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Within 48 hours, we might know EMA approval
Midas, the link you gave says this at the bottom: "It will be possible to request access to this document or download it within 48 hours"
So maybe we will know about EMA approval within 2 days from when that was posted (which was probably much earlier today).
If so, then we might know Friday or Monday at the latest (assuming they mean 48 business hours)
Protalix Biotherapeutics, Inc. (PLX) Q1 2023 Earnings Call Transcript
May 04, 2023 12:55 PM ETProtalix BioTherapeutics, Inc. (PLX)
Protalix Biotherapeutics, Inc. (NYSE:PLX) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET
Company Participants
Charles Padala - IR
Dror Bashan - President, CEO & Director
Eyal Rubin - SVP, CFO, Treasurer & Corporate Secretary
Conference Call Participants
John Vandermosten - Zacks
Operator
Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2023 Financial Business Results Conference Call. As a reminder, this conference is being recorded.
I will now turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protalix. You may now begin.
Charles Padala
Thank you, Tina. Welcome, everyone, to the Protalix BioTherapeutics First Quarter 2023 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Protalix; and Eyal Rubin, Senior Vice President and Chief Financial Officer.
A press release announcing the results and the update was issued this morning and is now available on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and Protalix's filing with the U.S. Securities and Exchange Commission.
I will now turn the call over to Mr. Dror Bashan. Dror?
Dror Bashan
Thank you, Chuck, and welcome, everyone, to our First Quarter 2023 Financial Results and Business Update Call. I will begin by reviewing our recent progress and accomplishments. Following my remarks, Eyal Rubin will provide a more detailed review of our financial results. We will then open the line for questions.
As we updated earlier this morning, we, together with our development and commercialization partner, Chiesi Global Rare Diseases, are waiting on EC decision, which should be announced in the next couple of days. In addition to the EU, we are also quickly approaching potential approval in the United States. Our signed PDUFA target action date is next week, May 9, 2023, and we look forward to providing you with an update when we hear from the FDA.
We are grateful for the Protalix team as well as our partnership with Chiesi that has brought us to this stage. We are confident that if approved, Chiesi is well-equipped to realize the full potential of PRX-102. They have ramped up commercial activities and are prepared for launch. Fabry disease represents a potential significant opportunity in a multibillion-dollar market that is in need of an alternative treatment option and we, together with Chiesi, are prepared to deliver.
Now turning to our pipeline. We are continuing to make progress in our earlier stage programs. PRX-115 is a novel PEGylated uricase in development for the treatment of severe gout. In March of 2023, the first patient was dosed in our Phase I first in human clinical trial for PRX-115 in patients with elevated uric acid levels. And the trial is a double-blind placebo-controlled single-ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX-115 in up to 56 patients.
The study is being conducted in New Zealand. And to date, 9 patients have been -- already have been dosed in this trial. We look forward to continued enrollment and dosing of patients.
We also continued to progress on PRX-119, a PEGylated recombinant human DNase I protein designed to elongate DNase half-life in circulation for treatment of NETs-related diseases. We have conducted preclinical studies to demonstrate the feasibility of PRX-119. We look forward to providing updates on these programs and others as we look to build our growing pipeline.
You may recall that last December, in 2022, we announced our decision that it was in our company's best interest to voluntarily delist our common stock from Tel Aviv Stock Exchange. On March 22 of this year, 2023, our common stock was delisted from the Tel Aviv Stock Exchange, and the last trading day on the Tel Aviv Stock Exchange was March 20, 2023. Finally, our balance sheet provides us with sufficient runway to the third quarter of 2023, supporting the company through potential approvals in addition to continuing to develop our earlier-stage pipeline programs.
I will now turn to Eyal -- thank you. I will now -- yes, of course. I will now turn to Eyal for a review of our financials. Eyal, please?
Eyal Rubin
Well, thank you, Dror. And just to make it clear, obviously, the cash runway is until third quarter of 2024. Thank you, everybody, for joining the call today. Let me review our first quarter 2023 financials.
