Four biotechs and a Matthew Ro­den-led SPAC price IPOs, rais­ing a com­bined $528M

Four more biotechs and a SPAC led by Bris­tol My­ers Squibb vet Matthew Ro­den have priced IPOs, clos­ing out an­oth­er busy week on Wall Street.

To­geth­er, Prax­is Pre­ci­sion Med­i­cines, Tar­sus Phar­ma­ceu­ti­cals, Ali­gos Ther­a­peu­tics, Kiromic Bio­Phar­ma and Turmer­ic Ac­qui­si­tion — MPM’s blank check com­pa­ny — have raised $528 mil­lion on their pub­lic de­buts.

Prax­is Pre­ci­sion Med­i­cines burst out of stealth mode with $100 mil­lion in May, quick­ly sweep­ing up an­oth­er $110 mil­lion in Ju­ly. And on Thurs­day, it raised $190 mil­lion — near­ly dou­ble its orig­i­nal goal — in an up­sized IPO. The Cam­bridge, MA-based biotech $PRAX of­fered 10 mil­lion shares at $19 apiece, up from its ini­tial of­fer of 7.4 mil­lion shares at a $17 to $18 range.

Be­tween $70 to $80 mil­lion are tagged for clin­i­cal de­vel­op­ment PRAX-114, the com­pa­ny’s lead CNS can­di­date. The mon­ey will fund a fu­ture Phase II/III tri­al in ma­jor de­pres­sive dis­or­der, and com­ple­tion of an on­go­ing Phase IIa. An­oth­er $30 to $40 mil­lion will go to­ward an on­go­ing Phase IIa study of PRAX-944 in es­sen­tial tremor. And $20 to $30 mil­lion should see a Phase I tri­al of PRAX-562 — Prax­is’ can­di­date for rare CNS dis­or­ders like se­vere pe­di­atric epilep­sy and adult cephal­gia — through com­ple­tion.

Since its launch, Prax­is has burned through more than $104 mil­lion, ac­cord­ing to the S-1/A. Black­stone holds 23.1% of the shares, fol­lowed by Even­tide with 9.4%, Vi­da Ven­tures with 7.3%, and No­vo Hold­ings with 6.6%.

“We ex­pect mul­ti­ple topline clin­i­cal tri­al read­outs from our three clin­i­cal-stage prod­uct can­di­dates pri­or to the end of 2021 and an­tic­i­pate the launch of a new clin­i­cal de­vel­op­ment pro­gram in 2021,” the S-1/A states.

Tar­sus Phar­ma­ceu­ti­cals al­so came in slight­ly above its ini­tial goal, rais­ing $88 mil­lion by pric­ing 5.5 mil­lion shares at $16 apiece. The Irvine, CA-based biotech $TARS filed for an $86 mil­lion IPO on Sept 25. It up­sized its of­fer by 575,000 shares, ac­cord­ing to an SEC fil­ing.

A ma­jor­i­ty of the pro­ceeds — about $65 mil­lion — will be poured in­to the com­pa­ny’s lead oph­thalmic can­di­date TP-03. The drug is cur­rent­ly in a Phase IIb/III tri­al for De­mod­ex ble­phar­i­tis, a con­di­tion char­ac­ter­ized by eye in­flam­ma­tion and caused by the in­fes­ta­tion of mites. Tar­sus ex­pects a Phase III launch in 2021. The re­main­ing funds may go to the biotech’s oth­er can­di­dates, TP-04 and TP-05, which it plans to en­ter in Phase I/II tri­als for rosacea and Ly­me dis­ease in 2021, re­spec­tive­ly.

Bobak Aza­mi­an

Since its found­ing in 2017, Tar­sus has spent a to­tal of $11.2 mil­lion. Vi­vo Cap­i­tal holds 15.77% of shares, while CEO Bobak Aza­mi­an has a 9.7% piece of the pie.

Ali­gos Ther­a­peu­tics $AL­GS filed for a $100 mil­lion IPO back in Sep­tem­ber to de­vel­op its chron­ic he­pati­tis B (CHB) and NASH ther­a­pies. Now the South San Fran­cis­co, CA-based biotech is rak­ing in $150 mil­lion through 10 mil­lion shares priced at $15 apiece, the mid­point of a $14 to $16 range.

