August 25, 2025 • 24 mins
There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.
The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.
View full story: https://www.biocentury.com/article/656849
#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO
00:00 - Introduction
02:48 – LB Pharma Tests IPO Market
07:01 – Hong Kong IPO Momentum
09:53 – China Summit Preview
13:40 – FDA Reversal on Stealth Bio
18:15 – Bayh-Dole Clash & Innovation Threats
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
[AI-generated transcript.]
Jeff Cranmer (00:01):
There's been a rarity on NASDAQ as late
last week LB Pharma filedto go public on the market.
This comes as green shootscontinue to appear on the
Hong Kong stock exchange.
We'll discuss the state ofthe market for fresh paper,
(00:23):
on the latest BioCentury ThisWeek, plus the latest twist
in Stealth Biotherapeuticsdecade long regulatory
rollercoaster is FDA's aboutface on Stealth's Barth syndrome
application, a positive signfor rare disease therapies,
air piece, and the university.
(00:44):
Industry engine that drivesU.S. innovation is under attack.
So says David Beyer and JohnOsborne in a guest commentary
in BioCentury, and we'll hearfrom our colleague on the BD
side, Josh Berlin as he getsready to head to Asia for a
couple of big events this fall.
(01:05):
I'm Jeff Cranmer joiningme today on the BioCentury
This Week podcast.
Are my colleagues.
Steve Usdin (01:10):
Steve Usdin, Washington Editor.
Paul Bonanos (01:12):
Paul Bonanos, Director of
Biopharma Intelligence.
Josh Berlin (01:15):
And Josh Berlin, Head of Business Development.
Jeff Cranmer (01:17):
Excellent.
Well, we received a few commentsfrom listeners, uh, last week.
one was, Hey, you guysstart talking about Japan.
there's more, biotechin Asia than just.
China.
so I promise that we'll becoming in an upcoming episode.
I have a Japan story thatit was coming out soon.
Uh, it'll give us somefodder to chat about
(01:39):
things, biotech in Japan.
Uh, in the meantime, I dowanna give a shout out to
Ken Horn, who's on ventures.
recently closed itsdebut, Japan focused fund.
We also received a note froma long time listener who is a
licensing and patent attorneywho recently headed over to
(01:59):
China and he wanted to sharesome of his takeaways, but had
a little trouble getting themto us, and so I had to learn how
all this works by working withour production engineer Cole.
The Reach us by sending atext link in our episode
description is a one way street.
That you can use ona mobile device, for
(02:20):
listeners to post comments.
We can see your messages.
We can't reply strangelyenough, so feel free to
send your comments via emailto podcasts@BioCentuy.com,
which is our address.
If you want feedback fromus, we'd love to hear from
this longtime listenerand get his take on what,
(02:42):
he or she is, uh, seeing.
On the ground in China, Ican also be re reached via
LinkedIn, Alright, well,Paul, you signed off Friday to
hit the swampy Little LeagueDiamonds of Gainesville.
And surprise me by popping backon late last, Friday night to
file a story, on an IPO filing.
(03:03):
I guess the rare nature ofthis, uh, little bit of news,
not, not an IPO pricing mindyou, just a filing, was enough
to get you back to your desk.
what can you tell us Paul?
Paul Bonanos (03:16):
They, there have not been very many of those
lately, and, uh, when they landthey tend to land late Friday.
So, as you know, and as yousaid, the IPO market has
been very quiet, for biotechslooking to get out on nasdaq.
We haven't really seenanything substantial buy a
therapeutics pure play rather,in more than six months now,
uh, there have been a coupleof very small offerings,
but nothing bigger than.
(03:36):
You know, we usually putthe floor at 25 million,
for what we think of as amore substantial offering.
Um, and the companytesting the market this
time is LB Pharmaceuticalsbased in New York.
It's more or less a singleasset company with a
neuropsychiatry program.
their molecule is called LB-102It's an antagonist of
serotonin and two dopaminereceptors, D2 and D3.
(04:00):
There's a generic drug availablein Europe called amisulpride,
and this is a methylatedformulation of amisulpride,
with some dosing and potencyadvantages, and, uh, result
in IP protection as well.
and as we've said a few timesover the past few years since
IPO started becoming scarce,the best candidates to get out,
generally have some clinicaldata and LB indeed has some.
(04:23):
In January they announced PhaseII data showing a treatment
effect in schizophrenia,significance on a scale
measuring symptoms positiveand negative symptoms.
It's a PANSS scale you mayhave seen, and LB believes
that the study, could serveas one of two pivotal trials.
So it's looking to fund aPhase 3 program now, and
that's where the IPO comes in.
Its cash position isn'tespecially strong right now.
(04:46):
The prospectus says they have$14.2 million in cash and
equivalence at June 30th.
So, uh, maybe a year ofcash for a lien operation.
But they're looking tomove ahead with that second
pivotal trial and thisis how they'll fund it.
they are privately held.
Uh, obviously they'veraised about 120 little
more than $120 million inequity funding thus far.
(05:07):
Some of the top shareholdersI'll name for you, uh, Deep
Track Capital, Vida Ventures,Pontifax and TCG Crossover.
and I, I should also mentionthe company's CEO is Heather
Turner, who was president andCEO at Carmot Therapeutics.
You may remember Rochebuying it in a 2023 deal.
we don't know how muchthey're gonna raise, but
the banks are Leerink,Piper Sandler and Stifel.
(05:28):
which are typically associatedwith substantial raises,
so, we'll, we'll haveto see how demand goes.
remember a couple of companiesthat filed for IPOs didn't
get out this year and, uh,withdrew their offerings.
So, you know, we'll seehow it goes for them.
Stay tuned.
