) treatment of hypertension, to lower
blood pressure in adults and children greater than 6 years old, (ii) reduction of the risk of stroke in patients with hypertension and
9 unchanged sentences
and has reduced dosing volume and long-term shelf life at room temperature storage.
−Removed: has two formulation composition and method of use patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence
+Added: has three formulation composition and method of use patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly referred to as the “orange book”:
5 unchanged sentences
2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”.
−Removed: SCN-102 also has a third patent titled “LOSARTAN LIQUID FORMULATION AND METHODS OF USE” that was issued
−Removed: on April 21, 2026, and expires on October 7, 2041.
−Removed: SCN-110 (REZENOPY TM – Naloxone HCl Nasal Spray)
−Removed: LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with Summit Biosciences Inc.,
−Removed: a wholly-owned subsidiary of Kindeva, on March 4, 2025, pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable,
−Removed: non-sublicensable right and license to commercialize REZENOPY TM (Nalaxone HCI nasal spray 10mg/0.11mL) within the United States
−Removed: and its territories.
−Removed: Scienture LLC intends to use the exclusive right and license to price, launch, promote, market, distribute, and educate
−Removed: the public on REZENOPY TM .
−Removed: Approved by the FDA in 1971, naloxone
−Removed: is considered the standard of care and has been shown to be effective in opioid overdose reversals.
−Removed: The opioid overdose reversal market
−Removed: (specifically for naloxone-based products) includes several branded and generic products across nasal spray, auto-injector, and injectable
−Removed: formulations.
−Removed: Most growth in recent years has been in intranasal products, such as Narcan 4mg, RiVive 3mg and Kloxxado 8mg, which are
−Removed: needle free and easier for bystanders and community responders to use.
−Removed: Real world studies suggest the need for multiple naloxone administrations
−Removed: (“MNA”) using these products among bystanders and EMS providers continues to increase.
−Removed: With the increase of synthetic opioids
−Removed: and the rapid onset of effect, evidence is emerging suggesting the need for increased doses of naloxone to reverse opioid toxicity.
−Removed: (Naloxone HCl Nasal Spray, 10mg) is the highest FDA-approved nasal spray dose available in the U.S.
+Added: SCN-102 also has a third patent titled “LOSARTAN LIQUID
+Added: FORMULATION AND METHODS OF USE” that was issued on April 21, 2026, and expires on October 7, 2041.
+Added: (REZENOPY ™ – Naloxone HCl Nasal Spray)
+Added: March 4, 2025, Scienture, LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with
+Added: Summit Biosciences Inc., a wholly-owned subsidiary of Kindeva, pursuant to which Kindeva granted us an
+Added: exclusive, non-transferrable, non-sublicensable right and license to commercialize REZENOPY TM (Nalaxone hydrochloride nasal spray
+Added: 10mg/0.11mL) within the United States and its territories.
+Added: We intend to use the exclusive right and license to price,
+Added: launch, promote, market, distribute, and educate the public on REZENOPY TM .
+Added: by the FDA in 1971, naloxone is considered the standard of care and has been shown to be effective in opioid overdose reversals.
+Added: opioid overdose reversal market (specifically for naloxone-based products) includes several branded and generic products across nasal
+Added: spray, auto-injector, and injectable formulations.
+Added: Most growth in recent years has been in intranasal products, such as Narcan 4mg, RiVive
+Added: 3mg and Kloxxado 8mg, which are needle free and easier for bystanders and community responders to use.
+Added: Real world studies suggest the
+Added: need for multiple naloxone administrations (“MNA”) using these products among bystanders and EMS providers continues to increase.
+Added: With the increase of synthetic opioids and the rapid onset of effect, evidence is emerging suggesting the need for increased doses of
+Added: naloxone to reverse opioid toxicity.
+Added: (Naloxone hydrochloride Nasal Spray, 10mg) is the highest FDA-approved nasal spray dose available in the U.S.
The product provides maximum
1 unchanged sentence
stabilization in emergency situations.
−Removed: REZENOPY TM provides potential longer duration of opioid receptor block, improves chances
+Added: REZENOPY ™ provides potential longer duration of opioid receptor block, improves chances
of quicker reversal and possible coverage against multiple abuse agents inclusive of synthetic opioids and combinations, through a single
2 unchanged sentences
and reducing the requirement of MNA.
−Removed: has one issued formulation composition and method of use patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence
+Added: has two issued formulation composition and method of use patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly referred to as the “orange book”:
(i) Patent #:
−Removed: 12,514,854 B2, Issue Date:
+Added: 12,514,854, Issue Date:
January 6, 2026, an Orange
Book-listable patent, titled “DRUG PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF”, Expiration Date:
+Added: 2041 and (ii) Patent #:
+Added: 12,622,903, Issue Date:
+Added: June 2, 2026, an Orange Book-listable patent, titled “DRUG PRODUCTS
+Added: FOR INTRANASAL ADMINISTRATION AND USES THEREOF”, Expiration Date:
+Added: February 5, 2041.
(Multi-dose Dihydroergotamine Mesylate (“ DHE ”) injection pen)
24 unchanged sentences
to have no toxicological significance across hematology, coagulation parameters, clinical chemistry and urinalysis.
