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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 13, 2026
SCIENTURE
HOLDINGS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
| Delaware |
|
001-39199 |
|
46-3673928 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
No.) |
|
(I.R.S.
Employer
Identification
No.) |
20
Austin Blvd.
Commack,
NY 11725
(Address
of Principal Executive Offices)
(631)
670-6039
(Registrant’s
Telephone Number)
Not
Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
stock, par value $0.00001 per share |
|
SCNX |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On
October 13, 2026, Scienture Holdings, Inc. issued a press release announcing certain preliminary financial results for the quarter ending
September 30, 2026, and other recent operational highlights. A copy of the press release is furnished as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference.
The
information in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item
3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
As
previously disclosed, on October 14, 2025, Scienture Holdings, Inc. (the “Company”) received a written notice
from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”)
indicating that the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”),
as the minimum bid price of the Common Stock had been below $1.00 per share for 30 consecutive business days. In accordance with Nasdaq
Listing Rule 5810(c)(3)(A), the Company was provided an initial compliance period of 180 calendar days, or until April 14, 2026, to regain
compliance with the Minimum Bid Price Requirement. The Company subsequently was provided an additional 180 calendar day compliance period,
or until October 12, 2026, to regain compliance with the Minimum Bid Price Requirement.
On
October 19, 2026, the Company received written notice from the Staff stating Nasdaq has determined that the closing bid price of the
Company’s shares of common stock was at least $1.00 per share for the ten consecutive trading days between October 5, 2026 and
October 16, 2026 (the “Compliance Notice”). Accordingly, the Company has regained compliance with the Minimum
Bid Price Requirement.
Prior
to receiving the Compliance Notice, the Company received a determination letter from the Staff notifying the Company that it had not
regained compliance with the Minimum Bid Price as of the end of the second compliance period on October 12, 2026. However, the Company
subsequently regained compliance with the Minimum Bid Price Requirement as confirmed in the Compliance Notice. As a result, Nasdaq has
determined that this matter is now closed and the Company’s securities will remain listed for trading on Nasdaq.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Press Release, dated October 13, 2026. |
| 104 |
|
Cover
Page Interactive Data File (embedded with the Inline XBRL document). |
Forward
Looking Statements
This
Current Report on Form 8-K contains certain statements that may be deemed to be “forward-looking statements” within the federal
securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are
not historical are forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange.
Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements
are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our
beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our management team’s
expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the success those
products may have in the marketplace, such as Arbli™ and REZENOPY™, and our strategies related to those products. In addition,
any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying
assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “ongoing,” “plan,” “potential,” “predict,” “project,”
“should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that
a statement is not forward-looking. These statements are based on our expectations and involve risks, uncertainties and other important
factors that could cause our actual results performance or achievements (or entities in which we have an interest), or industry results,
to differ materially from future results, performance or achievements expressed or implied by such forward-looking statements. Certain
factors that could cause our actual future results to differ materially from those discussed are noted in connection with such statements,
but other unanticipated factors (including those beyond our control) could arise. Certain risks regarding our forward-looking statements
are discussed in our filings with the Securities and Exchange Commission, including an extensive discussion of these risks in our Annual
Report on Form 10-K for the year ending December 31, 2025, as amended, and subsequent Quarterly Reports on Form 10-Q. Readers are cautioned
not to place undue reliance on these forward-looking statements which reflect management’s view only as of the date of this Current
Report on Form 8-K. We undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events
or circumstances after the date hereof or to reflect the occurrence of unanticipated events, conditions or circumstances.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
SCIENTURE
HOLDINGS, INC. |
| |
|
|
| |
By:
|
/s/
Dr. Narasimhan Mani |
| |
|
Dr.
Narasimhan Mani |
| |
|
Co-Chief
Executive Officer |
| |
|
|
| Date:
October 19, 2026 |
|
|
Exhibit
99.1
Continued
Arbli™ sales growth, combined with REZENOPY™ commercial launch in August 2026
and initial wholesale
shipments, drives significant sequential revenue growth
Arbli™
wholesale unit sales increased 74% sequentially, with recent institutional formulary
additions supporting continued commercial expansion
COMMACK,
NY, Oct. 13, 2026 (GLOBE NEWSWIRE) — SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) (“Scienture”), a holding company for
existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through
the development, commercialization, and distribution of novel specialty products that address unmet market needs, today announced preliminary,
unaudited revenue of approximately $1.22 million for the third quarter ended September 30, 2026, representing an increase of 256% compared
to approximately $344,000 in the second quarter of 2026.
The
substantial sequential increase in preliminary revenue reflects the successful commercial launch of REZENOPY™ and initial
wholesale shipments, as well as continued sales growth and increasing market adoption of Arbli™. These results mark
an important milestone in Scienture’s commercial expansion, reflecting the addition of a second FDA-approved product and continued
progress toward building a diversified, multi-product pharmaceutical portfolio.
“These
preliminary third-quarter revenue results mark a significant inflection point for Scienture, demonstrating the accelerating commercial
momentum of our expanding pharmaceutical portfolio,” said Narasimhan Mani, President and Co-Chief Executive Officer of Scienture
Holdings. “With Arbli™ continuing to gain traction and REZENOPY™ becoming our second commercial-stage
product following its August 2026 launch, we believe Scienture is well-positioned to meaningfully accelerate top-line revenue growth
through the remainder of 2026 and into 2027. As we work to expand our distribution channels and drive commercial adoption, we believe
our historically high gross margins will provide significant operating leverage, supporting our goal of achieving profitability in 2027.”
