James Sapirstein, President and Chief Executive Officer of AzurRx BioPharma (NASDAQ: AZRX), has issued the following letter to its shareholders and the investment community.
Here are the Highlights…
Let’s begin this year with great optimism and look forward to 2021 with a sense of excitement. Last year wasn’t one to be forgotten, and I am incredibly proud of our exemplary achievements in the face of so many challenges. This year, we have already built on the momentum created by last year and announced that we had signed a transformative in-licensing arrangement with First Wave Bio, bringing two new GI indications and a new asset into our development pipeline, James stated to start with.
From a strategic, operational, and financial standpoint, AzurRx is a stronger company today than a year ago. We now have three targeted, non-systemic GI assets in our pipeline. These assets address significant unmet clinical needs that can translate into billion-dollar markets. The shareholders will gain from our efforts. To secure up-front licensing for MS1819, the Company recently raised capital without having to impact clinical timelines for MS1819. AzurRx is in a much stronger position to provide valuable products and generate significant market opportunities in the GI space in the long run.
Our focus remains on developing an effective therapy for patients with cystic fibrosis and chronic pancreatitis with MS1819 as part of our lead program. We stay on track to meet our previously-announced clinical milestones. In Q1 2021, we expect top-line results from our Phase 2b OPTION 2 monotherapy trial and the Phase 2 CF combination trial (MS1819 + PERT) in Q2 2021. We remain optimistic that MS1819 will attract partnership opportunities and licensing interest from Big Pharma, given its substantial target market of over $1.4 billion in the U.S. and over $2 billion in the global market.
Micronized niclosamide is an excellent addition to our portfolio. Niclosamide has been used for years and safely by millions of patients with broad-spectrum anti-viral and anti-inflammatory properties. Using a patented proprietary process, First Wave has developed a niclosamide formulation that maintains a proven drug’s safety profile while enhancing its beneficial properties.
Despite its efficacy and safety profile, micronized niclosamide was also attractive because of its commercial potential in checkpoint-inhibitor-associated colitis. ICIs represent a significant market; their sales were over $22 billion in 2019 and increased. But high dose ICIs, or combinations of ICIs, can have potentially life-threatening side effects, such as checkpoint-inhibitor associated colitis. Those who suffer from these side effects may have to interrupt or stop their cancer therapy. There is currently no approved treatment for grade 1 colitis.
Our new treatment’s potential, with its unique non-steroidal properties, is unique in preventing the progression of grade 1 ICI colitis to more severe and potentially fatal later stages. Patients would continue their cancer therapy without interruption or spend minimal time off of their ICI treatment programs.
In the first half of 2021, we anticipate entering two micronized niclosamide clinical trials, one Phase 1b/2a trial for grade 1 Immune Checkpoint Inhibitor-Associated Colitis (ICI-AC) and the other for COVID-19 infections.
We will help drive value throughout the year as we advance MS1819 clinical development, initiate new trials of micronized niclosamide in immune checkpoint colitis and COVID-19 GI, and prepare for an anticipated end of Phase 2 meeting with the FDA for MS1819.
Our public relations and investor initiatives will continue. We will position the Company to attract additional investors and awareness worldwide to provide long-term returns to our shareholders.
Finally, to close the statement, James thanked the company’s investors for continued support and said that everybody connected with this Company is looking forward to another productive and rewarding year.
This upbeat statement by the President and CEO of the Company and infect the whole letter have boosted investor morale to push shares higher in the pre-market today. AzurRxBioPharma Inc (AZRX) stock was up 47.56% to reach $1.22 during the early morning session.