aibioEntera Bio signs OPKO oral GLP-1/glucagon deal and sells OPKO shares for $8.0 million
Tickers ENTX
OPKO bought 3,685,226 Entera ordinary shares at about $2.17. Entera will hold the money in escrow to fund its 40% share of development costs. Entera can opt out after Phase 1.
Key facts
- Company
- Entera Bio Ltd. (NASDAQ: ENTX)
- News type
- Financings
- Primary source
- Entera Bio Ltd. Form 8-K filed March 17, 2025 (SEC EDGAR)
Entera Bio Ltd. (Nasdaq: ENTX) signed a collaboration and license agreement with OPKO Health, Inc. and OPKO Biologics Ltd. on March 16, 2025, to develop an oral tablet form of a dual GLP-1/glucagon peptide for obesity, metabolic and fibrotic disorders. In the same transaction, Entera sold OPKO 3,685,226 ordinary shares for $8.0 million. Entera reported both in a Form 8-K filed March 17, 2025, signed by Chief Executive Officer Miranda Toledano.
The program and the license
The program combines OPKO's long-acting oxyntomodulin analog, OPK-88006, a dual GLP-1/glucagon agonist, with Entera's proprietary N-Tab technology. The collaboration covers preclinical and clinical development and decision making for an oral dosage form of the peptide in humans.
Entera granted OPKO an exclusive, sublicensable and non-transferable worldwide license to its intellectual property, solely to develop, manufacture and commercialize any GLP-1/glucagon dual agonist as an oral treatment for obesity, metabolic, cardiovascular and fibrotic disorders. OPKO granted Entera a non-exclusive license to its own technology, only to the extent Entera needs it to perform its obligations. Until Entera opts out or the agreement ends, neither company may run an internal or third-party program, or license one out, for an oral GLP-1/glucagon dual agonist aimed at those disorders, subject to limits and exceptions.
Costs, proceeds and the opt-out
Entera and OPKO will keep 40% and 60%, respectively, of all proceeds from the program, and will bear 40% and 60% of its development costs. After the Phase 1 stage, Entera can keep funding its 40% share to keep its right to proceeds, or opt out. If it opts out, Entera keeps 15% of proceeds, OPKO keeps 85%, and OPKO becomes solely responsible for ongoing development and commercialization funding. The filing does not date the end of Phase 1, which is the point at which Entera must decide.
The agreement continues indefinitely unless it is terminated earlier, and if Entera opts out it stays in effect for as long as OPKO receives proceeds from the program. The 8-K gives no budget or timetable for the program, so the size of Entera's 40% share is not disclosed.
The $8.0 million share sale
OPKO bought 3,685,226 ordinary shares at about $2.17 each. The filing says that price equals the volume weighted average price over the 30 trading days before the agreement date. OPKO agreed to a customary lockup that bars it from selling or transferring the shares for 12 months after March 16, 2025. It also agreed to a standstill, under which for 24 months it may not buy more Entera equity or take certain other actions without Entera's consent.
The proceeds are not free cash. Entera must use them solely to fund its development cost obligations under the agreement. The money goes into an escrow arrangement with OPKO and an escrow agent, and is paid out to cover those costs. If the agreement expires or is terminated for any reason, funds left in escrow go back to Entera.
The shares were sold under the exemption in Section 4(a)(2) of the Securities Act, based partly on OPKO's representation that it is an accredited investor.
The company behind the deal
The two companies already worked together. Entera's annual report for 2023 says it signed a research collaboration with OPKO Biologics, Inc., a subsidiary of OPKO Health, in September 2023. Entera's lead candidate, EB613, is a once daily tablet form of teriparatide for osteoporosis. That report says its Phase 2 trial of EB613 was the largest it had run and that it has never run trials of the size regulators require for approval.
The same report carries a warning about money. It says Entera had cash and cash equivalents of approximately $9.8 million as of March 1, 2024, expected to fund operations through the second quarter of 2025. Management and the company's independent auditor both expressed substantial doubt about its ability to continue as a going concern. The 8-K does not give a newer cash balance. Entera's principal executive offices are in Jerusalem, Israel, and the full agreement is filed as Exhibit 10.1 with schedules omitted.