Entera Bio Ltd (ENTX) News

ENTX.....................................https://stockcharts.com/h-sc/ui?s=ENTX&p=W&b=5&g=0&id=p86431144783

ENTX new 52+hi

ENTX new 52 hi

ENTX new 52 hi

ENTX...................................................https://stockcharts.com/h-sc/ui?s=ENTX&p=W&b=5&g=0&id=p86431144783

ENTX...........................https://stockcharts.com/h-sc/ui?s=ENTX&p=W&b=5&g=0&id=p86431144783

Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome

ENTX under $2=

ENTX..NEXT MINI BIO BEAST READY TO FLY TO 1.95

ENTX MINI MONSTER SETTING UP

ENTX..................................................https://stockcharts.com/h-sc/ui?s=ENTX&p=W&b=5&g=0&id=p86431144783

ENTX under $2

Monday should be even better for this ticker

Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis

https://finance.yahoo.com/news/entera-bio-announces-fda-agreement-110000125.html

- Total Hip BMD Established as Primary Endpoint -

JERUSALEM, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, announced today the successful conclusion of its Type C meeting and agreement from the U.S. Food and Drug Administration (FDA) that a single Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission of EB613 (oral hPTH (1-34), teriparatide tablets) under the 505(b)(2) regulatory pathway. The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post-menopausal osteoporosis patients.

The single pivotal Phase 3 clinical trial includes a 24-month placebo-controlled duration with change in Total Hip BMD assessed as the primary endpoint. The 2:1 randomization (EB613 vs. placebo) and planned 400 patients exposed to EB613 are expected to be sufficient to support both the safety and efficacy assessments for the NDA. Furthermore, the FDA agreed with Entera’s proposed enrollment of post-menopausal women with osteoporosis based on a BMD T-score of ≤-2.5 to -3.0 and no major fracture history. This patient population is consistent with that studied during Entera’s Phase 2 6-month dose ranging study of EB613, which met all primary and key secondary endpoints of biochemistry and BMD. Finally, Entera intends to submit relative PK data comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo® to support the 505(b)(2) pathway.

"This is a major milestone for Entera. We greatly appreciate the opportunity to work collaboratively with the FDA, which was essential for reaching concurrence on all critical elements proposed for the registrational path of EB613,” said Miranda Toledano, Chief Executive Officer of Entera. “We have agreement with FDA to continue to treat the same patient population that significantly benefited from EB613 treatment during our Phase 2 study. These low BMD patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent a large unmet need; 40% of the 3 million currently treated patients across the United States, according to our market research. As the first daily tablet PTH osteoanabolic treatment, we believe EB613 could significantly impact the osteoporosis treatment paradigm. We look forward to advancing EB613 into Phase 3 and initiating patient enrollment during 2023,” said Miranda Toledano, Chief Executive Officer of Entera.

About EB613 (a.k.a. EBP05)

EB613 is the first and most advanced oral, daily tablet formulation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo® which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. Entera’s Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late-breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose-related BMD at the Lumbar Spine, Total Hip, and Femoral Neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in Lumbar Spine BMD (p<0.008) which is similar to the 3.9% increase in Lumbar Spine BMD seen with Forteo® in clinical studies reported in the literature. Increases in Total Hip and Femoral Neck BMD were greater than those previously reported with Forteo® at 6 months. EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

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 is contractually obligated to provide, such as those pursuant to Entera’s agreement with Amgen; 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.

CONTACT: Contact: Entera Bio: Ms. Miranda Toledano Chief Executive Officer Entera Bio Email: miranda@enterabio.com IR: Christopher M. Calabrese Managing Director LifeSci Advisors 917-680-5608 ccalabrese@lifesciadvisors.com Kevin Gardner Managing Director LifeSci Advisors 617-283-2856 kgardner@lifesciadvisors.com

10% looking good for a break out of flag pattern.

Either or made money, hope all do. I'll be on my tricked out tritoon on the lake in about 30 minutes. Hope works out.

Alright then

Because they like being bashbags that are mad that they didn't get to buy much cheaper.

