Q3 2022 Alpine Immune Sciences Inc Earnings Call

Yes.

[music].

Please standby.

Welcome to the Alpine immune sciences third quarter earnings call.

Currently all participants are in a listen only mode.

As a reminder, this event is being recorded.

I would now like to introduce Camry Johnson senior director of Investor Relations and corporate communications at Alpine.

Johnson I will now turn the call over to you.

Thank you operator, good afternoon, and thank you for joining US with me on today's call are Dr. Michael <unk> Executive Chairman and Chief Executive Officer, Dr. Sandra Pang, President and head of R&D, Dr. Andrew Chandler, Chief Medical Officer, Ricky Chief Financial Officer, and Dr. Remy Joanna Chief business Officer.

Before I turn the call over to Mitch I would like to remind you that we'll be making forward looking statements. During the course of today's call I encourage you to refer to the most recent SEC filings regarding the risk factors associated with these statements Mitch. Please go ahead.

Thank you Geoffrey.

For the quarter about several important milestones.

Starting with our inaugural R&D day in September .

In my presentation at multiple scientific meetings over the last several months, we showed promising data that supports the best in class potential for our lead program at Alpine C O three.

Right now operationalized, a near term Rob developed a plan for alpine degree of three and multiple indications with most profitable studies to begin in a renal basket as well as the hematology basket.

Dissipated data from these studies by the end of next year.

Importantly, based on data from there won't be one study we plan to move forward with a convenient dosing schedule. Once every four weeks.

Best in class profile of inhibiting both April and Bath simultaneously.

To further accelerate development at alpine across multiple indications in recycled created a successful and oversubscribed I don't know if <unk>.

$10 million of power.

Bringing additional top tier investors and extending our cash run rate through the end of 2025.

This additional capital will fund key catalysts for alpine is good but the initial data by the end of next year.

So, enabling the initiation of pivotal or accelerated approval studies in certain indications.

Following the termination of enrollment in the alpine to achieve clinical studies last month.

Our plan is now focused squarely on driving value from it.

<unk> and inflammation activities.

Including our collaborations with Abbvie and horizon.

I'll now hand, the call over Stanford the talk about alpine three of three in more detail effort.

Thank you Mitch.

As a reminder, all thank for your three FC fusion of engineered tactically and our potent dual inhibitor of the past April T cell cytokines and develop anika lupus and other auto antibodies Lee.

Rationale is strongly supported by prior clinical experience with multiple drugs in this pathway.

Including the anti <unk> antibody for linear math.

Anti April antibody, a two well pad tacky FC fusion.

Hi, Tech, which restructuring related to our <unk> III and target back in April .

Easter eggs collectively have been approved for and are showing significant promise for the treatment and lupus and lupus nephritis indoor show encouraging initial data Iga nephropathy and other indications.

Okay, and autoimmune programs on a Friday tradition, therefore of particular interest for all parts of Q3, but based on that kind of action. It may prove effective for many other auto antibody for needed diseases as well.

Over the past few months, we reported that a key advantage of <unk> engineering, which result in a highly potent inhibitor of both GAAP and April distinguishing it from the wild type chassis, which do not appear to inhibit April as well.

Therefore suggests that felt like tier three need it they need a first truly dual potent inhibitor of <unk> cytokines.

Consistent with the multiple preclinical studies, demonstrating superior efficacy versus other inhibitors, a basket or April including Wild type testing.

We have conducted and reported initial data from our first in human.

Those studies.

Three adult healthy volunteers, who would be one at a few different sides of the costs.

Overall, the drug has been very well tolerated.

Org, which could be at doses up to 960 milligrams demonstrated dose.

Dose dependent pharmacokinetics.

The pharmacodynamic effects have been quite encouraging.

<unk> pre cytokine circulating hemoglobin antibodies <unk> and the Iga nephropathy related biomarker Blackberry.

Right.

Based on these findings, we anticipate therapeutic doses 80.

240 milligram doses administered subcutaneously at every four weeks.

The key to creating data we're now in the process of initiating clinical studies, including <unk>, two placebo controlled dose ranging randomized phase III study in systemic sclerosis.

Briefly this study will include adults with moderately to severely active.

Similar in design to start having sales day.

In addition, we're moving forward with really three an open label dose ranging study in autoimmune profile of a Friday Iga nephropathy.

And primary membranous Wow.

Well, it's been before.

They went back to studying in autoimmune cytopenia, including immune thrombocytopenia warm autoimmune hemolytic anemia and call includes entities.

