Entera Bio adds up to 30,000,000 shares to its at-the-market program

The supplement and the sales agreement

Entera Bio Ltd. (Nasdaq: ENTX) filed Supplement No. 1, dated January 10, 2025, to its prospectus supplement of September 2, 2022. The supplement adds up to 30,000,000 ordinary shares, par value NIS 0.0000769 per share, that the company may sell through Leerink Partners LLC under a sales agreement with Leerink dated September 2, 2022. The underlying prospectus is dated June 9, 2022 and is filed under registration number 333-265286. The supplement says that of the 5,000,000 shares first registered, the company had sold 4,940,156 ordinary shares through Leerink, for an aggregate gross sales price of approximately $10.1 million. The new 30,000,000 shares are part of the $100.0 million of securities the company may sell under its shelf registration, which became effective on June 9, 2022. The company says it will not offer securities under the supplement beyond the amount still left on that shelf. Sales would be made at the market, meaning in what the filing calls an at-the-market offering under Rule 415. Leerink may act as agent or principal and will use commercially reasonable efforts, consistent with its normal trading and sales practices. Leerink is not required to sell any specific dollar amount or number of shares. The company says there is no arrangement for funds to be received in escrow or trust.

Who sells and what it costs

Leerink Partners LLC is the only sales agent named. Its compensation is a fixed commission of 3.0% of the gross sales price of each share sold under the sales agreement. The supplement names no underwriter or placement agent beyond Leerink. Because the amount sold is not fixed, the filing says the total offering amount, the commissions and the proceeds to the company "are not determinable at this time." Use of proceeds is stated in general terms. The company intends to use the net proceeds, if any, primarily for general corporate purposes, which may include research and development costs, clinical trials and process development. If all 30,000,000 shares were sold, the supplement says up to 71,537,220 ordinary shares would be outstanding afterward. The ordinary shares trade on the Nasdaq Capital Market, and the closing price on January 9, 2025 was $2.45 per share.

The company behind the shares

Entera describes itself as a clinical-stage company developing first-in-class oral tablet formats of peptides and protein replacement therapies. Its platform is called N-Tab, and the pipeline includes five oral peptide programs, run from Jerusalem, Israel. Its most advanced candidate, EB613, is an oral PTH (1-34) tablet being developed as a once-daily bone-building treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis. The supplement says a placebo-controlled, dose-ranging Phase 2 study of EB613 tablets, with 161 patients, met its primary endpoint, a bone turnover biomarker called PD, and its secondary endpoint, bone mineral density. The supplement does not give effect sizes for either endpoint. A biomarker is a proxy, so the primary result does not show a fracture or bone density benefit by itself. EB612 is being developed as the first oral PTH (1-34) tablet for hypoparathyroidism. With OPKO Health, Entera is developing an oral oxyntomodulin tablet for obesity, a dual GLP-1 and glucagon peptide, and an oral GLP-2 tablet for rare malabsorption conditions such as short bowel syndrome.

What the filing leaves open

Among the risks the supplement lists is the failure to achieve a publicly announced milestone, and it points readers to the 10-K for the year ended December 31, 2023, filed March 8, 2024. The supplement gives no cash, net loss or runway figures for the company.

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