Full Press Release Details
Pharmaceuticals Reports First Quarter 2021 Financial and Operating Results and Provides Business Update
Acquisition of Zikani Therapeutics, Ribosomal
Modulation Company; Combined Company Advancing Ribosomal RNA-Targeted Genetic Therapies
Additional Treatment Arm Added to Ongoing Phase
2 Clinical Studies for Cystic Fibrosis (CF)
Cystic Fibrosis Foundation (CF Foundation) Increases
Clinical Trial Funding to Include Europe and Israel
ELX-02 Phase 1 Results Published in Multiple
WALTHAM, MA - May 6, 2021 - 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, 2021 and provided a business update.
"The beginning of 2021 has been transformative for Eloxx and
was extremely important in laying the groundwork for the future success of ELX-02, our candidate for cystic fibrosis, and in amplifying
the potential of Eloxx's innovative science and be a leader in RNA-targeted genetic therapies. Our enthusiasm has only increased
in the short period since the acquisition," said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. "We remain
incredibly excited by the potential of ELX-02 to help treat CF patients affected by nonsense mutations and look forward to completing
enrollment in the first four treatment arms by mid-year, and expect to report data in the second half of 2021."
First Quarter 2021 and Subsequent Highlights
First Quarter 2021 Financial Results
For the three months ended March 31, 2021, we incurred a net loss of
$8.7 million or $0.22 per share, which includes $1.3 million in stock-based compensation. For the same period in the prior year, we incurred
a net loss of $13.9 million, or $0.35 per share.
Our research and development expenses (R&D) were $4.1 million for
the three months ended March 31, 2021, which includes $0.2 million in stock-based compensation. For the same period in the prior year,
R&D expenses were $4.8 million. The decrease in R&D expenses was driven by reduced expenses related to the development of ELX-02
due to the impact of the COVID-19 and realignment actions taken in February 2020 that included reductions in R&D headcount and external
Our general and administrative (G&A) expenses were $4.3 million
for the three months ended March 31, 2021, which includes $1.1 million in stock-based compensation. For the same period in the prior year,
G&A expenses were $5.0 million. The decrease was primarily driven by realignment actions taken in February 2020 that included reductions
in general and administrative headcount and external spending.
As of March 31, 2021, we had cash and cash equivalents of $18.2 million,
which we expect will be sufficient to fund our operations into the third quarter of 2021.
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 Ribsome 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. 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 the expected timing of trials
and results from clinical studies of our product candidate, the expansion of our clinical trial sites 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 31, 2020, as any such factors
may be updated from time to time in our other filings with the SEC, including our Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2021, accessible on the SEC's website at www.sec.gov and the "Financials & Filings" page of our
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
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| March 31, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,247 | $ | 24,668 | ||||
| Restricted cash | 54 | 56 | ||||||
| Prepaid expenses and other current assets | 1,659 | 1,169 | ||||||
| Total current assets | 19,960 | 25,893 | ||||||
| Property and equipment, net | 117 | 133 | ||||||
| Operating lease right-of-use asset | 289 | 421 | ||||||
| Other long-term assets | - | 30 | ||||||
| Total assets | $ | 20,366 | $ | 26,477 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 485 | $ | 481 | ||||
| Accrued expenses | 2,917 | 2,886 | ||||||
| Current portion of long-term debt | 5,562 | 5,239 | ||||||
| Advances from collaboration partners | 3,411 | 805 | ||||||
| Current portion of operating lease liability | 280 | 389 | ||||||
| Taxes payable | 38 | 38 | ||||||
| Total current liabilities | 12,693 | 9,838 | ||||||
| Long-term debt | 4,913 | 6,376 | ||||||
| Operating lease liability | 10 | 33 | ||||||
| Total liabilities | 17,616 | 16,247 | ||||||
| Total stockholders' equity | 2,750 | 10,230 | ||||||
| Total liabilities and stockholders' equity | $ | 20,366 | $ | 26,477 |
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 4,073 | $ | 4,767 | ||||
| General and administrative | 4,341 | 5,006 | ||||||
| Restructuring charges | - | 3,994 | ||||||
| Total operating expenses | 8,414 | 13,767 | ||||||
| Loss from operations | (8,414 | ) | (13,767 | ) | ||||
| Other expense, net | 280 | 179 | ||||||
| Net loss | $ | (8,694 | ) | $ | (13,946 | ) | ||
| Net loss per share, basic and diluted | $ | (0.22 | ) | $ | (0.35 | ) | ||
| Weighted average number of shares of common stock used in computing net loss per share, basic and diluted | 40,180,131 | 40,074,275 |