Scilex - SCLX - US80880W1062

[Steven]

Vandaag 11% in het rood om wat? Ik heb alleen dit nieuws kunnen vinden:


Scilex Holding Company and CH Trading Group Announce Territory Distribution Agreement to Expand Commercialization of ZTlido® for the Middle East and North Africa (MENA) With $105 Million Minimum Multi-Year Purchase Commitment
Scilex Holding Company
Wed, March 8, 2023 at 4:13 PM GMT+1·8 min read

CH Trading Group will serve as exclusive territories distributor in the Middle East and North Africa countries with US $105 million minimum purchase commitment.

CH Trading Group to immediately start the process to expand commercialization of ZTlido® in Middle East and North Africa markets and has the opportunity to distribute across the broader Islamic world and further expand the relationship for other products in Scilex’s non-opioid pain portfolio.

PALO ALTO, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced territory distribution agreement for ZTlido® in the Middle East and North Africa with $105 million minimum purchase commitment over 5 years. CH Trading Group will serve as exclusive territories distributor and will provide open access across the Middle East and North Africa markets and the broader Islamic world. Scilex has the opportunity to expand across other products in their non-opioid pain management portfolio.

“Based on market demand for Scilex’s innovative non-opioid pain management products, we believe there is a significant commercial opportunity across the Middle East and North Africa markets,” said Sayad Zeyan, CEO of CH Trading Group. “We are excited to be in a position with our partners to expand access to ZTlido patches and in the future other important pain solutions with Scilex.”

According to the most recent analysis by Precedence Research March 2022 Pain Management Therapeutics Market Size, the pain management market size is estimated to reach US$101.27 billion by 2029 and growing at a CAGR of 4.3% from 2022 to 2030.1

ZTlido® is a lidocaine topical system approved for the relief of neuropathic pain associated with PHN. ZTlido® was strategically designed to address the limitations of current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief throughout the 12-hour administration period.

“We are pleased to further our partnership with the CH Group which represents another critical milestone towards bringing our innovative Circle H International halal certified non-opioid pain management medicines to ex-US markets,” said Jaisim Shah, Chief Executive Officer and President of Scilex.

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 has applied for breakthrough therapy designation and expects to seek priority review for SEMDEXA™ for the treatment of sciatica. 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 in October 2018, in-licensed a commercial product in June 2022, and is 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 postherpetic 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 is planning to commercialize Gloperba® in 2023 and is well-positioned to market and distribute the product. Scilex also in-licensed exclusive rights to 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’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, triple-strength formulation of ZTlido®, for the treatment of low back pain, with FDA Fast Track status; 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 expected to initiate Phase 2 trials this year. For further information regarding the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161 – Corticosteroid Lumbar Epidural Analgesia for Radiculopathy – Full Text View – ClinicalTrials.gov.

Scilex Holding Company is headquartered in Palo Alto, California. For further information please visit www.scilexholding.com.

About CH Trading Group

CH Trading Group LLC ("CH Trading") is part of the CH Group family of companies (www.chgroupus.com). CH Group constitutes a diversified conglomerate targeting eight economic "Sectors": healthcare, pharmaceuticals, food, finance, cosmetics, tourism, fashion, media/entertainment. Spanning a variety of multi-national products, services and solutions, its world mission involves connecting, developing and promoting, from Local to Global™ and throughout the world, all aspects of a wholesome, healthy and productive lifestyle.

CH Trading focuses on international import/export and trade, prioritizing the countries of the Organization of Islamic Cooperation (OIC), as well as the Middle East and North Africa (MENA) and Gulf Cooperation Council (GCC) Regions. It has responded to worldwide demands for identifying and securing supply chains by introducing innovative products, including from the US, and developing a robust distribution network for goods.

To learn more, visit www.chgroupus.com.

