Scilex Holding Company announces filing of 10-Q, regaining Nasdaq compliance, focusing on non-opioid pain management innovations.
Quiver AI Summary
Scilex Holding Company, based in Palo Alto, California, announced the filing of its Quarterly Report for the quarter ending September 30, 2024, and anticipates regaining compliance with Nasdaq Listing Rule 5250(c)(1). The company focuses on developing non-opioid pain management products for acute and chronic pain, alongside planned initiatives in neurodegenerative and cardiometabolic diseases through a joint venture with IPMC Company. Scilex's current portfolio includes FDA-approved products like ZTlido®, ELYXYB®, and Gloperba®, as well as candidates in development such as SP-102, SP-103, and SP-104. The company emphasizes addressing significant market needs with innovative therapies while navigating potential risks related to compliance, market acceptance, and regulatory processes.
Potential Positives
- Scilex Holding Company has filed its Quarterly Report on Form 10-Q, indicating progress in financial reporting and corporate governance.
- The company expects to regain compliance with Nasdaq Listing Rule 5250(c)(1), which is a positive sign for its stock market standing.
- Scilex is focusing on non-opioid pain management solutions, addressing critical unmet medical needs in the pain management market.
- The formation of a proposed joint venture with IPMC Company could lead to the development of treatments for neurodegenerative and cardiometabolic diseases, potentially expanding Scilex's product offerings and market reach.
Potential Negatives
- Scilex is under scrutiny for its compliance with Nasdaq Listing Rule 5250(c)(1), indicating potential operational or financial issues that could affect its stability as a publicly traded company.
- The company faces significant risks related to the commercialization of its product candidates, including the unpredictability of developing effective therapies and the potential for unmet regulatory requirements.
- The press release contains a range of forward-looking statements that underscore the uncertainty surrounding Scilex’s future performance, suggesting that investors may need to exercise caution regarding the company's expected outcomes.
FAQ
What is Scilex Holding Company focused on?
Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain treatment.
What compliance status has Scilex achieved with Nasdaq?
Scilex expects to regain compliance with Nasdaq Listing Rule 5250(c)(1) following its latest Quarterly Report.
What key products does Scilex offer?
Scilex offers ZTlido®, ELYXYB®, and Gloperba®, along with several promising product candidates for pain management.
What is the purpose of the joint venture with IPMC Company?
The joint venture aims to focus on treatments for neurodegenerative and cardiometabolic diseases alongside existing pain management solutions.
How can I find more information about Scilex products?
You can visit Scilex's website and specific product pages for detailed information and prescribing information.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SCLX Insider Trading Activity
$SCLX insiders have traded $SCLX stock on the open market 10 times in the past 6 months. Of those trades, 10 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $SCLX stock by insiders over the last 6 months:
- JAISIM SHAH (See Remarks) has made 3 purchases buying 92,000 shares for an estimated $75,221 and 0 sales.
- YUE ALEXANDER WU purchased 20,000 shares for an estimated $18,992
- HENRY JI (Executive Chairperson) has made 2 purchases buying 18,888 shares for an estimated $18,061 and 0 sales.
- STEPHEN HOI MA (Chief Financial Officer) purchased 6,700 shares for an estimated $6,499
- JAY CHUN purchased 5,000 shares for an estimated $4,750
- DAVID LEMUS purchased 2,000 shares for an estimated $1,800
- DORMAN FOLLOWWILL purchased 1,000 shares for an estimated $990
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$SCLX Hedge Fund Activity
We have seen 31 institutional investors add shares of $SCLX stock to their portfolio, and 15 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC removed 8,440,000 shares (-70.6%) from their portfolio in Q3 2024, for an estimated $7,803,624
- MILLENNIUM MANAGEMENT LLC added 1,202,992 shares (+466.2%) to their portfolio in Q3 2024, for an estimated $1,112,286
- VANGUARD GROUP INC added 700,950 shares (+13.1%) to their portfolio in Q3 2024, for an estimated $648,098
- CITIGROUP INC added 479,630 shares (+577.3%) to their portfolio in Q3 2024, for an estimated $443,465
- CITADEL ADVISORS LLC added 437,558 shares (+275.9%) to their portfolio in Q3 2024, for an estimated $404,566
- LAURION CAPITAL MANAGEMENT LP removed 257,785 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $238,348
- JANE STREET GROUP, LLC removed 247,271 shares (-89.1%) from their portfolio in Q3 2024, for an estimated $228,626
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
PALO ALTO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease, today announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and expects to receive notification from The Nasdaq Stock Market LLC that it has regained compliance with Nasdaq Listing Rule 5250(c)(1).
For more information on Scilex Holding Company, refer to
www.scilexholding.com
For more information on Semnur Pharmaceuticals, Inc., refer to
www.semnurpharma.com
For more information on Scilex Holding Company Sustainability Report, refer to
www.scilexholding.com/investors/sustainability
For more information on ZTlido
®
including Full Prescribing Information, refer to
www.ztlido.com
.
For more information on ELYXYB
®
, including Full Prescribing Information, refer to
www.elyxyb.com
.
For more information on Gloperba
®
, including Full Prescribing Information, refer to
www.gloperba.com
.
https://www.facebook.com/scilex.pharm
https://www.linkedin.com/company/scilex-holding-company/
About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido
®
(lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB
®
, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba
®
, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.
Scilex Holding Company is headquartered in Palo Alto, California.
About Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica.
Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California.
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s expectation to receive notification from The Nasdaq Stock Market LLC that it has regained compliance with Nasdaq Listing Rule listing rule 5250(c)(1), and Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease.
Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to regain compliance with the Nasdaq continued listing standards and to maintain the listing of the Company’s securities thereon, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.
Contacts:
Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website:
www.scilexholding.com
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.
ZTlido
®
is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.
Gloperba
®
is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark.
ELYXYB
®
is a registered trademark owned by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2025 Scilex Holding Company All Rights Reserved.
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
