Form 8-K - Current report

 

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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): August 9, 2024

 

Entera Bio Ltd.

(Exact Name of Registrant as Specified in Its Charter)

 

Israel		001-38556		Not Applicable
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification)

 

KIRYAT HADASSAH, MINRAV BUILDING – FIFTH FLOOR, JERUSALEM, Israel 9112002
(Address of principal executive offices) (Zip Code)

[phone]

(Registrant’s Telephone Number, Including Area Code)

  

 

(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):

 

☐	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
Ordinary Shares, par value of NIS 0.0000769		ENTX		Nasdaq Capital 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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

 

On August 9, 2024, Entera Bio Ltd., a company organized under the laws of the State of Israel (“we,” “us,” “our” or the “Company”), issued a press release announcing its financial results for the three months ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item 2.02.

 

Item 7.01 Regulation FD Disclosure.

 

The information contained in Item 2.02 of this Current Report on Form 8-K is incorporated by reference in this Item 7.01.

 

The information contained in this Current Report on Form 8-K, including in Exhibit 99.1 attached hereto, is “furnished” and not “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. Such information shall not be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent such other filing specifically incorporates such information by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release dated August 9, 2024 announcing the Company’s financial results for the three months ended June 30, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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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 thereunto duly authorized.

		ENTERA BIO LTD.
Date: August 9, 2024	By:		/s/ Miranda Toledano
			Name: Miranda Toledano Title: Chief Executive Officer

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Exhibit 99.1

 

 

Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates

 

JERUSALEM – August 9th, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended June 30, 2024.

 

"We continue to deliver strong execution with key milestones achieved during the second quarter of 2024 across each of our N-Tab™ oral peptide programs dedicated to patients with OBGYN/endocrinology, GI and metabolic diseases” said Miranda Toledano, Entera’s CEO. “Importantly, we are now just five months away from FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, which we view as a major catalyst for EB613. We are especially keen to start our pivotal study of EB613 in a much wider population where injectable anabolic drugs do not play a dominant role. Because of its potential dual mechanism of action, faster onset of action as an anabolic boosting agent and oral minitablet format, we believe EB613 is uniquely positioned to support earlier osteoanabolic intervention in post-menopausal women at high risk of fracture,” she added.

 

EB613: First Oral PTH(1-34) Daily Osteoanabolic Tablets for Osteoporosis

 

•

In April 2024, the Journal of Bone and Mineral Research (JBMR) published “Oral daily PTH(1-34) Tablets [EB613] in Postmenopausal Women with Low BMD or Osteoporosis: A Randomized, Placebo-Controlled, 6-Month, Phase 2 Study”

 

•

In May 2024, Entera welcomed Dr. Rachel Wagman as Key Clinical Advisor to lead EB613 clinical development.  Wagman has successfully advanced the development of five molecules, including the osteoporosis products Forteo®, Prolia® and Evenity® through registration

 

•

In June 2024, the JMBR published an independent editorial titled “A Novel Oral hPTH(1-34) [EB613] Unveils the Promise of Modeling-Based Anabolism with No Increase in Bone Remodeling”

 

•

In July 2024, Entera announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the ASBMR September 2024 Annual Meeting in Toronto

 

•

In July 2024, Entera announced that the SABRE (Study to Advance BMD as a Regulatory Endpoint) is expected to provide an update at the ASBMR September 2024 Annual Meeting in Toronto

 

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EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

 

•

In June 2024, Entera presented Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612, at the Endocrine Society ENDO 2024 Annual Meeting. Entera showed that the data supports potentially moving the BID (twice-daily) tablet dose to Phase 2 development in patients with hypoparathyroidism

 

•

Entera continues to collaborate with a third party on the development of another PTH replacement treatment for hypoparathyroidism

 

First GLP-2 Peptide Tablets for Short Bowel Syndrome

•

In March 2024, Entera announced positive in vivo PK results from its program combining OPKO Health, Inc.’s (Nasdaq: OPK) long acting GLP-2 analogue with N-Tab™ technology. Pharmacology data is expected early in the second half of 2024

 

First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

 

•

Collaborative work is ongoing combining N-Tab™ with OPKO’s long-acting Oxyntomodulin (OXM) analogues for potential treatment for obesity and other metabolic diseases. PK data for the oral OXM tablet are expected early in the second half of 2024

 

Financial Results for the Quarter Ended June 30, 2024

 

As of June 30,2024, Entera had cash and cash equivalents of $9.1 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.

