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Scienture Holdings, Inc.

For the period ended Jun 30, 2026. Filed Aug 13, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 13, 2026

SCNX$3.13+0.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-15.

0001493152-26-023862

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-13.

0001493152-26-037754

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 99 previous paragraphs and 105 current paragraphs.

37 unchanged; 45 reworded; 18 added; 15 removed; 2 previous and 5 current paragraphs rearranged.

Tables are not compared: 9 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (18)

Current report

In connection with our $11 million financing facility with Streeterville that we established in April 2026, we formed a wholly owned subsidiary—SCNX Holdings, LLC (“SCNX Sub”). SCNX Sub exists solely in connection with the financing facility and has no operations. At closing of the financing facility, Streeterville paid deposited $3 million into a bank account held by SCNX Sub, which is secured pursuant to a deposit account control agreement among SCNX Sub, Streeterville, and the bank.

Current report

Revenues for the three months ended June 30, 2026, were $343,639, compared to $0 for the three months ended June 30, 2025. The increase was primarily attributable to the continued ramp of wholesale distribution sales of SCN-102 (ARBLI™) following its commercial launch. Gross product sales for the quarter were $392,700, which were reduced by $49,061 of wholesale distribution fees, rebates and chargebacks to arrive at net revenues. All ARBLI™ product sales in the quarter were made through three national wholesale distributors — McKesson Corporation, Cencora and Cardinal Health — with McKesson accounting for approximately two-thirds of gross product sales. While we expect ARBLI™ revenues to continue to grow as prescription demand and payor coverage build, quarterly revenues may fluctuate with wholesaler ordering patterns and with the level of rebates, chargebacks and distribution fees, which will vary with payor and channel mix. Two of these distributors accounted for approximately 84% and 82% of revenues for the three and six months ended June 30, 2026, respectively (see “Concentration of Credit Risks and Major Customers” in the notes to our unaudited condensed consolidated financial statements). We expect this concentration to continue, and the loss of, or a material reduction in purchases by, any of these distributors could materially and adversely affect our revenues and cash flows.

Current report

Wage and salary expense decreased by $362,328 for the three months ended June 30, 2026 to $411,411, compared to $773,739 for the comparable period in 2025. The decrease was primarily due to lower headcount following the disposition of legacy subsidiaries in April 2025. Following the dispositions, our workforce is concentrated in a small number of research and development, commercial and administrative personnel, and we have engaged a contract commercial organization — the cost of which is reflected in professional fees — in lieu of building an internal sales force.

Current report

Professional 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. The increase was primarily attributable to outsourced commercial costs supporting the launch of ARBLI™ — including our contract commercial organization, sales training, market access consulting, pharmacy and sample fulfillment services, and commercial data purchases — which had no counterpart in the prior-year quarter. We expect professional fees to remain elevated relative to prior-year periods for as long as we commercialize ARBLI™ through an outsourced commercial model.

Current report

Accounting 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. The decrease was primarily due to elevated activity in the prior-year quarter associated with the disposition of the legacy subsidiaries and related corporate transactions and SEC filings, which did not recur in 2026. With our simplified corporate structure, we expect accounting and legal expense to remain below prior-year levels for the remainder of 2026.

Current report

General 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. The decrease was primarily because the prior-year quarter included substantial non-cash charges for common stock issued for services, which did not recur in 2026; stock option expense recognized in the three months ended June 30, 2026 was $103,457. The decrease occurred notwithstanding the inclusion in the 2026 quarter of $453,846 of amortization of intangible assets, which had no counterpart in the prior-year quarter and is expected to continue at a comparable quarterly rate.

Current report

Interest income was $147,147 for the three months ended June 30, 2026, compared to $63,148 for the three months ended June 30, 2025. The increase was primarily attributable to interest earned on Treasury Bill holdings and on the note receivable, together with interest credited on the restricted deposit account established in April 2026.

Current report

We recognized no loss on disposition of subsidiaries for the three months ended June 30, 2026, compared to a loss on disposition of subsidiaries of $385,528 for the three months ended June 30, 2025, which arose on the divestiture of the legacy subsidiaries in April 2025.

Current report

Cost 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 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.

Current report

Professional 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 2025. The increase was primarily attributable to outsourced commercial costs supporting the launch of ARBLI™ — including our contract commercial organization, sales training, market access consulting, pharmacy and sample fulfillment services, and commercial data purchases — which had no counterpart in the prior-year period. We expect professional fees to remain elevated relative to prior-year periods for as long as we commercialize ARBLI™ through an outsourced commercial model.

Current report

Accounting 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 in 2025. The decrease was primarily due to elevated activity in the prior-year period associated with the disposition of the legacy subsidiaries and related corporate transactions and SEC filings, which did not recur in 2026. With our simplified corporate structure, we expect accounting and legal expense to remain below prior-year levels for the remainder of 2026.