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 their 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 potential plans and timing to launch ELYXYB™, the status of Scilex’s negotiations of a distribution agreement with a major third-party logistics provider, ELYXYB™’s potential to further expand Scilex’s non-opioid portfolio and increase Scilex’s revenue, cash flow and earnings, the potential market size for U.S. oral migraine drugs and for pain management therapeutics, Scilex’s long-term objectives and commercialization plans, including the re-launch plans for ELYXYB™, 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 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 that Scilex may not achieve the results expected from the commercialization of ELYXYB™; 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 results of the Phase 2 trial for SP-103 or Phase 1 trials for 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 SEC. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as may be required by law.

[Steven]

Ik ben vergeten het ISIN nummer in de titel toe te voegen: US80880W1062

[Steven]

Meer over Scilex:

Scilex Holding Company, een biofarmaceutisch bedrijf, richt zich op het ontwikkelen en commercialiseren van niet-opioïde managementproducten voor de behandeling van acute en chronische pijn. Het commerciële product is ZTlido 1,8%, een lidocaïne-topisch product op recept voor de verlichting van neuropathische pijn die verband houdt met postherpetische neuralgie, een vorm van zenuwpijn na gordelroos. Het biedt ook SP-102, een stroperige gelformulering van corticosteroïden voor epidurale injecties die zich in een fase III klinische studie bevindt om lumbosacrale radiculaire pijn te behandelen; SP-103, dat zich in Fase II klinisch onderzoek bevindt voor de behandeling van lage rugpijn; en SP-104, een nieuwe lage dosis naltrexonhydrochlorideformulering met vertraagde afgifte die de klinische fase I-studie voor de behandeling van fibromyalgie heeft voltooid. Het hoofdkantoor van het bedrijf bevindt zich in Palo Alto, Californië.

[ancaoli]

Bij Sorrento is het ook altijd sell on news, niets speciaals wat mij betreft. Ik kijk momenteel ook amper naar die koers; mijn aandelen zijn niet verhandelbaar en staan op 0.

[neku]

Houd ook rekening met het "nieuws van de dag" zoals welke kleur scheet Powell laat

Heeft meer effect op bio en tech in het algemeen

[Nico F.]

De agenda van de aandeelhoudersvergadering op 6 april en de regels rond het kunnen stemmen.

https://www.sec.gov/Archives/edgar/data ... def14a.htm

Zoals verwacht, niets bijzonder op de agenda.
Met punt 4 laten ze wel open dat er nog een agendapunt kan toegevoegd worden als het nodig is.

1.
To elect two Class I directors to serve until the 2026 annual meeting of stockholders and until their successors are duly elected and qualified;

2.
To ratify the appointment of Ernst & Young LLP as our independent registered public accounting firm for our fiscal year ending December 31, 2023;

3.
To approve the amendment to the Scilex Holding Company 2022 Equity Incentive Plan to (i) increase the number of shares authorized for issuance thereunder by 10,000,000 shares to 30,276,666 shares, (ii) increase the number of shares authorized for issuance thereunder pursuant to the exercise of incentive stock options (“ISOs”) to 30,276,666 shares, and (iii) modify the commencement date of the automatic increase in the number of shares authorized for issuance thereunder pursuant to the exercise of ISOs to January 1, 2024; and

4.
To transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof.

Toch ben ik benieuwd waarom ze deze vergadering vervroegd hebben.

[Nico F.]

Een niet bevestigd bericht of het over semdexa gaat (gekopieerd van reddit), maar verschillende boards lijken het toch wel te concluderen.
In een uitgegeven scilex PR wordt er in de "kleine" lettertjes verwezen naar een eventuele afspraak met de FDA over een nieuw type goedkeuring (D) voor een medicijn.

Daar semdexa zowat het enige scilex medicijn is dat op korte termijn een goedkeuring zoekt, is de kans wel bestaande dat het hierover gaat.

Een approval voor semdexa zal dan de eerste maanden wss niet uit de lucht vallen.

