Company: ARVN
Filing Date: 2025-05-01
Form Type: 10-Q
Source: 0001655759-25-000085
Chunk: 172

Company: ARVINAS, INC.
Filing Date: 2025-05-01
Form: 10-Q
Item: Part I, Item 8
Chunk 172
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 recognize primarily in the second quarter of 2025. The estimates of costs that we expect to incur, and the timing thereof, are subject to a number of assumptions and actual results may differ. Additionally, the workforce reduction could impact our operations, including our planned submission of an NDA to the FDA for vepdegestrant, which could affect our ability to generate future revenue.

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. In addition to any additional costs not currently contemplated due to events associated with or resulting from the workforce reduction noted above, our ability to achieve profitability and our financial position will depend, in part, on the rate of our future expenditures, on product revenue, if any, collaboration revenue, if any, and our ability to obtain additional funding. We expect to continue to incur significant expenses and anticipate that our expenses will increase substantially if and as we:

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•continue our ongoing and planned clinical trials of our product candidates, including vepdegestrant, for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer, ARV-102, our PROTAC degrader designed to target the LRRK2 protein, and ARV-393, our PROTAC protein degrader designed to target the BCL6 protein, and progress ARV-806, our KRAS G12D program, into a planned first-in-human Phase 1 clinical trial; 

•progress additional PROTAC protein degrader programs into IND- or CTA-enabling studies;

•apply our PROTAC Discovery Engine to advance additional product candidates into preclinical and clinical development;

•expand the capabilities of our PROTAC Discovery Engine; 

•seek marketing approvals for any product candidates that successfully complete clinical trials; 

•make decisions with respect to our personnel, including retention or future hiring of key employees, and establishment of a sales, marketing, market access, and distribution infrastructure to launch commercial sales of our products, if and when approved, whether alone or in collaboration with others;

•make decisions with respect to our infrastructure and capabilities, including to support our operations as a public company and our research, product development and future commercialization efforts;

•make or maintain arrangements with third-party manufacturers, or establish manufacturing capabilities, for both clinical and commercial supplies of our product candidates; and

•expand, maintain and protect our intellectual property portfolio.

Our expenses could increase beyond our expectations if we are required by the FDA, EMA, or other regulatory authorities to perform trials