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VK2735 has specific liver fat reduction properties that are promising. See #msg-173042423. Time will tell if it also has an a "clinically meaningful" effect on fibrosis like the dual GLP1-GIP agonist trizepatide which does not exist as an oral.
Picking any small molecule GLP1 is not likely to be as effective.
Thanks for the link to the full article. They say it costs $70,000 to make a kilogram of semaglutide which implies 7 cents per mg. for material. It appears to me they are indeed neglecting the capital involved for building the factory which is not trivial.
“The outgoing CEO of AlmataBio (the private company AVTX is acquiring) is Patrick Crutcher, who used to be a co-moderator of this message board.”
Very cool. Sounds like he is going to make out quite well. The company is due 7.5 M in cash now and 5M upon dosing the first patient into phase 2 which is a near certainty, along with stock valued at 15M. Another 15M (cash and or stock ) if it makes it to phase 3. Good for him.
We might get a more definitive answer to this now that GSK might be incentivized to bear the cost of a large trial. The upside to their Shingrix franchise would be very significant if positive.
A corollary here is that if you have a small molecule drug with lower efficacy but very clean safety and distinct MOA (i.e. combinable with a GLP-1 backbone) it might be written off by analysts due to efficacy when in fact it could have tremendous value in combination. That would be an entry I might eye in this area bc right now I’m late to the party and valuations are sky high. I have no idea what regimens will ultimately win the day but at least that would be an under appreciated entry
IBIO—A second company issued a PR today mentioning both AI and obesity drugs—and it was good for a +192% move:
…if [VK2735] can be proven to work as an oral, an all oral combination with VK2809 for NASH is also appealing as we have discussed before.
MRK and LLY have stayed near their highs. BMY and ABBV are still way off their lows,
MRK, LLY, and BMY hitting new highs. GILD too. ABBV has not returned to highs.
Tautological PR header?
https://www.globenewswire.com/news-release/2024/03/27/2853659/0/en/By-2035-Canada-could-have-the-most-enviable-healthcare-system-in-the-world-if-obesity-is-recognized-as-a-chronic-disease-predicts-Obesity-Canada.html
By 2035, Canada could have the most enviable healthcare system in the world if obesity is recognized as a chronic disease, predicts Obesity Canada
VTRS Investor Day slide deck shows 2026 as “anticipated launch date” for Botox-biosimilar collaboration with RVNC:
https://investor.viatris.com/static-files/b01a07f3-e549-4522-8480-c31b359a6a4f (slide #14)
If this pans out it will generate material cash flow for RVNC in the next couple of years. The collaboration has $70M of remaining clinical and regulatory milestone payments. The collaboration also has up to $225M of sales-based milestones, although these presumably won’t be triggered until later in the decade.
IBIO—A second company issued a PR today mentioning both AI and obesity drugs—and it was good for a +192% move:
https://finance.yahoo.com/news/ibio-astralbio-announce-transformative-ai-110000784.html
Caveat emptor, LOL.
Loosely similar PR from 2020: #msg-155310524.
Here you go friend: https://archive.ph/Nh2Yq
Given what we now know about Viking's subQ and oral data, what price could the company command in a potential bidding war? $20B? $25B?
AVTX is +250% in AH trading. The outgoing CEO of AlmataBio (the private company AVTX is acquiring) is Patrick Crutcher, who used to be a co-moderator of this message board.
This deal is structured as a regular-way merger, but it’s conceptually a reverse-merger insofar as AVTX’s lead asset is the one they just licked up from AlmataBio.
$avtx
Avalo acquires Phase 2-ready anti-IL-1ß mAb, AVTX-009, through acquisition of AlmataBio, Inc.
Topline results from planned Phase 2 trial in hidradenitis suppurativa expected in 2026
Executed private placement financing of up to $185 million, including initial upfront investment of $115.6 million; expected to extend cash runway into 2027
Webcast to be held tomorrow, March 28, 2024 at 8:30 a.m. E.T.
