Three biotechs hunt $336M-plus in a new round of IPOs — while Der­ma­vant pulls back

Raise mon­ey when you can, not when you must — the com­mon re­frain rang loud in two IPO fil­ings late Fri­day as ADC Ther­a­peu­tics and Fre­quen­cy Ther­a­peu­tics looked to top up their re­cent rais­es with mega IPOs.

But when you can’t, as Der­ma­vant found af­ter a sec­ond try, then quit­ting might be im­per­a­tive.

ADC and Fre­quen­cy were joined by lit­tle can­cer biotech Aprea Ther­a­peu­tics, seek­ing a col­lec­tive $336 mil­lion from Wall Street.

ADC Ther­a­peu­tics: $558M and count­ing

Chris Mar­tin ADC

Lau­sanne, Switzer­land-based ADC Ther­a­peu­tics is gun­ning for $150 mil­lion as it plots two piv­otal tri­als for its sig­na­ture and name­sake an­ti­body-drug con­ju­gates. AD­CT-402, which tar­gets CD19, is be­ing eval­u­at­ed in re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma; AD­CT-301 hits CD25 and is be­ing test­ed in stub­born cas­es of Hodgkin’s lym­phoma. As­sum­ing pos­i­tive re­sults, the com­pa­ny en­vi­sions BLA sub­mis­sions in late 2020 and the first half of 2022, re­spec­tive­ly.

The SEC fil­ing ar­rives two months af­ter CEO Chris Mar­tin brought the to­tal haul so far to $558.6 mil­lion by adding $103 mil­lion to a mam­moth $200 mil­lion Se­ries E.

ADC’s pitch cen­ters around a next-gen ap­proach to com­bin­ing an anti­gen-bind­ing an­ti­body with a cy­to­tox­ic pay­load, with the promise that its pyrroloben­zo­di­azepine (PBD) war­heads are “ap­prox­i­mate­ly 100 times more po­tent than war­heads used in cur­rent­ly mar­ket­ed AD­Cs.”

With a new in­fu­sion, the com­pa­ny plans to see two more ear­ly tri­als to fruition, in­clud­ing the CD22-tar­get­ing AD­CT-602 for acute lym­phoblas­tic leukemia and the AXL-tar­get­ing AD­CT-601 for sol­id tu­mors. Scal­ing up of com­mer­cial op­er­a­tions, along­side man­u­fac­tur­ing plans, will al­so be­gin in earnest.

Pe­ter Corr

Chair­man Pe­ter Corr and board mem­ber Stephen Evans-Freke stand to reap the biggest re­wards from the IPO, hav­ing se­cured a 42.7% stake through their pri­vate eq­ui­ty firm Au­ven Ther­a­peu­tics Man­age­ment. HP­WH, a stock cor­po­ra­tion tied to Swiss busi­ness Hans-Pe­ter Wild, con­trols 11.6% while As­traZeneca claims 7.1%.

Mar­tin, who was cred­it­ed for spin­ning off ADC from Spirogen af­ter he sold that ven­ture to As­traZeneca, holds 2.2% of the stock. CFO (and ex-CEO) Michael For­er has 1.7%.

Fre­quen­cy tunes in on $100M IPO

It has tak­en David Lucchi­no 2.5 years and $61.8 mil­lion to steer Fre­quen­cy out of stealth mode in­to a pub­lic de­but $FREQ, for which he’s set a $100 mil­lion goal.

David Lucchi­no

Lucchi­no, the CEO, and CSO Christo­pher Loose co-found­ed the biotech with Robert Langer back in 2014 based on the prog­en­i­tor cell ac­ti­va­tion tech in­vent­ed by the il­lus­tri­ous MIT re­searcher and Jeff Karp, a col­lab­o­ra­tor from Har­vard. The trio had pre­vi­ous­ly launched a medtech ven­ture to­geth­er that ul­ti­mate­ly sold for $30 mil­lion up­front.

The PCA plat­form is de­signed to gen­er­ate small mol­e­cules that spur re­gen­er­a­tion of tar­get cells. By tin­ker­ing with lo­cal prog­en­i­tor cells that are pre-pro­grammed to serve the pur­pose, the biotech be­lieves it can of­fer a safer and more ef­fi­ca­cious al­ter­na­tive to stem cell ther­a­pies.

