Eloxx Pharmaceuticals Reports First Quarter 2022 Financial and Operating Results and Provides Business Update
Cystic Fibrosis Foundation (CF Foundation) awarded up to $15.9 million for the ongoing ELX-02 clinical program
Topline data from cystic fibrosis (CF) Phase 2 expansion treatment arms evaluating combination with ivacaftor expected at the end of the first half of 2022
Expanded development of ELX-02 for the treatment of Alport syndrome, a rare kidney genetic disorder, with Phase 2 expected to start in second half of 2022
Expect to submit an Investigational New Drug (IND) application for the inhaled delivery of ELX-02 in the second half of 2022
On track to start First in Human Phase 1 study in 2022 with ZKN-013 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) patients with nonsense mutations cells
Cash and equivalents expected to be sufficient to fund operations into the second quarter of 2023
WATERTOWN, Mass., May 10, 2022 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported its financial results for the three months ended March 31, 2022 and provided a business update.
“During the first quarter, we made significant progress, highlighted by the funding award from the CF Foundation and the expansion of our development program for ELX-02 in Alport syndrome, as we begin to fully capture the potential of ELX-02 as a novel readthrough agent,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. “Combined with the continuing progress for our novel Ribosome Modulating Agents in RDEB and familial adenomatous polyposis, we believe we are poised to deliver on multiple potential value-creating events over the next twelve months.”
First Quarter 2022 and Subsequent Highlights
Class 1 Cystic Fibrosis
Recessive Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa (JEB)
Familial Adenomatous Polyposis
First Quarter 2022 Financial Results
For the three months ended March 31, 2022, we incurred a net loss of $11.6 million, or $0.13 per share, which included $0.9 million in stock-based compensation. For the same period in the prior year, we incurred a net loss of $8.7 million, or $0.22 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 March 31, 2022, which includes $0.4 million in stock-based compensation. For the same period in the prior year, R&D expenses were $4.1 million. The increase was primarily related to increases in expenses related to preclinical activities, the continued development of ELX-02, salaries and other personnel related costs, stock-based compensation and operational facilities.
Our general and administrative (G&A) expenses were $3.1 million for the three months ended March 31, 2022, which includes $0.6 million in stock-based compensation. For the same period in the prior year, G&A expenses were $4.3 million. The decrease was primarily related to decreases in salaries and other personnel related costs, stock-based compensation expense, consultant and professional fees, and operational facilities.
As of March 31, 2022, we had cash and cash equivalents of $39.8 million (inclusive of the $7.0 million from the CF Foundation), which 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. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ELX-02 for the treatment of CF patients with nonsense mutations. In addition, ELX-02 has also been granted Orphan Drug Designation for the treatment of CF patients with nonsense mutations by the FDA and orphan medicinal product designation by the European Commission. 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.
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 sufficiency of our cash and cash equivalents to fund our operations, 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, 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.
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Source: Eloxx Pharmaceuticals, Inc.