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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 |
“The recently announced funding from the CF Foundation, together with positive topline clinical results from the monotherapy arm of Phase 2 of the ELX-02 clinical trial announced in November 2021, has increased our confidence in the potential of ELOX-02 to transform the lives of Class 1 CF patients with nonsense mutations,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. “In addition to the ELOX-02 CF program, we believe we continue to make significant progress across our portfolio of product candidates. With the addition of a new program in Alport syndrome, a rare kidney disease, we believe we are beginning to fully capture the potential of ELX-02 as a novel readthrough agent while at the same time, our oral RMAs continue to advance forward with encouraging preclinical data in RDEB and FAP that demonstrate the potential of ribosome modulation.”
Fourth Quarter 2021 and Subsequent Highlights
Class 1 Cystic Fibrosis
Alport Syndrome
Recessive Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa (JEB)
Familial Adenomatous Polyposis and Targeted Oncology
Corporate Update
Fourth Quarter 2021 Financial Results
For the three months ended December 31, 2021, we incurred a net loss of $12.1 million, or $0.14 per share, which includes $1.6 million in stock-based compensation. For the same period in the prior year, we incurred a net loss of $6.1 million, or $0.15 per share. Since the closing date of Eloxx’s acquisition of Zikani Therapeutics, Inc. in April 2021, the results of Zikani’s operations have been included in the Eloxx’ condensed consolidated financial statements.
Our research and development expenses (R&D) were $7.9 million for the three months ended December 31, 2021, which includes $0.6 million in stock-based compensation. For the same period in the prior year, R&D expenses were $2.6 million. The increase was primarily related to expenses related to the continued development of ELX-02 due to the impact of the COVID-19 pandemic in the prior year period, an increase in salaries and other personnel related costs, and an increase in operational facilities.
Our general and administrative (G&A) expenses were $3.7 million for the three months ended December 31, 2021, which includes $1.0 million in stock-based compensation. For the same period in the prior year, G&A expenses were $3.1 million. The increase was primarily related to an increase in stock-based compensation expense, an increase in salaries and other personnel related costs, as well as an increase in legal, accounting and other professional fees.
As of December 31, 2021, we had cash and cash equivalents of $42.3 million, which combined with $7.0 million from the CF Foundation, we expect will be sufficient to fund our operations into the second quarter of 2023.
About Nonsense Mutations
Nonsense mutations cause a premature stop codon in the mRNA resulting in less than full length or loss of function proteins. These remain highly underserved with no approved disease modifying therapies. An estimated 10-12% patients across over 8,000 inherited genetic rare diseases harbor nonsense mutations in one or both alleles harboring nonsense mutations.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZMTM chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). 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 clinical development, focusing on cystic fibrosis (US Trial NCT04135495, EU/IL Trial NCT04126473). Eloxx also has preclinical programs focused on select rare diseases, including inherited diseases, cancer caused by nonsense mutations, kidney diseases, including autosomal dominant polycystic kidney disease, as well as rare ocular genetic disorders.
For more information, please visit www.eloxxpharma.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of present and historical facts contained in this press release, including without limitation, statements regarding our future financial results, the expected timing of trials and results from clinical studies of our product candidates and the potential of our product candidate to treat nonsense mutations are forward-looking statements. Forward-looking statements can be identified by the words “aim,” “may,” “will,” “would,” “should,” “expect,” “explore,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms similar expressions, although not all forward-looking statements contain these words.
Forward-looking statements are based on management's current plans, estimates, assumptions and projections based on information currently available to us. Forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and actual results or outcomes may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to progress any product candidates in preclinical or clinical trials; the uncertainty of clinical trial results and the fact that positive results from preclinical studies are not always indicative of positive clinical results; the scope, rate and progress of our preclinical studies and clinical trials and other research and development activities; the competition for patient enrollment from drug candidates in development; the impact of the global COVID-19 pandemic on our clinical trials, operations, vendors, suppliers, and employees; our ability to obtain the capital necessary to fund our operations; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain financial in the future through product licensing, public or private equity or debt financing or otherwise; general business conditions, regulatory environment, competition and market for our products; and business ability and judgment of personnel, and the availability of qualified personnel and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December, 2021, as any such factors may be updated from time to time in our other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the “Financials & Filings” page of our website at https://investors.eloxxpharma.com/financials-filings.
All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contact
InvestorsJohn Woolfordjohn.woolford@westwicke.com443.213.0506
MediaLaureen Cassidylaureen@outcomescg.com
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(Amounts in thousands, except share and per share data) | ||||||
December 31,2021 | December 31,2020 | |||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 42,268 | $ | 24,668 | ||
Restricted cash | 299 | 56 | ||||
Prepaid expenses and other current assets | 913 | 1,169 | ||||
Total current assets | 43,480 | 25,893 | ||||
Property and equipment, net | 216 | 133 | ||||
Operating lease right-of-use assets | 1,443 | 421 | ||||
Other long-term assets | - | 30 | ||||
Total assets | $ | 45,139 | $ | 26,477 | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 1,379 | $ | 481 | ||
Accrued expenses | 4,196 | 2,924 | ||||
Current portion of long-term debt | - | 5,239 | ||||
Advances from collaboration partners | 3,723 | 805 | ||||
Current portion of operating lease liabilities | 657 | 389 | ||||
Total current liabilities | 9,955 | 9,838 | ||||
Long-term debt | 11,996 | 6,376 | ||||
Operating lease liabilities | 804 | 33 | ||||
Total liabilities | 22,755 | 16,247 | ||||
Total stockholders’ equity | 22,384 | 10,230 | ||||
Total liabilities and stockholders' equity | $ | 45,139 | $ | 26,477 | ||
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||||||||||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(Amounts in thousands, except share and per share data) | ||||||||||||||||
Three Months EndedDecember 31, | Year EndedDecember 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 7,912 | $ | 2,640 | $ | 22,899 | $ | 14,590 | ||||||||
General and administrative | 3,718 | 3,142 | 20,449 | 14,847 | ||||||||||||
In process research and development | — | — | 22,670 | — | ||||||||||||
Restructuring charges | — | 24 | — | 4,018 | ||||||||||||
Total operating expenses | 11,630 | 5,806 | 66,018 | 33,455 | ||||||||||||
Loss from operations | (11,630 | ) | (5,806 | ) | (66,018 | ) | (33,455 | ) | ||||||||
Other expense, net | 460 | 321 | 709 | 1,122 | ||||||||||||
Net loss | $ | (12,090 | ) | $ | (6,127 | ) | $ | (66,727 | ) | $ | (34,577 | ) | ||||
Basic and diluted net loss per share | $ | 0.14 | $ | 0.15 | $ | 0.95 | $ | 0.86 | ||||||||
Weighted average number of common shares used in computing net loss per share, basic and diluted | 86,386,335 | 40,153,552 | 69,962,843 | 40,124,953 | ||||||||||||
Source: Eloxx Pharmaceuticals
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