Aug 7, 2026, 4:06 PM ETHealthcare

Entera Bio Ltd. — Second Quarter 2026 Earnings Summary

ENTXENTERA BIO LTD

Financial Performance

Reported no revenues for the three months ended June 30, 2026, compared to zero in the same period in 2025.
Research and development expenses increased to $3.2 million for the quarter ended June 30, 2026, from $1.5 million in the prior year period, driven by costs related to the EB613 Phase 3 program and OPKO collaboration activities.
General and administrative expenses rose to $1.4 million for the quarter ended June 30, 2026, from $1.1 million in the prior year period.
Net loss was $7.3 million ($0.14 per share) for the quarter ended June 30, 2026, compared to $2.7 million ($0.06 per share) in the prior year period; the increase was primarily due to a $2.7 million non-cash fair value remeasurement of pre-funded warrants classified as a financial liability.
Cash and cash equivalents stood at $11.3 million as of June 30, 2026, with restricted cash of $7.1 million designated for the OPKO collaboration.
Total assets were $19.5 million as of June 30, 2026, compared to $16.0 million as of December 31, 2025.
Total liabilities were $12.2 million as of June 30, 2026, compared to $2.9 million as of December 31, 2025, largely due to the $9.6 million pre-funded warrants liability.

The registrational Phase 3 study for EB613 is planned to initiate in late 2026, with topline data anticipated in the second half of 2028.
An Investigational New Drug (IND) application for EB612 is intended to be filed in the first half of 2027.
Net proceeds from the July 2026 private placement are expected to fund the EB613 Phase 3 program through the anticipated NDA submission and extend the company's cash runway into 2030.

EB613 (Osteoporosis): Received positive FDA feedback on a 12-month, single, randomized, double-blind, placebo-controlled Phase 3 trial involving approximately 750 postmenopausal women; the primary endpoint is percent change in total hip bone mineral density at Month 12. The NDA package will include a scientific bridge analysis with Forteo® under the 505(b)(2) pathway and a bone biopsy sub-study.
EB613 Data: Presented comparative Phase 1 data at ENDO 2026 showing single-tablet EB613 achieved pharmacokinetic and pharmacodynamic profiles comparable to multi-tablet EB613 and Forteo®. Phase 2 analysis was selected for a plenary poster presentation at ASBMR 2026.
EB612 (Hypoparathyroidism): Presented robust preclinical data at ENDO 2026 across rat, minipig, and non-human primate models demonstrating robust bioavailability and sustained serum calcium increases lasting approximately three days; Entera and OPKO intend to file the IND in the first half of 2027.
EB618 (Obesity/Metabolic Disorders): Presented non-human primate PK/PD data at ENDO 2026 showing dose-proportional systemic exposure and pharmacologic effects on postprandial blood glucose; clinical development initiation is pending analysis of OPKO's subcutaneous injectable OXM Phase 1 studies.
Collaboration: Expanded collaboration with OPKO Health in February 2026 to advance EB612 and an oral GLP-2 tablet for short bowel syndrome.

Management highlights osteoporosis as a globally underserved health issue with rising fracture rates despite existing treatments, noting an urgent need for oral anabolic therapies.
EB613 is positioned as the first oral anabolic tablet for osteoporosis, aiming to address the treatment gap for an oral alternative to injectable therapies like Forteo®.
EB612 is developed as the first oral long-acting PTH(1-34) replacement tablet for hypoparathyroidism.
EB618 is positioned as a potential first-in-class oral once-daily GLP-1/glucagon receptor agonist for obesity and metabolic disorders.

The company faces risks related to the timing, design, and results of the planned Phase 3 registrational study of EB613.
Regulatory risks include the FDA's ongoing review of the EB613 program, interpretation of clinical data, and the ability to obtain and maintain regulatory approvals for product candidates.
The company relies on third parties to conduct clinical trials and maintain development and commercialization collaborations.
As a development-stage company with limited operating history, the company faces risks regarding its ability to continue as a going concern absent access to liquidity sources.
Risks include the potential for changes in market size, growth of potential markets, and the company's competitive position against other products in development.

CEO Miranda Toledano described the first half of 2026 as one of the most consequential periods in the company's history, citing the reconstruction of the science and pipeline despite scarce resources.
Management expressed confidence in the N-Tab platform, noting it is developing one of the richest pipelines of clinical and near-clinical first-in-class oral peptide assets.
The CEO characterized the July 2026 private placement as transformational, noting it is the largest biotech PIPE and the 9th largest PIPE in Israel on record.
Management stated an intent to continue shattering records across all programs with a cohesive global team.

Announced an oversubscribed $275 million private placement in July 2026 led by BVF Partners L.P., with participation from investors including Longitude Capital, Vivo Capital, TCGX, Spruce Street Capital, Venrock Healthcare Capital Partners, RA Capital Management, Perceptive Advisors, Driehaus Capital Management, Logos Capital, and Catalio Capital Management.
Upon closing of the private placement, BVF was granted the right to designate two directors to the Company's board of directors.
In April 2026, the company completed a direct investment private placement led by BVF for approximately $10.0 million in gross proceeds, with potential for up to $24.5 million in total proceeds upon full exercise of five-year warrants.
The July 2026 private placement proceeds are anticipated to fully support the EB613 Phase 3 program through NDA submission and extend the cash runway into 2030.