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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Eloxx Pharmaceuticals Inc | NASDAQ:ELOX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.82 | 3.60 | 3.75 | 0 | 01:00:00 |
“I am highly confident that we have the right team and resources in place to achieve our clinical and portfolio objectives. Our highest priority is to complete enrollment of our Phase 2 clinical trials for Cystic Fibrosis and report topline data in the first half of this year,” said Dr. Gregory Williams, Chief Executive Officer of Eloxx Pharmaceuticals. “We believe that proof of concept data in cystic fibrosis will be a substantial value inflection point for the Company. Our recent organizational realignment extends our cash runway through the end of 2021 and strengthens our strategic flexibility.”
Organizational Realignment
Cystic Fibrosis Program Updates
Kidney Program Updates
Additional Development Programs
ELX-02 is an investigational agent not approved by any regulatory agency for therapeutic use which is currently in Phase 2 clinical trials in cystic fibrosis and cystinosis.
Fourth Quarter 2019 Financial Results
As of December 31, 2019, we had cash, cash equivalents and marketable securities of $56.3 million, which we expect will be sufficient to fund our operations through the end of 2021, well beyond topline data from our Phase 2 clinical trials in cystic fibrosis.
For the three months ended December 31, 2019, we incurred a loss of $11.6 million or $0.29 per share, which includes $2.7 million non-cash expense related to stock-based compensation. For the same period in the prior year, we incurred a net loss of $14.0 million, or $0.40 per share.
Our research and development expenses were $5.7 million for the three months ended December 31, 2019 which includes $0.5 million non-cash expense related to stock-based compensation. For the same period in the prior year, R&D expenses were $6.5 million. The quarter to quarter decrease in R&D expenditures was driven by the timing of significant activities in our Phase 2 clinical trials, along with pre-clinical and CMC costs, and lower non-cash stock compensation.
Our general and administrative expenses were $5.8 million for the three months ended December 31, 2019 which includes $2.2 million in non-cash expense related to stock-based compensation. For the same period in the prior year, G&A expenses were $7.6 million. The change was primarily driven by decreases in professional service fees and non-cash stock compensation expense.
Full Year 2019 Financial Results
For the twelve months ended December 31, 2019, we incurred a loss of $50.9 million or $1.34 per share, which includes $11.3 million in non-cash expense related to stock-based compensation. For the prior year, we incurred a net loss of $47.2 million, or $1.45 per share.
Our research and development expenses were $25.8 million for the twelve months ended December 31, 2019 which includes $2.5 million in non-cash expense related to stock-based compensation. For the same period in the prior year, R&D expenses were $20.5 million. The year over year increase in R&D expenditures was driven primarily by growth in salaries and other personnel costs and increases in clinical operations costs related to our Phase 2 clinical trials.
Our general and administrative expenses were $24.7 million for the twelve months ended December 31, 2019 which includes $8.9 million in non-cash stock-based compensation. For the prior year, G&A expenses were $26.5 million. The year over year decline in our G&A expenses was primarily related to lower non-cash expense related to stock-based compensation and a decrease in infrastructure-related costs offset by increases in salaries and other personnel costs.
Conference Call and Webcast Information:Date: Thursday, March 5, 2020Time: 4:30 p.m. ETDomestic Dial-in Number: (866) 913-8546International Dial-in Number: (210) 874-7715Conference ID: 3149964Live 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/8d96keug
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.
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
SOURCE: Eloxx Pharmaceuticals, Inc.
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES | |||||||
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
(Amounts in thousands, except share and per share data) | |||||||
December 31, | |||||||
2019 | 2018 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 22,493 | $ | 48,606 | |||
Marketable securities | 33,783 | — | |||||
Restricted bank deposit | 43 | 45 | |||||
Prepaid expenses and other current assets | 1,390 | 1,690 | |||||
Total current assets | 57,709 | 50,341 | |||||
Property and equipment, net | 201 | 248 | |||||
Operating lease right-of-use asset | 924 | — | |||||
Other long-term assets | 113 | 129 | |||||
Total assets | $ | 58,947 | $ | 50,718 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,871 | $ | 747 | |||
Accrued expenses | 4,655 | 6,938 | |||||
Current portion of long-term debt | 4,336 | — | |||||
Advances from collaboration partners | 403 | — | |||||
Current portion of operating lease liability | 499 | — | |||||
Taxes payable | 43 | 122 | |||||
Total current liabilities | 11,807 | 7,807 | |||||
Long-term debt | 10,502 | — | |||||
Operating lease liability | 425 | — | |||||
Total liabilities | 22,734 | 7,807 | |||||
Stockholders’ equity: | |||||||
Preferred stock, $0.01 par value per share, 5,000,000 shares authorized, no shares issued or outstanding at December 31, 2019 and 2018 | — | — | |||||
Common stock, $0.01 par value per share, 500,000,000 shares authorized, 40,186,469 and 35,951,537 shares issued and 40,030,763 and 35,860,114 shares outstanding as of December 31, 2019 and 2018, respectively | 402 | 360 | |||||
Common stock in treasury, at cost, 155,706 and 91,423 shares as of December 31, 2019 and 2018, respectively | (1,703 | ) | (1,129 | ) | |||
Additional paid-in capital | 174,515 | 129,825 | |||||
Accumulated other comprehensive income | 18 | — | |||||
Accumulated deficit | (137,019 | ) | (86,145 | ) | |||
Total stockholders’ equity | 36,213 | 42,911 | |||||
Total liabilities and stockholders' equity | $ | 58,947 | $ | 50,718 | |||
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES | |||||||||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
(Amounts in thousands, except share and per share data) | |||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 5,682 | $ | 6,530 | $ | 25,842 | $ | 20,489 | |||||||
General and administrative | 5,806 | 7,584 | 24,713 | 26,482 | |||||||||||
Reverse merger related expenses | — | — | — | 594 | |||||||||||
Total operating expenses | 11,488 | 14,114 | 50,555 | 47,565 | |||||||||||
Loss from operations | (11,488 | ) | (14,114 | ) | (50,555 | ) | (47,565 | ) | |||||||
Other expense (income), net | 145 | (209 | ) | 319 | (502 | ) | |||||||||
Loss before income taxes | (11,633 | ) | (13,905 | ) | (50,874 | ) | (47,063 | ) | |||||||
Provision for income taxes | — | 122 | — | 122 | |||||||||||
Net loss | $ | (11,633 | ) | $ | (14,027 | ) | $ | (50,874 | ) | $ | (47,185 | ) | |||
Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.40 | ) | $ | (1.34 | ) | $ | (1.45 | ) | |||
Weighted-average number of shares of common stock used in computing net loss per share, basic and diluted | 39,981,335 | 35,259,810 | 38,063,173 | 32,436,506 |
1 Year Eloxx Pharmaceuticals Chart |
1 Month Eloxx Pharmaceuticals Chart |
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