Arvinas shifts ARV-806 plans, sees runway into 2028
Arvinas, Inc. filed a current report outlining a portfolio re‑prioritization and updated plans for its ARV-806 program, along with an investor presentation for use at the Jefferies Global Healthcare Conference and other meetings.
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Form Type
8-K
Rhea-AI Filing Summary
Arvinas, Inc. filed a current report outlining a portfolio re‑prioritization and updated plans for its ARV-806 program, along with an investor presentation for use at the Jefferies Global Healthcare Conference and other meetings.
After a strategic review, the company plans to complete the ongoing Phase 1 monotherapy dose escalation trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations and share clinical data in 2026. For any further development, such as dose expansion or combination trials, Arvinas intends to seek an out-licensing partner rather than advance ARV-806 alone. The company also reiterates that its cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund planned operating and capital spending into the second half of 2028.
Insights
Arvinas narrows internal ARV-806 role while extending cash runway visibility.
Arvinas is refocusing its pipeline by limiting ARV-806 development to completion of the current Phase 1 dose escalation trial, with clinical data expected in 2026. Any additional ARV-806 trials are intended to proceed only through an out‑licensing arrangement.
This shifts later-stage investment risk on ARV-806 toward a potential partner, while Arvinas preserves optionality through licensing. The reiterated guidance that cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund operations into the second half of 2028 suggests multi‑year funding for its remaining priorities.
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Conference start date: June 2, 2026
Cash runway horizon: Into the second half of 2028
Clinical data timing: 2026
3 metrics
Conference start date
June 2, 2026
Investor presentation use and Jefferies Global Healthcare Conference participation
Cash runway horizon
Into the second half of 2028
Based on cash, cash equivalents and marketable securities as of March 31, 2026
Clinical data timing
2026
Planned timing to share clinical data from ARV-806 Phase 1 monotherapy dose escalation trial
Key Terms
Regulation FD Disclosure, Phase 1 clinical trial, dose escalation, out-licensing agreement, +1 more
5 terms
Regulation FD Disclosure regulatory
"Item 7.01 Regulation FD Disclosure. Representatives of Arvinas, Inc."
Regulation FD disclosure requires public companies to share important, market-moving information with everyone at the same time instead of tipping off analysts or large investors first. Think of it as making sure all players on a field hear the same announcement simultaneously; that fairness helps investors trust that stock prices reflect the same information and reduces the risk of sudden, unfair trading advantages or regulatory penalties for selective leaks.
Phase 1 clinical trial medical
"completed dose escalation enrollment of the Phase 1 clinical trial evaluating ARV-806"
A phase 1 clinical trial is the first stage of testing a new drug or treatment in people, typically involving a small group to assess safety, how the body handles the treatment, and appropriate dosing. For investors, phase 1 results are an early risk check — like a test drive that can reveal fatal flaws or promising signals — and they often cause big changes in a drug’s perceived value and the company’s prospects.
dose escalation medical
"completed dose escalation enrollment of the Phase 1 clinical trial"
Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.
out-licensing agreement financial
"plans to seek an out-licensing agreement for any additional clinical trials"
An out-licensing agreement is a contract where the owner of intellectual property—commonly a drug candidate, technology, or patent—grants another company the rights to develop, manufacture, or sell that asset in exchange for upfront fees, milestone payments, and/or royalties. It matters to investors because these deals can provide immediate cash, shift development cost and risk to the licensee, and create future revenue streams that change a company’s growth prospects and valuation, like renting out the right to sell a product instead of selling it yourself.
forward-looking statements regulatory
"This on Form 8-K contains forward-looking statements that involve substantial risks"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What pipeline change did Arvinas (ARVN) announce regarding ARV-806?
Arvinas plans to finish the current Phase 1 monotherapy dose escalation trial of ARV-806 and then pursue out-licensing for any further development. This means future dose expansion or combination studies are expected to be handled with, or by, a partner rather than solely by Arvinas.
What is the status of Arvinas (ARVN) ARV-806 Phase 1 trial?
Arvinas has completed dose escalation enrollment in its Phase 1 trial of ARV-806 for solid tumors with KRAS G12D mutations. The company plans to complete this monotherapy dose escalation trial and share clinical data in 2026, providing the first detailed clinical readout from this program.
How long does Arvinas (ARVN) expect its cash to last?
Arvinas expects its cash, cash equivalents and marketable securities as of March 31, 2026 to fund planned operating expenses and capital expenditures into the second half of 2028. This guidance indicates the company sees a multi-year financial runway for its current strategic plans.
What did Arvinas (ARVN) say about out-licensing ARV-806?
Arvinas plans to seek an out-licensing agreement for additional ARV-806 clinical trials beyond the current Phase 1 dose escalation study. This includes potential dose expansion or combination trials, indicating the company prefers to advance later-stage development with a licensing partner.
What is included in Arvinas (ARVN) new investor presentation?
Arvinas prepared an investor presentation for meetings and a fireside chat at the Jefferies Global Healthcare Conference beginning June 2, 2026. The presentation, furnished as Exhibit 99.1, may be updated over time and is provided for informational purposes rather than filed financial reporting.
Does Arvinas (ARVN) 8-K include forward-looking statements?
Yes. The report contains forward-looking statements about strategy, ARV-806 plans and financial runway that involve risks and uncertainties. Arvinas highlights that actual results may differ materially and refers readers to risk factor sections in its quarterly and annual SEC reports for further detail.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Accepted by SEC EDGAR
Learn about SEC filing dates
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________________
FORM 8-K
__________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 2, 2026
__________________
(Exact name of registrant as specified in its charter)
__________________
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | ||||
Registrant’s telephone number, including area code: (203 ) 535-1456
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
__________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
The | ||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 7.01 Regulation FD Disclosure.
Representatives of Arvinas, Inc. (the "Company") intend to use a presentation (the "Investor Presentation") at various meetings with investors, analysts or others from time to time, including in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 3, 2026, beginning Tuesday, June 2, 2026. The Investor Presentation may be amended or updated at any time and from time to time through another Current Report on Form 8-K, a later company filing, or other means. A copy of the Investor Presentation is furnished herewith as Exhibit 99.1 and is incorporated into this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
Following a strategic review of its pipeline, the Company has made the decision to re-prioritize its portfolio. As previously disclosed, in the second quarter of 2026, the Company announced that it had completed dose escalation enrollment of the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring Kirsten rat sarcoma ("KRAS") G12D mutations. The Company is planning to complete this Phase 1 monotherapy dose escalation clinical trial and share clinical data in 2026. The Company plans to seek an out-licensing agreement for any additional clinical trials, including dose expansion or combination clinical trials, for ARV-806.
The Company continues to believe that its cash, cash equivalents and marketable securities as of March 31, 2026, will enable the Company to fund its planned operating expenses and capital expenditure requirements into the second half of 2028.
Item 9.01 Financial Statements and Exhibits.
| Exhibit Number | Description of Exhibit | |||||||
99.1 | Company Presentation, for use beginning June 2, 2026 | |||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | |||||||
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the Company's plans with respect to ARV-806, including any potential out-licensing agreement for additional clinical trials of ARV-806. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K, including statements regarding the Company’s strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements made by the Company as a result of various risks and uncertainties, including the risk factors discussed in the “Risk Factors” sections contained in the Company’s quarterly and annual reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this filing reflect the Company’s current views with respect to future events, and the Company assumes no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Current Report on Form 8-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ARVINAS, INC. | ||||||||
| Date: June 2, 2026 | By: | /s/ Jared Freedberg | ||||||
Jared Freedberg General Counsel | ||||||||
