Our first note on Entera Bio (Nasdaq: ENTX), back in February 2024, focused on obesity. Specifically, it covered an oral formulation of oxyntomodulin, a dual GLP-1/glucagon agonist, and the company’s earliest-stage program. We were, in effect, flipping the pipeline chart upside down and focusing on the bottom row.
We did that for a reason. The top row belonged to EB613, Entera’s oral parathyroid hormone (PTH 1-34, teriparatide), an asset that was Phase 3-ready and, at the time, seemed completely stuck. EB613 was not waiting on data. It was waiting on FDA, specifically a drawn-out qualification decision regarding total hip bone mineral density (BMD) as a surrogate endpoint for osteoporosis approvals — a process with no enforceable timeline and no leverage for the company. The most advanced program in the pipeline was the hardest to write about.
To its credit, Entera never stopped pushing. Over the past two and a half years, the obstacles have come down one at a time: the endpoint, then the protocol, then the formulation. This week, the last one came down. The company is now fully funded to run its single registrational Phase 3 osteoporosis study.
The Financing
On Monday, Entera announced an oversubscribed private placement of approximately $275 million, led by existing holder BVF Partners and joined by 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, among others. The company is issuing 122,961,215 shares, along with pre-funded warrants for an additional 11,842,695 shares at $2.04. BVF has the right to designate two directors.
This was a complete recapitalization of the company. Usually, when we see these types of private placements, the buyers extract a pound of flesh from the issuer, in the form of warrants or a heavy discount. Remarkably, that was not the case here. The deal was priced at market, without any warrant coverage. Based on our calculations, after the deal closes, Entera will have approximately 185 million shares and pre-funded warrants outstanding. At the time of writing, the equity was moving around quite a bit, but assuming a $3.25 share price, that translates to a $600 million market cap. Although the stock has moved nicely off the financing news, that’s still a palatable valuation when you consider the size of the osteoporosis prize they are pursuing.
How We Got Here
The financing is the important final piece, not the first, that should enable Entera to begin its registrational Phase 3 study. Nevertheless, it is worth reiterating the sequence of events that brought the company to the cusp of Phase 3 initiation for those new to Entera.
The endpoint. In January 2025, we wrote that Entera was the public company most leveraged to FDA’s qualification decision on total hip BMD. That FDA decision slipped repeatedly, and in April 2025 we were writing about a three-month delay with no updated timeline. Finally, on December 19, 2025, FDA issued a broad qualification of total hip BMD as a validated surrogate endpoint for osteoporosis drug development, the first surrogate qualified under the Biomarker Qualification Program established by the 21st Century Cures Act. Our regular readers will know that we frequently poke fun at ourselves for sometimes being too early, and this was another example. We got the outcome right, but the timing wrong.
The protocol. Entera got ahead of the qualification. In July 2025, in a written response to a Type A meeting, FDA agreed that a single multinational, randomized, double-blind, placebo-controlled Phase 3 study with change in total hip BMD at 24 months as the primary endpoint could support an NDA filing for EB613. However, the language around that FDA alignment included a curious line about the incidence of new or worsening vertebral fractures as the key secondary endpoint. In our opinion, this statement suggested the FDA may have been hedging its bet on BMD (recall this was before the December BMD qualification) by making fracture a “key secondary.” The ambiguity around FDA’s expectations regarding fracture, which could have been a major determinant of sample size at the time, likely made funding Phase 3 a challenge for Entera.
Undeterred, Entera submitted a streamlined protocol in March 2026 and received positive FDA feedback on June 22, 2026, including agreement on a protocol with a 12-month BMD endpoint and a parallel open-label extension that carries patients through 24 months. That streamlined protocol shaved roughly a year off Entera’s Phase 3 timeline. Importantly, there was no mention of fracture as a key secondary. Undoubtedly, fracture will still be measured, but given the reasonable 750-patient sample size and the shorter 12-month endpoint, it seems unlikely the company faces a statistical hurdle on fracture. In our opinion, this new streamlined protocol was key to Entera securing this week’s funding.
The candidate. At ENDO 2026 in June, Entera presented late-breaking Phase 1 bridging data showing that the single-tablet formulation of EB613 delivered PK and PD profiles comparable to both the multi-tablet formulation used in Phase 2 and to subcutaneous Forteo. The single tablet is now the Phase 3 candidate, as we predicted in our January 2026 note.
Endpoint, protocol, formulation, capital. All the pieces are now in place. The Phase 3 initiation is planned for late 2026, with topline anticipated in 2H2028.
The Prize
It is difficult to overstate the magnitude of the medical need and market opportunity for osteoporosis. In its March 2026 issue, The Lancet Diabetes & Endocrinology put it plainly in an editorial titled “A new dawn for osteoporosis drug development” stating, “The need for new therapies for osteoporosis could not be more urgent.” No new osteoporosis drug has been approved by FDA since 2019. More than 200 million women globally are estimated to have osteoporosis, and roughly one in two women over age 50 will suffer an osteoporotic fracture. Anabolic, bone-building therapy is the most effective intervention available, yet it is used in only a small minority of eligible patients, not for reasons of efficacy but because of its inconvenience. Osteoporosis is a “silent disease,” and many women balk at the idea of taking a daily injectable for fracture prevention, preferring less effective yet more convenient oral bisphosphonates. Yet Forteo (teriparatide) generated peak worldwide sales near $1.7bn as a daily injectable in that constrained market.
EB613 would be the first oral osteoanabolic ever approved. The Phase 2 study in 161 postmenopausal women met its primary biomarker endpoint and its secondary BMD endpoints, with statistically significant increases at the lumbar spine, total hip, and femoral neck, and a six-month total hip increase comparable to published Forteo data. The clinical and commercial case was never the hard part here. The hard part was always regulatory and financial, and both have been resolved over the past several months.
Patience Required
The prize is big, but the wait is long. Topline is guided for 2H2028. Between now and then, for EB613, execution is all that remains. Enroll the study, run it on schedule, and read it out.
There’s also the pipeline, which includes the aforementioned oral oxyntomodulin (OXM) for obesity and an oral long-acting PTH(1-34) analog for hypoparathyroidism. Both are interesting but early, and both are partnered with OPKO Health (Nasdaq: OPK) — Entera holds 40% of the oral OXM program and 50% of the LA-PTH program, so neither is wholly its own.
Regardless, it’s clear that the impressive roster of investors who poured $275 million into Entera this week is focused on EB613 and osteoporosis. Patience will be required on that front, but if the Phase 3 trial is successful, the reward should be substantial.