BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor (ER) degrader, being jointly ...

Shares of Arvinas, Inc. (ARVN) have gained 13.2% over the past four weeks to close the last trading session at $46.30, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $58.65 indicates a potential upside of 26.7%.The mean estimate comprises 17 short-term price targets with a standard deviation of $23.32. While the lowest estimate of $20 indicates a 56.8% decline from the current ...

-- Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC®) protein degrader designed to target and degrade the estrogen receptor (ER) protein -- NEW HAVEN, Conn. and NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN) and Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of vepdegestrant (ARV-471) for monotherapy in the treatment of adults with estrogen receptor (ER) positiv ...

Company Overview - Arvinas, Inc. (ARVN) shares increased by 10% to close at $45.65, with trading volume significantly higher than usual [1] - The stock's performance over the past four weeks showed a modest gain of 0.7% [1] Pipeline Progress - The surge in stock price is linked to positive investor sentiment regarding Arvinas' clinical pipeline, particularly the lead candidate vepdegestrant [1] - Vepdegestrant is being evaluated in two late-stage studies: VERITAC-2 and VERITAC-3, targeting second-line breast cancer as a monotherapy and in combination with Pfizer's Ibrance [1] - Arvinas also has two mid-stage candidates in development for prostate cancer [1] Financial Expectations - The company is projected to report a quarterly loss of $1.28 per share, reflecting an 18% year-over-year increase in losses [2] - Expected revenues for the upcoming quarter are $44.63 million, which is a 17.5% increase compared to the same quarter last year [2] - The consensus EPS estimate has been revised down by 6.6% over the last 30 days, indicating a negative trend in earnings estimate revisions [2] Industry Context - Arvinas is classified under the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Prothena (PRTA) [3] - Prothena's stock closed 3.6% lower at $27.37, with a significant decline of 25.4% over the past month [3] - Prothena's consensus EPS estimate remains unchanged at -$1.07, representing a drastic change of -991.7% from the previous year [3]

Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing therapies that degrade disease-causing proteins using its proprietary PROTAC Discovery Engine platform [2] - The company aims to improve the lives of patients with debilitating and life-threatening diseases through the discovery, development, and commercialization of these therapies [2] Clinical Programs - Arvinas has a robust preclinical pipeline of PROTAC protein degraders targeting both validated and "undruggable" targets [2] - The company is advancing three investigational clinical-stage programs: - Vepdegestrant (ARV-471) for locally advanced or metastatic ER+/HER2- breast cancer - ARV-766 and bavdegalutamide for metastatic castration-resistant prostate cancer [2] Upcoming Events - Ron Peck, M.D., Chief Medical Officer, and Randy Teel, Ph.D., Senior Vice President, Corporate and Business Development will participate in a fireside chat at the 6th Annual Guggenheim Biotechnology Conference on February 7, 2024 [1] - A live audio webcast of the presentation will be available on the company's website [1]

Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing therapies that degrade disease-causing proteins using its proprietary PROTAC Discovery Engine platform [2] - The company aims to improve the lives of patients with debilitating and life-threatening diseases through the discovery, development, and commercialization of these therapies [2] Clinical Programs - Arvinas has a robust preclinical pipeline of PROTAC protein degraders targeting both validated and "undruggable" targets [2] - The company is advancing three investigational clinical-stage programs: - Vepdegestrant (ARV-471) for locally advanced or metastatic ER+/HER2- breast cancer - ARV-766 and bavdegalutamide for metastatic castration-resistant prostate cancer [2] Upcoming Events - Ron Peck, M.D., Chief Medical Officer, and Randy Teel, Ph.D., Senior Vice President, Corporate and Business Development will participate in a fireside chat at the 6th Annual Guggenheim Biotechnology Conference on February 7, 2024 [1] - A live audio webcast of the presentation will be available on the company's website [1]

Investors might want to bet on Arvinas, Inc. (ARVN) , as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a c ...

