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Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development

JERUSALEM – November 14th, 2023 (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 corporate updates and financial results for the third quarter ended September 30th, 2023.

 

“Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.  It is our goal to potentially move five high value, first-in-class programs, Phase 1 through Phase 3, into the clinic by the end of 2025.”

 

“Our disruptive and proprietary technology simultaneously inhibits gastrointestinal enzymatic degradation and consistently produces bioavailability of peptides, via a simple tablet format (around 6mm in diameter). Each of our oral peptide programs has been carefully selected based on platform alignment and our mission to successfully develop treatments that stand to become the number one choice for patients. Importantly Entera has sufficient cash on hand to enable key read-outs from our significant pipeline expansion efforts over the coming year.” Said Miranda Toledano, Chief Executive Officer of Entera.

 

“With our Phase 3 ready EB613 (oral PTH (1-34) peptide), we aim to transform the lives of osteoporosis patients, starting with the estimated 200 million women globally at-risk of fracture. We are also exploring the potential use of EB613 to accelerate stress fracture healing due to high intensity athletic or military training. Our EB612 program aimed at the development of a once-a-day (oral PTH (1- 34) peptide) replacement therapy for patients suffering from hypoparathyroidism, a disease which also disproportionately afflicts women, is being tested using a new generation of our platform. In September 2023, we announced a transformative collaboration with OPKO Health, Inc. (“OPKO”) that expands our oral delivery technology across two additional peptides: GLP-2 for the treatment of short bowel syndrome, and oxyntomodulin, a dual targeted GLP-1 / glucagon agonist, for the treatment of obesity.” Said Ms. Toledano

 

“On a separate note, we would like to thank our collaborators, partners, and shareholders around the world for reaching out during the last six weeks since the war in Israel erupted to ensure the safety of our team and loved ones. Entera houses R&D, some manufacturing and key personnel across Israel, alongside our clinical, supply chain, regulatory and other functions in the U.S., UK and the EU. While our entire team at Entera is “safe” and continues to meet goals; we are all deeply affected by the current situation. Entera stands with Israel and its right to protect its diverse population of Jewish, Muslim, Druze and Christian citizens and residents. All of us are united in the protection and preservation of our heterogeneous and democratic country.” said Ms. Toledano.

 

 

Entera Q3 2023 Updates and Goals for 5 Oral Peptide Programs:

 

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

EB613: First Oral PTH(1-34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries

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

First GLP-2 Peptide Tablets for Short Bowel Syndrome

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

 

Financial Results for the Three Months Ended September 30, 2023

 

As of September 30, 2023, Entera had cash and cash equivalents of $7.6 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2024, which includse the capital required to fund our ongoing operations, including the completion of the Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.

Research and development expenses for the three months ended September 30, 2023 and 2022 were approximately $1.4 million. For the quarter ended September 30, 2023, there was an increase of $0.4 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which was offset by a decrease of $0.3 million materials and production costs and a decrease of $0.1 million in share-based compensation expense.

 

 

Operating expenses for the three months ended September 30, 2023 were $2.4 million, as compared to $2.9 million for the three months ended September 30, 2022.

 

Net loss was $2.4 million, or $0.08 per ordinary share (basic and diluted), for the three months ended September 30, 2023, as compared to $3.1 million, or $0.11 per ordinary share (basic and diluted), for the three months ended September 30, 2022.

 

About Entera Bio

 

Contact:

Entera Bio:

Ms. Miranda Toledano

Chief Executive Officer

Entera Bio

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.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)

		September 30				December 31
		2023				2022
		(Unaudited)				(Audited)
Cash and cash equivalents			7,585				12,309
Accounts receivable and other current assets			431				540
Property and equipment, net			108				139
Other assets, net			441				139
Total assets			8,565				13,127
Accounts payable and other current liabilities			2,027				1,341
Total non-current liabilities			302				32
Total liabilities			2,329				1,373
Total shareholders' equity			6,236				11,754
Total liabilities and shareholders' equity			8,565				13,127

 

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

(Unaudited)

 

 

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