NEW HAVEN, Conn., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
“We continued making strong progress in the third quarter of 2023 as we executed across our entire portfolio of PROTAC® protein degraders,” said John Houston, Ph.D., chairperson, chief executive officer, and president at Arvinas. “We remain focused on developing best-in-class medicines and are very pleased with the progress of our ER and AR degraders, both of which have the potential to make meaningful differences for patients. In the second half of next year, we anticipate completion of our first Phase 3 trial with our novel PROTAC ER degrader, vepdegestrant, in a second-line metastatic breast cancer setting, which we are jointly developing with Pfizer. Additionally, the profile of our PROTAC AR degrader, ARV-766, gives us the confidence to initiate a Phase 3 trial in metastatic castration resistant prostate cancer as soon as possible. We are also preparing to move two new compounds – our LRRK2 and BCL6 PROTAC protein degraders – into the clinic in 2024, with two more PROTAC protein degraders in IND-enabling studies by the end of 2023. We have a lot of milestones to deliver on in 2024 and I look forward to Arvinas’ continued success, with the ultimate, and most important goal of improving the lives of patients with serious diseases.”
Recent Developments and Third Quarter Business Highlights
Androgen Receptor Franchise
Vepdegestrant (ARV-471)
Anticipated Upcoming Milestones and Expectations
Vepdegestrant (ARV-471)
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:
Androgen Receptor (AR) Franchise (ARV-766/bavdegalutamide (ARV-110))
Pipeline:
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of September 30, 2023, is sufficient to fund planned operating expenses and capital expenditure requirements into 2026.
Third Quarter Financial Results
Cash, Cash Equivalents and Marketable Securities Position: As of September 30, 2023, cash, cash equivalents, restricted cash and marketable securities were $1,004.0 million as compared with $1,210.8 million as of December 31, 2022. The decrease in cash, cash equivalents, restricted cash and marketable securities of $206.8 million for the nine months ended September 30, 2023 was primarily related to cash used in operations of $253.0 million (net of $2.5 million received from two collaborators), leasehold improvements of $2.8 million and loss on the sale of marketable securities of $0.9 million, partially offset by net proceeds from the issuance of common stock under our ATM offering of $36.0 million, unrealized gains on marketable securities of $10.0 million and proceeds from the exercise of stock options of $3.9 million.
Research and Development Expenses: Research and development expenses were $85.9 million for the quarter ended September 30, 2023, as compared with $77.5 million for the quarter ended September 30, 2022. The increase in research and development expenses of $8.4 million for the quarter was primarily due to increases our AR program of $5.2 million, which includes ARV-766 and bavdegalutamide, and our ER program of $6.2 million, which is net of the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement, offset by a decrease in our platform and exploratory programs of $3.0 million.
General and Administrative Expenses: General and administrative expenses were $22.6 million for the quarter ended September 30, 2023, as compared with $20.0 million for the quarter ended September 30, 2022. The increase of $2.6 million was primarily due to increased investments in our commercial operations of $1.0 million, an increase in personnel and infrastructure related costs of $1.1 million, and an increase in professional fees of $0.5 million.
Revenues: Revenues were $34.6 million for the quarter ended September 30, 2023, as compared with $33.2 million for the quarter ended September 30, 2022. Revenue is related to the Vepdegestrant (ARV-471) Collaboration Agreement, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, the amended and restated option, license and collaboration agreement with Genentech and revenue related to our Oerth Bio joint venture which was initiated in July 2019. The increase in revenues of $1.4 million was primarily due to an increase in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement totaling $6.4 million, partially offset by a decrease in revenue of $2.8 million of previously constrained deferred revenue related to our Oerth Bio joint venture and a decrease of $1.8 million related to the conclusion of the performance period under the collaboration agreement with Genentech.
Income Tax Expense: Income tax was zero for the quarter ended September 30, 2023, as compared with an income tax expense of $2.2 million for the quarter ended September 30, 2022. Current year income tax expense was driven by valuation allowance recorded against the full amount of its net deferred tax assets. Prior year income tax expense was driven by revenue recognized in 2022 for tax purposes from the Vepdegestrant (ARV-471) Collaboration Agreement.
Loss from Equity Method Investment: Loss from equity method investment was $0.1 million for the quarter ended September 30, 2023, as compared with $2.9 million for the quarter ended September 30, 2022, due to fully recognizing the remaining Oerth Bio related constrained revenue, which limited the amount of equity method losses recognized during the quarter.
Net Loss: Net loss was $64.0 million for the quarter ended September 30, 2023, as compared with $66.2 million for the quarter ended September 30, 2022. The decrease in net loss for the quarter was primarily due to increased revenue and interest income from our marketable securities, as well as decreased income tax expense and loss from equity method investments, partly offset by increased research and development expenses and general and administrative expenses.
About ARV-766 and bavdegalutamide (ARV-110)
ARV-766 and bavdegalutamide (ARV-110) are investigational orally bioavailable PROTAC® protein degraders designed to selectively target and degrade the androgen receptor (AR). ARV-766 and bavdegalutamide are being developed as potential treatments for men with prostate cancer. Preclinically, both investigational agents have demonstrated activity in models of wild type tumors in addition to tumors with AR mutation or amplification, both common mechanisms of resistance to currently available AR-targeted therapies.
About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits. Ongoing and planned clinical trials will continue to monitor and evaluate the safety and anti-tumor activity of vepdegestrant.
