bFGF

TOKYO, Oct. 1, 2024 /PRNewswire/ -- PeptiGrowth Inc. (Headquarters: Chiyoda-ku, Tokyo; President: Jiro Sugimoto) has successfully developed a novel synthetic peptide called "FGF2 alternative peptide (FGFR1c agonist)", which has equivalent function to recombinant FGF2 (Fibroblast Growth Factor 2, basic FGF (bFGF)). This product will be on the market at the beginning of October 2024. Development of Synthetic Peptide Growth Factors by PeptiGrowth Continue Reading Conceptual Diagram of the Mechanism of Action of PG-011 Proliferation of human MSCs by PG-011 and observations of cell morphology of iPSCs after 3 passages of culturing in the presence of PG-011 or FGFs, as well as the measurement of undifferentiated markers on Day 7 at P3. Traditional growth factors and cytokines used in regenerative medicine and cell therapy manufacturing face several quality issues, including lot-to-lot variability, potential contamination with biological impurities, low stability, and high costs. PeptiGrowth has focused on developing a series of synthetic peptides that address these challenges while maintaining functionality equivalent to conventional growth factors and cytokines. Their peptides are completely chemically synthesized and free from animal components, enabling the formulation of xeno-free and chemically defined cell culture media. About FGF2 alternative peptide (FGFR1c agonist) [Product code: PG-011] The FGF2 Alternative Peptide ( PG-011) is a dimeric peptide composed of cyclic peptides that bind to human FGFR1c. PG-011 exhibits agonist activity toward FGFR1c by binding to it, thereby activating signaling pathways in various cell types. PeptiGrowth has confirmed that PG-011 promotes the proliferation of human mesenchymal stem cells (MSCs) at approximately one-third the concentration of FGF2 when compared on a ng/mL basis. Additionally, in collaboration with the CiRA Foundation, they evaluated PG-011's ability to maintain the undifferentiated state of human iPSCs. Three iPSC lines were cultured for 7 days in media containing either 100 ng/mL (~5.9 nM) of FGF2 or the same molar concentration (equivalent to ~30 ng/mL) of PG-011, followed by three passages. Afterward, cell morphology observations and undifferentiated marker measurements were conducted. Following three passages, iPSCs cultured in both PG-011 and FGF2 exhibited nearly identical morphology. Furthermore, analysis of undifferentiated markers (SSEA4 and TRA-1-60) indicated that iPSCs cultured with PG-011 displayed a similar positivity rate to those cultured with FGF2. Cell proliferation rates during the culture period were also equivalent under both conditions. These results suggest that PG-011 has the ability to maintain iPSCs in an undifferentiated state, comparable to FGF2. Recombinant FGF2 is known for its low stability, as it degrades and loses activity easily under culture conditions. This necessitates higher concentrations and frequent medium changes, significantly increasing production costs and workload. PeptiGrowth has confirmed that PG-011 maintained its full activity even after 4 days of incubation at 37°C, whereas FGF2's activity significantly declined under the same conditions, demonstrating the superior stability of PG-011. Moreover, they assessed the reactivity of PG-011 with bovine cells, as FGF2 is a key growth factor in cultivated meat production. PG-011 efficiently promoted the proliferation of bovine muscle satellite cells, suggesting that PG-011 may demonstrate cross-reactivity across various cell types, including those of non-human origin, making it a promising candidate for use in cultivated meat production. PG-011 provides cell proliferation and undifferentiated state maintenance comparable to FGF2 but with superior stability, reducing both usage costs and workload. It also shows excellent proliferation activity in both human and bovine cells, making it a compelling choice for regenerative medicine and cultivated meat production. Product Overview Product name: FGF2 alternative peptide (FGFR1c agonist) Product code: PG-011 Product form: Lyophilized Storage conditions: -20°C or less Purity: ≥95% by HPLC Molecular weight: 5127.81(Acetate) Size: 10 µg, 50 μg (volume per glass vial)*This product can be provided with an Animal Component Free (ACF) certificate. *This product is for testing and research use only (RUO). *There is a possibility that the specifications can change. Purchase Our Product If you