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SCILEX, A SORRENTO COMPANY, ANNOUNCES INITIATION OF A PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SP-103 IN SUBJECTS WITH ACUTE LOW BACK PAIN
Dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial will enroll 80 patients with acute lower back pain.
SP-103 is a pharmacologically validated drug candidate and has the potential as a best-in-class agent of pain treatment for low back pain without the limitations of current therapies, including the addictive potential of opioids.
An estimated 65 million adults in the U.S., or 25% of U.S. adults, suffer from acute low back pain 1 with a total potential global market opportunity of approximately $10.0 billion by 2026 (Brand Essence Research 2020).
PALO ALTO, Calif., May 18, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100% or over 99.9% majority-owned subsidiary of Sorrento Therapeutics, Inc.) (Nasdaq: SRNE, “Sorrento”) and a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with acute LBP.
“It is a significant milestone for Scilex to begin the next development phase of the triple-dose strength of FDA-approved ZTlido ® (lidocaine topical system) 1.8% (“ZTlido ® ”). Most of the off-label use of topical lidocaine products is for the treatment of LBP. However, the low dosage strength of existing lidocaine products does not always provide sufficient pain relief 3 . A higher concentration of lidocaine per given area of a patch may lead to better efficacy and provide evidence for registering SP-103 for the treatment of acute LBP in patients with mostly superficial muscular pain. Based on the favorable data from the pharmacokinetics study, Scilex is advancing this program into Phase 2 with initiation of the study in LBP patients,” said Dr. Dmitri Lissin, Chief Medical Officer of Scilex.
“It is exciting to see a product in development with a higher concentration of lidocaine and great adhesion qualities. This product may greatly help patients with muscular pain in the lower back, and may also help to avoid use of systemic medications, associated with systemic side effects, including opioids,” said Alan Miller, M.D., Director of Interventional Pain Management at Coastal Spine & Pain Center, Fernandina Beach, Florida.
Scilex’s current marketed product, ZTlido (lidocaine topical system), has label claims regarding superior adhesion qualities as compared to other products and SP-103 has the same adhesion characteristics.
“SP-103 has the potential to meet our core goal of developing best-in-class pain management therapies to significantly improve the lives of patients with LBP who are seeking new effective treatments. Scilex is excited about this potentially safe and effective treatment without the limitations of currently used off-label therapies, including opioids with risks of abuse and addiction. ZTlido is already approved for use of up to 3 patches at once with proven safety. We believe that one SP-103 patch with the same systemic exposure to lidocaine may have a good probability of efficacy in this indication with a very low risk for safety concerns,” said Jaisim Shah, Chief Executive Officer of Scilex.
Scilex is developing SP-103 to be a triple-strength, non-aqueous lidocaine topical system for the treatment of acute LBP. Acute LBP can range in intensity from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. It is estimated that approximately 65 million adults in the U.S., or 25% of U.S. adults, suffer from acute back pain 1 with a total potential global market opportunity of approximately $10.0 billion by 2026.
There are currently no approved non-NSAID (non-steroidal anti-inflammatory drugs) pharmaceutical treatments specifically indicated for the treatment of acute LBP. The market we intend to address with SP-103, if approved, includes etiologies that are currently treated with non-procedural or non-surgical interventions, and where available treatments provide inadequate pain relief or result in unacceptable adverse effects. These treatments may include NSAIDs, antidepressants and opioids, as well as off-label use of lidocaine patches.
The safe and effective treatment of acute LBP represents high unmet needs and creates a large market opportunity. LBP is one of the costliest benign conditions in industrialized countries. Experts have estimated that approximately 80% of Americans will experience LBP during their lifetime. The annual prevalence of LBP is 15% to 45% with a point prevalence of approximately 30% in the United States. Sixty percent of those who suffer from acute LBP recover in six weeks and up to 80-90% recover within 12 weeks 2 . However, the recovery of the remaining patients with LBP is less certain. LBP accounts for 19% of all workers' compensation claims in the United States. Americans spent at least $135 billion in 2016 on treating low back and neck pain, which was the highest expenditure among 154 conditions studied by the Department of the Institute for Health Metrics and Evaluation at the University of Washington.
Scilex’s triple-strength SP-103 is an investigational, non-aqueous lidocaine topical system undergoing clinical development in acute LBP conditions. SP-103 builds on the learnings from ZTlido because both products share the same adhesive drug delivery formulation and manufacturing technology. If approved, we believe that SP-103 could become the first-in-class lidocaine topical product for acute LBP indications. All current uses of topical lidocaine products for acute LBP are off label. SP-103 has three times the drug load of ZTlido (108 mg versus 36 mg) in the same adhesive system to potentially deliver threefold the level of the drug within a targeted area, still with the convenience of a single topical system. Additionally, SP-103 is designed to deliver a localized dose of lidocaine that is three times greater than any lidocaine topical product that we are aware of either on the market or in development. If approved, we believe SP-103 may be able to address the limitations of prescription lidocaine patches in treating acute LBP by delivering a higher dose of lidocaine to the application site. As part of the lifecycle management, Scilex will also target localized musculoskeletal pain, acute and chronic pain conditions, and post operation pain management to focus on developing and commercializing non-opioid therapies for patients with acute and chronic pain. Scilex expects to complete this trial in one year. The outcome should enable planning of subsequent phase 3 trial(s).
