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Eloxx Pharmaceuticals Reports Second Quarter 2022 Financial and Operating Results and Provides Business UpdateTopline data from cystic fibrosis (CF) Phase 2 expansion treatment arms evaluating combination with ivacaftor expected by the end of the third quarter of 2022 On track to initiate a proof-of-concept clinical trial with ELX-02 in up to eight Alport syndrome patients with nonsense mutations in the second half of 2022 On track to submit an Investigational New Drug (IND) application for the inhaled delivery of ELX-02 in the fourth quarter of 2022 On track to submit IND application for ZKN-013 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) patients with nonsense mutations cells in the fourth quarter of 2022 Announces results of ZKN-013 Dose Response Study in APCMin Model that confirmed the results from prior study which concluded in March 2022 and expect to submit an IND application for Familial Adenomatous Polyposis (FAP) in the second half of 2023 Cash and equivalents expected to be sufficient to fund operations into the fourth quarter of 2023 WATERTOWN, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, reported its financial results for the three months ended June 30, 2022 and provided a business update. “We continue to make significant progress advancing our pipeline of novel products for patients with substantial unmet medical needs. With multiple potential value-creating events expected over the next twelve months, including topline data readouts for ELX-02 in both CF and Alport syndrome, we are approaching an exciting and eventful period for the company,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. “As further evidence of the potential of our technology platform, today we are pleased to announce results of a repeat study of ZKN-013 in a validated model, which provides further confirmation for the potential of ZKN-013 to treat FAP,” said Sumit Aggarwal, President and CEO of Eloxx Pharmaceuticals. “Based on the continuing positive preclinical results, we now expect to submit an IND to the U.S. Food and Drug Administration in the fourth quarter of 2023 for ZKN-013 for FAP.” Second Quarter 2022 and Subsequent Highlights Class 1 Cystic Fibrosis
Alport Syndrome
Recessive Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa (JEB)
Familial Adenomatous Polyposis
Second Quarter 2022 Financial Results For the three months ended June 30, 2022, we incurred a net loss of $10.6 million, or $0.12 per share, which included $0.7 million in stock-based compensation. For the same period in the prior year, we incurred a net loss of $36.1 million, or $0.54 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. The second quarter of 2021 included a $22.7 million expense for in process research and development (R&D) related to the Zikani acquisition. Our R&D expenses were $7.7 million for the three months ended June 30, 2022, which includes $0.3 million in stock-based compensation. For the same period in the prior year, R&D expenses were $5.7 million, which included $0.1 million of stock-based compensation. The increase was primarily related to increases in expenses related to preclinical and development activities, the continued development of ELX-02 related primarily to Cystic Fibrosis Foundation funded activities, facility and overhead expenses and salaries and stock-based compensation. Our general and administrative (G&A) expenses were $2.6 million for the three months ended June 30, 2022, which includes $0.4 million in stock-based compensation. For the same period in the prior year, G&A expenses were $7.4 million, which included $3.9 million of stock-based compensation. The decrease was primarily related to decreases in salaries and other personnel related costs, stock-based compensation and facility and overhead expenses. As of June 30, 2022, we had unrestricted cash and cash equivalents of $30.0 million. The Hercules Term Loan Agreement contains customary affirmative and negative covenants, which among others require the Company to maintain at all times a minimum qualified cash balance. As of June 30, 2022, the Company was in compliance with all debt covenants. If our lender does not accelerate our debt upon our failure to comply with the minimum cash covenant, we expect our current cash position will be sufficient to fund our operations into the fourth quarter of 2023. 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. 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, our cash runway, 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 quarter ended June 30, 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/financial-information/sec-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 Investors Media
Source: Eloxx Pharmaceuticals |