would like to purchase our products, please contact us using the information below. For customers who would like to purchase GMP compliant products as well as the above PG products in bulk scale, please contact us using the information below. Development of other peptides from PeptiGrowth We have developed alternative peptides targeting numerous growth factors and cytokines. To date, we have launched 11 products and plan to launch several additional growth factor alternative peptides targeting PDGF-AA, KGF, and IL-15 between late 2024 and mid- 2025. Details will be updated on our website () . If you are interested, please contact us using the following contact information. Contacts for inquiries or additional information: PeptiGrowth Inc. E-mail: [email protected] TEL：+81-70-4503-1497 Photo - Photo - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– World’s First Therapeutic Agent for Regenerating Brain – TOKYO, Japan I July 31, 2024 I SanBio Co., Ltd. (TOKYO:4592) (head office: Tokyo, representative director & CEO: Keita Mori) hereby announces that today on July 31 2024, it obtained conditional and time-limited marketing approval for the human somatic stem cell-processed product “AKUUGO ® suspension for intracranial implantation” (INN: vandefitemcel; hereafter, “AKUUGO ® ”) in Japan, for the indication of improving chronic motor paralysis resulting from traumatic brain injury. Traumatic brain injury (TBI) is caused by a strong external force, such as from a traffic accident or a fall, applied to the head, damaging the brain tissue within the skull. The manifestation and timing of symptoms of TBI vary widely among patients, and depending on the affected area of the brain, patients may experience aftereffects such as motor dysfunction or higher brain dysfunction. Studies suggest that destroyed or damaged brain tissues do not regenerate naturally, and patients who enter the chronic phase of TBI and develop motor paralysis face lifelong impacts on their daily and social lives, indicating that there is a significant unmet medical need. AKUUGO ® has been shown to be effective in improving chronic motor paralysis associated with TBI, and is the world’s first and only allogeneic cell therapeutic agent* approved for this indication. AKUUGO ® is also a world first in that it facilitates the regeneration of brain, and its approval for practical clinical use marks a significant milestone. AKUUGO ® is an allogeneic cell product manufactured by culturing bone marrow-derived mesenchymal stem cells collected from healthy donors and transiently transfecting the human Notch-1 intracellular domain gene into the cultured cells to enhance their ability to regenerate nerve cells. The transplantation of AKUUGO ® into damaged nerve tissues in the brain is expected to trigger the release of FGF-2 (a type of protein) and other substances, which in turn will promote the natural regenerative ability of damaged nerve cells and induce proliferation and differentiation of nerve cells. The results of basic research have also shown that AKUUGO ® has protective effects on nerve cells, induces angiogenesis, and demonstrates immunomodulating effects. Mori Keita CEO of SanBio commented as follows. “We are extremely pleased to announce that we have obtained conditional and time-limited approval for AKUUGO ® after 24 years in operation, enabling us to provide it as a new treatment option for TBI patients in Japan. AKUUGO ® , which is directly administered to the brain, represents an innovative and crucial choice for patients with chronic motor paralysis associated with TBI. Through AKUUGO ® , we hope to bring hope to the lives of as many TBI patients as possible.” The approval of AKUUGO ® was based on the results of the global Phase 2 clinical trial SanBio conducted in Japan and the United States. Dr. Nobuhito Saito, Professor of Neurology at the University of Tokyo led the clinical trial, commented as follows. “Traumatic brain injury can affect various areas of the brain, and the site and extent of the damage determine the duration and severity of symptoms, as well as aftereffects. Rehabilitation in the acute phase is effective in restoring a certain level of motor function; however, because damaged brain cells do not regenerate, there has been no effective treatment for chronic motor deficit and other aftereffects of traumatic brain injury. The approval of AKUUGO ® may provide a new treatment option for