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Any idea how long we will have to wait before we get the results from this phase 1?
Any idea how long we will have to wait before we get the results from this phase 1? Also, if the results end up being very positive, what are the chances that the FDA will let them advance directly to a phase 3 trial?
A very early stage, therefore i do not forsee
a robust impact on sp, however hopefully
it will offset some of the tax selling.
BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease
https://finance.yahoo.com/news/biolinerx-announces-first-patient-dosed-120000575.html
- Proof-of-concept study is initial step toward goal of identifying more efficient CD34+ HSC mobilization regimen for patients with sickle cell disease choosing gene therapy -
TEL AVIV, Israel, Dec. 21, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). The proof-of-concept trial, which plans to enroll five patients diagnosed with SCD, is being conducted in collaboration with Washington University School of Medicine in St. Louis and will assess the safety and tolerability of the two regimens.
"Stem-cell based gene therapy has delivered significant progress in the treatment of sickle cell disease; however, identifying novel mobilization approaches that safely and reliably secure the necessary stem cell collection numbers is clinically relevant for patients," said Zachary Crees, MD, principal investigator for the trial, Division of Oncology, Washington University School of Medicine. "This is an exciting area of clinical research with the potential to meaningfully increase patients' access to stem-cell based gene therapies."
Approved gene therapies rely on the collection of significant quantities of CD34+ hematopoietic stem cells to enable therapeutic manufacturing and backup storage. However, available mobilization regimens may not reliably yield desired numbers of HSCs for gene therapy, and the common mobilization agent G-CSF is contraindicated in patients with SCD. Difficulties in obtaining target quantities of HSCs may extend patient treatment journeys and increase patient and caregiver burdens.
"The recent FDA approvals of two gene therapies for sickle cell disease in the U.S. is an exciting development for the sickle cell community, and we are eager to advance clinical research of motixafortide that may potentially lead to additional CD34+ hematopoietic stem cell mobilization options in the future for patients with this condition," said Ella Sorani, PhD, Chief Development Officer at BioLineRx. "We'd like to thank the patients participating in this important collaboration with Washington University who are helping to advance the field's understanding in this area where there is unmet need."
Initial data from this study is expected in the second half of 2024. Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®.
About the Clinical Trial of Motixafortide in Sickle Cell Disease (SCD)
The trial (ClinicalTrials.gov Identifier: NCT05618301) is a safety and feasibility study to evaluate motixafortide (CXCR4 inhibitor) as monotherapy and in combination with natalizumab (VLA-4 inhibitor) as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in SCD. The study plans to enroll five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial's primary objective is to assess the safety and tolerability of motixafortide alone and the combination of motixafortide + natalizumab in SCD patients, defined by dose-limiting toxicities. Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the kinetics of CD34+ HSPC mobilization to peripheral blood in response to motixafortide alone and motixafortide + natalizumab in SCD patients.
About Sickle Cell Disease
Sickle cell disease (SCD) is one of the most common genetic diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. Sickle cell disease arises from mutations in the hemoglobin gene, ultimately leading to the production of abnormally shaped (sickle) red blood cells that tend to stick within blood vessels causing their occlusion. The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.
About BioLineRx
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
A day of honey, a day of onion.
Today is onion day.
(Translation: Life alternates, one day of honey,
one day of onion. Meaning: Just as you take the
good times, you have to accept the bad ones.)
THANK YOU. Much better so far today.
Buyers in sub $1 selling for tax reasons
IMO.
No bad news i am aware of.
Is there any negative news floating around or is it shorts or a specific group pulling it down for their cause.
A quite frustrating situation, however i have
high hopes for the future of the company!
Market makers this morning are playing the manipulation game by hitting the bid with 100 share trades to lower the share price. there is absolutely nothing in the news to cause this slow downward move other than manipulation.
1.8700+0.1800 (+10.6509%)
As of 10:32AM EST. Market open.
It's getting better
1.7997+0.1097 (+6.4911%)
As of 10:17AM EST. Market open.
Nice!
Happy Hannukah!
In my opinion anyone being a doctor and writing for Seeking Alpha getting paid by the number of "CLICKS" (people reading the article to me shows a little disrespect for The DR. title. Most "doctors" would not waste their time. This is again my opinion and should be taken that way. Yes another 25 cents was paid to the doc because I read his article. Even I can write on Seeking Alpha (but would not spend my valuable time doing so). Keep in mind this person is not a employee of BioLineRx there for his knowledge is very limited to the same we are limited to. Nothing he wrote in his second article is anything we shareholders don't already know. ENOUGH SAID...........
Dr. Alvarez comments about the Sickle Cell study at U of Washington and the Pancreatic Study are misleading. Aphexda is THE DRUG being studied in both which he failed to mention. In fact, he refers to Aphexda as one of two drugs being studied. He said "the company has two Phase 2 drugs, one for sickle cell disease [SCD], working in collaboration with Washington University in St. Louis, and AGI-134 medication for treating Solid Tumors. Additionally, BLRX is researching Phase 1 with a drug to treat Pancreatic Cancer in partnership with Columbia University"
After reading Dr. Myriam Hernandez Alvarez's article it kind of took my breath away. Yes I own a lot of shares of this company and yes I am a positive investor in this company. I am here because I do not expect great happenings in my lifetime as I am up in years. What I am banking on is a nest egg for my five grandchildren. Biotech stocks are a tremendous risk as is going to a casino. The difference in buying this stock is if it begins to show failure one can immediately sell and if need be take a measured loss. BioLineRx seems to have secure management and an FDA-approved product in a market that very well could make them a lot of revenue in many different ways. It also could be bought out which would we hope be profitable one way or the other.
JUST MY REASONS WHY I AM HERE!!!!!!!!
BioLineRx: Weighing Aphexda's Breakthrough Against Financial Challenges
Dec. 02, 2023 11:25 PM ETBioLineRx Ltd. (BLRX)
Summary
BioLineRx is a biopharmaceutical company specializing in cancer and rare disease therapies.
The company's main product, Aphexda, was FDA-approved for stem cell mobilization in multiple myeloma patients.
BioLineRx's low cash reserves and need for additional financing pose risks, but its valuation appears relatively conservative.
Overall, BLRX offers enough upside potential to warrant a speculative "buy" rating for more enterprising investors if it successfully commercializes Aphexda.
microscope of cell, Embryonic stem cell.
anusorn nakdee
BioLineRx Ltd. (NASDAQ:BLRX) is a biopharmaceutical company founded in 2003 with headquarters in Israel and offices in the US. BLRX’s shares are traded in NASDAQ and TASE. Notably, BLRX has developed Aphexda, motixafortide for injection, the first drug FDA-approved for stem cell mobilization in multiple myeloma patients in a decade. The FDA approved Aphexda in September 2023. The expansion of motixafortide in the Asian market through a licensing agreement with GloriaBio marks a new chapter for BLRX's global outreach and financial strengthening. However, a deeper look at its balance sheet reveals a desperate need for cash, as BLRX’s reserves appear stretched. This paints a picture of a company rushing to commercialize Aphexda on a last stretch, which could be its lifeline to turn it into a sustainable biotech company. Due to its low valuation multiple, BLRX’s valuation appears to account for this. Thus, as a whole, I think BLRX is a viable speculative bet for some more enterprising investors as long as they know the considerable potential pitfalls.
Business Overview
BioLineRx Ltd. is a biopharmaceutical company based in Israel with offices in the US. The company’s shares are traded in NASDAQ and on the Tel Aviv Stock Exchange [TASE]. It was founded in 2003 and had an IPO on TASE in February 2007. BLRX specializes In developing therapies for cancer and rare diseases. Its pipeline of products includes two approved medications, one recently authorized, and one legacy drug: Aphexda for multiple myeloma. BLRX also has BL-5010 for skin lesions.
The company doesn’t have any meaningful revenues as of 2023. However, out of its current IP portfolio, only one drug can soon become a significant revenue contributor. Thus, this places BLRX squarely in the pre-commercial stage of biotechnology companies. This significantly reduces the uncertainties related to speculating about potential FDA approvals, but uncertainties remain. After all, we still have to see early sales data to assess market acceptance and evaluate BLRX and its prospects properly.