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“Vickers”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol “SCLX” and “SCLXW”, respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of Vickers’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com .
SORRENTO THERAPEUTICS, INC. APPOINTS FORMER ROCHE EXECUTIVE TAMMY REILLY TO THE BOARD OF DIRECTORS
SAN DIEGO, May 18, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc (Nasdaq: SRNE, “Sorrento”), a commercial and clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies and diagnostics, announced today the appointment of former Roche Laboratories executive, Tammy Reilly, to Sorrento’s board of directors. Ms. Reilly brings more than 30 years of life science, big pharma and operating leadership experience within healthcare therapeutics, consumer merchandising and healthcare diagnostic companies to Sorrento.
“Sorrento continues to strengthen its already experienced board of directors,” said Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento. “We are excited to welcome Tammy who is a proven executive and entrepreneur. Tammy brings deep business and operating experience in innovative therapeutics, consumer merchandising and diagnostics, which will complement the existing capabilities of our board in several key areas. With the pivotal progress we have made with our late-stage clinical programs and the diagnostics commercialization underway worldwide, this is an important time for Sorrento and we look forward to continuing on our mission of advancing promising new targeted therapies and diagnostics for a vast majority of patients of all ages.”
Ms. Reilly is the managing partner of a life sciences advisory company, TRDx LLC, an independent firm that she founded 15 years ago to advise life science companies on life cycle management and business development solutions, which includes advice on mergers and acquisitions and strategic and capital markets transactions. Prior to founding TRDx, Ms. Reilly spent nine years as a founder and Managing Partner of Real Life Products LLC, a consumer merchandising and manufacturing company that launched and sold six patented products via e-commerce and major retail chains, including Walmart, Home Depot and Amazon. From 2004 to 2008, she served as Chief Commercial Officer of XDx, Inc., which is now known as CareDx, Inc. Prior to this, Ms. Reilly served in various roles at Roche Laboratories for over 14 years, including sales and marketing leadership positions and most recently in 2005 as Executive Vice President for Oncology and Dermatology at Roche, managing a business with over $1 billion in revenue. In 2000, Ms. Reilly was named Healthcare Businesswomen Association Rising Star. Ms. Reilly holds a B.S. degree in Special Education with a minor in Psychology and a MBA from the University of Delaware.
“I am thrilled to be part of Sorrento’s bold vision to redefine cancer, immunology and virology drug development and to advance innovative targeted therapies and diagnostics for patients in need,” said Ms. Reilly. “As the Company enters late-stage clinical development for its lead programs and commercialized diagnostics worldwide, I look forward to working with Sorrento’s talented management team and board who share a strong expertise and commitment to my passion of advancing novel diagnostics and breakthrough drug development therapeutics in high unmet need areas. Sorrento has a highly unique portfolio of very valuable assets and a team of incredibly talented and innovative scientists. I am honored to have the opportunity to work with them.”
SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that its license partner, China Oncology Focus Limited (“COF”), a subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”), has completed the patient enrollment for a Phase III, multicenter, randomized, double blinded, placebo-controlled clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (“ES-SCLC”).
This clinical trial involves 54 centers and is led by Prof. Shun Lu (??) from Shanghai Chest Hospital (???????). The clinical trial approval was granted by China’s National Medical Products Administration (“NMPA”) on 1 March 2021, and the first patient was enrolled on 15 July 2021. A total of 498 patients have been enrolled into the study. An interim analysis is expected to be conducted in April 2023.
Socazolimab is an in-licensed product from Sorrento for the People’s Republic of China, Hong Kong, Macau and Taiwan. To date, three Phase I clinical trials of Socazolimab monotherapy have been completed: (1) recurrent or metastatic cervical cancer; (2) advanced urothelial carcinoma; and (3) high-grade osteosarcoma after adjuvant chemotherapy for maintenance purpose.
For recurrent or metastatic cervical cancer, a pivotal study has been completed and breakthrough therapy designation has been granted by the NMPA in February 2021, and a New Drug Application therefor was submitted to and accepted by the Center for Drug Evaluation of the NMPA for review in October 2021. Apart from monotherapies, several studies of Socazolimab combined with chemotherapy are being conducted in advanced urothelial carcinoma (Phase Ib), ES-SCLC (Phase III), neoadjuvant treatment in esophageal carcinoma (Phase Ib+II), metastatic melanoma (Phase Ib) and resected biliary tract cancer (Phase I).
SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received clearance from the FDA for its investigational new drug application (IND) for Abivertinib (Fujovee™) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castrate resistant prostate cancer (mCRPC) at multiple centers in the United States. The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-naïve and abiraterone-progressing mCRPC. The MAVERICK trial will be conducted as an open-label study of Abivertinib with abiraterone in up to 100 participants harboring the adrenal-permissive HSD3ß1 allele (heterozygous or homozygous). The primary objective of the study is to evaluate the efficacy of Abivertinib with abiraterone via an assessment of 6-month radiographic progression-free survival (rPFS) and the primary endpoint is the 6-month rPFS defined as a percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. Participants will remain on treatment until radiographic progression, unacceptable toxicity, intercurrent illness or other reasons (such as subject withdrawal).