$PDSB
$PDSB management team is living the dream with shareholders like this person.
— Adam Feuerstein ✡️ (@adamfeuerstein) March 27, 2024
Please, take more of my money!!!! pic.twitter.com/Y3eKD50H2L
NVO Ozempic costs- Bloomberg ran a similar story but most of it is behind a paywall and I don't subscribe. Here was the headline there:
Ozempic, Novo’s $1,000 Diabetes Shot, Can Be Made for Under $5 a Month
-Active ingredient in Ozempic costs 7 cents a dose, study finds
-Novo says it’s invested billions in research and production
WorstLuck
The key to me is that they're spending $1.47 in Q4 ($1.58 last year) for every $1.00 in sales after one year. So if the RHA is not growing it'll put more pressure on Daxi before we see any return.
Market watch ( as of 3/15/24) = % OF FLOAT SHORTED
17.93%
Ozempic manufacturing costs could be 89c per month, study finds
Novo Nordisk's (LLY) Ozempic could be manufactured for 89c to $4.73 for one month's supply, according to an investigation published in JAMA Network Open.
The study asks what prices of insulins, sodium-glucose cotransporter inhibitors and glucagonlike peptide 1 agonists could be if they were closer to the cost of production. "High prices limit access to newer diabetes medicines in many countries. The findings of this study suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally," the paper states.
The study argues that prices could decrease to $1.30 per month for treatment with SGLT2Is and under 75c for treatment with GLP1As. Further price reductions will likely become possible once a robust global generic and biosimilar market emerges, it adds.
Read more at:
https://thefly.com/n.php?id=3888598
On the CC , it was like the 3rd rail seeing not 1 of the analysts ( respectable peeps,-GS, MS, RJ, etc.) asked( if my recall is correct) …mgmt didn’t even guide (LYFGENIA- sickle cell) with clarity other than to say 50% of the 85-100 patient starts across 62 qualified treatment centers (QTCs) …a Q&A regarding TAM ( worldwide-all 3 fda approved indications ) was mid single digits ( ~3B+I believe)… so it’s wait and see what Q1, 24’ conf call suggests..
My take away is that they are going at this alone
( US) and will consider collaborating in other countries once they understand Payers & Regulations and who to dance with ….
Market digesting late 10k /amend and maybe short covering perhaps( thought I saw 15-18%)
What is BLUE’s guidance with respect to attaining profitability?
Yes(accounting screw-ups), AND this management burns exorbitant amounts of cash consistently, but the Hercules Credit Facility should provide runway until Q1, 2026 per CC 🙏
Q1/2, 24’ should be decent considering several patients (ZYNTEGLO, SKYSONA) starts (cell collections) and Sickle cell( LYFGENIA) in Q3/4…
Hopefully Kevin Tang continues to build position(~1.7mm sh), as well as other Funds…
This kind of reminds me of RV*C, not sure what Rollout has been worse! ( and perhaps Mgmt) :(
However, Long both and accumulating 🙏
PIRS terminates all R&D—becomes royalty-collection vehicle:
https://finance.yahoo.com/news/pieris-pharmaceuticals-announces-strategy-maximize-120000564.html
Recent Biotech Bankruptcies/Liquidations/Dissolutions
[Added AMPE, BTTX, GMDA, and NBSE.]
*Emerged from bankruptcy as FCSC.