Jeff Cranmer (05:42):
Thanks for that update, Paul, you
mentioned a long droughtsince a few offerings
priced early this year.
who were those companies?
Uh, I recall Metseramaybe being one.
And, and how have theydone in the aftermarket?
Paul Bonanos (05:56):
That is one, and I was actually a little surprised
when I looked this morning.
There were really four pureplay therapeutics companies
that went public in January andFebruary and none since I, I
don't mean to disregard a coupleof life sciences companies
that got out since then.
there's like a cell analysiscompany, Caris Life Sciences,
but among drug developers.
Yes, we had Metsera, ametabolic company, uh, Maze,
(06:17):
doing renal and metabolic,Sionna Cystic Fibrosis Company
and Aardvark, which, uh, hastreatments for hunger disorders,
and it turns out Metsera.
that one is the big winner.
It's almost doubled invalue since pricing.
Um, Sionna is also up.
By about a littlemore, about 35%.
since getting out, Maze is downa few ticks, but not a ton.
(06:41):
And, um, Aardvark not so much.
Um, it hasn't exactly cratered,but it has lost some value.
so aftermarket performancehas not been the worst.
I did mention somewithdrawn offerings as well.
Uh, Odyssey Therapeutics,the immunology company, and
also Aurion Biotech with anophthalmic program they filed in
January and never made it out.
Jeff Cranmer (07:01):
Paul, we've both been watching, uh,
what's happening in HongKong, uh, certainly a bit
more activity than on Nasdaq.
what have you been seeing?
Paul Bonanos (07:08):
There have been a few.
Yes, we've seen some activity,overseas and one company
that went public in Hong Kongrecently, a metabolic company
called Innogen, out this monthand it's performed very well.
It raised about $87 millionU.S. and at Friday's close
it had nearly tripled overits first week of trading.
a little more than a week.
I think it went outthe previous Friday.
(07:31):
Um, and then since then, sinceit priced, there have been two
more companies called LongBioPharma and Shanghai Bao Pharma
that joined the queue last weekto list in Hong Kong as well.
So that's encouraging,especially with lots of
discussion about licensingdeals for assets from China.
Here are some companiesthat are looking to build
sustainable businesses, goingpublic and, gaining value,
(07:52):
once they gain liquidity.
Jeff Cranmer (07:54):
Josh, you're always on the horn
with folks, from Japan,China, India, you name it.
among, white guys from theEast coast, you're probably
the number one we chatter.
what are you hearing?
Josh Berlin (08:08):
maybe I'm an influencer even.
Huh?
Jeff?
Uh, I, you know.
Jeff Cranmer (08:12):
You know.
Josh Berlin (08:13):
Yeah, I, you know, I, I think, um, the Hong Kong
Stock Exchange has really, beena, you know, a, an amazing story
this year that I'm not sure isfully sort of understood by,
by everyone in our network.
but you know, the, the Chinapartnering craze really in
part started because of thebear market in Hong Kong,
(08:33):
and it was really the.
First bear market inbiotech history in China.
And that forced a lot ofcompanies to become, much more
creative in terms of, findingways to, finance the company,
primarily via deal making.
and now you see the deal makingis really starting to have
an impact, I think, on, theHong Kong exchange itself.
(08:55):
So you're, you're seeing.
The IPOs that, you know,Paul was just talking about.
and I think the other thingyou're seeing is, uh, you know,
if you just go look at the, theHang Seng biotech index over
this year, since the beginningof the calendar year, you know,
I think at the beginning of thecalendar year was around 8,000.
It's now around 17,000.
Jeff Cranmer (09:15):
Yep.
Year, year to date up.
Uh, yeah.
Sorry to cut youoff there, Josh.
Year to date up ahundred, and 8%.
And I remember, uh, back inMarch, Josh, you and I were,
uh, hanging out in those,Super cool artificial super
trees in Singapore and, uh,chatting up some bankers
(09:35):
biotech bankers and, at thattime they were still saying,
you know, NASDAQ's the onlygame in town for Asia biotechs.
And, you know, it's,it's changed now.
When I talk to CFOs, they're,looking seriously at Hong Kong.
they're weighing the bestplace to tell their story.
so look, we'll see howthis continues to develop.
Well, first up this willbe a big theme at our
China Healthcare Summit.
(09:57):
that will be in Shanghai.
It will be October 22nd to 24th.
Is that right, Josh?
Josh Berlin (10:04):
correct.
Yeah.
October 22 to 24 in Shanghai.
Jeff Cranmer (10:07):
Excellent.
So this will be abig theme of that.
advanced rates for themeeting, end Friday.
Uh, we're still recruiting,presenting companies.
we have some great names there.
And, we'll have some bignames on the panels as well.
Josh, who do we have?
We have, uh, the CEOsof Duality, Innovent.
Who else do we have?
Josh Berlin (10:25):
Yeah, we have, uh, just sort of a who's who
of, CEOs, like you mentionedduality, Inno vent we have
3SBio Chairman and CEO,Argo Bio, another company
that's, done some deals.
Crystal Q in of LaNova Medicinesjust confirmed, you know, they
were the biotech that was justbought out by Sino Biopharma.
and, Dajun Yang of Ascentagewill be there, you know,
(10:47):
which is a, a dual listed,China biotech, also on NASDAQ.
So it's gonna be a, a reallygood opportunity to meet a
lot of these CEOs that you'vebeen reading about, via all
the deal flow in the news.
Jeff Cranmer (11:00):
not China.
We'll have a great.
Asia Biotech, CEOpanel will have Piers
Ingram of Hummingbird.
we'll have the CEOs of,Gexval from Japan and
Korea's Orem Therapeutics.
the CEO uh, SJ Lee was, recentlya guest on our sister podcast.
the BioCentury show.
