DICE Therapeutics, Inc.

Eli Lilly lowered the top end of its full-year revenue guidance by $600 million on Wednesday, as its third-quarter sales were about $800 million below Wall Street’s expectations. The pharma giant had upped its full-year revenue expectations by $3 billion last quarter. But in its third-quarter update, Lilly said it was lowering the top end from $46.6 billion to $46 billion. Lilly attributed its updated revenue guidance to “investing heavily in increasing the supply of tirzepatide and has been balancing demand creation activities and launches into new markets.” Its shares $LLY immediately tanked 9% when its earnings report was released. It marks a rough transition for the drugmaker’s new CFO Lucas Montarce, a decadeslong veteran of the company. The company reported $11.44 billion in sales for July through September, a 20% increase over the same period in 2023. The Street consensus for Q3 revenue was $12.2 billion, according to a preview note earlier this month from Leerink Partners. Lilly missed expectations on Zepbound sales by almost $400 million. But on the overall tirzepatide franchise, it reached the Street’s anticipated $4.37 billion in sales. In this earnings season, the Indianapolis pharma giant reported earnings a week in advance of Novo Nordisk. Last quarter, Novo slipped in trading when it presented a day before Lilly . Lilly also disclosed the removal of two Phase 2 assets — DC-806 for psoriasis and peresolimab for rheumatoid arthritis — and one Phase 1 drug, an APOC3 siRNA for cardiovascular disease. Lilly got DC-806, an oral IL-17 inhibitor, from its $2.4 billion DICE Therapeutics acquisition last year. At the time, DICE said it had another molecule in development, DC-853, that could have better potency. This is an evolving story and will be updated.

iStock, Artur Plawgo Candid Therapeutics, which is repositioning two antibodies for autoimmune indications, will be led by Ken Song who was previously CEO of RayzeBio and oversaw its $4.1 billion acquisition by Bristol Myers Squibb. Candid Therapeutics officially launched on Monday with a strong capital raise that the startup hopes will help drive it to frontrunner status in the T cell engager market. Aiming to develop “potentially transformative” therapies for autoimmune diseases, Candid is debuting with more than $370 million in seed funding from a high-powered roster of backers, including Third Rock Ventures, OrbiMed, Foresite Capital and LifeSci Venture Partners. Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners co-led Candid’s funding. For its initial pipeline, Candid pulled off a three-way merger by acquiring Vignette Bio and TRC 2004, giving it two bispecific T cell engagers. The first, dubbed CND106, targets the B-cell maturation antigen, a protein typically found in mature B cells and when overexpressed is usually a driving factor of multiple myeloma. Vignette last week licensed CND106 from Shanghai-based EpimAb for $60 million upfront and $575 million in potential milestones. Candid’s second pipeline asset is CND261, which comes from TRC 2004. It binds to the CD20 antigen, which is also found on B cells and may be expressed in abnormal levels in certain lymphomas and leukemias. CND261 comes from another Chinese biotech, Genor Biopharma, and was also licensed by TRC last month . Both CND106 and CND261 also target the CD3 antigen on T-cells, allowing them to bridge the body’s immune system with the target B cells. Candid has yet to reveal what specific indications these candidates will target, but CEO Ken Song revealed that the startup will focus its efforts on autoimmune diseases. “The drugs we are developing at Candid have the potential to go above and beyond the clinical and commercial success of Humira and Rituxan,” Song said in a statement. “We can possibly make history by changing the paradigm in how autoimmune diseases are treated.” For Song, Candid’s launch comes just months after he successfully wrapped up the $4.1 billion acquisition deal involving RayzeBio—which he previously led as its president and CEO—and Bristol Myers Squibb. The agreement was first announced in late December 2023 and was closed in February 2024 . To help lead Candid, Song will be joined by Timothy Lu, chief medical and scientific officer, who was involved in the development of oral IL-17 therapies at DICE Therapeutics, which was acquired in June 2023 by Eli Lilly for $2.4 billion. Viridian Therapeutics alum Bernie Hyunghe will serve as Candid’s chief technology officer, while Arvind Kush will act as its chief financial and business officer.