Company Announcement - Arvinas, Inc announced the appointment of Jared Freedberg as General Counsel, bringing over 20 years of legal and commercial experience to the company [1] - Jared Freedberg's previous roles include General Counsel at Intercept Pharmaceuticals and Immunomedics, Inc, as well as Vice President, Legal, Business Development and Licensing at Mallinckrodt Pharmaceuticals [1] - The company granted Mr Freedberg an option to purchase 67,314 shares of common stock and a restricted stock unit award for 45,504 shares as part of his employment inducement [2] Executive Compensation - The stock option has a 10-year term with an exercise price of $38.10 per share, equal to the closing price on the grant date [3] - The option vests over four years, with 25% vesting after one year and the remainder vesting monthly thereafter [3] - The restricted stock units vest in four equal annual installments, contingent on continued employment [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies that degrade disease-causing proteins using its proprietary PROTAC Discovery Engine platform [4] - The company has three clinical-stage programs: vepdegestrant (ARV-471) for ER+/HER2- breast cancer, and ARV-766 and bavdegalutamide for metastatic castration-resistant prostate cancer [4] Strategic Focus - The company aims to advance its pipeline of earlier stage assets driven by the PROTAC protein degrader platform while preparing for potential product commercialization [1] - Arvinas is pioneering scientific advancements in protein degradation to improve treatment options for patients with serious diseases [2][4]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ FORM 10-Q __________________________________________ (Mark One) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------------------------ ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Arvinas, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2023, reflecting a net loss of **$148.5 million** and approximately **$1.0 billion** in cash and marketable securities [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to **$1,083.5 million** from **$1,268.8 million**, driven by reduced marketable securities, while total liabilities and equity also declined Condensed Consolidated Balance Sheet Highlights (in millions) | Balance Sheet Item | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and marketable securities | $1,038.8 | $1,205.3 | | Total Assets | $1,083.5 | $1,268.8 | | **Liabilities & Equity** | | | | Deferred Revenue (Current & Non-current) | $540.6 | $623.7 | | Total Liabilities | $619.9 | $703.9 | | Total Stockholders' Equity | $463.6 | $564.9 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue increased to **$87.0 million** for the six months ended June 30, 2023, but rising operating expenses led to a net loss of **$148.5 million** Statement of Operations Summary (in millions, except per share data) | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Revenue | $87.0 | $60.3 | | Research and development | $198.6 | $139.2 | | General and administrative | $50.7 | $44.5 | | Loss from operations | $(162.3) | $(123.4) | | Net loss | $(148.5) | $(133.4) | | Net loss per common share | $(2.78) | $(2.51) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$179.9 million** for the six months ended June 30, 2023, offset by **$187.2 million** from investing activities Cash Flow Summary (in millions) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(179.9) | $(135.7) | | Net cash provided by investing activities | $187.2 | $117.6 | | Net cash provided by financing activities | $2.0 | $3.0 | | Net increase (decrease) in cash | $9.3 | $(15.1) | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes cover accounting policies, significant collaboration revenues, a **$10.0 million** contract dispute accrual, and a prior period error correction for the Oerth Bio joint venture - The company is a clinical-stage biotechnology firm focused on therapies that degrade disease-causing proteins and has not yet generated revenue from product sales. Operations are financed through equity sales, collaborations, grants, and debt[26](index=26&type=chunk)[31](index=31&type=chunk) - As of June 30, 2023, the company had **$540.6 million** in deferred revenue from its collaboration agreements, with **$110.2 million** anticipated for recognition in the remainder of 2023[48](index=48&type=chunk)[49](index=49&type=chunk) - The company accrued **$10.0 million** as of June 30, 2023, related to an early-stage contract dispute, with the ultimate resolution and possible range of loss currently unknown[95](index=95&type=chunk) - A prior period error related to the Oerth Bio joint venture accounting was corrected, adjusting previously reported revenue and loss from equity method investment for the three and six months ended June 30, 2022, without impacting net loss or EPS[90](index=90&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business overview, clinical program developments, financial results, and liquidity, with **$87.0 million** revenue, **$198.6 million** R&D expenses, and a **$148.5 million** net loss for H1 