Acumen Prescribed drugs, Inc. (ABOS) This fall 2021 Earnings Name Transcript

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Acumen Prescribed drugs, Inc. ( ABOS 2.56% )
This fall 2021 Earnings Name
Mar 28, 2022, 4:30 p.m. ET

Contents:

• Ready Remarks
• Questions and Solutions
• Name Contributors

Ready Remarks:

Operator

Thanks for standing by, and welcome to the Acumen Prescribed drugs fourth quarter and full yr 2021 replace name. [Operator instructions] At present’s name is being recorded. And I’d now like to show the decision over to John Woolford from Westwicke. Please go forward.

John Woolford — Investor Relations

Thanks, operator. Good afternoon. Thanks for becoming a member of us right now to assessment Acumen’s fourth quarter and full yr 2021 operational progress and monetary outcomes. Earlier than we begin, we encourage you to view the slides for this webcast, in addition to the operational and monetary outcomes press launch issued this afternoon, each of that are accessible on our web site within the traders part.

As proven on Slide 2, please be aware that in right now’s convention name, we might make forward-looking statements inside the that means of the federal securities legal guidelines, together with statements regarding our monetary outlook and anticipated enterprise plans. All these statements are topic to dangers and uncertainties that would trigger precise outcomes to vary materially from these described within the forward-looking statements. Our precise outcomes might differ materially on account of a variety of elements, together with the extent and period of the consequences of the COVID-19 pandemic and the timing and extent of restoration from it. Please check with our current filings with the SEC for a full assessment of the dangers and uncertainties related to our enterprise.

Ahead-looking statements communicate solely as of the date on which they’re made and Acumen undertakes no obligation to replace or revise any forward-looking statements. Daniel O’Connell, president and chief government officer, will start right now’s name with a excessive degree overview of Acumen and assessment choose 2021 enterprise highlights. Dr. Eric Siemers, chief medical officer, will then present a fast primer on amyloid-beta oligomers and talk about the continuing INTERCEPT-AD trial.

Subsequent, Matt Zuga, chief monetary officer, will present a quick monetary replace. We are going to then open the decision for Q&A. I will now hand the decision over to Dan O’Connell, president and chief government officer.

Dan O’Connell — Chief Government Officer

Thanks, John. Good afternoon, and thanks to everybody becoming a member of the decision right now. I am delighted to be right here on our first convention name as a public firm. Shifting to Slide 3, 2021 was a transformational yr for Acumen, highlighted by the achievement of a number of main accomplishments, together with our profitable IPO.

As that is our first public name, I need to take a second to supply a quick introduction to Acumen for these which may be new to the corporate. Acumen is concentrated on the event of novel focused therapeutics for Alzheimer’s illness, which has obtained important consideration over the past yr given the approval and launch of Biogen’s Aduhelm. Whereas controversial to Aduhelm approval has introduced substantial wanted consideration to the large want to assist folks residing with Alzheimer’s illness. Whereas many firms have pursued remedies focused to amyloid plaques, fibrils for monomers, Acumen is concentrated on concentrating on amyloid-beta oligomers.

We consider there may be an rising scientific consensus that oligomers are essentially the most poisonous type of amyloid beta and the event of a product that reduces toxicity of oligomers is likely one of the most promising approaches for the potential remedy and prevention of the development of Alzheimer’s. Our lead product is ACU193, the primary monoclonal antibody developed to selectively goal amyloid-beta oligomers to enter scientific testing. ACU193’s potential is supported by intensive preclinical information supporting its differentiation from different anti-amyloid applications. To information ACU193’s improvement, we now have assembled an skilled management group with important business experience in Alzheimer’s drug discovery and improvement.

Lots of our staff have been previously a part of Eli Lilly’s Alzheimer’s group. As I discussed earlier, we efficiently accomplished an IPO in 2021. We raised roughly $184 million in gross proceeds within the providing that included a number of nicely revered biotech traders and gives us the monetary assets to advance ACU193 by means of a number of scientific milestones and lengthening our money runway by means of 2025. The following key milestone for ACU193 is proof of mechanism information from our ongoing Section 1 trial in early Alzheimer’s illness, which is now anticipated within the first half of 2023.

