Co­di­ak lands on Wall Street in sec­ond shot at IPO, rais­es $83M

Co­di­ak Bio­sciences fi­nal­ly hit Wall Street on Tues­day in its sec­ond at­tempt to go pub­lic, but didn’t quite reach its $100 mil­lion goal.

The Cam­bridge, MA-based biotech raised $83 mil­lion by pric­ing 5.5 mil­lion shares at $15, the mid­point of a $14 to $16 range. When Co­di­ak $CDAK sub­mit­ted pa­per­work with the SEC in Sep­tem­ber, it ini­tial­ly pro­posed a $100 mil­lion raise — up from the $86.2 mil­lion raise it sought back in April 2019. Un­fa­vor­able mar­ket con­di­tions led Co­di­ak to back out of the first IPO last Ju­ly.

So far, 2020 has been the year for biotech IPOs. Nas­daq head of health­care list­ings Jor­dan Saxe told End­points News that he wouldn’t be sur­prised if there were 65-70 biotech IPOs (on the low end) be­fore New Year’s. That num­ber is well over the 47 tracked last year by Brad Lon­car.

Co­di­ak is en­gi­neer­ing ex­o­somes for use as de­liv­ery ve­hi­cles for a range of ther­a­peu­tic pay­loads. Its fo­cus is on a pro­gram that us­es a STING path­way ag­o­nist, li­censed from the French biotech Kay­la Ther­a­peu­tics. Near­ly 30% of the IPO pro­ceeds — $24.8 mil­lion — will go to­ward clin­i­cal de­vel­op­ment of Co­di­ak’s lead can­di­date, ex­oST­ING, which is in a Phase I/II tri­al in pa­tients with ad­vanced/metasta­t­ic, re­cur­rent, in­jectable sol­id tu­mors.

An­oth­er $34.3 mil­lion is des­ig­nat­ed for the ex­pan­sion of what Co­di­ak calls its en­gEx Plat­form — the en­gi­neer­ing of the so-called de­liv­ery ve­hi­cles. As stat­ed in the S-1/A:

Us­ing our en­gEx Plat­form, we have demon­strat­ed pre­clin­i­cal­ly our abil­i­ty to en­gi­neer ex­o­somes to in­cor­po­rate var­i­ous types of bi­o­log­i­cal­ly ac­tive drug mol­e­cules ei­ther on the ex­o­some sur­face, us­ing PT­GFRN as a scaf­fold, or in­side the lu­men of the ex­o­some, us­ing BASP1 as a scaf­fold, to tar­get mem­brane or cy­to­plas­mic and nu­clear drug tar­gets in spe­cif­ic cells.

Fi­nal­ly, $10 mil­lion will be used to give ex­oIL-12, an­oth­er en­dEx can­di­date, a push. That can­di­date’s in a Phase I tri­al in healthy vol­un­teers and pa­tients with ear­ly stage cu­ta­neous T cell lym­phoma, ac­cord­ing to the S-1/A.

Doug Williams

Since it was found­ed in 2015, Co­di­ak has burned through $234.8 mil­lion. The com­pa­ny is helmed by ex-Bio­gen re­search chief Doug Williams, who now holds a 3.49% stake af­ter the of­fer­ing. ARCH Ven­ture Funds, Flag­ship Ven­ture Funds and Fi­deli­ty hold 19.47%, 13.14% and 10.41% of shares, re­spec­tive­ly.

Last Jan­u­ary, Co­di­ak bagged $56 mil­lion up­front in a deal with Jazz Phar­ma­ceu­ti­cals. And this June, it signed a $72.5 mil­lion deal with Sarep­ta to build out its gene ther­a­py tar­gets.

On Mon­day, SQZ Biotech and Lux Health Tech Ac­qui­si­tion, a SPAC formed by Lux Cap­i­tal, al­so filed to go pub­lic. SQZ pro­posed a $75 mil­lion raise to de­vel­op its cell ther­a­pies, while Lux is look­ing to nab $300 mil­lion.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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