Extragonadal androgen production requires the activity of 3ß-hydroxysteroid dehydrogenase isoenzyme-1 (3ß-HSD1) encoded by the HSD3ß1 allele and an identified single nucleotide polymorphism (SNP) can create an adrenal-permissive phenotype that allows for more rapid development of mCRPC resulting in earlier castration resistance and shortened overall survival. Increased BTK expression has been observed in various solid tumors, including prostate cancer, and it is believed that the interplay between BTK inhibition and 3ßHSD is responsible. BTK inhibition has been shown to inhibit androgen production, particularly from extragonadal precursor steroids, in preclinical models. In addition to selectively targeting both mutant forms of EGFR (T790M and exon 19 and 21 mutations), Abivertinib irreversibly binds to the BTK receptor, preventing phosphorylation of the receptor. Abivertinib is an oral capsule taken twice daily and has been well tolerated across multiple cancer types in doses up to 300 mg twice daily.
The global market for CRPC for 2021 was $2.7 billion, with the U.S. accounting for 67% ($1.83 billion), and a CAGR of 4.15%, projected to reach $4.56 billion, with the U.S. projected to account for 68% ($3.08 billion) by 2031(1).
A LOT in the S-4 filing...few quick takes:
Page 117: SP-102/SEMDEXA is projecting revenue of $24ML in 2022?? what does that suggest...duh !! :) $193ML in 2023; $669ML in 2024, etc...and these are conservative lowball numbers !!!
Page 215, SEMDEXA commercial production will be supplied by Lifecore (existing trial supplier) and Sanofi. Interestingly, SRNE is currently suing Sanofi re: ZTlido (exhibit F-45)
SRNE $45ML Feb. loan explained !!! SRNE advanced $35ML in a loan to Scilex to allow Scilex to repurchase $20ML note...
SCILEX HOLDING COMPANY, A SORRENTO COMPANY, AND VICKERS VANTAGE CORP. I ANNOUNCED TODAY THE FILING OF A REGISTRATION STATEMENT ON FORM S-4 WITH THE SECURITIES AND EXCHANGE COMMISSION RELATING TO THE PREVIOUSLY ANNOUNCED PROPOSED BUSINESS COMBINATION BETWEEN SCILEX AND VICKERS
PALO ALTO, Calif. and NEW YORK, May 16, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100% or over 99.9% majority-owned subsidiary of Sorrento Therapeutics, Inc.) (Nasdaq: SRNE, “Sorrento”) and Vickers Vantage Corp. I (Nasdaq: VCKA “Vickers”) today announced the filing of a Registration Statement on Form S-4 (the “Registration Statement”) by Vickers with the Securities and Exchange Commission (the "SEC") on May 13, 2022, relating to the previously announced proposed business combination between Scilex and Vickers (the "Business Combination").
The Registration Statement contains a preliminary proxy statement/prospectus in connection with the Business Combination. While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Scilex and Vickers, as well as the proposed Business Combination.
About Scilex Holding Company
Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100% or over 99.9% majority-owned subsidiary of Sorrento Therapeutics, Inc.) (Nasdaq: SRNE, “Sorrento”) and a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced pivotal Phase 3 SEMDEXATM data presentation at the American Society of Interventional Pain 2022 annual meeting. The pivotal Phase 3 SP-102 (SEMDEXATM) trial has a highly positive results evaluating SEMDEXATM in sciatica patients following an epidural injection was presented at the Innovation summit session of the 2022 American Society of Interventional Pain (ASIPP) Annual Scientific Meeting in Las Vegas, Nevada. Results from this multicenter, randomized, double-blind, placebo-controlled study demonstrated that patients experienced rapid onset of pain reduction in sciatica pain and the effect lasted for up to 99 days following a single injection of SEMDEXATM at the end of the procedure. This is the first time this trial study data has been presented at a major North American medical meeting.
The podium presentation described the Phase 3 trial, known as the C.L.E.A.R. trial program, randomized 401 lumbosacral radicular pain/sciatica patients at 40 sites across 25 states in the U.S., which is the largest double-blind randomized controlled epidural steroid injection clinical trial in sciatica.
Presenting Author: Prof. Dr. Nebojsa Nick Knezevic, M.D., Ph.D., Professor of Anesthesiology and Surgery, College of Medicine, University of Illinois at Chicago, President of the Illinois Society of Interventional Pain Physicians, Director-at-Large of the North American Society of Neuromodulation, Vice-Chair for Research and Education, Advocate Illinois Masonic Medical Center, Department of Anesthesiology and Pain Management.
