BioLineRx Ltd (BLRX)

[Fmello]

Where do you think the stockprice will get pushed up to prior to the FDA decision? I've been hearing between $2.10-$4 range. The higher the better imho since positive news will translate at a minimum to an 80-100% jump to the stock price.

[turning stone]

As long as Tuesday is positive who knows where we will go up to on the 8th or 11th.


BEST TO ALL US LONGS

[midastouch017]

Here we go:
Volume 3,273,126
Avg. Volume 501,274

[turning stone]

9/01/2023 Closing 3,264,324. Shares traded Closing $2.02/share breaks yesterday's close.




YIPPE !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!/b]

[turning stone]

We have set another volume record 3,060,000 with 7 minutes still to go before close.

[midastouch017]

Remember, it's not a loss until you sell :)

Right you are! I meant paper loss not actual purse loss!

Keep an eye on this one!

Even better
I keep both my eyes on all 3, PLX-GMDA-BLRX.

[Spideyboy]

Remember, it's not a loss until you sell :)

Regards BLRX, enjoying the run up.

Keep an eye on this one!

[midastouch017]

'

straight common equity investment of $14.6 million in BioLineRx at $2.136 per ADS with no warrants'

Methinks $2.13 is the benchmark (before approval)
After approval (God willing) the sky is the limit!

[midastouch017]

2.1000+0.3500 (+20.0000%)
As of 11:49AM EDT. Market open.
Volume 1,844,012
Avg. Volume 452,565

[midastouch017]

BLRX breaks the 52w/h
with huge volume!
That's great!

[midastouch017]

1.8900+0.1400 (+8.0000%)
As of 09:57AM EDT. Market open.

Volume 583,519
Avg. Volume 452,565

[midastouch017]

Volume 3,034,556
Avg. Volume 410,430

Shorts covering? New investors/traders/tutes
swarming in?

[midastouch017]

I wouldn’t be surprised with an announcement tomorrow or Tuesday.

I concur!

The question is what happens afterwards?

Since BLRX is in sound financial condition, no offering plan
is on the table (Big relief)
New agreements will be announced further strengthening
their financial situation.

I think this will be the better horse to ride in the short term.

Agreed 2

GMDA has indeed been a big disappointment so far!

[midastouch017]

If everything rolls our way with an FDA approval, how much do think the stock price will jump on it's first full day of trading?

Methinks at its HOD, $2.75-3.25

FDA decision

Will be published next week, earlier than Sep 9th (Imo)

[midastouch017]

You back in Blrx then?

Yes, big time! Sep 9th (and most probably somewhat before)
time to recoup losses from GMDA and PLX

Good luck!

[turning stone]

Some of today's numbers from Investors Hub

Up at 4PM Buy Volume 1,529,884
Sell Volume 1,054,035
? Volume 452,551 Have no idea what ? volume is
Total trades 8,422
TODAY WAS THE HIGHEST VOLUME DAY SO FAR THIS YEAR

[murocman]

Looking like a good old fashioned pre PDUFA run up! A rare event these days.

I wouldn’t be surprised with an announcement tomorrow or Tuesday. The question is what happens afterwards?

Gamida has been a disappointment due to their financial overhang and still not a lot of solid data on actual patients being treated.

Am thinking this may pull back a bit after an initial pop. However this also has PDAC data coming which will be another near term catalyst.

Unless Gamida announces a buyout or partnership, I think this will be the better horse to ride in the short term.

Murocman

[Fmello]

If everything rolls our way with an FDA approval, how much do think the stock price will jump on it's first full day of trading?

Also, September 9th falls on a Saturday. Do you think we will get the FDA decision on Friday after the closing bell or on Monday morning before the starting bell?

[turning stone]

Looks like market makers are trying to hold it back by slapping the bid with 100 share trades after it tries to move up again. Just wait for explosion day Sept 9th, 2023. Mark that date down in your memory bank.

[Spideyboy]

Hi Midas, yes I am and happy with the gains recently.

I am thinking we finally start having the speculative PDUFA run up now. Coming in a bit late. Normally this would have started a good month or two ago.

While PDUFA is always a crapshoot, I think the data is very compelling and was well controlled against placebo.

The efficacy data far outperforms plerixafor and the safety appears solid from what we can see.

Given that I think it has a 90+% chance of approval.

You back in Blrx then?

[midastouch017]

Hi Spideyboy,

Do you still have interest in BLRX?

[midastouch017]

1.5690+0.1790 (+12.8777%)
As of 10:45AM EDT. Market open.
Volume 831,623
Avg. Volume 408,161

[midastouch017]

Imo FDA approval will come even sooner!
GLTU

[turning stone]

Can't wait for Sept. 9th MOTHER GOOSE is laying on my GOLDEN EGGS. GMDA----BLRX (more BLRX)

[midastouch017]

BioLineRx Ltd. (BLRX) Q2 2023 Earnings Call Transcript

Aug. 30, 2023 12:58 PM ETBioLineRx Ltd. (BLRX)

BioLineRx Ltd. (NASDAQ:BLRX) Q2 2023 Earnings Conference Call August 30, 2023 7:30 PM ET

Company Participants

John Lacey - Head of Investor Relations and Corporate Communications

Phil Serlin - Chief Executive Officer

Mali Zeevi - Chief Financial Officer

Holly May - Chief Commercial Officer

Conference Call Participants

Joe Pantginis - H.C. Wainwright

John Vandermosten - Zacks

John Lacey

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call, other than historical facts, are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project and other similar expressions are used typically to identify such forward-looking statements.

These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLineRx's business, financial condition and other operating results. These include but are not limited to, the risk factors and other qualifications contained in BioLineRx's annual report on Form 20-F, quarterly reports filed in a 6-K and other reports filed by BioLineRx with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements.

At this time, it is now my pleasure to turn the call over to Phil Serlin, Chief Executive Officer of BioLineRx.

Phil Serlin

Thank you, John, and good morning, everyone. And thank you for joining us on our second quarter 2023 results conference call today. Earlier this morning, 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.

As is our practice, I will begin with an overview, then Mali Zeevi our Chief Financial Officer, will provide a discussion of our financial results. We will then open up the call and are looking-forward to your questions. Also joining the call today for Q&A are Ella Sorani, Chief Development Officer and Holly May, President of BioLineRx USA.

Beginning with our lead program, Motixafortide stem cell mobilization for multiple myeloma patients. We continue to finalize preparations for our upcoming PDUFA target action date of September 9, 2023. If approved, the Motixafortide would formally transition us to a commercial stage company, a very important milestone in our company's history that would open our future to many additional growth opportunities. Based on the strong efficacy data from the GENESIS Phase 3 clinical trial used to support our NDA application, we believe Motixafortide may play a critical role in addressing unmet needs and could introduce a new treatment paradigm for those with multiple myeloma, who require an autologous stem cell transplant.

