Item
8.01 Other Events
Eloxx Pharmaceuticals, Inc. (the “Company”) is providing
the following business update.
Recent Developments
On June 6, 2023, the Company announced that, following
the Company’s hearing on May 18, 2023 before the Hearing Panel of the Nasdaq Stock Market LLC (“Nasdaq”), the Hearings
Panel granted the Company’s extension request through July 30, 2023 (the “Extension”) to regain compliance with Nasdaq
Listing Rule 5550(b)(2), which requires a listed company to have at least $35 million in market value of listed securities in order to
qualify for continued listing on the Nasdaq Capital Market. The Extension is conditioned upon achievement of certain milestones included
in a plan of compliance which the Company previously submitted to the Hearings Panel.
The Company intends to advance ELX-02 into a pivotal
study in Alport Syndrome patients with nonsense mutations, following the completion of dosing of the third patient with ELX-02 in the
Company’s the ongoing proof-of-concept Phase 2 open-label clinical trial (NCT05448755) and pending discussions with the U.S. Food
and Drug Administration and the Company obtaining the necessary capital.
Forward-looking Statements
This
Current Report on Form 8-K 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 current report, including without limitation,
statements regarding our regaining compliance with Nasdaq's listing requirements, 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.
All forward-looking statements speak only as of
the date of this Current Report on Form 8-K 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.
