Full Press Release Details
Eloxx Pharmaceuticals
Reports Second Quarter 2020 Financial and Operating Results and
Provides Business Update
Enrollment in our Phase 2 clinical trial
program for ELX-02 in cystic fibrosis has been resumed in Europe and Israel after being temporarily
paused due to the COVID-19
U.S. FDA has granted orphan drug designation
for ELX-02 for the treatment of cystic fibrosis
Completing enrollment in our Phase 2
cystic fibrosis clinical trials and reporting top line data remain our highest priorities
Preclinical studies continuing
to advance in autosomal dominant polycystic kidney disease (ADPKD) and inherited retinal disorders
cash equivalents of $37.1 million as of June 30, 2020 provides cash runway through the end of 2021
Company to host webcast
and conference call today, Thursday, August 6, 2020, at 2:00 pm ET
MA - August 6, 2020 - Eloxx Pharmaceuticals, Inc.,
(NASDAQ: ELOX) a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics
to treat cystic fibrosis 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, 2020 and provided a business update.
"We are pleased that
enrollment in our Phase 2 cystic fibrosis clinical trial has been resumed in Europe and Israel after having been temporarily paused
in response to the COVID-19 pandemic in support of global healthcare providers and our
shared commitment to ensure patient safety. In the U.S., we are gratified to have received orphan
drug designation for ELX-02 for cystic fibrosis from the FDA which confers substantial benefits to the program including seven
years of exclusivity upon marketing approval and a potential waiver of the PDUFA application fee," said Dr. Gregory Williams,
Chief Executive Officer of Eloxx Pharmaceuticals. "We are working very closely with our clinical investigators and study
sites and evaluating additional sites where patient enrollment may be feasible. Our highest priority is to complete our Phase 2
proof of concept clinical trial program for ELX-02 in cystic fibrosis as soon as possible, as we believe the data from these trials
will represent a substantial value inflection point for the Company."
Cystic Fibrosis Phase 2 Program
ADPKD Kidney Program Update
Ocular Program Update
ELX-02 is an investigational agent not approved by any regulatory
authority for therapeutic use, which is currently in Phase 2 clinical trials in cystic fibrosis.
Second Quarter 2020 Financial Results
As of June 30, 2020, we had cash, cash
equivalents and marketable securities of $37.1 million, which we expect will be sufficient to fund our operations through the end
For the three months ended June 30, 2020,
we incurred a loss of $7.9 million or $0.20 per share, which includes $2.0 million in non-cash stock-based compensation. For the
same period in the prior year, we incurred a net loss of $14.4 million, or $0.40 per share.
Our research and development expenses were $3.5 million for
the three months ended June 30, 2020, which includes $0.3 million in non-cash expense related to stock-based compensation. For
the same period in the prior year, R&D expenses were $7.3 million. The quarter to quarter decrease in R&D expenses
of $3.8 million was driven by reduced professional service fees largely due to the pause in our clinical trials due to COVID-19,
and reduced headcount and related salaries for a portion of the 2020 period.
Our general and administrative expenses were $4.1 million for
the three months ended June 30, 2020, which includes $1.7 million in non-cash expense related to stock-based compensation. For
the same period in the prior year, G&A expenses were $7.0 million. The decrease was primarily driven by lower headcount and
professional services costs.
First Half 2020 Financial Results
For the six months ended June 30, 2020,
we incurred a loss of $21.8 million or $0.54 per share, which includes a one-time restructuring charge of $4.0 million associated
with our realignment in the first quarter (comprised of $2.1 in non-cash stock based compensation and $1.9 million in cash severance)
and $3.8 million in non-cash stock-based compensation associated with ongoing operations. For the same period in the prior year,
we incurred a net loss of $26.4 million, or $0.73 per share.
Our research and development expenses were $8.1 million for
the six months ended June 30, 2020, which includes $0.5 million in non-cash expense related to stock-based compensation. For the
same period in the prior year, R&D expenses were $13.4 million. The year over year decrease in R&D expenses of $5.3
million was driven by reduced professional service fees largely due to the pause in our clinical trials due to COVID-19, and reduced
headcount and related salaries for a portion of the 2020 period.
Our general and administrative expenses were $9.3 million for
the six months ended June 30, 2020, which includes $3.4 million in non-cash expense related to stock-based compensation. For the
same period in the prior year, G&A expenses were $12.9 million. The decrease of $3.6 million was primarily driven by lower
headcount and professional services costs.
Conference Call and Webcast Information:
Date: Thursday, August 6, 2020
Domestic Dial-in Number: (866) 913-8546
International Dial-in Number: (210) 874-7715
Conference ID: 2191126
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/mmc/p/nxdhnad8.
Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company developing novel RNA-modulating drug candidates (each designed to be a eukaryotic ribosomal selective glycoside, or ERSG)
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,
currently focusing on cystic fibrosis. ELX-02 is an investigational drug that has not been approved by any global regulatory authority.
Eloxx's preclinical candidate pool consists of a library of novel ERSG drug candidates identified based on read-through potential.
Eloxx also has preclinical programs focused on kidney diseases including autosomal dominant polycystic kidney disease, as well
as rare ocular genetic disorders. Eloxx is headquartered in Waltham, MA, with operations in Rehovot, Israel and Morristown, NJ.
For more information, please visit www.eloxxpharma.com.
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