Full Press Release Details
CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL
RESULTS, ANNOUNCES REVERSE STOCK SPLIT AND PROVIDES BUSINESS
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Berkeley Heights, NJ Mar. 14, 2019 CorMedix Inc. (NYSE American: CRMD),
a biopharmaceutical company focused on developing and
commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today announced
financial results for the fourth quarter and full-year ended
December 31, 2018 and provided an update on recent business
The Company also announced today that its Board of Directors has
approved a one-for-five reverse stock split of its common stock
that is scheduled to become effective before trading opens on March
26, 2019, after which time the CorMedix common stock will trade on
a split-adjusted basis under a new CUSIP number 21900C308. As
previously disclosed, at the CorMedix Annual Meeting of
Stockholders held on June 26, 2018, the Company's
stockholders approved a proposal authorizing the Company's
Board of Directors to effect a reverse stock split at a ratio of
between one-for-five and one-for-ten.
Recent Corporate and Clinical Highlights:
Announced statistically significant topline
results of the interim analysis and full data set of its Phase 3
LOCK-IT-100 Study in Neutrolin. A total of 41 catheter
related blood stream infections (CRBSI) was determined by the
Clinical Adjudication Committee (CAC) in the full data set,
compared with 28 CRBSI cases in the interim analysis. The
full data set showed a 71% reduction in the risk of occurrence of
CRBSIs compared with the active control of heparin, which is well
in excess of the study's assumed treatment effect size of a
55% reduction and statistically significant with a p-value of
that the FDA has agreed that the
Company can request consideration of Neutrolin for approval under
the LPAD (Limited Population Pathway for Antibacterial and
Antifungal Drugs) pathway. Per FDA guidance, the formal request for
consideration of the LPAD pathway is made as part of the
Strengthened the Board of Directors with the appointment of Alan W.
Dunton, M.D. as a Director.
Closed a senior secured convertible debt financing
with gross proceeds of $7.5 million with its largest shareholder. The loan has a
three-year maturity, carries an interest rate of 10% per annum, and
is convertible into the Company's common stock at $1.50 per
share. The loan is callable by the Company beginning in June
at December 31, 2018 amounted to $17.6 million.
We were excited to begin the year with the favorable news
that the interim analysis of our LOCK-IT-100 study had hit
statistical significance of p=0.0034 with its primary
endpoint, said Khoso Baluch, CEO of CorMedix. We were
delighted that the analysis of the full data set supported the
interim analysis data, yielding 41 CRBSI cases and a p-value of
0.0006. In our view, these data strongly support our case for
Neutrolin's efficacy as a catheter lock solution in
hemodialysis patients. Because the unblinding of the full data set
had occurred just prior to our meeting with the FDA, we agreed to
provide a detailed analysis of the data to the FDA as soon as
Mr. Baluch continued, We were also pleased that the FDA
agreed the Company could request consideration of Neutrolin for
approval under the LPAD pathway. We believe this strengthens our
position that the results of the LOCK-IT-100 study are sufficiently
robust to demonstrate safety and effectiveness, and support filing
of an NDA for Neutrolin.
Mr. Baluch concluded, We successfully progressed the
Neutrolin development program during 2018. Now that our cash
position has been strengthened and we anticipate that existing cash
can fund us into the second quarter of 2020, we believe we are well
positioned to make significant progress during 2019. We believe
also that because we desire to attract more institutional interest
into our stock and need to have available unissued shares to
reserve for past transactions and provide for future opportunities,
it is a good time to move ahead with the reverse stock split
approved by the stockholders last year.
reverse stock split will uniformly affect all issued and
outstanding shares of the Company's common stock. The reverse
stock split will not alter any stockholder's percentage
ownership interest in CorMedix, except to the extent that the
reverse stock split results in fractional shares. No fractional
shares will be issued in connection with the reverse stock split.
Stockholders who would otherwise be entitled to receive a
fractional share will instead receive one whole share of the
Company's common stock. The par value of the Company's
common stock will remain unchanged at $0.001 per share after the
reverse stock split.
number of shares of common stock available for issuance under the
Company's equity incentive plans and issuable upon the
exercise of stock options, warrants and preferred stock outstanding
immediately prior to the reverse split will be proportionately
affected by the reverse stock split. The exercise prices of the
Company's outstanding options and warrants, and the
conversion price of its outstanding preferred stock will be
adjusted in accordance with their respective terms.
result of the reverse stock split, the number of shares of common
stock issued and outstanding will be reduced from approximately
119.0 million to approximately 23.8 million shares. There will be
no change to the number of authorized shares.
Transfer, LLC will act as the exchange agent and transfer agent for
the reverse stock split. Computershare will provide instructions to
stockholders with physical certificates regarding the optional
process for exchanging their pre-split stock certificates for
post-split stock certificates.
Fourth Quarter 2018 Financial Highlights
fourth quarter 2018, CorMedix recorded a net income of $2.2