patients suffering from the chronic aftereffects of traumatic brain injury, and I look forward to seeing further progress in research and analysis.” Dr. David O. Okonkwo, Professor of neurological surgery and director of the Neurotrauma Clinical Trials Center at University of Pittsburg commented as follows. “Patients with chronic traumatic brain injury experience lifelong disability affecting quality of life, particularly those with motor deficits. Living with traumatic brain injury also places burdens on the caregivers who support them. The approval of AKUUGO ® is a breakthrough and opens a new chapter in the treatment of motor deficits in chronic traumatic brain injury.” Dr. Hideyuki Okano, a Keio University professor and SanBio’s founding scientist who has supported the Company over many years, commented as follows. “For more than 20 years, SanBio has conducted R&D in the field of brain regenerative medicine. I’m pleased that AKUUGO ® has been approved for treating chronic motor paralysis resulting from traumatic brain injury, the first such treatment to be approved in the world, and thrilled to offer the product as a new treatment option to patients in Japan. The approval of AKUUGO ® in Japan, ahead of anywhere else in the world, brings us closer to achieving our goal of supporting patients with central nervous system disorders, especially brain disorders, around the world who still suffer from the lack of effective treatment options.“ Reference Product Overview *About allogeneic cell transplantation Regenerative medicine therapies can be classified into autologous and allogeneic cell therapies. In autologous cell transplantation, the patient’s own cells are harvested and used, but cell processing procedures are time-consuming and labor-intensive. In allogeneic cell transplantation, on the other hand, cells are collected from a donor and cultured in large quantities. Since allogeneic cell medicines can be mass produced, they can treat a large number of patients. About Traumatic Brain Injury Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases* 1 . Overall, TBI and long-term motor deficits secondary to TBI significantly impair a person’s self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide. In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term disabilities* 2 , and it is estimated that 3.17 million people are living with long-term disabilities secondary to TBI* 3 . There are about 60,000* 4 TBI patients in Japan, and of which, 20%* 5 are estimated to suffer from aftereffects of the injury. About “AKUUGO ® suspension for intracranial implantation” AKUUGO ® suspension for intracranial implantation(INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. The transplantation of AKUUGO ® into damaged nerve tissues in the brain is expected to trigger the release of FGF-2 (a type of protein) and other substances, which in turn will promote the natural regenerative ability of damaged nerve cells and induce proliferation and differentiation of nerve cells. The conditional and time-limited approval was based on the results of SanBio’s global Phase 2 clinical trial. The primary endpoint of the trial—mean change from baseline in Fugle-Meyer Motor Scale (FMMS) score at 24 weeks after treatment—was met, with the AKUUGO ® -treated group reporting 8.3-point improvement versus 2.3 for the control group, demonstrating a statistically significant difference. The final analysis of the study was presented at the annual meeting of American Academy of Neurology. We are pushing forward with R&D targeting multiple indications, including chronic effects associated with chronic cerebral infarction. About SanBio Group (SanBio Co., Ltd. and SanBio, Inc.) SanBio is engaged in the regenerative cell business—we research, develop, manufacture, and sell regenerative cell medicines. In July 2024, under the Sakigake Designation Program, we obtained conditional and time-limited approval for our mainstay product AKUUGO ® for the indication of improving chronic motor deficit resulting from traumatic brain injury. Going forward, we will continue focusing our R&D efforts on central nervous system disorders with significant unmet medical needs that cannot be addressed by existing medicine or drugs. The Company is headquartered in Tokyo, Japan and Oakland, California, and additional information about SanBio Group is available at https://sanbio.com/en/ References 1 James SL, et al. “Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990- 2016: a systematic analysis for the Global Burden of Disease Study 2016.” Lancet Neurol 2019;18:56-87. 