Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119846
Chunk: 222

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 222
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 characterizing safety, tolerability and preliminary efficacy of SP-103 in acute LBP associated with muscle spasms. SP-103 was safe and well                                                                                   
 tolerated. The increase of lidocaine load in topical system by three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month 
 treatment. SP-103 received FDA Fast Track status in LBP. We will continue to analyze the SP-103 Phase 2 trial data along with an investigator study of ZTlido in patients                                                                             
 with chronic neck pain completed in the second half of 2023, which also has shown promising top-line efficacy and safety results. SP-103, if approved, could become the                                                                               
 first FDA-approved lidocaine topical product for the treatment of acute pain.                                                                                                                                                                         |

| • |     | Pursue clinical development of SP-104 for the treatment of                                                                                                     
 fibromyalgia, which has very few approved therapies that are marginally effective and have unpleasant side-effects. We are developing SP-104 for fibromyalgia. 
 Low-dose naltrexone hydrochloride delayed-release capsules are                                                                                                 |

140

| routinely used off-label to treat fibromyalgia and other chronic pain conditions such as complex regional pain.                                                                                                                                 
 SP-104 addresses the shortcomings of using the high-dose commercial products and pharmacy-compounded products by delivering a low-dose of naltrexone hydrochloride                                                                              
 (approximately 11 times less than the commercial product) in a delayed-release formulation that bypasses the stomach and releases the drug in the gut (upper intestine). These product characteristics mitigate against the known safety issues 
 associated with the high-dose commercial products and immediate release pharmacy-compounded products, and the overall reliability issues associated with pharmacy-compounded products. SP-104 has completed two                                 
 Phase 1 studies to characterize the pharmacokinetics (“PK”) and safety of the product.                                                                                                                                                          |

| • |     | Expand our product portfolio by developing or acquiring non-opioid                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
 assets that leverage our novel delivery and adhesion technologies and our existing commercial infrastructure. We are continuously evaluating opportunities to leverage our research and development experience to develop non-opioid therapeutics for pain management indications that are not adequately served with existing treatment options. We also seek to in-license or acquire non-opioid therapeutics that can both complement our existing product