(11:22):
and, the CEO ofImmuneel, from India.
I think it should be,uh, quite a fun event.
But you're, before thatyou're heading to Japan,
is that right Josh?
Josh Berlin (11:32):
Yeah, I'm, I'm looking forward to getting
out to, uh, BioJapan thisyear, which I haven't been
to, in a very, very long time.
really thankful to our friendsat, uh, JBA for the invite to
come out there, join a panel.
and sort of see whatBioJapan is all about.
It's become a much, muchbigger event than it used
to be, is my understanding.
And then we're also, uh, gonnabe co-hosting a reception,
(11:54):
for those of you who know,Tim Kendall and his company
ConneKTia in Japan, Tim and,and BioCentury teaming up on
a reception, uh, October 7th,in Yokohama the night before.
BioJapan.
So if you're uh, in town and,and wanna join the reception,
please send, uh, me a note orsend Jeff a note or we'd be
happy to have you join us.,
Jeff Cranme (12:12):
Yeah, Tim is great.
he, really knows his Japan,uh, had a good chat with
him from my Japan story.
Recently and, heknows his stuff.
Alright, we're gonna takea quick break and then we
will, uh, come back and, uh,welcome Mr. Usdin back, from
his travels and talk aboutStealth Biotherapeutics and
IP and quite a bit more.
Alanna Farro (12:35):
By Century this week is brought to
you by the 12th ChinaHealthcare Summit in Shanghai.
From in-licensing to New coscross-border deals from Asia are
transforming global biopharma.
Meet top decision makersand investors at the 12th
China Healthcare Summit.
To explore emergingopportunities and tackle
key challenges in thisrapidly evolving landscape.
(12:55):
Join us in Shanghai,October 22nd to 24.
To get a firsthand lookat China's dynamic life
sciences ecosystem,register and learn more at
BioCentury China summit.com.
Jeff Cranmer (13:11):
We are back.
And Steve, how was the,how was the getaway
Steve Usdin (13:15):
I don't know why I came back to tell.
Jeff Cranmer (13:17):
to, to talk to us?
Yeah.
thank you for sending mea cat picture of the day.
The cats really look like they,uh, they run that country.
All right.
No, no further comment.
Uh, Steve is, uh, wheneverhe is in Turkey or Greece,
he, uh, he always seems toencounter some amazing cats.
But, uh, Steve, you know,I think you, uh, you were
(13:40):
writing about StealthBiotherapeutics when you left.
And, you're gonna writeabout 'em again today.
what's going on here?
There's a bit ofa, an about face.
This is a company that foryears now has been, trying
to get a therapy to the,Barth syndrome, community.
it's community where there isa, uh, dire need for, a therapy.
(14:03):
Steve, what, is going on withthis latest, seeming about face?
Steve Usdin (14:08):
So yeah, look, it's another
extraordinary turn of events.
For stealth andfor, birth patients.
know, as you said,we've been following
this closely for years.
It's a Byzantine story,but basically they've
been getting the runaroundfrom, FDA for years.
The company's bouncedbetween four FDA review
divisions over five years.
during that time, FDA is toldstealth to submit an NDA.
(14:31):
Then gave it a refuseto file letter.
It approved a naturalhistory study design.
Then later declared that theresults are uninterpretable.
at different points, the agencysaid approval would depend on
a new placebo controlled trial,and then said that, it would
be unethical or impossible toconduct that kind of trial.
Last year it seemed like thingswere coming to, to an end.
An advisory committee voted10 to six, that stealth
(14:53):
biotherapeutics had demonstratedsafety and efficacy of
its drug elamipretide.
At the end of May, theFDA issued a complete
response letter.
Big surprise, but it didn't askfor substantial new information.
This was devastating for Barthpatients and for Stealth.
Stealth laid off 30% of itsworkforce, and it said it
didn't know if it would beable to stay in business
(15:14):
long enough to receive aresponse from a resubmission.
The patient community has beenextraordinarily active, in the
media and in lobbying, membersof Congress, the Wall Street
Journal editorial page calledon FDA, commissioner Marty
Makary to approve the drug.
there have been storieson national television
programs last Thursday.
(15:34):
FDA said it would grant a finaldecision on the resubmitted
NDA by September 26th.
That's months earlierthan the deadline.
And what's interesting onFriday, Barth syndrome patients
met with the FDA commissionerand came out of it, really
thrilled and ecstatic.
That's really anextraordinary thing.
I can't think of anothertime when an FDA commissioner
(15:56):
has met with advocates.
For a drug that's under,review, that's pending
review, at the agency.
So yeah, it looks like it'son the verge of granting
accelerated approval.
Something FDA ruled outlast year, based on data
that really hasn't changed,over the last four years.
So if that happens,it'll be great news for
Barth syndrome patients.
(16:17):
But on the whole, I'dsay the, the saga isn't
really good news for raredisease patients at all.
Jeff Cranmer (16:22):
Yeah, that's what I was gonna ask is there
gonna be a read through toother, companies developing
rare disease therapies?
Steve Usdin (16:28):
Well could be, but we, we really
need to see what happens.
First of all, the only reasonit was possible for stealth
to consider developing adrug for Barth, which has
about 150 patients in theU.S., not all of whom would
be candidates for the drug.
Is because it was eligible fora priority review voucher, a
priority review voucher fora rare pediatric disease.
(16:50):
Congress allowed the rarepediatric priority review
program to expire last year.
If it isn't renewed,there aren't gonna be any
more drugs for conditionslike, birth syndrome.
there's no economic case fordoing it in the absence of
a priority review voucher.
Second.