Eric will talk about the trial shortly. I will now transfer to some key enterprise highlights in 2021 as proven on Slide 4. Following the funding of a $30 million tranche from a Sequence B financing in June, we quickly strengthened our stability sheet additional with the completion of our IPO elevating gross proceeds of $184 million as I discussed. We then initiated the INTERCEPT-AD trial, dosing the primary affected person in October.

We have been then happy to be accepted to current on the 2021 scientific trials on Alzheimer’s illness or CTAD convention in November in Boston. On the convention, we mentioned the scientific rationale for concentrating on amyloid-beta oligomers, the scientific trial design of INTERCEPT-AD and the way the examine is designed to ascertain security and proof of mechanism and assess any potential enhancements in cognition and blood circulation within the mind. To help our anticipated progress over the approaching years, we not too long ago made a number of senior degree appointments to the corporate’s management group. The brand new leaders embrace Julie Bockenstette, head of human relations; Siew Tin Gan, head of scientific operations; and Stephen Reynolds, company controller and treasurer.

All three convey deep expertise and collective ardour for bettering the lives of sufferers with Alzheimer’s illness. I would additionally like to make use of this chance to welcome Kim Drapkin to our board of administrators efficient April 1. Ms. Drapkin brings to us greater than 20 years of expertise working the non-public and publicly traded biotechnology and pharmaceutical firms, together with constructing and main finance capabilities elevating capital and main strategic monetary planning.

Turning to Slide 5. We proceed to make important progress in advancing the INTERCEPT-AD trial. As I discussed beforehand, we now count on to report top-line ends in the primary half of 2023, a slight revision from our earlier timing of year-end ’22. We consider the COVID-19 pandemic impacted our site-activation time line and enrollment considerably.

Nevertheless, given our robust monetary place, we additionally now plan to include a bigger dataset expanded to the top of examine and database lock. Concerning enrollment, we now have skilled continued success in activating scientific trial websites, and enrollment is now ongoing at eight lively websites, with six further websites chosen for potential activation. Time to activation of those websites has accelerated dramatically beginning in 2022. In parallel to conducting the INTERCEPT-AD trial, we now have additionally made important progress in getting ready for a future Section 2/3 trial of AUC193.

Power GLP toxicity testing has been initiated in our new drug substance manufacturing course of, and drug product formulation are being finalized. We now have begun designing the Section 2/3 examine and planning for an finish of Section 2 assembly with the FDA. Given this headway, we anticipate having the ability to provoke the subsequent trial quickly after demonstrating proof of mechanism within the INTERCEPT-AD trial. I will now flip the decision over to Dr.

Eric Siemers, our chief medical officer.

Eric Siemers — Chief Medical Officer

Thanks, Dan. Good afternoon, everybody. I will begin right now with a fast primer on ACU193 and amyloid-beta oligomers. Turning to Slide 6.

As Dan talked about, our monoclonal antibody, ACU193, is designed to handle a serious part of Alzheimer’s illness pathology by binding to amyloid-beta oligomers, also called a-beta oligomers, that are a poisonous type of the a-beta proteins. A rising physique of proof signifies that these oligomers are a major set off and protracted driver of Alzheimer’s pathology and neurodegeneration. The buildup of a-beta oligomers is related to lack of the connections between nerves, in addition to irritation. If there may be substantial proof that a-beta oligomers result in the reminiscence impairment, cognitive decline and progressive neurodegeneration which might be seen in Alzheimer’s illness.

By binding to a-beta oligomers, ACU193 prevents them for binding to specialised components of nerves referred to as dendritic SPARrings, which we consider might assist to protect nerve perform and defend cells from neurodegeneration. What makes ACU193 so distinctive and differentiated from different monoclonal antibody studied in Alzheimer’s illness is AUC193’s excessive selectivity for a-beta oligomers relative to different anti-amyloid monoclonal antibodies which might be much less selective will goal completely different amyloid species akin to a-beta monomers or deposited a-beta amyloid plaques. We consider this will result in improved scientific efficacy in comparison with different monoclonal antibodies studied in Alzheimer’s illness and importantly, with an anticipated lack of ARIA-related security issues, that are seen with different monoclonal antibodies. We additionally consider there may be some potential for potential cognitive enchancment along with illness ahead.

