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Eloxx Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial and Operating Results and Provides Business Update We expect to report top line data from our Phase 2 cystic fibrosis clinical trials in the first

Key Takeaway: Eloxx Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial and Operating Results and Provides Business Update We expect to report top line data from our Phase 2 cystic fibrosis clinical trials in the first half of this year We have expanded our global Phase 2

Full Press Release Details

Eloxx Pharmaceuticals
Reports Fourth Quarter and Full Year 2020 Financial and Operating Results and Provides Business Update
We expect to report top line data from
our Phase 2 cystic fibrosis clinical trials in the first half of this year
We have expanded our
global Phase 2 clinical trial beyond the U.S., Europe and Israel; opening additional clinical sites in Australia and Canada
Cystic Fibrosis Foundation
(CF Foundation) has increased its partial funding of our clinical trial program beyond the U.S. portion to include Europe and Israel
The independent Safety
Review Committees for our Phase 2 cystic fibrosis clinical trial program have allowed dose escalation up to the fourth and highest
Cash and cash equivalents
of $24.7 million as of December 31, 2020
We will host a webcast
and conference call today, Thursday, March 11, 2021 at 4:30 pm ET
MA - March 11, 2021 - 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 twelve months ended December 31, 2020 and provided a business update.
on track to report top line data from our global Phase 2 cystic fibrosis clinical trials in the first half of this year. In addition
to Europe, Israel and the U.S., we are opening additional clinical sites in Australia and Canada. It is our highest priority 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," said Dr. Gregory Williams, Chief
Executive Officer of Eloxx Pharmaceuticals. "We are pleased that the CF Foundation has increased its financial support for
the global clinical trial program and that the independent Safety Review Committees have allowed dose escalation up to the highest
dose level and, to date, no drug related serious adverse events have been reported."
Cystic Fibrosis Phase 2 Program
ADPKD Kidney Program
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.
Fourth Quarter 2020 Financial Results
As of December 31, 2020, we had cash and
cash equivalents of $24.7 million, which we expect will be sufficient to fund our operations though top line data and into the
For the three months ended December 31,
2020, we incurred a net loss of $6.1 million or $0.15 per share, which includes $1.3 million in non-cash stock-based compensation.
For the same period in the prior year, we incurred a net loss of $11.6 million, or $0.29 per share.
Our research and development expenses were $2.6 million for
the three months ended December 31, 2020, which includes $0.2 million in non-cash expense related to stock-based compensation.
For the same period in the prior year, R&D expenses were $5.9 million. The quarter-to-quarter decrease in R&D expenses
of $3.3 million was driven by reduced headcount and related salaries as well as decreases in certain clinical and pre-clinical
research costs for the 2020 period.
Our general and administrative expenses were $3.1 million for
the three months ended December 31, 2020, which includes $1.1 million in non-cash expense related to stock-based compensation.
For the same period in the prior year, G&A expenses were $5.6 million. The decrease was primarily driven by lower headcount
and professional services costs for the 2020 period.
Full Year 2020 Financial Results
For the twelve months ended December 31,
2020, we incurred a net loss of $34.6 million, or $0.86 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 $6.6 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 $50.9 million, or $1.34 per share.
Our research and development expenses were $14.6 million for
the twelve months ended December 31, 2020, which includes $1.0 million in non-cash expense related to stock-based compensation.
For the same period in the prior year, R&D expenses were $26.3 million. The year over year decrease in R&D expenses
of $11.7 million was driven by reduced headcount and related salaries for a portion of the 2020 period as well as reduced costs
relating to certain clinical and preclinical activities.
Our general and administrative expenses were $14.8 million for
the twelve months ended December 31, 2020, which includes $5.6 million in non-cash expense related to stock-based compensation.
For the same period in the prior year, G&A expenses were $24.2 million. The decrease of $9.4 million was primarily driven by
lower headcount and professional services costs.
Conference Call Information:
Date: Thursday, March 11, 2021
Domestic Dial-in Number: (866)
International Dial-in Number: (210) 874-7715
Conference ID: 4772135
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/m65hdyjn.
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. 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 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
the Company's preliminary studies, preclinical research, clinical trials, and related regulatory filings; the ability of
the Company to consummate additional financings as needed; the impact of global health concerns, such as the COVID-19 global pandemic,
on our ability to continue our clinical and preclinical programs and otherwise operate our business effectively; 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.
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
Last updated: Mar 11, 2021