We believe Motixafortide if approved can provide improved treatment journeys for patients and more certainty for transplant centers, and our commercial team of account directors are actively meeting with payers and reviewing the potential positive benefits of Motixafortide to patients and to the healthcare system. In preparation for anticipated approval, we have assembled a world-class transplant sales team with fast industry experience in general and multiple years of experience with product launches. They also have multiple years of experience specifically in transplant multiple myeloma and rare disease. Their strong backgrounds and knowledge of the U.S. transplant center community has allowed us to continue to sharpen our commercial launch strategy.

We have also substantially advanced supply chain market access and medical affairs activities and are confident that we will be able to launch product soon after potential approval. The U.S. market dynamics for mobilization agents used in stem cell transplants is evolving, but remains strong and growing. We estimate the overall U.S. market potential at around $300 million with about 50% from Autologous stem cell transplant in multiple myeloma. If approved Metixuportide would be the first true advancement in stem cell mobilization in a decade. With the team that we have assembled, I believe we are incredibly well positioned to capture a significant share of the multiple myeloma transplant market over time.

On previous calls, we've discussed partnership conversations relating to ex-U.S. development and commercialization Metixuportide and this morning, we were excited to announce the signing of an exclusive license agreement to Metixuportide in Asia alongside a concurrent equity investment. The license agreement includes a $15 million upfront payment plus up to approximately $50 million based on the achievement of specific development and regulatory milestones in China and Japan and up to nearly $200 million in commercial milestones based on defined sales targets.

We are also eligible to receive tiered double-digit royalties on sales. Closing of the transactions is contingent among other things upon approval by the Israeli Innovation Authority of the license agreement within four months of execution, as well as other closing conditions, none of which are related to FDA approval. The agreements were published this morning as part of a separate 6-K.

In the area of pancreatic cancer, which is our second major development program for Metixuportide, our clinical program partnerships with Columbia University, and now for the new strategic partnership in Asia announced today, offer the potential to add meaningful and determinative patient data on top of the positive results we've seen in our earlier clinical development trials.

As a reminder, our Phase 2a combat COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide, KEYTRUDA and chemotherapy as a second-line therapy demonstrated substantial improvements across all study endpoints relative to historical data, including overall survival, progression free survival, and overall response rate in the most challenging PDAC patients, all diagnosed with unresectable Stage 4 disease. The combination also appeared to be well tolerated with low incidence of neutropenia and infections in treated patients.

As part of our agreement announced this morning, the execution of a randomized Phase 2/3 clinical trial in China is envisioned that will evaluate Motixafortide in combination with a PD-1inhibitor and standard-of-care chemotherapy in first-line metastatic pancreatic cancer. There is significant unmet need in China in the treatment of pancreatic cancer, and we believe there will be strong physician and patient interest in this clinical evaluation.

Additionally, we announced in mid-July the initiation of a randomized investigator initiated Phase 2 clinical trial, sponsored by Columbia University and jointly funded by Regeneron and BioLineRx in first-line metastatic pancreatic cancer based on promising data from single arm pilot phase. The original pilot study enrolled 10 patients and was to be expanded to 30 patients if data from the first 10 were encouraging, which was defined as three or more patients showing partial responses per resist criteria.

Following a review of the initial data, the investigators decided to skip the 30 patient single arm expansion and instead move to a larger randomized design. The amended randomized trial includes 102 patients, and compares the combination of Metixuportide to PD-1 inhibitor cemiplimab and standard-of-care chemotherapy to chemotherapy alone. We anticipate sharing data from the pilot phase at a medical conference in the second-half of this year.

We believe the additional data developed from these new partnerships could support larger registrational trial opportunities globally. Needless to say, we are excited about the potential of Metixuportide to form the back mode of new PDAC treatment regimens and give new hope to patients suffering from this very difficult to treat tumor type, while demonstrating the versatility of Metixuportide across both hematological and solid tumor cancers.

In parallel with our development work in stem cell mobilization in PDAC, we believe there are additional therapeutic areas where the demonstrated benefits of Metixuportide can be leveraged. One of these is autologous hematopoietic stem cell based gene therapy for patients suffering from sickle cell disease or SCD, one of the most common genetic diseases globally. To that end, in March, we announced a clinical trial collaboration with Washington University School of Medicine to evaluate Metixuportide in this indication. Unlike multiple myeloma patients, the current standard-of-care mobilization agent GCSF carries significant risks and potential side effects for patients suffering from SCD.

Furthermore, in many cases, current mobilization treatments failed to reliably yield optimal numbers of stem cells to facilitate gene therapy. As such this patient population is in urgent need of a new more effective mobilization regimen. Through this collaboration, we plan to conduct a proof-of-concept trial that will study Metixuportide as both a single agent and in combination with the immunomodulator natalizumab. The study will assess the safety and tolerability of the two regimens as mobilization agents of CD34 positive hematopoietic stem cells in patients with SCD and is anticipated to begin enrollment by the end of this year.

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, we will only go over a few significant items on this call, research and development 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.

Before we get into our review of the quarter, let me remind everyone that this morning's strategic partnership announcement, described in a separate 6-K, included a $15 million non-dilutive upfront payment related to the license agreement, as well as $14.6 million straight common equity investment. The transaction is subject to formal approval of the license agreement by the Israeli Innovation Authority as well as other closing conditions.

Now to the quarter. Research and development expenses for the three months ended June 30, 2023, were $3 million, a decrease of $2.4 million or 44.3%, compared to $5.4 million for the three months ended June 30, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities related to Motixafortide, as well as lower expenses associated with the completed AGI-134 clinical trial.

Let me now turn to net loss. Net loss for the three months ended June 30, 2023, was $18.5 million, compared to $7.4 million for the three months ended June 30, 2022. The company's net loss for the six months ended June 30, 2023, amounted to $30.7 million, compared to $12.4 million for the six months ended June 30, 2022.

The increase in net loss for both the three and the six months ended June 30, 2023, was due primarily to a non-operating expense of approximately $7.8 million and $10.8 million, respectively, related to the revaluation of outstanding warrants, resulting from an increase in the company's share price over the preceding three and six months. The company emphasized that this expense did not impact its cash position as of June 30, 2023, nor its projected cash runway.

Now turning to cash. The company held $32.8 million of cash, cash equivalents and short-term bank deposits as of June 30, 2023. Again, this does not include the roughly $30 million in funding from this morning's strategic partnership announcement nor does it include $30 million available to us under our debt agreement with Kreos Capital, which is tied to the payment of certain milestones. We believe we are well positioned to execute on our operating plans.

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.

First, potential FDA approval of APHEXDA in September 2023. Next, potential U.S. launch of APHEXDA in stem cell mobilization shortly after approval. Initiation of a clinical trial in collaboration with Washington University School of Medicine, to evaluate Metixaportide as monotherapy and in combination with natalizumab for CD34-positive hematopoietic stem cell mobilization for gene therapies in sickle cell disease in the second-half of this year.