With that introduction, I will now present a quick overview of the continuing INTERCEPT-AD Section 1 trial. As proven on Slide 7, the research are randomized, placebo-controlled Section 1a/b trial. As an ordinary, there are two parts, together with a single-ascending dose portion Half A and a multiple-ascending dose portion Half B. The trial is being carried out in sufferers with early Alzheimer’s illness, these with gentle cognitive impairment and gentle dementia.

To take part within the trial, sufferers have to be amyloid optimistic as decided by PET scans. As Dan talked about, a key goal of the trial is to show concentrating on nice engagement and proof of mechanism as decided by demonstrating that ACU193 is right down to oligomers in cerebral spinal fluid. Different essential outcomes embrace the analysis of security and tolerability, pharmacokinetics and measures of cognition. Slide 8 illustrates the trial design of INTERCEPT-AD.

Half A, the single-ascending dose portion, contains 4 cohorts with eight sufferers per cohort at doses of two, 10, 25 and 60 milligrams per kilogram or placebo. Half B, the multiple-ascending dose portion, contains three cohorts with 10 sufferers per cohort at doses of 10 and 60 milligrams per kilogram dosed each 4 weeks and 60 milligrams per kilogram dosed each two weeks or placebo. I need to spotlight that included within the trial design is the flexibility to provoke the primary cohort of the multiple-ascending dose parts after security and tolerability is demonstrated within the second cohort of the single-ascending dose portion. Slide 9 exhibits the targets of the trial intimately.

Within the curiosity of time, I am not gonna learn all of them out, however we needed to provide everybody a sign of the information that we plan to finally report from the examine. As you’ll be able to see, we count on the trial to supply a big quantity of information that can be essential within the design of the deliberate Section 2/3 trials, in addition to our regulatory technique. Finally, what’s most essential is that we count on that the information will justify development right into a Section 2/3 trial. Assuming INTERCEPT-AD demonstrates acceptable security and tolerability, exhibits ACU193 will get into the central compartment and confirms goal engagement, we plan to advance this system to the Section 2/3 examine.

With that, I’ll flip the decision over to Matt Zuga, our chief monetary officer and chief enterprise officer.

Matt Zuga — Chief Monetary and Enterprise Officer

Thanks, Eric. And because of everybody for becoming a member of. To start out, I need to reiterate what Dan stated earlier. On account of planning and executing on our non-public and public financing technique in 2020 and 2021, we’re well-capitalized and have the assets to attain a number of scientific improvement milestones.

As of December 31, 2021, we had roughly $225 million in money and marketable securities. Wanting forward, primarily based on our present working plan, we count on our money runway to final by means of 2025. Our robust stability sheet is the results of the proceeds from Sequence B and IPO financings accomplished in 2020 and 2021. Our full monetary outcomes for 2021 can be found within the press launch we issued this afternoon and in our 10-Okay, which can be filed shortly.

I am not gonna assessment our ends in element, however I do need to spotlight just a few gadgets. R&D bills have been $12.3 million in 2021. The rise over 2020 was primarily the results of the initiation of the INTERCEPT-AD trial throughout the yr. G&A bills have been $7.3 million in 2021, with the rise primarily the results of elevated headcount and the price of going public and being a public firm following our IPO.

This led to a loss from operations of $19.6 million for the complete yr. Word that our web loss for the complete yr was $100.6 million. This was primarily pushed by a non-cash expense of $81.2 million that represents the adjustments in honest worth of our Sequence B tranche legal responsibility and our Sequence A warrant legal responsibility. The tranche legal responsibility and the warrant legal responsibility have been initially recorded at honest worth as a legal responsibility on Acumen’s stability sheet and are subsequently remeasured at honest worth on the finish of every reporting interval.

Each liabilities have been extinguished by the conversion of our most well-liked shares and warrants to frequent shares on the IPO. We are going to proceed to work onerous over the approaching quarters to enroll INTERCEPT-AD and stay up for reporting top-line information within the first half of 2023. Importantly, we are going to proceed to function Acumen effectively and cost-effectively to make sure our money runway is maintained by means of 2025. We thank our shareholders and companions for his or her ongoing belief and help.

And we’ll now open up the ground for questions.