If FDA doesn't create apredictable and rational path
for approval, not one that'sdependent on getting the
(17:13):
Wall Street Journal or NBCNews or BioCentury to report
about you, it's not gonnabe possible to get companies
to invest in this space.
if you think about it, thereare thousands of rare diseases.
It isn't possible to havethis level of advocacy, this
level of public attention.
For all of them.
(17:33):
There needs to beone, there needs to be
priority review vouchers.
So there's an economic casefor, developing therapies for
these very, very rare diseases.
And there needs to be apredictable, rational FDA,
review process, that canget these, drugs approved
or, or not, but at leasta decision made on them.
in a reasonable periodof time, requiring the
(17:55):
level of, evidence that'sappropriate for the disease.
There has to be scientificrigor, but there also has to
be, a possibility for makingthis happen, and companies
and patient groups need toknow in advance what that
path is gonna look like.
Jeff Cranmer (18:08):
All right.
And, you'll be able tofind Steve's story, on
BioCentury podcast.com.
And, Steve, we adda guest commentary.
We published last week, DavidBeier, who's managing director
of Bay City Capital, and JohnOsborn, who's a professor of law
at the University of Washington,they argued that the university
(18:31):
industry engine driving U.S.
innovation is under attack.
What's your take on this?
Steve Usdin (18:38):
So here's the thing that precipitated it.
President Trump demandedthat Harvard account for its
compliance with the Bayh-Doleobligations across its entire
portfolio of almost 6,000patents arising from research
that was supported in wholeor in part with federal funds.
That's an extraordinary demandfor a couple of reasons.
(18:59):
the idea of the federalgovernment exercising, marching
rights on Bayh-Dole has been,anathema to Republicans.
Traditionally.
and the idea that auniversity would have to
go back retroactively andjustify all of the patents
that it's ever received,basically part, from federal
(19:19):
funding, is extraordinary.
What, David Byer, who bythe way was, years and
years ago was a domesticpolicy advisor for Al Gore.
he had senior positionsat, Genentech and at Amgen.
and as you mentioned,he's, at Bay City Capital.
what they argue is thatthis is retaliation
for the universities.
first amendmentprotected speech.
(19:39):
and basically they saythat by going after Harvard
on this, that, the Trumpadministration is creating
a threat t o the entire,American biopharma industry.
Here's a quote from theend of their commentary.
They say, "business leaders,especially those in the
life sciences and technologysectors, must recognize that
misguided attacks on researchuniversities threaten our
(20:02):
innovation infrastructure,and they must raise their
voices accordingly." theyurge countervailing advocacy
to support Harvard and otherresearch universities, and they
say that "a failure to enjointhis counterproductive and
illegal exercise of presidentialpower will lead to predictably
disastrous effects, underminingintellectual property rights
(20:23):
and limiting economic growth."
Jeff Cranmer (20:25):
All right, and you can find their guest commentary
on BioCentury podcasts.
Com, that is infront of the paywall.
I'll also drop a link in theshow notes, Also on BioCentury
dot com, how China speedis reshaping cross-border
business development.
(20:45):
A perspective, by Joshand myself, looking at
how deals are rapidly.
Evolving as China biotechsare gaining more leverage
at the negotiating tablewith Western companies.
And, Simone, had a greatconversation on our sister
podcast with Annalisa Jenkins.
(21:06):
she is, an influencer, inbiotech to say the least.
she is, uh, currently chairof Gemma Therapeutics and.
She and Simone talked aboutthe future of MHRA and, really
dug deep into where thingsare in the U.K. right now as
(21:27):
that biotech hub continuesto grow and our Back to
School issue is out now.
Steve, uh, wrote, uh, itwasn't as short as, uh,
you know, I was, uh, I wasled to believe it would be.
It's a a seven story, seriesand Steve will be joining
Simone, on our sister podcast,The BioCentury Show, first week
(21:49):
of September, and there'll bedigging deep into the issues.
Steve, top line,what's it all about?
Steve Usdin (21:55):
Basically what I did was I said, look, imagine
that you were starting from ablank sheet of paper and you
wanted to reimagine what medicalproducts regulation in the
United States would look like.
What would you do?
and I followed that through.
I talked to a number ofthought leaders, current and
former FDA officials, formerFDA commissioners, CEOs of
biotech companies, patientadvocates, the opinion leaders.
(22:18):
And, there were somecommonalities, some things that
they all agreed on, some thingsthat there was a little bit of,
Disagreement about my conclusionis that if you were going to
start over again, and I thinkthat at some point it's going
to be necessary to do this,one of the things you would do
would be to separate out medicalproduct regulation from the
regulation of foods, cosmetics,tobacco and veterinary products.
(22:41):
I also call for, reorganizingthe medical products regulation.
Primarily around therapeuticareas using the Oncology Center
of Excellence as a model forthe way that other therapeutic
areas, could be organized.
and abolishing the distinctionsbetween, the Center for
Biologics in this Centerfor Drugs in the long run.
(23:02):
I think also eliminatingthe Center for Devices.
I think that those arekind of outmoded ways of
thinking about things and,and organizing regulation.
There's a lot more toit, uh, as you said.
We'll, we'll get into the,um, details of it, with
Simone when we do showconversation about it.
Jeff Cranmer (23:19):
you can find the entire back to school
package on BioCentury.com.
I'll drop a linkin the show notes.
This is our 33rd back to school.
We've been doing it every yearsince David Flores and Karen
Bernstein founded BioCentury.
More than three decades agoand back to school is a forward
looking package that looksat a broad issue critical
(23:41):
to the biopharma industry.
All right.
Well thank you to Josh, Pauland Steve, for joining me today.
And thank you to Cole Travis,our production engineer, And
of course, Kendall SquareOrchestra, which provides the
music for BioCentury this week.
