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Altimmune (NASDAQ: ALT) - 25년 1분기 실적발표 1Q25 본문

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Altimmune (NASDAQ: ALT) - 25년 1분기 실적발표 1Q25

OCBC 2025. 5. 15. 12:30
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https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-first-quarter-2025-financial-results-and

original.pdf
4.20MB

 

https://ir.altimmune.com/news-releases/news-release-details/altimmune-secures-100-million-credit-facility-hercules-capital

 

25년 1분기 실적발표 + $100M debt financing 발표

기다렸던 IMPACT NASH/MASH 임상 결과는 발표되지 않음.

 

우선 $100M debt financing은 희석 방지용으로 나쁘지 않은것 같은데

$15M at closing, additional tranches upon achievement of certain clinical and financial milestones.

IMPACT 결과와 함께 트리거 되는게 있을듯? (IMPACT 발표하면 증자도 하긴 하겠지?)

25년 3월말 기준 $150M 현금 보유 + debt financing 하면 $250M 수준

24년 12월말 기준 $132M 정도였는데, ATM offering으로 돈을 은근 땡겼었네;

주식수가 5,273,368 증가했는데, ATM offering으로 $34.75M 유입되었으니, $6.59에 발행한 셈인듯.

 

기존 Shelf registraiton 만기되어서 2025-02-27 renwal로 $400M 할 수 있도록

($1.6B에 25% $400M을 보시는걸까요?? 제발...)

 

우선 개발현황 업데이트:

- Top-line data from IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) expected in Q2 2025

- Phase 2 trials in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD), expected to initiate in Q2 and Q3 2025, respectively

 

IMPACT 임상은 190명 목표에서 실제 212명 등록 완료

(등록 속도가 느린것도 아니고 추가로 늘린게 아니라 안심; high demand로 인해 추가 등록 되었다고 생각)

 

AUD & ALD는 이제 막 시작이라 관심 없는

어차피 IMPACT만 보는 플레이

 

Q&A에서 관심가는 질문들:

Liisa Bayko

Hi there. Thanks for taking the questions and congratulations on the progress. Can you talk a little bit about, what you're seeing in the study in terms of discontinuations, how you're handling the discontinuations in terms of the data, and how should we think about any loss from the rereads and things like that? Curious. Thanks.

Scott Harris

Yes. Liisa, let me answer that question. I can't give you absolute numbers and study discontinuations, but what I can say is looking across the trial, the discontinuations that we're seeing and also those due to adverse events, we're very, very happy with the data that we're seeing so far. The trial has been going very well, especially with regards to discontinuations. Obviously we'll have that data at the time of the readout. The discontinuations are handled in different ways in trials. As you know, some compounds have looked at completer analyses, others have done what's called the full intention to treat, where all discontinuations are treating as non-responders. And then there's the midway, which is an imputation method which has been used in other trials as well. Our goal is to have all that information available at the time of the readout. I can't give you finite information on the rereads at this point, but it's what we're seeing is in line with what we had projected for patients who qualify.

(imputation method로 봤던 파이프라인이 뭐가 있었지???)

 

Liisa Bayko

Very helpful, thank you. And then just final question from me. As you think about phase 3 and I know you'll be pending, all this data meeting with FDA towards the end of the year is taking the higher dose into phase 3 consideration. And also I know you're really focused on kind of like how rapid the response is and how are you thinking about a potentially earlier six month endpoint? Thank you.

Scott Harris

Well, those are great questions, Lisa. So we're strongly considering taking the 2.4 milligram dose into Phase 3. And it's not because we expect better MASH effects, it's that we expect to get better weight loss, reminding you that the 1.8 milligram dose that we have in this trial is not the optimal dose for achieving weight loss. Pertinent to your prior question, that has to be understood in looking at the data that we will get higher weight loss if we employ the 2.4 milligram dose in Phase 3 as we intend.

Now, regarding the more rapid response, the FDA and their guidance does not provide a time course for these trials. One possibility here, as you mentioned, would be to do readouts at not only the end of a year, 48 weeks or 52 weeks, but also at six months. That's something we're strongly considering for two reasons. The first is that it would then also make put a stake in the ground for earlier, more rapid mash effects. But second, it would also allow us to read out the trial results six months earlier. So both of those elements, adding the 2.4 milligram dose and doing an earlier readout are something that's strongly being considered. We are writing that program as we speak. We are well ahead of our timeline for having an end of Phase 2 meeting with the FDA in the fourth quarter, and these are things that we will discuss with them and I think they'll be very open to that discussion.

(2.4mg를 고려한다는건 IMPACT에서 좀 부족해보인다는 우려도 좀 생기긴 하는데;; 2.4mg면 titration을 또 해야될테니... 흠..)

 

눈에 들어오는 Q&A는 이정도?

 

3-reader approach, bipsy re-read 때문에 Placebo effect는 최소화될것 같은데

GCG로 하여근 direct liver effect로 24주차에 Placebo-adjusted Fibrosis Improvement는 +20% 이상은 반드시 필요할것 같음.

이상일수록 market expectation 초과 아닐까 싶음.

Jefferies는 FGF21을 뛰어 넘으면 3x 이상도 가능하다고 하니, 기대.

 

 

https://www.gsk.com/en-gb/media/press-releases/gsk-to-acquire-efimosfermin-a-phase-iii-ready-potential-best-in-class-specialty-medicine-to-treat-and-prevent-progression-of-steatotic-liver-disease-sld/

 

GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of st

Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options.

www.gsk.com

GSK가 Boston Pharma의 FGF21 agonist 파이프라인 Efimosfermin 도입 계약

upfront $1.2B + milestone $800M

Efimosfermin의 강점은 Q1M dosing 인것 같음.

LBP-22_Boston Pharma_Efimosfemrmin (BOS-580)_임상 2a상 in NASH (12-week).pdf
5.47MB

 

2023 EASL에서 발표한 결과가 있음.

12주차에 fat reduction은 괜찮은것 같기도 하고, Q1M을 보고 가져간것 같은데

(그간 Boston Pharma가 개발 진전이 뎌딘게 좀 이상)

GSK가 iTEOS Therapeutics (NASDAQ: ITOS) TIGIT 중단하고 바로 비싸게 가져가는 플레이

$1.2B upfront를 줘가면서까지 AKRO랑 ETNB 대비 어떤 부분을 보았을까?

GSK도 BD를 잘하는것 같기도 않음. 

 

Pemvidutide IMPACT NASH/MASH 임상데이터 끝내주게 나오게 해주세요

5/20과 6/4 Investor Event가 있는데, 5/20 전에 발표 할 수는 없을까!?!