The presentation at the Innovation Summit session, ASIPP on May 5, 2022, described the outcome of the C.L.E.A.R. trial. Key findings from this study include:
The study met its primary endpoint with a highly statistically significant reduction in average daily leg pain in patients receiving SEMDEXATM compared to placebo (p<0.001).A total of 401 sciatica patients were enrolled at 40 clinical sites in US.The median time (days) to repeat injection in Placebo group was 57 and 99 days in the SEMDEXATM group, according to Kaplan-Meier estimation (p<0.001).Safety analysis demonstrated a clean safety profile with no identified safety risks. There were no serious adverse events related to the drug or injection procedure, and no adverse events of special interest reported, such as hematoma and infection at the injection site, or paraplegia. The C.L.E.A.R trial also established the safety of repeat injections, as patients who experienced moderate-to-severe radicular pain between 4 and 23 weeks were allowed to receive open-label additional SP-102 (SEMDEXA™) injection. The key secondary endpoint of Oswestry Disability Index, the gold standard for measuring degree of disability and estimating quality of life, showed a 28% improvement at 4 weeks on SP-102 (SEMDEXA™) compared to baseline (minimal clinically meaningful improvement 8%-12%).
"These Phase 3 data demonstrate that the median time to repeat injection for patients treated with SEMDEXATM was significantly longer than those treated with placebo," said Dmitri Lissin, SVP and CMO of Scilex Holding. "We believe these data coupled with Phase 2 results from our repeat-dose trial and earlier PK/PD trial in sciatica patients will help support product registration with the FDA and utility of SEMDEXATM in a pain clinic setting. This is the first time that these pivotal Phase 3 data are being presented at a North American medical meeting and we believe this is another important milestone as we execute on our clinical and pre-commercial strategies."
There is about 60% use of opioid pain medications for chronic back pain2 which is directly linked to many new persistent opioid users every year and up to many new cases of Opioid Use Disorder annually, making low back pain opioid use an important contributor to the opioid epidemic in the United States.
“With more than 30 million low back pain and sciatica patients every year in the US3,4, there is enormous need for an approved treatment and a desperate need for effective non-opioid alternatives,” said Annu Navani, Secretary ASIPP and Medical Director, Comprehensive Spine & Sports Center and Adjunct Clinical Associate Professor, Stanford University School of Medicine. “Epidural steroid injections have been used more than half a century for low back and leg pain, and there has always been a need for safer, longer lasting and more efficacious formulations.”
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“VCKA”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol “SCLX”. The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com.
10 Q is out...
The increase in revenues in our Sorrento Therapeutics segment was attributed to $3.1 million in COVISTIX™ product sales during the three months ended March 31, 2022.
SAN DIEGO, May 03, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that its license and development partner, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun”), presented at this year’s Chinese Society of Clinical Oncology (CSCO) Guideline Conference (April 23-24, 2022) Phase 1 data for its anti-HER2-ADC, A166. To generate this site-specific third generation ADC, Kelun partnered with Levena Biopharma, a Sorrento company, which provided the proprietary ADC technologies for the generation and production of A166, including (1) a proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor, (2) K-Lock, a site-specific conjugation chemistry and (3) an enzymatically cleavable linker. Compared to Kadcyla®, the first Antibody-Drug Conjugate approved for the treatment of HER2-positive metastatic breast cancer, A166 demonstrated potentially better efficacy, as shown in the overall response rate (ORR) of 73.9% with A166 at 4.8mg/kg versus Kadcyla®, which had an ORR of 31.3%, as well as the progression-free survival (PFS) of 12.3 months with A166 versus 6 months with Kadcyla®.
SAN DIEGO, April 25, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received clearance from the FDA for its investigational new drug application (IND) for intravenous (IV) STI-9167 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers. STI-9167 is the IV formulation of the intranasal STI-9199 neutralizing antibody.
The Phase 1 study will be conducted at a single clinical site in the US and will be followed by multinational (USA, China and Mexico) Phase 2/3 trials. Sorrento plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization (EUA), if the trials meet the efficacy end-points of the pivotal study.
SAN DIEGO and PALO ALTO, Calif., April 25, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”) today announced that Dr. Henry Ji, Chairman and CEO of Sorrento and Executive Chairman of Scilex Holding Company (“Scilex”), will participate in the B. Riley Virtual Neuro & Opthalmology Healthcare Conference at 10:00AM ET on April 27, 2022. Live audio of the event can be accessed by visiting the “Events” page of Sorrento’s website at sorrentotherapeutics.com. Dr. Henry Ji will present on the Neuroscience programs and pipeline for Sorrento and Scilex.
B. Riley 2022 Virtual Neuro & Opthalmology Healthcare Conference
Presentation will be available on April 27-28, 2022
Presentation Time: 10:00AM – 10:30AM ET or 7:00AM – 7:30AM PT
Webcast Link: https://www.webcaster4.com/Webcast/Page/2875/45350
An updated corporate presentation will also be available at www.sorrentotherapeutics.com
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“VCKA”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol “SCLX”. The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com.
Good luck my friend ...
Puuuhhh ...SRNE Short Interest
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
03/31/2022 52,391,572 12,321,372 4.252089
03/15/2022 44,985,829 8,566,854 5.251149
02/28/2022 46,214,120 6,037,062 7.655068
02/15/2022 45,516,304 6,474,089 7.030534
01/31/2022 46,189,325 10,399,959 4.441299
01/14/2022 41,721,075 4,749,873 8.783619
PALO ALTO, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced an increase of 53% year-over-year preliminary unaudited gross ZTlido sales in March. ZTlido sold $8.1 million in March 2022 compared to $5.3 million in March 2021. In 1Q2022, the preliminary unaudited gross sales for ZTlido are approximately $18.4 million, compared to $14.6 million in 1Q2021, representing a growth of 26%.