Chris Loose

Fre­quen­cy is start­ing out with hair cells in the in­ner ear. Its lead drug can­di­date, FX-322, is in a Phase IIa tri­al with top-line da­ta ex­pect­ed in H2 2020. Astel­las has bought in­to ex-US de­vel­op­ment and com­mer­cial­iza­tion rights in a $625 mil­lion deal — $80 mil­lion up­front — an­nounced in Ju­ly. Soon af­ter­wards, the Woburn, MA-based biotech raised $62 mil­lion in Se­ries C cash.

An IND for the next pro­gram, one for mul­ti­ple scle­ro­sis, is planned for the sec­ond half of 2021, ac­cord­ing to the S-1.

In 2018 Lucchi­no took home a com­pen­sa­tion pack­age worth $743,700, while Loose got $578,134. Carl LeBel, the chief de­vel­op­ment of­fi­cer, re­ceived $477,721.

Per­cep­tive owns the largest chunk of shares at 7.8%, while Tai­wa­nia Cap­i­tal Man­age­ment Cor­po­ra­tion and Alexan­dria’s Joel Mar­cus each hold about 5%.

Aprea: All eggs in the p53 bas­ket

In the midst of re­cruit­ing for its first piv­otal tri­al, Aprea Ther­a­peu­tics has pen­ciled in $86 mil­lion for that and oth­er pro­grams around its lead drug, APR-246.

Chris­t­ian Schade

The Swedish com­pa­ny has all its eggs in the p53 bas­ket as the pro­tein is ex­pressed from TP53, a gene prone to mu­ta­tions in can­cer. APR-246, which is de­signed to re­ac­ti­vate mu­tant p53, is first di­rect­ed to myelodys­plas­tic syn­dromes in a com­bo with chemo. Both the FDA and the EMA have grant­ed or­phan sta­tus, with Eu­ro­pean reg­u­la­tors ex­tend­ing that des­ig­na­tion to acute myeloid leukemia and ovar­i­an can­cer.

David Sall­man of Mof­fitt Can­cer Cen­ter is a key col­lab­o­ra­tor in the US, sched­uled to give the fi­nal word on com­plete re­sponse rates from a Phase I/II study. Pierre Fe­naux is lead­ing an­oth­er study in France, which is al­so cit­ed to sup­port the up­com­ing Phase III (read­out slat­ed for 2020).

Al­so ex­pect­ed in 2020: an IND for APR-458, an oral p53 re­ac­ti­va­tor.

That ap­proach has at­tract­ed some high-pro­file in­vestors, all of whom are fea­tur­ing promi­nent­ly as prin­ci­pal stock­hold­ers: Karolin­s­ka De­vel­op­ment (17.21%), Ver­sant (17.73%), 5AM Ven­tures (17.73%), Health­Cap (14.77%), Red­mile Group (13.15%) and Sec­toral As­set Man­age­ment (10.35%). CEO Chris­t­ian Schade keeps 3.65%.

Aprea counts around $60 mil­lion in cash and cash equiv­a­lents.

Der­ma­vant fi­nal­ly gives up on IPO

Vivek Ra­maswamy’s der­ma­tol­ogy-fo­cused biotech off­shoot first filed for an IPO in March but post­poned a list­ing in June. Three months lat­er, Der­ma­vant has qui­et­ly con­ced­ed that $100 mil­lion raise is not hap­pen­ing any time soon by of­fi­cial­ly with­draw­ing.

Der­ma­vant was not iden­ti­fied among the five Vants that Sum­it­o­mo Dainip­pon gained con­trol of just a few days ago, but the $3 bil­lion cash deal does give the Japan­ese phar­ma an op­tion to buy up to six oth­er star­tups un­der the Roivant um­brel­la. Two pub­lic com­pa­nies — My­ovant and Urovant — were in­clud­ed in the pact.

Fol­low­ing Ra­maswamy’s strat­e­gy for spin­ning off themed com­pa­nies, Der­ma­vant ac­quired tap­inarof, a PhI­II-ready pso­ri­a­sis drug, from GSK. Todd Za­vod­nick was re­cruit­ed as CEO af­ter Jack­ie Fouse left for Agios.

The last cap­i­tal in­fu­sion for Der­ma­vant hap­pened last Au­gust when No­vaQue­st Cap­i­tal Man­age­ment pro­vid­ed $100 mil­lion “in ex­change for con­di­tion­al mile­stone pay­ments achieved by tap­inarof.”

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.