−Removed: has had discussions with the FDA regarding its development program for SCN-104, with the FDA indicating that the reference product selected
−Removed: for a comparative regulatory study and proposed plan for manufacturing New Drug Application registration batches are acceptable.
−Removed: FDA also provided Scienture with feedback on nonclinical safety studies and stability testing.
−Removed: Scienture is working to scale the formulation
−Removed: to enable future commercial scale production and the pen has been optimized for commercial use.
−Removed: Currently, Scienture is focused on planning
−Removed: bioequivalence studies and increasing manufacturing activities for the SCN-104 injection pen.
−Removed: Scienture plans to initiate a Phase 1 single
−Removed: dose study in healthy adults in 2026, following submission of an Investigational New Drug application (an “ IND ”),
−Removed: if the IND is cleared by the FDA.
+Added: have had discussions with the FDA regarding the development program for SCN-104, with the FDA indicating that the reference product
+Added: selected for a comparative regulatory study and proposed plan for manufacturing New Drug Application registration batches are
+Added: The FDA also provided us with feedback on nonclinical safety studies and stability testing.
+Added: We are working to scale the
+Added: formulation to enable future commercial scale production and the pen has been optimized for commercial use.
+Added: Currently, we are
+Added: focused on planning bioequivalence studies and increasing manufacturing activities for the SCN-104 injection pen.
+Added: initiate a Phase 1 single dose study in healthy adults in early 2027, following submission of an Investigational New Drug application (an
+Added: “ IND ”), if the IND is cleared by the FDA.
has a formulation composition and method of use application pending in the U.S.
2 unchanged sentences
(Potential Biosimilar)
−Removed: is developing a potential biosimilar, SCN-106, based on Cathflo Activase, a reference product that is a thrombolytic agent that binds
+Added: We are developing a potential biosimilar, SCN-106, based on Cathflo Activase, a reference product that is a thrombolytic agent that binds
to fibrin in clots and converts entrapped plasminogen to plasmin.
1 unchanged sentence
the complementary DNA for natural human tPA obtained from a Chinese hamster ovary cell-line.
−Removed: is working with Anthem Biosciences Pvt, Ltd.
−Removed: to develop a biosimilar product that utilizes the same mechanism(s) of action for the proposed
−Removed: condition of use, and has the same route of administration, dosage form, and strength as the reference product.
−Removed: The development program
−Removed: is focused on establishing the analytical similarity of SCN-106 to the reference product.
−Removed: Multiple clones of CHO cells have been produced
−Removed: to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key biochemical quality attributes
−Removed: as well as overall protein yield and finalization of a lead clone.
+Added: Specifically,
+Added: we are working with Anthem Biosciences Pvt, Ltd.
+Added: to develop a biosimilar product that utilizes the same mechanism(s) of action for
+Added: the proposed condition of use, and has the same route of administration, dosage form, and strength as the reference product.
+Added: development program is focused on establishing the analytical similarity of SCN-106 to the reference product.
+Added: Multiple clones of CHO
+Added: cells have been produced to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key
+Added: biochemical quality attributes as well as overall protein yield and finalization of a lead clone.
completed a Biosimilar Initial Advisory meeting with the FDA in June 2023 to discuss the CMC, non-clinical, and clinical studies required
for regulatory approval.
−Removed: As a result of this meeting, Scienture learned that its analytical strategy for initiating analytical similarity
+Added: As a result of this meeting, we learned that our analytical strategy for initiating analytical similarity
studies between SCN-106 and a proposed biosimilar product is acceptable.
−Removed: Scienture also learned that SCN-106 is suitable for further
+Added: We also learned that SCN-106 is suitable for further
development and received guidance from the FDA on a comparable clinical study needed to demonstrate biosimilarity of SCN-106 and the
reference product.
−Removed: In this regard, Scienture was informed that no additional safety, PK, toxicology or dose range finding studies will
+Added: In this regard, we were informed that no additional safety, PK, toxicology or dose range finding studies will
be required due to the method of use (very limited exposure) and the availability of an extensive amount of data on the original brand
1 unchanged sentence
are no clinically meaningful differences between SCN-106 and the currently marketed product.
−Removed: is a potential biosimilar and considered by the Company to be part of its product development portfolio, however the Company is not pursuing
+Added: is a potential biosimilar and considered by to be part of our product development portfolio, however we are not pursuing
patent protection for this product.
1 unchanged sentence
is a long-acting injection suspension formulation of a non-opioid analgesic that is indicated for postsurgical local and regional analgesia.
−Removed: Scienture’s long-acting formulation, SCN-107, is a novel microsphere-based formulation of bupivacaine that comprises the drug in
+Added: Our long-acting formulation, SCN-107, is a novel microsphere-based formulation of bupivacaine that comprises the drug in
polymer-based microspheres and is intended to provide pain management over a period of 5-7 days.
1 unchanged sentence
potentially provide longer term post-surgical pain relief compared to the currently available products in the market.
−Removed: on initial discussions with FDA regarding this program, Scienture believes this product candidate would require at least one Phase 3
+Added: on initial discussions with FDA regarding this program, we believe this product candidate would require at least one Phase 3
clinical trial to support submission of a marketing application.
−Removed: Scienture anticipates submitting an IND and, if cleared by the FDA,
−Removed: initiating a Phase 1 single dose study in healthy adults in 2025 to conduct an initial assessment of safety and tolerability of SCN-107.
