Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the ex­ecs at Nas­daq would like noth­ing bet­ter than to see that mo­men­tum con­tin­ue in­to the first half of next year.

Since Jan­u­ary, 72 biotech and bio­phar­ma com­pa­nies have hit Wall Street, ac­cord­ing to Nas­daq head of health­care list­ings Jor­dan Saxe, to­geth­er rais­ing $13.2 bil­lion.

Jor­dan Saxe

The lat­est is Flag­ship’s Foghorn Ther­a­peu­tics, which priced its shares last night at $16 apiece, the mid­point of a $15 to $17 range. The Cam­bridge, MA-based biotech — which ini­tial­ly filed for a $100 mil­lion raise on Oct. 2 — is net­ting $120 mil­lion from a 7.5 mil­lion-share of­fer­ing. The pro­ceeds will go right in­to its gene traf­fic con­trol plat­form, in­clud­ing two lead pre­clin­i­cal on­col­o­gy can­di­dates.

Foghorn was found­ed in 2016 by Dana-Far­ber re­searcher Cigall Kadoch, and has since blown through $123 mil­lion, ac­cord­ing to its S-1/A fil­ing. When Bris­tol My­ers Squibb vet Carl De­ci­c­co joined as CSO in 2018, one of his first or­ders of busi­ness was pick­ing the pro­grams to prep for clin­i­cal tri­als, with a goal of hit­ting the clin­ic by 2020.

Cigall Kadoch

Foghorn is fo­cused on drug­ging tar­gets in the chro­matin reg­u­la­to­ry sys­tem — the sys­tem that con­trols the move­ment of mol­e­cules that turn genes “on” and “off,” ac­cord­ing to the com­pa­ny. An IND could be com­ing for its lead can­di­date, an al­losteric AT­Pase in­hibitor dubbed FHD-286, in AML and uveal melanoma lat­er this year, ac­cord­ing to the S-1/A. About $35 mil­lion from the IPO raise will sup­port that pro­gram.

An­oth­er $20 mil­lion is go­ing in­to the biotech’s hema­to­log­ic can­cer and sol­id tu­mors can­di­date, FHD-609, for which it ex­pects to sub­mit an IND in the first half of 2021.

Flag­ship owns 35.09% of Foghorn’s shares, ac­cord­ing to the S-1/A. Kadoch holds 11.09% of shares, and CEO Adri­an Gottschalk has a 2.56% slice of the pie.

Carl De­ci­c­co

Back in Ju­ly, Mer­ck inked a $425 mil­lion deal to es­sen­tial­ly li­cense one of the fac­tors Foghorn had just be­gun test­ing, buy­ing ex­clu­siv­i­ty on any po­ten­tial drugs that emerge to tar­get it. “I think this bi­ol­o­gy has been un­ex­plored and un­ex­ploit­ed as a drug, and I think the time is right,” Gottschalk said at the time.

This year’s biotech IPO tal­ly far sur­pass­es the 47 tracked last year by Brad Lon­car. Saxe told End­points News last month that a va­ri­ety of fac­tors, in­clud­ing the Covid-19 pan­dem­ic, have cre­at­ed the “per­fect storm” for an IPO boom. He and his team have been in talks with mul­ti­ple com­pa­nies prep­ping for an IPO at the end of this year or ear­ly next year, he said.

Round­ing out the year with 75 IPOs and just un­der $14 bil­lion in pro­ceeds would be a “fair es­ti­mate,” he said on Fri­day.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,100+ biopharma pros reading Endpoints daily — and it's free.

Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more coverage, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. Biogen said on its earnings call that about 120 sites so far have infused at least one patient with Aduhelm, which is priced at $56,000 annually. Morgan Stanley previously predicted about 14,000 patients will access Aduhelm by the end of 2022.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,100+ biopharma pros reading Endpoints daily — and it's free.

Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,100+ biopharma pros reading Endpoints daily — and it's free.