“We are pleased with the progress we have made to ensure patient and physician awareness, access, and adoption to ZTlido. Strong year-over-year sales growth continues to be driven by the expanding payor coverage for ZTlido as a cornerstone of topical lidocaine treatment in neuropathic pain related to post-herpetic neuralgia (PHN) where it continues to be used as first-line therapy,” said Jaisim Shah, Chief Executive Officer of Scilex. “Importantly, our diversified portfolio of unique, best-in-class programs will increasingly allow us to offer complementary and standalone opioid-sparing outpatient pain management solutions.”
The Scilex commercial team has demonstrated success in expanding access and currently has prioritized and targeted select payor accounts representing approximately 200 million of over 300 million covered lives in the US.
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“VCKA”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol “SCLX”. The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com.
SORRENTO REPORTS FDA CLEARANCE FOR THE COMMENCEMENT OF A PHASE 2/3 STUDY FOR ABIVERTINIB IN TREATMENT OF HOSPITALIZED PATIENTS WITH SEVERE PNEUMONIA DUE TO COVID-19
Abivertinib is a novel oral small molecule tyrosine kinase inhibitor that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) as well as Bruton's tyrosine kinase (BTK) and potentially can reduce cytokine storm associated with acute respiratory distress syndrome (ARDS) in severe hospitalized COVID-19 patients.
Sorrento will be starting a multicenter, multinational Phase 3 study with a Phase 2 run-in to identify the recommended Phase 3 dose (RP3D) and to demonstrate the safety and efficacy of Abivertinib in patients with respiratory compromise due to COVID-19.
This clearance follows the successful completion of parallel phase 2 studies in the US and Brazil, both of which indicated that a high-risk population of patients requiring oxygen support by non-invasive ventilation or high flow oxygen appeared to be more likely to benefit from Abivertinib therapy than those receiving low flow oxygen in reducing progression of respiratory failure.
SAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), announced today that the FDA has given clearance for Sorrento to commence the Phase 3 clinical trial of Abivertinib in severe COVID-19 patients (hospitalized patients with respiratory compromise requiring oxygen supplementation). The clinical trial will be conducted in 2 phases, and the initial run-in will define the RP3D. In October 2021, Sorrento released preliminary results of two phase 2 studies that seemed to show that patients hospitalized with severe pneumonia due to COVID-19, especially those requiring non-invasive ventilation or high flow oxygen supplementation, were up to 5-fold more likely to benefit from Abivertinib therapy than those patients who required low flow supplementation. Such patients represent a high-risk population with few treatment options.
The study will be conducted at multiple sites in the USA, Mexico and Brazil. “We are encouraged by the results from our Phase 2 study, and excited to move Abivertinib to the next stage to help these patients who have no good alternatives,” said Dr. Henry Ji, Chairman and CEO of Sorrento.
Sorrento believes the availability of an oral dosage form to manage inflammatory disease progression is very relevant for severely afflicted patients with COVID-19-induced respiratory failure and potentially non-COVID acute respiratory distress syndrome (ARDS). This treatment has the potential to provide significant benefits across the globe with respect to logistical access, scalability and affordability by potentially providing a treatment in a convenient oral dosage form. Sorrento intends to explore the administration of Abivertinib for severe non-COVID related pneumonia and ARDS patients, as the mechanism of disease progression is very similar and the current medical options for treatment are limited.
About Abivertinib
Abivertinib is a novel dual target, small molecule tyrosine kinase inhibitor (TKI) designed to selectively target mutant forms of the epidermal growth factor receptor (EGFR) and Bruton's tyrosine kinase (BTK).
Abivertinib is a third generation EGFR inhibitor that irreversibly targets mutant forms of EGFR in advanced non-small cell lung cancer (NSCLC) patients resistant to first-line EGFR kinase inhibitor therapies with comparable efficacy and safety. Abivertinib demonstrated different resistant mechanisms with rare occurrence of acquired resistant mutation, C797S and potential inhibition of Osimertinib (Tagrisso) resistant tumors in PDX models.
Abivertinib also irreversibly binds to the BTK receptor, inhibiting the phosphorylation of the receptor required for malignant cell survival such as B lymphocytes and prostate cancer.
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
03/15/2022 44,985,829 8,566,854 5.251149
02/28/2022 46,214,120 6,037,062 7.655068
02/15/2022 45,516,304 6,474,089 7.030534
01/31/2022 46,189,325 10,399,959 4.441299
01/14/2022 41,721,075 4,749,873 8.783619
12/31/2021 42,893,502 6,752,829 6.351931
PALO ALTO, Calif., March 25, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced that it has entered into a non-binding term sheet with B. Riley Principal Capital, LLC (“BRPC”), a subsidiary of B. Riley Financial, Inc. (Nasdaq: RILY, together with its affiliates, “B. Riley”) for a committed equity financing facility (the “Facility”) under which it would be able to sell up to $5 billion of its registered common stock over a five-year period. The Facility would become effective in connection with the closing of the previously announced pending merger with Vickers Vantage Corp I (“Vickers”). Scilex would not be obligated to utilize any of the $5 billion facility and would be able to enter other financing transactions. No warrants will be issued in connection with the Facility.