Such a Debbie Downer standing on a second floor deck at a party, peeing on all those partying at the party as they walk on by, what if a very large biotechnology company came along and did a license deal with them before they burned up all the cash capital, perhaps then you might zip up.

I'm not saying now lol I hope the drug is a success but they will be burning 10's of millions of capital with less than a half mil revenue...

Revenue 480k
Operating Cash Flow -10.04M

That's just one example

Only phase 2 (Mid Stage..) still has a long process...

Also the volume is not sustainable add that history on pops drop.

Overall thinking about the cash burn, large market cap with basically no revenues and long time to go for a final product. What if some how it didn't make it and flopped or something better comes out?

Why would a company do a reverse split on a stock that has done 100% in less than 30 days and 600% in six months? You’re out of your mind.

Imho I believe we see money raises, share dilution and eventually a R/S. Volume is incredibly unstable.

ADVN froze. still moving on my monitor

did it just get halted?

Only phase 2 a lot more money to burn with nothing coming in. Only 480k

Never seen negative -2,273.13% operating margin, huge negative management effectiveness in the hundreds of %'s, hemorrhaging 10s of millions while bringing in 480 thousand....

Book Value $0.32
Revenue Per Share $0.03

Profitability
Profit Margin 0.00%
Operating Margin (ttm) -2,273.13%

Management Effectiveness
Return on Assets (ttm) -40.46%
Return on Equity (ttm) -187.80%

Income Statement
Revenue (ttm) 480k
Revenue Per Share (ttm) 0.03
Gross Profit (ttm) 156k
EBITDA -10.79M
Net Income Avi to Common (ttm) -16.55M
Diluted EPS (ttm) -0.8620

Balance Sheet
Total Cash (mrq) 16.38M
Total Cash Per Share (mrq) 0.69
Total Debt (mrq) 402k
Total Debt/Equity (mrq) 5.28
Current Ratio (mrq) 1.64
Book Value Per Share (mrq) 0.32

Cash Flow Statement
Operating Cash Flow (ttm) -10.04M
Levered Free Cash Flow (ttm) -410.25k

Did this thing get halted? No movement in 10 mins

3.60 support?

ENTX starting to move . Link for charts

10 min and daily charts

Looks like everyone's getting burnt today.

Igot burnt on these guys a little bit but no not since the first day of it running coulnd find any since.

Did you get your HTB locates?

Calm B4 the storm?! Remember the crazy volume last week, this is nothing!

itll get there had more than expected volume and prop halts but wont be consitent imho

do we get a gap...

Just yesterday you said it would be BELOW $3.00 TODAY! Do I really need to say the words that you need to hear right now?

* * $ENTX Video Chart 03-12-2021 * *

Link to Video - click here to watch the technical chart video

Yeah, gonna hold it. Came in low..$$

Low float and OS only 20 million. Superior osteoporosis drug.

$ENTX will go to $1 billion mkt cap soon.

The warrants also having a strong move $ENTXW range today is .5221 - 1.80. Right now consolidating at 1.15.

I'd be careful was $1.22 a couple days ago imho volume is totally unsustainable. When it dries up will fade. Not bashing just from what I've seen over 10 years. I just wish I could get locates lol Anyone know what broker has these kind of Hard To Borrow HTB locates? Would like at least 10,000 shares min and will add more on the way up. If anyone can help with a broker it would be appreciated.

Good for you but I'm holding this nugget. Selloffs occur naturally after a big spike. This is a strong co. low float great news about a new unique drug (first oral one) to help with osteoperosis...new price target $10. In my opinion it may double that.

IMO GLTA

Thanks. We're all good in here at this level. GLTU

with all these halts glad to get out at 9 from 4.60. good luck.

THIRD HALT!!!!!!!!!!!!!!!!!

HAHAHAHAHAHAHA!!!!!


GLTA

SECOND HALT! NEWS!!!???

GLTA

what is WALLSTREETBETS doing? Low float and OS only 20 million.

WOWWW YESSSS!!!!!

GLTA

Nice pick up

So glad I got this at $4 yesterday ;)