8-K
Eloxx Pharmaceuticals, Inc. (ELOX)
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 eventreported): May 27, 2021
Eloxx Pharmaceuticals, Inc.
(Exact name of registrant as specifiedin its charter)
| Delaware | 001-31326 | 84-1368850 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (I.R.S. Employer<br><br> <br>Identification No.) |
| 950 Winter Street<br><br> <br>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 changedsince 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<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement<br>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 CysticFibrosis Foundation for Development of Ribosome Modulating Agents
May 27, 2021
Leverages TURBO-ZM™ Synthetic Chemistry Platformfor Designing Oral Macrolide-based Ribosome Modulating Agents (RMAs)
Complements ELX-02 program in Phase 2 Clinical Trialsfor 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 containsforward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other thanstatements of present and historical facts contained in this press release, including without limitation, statements regarding theexpected timing of trials and results from clinical studies of our product candidate, the expansion of our clinical trial sites andthe potential of our product candidate to treat nonsense mutations are forward-looking statements. Forward-looking statements can beidentified 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 thenegative of these terms similar expressions, although not all forward-looking statements contain these words.
Forward-looking statements are based on management'scurrent plans, estimates, assumptions and projections based on information currently available to us. Forward-looking statements aresubject to known and unknown risks,uncertainties and assumptions, and actual results or outcomes may differ materially from those expressedor implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to progressany product candidates in preclinical or clinical trials; the uncertainty of clinical trial results and the fact that positive resultsfrom preclinical studies are not always indicative of positive clinical results; the scope, rate and progress of our preclinical studiesand 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 obtainthe capital necessary to fund our operations; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectualproperty rights; our ability to obtain financial in the future through product licensing, public or private equity or debt financingor otherwise; general business conditions, regulatory environment, competition and market for our products; and business ability andjudgment of personnel, and the availability of qualified personnel and other important factors discussed under the caption “RiskFactors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as any such factors may be updated fromtime 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 dateof this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statementscontained 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