Entera Bio Positions EB613 for Phase 3 Osteoporosis Studies

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Illustration of Entera Bio's investigational oral osteoporosis therapy EB613 with bone structure and oral peptide tablet representing Phase 3 clinical development supported by $275 million financing.
Image Source: Magnific

Entera Bio secured $275 million in an oversubscribed private placement to fully fund Phase 3 development of EB613, the first oral PTH(1-34) peptide tablet in development for osteoporosis, with operations funded into 2030.

Written By: Kalyani Boharapi,

M.Pharm (Reg. Affairs)

Reviewed By: Pharmacally Editorial Team

Entera Bio has secured financing expected to fully fund the Phase 3 registrational program of EB613, its investigational oral parathyroid hormone (PTH[1-34]) tablet for osteoporosis, through a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration. The capital also supports continued development of the company’s oral peptide pipeline, including EB612 for hypoparathyroidism, while extending operations into 2030.

EB613 Could Become the First Oral PTH(1-34) Tablet for Osteoporosis

EB613 is an investigational once-daily oral formulation of parathyroid hormone (PTH[1-34]), an osteoanabolic therapy that stimulates new bone formation. If approved, it would become the first oral PTH(1-34) peptide tablet for osteoporosis, offering a potential alternative to injectable anabolic therapies currently used to treat patients at high risk of fractures.

Osteoporosis affects millions of people worldwide, particularly postmenopausal women and older adults. Although anabolic therapies can increase bone mineral density and reduce fracture risk, their injectable administration has limited patient acceptance and long-term adherence. An oral bone-building therapy could improve convenience while expanding access to anabolic treatment.

Financing Positions EB613 for Registrational Development

The company expects the proceeds to fully fund the planned Phase 3 registrational studies of EB613 through anticipated FDA regulatory submission. In addition, the financing will support advancement of EB612, Entera’s oral PTH(1-34) replacement therapy being co-developed with OPKO Health, into Phase 1 clinical development for hypoparathyroidism.

Oversubscribed Private Placement Raises $275 Million

Entera expects to receive approximately $275 million in gross proceeds through an oversubscribed private placement. The financing was led by existing investor BVF Partners L.P., with participation from several new healthcare-focused institutional 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.

Under the purchase agreement, Entera will issue approximately 122.96 million ordinary shares and 11.84 million pre-funded warrants at a purchase price of $2.04 per share. The transaction is expected to close on or about July 28, 2026, subject to customary closing conditions. Upon closing, BVF will gain the right to nominate two directors to the company’s board, subject to applicable legal and Nasdaq requirements.

Path Forward

The financing is expected to extend Entera’s cash runway into 2030, providing sufficient capital to complete pivotal clinical development of EB613, pursue regulatory submission in the United States, advance EB612 into early clinical testing, and continue expanding the company’s oral peptide platform. This financial flexibility allows Entera to focus on advancing therapies that could offer oral alternatives to injectable peptide medicines for endocrine disorders.

Reference

Entera Bio Announces Pricing of Oversubscribed $275 Million Private Placement | Entera Bio Ltd.

About the Writer

Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.


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