Current report

General and administrative expenses (including stock-based compensation expense) decreased by $2,840,058 for the six months ended June 30, 2026, to $1,443,654, compared to $4,283,712 for the comparable period in 2025. 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 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 for the comparable period in 2025. The decrease occurred notwithstanding the inclusion in the 2026 period of $907,693 of amortization of intangible assets, which had no counterpart in the prior-year period.

Current report

Research 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, an increase of $542,361. The increase was primarily attributable to higher contract research and contract manufacturing organization costs, which comprised substantially all of our research and development expense for the period, driven principally by SCN-106 (Alteplase), which accounted for $989,059 of expense for the six months ended June 30, 2026, together with the continued advancement of SCN-104 (DHE). We expect research and development expense to continue to increase as our product candidates advance. Total expenses by program were as follows:

Current report

Interest 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. The decrease was primarily due to the repayment in full of certain convertible debentures during 2025 and the related cessation of debt discount amortization, partially offset by stated interest and debt discount amortization on the Streeterville notes issued in April 2026.

Current report

Interest income was $280,491 for the six months ended June 30, 2026, compared to $88,590 for the six months ended June 30, 2025. The increase was primarily attributable to interest earned on Treasury Bill holdings and on the note receivable, together with interest credited on the restricted deposit account established in April 2026.

Current report

We recognized no loss on conversion of note payable or loss on disposition of subsidiaries for the six months ended June 30, 2026, compared 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 30, 2025.

Current report

For 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. 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 30, 2025. 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 $(9,784,570) for the comparable periods in 2025, reflecting lower general and administrative expense and higher gross profit from the continued ramp of SCN-102 (ARBLI™) wholesale distribution revenues. Adjusted EBITDA improved for the three months ended June 30, 2026 but declined for the six months then ended, because the prior-year net loss included substantially larger non-cash and non-operating charges that are added back in the reconciliation. Non-cash 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. Interest expense was $269,785 and $306,804 for the three and six months ended June 30, 2026, compared to $653,493 and $1,324,277 for the comparable 2025 periods. Depreciation and amortization increased to $461,571 and $929,585, from $30,481 in each of the comparable 2025 periods, following commencement of amortization of the finite-lived intangible asset.
Removed paragraphs (15)

Previous report

On October 4, 2024, the Company and Softell entered into IPS Assignment Agreement, pursuant to which the Company transferred, and Softell accepted, 100% of the membership interests of IPS. As a result, IPS became a wholly-owned subsidiary of Softell. During the year ended December 31, 2023 and a portion of the quarter ended March 31, 2024, Softell, operated a web-based market platform that enabled commerce among healthcare buyers and sellers of pharmaceuticals, accessories and services. Softell’s current primary operations are conducted through IPS. IPS is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to customers. IPS’ customers include all healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide.

Previous report

On September 20, 2024, the Company fil changed its legal name from “TRxADE HEALTH, Inc.” to “Scienture Holdings, Inc.”

Previous report

Bonum Health, LLC was formed to hold certain telehealth assets acquired in October 2019. The “Bonum Health Hub” was launched in February 2020; however, the Company does not anticipate installations moving forward. On April 30, 2025, the Company completed the sale of Bonum Health, Inc. and Bonum Health, LLC.

Previous report

On April 8, 2025, the Company entered into a Membership Interest Purchase Agreement (the “IPS MIPA”) with Tollo Health, LLC (“Tollo”), pursuant to which Tollo agreed to purchase and the Company agreed to sell all of the Company’s membership interests in IPS.

Previous report

On April 8, 2025, the Company also entered into a Stock Purchase Agreement (the “Bonum and Softell SPA” and together with the IPS MIPA, the “Agreements”) with Tollo, pursuant to which Tollo agreed to purchase and the Company agreed to sell all issued and outstanding shares of common stock of Bonum Health, Inc. and Softell. Suren Ajjarapu, the Company’s former Chief Executive Officer, and Prashant Patel, the Company’s former President and Chief Operating Officer, each had a beneficial interest in Tollo at the time the Company entered into the each of the Agreements.

Previous report

In connection with each of the Agreements, the Company agreed to retain certain excluded liabilities of IPS, Softell and Bonum Health, Inc. including all liabilities: (i) related to, in connection with or arising out of any claims, charges, complaints, actions, suits, settlements, hearings, investigations, proceedings, or governmental or regulatory inquiries with respect to IPS, Softell or Bonum Health, Inc., respectively, prior to the closing under the applicable Agreement; (ii) related to, in connection with or arising out of any breach by the Company of the applicable Agreement or any other agreements and documents required to be delivered by the Company; (iii) not disclosed by the Company in accordance with each Agreement; (iv) related to any actions threatened or initiated by a governmental entity against IPS, Softell, or Bonum Health, Inc., respectively; and (v) related to tax returns or tax matters of the Company, IPS, Softell, or Bonum Health, Inc., respectively, for any periods prior to closing under the applicable Agreement.