Ken Song, M.D., specifically called out Humira and Biogen and Rituxan as autoimmune drugs he thinks Candid Therapeutic' T-cell engagers can dethrone. After overseeing the $4.1 billion sale of radiopharma player RayzeBio to Bristol Myers Squibb, biotech veteran Ken Song, M.D., didn’t take long to set up his next big venture. He is now chairman, president and CEO of Candid Therapeutics, which has debuted with a $370 million series A and a goal to dominate the T-cell engager market.In an unusual move, Candid’s launch combines fundraising and the acquisition of two biotechs, Vignette Bio and TRC 2004, along with their lead assets. There are big names among the backers: The round was co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners, with Foresite Capital and Third Rock Ventures also taking part, among others, according to a Sept. 9 press release.The round is one of the biggest so far this year, coming in ahead of the $325 million series C ArsenalBio announced just days ago.“It was unconventional to bring together ultimately what was three financings, two licensing transactions and an M&A,” Song told Fierce Biotech in an interview. “But it got done.” T-cell engagers are bispecific antibodies that bind to T cells and a molecule on a target cell, coercing the T cells to attack the target. The engagers Candid picked up from Vignette and TRC were both developed in China to treat cancer. CND106, from Vignette, targets B-cell maturation antigen, while CND262 from TRC binds to CD20. Both then also bind to CD3 on the surface of T cells.Song initially formed San Diego-based Candid as a shell company while scouting out the biotech landscape. “I probably looked at over 50 opportunities,” he said, before settling on T-cell engagers. It was data on CAR T-cell therapies’ ability to treat refractory autoimmune disease by depleting B cells that initially caught his eye.“Our view was, why are people doing this with cell therapy?” Song said. There are “many approved bispecifics, and they accomplish pretty much the same thing” while also being less intensive treatments, he said. If T-cell engagers prove that they can match or exceed the efficacy of cell therapies, Song thinks the industry should look to move on from cell therapies.“We should really focus our efforts on doing what we think is the right way, rather than trying to hold on to legacy stuff,” Song said. “We're not there yet, but I think we're going to get there.” On the assumption that a deluge of T-cell engager bispecific antibodies is coming, Song decided to strike. “What we wanted to do was to set up the company in a way that positioned us to be able to get first to market,” he said. Initially, they needed clinical-stage assets—CND106 and CND262 have both completed phase 1 trials—then the capital and the right team.Song recruited Timothy Lu, M.D., Ph.D., who developed oral IL-17 autoimmune drugs at DICE Therapeutics (since acquired by Eli Lilly), to be chief medical and scientific officer. Chief Technology Officer Bernie Huyghe, Ph.D., was initially recommended to him as a chemistry, manufacturing and controls consultant, but Song was impressed by his work and asked him to come aboard full-time. And he reunited with his former colleague from RayzeBio Arvind Kush, who is Candid’s chief financial and business officer.Song chose the name Candid because that’s how he wants the company to operate. “My view is a lot of companies in biotech and a lot of the way management teams operate is that they're not necessarily upfront or transparent in what's actually happening,” he said. “If the data sucks, the data sucks, right? And you should be able to own up to it.”Candid is now focused on filing IND applications for its new assets so that the company can study them in autoimmune disease; Song said he hopes they will have clinical data on at least the drugs’ safety by 2025. In the press release, Song specifically called out AbbVie’s Humira and Biogen and Genentech’s Rituxan as autoimmune drugs he thinks Candid’s T-cell engagers can dethrone.“How many companies can actually sit here and get investors to also believe you when you say these drugs could be bigger than Humira?” Song said. “This is like the same potential magnitude and impact as what we saw with immunotherapy and PD-1/PD-L1. This is what attracted us to it.”