אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השני של שנת 2024 ומספקת עדכונים עסקיים

אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השני של שנת 2024 ומספקת עדכונים עסקיים

ירושלים, 9 באוגוסט 2024 (GLOBE NEWSWIRE) –

אנטרה ביו  Entera Bio Ltd  (נאסד"ק: ENTX), ("אנטרה" או "החברה"), מובילה בפיתוח פפטידים וחלבונים טיפוליים הניתנים דרך הפה, דיווחה היום על תוצאותיה הכספיות ועדכונים עסקיים מרכזיים לרבעון שהסתיים ביום 30 ביוני 2024.

"אנו ממשיכים לספק ביצועים חזקים עם ציוני דרך מרכזיים שהושגו במהלך הרבעון השני של 2024 בכל אחת מתוכניות N-Tab™ oral peptide  שלנו המוקדשות לחולים עם OBGYN/אנדוקרינולוגיה, GI ומחלות מטבוליות", אמרה מירנדה טולדנו, מנכ"לית אנטרה. "חשוב לציין, אנו נמצאים כעת במרחק של חמישה חודשים בלבד מהפסיקה הפוטנציאלית פורצת הדרך של ה- FDA לגבי נקודת הקצה הרגולטורית ASBMR-FNIH SABRE עבור תרופות לאוסטאופורוזיס, שאנו רואים בהן זרז עיקרי עבור EB613. אנו להוטים במיוחד להתחיל את המחקר המרכזי שלנו על EB613 באוכלוסייה רחבה הרבה יותר שבה תרופות אנבוליות בהזרקה אינן ממלאות תפקיד דומיננטי. בגלל מנגנון הפעולה הכפול הפוטנציאלי שלו, תחילת פעולה מהירה יותר לצורך חיזוק אנבולי ופורמט מיני-טבליות אוראלי, אנו מאמינים כי EB613 ממוקם באופן ייחודי לתמיכה בהתערבות אוסטאואנאבולית מוקדמת יותר בנשים לאחר גיל המעבר בסיכון גבוה לשברים", הוסיפה.

Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates

JERUSALEM, Aug. 09, 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

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 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.

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 LinkedInTwitterFacebookInstagram.

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)

 

 

 

 

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

 
   

 

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

 

   

 

Contact:

 

Entera Bio:

Ms. Miranda Toledano

Chief Executive Officer

Entera Bio

Email: miranda@enterabio.com

 

 

 

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