About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs: ARV-766 and bavdegalutamide for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential advantages, therapeutic benefits and opportunity of vepdegestrant (ARV-471), ARV-766, bavdegalutamide (ARV-110), and Arvinas’ other candidates in its pipeline; the development and regulatory status of vepdegestrant (ARV-471), ARV-766, and bavdegalutamide (ARV-110), such as statements with respect to the initiation, continuation and timing of the timing of clinical trials, including the timing to complete enrollment, as well as the presentation and/or publication of data from those trials, discussions with regulatory authorities and plans for registration; Arvinas’ plans with respect to submission of investigational new drug (IND)/clinical trial authorization (CTA) applications; Arvinas’ plans to progress additional PROTAC protein degrader programs into IND- or CTA-enabling studies; and the sufficiency of Arvinas’ cash resources to fund planned operating expenses and capital expenditure requirements. All statements, other than statements of historical facts, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, 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.
Arvinas may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: Arvinas’ and Pfizer, Inc.’s (“Pfizer”) performance of their respective obligations with respect to the collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its product candidates, including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials on its expected timelines or at all; whether Arvinas obtains marketing approval for and commercializes vepdegestrant ARV-766 and its other product candidates on Arvinas’ current timelines or at all; Arvinas’ ability to maintain and protect its intellectual property portfolio; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas 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 Arvinas’ views as of any date subsequent to the date of this release.
Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
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Media:
Kirsten Owens
+1 (203) 584-0307
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| Arvinas, Inc. | ||||||
| Condensed Consolidated Balance Sheets (Unaudited) | ||||||
| (dollars and shares in millions, except per share amounts) | September 30, 2023 | December 31, 2022 | ||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 113.7 | $ | 81.3 | ||
| Restricted cash | 5.5 | 5.5 | ||||
| Marketable securities | 884.8 | 1,124.0 | ||||
| Accounts receivable | 15.7 | 1.0 | ||||
| Other receivables | 4.9 | 7.0 | ||||
| Prepaid expenses and other current assets | 8.4 | 21.4 | ||||
| Total current assets | 1,033.0 | 1,240.2 | ||||
| Property, equipment and leasehold improvements, net | 12.7 | 13.4 | ||||
| Operating lease right of use assets | 3.0 | 4.4 | ||||
| Collaboration contract asset and other assets | 9.6 | 10.8 | ||||
| Total assets | $ | 1,058.3 | $ | 1,268.8 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable and accrued liabilities | $ | 91.0 | $ | 74.7 | ||
| Deferred revenue | 224.2 | 218.6 | ||||
| Current portion of long term debt | 0.2 | — | ||||
| Current portion of operating lease liability | 1.9 | 1.8 | ||||
| Total current liabilities | 317.3 | 295.1 | ||||
| Deferred revenue | 281.9 | 405.1 | ||||
| Long term debt | 0.8 | 1.0 | ||||
| Operating lease liability | 1.1 | 2.7 | ||||
| Total liabilities | 601.1 | 703.9 | ||||
| Stockholders’ equity: | ||||||
| Common stock, $0.001 par value; 55.0 and 53.2 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 0.1 | 0.1 | ||||
| Accumulated deficit | (1,177.9 | ) | (965.4 | ) | ||
| Additional paid-in capital | 1,644.2 | 1,549.4 | ||||
| Accumulated other comprehensive loss | (9.2 | ) | (19.2 | ) | ||
| Total stockholders’ equity | 457.2 | 564.9 | ||||
| Total liabilities and stockholders’ equity | $ | 1,058.3 | $ | 1,268.8 | ||
| Arvinas, Inc. | ||||||||||||
| Condensed Consolidated Statements of Operations (Unaudited) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| (dollars and shares in millions, except per share amounts) | 2023 | 2022 | 2023 | 2022 | ||||||||
| Revenue | $ | 34.6 | $ | 33.2 | $ | 121.6 | $ | 93.6 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 85.9 | 77.5 | 284.5 | 216.7 | ||||||||
| General and administrative | 22.6 | 20.0 | 73.3 | 64.5 | ||||||||
| Total operating expenses | 108.5 | 97.5 | 357.8 | 281.2 | ||||||||
| Loss from operations | (73.9 | ) | (64.3 | ) | (236.2 | ) | (187.6 | ) | ||||
| Interest and other income | 10.0 | 3.2 | 25.5 | 5.9 | ||||||||
| Net loss before income taxes and loss from equity method investment | (63.9 | ) | (61.1 | ) | (210.7 | ) | (181.7 | ) | ||||
| Income tax (expense) benefit | — | (2.2 | ) | 0.7 | (10.1 | ) | ||||||
| Loss from equity method investment | (0.1 | ) | (2.9 | ) | (2.5 | ) | (7.8 | ) | ||||
| Net loss | $ | (64.0 | ) | $ | (66.2 | ) | $ | (212.5 | ) | $ | (199.6 | ) |
| Net loss per common share, basic and diluted | $ | (1.18 | ) | $ | (1.24 | ) | $ | (3.97 | ) | $ | (3.76 | ) |
| Weighted average common shares outstanding, basic and diluted | 54.1 | 53.2 | 53.6 | 53.1 | ||||||||
| Last Trade: | US$22.48 |
| Daily Change: | -2.44 -9.79 |
| Daily Volume: | 655,829 |
| Market Cap: | US$1.540B |
June 21, 2024 May 23, 2024 | |
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