Removal of FDA’s Hold on Clinical Trials: Cellectis S.A. (CLLS) stock Soars High Premarket

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On January 10, Cellectis S.A. (CLLS) shared that its licensed partner, Allogene Therapeutics Inc. has announced the removal of the FDA’s hold on its clinical trials. Consequently, the stock was trading at $8.83 per share premarket, at the last check on Tuesday.

In the previous session, CLLS stock added a value of 2.59% at its close of $7.92 with 234.49K shares exchanging. Following the announcement, the stock had gained a further 11.49% premarket, at the time of writing.

The clinical-stage biopharmaceutical company, Cellectis S.A. has a market capitalization of $361.75 million. Currently, the company has 45.48 million shares outstanding in the market.

What Happened?

On October 07, the FDA appointed a clinical hold on all the ongoing trials of Allogene. The reason for this clinical hold was a chromosomal abnormality report which was detected in a single patient of Allogene’s ALPHA2 study. Moreover, no other patient treated with the same ALLO-501A lot was affected by the abnormality. In addition, it was also not present in any product of AlloCAR TTM. Hence, the investigation resulted in the conclusion that the abnormality had no relation with TALEN® gene editing or Allogene’s manufacturing process. The investigations further concluded that the chromosomal abnormality had no clinical significance.

Furthermore, the abnormality involved certain regions of T cell receptor and immunoglobulin genes. As part of natural T cell or B cell maturation, these regions usually undergo rearrangement. Hence, the conclusion of the investigations led to the removal of the clinical hold on the trials.

CLLS and Allogene

Servier and Allogene are jointly developing ALLO-501 and ALLO-501A under a collaboration agreement. The agreement is based on an exclusive license that Cellectis granted to Servier. The allogeneic CAR-T programs of Allogene are based on CLLS’s technologies.

As per the collaboration agreement, Allogene has exclusive rights to the products in the U.S., and Servier retains the exclusive rights for the rest of the countries.

CLLS’s Financial Data

On November 04, the company declared its financial results for the third quarter of 2021.

In the third quarter of 2021, CLLS had consolidated revenues and other income of $11 million. This compares to $9 million in the third quarter of 2020.

The company had a consolidated net loss of $37 million in the third quarter of 2021, against $30 million in Q3 of 2020. Resultantly, the net loss per share was $0.82 and $0.71 in the third quarter of 2021 and 2020 respectively.

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