BioLineRx’s Product Pipeline
First, the FDA approved Aphexda, motixafortide, for injection for stem cell mobilization to treat multiple myeloma cancer in September 2023. Aphexda motixafortide is the first innovation for this type of treatment, approved in a decade by the FDA. APHEXDA plus filgrastim effectively mobilizes enough stem cells to the level required for successful transplantation in patients with multiple myeloma. Aphexda is undoubtedly BLRX’s crown jewel, the company’s only approved product.
Still, it’s worth noting that BLRX also has BL-5010, a legacy non-surgical drug for removing skin lesions, which is CE-approved. The product is an alternative to invasive treatments like cryotherapy, laser treatment, and surgery for lesion removal. However, BL-5010 was out-licensed to Innovative Pharmaceutical Concepts Inc., now part of Perrigo (PRGO), to be commercialized in Australia, Europe, and other selected countries. Thus, it’s no longer as relevant for BLRX as it was from a product pipeline perspective.
Lastly, the company has two Phase 2 drugs, one for sickle cell disease [SCD], working in collaboration with Washington University in St. Louis, and AGI-134 medication for treating Solid Tumors. Additionally, BLRX is researching Phase 1 with a drug to treat Pancreatic Cancer in partnership with Columbia University. But, as you can see, Phase 2 and Phase 1 drugs are still far from becoming tangible revenue contributors. Thus, Aphexda is BLRX’s main selling point at this time.
Source: BioLineRx Corporate Presentation
As you can see in the figure above, only Aphexda is completely under the control of BLRX and ready for commercialization. The rest of its IP is either licensed or too early in development. In my view, this is why BLRX is now essentially a story about Aphexda.
Strategic R&D Focus and Expanding Motixafortide in Asia
Furthermore, in BLRX’s latest earnings call, executives highlighted the approval of motixafortide, commercially called APHEXDA, as an advance for stem cell mobilization, especially for older multiple myeloma patients or people who underwent strong induction therapies. The drug's efficacy was demonstrated in the clinical trial phase 3 called Genesis, where many patients could receive transplantation after just one apheresis session. The reduced need for multiple apheresis sessions saves costs and is more convenient for patients. The focus for the application of the drug is the transplant center. However, motixafortide could be used in different indications because its role in modulating immune responses and impacting cancer cell behavior opens the possibility of its application in anti-tumor therapies and in controlling other immune-related conditions. These new applications are still a challenge that needs research but could unlock additional revenue verticals on top of BLRX’s existing IP.
On October 12, BLRX announced that the company had signed an agreement with GloriaBio for licensing motixafortide to be developed in Asia. BLRX receives $15 million upfront. After achieving regulatory milestones in China and Japan, they will receive $50 million and $200 million more after reaching sales targets. Additionally, BLRX will receive royalties on net sales in Asia. GloriaBio will develop and commercialize motixafortide in Asian markets. GloriaBio also signed to make an equity investment in BLRX by purchasing new ADS for $14.6 million.
Source: BioLineRx Corporate Presentation
A Seemingly Cheap Valuation
From a cash burn perspective, due to Aphexda’s launch activities, the company has increased sales and marketing expenses and reduced R&D expenses. This resulted in the company burning roughly $9.9 million in September 2023, an annualized burn rate of $39.6 million. Unfortunately, the company holds just $26.0 million in cash and equivalents as of September 2023, implying a concerning cash run of 0.66 years.
Nevertheless, BLRX believes it can leverage $30 million from its license agreement and deal with Gloria Biosciences and its $30 million debt agreement with Kreos Capital. Theoretically, if these two figures are added to the current cash position, extending the cash runway to 2.25 years would be enough. Notably, this would imply that BLRX has enough cash and financing to last into early 2026, and the company estimates that it has enough to support operations into 2025. However, I’d take those estimates with a grain of salt, as they seem rather optimistic. I think BLRX can leverage some of that additional financing to extend its cash runway, but at the end of the day, it only has $26.0 million in cash, which investors can truly depend on.
Still, the flip side of this concerning picture is that BLRX’s Aphexda does seem to tap into a relatively sizeable market. The company’s internal estimates from September 2022 projected that this drug could theoretically tackle a $360 million market in annual spending. Unfortunately, we don’t have much more than that vague figure from BLRX, as the company expects to capture a “significant share” of this market eventually. Yet, we don’t know how much a “significant share” is. Still, for the sake of argument, if BLRX manages to capture one-third of this market within the next few years, it’d set its current market cap of $106.28 million at roughly one times its annual sales. This valuation multiple seems rather low, especially considering BLRX’s sector P/S median multiple is 3.68. Also, since BLRX has an enterprise value of $93.31 million, it’d imply an EV/Sales ratio below one, assuming it captures a third of the market they claim to be targeting. From both perspectives, BLRX is trading on the cheaper side.
Buyer Beware
As previously mentioned, one of BLRX’s main risks is its limited cash runway. Even though they claim to have enough to last into 2025, the reality is that to commercialize Aphexda, they’ll likely require additional investments. I doubt they can successfully commercialize Aphexda at the necessary scale without a sizeable cash burn. If they start running low on cash without tangible results, it can quickly trigger an alarm on creditors. No one wants to lend to a company on the verge of bankruptcy. After all, cash is oxygen for businesses, and BLRX is certainly running low on cash.
Also, leaving aside the cash concerns, Aphexda itself remains rather speculative. All we have so far is the company’s estimates, even somewhat vague ones. It’s hard to pinpoint its annual revenues if it’s successfully commercialized accurately. It could be a resounding success, or it could disappoint substantially, potentially crippling BLRX’s already low cash reserves. So, considering those risks, I can see why the market appears tentative regarding BLRX despite its FDA approval for Aphexda.
TradingView
BLRX’s risks may be already accurately “priced in,” offering a viable price entry for new investors (TradingView)
Closing Thoughts: A Mixed Bag
Overall, it’s unfortunate that BLRX has such low cash reserves just as it’s starting to commercialize Aphexda. It truly adds a layer of risk that makes investing at this point highly speculative, given the potential downsides. If BLRX had $200 million in cash at this point, I’d be more certain about its success, as it’d have more than enough runway to commercialize Aphexda and enjoy its success successfully. However, as it stands today, BLRX is running low on funds, and that’s why it needs to potentially tap on credit lines and license its remaining IP to make it to the finish line. Indeed, the bull case is that Aphexda delivers on its financial promises for shareholders, and they’re nicely rewarded. But the flipside could involve additional shareholder dilution or, potentially, bankruptcy. The stakes are still high for BLRX, yet it’s also true that its valuation appears relatively conservative. This undoubtedly opens a window for more speculative investors who understand the risks. I think BLRX is a viable speculative “buy” at these levels for such a subset of investors. But it certainly isn’t fit for a substantial portion of anyone’s investment portfolio.
This article was written by
Myriam Alvarez
149 Followers
My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Business Management from Universidad Andina Simon Bolivar, Quito, Ecuador, and the Ph.D. degree in computer applications from the University of Alicante, Spain.Disclosure: I collaborate professionally with Edgar Torres H, who is also an author on Seeking Alpha. Our analyses are conducted independently, and we adhere to Seeking Alpha's Shared Association Guidelines.
Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
I gotta find more green to buy more BLRX. At this low price it is almost a give away.
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript
Published on November 21, 2023 at 3:45 pm by INSIDER MONKEY TRANSCRIPTS in News, Transcripts
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript November 20, 2023
Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2023 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management’s formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions] I would now like to turn the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.
John Lacey: Thank you, Johnny. Welcome, everyone. Thank you for joining us on our third quarter 2023 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I’d like to remind you that certain statements we make during the call will be forward-looking. If have such statements due to future events and are subject to more risks and uncertainty actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainty, please review our annual report on Form 20-F and our quarterly report on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin Chief Executive Officer of BioLineRx.
