Full Press Release Details
Inc. Reports Third Quarter 2016 Financial Results and Provides
Conference Call Today at 4:30 p.m. Eastern Time
Bedminster, NJ November 10, 2016 CorMedix
Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on
developing and commercializing therapeutic products for the
prevention and treatment of infectious
and inflammatory diseases, today reported financial results for the
third quarter ended September 30, 2016, and highlighted recent
business updates. The Company will host a conference call today at
4:30 p.m. Eastern Time.
Key Business and Financial Updates:
former Lilly and UCB executive Khoso Baluch as CEO, bringing >30
years of operational and product launch experience, both U.S. and
into collaboration with Pediatric Oncology Experimental
Therapeutics Investigators Consortium (POETIC) to develop
taurolidine-based therapies for treating rare pediatric
completed a comprehensive assessment of LOCK-IT 100, involving
principle investigators and other clinical staff from multiple
clinical trial sites
to enroll hemodialysis patients and engage new clinical sites;
currently expect to complete patient enrollment in LOCK-IT 100 in
the fourth quarter of 2017
LOCK-IT 200 Phase 3 study is planned to be conducted in oncology
patients with chronic central venous catheters; timing of
initiation will be based on the final trial protocol and
million in cash and short-term investments as of September 30,
2016, vs $28.6 million at June 30, 2016
Net change in cash during the third quarter was
$1.9 million; net cash used in
operation in the third quarter was $6.5 million
for a new $40 million at-the-market (ATM) program to replace, when
available, the current ATM program that has $4.1 million
Neutrolin has the potential to alleviate the significant
public health and pharmacoeconomic burden caused by
catheter-related bloodstream infections, to the benefit of patients
and healthcare systems worldwide, said Khoso Baluch,
CorMedix CEO. In the face of antibiotic resistance and a
vulnerable patient population, we expect Neutrolin to emerge as a
powerful anti-infective with a broad spectrum mechanism of action
against most types of bacterial and fungal infections, including
MRSA, without any evidence of microbial
Completing the Phase 3 program for Neutrolin as
expeditiously as possible remains our highest priority. Following a
comprehensive assessment of LOCK-IT 100, which involved our
principle investigators and other clinical staff from multiple
clinical sites in the study, as well as a number of our Key Opinion
Leaders, regulatory counsel and biostatisticians, we have developed
a multi-pronged strategy to enhance our trial processes and
accelerate patient enrollment. Based on current projections, we
expect to complete enrollment by the fourth quarter of 2017. We are
committed and energized to bring this much-needed product candidate
to market, and to deliver long-term value to our shareholders
through successful commercialization.
Mr. Baluch continued, Beyond Neutrolin, we are excited about
the prospects of our taurolidine-based platform based upon the
broad applicability of its anti-microbial and potentially
therapeutic properties. To that end, we are evaluating the
feasibility of new indications and formulations of taurolidine by
establishing several early research collaborations. Our newest
collaboration with POETIC to develop taurolidine as a therapy for
rare, orphan indications like pediatric neuroblastoma and
osteosarcoma is a prime example of how, if feasible, CorMedix may
unlock significant future value and build a pipeline of product
candidates based on the unique attributes of our taurolidine
Selected Financial Results for the Three Months and Nine Months
Ended September 30, 2016
three months ended September 30, 2016, CorMedix reported a net loss
of $9.1 million, or $0.23 per share, compared to a net loss of
$4.7, or $0.14 per share for the same period last year, an increase
of $4.4 million. For the nine months ended September 30, 2016, the
Company reported an operating loss of $18.2 compared to an
operating loss of $14.3 million for the same period last year, an
increase of $3.9 million. The increase in operating loss from the
previous quarter reflects the increased activity in the on-going
Phase 3 LOCK-IT-100 trial, manufacturing and product
Company had $26.7 million in cash and short-term investments as of
September 30, 2016, compared to $28.6 million as of June 30, 2016,
a net reduction of $1.9 million. For the third quarter 2016, the
Company used $6.5 million to fund operations, primarily focused on
conducting our Neutrolin Phase 3 program and related G&A
activities. The cash used to fund operations was partially offset
by cash from financing sources. CorMedix received approximately
$438,800 from the exercise of stock options for 567,500 common
shares and $4.2 million from the sale of 2,541,716 common shares
under the ATM program. As of September 30, 2016, there was
approximately $4.1 million remaining available under the current
ATM program. CorMedix will have an additional $40 million available
under a new ATM program, once it receives a waiver from Elliott
Associates, L.P. of participation rights and the associated
registration statement is declared effective by the SEC. Upon the
new ATM becoming effective, the $4.1 million remaining under the
current ATM will expire.
Company had 40.4 million, 37.3 million, and 36.1 million shares of
common stock outstanding as of September 30, 2016, June 30, 2016,
and March 30, 2016, respectively.
Mr. Baluch concluded, Our goal is to remain focused on
clinical execution in our Phase 3 studies while operating the
company as efficiently as possible, managing potential shareholder
dilution against our ability to reach key value inflection points.
We believe this strategy has the potential to deliver maximum value