About $40 to $43 mil­lion will go to­ward the com­pa­ny’s Phase I STOPS can­di­date ALG-010133, short for S-anti­gen trans­port-in­hibit­ing oligonu­cleotide poly­mer. An­oth­er $35 mil­lion to $38 mil­lion will fund an up­com­ing Phase I tri­al of its CAM (cap­sid as­sem­bly mod­u­la­tor) can­di­date ALG-000184. Twelve to $14 mil­lion will go to the NASH THR-b can­di­date ALG-055009. And Ali­gos ear­marked $12 to $15 mil­lion and $12 to $14 mil­lion for its CHB can­di­dates ALG-020572 and ALG-125097, re­spec­tive­ly.

The two-year-old biotech has spent $107 mil­lion, ac­cord­ing to its S-1/A. CEO Lawrence Blatt, for­mer head of in­fec­tious dis­ease at Janssen, holds 6.2% of shares. Roche Fi­nance, Ver­sant Ven­tures and Bak­er Broth­ers Ad­vi­sors each have 8.4% of the stock, fol­lowed by Vi­vo with 8.1%, No­vo with 6.6% and Welling­ton Man­age­ment with 5.2%.

Turmer­ic Ac­qui­si­tion, a blank check com­pa­ny formed by MPM Cap­i­tal, end­ed up down­siz­ing its of­fer from 10 mil­lion units to 8.5 mil­lion. The SPAC priced units at $10 each, rais­ing $85 mil­lion.

Matthew Ro­den

The com­pa­ny $TMP­MU is run by CEO Luke Evnin, who co-found­ed MPM Cap­i­tal in 1997, and chair­man Ro­den, who had a hand in Bris­tol My­ers Squibbs’ Cel­gene buy­out be­fore re­cent­ly join­ing MPM.

The duo — along­side the rest of the firm — now has two years to se­lect the pri­vate com­pa­ny to ride the shell of Turmer­ic to Nas­daq and in­her­it the in­vest­ment.

“We have not se­lect­ed any busi­ness com­bi­na­tion tar­get and we have not, nor has any­one on our be­half, ini­ti­at­ed any sub­stan­tive dis­cus­sions, di­rect­ly or in­di­rect­ly, with any busi­ness com­bi­na­tion tar­get,” the SPAC’s S-1/A states.

Kiromic Bio­Phar­ma $KRBP priced its shares at $12 apiece on Fri­day — the low end of its $12 to $14 range. The Hous­ton, TX-based biotech of­fered 1.3 mil­lion shares, rais­ing $15 mil­lion. The com­pa­ny is us­ing AI to de­vel­op can­cer ther­a­pies, and says the IPO funds will push its Alex­is iso­form mesothe­lin (for EOC) and PD-1 can­di­dates in­to the clin­ic.

By the end of last month, 56 biotechs had filed for IPOs this year — top­ping Brad Lon­car’s count of 47 last year. Both SQZ Biotech and Lux Health Tech Ac­qui­si­tion, a SPAC formed by Lux Cap­i­tal, filed to go pub­lic on Mon­day. SQZ pro­posed a $75 mil­lion raise to de­vel­op its cell ther­a­pies, while Lux is look­ing to nab $300 mil­lion. On Tues­day, Co­di­ak’s shares priced in at $15 apiece, net­ting $83 mil­lion.

Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

Covid-19 roundup: As­traZeneca could soon re­sume US vac­cine tri­als; Pfiz­er's dis­tri­b­u­tion plan in­volves spe­cial ship­ping box­es, no whole­salers 

AstraZeneca’s Covid-19 vaccine trial could resume in the US later this week, according to a Reuters report.

Experimental dosing of the candidate came screeching to a halt in September, when a participant in the UK suffered what’s believed to be the spinal inflammatory condition transverse myelitis. Trials have already resumed in the UK, Brazil, India, Japan and South Africa — and four anonymous sources told Reuters that a green light from the US could come as early as this week.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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