2 Selassie AW, et al. “Incidence of long-term disability following traumatic brain injury hospitalization, U.S.”, 2003. J Head Trauma Rehabil 2008;23:123-31 3 Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400. 4 The number of patients under “19 Injury, poisoning, and other consequences of external causes (intracranial injuries)” in Patient Survey 2020, the Ministry of Health, Labour and Welfare 5 The number of patients under “T905 After effects of intracranial injury” in Patient Survey 2020, the Ministry of Health, Labour and Welfare SOURCE: SanBio

– Completed enrollment in the study lead-in for the VERITAC-3 Phase 3 trial in the first-line setting; continued enrollment globally in multiple clinical trials of vepdegestrant in ER+/HER2- metastatic breast cancer, including the VERITAC-2 Phase 3 trial in the second-line setting– – Completion of enrollment in VERITAC-2 expected in 4Q24 and topline data readout now expected 4Q24/1Q25 – – Received $150 million upon close of ARV-766 license agreement and sale of preclinical AR-V7 program to Novartis; potential for up to an additional $1.01 billion based on achievement of development, regulatory and commercial milestones and future royalties – – Strengthened executive team with the appointment of Andrew Saik as Chief Financial Officer and the promotions of Ian Taylor to President of R&D, Angela Cacace to Chief Scientific Officer, and Randy Teel to Chief Business Officer – NEW HAVEN, Conn., July 30, 2024 (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 second quarter ended June 30, 2024, and provided a corporate update. “During the second quarter, we continued making meaningful progress across our entire portfolio, with upcoming milestones that will further support our mission to improve patient lives with pioneering therapies from our revolutionary PROTAC® protein degradation platform,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “The readout of VERITAC-2, our first Phase 3 clinical trial, will be a landmark event for Arvinas. We are on-track to complete enrollment in the fourth quarter of the year, with topline data anticipated in either the fourth quarter of 2024 or first quarter of 2025. If positive, we believe these results will support our first new drug application filing and our transition to a commercial-stage company, assuming regulatory approval.” “We are well on our way to becoming a multi-product, commercial-stage organization with strong leadership and a robust pipeline across several indications,” continued Dr. Houston. “Our first PROTAC degrader with the potential to treat neurodegenerative diseases, ARV-102, was recently cleared to initiate the multiple ascending dose portion of our Phase 1 clinical trial. In addition, we initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with our PROTAC BCL6 degrader ARV-393. I’m excited by the progress we have made and the ongoing confidence we have in our PROTAC platform, which was further validated by our recent strategic transaction with Novartis. We believe Novartis will accelerate and broaden the development of ARV-766 as a potential best-in-class treatment for patients with prostate cancer.” Recent Developments and 2Q Business Highlights Vepdegestrant Evaluated enrollment and blinded event rates in the ongoing VERITAC-2 Phase 3 monotherapy clinical trial (NCT05654623) in patients with metastatic breast cancer. The trial is on track to complete enrollment in 4Q24.Based on current trial status, the primary completion date has been reprojected to November 2024, with topline data now anticipated in 4Q24/1Q25. Completed enrollment of the study lead-in for the VERITAC-3 Phase 3 clinical trial of vepdegestrant in combination with palbociclib as a first-line treatment in patients with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer.Continued enrollment globally in multiple clinical studies of vepdegestrant in ER+/HER2- metastatic breast cancer.Presented updated clinical data from a Phase 1b clinical trial combination cohort evaluating vepdegestrant in combination with palbociclib in heavily pre-treated patients with locally advanced or metastatic ER+/HER2- breast cancer at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. After six months of additional follow-up, updated data from the trial continued to