Questions & Solutions:

Operator

[Operator instructions] Our first query comes from Paul Matteis with Stifel.

Alex Park — Stifel Monetary Corp. — Analyst

Hello there. Thanks for taking our questions. That is Alex on for Paul. I used to be questioning, I feel within the ready remarks, Dan, you talked about that the slight delay for intercepts would let you have an expanded information set for the highest line.

I’m wondering if you happen to might elaborate a little bit bit extra on form of what that appears like and the way that will impression the highest line information. Then I’ve a few different follow-ups. Thanks.

Dan O’Connell — Chief Government Officer

Hey, Alex, thanks on your query. Yeah, simply actual rapidly, I feel by way of the follow-up interval, what we have checked out is COVID has undoubtedly impacted the entrance finish of the examine. I feel we’re actually inspired by the speed of development, each on the web site degree and with enrollment. Proper now, we have got extra work to do, however definitely, the momentum is constructing.

When it comes to the follow-up interval, we’re taking a look at following sufferers out to a day 168 follow-up. There had been some dialogue round placing out preliminary top-line outcomes a little bit bit earlier, however I feel the prudence can be to hold out the examine to that day 168 follow-up and permit us to principally have the dataset that will be the premise for the top of Section 2 assembly and a subsequent presentation at a serious assembly because the dataset that is reported on. In order that’s actually our objective with the decision right now was to set expectations each on the time-frame and readability on what top-line outcomes is perhaps and after they can be introduced.

Alex Park — Stifel Monetary Corp. — Analyst

Yeah, that is smart. And I assume, I do not know if you happen to’ve commented on how far you’re by way of dosing. However I’m wondering if you happen to might verify that you simply began dosing sufferers and whether or not or not you’ve got had an opportunity to have a look at blinded security information and might verify any situations of ARIA. And if you cannot reply that, that is tremendous.

After which my ultimate query on runway. I’m wondering if you happen to might discuss a little bit bit about what’s embedded in your expectations for our 2025 runway and the way that or if that features expectations for Section 2/3 examine and the way you are fascinated about that. Thanks.

Dan O’Connell — Chief Government Officer

Yeah, yeah, thanks, Alex. So by way of the place we’re within the examine, I feel what we — we introduced within the — on the finish of the third quarter that we dosed the primary affected person. We proceed to dose sufferers at a number of websites. We’re not offering patient-level or cohort-level data at this level.

I can say that there’s nothing that we now have seen, and we now have checked out blinded security information, that has recommended us to switch or shift our expectations, each by way of the examine design and period. So we’re — it is actually simply extra of an operational component. I feel from the runway — the money runway perspective, we have all the time envisioned — a part of the capital technique from the B and in addition to the IPO was to make sure that we now have the assets available to hit a number of scientific milestones. So we do suppose the INTERCEPT-AD dataset basically that security goal engagement and normal observations to help shifting ahead right into a Section 2/3 examine, it’s intact, and actually, that the assets available would enable us to fund a Section 2 examine to its completion and to demonstration of proof of idea.

So I feel the markets have been a bit unstable on this current interval, however we’re feeling at a minimal that we now have the runway, offered that the product performs as we are going to hope within the INTERCEPT-AD examine to a minimum of carried into by means of a Section 2 examine.

Alex Park — Stifel Monetary Corp. — Analyst

Nice. That is useful. Thanks.

Operator

Our subsequent query comes from Geoff Meacham with Financial institution of America.

Jason Zemansky — Financial institution of America Merrill Lynch — Analyst

Good afternoon. That is Jason on for Geoff. Thanks a lot for taking our questions. Needed to get your broader-level feedback on, clearly, the regulatory surroundings.

Actually, there may be, on one hand, FDA’s signaled extra permissive perspective doubtlessly towards the approval of Alzheimer’s remedies, whereas on the identical time CMS has form of accomplished the alternative and recommended a way more strict surroundings by way of reimbursement. However has this dynamic influenced your pondering in any respect so far as shifting ahead with the outcomes of the Section 2 and a willingness to maneuver ahead with a Section 2/3? After which what dynamics are you particularly on the lookout for as you concentrate on placing these trials collectively? Clearly, it is a little bit early, however would like to get your pondering on this.