Previous report

The Company and Tollo consummated the closing of each of the Agreements on April 30, 2025. As consideration for acquiring IPS, Softell, and Bonum Health, Inc., Tollo agreed to pay the Company $5 million, with that consideration delivered in the form of a promissory note bearing interest at the prime rate. The promissory note matures on June 30, 2030. However, Tollo is required to pay 20% of the proceeds of a future equity financing toward repayment of the principal and accrued but unpaid interest owed under the promissory note. On June 24, 2025, the promissory note was assigned to Integral Health, Inc., which (at the time of the assignment) was owned by Suren Ajjarapu, the Company’s former Chief Executive Officer, and Prashant Patel, the Company’s former President and Chief Operating Officer.

Previous report

The divestitures are part of a broader strategic realignment at the Company designed to sharpen operational focus and unlock long-term value. It is aligned with the Company’s commitment to streamline its core operations, optimize its portfolio, and accelerate growth in the Branded and Specialty Pharma markets. The Company intends to use the proceeds obtained from the divestment to facilitate the high-growth commercial and strategic product development activities at its Scienture subsidiary.

Previous report

The Company believes that the key benefits of the divestitures include:

Previous report

Professional 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. The increase was primarily attributable to higher external consulting fees during the 2026 period.

Previous report

Accounting 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 period in 2025. The decrease was primarily due to lower SEC filing and corporate transaction-related professional services activity during the 2026 period.

Previous report

General and administrative expenses (including stock-based compensation expense) decreased by $281,084 for the three months ended March 31, 2026 to $1,074,864, compared to $1,355,948 for the comparable period in 2025. The decrease was primarily due to lower stock-based compensation expense during the 2026 period.
Reworded paragraphs (45)

Previous wording

On July 25, 2024, we acquired a wholly-owned subsidiary, Scienture LLC. Scienture LLC is a specialty pharmaceutical company focused on the commercialization and development of products for the treatment of Cardiovascular (“CVS”) and Central Nervous System (“CNS”) diseases. Scienture LLC launched its first commercial product for hypertension and is in the process of commercializing its second product for the treatment of opioid overdose. Its development pipeline consists of a broad range of novel product candidates including new potential treatments for migraine, thrombosis, pain and other related disorders. Scienture LLC’s mission is to bring to market innovative technology-based products to address unmet medical needs. Its targeted portfolio consists of short term and long-term opportunities with efficient development, regulatory, and go to market strategies.

Current wording

Together with our wholly-owned subsidiary, Scienture, LLC, which we acquired on July 25, 2024, we are a Commack, New York based specialty pharmaceutical company focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty pharmaceutical products to satisfy unmet market needs. We are particularly focused on the commercialization and development of products for the treatment of Cardiovascular (“CVS”) and Central Nervous System (“CNS”) diseases as well as a broad range of novel product candidates including new potential treatments for hypertension, migraine, pain and thrombosis and other related disorders. To date, we have launched ARBLI™, a commercial product for the treatment of hypertension, and we are in the process of commercializing a second product, REZENOPY™, for the treatment of opioid overdose. Our development pipeline consists of a broad range of novel product candidates including new potential treatments for migraine, thrombosis, pain and other related disorders. Our mission is to bring to market innovative technology-based products to address unmet medical needs. We target a diversified portfolio of short- and long-term opportunities with efficient development, regulatory, and go to market strategies.

Previous wording

After our acquisition of Scienture, we existed as a holding company owning all equity interests of Softell Inc. (f/k/a Trxade Inc.) (“Softell”), Integra Pharma Solutions, LLC d.b.a. Trxade Prime (“IPS”), Bonum Health, LLC, Bonum Health Inc., and Scienture.

Current wording

During the year ended December 31, We previously were known as TRxADE HEALTH, Inc. and operated a web-based market platform focused on enhancing commerce among healthcare participants, a licensed pharmaceutical wholesaler, and a digital telehealth company, through our ownership of Softell Inc. (f/k/a Trxade Inc.) (“Softell”), Integra Pharma Solutions, LLC d.b.a. Trxade Prime (“IPS”), Bonum Health, LLC, and Bonum Health Inc. In April 2025, we sold Softell, IPS, and Bonum Health Inc. We dissolved Bonum Health Inc. in November 2025. In connection with the acquisition of Scienture, LLC, we changed our legal name to “Scienture Holdings, Inc.” The divestiture of these legacy subsidiaries was part of a broader strategic realignment designed to sharpen operational focus and unlock long-term value. It is aligned with our commitment to streamline our core operations, optimize our portfolio, and accelerate growth in the Branded and Specialty Pharma markets.

