Eloxx Pharmaceuticals Granted Extension by Nasdaq to Regain Compliance with the Market Value of Listed Securities Continued Listing Requirement
June 06 2023 - 8:30AM
Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal
RNA-targeted genetic therapies for rare diseases, today announced
that the Nasdaq Hearings Panel has granted the Company’s extension
request through July 30, 2023 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,
conditioned upon achievement of certain milestones included in a
plan of compliance which the Company previously submitted to the
Hearings Panel.
“We are pleased that Nasdaq has granted us this extension and
intend to take the necessary steps to regain compliance with
Nasdaq’s minimum market value of listed securities requirement,”
said Sumit Aggarwal, President and CEO of Eloxx.
Since May 2023, Eloxx has made significant progress in advancing
its pipeline of small molecule genetic therapies for the potential
treatment in patients with rare genetic diseases harboring nonsense
mutations:
- Announced decision to
advance ELX-02 into a pivotal study in Alport Syndrome patients
with nonsense mutations:
- Remission in proteinuria was
observed in one of the first two patients in our Phase 2 trial of
ELX-02.
- The remission, which was achieved
after four weeks of dosing, was sustained through the eight-week
treatment period.
- This result supports advancement of
the program into a pivotal study, as patients with this rare
disease rarely demonstrate a reduction in proteinuria.
- Received clearance from the
U.S. Food and Drug Administration (FDA) to start Phase 1 study with
ZKN-013: ZKN-013, our lead TURBO-ZM™ based molecule, is
the first program developed from hit to lead for the potential
treatment of recessive dystrophic epidermolysis bullosa (RDEB),
junctional epidermolysis bullosa (JEB) and familial adenomatous
polyposis (FAP), which is supported by preclinical data in models
believed to have strong translation to the clinic.
On October 11, 2022, Nasdaq notified the Company that it no
longer complied with the Market Value of Listed Securities
requirement pursuant to Listing Rule 5550(b)(2). In accordance with
Listing Rule 5810(c)(3)(C), the Company was provided 180 calendar
days, or until April 10, 2023, to regain compliance. On April 11,
2023, Nasdaq notified the Company that it had determined to delist
the Company’s shares as it did not comply with the requirements for
continued listing on the Nasdaq Capital Market. A hearing on the
matter was held on May 18, 2023. Based on the information
presented, Nasdaq granted the Company’s request for an exception
through July 30, 2023 to regain compliance with the continued
listing requirements.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is engaged in the science of
ribosome modulation, leveraging its innovative
TURBO-ZM™ 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
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 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
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.
Contact
InvestorsJohn
Woolfordjohn.woolford@westwicke.com443.213.0506
MediaLaureen Cassidylaureen@outcomescg.com
SOURCE: Eloxx Pharmaceuticals, Inc.
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