Blog: ELOXX PHARMACEUTICALS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – Marketscreener.com

Item 7.01 Regulation FD Disclosure.

On September 14, 2022, Eloxx Pharmaceuticals, Inc. (the “Company”) issued a
press release announcing topline results from its Phase 2 combination clinical
trial of ELX-02 in Class 1 Cystic Fibrosis (“CF”) patients. A copy of the press
release and presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2,
respectively, and incorporated under this Item 7.01 by reference.

The information in this Item 7.01 of this Current Report on Form 8-K (including
Exhibits 99.1 and 99.2 hereto) shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that Section, nor shall it be
deemed to be incorporated by reference into any filing of the Company under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such filing.


 Item 8.01 Other Events



We are providing the following business update.



Recent Developments


On September 14, 2022, the Company announced topline results from the Phase 2
clinical trial of ELX-02 in combination with ivacaftor in Class 1 CF patients
with at least one nonsense mutation. The combination trial of ELX-02 with
ivacaftor was well tolerated but did not achieve statistical significance for
efficacy endpoints, including changes from baseline in sweat chloride
concentration (SCC) and percent forced expiratory volume (FEV1).

The Phase 2 combination clinical trial of ELX-02 was designed to evaluate safety
and assess biological activity in G542X nonsense mutation Class 1 CF patients as
monotherapy and in combination with ivacaftor. The trial included a 1-week
monotherapy period (1.5 mg/kg daily subcutaneous) followed by a four week
combination period (1.5 mg/kg daily subcutaneous and 150 mg ivacaftor twice
daily).

ELX-02 was generally well tolerated in the trial, with no treatment-related
serious adverse events noted. Overall, the study did not achieve statistical
significance for efficacy endpoints in the Phase 2 study in Class 1 CF for
efficacy endpoints, including changes from baseline in SCC and FEV1. No
incremental improvement was observed with ivacaftor combination. Evidence of
activity for ELX-02 was observed, as patients with higher baseline sweat
chloride levels demonstrated increased responses as indicated by SCC (p=0.00013
at Day 35). Trial results were potentially confounded by high variability in
sweat chloride and lung function measurement. The Company believes this
variability could have been caused by very low drug exposures in the lung.
Steady state lung drug levels in patients from this trial were on average 20%,
or 2µM, of the lowest levels at which drug activity has previously been seen in
preclinical testing. Lung drug exposure with inhaled delivery of ELX-02 is
expected to be at least 50-fold greater than with subcutaneous delivery.









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 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.

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; 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 June 30, 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 http://www.sec.gov and the “Financials & Filings”
page of our website at
https://investors.eloxxpharma.com/financial-information/sec-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.

Item 9.01 Financial Statements and Exhibits.





 (d) Exhibits.




Exhibit No.                                   Description

  99.1          Press Release of Eloxx Pharmaceuticals, Inc., dated September 14, 2022

  99.2          Presentation of Eloxx Pharmaceuticals, Inc., dated September 14, 2022

104           Cover Page Interactive Data File (embedded within the Inline XBRL document)

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