−Removed: has entered into Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies, B.V.
−Removed: (“ Innocore ”),
−Removed: as amended on December 2, 2022 (the “ Innocore License ”), for certain intellectual property rights associated
−Removed: with SCN-107.
−Removed: Under the Innocore License, Innocore granted Scienture a worldwide exclusive, milestone, royalty-bearing and sublicensable
−Removed: license to certain patent rights for the research and development of SCN-107 in postsurgical local and regional analgesia.
−Removed: the Innocore License, Scienture is required to make low single-digit percentage royalty payments based on annual net sales of licensed
−Removed: products for the first three years of sales on a country-by-country basis, subject to a low single digit increase as of the fourth year
−Removed: of sales on a country-by-country basis.
+Added: We anticipate submitting an IND in 2027 and, if cleared by the FDA,
+Added: plan to conduct an initial assessment of safety and tolerability of
+Added: LLC previously entered into a Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies, B.V.
+Added: (“ Innocore ”), as amended on December 2, 2022 (the “ Innocore License ”), for
+Added: certain intellectual property rights associated with SCN-107.
+Added: Under the Innocore License, Innocore granted us a worldwide
+Added: exclusive, milestone, royalty-bearing and sublicensable license to certain patent rights for the research and development of SCN-107
+Added: in postsurgical local and regional analgesia.
+Added: Pursuant to the Innocore License, we are required to make low single-digit
+Added: percentage royalty payments based on annual net sales of licensed products for the first three years of sales on a
+Added: country-by-country basis, subject to a low single digit increase as of the fourth year of sales on a country-by-country
has a formulation composition and method of use application pending in the U.S.
3 unchanged sentences
Applications in Canada and Europe are currently pending.
−Removed: As described above, the Company
−Removed: licenses certain patent rights from Innocore for the research and development of SCN-107.
+Added: As described above, we
+Added: license certain patent rights from Innocore for the research and development of SCN-107.
and Capital Resources
−Removed: was $3,542,754 as of March 31, 2026, compared to $6,662,008 as of December 31, 2025.
−Removed: We expect that our future available capital resources
−Removed: will consist primarily of cash generated from Scienture’s operations, remaining cash balances, borrowings, and additional funds
−Removed: raised through sales of debt and/or equity securities.
+Added: was $8,188,140 as of June 30, 2026, compared to $6,662,008 as of December 31, 2025.
+Added: In addition, we held restricted cash of $3,012,271
+Added: as of June 30, 2026, representing proceeds of the B Note held in a lender-controlled deposit account.
+Added: We expect that our future available
+Added: capital resources will consist primarily of cash generated from our operations, remaining cash balances, borrowings, and
+Added: additional funds raised through sales of debt and/or equity securities.
current assets, current liabilities, short term debt and working capital at the end of each period were as follows:
−Removed: $ (3,119,254 )
+Added: June 30, 2026
Current assets (excluding cash)
1 unchanged sentence
Working capital
−Removed: $ (3,210,681 )
principal sources of liquidity have historically been cash provided by operations, sales of business assets and operations from time
4 unchanged sentences
Outlook Cash Explanation
−Removed: primary objectives for the remainder of 2026 are expected to be the continued implementation of Scienture business plan, and to complete
−Removed: potential strategic transactions of our business-to-consumer subsidiaries, which may include a potential sale, spin-off, fund raising,
−Removed: combination or other strategic transaction.
+Added: primary objectives for the remainder of 2026 are expected to be the continued implementation of our business plan.
There can be no assurance that our operations will generate significant positive cash flow,
4 unchanged sentences
Our plan for the next twelve months is to continue exploring
−Removed: strategic transactions or relationships with counterparties in industries that we deem synergistic or complimentary to those of the Company,
−Removed: while also seeking to expand our Scienture operations organically or through acquisitions, as funding and opportunities arise.
+Added: strategic transactions or relationships with counterparties in industries that we deem synergistic or complimentary to us,
+Added: while also seeking to expand our operations organically or through acquisitions, as funding and opportunities arise.
event we require additional funding, we plan to raise that through the sale of debt or equity, which may not be available on favorable
2 unchanged sentences
moving forward, it may hurt our ability to grow and to generate future revenues.
−Removed: accompanying interim consolidated financial statements have been prepared assuming that the Company will continue as a going concern,
+Added: accompanying interim consolidated financial statements have been prepared assuming that we will continue as a going concern,
which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the
5 unchanged sentences
within one year after the date that the financial statements are issued.
−Removed: of March 31, 2026, the Company had an accumulated deficit of $83,953,501.
−Removed: As of March 31, 2026, the Company had $3,542,754 in cash.
−Removed: will need to raise additional capital or secure debt funding to support on-going operations, and to fund the assets and operations of
−Removed: any businesses or assets we acquire.
−Removed: The sources of this capital are expected to be the sale of equity and debt, which may not be available
−Removed: on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders.
−Removed: If we are unable to access additional
−Removed: capital moving forward, it may hurt our ability to grow and to generate future revenues, our financial position, and liquidity.
−Removed: factors raise substantial doubt about the ability of the Company to continue as a going concern.
−Removed: Unless management is able to obtain
−Removed: additional financing, it is unlikely that the Company will be able to meet its funding requirements during the next 12 months.