Surprised no one, myself included, picked up on this little nugget in today’s Scilex PR. Credit to ididathing9999 on ST for the catch!

“Scilex intends to submit a request to the FDA for a Type D meeting for purposes of pre-NDA discussion with the FDA.”

Apparently this is a new pre NDA type meeting that’s designed for speed and efficiency under certain circumstances with the goal to respond to the meeting request within 14 days and hold the meeting within 50 days. Here’s a link that explains a lot more.

Click for more info on FDA Type D Meetings

So perhaps this can quell the speculation as to whether or not a rolling NDA has already started. It doesn’t look like it but at least we have a better understanding of where we are in the Semdexa process!

See the “About” section at the bottom of today’s PR

https://www.scilexholding.com/scilex-ho ... -products/

[ancaoli]

Uit de Scilex filing vandaag!

Results of Operations and Financial Condition.
Scilex Holding Company (the “Company”) is providing certain preliminary unaudited financial results for the three months ended March 31, 2023, and as of March 31, 2023, based on currently available information. The Company’s independent auditor has not reviewed or audited these preliminary estimated financial results. The Company’s actual results may differ materially from these preliminary financial results, and may be outside the estimated ranges. This preliminary financial data has been prepared by and is the responsibility of the Company. The Company has not fully completed its review of these preliminary financial results for the three months ended March 31, 2023, and as of March 31, 2023.
The Company estimates that: ZTlido gross sales for the first quarter of 2023 were in the range of $26.7 million to $28.3 million, compared to $18.4 million in the first quarter of 2022, representing growth in the range of 45% to 54%; net sales for the first quarter of 2023 were in the range of $9.9 million to $11.0 million, compared to net sales of $6.8 million in the first quarter of 2022, representing growth in the range of 45% to 62%. Historically, sales for ZTlido are low during the first quarter of the year due to deductibles with managed healthcare plans.
In accordance with General Instructions B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K 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 liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

[ancaoli]

Sorrento Therapeutics, Inc.'s Bankruptcy Court Requires Brokerages to Provide Information Related to Scilex Common Stock
NEWS PROVIDED BY
Sorrento Therapeutics, Inc.
Apr 04, 2023, 13:49 ET
SAN DIEGO, April 4, 2023 /PRNewswire/ -- Sorrento Therapeutics, Inc. (OTC: SRNEQ, "Sorrento"), a biopharmaceutical company dedicated to the development of life-saving therapeutics to treat cancer, intractable pain, and infectious disease, today announced that the U.S. Bankruptcy Court for the Southern District of Texas entered an order requiring the top 25 brokers, dealers, banks, and other nominees that act as agents for Sorrento shareholders (the "Brokerages") to provide Sorrento with information related to the common stock of Scilex Holding Company (NASDAQ: SCLX, "Scilex"), in connection with Sorrento's chapter 11 case that was filed on February 13, 2023.

As previously disclosed, on December 30, 2022, Sorrento announced a dividend to its shareholders of 76 million shares of common stock of Scilex, a substantial amount of which was distributed to the Brokerages, who hold the distributed shares in custody as agents for Sorrento shareholders. The Brokerages, however, have failed to report the ownership of such shares to Broadridge Financial Solutions, Inc., the entity designated to collect, verify, and tabulate shareholder votes for Scilex's annual shareholder meeting on April 6, 2023. The Bankruptcy Court's order requires the Brokerages to provide Sorrento certain information regarding the ownership and trading of Scilex common stock.

As previously disclosed, due to the possibility of certain actions by a litigation creditor, Sorrento and its wholly-owned, non-operating subsidiary Scintilla Pharmaceuticals, Inc. sought chapter 11 relief to safeguard its business and ensure the continuation of business operations, while protecting and maximizing value for stakeholders. Scilex is not a debtor in the chapter 11 case.

[ancaoli]

Squeeze begint stilletjes aan ; + 20%