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

2023-07-10 19:36:22 ET

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. ( 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:

• Pain
• Significant weight loss
• Jaundice [Yellowing of the skin]

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 (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 own for the time being.

Thus, it might have to enact a cash raise, just in case it does ultimately receive FDA approval of Motixafortide. It states in its 6-K SEC filing that it will have to take one of a few options to generate sufficient cash to commercialize this product. It will attempt to raise capital through the issuance of debt or equity securities, or capital inflows from strategic partnerships. Regarding the last one, if it happens, I believe that it would be the best option. That's because having a partner to help commercialize Motixafortide for MM would be the best way for it to conserve cash. However, there is no guarantee that it will find a partner to help fund commercialization of this drug.

Risks To Business

There are several risks that investors should be aware of before investing in this biotech. The first risk to consider would be with respect to the established PDUFA date of September 9, 2023. That is the date set when the FDA will decide upon whether or not it should approve the U.S. marketing application of Motixafortide for Autologous Transplantation in Multiple Myeloma. While all primary and secondary endpoints were met with statistical significance, there is no guarantee that BioLineRx will receive FDA approval of this drug for this indication. A second risk to consider would be with respect to the two phase 2 studies that it will have, using Motixafortide + PD-1 inhibitor + chemotherapies, for the first-line treatment of patients with metastatic PDAC.

While there are two shots on goal in using this drug to treat these patients in combination regimens, there is no guarantee that one or both of these studies will ultimately end up being successful. A third and final risk to consider would be with respect to the cash position that it is in. That's because it believes that it only has enough cash to fund its operations into the 1st half of 2024. With this short cash runway, plus the need to prepare for pre-commercialization activities of Motixafortide for MM, it will need to find a way to raise cash in the coming months. Thus, there is a risk for investors in terms of being diluted.

Conclusion

The final conclusion is that BioLineRx is a good speculative biotech play to look into. The reason why I state that is because it has a few catalysts, which I believe investors can capitalize on. The first catalyst of which, involves the established PDUFA date of September 9, 2023. Again, that is when the FDA will review whether or not it should approve Motixafortide for Autologous Transplantation in Multiple Myeloma. Another catalyst of which I believe might be able to boost the stock price, might be with respect to release of results from a Columbia University investigator phase 2 study. Such a mid-stage study is exploring the use of Motixafortide in combination with LIBTAYO and SOC chemotherapy as a first-line treatment of patients with PDAC. Initial patient data from this study are going to be released 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.

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