Adam Morgan of Velan Capital Investment Management (L) and Radius Health CEO Kelly Martin

Ac­tivist in­vestors at­tempt to change the course at Ra­dius Health, six months af­ter two dis­ap­point­ing read­outs

Fol­low­ing a dis­ap­point­ing da­ta re­veal and sub­se­quent stock drop late last year, Ra­dius Health is now fac­ing an ac­tivist at­tack from two mi­nor­i­ty in­vestors aim­ing to right the ship.

Ve­lan Cap­i­tal In­vest­ment Man­age­ment and Reper­toire Part­ners filed their proxy state­ments Tues­day morn­ing in a bid to nom­i­nate a slate of three new board mem­bers at Ra­dius’ an­nu­al share­hold­er meet­ing next month. The Ve­lan-Reper­toire group, which col­lec­tive­ly owns a 7.7% stake, al­leges Ra­dius’ cur­rent di­rec­tors have un­der­tak­en a bad com­mer­cial strat­e­gy for its one ap­proved prod­uct and are un­fit to serve be­cause they own al­most no shares in the com­pa­ny.

“This rais­es an ob­vi­ous ques­tion: why should you con­tin­ue to trust a Board that has over­seen a pre­cip­i­tous de­cline in share price while re­main­ing large­ly in­su­lat­ed from the pain we as stock­hold­ers have felt?” the group posit­ed to share­hold­ers rhetor­i­cal­ly.

The proxy launch is not the first time Ra­dius has un­der­gone at­tempt­ed ac­tivist re­forms. Much of the biotech’s cur­rent C-suite and board were ap­point­ed fol­low­ing a sig­nif­i­cant shift in April 2020, which saw a new CEO, chair­man and five di­rec­tors jump aboard.

But Ve­lan and Reper­toire ar­gue this group was un­qual­i­fied to take the reins from the start, point­ing to the com­pa­ny’s poor stock per­for­mance rel­a­tive to the Nas­daq biotech in­dex — a neg­a­tive 48% rel­a­tive re­turn as of March 7 — and oth­er com­pos­ite fig­ures.

The ac­tivists al­so point­ed to con­text-free quotes from earn­ings calls and in­vestor events ap­pear­ing to show CEO Kel­ly Mar­tin ad­mit­ting his lack of knowl­edge in Ra­dius’ dis­ease re­search ar­eas, such as os­teo­poro­sis.

Should Ra­dius share­hold­ers vote for the three Ve­lan-Reper­toire nom­i­nees, the ac­tivists say they will cen­tral­ize the fo­cus on com­mer­cial­iz­ing its ap­proved os­teo­poro­sis drug Tym­los, en­sur­ing its ex­per­i­men­tal breast can­cer drug elaces­trant has enough fund­ing to push for­ward and dis­con­tin­u­ing de­vel­op­ment for oth­er “non-core” projects.

The group specif­i­cal­ly calls out RAD011 as a pro­gram it would drop. This can­di­date is cur­rent­ly un­der de­vel­op­ment for seizures as­so­ci­at­ed with An­gel­man syn­drome and hy­per­pha­gia as­so­ci­at­ed with Prad­er-Willi syn­drome.

For its part, Ra­dius ac­knowl­edged the at­tack in its own proxy state­ment and let­ter to share­hold­ers is­sued Mon­day. The com­pa­ny tout­ed its Tym­los com­mer­cial­iza­tion strat­e­gy and says it’s prepar­ing to file for a la­bel ex­pan­sion to in­clude male os­teo­poro­sis pa­tients and a new patent ap­proval ex­tend­ing its ex­clu­siv­i­ty to 2040.

Ex­ecs brushed back the at­tack in the let­ter, writ­ing to share­hold­ers:

To date Ve­lan and Reper­toire have not of­fered unique rec­om­men­da­tions, in­sights or analy­sis that this board and man­age­ment team have al­ready an­a­lyzed and de­ter­mined not to be in the best in­ter­ests of Ra­dius and our stock­hold­ers. They have on­ly stat­ed that they do not like or ap­pre­ci­ate the Com­pa­ny’s bal­anced ap­proach and port­fo­lio and in­stead would have the Com­pa­ny fo­cus all ef­forts on a sin­gle com­mer­cial prod­uct.

Tues­day’s news comes about six months af­ter Ra­dius re­vealed a Phase III study for an in­jectable ver­sion of Tym­los did not achieve non-in­fe­ri­or­i­ty com­pared to the orig­i­nal in post­menopausal women with os­teo­poro­sis. The com­pa­ny al­so re­port­ed at the time that a tri­al for elaces­trant mus­tered sta­tis­ti­cal sig­nif­i­cance, but in­vestors were dis­ap­point­ed by the re­sults, caus­ing the biotech’s shares $RDUS to fall more than 40%.

Ge­of­frey Porges, for­mer­ly of SVB Se­cu­ri­ties, wrote to in­vestors at the time that the Phase III Tym­los miss was “not such a ship­wreck” and could still hit the mar­ket by 2025. That would rep­re­sent a rough­ly two-year de­lay, how­ev­er, and Ra­dius would like­ly need to en­gage in “non-tra­di­tion­al” fi­nanc­ing to fund ad­di­tion­al stud­ies.

Tym­los was Ra­dius’ first-ever drug ap­proval, get­ting an FDA nod back in 2017 and go­ing up against heavy­weights in J&J and Am­gen. Elaces­trant’s glob­al com­mer­cial rights were ac­quired by the Menar­i­ni Group in 2020 for $30 mil­lion, and Menar­i­ni is on the hook for $320 mil­lion in mile­stones and roy­al­ties in the low to mid-teens.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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