Phil Serlin: Thank you, John, and good morning, everyone, and thank you for joining us on today’s call. Joining me today are Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with an overview of our Stem Cell Mobilization program, then Holly will provide an update on the effects to launch of activities and progress. I will then provide an update on our other clinical programs, notably the Motixafortide program in PDAC and Sickle Cell Disease. Finally, Mali will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. We have made substantial progress since our last quarterly update with our Stem Cell Mobilization program.
We were very pleased to announce in September the U.S. FDA approval of Motixafortide known commercially as APHEXDA in combination with G-CSF to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. The approval of APHEXDA is the culmination of tireless work by the entire BioLineRx team and transitions us to a commercial stage company that is bringing the patients, physicians and caregivers, the first true advancement in stem cell mobilization in more than a decade. And Holly will detail shortly, we have built out our U.S. commercial infrastructure, which has been engaging in pre-and post-launch activities to support a robust future for APHEXDA. Feedback from our initial outreach to top-tier transplant centers across the U.S. suggest that APHEXDA fills a significant unmet need for a more effective mobilization regimen, conferring benefits to centers, payers and patients alike.
This encouraging feedback gives us great optimism the long-term opportunity that is in front of us. There are many factors driving the need for improved stem cell mobilization regimen several of which we have covered in our prior calls. The population of multiple myeloma patients undergoing autologous Stem Cell Mobilization has expanded to include older patients over the past decade, with 36% of patients aged 65 or over in 2021, older age has been shown to impair Stem Cell Mobilization as stem cell counts decreased with age. In addition, the introduction of stronger induction therapies has further impaired mobilization, including drugs such as lenalidomide and natalizumab (ph), which are often given in combination. As a result, many patients may require multiple apheresis sessions.
Recall that the approval of APHEXDA was based on results from the highly successful GENESIS Phase 3 clinical trial and in this contemporary trial, most patients received lenalidomide containing induction regimen and the median age in the Motixafortide treatment arm was approximately 64 years old. Particularly relevant to the transplant centers in the GENESIS trial affect the plus G-CSF enabled almost 90% of patients who proceed to transplantation after only one apheresis session. Also, as a reminder, multiple myeloma is the second most common hematologic malignancy and autologous stem cell transplantation remains the standard of care treatment and has been shown to prolong the lives of patients with this cancer type. And historically, depending on treatment regimens, up to 47% of patients have faced challenges mobilizing the target number of stem cell after one session.
With APHEXDA as a potential backbone of a new mobilization paradigm, we are optimistic that many more multiple myeloma patients will be candidates for this life extending procedure and will benefit from what we are calling an A-plus transplantation experience. And at this point, I’d like to turn the call over to Holly May, President of BioLineRx USA for a review of our launch activities. Holly, please go ahead.
Holly May: Thank you, Phil. As Phil indicated, the approval of APHEXDA for stem cell mobilization in multiple myeloma patients represents the first true advancement in stems mobilization in over a decade. Our decision to commercialize effects to independently in the U.S. is key to our efforts to make this new mobilization agent available to transplant centers and patients as quickly as possible. I would now like to provide a brief update on our recent and ongoing activity supporting the commercial launch, which we initiated immediately after APHEXDA approval. First, it may be helpful to provide some statistics that support the significant opportunity that is in front of us, not just in terms of potential sales, but also an ability to help thousands of patients who today are having great difficulty mobilizing enough stem cells for transplantation.
As a reminder, there are approximately 35,000 patients diagnosed with multiple myeloma each year in the U.S. And of those, we estimate that about 18,000 are eligible for autologous stem cell transportation. On these eligible patients, approximately 8,000 procedures per annually, a figure that has nearly doubled since 2010. Autologous stem cell transportation remains the preferred first-line treatment for patients with multiple myeloma. However, due to a number of factors, including an aging patient population and the increased use of three and four drug induction therapies, as Phil indicated, up to 47% of patients have had challenges collecting the target number of stem cells in one apheresis session. As we will cover in more detail shortly, the requirements for multiple apheresis session leads to potentially more adverse events, higher costs and tremendous inconvenience and mental hardship for patients.
With the efficacy demonstrated in Phase 3 GENESIS trial, which supported the approval of effects to indecent indication, we believe we can overcome these challenges. We believe we are highly differentiated as a novel second-generation mobilization agent and that we have a significant value proposition for all stakeholders, that includes centers, patients and payers. Staying on the topic of differentiation for a moment, we have done extensive research on the market and have deep appreciation of the evolving landscape. Since our last earnings call and as expected, multiple abbreviated new drug applications or ANDA have been approved for generic [indiscernible] leading to rapid and significant price erosion for the first-generation mobilization agent.
This is something that we anticipated and what we have incorporated into our model. And why we consider, plerixafor to be in the same overall market basket at APHEXDA, it is not the same as APHEXDA. We have a highly differentiated product profile based on our stronger and more consistent mobilization outcomes. And our early discussions with customers support that the centers appreciate the innovation as we look to address their need for a better mobilizer. As such, we have indicated previously that we have price effects at [indiscernible] per vial. We believe this price adequately reflects the value that APHEXDA adds to the autologous stem cell transplant treatment landscape. Further, notwithstanding the existence of lower-priced generic plerixafor.
We believe the differentiated clinical attributes APHEXDA will drive long-term adoption and allow it to evolve into the new standard of care for mobilization. Over time, we strongly believe that differentiation will outweigh drug price as centers adopt the best treatment paradigm for their patients. As we indicated previously, our first priority has been to educate transplant centers on the unmet need of roughly 8,000 patients who progress to autologous stem cell transplant each year. We estimate the top 80 centers out of the band 212 nationally perform approximately 85% of all stem cell transplant procedures. Since approval, we have established initial contact with all of our top-tier centers and root activity has been extremely high. Increases shares can be in short supply at many transplant center and the potential for APHEXDA to allow for the collection of the targeted number of stem cells quite often in a single apheresis session should allow for the more efficient scheduling and utilization of those tiers.
This is of significant value to transplant centers, particularly those that perform a high number of procedures. We are in ongoing discussions with pharmacy and therapeutics committees at those centers that require positive PMP formulary decision prior to trialing the product and including APHEXDA in their protocols. We are making consistent and steady progress. We believe an important factor driving the future success of APHEXDA is inclusion in clinical treatment guidelines. Shortly after approval, APHEXDA was included in the national clinical practice guidelines in oncology otherwise known as NCCN, for stem cell mobilization broadly, including multiple myeloma. The American Society for transplantation in cellular therapy or ASTCT is also working on updated guidelines, which we anticipate next year.
Currently, ASTCT to [indiscernible] recommendations call for a recommended collection target of 3 million to 5 million cells per program and double that target with multiple transplants are planned. Recall that in the GENESIS trial, the median number of CD34 stem cells collected on the first day of apheresis was $8.5 million in the treatment arm versus $1.5 million in the control arm. As Phil indicated earlier, the addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session compared to 10.8% in the G-CSF, given the demonstrated performance of APHEXDA relative to the current treatment guidelines, we are confident that we will ultimately gain inclusion. Turning now to payers. The success of any new therapeutic launch is contingent upon establishing broad, affordable access from a coverage and reimbursement perspective.
This includes not only national and regional commercial health plans, but also the centers for Medicare and Medicaid services since a significant number of multiple myeloma patients are older and therefore, receive their health care through Medicare. The immediate upfront cost of stem cell collection independent of drug costs is 13,850 per patient and can range from 6,300 (ph) to $48,500 and the cost of one apheresis session is 6,200 to 6,600 again independent of drug costs. For the ability to more predictably and reliably achieve the target number of stem cells required for transplantation and fewer apheresis sessions can result in significant savings to payers over time. Payers view the effects of clinical data very favorably. And as a result, we have already established unrestricted access to over 90% of covered lives.
