ALPN - Alpine Immune Sciences: November 2023 Data Release Could Get Ball Rolling

2023-10-06 15:31:09 ET

Summary

• Preliminary clinical data from the Alpine Immune Sciences, Inc. ongoing phase 3 RUBY-3 study will be presented at the American Society of Nephrology Annual Kidney Week Meeting in November 2023.
• The study focuses on autoimmune glomerulonephritis but includes other autoimmune disorders such as IgA nephropathy, lupus nephritis, and primary membranous nephropathy.
• There are two shots on goal for the treatment of patients with systemic lupus erythematosus, which are povetacicept and acazicolcept.
• It is expected that the global Systemic Lupus Erythematosus Market is expected to reach $3.51 billion by 2030.

Alpine Immune Sciences, Inc. ( ALPN ) is a good speculative biotech play to look into. That's because it expects to present preliminary results from an ongoing phase 1b/2a open-label study using povetacicept to treat patients with glomerulonephritis at a medical conference in November of 2023. That is, it will reveal such data at the American Society of Nephrology [ASN] Annual Kidney Week Meeting November 2nd - 5th of 2023. Data from this study is going to be important, because it would give an indication of whether or not povetacicept does well for the treatment of autoimmune diseases. This is important, because this drug is being used to target other autoimmune disorders such as IgA nephropathy, lupus nephritis and primary membranous nephropathy.

Povetacicept For The Treatment Of Patients With Autoimmune Glomerulonephritis

Povetacicept is being developed to treat a multitude of autoimmune disorders, but in particular I want to put focus towards the autoimmune glomerulonephritis indication. The reason why I want to do so is because there is a catalyst approaching that investors might be interested in. I'm talking about the fact that Alpine Immune intends to release preliminary data from the ongoing phase 1b/2a RUBY-3 study at the American Society of Nephrology [ASN] Annual Kidney Week Meeting, set to take place November 2 - 5 of 2023.

Glomerulonephritis is a type of kidney disorder whereby part of the kidney [Glomeruli] that helps filter waste and fluids from the blood is damaged. This study is also being used to target other autoimmune disorders such as IgA nephropathy, lupus nephritis and primary membranous neuropathy. This phase 1/2 study is open-label and is expected to recruit up to 42 patients who are going to be treated with povetacicept. The trial is investigating upon whether or not this drug is safe/tolerable for patients to take. In addition, other endpoints being looked at for this study are going to be proteinuria, eGFR and various definitions of renal response as well.

Expansion Opportunity Of Povetacicept Across Multiple Autoimmune Conditions

The thing about Alpine Immune is that this is just the beginning for it in terms of what it is targeting with povetacicept. What do I mean by that? Well, for instance, when looking at the RUBY-3 phase 1b/2a study, the upcoming data is going to be for glomerulonephritis. However, this particular study is also investigating the use of this drug in other autoimmune disorders such as IgA nephropathy, lupus nephritis, and primary membranous nephropathy.

Even further than that, this biotech has already been able to initiate other studies, which are targeting other autoimmune conditions. For example, the phase 1b open-label RUBY-4 study is using this drug to treat patients with autoimmune cytopenias, including thrombocytopenia, warm hemolytic anemia and cold agglutinin disease. Lastly, it is even advancing the phase 2 RUBY-2 study, which is using povetacicept for the treatment of patients with systemic lupus erythematosus [SLE].

The two shots on goal for Alpine Immune might serve it well, because this is a large market opportunity. It is expected that the global Systemic Lupus Erythematosus Market is expected to reach $3.51 billion by 2030 . Thus, as you can see, there are multiple target indications on goal with povetacicept. There is another drug in the pipeline, which I have not yet touched upon, which is known as acazicolcept, which is a dual CD28/ICOS antagonist. It is being advanced for the treatment of patients with SLE in a phase 2 study.

Financials

According to the 10-Q SEC Filing , Alpine Immune had cash and investments of $239.6 million as of June 30, 2023. The company should have enough cash on hand to fund its operations for the time being. That's because it believes that it should be able to fund its operations through 2025.

Management may ultimately decide to start raising cash earlier, but there is another option available to raise funds as needed. This would be with respect to an "at the market" equity offering [Sales Agreement] that was made with Cowen and Company LLC., whereby shares could be sold by Alpine Immune as needed. The total aggregate gross proceeds for this agreement was set to be $100 million. As of June 30, 2023, the biotech had only sold 919,413 shares of common stock under this agreement. It sold these shares at a price of $10.93 per share and generated $10 million in gross proceeds from it.

Risks To Business

There are several risks that investors should be aware of before investing in Alpine Immune Sciences. The first risk to consider would be with respect to the release of results from the phase 1b/2a open-label study, which is using povetacicept for the treatment of patients with glomerulonephritis. There is no guarantee that results to be presented from this study at the American Society of Nephrology [ASN] Annual Kidney Week Meeting will turn out to be positive.

A second risk to consider would be with respect to the phase 2 RUBY-2 study, which is using povetacicept for the treatment of patients with SLE. There is no assurance that data from this particular study will turn out to be positive. On the other hand, at least Alpine Immune is also targeting this exact autoimmune indication with its other drug acazicolcept.

The third and final risk to consider would be a possible cash-raising activity. Why do I believe this to be the case? That's because it has sold some shares under the Sales Agreement made with Cowen. It may possibly elect to sell some shares from time to time to raise funds as needed, and this might dilute shareholders a bit.

Conclusion

Alpine Immune Sciences, Inc. is a good speculative biotech play to look into. The reason why I say that is because there is a specific catalyst that investors have to look forward to coming up. This would be with respect to the release of results from the phase 1b/2a open-label study, which is using povetacicept for the treatment of patients with glomerulonephritis at the American Society of Nephrology [ASN] Annual Kidney Week Meeting November 2nd - 5th of 2023.

Such results are important, because it would accomplish two things. The first item would be that this drug is capable of possibly being able to help treat this specific patient population. The second thing it would accomplish would be that it would show that povetacicept does well in autoimmune disorders and may be applicable towards others.

However, the company is not waiting around to test a few at a time. Thus, most of the studies noted above are basket studies. Whereby the goal is to test out this drug against multiple autoimmune indications.

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