−Removed: The financial
−Removed: statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: of June 30, 2026, we had an accumulated deficit of $86,775,872.
+Added: As of June 30, 2026, we had $8,188,140 in cash and
+Added: $3,012,271 in restricted cash.
+Added: will need to raise additional capital or secure debt funding to support on-going operations, and to fund the assets and operations
+Added: of any businesses or assets we acquire.
+Added: The sources of this capital are expected to be the sale of equity and debt, which may not be
+Added: available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders.
+Added: If we are unable to
+Added: access additional capital moving forward, it may hurt our ability to grow and to generate future revenues, our financial position,
+Added: and liquidity.
+Added: While these factors initially indicated substantial doubt about the ability of the Company to continue as a going
+Added: concern, management believes that its existing cash on hand, revenues from the commercialization of ARBLI™ (SCN-102) and
+Added: REZENOPY™ (SCN-110) and its planned financing activities alleviate that doubt.
following table summarizes our Consolidated Statements of Cash Flows for the following periods:
−Removed: Three Months Ended
Net cash used in operating activities
2 unchanged sentences
Net change in cash
−Removed: used in operating activities for the three months ended March 31, 2026 was $2,919,255, compared to cash used in operating activities
−Removed: of $2,956,457 for the three months ended March 31, 2025.
−Removed: The slight decrease was primarily due to changes in working capital, partially
−Removed: offset by higher operating expenses during the 2026 period.
−Removed: was no cash provided by or used in investing activities for the three months ended March 31, 2026 or 2025.
−Removed: used in financing activities for the three months ended March 31, 2026 was $200,000, compared to cash provided by financing activities
−Removed: of $4,697,999 for the three months ended March 31, 2025.
−Removed: Cash used in financing activities for the three months ended March 31, 2026
−Removed: reflected the $200,000 repayment of the development agreement liability.
−Removed: Cash provided by financing activities for the three months ended
−Removed: March 31, 2025 was primarily attributable to gross proceeds of approximately $4,598,000 from the issuance of common stock pursuant to
−Removed: the equity line commitment, partially offset by other financing activity.
+Added: used in operating activities for the six months ended June 30, 2026, was $6,051,597, compared to cash used in operating activities
+Added: of $4,990,704 for the six months ended June 30, 2025.
+Added: The increase of $1,060,893 was primarily due to the $400,000 repayment of the
+Added: development agreement liability and other changes in working capital, including reductions in accounts payable and accrued
+Added: liabilities, partially offset by a lower net loss during the 2026 period.
+Added: was no cash provided by or used in investing activities for the six months ended June 30, 2026, or 2025.
+Added: provided by financing activities for the six months ended June 30, 2026, was $10,590,000, compared to cash provided by financing activities
+Added: of $4,697,999 for the six months ended June 30, 2025.
+Added: Cash provided by financing activities for the six months ended June 30, 2026, reflected
+Added: $10,590,000 of proceeds from the issuance of the Streeterville notes in April 2026, net of issuance costs.
+Added: Cash provided by financing activities for the six months ended June 30,
+Added: 2025, was primarily attributable to gross proceeds of approximately $4,598,000 from the issuance of common stock pursuant to an equity
+Added: line commitment, partially offset by other financing activity.
of Operations
1 unchanged sentence
the notes to these statements included above.
−Removed: Month Period Ended March 31, 2026 compared to Three Month Period Ended March 31, 2025
+Added: Month Period Ended June 30, 2026 compared to Three Month Period Ended June 30, 2025
Three Months Ended
10 unchanged sentences
Change in fair value of derivative liability
−Removed: Loss on conversion of note payable
+Added: Loss on disposition of subsidiaries
Interest income
1 unchanged sentence
Benefit / (provision) for income taxes
−Removed: for the three months ended March 31, 2026 were $56,325, compared to $10,258 for the three months ended March 31, 2025, an increase of
−Removed: The increase was primarily attributable to the continued ramp of wholesale distribution sales of SCN-102 (ARBLI™) following
−Removed: its commercial launch.
−Removed: of goods sold for the three months ended March 31, 2026 was $2,475, compared to $9,585 for the three months ended March 31, 2025, resulting
−Removed: in gross profit of $53,850 for the three months ended March 31, 2026 compared to gross profit of $673 for the three months ended March
−Removed: and salary expense decreased by $276,060 for the three months ended March 31, 2026 to $420,008 compared to $696,068 for the comparable
−Removed: period in 2025.
−Removed: The decrease was primarily due to lower headcount following the disposition of legacy subsidiaries in April 2025.
−Removed: fees increased by $519,702 to $932,552 for the three months ended March 31, 2026, compared to $412,850 for the comparable period in 2025.
−Removed: The increase was primarily attributable to higher external consulting fees during the 2026 period.
−Removed: and legal expense decreased by $144,647 for the three months ended March 31, 2026 to $326,178, compared to $470,825 for the comparable
+Added: Revenues for the three months ended June 30, 2026, were $343,639, compared to $0 for the three months ended June 30, 2025.
+Added: The increase was
+Added: primarily attributable to the continued ramp of wholesale distribution sales of SCN-102 (ARBLI™) following its commercial
+Added: Gross product sales for the quarter were $392,700, which were reduced by $49,061 of wholesale distribution fees,
+Added: rebates and chargebacks to arrive at net revenues.