Previous wording

Scienture’s vision is to be a leader in the industry by developing and commercializing new medicines for the treatment of CNS and CVS diseases and across other therapeutic areas. Key elements of Scienture’s strategy to achieve this vision include:

Current wording

Our 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. Key elements of our strategy to achieve this vision include:

Previous wording

Scienture currently has four primary product candidates in its development pipeline, summarized below, and is engaged in a variety of research and development efforts to develop novel product candidates for the treatment of various disease conditions. To date, Scienture has generated limited revenue from product sales and will not generate meaningful revenues until it fully commercializes its FDA-approved product candidate (SCN-102) and successfully obtains regulatory approval for, and commercializes, its other product candidates. The progress of Scienture products its development pipeline to date is represented by the green bars shown below.

Current wording

We 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. To date, we have generated limited revenue from product sales and will not generate meaningful revenues until we fully commercializes our FDA-approved product candidates (Arbli™ and REZENOPY™) and successfully obtain regulatory approval for, and commercialize, our other product candidates. The progress of our products in our development pipeline to date is represented by the green bars shown below.

Previous wording

Scienture has devoted and will continue to devote significant resources to research and development activities, and expects to incur significant expenses as Scienture continues advancing its product candidates towards FDA approval and expanding product indications for approved products and its intellectual property portfolio. Scienture’s expectations regarding its research and development programs are subject to risks, including the risk that Scienture’s financial condition and results of operations may be materially and adversely affected by delays and failures in the completion of clinical development of its product candidates, which could increase its costs or delay or limit our ability to generate revenues.

Current wording

We have devoted and will continue to devote significant resources to sales and marketing of our commercial products and research and development activities, and expects to incur significant expenses as we continue advancing our product candidates towards FDA approval and expanding product indications for approved products and our intellectual property portfolio. Our expectations regarding our research and development programs are subject to risks, including the risk that our financial condition and results of operations may be materially and adversely affected by delays and failures in the completion of clinical development of our product candidates, which could increase costs or delay or limit our ability to generate revenues.

Previous wording

Scienture currently depends on third-party commercial manufacturing organizations (“CMOs”) for its manufacturing operations, including the production of raw materials, finished dosage form product, and product packaging for both its planned product commercialization and for use in its preclinical and clinical research. Scienture does not own or operate manufacturing facilities for the production of any of its product candidates nor does Scienture have plans to develop its own manufacturing operations in the foreseeable future to support clinical trials or commercial production. Scienture currently employs internal resources to manage its manufacturing contractors.

Current wording

We currently depend on third-party commercial manufacturing organizations (“CMOs”) for our manufacturing operations, including the production of raw materials, finished dosage form product, and product packaging for both our planned product commercialization and for use in our preclinical and clinical research. We do not own or operate manufacturing facilities for the production of 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. We currently employs internal resources to manage our manufacturing contractors.

Previous wording

Scienture is in discussion with CMOs headquartered in North America, Europe and Asia for its pipeline product candidates. These CMOs offer a comprehensive range of commercial contract manufacturing and packaging services.

Current wording

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.

Previous wording

If Scienture fails to produce its products and product candidates in the volumes that it requires on a timely basis, or fails to comply with stringent regulations applicable to pharmaceutical drug manufacturers, Scienture may face delays in the development and commercialization of its products and product candidates or be required to withdraw its products from the market** **for risks associated with manufacturing and supply of its products and product candidates.

Current wording

If we fail to produce our products and product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of our products and product candidates or be required to withdraw our products from the market** **for risks associated with manufacturing and supply of our products and product candidates.

Previous wording

SCN-102, with the brand name Arbli TM, 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 left ventricular hypertrophy, and (iii) treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. SCN-102 was approved by the FDA in March 2025, making SCN-102 the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market.

Current wording

SCN-102, 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 left ventricular hypertrophy, and (iii) treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. SCN-102 was approved by the FDA in March 2025, making SCN-102 the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market.

Previous wording

SCN-102 has two 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 #: 11,890,273, Issue Date: February 6, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration Date: October 7, 2041 and (ii) Patent # 12,156,869; Issue Date: December 3, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”. SCN-102 also has a third patent titled “LOSARTAN LIQUID FORMULATION AND METHODS OF USE” that was issued on April 21, 2026, and expires on October 7, 2041.