We recorded revenues from selling goods of $5.1 million during the 3 months ended March 31, 2023, a decrease of $3.9 million or 43% compared to revenue of $9 million for the 3 months ended March 31, 2022. The decrease resulted primarily from a decrease of $2.7 million in sales to Brazil and a decrease of $1.1 million in sales to Pfizer, both resulting from timing differences.
We recorded revenues from license and R&D services of $4.5 million for the 3 months ended March 31, 2023, a decrease of $2.6 million or 37% compared to revenues of $7.1 million for the 3 months ended March 31, 2022. Revenues from license and R&D services are comprised primarily of the revenue we recognized in connection with the Chiesi agreement.
Cost of goods sold was $3.1 million for the 3 months ended March 31, 2023, a decrease of $2.9 million or 48% from cost of goods sold of $6 million for the 3 months ended March 31, 2022. The decrease in cost of goods sold was primarily the result of decrease in sales of goods.
For the 3 months ended March 31, 2023, our total research and development expenses were approximately $5.8 million comprised of approximately $3.5 million in subcontractor related expenses, approximately $1.5 million of salary and related expenses, approximately $0.1 million of material-related expenses and approximately $0.7 million of other expenses.
For the 3 months ended March 31, 2022, our total research and development expenses were approximately $8.8 million comprised of approximately 5.8 million subcontracted rated expenses, approximately $2 million of salary and related expenses, approximately $0.2 million of material related expenses and approximately $0.8 million of other expenses.
Total decrease in research and development expenses was $3 million or 34% for the 3 months ended March 31, 2023, compared to the year ended March 31, 2022. The decrease in research and development expenses primarily resulted from the completion of both our Fabry clinical program and a substantial portion of the regulatory process related to the BLA and the MMA submission for PRX-102 as Dror described earlier.
Selling, general and administrative expenses were $3.1 million for the 3 months ended March 31, 2023, a decrease of $0.1 million or 3% compared to $3.2 million for the 3 months ended March 31, 2022. A decrease of approximately $0.4 million in salary and related expenses was partially offset by an increase of $0.3 million in professional fees.
Financial expenses net were $0.5 million for the 3 months ended March 31, 2023, compared to financial expenses net of $0.4 million for the 3 months ended March 31, 2022. In the 3 months ended March 31, 2022, we recorded income taxes of approximately $0.2 million. Cash and cash equivalents were approximately $33 million at March 31, 2023.
Net loss for the 3 months ended March 31, 2023, was approximately $3.1 million or $0.05 per share basic and diluted compared to a net loss of $2.3 million or $0.05 per share basic and diluted for the same period in 2022.
I will now turn the call back to you, Dror.
Dror Bashan
So thank you very much, Eyal, and thanks, everybody, for joining us on today's call. I'm sure everybody is under anticipation for the upcoming approvals. Clearly, it's an exciting time for us.
We are looking forward to providing you, of course, with the update once we have them, both from the EU and the FDA. And in addition, we are planning on hosting an investor event late June to discuss Protalix's strategic priorities going forward.
Now I will turn back to the operator and open the line for questions.
Question-and-Answer Session
Operator
[Operator Instructions]. The first question comes from John Vandermosten of Zacks.
John Vandermosten
Dror, and Eyal, how are you guys doing?
Dror Bashan
We are doing fine. Thank you, John.
John Vandermosten
That's good to hear. Next week is going to definitely be a big week for you guys, so we're all over here looking forward to that. But I thought I would spend a little time on PRX-115, just to understand kind of that a little bit better.
I guess you're running the trial in New Zealand, as you've mentioned many times. Are there any incentives that you're getting from running it there? I know that that's a pretty favorable place to do early-stage trials just because the benefits that the Australian and New Zealand government provide developers there.
Dror Bashan
John, can you repeat? I don't understand the question. What is the question exactly?
John Vandermosten
Sure. So in the Oceania area, in New Zealand and Australia, I noted frequently that there are very supportive environment in terms of tax benefits and credits and things like that to run trials down there. Is that something that you're benefiting from for PRX-115 down there?
Dror Bashan
Eyal?