iHub
Company Date Reference
ADLS 5/11 #msg-62813901
AFFY 6/14 #msg-103663749
AGIX 1/09 #msg-35019458
AKAO 4/19 #msg-148227772
ALNA 9/22 #msg-169875553
ALPIX.PA 11/23 #msg-173275218
ALTU 11/09 #msg-43509933
AMB.TO 8/09 #msg-40145970
AMPE 4/24 #msg-174111257
ANSV 1/10 #msg-45161615
ARAV 1/24 #msg-173646720
ARDM 2/19 #msg-146903332
ARLZ 8/18 #msg-142824112
ARNI 12/17 #msg-137120846
ARTE 12/08 #msg-33895436
ASP.TO 1/23 #msg-171046860
ATHX 1/24 #msg-173589749
ATNX 5/23 #msg-171913749
AXLA 12/23 #msg-173374718
BAXS 11/14 #msg-108147336
BCART.BR 9/23 #msg-172903024
BIND 5/16 #msg-122328088
BIOA 5/18 #msg-140549553
Biolex 7/12 #msg-77324773
BPUR 7/09 #msg-39629524
BTTX 3/24 #msg-174037486
BVTI‡ 3/13 #msg-85440257
CALA 1/23 #msg-170898055
CBIO 6/22 #msg-169273606
CDAK 3/23 #msg-171544942
CJB.TO 7/10 #msg-52557510
CHKT 12/08 #msg-33949508
CLSC 8/09 #msg-40685152
CLVS 12/22 #msg-170599077
CRXT 9/22 #msg-170229149
CWBR 11/23 #msg-173138450
DCGN 11/09 #msg-43629379
DDXS 6/16 #msg-123229557
DMK 2/24 #msg-173773814
DNDN 11/14 #msg-108004147
DXTR 12/17 #msg-136829445
Egenix 1/15 #msg-109921347
ENDP 8/22 #msg-169707980
Epix† 7/09 #msg-39900524
EPRS 7/16 #msg-123687350
EYES 6/20 #msg-156388471
FRTX 9/23 #msg-172854853
GMDA 3/24 #msg-174125313
GNCA 5/22 #msg-168957883
GNTA 8/12 #msg-78123007
GTOP 9/08 #msg-32249160
HEMA 4/12 #msg-74167597
HGEN 7/23 #msg-172432338
HSTO 9/23 #msg-172847239
ILIU 7/17 #msg-133264435
IMMG 8/17 #msg-134305213
IMNP 2/19 #msg-146936897
IMV 5/23 #msg-171814610
INFI 10/23 #msg-172941539
Inspiration 10/12 #msg-81024196
INSY 6/19 #msg-149302493
Introgen†† 12/08 #msg-33947783
Isolagen* 6/09 #msg-38746197
KBIO 12/15 #msg-119489701
KLDO 4/22 #msg-168491485
KV.A 8/12 #msg-78203130
LBPS 6/22 #msg-169255625
LHDX 2/22 #msg-171275021
LIAN 2/24 #msg-173835088
LMDX 12/23 #msg-173530663
MACK 2/24 #msg-173845049
MBRK 4/10 #msg-49658072
MBVX 3/19 #msg-151985211
MIIS 11/08 #msg-33720220
MIPI 12/10 #msg-57646943
MLNT 12/19 #msg-153074747
MNK 10/20 #msg-158843178
MRV.TO 3/23 PR link
NBSE 3/24 #msg-174119874
NEXI 11/23 #msg-173152495
NMTI 4/11 #msg-62251315
NMTR 7/23 SEC link
NOVN 7/23 #msg-172361873
NRGX 3/12 #msg-73415156
NRX 5/16 #msg-122331475
NSTG 2/24 #msg-173773766
NVDL 2/17 #msg-128923029
NVIV 2/24 #msg-173755991
NVLN 1/20 #msg-153111867
NVTA 2/24 #msg-173844970
OBSN.SW 2/24 #msg-173937364
ODT 3/21 #msg-162706983
ONCR 6/23 #msg-172037432
ONCS 6/23 #msg-172145325
OREX 3/18 #msg-139213097
ORPH 3/22 #msg-168169591
OSCI 7/09 #msg-39511719
OTIC 12/22 #msg-170737355
PEAR 4/23 #msg-171639648
PHAS 10/22 #msg-170272758
PLXP 4/23 #msg-171677346
PROMO.ST 10/23 #msg-173007859
PTX 2/19 #msg-146937356
PYMX 4/13 #msg-86313192
PZRX 12/17 #msg-136794351
QTNT 12/22 #msg-170676963
RCPI 8/16 #msg-127560117
REX 11/08 #msg-32189097
ROKA 8/17 #msg-133945967
ROSG 6/18 #msg-141797330
RUBY 2/22 #msg-171270235
RVALL 1/20 #msg-153358221
RVLP 10/23 #msg-173007859
RXPC 7/14 #msg-104103329
SCLX 2/23 #msg-171193757
SGYP 12/18 #msg-145394802
SIEN 2/24 #msg-173834941
SIGA 9/14 #msg-106313111
SIOX 12/22 #msg-170699458
SNNA 9/19 #msg-151196707
SPHS 5/20 #msg-155712447
SRGA 6/23 #msg-172201878
SRNE 2/23 #msg-171193757
SVNT 10/13 #msg-92997648