+Added: All ARBLI™ product sales in the quarter were made through three national wholesale
+Added: distributors — McKesson Corporation, Cencora and Cardinal Health — with McKesson accounting for approximately two-thirds of
+Added: gross product sales.
+Added: While we expect ARBLI™ revenues to continue to grow as prescription demand and payor coverage build, quarterly
+Added: revenues may fluctuate with wholesaler ordering patterns and with the level of rebates, chargebacks and distribution fees, which will
+Added: vary with payor and channel mix.
+Added: Two of these distributors accounted for approximately 84% and 82% of revenues for the three and six months
+Added: ended June 30, 2026, respectively (see “Concentration of Credit Risks and Major Customers” in the notes to our unaudited condensed
+Added: consolidated financial statements).
+Added: We expect this concentration to continue, and the loss of, or a material reduction in purchases by,
+Added: any of these distributors could materially and adversely affect our revenues and cash flows.
+Added: of goods sold for the three months ended June 30, 2026, was $7,860, compared to $0 for the three months ended June 30, 2025, resulting
+Added: in gross profit of $335,779 for the three months ended June 30, 2026 compared to $0 for the three months ended June 30, 2025.
+Added: and salary expense decreased by $362,328 for the three months ended June 30, 2026 to $411,411, compared to $773,739 for the
+Added: comparable period in 2025.
+Added: The decrease was primarily due to lower headcount following the disposition of legacy subsidiaries in
+Added: Following the dispositions, our workforce is concentrated in a small number of research and development, commercial
+Added: and administrative personnel, and we have engaged a contract commercial organization — the cost of which is reflected in professional
+Added: fees — in lieu of building an internal sales force.
+Added: fees increased by $753,989 to $963,752 for the three months ended June 30, 2026, compared to $209,763 for the comparable period in 2025.
+Added: The increase was primarily attributable to outsourced commercial costs supporting the launch of ARBLI™ — including our contract commercial organization,
+Added: sales training, market access consulting, pharmacy and sample fulfillment services, and commercial data purchases — which had no
+Added: counterpart in the prior-year quarter.
+Added: We expect professional fees to remain elevated relative to prior-year periods for as long as we
+Added: commercialize ARBLI™ through an outsourced commercial model.
+Added: and legal expense decreased by $263,868 for the three months ended June 30, 2026 to $117,815, compared to $381,683 for the comparable
period in 2025.
−Removed: The decrease was primarily due to lower SEC filing and corporate transaction-related professional services activity during
−Removed: the 2026 period.
−Removed: and administrative expenses (including stock-based compensation expense) decreased by $281,084 for the three months ended March 31, 2026
+Added: The decrease was primarily due to elevated activity in the prior-year quarter associated with the disposition of the legacy subsidiaries and related
+Added: corporate transactions and SEC filings, which did not recur in 2026.
+Added: With our simplified corporate structure, we expect accounting and
+Added: legal expense to remain below prior-year levels for the remainder of 2026.
+Added: and administrative expenses (including stock-based compensation expense) decreased by $2,558,974 for the three months ended June 30,
2026, to $368,790, compared to $2,927,764 for the comparable period in 2025.
−Removed: The decrease was primarily due to lower stock-based compensation
−Removed: expense during the 2026 period.
−Removed: expense decreased by $45,857 for the three months ended March 31, 2026 to $15,763, compared to $61,620 for the comparable period in 2025.
+Added: The decrease was primarily because the prior-year quarter included substantial non-cash charges for common stock issued for services, which
+Added: did not recur in 2026;
+Added: stock option expense recognized in the three months ended June 30, 2026 was $103,457.
+Added: The decrease occurred notwithstanding
+Added: the inclusion in the 2026 quarter of $453,846 of amortization of intangible assets, which had no counterpart in the prior-year quarter
+Added: and is expected to continue at a comparable quarterly rate.
+Added: expense decreased by $14,269 for the three months ended June 30, 2026, to $7,139, compared to $21,408 for the comparable period in 2025.
The decrease was primarily due to lower software-related expenses following the disposition of IPS in April 2025.
−Removed: and development expense for the three months ended March 31, 2026 was $793,984, compared to $574,679 for the comparable period in 2025,
+Added: and development expense for the three months ended June 30, 2026, was $1,166,605, compared to $843,549 for the comparable period in 2025,
an increase of $323,056.
−Removed: The increase was primarily due to higher contract research organization costs related to advancement of pipeline
−Removed: product candidates.
+Added: The increase was primarily attributable to higher contract research and contract manufacturing organization costs, which comprised substantially
+Added: all of our research and development expense for the quarter, driven by the continued advancement of SCN-106 (Alteplase) and SCN-104 (DHE).
+Added: We expect research and development expense
+Added: to continue to increase as our product candidates advance.
Total expenses by program were as follows:
1 unchanged sentence
Project Codes
−Removed: March 31, 2026
+Added: June 30, 2026
Total research and development expense
−Removed: expense was $37,019 for the three months ended March 31, 2026, compared to $670,784 for the three months ended March 31, 2025.
−Removed: was primarily due to the repayment in full of the Arena convertible debentures during 2025 and the related cessation of debt discount
−Removed: amortization.
−Removed: recognized a gain on the change in the fair value of the warrant liability of $10,910 for the three months ended March 31, 2026, compared
−Removed: to a gain of $645,986 for the three months ended March 31, 2025, in each case based on the underlying valuation inputs.