Current wording

SCN-102 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”: (i) Patent #: 11,890,273, Issue Date: February 6, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration Date: October 7, 2041 and (ii) Patent # 12,156,869; Issue Date: December 3, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”. SCN-102 also has a third patent titled “LOSARTAN LIQUID FORMULATION AND METHODS OF USE” that was issued on April 21, 2026, and expires on October 7, 2041.

Previous wording

Scienture LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with Summit Biosciences Inc., a wholly-owned subsidiary of Kindeva, on March 4, 2025, pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable, non-sublicensable right and license to commercialize REZENOPYTM (Nalaxone HCI nasal spray 10mg/0.11mL) within the United States and its territories. Scienture LLC intends to use the exclusive right and license to price, launch, promote, market, distribute, and educate the public on REZENOPYTM.

Current wording

On March 4, 2025, Scienture, LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with Summit Biosciences Inc., a wholly-owned subsidiary of Kindeva, pursuant to which Kindeva granted us an exclusive, non-transferrable, non-sublicensable right and license to commercialize REZENOPYTM (Nalaxone hydrochloride nasal spray 10mg/0.11mL) within the United States and its territories. We intend to use the exclusive right and license to price, launch, promote, market, distribute, and educate the public on REZENOPYTM.

Previous wording

REZENOPYTM (Naloxone HCl Nasal Spray, 10mg) is the highest FDA-approved nasal spray dose available in the U.S. market. The product provides maximum naloxone protection in a single easy-to-use device and caters to the segment of patients who need multiple doses of lower strength for stabilization in emergency situations. REZENOPYTM 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 dose administration of 10mg naloxone hydrochloride. High dose REZENOPY™ improves the chances of reversing potent opioids quickly and reducing the requirement of MNA.

Current wording

REZENOPY™ (Naloxone hydrochloride Nasal Spray, 10mg) is the highest FDA-approved nasal spray dose available in the U.S. market. The product provides maximum naloxone protection in a single easy-to-use device and caters to the segment of patients who need multiple doses of lower strength for stabilization in emergency situations. 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 dose administration of 10mg naloxone hydrochloride. High dose REZENOPY™ improves the chances of reversing potent opioids quickly and reducing the requirement of MNA.

Previous wording

SCN-110 has one 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 #: 12,514,854 B2, Issue Date: January 6, 2026, an Orange Book-listable patent, titled “DRUG PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF”, Expiration Date: February 5, 2041.

Current wording

SCN-110 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 #: 12,514,854, Issue Date: January 6, 2026, an Orange Book-listable patent, titled “DRUG PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF”, Expiration Date: February 5, 2041 and (ii) Patent #: 12,622,903, Issue Date: June 2, 2026, an Orange Book-listable patent, titled “DRUG PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF”, Expiration Date: February 5, 2041.

Previous wording

Scienture has had discussions with the FDA regarding its development program for SCN-104, with the FDA indicating that the reference product selected for a comparative regulatory study and proposed plan for manufacturing New Drug Application registration batches are acceptable. The FDA also provided Scienture with feedback on nonclinical safety studies and stability testing. Scienture is working to scale the formulation to enable future commercial scale production and the pen has been optimized for commercial use. Currently, Scienture is focused on planning bioequivalence studies and increasing manufacturing activities for the SCN-104 injection pen. Scienture plans to initiate a Phase 1 single dose study in healthy adults in 2026, following submission of an Investigational New Drug application (an “IND”), if the IND is cleared by the FDA.

Current wording

We have had discussions with the FDA regarding the development program for SCN-104, with the FDA indicating that the reference product selected for a comparative regulatory study and proposed plan for manufacturing New Drug Application registration batches are acceptable. The FDA also provided us with feedback on nonclinical safety studies and stability testing. We are working to scale the formulation to enable future commercial scale production and the pen has been optimized for commercial use. Currently, we are focused on planning bioequivalence studies and increasing manufacturing activities for the SCN-104 injection pen. We plan to initiate a Phase 1 single dose study in healthy adults in early 2027, following submission of an Investigational New Drug application (an “IND”), if the IND is cleared by the FDA.

Previous wording

Scienture is 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. SCN-106 is a sterile, purified glycoprotein that is synthesized using the complementary DNA for natural human tPA obtained from a Chinese hamster ovary cell-line.

Current wording

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. SCN-106 is a sterile, purified glycoprotein that is synthesized using the complementary DNA for natural human tPA obtained from a Chinese hamster ovary cell-line.

Previous wording

Scienture is working with Anthem Biosciences Pvt, Ltd. to develop a biosimilar product that utilizes the same mechanism(s) of action for the proposed condition of use, and has the same route of administration, dosage form, and strength as the reference product. The development program is focused on establishing the analytical similarity of SCN-106 to the reference product. Multiple clones of CHO cells have been produced to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key biochemical quality attributes as well as overall protein yield and finalization of a lead clone.

