We expect investors to focus on the updates related to
Entera Bio, Ltd. ( ENTX Quick Quote ENTX - Free Report) pipeline candidates when it reports fourth-quarter 2022 results (expected next month).
Shares of Entera Bio have declined 57.4% in the past year compared with the
industry’s decline of 7.4%. Image Source: Zacks Investment Research
ENTX’s earnings surpassed expectations in all the trailing four quarters, the average positive surprise being 89.07%. In the last reported quarter, Entera Bio reported a positive earnings surprise of 31.25%.
Let us see how things have shaped up for the quarter to be reported. Factors to Consider
In the absence of a marketed product, Entera Bio is expected to provide updates on its pipeline candidates,mainly EB613 and EB612, for the treatment of osteoporosis and hypoparathyroidism, respectively.
In October, Entera reached an agreement with the FDA for its pivotal study of its lead candidate, EB613, to treat osteoporosis. Per the terms of the agreement, Entera Bio has been authorized to submit a new drug application based on a single pivotal phase III study for EB613, abiding by the 505(b)(2) regulatory clause.
Agreement about the primary endpoint benchmark was also reached. The FDA agreed that the total hip bone mineral density, excluding fracture, would suffice as the primary endpoint for the study. The FDA has permitted Entera to use the same post-menopausal osteoporosis patient population who previously responded well in the phase II study of EB613. The phase II study results were reported back in 2021.
The agreement with the FDA was made based on the phase II study of EB613 tablets which showed a strong, statistically significant correlation between mean blood level and the dose of EB613 taken.
After the agreement, Entera recently announced that the FDA has accepted a Type D meeting review to affirm the study design, responding by Mar 30, 2023.
Enrollment for the phase III study is set to begin in the second half of 2023.
Enterera’s other lead product candidate, EB612, is currently under phase II study for the treatment of hypoparathyroidism. Since publishing the pilot 4-month phase II study data on EB612, back in 2021, the company has been working on an optimized formulation for EB612 which may enable twice-a-day administration (versus the previous 4 times a day). This formulation is based on new intellectual property and is expected to reduce daily dosing for hypoparathyroidism.
Entera anticipates the commencement of a PK study in the first half of 2023 for the new formulation of EB612.
The company is expected to earn most of its revenues from pre-clinical research and development services provided to Amgen as a part of its ongoing license agreement in the to-be-reported quarter.
Research and development expenses are also expected to go down due to the completion of the company’s phase II study for EB613 in September 2021.
Our proven model does not conclusively predict an earnings beat for Entera Bio this time around. The combination of a positive
Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy), or 3 (Hold) increases the odds of an earnings beat. Unfortunately, that is not the case here as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter. Earnings ESP: Entera Bio has an Earnings ESP of 0.00% as the Zacks Consensus Estimate and the Most Accurate Estimate both stand at a loss of 12 cents. Zacks Rank: Entera Bio currently carries a Zacks Rank #3. You can . see the complete list of today’s Zacks #1 Rank stocks here
Here are some stocks in the same industry that have the right combination of elements to beat on earnings this time around:
BeiGene, Ltd. ( BGNE Quick Quote BGNE - Free Report) has an Earnings ESP of +4.19% and a Zacks Rank #2.
BGNE’s stock has increased by 9% in the past year. BGNE beat earnings estimates in one out of the last four quarters. It has a loss surprise of 21.98% on average.
Allogene Therapeutics, Inc. ( ALLO Quick Quote ALLO - Free Report) has an Earnings ESP of +25.70% and a Zacks Rank #2.
ALLO’s stock declined 22.6% in the past year. ALLO beat earnings expectations in all the trailing four quarters. The average surprise was 9.44%.
Aligos Therapeutics, Inc. ( ALGS Quick Quote ALGS - Free Report) has an Earnings ESP of +4.08% and a Zacks Rank #3.
ALGS’ stock declined 29.8% in the past year. ALGS beat earnings expectations in two of the trailing four quarters. The average surprise was 4%.
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