Full Press Release Details
Eloxx Pharmaceuticals
Reports Fourth Quarter and Full Year 2018 Financial and Operating Results and Provides Business Update
Eloxx announces the hiring
of Dr. Susan Schneider as SVP Ophthalmology to lead the development of its rare inherited retinal disease programs
Abstract accepted for
presentation at European Cystic Fibrosis Society (ECFS) Basic Science Conference March 27-30, 2019 demonstrating ELX-02 activity
in restoring CFTR protein
ELX-03 abstract accepted
for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting April 28-May 2, 2019
On track to report top
line data from a Phase 2 clinical trial for ELX-02 in cystic fibrosis in the U.S. and Europe in 2019
Company to host webcast
and conference call on Friday, March 8, 2019 at 8:00 am ET
MA. - March 8, 2019 - Eloxx Pharmaceuticals, Inc.,
(NASDAQ: ELOX) a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics
to treat cystic fibrosis, cystinosis, inherited retinal disorders, and other diseases caused by nonsense mutations limiting production
of functional proteins, today reported its financial results for the three and twelve months ended December 31, 2018 and provided
"We are very pleased to be advancing ELX-02 in cystic
fibrosis and look forward to reporting top line data from our Phase 2 clinical trial in the U.S. and Europe in 2019. New positive
data for ELX-02 in cystic fibrosis patient-derived organoids with nonsense mutations consistently demonstrate dose responsive increases
in FIS swelling, and functional CFTR which correlate with CFTRmRNA elevations to levels at or above wild-type, and we believe
substantially de-risk our Phase 2 program. We look forward to presenting new important data on ELX-02 activity in restoring the
CFTR protein at ECFS later this month," said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. "As we advance
several new investigational product candidates from our library into development for inherited retinal diseases, we are grateful
to have attracted Dr. Susan Schneider, a recognized expert in ophthalmology, to lead the team and also for the support of the Foundation
Fighting Blindness."
Cystic Fibrosis Program Updates
ELX-02 is an investigational
agent not approved by any regulatory agency for therapeutic use.
Inherited Retinal Disease Program Updates
Fourth Quarter 2018 Financial Results
As of December 31, 2018, we had cash and
cash equivalents of $48.6 million, which does not include $14.8 million in net proceeds received from a debt financing transaction
completed in January 2019. We expect our total cash and cash equivalents, including the net debt proceeds, will be sufficient to
fund our operations through top line data from our Phase 2 clinical trial in cystic fibrosis for our lead investigational product,
ELX-02, and into the second quarter of 2020 based upon our current operating plans.
We incurred a loss for the three months ended December 31, 2018,
of $14.0 million or $0.40 per share, which includes $3.8 million non-cash expense related to stock-based compensation. For the
same period in the prior year, we incurred a net loss of $11.4 million, or $0.52 per share.
Our research and development expenses were $6.5 million for
the three months ended December 31, 2018, which includes $0.8 million non-cash expense related to stock-based compensation. For
the same period in the prior year, R&D expenses were $8.2 million. Quarter to quarter fluctuations were due to normal
timing of R&D activities.
Our general and administrative expenses were approximately $7.6
million for the three months ended December 31, 2018 compared to approximately $2.4 million for the same period in the prior year,
an increase of approximately $5.2 million. The increase in our general and administrative expenses was primarily related to non-cash
expense related to stock-based compensation of $2.9 million in the 2018 period, and an increase in our headcount and related salaries,
and professional service fees.
Full Year 2018 Financial Results
We incurred a loss for the twelve months ended December 31,
2018, of $47.2 million or $1.45 per share, which includes $13.4 million non-cash expense related to stock-based compensation, versus
a loss of $23.6 million, or $4.75 per share in the same prior year period.
Our research and development expenses were $20.5 million for
the twelve months ended December 31, 2018, which includes $1.7 million non-cash expense related to stock-based compensation, and
compares to $16.4 million for the same period in the prior year. The year over year increase of $4.1 million is in part due to
increased fees and salaries and growth in clinical development.
Our general and administrative expenses were approximately $27.1
million for the twelve months ended December 31, 2018, compared to approximately $4.0 million for the same period in the prior
year, an increase of approximately $23.0 million. The increase in our general and administrative expenses was primarily related
to non-cash stock-based compensation expense of $11.6 million and an increase in our headcount and related salaries, as well as
other personnel and professional service fees.
Conference Call Information:
Date: Friday, March 8, 2019
Domestic Dial-in Number: (866)
International Dial-in Number: (210) 874-7715
Conference ID: 7877535
Live Webcast: accessible
from the Company's website at www.eloxxpharma.com under Events and Presentations or with this link: https://edge.media-server.com/m6/p/hcyzfmto
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated
to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis
from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production
from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature
stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused
on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop
codons to produce full-length proteins. Eloxx's lead investigational product candidate, ELX-02, is a small molecule drug
candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development
focusing on cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory
body. Eloxx's preclinical candidate pool consists of a library of novel drug candidates designed to be eukaryotic ribosomal
selective glycosides identified based on read-through potential. Eloxx recently announced a new program focused on rare ocular
genetic disorders. Eloxx is headquartered in Waltham, MA, with operations in Rehovot, Israel. For more information, please visit
Forward-Looking Statements
contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can
be identified by the words "expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's
current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation
to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control.
Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact
of a number of factors, including: the development of the Company's read-through technology; the approval of the Company's
patent applications; the Company's ability to successfully defend its intellectual property or obtain necessary licenses
at a cost acceptable to the Company, if at all; the successful implementation of the Company's research and development programs
and collaborations; the Company's ability to obtain applicable regulatory approvals for its current and future product candidates;
the acceptance by the market of the Company's products should they receive regulatory approval; the timing and success of
the Company's preliminary studies, preclinical research, clinical trials, and related regulatory filings; the ability of
the Company to consummate additional financings as needed; as well as those discussed in more detail in our Annual Report on Form
10-K and our other reports filed with the Securities and Exchange Commission.