Bay Street News

Eloxx Pharmaceuticals Reports Third Quarter 2018 Financial and Operating Results and Provides Business Update

ELX-02 has been granted an orphan drug designation by the European Medicines Agency (EMA) for Cystic Fibrosis

Advancing several investigational drug candidates from our library in IND enabling studies for rare inherited retinal diseases

Announced scientific partnership with the Foundation Fighting Blindness to support ocular portfolio development

On track for top line data from two Phase 2 clinical trials in cystic fibrosis and cystinosis in 2019

Company to host webcast and conference call on Thursday, November 8, 2018 at 8:30 am ET

WALTHAM, Mass., Nov. 08, 2018 (GLOBE NEWSWIRE) — 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 nine months ended September 30, 2018 and provided a business update.

“We are very pleased that ELX-02 has been granted orphan drug designations from the European Medicines Agency for cystic fibrosis, and the Food and Drug Administration in the US for cystinosis, and we look forward to reporting top line data from our Phase 2 clinical trials in both indications in 2019. New positive data recently presented at the North American Cystic Fibrosis Conference demonstrated that ELX-02 is the first read-through agent to show dose responsive increases in CFTR function that was found to correlate with CFTRmRNA elevations to levels at or above wild-type,” said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. “We are also advancing several new investigational product candidates from our library in IND enabling studies in rare inherited retinal diseases, and we are very pleased to announce our strategic broad partnership with the Foundation Fighting Blindness as we identify a lead candidate later this year to move into clinical development.”

Recent Accomplishments

ELX-02 is an investigational agent not approved by any regulatory agency for therapeutic use.

Third Quarter 2018 Financial Results

As of September 30, 2018, we had cash and cash equivalents of $55.3 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 September 30, 2018, of $11.2 million or $0.32 per share, which includes $2.7 million non-cash expense related to stock-based compensation. We incurred a net loss for the three months ended September 30, 2017, of $4.0 million, or $1.15 per share. For the three months ended September 30, 2018, the net cash used in operating activities was $8.1 million. For the three months ended September 30, 2017, the net cash used in operating activities was $3.8 million driven primarily by our net loss.

Our research and development expenses were $5.4 million for the three months ended September 30, 2018, compared to $3.3 million for the three months ended September 30, 2017, an increase of $2.1 million due to increased fees and salaries and growth in clinical development.

Our general and administrative expenses were approximately $5.9 million for the three months ended September 30, 2018 compared to approximately $0.7 million for the three months ended September 30, 2017, an increase of approximately $5.2 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, and professional service fees.

Year to Date 2018 Financial Results

We incurred a loss for the nine months ended September 30, 2018, of $33.2 million or $1.05 per share, which includes $9.6 million non-cash expenses related to stock-based compensation. The Company incurred a net loss for the nine months ended September 30, 2017, of $10.6 million, or $2.92 per share. For the nine months ended September 30, 2018, the net cash used in operating activities was $22.3 million. For the nine months ended September 30, 2017, the net cash used in operating activities was $9.7 million, driven primarily by our net loss.

Our research and development expenses were $14.0 million for the nine months ended September 30, 2018, compared to $8.2 million for the nine months ended September 30, 2017, an increase of $5.8 million due to increased fees and salaries and growth in clinical development.

Our general and administrative expenses were approximately $18.9 million for the nine months ended September 30, 2018 compared to approximately $1.6 million for the nine months ended September 30, 2017, an increase of approximately $17.3 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 service fees.

Conference Call Information:
Date: Thursday, November 8, 2018
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 913-8546
International Dial-in Number: (210) 874-7715
Conference ID: 4287229
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/adeeqo7a

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 fromulated 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 and cystinosis. 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 recently announced a new program focused on rare ocular genetic disorders. Eloxx is headquartered in Waltham, MA, with R&D operations in Rehovot, Israel. For more information, please visit www.eloxxpharma.com.

Forward-Looking Statements

This press release 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.

Contact:

Barbara Ryan
203-274-2825
barbarar@eloxxpharma.com

 
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
         
    September 30,
2018
  December 31,
2017
ASSETS        
Current assets:        
Cash and cash equivalents   $ 55,336     $ 24,049  
Restricted bank deposit     46       102  
Prepaid expenses and other current assets     756       355  
Total current assets     56,138       24,506  
Property and equipment, net     345       278  
Other long-term assets     52        
Total   $ 56,535     $ 24,784  
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable   $ 1,352     $ 1,530  
Accrued expenses     3,727       1,893  
Total current liabilities     5,079       3,423  
Stockholders’ equity:        
Preferred stock, $0.01 par value per share, 5,000,000 shares authorized,
  no shares issued and outstanding at September 30, 2018 and December
  31, 2017
           
Common stock, $0.01 par value per share, 500,000,000 shares authorized,
  35,124,844 and 27,527,738 shares issued at September 30, 2018 and
  December 31, 2017, respectively
    351       274  
Common stock in treasury, at cost, 8,385 and 0 shares at September 30, 2018
  and December 31, 2017, respectively
    (83 )      
Additional paid in capital     123,306       60,047  
Accumulated deficit     (72,118 )     (38,960 )
Total stockholders’ equity     51,456       21,361  
Total   $ 56,535     $ 24,784  

ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
         
    Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2018   2017   2018   2017
Operating expenses:                
Research and development   $ 5,415     $ 3,280     $ 13,959     $ 8,230  
General and administrative     5,945       720       18,898       1,581  
Reverse merger related expenses                 594        
Total operating expenses     11,360       4,000       33,451       9,811  
Loss from operations     (11,360 )     (4,000 )     (33,451 )     (9,811 )
Other (income) expense, net     (199 )     40       (293 )     785  
Net loss   $ (11,161 )   $ (4,040 )   $ (33,158 )   $ (10,596 )
                 
Weighted average number of common shares in computing basic and diluted net
loss per share
    35,005,979       4,208,088       31,485,067       4,206,226  
Basic and diluted net loss per share   $ (0.32 )   $ (1.15 )   $ (1.05 )   $ (2.92 )
                                 

SOURCE: Eloxx Pharamaceuticals, Inc.