🔒Amid $350M fundraise, ‘promising’ clinical trial data, Arvinas sets sights on commercial drug launch

With a recent $350 million fundraise, New Haven biotech Arvinas says it’s financed through at least 2027 to pursue bringing its cancer-fighting drugs to market.

Arvinas in November entered into a securities purchase agreement to raise the money, which it plans to use to advance its drug pipeline and for working capital and other general corporate expenses.

The clinical-stage company, founded by Yale University scientist Craig Crews, is working on treatments for breast and prostate cancer. It has been focused on creating drugs that harness the body’s natural protein disposal system to remove disease-causing proteins.

Arvinas President and CEO John Houston said the company pursued a private investment in public equity (or a PIPE) deal, as a financial tool to raise cash.

More than a half-dozen investors — co-led by San Francisco-based EcoR1 Capital and entities managed by RTW Investments LP of New York City — were involved in the investment round.

“We were extremely pleased to get such a good cadre of investors to come into the PIPE,” Houston said. “It gives us some financial stability over the next several years, with funding into 2027.”

The company’s current focus is on bringing its pipeline of treatments to market, Houston said, as it has drug candidates in later-stage clinical trials.

“We have quite an extensive pipeline of drugs in the oncology space,” Houston said. “Phase three trials are incredibly expensive, so part of the plan was to get as much cash in now so that we can fund the clinical trials over the next several years.”

Arvinas has an ongoing collaboration with Pfizer to develop and commercialize Vepdegestrant, a breast cancer drug candidate in phase 3 clinical trials.

At the 2023 San Antonio Breast Cancer Symposium in December, Arvinas and Pfizer announced interim data from a phase 1b trial of Vepdegestrant, an estrogen receptor degrader, in combination with Pfizer’s drug Palbociclib (IBRANCE), in breast cancer patients.

The results demonstrated “encouraging clinical activity,” according to the companies. The human study involved 46 breast cancer patients who had previously undergone treatment with different therapies, such as chemotherapy.

The clinical benefit rate, or the percentage of participants whose tumors shrank or stopped growing for at least 24 weeks, was 63%, or 29 out of 46 patients.

Half of the people who took Vepdegestrant and Palbociclib lived without their condition getting worse for 11 months or longer, Arvinas said.

“We’re very pleased with the data,” Houston said. “The stock market reacted positively, but the main focus is on the benefit for patients. That’s the most exciting thing — to see a drug working in a situation where there’s still significant unmet need.”

The financials

Arvinas has been a publicly traded company since its 2018 IPO, when it raised $123 million. With its latest funding round, the company has raised $2.4 billion since its inception.

Arvinas currently has 450 employees and generated $121.6 million in revenue during the first nine months of 2023, up nearly 30% from the year-ago period.

Like most clinical-stage biotech companies, however, it continues to lose money as it tries to get its drugs to market. It lost $212.5 million during the first three quarters of 2023, up from $199.6 million a year earlier.

It currently generates revenue from collaboration and licensing agreements with larger pharmaceutical companies, like its partnership with Pfizer.

Arvinas and Pfizer have agreed to equally share development costs, commercialization expenses and profits of the breast cancer drug they are co-developing.

Arvinas’ stock price, as of Jan. 17, was trading at about $38 a share.

Drug pipeline

There continues to be a need for additional therapies to help treat breast cancer that has spread to other areas of the body, said Dr. Erika Hamilton, director of breast cancer research at Sarah Cannon Research Institute in Nashville, Tennessee, who is a lead investigator in the Vepdegestrant clinical trial program.

“I am encouraged by the early data seen in the phase 1b cohort of this study,” she said.

Houston said he anticipates data from ongoing phase 3 studies of Vepdegestrant by the end of 2024.

“If it’s positive, and the health authorities have approved the data, then we could be in a position in early 2025 to potentially have an approval,” Houston said.

If so, the drug could be brought to market later in 2025, he said. It would be the company’s first commercial product.

“That’d be very exciting for Arvinas, which would be transitioning from a late-stage development to a commercial company over the next couple of years,” Houston said.

Arvinas is not providing revenue projections for Vepdegestrant yet, though Houston said he anticipates it would be a “backbone therapy” in the metastatic breast cancer space.

Once Arvinas has drugs to market, its intention is to become a fully integrated pharmaceutical company, Houston said. There are no plans to merge or be acquired, he said.

Arvinas also is pursuing a prostate cancer treatment, with phase 3 trials expected to begin in the next year, Houston said. In addition to oncology, Arvinas is also pursuing potential neuroscience treatments for Huntington’s and Parkinson’s diseases.

Expanding New Haven footprint

Arvinas is based in Science Park in New Haven, which has extensive laboratory space, but will be adding a second location inside a new 525,000-square-foot life sciences building at 101 College St. in downtown New Haven, which is slated to be ready in early 2024.

The building is still undergoing interior work, and Houston anticipates starting to move into three leased floors within the College Street building in the first half of 2025.

Correction: A previous version of this article incorrectly stated when Arvinas would be moving into space at 101 College St., a new bioscience tower in New Haven. The company will occupy space there in the first half of 2025.