−Removed: was no gain or loss on the change in the fair value of the derivative liability for the three months ended March 31, 2026, as the derivative
−Removed: liability was fully derecognized in connection with the repayment of the Arena debentures during 2025.
−Removed: We recognized a gain on the change
−Removed: in the fair value of the derivative liability of $603,322 for the three months ended March 31, 2025.
−Removed: the three months ended March 31, 2026, the Company incurred a net loss of $3,402,264, compared to a net loss of $3,063,997 for the three
−Removed: months ended March 31, 2025.
−Removed: The increase in net loss of $338,267 was primarily attributable to the changes in operating expenses and
−Removed: non-operating income/(expense) discussed above.
+Added: expense was $269,785 for the three months ended June 30, 2026, compared to $653,493 for the three months ended June 30, 2025.
+Added: was primarily due to the repayment in full of certain convertible debentures during 2025 and the related cessation of debt discount
+Added: amortization, partially offset by stated interest and debt discount amortization on the Streeterville notes issued in April 2026.
+Added: income was $147,147 for the three months ended June 30, 2026, compared to $63,148 for the three months ended June 30, 2025.
+Added: was primarily attributable to interest earned on Treasury Bill holdings and on the note receivable, together with interest credited on
+Added: the restricted deposit account established in April 2026.
+Added: recognized no gain or loss on the change in the fair value of the warrant liability for the three months ended June 30, 2026, compared
+Added: to a gain of $76,122 for the three months ended June 30, 2025, in each case based on the underlying valuation inputs.
+Added: was no gain or loss on the change in the fair value of the derivative liability for the three months ended June 30, 2026, as the derivative
+Added: liability was fully derecognized in connection with the repayment of certain debentures during 2025.
+Added: We recognized a loss on the change
+Added: in the fair value of the derivative liability of $662,916 for the three months ended June 30, 2025.
+Added: recognized no loss on disposition of subsidiaries for the three months ended June 30, 2026, compared to a loss on disposition of subsidiaries
+Added: of $385,528 for the three months ended June 30, 2025, which arose on the divestiture of the legacy subsidiaries in April 2025.
+Added: the three months ended June 30, 2026, we incurred a net loss of $2,822,371, compared to a net loss of $6,720,573 for the
+Added: three months ended June 30, 2025.
+Added: The decrease of $3,898,202 was primarily attributable to the increase in revenue and changes in
+Added: operating expenses and non-operating income/(expense) discussed above.
+Added: Month Period Ended June 30, 2026 compared to Six Month Period Ended June 30, 2025
+Added: Six Months Ended
+Added: Cost of sales
+Added: Operating expenses:
+Added: Wage and salary expense
+Added: Professional fees
+Added: Accounting and legal expense
+Added: Technology expense
+Added: General and administrative (including stock-based compensation expense)
+Added: Research and development
+Added: Total operating expenses
+Added: Change in fair value of warrant liability
+Added: Change in fair value of derivative liability
+Added: Loss on conversion of note payable
+Added: Loss on disposition of subsidiaries
+Added: Interest income
+Added: Interest expense
+Added: Benefit / (provision) for income taxes
+Added: $ (6,224,635 )
+Added: $ (9,784,570 )
+Added: for the six months ended June 30, 2026, were $399,964, compared to $10,258 for the six months ended June 30, 2025 (all of which represented legacy pharmaceutical product resale revenue of the subsidiaries disposed of in April 2025), an increase of
+Added: The increase was primarily attributable to the continued ramp of wholesale distribution sales of SCN-102 (ARBLI™)
+Added: following its commercial launch.
+Added: As discussed above, our revenues remain concentrated among a small number of wholesale distributors.
+Added: of goods sold for the six months ended June 30, 2026, was $10,335, compared to $9,585 for the six months ended June 30, 2025, resulting
+Added: in gross profit of $389,629 for the six months ended June 30, 2026, compared to $673 for the six months ended June 30, 2025.
+Added: and salary expense decreased by $638,388 for the six months ended June 30, 2026, to $831,419, compared to $1,469,807 for the
+Added: comparable period in 2025.
+Added: The decrease was primarily due to lower headcount following the disposition of legacy subsidiaries in
+Added: As discussed above, following the dispositions our workforce is concentrated in research and development, commercial
+Added: and administrative functions, with outsourced commercial selling costs reflected in professional fees.
+Added: fees increased by $1,273,691 to $1,896,304 for the six months ended June 30, 2026, compared to $622,613 for the comparable period in
+Added: The increase was primarily attributable to outsourced commercial costs supporting the launch of ARBLI™ — including our contract commercial organization,
+Added: sales training, market access consulting, pharmacy and sample fulfillment services, and commercial data purchases — which had no
+Added: counterpart in the prior-year period.
+Added: We expect professional fees to remain elevated relative to prior-year periods for as long as we
+Added: commercialize ARBLI™ through an outsourced commercial model.
+Added: and legal expense decreased by $408,515 for the six months ended June 30, 2026, to $443,993, compared to $852,508 for the comparable period
+Added: The decrease was primarily due to elevated activity in the prior-year period associated with the disposition of the legacy subsidiaries and related
+Added: corporate transactions and SEC filings, which did not recur in 2026.
