Josh Hoffman, Zymergen CEO (Zymergen)

Zymer­gen's bid to dis­rupt a $3T in­dus­tri­al man­u­fac­tur­ing mar­ket goes vi­ral, earn­ing a mas­sive $500M IPO

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It’s not a sto­ry you hear every day: A biotech com­pa­ny that doesn’t use its plat­form to de­vel­op ther­a­peu­tics? De­spite some raised eye­brows ear­ly on, Emeryville, CA-based Zymer­gen has con­vinced in­vestors that its plan to dis­rupt in­dus­tri­al man­u­fac­tur­ing is worth the bet and now it’s priced an eye-pop­ping IPO to take its mis­sion to the next lev­el.

Syn­thet­ic bi­ol­o­gy firm Zymer­gen late Wednes­day priced its 16.13 mil­lion shares at $31, good for a pub­lic of­fer­ing in the range of $500 mil­lion, which would put the com­pa­ny in rar­i­fied air along with Sana Biotech­nol­o­gy as biotech com­pa­nies with half-bil­lion-dol­lar or more IPOs this year, ac­cord­ing to End­points News’ IPO track­er.

The up­sized pric­ing — Zymer­gen ini­tial­ly pen­ciled in a $100 mil­lion cash raise in its S-1 fil­ing last month  — puts Zymer­gen on track to con­tin­ue de­vel­op­ing its de­sign­er mol­e­cules it plans to use to dis­rupt a $3 tril­lion in­dus­tri­al man­u­fac­tur­ing mar­ket with ap­pli­ca­tions as far and wide as con­sumer care, agri­cul­ture and elec­tron­ics.

The com­pa­ny plans to get there by us­ing a process it calls “bio­fac­tur­ing,” us­ing ge­net­i­cal­ly en­gi­neered mol­e­cules to pro­duce in­dus­tri­al-grade prod­ucts with­out the need for tox­ic chem­i­cals of­ten used in the process or ex­pen­sive in­fra­struc­ture. All told, the com­pa­ny thinks it can cut costs by about 90% across the in­dus­try and pro­duce the same ma­te­ri­als in half the time.

It’s a fo­cus that has of­ten not been re­ward­ed among biotech in­vestors look­ing for a clear path to ther­a­pies, but Zymer­gen be­lieves it’s found its own huge un­met need — and the case keeps on flow­ing in. The $500 mil­lion cash raise comes on the heels of a $400 mil­lion Se­ries C back in 2018 and a $300 mil­lion raise in Sep­tem­ber.

All told, the com­pa­ny has raised some­where in the ball­park of $1.375 bil­lion since its ini­tial seed round way back in 2014.

While the com­pa­ny has broad am­bi­tions for its pipeline, it has just one prod­uct on the mar­ket: Hya­line, a high-qual­i­ty op­ti­cal film used in elec­tron­ics. Mean­while, the biotech is pur­su­ing can­di­dates across a trio of elec­tron­ics, agri­cul­ture and con­sumer care. Those ar­eas alone, it be­lieves, of­fer a mar­ket op­por­tu­ni­ty of about $1.2 tril­lion.

Zymer­gen plans a slate of roll­outs in those mar­kets in 2022 and 2023 and will use Hya­line as its ca­nary in the coal mine in terms of con­sumer in­ter­est. If all goes to plan, Zymer­gen thinks its bio­fac­tur­ing mod­el could prove dis­rup­tive across a range of in­dus­tries, po­ten­tial­ly crack­ing open its lofty $3 tril­lion mar­ket goals.

“Our pipeline of prod­ucts has been de­signed with rapid mar­ket adop­tion in mind,” the com­pa­ny said in its prospec­tus. “In ad­di­tion, these prod­ucts demon­strate our bio­fac­tur­ing plat­form’s abil­i­ty to de­vel­op com­mer­cial­ly rel­e­vant prod­ucts across mul­ti­ple ma­jor dis­tinct chem­i­cal class­es.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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