Tickets are now on sale for thegroup's eighth season, they'll
(24:02):
be rocking some Mahler, someBrahms, and you can find more
by going to their website.
for tuning in.
we will catch you next week.
[AI-generated transcript.]
Jeff Cranmer (00:01):
There's been a rarity on NASDAQ as late
last week LB Pharma filedto go public on the market.
This comes as green shootscontinue to appear on the
Hong Kong stock exchange.
We'll discuss the state ofthe market for fresh paper,
(00:23):
on the latest BioCentury ThisWeek, plus the latest twist
in Stealth Biotherapeuticsdecade long regulatory
rollercoaster is FDA's aboutface on Stealth's Barth syndrome
application, a positive signfor rare disease therapies,
air piece, and the university.
(00:44):
Industry engine that drivesU.S. innovation is under attack.
So says David Beyer and JohnOsborne in a guest commentary
in BioCentury, and we'll hearfrom our colleague on the BD
side, Josh Berlin as he getsready to head to Asia for a
couple of big events this fall.
(01:05):
I'm Jeff Cranmer joiningme today on the BioCentury
This Week podcast.
Are my colleagues.
Steve Usdin (01:10):
Steve Usdin, Washington Editor.
Paul Bonanos (01:12):
Paul Bonanos, Director of
Biopharma Intelligence.
Josh Berlin (01:15):
And Josh Berlin, Head of Business Development.
Jeff Cranmer (01:17):
Excellent.
Well, we received a few commentsfrom listeners, uh, last week.
one was, Hey, you guysstart talking about Japan.
there's more, biotechin Asia than just.
China.
so I promise that we'll becoming in an upcoming episode.
I have a Japan story thatit was coming out soon.
Uh, it'll give us somefodder to chat about
(01:39):
things, biotech in Japan.
Uh, in the meantime, I dowanna give a shout out to
Ken Horn, who's on ventures.
recently closed itsdebut, Japan focused fund.
We also received a note froma long time listener who is a
licensing and patent attorneywho recently headed over to
(01:59):
China and he wanted to sharesome of his takeaways, but had
a little trouble getting themto us, and so I had to learn how
all this works by working withour production engineer Cole.
The Reach us by sending atext link in our episode
description is a one way street.
That you can use ona mobile device, for
(02:20):
listeners to post comments.
We can see your messages.
We can't reply strangelyenough, so feel free to
send your comments via emailto podcasts@BioCentuy.com,
which is our address.
If you want feedback fromus, we'd love to hear from
this longtime listenerand get his take on what,
(02:42):
he or she is, uh, seeing.
On the ground in China, Ican also be re reached via
LinkedIn, Alright, well,Paul, you signed off Friday to
hit the swampy Little LeagueDiamonds of Gainesville.
And surprise me by popping backon late last, Friday night to
file a story, on an IPO filing.
(03:03):
I guess the rare nature ofthis, uh, little bit of news,
not, not an IPO pricing mindyou, just a filing, was enough
to get you back to your desk.
what can you tell us Paul?
Paul Bonanos (03:16):
They, there have not been very many of those
lately, and, uh, when they landthey tend to land late Friday.
So, as you know, and as yousaid, the IPO market has
been very quiet, for biotechslooking to get out on nasdaq.
We haven't really seenanything substantial buy a
therapeutics pure play rather,in more than six months now,
uh, there have been a coupleof very small offerings,
but nothing bigger than.
(03:36):
You know, we usually putthe floor at 25 million,
for what we think of as amore substantial offering.
Um, and the companytesting the market this
time is LB Pharmaceuticalsbased in New York.
It's more or less a singleasset company with a
neuropsychiatry program.
their molecule is called LB-102It's an antagonist of
serotonin and two dopaminereceptors, D2 and D3.
(04:00):
There's a generic drug availablein Europe called amisulpride,
and this is a methylatedformulation of amisulpride,
with some dosing and potencyadvantages, and, uh, result
in IP protection as well.
and as we've said a few timesover the past few years since
IPO started becoming scarce,the best candidates to get out,
generally have some clinicaldata and LB indeed has some.
(04:23):
In January they announced PhaseII data showing a treatment
effect in schizophrenia,significance on a scale
measuring symptoms positiveand negative symptoms.
It's a PANSS scale you mayhave seen, and LB believes
that the study, could serveas one of two pivotal trials.
So it's looking to fund aPhase 3 program now, and
that's where the IPO comes in.
Its cash position isn'tespecially strong right now.
(04:46):
The prospectus says they have$14.2 million in cash and
equivalence at June 30th.
So, uh, maybe a year ofcash for a lien operation.
But they're looking tomove ahead with that second
pivotal trial and thisis how they'll fund it.
they are privately held.
Uh, obviously they'veraised about 120 little
more than $120 million inequity funding thus far.
(05:07):
Some of the top shareholdersI'll name for you, uh, Deep
Track Capital, Vida Ventures,Pontifax and TCG Crossover.
and I, I should also mentionthe company's CEO is Heather
Turner, who was president andCEO at Carmot Therapeutics.
You may remember Rochebuying it in a 2023 deal.
we don't know how muchthey're gonna raise, but
the banks are Leerink,Piper Sandler and Stifel.
(05:28):
which are typically associatedwith substantial raises,
so, we'll, we'll haveto see how demand goes.
remember a couple of companiesthat filed for IPOs didn't
get out this year and, uh,withdrew their offerings.
So, you know, we'll seehow it goes for them.
Stay tuned.
Jeff Cranmer (05:42):
Thanks for that update, Paul, you
mentioned a long droughtsince a few offerings
priced early this year.
who were those companies?
Uh, I recall Metseramaybe being one.
And, and how have theydone in the aftermarket?
