Core Viewpoint - Scilex Holding Company has extended the maturity date of its Senior Secured Promissory Note with Oramed Pharmaceuticals, providing additional covenants to support its business operations and future growth in non-opioid pain management products and potential joint ventures [1] Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as treatments for neurodegenerative and cardiometabolic diseases through a proposed joint venture with IPMC Company [1][3] - The company aims to address high unmet needs in the market with non-opioid therapies, enhancing patient outcomes [3] Product Portfolio - Scilex's commercial products include: - ZTlido (lidocaine topical system) 1.8%, approved for neuropathic pain relief [3] - ELYXYB, an FDA-approved oral solution for acute migraine treatment [3] - Gloperba, the first liquid oral version of colchicine for gout flare prophylaxis [3] - The company has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections targeting lumbosacral radicular pain, with Phase 3 study completed [4] - SP-103, a next-generation lidocaine topical system for acute pain, recently completed Phase 2 trial [4] - SP-104, a low-dose naltrexone for fibromyalgia treatment [4] Financial and Strategic Developments - The maturity extension of the Oramed Note from March 21, 2025, to December 31, 2025, is aimed at providing the company with more flexibility in its financial obligations [1] - The agreement includes additional covenants that will guide the conduct of the company's business [1]

Core Viewpoint - Scilex Holding Company is advancing its strategy to commercialize non-opioid pain management products and has announced a joint venture with IPMC Company to enhance its capabilities in treating neurodegenerative and cardiometabolic diseases [1][3]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [3][4]. - The company is headquartered in Palo Alto, California [5]. Product Portfolio - Scilex's commercial products include: - ZTlido (lidocaine topical system) 1.8%, approved by the FDA for neuropathic pain relief [3]. - ELYXYB, the only FDA-approved ready-to-use oral solution for acute migraine treatment in adults [3]. - Gloperba, the first liquid oral version of colchicine for the prophylaxis of painful gout flares [3][11]. - The company has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections to treat lumbosacral radicular pain, which has completed a Phase 3 study [4]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completed a Phase 2 trial [4]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [4]. Recent Developments - Existing Tranche B senior secured convertible note holders intend to participate in funding and licensing Gloperba's ex-U.S. commercialization rights from Romeg Therapeutics, LLC [1]. - The note holders will also manage the worldwide licensing and distribution of Gloperba through a joint venture [1].

Core Viewpoint - Scilex Holding Company is advancing its non-opioid pain management portfolio by filing a Supplemental New Drug Application (SNDA) for ELYXYB, a new formulation of celecoxib aimed at treating acute pain, which is expected to enhance its market position in opioid-sparing therapies [1][5]. Group 1: Product Development and Efficacy - ELYXYB is a new oral liquid formulation of celecoxib that demonstrates superior analgesic efficacy and safety compared to placebo in treating acute pain following dental surgery, with significant improvements in pain intensity and treatment satisfaction across multiple doses [2][4]. - The formulation utilizes a self-microemulsifying drug delivery system (SMEDDS), enhancing bioavailability and allowing for effective treatment of acute migraine, as recognized by the American Headache Society [4][6]. Group 2: Market Opportunity - The acute pain market in the U.S. was approximately $3 billion in 2021, with around 100 million cases of acute pain reported, highlighting a significant opportunity for non-opioid therapies like ELYXYB [6]. - Approximately 40 million Americans are prescribed opioids annually for acute pain management, indicating a substantial market for opioid-sparing alternatives [6]. Group 3: Company Strategy and Future Outlook - The company aims to broaden the ELYXYB label to include additional acute pain indications, positioning it as a cornerstone in opioid-sparing pain management regimens [5]. - Scilex is focused on addressing high unmet needs in pain management through innovative non-opioid therapies, with a commitment to improving patient outcomes [8].