Initial cohort data from the ongoing Columbia University investigator-initiated study, evaluating Motixafortide in combination with the PD-1 inhibitor LIBTAYO or cemiplimab and standard-of-care chemotherapy in first-line metastatic PDAC patients.

With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

Question-and-Answer Session

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. Wainwright. Please go ahead.

Joe Pantginis

Hi, everybody. Good morning and good afternoon. And congratulations on the licensing agreement. Nice to see this external validation. So first, Phil, let me turn first to the upcoming PDUFA date. We all hope it's going to be positive, obviously. Anything you can share from now about the launch logistics or trajectory regarding how soon do you think you'd be able to launch the drug if it is approved and any sort of rate-limiting catalyst that we need to consider?

Phil Serlin

Yes. So first of all, thanks very much. It's great speaking to you. I'm going to turn that question over to Holly. Holly, can you take that, please?

Holly May

I would love to take that. So if approved by the FDA, we are ready to enter the market very quickly. So we have all of our supply and distribution setup. We have agreements with the major specialty distributors. We have for the last several months in -- a couple of months been out making connections with customers and all stakeholders from the payor level to institutional pharmacists to physicians, nurses, et cetera, and making relationships to build relationships. Not quite yet talking down effect, because obviously, we need approval and label, but we have been building very strong relationships and from a supply and distribution perspective, we are absolutely 100% ready to go. And our intention is to enter the market as quickly as we possibly can. Did that answer your question? Or was there a second part?

Joe Pantginis

Holly, it certainly did. Thank you very much for that. So I'd like to focus now on the Asian partnership and maybe some of the logistics around that. So I guess first, and I apologize, I've only gotten through the high level of the 6-K. So I apologize if it's in there. What is required or time lines for tech transfer and other factors around this agreement? And then also, I know there's multiple territories considered here, do you have an indication that these territories would accept the FDA approval? Or could there be a particular geographical requirements for, say, a small bridging or confirmatory study? Thank you.

Phil Serlin

Yes. So I'll take the second part, and I think that Ella, please help me if I'm -- if I misspeak in any way. So there are a number of countries in Asia that will rely to a great extent on the FDA approval. And so that the pathway in some of those countries, I'm just throwing out potentially countries like Singapore or perhaps Hong Kong and some other countries, other territories might -- it might be much easier to get approval even without a bridging study.

On the other hand, there are some countries, and we expect that to be the case in China and perhaps Japan and some of the bigger markets that will probably require some kind of bridging study in order to receive approval. And our partners are planning a development and commercialization plan in stem cell mobilization that will be tailor made for the particular countries that we're talking about.

As far as what will be required for a tech transfer, as we mentioned, there are a number of smallish closing conditions that we have to meet, including the Israeli Innovation Authority approval. The 6-K has some additional information regarding it. We need to appoint a director. They're going to have a representative on our Board of Directors and some other smaller closing conditions. Once the closing is complete, and I hope that, that will be done sometime in the next three to four weeks, hopefully, by the end of Q3, then we will set about -- we already have a draft commercial -- I'm sorry, development plan for pancreatic cancer, for example, as part of the agreement, and that -- we will start to execute on that and provide whatever technology transfer we need, and they will start to put together the necessary regulatory submissions et cetera in order to move forward in the development plan.

Joe Pantginis

That's very helpful. And then one last, if you don't mind. In fact, I'm going to quote some of your prepared comments where you say as is customary. So as is customary, I'm going to ask the question I ask all the time. So can you provide any guidance or body language as to the maturity of discussions in other territories?

Phil Serlin

Body language, you're very funny. I will just say, as I've said before, we are laser focused on the U.S. right now. We are -- obviously, we brought a deal right now in Asia. And so I can't say that we're not speaking to other parties as well. And we are obviously interested in maximizing the value of Motixafortide throughout the world. So we are continuing to discuss in other territories. But our focus right now is on the launch and on the approval. And we're only talking right now a PDUFA date of less than 10 days away.

So right now, I think that we've got a lot on our plate right now between the tech transfer that's necessary for the Asian market and the launch in the U.S. I think that once we successfully reach those objectives, we will start to turn to other territories as well on a more intensive basis.

Joe Pantginis

Absolutely. I really appreciate all the color, Phil and good luck coming into the PDUFA.

Phil Serlin

Thank you very much.

Operator

The next question is from John Vandermosten of Zacks. Please go ahead.

John Vandermosten

Thank you and hello, everyone. Let me to start with a question on the kind of continuum in the partnership in Asia. I know there were two entities there, and I just want to look the relationship between those and how that might help with the development and commercialization?

Phil Serlin

Yes. So the -- there is no direct relationship. At this point, we -- the primary development partner is Gloria Biosciences and the investor group so to speak, is a company called Hang Seng Technology. They're not affiliated at this time.

John Vandermosten

Okay. And what experience do these guys have in terms of commercial -- commercializing already in the region, do they have a lot of other products under their belt and how have they've done with that? Do they have a good process that they've put into place for that?

Phil Serlin

Yes. So Gloria Biosciences actually has an approved PD-1 in China. And they have received approval in two indications. And I believe that they have launched that product. I don't know on the top of my head what their revenues are right now. But like I said, they do have an approved PD-1 in China that has been launched already. I will also point out just parenthetically that the PD-1 that -- their PD-1 in China they have greater China rights for that.

And the rest of world rights are held by Arcus Biosciences and Gilead Sciences, who are running a number of studies global and otherwise, with the PD-1 is called ZIM in -- for the rest of the world. So this is -- actually, their PD-1 is quite robust, and there's a very significant development plan, both in China and globally for this PD-1.

John Vandermosten

Okay. So they might use a local PD-1 as a combination rather than another one?

Phil Serlin

Yes, they're going to use their approved PD-1, correct for the combination in pancreatic cancer, correct.

John Vandermosten

Okay. And congratulations on the partnership and the upfront investment. So obviously, that's almost $30 million there. Does that help you avoid having to take on any other tranches in the Kreos Capital? Or do you think you will still need that? And I guess this is also a question on just the expected cash burn to be over the next quarter?

Phil Serlin

Yes. So that's a good question. I mean we -- obviously, this is a very significant strengthening of our balance sheet. It provides us on a pro forma basis with over $60 million in cash and puts us in a really good position to continue to execute on our launch and on the rest of our programs without having any significant stress. We have a lot of optionality, I'd have to say, between what we have on our balance sheet and the Kreos Capital loan. And so we feel very comfortable right now going into launch whether we have -- we really do have plenty of capital to go forward. We haven't given the guidance right now because we have -- this is so new. We haven't had a chance to update our forecast. But I believe that this will give us adequate capital way past launch and into the latter half of 2024, if not beyond.

Our current burn rate, I think you asked, is somewhere in the $7.5 million to $10 million per quarter depending right now, we're in launch mode. We're in prelaunch mode and there is a lot of very heavy lifting that has to be done. I think it would probably settle out to closer to the $7 million to $8 million range going forward once we've completed all the heavy lifting in connection with the launch.