Eyal Rubin
Yes, that's correct, but that's not the reason we are running the trial there. We didn't apply in order to benefit from a tax credit. You need to open an on-site, on-the-ground site there in New Zealand and in Australia. And they obviously are running for at least the Phase I. We saw that it's too big of a burden. The reason was that the CRO that we picked and the sites are -- they have expertise and their enrollment capabilities are good for such reasons that we would pick the site and the CRO.
John Vandermosten
Okay. Great. And obviously, this is the Phase I where the primary goal is safety. But I wanted to see if you could share some of the secondary end points that you're looking at that might look at efficacy. And then also, if we're successful in these early stages, what might some of the endpoints be for a pivotal trial in terms of efficacy?
Dror Bashan
So John we planned, as I mentioned, up to 56 patients. And in addition to safety, of course, which is the first thing, we would like to see immunogenicity. We would like to see to what extent we reduce the uric acid, maybe hints or signs of frequency of dosing.
So -- but this has to be -- we are at the very beginning. So we will never show off, and there's nothing to show off it right now. So we -- hopefully, we plan to -- once we have the final reports, including the PK/PD to better analyze it and understand how to properly conduct the Phase II.
John Vandermosten
Sounds good. And the -- one of the major players in gout right now is KRYSTEXXA. And I'm just wondering if you have a comparison of how PRX-115 goes up against that guy.
Dror Bashan
No. We will have to see results before we can say anything.
John Vandermosten
Okay. Well, I was thinking in terms of mechanism of action or kind of the unmet need perhaps that 115 may address. Not ultimate efficacy, but just how it might work in terms of the MOA.
Dror Bashan
By the end of the day, we hope to have a differentiation in at least on an improved profile and in at least in one important aspect. We will have to see if it will be the frequ
*****FDA is going to pull the rug out again IMO and stock will fall huge
ENOUGH SAID
Approved or not (yet) approved,
by EMA - this is the question.
I suppose an offical PR will clarify
Hopefully the fda doesn’t pull the rug out again at the last minute. I still have scars from the last time.
Thank you!
So Far - So Good.
Conference call was average
For those who did not get a chance to listen, except that we are still waiting for EMA and FDA approvals. there was not much other exciting stuff.
Protalix BioTherapeutics Reports First Quarter 2023 Financial and Business Results
https://finance.yahoo.com/news/protalix-biotherapeutics-reports-first-quarter-105000458.html
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, May 4, 2023 /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® plant cell-based protein expression system, today reported financial results for the first quarter ended March 31, 2023 and provided a business update on recent regulatory, clinical and corporate developments.
"While we are awaiting for the European Commission and the U.S. Food and Drug Administration decisions, we and our partner, Chiesi, remain committed to bringing PRX-102 to market and improving the lives of patients with Fabry disease," said Dror Bashan, Protalix's President and Chief Executive Officer. "In addition, we are making progress in our early stage PRX–115 program in severe gout with the initiation of our first-in-human Phase I clinical trial."
2023 First Quarter and Recent Business Highlights
Regulatory Advancements
On February 24, 2023, the Company, together with its development and commercialization partner for PRX–102, Chiesi Global Rare Diseases (Chiesi), announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) had adopted a positive opinion, recommending marketing authorization for PRX–102 (pegunigalsidase alfa) for adult patients with Fabry disease. The positive opinion was based on a marketing authorization application (MAA) submitted to the EMA on February 7, 2022. The MAA included final data from the Company's phase III BRIDGE and BRIGHT clinical trials; 12–month interim data from the Company's phase III BALANCE clinical trial; and final data from the Company's phase I/II clinical trial from naïve/untreated patients, including the related extension study, using 1 mg/kg every two weeks dosing. Data from the 24-month final analysis of the phase III BALANCE clinical trial was submitted to the EMA during the review period. The CHMP opinion was referred for final action to the European Commission.
Clinical Developments
On March 27, 2023, the Company announced that the first patient was dosed in a First in Human (FIH) phase I clinical trial of PRX–115, the Company's recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in approximately 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. The study is being conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines.
Corporate Developments
On March 22, 2023, the Company's request for a voluntary delisting of the Company's common stock from the Tel Aviv Stock Exchange ("TASE") took effect. The last trading day on the TASE was March 20, 2023.
