0001193125-23-268931.txt : 20231102 0001193125-23-268931.hdr.sgml : 20231102 20231102090103 ACCESSION NUMBER: 0001193125-23-268931 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20231102 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231102 DATE AS OF CHANGE: 20231102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Scilex Holding Co CENTRAL INDEX KEY: 0001820190 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39852 FILM NUMBER: 231370310 BUSINESS ADDRESS: STREET 1: 960 SAN ANTONIO ROAD CITY: PALO ALTO STATE: CA ZIP: 94303 BUSINESS PHONE: (650) 516-4310 MAIL ADDRESS: STREET 1: 960 SAN ANTONIO ROAD CITY: PALO ALTO STATE: CA ZIP: 94303 FORMER COMPANY: FORMER CONFORMED NAME: Scilex Holding Company/DE DATE OF NAME CHANGE: 20221117 FORMER COMPANY: FORMER CONFORMED NAME: Vickers Vantage Corp. I DATE OF NAME CHANGE: 20200804 8-K 1 d545216d8k.htm 8-K 8-K
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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): November 2, 2023

 

 

SCILEX HOLDING COMPANY

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39852   92-1062542

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

960 San Antonio Road, Palo Alto, California, 94303

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (650) 516-4310

N/A

(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:

 

☐

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 $0.0001 per share   SCLX   The Nasdaq Stock Market LLC
Warrants to purchase one share of common stock, each at an exercise price of $11.50 per share   SCLXW   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 8.01.

Other Events.

On November 2, 2023, Scilex Holding Company (the “Company”) issued a press release announcing the Company has reached agreement with the U.S. Food and Drug Administration (FDA) on the path forward to advance the clinical development for SP-102 (SEMDEXA) in Lumbosacral Radicular Pain and on the requirements to file a New Drug Application. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

   

Description

99.1    Press Release, dated November 2, 2023.
104    Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

2

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.

 

SCILEX HOLDING COMPANY
By:  

/s/ Jaisim Shah

Name:   Jaisim Shah
Title:   Chief Executive Officer & President

Date: November 2, 2023

 

3

EX-99.1 2 d545216dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO   

 

FOR IMMEDIATE RELEASE   

 

November 2, 2023

Scilex Holding Company Announces Positive Type C Meeting with the FDA and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica)

PALO ALTO, CA. November 2, 2023 /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, today announced a positive Type C meeting with the U.S. Food and Drug Administration (“FDA”). The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (“NDA”).

Recently, during the Type C meeting with the FDA, the Company received an advisement on expectations and requirements to file the NDA, including clinical and preclinical data. Scilex intends to file the SP-102 NDA utilizing the 505(b)(2) regulatory pathway to reference the currently approved drug, Dexamethasone sodium phosphate injection. The FDA provided guidance regarding expectations for the size of safety database needed prior to the NDA filing and circumstances under which one adequate and well-controlled trial would be sufficient for product registration. Based on the advisement received, Scilex is planning to commence an open-label multi-center safety and efficacy trial in the first half of 2024 in which it will seek to enroll approximately 700 patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection. SP-102 (SEMDEXA™) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment in the trial is projected to occur in 2025.

“We are very pleased with the outcome of our recent Type C meeting with the FDA, and are excited to progress the SP-102 development program forward with a clear path to product registration, as advised by the FDA, enhancing safety database and generating new data to reflect how epidural steroid injections are currently being used in clinical practice,” said Dmitri Lissin, MD, Chief Medical Officer and Senior Vice President of Clinical Development and Medical Affairs.

“We are anxiously awaiting a new injectable gel formulation of dexamethasone. If approved by the FDA, SP-102 would be the first corticosteroid with an indication for epidural administration in the U.S., resulting in rapid pain relief and addressing safety issues with off-label steroid preparations. SP-102 would be a welcome addition to the armamentarium of interventional pain physicians, providing a non-surgical, non-opioid alternative for a condition affecting millions of people,” said Dr. Steven P. Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology, Physical Medicine & Rehabilitation, and Psychiatry & Behavioral Sciences at the Johns Hopkins School of Medicine, and a Professor of Anesthesiology and Physical Medicine & Rehabilitation at Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.

