Full Press Release Details
Eloxx Pharmaceuticals
Reports Second Quarter 2018 Financial and Operating Results and Provides Business Update
CTA approved in Belgium
and IND open in the U.S. for investigational drug candidate, ELX-02
On track to initiate
Phase 2 clinical trials in cystic fibrosis and cystinosis in 2018
Expanded Leadership Team
with Global Pharmaceutical Executives to Accelerate Growth
Company to host webcast
and conference call on Tuesday, August 7, 2018 at 4:30 pm ET
MA. - August 7, 2018 - Eloxx Pharmaceuticals, Inc.,
(NASDAQ: ELOX) a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics
to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins,
today reported its financial results for the three and six months ended June 30, 2018 and provided a business update.
"We are pleased to have achieved important regulatory
milestones in Europe and the U.S. gaining clearance to initiate two Phase 2 clinical trials for our lead investigational product
candidate, ELX-02, in cystic fibrosis and cystinosis, respectively. We are on track to initiate these this year and we are funded
through data readouts," said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. "I am very gratified to have
been successful in attracting experienced pharmaceutical executives to our leadership team who I am confident will add significant
value as we build a high-performance culture committed to maximizing the value of ELX-02 and our library of novel compounds and
pursue global collaborations."
Recent Accomplishments
presented two abstracts at the 41st European Cystic Fibrosis Conference (ECFS) in Belgrade Serbia; a Late Breaker
titled "Evaluation of ELX-02 in Cystic Fibrosis Patient Organoids with Non-Sense Mutations", and an oral presentation
titled "Translational Read-Through of CFTR Non-Sense Mutations and Inducement of Cystic Fibrosis Transmembrane Conductance
Regulator (CFTR) Function by ELX-02 Treatment".
Second Quarter 2018 Financial Results
As of June 30, 2018, we had cash and cash
equivalents of $63.4 million. As a result of our equity capital raise in April 2018, which provided net proceeds of approximately
$53.6 million, we expect that our current cash and cash equivalents will be sufficient to fund our current operations to 2020 and
through data readouts for our Phase 2 clinical trials for our investigational product, ELX-02, in cystic fibrosis and cystinosis.
We incurred a loss for the three months ended June 30, 2018,
of $13.4 million or $0.42 per share, which includes $6.2 million non-cash expense related to stock-based compensation. The Company
incurred a net loss for the three months ended June 30, 2017, of $3.9 million, or $1.04 per share. For the three months ended June
30, 2018, the net cash used in operating activities was $8.5 million. For the three months ended June 30, 2017, the net cash used
in operating activities was $3.2 million driven primarily by our net loss.
Our research and development expenses were $4.2 million for
the three months ended June 30, 2018, compared to $2.6 million for the three months ended June 30, 2017, an increase
of $1.6 million due to increased fees and salaries and growth in clinical development.
Our general and administrative expenses were approximately $9.6
million for the three months ended June 30, 2018 compared to approximately $0.6 million for the three months ended June 30, 2017,
an increase of approximately $9.0 million. The increase in our general and administrative expenses was primarily related to
an increase in our headcount and related salaries, non-cash stock-based compensation, and professional service fees.
Year to Date 2018 Financial Results
We incurred a loss for the six months ended June 30, 2018, of
$22.0 million or 0.74 per share, which includes $6.9 million non-cash expenses related to stock-based compensation. The Company
incurred a net loss for the six months ended June 30, 2017, of $6.6 million, or $1.77 per share. For the six months ended June
30, 2018, the net cash used in operating activities was $14.2 million. For the six months ended June 30, 2017, the net cash used
in operating activities was 5.9 million, driven primarily by our net loss.
Our research and development expenses were $8.5 million for
the six months ended June 30, 2018, compared to $5.0 million for the six months ended June 30, 2017, an increase
of $3.5 million due to increased fees and salaries and growth in clinical development.
Our general and administrative expenses were approximately $13.0
million for the six months ended June 30, 2018 compared to approximately $0.9 million for the six months ended June 30, 2017, an
increase of approximately $12.1 million. The increase in our general and administrative expenses was primarily related to an
increase in our headcount and related salaries, non-cash stock-based compensation, as well as other personnel and professional
Conference Call Information:
Date: Tuesday, August 7, 2018
Domestic Dial-in Number: (866)
International Dial-in Number: (210) 874-7715
Conference ID: 7858608
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/n7s8dtq6.
A replay will be available on the Company's website approximately two hours after the call.
Conference Call Replay Information:
Domestic Dial-in Number: (855)
International Dial-in Number: (404)
Conference ID: 7858608
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 designed 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. 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. 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 is headquartered in Waltham, MA, with R&D operations in
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.
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