Allogene Therapeutics, Inc. (ALLO), a clinical-stage immuno-oncology company, has dipped 32.73% and hence, ALLO stock was trading at $16.40 when last checked. The reason for this massive decline seems to be the FDA clinical hold of AlloCAR T trials. On Thursday, ALLO stock closed the day at 24.338% after increasing 1.71%.
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FDA hold over AlloCAR T trial
On Thursday, ALLO announced that US FDA has placed a holdover company’s AlloCAR T clinical trials following the report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study. The company said that it expects to provide additional updates regarding the matter in the next few weeks following eh consultations with FDA. The FDA continues to actively review the end of phase-1 materials submitted in anticipation of the ALLO-501A pivotal phase-2 trial. The clinical hold came after the company’s notification of the FDA of a chromosomal abnormality in the ALPHA2 study patient. The abnormality was figured out in bone marrow biopsy which was undertaken to assess the low blood count. The investigation was underway to further characterize the observed abnormality which includes any clinical relevance, any evidence of clonal expansion, as well as the potential relationship to gene editing.
Q2 2021 financial results
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In early August, ALLO reported the financial results for the second quarter of the fiscal year 2021, which ended on 30th June 2021. According to the details, the company generated collaboration revenue of $44,000 during the quarter. The total operating expenses for three month period were $71.07 million, while for an equivalent period of 2020, these were $63.15 million. The company suffered a loss of $71.02 million from the operations, while the loss from operations for an equivalent period of 2020 stood at $63.15 million. The net loss for three month period stood at $70.93 million, while for an equivalent three month period of 2020, the net loss hovered around $60.97 million. The net loss per basic and diluted share remained at $0.53 for the three months, while for an equivalent period of 2020, the loss per basic and diluted share was the same, i.e. $0.53. The company had cash and cash equivalents of $913.23 million on 30th June. The total assets stood at $1.12 billion, while total liabilities were $102.91 million.
What’s next for ALLO?
The ALLO stock has shown a dismal performance during the recent past, mainly due to some lacklustre quarterly performance as well as regulatory troubles. The recent FDA related issue has had a serious impact on ALLO stock, but analysts believe that ALLO stock could be on the way to success in the near future.