First Quarter 2023 Financial Highlights
The Company recorded revenues from selling goods of $5.1 million during the three months ended March 31, 2023, a decrease of $3.9 million, or 43%, compared to revenues of $9.0 million for the three months ended March 31, 2022. The decrease resulted primarily from a decrease of $2.7 million in sales to Brazil and a decrease of $1.1 million in sales to Pfizer, both resulting from timing differences.
The Company recorded revenues from license and R&D services of $4.5 million for the three months ended March 31, 2023, a decrease of $2.6 million, or 37%, compared to revenues of $7.1 million for the three months ended March 31, 2022. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with the Chiesi Agreements.
Cost of goods sold was $3.1 million for the three months ended March 31, 2023, a decrease of $2.9 million, or 48%, from cost of goods sold of $6.0 million for the three months ended March 31, 2022. The decrease in cost of goods sold was primarily the result of the decrease in sales of goods.
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 in 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. For the three months ended March 31, 2022, the Company's total research and development expenses were approximately $8.8 million comprised of approximately $5.8 million in subcontractor-related expenses, approximately $2.0 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.8 million of other expenses. Total decrease in research and developments expenses was $3.0 million, or 34%, for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. The decrease in research and development expenses primarily resulted from the completion of the Company's Fabry clinical program and of a substantial portion of the regulatory processes related to the Biologics License Application resubmission (BLA) and MAA submission for PRX–102.
Selling, general and administrative expenses were $3.1 million for the three months ended March 31, 2023, a decrease of $0.1 million, or 3%, compared to $3.2 million for the three months ended March 31, 2022. A decrease of approximately $0.4 million in salary and related expenses was partially offset by an increase of $0.3 million in professional fees.
Financial expenses, net were $0.5 million for the three months ended March 31, 2023, compared to financial expenses, net of $0.4 million for the three months ended March 31, 2022.
In the three months ended March 31, 2023, the Company recorded income taxes of approximately $0.2 million. Income taxes were recorded as Section 174 of the U.S. Tax Cuts and Jobs Act of 2017 went into effect on January 1, 2022.
Cash and cash equivalents were approximately $33.0 million at March 31, 2023.
Net loss for the three months ended March 31, 2023 was approximately $3.1 million, or $0.05 per share, basic and diluted, compared to a net loss of $2.3 million, or $0.05 per share, basic and diluted, for the same period in 2022.
Conference Call and Webcast Information
The Company will host a conference call today, May 4, 2023 at 8:30 am EDT, to review the regulatory, clinical and corporate developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date:
Thursday, May 4, 2023
Time:
8:30 a.m. Eastern Daylight Time (EDT)
Toll Free (U.S.):
1-800-954-0653
International:
1-212-231-2918
Conference ID:
22026736
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: Registration – https://tinyurl.com/4ye3uhu5
Conference ID: 22026736
Please access the websites at least 15 minutes ahead of the conference call to register, download and install any necessary audio software.
