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Eloxx Pharmaceuticals Reports First Quarter 2018 Financial and Operating Results and Provides Business Update Company on track to initiate Phase 2 clinical trials for investigational drug ELX-02 in cystic fibrosis and cy

Key Takeaway: Eloxx Pharmaceuticals Reports First Quarter 2018 Financial and Operating Results and Provides Business Company on track to initiate Phase 2 clinical trials for investigational drug ELX-02 in cystic fibrosis and cystinosis in 2018 and sufficiently funded to top line data Format

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Eloxx Pharmaceuticals Reports First Quarter 2018 Financial and Operating Results and Provides Business
Company on track to initiate Phase 2 clinical trials for investigational drug ELX-02
in cystic fibrosis and cystinosis in 2018 and sufficiently funded to top line data
Formation of Scientific Advisory Board with
expertise in nonsense mutations and nonsense mediated decay
Company to host webcast and conference call on Thursday, May 10,
Waltham, MA. May 10, 2018 Eloxx Pharmaceuticals, Inc. ( Eloxx ),
(ELOX, NASDAQ) 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 months ended March 31, 2018, and provided a business update.
Recent Accomplishments
We are pleased to have successfully raised $53.4 million in a public offering in April and to be trading on the Nasdaq. We are on
track to seek regulatory clearance to initiate Phase 2 clinical trials for our lead investigational product candidate, ELX-02, in cystic fibrosis and cystinosis this year, and are funded through to top line
data readouts, said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. We look forward to sharing additional scientific data for ELX-02 with the scientific community at the European Cystic
Fibrosis Society Meeting in Belgrade, Serbia June 5-9, 2018. We are also extremely gratified to have attracted high caliber experts to our inaugural Scientific Advisory Board and expect that they will provide
us with wise counsel as we advance our library of product candidates designed to be eukaryotic ribosomal selective glycosides.
Investigational Drug ELX-02 in Cystic Fibrosis and Cystinosis
We are currently developing our lead
investigational drug, ELX-02, for the treatment of cystic fibrosis and cystinosis patients with diagnosed nonsense mutations. We have held pre-clinical trial application
(CTA) discussions with the Federal Agency for Medicines and Health Products (FAMHP) in Brussels,
Belgium and pre-IND discussions with the U.S. Food & Drug Administration (FDA) for cystic fibrosis and cystinosis, respectively.
Currently, the European Medicines Agency (EMA) has designated ELX-02 as an orphan medicine for the treatment of
mucopolysaccharidosis type I (MPS I), and the FDA has granted orphan drug designation to ELX-02 for the treatment of cystinosis, MPS I and for the treatment of Rett Syndrome.
41st European Cystic Fibrosis Conference (ECFS)
Eloxx will present two abstracts at ECFS in Belgrade, Serbia, June 6-9, 2018, including one Later-Breaker, for our lead
investigational candidate, ELX-02. The details of these presentations are as follows:
Presenter: Neal Sharpe, Ph.D., Vice President, Translational
Sciences, R & D, Eloxx Pharmaceuticals
Time: Thursday, June 7, 2018 from 3:30 pm - 3:45 pm CET, or 9:30 am - 9:45 am
Presenter: Dr. Pedro Huertas, Chief Medical Officer, Eloxx Pharmaceuticals
Time: Friday, June 8, 2018 from 5:00 pm - 5:30 pm CET, or 11:00 am - 11:30 pm ET
Scientific Advisory Board
Eloxx announced today the
formation of its inaugural Scientific Advisory Board (SAB) and the appointment of the following world leading experts:
Eloxx today also announced that it has entered into a technology evaluation agreement with Ionis Pharmaceuticals,
Inc. to explore potential therapeutic applications of antisense technology and eukaryotic ribosomal selective glycosides for use in rare or ultrarare genetic disorders.
