Ex-con Sam Wak­sal's start­up prices IPO, join­ing pa­rade of biotechs with Nas­daq news

Biotechs are com­ing out of the wood­work this morn­ing to set terms for their IPOs. So far, we’ve tracked five com­pa­nies rais­ing rough­ly $486 mil­lion com­bined, in­clud­ing an IPO from ex-con Sam Wak­sal’s Kad­mon spin­off MeiraGTx $MGTX.

MeriaGTx — $75 mil­lion

Sam Wak­sal

The com­pa­ny’s founder, Wak­sal, is a biotech ex­ec once sen­tenced to prison for his in­sid­er trad­ing con­vic­tion in­volv­ing Martha Stew­art. He was al­so the founder of Kad­mon, a com­pa­ny he had to bail from be­fore it could file its own IPO back in 2016. And now his brain­child — un­der the di­rec­tion of for­mer Kad­mon com­mer­cial chief Alexan­dria Forbes — has filed to raise $75 mil­lion.

Alexan­dria Forbes

The gene ther­a­py com­pa­ny said it’s priced its IPO at $15 per share, in­tend­ing to use the new cash to push five of its prod­uct can­di­dates in­to Phase I/II tri­als. The com­pa­ny has been build­ing out gene ther­a­py man­u­fac­tur­ing op­er­a­tions to sup­port its work, which is ini­tial­ly fo­cused on oph­thal­mol­o­gy, or eye dis­eases, where the first gen­er­a­tion of de­vel­op­ers found some ear­ly suc­cess­es. MeiraGTx said much of the new IPO mon­ey will go to­ward four oph­thal­mol­o­gy pro­grams and one sali­vary gland pro­gram.

Ma­gen­ta Ther­a­peu­tics — $100M

Join­ing MeiraGTx in pric­ing this morn­ing is Ma­gen­ta Ther­a­peu­tics $MG­TA, which plans to sell at $14 to $16 per share. We cov­ered Ma­gen­ta’s IPO plans late last month, when the com­pa­ny had pen­ciled in a $100 mil­lion pub­lic of­fer­ing. At the range Ma­gen­ta an­nounced to­day, the com­pa­ny should raise right around that mark.

Ac­cord­ing to a state­ment filed with the SEC, the cash will be used to push for­ward Ma­gen­ta’s most ad­vanced clin­i­cal pro­gram: a cell ther­a­py called MG­TA-456. The drug, cur­rent­ly in Phase II tri­als, is be­ing test­ed in pa­tients with in­her­it­ed meta­bol­ic dis­or­ders. Ma­gen­ta says new IPO mon­ey would ad­vance the treat­ment through a piv­otal tri­al, pay for some com­mer­cial­iza­tion ac­tiv­i­ties, and al­so fund re­search in­to ad­di­tion­al in­di­ca­tions for the ther­a­py, such as sick­le cell dis­ease and blood can­cers. Be­yond that, Ma­gen­ta might use the new funds to back MG­TA-145, a nov­el stem cell mo­bi­liza­tion prod­uct can­di­date.

Kezar Life Sci­enes — $86M

Next up is Kezar Life Sci­ences, which ex­pects to sell be­tween $14 and $16 per share. This one al­so isn’t brand new to us, as we cov­ered their ini­tial S-1 fil­ing in late May.  The com­pa­ny’s amend­ed S-1 notes the max cap­i­tal raised could be $85.9 mil­lion.

Kezar $KZR has plans to use the IPO mon­ey to push for­ward its pipeline of au­toim­mune drugs. Spun out of Am­gen with small mol­e­cules from the plate of the for­mer Onyx Phar­ma­ceu­ti­cals, Kezar’s lead prod­uct is KZR-616. The drug is a se­lec­tive im­muno­pro­tea­some in­hibitor that’s about to be test­ed in a Phase Ib/II tri­al in lu­pus and lu­pus nephri­tis. The IPO might al­so fu­el KZR-616 for the treat­ment of id­io­path­ic in­flam­ma­to­ry my­opathies and up to three ad­di­tion­al au­toim­mune in­di­ca­tions in­to Phase Ib or Phase II clin­i­cal tri­als.

