Full Press Release Details
Eloxx Pharmaceuticals Reports Third Quarter
2021 Financial and Operating Results and Provides Business Update
Data from Monotherapy Arms of Ongoing Phase
2 ELX-02 Cystic Fibrosis (CF) Clinical Trials Expected in Fourth Quarter of 2021
Received FDA Fast Track Designation for ELX-02
for the Treatment of CF Patients with Nonsense Mutations
Hosted Call and Webcast on CF Programs Featuring
CF Expert Dr. Eitan Kerem
Appointed Ali Hariri, M.D. as Chief Medical
Entered into Senior Debt Facility from Hercules
Capital for Borrowings of Up to $30 Million
WATERTOWN, MA - Nov 9, 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 and nine months ended September 30, 2021 and provided a business update.
"We continue to make significant progress across our portfolio
of therapeutic programs," said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. "We are on track to report
data from the ongoing Phase 2 clinical trials for ELX-02 in the fourth quarter of 2021. In addition, our preclinical programs continue
to advance demonstrating the potential of our oral RMAs. We intend to provide additional updates on these programs in the coming quarters."
Third Quarter 2021 and Subsequent Highlights
Class 1 Cystic Fibrosis
Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional
Epidermolysis Bullosa (JEB)
Rare Inherited and Targeted Oncology
Third Quarter 2021 Financial Results
For the three months ended September 30, 2021, we incurred a net loss
of $9.9 million, or $0.11 per share, which includes $2.2 million in stock-based compensation. For the same period in the prior year, we
incurred a net loss of $6.6 million, or $0.16 per share. Results for the third quarter of 2021 included costs related to the acquisition
of Zikani. Since the closing date of the acquisition, the results of Zikani's operations have been included in the Eloxx'
condensed consolidated financial statements.
Our research and development expenses (R&D) were $5.2 million for
the three months ended September 30, 2021, which includes $0.4 million in stock-based compensation. For the same period in the prior year,
R&D expenses were $3.4 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 $5.0 million
for the three months ended September 30, 2021, which includes $1.9 million in stock-based compensation. For the same period in the prior
year, G&A expenses were $2.9 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 September 30, 2021, we had cash and cash equivalents of $52.4
million, which we expect will be sufficient to fund our operations into the first 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 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
For more information, please visit www.eloxxpharma.com.
Forward-looking Statements
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 expected cash burn and 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.
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 September 30, 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/financial-information/sec-filings
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
(in thousands, except share and per share data)
| September 30, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,432 | $ | 24,668 | ||||
| Restricted cash | 246 | 56 | ||||||
| Prepaid expenses and other current assets | 864 | 1,169 | ||||||
| Total current assets | 53,542 | 25,893 | ||||||
| Property and equipment, net | 224 | 133 | ||||||
| Operating lease right-of-use assets | 1,617 | 421 | ||||||
| Other long-term assets | - | 30 | ||||||
| Total assets | $ | 55,383 | $ | 26,477 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,509 | $ | 481 | ||||
| Accrued expenses | 2,611 | 2,924 | ||||||
| Current portion of long-term debt | - | 5,239 | ||||||
| Advances from collaboration partners | 3,723 | 805 | ||||||
| Current portion of operating lease liabilities | 667 | 389 | ||||||
| Total current liabilities | 9,510 | 9,838 | ||||||
| Long-term debt | 11,911 | 6,376 | ||||||
| Operating lease liabilities | 964 | 33 | ||||||
| Total liabilities | 22,385 | 16,247 | ||||||
| Total stockholders' equity | 32,998 | 10,230 | ||||||
| Total liabilities and stockholders' equity | $ | 55,383 | $ | 26,477 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,210 | $ | 3,445 | $ | 14,987 | $ | 11,950 | ||||||||
| General and administrative | 5,035 | 2,851 | 16,731 | 11,705 | ||||||||||||
| In process research and development | - | - | 22,670 | - | ||||||||||||
| Restructuring charges | - | - | - | 3,994 | ||||||||||||
| Total operating expenses | 10,245 | 6,296 | 54,388 | 27,649 | ||||||||||||
| Loss from operations | (10,245 | ) | (6,296 | ) | (54,388 | ) | (27,649 | ) | ||||||||
| Other income (expense), net | 360 | (321 | ) | (249 | ) | (801 | ) | |||||||||
| Net loss | $ | (9,885 | ) | $ | (6,617 | ) | $ | (54,637 | ) | $ | (28,450 | ) | ||||
| Basic and diluted net loss per share | $ | (0.11 | ) | $ | (0.16 | ) | $ | (0.85 | ) | $ | (0.71 | ) | ||||
| Weighted average number of common shares used in computing net loss per share, basic and diluted | 86,208,754 | 40,142,178 | 64,428,187 | 40,115,351 |