TDLP 6/11 #msg-64744114
TLCV 12/09 #msg-44751578
TMBR 11/23 #msg-173254229
TOMDF 12/23 #msg-173490278
TPPH 2/08 #msg-26765260
VION 12/09 #msg-44654555
VLRX 2/20 #msg-153741993
VRA 10/07 #msg-18053275
VRAY 7/23 #msg-172361873
VVUS 7/20 #msg-156752080
ZSAN 6/22 #msg-169035970
GMDA—(-82%)—announces “packaged bankruptcy” recapitalization:
https://finance.yahoo.com/news/gamida-cell-announces-commencement-restructuring-110000176.html
AVIR completes enrollment of phase-3 COVID trial—cancels interim analyses:
https://www.globenewswire.com/news-release/2024/03/27/2853010/0/en/Atea-Pharmaceuticals-Completes-Patient-Enrollment-in-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Oral-Antiviral-Bemnifosbuvir-for-COVID-19-in-High-Risk-Patients.html
Atea Pharmaceuticals…today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort… The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients.
“Since full enrollment was achieved ahead of the two planned interim analyses for safety and futility by the Data Safety Monitoring Board (DSMB), the analyses are no longer relevant, and in agreement with the DSMB, we will proceed to the full analysis of the trial. We look forward to reporting SUNRISE-3 results in the second half of 2024…
Jbog: I have no idea on RHA. Expanding Daxi sales would seem to be a driver of sales there, no?
potentially as late as Friday.
HOTH cites AI and obesity drugs_in_same_PR and gets only a 3% bump, LOL:
Hoth Therapeutics' Wholly Owned Subsidiary Merveille.ai, Advances AI-Driven Discovery for Obesity Treatment
Lots of differing opinions on how much muscle loss comes with weight loss and for what reason. Obviously, you will get different percentages based on what your base BMI is but then it is be affected by lots of factors like how much exercise one does while in caloric deficit and/or how much protein is consumed.
I posted on ALT claim as I believe going forward, how much muscle is lost while on a weight loss drug will become a battleground between different drugs and an important market segment. Their specific claim was "only 25.5% from lean mass, comparable to the effects historically associated with weight loss from diet and exercise programs,” Anecdotally, I believe the general consensus is that 30%-40% of the typical weight loss for an obese individual is muscle. (BTW- A big problem occurs when people yo-yo back up as the weight they put back on is disproportionately higher in fat) . An article I reference below says the muscle loss figure is one third, so take your pick as to what an "average/typical" number is.
“When we look at weight reduction from any intervention, about one-third of the weight we lose tends to be lean mass, and that can be problematic,” said Dr. Jaime Almandoz, an associate professor of internal medicine in the Division of Endocrinology at UT
A 2021 clinical trial that tested the weight loss effects of Wegovy found that while about 40% of the weight people lost tended to be lean mass, including muscle, at the end of 68 weeks, people who took the drug had a lower risk of heart disease and better physical function compared to a placebo group.