John Vandermosten

Okay, great. Thank you, Phil.

Phil Serlin

No problem.

Operator

There are no further questions at this time. 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 two hours after the conference. In the U.S. please call 1 [phone]. In Israel, please call [phone]. 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 preparing for the potential U.S. approval of our first therapy in stem cell mobilization and we are ready for commercial launch. We have worked to strengthen our balance sheet through the strategic relationship announced today, made significant advancements in our pancreatic development program and further positioned Motixafortide for development in Asia for stem cell mobilization indications.

We have also taken important additional life cycle management steps by entering into a collaboration to execute a clinical trial with the Motixafortide as a mobilization agent in gene therapies. I'm extremely pleased with our progress during the second quarter, and I'm excited about what we are in the process of achieving this year.

I want to thank you all very much for your continued interest in BioLineRx. Be safe, and have a great day.

Operator

Thank you. This concludes the BioLineRx Investor Relations Call. Thank you for your participation. You may go ahead and disconnect.

[midastouch017]

BioLineRx Reports Significant Decrease in Losses and Promising Financial Stability

https://beststocks.com/biolinerx-reports-significant-decrease-in-los/

Yasmim Mendonça by Yasmim Mendonça August 30, 2023 in News Reading Time: 3 mins read

BioLineRx (NASDAQ:BLRX) recently announced its financial results for the second quarter of 2022, revealing a significant decrease in losses compared to the same period last year. The company reported a quarterly loss of $(0.30) per ADS, marking a 1400% decrease from the $(0.02) per ADS loss reported in the previous year. This improvement is undoubtedly a positive sign for BioLineRx.

Looking at the company’s net loss for the six months ended June 30, 2022, we can see a noteworthy reduction. The net loss amounted to $12.4 million, a considerable improvement compared to the net loss of $17.0 million for the same period in the previous year. This indicates that BioLineRx has been successful in managing its expenses and narrowing its losses.

In terms of financial stability, BioLineRx seems to be in a favorable position. The company currently holds $32.8 million in cash and equivalents. With this amount, BioLineRx is projected to have sufficient funds to sustain its operations until the first half of 2024. This financial stability provides a promising outlook for the company’s future endeavors.

It’s worth mentioning that BioLineRx also released its first-quarter 2023 financial results, but they are not directly relevant to the question at hand. However, these results might offer additional insights into the company’s performance and growth trajectory.

Overall, BioLineRx’s financial results for the second quarter of 2022 showcase a significant improvement in reducing losses compared to the previous year. With a solid cash position and promising financial stability, the company appears to be on the right track towards achieving its goals.

[midastouch017]

Here are the specific regulatory milestones for HST.

Item 6.2 of the agreement.

https://www.sec.gov/Archives/edgar/data/1498403/000117891323003014/exhibit_10-1.htm

12 total regulatory milestones. The specific milestone amounts are redacted, but we know from the PR that the cumulative amount if all 12 milestones are reached is $49m.

Basically broken down into trials/approvals in China and Japan fro 3 separate indications.

6.2.1 - 6.2.4: For IND and regulatory approval in SCM in China & Japan

6.2.5-6.2.8: For IND & regulatory approval in solid tumor/PDAC in China & Japan

6.2.9-6.2.12: For IND & regulatory approval in 1st orphan hematologic indication in China & Japan

[midastouch017]

Signed exclusive license agreement to develop and commercialize motixafortide in Asia with concurrent equity investment; license agreement includes $15 million upfront payment, plus potential development, regulatory and sales milestones, and tiered double-digit royalties, as well as various development obligations for the licensee, including the planned initiation in China of a registrational study in stem-cell mobilization and a randomized Phase 2/3 study in first-line pancreatic cancer; straight common equity investment of $14.6 million in BioLineRx at $2.136 per ADS with no warrants; effectiveness and closing of transactions is contingent upon approval by Israeli Innovation Authority of license agreement within four months of execution, and other closing conditions

Now, isn't this item interesting?

[midastouch017]

BioLineRx GAAP EPS of -$0.02

Aug. 30, 2023 7:02 AM ETBioLineRx Ltd. (BLRX)

By: Deepa Sarvaiya, SA News Editor

BioLineRx press release (NASDAQ:BLRX): Q2 GAAP EPS of -$0.02.
As of June 30, 2023, the Company held cash, cash equivalents, and short-term bank
deposits of $32.8 million and anticipates this will be sufficient to fund operations, as
currently planned, into the first half of 2024.

[midastouch017]

BioLineRx Reports Second Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

https://finance.yahoo.com/news/biolinerx-reports-second-quarter-2023-110000116.html

- On Track for September 9, 2023 PDUFA Target Action Date on NDA for Motixafortide in Stem Cell Mobilization (SCM) for Autologous Transplantation in Multiple Myeloma (MM) -

- Signed Exclusive License Agreement to Motixafortide in Asia Region with Concurrent Equity Investment -

- Announced Initiation of Investigator-Initiated Randomized Phase 2 Combination Trial with Motixafortide in First Line PDAC in Collaboration with Columbia University -

- Management to host conference call today, August 30, at 10:00 am EDT -

TEL AVIV, Israel, Aug. 30, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, today reported its unaudited financial results for the second quarter ended June 30, 2023, and provided corporate and portfolio updates.

"We had a very productive second quarter across all areas of the company, including our focused pre-launch preparation activities tied to the potential U.S. approval of motixafortide in the next few weeks, as well as the formation of a new strategic partnership, announced today, to develop and commercialize motixafortide in Asia," said Philip Serlin, Chief Executive Officer of BioLineRx. "The partnership, which is subject to certain closing conditions, provides a pathway forward to pursue potential indications for motixafortide in stem cell mobilization and pancreatic cancer in Asia, as well as a source of substantial funding to the company.

Additionally, we advanced our second major development program for motixafortide in pancreatic cancer through the initiation of a randomized Phase 2 clinical trial with Columbia University in first line metastatic pancreatic cancer based on promising data from a single-arm pilot phase.

"Finally, our clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress, and we anticipate clinical trial initiation this year. I am extremely pleased with our progress to date and look forward to a fruitful second half of the year, including our potential transition to a commercial stage company," Mr. Serlin concluded.

