Peloton Therapeutics, Inc.

The second blank-check vehicle from Cormorant’s Bihua Chen plans to take BridgeBio’s oncology spinout onto the Nasdaq. The special purpose acquisition company — known as Helix Acquisition Corp. II — will combine with BridgeBio Oncology Therapeutics, the companies said Friday morning. The deal includes about $260 million by way of a PIPE and $196 million from Helix’s trust account. The company will trade under the ticker “BBOT,” which is its abbreviation. BBOT is expected to have approximately $550 million in cash and a pro forma equity value of about $949 million when the deal closes, the companies said. They anticipate it will close in the third quarter. “They reached out to us, and it felt like a good way to raise capital in today’s market,” BBOT CEO Eli Wallace said in an interview with Endpoints News . BBOT was planning to do another round of funding in 2025, but hadn’t selected the exact mechanism when Helix had approached it, Wallace said. BBOT and its board evaluated a crossover and IPO, or the “traditional route,” as its “main other option.” Five biotech startups have gone public via an IPO in the US so far this year . The Helix-BBOT merger is one of a few biotech SPAC deals to take place in recent quarters. The alternative route to going public had surged in popularity during 2020 and 2021 but then cooled off in the ensuing years. Chen and her team have been successful with the financing vehicle in the past. They took Swiss immunology biotech MoonLake public in 2022 . The clinical-stage drug developer had been trading well above its initial share price for the first two years post-combination, but its stock price $MLTX is now down about 22% year-to-date. Chen’s second SPAC had been hunting for a combination target for about a year. The blank-check company closed its initial public offering of $184 million last February. Shortly after, the Cormorant leader told Endpoints News she was looking for the “same rigor in terms of science and data and a commercial aspect” in a SPAC combination target, following the MoonLake deal. Her investment firm was already familiar with BBOT. Cormorant led a $200 million round in BBOT when it split from BridgeBio last May. BridgeBio had a 38% ownership stake in BBOT as of a corporate presentation this month. That spinout round, technically considered a Series B, had included a who’s who of crossover investors, including Omega Funds, Deerfield Management affiliates, GV, EcoR1 Capital, Wellington Management, Enavate Sciences, Citadel’s Surveyor Capital, Aisling Capital, Casdin Capital and Longwood Fund. BBOT is in the clinic with two drug candidates so far. Its first oral small molecule is BBO-8520 , a KRAS G12C inhibitor that targets both the on and off states of the protein and is being studied in patients with certain forms of non-small cell lung cancer. The other oral small molecule, BBO-10203, aims to block the interaction between RAS and PI3K alpha. That Phase 1 in advanced solid tumors began in October. “In the context of the rest of their extensive portfolio, this portfolio wasn’t getting the recognition that it deserved,” Cormorant’s Raymond Kelleher, a BBOT board member, told Endpoints at the time of the company’s unveiling in 2024. BBOT was previously known inside BridgeBio as “TheRas” for its work on a common driver of cancer known as RAS mutations. Amgen and Bristol Myers Squibb’s Mirati opened up the KRAS field with their respective Lumakras and Krazati approvals. The 60-employee biotech plans to move a third program into the clinic next quarter, as well, Wallace said. He joined BridgeBio in 2019 after serving as science chief at Peloton Therapeutics, the Welireg developer bought by Merck in 2019. He noted BBOT expects to have clinical data for all three of its programs over the coming 18 months.