The term sheet contemplates that in connection with the closing of the merger with Vickers, Scilex would enter into definitive agreements with respect to the Facility. Scilex would be able to determine, in its sole discretion, the timing, dollar amount and floor price per share of each draw under the Facility, subject to certain conditions. Any resales of shares sold by Scilex to BRPC under the Facility will be made pursuant to a registration statement to be filed with the Securities and Exchange Commission (the “SEC”) following the closing of the merger.
“We're pleased to establish a relationship with B. Riley, a leader in providing capital markets access to clinical and commercial stage biopharmaceutical companies," commented Henry Ji, Ph.D., Scilex’s Executive Chairman and Chairman, CEO for Sorrento Therapeutics Inc. "We expect the Facility to enhance Scilex’s financial flexibility as we work to advance our drug development programs and business development initiatives."
“As we prepare to begin our registration and pre-commercialization plans of our recently successfully completed SP-102 (SEMDEXATM) Phase 3 clinical trial program, this Facility is an important addition to our menu of financing options. It will give us the ability to raise capital quickly, at a competitive cost, and the flexibility to issue shares in multiple tranches for a period of five years. We believe these advantages will be of significant benefit to Scilex and our shareholders as we continue to execute on our business plan,” said Jaisim Shah, Chief Executive Officer of Scilex.
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“VCKA”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol “SCLX”. The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com.
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COVIMARK
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SCILEX HOLDING COMPANY, A MAJORITY-OWNED SUBSIDIARY OF SORRENTO THERAPEUTICS, INC., ANNOUNCES FINAL RESULTS FOR SP-102 (SEMDEXA(TM)) EFFICACY AND SAFETY FROM ITS PIVOTAL PHASE 3 CLINICAL TRIAL PROGRAM FOR SCIATICA PAIN MANAGEMENT SUPPORTING THE POTENTIAL FOR FIRST TO MARKET OPPORTUNITY
SP-102 (SEMDEXA™), with 401 patients enrolled in the C.L.E.A.R. trial (Corticosteroid Lumbosacral Epidural Analgesia in Radiculopathy), experienced a rapid onset of pain relief, measured by Numeric Pain Rating Scale of average daily pain in the affected leg, with highly statistically significant improvement against placebo over the first 4 weeks, following a single transforaminal injection, LS Mean (SEM) difference -1.08 (0.17), with a p-value < 0.001.
SP-102 (SEMDEXA™) showed continued reduction of pain beyond one month, and the median time to open-label repeat injection was 99 days (95% CI: 78, 129 days) according to a Kaplan-Meier estimation. By contrast, off-label injectable steroids typically provide pain relief for periods ranging from less than a week and up to one month, and then a repeat injection may be required.
The key secondary endpoint of Oswestry Disability Index, the gold standard for measuring degree of disability and estimating quality of life, showed a 28% improvement at 4 weeks on SP-102 (SEMDEXA™) compared to baseline (minimal clinically meaningful improvement 8%-12%) 15 . The LS Mean (SEM) difference as compared to placebo was -6.28 (1.49), with a p-value < 0.001.
Safety analysis demonstrated a very clean safety profile with no identified safety risks. There were no serious adverse events related to the drug or injection procedure, and no adverse events of special interest reported, such as hematoma and infection at the injection site, or paraplegia. These events are associated with the off-label use of non-approved injectable steroid preparations. The C.L.E.A.R trial also established the safety of repeat injections, as patients who experienced moderate-to-severe radicular pain between 4 and 23 weeks were allowed to receive open-label additional SP-102 (SEMDEXA™) injection. The safety analysis was comparable between treatment groups through 4, 12 and 24 weeks of study period.
PALO ALTO, Calif., March 18, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), today announced highly significant positive final results from its SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program. SP-102 (SEMDEXA™) has received Fast Track status from the FDA.
The C.L.E.A.R. Trial (Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy) was designed to investigate safety and analgesic effects of a single and repeat transforaminal injections of SP-102 (SEMDEXA™) compared to placebo (saline injection). The trial enrolled 401 low back pain subjects with unilateral intervertebral disc herniation in lumbar spine resulting in radicular pain symptoms of moderate to severe leg pain. It is the largest known randomized well-controlled trial in sciatica using epidural steroid injections. The primary endpoint of change in average daily pain in the affected leg over 4 weeks following the initial injection demonstrated LS Mean (SEM) group difference of -1.08 (0.17) compared to placebo with a p-value <0.001. SP-102 (SEMDEXA™) is the first non-opioid novel injectable corticosteroid gel formulation product in development for the treatment of lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates.
The key secondary endpoint of Oswestry Disability Index, the gold standard for measuring degree of disability and estimating quality of life, showed a 28% improvement at 4 weeks on SEMDEXA™ compared to baseline (minimal clinically meaningful improvement 8%-12%) 15 . The LS (Lest Square) Mean (Standard Error of Means) difference as compared to placebo was -6.28 (1.49), with a p-value < 0.001.
