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3 Top Penny Stocks for 5,000% Upside in 2024 and Beyond
Only extreme speculators need apply
https://investorplace.com/2024/02/3-top-penny-stocks-for-5000-upside-in-2024-and-beyond/
15h ago · By Josh Enomoto, InvestorPlace Contributor
If you want the ultimate in extreme penny stocks, this list should do it.
BioLine (BLRX): BioLine drug discovery specialty aligns with a wide addressable market.
BioLine (BLRX)
A drug development company, BioLine (NASDAQ:BLRX) utilizes its acumen to power novel drug ideas past the bench. From the clinical development process to approval and commercialization, BioLine helps deliver meaningful therapeutics that address critical needs. Per its website, the company seeks to accelerate innovative ideas into the hands of the people who need them most: desperate patients seeking answers to their conditions.
Fundamentally, BioLine benefits from a massive total addressable market. According to Acumen Research and Consulting, the global drug discovery sector reached a valuation of $81.5 billion in 2022. Further, experts believe that the space could be worth $181.4 billion by 2032. If so, that would translate to a compound annual growth rate (CAGR) of 8.5%.
Given that the market capitalization of BLRX stock is only $96 million, it technically enjoys a robust upside pathway. However, the company will need to print something on the top line eventually to satisfy investors.
Still, H.C. Wainwright’s willing to bet on BioLine, rating shares a “buy” with a $21 target. That comes out to almost 1,594% upside. Therefore, BLRX ranks among the penny stocks to consider.
The increase with robust volume is
indeed a positive sign.
Hope the momentum continues today!
I am smiling as the increase is now showing in the after-hours trading. Yummy - Yummy finally some positive action.
1.2401+0.0901 (+7.8348%)
As of 02:52PM EST. Market open.
Volume 312,266
Avg. Volume 309,441
Smile!
1.2600+0.1500 (+13.5135%)
As of 01:14PM EST. Market open.
Volume 560,076
Avg. Volume 301,411
That's more like it!
The company was also featured in a tipranks article saying it’s a compelling investment due to growing revenue and earnings potential given their recent approval.
That probably is hurting either.
Murocman
Sure seems like market reaction
to the news is somewhat lukewarm.
BioLineRx Announces Acceptance of Two Poster Presentations on APHEXDA® (motixafortide) for CD34+ Hematopoietic Stem Cell (HSC) Mobilization in Patients with Multiple Myeloma at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
https://finance.yahoo.com/news/biolinerx-announces-acceptance-two-poster-120000916.html
Results include pharmacokinetic and pharmacodynamic data, and post-hoc subgroup analyses of the Phase 3 GENESIS trial
Presentations on Thursday, February 22, 2024 in San Antonio, Texas
TEL AVIV, Israel, Feb. 16, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new post-hoc subgroup analyses and pharmacodynamic data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®), taking place February 21-24, 2024, in San Antonio, Texas.
Results include pharmacokinetics (PK) and pharmacodynamics (PD) data as well as post-hoc subgroup analyses from the Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim, compared to placebo plus filgrastim (G-CSF), for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Phase 1 study results demonstrated an extended PD effect with complete receptor occupancy by motixafortide starting at a concentration of 3nM. In the GENESIS trial, post-hoc subgroup analyses based on baseline characteristics and risk factors for impaired HSC mobilization demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients.
Poster Presentations at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the ASTCT and the CIBMTR.
Henry B. González Convention Center, San Antonio, Texas
Poster Session Details
Poster: Number 537. See abstract.
Title: Motixafortide Enables Consistent, Robust Hematopoietic Stem Cell Collection (HSC) across Populations with Increased Impaired HSC Mobilization: A Sub-Group Analysis of the Genesis Study
Presenter: Zachary D. Crees, MD, Washington University School of Medicine in St. Louis
Poster Session: Myeloma - Clinical
Date: Thursday, February 22, 2024
Time: 6:45 PM - 7:45 PM
Poster: Number 535. See abstract.
Title: Prolonged CXCR4 Receptor Occupancy By Motixafortide Following a Single Subcutaneous Injection Is Associated with Extended Mobilization of CD34+ Cells in Peripheral Blood for > 24 Hours
Presenter: Ella Sorani, PhD, BioLineRx Ltd
Poster Session: Myeloma - Clinical
Date: Thursday, February 22, 2024
Time: 6:45 PM - 7:45 PM
About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize = 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize = 6 million CD34+ cells in one apheresis session.
About Multiple Myeloma 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. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.1 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.