Corporate Updates

On track for September 9, 2023 PDUFA target action date on NDA for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma

Signed exclusive license agreement to develop and commercialize motixafortide in Asia with concurrent equity investment; license agreement includes $15 million upfront payment, plus potential development, regulatory and sales milestones, and tiered double-digit royalties, as well as various development obligations for the licensee, including the planned initiation in China of a registrational study in stem-cell mobilization and a randomized Phase 2/3 study in first-line pancreatic cancer; straight common equity investment of $14.6 million in BioLineRx at $2.136 per ADS with no warrants; effectiveness and closing of transactions is contingent upon approval by Israeli Innovation Authority of license agreement within four months of execution, and other closing conditions

Clinical Portfolio Updates

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Announced publication in Nature Medicine of GENESIS Phase 3 clinical trial data evaluating motixafortide and G-CSF in stem cell mobilization for autologous transplantation in multiple myeloma

Pancreatic Ductal Adenocarcinoma

Announced initiation of randomized, investigator-initiated Phase 2 clinical trial in collaboration with Columbia University, with joint funding of the study by Regeneron and BioLineRx, assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with mPDAC. Anticipate initial patient data in 2023. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June

Sickle Cell Disease & Gene Therapy

Continued to advance plans for a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate trial initiation later this year

AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Evaluating next development pathways for AGI-134 program in consultation with scientific advisory board. Results from Phase 1/2a first-in-human, single-agent study announced in Q4 2022. Study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers

Second Quarter 2023 Financial Results

Research and development expenses for the three months ended June 30, 2023 were $3.0 million, a decrease of $2.4 million, or 44.3%, compared to $5.4 million for the three months ended June 30, 2022. The decrease resulted primarily from lower expenses related to 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 June 30, 2023 were $5.6 million, an increase of $4.4 million, or 383.9% compared to $1.2 million for the three months ended June 30, 2022. The increase resulted primarily from the ramp-up of pre-launch activities related to motixafortide

General and administrative expenses for the three months ended June 30, 2023 were $1.3 million, an increase of $0.3 million, or 24.4% compared to $1.0 million for the three months ended June 30, 2022. The increase resulted primarily from an increase in payroll and related expenses due to a small increase in headcount and share-based compensation, as well as small increases in a number of G&A expenses

Net loss for the three months ended June 30, 2023 was $18.5 million, compared to $7.4 million for the three months ended June 30, 2022. The Company's net loss for the six months ended June 30, 2023 amounted to $30.7 million, compared to $12.4 million for the six months ended June 30, 2022. The increases in net loss for both the three and six months ended June 30, 2023 were due primarily to a non-operating expense of approximately $7.8 million and $10.8 million respectively, related to the revaluation of outstanding warrants resulting from an increase in the Company's share price over the preceding three and six months

As of June 30, 2023, the Company held cash, cash equivalents, and short-term bank deposits of $32.8 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024. This amount does not include $29.6 million in total funding from the exclusive license agreement and equity investment announced today, which the Company anticipates closing in Q3 subject to formal transaction approval by the Israeli Innovation Authority and other closing conditions

Conference Call and Webcast Information

To access the conference call, please dial [phone] from the U.S. or [phone] 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 September 1, 2023; please dial [phone] from the US or [phone] internationally.

About BioLineRx

BioLineRx Ltd. is a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases. The company is advancing a pipeline of investigational medicines for patients with multiple myeloma, sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., BioLineRx 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.

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, our planned and ongoing clinical trials, the plans and objectives of management for future operations, regulatory filings submitted to the FDA (including potential timing of the FDA's review of the NDA for motixafortide), commercial potential of motixafortide, expectations regarding the announced license agreement, statements relating to the private placement, including, as to the consummation of the private placement and license agreement, and our financial condition and results of operations. 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; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals, including BioLineRx's ability to secure adequate and viable pricing and reimbursement coverage of any marketed product; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate and academic collaborations and licensees, including the collaboration contemplated in the license; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation or characterization 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; risks related to changes in healthcare laws, rules and regulations in the United States, Asia, or elsewhere; competitive companies, technologies and BioLineRx's industry, including generic entrants; risks related to unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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
[e-mail]

Israel
Moran Meir
LifeSci Advisors, LLC
[e-mail]





BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)









December 31,

June 30,



2022

2023



in USD thousands

Assets





CURRENT ASSETS





Cash and cash equivalents

10,587

10,104

Short-term bank deposits

40,495

22,711

Prepaid expenses

198

1,749

Other receivables

721

128

Total current assets

52,001

34,692







NON-CURRENT ASSETS





Property and equipment, net

726

648

Right-of-use assets, net

1,772

1,583

Intangible assets, net

21,885

22,013

Total non-current assets

24,383

24,244

Total assets

76,384

58,936







Liabilities and equity





CURRENT LIABILITIES





Current maturities of long-term loan

1,542

3,078

Accounts payable and accruals:





Trade

6,966

6,733

Other

1,744

2,260

Current maturities of lease liabilities

427

375

Total current liabilities

10,679

12,446

NON-CURRENT LIABILITIES





Warrants

4,509

15,352

Long-term loan, net of current maturities

8,626

8,495

Lease liabilities

1,729

1,589

Total non-current liabilities

14,864

25,436







Total liabilities

25,543

37,882







EQUITY





Ordinary shares

27,100

27,100

Share premium

338,976

339,045

Warrants

1,408

1,408

Capital reserve

14,765

15,616

Other comprehensive loss

(1,416)

(1,416)

Accumulated deficit

(329,992)

(360,699)

Total equity

50,841

21,054

Total liabilities and equity

76,384

58,936





BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)





Three months ended June 30,

Six months ended June 30,



2022

2023

2022

2023



in USD thousands

in USD thousands

RESEARCH AND DEVELOPMENT EXPENSES

(5,395)

(3,006)

(9,830)

(6,690)

SALES AND MARKETING EXPENSES

(1,158)

(5,604)

(1,795)

(9,478)

GENERAL AND ADMINISTRATIVE EXPENSES

(1,049)

(1,305)

(2,056)

(2,603)

OPERATING LOSS

(7,602)

(9,915)

(13,681)

(18,771)

NON-OPERATING INCOME (EXPENSES), NET

458

(7,733)

1,726

(10,649)

FINANCIAL INCOME

80

440

147

977

FINANCIAL EXPENSES

(379)

(1,337)

(565)

(2,264)

NET LOSS AND COMPREHENSIVE LOSS

(7,443)

(18,545)

(12,373)

(30,707)













in USD

in USD

LOSS PER ORDINARY SHARE - BASIC AND DILUTED

(0.01)

(0.02)

(0.02)

(0.03)











WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE

715,365,554

922,958,942

715,260,781

922,958,942



























CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)







Ordinary



Share





Capital

Other

comprehensive



Accumulated





shares

premium

Warrants

reserve

loss

deficit

Total



in USD thousands

BALANCE AT JANUARY 1, 2022

21,066

339,346

975

13,157

(1,416)

(305,041)

68,087

CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2022:















Issuance of share capital, net

89

177

-

-

-

-

266

Employee stock options exercised

2

12

-

(12)

-

-

2

Employee stock options expired

-

135

-

(135)

-

-

-

Share-based compensation

-

-

-

586

-

-

586

Comprehensive loss for the period

-

-

-

-

-

(12,373)

(12,373)

BALANCE AT JUNE 30, 2022

21,157

339,670

975

13,596

(1,416)