Studies showed similar results for the drug tirzepatide, which is sold under the brand name Mounjaro. In a phase 3 clinical trial, “a reduction in lean mass was reported at a similar rate as what is seen in lifestyle-based treatments for obesity,” Jessica Thompson, a spokesperson for tirzepatide-maker Eli Lilly, said in an emailed statement
A new analysis of data from the same trial found that after 72 weeks of taking the drug, about 25% of the weight participants lost was lean mass. However, the participants had an overall healthier body composition. Aronne, who worked on the trial, presented the findings this week at the European Congress on Obesity in Dublin.
How do these lean tissue numbers compare to VKTX and other drugs in this space
Our data show that 74.5% of weight loss was derived from adipose tissue and only 25.5% from lean
Altimmune Announces Positive Lean Mass Preservation Data for Pemvidutide along with 4thQ/yearend results:
“We are extremely pleased with the results of the body composition analysis from our recently completed MOMENTUM 48-week Phase 2 obesity trial of pemvidutide. Our data show that 74.5% of weight loss was derived from adipose tissue and only 25.5% from lean mass, comparable to the effects historically associated with weight loss from diet and exercise programs,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune.
“Based on compelling weight loss, a clean safety profile, robust reductions in serum lipids and blood pressure, and now preservation of lean mass observed in our clinical trials, we believe that pemvidutide has the potential to distinguish itself broadly from other therapies for the treatment of obesity.
We also remain excited about the outcome of our ongoing IMPACT Phase 2b MASH trial with topline 24-week data on the key endpoints of MASH resolution or fibrosis improvement anticipated in the first quarter of 2025. The results from a recently completed preclinical study demonstrating direct anti-fibrotic activity of pemvidutide only adds to our optimism about achieving a positive outcome in this trial.”
FDA approves MRK’s Winrevair—(sotatercept)—for PAH:
https://www.businesswire.com/news/home/20240326077272/en
This is the first approved drug for PAH that is thought to be disease modifying. MRK acquired sotatercept in the $11.5B buyout of XRLN in 2021 (#msg-166156870).
There is data that shingrix (and before that zostavax) is associated with lower rates of dementia.
RVNC
In 4th q 22 sales were $34.7m and 2023 sales were $30.3, $31.7, $32.1 and $34.5 for the 4 quarters. Total sales year over year were nice but I'm not sure why it looks they hit a wall.
Thanks. See #msg-174114321 for more color on the same topic.
$VKTX conference call done- Summary
— Pharmdca (@Pharmdca) March 26, 2024
1) Safety profile similar to placebo even at high dose of 40mg
2) Expecting higher dose cohorts, no disclosure on how many in ph2
3) High placebo effect due to small N and diarrhea in placebo arm
4) Expecting placebo effect to move back…
$VKTX there’s seems to be no side effects with oral drug even at high doses
— Pharmdca (@Pharmdca) March 26, 2024
Profile like placebo
Remember- $VKTX is the only, only dual agonist and GIP agonist helping with counterbalancing GI side effects
✅✅
NBSE prepares for dissolution:
https://www.sec.gov/Archives/edgar/data/1173281/000110465924038432/tm249597-1_pre14a.htm
To Our Stockholders:
You are cordially invited to attend a Special Meeting of Stockholders (the “Special Meeting”) of NeuBase Therapeutics, Inc. (the “Company”) to be held on May 13, 2024, at 8:30 a.m., Eastern Time, exclusively online via live audio-only webcast.
The purpose of the Special Meeting is to approve the liquidation and dissolution of the Company (the “Dissolution”) and the Plan of Liquidation and Dissolution (the “Plan of Dissolution”), which, if approved, will authorize the Company’s Board of Directors (the “Board”) to liquidate and dissolve the Company in accordance with the Plan of Dissolution.
NKTX 9.87 - the April19-$10-Call Option is currently bidding at $1.10. Their recent K filing showed $5+ cash remaining and they just secondaried at $10 which should put them well above $5+ cash per share accompanied by some upcoming inevitable touting...one can only hope the option premiums remain this high?
https://finance.yahoo.com/news/nkarta-announces-pricing-240-million-103000060.html
New and existing investors participated in the offering, including Adage Capital Partners LP, Boxer Capital, Commodore Capital, Cormorant Asset Management, an affiliate of Deerfield Management, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, Ridgeback Capital Investments, Samsara BioCapital, SR One, and a leading mutual fund.