This represents a mix of both commercial and government payers, and we continue to work to increase this number so that APHEXDA is as broadly accessible to patients as possible. In summary, I am very pleased with our launch progress to date. Both our commercial and medical affairs teams, which include many individuals with decades of experience in both stem cell mobilization and multiple myeloma are generating results in the early stages of this launch as we continue to engage with top transplant centers, physician leaders and payers on this exciting new treatment option. At this point, I’ll turn the call back to Phil to provide an update on our other programs.
Phil Serlin: Thank you, Holly. At this point, I would like to provide an update on opportunities that we are pursuing in Stem Cell Mobilization for multiple myeloma outside of the United States. Just a few weeks ago, we closed an exclusive license agreement with the development commercialization of Motixafortide in Asia across multiple indications. As part of the agreement in Stem Cell Mobilization cell mobilization, our partner, Gloria Biosciences plans to execute a 30 to 50 patient bridging study in China to support approval and commercialization of APHEXDA for Stem Cell Mobilization in multiple myeloma. And we’ll also seek approval in other Asian countries. In prior clinical trials, Gloria Biosciences has demonstrated an ability to enroll patients quickly, and we believe they will be able to complete this trial with similar efficiency.
In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma, the largest number of multiple myeloma cases globally. So this is an area of great unmet need in those territories as well. And in China, autologous stem cell translocation for multiple myeloma is already included in medical insurance reimbursement. We continue to evaluate additional commercialization partnership opportunities in significant markets for APHEXDA in stem cell mobilization. Turning now to our second development indication for Motixafortide pancreatic cancer, our license agreement with Gloria Biosciences covers this indication as well. Gloria Biosciences is a leader in the development of cancer immunotherapies in Greater China having developed and commercially launched the anti-PD-1 monoclonal antibody, zimberelimab, which is approved in the region for relapsed or refractory classical Hodgkin lymphoma into a recurrent or metastatic cervical cancer.
Gloria Biosciences went from IND to commercialization of zimberelimab in its first indication in China in only four years. So we believe they are uniquely positioned to explore the potential utility of Motixafortide in combination trials against this difficult to treat cancer. Recapping the terms of the agreement, we received $15 million upfront and are eligible to receive up to approximately $50 million in development milestones based on the achievement of specific development milestones in China and Japan. Additionally, we are eligible to receive up to approximately $200 million in potential commercial milestones and royalties ranging from 10% to 20% of net sales following the approval of Motixafortide in any indication in the Asia region.
In addition, the transaction included an equity investment of $14.6 million in BioLineRx, with the purchase of newly issued American depositary shares and of price at $2.14 per ADS. No warrants were issued in the transaction. In other PDAC developments in July, we announced the initiation of a randomized Phase 2 combination clinical trial of Motixafortide first-line pancreatic cancer. The trial known as CheMo4METPANC is sponsored by Columbia University, and it was recommended to precede the randomized phase of the study based on the very compelling preliminary data in the single-arm pilot phase of the study. Recall that the original pilot study was to enroll approximately 10 patients and was to be expanded to 30 patients if data from the first 10 patients were encouraging which was defined as three or more patients showing the partial response per the RECIST criteria.
As we recently presented at the AACR Special Conference on Pancreatic Cancer in September, seven of 11 patients were 64% experienced a partial response, of which five were confirmed PRs with one patient even experiencing resolution of the metastatic lesion in the liver. Along with the three patients were 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare very favorably to historic partial response and disease control rate of 23% and 48%, respectively, reported with the current standard of care. Based on these compelling data, the original trial design was amended from a single-arm study with a target enrollment of 30 patients is mentioned to a much larger randomized study of 108 patients.
The trial’s primary endpoint is progression-free survival PFS. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. Enrollment in the study is expected to begin in the next few months. As is well known, PDAC is a tumor type in dire need of new effective treatment options. Neuro immunotherapies have shown promise in other tumor types with limited efficacy in PDAC due to immunosuppressive pathways. On our more optimism for this trial is also based on the success of our COMBAT/KEYNOTE-202 triple combination Phase 2a study for which we announced results in December 2020. Recall that the COMBAT/KEYNOTE study evaluated the combination of motixafortide, KEYTRUDA and chemotherapy as a second-line therapy.
Substantial improvement was observed across all study end points including overall survival, progression fee survival and overall response in the most challenging PDAC patients, those initially diagnosed with stage four cancer. The combination also appeared to be well tolerated with a low incidence of neutropenia and infections in treated patients. Needless to say, we are excited about the potential of Motixafortide to form the backbone of new PDAC treatment regimens giving new hope to patients suffering from this very difficult to treat tumor type, while demonstrating the versatility of Motixafortide across both hematological and solid tumor cancers. It is also worth mentioning that based on the promising data to date in PDAC, we see opportunities to explore Motixafortide as part of exciting new combination therapies to treat other solid tumor types.
This only adds to our optimism for the long-term potential of this molecule. Another area where we are exploring the potential utility of Motixafortide in autologous hematopoietic stem cell-based gene therapy for patients suffering from sickle cell disease one of the most common genetic diseases globally. To that end, in March, we announced the clinical trial collaboration with Washington University School of Medicine to evaluate Motixafortide in this indication. Unlike multiple myeloma patients, the current standard of care mobilization G-CSF carries significant risks and potential severe side effects for patients suffering from sickle cell disease. Furthermore, in many cases, current mobilization treatments fail to reliably yield optimal number of stem cells to facilitate gene therapy.
As such, this patient population is in need of an effective new mobilization regimen. Through this collaboration, we are conducting a proof-of-concept trial to study Motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. The study is evaluating the safety and tolerability of the two regimens as mobilization agents of CD34+ in motixafortide stem cells in patients with sickle cell disease. Study enrollment has recently begun, and we anticipate data in the second half of 2024. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our main financial results. Mali, please go ahead.
Mali Zeevi: Thank you, Phil. As is our practice in our financial discussion on this call, we will only go over the most significant items in our financial statements. Sales and marketing expenses, research and development expenses, non-operating expenses, net loss and cash. Therefore, let me invite you to review the filings we made this morning, which contain our financials, 20-F and press release for additional information. Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million or 517.4% compared to $1.3 million for the corresponding period last year. The increase resulted from the significant launch-related activities for Motixafortide in the U.S. Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million or 37.6% compared to $4.3 million for the corresponding period last year.
The decrease resulted primarily from lower expenses for NDA supporting activities related to Motixafortide as well as lower expenses associated with the completed AGI-134 clinical trials. Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million compared to nonoperating income of $0.4 million for the corresponding period last year. The increase relates primarily to a non-cash expense from revaluation of outstanding warrants due to an increase in the company’s share price during the 2023 period. Let me now turn to net loss. Net loss for the three months ended September 30, 2023, was $16 million compared to $6.8 million for the corresponding period last year. Net loss for the nine months ended September 30, 2023, amounted to $46.7 million compared to $19.2 million for the corresponding period last year.
The increases in net loss for both the three and the nine months period in 2023 were primarily due to the significant nonoperating expenses related to revaluation of outstanding warrants as well as the significant increases in sales and marketing expenses related to launch activities which were partially offset by a decrease in research and development expenses. The company emphasizes the non-cash expenses associated with the warrant revaluation did not impact its cash position as of September 30, 2023, note that they affect the company’s projected cash runway going forward. Turning to cash. The company held $26 million of cash, cash equivalents and short-term bank deposits as of September 30, 2023. This does not include the roughly $30 million consideration from the license agreement and the equity investment in the deal with Gloria Biosciences nor does it include the $30 million available to us under our debt agreement with Kreos Capital, which is tied to the attainment of certain milestones.
We believe we are well financed to fund our operations as currently planned into 2025. And with that, I’ll turn the call back over to Phil.
Phil Serlin: Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. Commercial ramp-up of effects to U.S. sales and an ongoing evaluation of commercial partnership opportunities for APHEXDA in additional markets. Recruitment in the chemo for met Phase 2 randomized clinical trial in first-line PDAC sponsored by Columbia University. Recruitment in the Phase I pilot study of Motixafortide Hematopoietic Stem Cell Mobilization for gene therapies in sickle cell disease led by Washington University School of Medicine with initial data expected in the second half of 2024. Initiation by Gloria Biosciences of a 30 to 50 patient bridging study in 2024 to support approval of APHEXDA and Stem Cell Mobilization for multiple myeloma in China in preparation activities with Gloria Biosciences on a randomized Phase II/III clinical trial, evaluating ixaportid in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer.
