By Brad Sorensen, CFA
READ THE FULL SCLX RESEARCH REPORT
Scilex Holding Firm (NASDAQ:SCLX) is a revenue-generating firm that’s centered on addressing one of many greatest points dealing with humanity in the present day—that of the overuse of opioids. Scilex is targeted on creating non-opioid ache administration merchandise that present the aid sufferers so desperately want, whereas avoiding the debilitating dependancy that usually comes with using opioids. Roughly 112,000 Individuals died in 2023 from overdoses and there we’ve little question {that a} good variety of these concerned opioid use in some unspecified time in the future to cut back bodily ache of varied sorts.
Scilex introduced that its subsidiary, Semnur, whose lead product is SP-102 and is described under, and a SPAC referred to as the Denali Capital Acquisition Corp (DECA-NASDAQ) have come to a merger settlement. The merger is anticipated to shut in early 2025, at which era, the corporate notes, the mixed entity will probably be spun off and start buying and selling on the Nasdaq underneath the image SMNR. We consider this can be a constructive improvement for shareholders that may assist to unlock worth for current shareholders of SCLX and supply the wanted capital to advance SP-102 towards the commercialization stage.
SP-102 (with the commerce title Semdexa), is the primary non-opioid novel injectable corticosteroid gel formulation for sufferers with reasonable to extreme continual radicular ache/sciatica, containing no preservatives, surfactants, solvents, or particulates. The corporate notes that if the drug is accepted by the FDA, it is going to be out there in a pre-filled syringe formulation and will probably be administered as an epidural injection for the therapy of sciatica. The Scilex subsidiary, Semnur, has accomplished a Section 3 trial for SP-102, which met major and essential key secondary endpoints, lowering ache depth for over a month in sciatica sufferers and leading to statistically important and clinically significant enchancment within the incapacity index rating whereas sustaining security corresponding to placebo. The corporate notes that this Section 3 research represents a possible important enchancment in therapy of grownup sufferers with lumbosacral radicular ache (sciatica), who battle with the medical penalties of no at present FDA accepted therapies, suboptimal formulations of corticosteroids used off-label and/or extra ache and incapacity.
Sciatica is a time period used to explain a set of signs moderately than a selected medical situation. It refers to ache that radiates alongside the trail of the sciatic nerve, which is the longest nerve within the human physique. The sciatic nerve runs from the decrease again, by means of the buttocks, and down every leg. Sciatica sometimes impacts just one aspect of the physique.
The commonest reason behind sciatica is compression or irritation of the sciatic nerve, typically on account of a herniated or slipped disc within the lumbar backbone (decrease again). Different potential causes of sciatica embody spinal stenosis (narrowing of the spinal canal), spondylolisthesis (a situation the place one vertebra slips over one other), piriformis syndrome (compression of the sciatic nerve by the piriformis muscle within the buttocks), and even damage to the nerve itself.
The first symptom of sciatica is ache, which might differ in depth and placement however normally follows the trail of the sciatic nerve. Frequent signs and traits of sciatica embody:
1. Sharp or capturing ache: This ache may be extreme and should really feel like an electrical shock.
2. Fixed ache: Sciatica ache may be steady or intermittent, and it typically worsens with actions like coughing or sneezing.
3. Numbness and tingling: Individuals with sciatica might expertise numbness, tingling, or a “pins and needles” sensation within the affected leg or foot.
4. Weak spot: Some people with sciatica might also expertise weak point within the leg or foot on the affected aspect, making it tough to maneuver or bear weight.
It’s straightforward to see why an improved and efficient therapy that gives aid from the ache of sciatica would doubtless be welcomed enthusiastically by victims. In actual fact, the corporate notes that, primarily based on the impartial market analysis carried out by Syneos Well being Consulting in 2020 and 2021, given the potential substantial utilization of SP-102, by the fifth yr of launch, gross sales of Semdexa in sciatica are projected to achieve $1.5 billion to $2.0 billion yearly.
This announcement and plans for the longer term that we’ve mentioned at size reinforce our perception that SCLX is poised to renew its transfer greater and that buyers proceed to underestimate the worth of the remedies the corporate at present has and is creating. We recognize that the corporate is trying to unlock a few of that worth by this transaction and urge buyers to try an organization that’s incomes income, rising that income in a significant means, and including to its portfolio of crucial remedies earlier than the remainder of the investing neighborhood realizes the story creating at Scilex.
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