First Quarter 2018 Financial Results
March 31, 2018, we had cash and cash equivalents of $18.3 million, On April 30, 2018, we closed on an underwritten public offering raising an estimated $53.4 million, net of fees. 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 investigation product, ELX-02, in cystic fibrosis and cystinosis.
We incurred a loss for the three months ended March 31, 2018, of $8.6 million or 0.31 per share, which includes
one-time charges of $2.1 million in working capital, and $0.7 million non-cash expenses related to stock-based compensation. The Company incurred a net loss
for the three months ended March 31, 2017, of $2.7 million, or $0.73 per share. For the three months ended March 31, 2018, the net cash used in operating activities was $5.8 million. For the three months ended March 31,
2017, the net cash used in operating activities was $2.7 million driven primarily by our net loss.
Our research and development expenses were
$4.0 million for the three months ended March 31, 2018, compared to $2.4 million for the three month period ended March 31, 2017, an increase of $1.6 million due to increased fees and salaries and growth in clinical
Our general and administrative expenses were approximately $2.5 million for the three months ended March 31, 2018 compared to
approximately $0.3 million for the three months ended March 31, 2017, an increase of approximately $2.2 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 facility related costs.
Date: Thursday, May 10, 2018
Domestic Dial-in Number: (866) 913-8546
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) 859-2056
International Dial-in Number: (404) 537-3406
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 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 Rehovot, Israel.
Forward-Looking Statements
Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and
involve a number of risks and uncertainties. These statements may be identified by introductory words such as may, expects, plan, believe, will, achieve, anticipate,
would, should, subject to or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. These include statements of management s intentions, beliefs, plans
and future expectations and, therefore, you are cautioned not to place undue reliance on them. Such forward-looking statements involve risks and uncertainties and actual results could differ materially from any forward-looking statements expressed
or implied herein. The risks and uncertainties that could result in actual results to differ materially from these forward-looking statements expressed or implied herein include, but are not limited to: 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 the 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 success of the Company s license agreements; 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 ability of the Company to manage the transition to being listed on The Nasdaq Global Market; the ability of the Company to work with its Scientific
Advisory Board; as well as other factors expressed from time to time in the Company s periodic filings with the Securities and Exchange Commission (the SEC ). As a result, this press release should be read in conjunction with the
Company s 10-K, 10-Qs and other filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the
Company undertakes no obligation to publicly update or revise such forward-looking statements to reflect subsequent events or circumstances.
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
March 31, 2018 December 31, 2017
ASSETS
Current assets:
Cash and cash equivalents $ 18,290 $ 24,049
Restricted bank deposit 106 102
Prepaid expenses and other current assets 445 355
Total current assets 18,841 24,506
Property and equipment, net 314 278
Total $ 19,155 $ 24,784
LIABILITIES AND STOCKHOLDERS EQUITY
Current liabilities:
Accounts payable $ 2,173 $ 1,530
Accrued expenses 3,478 1,893
Total current liabilities 5,651 3,423
Stockholders equity:
Series A, B-1, B-2 and C Preferred Stock; Preferred stock, $0.01 par value 5,000,000 shares authorized, no shares issued and outstanding at March 31, 2018 and December 31, 2017
Common stock, $0.01 par value 500,000,000 shares authorized, 27,527,738 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively 274 274
Additional paid in capital 60,782 60,047
Accumulated deficit (47,552 ) (38,960 )
Total stockholders equity 13,504 21,361
Total $ 19,155 $ 24,784
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended March 31,
2018 2017
Operating expenses:
Research and development $ 4,013 $ 2,355
General and administrative 2,480 277
Reverse merger related expenses 2,055
Total operating expenses 8,548 2,632
Loss from operations (8,548 ) (2,632 )
Financial and other expenses 43 46
Net loss $ (8,591 ) $ (2,678 )
Basic and diluted net loss per share $ (0.31 ) $ (0.73 )
Weighted average number of common shares in computing basic and diluted net loss per share 27,527,738 4,205,278
Last updated: May 10, 2018