With that, we have now concluded the formal part of our presentation. Operator, we will now open the call to questions.
Operator: Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Joe Pantginis of H.C. Wainright. Please go ahead.
Joe Pantginis: Hi, everybody. Good morning. Thank for taking the questions. And first, I just wanted to extend my well wishes to everybody, not only for these difficult and turbulent times, but also for the holidays. So we have all of our best — so I’d like to focus on two things for stem cell transplantation and then one on PANC (ph), if you don’t mind. So first, Holly, I really appreciate all the details that it definitely is encouraging to hear all the details that you shared about the launch. So hopefully, I’m not getting too much into the weeds because it is early. I guess, when you’re early in the launch, I’m just considering what places or areas that you feel the company has had nimble in according to the plans that you had and saying, okay, we learned we might need more emphasis in a particular geography or anything of that such of those details. Yeah.
Phil Serlin: Holly, go ahead.
Holly May: Yeah. Sure. Thanks, Joe. So much of what we’re doing right now is as expected as planned. We have said this previously, I spoke again in my comments this morning about the fact that transplant centers make up about 85% of all of the transplantations in the U.S. And therefore, we are — we have a deployment plan with field individuals, both sales account type people as well as medical affairs type people. And I think we kind of got that one right. The deployment plans and our ability to reach and hit the right frequency with in those institutions is spot on. I think one of the things that’s been interesting for us, I don’t know if it’s a huge shift, but it’s been interesting to speak to some of these decision makers within the centers about the — what we would — we have three pillars of value — and the one I think that maybe not surprising, but we’re finding a lot of interest in is that the efficiency of this product.
And that has to do really around the planning and logistics asset centers as well as the pharmacokinetics. So that’s an area I think that we are spending perhaps a little bit more time than maybe we had originally the strong clinical data, which is our efficacy pillar the Phase 3 GENESIS data is resonating quite well. But I think the thing that we’re spending some more time on is probably the efficiency and what that means. I do want to add, though, you didn’t ask this, but the third, I’ve spoken about the efficacy and the efficiency of the other really important part of our value proposition is the experience that patient experience as well. So we are out there with all of that messaging, but the one I think that we’re really finding to resonate for maybe a few more questions than we initially thought was that efficiency color.
Joe Pantginis: That’s really, really helpful. Thank you for that. And I guess the thing that I’m curious about is because it’s pretty intriguing is the fact that it’s huge that you’re on the NCCN guidelines. And you said for SCM broadly, so I wanted to get a sense of how that impacts your potential development plan. And I know you can’t really talk to off-label use in other indications, but I think this could help drive, I guess, how you develop for other indications. I don’t know if you have any comments on that.
Phil Serlin: Holly, do you want to take that?
Holly May: I can. Yes. So we are very much staying the course on thinking about what we want to do for add-on indications, either things that would be driven within our own clinical planning. We do have an active IS independent sponsored studies that is open and available for various institutions or physicians that have an area of interest [indiscernible] in stem cell mobilization. We are constantly looking at the data that required for making sure that we shore up our label and that. But I’m certainly not going to speak at all to any kind of off-label utilization that the guidelines may or may not afford. Did that answer your question?
Joe Pantginis: It does. I’d like to add something.
Phil Serlin: Joe, I’d like to add something — I just I’m sorry, I sorry to interrupt you. I just wanted to add, first of all, hi, good to speak to you. But I do want to add, we mentioned the gene therapy in the sickle cell disease area. And obviously, that’s an area that we’re putting a lot of focus on in a big way. And so we see that as a very key life cycle management upside for the company.
Joe Pantginis: Great. And then just the last question. I mean, short question, but maybe more elaborate answer. Maybe. The Phase II pilot study being run with Colombia. Obviously, you’re having a nice expansion into a larger set of patients. I guess a question this way. To what extent do data from this study impact or serve as a rate-limiting step for potential business development?
Phil Serlin: Okay. So let me just make sure that I understand. So I mean, I mean I think I do understand. I think we are obviously looking to generate data I think that we’ve made it clear that we are looking to generate data to move this forward. We were — we entered into agreement with Gloria Biosciences. In Asia, part of that deal, a significant part of that deal is for them to generate Phase IIb data in a randomized study, Phase II, III data in a randomized study in PDAC and we’re running this trial or we’re cooperating or collaborating with Columbia University in this IST trial. Depending on the data, we are hoping to be able to take this data and move forward from a business development perspective and speaking with large pharma companies, that would be the idea.
Of course, I’m not ruling out us potentially taking this forward ourselves depending on the situation. but it’s likely in a very significant indication like this. And when we’re talking about PDAC, we’re not only talking about PDAC. We look at this as sort of as a proof of concept for other solid tumors as well. And so obviously, that would speak to a larger company conducting many studies, many Phase III studies across the board in order to get broad approval in a number of indications. So I hope that answered your question. I think that we’re looking at this as a potential launch launching pad, so to speak, for business development with larger companies in this particular area of solid tumors.
Joe Pantginis: It certainly answer the question. I appreciate the color and as usual what I’m hearing personally is that you continue to have a lot of optionality going forward. Thanks a lot guys.
Phil Serlin: Thank you.
Holly May: Thank you.
Operator: The next question is from John Vandermosten of Zacks. Please go ahead.
John Vandermosten: All right. Thank you and hello, Phil, Holly and Mali. As the previous — as Joe mentioned, APHEXDA was added to the NCCN guidelines, how quickly is a change like that incorporated into practice?
Phil Serlin: Holly, do you want to take that?
Holly May: Sure. I mean from a market access perspective, that’s what many of these payers will mean on it for decisions about the reimbursability, et cetera. So from an NCCN perspective, pretty much immediately.
John Vandermosten: That’s great. And then looking at gene therapy, I mean, personally, I think that’s one of the greater options that you guys have out there. You’ve got quite a few. But there was recently a sickle cell disease drug approved Vertex, I think, in the UK. And I think they’re also applied in the EU and the U.S. as well. Is that what are the bottlenecks there in terms of gene therapy for sickle cell disease is stem cell mobilization part of the bottleneck there. Is that approval and potentially two others and somewhere where you can get into as well? I mean you’re doing work there. Maybe you can help me understand kind of how that drug that just got approved in the UK might be something that you could take advantage of.
Phil Serlin: Holly, do you want to take that? I mean…
Holly May: Why don’t I begin and then you can add on if I set some gap. And I may be a good one to ask just because it’s a world I came from. So prior to this, I was the Chief Commercial Officer at a gene therapy company. So I certainly understand the challenges — we also know that both Vertex and Bluebird are looking at PDUFA dates in December here in the U.S., so that could be significant. I think that the thing that is that gene therapy company to these ex-vivo gene therapy customers are always looking to solve for is that entire patient journey and what kind of improvements can be made. And that can happen on several different fronts conditioning with one area that, of course, they’re always looking at, but also [indiscernible] is another area.
And I think this is especially true with sickle cell disease because the standard for mobilization. We see it with our multiple myeloma indication is G-CSF plus a mobilizer such as APHEXDA and with that, we know that sickle stop patients are unable to be unable to use G-CSF in sickle cell patients. So I think it produces a an appendage situation in sickle cell. That’s not to say that symptom mobilization isn’t also something that’s looked at for some of these other applications. And in the future as these come to market. We will — we could also be looking at those. But right now, of course, our efforts are focused on the high unmet need in sickle cell. And as has been announced, we do have the study at Wash, which is looking at some of that.
So did I forget into, was there anything you wanted to add to that?