SP-102 (SEMDEXA™) demonstrated pain relief that continued through 12 weeks. Other pain measurements, such as worst daily and current pain in the affected leg and average daily pain in lower back, demonstrated statistically significant results compared to placebo. Most of the other secondary endpoints in hierarchical arrangement for sequential testing procedure also demonstrated statistically significant results, and included Global Impression of Change, Brief Pain Inventory, PainDETECT, and cumulative use rescue medications (acetaminophen).
Safety analysis demonstrated a very clean safety profile with no identified safety risks. There were no serious adverse events related to the drug or injection procedure, and no adverse events of special interest reported, such as hematoma and infection at the injection site, or paraplegia. These events are associated with the off-label use of non-approved steroid preparations. The C.L.E.A.R trial had also established safety of repeat injections, as patients who experienced moderate-to-severe radicular pain between 4 and 23 weeks were allowed to receive open-label additional SP-102 (SEMDEXA™) injection. The safety analysis was comparable between treatment groups through 4, 12 and 24 weeks of study period.
“We are very pleased with the positive outcome and these trial results are very remarkable. They will impact greatly the pain management community and will enable us to proceed with our plans for registering SP-102 (SEMDEXA™) with the FDA for the treatment of subacute lumbosacral radicular pain. We believe SP-102 (SEMDEXA™) has the potential to be a transformative treatment option for sciatica, an area that has not seen any significant advancement in therapies that patients and physicians have been seeking for decades. We plan to present the results from the Phase 3 C.L.E.A.R trial at upcoming scientific conferences and submit for publication in a peer-reviewed journal,” said Dmitri Lissin, MD, Chief Medical Officer of Scilex.
Scilex intends to use the results from this pivotal Phase 3 trial to discuss with the FDA in 2022 licensure application requirements and Breakthrough Designation Status for the high unmet need sciatica indication for which no treatments have been approved in the U.S. Scilex has extensive clinical and pre-clinical data (including multiple Phase 2 clinical trials) with the novel viscous gel formulation of SP-102 (SEMDEXA™), which was designed to provide extended local effect and non-opioid pain relief for sciatica patients. Scilex expects to present the robust data collected over the course of the company’s multi-year clinical development program to the FDA as part of a New Drug Application (NDA).
More than 60% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP) 1 despite the fact that opioids are associated with serious and potentially life-threatening side effects and have not demonstrated efficacy in the treatment of CLBP. 2 , 3 , 4 In 2018, more than 67,000 drug overdose deaths occurred in the United States 5 of which almost 47,000 (70%) were opioid related. Over 70% of the 70,630 deaths in 2019 involved an opioid. 6 Provisional data release by the Centers for Disease Control and Prevention showed drug overdose deaths rose by nearly 29% over a 12-month period ending in April 2021, to an estimated 100,306. 7
“We are delighted with these highly significant positive clinical results for the pivotal SP-102 (SEMDEXA™) Phase 3 trial and this may provide encouraging news for the many millions of people worldwide who are confronting painful radicular pain (sciatica). We believe that SP-102 (SEMDEXA™) could be the first FDA-approved epidural steroid gel injection product for patients suffering from this common, very painful condition. I really appreciate the work of the Scilex team and their passion for addressing America's opioid crisis and in continuing our mission to improve our ability to help millions of patients dealing with acute and chronic pain issues, in exciting new ways. These final data results mark an exciting and important milestone in our journey to become the premier non-opioid pain management company,” said Jaisim Shah, President and Chief Executive Officer of Scilex.
SP-102 (SEMDEXA™) is the first non-opioid novel injectable corticosteroid gel formulation product in development for the treatment of lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates. If approved by the FDA, the SP-102 (SEMDEXA™) formulation will be available in a pre-filled syringe formulation and will be administered as an epidural injection for the treatment of sciatica. Based on preclinical and clinical studies, SP-102 (SEMDEXA™) extends the residency time at the site of injection and does not show the safety concerns that led the FDA to warn against using other injectable steroid formulations by the epidural route of administration.
While off-label used steroids provide pain relief for periods ranging from less than a week and up to one month, after which a repeat injection may be required, SP-102 (SEMDEXA™) showed continued reduction of pain beyond one month, and the median time to open-label repeat injection was 99 days (95% CI: 78, 129 days) according to Kaplan-Meier estimation.
By 2022, the overall estimated number of epidural steroid injection (ESI) procedures in the U.S. is expected to be 12.1 million across all Medicare and private coverage patients, with lumbar radiculopathy/sciatica procedures comprising approximately 88% of all ESIs administered, according to a proprietary study by Syneos Health Consulting. Despite widespread utilization of ESIs, concerns persist in the market about particulate steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. As a result, a significant unmet medical need exists within the market for a novel, non-particulate ESI formulation that demonstrates safety and effectiveness in controlled clinical trial evaluations. 14
In the U.S., more than 30 million people suffer from low back and radicular pain. This population is expected to grow as the overall population ages. 8,9 Many patients experience moderate to severe pain with intolerance of and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs). 10,11 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids. 9
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“VCKA”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA"). Upon closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol “SCLX”. The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com .
Spot on James ...
