AzurRx BioPharma CEO Issues Letter to Shareholders

Rhea-AI Summary

AzurRx BioPharma (NASDAQ: AZRX) celebrates the one-year anniversary of CEO James Sapirstein's leadership, highlighting significant achievements in developing MS1819, a potential replacement for porcine-derived pancreatic enzyme therapy. The company raised $22.1 million in capital, ensuring adequate funds for two ongoing Phase 2 clinical trials. Despite challenges from COVID-19, patient enrollment continues, with positive interim data reported. AzurRx has exited preclinical programs to streamline operations and aims for top line data releases in early 2021.

Positive

• Raised approximately $22.1 million through various financing methods.
• Positive interim data from Phase 2 Combination trial with clinically meaningful results.
• Active enrollment for Phase 2b clinical trials with top line data expected in Q1 and Q2 2021.
• Improved financial position with a debt-free balance sheet.

Negative

• Closure of the French laboratory and discontinuation of preclinical programs may limit future research options.
• Potential delays in trial enrollment due to COVID-19 resurgence in Spain and site initiation challenges.

NEW YORK, Oct. 07, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

Dear AzurRx Shareholders,

This week marks my one-year anniversary as President and Chief Executive Officer of AzurRx. I’d like to take this opportunity to reflect on our team’s accomplishments over the past year and to provide an update on the current status of our business operations. I am pleased to report that we have been successful in achieving many of the milestones I have originally shared with you, which I will highlight in this letter. Based on the clinical results we’ve seen to date, I continue to believe that MS1819 has the potential to replace porcine-derived pancreatic enzyme replacement therapy (PERT) as the standard of care for exocrine pancreatic insufficiency (EPI), and that we will increase shareholder value as we continue to advance the drug’s development.

Financial

Capital Raised in Past 12 Months

• $6.9M from convertible promissory notes and warrants (December 2019 - January 2020)
• $15.2M from Series B convertible preferred stock and warrants (July 2020)
• $2.5M in CIR (French Research Tax Credit) (Received in 2020 for years 2017-2019)
  

One of the most evident indicators of our evolution over the past year is reflected in our vastly improved financial position. To that end, we have raised gross cash capital of approximately $22.1 million through our convertible notes and Series B convertible preferred stock financings, plus an additional $2.5 million in cash from the receipt in 2020 of French Research Tax Credits for the years 2017-2019. In July 2020, we received net proceeds from our Series B convertible preferred stock financing of approximately $13.5 million. Additionally, in July 2020, we solidified our financial position creating an effectively debt-free balance sheet by exchanging substantially all of our outstanding convertible notes into the Series B convertible preferred stock financing.

Ensuring the company has sufficient capital to support our business operations has been a key focus. On that note, I would like to reiterate that we are in a financially secure position to complete our two Phase 2 MS1819 clinical trial programs; the OPTION 2 monotherapy trial and the Combination therapy trial, and to begin preparations in 2021 for a pivotal Phase 3 study. While we have the ability to access up to approximately $14 million in additional capital through an equity line program with Lincoln Park Capital, we do not anticipate accessing such financing and are suspending any near term draw-downs as we have enough cash on hand to fund the Company’s existing operational and clinical plans through Q3 2021.

Sizing Down Scientific Operations

As our company has successfully shifted from researching preclinical assets to developing clinical assets, we made the decision to discontinue both our AZX1103 beta-lactamase and MTAN pre-clinical programs earlier this year and to close our laboratory located in France by the end of this year. While we will maintain a small administrative office to oversee our European clinical trials, closing the laboratory and reducing headcount will further cut our expenses as we continue to prudently manage our finances.

Clinical

We have made significant progress in advancing our MS1819 clinical program during the past year.

