Shut­down thrusts Gos­samer Bio on­to a rarely used path for fixed-price IPO

From day 1 Gos­samer has al­ways been a biotech in a hur­ry. And they’re not about to let a lit­tle thing like a gov­ern­ment shut­down stymy their plans for an IPO.

As the par­tial US gov­ern­ment shut­down con­tin­ues to par­a­lyze the SEC, Gos­samer Bio has elect­ed to use a rare and riski­er method to make the leap in­to Nas­daq. The biotech is fore­go­ing the typ­i­cal­ly lengthy SEC re­view of their prospec­tus to green­light the list­ing in fa­vor of en­abling their reg­is­tra­tion by lock­ing in their IPO price 20 days be­fore mak­ing a mar­ket de­but.

Ac­cord­ing to the amend­ed fil­ing, it plans to of­fer 14.4 mil­lion shares priced at $16/share, which will al­low the com­pa­ny to raise rough­ly $230 mil­lion in gross pro­ceeds. Mean­while, ex­ist­ing stock­hold­ers have in­di­cat­ed their in­ter­est in pur­chas­ing about $100 mil­lion in shares in the of­fer­ing at the IPO price of $16.

The San Diego-based biotech orig­i­nal­ly filed its prospec­tus with the SEC on De­cem­ber 21, one day pre­ced­ing the shut­down, but on Wednes­day amend­ed that fil­ing to re­flect its new plan to go pub­lic via the fixed-price IPO. This type of reg­is­tra­tion will al­low it to be­gin trad­ing on Feb­ru­ary 13 on the Nas­daq un­der the sym­bol $GOSS.

The road to an IPO can be long and lit­tered with SEC com­mu­ni­ca­tion that re­flects the agency’s deep dive in­to the com­pa­ny’s dis­clo­sures be­fore the green light is sanc­tioned, fol­low­ing which in­vestors in­di­cate their en­thu­si­asm or lack there­of by mak­ing bids on the high­er or low­er end of the price band of­fered. The ab­sence of an ex­plic­it SEC en­dorse­ment could serve to haunt the com­pa­ny lat­er down the line, if the dis­clo­sures made by the com­pa­ny come up short or the SEC ques­tions them up­on re­open­ing.

The Wall Street Jour­nal ear­li­er this week sug­gest­ed that Nas­daq has balked at the 20-day rule. Nev­er­the­less, Gos­samer will test the wa­ters and per­haps in­spire oth­ers to fol­low suit. TCR2 is al­so study­ing the IPO gam­bit, ac­cord­ing to the WSJ re­port.

The com­pa­ny, orig­i­nal­ly named FSG Bio, was found­ed by for­mer Re­cep­tos CMO Sheila Gu­jrathi and Fa­heem Has­nain, the ex-Re­cep­tos CEO, in 2015, short­ly af­ter Re­cep­tos was bought out by Cel­gene. Cur­rent­ly 14 se­nior ex­ec­u­tives and di­rec­tors to­geth­er hold near­ly 33% of the com­pa­ny, whose two biggest share­hold­ers are ARCH Ven­ture Part­ners with 17.5% and Omega Fund V with 15.1%.

Fa­heem Has­nain on stage at the End­points News / Pharm­Cube #BI­IS18 sum­mit in Shang­hai, Oc­to­ber 2018End­points News

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Gos­samer’s name is tied to the sym­bol­ism be­hind the gos­samer thread, a frag­ile, in­vis­i­ble con­nec­tion that binds re­la­tion­ships. The biotech is fo­cused on im­munol­o­gy, in­flam­ma­tion and on­col­o­gy, has three drugs in the clin­ic, and an­oth­er in pre­clin­i­cal test­ing.

Bo­fA Mer­rill Lynch, Leerink, Bar­clays, and Ever­core are the joint bookrun­ners on the deal.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.