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Eloxx Pharmaceuticals Reports First Quarter 2022 Financial and Operating Results and Provides Business Update Cystic Fibrosis Foundation (CF Foundation) awarded up to $15.9 million for the ongoing ELX-02 clinical program

Key Takeaway: Eloxx Pharmaceuticals Reports First Quarter 2022 Financial and Operating Results and Provides Business Update Cystic Fibrosis Foundation (CF Foundation) awarded up to $15.9 million for the ongoing ELX-02 clinical program Topline data from cystic fibrosis (CF) Phase 2 expansi

Full Press Release Details

Eloxx Pharmaceuticals Reports First Quarter
2022 Financial and Operating Results and Provides Business Update
Cystic Fibrosis Foundation (CF Foundation)
awarded up to $15.9 million for the ongoing ELX-02 clinical program
Topline data from cystic fibrosis (CF) Phase
2 expansion treatment arms evaluating combination with ivacaftor expected at the end of the first half of 2022
Expanded development of ELX-02 for the treatment
of Alport syndrome, a rare kidney genetic disorder, with Phase 2 expected to start in second half of 2022
Expect to submit an Investigational New Drug
(IND) application for the inhaled delivery of ELX-02 in the second half of 2022
On track to start First in Human Phase 1 study
in 2022 with ZKN-013 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) patients with nonsense mutations cells
Cash and equivalents expected to be sufficient
to fund operations into the second quarter of 2023
WATERTOWN, MA - May 10, 2022 - 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, 2022 and provided a business update.
"During the first quarter, we made significant progress, highlighted
by the funding award from the CF Foundation and the expansion of our development program for ELX-02 in Alport syndrome, as we begin to
fully capture the potential of ELX-02 as a novel readthrough agent," said Sumit Aggarwal, President and Chief Executive Officer
of Eloxx. "Combined with the continuing progress for our novel Ribosome Modulating Agents in RDEB and familial adenomatous polyposis,
we believe we are poised to deliver on multiple potential value-creating events over the next twelve months."
First Quarter 2022 and Subsequent Highlights
Class 1 Cystic Fibrosis
Recessive Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis
Familial Adenomatous Polyposis
First Quarter 2022 Financial Results
For the three months ended March 31, 2022, we incurred a net loss of
$11.6 million, or $0.13 per share, which included $0.9 million in stock-based compensation. For the same period in the prior year, we
incurred a net loss of $8.7 million, or $0.22 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.
Our research and development expenses (R&D) were $7.9 million for
the three months ended March 31, 2022, which includes $0.4 million in stock-based compensation. For the same period in the prior year,
R&D expenses were $4.1 million. The increase was primarily related to increases in expenses related to preclinical activities, the
continued development of ELX-02, salaries and other personnel related costs, stock-based compensation and operational facilities.
Our general and administrative (G&A) expenses were $3.1 million
for the three months ended March 31, 2022, which includes $0.6 million in stock-based compensation. For the same period in the prior year,
G&A expenses were $4.3 million. The decrease was primarily related to decreases in salaries and other personnel related costs, stock-based
compensation expense, consultant and professional fees, and operational facilities.
As of March 31, 2022, we had cash and cash equivalents of $39.8 million
(inclusive of the $7.0 million from the CF Foundation), which we expect will be sufficient to fund our operations into the second quarter
About Nonsense Mutations
Nonsense mutations cause a premature stop codon in the mRNA resulting
in less than full length or loss of function proteins. These remain highly underserved with no approved disease modifying therapies. An
estimated 10-12% patients across over 8,000 inherited genetic rare diseases harbor nonsense mutations in one or both alleles harboring
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, the sufficiency of our cash and cash equivalents to fund our operations, 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 quarterly period ended March
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
(in thousands, except share and per share data)
March 31, 2022 December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents $ 39,768 $ 42,268
Restricted cash 297 299
Prepaid expenses and other current assets 2,082 913
Total current assets 42,147 43,480
Property and equipment, net 206 216
Operating lease right-of-use assets 1,265 1,443
Total assets $ 43,618 $ 45,139
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,903 $ 1,379
Accrued expenses 4,631 4,196
Advances from collaboration partners 10,723 3,723
Derivative liabilities 270 -
Current portion of operating lease liabilities 647 657
Total current liabilities 19,174 9,955
Long-term debt 12,120 11,996
Operating lease liabilities 638 804
Total liabilities 31,932 22,755
Total stockholders' equity 11,686 22,384
Total liabilities and stockholders' equity $ 43,618 $ 45,139
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Three Months Ended March 31,
2022 2021
Operating expenses:
Research and development $ 7,899 $ 4,073
General and administrative 3,054 4,341
Total operating expenses 10,953 8,414
Loss from operations (10,953 ) (8,414 )
Other expense, net 667 280
Net loss $ (11,620 ) $ (8,694 )
Basic and diluted net loss per share $ 0.13 $ 0.22
Weighted average number of common shares used in computing net loss per share, basic and diluted 86,651,036 40,180,131
Last updated: May 10, 2022