Phil Serlin: I think I might want to add. I think we’ve mentioned this previously, but we look at this area as something that we can really, really find a real place for it. There is an unmet need. There’s a huge amount of cells that are required to be mobilized in — for gene therapy. We’re talking about 15 million to 20 million CD34+ positive cells per kilogram. And just for example, in multiple myeloma, our phase III, we’re talking about 6 million cells per kilogram. And so a significantly higher number of cells need to be mobilized in order to move forward in gene therapy. And in addition, as Holly mentioned, these patients cannot receive G-CSF and therefore, it’s that much more difficult to mobilize. So the current mobilization regimen require these patients to go through multiple cycles of after recessions and mobilization and collection with usually a 30-day period between each cycle.
So therefore, the collection of the cells could be something that takes two to three months or even longer in some circumstances. And therefore, we hope and we think that we may be able to show better mobilization and perhaps even reduce the number of mobilization cycles to a bare minimum and therefore, save a significant amount of time and discomfort for the sickle cell patients since that’s the idea behind our value proposition there.
Holly May: There’s one other thing that you were speaking that I thought I would add on that is very unique about these approaches to gene therapy that you mentioned, in particular, John, the Vertex product. And that is the manufacturing and the manufacturing of the cells that go into that. That’s one — another reason why a very high number of CD34+ themselves are required for these types of therapies just because there’s always the need for backup in case something this is personalized medicine and gene therapy, obviously, that is manufactured for the individual. And so there is always a need for back up through the manufacturing processes, which just, again, drives the need for a very, very high number of stem cells.
John Vandermosten: Okay. Great. Yeah. It will be exciting to see how this turns out with that product and maybe you guys will be involved. A couple of questions on — there’s been a lot of, I guess, cash flow movements and share movements recently. And I’m wondering if you can give me some kind of sense of where cash and share balance might be at the beginning of the — at the end of the year, beginning of the year, December 31. Can you help me with that?
Phil Serlin: Yes. So I mean, I think we discussed our cash. We including the almost $30 million that we received from the deals or the agreements, the license and the equity investment. We have in excess of $50 million in cash on a pro forma basis, which, as we mentioned, is enough to take us into 2025. We also, as Molly mentioned, we have a $30 million debt facility that’s available to us. And so we feel quite comfortable from a cash perspective that we can meet everything that we need to do from a launch perspective in the near future. from that. So as a — you also asked about the number of shares, is that what you asked? Do you want to?
John Vandermosten: Yes, yes, exactly.
Phil Serlin: I think what Molly. No, but in ADS, I think we have about 70. We have somewhere — the exact number is in front of me. I apologize. I think it’s somewhere around 70 million (ph) outstanding ADSs.
John Vandermosten: Okay. Great. And then last one for me is just any kind of revenue guidance that you can provide us for the fourth quarter?
Phil Serlin: Yes. I mean that’s the question. So listen, John, I mean, we’re happy, as Holly mentioned, we’re happy with the way things are progressing. And there’s a lot of activity that we’re doing on all fronts, hospitals KOLs. The committees, P&T committees, as you know, we also got on the NCCN guidelines, et cetera. But as I’m sure you’re aware, we can’t, of course, get into sales forecast and companies usually don’t give forecast on commercial launches. And so that’s about all we can say at this point.
John Vandermosten: Right. I mean, lots of [indiscernible] there. Well thank you. You guys are in a great place and I appreciate you taking my questions.
Phil Serlin: Thanks so much.
Operator: This concludes the question-and-answer session. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin 2 hours after the conference. In the U.S. please call 1 (888) 295-2634. In Israel, please call (03) 925-5904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statements?
Phil Serlin: Yes. Thank you, operator. In closing, we are progressing through 2023 with significant momentum. We are launching our first therapy in stem cell mobilization and are making significant progress, raising awareness of the many benefits APHEXDA can bring to payers and transplant centers. We completed our first ex-U.S. partnership agreement for APHEXDA and are evaluating the potential of commercial partnerships in other significant markets. We have made important additional life cycle management steps through both our PDAC program as well as our program for stem cell mobilization for gene therapies. I am very pleased with our progress during the third quarter, and I’m excited about what we are in the process of achieving. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in March. Be safe, and have a great day.
Operator: Thank you. This concludes the BioLineRx third quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.
To be expected. Fundamentals remain :)
Quarterly report could have been better. All the technical stuss was positive but the financial stuff was in the tank. No sales and all the cost to get sales SUCKS. Hope they clean some of this up on the conference call.
BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates
https://finance.yahoo.com/news/biolinerx-reports-third-quarter-2023-120000394.html
- Received FDA Approval of APHEXDA® (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma -
- Closed Exclusive License Agreement for Motixafortide in Asia Region with Concurrent Strategic Equity Investment -
- Presented Encouraging Data at AACR from Pilot Phase of Randomized Phase 2 Combination Trial with Motixafortide in Patients with First Line PDAC -
- Began Enrollment of Phase 1 Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease -
- Management to host conference call today, November 20, at 10:00 a.m. EST -
TEL AVIV, Israel, Nov. 20, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the third quarter ended September 30, 2023, and provided corporate and portfolio updates.
"FDA approval of APHEXDA® in September was a transformative event for the company, and our U.S. commercial team is now working with payers and providers to make this important innovation available to patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "We were pleased that APHEXDA® was recently added to the NCCN guidelines, and we believe that as centers adjust their protocols to include and gain experience with APHEXDA®, transplant teams will gain a deep appreciation for the efficiencies that it can provide, and more importantly, the improved treatment journey patients experience as they navigate their essential transplant process.
"In addition, the company also closed its motixafortide licensing agreement covering the important Asia market. The agreement, which provided significant upfront funding, will first advance potential indications in the region for stem cell mobilization and pancreatic cancer, areas of high unmet need. We continue to evaluate additional commercial partnership opportunities in other markets.
"Lastly, exciting data were presented at AACR from the single-arm pilot phase of the randomized Phase 2 combination clinical trial with motixafortide in first-line pancreatic cancer by the study's lead investigator at Columbia University. The highly encouraging data triggered a change in the protocol, from a small, single-arm study to a much larger randomized study. This study, as well as the enrolling Phase 1 study evaluating motixafortide for stem cell mobilization in patients with sickle cell disease seeking gene therapy, highlight the potential versatility of motixafortide and the tremendous progress we are making to realize the full promise of this novel molecule for patients around the world," Mr. Serlin concluded.