(317,414)

56,568





















Ordinary



Share





Capital

Other

comprehensive



Accumulated





shares

premium

Warrants

reserve

loss

deficit

Total



in USD thousands

BALANCE AT JANUARY 1, 2023

27,100

338,976

1,408

14,765

(1,416)

(329,992)

50,841

CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2023:















Employee stock options expired

-

69

-

(69)

-

-

-

Share-based compensation

-

-

-

920

-

-

920

Comprehensive loss for the period

-

-

-

-

-

(30,707)

(30,707)

BALANCE AT JUNE 30, 2023

27,100

339,045

1,408

15,616

(1,416)

(360,699)

21,054





















BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)







Six months ended June 30,



2022

2023



in USD thousands







CASH FLOWS - OPERATING ACTIVITIES





Net loss for the period

(12,373)

(30,707)

Adjustments required to reflect net cash used in operating activities
(see appendix below)

498

13,009

Net cash used in operating activities

(11,875)

(17,698)







CASH FLOWS – INVESTING ACTIVITIES





Investments in short-term deposits

(9,000)

(6,006)

Maturities of short-term deposits

24,141

24,000

Purchase of property and equipment

(62)

(99)

Purchase of intangible assets

-

(153)

Net cash provided by investing activities

15,079

17,742







CASH FLOWS – FINANCING ACTIVITIES





Issuance of share capital and warrants, net of issuance costs

266

-

Employee stock options exercised

2

-

Repayments of loan

(1,812)

-

Repayments of lease liabilities

(88)

(183)

Net cash used in financing activities

(1,632)

(183)







INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

1,572

(139)

CASH AND CASH EQUIVALENTS - BEGINNING

OF PERIOD

12,990

10,587

EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

(562)

(344)

CASH AND CASH EQUIVALENTS - END OF PERIOD

14,000

10,104











BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)







Six months ended June 30,



2022

2023



in USD thousands













Adjustments required to reflect net cash used in operating activities:





Income and expenses not involving cash flows:





Depreciation and amortization

314

457

Exchange differences on cash and cash equivalents

562

344

Fair value adjustments of warrants

(1,673)

10,843

Share-based compensation

586

920

Interest and exchange differences on short-term deposits

(142)

(210)

Interest on loan

68

1,405

Exchange differences on lease liability

(205)

(75)



(490)

13,684







Changes in operating asset and liability items:





Increase in prepaid expenses and other receivables

(688)

(958)

Increase in accounts payable and accruals

1,676

283



988

(675)



498

13,009













Supplemental information on interest received in cash

146

761







Supplemental information on interest paid in cash

217

640







Supplemental information on non-cash transactions:





Acquisition of right-of-use asset

-

66



















Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2023-financial-results-and-recent-corporate-and-portfolio-updates-301913045.html

SOURCE BioLineRx Ltd

[midastouch017]

Interesting day tomorrow!
Imho

[midastouch017]

These data suggest that Aphexda has the potential to “become the standard
of care in the multiple myeloma transplant setting,”

Time will tell!

[midastouch017]

BioLineRx Proposes Aphexda for Stem Cell Mobilization

https://www.biospace.com/article/fda-action-alert-bms-outlook-and-biolinerx/

Next week, on or before Sept. 9, the FDA will decide on BioLineRx’s NDA proposing Aphexda (motixafortide) as a stem cell mobilization agent for patients with multiple myeloma scheduled for autologous stem cell transplantation (ASCT).

In multiple myeloma, as in many other blood cancers, ASCT is part of the standard treatment regimen, often used alongside high-dose chemotherapy.

To eliminate the cancer cells from the body, patients with multiple myeloma are exposed to systemic aggressive treatments, including chemotherapy and whole-body radiation therapy. However, these also often end up damaging healthy stem cells. ASCT replenishes these cells and helps the body make healthy blood cells.

Before stem cells can be harvested from the body, they must first be mobilized, a process by which the stem cells are drawn into the bloodstream from the bone marrow. This is usually achieved through chemotherapy itself or with the use of colony stimulating factors (CSF).

In its NDA, BioLineRx presented data from the Phase III GENESIS trial, which assessed the effect of adding Aphexda to granulocyte-CSF on stem cell mobilization. Just one round of add-on Aphexda in a single apheresis session mobilized the optimal number of stem cells in around 90% of patients, who were then able to proceed directly to transplantation. In comparison, only 10% of patients who received granulocyte-CSF with placebo reached a similar level of stem cell mobilization.

These data suggest that Aphexda has the potential to “become the standard of care in the multiple myeloma transplant setting,” BioLineRx CEO Philip Serlin said in a statement announcing the NDA’s acceptance.

[midastouch017]

BioLineRx to Report Second Quarter 2023 Results on August 30, 2023

https://finance.yahoo.com/news/biolinerx-report-second-quarter-2023-110000645.html

- Management to Hold Conference Call at 10:00 a.m. EDT -

TEL AVIV, Israel, Aug. 22, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, announced today it will release its unaudited financial results for the quarter ended June 30, 2023 on Wednesday, August 30, 2023, before the U.S. markets open.

The Company will host a conference call at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.

To access the conference call, please dial [phone] from the U.S. or [phone] 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 September 1, 2023; please dial [phone] from the US or [phone] internationally.

[AGORDON]

plerixafor is going off patent... will aphexda have to compete direct with generics?

[midastouch017]

My gut feeling says FDA approval will
be granted much earlier than Sep 9th.

[INFINITI]

BioLineRx Ltd.
(BLRX) APHEXDA (NDA) 09/09/2023
FDA decision on proposed use of APHEXDA in stem cell mobilization for autologous transplantation in multiple myeloma patients

[midastouch017]

Form 6-K

Further to its Current Report on Form 6-K dated June 23, 2023, the registrant announces the following results of its Annual General Meeting of Shareholders (the “Meeting”) which was held on August 7, 2023, at 3:00 p.m. (Israel time):

In respect of Proposal 1 – The required majority of shareholders who participated in the Meeting voted in favor of the re-election of the following persons to the Board of Directors, each to serve for staggered terms ending at the annual general meetings of shareholders in accordance with their class: Aharon Schwartz, Michael Anghel, B.J. Bormann, Raphael Hofstein and Sandra Panem.

In respect of Proposal 2 – The proposal regarding the equity compensation of Philip Serlin, the Company’s Chief Executive Officer, was not approved by the shareholders.

In respect of Proposal 3 – The required majority of shareholders who participated in the Meeting voted to approve certain amendments to the Company’s Articles of Association relating to the appointment of directors of the Company, including to classify the Board of Directors (other than the external directors) into three classes with staggered three-year terms.

In respect of Proposal 4 – The required majority of shareholders who participated in the Meeting voted in favor of the appointment of Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited, as the Company’s independent registered public accounting firm for the year ending December 31, 2023 and authorizing the Audit Committee of the Board of Directors to fix the compensation of said auditors in accordance with the scope and nature of their services.

