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.

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.

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.

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.