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):

June 13, 2019

 


 

ENTASIS THERAPEUTICS HOLDINGS INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware

 

001-38670

 

82-4592913

(state or other jurisdiction of incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

 

35 Gatehouse Drive
Waltham, Massachusetts

 

02451

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (781) 810-0120

 

 

(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 (see General Instruction A.2. below):

 

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

 

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

 

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

 

o            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 Exchange Act:

 

Title of each class:

 

Trading Symbol(s)

 

Name of each exchange on which
registered

Common Stock, $0.001 par value

 

ETTX

 

The Nasdaq Stock Market, LLC

 

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 x

 

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.  x

 

 

 


 

Item 7.01.   Regulation FD Disclosure.

 

On June 13, 2019, Entasis Therapeutics Holdings Inc. (the “Company”) issued a press release announcing initial preliminary results from the first-in-human Phase 1 clinical trial of its novel, oral beta-lactamase inhibitor ETX0282.  A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information provided in this Form 8-K, including Exhibit 99.1 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 incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01.   Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press release of the Company, dated June 13, 2019

 

2


 

SIGNATURES

 

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.

 

 

ENTASIS THERAPEUTICS HOLDINGS INC.

 

 

 

By:

/s/ Michael Gutch

 

 

Michael Gutch

 

 

Chief Financial Officer and Chief Business Officer

 

 

Dated: June 13, 2019

 

 

3


Exhibit 99.1

 

 

Entasis Therapeutics Announces Initial ETX0282 Phase 1 Results

 

WALTHAM, Mass. June 13, 2019 — Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company developing novel antibacterials to treat serious drug-resistant infections, today reported initial preliminary results from the first-in-human Phase 1 clinical trial of its novel, oral beta-lactamase inhibitor ETX0282. The Phase 1 trial is evaluating the safety, tolerability and pharmacokinetics of ETX0282 either alone or in combination with cefpodoxime proxetil, ETX0282CPDP, in healthy volunteers. The Company is developing ETX0282CPDP as an oral therapy for infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including ESBL-producing and carbapenem-resistant Enterobacteriaceae.

 

This Phase 1 clinical trial (NCT03491748) is a randomized, double-blind, placebo-controlled study of ETX0282 in healthy subjects and consists of several parts including: single-ascending dose, multiple-ascending dose, effect of food on absorption, and assessment of drug-drug interaction between ETX0282 and cefpodoxime proxetil. The trial has currently enrolled 79 healthy subjects with 61 subjects having received at least one oral dose of ETX0282 between 100mg — 800mg. In the Phase 1 trial, ETX0282 in a “powder in capsule” formulation was rapidly absorbed, and plasma concentrations of the beta-lactamase inhibitor were in the projected therapeutic range. There was no drug-drug interaction between ETX0282 and cefpodoxime proxetil. When administered with a high fat meal, ETX0282 demonstrated similar overall exposures as compared to fasting subjects, but with a modified pharmacokinetic profile including decreased peak concentrations. ETX0282 was generally well tolerated either alone or in combination with cefpodoxime proxetil, with no serious adverse events reported. While eight subjects reported mild-to-moderate, transient emesis (vomiting), none of the volunteers who received ETX0282 with a high fat meal reported emesis. Additional studies are planned to further investigate the potential correlation between absorption profile and emesis and to formulate ETX0282 for further clinical development.

 

“These preliminary Phase 1 data support the ongoing development of ETX0282CPDP as a potential oral treatment for patients with Gram-negative infections caused by MDR Enterobacteriaceae,” said Robin Isaacs, MD, Chief Medical Officer of Entasis. “We believe there are meaningful benefits to both the patient and the hospital to enable oral treatment of MDR Gram-negative infections and there are currently limited treatment options available. With its ability to provide broad coverage of MDR Enterobacteriaceae, ETX0282CPDP has the potential to become a best-in-class oral therapeutic option for treatment of such infections. We look forward to continuing the development of ETX0282CPDP as a treatment option for this growing medical need.”

 

About ETX0282CPDP

 

ETX0282 is an orally available, broad spectrum inhibitor of Class A and C beta-lactamases. Entasis is developing ETX0282 in combination with cefpodoxime proxetil, an orally available cephalosporin approved for treatment of a variety of bacterial infections. Cefpodoxime proxetil’s clinical utility is currently limited by beta-lactamase-mediated resistance. In preclinical studies, ETX0282 restored cefpodoxime proxetil’s antimicrobial activity against a variety of pathogens, including Enterobacteriaceae resistant to fluoroquinolones, cephalosporins and carbapenems. ETX0282CPDP, the combination of ETX0282 and cefpodoxime proxetil, is being developed for the treatment of infections caused by Enterobacteriaceae, including multidrug-resistant and carbapenem-resistant Enterobacteriaceae (CRE). The ETX0282CPDP program is partially supported by an award from CARB-X.

 

About Entasis

 

Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-

 


 

negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae), and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections). For more information, visit www.entasistx.com.

 

ETX0282 Research Support

 

Research reported in this press release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements about the continued development, progress, and scope of the Phase 1 clinical trial of ETX0282. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected and changes in expected or existing competition. Other factors that could adversely affect Entasis’ business and prospects are described under the “Risk Factors” section in its filings with the Securities and Exchange Commission (“SEC”).  Entasis’ SEC filings are available for free by visiting the investor section of its website, www.entasistx.com, or the SEC’s website, www.sec.gov.  Except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

 

Entasis Company Contact

Kyle Dow

Entasis Therapeutics

(781) 810-0114

kyle.dow@entasistx.com

 

Investor Relations Contacts
Tram Bui / Janhavi Mohite
The Ruth Group
(646) 536-7035 / 7026
tbui@theruthgroup.com
jmohite@theruthgroup.com

 

Media Contact

Kirsten Thomas

The Ruth Group

(508) 280-6592

kthomas@theruthgroup.com