This Form 6-K is hereby incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933.

[Fmello]

...we are very encouraged by the results seen in the initial pilot phase of the study in patients receiving first line treatment.

Does anyone know the details of the results using Motixafortide?

[midastouch017]

BioLineRx Announces Initiation of Randomized Phase 2 Clinical Trial in First Line Metastatic Pancreatic Cancer Based on Preliminary Data from Single-Arm Pilot Phase; Combination Trial Includes Investigational Candidate Motixafortide

https://finance.yahoo.com/news/biolinerx-announces-initiation-randomized-phase-110000675.html


TEL AVIV, Israel, July 17, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, today announced the initiation of a randomized, investigator-initiated Phase 2 clinical trial in first line metastatic pancreatic cancer based on preliminary data from the single-arm pilot phase. The combination drug trial includes the investigational candidate motixafortide. Sponsored by Columbia University, the amended study will modify a single-arm trial whose original design called for expansion to an additional 30 patients if data from a pilot phase of 10 patients was encouraging (defined as ≥3 patients with partial response by RECIST criteria). The amended randomized study will compare combination treatment with the Company's CXCR4 inhibitor (motixafortide), a PD-1 inhibitor (cemiplimab), and chemotherapy (gemcitabine, nab-paclitaxel) to chemotherapy alone in a larger number of patients (n= 102).

A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

"Metastatic pancreatic cancer is a uniformly fatal disease for which current treatments result in limited benefits," said Tami Rachmilewitz, MD, Chief Medical Officer at BioLineRx. "Unfortunately, newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways. Combining checkpoint inhibitors, chemotherapy, and a CXCR4 inhibitor has shown promise in earlier preclinical and clinical studies, including an earlier single arm study using motixafortide as the CXCR4 inhibitor (COMBAT/KEYNOTE-202) in patients receiving second line treatment for pancreatic cancer, and we are very encouraged by the results seen in the initial pilot phase of the study in patients receiving first line treatment. We look forward to continuing the clinical research of this treatment regimen in this randomized trial."

"Working with our collaborators, we are excited to be advancing the clinical development of motixafortide in pancreatic cancer and look forward to the presentation of data from the pilot phase of the randomized trial later this year," said Philip Serlin, Chief Executive Officer of BioLineRx. "This is an important area of growth for the company, alongside the potential approval and U.S. commercialization of motixafortide this year in stem cell mobilization for autologous transplantation in multiple myeloma."

Data from the pilot stage of the Phase 2 study is planned for submission to a congress later this year. The primary endpoint of the randomized trial is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.

The U.S. Food and Drug Administration has accepted the company's New Drug Application for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma and assigned the NDA a PDUFA date of September 9, 2023.

About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,050 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 495,773 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of people who are diagnosed after the cancer has spread to a distant part of the body, the 5-year relative survival rate is 3%. These data highlight the need for the development of new therapeutic options.

About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.

[midastouch017]

BioLineRx: PDUFA Catalyst And PDAC Advancement Make This Worth A Look

Jul. 10, 2023 7:36 PM ETBioLineRx Ltd. (BLRX)IPSEF, IPSEY1 Comment

Terry Chrisomalis

Summary

A PDUFA date of September 9, 2023 has been established for review of Motixafortide for Autologous Transplantation in Multiple Myeloma.
Results from a phase 2 Columbia University investigator study, using Motixafortide in combination with LIBTAYO + SOC chemotherapy for first-line metastatic PDAC patients, are expected to be released in 2023.

Initiation of a phase 2b study partnered with Genfleet, using Motixafortide + PD-1 inhibitor + SOC chemotherapy for first-line metastatic PDAC patients, is expected in 2023.

It is expected that the global pancreatic cancer market size will reach $7.4 billion by 2032; Potential competitor might be Ipsen Pharmaceuticals with Onivyde as an FDA PDUFA date of February 13, 2024 has been established for review of its drug.

BioLineRX Ltd. (NASDAQ:BLRX) is a good speculative biotech play to look into. The reason why I say that is because it has a few catalysts which are expected to take place before the end of 2023. The first catalyst to look forward to would be an established Prescription Drug User Fee Act [PDUFA] date of September 9, 2023. That is when the FDA will decide upon whether or not it should approve the drug Motixafortide in Stem Cell Mobilization [SCM] for Autologous Transplantation in Multiple Myeloma [MM]. The phase 3 study, known as GENESIS, was successful in showing that Motixafortide and G-CSF was successful for autologous transplantation in multiple myeloma [MM]. This isn't the only catalyst that investors have to look forward to. There are going to be two other big catalysts relating to the advancement of this drug for the treatment of patients with pancreatic cancer.BioLineRX Ltd. (NASDAQ:BLRX) is a good speculative biotech play to look into. The reason why I say that is because it has a few catalysts which are expected to take place before the end of 2023. The first catalyst to look forward to would be an established Prescription Drug User Fee Act [PDUFA] date of September 9, 2023. That is when the FDA will decide upon whether or not it should approve the drug Motixafortide in Stem Cell Mobilization [SCM] for Autologous Transplantation in Multiple Myeloma [MM]. The phase 3 study, known as GENESIS, was successful in showing that Motixafortide and G-CSF was successful for autologous transplantation in multiple myeloma [MM]. This isn't the only catalyst that investors have to look forward to. There are going to be two other big catalysts relating to the advancement of this drug for the treatment of patients with pancreatic cancer.

That is, it is also going to end up evaluating the use of Motixafortide in combination with PD-1 inhibitors and chemotherapies for the treatment of patients with first-line metastatic pancreatic ductal adenocarcinoma [PDAC]. The first catalyst relates to the release of initial patient data from a phase 2 study, which is using Motixafortide in combination with cemiplimab [LIBTAYO] and standard of care [SOC] chemotherapy as a first-line treatment for the patients with metastatic pancreatic cancer. Results from this investigator phase 2 study are expected in 2023. A second catalyst would be with the initiation of a randomized 200 patient phase 2b study, which is going to use Motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy as a first-line treatment for patients with metastatic pancreatic cancer. This phase 2b study will be initiated at some point in 2023. With a PDUFA date for FDA review of Motixafortide for multiple myeloma patients, plus a few other catalysts expected in 2023, these are the reasons why I believe that BioLineRx is a good speculative biotech play to look into.

Motixafortide Has Potential As An Option For Dire First-Line Metastatic Pancreatic Cancer Patients
As I stated above, a good thing about BioLineRx is that it is not just focused upon advancing the use of Motixafortide for autologous transplantation in Multiple Myeloma [MM] patients. It is also working on combining this drug with a PD-1 inhibitor and chemotherapies for the treatment of first-line patients with metastatic pancreatic cancer. Pancreatic cancer as the name suggests is a type of disease whereby cancer cells form in the tissues of the pancreas. One major problem about this cancer is that it is typically not diagnosed until the cancer has reached to the advanced stages. That is, it is difficult to diagnose it early on. If symptoms are eventually present for someone who has this, they are as follows:


Jaundice occurs as a result of too much bilirubin in the blood. It is typically seen in patients with liver disease, however, in pancreatic cancer it occurs because of a blockage of a person's bile duct. It is expected that the global pancreatic cancer market size will reach $7.4 billion by 2032. This is a large market opportunity for sure and the hope is that BioLineRx can eventually find a more suitable treatment option for these patients and capture this large market opportunity. Why is that? Consider that there are not many first-line treatment options available for these patients.