Phase 2b Cystic Fibrosis OPTION 2 Trial

• Trial initiated Q3 2020
• Dose escalation trial, using enteric capsules, designed to investigate the safety, tolerability and efficacy of MS1819 in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills (30 patients)
• Primary efficacy endpoint is the coefficient of fat absorption (CFA)
• Eight sites in the U.S. and three sites in Europe activated
• Enrollment is ongoing
• Top line data expected in Q1 2021

The Phase 2b OPTION 2 monotherapy dose escalation trial, using enteric capsules in a head-to-head comparison to PERT, was initiated in July. To date, we have activated a total of 11 sites and patient enrollment and dosing are ongoing. Despite the challenges of running a clinical trial during the COVID-19 pandemic, we are encouraged by the pace of enrollment and anticipate top line data in Q1 2021.

Phase 2 Cystic Fibrosis Combination Trial

• Trial initiated Q4 2019
• Dose escalation study, atop a stable dose of PERT, in patients with severe EPI (20 patients)
• Primary efficacy endpoint is the coefficient of fat absorption (CFA)
• Positive CFA interim data on first 5 patients (25% of study)
  • Clinically meaningful data in first five patients; primary and secondary efficacy endpoints met with no safety issues
• Enrollment is ongoing
• Sites in Hungary activated, Spain and Turkey pending
• Top line data expected in Q2 2021

In August, we released positive interim data on the first five patients in the Phase 2 Combination trial. As reported, the primary efficacy endpoint was met, with CFAs greater than 80% for all patients across all visits, which are clinically meaningful. For secondary efficacy endpoints, we observed that stool weight decreased, the number of stools per day decreased, steatorrhea improved, and body weight increased. Additionally, no serious adverse events were reported. We are continuing to enroll patients in Hungary and seeking to initiate sites in Spain and other European countries. Unfortunately, Spain has recently reported a surge of COVID-19 cases again and any potential lockdowns may affect our site initiation and enrollment. To mitigate this risk, we are planning to open sites in Turkey and also evaluating additional sites in Eastern Europe. We are taking all the necessary steps to minimize delays and ensure continued recruitment into the trial in order to have top line data in Q2 2021.

Management and Board Additions

One of the most important assets of any company is its personnel, and over the last twelve months we’ve made some great additions to our team, namely Daniel Schneiderman as Chief Financial Officer and Gregory Oakes, to our Board of Directors. We have also made additional new hires to strengthen our internal financial controls and to effectively manage our manufacturing program. I am very proud of our team and culture; we work collaboratively, and everyone is dedicated to the continued success of AzurRx.

Outlook Ahead

Despite obvious challenges presented by COVID-19, we have made tremendous progress this year and expect to continue moving forward. We are committed to the business and clinical developments outlined in my previous letters and are confident that 2021 will bring additional value building catalysts and events as we advance the clinical development of MS1819, undergo animal toxicity studies, and create a pediatric plan before an anticipated end of Phase 2 meeting with the FDA in 2021.

We will continue our investor and public relations initiatives and position the company to attract new investors through conferences and individual meetings. In parallel, we are continuing our partnering outreach to PERT strategics and GI specialty pharma companies and anticipate further discussions following the release of topline data from our two Phase 2 clinical trials.

We look forward to sharing our future successes and thank you for your continued support.

Sincerely,

James Sapirstein
President & CEO
AzurRx BioPharma, Inc.

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in Brooklyn, NY and clinical operations in Hayward, CA.  Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements

This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
info@azurrx.com

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
hans@lifesciadvisors.com 

FAQ

What are the key financial achievements of AzurRx BioPharma in the past year?

AzurRx BioPharma raised approximately $22.1 million, improving its financial position significantly.

What clinical trials is AzurRx currently conducting?

AzurRx is conducting two Phase 2 clinical trials for MS1819: the OPTION 2 monotherapy trial and the Combination therapy trial.

When can we expect top line data from AzurRx's clinical trials?

Top line data is expected in Q1 2021 from the Phase 2b trial and Q2 2021 from the Phase 2 Combination trial.

How has the COVID-19 pandemic affected AzurRx's operations?

The pandemic has posed challenges for clinical trial enrollment, particularly in Spain, which may impact timelines.

What is the significance of the MS1819 drug being developed by AzurRx?

MS1819 has the potential to replace current porcine-derived pancreatic enzyme replacement therapy for exocrine pancreatic insufficiency.