Corporate Updates
Received U.S. Food and Drug Administration approval of APHEXDA® (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
Closed exclusive license agreement to develop and commercialize motixafortide in Asia, alongside strategic equity investment:
License agreement included $15 million upfront payment, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones, and tiered double-digit royalties on sales
Straight common equity investment of $14.6 million in BioLineRx American Depository Shares (ADSs)
Gloria Biosciences expected to begin pivotal bridging study to support potential approval and commercialization of motixafortide in stem cell mobilization in China
Gloria Biosciences planning randomized Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
Received inclusion of APHEXDA® in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
Received acceptance of an abstract on combination premedication benefits in the Phase 3 GENESIS trial, further educating on the use of APHEXDA at transplant centers. The poster will be presented at the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, in San Diego, California
Initiated pivotal bridging study preparation activities with Gloria Biosciences to support potential approval and commercialization of motixafortide in stem cell mobilization in China
Pancreatic Ductal Adenocarcinoma
Presented data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial in first-line pancreatic cancer (PDAC) at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer. Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced a partial response (PR), of which 5 (45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 91%. Based on these encouraging results, the study was substantially revised to a multi-institution, randomized trial of 108 patients
Initiated preparation activities with Gloria Biosciences to support the development of a randomized Phase 2/3 clinical trial evaluating motixafortide in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer
Sickle Cell Disease & Gene Therapy
Began enrollment in investigator-initiated Phase 1 pilot study led by Washington University School of Medicine in St. Louis evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate data in 2H of 2024
AGI-134 (synthetic alpha-Gal glycolipid)
Solid Tumor Immunotherapy
Evaluating next development pathways for AGI-134 program. The Phase 1/2a first-in-human, single-agent study, results of which were announced in Q4 2022, met the primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers
Third Quarter 2023 Financial Results
Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million, or 37.6%, compared to $4.3 million for the three months ended September 30, 2022. The decrease resulted primarily from lower expenses associated with NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial
Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million, or 517.4% compared to $1.3 million for the three months ended September 30, 2022. The increase resulted primarily from the ramp-up of pre-commercialization activities related to motixafortide
General and administrative expenses for the three months ended September 30, 2023 were $1.5 million, an increase of $0.1 million, or 7.7% compared to $1.4 million for the three months ended September 30, 2022. The increase resulted from small increases in a number of individual G&A expenses
Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million, compared to non-operating income of $0.4 million for the three months ended September 30, 2022. The increase relates primarily to the revaluation of outstanding warrants resulting from an increase in the company's share price during the 2023 period
Net loss for the three months ended September 30, 2023 was $16.0 million, compared to $6.8 million for the three months ended September 30, 2022. Net loss for the nine months ended September 30, 2023 amounted to $46.7 million, compared to $19.2 million for the nine months ended September 30, 2022. The increases in net loss for both the three- and nine-month periods in 2023 were primarily due to the significant non-operating expenses (which were also non-cash) related to revaluation of outstanding warrants, as well as the significant increases in sales and marketing expenses related to pre-commercialization and commercialization activities, which were partially offset by a decrease in research and development expenses
As of September 30, 2023, we held $26.0 million of cash, cash equivalents and short-term bank deposits. We anticipate that this amount, as well as the consideration from the exclusive license agreement and the securities purchase agreement of $29.6 million that was received in October 2023, will be sufficient to fund operations, as currently planned, into 2025
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 22, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
Looks like market makers are having fun this morniing. (99%) of the trades so far today are 100 shares or under, !00 share trades are usually signals amounst market makers.
1.7100+0.1700 (+11.0390%)
As of 01:26PM EST. Market open.
Nice
BioLineRx to Report Third Quarter 2023 Results on November 20, 2023
https://finance.yahoo.com/news/biolinerx-report-third-quarter-2023-120000735.html
- Management to Hold Conference Call at 10:00 a.m. EST -
TEL AVIV, Israel, Nov. 13, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its unaudited financial results for the quarter ended September 30, 2023 on Monday, November 20, 2023, before the U.S. markets open.
The Company will host a conference call at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 22, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
Mozobil sales down 23% last quarter. Lots of generics. Can BLRX really compete in this environment even given that they have a better product? I thought Rolvedon could with Nualesta and boy was i wrong $ASRT
agree. Aphexda has been added to several Formularies of very large insurance plans. I think we'll hear just how good the roll out (very good imo) has been and may be an early sales projection.
Looks like this little gem is finally beginning to shine. Hope the earnings report 11/9 will help to continue the upward momentum.
GOOD LUCK TO US LONGS
They have a few facts wrong in that article, namely that BLRX has no products on the market!
The lack of basic fact checking, research and due diligence in “Journalism” these days is the reason everything needs to be taken with a grain of salt an nothing should be trusted at face value.
Murocman
3 Tech Stocks That Wall Street Loves More Than Nvidia
https://investorplace.com/2023/11/3-tech-stocks-that-wall-street-loves-more-than-nvidia/
BioLine RX (BLRX)
BioLine RX (NASDAQ:BLRX) is a therapeutics company driven by drug development in various blood-related regions. With current collaborations with Columbia University and the Washington University School of Medicine, BioLine is in a great place to grow from the current valuation of $1.29, making a year-over-year growth of 52.38%.
The current stage of the biopharmaceutical industry is well off, with positive growth seen from the 2021 revenue of $328 billion. Further, by 2030, expect the sector to bring in $853 billion in revenue, marking a CAGR of 11.3% for that period. BioLine RX, based out of Israel, is one of the only Israeli companies competing in this industry, proving to be profitable for BLRX.
Revenue-wise for BioLine RX, the company is currently in a pre-commercial status with no current products on the market, but expect that to change in the near future after the FDA accepts their new discovery APHEXDA. Although the financial reports all show net negatives across the board, BioLine has managed to keep operating expenses at a low during the time of pre-commercial status, so expect profitability soon.
Overall, the largest strong point of BLRX has been the recent development in their commercial activity. In this September, BioLine RX received the news that APHEXDA, their flagship drug, has just been approved by the FDA to begin commercial testing and activity. This drug, a subcutaneous drug for stem cell transplantation in patients with myeloma, is a major victory in the industry overall due to it being the first stem-cell mobilization product to be approved in 10 years. Expect APHEXDA to carry BLRX to victory, and create profitability.
BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures
https://finance.yahoo.com/news/biolinerx-entered-exclusive-license-agreement-130000593.html
NEW YORK, Oct. 31, 2023 /CNW/ -- M.S.Q. Ventures ("MSQ") is pleased to announce that its client, BioLineRx Ltd. ("BioLineRx") (NASDAQ/TASE: BLRX), has entered into an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia.
MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. From understanding key segments of the China healthcare market to identifying and vetting the high potential counterparties to negotiating deals aimed at maximizing value creation, our team focuses on results, prioritizes efficiency to guide our clients through the entire process. (PRNewsfoto/MSQ Ventures)
MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. From understanding key segments of the China healthcare market to identifying and vetting the high potential counterparties to negotiating deals aimed at maximizing value creation, our team focuses on results, prioritizes efficiency to guide our clients through the entire process. (PRNewsfoto/MSQ Ventures)More
The license agreement provides for a $15 million upfront payment and an equity investment of $14.6 million, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones and tiered double-digit royalties on sales.
"Given GloriaBio's expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. GloriaBio has demonstrated a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and this transaction provides us with additional capital to continue our launch plans in the U.S.," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "We are very excited about the swift and successful conclusion of this monumental Asian market licensing agreement. The MSQ team showed remarkable agility and a deep understanding of mutual benefits to both parties right from our initial discussions. MSQ's disciplined deal management ensured a seamless process. Echo, with her visionary leadership, expertise, and impressive execution skills, played a key role in making this collaboration happen."
"We are pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio's portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "The MSQ team's great efforts made a huge impact on the closing of this successful transaction in such a short time. The MSQ team provided valuable advice for both sides. We are impressed with the MSQ team's extensive knowledge of financial structures and drug development".
Echo Hindle-Yang, CEO of MSQ, reflecting on the transaction, "We're thrilled about the cross-border collaboration between BioLineRx, the pioneering company behind FDA-approved APHEXDA™ (motixafortide), and GloriaBio, the team behind the PD-1 inhibitor YuTuo® (zimberelimab). This partnership showcases their commitment to advancing global drug development and benefiting patients on a global scale. BioLineRx brings an innovative pipeline, successful FDA approval of APHEXDA™ for stem cell mobilization, strategic collaboration abilities, and a seasoned team to the table. On the other hand, GloriaBio, with their expertise in cancer immunotherapies, clinical development capabilities, and strong commercialization capabilities in Asia, is a formidable partner. The dedication of leaders like Mr. Serlin, Dr. Zhu, and their stellar teams played a pivotal role in swiftly achieving the success of this transformative deal. As part of this momentous partnership, we eagerly anticipate the positive developments ahead, promising an even brighter future for global patients."
About MSQ
M.S.Q. Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights.
info@msqventures.com
Cision
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/biolinerx-entered-exclusive-license-agreement-to-motixafortide-in-asia-advisored-by-msq-ventures-301972192.html
SOURCE MSQ Ventures
Cision
Cision
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2023/31/c5866.html
BioLine RX (BLRX)
https://investorplace.com/2023/10/3-top-penny-stocks-to-make-you-a-millionaire-in-5-years/
BioLine RX (NASDAQ:BLRX) is an Israeli biotech firm with U.S. operations. The company has multiple FDA-approved treatments in its pipeline and more on the way potentially.
Bioline RX received FDA approval for APHEXDA for use in the collection of stem cells in the treatment of multiple myeloma. It is injected and allows most patients to reach a collection goal of more than 6 million hematopoietic stem cells. That improves stem cell transplantation, a standard treatment for multiple myeloma.