Core Insights - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, and plans to expand into neurodegenerative and cardiometabolic diseases through a joint venture with IPMC Company [1][3][4] Company Overview - Scilex is headquartered in Palo Alto, California and aims to address high unmet needs in pain management with non-opioid therapies [5][3] - The company’s commercial products include ZTlido® for neuropathic pain, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis [3][4] Product Pipeline - Scilex has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections targeting lumbosacral radicular pain, which has completed Phase 3 studies and received Fast Track status from the FDA [4] - SP-103, a next-generation lidocaine topical system for acute pain, which has recently completed a Phase 2 trial and also received Fast Track status [4] - SP-104, a low-dose naltrexone hydrochloride capsule for fibromyalgia treatment [4] Compliance and Financial Reporting - The company has filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and anticipates regaining compliance with Nasdaq Listing Rule 5250(c)(1) [1][8]

Financial Performance - Net revenue for the three months ended September 30, 2024, was $14.4 million, compared to $10.1 million in the same period in 2023[22] - Net loss for the three months ended September 30, 2024, was $4.4 million, compared to $35.5 million in the same period in 2023[22] - Net loss per share for the three months ended September 30, 2024, was $0.03, compared to $0.63 in the same period in 2023[22] - Total net operating costs and expenses for the three months ended September 30, 2024, were $34.4 million, compared to $48.9 million in the same period in 2023[22] - Comprehensive loss for the three months ended September 30, 2024, was $1.2 million, compared to $35.5 million in the same period in 2023[22] - Net loss for Q1 2024 was $24.37 million, increasing to $37.58 million in Q2 2024, and further to $4.39 million in Q3 2024[23] - Net loss for Q1 2023 was $30.75 million, decreasing to $26.65 million in Q2 2023, and increasing to $35.53 million in Q3 2023[24] - Net loss for the nine months ended September 30, 2024, was $(66.3 million), compared to $(92.9 million) in the same period in 2023, showing a reduction in losses[27] - The company's net loss for the three months ended September 30, 2024 was $4.4 million, compared to $35.5 million for the same period in 2023[211] - The company's net loss for the nine months ended September 30, 2024 was $66.3 million, compared to $92.9 million for the same period in 2023[211] Cash and Liquidity - Cash and cash equivalents decreased from $3.9 million in December 2023 to $77 thousand in September 2024[21] - Total cash, cash equivalents, and restricted cash increased to $8.116 million as of September 30, 2024, compared to $4.729 million as of December 31, 2023[45] - Net cash proceeds from operating activities were $16.8 million for the nine months ended September 30, 2024, compared to $(15.3 million) used in the same period in 2023[27] - The company had an outstanding balance of $14.3 million under the Revolving Facility as of September 30, 2024, which was fully repaid by October 8, 2024[58] - The company received a $10.0 million FSF Deposit on June 18, 2024, and issued a warrant to purchase up to 3,250,000 shares of Common Stock at $1.20 per share[60] - The company delivered 28,000 cartons of ZTlido to Endeavor in November 2024, fully satisfying the remaining obligations of the FSF Deposit[62] - The company reported a negative working capital of $241.7 million and an accumulated deficit of $556.6 million as of September 30, 2024[63] - The company plans to fund operations through equity offerings, debt financings, collaborations, and future sales of ZTlido, ELYXYB, and GLOPERBA[64] - Scilex Pharma paid off all obligations under the eCapital Credit Agreement on October 8, 2024, terminating the agreement and related documents[109] - The company made mandatory prepayments of $9,578,835 and $7,000,000 to Oramed, representing 70% of net cash proceeds from the Registered Direct Offering and FSF Deposit, respectively[111] - The company issued $50 million in Tranche B Notes on October 7, 2024, with $22.5 million in cash received from investors and $22.5 million in exchange for a reduction in the principal balance of the Oramed Note[215] Assets and Liabilities - Accounts receivable decreased from $34.6 million in December 2023 to $31.6 million in September 2024[21] - Inventory decreased from $4.2 million in December 2023 to $2.4 million in September 2024[21] - Total stockholders' deficit increased from $172.94 million at the end of 2023 to $211.32 million by September 30, 2024[23] - Total stockholders' deficit increased from $36.24 million at the end of 2022 to $162.69 million by September 30, 2023[24] - The company recorded $1.2 million in allowances for credit losses on accounts receivable as of September 30, 2024, compared to no allowances as of December 31, 2023[46] - The weighted-average interest rate for short-term loans, including Convertible Debentures, the Oramed Note, and FSF Deposit, was 13.43% as of September 30, 2024, slightly down from 13.55% as of December 31, 2023[49] - The fair value of the Oramed Note was $69.9 million as of September 30, 2024, with a discount rate of 52.00%, resulting in a $7.6 million loss in fair value change for the nine months ended September 30, 2024[76] - The FSF Deposit had a fair value