Paul Bonanos (05:56):
That is one, and I was actually a little surprised
when I looked this morning.
There were really four pureplay therapeutics companies
that went public in January andFebruary and none since I, I
don't mean to disregard a coupleof life sciences companies
that got out since then.
there's like a cell analysiscompany, Caris Life Sciences,
but among drug developers.
Yes, we had Metsera, ametabolic company, uh, Maze,
(06:17):
doing renal and metabolic,Sionna Cystic Fibrosis Company
and Aardvark, which, uh, hastreatments for hunger disorders,
and it turns out Metsera.
that one is the big winner.
It's almost doubled invalue since pricing.
Um, Sionna is also up.
By about a littlemore, about 35%.
since getting out, Maze is downa few ticks, but not a ton.
(06:41):
And, um, Aardvark not so much.
Um, it hasn't exactly cratered,but it has lost some value.
so aftermarket performancehas not been the worst.
I did mention somewithdrawn offerings as well.
Uh, Odyssey Therapeutics,the immunology company, and
also Aurion Biotech with anophthalmic program they filed in
January and never made it out.
Jeff Cranmer (07:01):
Paul, we've both been watching, uh,
what's happening in HongKong, uh, certainly a bit
more activity than on Nasdaq.
what have you been seeing?
Paul Bonanos (07:08):
There have been a few.
Yes, we've seen some activity,overseas and one company
that went public in Hong Kongrecently, a metabolic company
called Innogen, out this monthand it's performed very well.
It raised about $87 millionU.S. and at Friday's close
it had nearly tripled overits first week of trading.
a little more than a week.
I think it went outthe previous Friday.
(07:31):
Um, and then since then, sinceit priced, there have been two
more companies called LongBioPharma and Shanghai Bao Pharma
that joined the queue last weekto list in Hong Kong as well.
So that's encouraging,especially with lots of
discussion about licensingdeals for assets from China.
Here are some companiesthat are looking to build
sustainable businesses, goingpublic and, gaining value,
(07:52):
once they gain liquidity.
Jeff Cranmer (07:54):
Josh, you're always on the horn
with folks, from Japan,China, India, you name it.
among, white guys from theEast coast, you're probably
the number one we chatter.
what are you hearing?
Josh Berlin (08:08):
maybe I'm an influencer even.
Huh?
Jeff?
Uh, I, you know.
Jeff Cranmer (08:12):
You know.
Josh Berlin (08:13):
Yeah, I, you know, I, I think, um, the Hong Kong
Stock Exchange has really, beena, you know, a, an amazing story
this year that I'm not sure isfully sort of understood by,
by everyone in our network.
but you know, the, the Chinapartnering craze really in
part started because of thebear market in Hong Kong,
(08:33):
and it was really the.
First bear market inbiotech history in China.
And that forced a lot ofcompanies to become, much more
creative in terms of, findingways to, finance the company,
primarily via deal making.
and now you see the deal makingis really starting to have
an impact, I think, on, theHong Kong exchange itself.
(08:55):
So you're, you're seeing.
The IPOs that, you know,Paul was just talking about.
and I think the other thingyou're seeing is, uh, you know,
if you just go look at the, theHang Seng biotech index over
this year, since the beginningof the calendar year, you know,
I think at the beginning of thecalendar year was around 8,000.
It's now around 17,000.
Jeff Cranmer (09:15):
Yep.
Year, year to date up.
Uh, yeah.
Sorry to cut youoff there, Josh.
Year to date up ahundred, and 8%.
And I remember, uh, back inMarch, Josh, you and I were,
uh, hanging out in those,Super cool artificial super
trees in Singapore and, uh,chatting up some bankers
(09:35):
biotech bankers and, at thattime they were still saying,
you know, NASDAQ's the onlygame in town for Asia biotechs.
And, you know, it's,it's changed now.
When I talk to CFOs, they're,looking seriously at Hong Kong.
they're weighing the bestplace to tell their story.
so look, we'll see howthis continues to develop.
Well, first up this willbe a big theme at our
China Healthcare Summit.
(09:57):
that will be in Shanghai.
It will be October 22nd to 24th.
Is that right, Josh?
Josh Berlin (10:04):
correct.
Yeah.
October 22 to 24 in Shanghai.
Jeff Cranmer (10:07):
Excellent.
So this will be abig theme of that.
advanced rates for themeeting, end Friday.
Uh, we're still recruiting,presenting companies.
we have some great names there.
And, we'll have some bignames on the panels as well.
Josh, who do we have?
We have, uh, the CEOsof Duality, Innovent.
Who else do we have?
Josh Berlin (10:25):
Yeah, we have, uh, just sort of a who's who
of, CEOs, like you mentionedduality, Inno vent we have
3SBio Chairman and CEO,Argo Bio, another company
that's, done some deals.
Crystal Q in of LaNova Medicinesjust confirmed, you know, they
were the biotech that was justbought out by Sino Biopharma.
and, Dajun Yang of Ascentagewill be there, you know,
(10:47):
which is a, a dual listed,China biotech, also on NASDAQ.
So it's gonna be a, a reallygood opportunity to meet a
lot of these CEOs that you'vebeen reading about, via all
the deal flow in the news.
Jeff Cranmer (11:00):
not China.
We'll have a great.
Asia Biotech, CEOpanel will have Piers
Ingram of Hummingbird.
we'll have the CEOs of,Gexval from Japan and
Korea's Orem Therapeutics.
the CEO uh, SJ Lee was, recentlya guest on our sister podcast.
the BioCentury show.
(11:22):
and, the CEO ofImmuneel, from India.
I think it should be,uh, quite a fun event.
But you're, before thatyou're heading to Japan,
is that right Josh?
