Greenwich LifeSciences (NASDAQ:GLSI) stock rose on Tuesday after the U.S. Food and Drug Administration (FDA) lifted a hold on the Flamingo-01 Phase III clinical trial.
Greenwich Shares Soared More than 50% After the News
The biotech company announced on Tuesday that the FDA had lifted the hold of a Phase III clinical trial for GLSI-100, an immunotherapy in HLA-A*02 positive and HER2/neu protein-positive subjects who are at high risk of breast cancer recurrence. As the hold was removed, the regulators authorized the continuation of the pivotal trial, dubbed Flamingo-01.
Investors jumped on the news, sending shares of Greenwich up more than 50% in Tuesday morning trading.
This FDA suspension prevented the biopharmaceutical company from advancing its Phase III Flamingo-01 clinical trial. This study looks at GP2, which is “an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery.” The trial is for patients who have completed both standard neoadjuvant and postoperative care treatment. According to clinictrials.gov, 598 participants took part in the Greenwich trials.
Manufacturing and Pharmacy Process Issues
The company stated that the Phase III trial had been put on hold after the FDA raised issues with the drug’s manufacturing and pharmaceutical process.
According to Greenwich’s first-quarter report to the SEC, the company had completed the final stages of manufacturing GP2. It released three clinical batches of pharmaceuticals believed to have met all release specifications. Biotech was awaiting FDA review of manufacturing data.
However, Greenwich said the FDA had previously informally asked the company to delay the Phase III trial until it submitted updated manufacturing information. That dataset was incomplete, with some batches still being tested for the first time. The FDA then imposed a hold to halt the start of the trial until Greenwich provided that information.
Greenwich Lifesciences notes that it has responded to complaints raised by the FDA. On July 11, 2022, the FDA officially lifted the clinical hold. Therefore, the Phase III clinical trial of Flamingo-01 can proceed as planned.
Greenwich will integrate additional GP2 testing into the pharmacy process as part of the trial resumption.
The company has already begun site orientation tours and plans to provide further updates in the future.
Another report last December said Greenwich does not own or operate manufacturing facilities to produce its product candidate, nor does it have any plans to develop manufacturing operations anytime soon. The company depends on third-party contractors for all candidate raw materials, APIs, and finished products required for its testing and potential commercial supply.
With the manufacturing issues resolved, investors’ confidence in Greenwich came back. The company shares are still down approximately 50% since the start of the year.
Suspension of Share Repurchase Program
On July 11, Greenwich announced that its Board of Directors had suspended the company’s previously announced share buyback program.
Under the now-suspended share buyback program, Greenwich repurchased approximately 520,000 common shares for an aggregate purchase price of roughly $7.5 million. Following these repurchases, the company had about 12.8 million common shares outstanding.
Company Profile
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy to prevent breast cancer recurrence in post-surgery patients. GP2 is a 9 amino acid transmembrane peptide of HER2/neu (human epidermal growth factor receptor 2) protein. This cell surface receptor protein is expressed in a variety of common cancers, including 75% of breast cancers at low (1+), intermediate (2+) and high (3+ or “over-expressor”) levels.
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