of $14.7 million as of September 30, 2024, with a $4.7 million loss in fair value change for the nine months ended September 30, 2024[77] - The company recorded a gain of $2.4 million in derivative liabilities for the nine months ended September 30, 2024, with a fair value of $11.5 million related to outstanding warrants[80][81] - The company issued a convertible promissory note with a principal amount of up to $180,000, with a balance of $30.1 thousand as of September 30, 2024[85] - The fair value of the Oramed Note was $69.9 million as of September 30, 2024, classified as a current liability[114] - The fair value of the FSF Deposit was $14.7 million as of September 30, 2024, classified as a current liability[123] - The company recorded goodwill of $13.5 million as of September 30, 2024, with no impairment recognized[94] - Intangible assets, net decreased from $36.5 million in December 2023 to $33.5 million in September 2024, with patent rights accounting for $15.4 million[95] - Estimated future amortization expense for intangible assets is $33.5 million, with $16.4 million expected after 2028[96] - The company issued Convertible Debentures totaling $25.0 million, with $15.0 million issued in April 2023 for $14.4 million in net cash proceeds[97][101] - The company repaid $4.4 million of Convertible Debentures during the first quarter of 2024, reducing the outstanding balance to $0[101][103] - Scilex Pharma entered into a Revolving Facility agreement for up to $30.0 million, with interest accruing at the Wall Street Journal Prime Rate plus 1.5%[104][105] - Scilex Pharma's outstanding balance under the Revolving Facility was $14.3 million as of September 30, 2024, and $17.0 million as of December 31, 2023[107] - The Oramed Note has a principal amount of $101.9 million, with six principal installments totaling $101.9 million, and an exit fee of approximately $3.1 million due upon full repayment[111] - The company entered into a Commitment Letter with FSF Lender for a $100.0 million loan, with $85.0 million due within 70 days of receiving the FSF Deposit and $15.0 million within 60 days of the Initial Closing[119] - The FSF Deposit of $10.0 million was received on June 18, 2024, and is creditable towards the $85.0 million required at the Initial Closing[120] - The company issued a Deposit Warrant to FSF Lender for 3,250,000 shares of Common Stock at an exercise price of $1.20 per share, expiring five years from issuance[120] - The fair value of the Fee Warrant issued to IVI was $0.3 million as of the date of issuance[124] - The company delivered 28,000 cartons of ZTlido to Endeavor, fully satisfying the remaining obligations of the FSF Deposit by December 31, 2024[125] - The fair value of the FSF Deposit increased by $4.69 million, resulting in an ending balance of $14.69 million as of September 30, 2024[126] - The company provided a $20.0 million Junior DIP Facility to Sorrento with an annual interest rate of 12.00%, which was fully settled by September 21, 2023[127][129][130] - The company repurchased 60,068,585 shares of Common Stock, 29,057,097 shares of Preferred Stock, and 4,490,617 warrants from Sorrento, with the Preferred Stock valued at $52.6 million[131][135] - The company issued Penny Warrants with a fair value of $10.4 million as of September 21, 2023, exercisable at $0.01 per share[143] - The company accrued $1.3 million in excise tax liability related to stock repurchases under the Sorrento SPA[144][146] - As of September 30, 2024, there were 5,467,692 Public Warrants and 1,000,000 Private Warrants outstanding[152][153] - The company repurchased 4,000,000 SPAC Warrants from Oramed on September 20, 2024, which were subsequently cancelled[152] - The company sold 96,982 shares of Common Stock under the A&R Yorkville Purchase Agreement for net proceeds of $0.2 million during the nine months ended September 30, 2024[158] - The company terminated the A&R Yorkville Purchase Agreement effective March 25, 2024[158] - The company did not sell any shares under the B. Riley Purchase Agreement during the nine months ended September 30, 2024 and terminated the agreement effective February 16, 2024[162] - The company sold 92,295 shares of Common Stock under the ATM Sales Agreement for net proceeds of approximately $0.1 million as of September 30, 2024[167] - The company completed a Bought Deal Offering on March 5, 2024, selling 5,882,353 shares of Common Stock and warrants at a combined price of $1.564 per share, raising approximately $9.2 million[169] - The company conducted a Registered Direct Offering on April 23, 2024, selling 15,000,000 shares of Common Stock and warrants at $1.00 per share, raising $15 million before fees[172] - As of September 30, 2024, the company had 20,129,644 shares of Common Stock reserved for future issuance under the Equity Incentive Plan[181] - The company had 34,361,475 stock options outstanding as of September 30, 2024, with a weighted-average exercise price of $4.17[183] - Total stock-based compensation was $10.9 million for the nine months ended September 30, 2024[184] - The company had $31.5 million in unrecognized compensation costs related to unvested stock options as of September 30, 2024, expected to be recognized over 2.6 years[185] - Total stock-based compensation for the ESPP was $74.2 thousand and $196.3 thousand for the three and nine months ended September 30, 2024, respectively[187] - As of September 30, 2024, 167,369 shares of