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Eloxx Pharmaceuticals Reports Second Quarter 2018 Financial and Operating Results and Provides Business UpdateCTA approved in Belgium and IND open in the U.S. for investigational drug candidate, ELX-02 On track to initiate Phase 2 clinical trials in cystic fibrosis and cystinosis in 2018 Expanded Leadership Team with Global Pharmaceutical Executives to Accelerate Growth Company to host webcast and conference call on Tuesday, August 7, 2018 at 4:30 pm ET WALTHAM, Mass., Aug. 07, 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 six months ended June 30, 2018 and provided a business update. “We are pleased to have achieved important regulatory milestones in Europe and the U.S. gaining clearance to initiate two Phase 2 clinical trials for our lead investigational product candidate, ELX-02, in cystic fibrosis and cystinosis, respectively. We are on track to initiate these this year and we are funded through data readouts,” said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. “I am very gratified to have been successful in attracting experienced pharmaceutical executives to our leadership team who I am confident will add significant value as we build a high-performance culture committed to maximizing the value of ELX-02 and our library of novel compounds and pursue global collaborations.” Recent Accomplishments
Eloxx presented two abstracts at the 41st European Cystic Fibrosis Conference (ECFS) in Belgrade Serbia; a Late Breaker titled “Evaluation of ELX-02 in Cystic Fibrosis Patient Organoids with Non-Sense Mutations”, and an oral presentation titled “Translational Read-Through of CFTR Non-Sense Mutations and Inducement of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function by ELX-02 Treatment”. Second Quarter 2018 Financial Results As of June 30, 2018, we had cash and cash equivalents of $63.4 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 June 30, 2018, of $13.4 million or $0.42 per share, which includes $6.2 million non-cash expense related to stock-based compensation. The Company incurred a net loss for the three months ended June 30, 2017, of $3.9 million, or $1.04 per share. For the three months ended June 30, 2018, the net cash used in operating activities was $8.5 million. For the three months ended June 30, 2017, the net cash used in operating activities was $3.2 million driven primarily by our net loss. Our research and development expenses were $4.2 million for the three months ended June 30, 2018, compared to $2.6 million for the three months ended June 30, 2017, an increase of $1.6 million due to increased fees and salaries and growth in clinical development. Our general and administrative expenses were approximately $9.6 million for the three months ended June 30, 2018 compared to approximately $0.6 million for the three months ended June 30, 2017, an increase of approximately $9.0 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 six months ended June 30, 2018, of $22.0 million or $0.74 per share, which includes $6.9 million non-cash expenses related to stock-based compensation. The Company incurred a net loss for the six months ended June 30, 2017, of $6.6 million, or $1.77 per share. For the six months ended June 30, 2018, the net cash used in operating activities was $14.2 million. For the six months ended June 30, 2017, the net cash used in operating activities was 5.9 million, driven primarily by our net loss. Our research and development expenses were $8.5 million for the six months ended June 30, 2018, compared to $5.0 million for the six months ended June 30, 2017, an increase of $3.5 million due to increased fees and salaries and growth in clinical development. Our general and administrative expenses were approximately $13.0 million for the six months ended June 30, 2018 compared to approximately $0.9 million for the six months ended June 30, 2017, an increase of approximately $12.1 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: Tuesday, August 7, 2018 Time: 4:30 p.m. ET 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 investigational 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 Contact: Barbara Ryan ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES UNAUDITED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data)
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
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