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Eloxx Pharmaceuticals Reports Fourth Quarter 2022 Financial and Operating Results and Provides Business Update Three patients now dosed in Phase 2 clinical study evaluating ELX-02 for the treatment of Alport syndrome; en

Key Takeaway: Eloxx Pharmaceuticals Reports Fourth Quarter 2022 Financial and Operating Results and Provides Business Update Three patients now dosed in Phase 2 clinical study evaluating ELX-02 for the treatment of Alport syndrome; encouraging initial reduction in proteinuria has been obser

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Eloxx Pharmaceuticals Reports Fourth Quarter
2022 Financial and Operating Results and Provides Business Update
Three patients now dosed in Phase 2 clinical
study evaluating ELX-02 for the treatment of Alport syndrome; encouraging initial reduction in proteinuria has been observed in one patient
Investigational New Drug (IND) application for
ZKN-013 filed for treatment of recessive dystrophic epidermolysis bullosa (RDEB)
WATERTOWN, MA - April 3,
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 December 31, 2022 and provided a business update.
"With topline data expected for ELX-02 in Alport syndrome in
the first half of 2023, we believe we are approaching a significant milestone for the company, to advance into our first Phase 3 study,
with the potential to create significant value for both patients and shareholders," said Sumit Aggarwal, President and Chief Executive
Officer of Eloxx. "Positive data from the trial would also be a validation of our potential to treat other rare kidney diseases
and develop small molecule genetic therapy products."
Fourth Quarter 2022 and Subsequent Highlights
Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional
Epidermolysis Bullosa (JEB)
Familial Adenomatous Polyposis (FAP)
Fourth Quarter 2022 Financial Results
For the three months ended December 31, 2022, we incurred a net
loss of $6.3 million, or $2.92 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 $12.1 million, or $5.60 per share, which included $1.6 million in stock-based compensation.
R&D expenses were $3.3 million for the three months ended December 31,
2022, which includes $0.3 million in stock-based compensation. For the same period in the prior year, R&D expenses were $7.9 million,
which included $0.6 million of stock-based compensation. The decrease was related to a decrease in clinical trial expenses related primarily
to Cystic Fibrosis Foundation funded activities, and a decrease in salaries and other personnel costs.
General and administrative (G&A) expenses were $2.7 million for
the three months ended December 31, 2022, which includes $0.3 million in stock-based compensation. For the same period in the prior
year, G&A expenses were $3.7 million, which included $1.0 million of stock-based compensation. The decrease was primarily related
to a decrease in salaries and other personal related costs due to reduced headcount and outsourcing certain functions, a decrease in expenses
attributable to professional and consulting fees, and a decrease in stock-based compensation expense.
As of December 31, 2022, we had unrestricted cash and cash equivalents
of $19.2 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 Eloxx will be required to make principal payments,
plus interest, beginning in September 2023. 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. 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
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 Annual Report on Form 10-K for the fiscal year ended December 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.
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.
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
December 31, 2022 December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents $ 19,207 $ 42,268
Restricted cash 261 299
Prepaid expenses and other current assets 661 913
Total current assets 20,129 43,480
Property and equipment, net 169 216
Operating lease right-of-use assets 825 1,443
Total assets $ 21,123 $ 45,139
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Current liabilities:
Accounts payable $ 3,020 $ 1,379
Accrued expenses 2,799 4,196
Current portion of long-term debt 3,980 -
Advances from collaboration partners 12,535 3,723
Current portion of operating lease liabilities 712 657
Derivative liabilities 45 -
Total current liabilities 23,091 9,955
Long-term debt 8,557 11,996
Operating lease liabilities 135 804
Total liabilities 31,783 22,755
Total stockholders' (deficit) equity (10,660 ) 22,384
Total liabilities and stockholders' (deficit) equity $ 21,123 $ 45,139
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
Three Months Ended December 31, Year Ended December 31,
2022 2021 2022 2021
Operating expenses:
Research and development $ 3,297 $ 7,912 $ 23,727 $ 22,899
General and administrative 2,731 3,718 10,692 20,449
In process research and development - - - 22,670
Total operating expenses 6,028 11,630 34,419 66,018
Loss from operations (6,028 ) (11,630 ) (34,419 ) (66,018 )
Other expense, net 291 460 1,646 709
Net loss $ (6,319 ) $ (12,090 ) $ (36,065 ) $ (66,727 )
Basic and diluted net loss per share $ (2.92 ) $ (5.60 ) $ (16.65 ) $ (38.15 )
Weighted average number of common shares used in computing net loss per share, basic and diluted 2,166,356 2,159,658 2,166,311 1,749,071
Last updated: Apr 3, 2023