Protalix renews $20,000,000 at-the-market stock program with H.C. Wainwright

Protalix BioTherapeutics, Inc. (NYSE American: PLX) filed a prospectus supplement on August 22, 2025 to keep its at-the-market stock program running under a new shelf registration. The program covers up to $20,000,000 of common stock, sold through H.C. Wainwright & Co., LLC as sales agent. Before the earlier registration statement expired, Protalix sold shares under the agreement for aggregate gross proceeds of $4.3 million, which leaves approximately $15.7 million available.

The terms

Protalix signed the At The Market Offering Agreement with H.C. Wainwright on February 27, 2023, with letter amendments dated March 17, 2025 and August 22, 2025. The second amendment, in a Form 8-K filed the same day, reflects the effectiveness of a new registration statement on Form S-3 (Registration No. 333-286802), which replaces the prior one.

Sales may be made on the NYSE American or otherwise at market prices, at prices related to market prices or at negotiated prices. The agent need not sell any specific number or dollar amount. Protalix may also sell shares to the agent as principal for its own account at an agreed price, under a separate terms agreement.

The agent receives a commission of 3.0% of the gross sales price of each share it sells. Protalix also agreed to reimburse certain fees and expenses of the agent, including the fees and disbursements of the agent's counsel, up to $50,000, and to indemnify the agent against certain civil liabilities, including liabilities under the Securities Act.

Banks and counsel

H.C. Wainwright & Co., LLC is the only sales agent the filings name; they name no other bank or financial advisor. Mayer Brown LLP of New York, New York, is Protalix's counsel and gave the legality opinion filed with the 8-K. Ellenoff Grossman & Schole LLP of New York, New York, is counsel to the sales agent.

What the money is for, and the dilution risk

Protalix says net proceeds will go to general corporate purposes, which may include working capital and funding clinical trials, and that management has broad discretion over their use. The prospectus supplement says there is no certainty that gross proceeds of $20,000,000 will be raised, because the offering has no minimum and the company may raise substantially less than the maximum or nothing at all. It lists 79,732,115 shares of common stock outstanding before the offering; the last reported sale price on August 21, 2025 was $1.58.

The document warns that sales or the perception of sales could depress the share price and that future issuances may dilute existing holders, who have no preemptive right to take part. The supplement gives no cash or loss figures. It points readers to the annual report filed March 17, 2025.

The business behind the program

Protalix calls itself a commercial stage biopharmaceutical company that makes recombinant proteins in its ProCellEx plant cell-based system. It has two commercial enzyme replacement therapies. Elfabrio (pegunigalsidase alfa) treats adult Fabry disease and is partnered with Chiesi Farmaceutici S.p.A. under two exclusive global licensing and supply agreements. Protalix remains entitled to potential milestone payments and tiered payments for drug product Chiesi purchases. Elelyso (taliglucerase alfa) treats Gaucher disease; Pfizer Inc. holds the rights outside Brazil and sells it, keeping the revenue, while Protalix sells it drug substance.

Elfabrio carries an FDA boxed warning for hypersensitivity reactions and anaphylaxis. According to the company's annual report, the FDA's released review found that the phase III BALANCE study met its primary endpoint, the annualized rate of change in eGFR over 104 weeks, but that its results did not support a non-inferiority claim against the comparator because of the lack of data to support a non-inferiority margin. The approvals cover 1 mg/kg every two weeks.

The pipeline is early. PRX-115 for uncontrolled gout has finished a phase I first-in-human trial, and Protalix expects to start phase II in the second half of 2025. PRX-119, a long acting DNase I for NETs-related diseases, and other assets are earlier. The prospectus supplement lists among its risks Elfabrio's market acceptance, competition and reimbursement, hostilities in Israel, and whether Fiocruz, the Brazilian licensee of Elelyso, meets its purchase obligations, a failure that could end that agreement.

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