Current wording

Specifically, we are working with Anthem Biosciences Pvt, Ltd. to develop a biosimilar product that utilizes the same mechanism(s) of action for the proposed condition of use, and has the same route of administration, dosage form, and strength as the reference product. The development program is focused on establishing the analytical similarity of SCN-106 to the reference product. Multiple clones of CHO cells have been produced to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key biochemical quality attributes as well as overall protein yield and finalization of a lead clone.

Previous wording

Scienture 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. As a result of this meeting, Scienture learned that its analytical strategy for initiating analytical similarity studies between SCN-106 and a proposed biosimilar product is acceptable. Scienture 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. In this regard, Scienture was 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 product. The only clinical requirement is a comparative phase 3 clinical study in the sensitive population to demonstrate that there are no clinically meaningful differences between SCN-106 and the currently marketed product.

Current wording

We 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. 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. 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. 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 product. The only clinical requirement is a comparative phase 3 clinical study in the sensitive population to demonstrate that there are no clinically meaningful differences between SCN-106 and the currently marketed product.

Previous wording

SCN-106 is a potential biosimilar and considered by the Company to be part of its product development portfolio, however the Company is not pursuing patent protection for this product.

Current wording

SCN-106 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.

Previous wording

SCN-107 is a long-acting injection suspension formulation of a non-opioid analgesic that is indicated for postsurgical local and regional analgesia. Scienture’s 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. The product candidate is designed to potentially provide longer term post-surgical pain relief compared to the currently available products in the market.

Current wording

SCN-107 is a long-acting injection suspension formulation of a non-opioid analgesic that is indicated for postsurgical local and regional analgesia. 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. The product candidate is designed to potentially provide longer term post-surgical pain relief compared to the currently available products in the market.

Previous wording

Based on initial discussions with FDA regarding this program, Scienture believes this product candidate would require at least one Phase 3 clinical trial to support submission of a marketing application. Scienture anticipates submitting an IND and, if cleared by the FDA, initiating a Phase 1 single dose study in healthy adults in 2025 to conduct an initial assessment of safety and tolerability of SCN-107.

Current wording

Based 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. We anticipate submitting an IND in 2027 and, if cleared by the FDA, plan to conduct an initial assessment of safety and tolerability of SCN-107.

Previous wording

Scienture has entered into Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies, B.V. (“Innocore”), as amended on December 2, 2022 (the “Innocore License”), for certain intellectual property rights associated with SCN-107. Under the Innocore License, Innocore granted Scienture a worldwide exclusive, milestone, royalty-bearing and sublicensable license to certain patent rights for the research and development of SCN-107 in postsurgical local and regional analgesia. Pursuant to the Innocore License, Scienture is required to make low single-digit percentage royalty payments based on annual net sales of licensed 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 of sales on a country-by-country basis.

Current wording

Scienture, LLC previously entered into a Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies, B.V. (“Innocore”), as amended on December 2, 2022 (the “Innocore License”), for certain intellectual property rights associated with SCN-107. Under the Innocore License, Innocore granted us a worldwide exclusive, milestone, royalty-bearing and sublicensable license to certain patent rights for the research and development of SCN-107 in postsurgical local and regional analgesia. Pursuant to the Innocore License, we are required to make low single-digit percentage royalty payments based on annual net sales of licensed 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 of sales on a country-by-country basis.

Previous wording

SCN-107 has a formulation composition and method of use application pending in the U.S. (Appl. No. 17/996,995; Filing Date: October 24, 2022; Expiration Date: on or after April 22, 2041). Applications in Canada and Europe are currently pending. As described above, the Company licenses certain patent rights from Innocore for the research and development of SCN-107.

Current wording

SCN-107 has a formulation composition and method of use application pending in the U.S. (Appl. No. 17/996,995; Filing Date: October 24, 2022; Expiration Date: on or after April 22, 2041). Applications in Canada and Europe are currently pending. As described above, we license certain patent rights from Innocore for the research and development of SCN-107.

Previous wording

Cash was $3,542,754 as of March 31, 2026, compared to $6,662,008 as of December 31, 2025. We expect that our future available capital resources will consist primarily of cash generated from Scienture’s operations, remaining cash balances, borrowings, and additional funds raised through sales of debt and/or equity securities.

Current wording

Cash was $8,188,140 as of June 30, 2026, compared to $6,662,008 as of December 31, 2025. In addition, we held restricted cash of $3,012,271 as of June 30, 2026, representing proceeds of the B Note held in a lender-controlled deposit account. We expect that our future available capital resources will consist primarily of cash generated from our operations, remaining cash balances, borrowings, and additional funds raised through sales of debt and/or equity securities.