+Added: With our simplified corporate structure, we expect accounting and
+Added: legal expense to remain below prior-year levels for the remainder of 2026.
+Added: and administrative expenses (including stock-based compensation expense) decreased by $2,840,058 for the six months ended June 30, 2026,
+Added: to $1,443,654, compared to $4,283,712 for the comparable period in 2025.
+Added: The decrease was primarily because the 2025 period included $3,781,253 of non-cash charges for common stock issued for services, which did not
+Added: recur in 2026, while stock option expense was broadly comparable at $205,777 for the six months ended June 30, 2026 compared to $162,874
+Added: for the comparable period in 2025.
+Added: The decrease occurred notwithstanding the inclusion in the 2026 period of $907,693 of amortization
+Added: of intangible assets, which had no counterpart in the prior-year period.
+Added: expense decreased by $60,126 for the six months ended June 30, 2026, to $22,902, compared to $83,028 for the comparable period in 2025.
+Added: The decrease was primarily due to lower software-related expenses following the disposition of IPS in April 2025.
+Added: and development expense for the six months ended June 30, 2026, was $1,960,589, compared to $1,418,228 for the comparable period in 2025,
+Added: an increase of $542,361.
+Added: The increase was primarily attributable to higher contract research and contract manufacturing organization costs, which comprised substantially
+Added: all of our research and development expense for the period, driven principally by SCN-106 (Alteplase), which accounted for $989,059 of
+Added: expense for the six months ended June 30, 2026, together with the continued advancement of SCN-104 (DHE).
+Added: We expect research and development expense to continue to increase as
+Added: our product candidates advance.
+Added: Total expenses by program were as follows:
+Added: Six Months Ended
+Added: Project Codes
+Added: June 30, 2026
+Added: Total research and development expense
+Added: expense was $306,804 for the six months ended June 30, 2026, compared to $1,324,277 for the six months ended June 30, 2025.
+Added: was primarily due to the repayment in full of certain convertible debentures during 2025 and the related cessation of debt discount
+Added: amortization, partially offset by stated interest and debt discount amortization on the Streeterville notes issued in April 2026.
+Added: income was $280,491 for the six months ended June 30, 2026, compared to $88,590 for the six months ended June 30, 2025.
+Added: was primarily attributable to interest earned on Treasury Bill holdings and on the note receivable, together with interest credited on
+Added: the restricted deposit account established in April 2026.
+Added: recognized a gain on the change in the fair value of the warrant liability of $10,910 for the six months ended June 30, 2026, compared
+Added: to a gain of $722,108 for the six months ended June 30, 2025, in each case based on the underlying valuation inputs.
+Added: was no gain or loss on the change in the fair value of the derivative liability for the six months ended June 30, 2026, as the derivative
+Added: liability was fully derecognized in connection with the repayment of certain debentures during 2025.
+Added: We recognized a loss on the change
+Added: in the fair value of the derivative liability of $59,594 for the six months ended June 30, 2025.
+Added: recognized no loss on conversion of note payable or loss on disposition of subsidiaries for the six months ended June 30, 2026, compared
+Added: to a loss on conversion of note payable of $96,646 and a loss on disposition of subsidiaries of $385,528 for the six months ended June
+Added: the six months ended June 30, 2026, we incurred a net loss of $6,224,635, compared to a net loss of $9,784,570 for the six months
+Added: ended June 30, 2025.
+Added: The decrease of $3,559,935 was primarily attributable to the changes in operating expenses and non-operating income/(expense)
+Added: discussed above.
Accounting Policies
7 unchanged sentences
or complex judgments, often as a result of the need to make estimates about the effects of matters that are inherently uncertain.
−Removed: Company accounts for acquisitions and investments in businesses as business combinations if the target meets the definition of a business
−Removed: and (a) the target is a variable interest entity and the Company is the target’s primary beneficiary, and therefore the Company
−Removed: must consolidate its financial statements, or (b) the Company acquires more than 50% of the voting interest of the target and it was
+Added: We account for acquisitions and investments in businesses as business combinations if the target meets the definition of a business
+Added: and (a) the target is a variable interest entity and we are the target’s primary beneficiary, and therefore we
+Added: must consolidate its financial statements, or (b) we acquire more than 50% of the voting interest of the target and it was
not previously consolidated.
−Removed: The Company records business combinations using the acquisition method of accounting, which requires all
+Added: We record business combinations using the acquisition method of accounting, which requires all
the assets acquired and liabilities assumed to be recorded at fair value as of the acquisition date.
3 unchanged sentences
in the determination of the fair value of assets acquired and liabilities assumed in order to properly
−Removed: Company accounts for stock-based compensation to employees in accordance with ASC 718, “ Compensation-Stock Compensation ”.
+Added: We account for stock-based compensation to employees in accordance with ASC 718, “ Compensation-Stock Compensation ”.
ASC 718 requires companies to measure the cost of employee services received in exchange for an award of equity instruments, including
3 unchanged sentences
date of employee termination.
−Removed: Effective January 1, 2019, the Company adopted ASU 2018-07 for the accounting of share-based payments granted
+Added: Effective January 1, 2019, we adopted ASU 2018-07 for the accounting of share-based payments granted
to non-employees for goods and services.