“Our
preliminary third-quarter revenues reflect the progress we have made in executing our commercial strategy and establishing Scienture
as a growing specialty pharmaceutical company,” said Shankar Hariharan, Executive Chairman and Co-Chief Executive Officer of Scienture
Holdings. “Looking ahead, we see significant opportunities to further penetrate our addressable markets, particularly as we focus
on increasing institutional adoption, expanding healthcare provider engagement and entering strategic commercial partnerships. With two
differentiated FDA-approved products addressing important unmet needs commercialized, we believe Scienture is well-positioned to build
a sustainable, high-value pharmaceutical business and deliver long-term value to shareholders.”
The preliminary revenue figures described in this press release are unaudited and subject to customary adjustments. The Company’s
full financial results for Q3 2026 will be included in a Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission
in accordance with federal securities rules and regulations.
About
Arbli™
Arbli™
is a novel proprietary formulation of losartan, a widely prescribed angiotensin receptor blocker (ARB) for hypertension. It is the first
and only liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf
life at room temperature storage. Arbli™ is FDA-approved for the treatment of hypertension in patients greater than
six years old, for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for treating diabetic
nephropathy in certain patients with type 2 diabetes. By offering a safe, effective, and convenient liquid alternative, Arbli™
provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, Arbli™
provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded
losartan prescriptions. Arbli™ has two issued patents from the USPTO, which are also listed in the FDA Orangebook.
Arbli™
is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli™ comes in a 165 mL bottle
as a peppermint flavored suspension that does not require refrigeration and has been approved for a shelf life of 24 months from the
date of manufacture when stored at room temperature.
INDICATION
Arbli™
is an angiotensin II receptor blocker (ARB) indicated for:
| | ● | Treatment
of hypertension, to lower blood pressure in adults and children greater than 6 years old.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily
strokes and myocardial infarctions. |
| | | |
| | ● | Reduction
of the risk of stroke in patients with hypertension and left ventricular hypertrophy. |
| | | |
| | ● | Treatment
of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with
type 2 diabetes and a history of hypertension. |
IMPORTANT
SAFETY INFORMATION
| | ● | Do
not take Arbli™ when pregnant. When pregnancy is detected, discontinue Arbli™
as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury
and death to the developing fetus. Arbli™ can cause fetal harm when
administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during
the second and third trimesters of pregnancy reduces fetal renal function and increases fetal
and neonatal morbidity and death. |
| | | |
| | ● | Do
not co-administer Arbli™ with aliskiren in patients with diabetes. Avoid
use of aliskiren with Arbli™ in patients with renal impairment (GFR <60 mL/min). |
| | | |
| | ● | Do
not administer Arbli™ in patients with severe hepatic impairment. Arbli™
has not been studied in patients with severe hepatic impairment. |
| | | |
| | ● | The
most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness,
upper respiratory infection, nasal congestion, and back pain. |
You
are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You may also contact Scienture at 1-833-754-4917.
Please
see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.
About
Hypertension
Hypertension
(high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According
to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or approximately 119.9 million
people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher.
Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk
of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and
drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic
blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
About
REZENOPY™
REZENOPY™
(naloxone hydrochloride) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid
overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate
administration as emergency therapy in settings where opioids may be present.
REZENOPY™
nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.
IMPORTANT
SAFETY INFORMATION
REZENOPY™
(naloxone hydrochloride) Nasal Spray 10 mg is an opioid antagonist indicated for the emergency treatment of known or suspected opioid
overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate
administration as emergency therapy in settings where opioids may be present and is not a substitute for emergency medical care.
Important
Safety Information
| | ● | Contraindications:
REZENOPY™ nasal spray is contraindicated in patients known to be hypersensitive
to naloxone hydrochloride or to any of the other ingredients. |
| | | |
| | ● | Warnings
and Precautions: |
| | | |
| | ● | Risk
of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative
to the opioid, keep the patient under continued surveillance and administer additional doses
as necessary while awaiting emergency medical assistance. |
| | | |
| | ● | Risk
of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory
depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine
and pentazocine, may be incomplete. Larger or repeat doses may be required. |
| | | |
| | ● | Precipitation
of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid
withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and
properly treated. Monitor for the development of opioid withdrawal. |
| | | |
| | ● | Risk
of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result
in adverse cardiovascular effects. These events have primarily occurred in patients who had
pre-existing cardiovascular disorders or received other drugs that may have similar adverse
cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting
after use of naloxone hydrochloride. |
| | | |
| | ● | Adverse
Reactions: The following adverse reactions were observed in a REZENOPY™
nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia. |
For
complete product information, including Patient Information, please refer to the full Prescribing Information.
About
Scienture Holdings, Inc.
SCIENTURE
HOLDINGS, INC. (NASDAQ: SCNX), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company
focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market
needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals
who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare
systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and
channels. For more information please visit: www.scientureholdings.com and www.scienture.com.
Cautionary
Statements Regarding Forward-Looking Statements
This
press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities
laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical
are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking
statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry,
our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management
team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the
success those products may have in the marketplace, such as Arbli™ and REZENOPY™, and our strategies
related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking
statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,”
“project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words
does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties
(some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or
implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These
risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of
such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain
of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Stock Market LLC; claims relating to
alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings
that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed
in our most recent Annual Report on Form 10-K, as amended, and subsequent reports filed with the Securities and Exchange Commission.
Forward-looking
statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided
by law.
Contact:
SCIENTURE
HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Email: IR@Scienture.com