About APHEXDA® APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.2
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
APHEXDA is indicated 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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.
WARNINGS AND PRECAUTIONS
Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.
Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.
Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.
Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.
Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.
ADVERSE REACTIONS
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).
USE IN SPECIFIC POPULATIONS
Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.
Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.
Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.
Please see the accompanying full Prescribing Information.
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.
Well raise the flag at least we did not finish in the red today
BarrellofHay
Let's think about your posts. If you had cancer and were in line to die would you be willing to spend more to try to saving your life knowing that the drug that cost more has a better chance than the generic that cost less but does not have as good a chance to keep you alive. Keep in mind the real thing is covered under Medicare. Even if it cost more it is your life at stake.
Anyone know the pricing. Worried about generics regardless of whether its better or not.
Don't speak Yiddish me no understand. Put it into English, please. What do you see as their problem? If it is major it must be reported.
I do not want the PR morons to float out fluff what they could say is as an update things are moving as we expect them to. We expect to have further comments as we move toward our upcoming quarterly report. This is calming by saying nothing the SEC would jump on. I did PR work in my younger years for a company that was on the OTC-BB
As much as i am disappointed it is not
the companys duty to comment on
share price movements.
The company is obliged to inform only
whenever material events occur.
I am troubled by the robust volume:
Volume 947,453
Avg. Volume 315,706
I am so pissed off I could scream. Where are our PR morons to calm this thing down. No fluff just a few sentences to take the blood out of the water? Unless there is a real problem. OH just leave us hanging from a rope around a tree limb!!!!! SHAME ON OUR PR PEOPLE WHO GET PAID TO DO THEIR JOB.
I am at complete loss of words. I have no idea
of the downfall in sp. At first i thought it had to
do with the ongoing war and that foreign investors
hurried to get rid of any Israel stock although
there is a general negative sentiment towards
Israeli stocks in general.
What is going on with this stock? It is getting hammered.
midastouch017
bought back a little over 6000 shares of BLRX today and thought it was a decent price. Now it is dropping more. Any whispers I should know about? Will probably go for another 3 to 6,000 more if it drops more tomorrow. Hope the first patient on the dosage did not die on them.
Looks like we are in a rut at this time. My feelings are we stay here till closer to next quarter report time. They will have to show some sales or the rut will get deeper. My opinion is they will.
Met with the CEO of PASG as the company is a little under 20 miles from my house. He was down to earth and told me his company is looking forward to big things beginning at the end of this year into mid-2025. Pipeline is big but he also said a lot can happen both ways in that amount of time. Their office is in a downtown high-rent area. I bought shares but still have an eye-watching BLRX. Passage Bio Inc. numbers are not good currently but time will tell. It is a wait and see situation with hope on the other end.
midastouch017
I sold out my BLRX last week with a very nice gain. I put a chunk into BCLI as a holding pattern till I get a feeling toward the next quarter on BLRX. I want to see some earnings not another GMDA. I remain bullish on BLRX but I want to see some internal movement in sales.
1.4400-0.0700 (-4.6358%)
As of 02:03PM EST. Market open.
Very disappointing!
Your friend over here worries that the man running our country has no balls. Worse than that his brain is dead but next in line Kamala would be worse as she has no balls either. HA HA!!! but not funny. Her brain is alive but non -functioning. Trump was a panic but at least he kept us out of any wars. I would think killing the deputy chief of Hamas would be a good news point in your country.
Israeli stocks were hammered down due to this news piece:
midastouch017
I bought 5000 shares of CGEN today in 1000 shares at a time to average my price down to $2.02cents per share. I like that they have a lot of irons in the fire and that they are dealing with major Bio companies. BLRX right now is standing in quicksand. At least they are standing and not sinking. NASDAQ got bombed today was not a good start for them or me. Thought after the end-of-year tax loss selloff things would turn around today. Man was I wrong. Did decide not to move on selling anything though. My Israel stocks had better come through for me this year. The volume on BLRX was terrible today I was surprised.
Happy New Year BLRX shareholders. With tax loss selling now over let's hope that we trend upward for a while. If the Israeli market today was any indication we should finish up tomorrow. I have a final buy order in at $1.54 thinking the open should start at a downward movement to deal with some of the leftover trades that did not make the close on Friday. If it does not trend down at the open I will pull my trade. I am really looking forward to an announcement of some early sales numbers as well as some type of indication as to some European movement. Finally, I sure hope that 2024 leads to a more open IR relationship with us the investors in this company. Management does a very POOR JOB in promoting our little company.
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
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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.
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