Protalix BioTherapeutics Reports First Quarter 2024 Financial and Business Results
PR Newswire
CARMIEL, Israel, May 10, 2024
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, May 10, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx$(R)$ plant cell-based protein expression system, today reported financial results for the quarter ended March 31, 2024, and provided a business and clinical update.
"We are pleased to announce that initial top-line results from the first seven cohorts of the first-in-human phase I clinical trial of our recombinant uricase candidate, PRX-115, are encouraging, enabling us to expand into an eighth cohort and to begin planning a phase II trial," said Dror Bashan, Protalix's President and Chief Executive Officer. "We will analyze and announce the full results from the expanded trial following the completion of the new cohort. We believe that our strong cash position is sufficient to enable the repayment of our convertible notes due September 2024, and for our ongoing operations."
First Quarter 2024 and Recent Business Highlights
Clinical Developments
The PRX--115 trial is a double blind, placebo-controlled, single ascending dose (SAD), First-in-Human phase I clinical trial of PRX--115 for the potential treatment of uncontrolled gout (the "FIH Study") that the Company designed to evaluate the safety, pharmacokinetics $(PK)$ and pharmacodynamics (PD; reduction of uric acid) following single dose of PRX-115 in subjects with elevated uric acid levels. Of the 56 randomized subjects enrolled in the study across seven cohorts, 42 subjects were treated with PRX--115 and 14 subjects were treated with a placebo.
After a review of the initial positive top--line results from the seven cohorts, and following the review and acceptance of the safety data from cohort 7 by the safety and monitoring committee for dose escalation for the FIH Study, the Company decided to expand the study by adding an eighth cohort of eight new subjects to analyze a higher dose and its potential to result in increased exposure time. In addition to the expansion of the FIH Study, the Company also decided to commence preparations for a phase II clinical trial of PRX-115.
Key preliminary results from the FIH Study are as follows:
-- Exposure to PRX--115 increased in a dose--dependent manner.
-- PRX--115 rapidly reduced plasma uric acid concentrations to below
6.0 mg/dL over time following a single administration. The effect of
PRX--115 on plasma uric acid concentrations and the duration of response
was found to be dose dependent.
-- PRX--115 was well-tolerated. Twenty-six percent (11/42) of the subjects
treated with PRX--115 in the first seven cohorts reported study
drug-related adverse events (AEs), the majority being mild to moderate
and transient in nature. One subject in cohort 2 experienced an
anaphylactic reaction immediately following the commencement of the
infusion, and the reaction was fully resolved. There were no other
serious AEs reported in the study, and no AEs were reported in the
highest doses, cohorts 6 and 7.
Research & Development
In addition, to PRX-115 and PRX-119, the Company's plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases, the Company is focusing its research & development efforts on early-stage development assets to build its product development pipeline.
First Quarter 2024 Financial Highlights
-- The Company recorded revenues from selling goods of $3.7 million for the
three months ended March 31, 2024, a decrease of $1.4 million, or 27%,
compared to revenues of $5.1 million for the three months ended March 31,
2023. The decrease resulted primarily from a decrease of $1.1 million in
sales to Pfizer, and of $0.3 million in sales to Brazil. The decreases
resulted primarily from the timing of delivery.
-- The Company recorded revenues from license and R&D services of
$0.1 million for the three months ended March 31, 2024, a decrease of
$4.4 million, or 98%, compared to revenues of $4.5 million for the three
months ended March 31, 2023. Revenues from license and R&D services are
comprised primarily of revenues we recognized in connection with the
Chiesi Agreements. The decrease resulted primarily from the completion of
the Company's research and development obligations with respect to
Elfabrio and, as Elfabrio was approved in the United States and the
European Union in May 2023, from the completion of the regulatory
processes related to the review of the BLA and the MAA and for Elfabrio
by the FDA and EMA, respectively.
-- Cost of goods sold was $2.6 million for the three months ended March 31,
2024, a decrease of $0.5 million, or 16%, from cost of goods sold of $3.1
million for the three months ended March 31, 2023. The decrease in cost
of goods sold was primarily the result of the decrease in sales to Pfizer
and to Brazil.
-- For the three months ended March 31, 2024, the Company's total research
and development expenses were approximately $2.9 million, comprised of
approximately $0.5 million in subcontractor-related expenses,
approximately $1.5 million of salary and related expenses, approximately
$0.2 million of materials-related expenses and approximately $0.7 million
of other expenses. For the three months ended March 31, 2023, the
Company's total research and development expenses were approximately $5.8
million comprised of approximately $3.5 million of subcontractor-related
expenses, approximately $1.5 million of salary and related expenses,
approximately $0.1 million of materials-related expenses and
approximately $0.7 million of other expenses. Total decrease in research
and developments expenses for the three months ended March 31, 2024 was
$2.9 million, or 50%, compared to the three months ended March 31, 2023.
The decrease in research and development expenses primarily resulted from
the completion of the Company's Fabry clinical program and the regulatory
processes related to the BLA and MAA review of Elfabrio by the applicable
regulatory agencies.
-- Selling, general and administrative expenses were $3.1 million for the
three months ended March 31, 2024 and for the three months ended March
31, 2023.
-- Financial income, net were $0.1 million for the three months ended March
31, 2024, compared to financial expenses, net of $0.5 million for the
three months ended March 31, 2023. The change resulted primarily from
higher interest income on bank deposits and lower notes interest expenses
due to note conversions executed in 2023.
-- In the three months ended March 31, 2024, the Company recorded a tax
benefit of approximately $(0.1) million, compared to income taxes of $0.2
million for the three months ended March 31, 2023. Income taxes recorded
are primarily from the provision for current taxes on income mainly
derived from U.S. taxable global intangible low-taxed income (GILTI)
mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act.
-- Cash, cash equivalents and short-term bank deposits were approximately
$48.5 million at March 31, 2024.
-- Net loss for the three months ended March 31, 2024 was approximately $4.6
million, or $0.06 per share, basic and diluted, compared to a net loss of
$3.1 million, or $0.05 per share, basic and diluted, for the same period
in 2023.
Conference Call and Webcast Information
The Company will host a conference call today, May 10, 2024, at 8:30 am EDT to review the financial results and provide a business and clinical update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: Friday, May 10, 2024 Time: 8:30 a.m. Eastern Daylight Time (EDT) Toll Free: 1-877-423-9813 International: 1-201-689-8573 Israeli Toll Free: 1-809-406-247 Conference ID: 13745800 Call me$(TM)$: https://tinyurl.com/4pkhcxcj
The Call me(TM) feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
The conference will be webcast live from the Company's website and will be available via the following links:
Company Link: https://protalixbiotherapeutics.gcs-web.com/events0 Webcast Link: https://tinyurl.com/3r8rks24 Conference ID: 13745800
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
About Protalix BioTherapeutics, Inc.
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