PPGL is a group of rare neuroendocrine tumours originating from adrenal gland tissue or paraganglia. Credit: Witthaya Prasongsin via Getty Images. The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to include its use for the treatment of the rare cancer pheochromocytoma and paraganglioma (PPGL). The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 26 May 2025. The new label is intended to cover adult and paediatric patients aged 12 years and older with advanced, unresectable, or metastatic PPGL. MSD’s submission is based on efficacy and safety data from the Phase II LITESPARK-015 trial (NCT04924075), which evaluated Welireg in patients with advanced PPGL. The study measured the objective response rate (ORR) and duration of response (DOR) as primary endpoints and included other secondary endpoints such as disease control, progression-free survival (PFS), and safety. Results from the trial are expected to be presented at an upcoming medical meeting. MSD acquired Welireg when it bought Peloton Therapeutics for an upfront payment of $1.05bn in 2019. In August 2021, the drug was first approved by the FDA for the treatment of a rare disorder called von Hippel-Lindau (VHL) disease. Welireg is also approved for treating some patients with advanced renal cell carcinoma (RCC). PPGL is a group of rare neuroendocrine tumours originating from adrenal gland tissue or paraganglia. These tumours are often challenging to treat in advanced stages, and current therapeutic options are limited. A gap in the PPGL treatment market was left following the withdrawal of Lantheus ’s Azedra (iobenguane I-131), a radiopharmaceutical therapy approved by the FDA for treating unresectable, locally advanced, or metastatic PPGL requiring systemic anticancer therapy in 2018. Azedra was the first FDA-approved therapy specifically for this rare indication. However, the drug was voluntarily withdrawn from the market due to manufacturing challenges that affected its commercial availability in 2023. Welireg inhibits hypoxia-inducible factor-2 alpha (HIF-2α), thereby targeting pathways involved in tumour growth and survival under low-oxygen conditions. Welireg generated $218m in global sales in 2023, as per MSD’s financials, with expectations to reach up to $1.5bn in annual sales in 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. Welireg comes with a boxed warning about its potential to cause embryo-foetal harm if used during pregnancy. It can also render hormonal contraceptives ineffective and cause severe anaemia and severe hypoxia.

Pictured: 3D image of a KRAS oncogene iStock/Gilnature BridgeBio announced Thursday that it has secured $200 million in financing to spinout a former subsidiary to develop a KRAS-focused oncology portfolio. Called BridgeBio Oncology Therapeutics (BBOT), the company was initially formed as a subsidiary of BridgeBio known as TheRas. According to an SEC filing, the subsidiary has existed since 2016 and formed a research and development agreement with Leidos Biomedical Research in 2017. BBOT’s mission now is to generate a pipeline of small molecule therapeutics targeting RAS and PI3K malignancies. The company aims to advance three programs, including BBO-8520, a direct inhibitor of KRAS that seeks to bind to the protein’s “on” and “off” states. The spinout is enrolling patients with mutant non-small cell lung cancer in a Phase Ia/Ib trial. A second asset that BBOT will be advancing is BBO-10203, a PI3Kα:RAS breaker that blocks the interaction between RAS and PI3Ka to inhibit the PI3Kα/AKT effector signaling in tumors. The company plans to IND application sometime in the second quarter of 2024 and enroll patients later this year. The other asset is BBO-11818, a pan-KRAS inhibitor that is going after the “on” and “off” states of KRASG12X, and BBOT plans to IND sometime in early 2025. The company is also pursuing a discovery-stage research program focused on developing assets that target additional oncogenic drivers within the RAS and PI3K pathways. “We believe the launch of BBOT better aligns investors with an opportunity that was being hidden in our pipeline, and our partnership with these new investors enables us to prosecute these oncology programs more quickly and with higher fidelity,” BridgeBio CEO Neil Kumar said in a statement. The spinout secured its $200 million financing in an oversubscribed round led by Cormorant Asset Management and co-led by Omega Funds. There was also participation from GV (Google Ventures), Deerfield Management, EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital, Casdin Captial, Aisling Capital, and Longwood Fund. BBOT will headed by Eli Wallace, BridgeBio’s CEO of oncology R&D. Wallace joined BridgeBio in 2019 after serving as the chief scientific officer at Peloton Therapeutics. Kumar will also serve as a director of BBOT. “In conjunction with BridgeBio and an amazing suite of investors, we look forward to seeing all three of our programs progress into the clinic over the next 12 months,” Wallace said in a statement. BridgeBio has gone down the spinout path before, launching QED Therapeutics in 2018. The company secured $65 million and aimed to develop infigratinib, a cancer asset that Novartis abandoned. Infigratinib was given accelerated approval by the FDA in 2021. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.