Semnur Pharmaceuticals to go public in $2bn SPAC deal

2024-07-04

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来源: Pharmaceutical Technology

Senmur is a subsidiary of non-opioid pain management specialist Scilex Holding Company. Image credit: Shutterstock / Dmitry Demidovich.

Semnur Pharmaceuticals has signed a letter of intent to go public via a merger with the special purpose acquisition company (SPAC) Denali Capital Acquisition Corp.

The business combination equity is valued at up to $2bn, with proceeds of up to $40m dependent on the number of acquired SPAC shares.

Semnur plans to seek approval from the SPAC’s shareholders in the second half of 2024. The combined company, if the deal goes through, will operate as Semnur Pharmaceuticals, according to a 2 July press release.

Semnur is a subsidiary of non-opioid pain management specialist Scilex Holding Company.

The publicly traded biopharma plans to capitalise on Semnur’s product candidate, SP-102 (dexamethasone sodium phosphate injectable gel). Also known by the brand name Semdaxa, the drug is being developed for patients with moderate to severe chronic radicular pain, or sciatica, which is the pinching or compression of the sciatic nerves that run down the lower back and into the legs.

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More than 30 million people in the US live with low back and radicular pain. Opioid prescriptions account for around 40% of the chronic pain market but can carry a risk of dependency and abuse. Semnur stated there is a “need for alternate pain therapies without the medical and societal challenges”.

Semdaxa has demonstrated positive data in a Phase III trial (NCT0337216), meeting primary and key secondary endpoints. Sciatica patients receiving the therapy experienced decreased pain intensity over a month and had improved disability index scores.

Semnur said that the data represents a “potential significant improvement in the treatment of adult patients with lumbosacral radicular pain (sciatica). There are currently no US Food and Drug Administration (FDA) approved therapies for the condition, only corticosteroids that are used off-label”.

Semnur’s Semdaxa will be available in a pre-filled syringe formulation and administered epidurally. The company reported a positive Type C meeting with the FDA in November 2023, saying it has agreed on the requirements for a new drug application (NDA). Semdaxa was awarded fast track status by the FDA in 2022.

Semdaxa is estimated to generate annual sales of $3.6bn five years after launch, according to research highlighted by Semnur.

Scilex CEO Jaisim Shah said: “This is an important milestone in our path towards unlocking the value of SP-102 (Semdaxa) treatment for lumbar radicular pain or sciatica. We look forward to closing the proposed business combination as soon as reasonably practicable and look forward to collaborating with the Denali team in this exciting next chapter.”

The healthcare SPAC market has experienced a significant decline since a pandemic boom in 2021. Despite this, there have still been big deals in the past year. T cell therapy specialist Tevogen Bio went public with a $1.2bn deal in June 2023, and HDL Therapeutics – a medical device developer – merged with Swiftmerge Acquisition in a $480m deal two months later.

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