Josh Berlin (11:32):
Yeah, I'm, I'm looking forward to getting
out to, uh, BioJapan thisyear, which I haven't been
to, in a very, very long time.
really thankful to our friendsat, uh, JBA for the invite to
come out there, join a panel.
and sort of see whatBioJapan is all about.
It's become a much, muchbigger event than it used
to be, is my understanding.
And then we're also, uh, gonnabe co-hosting a reception,
(11:54):
for those of you who know,Tim Kendall and his company
ConneKTia in Japan, Tim and,and BioCentury teaming up on
a reception, uh, October 7th,in Yokohama the night before.
BioJapan.
So if you're uh, in town and,and wanna join the reception,
please send, uh, me a note orsend Jeff a note or we'd be
happy to have you join us.,
Jeff Cranme (12:12):
Yeah, Tim is great.
he, really knows his Japan,uh, had a good chat with
him from my Japan story.
Recently and, heknows his stuff.
Alright, we're gonna takea quick break and then we
will, uh, come back and, uh,welcome Mr. Usdin back, from
his travels and talk aboutStealth Biotherapeutics and
IP and quite a bit more.
Alanna Farro (12:35):
By Century this week is brought to
you by the 12th ChinaHealthcare Summit in Shanghai.
From in-licensing to New coscross-border deals from Asia are
transforming global biopharma.
Meet top decision makersand investors at the 12th
China Healthcare Summit.
To explore emergingopportunities and tackle
key challenges in thisrapidly evolving landscape.
(12:55):
Join us in Shanghai,October 22nd to 24.
To get a firsthand lookat China's dynamic life
sciences ecosystem,register and learn more at
BioCentury China summit.com.
Jeff Cranmer (13:11):
We are back.
And Steve, how was the,how was the getaway
Steve Usdin (13:15):
I don't know why I came back to tell.
Jeff Cranmer (13:17):
to, to talk to us?
Yeah.
thank you for sending mea cat picture of the day.
The cats really look like they,uh, they run that country.
All right.
No, no further comment.
Uh, Steve is, uh, wheneverhe is in Turkey or Greece,
he, uh, he always seems toencounter some amazing cats.
But, uh, Steve, you know,I think you, uh, you were
(13:40):
writing about StealthBiotherapeutics when you left.
And, you're gonna writeabout 'em again today.
what's going on here?
There's a bit ofa, an about face.
This is a company that foryears now has been, trying
to get a therapy to the,Barth syndrome, community.
it's community where there isa, uh, dire need for, a therapy.
(14:03):
Steve, what, is going on withthis latest, seeming about face?
Steve Usdin (14:08):
So yeah, look, it's another
extraordinary turn of events.
For stealth andfor, birth patients.
know, as you said,we've been following
this closely for years.
It's a Byzantine story,but basically they've
been getting the runaroundfrom, FDA for years.
The company's bouncedbetween four FDA review
divisions over five years.
during that time, FDA is toldstealth to submit an NDA.
(14:31):
Then gave it a refuseto file letter.
It approved a naturalhistory study design.
Then later declared that theresults are uninterpretable.
at different points, the agencysaid approval would depend on
a new placebo controlled trial,and then said that, it would
be unethical or impossible toconduct that kind of trial.
Last year it seemed like thingswere coming to, to an end.
An advisory committee voted10 to six, that stealth
(14:53):
biotherapeutics had demonstratedsafety and efficacy of
its drug elamipretide.
At the end of May, theFDA issued a complete
response letter.
Big surprise, but it didn't askfor substantial new information.
This was devastating for Barthpatients and for Stealth.
Stealth laid off 30% of itsworkforce, and it said it
didn't know if it would beable to stay in business
(15:14):
long enough to receive aresponse from a resubmission.
The patient community has beenextraordinarily active, in the
media and in lobbying, membersof Congress, the Wall Street
Journal editorial page calledon FDA, commissioner Marty
Makary to approve the drug.
there have been storieson national television
programs last Thursday.
(15:34):
FDA said it would grant a finaldecision on the resubmitted
NDA by September 26th.
That's months earlierthan the deadline.
And what's interesting onFriday, Barth syndrome patients
met with the FDA commissionerand came out of it, really
thrilled and ecstatic.
That's really anextraordinary thing.
I can't think of anothertime when an FDA commissioner
(15:56):
has met with advocates.
For a drug that's under,review, that's pending
review, at the agency.
So yeah, it looks like it'son the verge of granting
accelerated approval.
Something FDA ruled outlast year, based on data
that really hasn't changed,over the last four years.
So if that happens,it'll be great news for
Barth syndrome patients.
(16:17):
But on the whole, I'dsay the, the saga isn't
really good news for raredisease patients at all.
Jeff Cranmer (16:22):
Yeah, that's what I was gonna ask is there
gonna be a read through toother, companies developing
rare disease therapies?
Steve Usdin (16:28):
Well could be, but we, we really
need to see what happens.
First of all, the only reasonit was possible for stealth
to consider developing adrug for Barth, which has
about 150 patients in theU.S., not all of whom would
be candidates for the drug.
Is because it was eligible fora priority review voucher, a
priority review voucher fora rare pediatric disease.
(16:50):
Congress allowed the rarepediatric priority review
program to expire last year.
If it isn't renewed,there aren't gonna be any
more drugs for conditionslike, birth syndrome.
there's no economic case fordoing it in the absence of
a priority review voucher.
Second.
If FDA doesn't create apredictable and rational path
for approval, not one that'sdependent on getting the
(17:13):
Wall Street Journal or NBCNews or BioCentury to report
about you, it's not gonnabe possible to get companies
to invest in this space.
if you think about it, thereare thousands of rare diseases.
