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Statera BioPharma Inc (STAB) RSS Feed

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Created
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PIPELINE https://www.staterabiopharma.com/pipeline/

Catalysts:
For years, the company has been developing its pipeline following three basic guidelines – a balanced approach, comprehensive and complex development as well as safety and foresight. By implementing those principles in its discovery, the company has created evolving therapeutics and continues to test and screen multiple cell types to ensure its drugs’ effectiveness.

In light of the company’s commitment, STAB recently reported major financial growth for 2021 with revenues of over $1.4 million – a 100% increase from the year-ago period. This massive increase was largely the result of the company’s acquisition of ImQuest Life Sciences, Inc. – a research and development company with a focus on cancer, inflammation and infectious disease treatments.

In terms of its expenses, STAB reported operating costs of over $31 million – a massive 191% increase from its year-ago period. Even though it is currently operating at a loss, CEO Michael Handley emphasized that STAB has “taken numerous steps to further develop its clinical stage pipeline.” As of now, it has invested in the expansion of clinical trial programs for its Crohn’s disease and COVID-19 drug treatments. For this reason, Handley believes the company is “well-positioned to achieve numerous milestones in 2022.”

The company seems poised for growth in the months ahead given that its all-stock deal to acquire ImQuest Life Sciences has previously provided STAB with the assets necessary to advance its internal drug development program. By integrating ImQuest BioSciences – the drug development department of ImQuest Life Sciences – into STAB’s existing drug development operations, the company can now offer a direct evaluation of all vaccines, biologics and pharmaceuticals in preclinical development.

In this way, STAB could capitalize on ImQuest BioSciences and its ability to achieve its mission of developing new immune therapies targeting cancers, infectious diseases and autoimmune disorders. This, in turn, will allow the company to develop a competitive advantage over other players in the industry.

As of now, STAB is developing a number of drug treatments covering several widespread diseases. Currently in its phase 2 trial, the company’s lead investigational drug candidate – STAT-201 – is developed for the treatment of pediatric patients with Crohn’s disease. After the FDA granted STAT-201 Orphan Drug Designation for the treatment of Crohn’s Disease in pediatric patients, STAB intends to initiate its Phase 3 clinical trials in the coming months. Given that Crohn’s disease affects an estimated 3 million US adults on an annual basis, the upside potential for this drug is looking promising.

The company is also capitalizing on the increase in demand for treatments of acute and post-acute COVID-19. Currently in phase 1 clinical trials, STAT-205 has the potential to treat these infections by modulating immune system functions and decreasing inflammatory responses affiliated with SARS-CoV-2 viral infections.

STAB is in prime position to achieve a breakthrough in its current studies given the proceeds from its latest direct offering. Handley has previously emphasized the company’s plans to “use proceeds from the direct offering to start the enrollment of patients in Q2 – in addition to including patients with acute COVID-19 infection in the company’s STAT-205 study”.

Recently, STAB announced it was granted approval by the Central Institutional Review Board to begin the Phase 3 clinical trial for STAT-201 in the treatment of pediatric Crohn’s Disease. Now that the sites are being selected, the company plans to include at least 165 patients in the trial – which is expected to begin as soon as Q2. As it initiates this trial, STAB could be among the best pharma stocks to buy this week.

Pancreatic cancer:

Statera is developing STAT-401 as an adjunct to standard of care therapy to extend the duration of disease remission in patients with pancreatic cancer. The U.S. Food and Drug Administration (FDA) granted STAT-401 Orphan Drug Designation for the disease. In August 2021, the company received feedback following a Type C meeting with the U.S. regulators regarding the STAT-401 clinical development program. The Company has established an advisory panel of oncology experts, and now expects to initiate a Phase 1b/2 clinical trial during the first half of 2022.


Michael K. Handley, President and CEO of Statera Biopharma, stated, “Pancreatic cancer remains a devastating disease despite the tremendous advances in cancer research. The American Cancer Society predicts that it could become the second-leading cause of cancer-related death behind lung cancer. We are harnessing our deep understanding of immune modulation to develop STAT-401 to help address this high need cancer population. With our advisory panel now in place, we look forward to advancing our clinical program and bringing hope to the patients and their families fighting this dreaded disease.

Statera Biopharma Submits Phase 1 Clinical Trial Protocol to FDA 

for Investigational Treatment of Long-Haul COVID-19

 

The Company expects to conclude enrollment during the third quarter and report topline results in the fourth quarter.



https://ir.staterabiopharma.com/news-releases/news-release-details/correction-statera-biopharma-submits-phase-1-clinical-trial
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