AzurRx BioPharma Issues Letter to Shareholders

AzurRx BioPharma Issues Letter to Shareholders

YORK, April 21, 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

AzurRx Shareholders,

that all is well with you and your families during these difficult

and unprecedented times of the COVID-19 pandemic. When I last wrote

to you six months ago (on October 22, 2019), as the newly appointed

President and CEO of AzurRx, I spoke about my strong belief in the

potential of MS1819, our focus on building shareholder value and in

raising sufficient capital to achieve our milestones. I am pleased

to say we have made progress towards all of these goals. Let me now

provide a more detailed update on our progress and share with you

our goals for 2020 and 2021, including our plans to develop MS1819

into a Phase 3 ready asset that can potentially be

COVID-19, we currently anticipate only minor delays in initiating

and completing our dose-escalating Phase 2 OPTION 2 monotherapy

clinical trial, using 2.2g and 4.4g doses of MS1819 in enteric

capsules in the U.S. and Poland. During Q1 2020, we executed

contracts with our clinical research organizations (CROs) and began

preparation for the trial, including identifying the trial sites

and investigators. In addition, the clinical trial protocol has

been reviewed by the FDA with no comments, and we intend to begin

Institutional Review Board (IRB) reviews shortly. Barring any

significant coronavirus developments, we should be able to initiate

the OPTION 2 Trial by the end of Q2 2020 and expect top line data

2019 we dosed the first patient in our Phase 2 combination therapy

clinical trial in Hungary. In January 2020 we reported that the

data from the first five patients in the study, for primary and

secondary efficacy endpoints, was positive and that there were no

safety issues. We are completing the trial in sites in Hungary and

plan to open new trial sites in Spain, and possibly in Turkey, in

Q3 2020. We plan to release interim data during Q3 2020, anticipate

completion of the Combination Trial by the end of 2020 and top line

we are very pleased with our current clinical trial progress, the

impact of COVID-19 on clinical trials changes on a daily basis and

could in the future impact the progress of our trials. We intend to

provide updates if required as the COVID-19 pandemic continues to

Clinical Supply Chain (CMC)

this month we signed a manufacturing agreement with Delpharm, a

leading contract development manufacturing organization (CDMO), for

the clinical drug supply of MS1819 for the OPTION 2 clinical trial

scheduled to initiate in Q2 2020. This marks the first time that

MS1819 will be manufactured with enteric capsules, which we believe

should prevent the MS1819 lipase from breaking down prior to

reaching the duodenum so that substantially more (~50%) drug

product can be released. Our supply chain remains intact and, as of

today, has not been impacted by COVID-19.

COVID-19 highlights both the health risk of animal pathogens in

medicinal products and the risk of supply chain disruption, when

animals are either quarantined or culled. For example, in 2019 the

Chinese government ordered the culling of half of their pig

population following a swine flu epidemic. Chinese pigs are the

source of a majority of the world's porcine pancreases used

in pancreatic enzyme replacement therapy (PERT) products. In

contrast, MS1819 is a synthetic recombinant yeast that can be

safely and reliably produced in fermenters under the strictest

taken several steps to strengthen our team, broaden our talent pool

and consolidate and streamline our operations:

Finance: hiring Daniel Schneiderman as

our Chief Financial Officer and a new Controller;

Clinical Operations: consolidation of

all U.S.-European clinical trial programs under Jim Pennington,

M.D., our Chief Medical Officer;

Chemistry, Manufacturing & Controls

(CMC): hiring Ted Stover to serve as global Product

Development Manager for MS1819; and

Board of Directors: appointing Greg

Oakes, a seasoned biotech executive with significant experience and

a track record in pharma commercialization and

made considerable progress in strengthening our balance sheet,

realigning and reducing operating expenses and improving our

November 2019, we entered into a purchase agreement for a $15

million equity line of credit with Lincoln Park Capital Fund, a

Chicago-based institutional investor and a long-standing investor

in AzurRx. This has provided us with access to sufficient capital

to move forward with our two Phase 2 clinical trials for

follow up to the Lincoln Park equity line, in December 2019 and

January 2020, we closed a $6.9 million private placement consisting

of senior convertible promissory notes and warrants. The

convertible notes are convertible into common stock at $0.97 per

share, accrue interest at 9% per annum and mature on September 20,

2020. Many of our long-standing investors participated in this

round, and we greatly appreciate their continued support of

these funds, we have been able to continue investing in our

clinical trials by funding both the combination therapy

study in Europe and preparations for the upcoming OPTION 2

monotherapy study in the United States and Poland. Simultaneous to

our fundraising efforts, we also significantly reduced our

liabilities by restructuring and paying off most of our

short-term obligations, including accounts payable and promissory

addition, in Q1 2020, we received an aggregate total of $1.77

million in non-dilutive funding from our French R&D tax credit

(CIR) for the years 2017 and 2018. We anticipate receiving our 2019

CIR towards the end of the year.

in April 2020, we received a CARES Act Paycheck Protection Program

(PPP) loan of approximately $180,000 through the Small Business