Au­to­lus Ther­a­peu­tics — $125M

Then there’s Lon­don-based Au­to­lus Ther­a­peu­tics, which is de­vel­op­ing can­cer ther­a­pies based on CAR-T cell tech­nol­o­gy. The com­pa­ny plans to raise $125 mil­lion by of­fer­ing 7.8 mil­lion shares be­tween $15 and $17 per share.

The com­pa­ny, found­ed in 2014, will use a big chunk of the pro­ceeds to get proof-of-con­cept in Phase I/II clin­i­cal tri­als of AU­TO2 in mul­ti­ple myelo­ma, AU­TO3 in pe­di­atric ALL and DL­B­CL, and AU­TO4 in pe­riph­er­al T-cell lym­phoma. It hopes to ad­vance three prod­uct can­di­dates through lat­er phas­es of clin­i­cal de­vel­op­ment and, po­ten­tial­ly, reg­is­tra­tion, ac­cord­ing to its F-1.

Ei­dos Ther­a­peu­tics — $100M

Neil Ku­mar

Last up is San Fran­cis­co-based Ei­dos Ther­a­peu­tics, Bridge­Bio’s start­up fo­cused on TTR amy­loi­do­sis. The biotech is out of the IPO chute look­ing at $100 mil­lion by of­fer­ing 6.3 mil­lion shares at $15 to $17 per share. In­sid­ers are buy­ing up half.

Bridge­Bio chief Neil Ku­mar has been bull­ish about this par­tic­u­lar sub­sidiary in the group, even though it’s up against some heavy­weight play­ers in drug de­vel­op­ment, in­clud­ing Al­ny­lam, Io­n­is and even Pfiz­er.

Their drug was ini­tial­ly ad­vanced by Is­abel­la Graef at Stan­ford and Mamoun Al­hamad­sheh, the com­pa­ny sci­en­tif­ic co-founders, who nailed down pre­clin­i­cal ev­i­dence that the drug can sta­bi­lize TTR and pre­vent the cas­cade of events that caus­es the dis­ease — a dis­ease mod­i­fy­ing ap­proach that will now head to the clin­ic.

Ei­dos says most of the pro­ceeds will fund the clin­i­cal de­vel­op­ment of AG10 for the treat­ment of AT­TR-CM and AT­TR-PN, in­clud­ing its on­go­ing Phase II AT­TR-CM and planned Phase III AT­TR-PN clin­i­cal tri­als.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.

Laurie Glimcher and Ansbert Gadicke (Justin Knight, Dana-Farber Cancer Institute)

Ty­ing ba­sic sci­ence to spin­outs, Dana-Far­ber de­buts sis­ter funds to­tal­ing $126M with MPM Cap­i­tal

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?

FDA mon­i­tor­ing 20 drugs at risk of short­age due to Coro­n­avirus

As part of its efforts to ensure the supply of medical products from China during the ongoing coronavirus (COVID-19) outbreak, the FDA has identified 20 drugs that are made in or produced solely from active pharmaceutical ingredients (APIs) sourced from China.

In a statement to Focus, FDA spokesperson Stephanie Caccomo said the agency has been in contact with the companies that make the 20 products and that “none of these firms has reported any shortage to date.”

Source: Shutterstock

Theft vic­tim or da­ta bul­ly? IQVIA ex­changes blows with small ri­val it says de­stroyed ev­i­dence in le­gal fight

Three years into their legal battle, the plot around health information giant IQVIA and Veeva’s dispute over reference data and software managing those data continues to thicken.

Just a week after IQVIA filed a motion for default judgment in their trade theft suit with salacious allegations that Veeva intentionally deleted evidence that would prove they stole information from the data giant, Veeva said it’s expanding its antitrust counterclaims to put an end to IQVIA’s “long history of abusing its monopoly position.”

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