Swe­den's Cal­lid­i­tas seeks $75M IPO haul to bring its oral steroid to pa­tients with an or­phan kid­ney dis­ease

As biotech af­ter biotech elic­its en­thu­si­as­tic in­vestor sup­port for this cor­ner of the IPO mar­ket, a Swedish play­er is join­ing the Nas­daq line to fund the last leg of its clin­i­cal jour­ney.

Cal­lid­i­tas Ther­a­peu­tics is eye­ing a $75 mil­lion raise, a mod­est sum com­pared to some of the big­ger pub­lic de­buts we’ve seen in re­cent days — but they could well up­size the of­fer­ing like oth­er small, ob­scure com­pa­nies be­fore them have done.

The pitch cen­ters around the drug that Cal­lid­i­tas was found­ed on: Ne­fe­con, an oral for­mu­la­tion of the cor­ti­cos­teroid budes­onide. Af­ter li­cens­ing it from Bengt Fell­ström and Roger Häll­gren at Up­p­sala Uni­ver­si­ty, the biotech stayed laser-fo­cused on an or­phan au­toim­mune re­nal dis­ease known as IgA nephropa­thy, or IgAN. By sup­press­ing the im­mune re­ac­tion, the hope is that Ne­fe­con can keep pa­tients from pro­gress­ing to end-stage re­nal dis­ease.

Renée Aguiar-Lu­can­der

Hav­ing di­vid­ed the on­go­ing Phase III tri­al in­to two parts, Cal­lid­i­tas is plan­ning to seek ac­cel­er­at­ed ap­proval if the drug hits the pri­ma­ry end­point on pro­tein­uria — a bio­mark­er in­di­cat­ing pro­tein in dis­ease — in Part A. Part B would then con­firm the clin­i­cal ben­e­fit of Ne­fe­con post-ap­proval.

In Phase IIb, the com­pa­ny not­ed, the drug-in­duced sta­bi­liza­tion of kid­ney func­tion com­pared to place­bo among 150 pa­tients.

The first cut of Phase III da­ta, from 19 sites around the world, is ex­pect­ed in the fourth quar­ter of this year, set­ting up an NDA fil­ing for the first half of 2021 and a launch in 2022..

“Al­though re­cruit­ment in the first quar­ter of 2020 for Part B of Ne­fI­gArd ex­ceed­ed our plans, re­cruit­ment rates have slowed and we ex­pect a re­duced re­cruit­ment rate over the next sev­er­al months due to the im­pact of the COVID-19 pan­dem­ic,” an SEC fil­ing read. “How­ev­er, based on ex­ist­ing en­roll­ment in Part B and ex­pect­ed com­ple­men­tary re­cruit­ment ac­tiv­i­ties in Chi­na, we con­tin­ue to ex­pect to re­port da­ta from Part B in 2022.”

An­drew Udell

While Cal­lid­i­tas in­tends to com­mer­cial­ize in the US on its own with an ini­tial sales­force of 40 — An­drew Udell, the VP of North Amer­i­ca com­mer­cial, will be in charge of that — Ever­est Med­i­cines has paid $15 mil­lion up­front to grab the rights in Chi­na and Sin­ga­pore. Re­gion­al deals for Eu­rope will fol­low.

Scan­di­na­vian in­vestors made up most of the syn­di­cate, with Stif­telsen In­dus­tri­fonden (14.91%), Linc AB (12.49%) and In­vesti­nor AS (10.67%) rank­ing as the top share­hold­ers.

CEO Renée Aguiar-Lu­can­der, al­so holds 1.05% of the stock, the break­down of which is clear­ly dis­played in her bi­og­ra­phy on the Cal­lid­i­tas web­site. This marks the for­mer in­vest­ment banker and sea­soned ven­ture cap­i­tal­ist’s first go on the front­lines of biotech.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Look­ing to push CAR-T in sol­id tu­mors, Bay Area biotech goes pub­lic in SPAC flip — with slight name change

SPACs might be slowly creeping back.

Monday evening, Estrella Biopharma said it was going public via a SPAC deal with TradeUP Acquisition Corp. The deal is set to close in the first half of 2023, and if all goes as planned, the public version of Estrella — dubbed Estrella Immunopharma — will be worth around $398.5 million.

The Bay Area biotech will also get around $45.4 million in cash, and TradeUp stockholders will get around 15% stock in the public biotech.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.