Each of the indications in the basket study across scientific rationale for <unk> based on the importance of specific auto antibody into each pathogen.

Well at a high medical need.

We anticipate proceeding into randomized studies in one or more of these indications based on initial data by the end of next year.

<unk> in the context of an accelerated development pathway.

I'll turn the call over to Paul.

Thank you Seth I'll now provide an overview of our financials for the third quarter ended September 32022.

Cash cash equivalents and investments totaled $277 1 million as of September 32022.

In September we completed a $100 million underwritten public offering where we sold $13 6 million shares of our common stock with net proceeds of approximately $93 5 million after deducting underwriting commissions and estimated expenses.

An additional one 9 million shares of our common stock were sold pursuant to the underwriters' exercise of their overallotment option, providing an additional net proceeds of $13 1 million received upon closing on October 4th 2022, bringing our pro forma cash balance to $290 2 million as of September 32000.

<unk> 22, which should be sufficient to fund current planned operations through 2025.

Collaboration revenue for the third quarter was $8 4 million compared to approximately $8 5 million in the third quarter of last year.

The 2022 amounts were primarily attributable to revenue recognized under the company's Abbvie and horizon collaborations while 2021 revenue recognized solely related to the Abbvie collaboration.

Research and development expenses were $17 6 million in the third quarter of 2022 compared to $18 3 million in the third quarter of last year.

The decrease primarily related to decreased clinical development activities on a year over year basis, partially offset by increased personnel costs.

General and administrative expenses for the third quarter 2022 for $4 6 million compared to $3 5 million for the third quarter of last year, primarily due to increased personnel costs.

I'll find recorded a net loss of $13 3 million in the third quarter of 2022 compared to $13 5 million in the third quarter of 2021.

With that I will now hand, the call back yes.

Thanks, Paul.

The Sanford highlighted recent positive updates for alpine figure three continue to reinforce that we believe to be the significant potential for the molecule to improve the lives of patients suffering from severe autoimmune and inflammatory diseases.

Do you believe the alpine career three is potentially the only truly.

Dual April back inhibitor.

And combined with its convenient once every four week dosing alpha.

Alpine two or three is poised to launch it in a broad development plan, which includes the phase two lupus study.

As well as basket studies in renal hematologic and other autoimmune diseases.

We expect to bring data from our basket studies to read out by the end of 2023 and.

Stanford mentioned potentially enabling initiation of pivotal or accelerated approval studies in certain indications.

In closing our best in class profile for alpine two or three.

And our cash runway of three plus years.

We have laid a strong foundation so onto the next phase of growth for alpine.

As we execute on our ambitious talks about implants, and a broad range of B cell mediated autoimmune.

<unk> diseases.

With that operator, we'll now open the phones for questions.

Thank you Dr. Goldman if you'd like to ask a question. Please signal by pressing star one on your telephone keypad. If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment.

Again press Star one to ask a question.

And we'll now pause as we wait for questions from the audience.

And our first question will come from Mark Breidenbach with Oppenheimer.

Hi, This is Jack clinical Mark from Oppenheimer.

Oh, what is quite clear and something in the basket study for which indication in the basket study.

The time to answer to see data on wise.

Okay.

I think it was.

Little bit hard to understand but the part that I heard at the gangway, which indication the basket studies would you view the fastest readouts for data was that the question.

Right Yeah.

Okay.

Well, we're not restricting enrollment across the three indications in each of the basket studies. So right now we expect the enrollment to reflect perhaps.

Frequency or the epidemiology of indications so most likely we'll see more I Dan subjects in renal basket anymore ITT subjects in the basket.

But we'll be operationalized as fast as we can.

Okay.

A couple of question was what kind of what kind of can you healthy volunteer data that will be included in the upcoming ash presentation on there will be one that we haven't already.

I see.

There'll be some updates with regard to some.

Some of the Biomarkers.

Although what is particularly new in that.

In that poster will be some preclinical data supporting the target indications hematology target indication.

Okay.

Thank you for taking our questions.

Right and for the next question.

Thank you and once again, if you would like to ask a question. Please press star one again, we'll pause for just a moment.

And there are no further questions at that brings us to the end of our time for questions. After goes I will turn the call back over to you.

Thank you operator, I'd like to thank everyone that took part of today's call, especially those in attendance, our investigators and the volunteers and patients participating in our clinical trials.

You can tell we're highly enthusiastic about the potential of <unk> programs to meaningfully impact patients' lives. We look forward to providing updates in the months ahead. Thank you very much.

Okay.

And this concludes today's conference call you may now disconnect.