Previous wording

Our primary objectives for the remainder of 2026 are expected to be the continued implementation of Scienture business plan, and to complete potential strategic transactions of our business-to-consumer subsidiaries, which may include a potential sale, spin-off, fund raising, combination or other strategic transaction. There can be no assurance that our operations will generate significant positive cash flow, or that additional funds will be available to us, through borrowings or otherwise, on favorable terms if required in the future, or at all. We may also raise additional funding in the future through the sale of equity securities.

Current wording

Our 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, or that additional funds will be available to us, through borrowings or otherwise, on favorable terms if required in the future, or at all. We may also raise additional funding in the future through the sale of equity securities.

Previous wording

We may require additional funding in the future to implement on our business plan and potentially to expand or complete acquisitions. The sources of this capital are expected to be equity investments and notes payable. Our plan for the next twelve months is to continue exploring strategic transactions or relationships with counterparties in industries that we deem synergistic or complimentary to those of the Company, while also seeking to expand our Scienture operations organically or through acquisitions, as funding and opportunities arise. In the event we require additional funding, we plan to raise that through the sale of debt or equity, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders. If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate future revenues.

Current wording

We may require additional funding in the future to implement on our business plan and potentially to expand or complete acquisitions. The sources of this capital are expected to be equity investments and notes payable. Our plan for the next twelve months is to continue exploring strategic transactions or relationships with counterparties in industries that we deem synergistic or complimentary to us, while also seeking to expand our operations organically or through acquisitions, as funding and opportunities arise. In the event we require additional funding, we plan to raise that through the sale of debt or equity, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders. If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate future revenues.

Previous wording

The accompanying interim consolidated financial statements have been prepared assuming that the Company 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 date the consolidated financial statements are issued. In accordance with Financial Accounting Standards Board, or the FASB, Accounting Standards Update No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.

Current wording

The 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 date the consolidated financial statements are issued. In accordance with Financial Accounting Standards Board, or the FASB, Accounting Standards Update No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.

Previous wording

As of March 31, 2026, the Company had an accumulated deficit of $83,953,501. As of March 31, 2026, the Company had $3,542,754 in cash.

Current wording

As of June 30, 2026, we had an accumulated deficit of $86,775,872. As of June 30, 2026, we had $8,188,140 in cash and $3,012,271 in restricted cash.

Previous wording

We will need to raise additional capital or secure debt funding to support on-going operations, and to fund the assets and operations of any businesses or assets we acquire. The sources of this capital are expected to be the sale of equity and debt, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders. If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate future revenues, our financial position, and liquidity. These factors raise substantial doubt about the ability of the Company to continue as a going concern. Unless management is able to obtain additional financing, it is unlikely that the Company will be able to meet its funding requirements during the next 12 months. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Current wording

We will need to raise additional capital or secure debt funding to support on-going operations, and to fund the assets and operations of any businesses or assets we acquire. The sources of this capital are expected to be the sale of equity and debt, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders. If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate future revenues, our financial position, and liquidity. While these factors initially indicated substantial doubt about the ability of the Company to continue as a going concern, management believes that its existing cash on hand, revenues from the commercialization of ARBLI™ (SCN-102) and REZENOPY™ (SCN-110) and its planned financing activities alleviate that doubt.

Previous wording

Cash used in operating activities for the three months ended March 31, 2026 was $2,919,255, compared to cash used in operating activities of $2,956,457 for the three months ended March 31, 2025. The slight decrease was primarily due to changes in working capital, partially offset by higher operating expenses during the 2026 period.

Current wording

Cash used in operating activities for the six months ended June 30, 2026, was $6,051,597, compared to cash used in operating activities of $4,990,704 for the six months ended June 30, 2025. The increase of $1,060,893 was primarily due to the $400,000 repayment of the development agreement liability and other changes in working capital, including reductions in accounts payable and accrued liabilities, partially offset by a lower net loss during the 2026 period.

Previous wording

There was no cash provided by or used in investing activities for the three months ended March 31, 2026 or 2025.

Current wording

There was no cash provided by or used in investing activities for the six months ended June 30, 2026, or 2025.

Previous wording

Cash used in financing activities for the three months ended March 31, 2026 was $200,000, compared to cash provided by financing activities of $4,697,999 for the three months ended March 31, 2025. Cash used in financing activities for the three months ended March 31, 2026 reflected the $200,000 repayment of the development agreement liability. Cash provided by financing activities for the three months ended March 31, 2025 was primarily attributable to gross proceeds of approximately $4,598,000 from the issuance of common stock pursuant to the equity line commitment, partially offset by other financing activity.