Common Stock were issued under the ESPP[187] - The Company made matching contributions to the 401(k) plan totaling $0.5 million and $0.3 million for the nine months ended September 30, 2024 and 2023, respectively[190] - Scilex Pharma made royalty payments of $2.8 million and $1.1 million for the three months ended September 30, 2024 and 2023, respectively, and $7.2 million and $5.3 million for the nine months ended September 30, 2024 and 2023, respectively[195] - Total royalty expense recorded within cost of revenue was $2.2 million and $1.8 million for the three months ended September 30, 2024 and 2023, respectively, and $6.9 million and $6.1 million for the nine months ended September 30, 2024 and 2023, respectively[195] - The Company issued 4,000,000 shares of Common Stock to a law firm under the 2023 SIA and 10,000,000 shares under the 2024 SIA[191] - The Company entered into a settlement agreement with Virpax, which included payments of $3.5 million (Initial Payment), $2.5 million by July 1, 2024, and potential royalty payments of 6% of annual Net Sales for certain drug candidates[201] - The Company is appealing a court decision that found Aveva's product does not infringe the Company's ZTlido Patents[204] - The Company entered into a Settlement Agreement with Takeda to resolve the GLOPERBA Patent Litigation and obtained a non-exclusive license for certain patents[205] - The company's operating lease expense was $0.3 million for each of the three months ended September 30, 2024 and 2023, and $0.8 million for each of the nine months ended September 30, 2024 and 2023[209] - The company's total lease payments under operating leases are approximately $2.8 million, with a total lease liability of $2.4 million as of September 30, 2024[210] - The company's weighted average remaining lease term for operating leases is 3.0 years, with a weighted average discount rate of 11.0% as of September 30, 2024[210] - The company recognized additional ROU assets and corresponding lease liabilities of $2.5 million due to a lease term modification for its principal executive offices in April 2023[208] - The company issued October Common Warrants exercisable for 7.5 million shares of Common Stock at $1.09 per share, with the exercise price reduced to $1.04 per share after the December RDO[216] - The company issued 2.2 million Placement Agent Shares and Placement Agent Warrants exercisable for 3.7 million shares of Common Stock in connection with the Tranche B Notes offering[219] - The company is responsible for $2 million in placement agent fees and $950,000 in non-accountable legal fees related to the Tranche B Notes offering[218] Product Development and Commercialization - The company launched ELYXYB in the U.S. in April 2023 and commercialized GLOPERBA in the U.S. in June 2024[30] - The company is developing three product candidates: SP-102, SP-103, and SP-104, with SP-102 completing a Phase 3 study and SP-103 completing a Phase 2 trial in Q3 2023[31] - The company acquired SP-104 Assets in May 2022, with potential milestone payments of $3.0 million upon FDA approval and $20.0 million upon achieving certain net sales[66] - The company paid an upfront license fee of $2.0 million to Romeg and agreed to potential milestone payments of up to $13.0 million, with royalties ranging from mid-single digit to low-double digit percentages based on annual net sales of licensed products[70] - The company recorded an intangible asset of $5.7 million for acquired licenses, including a $2.0 million upfront fee and $3.7 million in deferred consideration for future minimum royalty payments[71] - The company acquired rights to ELYXYB in the U.S. and Canada, assuming obligations including contingent sales and regulatory milestone payments, with accrued royalty payables of $0.1 million as of September 30, 2024[73] Equity and Stock Transactions - Common stock shares increased from 160,084 at the end of 2023 to 191,791 by September 30, 2024, primarily due to equity issuances[23] - Common stock shares increased from 141,349 at the end of 2022 to 154,185 by September 30, 2023, primarily due to equity issuances[24] - Stock-based compensation expenses totaled $3.56 million in Q1 2024, $3.61 million in Q2 2024, and $3.71 million in Q3 2024[23] - Stock-based compensation expenses totaled $3.72 million in Q1 2023, $3.59 million in Q2 2023, and $3.51 million in Q3 2023[24] - The company sold 92,295 shares of Common Stock under the ATM Sales Agreement for net proceeds of approximately $0.1 million as of September 30, 2024[59] - The company entered into a merger agreement with Semnur and Denali Merger Sub on August 30, 2024[86] - Semnur's equity value is $2.5 billion as per the Semnur Merger Agreement[89] - The Company purchased 500,000 Class B ordinary shares from the Sponsor for $2 million in cash and 300,000 shares of Common Stock, totaling $2.3 million[90] - The company issued 4,000,000 shares of Common Stock to a law firm under the 2023 SIA and 10,000,000 shares under the 2024 SIA[191] Legal and Regulatory Matters - The Company is appealing a court decision that found Aveva's product does not infringe the Company's ZTlido Patents[204] - The Company entered into a Settlement Agreement with Takeda to resolve the GLOPERBA Patent Litigation and obtained a non-exclusive license for certain patents[205] - The company entered into a settlement agreement with Virpax, which included payments of $3.5 million (Initial Payment),

