Sanjiv Patel, Relay CEO

Re­lay reaps $400M IPO wind­fall af­ter draw­ing the cur­tain on mo­tion-based drug de­sign pipeline

A red-hot ven­ture mar­ket back in 2018 pro­pelled Re­lay Ther­a­peu­tics to a whop­ping $400 mil­lion crossover round. And now, the biotech is rid­ing on a red-hot IPO mar­ket to a pub­lic de­but that brought in the same ex­act amount.

The $400 mil­lion raise breaks down to 20 mil­lion shares sold at $20 each — above even the amend­ed pro­posed range of $16 to $18.

It’s al­so dou­ble what Re­lay had pen­ciled in with the ini­tial S-1 fil­ing, in yet an­oth­er il­lus­tra­tion that those fig­ures are of­ten noth­ing more than a place­hold­er these days.

On a mis­sion to piv­ot from the in­dus­try stan­dard struc­ture-based drug de­sign to “mo­tion-based drug de­sign,” Re­lay’s Dy­namo plat­form promis­es to find bet­ter ways to drug a tar­get pro­tein by sim­u­lat­ing its dy­nam­ic over time.

Dorothee Kern

“The whole beau­ty of en­zymes is that they ac­tu­al­ly move,” Dorothee Kern, a Bran­deis pro­fes­sor and one of four sci­en­tist co-founders, pre­vi­ous­ly told End­points News. “And if they don’t move they are dead. There’s a rea­son life doesn’t ex­ist be­low 180 kelvin.”

To­geth­er with bil­lion­aire David Shaw, Matthew Ja­cob­son of UCSF and Mark Mur­cko of MIT (and with the help of Third Rock) Kern found a way to in­cor­po­rate troves of ge­nom­ic da­ta, new ex­per­i­men­tal tech­niques and ma­chine learn­ing in­to the com­pa­ny — buzzy con­cepts that lured Soft­Bank, GV and Fore­site, among oth­ers, in­to the syn­di­cate.

As the team, led by CEO San­jiv Pa­tel, has played its cards close to the vest burn­ing through $214 mil­lion, the IPO doc­u­ments of­fered the first glimpse at the lead pro­grams, now in Phase I.

They rec­og­nize they are not the on­ly ones eye­ing these tar­gets. RLY-1971 will be com­pet­ing with Rev­o­lu­tion Med­i­cines (part­nered with Sanofi) and Ja­co­bio Phar­ma­ceu­ti­cals (part­nered with Ab­b­Vie) in the SHP2 space. And RLY-4008 has even more ri­vals al­so pur­su­ing FGFR2, in­clud­ing In­cyte, Janssen, Ei­sai and Ot­su­ka sub­sidiary Tai­ho, as well as Chi­nese play­er In­no­Core.

Then there’s the mu­tant-se­lec­tive PI3Kα in­hibitor pro­gram, for which Re­lay plans to se­lect a can­di­date with the pro­ceeds. It’s go­ing up against Piqray, mar­ket­ed by gi­ant No­var­tis, in ad­di­tion to ex­per­i­men­tal ef­forts at Roche and oth­ers.

So Re­lay has plen­ty to prove.

Soft­Bank Vi­sion Fund re­tains the largest chunk of stock — 32.12% — af­ter the of­fer­ing, while Third Rock kept 15.38%.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.