Protalix Biother SEC Filings

Protalix BioTherapeutics (PLX) filed its Q3 2025 10‑Q, highlighting steady operations and pipeline updates. Total revenue reached $43.6 million for the nine months ended September 30, 2025, up from $35.2 million a year ago, driven by product sales to partners. Q3 revenue was $17.9 million. The company posted Q3 net income of $2.4 million, while recording a nine‑month net loss of $1.1 million.

Cash and cash equivalents were $13.6 million, with $15.7 million in short‑term deposits. Operating cash flow was $(14.0) million for the nine months, partly offset by $9.2 million from financing, including $6.8 million raised under its Sales Agreement and $2.4 million from exercises. Approximately $15.7 million in capacity remained under the Sales Agreement as of September 30, 2025.

Leases were amended, extending options through December 31, 2031; right‑of‑use assets were remeasured by $3.1 million. The company reported its cash resources are sufficient for at least 12 months. Recent updates include an effective IND for PRX‑115 Phase 2, a CHMP negative opinion on Elfabrio’s E4W dosing with re‑examination requested, and a CFO transition. Shares outstanding were about 80,421,181 as of November 1, 2025.

Protalix BioTherapeutics furnished a Form 8-K noting it issued a press release with financial results for the fiscal quarter ended September 30, 2025 and provided a business and clinical update.

The press release is included as Exhibit 99.1. In accordance with General Instruction B.2, the information, including Exhibit 99.1, is furnished and not deemed filed under the Exchange Act.

Protalix BioTherapeutics (PLX) reported that, together with partner Chiesi Global Rare Diseases, it has requested a re-examination of the European Medicines Agency’s CHMP negative opinion on the proposed dosing regimen for Elfabrio (pegunigalsidase alfa). The request pertains to a regimen of 2 mg/kg infused every 4 weeks (E4W).

The company furnished a press release as Exhibit 99.1 with additional details. This update reflects an ongoing EU regulatory process focused specifically on the proposed E4W dosing for Elfabrio.

Protalix BioTherapeutics (PLX) announced a regulatory update and investor materials. Together with partner Chiesi Global Rare Diseases, the company reported that the EMA’s Committee for Medicinal Products for Human Use issued a negative opinion on adding a dosing regimen of 2 mg/kg infused every 4 weeks for Elfabrio (pegunigalsidase alfa). The currently approved regimen of 1 mg/kg infused every 2 weeks remains in place.

The company also furnished an October 2025 corporate presentation on its website. A related press release and the presentation were provided as exhibits.

Forster Eliot, a director of Protalix BioTherapeutics, Inc. (PLX), reported transactions on 09/03/2025 showing an acquisition of equity awards. The filing discloses 7,500 restricted shares of common stock awarded under the companys amended 2006 Stock Incentive Plan, held indirectly through a trust and vesting in 12 equal quarterly installments commencing on the grant date. The reporting person also received 15,000 stock options with a $1.64 exercise price that were granted the same date; those options vest in 12 equal quarterly installments and expire on 09/03/2035. The Form 4 also notes existing options to buy 85,715 shares at $1.75 expiring 09/14/2033. The document is signed by an attorney-in-fact on 09/04/2025.

Protalix BioTherapeutics insider grant and option award reported. Director Gwen A. Melincoff was awarded 7,500 restricted shares of common stock on 09/03/2025 under the company’s Amended and Restated 2006 Stock Incentive Plan; the restricted shares vest in 12 equal quarterly installments and are registered in the name of a trustee to qualify for Israeli tax benefits. On the same date she was granted 15,000 stock options with an exercise price of $1.64 that expire on 09/03/2035; the option shares vest in 12 equal quarterly installments. The reporting person’s indirect ownership following the restricted-share grant is 7,500 shares, and 15,000 underlying shares are held directly via the option grant.

Reporting person: Pol F. Boudes, a director of Protalix BioTherapeutics, Inc. (PLX). Transaction date: 09/03/2025.

The Form 4 discloses that the reporting person was awarded 7,500 restricted shares of common stock under the companys 2006 Stock Incentive Plan, held indirectly by a trustee to qualify for Israeli tax treatment, with the restricted shares vesting in 12 equal quarterly installments. The filing also shows the acquisition of 15,000 stock options with an exercise price of $1.64, granted 09/03/2025, exercisable through 09/03/2035, with the underlying shares vesting in 12 equal quarterly installments. The Form notes additional outstanding option grants held by the reporting person that are not part of this grant.

Director Christian Elze acquired equity in Protalix BioTherapeutics (PLX) on 09/03/2025. The Form 4 reports an acquisition of 7,500 restricted shares of common stock that are registered in the name of a trustee to qualify for Israeli tax treatment, with the restricted shares vesting in 12 equal quarterly installments beginning on the grant date. The filing also shows an award of stock options to purchase 15,000 shares at an exercise price of $1.64, exercisable through 09/03/2035, with the options vesting in 12 equal quarterly installments commencing on the grant date. Following the reported transactions, the reporting person beneficially owns 7,500 common shares (indirect) and 15,000 options (direct).

Aharon Schwartz, a director of Protalix BioTherapeutics, Inc. (PLX), reported equity awards and option grants on 09/03/2025. He was awarded 7,500 restricted shares of common stock that vest in 12 equal quarterly installments and are held indirectly by a trust to qualify for Israeli tax benefits. He disposed of 303,000 shares on the same date. He was also granted stock options to buy 15,000 shares at a $1.64 exercise price, exercisable beginning 09/03/2025 and expiring 09/03/2035, with the underlying shares vesting in 12 equal quarterly installments. The reporting notes additional outstanding options totaling 151,676 shares across prior grants at various exercise prices and expirations.