ex99-1
Exhibit 99.1
AzurRx BioPharma CEO Issues Clarifying Statement to
Shareholders
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
Officer.
Dear
AzurRx Shareholders,
I am
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
developments.
Clinical Trials
Combination Therapy Trial
As
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
summary:
●
The Primary Efficacy Endpoint was met
o
CFA > 80% for
all patients, across all visits
●
The Secondary Efficacy Endpoints all showed positive
changes
●
The number of
Stools/Day decreased
●
Safety – MS1819 is safe, with no serious adverse
events
Option 2 Trial
On July
22nd, we
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
Prior
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
enrollment.
Financing and Capitalization
On July
16th, we
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
Placement.
As a
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.
As
such, I want to reiterate that we are not looking to raise any
additional capital to fund the Phase 2 MS1819 clinical
programs.
Following
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
options.
Equity Incentive Plan
I want
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.
Firstly,
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.
Secondly,
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
allows.
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.
Looking Ahead
We are
committed to delivering on our milestones and focused on executing
our plan to have topline data for the Phase 2b OPTION 2 monotherapy
trial in Q1 2021 and the Phase 2 combination therapy trial in Q2
2021. We have raised sufficient capital to fully fund both trials
and to begin preparations for a pivotal Phase 3 trial by the end of
2021. Our interim data from the combination therapy trial is
positive and demonstrates that MS1819 has efficacy and is safe. The
OPTION 2 monotherapy trial is actively recruiting
patients.
I
believe that we are on track and will be successful in meeting our
objectives and increasing shareholder value.
Once
again, I want to extend my personal thanks to all of you for your
support of AzurRx and my personal wish that you and your loved ones
stay healthy and safe.
Best
regards,
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 headquartered in New York, NY, with scientific operations based
in Langlade, France and clinical operations in Hayward,
California. Additional information on the Company can be
found at www.azurrx.com.
Important Information about the
2020 Annual Meeting
The Company has filed with the Securities and Exchange Commission
(the “SEC”) a definitive proxy statement in connection
with the matters to be considered at the 2020 Annual Meeting of
Stockholders (the “2020 Annual Meeting”), which it
anticipates to mail its stockholders on or about August 11, 2020.
The definitive proxy statement contains important information about
the Company and the matters to be considered at the 2020 Annual
Meeting. Stockholders are urged to read the proxy statement
carefully. Stockholders are able to obtain free copies of the proxy
statement and other documents filed with the SEC by the Company
through the SEC’s website at www.sec.report. In addition,
Stockholders are able to obtain free copies of the proxy statement
from the Company by contacting the Chief Financial Officer at (646)
699-7855.
The Company and its directors and executive officers may be deemed
to be participants in the solicitation of proxies with respect to
the matters to be considered at the 2020 Annual Meeting. Additional
information regarding interests of such participants is included in
the Company’s definitive proxy statement, which was initially
filed with the SEC on August 7, 2020, as amended and restated on
August 11, 2020.
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