Current wording

Cash provided by financing activities for the six months ended June 30, 2026, was $10,590,000, compared to cash provided by financing activities of $4,697,999 for the six months ended June 30, 2025. Cash provided by financing activities for the six months ended June 30, 2026, reflected $10,590,000 of proceeds from the issuance of the Streeterville notes in April 2026, net of issuance costs. Cash provided by financing activities for the six months ended June 30, 2025, was primarily attributable to gross proceeds of approximately $4,598,000 from the issuance of common stock pursuant to an equity line commitment, partially offset by other financing activity.

Previous wording

Cost 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 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 31, 2025.

Current wording

Cost 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 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.

Previous wording

Technology 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. The decrease was primarily due to lower software-related expenses following the disposition of IPS in April 2025.

Current wording

Technology 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.

Previous wording

Research and development expense for the three months ended March 31, 2026 was $793,984, compared to $574,679 for the comparable period in 2025, an increase of $219,305. The increase was primarily due to higher contract research organization costs related to advancement of pipeline product candidates. Total expenses by program were as follows:

Current wording

Research 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. The increase was primarily attributable to higher contract research and contract manufacturing organization costs, which comprised substantially all of our research and development expense for the quarter, driven by the continued advancement of SCN-106 (Alteplase) and SCN-104 (DHE). We expect research and development expense to continue to increase as our product candidates advance. Total expenses by program were as follows:

Previous wording

Interest expense was $37,019 for the three months ended March 31, 2026, compared to $670,784 for the three months ended March 31, 2025. The decrease was primarily due to the repayment in full of the Arena convertible debentures during 2025 and the related cessation of debt discount amortization.

Current wording

Interest expense was $269,785 for the three months ended June 30, 2026, compared to $653,493 for the three months ended June 30, 2025. The decrease was primarily due to the repayment in full of certain convertible debentures during 2025 and the related cessation of debt discount amortization, partially offset by stated interest and debt discount amortization on the Streeterville notes issued in April 2026.

Previous wording

There 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 liability was fully derecognized in connection with the repayment of the Arena debentures during 2025. We recognized a gain on the change in the fair value of the derivative liability of $603,322 for the three months ended March 31, 2025.

Current wording

There 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 liability was fully derecognized in connection with the repayment of certain debentures during 2025. We recognized a loss on the change in the fair value of the derivative liability of $662,916 for the three months ended June 30, 2025.

Previous wording

During 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 months ended March 31, 2025. The increase in net loss of $338,267 was primarily attributable to the changes in operating expenses and non-operating income/(expense) discussed above.

Current wording

During 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 three months ended June 30, 2025. The decrease of $3,898,202 was primarily attributable to the increase in revenue and changes in operating expenses and non-operating income/(expense) discussed above.

Previous wording

Revenues 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 $46,067. The increase was primarily attributable to the continued ramp of wholesale distribution sales of SCN-102 (ARBLI™) following its commercial launch.

Current wording

Revenues 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 $389,706. The increase was primarily attributable to the continued ramp of wholesale distribution sales of SCN-102 (ARBLI™) following its commercial launch. As discussed above, our revenues remain concentrated among a small number of wholesale distributors.

Previous wording

Wage 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 period in 2025. The decrease was primarily due to lower headcount following the disposition of legacy subsidiaries in April 2025.

Current wording

Wage 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 comparable period in 2025. The decrease was primarily due to lower headcount following the disposition of legacy subsidiaries in April 2025. As discussed above, following the dispositions our workforce is concentrated in research and development, commercial and administrative functions, with outsourced commercial selling costs reflected in professional fees.

Showing the first 40 of 45 pairs. Open the source sections for the rest.

Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

We 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 to a gain of $76,122 for the three months ended June 30, 2025, in each case based on the underlying valuation inputs.

Current report — wording carried from elsewhere

Six Month Period Ended June 30, 2026 compared to Six Month Period Ended June 30, 2025

Current report — wording carried from elsewhere

Technology 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. The decrease was primarily due to lower software-related expenses following the disposition of IPS in April 2025.

Current report — wording carried from elsewhere

There 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 liability was fully derecognized in connection with the repayment of certain debentures during 2025. We recognized a loss on the change in the fair value of the derivative liability of $59,594 for the six months ended June 30, 2025.

Current report — wording carried from elsewhere

For 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 ended June 30, 2025. The decrease of $3,559,935 was primarily attributable to the changes in operating expenses and non-operating income/(expense) discussed above.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Subsequent to the disposition of IPS, Softell, and Bonum Health, Inc. we now exist as a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty pharmaceutical products to satisfy unmet market needs. We are in the process of winding down our Bonum Health, LLC subsidiary.

Previous report — wording carried elsewhere

Operating since 2019, Scienture, located in Commack, New York, is a specialty pharmaceutical company focused providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. In this regard, Scienture is 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 for hypertension, migraine, pain and thrombosis and other related disorders.