The best available 1st-line treatment options for these metastatic PDAC patients at the moment are chemotherapies as follows:

FOLFIRINOX [5-FU, leucovorin, irinotecan, and oxaliplatin
nab-paclitaxel plus gemcitabine
On the flip side, should BioLineRx eventually get through all of its trials and approvals, there is a competitor it might have to deal with. That's because Ipsen Pharma (OTCPK:IPSEY) filed a Supplemental New Drug Application [sNDA] of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin as a first-line treatment for metastatic pancreatic ductal adenocarcinoma [mPDAC] patients. The reason why is because the company achieved positive results from the phase III NAPOLI 3 study, whereby Onivyde achieved statistical significance in terms of overall-survival [OS] and progression-free survival [PFS] compared to nab-paclitaxel plus gemcitabine. However, the FDA set a PDUFA date of February 13, 2024 to review Ipsen's application. It remains to be seen if it can receive sNDA approval of Onivyde for these patients, but it might be a competitor that BioLineRx may have to ultimately deal with.

As I alluded to above, there are going to be two shots on goal for BioLineRX being able to treat patients with first-line metastatic PDAC. The first of which include a collaboration between it and the Columbia University with an investigator sponsored phase 2 study using Motixafortide in combination with LIBTAYO [cemiplimab] and standard-of-care chemotherapy for the treatment of first-line metastatic PDAC patients. I believe it is important to bring this program up because initial results from it are going to be released in 2023. I believe should the results from this study turn out to be good, it could provide a boost in the stock price and value for this biotech.

A second advancement of Motixafortide for this first-line metastatic PDAC patient population would be in combination with another PD-1 inhibitor + SOC chemotherapy as a first-line treatment of patients with pancreatic cancer. However, this program is going to be far more advanced than the other one I described above. That's because this program is going to be explored in a phase 2b study, treating about 200 patients with this combination. One thing to note about this trial is that BioLineRX is working with a partner on this one, known as GenFleet. A catalyst relating to this program is that this phase 2b study is expected to start in 2023.

Financials
According to the 6-K SEC Filing, BioLineRx had cash, cash equivalents and short-term bank deposits of $43.3 million. It believes that it will have enough cash to fund its operations into the 1st half of 2024. Being that this estimated period is rapidly approaching, I believe it will likely have to raise cash in the coming weeks/months for starters. Secondly, this estimate does not include the possibility of it receiving FDA approval of Motixafortide for autologous transplantation in Multiple Myeloma. Such a decision is expected by September 9, 2023 and there is no assurance that it will receive U.S. approval of this drug for this patient population. Regardless, the plan is for it to commercialize the drug on its

(This is all i could copy/paste, if anbody could add the rest of the SA article, please do)
TIA

[midastouch017]

BioLine RX (BLRX)

https://finance.yahoo.com/news/3-most-undervalued-biotech-stocks-180035132.html

The last time I highlighted BioLine RX (NASDAQ:BLRX), it traded at about $1.15 on May 4. Today, after testing a high of $1.70, it trades at $1.63 a share.

The US FDA recently accepted its APHEXDA (motixafortide) new drug application (NDA). This is for stem cell mobilization for autologous transplantation in multiple myeloma patients. There’s a PDUFA target date of Sept. 9.

Two, BLRX just announced the publication of data from its GENESIS Phase 3 clinical trial of motixafortide plus granulocyte colony-stimulating factor in treating patients with multiple myeloma prior to autologous stem cell transplantation. If eventually approved, it could be used as a way to enhance treatment options.

On the date of publication, Ian Cooper did not have (either directly or indirectly) any positions in the securities mentioned. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Ian Cooper, a contributor to InvestorPlace.com, has been analyzing stocks and options for web-based advisories since 1999.

[midastouch017]

Lol, first (indication) comes first!

there are many other therapies requiring Stem Cell harvesting that fit perfectly in BLRX's model.

The more the merrier.

GLTU

[bubbarayjr]

keep in mind that this estimate is for Multiple Melanoma only. there are many other therapies requiring Stem Cell harvesting that fit perfectly in BLRX's model.

[midastouch017]

What is the size of the market for that drug?

"Our independent market research suggests that the U.S. market for mobilization agents used in stem cell transplants is approximately $360 million annually and growing," said Holly May, President, BioLineRx USA. "Given the totality of clinical and pharmacoeconomic data that we have compiled to date, we believe APHEXDA, if approved, can quickly become part of a new standard of care, allowing us to capture a significant share of this opportunity.

https://www.prnewswire.com/il/news-releases/biolinerx-announces-us-commercialization-plan-for-aphexda-motixafortide-in-stem-cell-mobilization-301633337.html

[bubbarayjr]

I've managed to find a few 'flying under the radar' stocks over the years and I think this is another one. I got on NNOX when it was at $7 and OTLK at just over $1. The parallels between BLRX and OTLK are remarkable but BLRX has more potential imo

[midastouch017]

but the PPS has not moved.

Look at the chart, the price at Mar 10th was
0.56!!! Please check the chart from that date
onwards to date.

PDUFA date is when the FDA will approve or not a drug/therapy.

That is 100% correct!

BLRX's Phase 3 study was a huge success plus they have a promising pipeline

Correct!!!

the number of small offerings (dilution) the company had over the last 3-4 years
has pushed the stock price down.

I concur.

[bubbarayjr]

Hey Mello, I have the same questions. I came across this stock while researching OTLK which has an almost identical story. For starters, the PDUFA date is when the FDA will approve or not a drug/therapy. BLRX's Phase 3 study was a huge success plus they have a promising pipeline but the PPS has not moved. I think this has to do with Wall Street not paying attention, shorts are probably controlling the PPS which is easy to do with low volume stocks and the number of small offerings (dilution) the company had over the last 3-4 years has pushed the stock price down. It's still hard to believe that BLRX has a market cap of less than $100M with this much potential. An analyst with WainWright has a target price of $19 so I guess we'll see what happens on 9/9/23.

[Fmello]

Hey Midas, just heard about this stock & I'm trying to do my due diligence. I'm confused why this stock is so cheap. I've read online that "the FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of September 9, 2023". I'm not really familiar with that. Is that when the FDA will render their decision to approve Motixafortide or not? What is the size of the market for that drug?

Thanks.

[bubbarayjr]

market cap under $100M? doesn't make sense to me based on the news