1 unchanged sentence
addition to our financial results determined in accordance with the generally accepted accounting principles in the United States (“GAAP”),
−Removed: our management uses earnings before interest, taxes, depreciation, and amortization expenses to net income (“EBITDA”), a
−Removed: non-GAAP measure, as a key measure in operating our business.
−Removed: We use EBITDA to make strategic decisions, establish business plans and
−Removed: forecasts, identify trends affecting our business, and evaluate performance.
−Removed: For example, we use adjusted EBITDA as a measure of our
−Removed: operating performance.
−Removed: Adjusted EBITDA is presented for supplemental informational purposes only, should not be considered a substitute
−Removed: for, or a more meaningful measure than, financial information presented in accordance with GAAP, and may be different from similarly
−Removed: titled non-GAAP measures used by other companies.
−Removed: A reconciliation is provided below for adjusted EBITDA to the most directly comparable
−Removed: financial measure presented in accordance with GAAP.
−Removed: Investors are encouraged to review the related GAAP financial measure and the reconciliation
−Removed: of adjusted EBITDA to its most directly comparable GAAP financial measure.
−Removed: the three months ended March 31, 2026, adjusted EBITDA was $(2,939,166), compared to adjusted EBITDA of $(2,475,856) for the three months
−Removed: ended March 31, 2025.
−Removed: The increase in the adjusted EBITDA loss of $463,310 was primarily attributable to a higher net loss of $(3,402,264)
−Removed: for the three months ended March 31, 2026 compared to $(3,063,997) for the prior-year period, driven by increased operating expenses
−Removed: including higher professional fees and research and development costs associated with pipeline advancement, partially offset by higher
−Removed: gross profit from the continued ramp of SCN-102 (ARBLI™) wholesale distribution revenues.
−Removed: The decrease was further moderated by
−Removed: lower non-cash stock-based compensation expense of $102,320 in the current period compared to $1,080,437 in the prior-year period, a
−Removed: significant reduction in interest expense to $37,019 from $670,784 following the repayment of the Arena convertible debentures during
−Removed: 2025, and higher depreciation and amortization of $468,013 compared to $15,024 in the prior-year period.
−Removed: The following table reconciles
−Removed: net loss to adjusted EBITDA for the three months ended March 31, 2026 and 2025:
+Added: our management uses adjusted EBITDA, which we define as net loss before interest, taxes, depreciation and amortization, further adjusted
+Added: for stock-based compensation and other non-cash and non-recurring items, as a key measure in operating our business.
+Added: We use EBITDA to
+Added: make strategic decisions, establish business plans and forecasts, identify trends affecting our business, and evaluate performance.
+Added: example, we use adjusted EBITDA as a measure of our operating performance.
+Added: Adjusted EBITDA is presented for supplemental informational
+Added: purposes only, should not be considered a substitute for, or a more meaningful measure than, financial information presented in accordance
+Added: with GAAP, and may be different from similarly titled non-GAAP measures used by other companies.
+Added: A reconciliation is provided below for
+Added: adjusted EBITDA to the most directly comparable financial measure presented in accordance with GAAP.
+Added: Investors are encouraged to review
+Added: the related GAAP financial measure and the reconciliation of adjusted EBITDA to its most directly comparable GAAP financial measure.
+Added: the three months ended June 30, 2026, adjusted EBITDA was $(2,134,705), compared to $(2,263,734) for the three months ended June 30, 2025.
+Added: For the six months ended June 30, 2026, adjusted EBITDA was $(5,073,870), compared to $(4,754,615) for the six months ended June
+Added: Net loss decreased to $(2,822,371) and $(6,224,635) for the three and six months ended June 30, 2026, from $(6,720,573) and
+Added: $(9,784,570) for the comparable periods in 2025, reflecting lower general and administrative expense and higher gross profit from the
+Added: continued ramp of SCN-102 (ARBLI™) wholesale distribution revenues.
+Added: Adjusted EBITDA improved for the three months ended June 30, 2026 but declined for the six months then ended, because
+Added: the prior-year net loss included substantially larger non-cash and non-operating charges that are added back in the reconciliation.
+Added: stock-based compensation was $103,457 and $205,777 for the three and six months ended June 30, 2026, compared to $2,863,691 and $3,944,127 for the comparable 2025 periods.
+Added: Interest expense was $269,785 and $306,804 for the three and six months ended June 30, 2026, compared to
+Added: $653,493 and $1,324,277 for the comparable 2025 periods.
+Added: Depreciation and amortization increased to $461,571 and $929,585, from $30,481
+Added: in each of the comparable 2025 periods, following commencement of amortization of the finite-lived intangible asset.
+Added: following table reconciles net loss to adjusted EBITDA for the three and six months ended June 30, 2026 and 2025:
Three Months Ended
+Added: Six Months Ended
$ (2,822,371 )
$ (6,720,573 )
+Added: $ (6,224,635 )
+Added: $ (9,784,570 )
Depreciation and amortization
5 unchanged sentences
$ (2,263,734 )
+Added: $ (5,073,870 )
+Added: $ (4,754,615 )
Issued Accounting Standards
4 unchanged sentences
to Item 305(e) of Regulation S-K (17 C.F.R.
−Removed: § 229.305(e)), the Company is not required to provide the information required by
−Removed: this Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1).
+Added: § 229.305(e)), we are not required to provide the information required by this
+Added: Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1).
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.