Dan O’Connell — Chief Government Officer

15 Hey, Jason, thanks for the query, and it is good one. And I’ll say we’ll all study a little bit bit extra on the premise of the CMS willpower on the eleventh of April. So that’s, I feel, an essential improvement for the Alzheimer’s drug improvement area. We’re tuned into that.

I feel we may even be observant of different examine readouts and regulatory actions over the course of the subsequent 12 months. To be clear, our plan is to take the INTERCEPT-AD dataset into an finish of Section 2 kind of interplay with the FDA with these outcomes and actually set up the premise for the subsequent examine to be both a Section 2 or, if sure standards are met on an interim foundation, transfer to a Section 3 examine. The opportunity of submitting on the Section 2 information exists, however I feel we’ll have — it is in all probability too early for me to take a position as to how and when that will come about. And once more, we’re gonna study a lot from the extra regulatory interactions that a few of our friends will undertake within the subsequent 12, 18 months.

Jason Zemansky — Financial institution of America Merrill Lynch — Analyst

Excellent. Actually thanks for the colour.

Operator

Our subsequent query comes from Judah Frommer with Credit score Suisse.

Judah Frommer — Credit score Suisse — Analyst

Yeah, hello, guys, thanks for taking the questions. Possibly only a fast follow-up on that one. Possibly simply your ideas on pricing for a-beta antibodies, proper? Clearly, Aduhelm began at a better worth than the place it’s now and form of how which may have an effect on or possibly not have an effect on your inside pricing assumptions. After which past that, is it proper to consider now doubtlessly having longer follow-up for these earlier cohorts, after we do get the Section 1 information? And in that case, how would possibly that have an effect on the COGS state battery? Would that be given, I assume, past these 168 days for the sooner cohorts?

Dan O’Connell — Chief Government Officer

Yeah, hey, thanks, Judah. When it comes to pricing and like, I feel we now have — we actually have not adopted or modified any of our specific fashions. I imply, I feel, the Biogen historical past recommended they got here out — excessive relative to possibly expectations they made a modification. We’ll see the place CMS goes, I feel that we now have — we’re cognizant of taking a look at price of supplies and dosing and making certain that we now have pharmaceutical margins at a specific worth level which may be in a market that has a number of different merchandise accredited.

So we — I assume, the straightforward reply is it is in all probability a little bit bit too early for us to enter a pricing dialogue. However once more, we’re able to have a look at what — how the market develops, what reimbursement charges can be found, and finally our objective is to generate differentiated information each by way of ARIA security and finally, with scientific efficacy. And I feel these are elements that definitely would have an effect on — would contribute to a pricing technique that we might pursue sooner or later. I feel on the second query by way of the follow-up period, basically, this provides us further imaging and different scientific assessments primarily for security.

You referenced the COGS state battery, and sure, we’re using a compute battery actually in curiosity that if there may be an acute pharmacodynamic impact primarily based on neutralizing the toxicity of a-beta oligomers that that extremely repeated and extremely delicate measure administered on a pc would be capable to detect these sorts of alerts. We actually — once more only a phrase of warning, we’re not powered or calling that out as a standards for this Section 1 examine. And I feel it is unlikely that these measurements would impression the day 168 follow-up, which is de facto only a full willpower of the security profile.

Judah Frommer — Credit score Suisse — Analyst

Acquired it. Thanks.

Operator

And I am not displaying any additional questions right now. I would like to show the decision again over to Dan for any closing remarks.

Dan O’Connell — Chief Government Officer

Nicely, thanks, Kevin and thanks all people for becoming a member of our first public firm earnings and enterprise highlights name. We stay up for be participating with you within the close to future and updating you on our progress, each within the clinic and with the corporate. So thanks, everybody.

Operator

[Operator signoff]

Length: 25 minutes

Name individuals:

John Woolford — Investor Relations

Dan O’Connell — Chief Government Officer

Eric Siemers — Chief Medical Officer

Matt Zuga — Chief Monetary and Enterprise Officer

Alex Park — Stifel Monetary Corp. — Analyst

Jason Zemansky — Financial institution of America Merrill Lynch — Analyst

Judah Frommer — Credit score Suisse — Analyst

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