Core Viewpoint - Scilex Holding Company has amended its existing license agreement with Romeg Therapeutics to include ex-US rights for Gloperba®, expanding its commercialization efforts for this innovative anti-gout medication [1][10]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as treatments for neurodegenerative and cardiometabolic diseases through a proposed joint venture with IPMC Company [1][6]. - The company's commercial products include ZTlido®, ELYXYB®, and Gloperba®, with Gloperba® being the first and only liquid oral version of colchicine for gout flare prophylaxis [6][10]. Product Details - Gloperba® is administered orally, with a dosage of 0.6mg per 5ml, providing a solution for patients who have difficulty swallowing pills and allowing for flexible dosing options [2][5]. - Over 70% of gout patients have comorbid conditions that may necessitate dose adjustments, making them a target population for Gloperba® [5]. - The global incidence of gout flares is estimated at 0.1% to 0.3% of the population, with a significant increase in prevalence over the past 30 years, rising from 22 million to 53 million individuals [5]. Market Context - Gout affects between 1% and 6.8% of the population, with rising prevalence attributed to factors such as obesity and comorbidities [3][5]. - Management of gout remains inadequate, with less than half of patients receiving effective urate-lowering therapy, highlighting a significant unmet medical need [3].

Core Insights - Scilex Holding Company announced that Pain Medicine News published retrospective claims data indicating that its product ZTlido® is associated with decreased opioid utilization compared to the 5% lidocaine patch in patients with neuropathic pain [1][2][5] Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, and is forming a joint venture with IPMC Company to address neurodegenerative and cardiometabolic diseases [1][7] - The company’s flagship product, ZTlido® (lidocaine topical system 1.8%), is FDA-approved for neuropathic pain relief associated with postherpetic neuralgia [7] Study Findings - The study revealed that 51.9% of patients treated with ZTlido® experienced a decrease or discontinuation of opioid use compared to 45.5% for those treated with the 5% lidocaine patch [5][6] - Among patients reporting a decrease in opioid use, 21.3% in the ZTlido® group had a reduction of 20% or greater, compared to 13.4% in the 5% lidocaine patch group [5][6] - Patients using ZTlido® showed a non-significant change in baseline opioid use (+3.1%), while those on the 5% patch experienced a significant increase (+42.9%) [5][6] Product Pipeline - Scilex has additional products including ELYXYB®, an FDA-approved oral solution for acute migraine treatment, and Gloperba®, a liquid oral version of colchicine for gout flare prophylaxis [7][8] - The company is also developing three product candidates: SP-102 for lumbosacral radicular pain, SP-103 as a next-generation lidocaine formulation, and SP-104 for fibromyalgia [8]

PALO ALTO, Calif., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing the treatment for neurodegenerative and cardiometabolic disease, and non-opioid pain management products for the treatment of acute and chronic pain, today announced the closing of its previously announced registered direct offering of an aggregate of 26,355,347 shares of its common stock, par valu ...

PALO ALTO, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing the treatment for neurodegenerative and cardiometabolic disease, and non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 26, ...

Currently enrolling randomized, double-blind, placebo-controlled, dose-finding, Phase 2 clinical trial to evaluate the safety and efficacy of KDS2010 in patients with Alzheimer’s disease with mild cognitive impairment and mild dementia is currently recruiting in South Korea in 114 patients and U.S. cohort will be added in 2025.KDS2010 (Tisolagiline) is a new reversible selective monoamine oxidase B (MAO-B) inhibitor being studied for its potential in treating neurodegenerative diseases like Alzheimer's dise ...