NEW YORK and PALO ALTO, Calif., March 17, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, and Vickers Vantage Corp. I (Nasdaq: VCKA; VCKAW) (“VCKA”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, today announced that they have entered into a definitive business combination agreement ("BCA"). Prior to the closing of the transaction, VCKA will be redomesticated as a Delaware corporation. Upon closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock and warrants are expected to be listed on Nasdaq under the ticker symbols “SCLX” and “SCLXW”, respectively. The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
"We are thrilled to have the opportunity to partner with the team at Scilex. We believe Scilex is a uniquely compelling company with excellent non-opioid pain management therapies, which we expect may become cornerstone therapies for treating many acute and chronic pain conditions worldwide," said Dr. Jeffrey Chi, Chief Executive Officer and Chairman of VCKA and Vice Chairman of Vickers Venture Partners.
More than 60% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP)1 despite the fact that opioids are associated with serious and potentially life-threatening side effects and have not demonstrated efficacy in the treatment of CLBP.2,3,4 In 2018, more than 67,000 drug overdose deaths occurred in the United States5 of which almost 47,000 (70%) were opioid-related. Over 70% of the 70,630 deaths in 2019 involved an opioid.6 Provisional data released by the Centers for Disease Control and Prevention showed drug overdose deaths rose by nearly 29% over a 12-month period ending in April 2021, to an estimated 100,306.7
“Scilex was advanced through key milestones, and we are proud of Scilex’s continued path of success, most notably with the FDA approval and commercialization of ZTlido® along with the highly significant positive top-line pivotal Phase 3 results of SP-102 (SEMDEXA™) previously announced in December 2021,” said Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento and Executive Chairman of Scilex. “With Scilex on its way to becoming a publicly-traded entity, our unique model continues to demonstrate the multiple ways in which we are generating value at Sorrento, including equity stakes in public and private entities, royalties and milestone payments due to us from certain proprietary products, pharma collaborations worldwide to advance core programs, and most importantly, our rapidly progressing and advanced wholly-owned pipeline which we see as our major value driver going forward. In addition to Sorrento’s advanced pipeline of oncology, immunology and virology assets, its wholly and majority owned subsidiaries are an additional source of value and Scilex is now set to join the growing list of publicly-traded entities in which Sorrento is an investor, which also include Celularity Inc., which was funded by Sorrento at its inception.”
The Combined Company is expected to have funds of up to $140 million held in VCKA’s trust account at closing before expenses, assuming no redemptions from Vickers Vantage Corp I’s existing public shareholders, and will be led by Scilex's experienced management team, headed by Jaisim Shah, Chief Executive Officer. The Combined Company might raise additional capital through a PIPE or other financing method as it might see fit for the business, although there are no specific plans for such an offering at this time.
"I am proud of the many landmark milestones delivered by the Scilex team this past year, including completion of our phase 3 study for SP-102 (SEMDEXA™) and a highly successful pivotal Phase 3 program demonstrating robust efficacy and safety in sciatica patients and the upcoming expected initiation of broad Phase 1 and 2 non-opioid programs for SP-102 (SEMDEXA™) with both first-in-class and best-in-class potential in multiple areas of acute and chronic pain with high unmet patient need. We believe the efficacy and safety profile demonstrated by SP-102 (SEMDEXA™) to date and the observed duration of effect represent important differentiating features of this potentially first-to-market non-opioid candidate for the many millions of sciatica patients who are confronting this very painful condition. I would like to thank the team at VCKA and existing shareholders and all of the teams at Scilex and Sorrento and our advisors for their dedication in preparing for this business combination. Today's transaction will allow us to continue to pursue our vision to enhance lives for millions of patients with acute and chronic pain conditions," said Jaisim Shah, Chief Executive Officer of Scilex.
Available proceeds from the transaction are expected to fund commercialization plans for SP-102 (SEMDEXA™), if approved, along with potential Phase 3 and Phase 2 clinical development programs. Scilex also intends to pursue additional indications for SP-102 (SEMDEXA™) in the future. Scilex also plans to use the funding from the transaction to bolster the continued build out of the commercial team, enhance business development activities and support general corporate activities.
A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com.
Key Transaction Terms
Assuming no redemptions from VCKA’s shareholders, it is estimated that the current stockholders of Scilex will own approximately 88% of the outstanding shares of the Combined Company, assuming no debt adjustment. As part of the transaction, Scilex’s existing equity holders will roll 100% of their equity into the Combined Company. In connection with the transactions, VCKA's sponsors have agreed to cancel 40% of their private warrants if redemptions exceed 75%.
The Combined Company is expected to have funds of up to $140 million held in VCKA’s trust account at closing before expenses, assuming no redemptions from VCKA’s shareholders, which is expected to occur by the third quarter of 2022. The close of the transaction is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction.
The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the definitive agreement relating to the transaction. A copy of the definitive agreement, this press release and a corporate presentation will be filed by VCKA and Sorrento with the Securities and Exchange Commission (the "SEC") as exhibits to a Current Report on Form 8-K, which can be accessed through the SEC's website at www.sec.gov.
Loeb & Loeb, LLP is serving as legal counsel to VCKA. Paul Hastings LLP is serving as legal counsel to Scilex.
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