Research and development expenses for the three months ended June 30, 2024 were $1.1 million, as compared to $1.2 million for the three months ended June 30, 2023. The decrease of $0.1 million was primarily due to a decrease of $0.3 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which completed its first stage in 2023.

 

General and administrative expenses for both the three months ended June 30, 2024 and 2023 were $1.1 million.

 

Operating expenses for the period ended June 30, 2024 were $2.2 million, as compared to $2.3 million for the quarter ended June 30, 2023.

 

Net loss was $2.1 million, or $0.06 per ordinary share (basic and diluted), for the quarter ended June 30, 2024, as compared to $2.3 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended June 30, 2023.

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About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Contact:

Entera Bio:

Ms. Miranda Toledano

Chief Executive Officer

Entera Bio

Email: [e-mail]

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Cautionary Statement Regarding Forward Looking Statements

 

Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.  There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

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ENTERA BIO LTD.

CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands)

		June 30,				December 31,
		2024				2023
		(Unaudited)				(Audited)
Cash and cash equivalents			9,056				11,019
Accounts receivable and other current assets			539				238
Property and equipment, net			76				100
Other assets, net			364				408
Total assets			10,035				11,765
Accounts payable and other current liabilities			1,294				1,091
Total non-current liabilities			219				288
Total liabilities			1,503				1,379
Total shareholders' equity			8,532				10,386
Total liabilities and shareholders' equity			10,035				11,765

 

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ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)

 

		Three Months Ended June 30,
		2024				2023
REVENUES			57				-
COST OF REVENUES			48				-
GROSS PROFIT			9				-
OPERATING EXPENSES:
Research and development			1,086				1,209
General and administrative			1,088				1,135
Other income			-				(14	)
TOTAL OPERATING EXPENSES			2,174				2,330
OPERATING LOSS			2,165				2,330
FINANCIAL INCOME, NET			(20	)			(5	)
NET LOSS			2,145				2,325
LOSS PER SHARE BASIC AND DILUTED			0.06				0.08
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE			37,090,160				28,812,375

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Document and Entity Information	Aug. 09, 2024
Entity Listings [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 09, 2024
Entity File Number	001-38556
Entity Registrant Name	Entera Bio Ltd.
Entity Central Index Key	0001638097
Entity Incorporation, State or Country Code	L3
Entity Tax Identification Number	00-0000000
Entity Address, Address Line One	KIRYAT HADASSAH, MINRAV BUILDING
Entity Address, Address Line Two	FIFTH FLOOR
Entity Address, City or Town	JERUSALEM
Entity Address, Country	IL
Entity Address, Postal Zip Code	9112002
City Area Code	972
Local Phone Number	2-532-7151
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Ordinary Shares, par value of NIS 0.0000769 [Member]
Entity Listings [Line Items]
Title of 12(b) Security	Ordinary Shares, par value of NIS 0.0000769
Trading Symbol	ENTX
Security Exchange Name	NASDAQ
Warrants, each Warrant exercisable for half of an Ordinary Share at an exercise price of $5.85 per Ordinary Share [Member]
Entity Listings [Line Items]
Title of 12(b) Security	Warrants, each Warrant exercisable for half of an Ordinary Share at an exercise price of $5.85 per Ordinary Share
Trading Symbol	ENTXW
Security Exchange Name	NASDAQ

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