So, it is arguably the exact time to consider BLRX stock as it moves into the revenue production stages. The company is developing other drugs for commercialization in areas as diverse as sickle cell anemia and pancreatic cancer. Pancreatic cancer is a particularly lethal form of cancer that is often intractable because it is detected late in many cases. In short, BioLine RX offers immediate upside potential and longer-term upside due to the suite of drugs it continues to develop that address unmet needs.
Aphexda has been added to several Drug Formularies for large health insurance plans like the National Association of Letter Carriers Health Insurance and today it was added to Kaiser Permanente's Formulary Health Plan (the largest not for profit Health plan in the US).
I believe with the current naked short ruling we as shareholders can go after Sabby and any other naked short seller (perhaps wainwright?) especially if it led to predatory financing, which i am sure it did. i would be very interested in such a class action. I predict law firms are going to be all over this. much easier to sue giant investment firms flush with cash than biotechs struggling. whos in? get enough folks here and we can crush them and make an example
Have you checked the NBI index lately?
The XBI?
Look what happened in the past few months.
There is the answer to your question!
Fmello
I have stopped guessing what PR'S will do for BLRX my concern is what they will do down the road when the company starts showing EARNINGS.
It's weird that the news only caused a 2% pop to the stock.
The geat positive point in this PR is that
there was no backing from the agreement
as some thought due to the situation in
Israel.
A great sign of confidence.
BioLineRx Announces Closing of Exclusive License Agreement to Motixafortide in Asia and Concurrent Strategic Equity Investment
https://finance.yahoo.com/news/biolinerx-announces-closing-exclusive-license-110000024.html
- License agreement includes $15 million upfront, up to $50 million in potential development and regulatory milestones; up to ~$200 million in potential commercial milestones, and tiered double-digit royalties on sales -
- Gloria Biosciences expected to begin bridging study to support potential approval and commercialization of motixafortide in the territory in stem cell mobilization -
- Gloria Biosciences expected to initiate randomized Phase 2/3 first-line pancreatic cancer clinical trial, evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy -
TEL AVIV, Israel, Oct. 12, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the closing of an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia. Motixafortide is a novel, high-affinity CXCR4 inhibitor that received approval for its first indication in September 2023 by the U.S. Food and Drug Administration (FDA) for stem cell mobilization (SCM) in autologous stem cell transplantation (ASCT) in patients with multiple myeloma. Motixafortide is also being studied for other potential uses in oncologic and hematologic diseases.
The license agreement provides for a $15 million upfront payment (which was received at closing), up to $50 million in potential development and regulatory milestones in China and Japan, and up to $200 million in potential commercial milestones based on defined sales targets. BioLineRx is also eligible to receive tiered double-digit royalties on net sales.
In addition, the transaction included an equity investment of $14.6 million in BioLineRx through the purchase of newly issued American Depositary Shares (ADSs) at a price of $2.136 per ADS in a private placement. No warrants were issued in the transaction. Along with the investment, the purchaser received the right to appoint one representative to the BioLineRx Board of Directors.
Collaboration Details
Under the terms of the license agreement, GloriaBio will be responsible for development and commercialization of motixafortide in Asia initially in SCM. With the recent FDA approval of APHEXDA for this indication, GloriaBio plans to initiate a bridging study to support potential approval and commercialization of motixafortide in the licensed territories in SCM for ASCT in patients with multiple myeloma.
In addition, GloriaBio plans to initiate a Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy. BioLineRx has been developing motixafortide in combination with PD-1 inhibitors and standard of care combination chemotherapies in pancreatic cancer, and recently announced the initiation of a randomized Phase 2 clinical trial sponsored by Columbia University in first-line metastatic pancreatic cancer based on promising preliminary data from a single-arm pilot phase reported on September 29 at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer.
"We are tremendously pleased by the swift closing of this significant licensing agreement for the Asian market, which brings substantial benefits to BioLineRx, and ultimately, to patients, including the advancement of our two leading development programs," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Given GloriaBio's expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. The combined initial investment of nearly $30 million through the upfront payment and equity investment demonstrates a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and provides us with additional capital to continue our aggressive launch plans in the U.S."
"We are very pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio's portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "There are very significant unmet patient needs in pancreatic cancer in Asia, especially in China. We are excited to see the encouraging clinical data of motixafortide in combination with PD-1 inhibitors and chemotherapy in pancreatic cancer and look forward to initiating a Phase 2/3 randomized trial in a first-line pancreatic cancer, as well as investigating additional indications for motixafortide in Asia."
MSQ Ventures served as advisor to BioLineRx on this transaction.
About Pancreatic Cancer in Asia
At nearly 240,000 reported cases in 2022, it is estimated that Asia had the largest number of pancreatic cancer cases globally (496,000 estimated cases worldwide). In China alone, the number of pancreatic cancer cases in 2020 reached approximately 125,000, with a 5-year survival rate of just 7.2%.
About Multiple Myeloma and Autologous Stem Cell Transplantation in Asia
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow.
In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma (MM), the largest number of MM cases globally. New cases of MM reached over 20,000 in Greater China in 2018, and MM incidence is predicted to increase at an annual growth rate of 2.9%.
Autologous stem cell transplantation (ASCT) can be an important treatment paradigm for a number of blood cancers, including multiple myeloma. In China, ASCTs are included in medical insurance reimbursement, and in 2019, the total number of ASCTs in China reached more than 10,000 for the first time (for comparative purposes, as many as 14,000 ASCTs are performed each year in the U.S.).
*About Zimberelimab (YuTuo®)
Zimberelimab is a fully human anti-PD-1 monoclonal antibody. GloriaBio is developing and commercializing zimberelimab in Greater China, including mainland China, Hong Kong, Macao and Taiwan, where zimberelimab is approved for relapsed or refractory classical Hodgkin's lymphoma and recurrent or metastatic cervical cancer. Arcus Biosciences, and development partner Gilead Sciences, have the exclusive rights to develop and commercialize zimberelimab throughout the world except in Greater China and certain territories.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
About Gloria Biosciences
Gloria Biosciences is a commercial stage biopharma company focused on the development and commercialization of novel or highly differentiated immunotherapies and biologics for oncology. Toward the company's ultimate goal of improving accessibility, affordability, and availability for patients with innovation, Gloria Biosciences is striving to build a pipeline of more efficacious and patient-centered treatments to address unmet medical needs, driven by the company's efficient execution of clinical development, proven fast-to-market commercialization ability, world-class GMP-compliant manufacturing capability and global partnerships.
Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contacts:
United States
John Lacey
BioLineRx
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
China
Ying Huang
Gloria Biosciences
IR@gloriabio.com
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-closing-of-exclusive-license-agreement-to-motixafortide-in-asia-and-concurrent-strategic-equity-investment-301954789.html
SOURCE BioLineRx Ltd
midastouch017
If there is any way I can help please let me know.
It looks like 5.5M shares traded at the TASE close when the price spiked.
Yes, on TASE, alas, no data, no PR, but it
certainly had an (delayed) effect in the Naz.
From minus 10% to plus 5% or so is quite
strange. Perhaps we will hear news tomorrow!
Very strange indeed
Did that bump happen today?
BioLineRx Ltd. (BLRX.TA)
Tel Aviv - Tel Aviv Delayed Price. Currency in ILA (0.01 ILS)
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44.00+7.30 (+19.89%)
At close: 05:30PM IDT
https://finance.yahoo.com/quote/BLRX.TA?p=BLRX.TA&.tsrc=fin-srch
Very strange indeed. BLRX/Naz should follow suit imo
Thank - you, still alive and kicking!
A very sad situation. Just terrible!
midastouch017
Are you okay. Am following situation all day from here. Stay safe!!!!!!!!
midastouch017
woke up to find PRZO doubled my money and I sold out. Will take 1/2 of my profit to buy more BLRX and then wait for Przo to pull back and then buy back in. The sun is shining this morning.
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