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Eloxx Pharmaceuticals Reports Third Quarter 2020 Financial and Operating Results and Provides Business Update Expect to report top line data from our Phase 2 cystic fibrosis clinical trials in the first half of 2021 The

Key Takeaway: Eloxx Pharmaceuticals Reports Third Quarter 2020 Financial and Operating Results and Provides Business Update Expect to report top line data from our Phase 2 cystic fibrosis clinical trials in the first half of 2021 The independent Safety Review Committees for our Phase 2 cy

Full Press Release Details

Eloxx Pharmaceuticals
Reports Third Quarter 2020 Financial and Operating Results and Provides Business Update
Expect to report top line data from our
Phase 2 cystic fibrosis clinical trials in the first half of 2021
The independent Safety
Review Committees for our Phase 2 cystic fibrosis clinical trial program have allowed dose escalation up to the highest dose level
Preclinical studies continue
to advance in autosomal dominant polycystic kidney disease (ADPKD) and inherited retinal disorders
cash equivalents of $30.6 million as of September 30, 2020 provides cash runway through the end of 2021
Company to host webcast
and conference call today, Thursday, November 5, 2020, at 4:30 pm ET
MA - November 5, 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 nine months ended September 30, 2020 and provided a business update.
resumed our Phase 2 cystic fibrosis clinical trials in Europe, Israel and the U.S., we now expect to report top line data in the
first half of 2021, contingent on no further disruptions due to the COVID-19 pandemic. 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, following several planned meetings, the independent Safety Review
Committees for this clinical trial program have allowed dose escalation up to the highest dose level and, to
date, no drug related serious adverse events have been reported."
The details for the two ELX-02 poster presentations
Poster Session Presentation
Title: "ELX-02 Generates Protein Via Premature Stop Codon Read-through Without Inducing Native Stop Codon Read-through
Presenter: Dr. Dan Crawford, Eloxx Pharmaceuticals
Poster Session Presentation
Title: "CFTR Restoration By ELX-02 Across CF Nonsense Genotypes: Utilizing Patient-Derived Organoids to Survey
Presenter: Dr. Matthew Goddeeris, Eloxx Pharmaceuticals
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.
Third Quarter 2020 Financial Results
As of September 30, 2020, we had cash and
cash equivalents of $30.6 million, which we expect will be sufficient to fund our operations through the end of 2021.
For the three months ended September 30,
2020, we incurred a net loss of $6.6 million or $0.16 per share, which includes $1.4 million in non-cash stock-based compensation.
For the same period in the prior year, we incurred a net loss of $12.9 million, or $0.32 per share.
Our research and development expenses were $3.2 million for
the three months ended September 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 $6.8 million. The quarter to quarter decrease in R&D expenses
of $3.6 million was driven by reduced professional service fees primarily the result of the temporary pause in our clinical trials
due to COVID-19, and reduced headcount and related salaries for the 2020 period.
Our general and administrative expenses were $3.1 million for
the three months ended June 30, 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 $6.0 million. The decrease was primarily driven by lower headcount and
professional services costs.
First Nine Months 2020 Financial Results
For the nine months ended September 30,
2020, we incurred a net loss of $28.5 million, or $0.71 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 $5.3 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 $39.2 million, or $1.05 per share.
Our research and development expenses were $11.3 million for
the nine months ended September 30, 2020, which includes $0.8 million in non-cash expense related to stock-based compensation.
For the same period in the prior year, R&D expenses were $20.2 million. The year over year decrease in R&D expenses
of $8.9 million was driven by reduced professional service fees primarily the result of the temporary 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 $12.3 million for
the nine months ended September 30, 2020, which includes $4.5 million in non-cash expense related to stock-based compensation.
For the same period in the prior year, G&A expenses were $18.9 million. The decrease of $6.6 million was primarily driven by
lower headcount and professional services costs.
Conference Call and Webcast Information:
Date: Thursday, November 5, 2020
Domestic Dial-in Number: (866)
International Dial-in Number: (210) 874-7715
Conference ID: 9467336
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/gucnkjge.
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,
Last updated: Nov 5, 2020