The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified stabilized version of the recombinant human a–Galactosidase–A protein for the treatment of Fabry disease; PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the timing, progress and likelihood of final approval by the EMA of the PRX-102 MAA or by the FDA of the resubmitted PRX-102 BLA by the PDUFA action date, if at all, and, if approved, whether either the EMA or the FDA will impose significant limitations on the use of PRX-102; risks related to, if approved, the commercialization of PRX–102 or that PRX–102's revenue, expenses and costs may not be as expected; risks relating to PRX–102's market acceptance, competition, reimbursement and regulatory actions, if approved; risks related to our commercialization partner's ability to obtain and maintain reimbursement for PRX–102 if approved, and the extent to which patient assistance programs and co-pay programs are utilized; the likelihood that the FDA, EMA or other applicable health regulatory authorities will approve an alternative dosing regimen for PRX–102; risks related to the commercial success of Protalix's other product and product candidates, if approved; failure or delay in the commencement or completion of our preclinical studies and clinical trials of our other product candidates, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and inability to monitor patients adequately during or after treatment; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our product candidates, and other risks relating to the review process; risks associated with the novel coronavirus disease, or COVID–19, outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; the risk that the results of the clinical trials of our product candidates will not support the applicable claims of safety or efficacy, or that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to the amount and sufficiency of our cash and cash equivalents; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
March 31, 2023
December 31, 2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
33,036
$
17,111
Short-term bank deposits
—
5,069
Accounts receivable – Trade
1,304
4,586
Other assets
758
1,310
Inventories
20,303
16,804
Total current assets
$
55,401
$
44,880
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement
$
1,252
$
1,267
Property and equipment, net
4,704
4,553
Operating lease right of use assets
5,202
5,087
Total assets
$
66,559
$
55,787
LIABILITIES AND STOCKHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY)
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade
$
5,105
$
5,862
Other
13,471
12,271
Operating lease liabilities
1,149
1,118
Contracts liability
11,790
13,178
Total current liabilities
$
31,515
$
32,429
LONG TERM LIABILITIES:
Convertible notes
$
28,267
$
28,187
Liability for employee rights upon retirement
1,617
1,642
Operating lease liabilities
4,152
4,169
Total long term liabilities
$
34,036
$
33,998
Total liabilities
$
65,551
$
66,427
COMMITMENTS
STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)
1,008
(10,640)
Total liabilities and stockholders' equity (net of capital deficiency)
$
66,559
$
55,787
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
March 31, 2023
March 31, 2022
REVENUES FROM SELLING GOODS
$
5,066
$
9,028
REVENUES FROM LICENSE AND R&D SERVICES
4,522
7,057
TOTAL REVENUE
9,588
16,085
COST OF GOODS SOLD (1)
(3,085)
(6,034)
RESEARCH AND DEVELOPMENT EXPENSES (2)
(5,847)
(8,767)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (3)
(3,115)
(3,154)
OPERATING LOSS
(2,459)
(1,870)
FINANCIAL EXPENSES
(649)
(618)
FINANCIAL INCOME
172
202
FINANCIAL EXPENSES, NET
(477)
(416)
LOSS BEFORE TAXES ON INCOME
(2,936)
(2,286)
TAXES ON INCOME
(195)
-
NET LOSS FOR THE PERIOD
$
(3,131)
$
(2,286)
LOSS PER SHARE OF COMMON STOCK – BASIC AND DILUTED
$
(0.05)
$
(0.05)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK
USED IN COMPUTING LOSS PER SHARE – BASIC AND DILUTED
57,480,009
45,843,563
(1) Includes share-based compensation
$
58
$
(6)
(2) Includes share-based compensation
$
180
$
76
(3) Includes share-based compensation
$
308
$
766
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-first-quarter-2023-financial-and-business-results-301815933.html
SOURCE Protalix BioTherapeutics, Inc.
Business Wire
Inhibition of Pancreatic Cancer by N
Two years ago I had a nice fat profit at 7+ just before the FDA pulled the last minute rug under PLX. I'm surprised with both the EU and FDA pending that we're just now even hitting the 3's!
I just found it very interesting that Cheisi has this whole info page set up about Fabry - have not seen anything about it here or ST etc. To me it says they are very confident they will have a product to advertise and sell.
Lots of buys ahead of the conference call tomorrow. Hopefully it’s not just a buy the rumor sell the news situation.
Outstanding close today. If tomorrow brings good news, the sky is the limit in the near future.
Can't see anything else than EMA approval, volume and price are too high for normal trade
Agreed again.
Yes some (probably many) of them are wishful thinkers-I carefully try to avoid spending too much time reading or discussing with those ones. :)
Cheers & mazel tov!!
The volume speaks volumes
Volume 4,750,709
Avg. Volume 1,354,471
3.0200+0.3800 (+14.3939%)
As of 01:46PM EDT. Market open.
New 52w/h
Volume 2,384,280
Avg. Volume 1,354,471
Agreed.
Just wanted to share some of the good thinkers on stocktwits with others here as we now wait for the final moments after years of waiting.
On a completely separate note, thanks for all your messages on this board over the years. Much appreciated.