 

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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. Scilex is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica) with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido® in October 2018, in-licensed a commercial product Gloperba® in June 2022, and launched its third FDA-approved product Elyxyb™ in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize Elyxyb™ (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched Elyxyb™ in April 2023, and is planning to commercialize Gloperba® by 2024, and is well-positioned to market and distribute those products. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2 study, triple-strength formulation of ZTlido®, for the treatment of chronic neck pain, with FDA Fast Track status. We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved its objectives characterizing safety, tolerability and preliminary efficacy of SP-103 in acute low back pain associated with muscle spasms. SP-103 was safe and well-tolerated. Increase of lidocaine load in topical system by three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. We will continue to analyze the SP-103 Phase 2 trial data along with a recently completed investigator study of ZTlido in patients with chronic neck pain which also has showed promising top-line efficacy and safety results. Scilex is planning to initiate Phase 2/3 trial in chronic neck pain in 2024; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2024.

Scilex Holding Company is headquartered in Palo Alto, California.

 

Page | 2

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 the Company’s expectations for the design and timing of the open-label multi-center safety and efficacy trial of SP-102 for patients with moderate-to-severe LRP, the expected size and timing of enrollment thereof, the expected timing for filing an NDA for SP-102, the potential of SP-102 to offer unique or meaningful therapeutic benefits to patients, Scilex’s plans to initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that it is well positioned to continue its growth over the next several years, Scilex’s long-term objectives and commercialization plans, Scilex’s potential to attract new capital, future opportunities for Scilex, Scilex’s future business strategies, the expected cash resources of Scilex and the expected uses thereof; Scilex’s current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido®, Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s development and commercialization plans; and Scilex’s products, technologies and prospects.

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: 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 the ongoing COVID-19 pandemic; 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 for SP-102, SP-103 or SP-104 may not be successful; risks that the prior results of the clinical 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 set forth in Scilex’s filings with the Securities and Exchange Commission. 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.

 

Page | 3

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 use the registered trademark by Scilex Holding Company.

ELYXYB® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2023 Scilex Holding Company All Rights Reserved.

 

Page | 4

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Document and Entity Information
Nov. 02, 2023
Document And Entity Information [Line Items]  
Entity Registrant Name Scilex Holding Co
Amendment Flag false
Entity Central Index Key 0001820190
Document Type 8-K
Document Period End Date Nov. 02, 2023
Entity Incorporation State Country Code DE
Entity File Number 001-39852
Entity Tax Identification Number 92-1062542
Entity Address, Address Line One 960 San Antonio Road
Entity Address, City or Town Palo Alto
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94303
City Area Code (650)
Local Phone Number 516-4310
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Entity Ex Transition Period true
Common Stock Par Value 0.0001 Per Share [Member]  
Document And Entity Information [Line Items]  
Security 12b Title Common stock, par value $0.0001 per share
Trading Symbol SCLX
Security Exchange Name NASDAQ
Warrants To Purchase One Share Of Common Stock Each At An Exercise Price Of 11.50 Per Share [Member]  
Document And Entity Information [Line Items]  
Security 12b Title Warrants to purchase one share of common stock, each at an exercise price of $11.50 per share
Trading Symbol SCLXW
Security Exchange Name NASDAQ
XML 9 d545216d8k_htm.xml IDEA: XBRL DOCUMENT 0001820190 2023-11-02 2023-11-02 0001820190 sclx:CommonStockParValue0.0001PerShareMember 2023-11-02 2023-11-02 0001820190 sclx:WarrantsToPurchaseOneShareOfCommonStockEachAtAnExercisePriceOf11.50PerShareMember 2023-11-02 2023-11-02 Scilex Holding Co false 0001820190 8-K 2023-11-02 DE 001-39852 92-1062542 960 San Antonio Road Palo Alto CA 94303 (650) 516-4310 false false false false Common stock, par value $0.0001 per share SCLX NASDAQ Warrants to purchase one share of common stock, each at an exercise price of $11.50 per share SCLXW NASDAQ true true EXCEL 10 Financial_Report.xlsx IDEA: XBRL DOCUMENT begin 644 Financial_Report.xlsx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