Shares in Sorrento rose 2.7% in Monday’s extended market session after the company entered into an exclusive license agreement with Personalized Stem Cells (PSC) to buy the global rights to its adipose derived mesenchymal stem cells (MSCs) to treat patients suffering from COVID-19 acute respiratory distress syndrome (ARDS).
Sorrento (SRNE) said that the MSC program has been cleared for a Phase 1 clinical trial by the US Food and Drug Administration to the pipeline of COVID-19 focused rescue therapies. As part of the agreement, the company will conduct the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies in consultation with regulatory authorities.
Sorrento noted that stem cells have shown to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for patients. More specifically, the company believes that stem cells have a high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in its pipeline, including small molecules (abivertinib or salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).
“Stem cells were a missing piece in our comprehensive portfolio of potential solutions against COVID-19. We now cover multiple stages of the continuum of care from prevention to potential therapeutic solutions for the most advanced stages of the disease,” said Sorrento CEO Henry Ji. “With PSC’s Phase 1 product candidate, we hope to move quickly through the next clinical trials, and, if successful, be able to provide a supportive therapy that may save the lives of the most advanced patients and may also ensure patients who have to undergo intensive care can benefit from a therapy with the potential to minimize the long-term effects of the disease due to the lung damage created by the virus early in the infection.”
The single arm, non-randomized Phase 1 study will evaluate the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site as the enrolled patients.
The primary objective is to test the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to trial a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.
Sorrento has received two recent Buy ratings from the Street, with Dawson James publishing a $21 price target (84% upside potential) and HC Wainwright setting a more bullish $30 price target (163% upside potential).
That’s with shares already up almost 234% year-to-date, boosted by investor optimism for Sorrento’s COVID-19 candidates including its COVI-SHIELD, an antibody cocktail treatment. Dawson James’ Jason Kolbert said he assumes that the company will successfully develop COVI-Shield (and non-opioid Pain Medication, RTX).
“We apply a probability of success of just 50%, but given the size of the indication, the valuation potential for COVID alone is significant,” Kolbert wrote in a note to investors. “For Sorrento, we additionally apply a 30% discount rate. Our valuation conclusion is an equally-weighted average of our FCFF, EPS, and sum-of-the-parts analysis rounded to the nearest whole number.” (See SRNE stock analysis on TipRanks).
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