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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

  

 

  

FORM 8-K

 

 

  

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 27, 2021

 

 

 

Eloxx Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

  

Delaware   001-31326   84-1368850

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

950 Winter Street

Waltham, MA

  02451
(Address of principal executive offices)   (Zip Code)

 

(Registrant’s telephone number, including area code): (781) 577-5300

  

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, $0.01 par value per share ELOX The Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

 

Item 8.01.Other Events.

 

On May 27, 2021, Eloxx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the receipt of an award of up to $2.6M from the Cystic Fibrosis Foundation to help identify optimized oral RMAs for further development in the treatment of cystic fibrosis patients with nonsense mutations. A copy of the Company’s press release is being furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

 

Item 9.01.Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1   Press Release dated May 27, 2021.
104   Inline XBRL for the cover page of this Current Report on Form 8-K

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ELOXX PHARMACEUTICALS, INC.
   
Date: May 27, 2021 By: /s/ Neil S. Belloff
  Name:  Neil S. Belloff 
  Title: Chief Operating Officer, General Counsel and Corporate Secretary

 

 

 

 

Exhibit 99.1

 

 

 

Eloxx Pharmaceuticals Announces Funding Award from Cystic Fibrosis Foundation for Development of Ribosome Modulating Agents

 

May 27, 2021

 

Leverages TURBO-ZM™ Synthetic Chemistry Platform for Designing Oral Macrolide-based Ribosome Modulating Agents (RMAs)

 

Complements ELX-02 program in Phase 2 Clinical Trials for the Treatment of Cystic Fibrosis

 

WALTHAM, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the Company has received an award of up to $2.6M from the Cystic Fibrosis Foundation.This award will help to identify optimized oral RMAs for further development in the treatment of cystic fibrosis (CF) patients with nonsense mutations.

 

“We are honored to receive this funding from theCystic Fibrosis Foundation in our ongoing commitment to identify and develop new treatments for CF. Their support of novel technologies enables critical research to advance and further evaluate the potential of the TURBO-ZM™ synthetic chemistry platform to develop a new class of therapies. We have tremendous confidence in the potential of RMAs designed with TURBO-ZM™ to treat rare genetic diseases,” said Sumit Aggarwal, President and Chief Executive Officer. “In preclinical models, novel RMAs have demonstrated the potential for significant readthrough and functional activity.”

 

Mr. Aggarwal continued, “In addition, the development of a Ribosome Modulating Agent for the treatment of CF with support from theCystic Fibrosis Foundation complements our ongoing ELX-02 program, currently in Phase 2 clinical trials. Data from these Phase 2 trials is expected in the second half of this year.”

 

About Eloxx Pharmaceuticals

 

Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging both 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 clinical development focusing on cystic fibrosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. 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 the expected timing of trials and results from clinical studies of our product candidate, the expansion of our clinical trial sites 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2020, 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/financial-information/sec-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

 

Investors

John Woolford

john.woolford@westwicke.com

443.213.0506

 

Media

Laureen Cassidy laureen@outcomescg.com

 

SOURCE: Eloxx Pharmaceuticals, Inc.

 

 

 

Source: Eloxx Pharmaceuticals