BLUE—(-13%)—discloses accounting screw-up—issues 2024 patient-start guidance:
https://finance.yahoo.com/news/bluebird-bio-reports-fourth-quarter-110100135.html
On March 26, 2024, bluebird announced that it will restate its consolidated financial statements for 2022, and for the first three quarters of both 2022 and 2023 in its Annual Report on Form 10-K for the year ended December 31, 2023 (the "2023 Form 10-K"). The restatements relate to the identification of embedded leases and the treatment of non-lease components contained in lease agreements with contract manufacturers. As a result, the Company anticipates recording an increase in lease assets and lease liabilities, as well as an increase in non-cash interest expense in each restated period.
VKTX up 20%, enta up 17% riding its coattails (just kidding i have no clue why enta also up today could be something on the legal front but nothing obvious that I can find https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc)
SWAV. (Reuters)
-Johnson & Johnson is in talks to buy medical device maker Shockwave Medical, the Wall Street Journal reported on Tuesday, with a deal likely to help the healthcare giant expand its presence in cardiovascular devices.
Shockwave, a company that makes devices to treat heart disease, has a market capitalization of around $11 billion, according to LSEG data.
A deal could be finalized in the coming weeks, assuming talks don't fall apart, and it is also possible another suitor could emerge, the report said, citing people familiar with the matter.
FIXX—>QTTB, pursuant to previously announced reverse-merger:
https://www.prnewswire.com/news-releases/q32-bio-announces-closing-of-merger-with-homology-medicines-and-concurrent-private-placement-of-42-million-302098557.html
MRNA’s next-gen COVID vaccine produces_stronger immune response_than Spikevax:
https://www.accesswire.com/846784/moderna-achieves-positive-interim-results-from-phase-3-trial-of-next-generation-covid-19-vaccine
The next-gen vaccine, mRNA-1283, also has a longer shelf life and less onerous storage requirements compared to Spikevax.
OT
[Dementia is] not even a little bit good for those around you. That may require some thought and personal choices made early in the progression...
Yes the cause is probably multi factorial and the disease heterogeneous as well
VKTX cc on VK2735 was very well received by the analyst community. Most seemed amazed by the tolerability/safety results. Here are some initial thoughts:
Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Oral Tablet Formulation of Dual GLP-1/GIP Receptor Agonist VK2735
https://ir.vikingtherapeutics.com/2024-03-26-Viking-Therapeutics-Announces-Results-from-Phase-1-Clinical-Trial-of-Oral-Tablet-Formulation-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735
Insider-trading trial against Medivation executive tests_the_definition_of_the_term:
https://finance.yahoo.com/news/sec-tests-insider-trading-theory-000517436
The civil trial that began Monday in San Francisco will answer the novel question of whether buying or selling another company’s stock based on specialized industry knowledge constitutes insider trading.
… Securities traders and lawyers are closely watching the San Francisco case of Matthew Panuwat, the SEC’s first attempt to pursue so-called shadow trading. It also underscores how Congress has never explicitly defined insider trading, leaving courts to decide when the SEC oversteps its authority.
… Seven minutes after receiving an August 2016 email from Medivation’s CEO that said Pfizer Inc. was interested in acquiring it, Panuwat invested more than $117,000, or almost half of his annual salary, on call options in rival Incyte Corp., according to the agency.
Pfizer announced the $14 billion Medivation deal days later. By taking one mid-cap biopharma company off the market, the deal made Incyte a more valuable acquisition target, the SEC alleged in its suit against Panuwat.
AMPE voluntarily delists—prepares for likely liquidation:
https://finance.yahoo.com/news/ampio-announces-voluntary-delisting-sec-210000274.html
…the Board has determined that it is in the Company's best interests that the Company take steps designed to ensure sufficient cash to adequately fund an orderly wind down of the Company's operations…
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