Cheers
I would not worry too much at this point of
time about a would be B/O.
First comes first, lets receive positive EMA
and FDA replies.
The B/O can wait!
Anyway if replies are negative (God forbid)
nobody will even look at PLX.
The EMA & FDA agree 90%+ of the time
I am copying a post from a user named cash_flow from stocktwits, who as previously mentioned, is one of the smarter people on the PLX board. He wrote:
"For those that are worried about the FDA next week, as well… the EMA and FDA agree 90%+ of the time.. and if you factor in the drugs that were denied by either/or but ultimately approved, it is greater than 95%."
https://stocktwits.com/Cash_Flow/message/525890293
Another argument for a buyout
Another SEC filing came out today; here's what another user on stocktwits wrote:
"How can you read that filing and not see that the company is heading towards a total buyout?" https://stocktwits.com/PortfolioMgmt23/message/525863149
Here again is the location of the SEC filings. I searched for the word "severance" to see what the above stocktwits user meant:
https://protalixbiotherapeutics.gcs-web.com/sec-filings
Hi Midas,
Any thought on today's downward movement? I hope its not insiders that know something about May 9th that we don't.
Possibility of an acquisition
I prefer no acquisition so that PLX grows by itself. I am quoting one of the better thinkers (cash_flow) from stock twits who wrote, "This 10k has acquisition written all over it". His post is here:
https://stocktwits.com/Cash_Flow/message/525536554
Here is the 10K from today:
https://protalixbiotherapeutics.gcs-web.com/sec-filings
If anyone here knows how to read a 10K for hints of an acquisition, I welcome your thoughts.
2.8000+0.1300 (+4.8689%)
As of 03:15PM EDT. Market open.
New 52w/h
Fair support here (2.50's) to 2.30's for accumulation/consolidation. I like it.
Buy on rumor imo.
It’s long overdue. Unfortunately all of the BS over the last several years has destroyed investors. PLX is littered with roadkill.
Protalix BioTherapeutics to Announce First Quarter 2023 Financial and Business Results on May 4, 2023
https://finance.yahoo.com/news/protalix-biotherapeutics-announce-first-quarter-105000793.html
Company to host conference call and webcast at 8:30 a.m. EDT
CARMIEL, Israel, April 27, 2023 /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® plant cell-based protein expression system, today announced that it will release its financial results for the first quarter ended March 31, 2023 and provide a business update on Thursday, May 4, 2023.
Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments at 8:30 a.m. Eastern Daylight Time (EDT).
Conference Call Details:
Date: Thursday, May 4, 2023
Time: 8:30 a.m. Eastern Daylight Time (EDT)
Toll Free (U.S.): 1-800-954-0653
International: 1-212-231-2918
Conference ID: 22026736
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: Registration – https://tinyurl.com/4ye3uhu5
Conference ID: 22026736
Please access the websites at least 15 minutes ahead of the conference call to register, download and install any necessary audio software.
The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified stabilized version of the recombinant human a–Galactosidase–A protein for the treatment of Fabry disease; PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Investor Contact:
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
chuck@lifesciadvisors.com
Logo: https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-announce-first-quarter-2023-financial-and-business-results-on-may-4-2023-301809451.html
SOURCE Protalix BioTherapeutics, Inc.
PR Newswire
BioLineRx Regains Compliance with Nasdaq Minimum Bid Price Requirement
Tue, April 25, 2023 at 2:00 PM GMT+3
In this article:
BLRX.TA
-5.86%
Watchlist
Watchlist
BLRX
-3.57%
At 05/9 FDA decision.
At any day from now Europe decision and we can be quite sure about the outcome.
So we have something to wait for.
I believe this time plx will deliver the goods
PLX - Double average volume. Someone knows something, but no news on ticker that I could find...
2.6100+0.1200 (+4.8193%)
As of 11:47AM EDT. Market open.
PLX just broke 52w/h
Yay and hurrrah!
By mid May most probably
much more!
Looks to be heading back over $3 imo.
2.3050+0.0550 (+2.4444%)
As of 09:44AM EDT. Market open.
Just broke 52w/h!
