Full Press Release Details
AzurRx BioPharma CEO Issues Clarifying Statement to
NEW YORK, August 12, 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
AzurRx Shareholders,
writing to provide clarification on yesterday's press release
and conference call where we discussed the positive interim data
from the first patient cohort of our combination therapy trial. We
have also received a number of questions from investors regarding
the study, our clinical trial timelines, our financing needs and
recent changes to our proposed 2020 equity incentive plan and I
would like to take this opportunity to clarify any
misunderstandings and update you on recent
Combination Therapy Trial
reported yesterday, we believe that the interim data from the first
cohort of five patients in the trial (of daily dose of PERT with
MS1819 in patients with cystic fibrosis with severe exocrine
pancreatic insufficiency) is positive and clinically meaningful.
Our data and analysis shows that MS1819 is clearly responsible for
the change in the Coefficient of Fat Absorption (CFA) and the
improvements in the primary and secondary efficacy endpoints were
consistent for all patients, across all visits. By way of
The Primary Efficacy Endpoint was met
all patients, across all visits
The Secondary Efficacy Endpoints all showed positive
Stools/Day decreased
Safety MS1819 is safe, with no serious adverse
announced the initiation of the Phase 2b OPTION 2 clinical trial of
MS1819 in patients with cystic fibrosis, with the first patient
screened and the first three clinical trial sites activated. The
trial is proceeding according to schedule and we will be providing
updates in due course.
Clinical Trial Timelines
to COVID-19 we anticipated top-line results from both Phase 2
clinical trials by the end of Q4 2020. Subsequently, we have
revised this to the release of topline data for OPTION 2 in Q1 2021
and the release of topline data for the combination therapy trial
in Q2 2021 (1H 2021), barring any major disruptions from a second
wave of COVID-19. Based on communication with our clinical trials
sites in the U.S. and Europe we do not anticipate delays to these
new timelines. As discussed on yesterday's call, European
sites are re-opening and being initiated for the Combination
Therapy trial and the OPTION 2 clinical trials sites in the U.S.
are being activated and patients are currently been screened for
Financing and Capitalization
completed a private placement (the Series B Private
Placement ) of Series B Preferred Stock and warrants that
resulted in gross cash proceeds of approximately $15.2 million and
net cash proceeds of $13.5 million, and we additionally exchanged
approximately $6.9 million principal amount plus accrued interest
of senior convertible promissory notes into the Series B Private
result of the Series B Private Placement, the Company is in a
secure financial position with a debt-free balance sheet and
sufficient cash on hand to fund our operations for over a one-year
period (currently expected through Q3 2021) that will enable us to
complete our two Phase 2 clinical trials and initiate preparations
for a pivotal Phase 3 clinical trial of MS1819.
such, I want to reiterate that we are not looking to raise any
additional capital to fund the Phase 2 MS1819 clinical
the Series B Preferred Stock transactions, we currently have a
total of approximately 87.5 million shares of common stock or
reserved for issuance upon exercise or conversion of currently
outstanding Series B Preferred Stock, warrants and stock
Equity Incentive Plan
to clarify a few things regarding the amended and restated 2020
Omnibus Equity Incentive Plan (the 2020 Plan ), which
has been designed with an expected life of ten years.
we are very mindful of the potential dilution resulting from the
2020 Plan and other capital raises. We have proposed an initial
10,000,000 shares, which is approximately 11-12% of the current
fully diluted outstanding.
the 2020 Plan aims to initially authorize 10,000,000 shares with
potential increases to maintain availability of up to a maximum of
10% of the fully diluted share outstanding, on an as converted
basis (not including shares issued and reserved under the 2020
Plan). This is consistent with the increases that have to date been
automatically made under the current 2014 Omnibus Equity Incentive
Plan (the 2014 Plan ). However, the proposed 2020 Plan
increases are only effected on an annual basis every January 1st,
rather than on a rolling basis, as per the current 2014 Plan. The
proposed 2020 Plan also gives our board of directors discretion not
to have such increases take effect, whereas under the 2014 Plan
such increases were automatic. Both are key differences, which
impose greater limitations on potentially dilutive increases under
the 2020 Plan, as compared to what the 2014 Plan
Lastly, the number of permitted
to be issued as incentive stock options
( ISOs ) under the 2020 Plan has been reduced, in our
amended and restated proxy statement just refiled earlier this
morning, to 15,000,000 from 100,000,000. I want to be very clear
that this number in no way means that these shares have been
authorized to be issued, but rather establishes a permanent maximum
limit for reasonable capital expansion over the expected ten-year
life of the 2020 Plan.
committed to delivering on our milestones and focused on executing
our plan to have topline data for the Phase 2b OPTION 2 monotherapy