Jay Galeota, Kallyope CEO

In putting to­geth­er a $236M Se­ries D, one biotech spurns Nas­daq and sig­nals the dim­ming al­lure of IPOs

As the biotech IPO mar­ket con­tin­ues to floun­der af­ter a record pan­dem­ic run, the ques­tion must be asked: Are com­pa­nies be­com­ing so IPO-averse that they would rather seek ad­di­tion­al pri­vate rais­es than risk go­ing pub­lic? For at least one biotech, the an­swer ap­pears to be yes.

Kally­ope closed a $236 mil­lion Se­ries D on Tues­day morn­ing about two years af­ter its last fund­ing round, aim­ing to push for­ward a slate of clin­i­cal pro­grams in­to fur­ther stud­ies. CEO Jay Ga­le­o­ta told End­points News that while his com­pa­ny nev­er closed the IPO door fol­low­ing its $112 mil­lion Se­ries C in March 2020, the cur­rent mar­ket played, at least in part, a role in its de­ci­sion mak­ing.

“I think it’s fair to say that we were open to mul­ti­ple op­tions,” Ga­le­o­ta said. “And at the same time, as the mar­ket con­di­tions be­came less ob­vi­ous for a pub­lic of­fer­ing, we piv­ot­ed to, if you will — or grav­i­tat­ed is prob­a­bly a bet­ter way to de­scribe it — more to­wards a Se­ries D round to achieve the goals that we have. And that turned out to be the best fit for us.”

Tues­day’s round was co-led by Mubadala In­vest­ment Com­pa­ny and The Col­umn Group.

Af­ter a pe­ri­od that saw near­ly 200 com­pa­nies go pub­lic and raise rough­ly $25 bil­lion to $30 bil­lion in funds, IPO ac­tiv­i­ty has cooled con­sid­er­ably since last sum­mer. There have on­ly been a hand­ful of S-1s filed so far in 2022, com­pared to about a dozen by this point last year when the nine-fig­ure rais­es were com­mon­place.

On the out­side, Kally­ope ap­peared to fit in­to a sim­i­lar mold as many of the oth­er biotechs seek­ing IPOs last year. It had se­cured a nine-fig­ure crossover with some promi­nent back­ers like Cas­din Cap­i­tal and was prepar­ing to en­ter the clin­ic, all while the fa­vor­able pan­dem­ic mar­ket con­di­tions were just be­gin­ning to emerge.

But Kally­ope took a much more de­lib­er­ate route than its biotech cousins, an os­ten­si­bly smart de­ci­sion in hind­sight. The ap­proach has been in­ten­tion­al, Ga­le­o­ta said, though not for the rea­sons one might think.

“Vir­tu­al­ly all of the sci­en­tists have been just head down on the bench do­ing the work. And as a re­sult, we haven’t been talk­ing much about it,” Ga­le­o­ta said. “So we’re at a point now where we’re start­ing to share what we’ve been do­ing, be­cause the progress has been so con­sis­tent and so ex­cit­ing.”

That progress has in­volved mov­ing four ther­a­peu­tic can­di­dates in­to clin­i­cal tri­als over the last two years, he said. The biotech has been re­search­ing how the unique con­nec­tions be­tween the brain and the gut can in­form drug de­vel­op­ment for things like di­a­betes, IBD and celi­ac dis­ease.

Tues­day’s fund­ing gives Kally­ope the abil­i­ty to con­tin­ue ad­vanc­ing its ini­tial leads while al­so help­ing jump­start po­ten­tial clin­i­cal ef­forts on more than 20 oth­er can­di­dates. There’s about three years of cash run­way here, Ga­le­o­ta said, al­low­ing the biotech to take each of its clin­i­cal com­pounds in­to Phase II and file at least one new IND per year.

And if an IPO ever comes call­ing, the new cash will con­tin­ue to al­low Kally­ope to keep its op­tions open.

“This is an en­abler that’s very much aligned with where the com­pa­ny is strate­gi­cal­ly and where it wants to go,” Ga­le­o­ta said of the round. “And it gives us, again, max­i­mum op­tion­al­i­ty. As the sci­ence de­liv­ers, there may be op­por­tu­ni­ties to go even big­ger and even faster, which we’re cer­tain­ly go­ing to be pre­pared for.”

In ad­di­tion to Mubadala and The Col­umn Group, Tues­day’s fi­nanc­ing al­so saw re­turn­ing par­tic­i­pa­tion from Alexan­dria Ven­ture In­vest­ments, Bill Gates, Cas­din Cap­i­tal, Eu­clid­ean Cap­i­tal, Il­lu­mi­na Ven­tures, Lux Cap­i­tal, Po­laris Part­ners, Two Sig­ma Ven­tures and Step­Stone Group. New in­vestors in­clud­ed DNS Cap­i­tal, Hart­ford Health­care En­dow­ment, Park­wood LLC and Tao Cap­i­tal.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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