Full Press Release Details
Eloxx Pharmaceuticals Reports First Quarter
2023 Financial and Operating Results and Provides Business Update
to include biopsy results for the Phase 2 clinical study evaluating ELX-02 for the potential treatment of Alport syndrome expected in
first half of 2023; meaningful protein reduction has been observed in one patient to date
Received U.S. Food and Drug Administration (FDA)
clearance to begin a single ascending dose (SAD) clinical trial for ZKN-013 for the potential treatment of recessive Dystrophic Epidermolysis
Bullosa (RDEB) with nonsense mutations
WATERTOWN, MA - May 15, 2023 - 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, 2023 and provided a business update.
"We are approaching a significant milestone for Eloxx, with topline
data, including kidney biopsy results, expected for ELX-02 in Alport syndrome in the coming weeks," said Sumit Aggarwal, President
and Chief Executive Officer of Eloxx. "In addition, ZKN-013, our lead TURBO-ZM based molecule, is the first program developed
from hit to lead and our excitement for the program continues to grow. Eloxx has additional promising TURBO-ZM based discovery programs
in cystic fibrosis (fully funded by the Cystic Fibrosis Foundation) and in certain cMYC-overexpressing cancers."
First Quarter 2023 and Subsequent Highlights
Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional
Epidermolysis Bullosa (JEB)
Familial Adenomatous Polyposis (FAP)
First Quarter 2023 Financial Results
For the three months ended March 31, 2023, we incurred a net loss of
$6.2 million, or $2.88 per share, which included $0.6 million in stock-based compensation. For the same period in the prior year, we incurred
a net loss of $11.6 million, or $5.36 per share, which included $0.9 million in stock-based compensation.
R&D expenses were $3.5 million for the three months ended March
31, 2023, which included $0.3 million in stock-based compensation. For the same period in the prior year, R&D expenses were $7.9 million,
which included $0.4 million of stock-based compensation. The decrease was primarily related to a decrease in clinical trial expenses for
activities related to inhaled delivery of ELX-02 in cystic fibrosis and a decrease in clinical trial expenses related to a decrease in
Cystic Fibrosis Foundation funded activities.
General and administrative (G&A) expenses were $2.0 million
for the three months ended March 31, 2023, which included $0.3 million in stock-based compensation. For the same period in the prior
year, G&A expenses were $3.1 million, which included $0.6 million of stock-based compensation. The decrease was primarily
related to a decrease in salaries and other personal related costs, a decrease in expenses attributable to professional and
consulting fees, and a decrease in facility and overhead expenses.
As of March 31, 2023, we had unrestricted cash and cash equivalents
of $4.9 million. In March 2023, we amended the terms of the Hercules Term Loan Agreement and repaid $7.5 million of the outstanding principal.
The minimum qualified cash balance requirement was reduced to $2.25 million and the interest only payment period was extended to September
1, 2023, at which time the Company will be required to begin making principal payments. Assuming that we initiate Phase 3 clinical trial
activities in the third quarter of 2023, our expectation is that our current cash position and assuming maintaining compliance with our
debt covenants, will be sufficient to fund our operations into the third 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. ELX-02
is in Phase 2 clinical development for the treatment of Alport syndrome in patients with nonsense mutations. For more information, please
visit www.eloxxpharma.com.
Forward-looking Statements
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 cash runway and our ability to comply with the covenants in our debt agreement, the expected timing of and results from trials 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; our
ability to meet the continued listing requirements of the Nasdaq Capital Market; 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, 2023, 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.
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 CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 3,488 | $ | 7,899 | ||||
| General and administrative | 1,995 | 3,054 | ||||||
| Total operating expenses | 5,483 | 10,953 | ||||||
| Loss from operations | (5,483 | ) | (10,953 | ) | ||||
| Other expense, net | 747 | 667 | ||||||
| Net loss | $ | (6,230 | ) | $ | (11,620 | ) | ||
| Net loss per share, basic and diluted | $ | (2.88 | ) | $ | (5.36 | ) | ||
| Weighted average number of shares of common stock used in computing net loss per share, basic and diluted | 2,166,356 | 2,166,275 |
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
| March 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,904 | $ | 19,207 | ||||
| Restricted cash | 261 | 261 | ||||||
| Prepaid expenses and other current assets | 1,238 | 661 | ||||||
| Total current assets | 6,403 | 20,129 | ||||||
| Property and equipment, net | 143 | 169 | ||||||
| Operating lease right-of-use asset | 654 | 825 | ||||||
| Total assets | $ | 7,200 | $ | 21,123 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,434 | $ | 3,020 | ||||
| Accrued expenses | 2,230 | 2,799 | ||||||
| Current portion of long-term debt | 1,536 | 3,980 | ||||||
| Advances from collaboration partners | 12,535 | 12,535 | ||||||
| Current portion of operating lease liability | 667 | 712 | ||||||
| Derivative liabilities | 58 | 45 | ||||||
| Total current liabilities | 19,460 | 23,091 | ||||||
| Long-term debt, net of current portion | 4,027 | 8,557 | ||||||
| Operating lease liability | 6 | 135 | ||||||
| Total liabilities | 23,493 | 31,783 | ||||||
| Total stockholders' deficit: | (16,293 | ) | (10,660 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 7,200 | $ | 21,123 |