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Phase 2 cystic fibrosis clinical trial IND is open in the U.S., protocol endorsed by the Cystic Fibrosis Foundation (CFF)
Initiated a Phase 2 clinical trial for ELX-02 in cystinosis in Canada and received non-dilutive funding from Genome Quebec and Genome Canada
On track to report top line data from Phase 2 clinical trials for ELX-02 in cystic fibrosis and cystinosis in the U.S., Europe, Israel and Canada in 2019
Three abstracts for ELX-02 were accepted for presentation at the North American Cystic Fibrosis Conference, October 31-November 2, 2019
Company to host webcast and conference call on Wednesday, August 7, 2019 at 8:30 am ET
WALTHAM, Mass., Aug. 07, 2019 (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, inherited retinal disorders, 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, 2019 and provided a business update.
“We are pleased to be rapidly advancing our Phase 2 programs for ELX-02. Our IND for a Phase 2 clinical trial in cystic fibrosis is open in the U.S. and the protocol has been endorsed by the Cystic Fibrosis Foundation (CFF). We believe that the positive data we have generated for ELX-02 in cystic fibrosis patient-derived organoids substantially de-risk our Phase 2 program,” said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. “We have initiated a Phase 2 clinical trial in Canada in cystinosis and we look forward to reporting top line data from both of these programs this year.”
“We are gratified to have two leading CF experts leading our Phase 2 clinical trial of ELX-02 in cystic fibrosis patients: Dr. Ahmet Uluer, Director of the Adult Cystic Fibrosis Program at Boston Children’s Hospital/Brigham and Women’s Hospital CF Center, has agreed to be the lead study investigator in the U.S., and Dr. Eitan Kerem, Head of the Division of Pediatrics, Children’s Hospital, Hadassah Medical Center, will serve as the Global Lead Investigator, said Dr. Greg Williams, Chief Operating Officer of Eloxx. “ELX-02 is the only read-through agent to have demonstrated positive results in organoids derived from cystic fibrosis patients across the majority of nonsense mutations and studies have shown the organoid model to be highly predictive of clinical benefit. We believe these data de-risk our Phase 2 clinical trial program in cystic fibrosis.”
Cystic Fibrosis Program Updates
Cystinosis Program Updates
ELX-02 is an investigational agent not approved by any regulatory agency for therapeutic use.
Second Quarter 2019 Financial Results
As of June 30, 2019, we had cash, cash equivalents and marketable securities of $76.3 million, which we expect will be sufficient to fund our operations through top line data from our Phase 2 clinical trials in cystic fibrosis and cystinosis in 2019 and our current and planned operations into the first quarter of 2021.
For the three months ended June 30, 2019, we incurred a loss of $14.4 million or $0.40 per share, which includes $3.0 million non-cash expense related to stock-based compensation. For the same period in the prior year, we incurred a net loss of $13.4 million, or $0.42 per share.
Our research and development expenses were $7.3 million for the three months ended June 30, 2019 which includes $2.3 million non-cash expense related to stock-based compensation. For the same period in the prior year, R&D expenses were $4.2 million. Quarter over quarter increases in R&D expenditures were driven by our Phase 1 clinical studies, the renal impairment study, and preparations for our multiple Phase 2 clinical trials, along with pre-clinical and CMC operations.
Our general and administrative expenses were $7.0 million for the three months ended June 30, 2019 which includes $0.7 million in non-cash expense related to stock-based compensation. For the same period in the prior year, G&A expenses were $9.6 million. The year over year decrease in our G&A expenses was primarily related to lower non-cash expense related to stock-based compensation in the 2019 period, partially offset by an increase in salary related costs reflective of our year over year headcount growth and increases in professional service fees.
First Half 2019 Financial Results
For the six months ended June 30, 2019, we incurred a loss of $26.4 million or $0.73 per share, which includes $5.7 million in non-cash expense related to stock-based compensation. For the same period in the prior year, we incurred a net loss of $22.0 million, or $0.74 per share.
Our research and development expenses were $13.3 million for the six months ended June 30, 2019 which includes $4.4 million in non-cash expense related to stock-based compensation. For the same period in the prior year, R&D expenses were $8.5 million. The year over year increase in R&D expenditures was driven primarily by growth in our clinical and preclinical operations.
Our general and administrative expenses were $12.9 million for the six months ended June 30, 2019 which includes $1.3 million in non-cash stock-based compensation. For the same period in the prior year, G&A expenses were $13.0 million. Lower non-cash expense related to stock-based compensation million in the 2019 period, was partially offset by an increase in salary related costs reflective of our year over year headcount growth and increases in professional service fees.
Conference Call Information
Date: Wednesday, August 7, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 913-8546
International Dial-in Number: (210) 874-7715
Conference ID: 1754316
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 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 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 operations in Rehovot, Israel. For more information, please visit www.eloxxpharma.com.
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.
SOURCE: Eloxx Pharmaceuticals, Inc.
|ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS|
|(Amounts in thousands, except share and per share data)|
|Cash and cash equivalents||$||49,326||$||48,606|
|Restricted bank deposit||45||45|
|Prepaid expenses and other current assets||1,392||1,690|
|Total current assets||77,736||50,341|
|Property and equipment, net||214||248|
|Operating lease right-of-use asset||989||—|
|Other long-term assets||100||129|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current portion of long-term debt||2,231||—|
|Current portion of operating lease liability||473||—|
|Total current liabilities||10,993||7,807|
|Operating lease liability||516||—|
|Common stock, $0.01 par value per share, 500,000,000 shares authorized, 40,043,365 and 35,951,537 shares issued and 39,914,668 and 35,860,114 shares outstanding as of June 30, 2019 and December 31, 2018, respectively||402||360|
|Common stock in treasury, at cost, 128,697 and 91,423 shares at June 30, 2019 and December 31, 2018, respectively||(1,539||)||(1,129||)|
|Additional paid in capital||168,848||129,825|
|Accumulated other comprehensive income||24||—|
|Total stockholders’ equity||55,224||42,911|
|Total liabilities and stockholders' equity||$||79,039||$||50,718|
|ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|UNAUDITED CONSOLIDATED INCOME STATEMENTS|
|(Amounts in thousands, except share and per share data)|
Three Months Ended
Six Months Ended
|Research and development||$||7,340||$||4,150||$||13,359||$||8,544|
|General and administrative||6,971||9,560||12,929||12,953|
|Reverse merger related expenses||—||(167||)||—||594|
|Total operating expenses||14,311||13,543||26,288||22,091|
|Loss from operations||(14,311||)||(13,543||)||(26,288||)||(22,091||)|
|Other expense (income), net||138||(137||)||78||(94||)|
|Basic and diluted net loss per share||$||(0.40||)||$||(0.42||)||$||(0.73||)||$||(0.74||)|
|Weighted average number of Common Shares used in computing basic and diluted net loss per share||36,278,567||31,839,303||36,098,171||29,695,430|