Cash-strapped Reg­u­lus braces for dras­tic down­siz­ing while hit­ting the brakes on lead pro­grams

Still suf­fer­ing from fi­nan­cial woes trig­gered by a streak of set­backs over the past two years, Reg­u­lus Ther­a­peu­tics is now putting its two clin­i­cal pro­grams on hold — and ax­ing 60% of its re­main­ing staff.

The news land­ed qui­et­ly just af­ter the Ju­ly 4th hol­i­day, which didn’t pre­vent Reg­u­lus’ al­ready bat­tered stock price $RGLS from tak­ing a steep dive of 52% to date. Al­to­geth­er, the changes are ex­pect­ed to trans­late in­to $20 mil­lion in an­nu­al­ized sav­ings, fu­el­ing the com­pa­ny through mid-2019 when added to the $45.1 mil­lion the com­pa­ny al­ready has in the bank as of March 31.

Jay Ha­gan

A joint ven­ture cre­at­ed by Al­ny­lam and Io­n­is in 2007 to de­vel­op mi­croR­NA ther­a­pies, Reg­u­lus’ clin­i­cal pro­grams bare­ly took off be­fore it got slammed with a full clin­i­cal hold from the FDA in 2016, af­ter two pa­tients tak­ing RG-101, its RNAi treat­ment for he­pati­tis C, be­gan de­vel­op­ing jaun­dice. Hav­ing boot­ed its CEO and slashed 30% of its staff last May, the La Jol­la, CA-based biotech put the pro­gram to bed a month lat­er as it chopped an­oth­er pro­gram and saw As­traZeneca walk away from a part­ner­ship on NASH.

RG-012, a Sanofi-part­nered pro­gram vault­ed to the lead po­si­tion af­ter the saga, was sup­posed to be Reg­u­lus’ sav­ing grace. But now, re­cruit­ment ac­tiv­i­ties for the PhII tri­al are com­ing to a halt “while dis­cus­sions with Sanofi to po­ten­tial­ly re­struc­ture the part­ner­ship are on­go­ing.”

“I am very dis­ap­point­ed that we need to take these dras­tic steps to pre­serve our cap­i­tal, es­pe­cial­ly giv­en the sig­nif­i­cant con­tri­bu­tions by our ded­i­cat­ed em­ploy­ees to the progress made to­ward un­lock­ing the po­ten­tial of tar­get­ing mi­croR­NAs,” said pres­i­dent and CEO Jay Ha­gan, who got pro­mot­ed to the job in the last re­struc­tur­ing, in a state­ment.

Right now, Ha­gan added, Reg­u­lus will fo­cus on re­solv­ing some sur­prise tox­i­c­i­ty is­sues iden­ti­fied in a mouse study of RGLS4326, a drug in­tend­ed to treat au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease. While they con­duct a sec­ond 27-week mouse chron­ic tox­i­c­i­ty study fea­tur­ing changes that they hope will ad­dress the con­cerns, the Phase I tri­al will be on pause.

Reg­u­lus em­pha­sized that they are al­so work­ing on a pre­clin­i­cal pro­gram in HBV, which they are brand­ing as “the most at­trac­tive op­por­tu­ni­ty in its pipeline for in­vest­ment.” The plan is to file an IND in the sec­ond of 2019 — if they haven’t run out of mon­ey by then.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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