It isn't possible to havethis level of advocacy, this
level of public attention.
For all of them.
(17:33):
There needs to beone, there needs to be
priority review vouchers.
So there's an economic casefor, developing therapies for
these very, very rare diseases.
And there needs to be apredictable, rational FDA,
review process, that canget these, drugs approved
or, or not, but at leasta decision made on them.
in a reasonable periodof time, requiring the
(17:55):
level of, evidence that'sappropriate for the disease.
There has to be scientificrigor, but there also has to
be, a possibility for makingthis happen, and companies
and patient groups need toknow in advance what that
path is gonna look like.
Jeff Cranmer (18:08):
All right.
And, you'll be able tofind Steve's story, on
BioCentury podcast.com.
And, Steve, we adda guest commentary.
We published last week, DavidBeier, who's managing director
of Bay City Capital, and JohnOsborn, who's a professor of law
at the University of Washington,they argued that the university
(18:31):
industry engine driving U.S.
innovation is under attack.
What's your take on this?
Steve Usdin (18:38):
So here's the thing that precipitated it.
President Trump demandedthat Harvard account for its
compliance with the Bayh-Doleobligations across its entire
portfolio of almost 6,000patents arising from research
that was supported in wholeor in part with federal funds.
That's an extraordinary demandfor a couple of reasons.
(18:59):
the idea of the federalgovernment exercising, marching
rights on Bayh-Dole has been,anathema to Republicans.
Traditionally.
and the idea that auniversity would have to
go back retroactively andjustify all of the patents
that it's ever received,basically part, from federal
(19:19):
funding, is extraordinary.
What, David Byer, who bythe way was, years and
years ago was a domesticpolicy advisor for Al Gore.
he had senior positionsat, Genentech and at Amgen.
and as you mentioned,he's, at Bay City Capital.
what they argue is thatthis is retaliation
for the universities.
first amendmentprotected speech.
(19:39):
and basically they saythat by going after Harvard
on this, that, the Trumpadministration is creating
a threat t o the entire,American biopharma industry.
Here's a quote from theend of their commentary.
They say, "business leaders,especially those in the
life sciences and technologysectors, must recognize that
misguided attacks on researchuniversities threaten our
(20:02):
innovation infrastructure,and they must raise their
voices accordingly." theyurge countervailing advocacy
to support Harvard and otherresearch universities, and they
say that "a failure to enjointhis counterproductive and
illegal exercise of presidentialpower will lead to predictably
disastrous effects, underminingintellectual property rights
(20:23):
and limiting economic growth."
Jeff Cranmer (20:25):
All right, and you can find their guest commentary
on BioCentury podcasts.
Com, that is infront of the paywall.
I'll also drop a link in theshow notes, Also on BioCentury
dot com, how China speedis reshaping cross-border
business development.
(20:45):
A perspective, by Joshand myself, looking at
how deals are rapidly.
Evolving as China biotechsare gaining more leverage
at the negotiating tablewith Western companies.
And, Simone, had a greatconversation on our sister
podcast with Annalisa Jenkins.
(21:06):
she is, an influencer, inbiotech to say the least.
she is, uh, currently chairof Gemma Therapeutics and.
She and Simone talked aboutthe future of MHRA and, really
dug deep into where thingsare in the U.K. right now as
(21:27):
that biotech hub continuesto grow and our Back to
School issue is out now.
Steve, uh, wrote, uh, itwasn't as short as, uh,
you know, I was, uh, I wasled to believe it would be.
It's a a seven story, seriesand Steve will be joining
Simone, on our sister podcast,The BioCentury Show, first week
(21:49):
of September, and there'll bedigging deep into the issues.
Steve, top line,what's it all about?
Steve Usdin (21:55):
Basically what I did was I said, look, imagine
that you were starting from ablank sheet of paper and you
wanted to reimagine what medicalproducts regulation in the
United States would look like.
What would you do?
and I followed that through.
I talked to a number ofthought leaders, current and
former FDA officials, formerFDA commissioners, CEOs of
biotech companies, patientadvocates, the opinion leaders.
(22:18):
And, there were somecommonalities, some things that
they all agreed on, some thingsthat there was a little bit of,
Disagreement about my conclusionis that if you were going to
start over again, and I thinkthat at some point it's going
to be necessary to do this,one of the things you would do
would be to separate out medicalproduct regulation from the
regulation of foods, cosmetics,tobacco and veterinary products.
(22:41):
I also call for, reorganizingthe medical products regulation.
Primarily around therapeuticareas using the Oncology Center
of Excellence as a model forthe way that other therapeutic
areas, could be organized.
and abolishing the distinctionsbetween, the Center for
Biologics in this Centerfor Drugs in the long run.
(23:02):
I think also eliminatingthe Center for Devices.
I think that those arekind of outmoded ways of
thinking about things and,and organizing regulation.
There's a lot more toit, uh, as you said.
We'll, we'll get into the,um, details of it, with
Simone when we do showconversation about it.
Jeff Cranmer (23:19):
you can find the entire back to school
package on BioCentury.com.
I'll drop a linkin the show notes.
This is our 33rd back to school.
We've been doing it every yearsince David Flores and Karen
Bernstein founded BioCentury.
More than three decades agoand back to school is a forward
looking package that looksat a broad issue critical
(23:41):
to the biopharma industry.
All right.
Well thank you to Josh, Pauland Steve, for joining me today.
And thank you to Cole Travis,our production engineer, And
of course, Kendall SquareOrchestra, which provides the
music for BioCentury this week.
Tickets are now on sale for thegroup's eighth season, they'll
(24:02):
be rocking some Mahler, someBrahms, and you can find more
by going to their website.
for tuning in.
we will catch you next week.
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