Projected Stock Price
11.22 (424.30%)
https://fintel.io/sfo/us/PLX?utm_source=stocktwits.com&utm_medium=referral&utm_campaign=pricetarget
2.2700+0.0600 (+2.7149%)
As of 09:33AM EDT. Market open.
New 52w/h
Momentum continues!
Day's Range 2.1200 - 2.2200
52 Week Range 0.9800 - 2.2200
Volume 2,176,311
Avg. Volume 1,019,409
And over double the volume
Volume 2,102,709
Avg. Volume 1,019,409
Positive CHMP = over 90% approved
I know this was discussed before, but don't recall if anyone gave the link below from Zacks.
"While we were not able to find any specific studies that estimated the probability of approval for a rare disease candidate after a positive CHMP opinion, a review of literature addressing the topic suggests that greater than 90% of products that receive such an opinion are ultimately approved."
https://scr.zacks.com/news/news-details/2023/PLX-May-is-a-Big-Month-article/default.aspx
Protalix BioTherapeutics Announces First Patient Dosed in First in Human Phase I Clinical Trial of PRX-115 for the Treatment of Severe Gout
https://finance.yahoo.com/news/protalix-biotherapeutics-announces-first-patient-105000063.html
PRX-115 is a PEGylated recombinant uricase produced from the proprietary ProCellEx® platform as a potential treatment of severe gout
CARMIEL, Israel, March 21, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that the first patient has been dosed in the Company's phase I First in Human (FIH) clinical trial of PRX-115, the Company's recombinant PEGylated uricase product candidate under development as a potential treatment of severe gout.
The phase I FIH trial is a double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, pharmacodynamics (reduction of uric acid) and immunogenicity of PRX-115 in patients with elevated uric acid levels (>6.0 mg/dL). The trial is a single ascending dose (SAD) study with up to seven cohorts, and patients are to be randomized 3:1 to receive a single intravenous (IV) dose of PRX-115 or a placebo. The study is being conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines, and is expected to enroll approximately 56 patients with no previous exposure to PEGylated uricase.
"We are pleased to initiate this first in human trial of PRX-115," said Dror Bashan, Protalix's President and Chief Executive Officer. "This milestone highlights our commitment to building and strengthening our pipeline. Given our corporate mission to deliver new medicines to patients with high, unmet needs, we look forward to continued enrollment and dosing of patients in this trial."
90% sure that’s the MAX date we will have to wait. Some say decision could be late April.
Maybe May 2nd or 3rd.
From Stocktwits board, I see a few posters saying the above dates.
What day for EMA approval?
I know FDA is set for May 9th. The below article says early May for EMA approval. Anyone see a specific date in writing anywhere?
https://fabrydiseasenews.com/news/may-decision-expected-ec-fabry-enzyme-replacement-therapy/?cn-reloaded=1p
Protalix BioTherapeutics Issues Statement Related to Silicon Valley Bank and Signature Bank
https://finance.yahoo.com/news/protalix-biotherapeutics-issues-statement-related-105000761.html
CARMIEL, Israel, March 13, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, announced today that it does not hold cash deposits or securities at either Silicon Valley Bank or Signature Bank, nor does it have any credit facility or other financial relationship with either institution. The Company maintains a majority of its cash and short-term bank deposits in money center banks in the United States with the remainder deposited in a large financial institution in Israel. The Company does not expect the closure of Silicon Valley Bank or Signature Bank to have any impact on its operations. The Company intends to monitor the situation and any potential impact it may have on the Company's partners, suppliers or other relevant parties.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified stabilized version of the recombinant human a–Galactosidase–A protein for the treatment of Fabry disease; PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Factors that might cause material differences include, among others: risks, if any, related to the impact on our commercial partners of the closure of Silicon Valley Bank or Signature Bank; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks related to our ability to maintain and manage our relationship with our collaborators, distributors or partners; risks related to the amount and sufficiency of our cash, cash equivalents and short-term deposits; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Protalix Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
Logo: https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-issues-statement-related-to-silicon-valley-bank-and-signature-bank-301769979.html
SOURCE Protalix BioTherapeutics, Inc.
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