2023 [Overview](index=22&type=section&id=Overview) Arvinas, a clinical-stage biotech, is advancing PROTAC degraders like Vepdegestrant (Phase 3), Bavdegalutamide, and ARV-766, while expanding its preclinical pipeline with planned IND/CTA submissions by year-end 2023 - Vepdegestrant (ARV-471): The study-lead in of the VERITAC-3 Phase 3 trial in combination with palbociclib for first-line ER+/HER2- breast cancer has been initiated, and enrollment continues in the VERITAC-2 Phase 3 monotherapy trial[105](index=105&type=chunk)[107](index=107&type=chunk) - Bavdegalutamide (ARV-110): A global Phase 3 trial for mCRPC with specific AR tumor mutations is planned for initiation in the second half of 2023[112](index=112&type=chunk) - ARV-766: Showed promising activity in heavily pre-treated mCRPC patients, with **42%** of those with AR LBD mutations achieving PSA50, and a Phase 1b/2 combination trial with abiraterone is anticipated in the second half of 2023[115](index=115&type=chunk)[116](index=116&type=chunk) - Pipeline Expansion: The company expects to submit an IND/CTA for its BCL6 and LRRK2 PROTAC degraders by year-end 2023 and advance at least two additional programs into IND/CTA-enabling studies[119](index=119&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Revenue increased by **$26.7 million** to **$87.0 million**, while R&D expenses rose by **$59.4 million** to **$198.6 million**, leading to a **$15.1 million** higher net loss for the six months ended June 30, 2023 Financial Results Comparison (in millions) | Item | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Revenue | $87.0 | $60.3 | $26.7 | | Research and development expenses | $(198.6) | $(139.2) | $(59.4) | | General and administrative expenses | $(50.7) | $(44.5) | $(6.2) | | Net loss | $(148.5) | $(133.4) | $(15.1) | - The increase in revenue for the first six months of 2023 was primarily driven by a **$40.1 million** increase from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer[153](index=153&type=chunk) R&D Expenses by Program (in millions) | Program | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | AR program | $38.4 | $27.4 | | ER program | $59.7 | $34.9 | | Other research and development | $100.5 | $76.9 | | **Total R&D** | **$198.6** | **$139.2** | [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) With approximately **$1.0 billion** in cash and marketable securities as of June 30, 2023, the company expects to fund operations into 2026, despite **$179.9 million** net cash used in operating activities - The company had cash, cash equivalents, restricted cash, and marketable securities totaling approximately **$1.0 billion** as of June 30, 2023[174](index=174&type=chunk) - Management believes the current cash position will be sufficient to fund planned operating expenses and capital expenditure requirements into 2026[174](index=174&type=chunk) Cash Flow Summary (in millions) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(179.9) | $(135.7) | | Net cash provided by investing activities | $187.2 | $117.6 | | Net cash provided by financing activities | $2.0 | $3.0 | [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and marketable securities, while its **$1.0 million** fixed-rate debt mitigates related risk - The company's main market risk is interest rate sensitivity on its cash, cash equivalents, and marketable securities, with interest income for the six months ended June 30, 2023, increasing to **$16.6 million** from **$2.9 million** in the prior year due to higher interest rates[179](index=179&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[181](index=181&type=chunk) - No changes occurred during the quarter ended June 30, 2023, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[182](index=182&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may encounter litigation in the ordinary course of business - As of the filing date, Arvinas is not a party to any material legal proceedings[184](index=184&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Investors are directed to the Annual Report on Form 10-K for comprehensive risk factors, as no new material risks are presented in this quarterly report - The company directs investors to review the risk factors disclosed in its Annual Report on Form 10-K filed on February 23, 2023, for a comprehensive understanding of the risks involved in investing in its common stock[185](index=185&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were issued during the three and six months ended June 30, 2023 - There were no sales of unregistered equity securities during the second quarter of 2023[186](index=186&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2023 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the quarterly period covered by this report[187](index=187&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including lease and collaboration agreement amendments, and officer certifications - Exhibits filed include the Sixth Amendment to a lease with Science Park Development Corporation and the First Amendment to the Collaboration and License Agreement with Bayer AG[189](index=189&type=chunk)