demonstrate an encouraging clinical benefit rate, objective response rate and progression-free survival, and a consistent safety profile as previously reported at the San Antonio Breast Cancer Symposium (SABCS) in December 2023.The clinical benefit rate across all dose levels (n=46) was 63%; the objective response rate in evaluable patients with measurable disease at baseline (n=31) was 42%; median progression-free survival based on 27 (59%) events across all dose levels was 11.2 months (95% CI: 8.2 – 16.5) and the safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023.Patients receiving the recommended Phase 3 dose of vepdegestrant (200mg) in combination with palbociclib 125mg (n=21), achieved a median progression-free survival of 13.9 months (95% CI: 8.1-NR). Strategic Transaction with Novartis Entered into a license agreement and asset purchase agreement with Novartis (NYSE: NVS) for the exclusive, worldwide development, manufacture and commercialization of ARV-766, Arvinas’ second generation PROTAC® androgen receptor (AR) degrader for patients with prostate cancer, and the sale of Arvinas’ preclinical AR-V7 program, which closed on May 28, 2024. Arvinas received a one-time, upfront payment in the aggregate amount of $150.0 million in accordance with the terms of the license agreement and the asset purchase agreement. Under the terms of the license agreement, Arvinas is also eligible to receive up to an additional $1.01 billion as contingent payments based on specified development, regulatory, and commercial milestones for ARV-766 being met, as well as tiered royalties based upon worldwide net sales of ARV-766. Pipeline ARV-102: Oral PROTAC LRRK2 degrader Presented preclinical data at the Biennial International LRRK2 Meeting further supporting the potential of PROTAC-induced leucine-rich repeat kinase 2 (LRRK2) degradation as a potential treatment for neurodegenerative diseases. Key findings included: With Arvinas' PROTAC LRRK2 degrader, near-complete LRRK2 target engagement, as well as LRRK2 degradation, in mouse and non-human primate lung and brain.Differing effects of the LRRK2 PROTAC degraders in the lungs compared to kinase inhibitors, suggesting reduced pulmonary function risk. Substantially less Type II pneumocyte enlargement compared to MLi-2, an experimental LRRK2 kinase inhibitor.Surfactant protein accumulation in mouse lung observed after treatment with the LRRK2 kinase inhibitor MLi-2, but not after treatment with the PROTAC LRRK2 degrader.No evidence of collagen deposition in lung to date with PROTAC LRRK2 degraders in non-human primates. Received health authority approval to initiate the multiple ascending dose portion of the ongoing Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2 degrader ARV-102. ARV-393: Oral PROTAC BCL6 degrader Presented preclinical data for ARV-393 at the European Hematology Association 2024 Annual Congress that showed ARV-393: Potently and rapidly degraded the BCL6 protein and inhibited cell growth in diffuse large B-cell lymphoma (DLBCL) and Burkitt cell lines.Showed tumor growth inhibition, including tumor regression, in various DLBCL cell line-derived xenograft (CDX) models and in multiple patient-derived xenograft (PDX) models of non-Hodgkin lymphoma (NHL), including germinal center B-cell-like (GCB), activated B-cell (ABC), GCB/ABC, BCL not otherwise specified (BCL/NOS) subtypes of DLBCL, and Burkitt lymphoma. Initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with PROTAC BCL6 degrader ARV-393. Corporate Announced the appointment of Andrew Saik, MBA, to the role of Chief Financial Officer.Announced the promotion of Ian Taylor, Ph.D., to President of Research and Development.Announced the promotion of Angela Cacace, Ph.D., to Chief Scientific Officer.Announced the promotion of Randy Teel, Ph.D., to Chief Business Officer. Anticipated Upcoming Milestones and Expectations Vepdegestrant (ARV-471)As part of Arvinas’ global collaboration with Pfizer, the companies plan to: Complete enrollment (4Q24) and announce topline data (4Q24/1Q25) for the VERITAC-2 Phase 3 monotherapy clinical trial.Evaluate data from the study lead-in of the VERITAC-3 Phase 3 trial to support dose selection for vepdegestrant plus palbociclib in planned Phase 3 combination trials in patients with ER+/HER2- locally advanced or metastatic breast cancer (2H24).Present initial safety and pharmacokinetic data from the abemaciclib arm of the ongoing TACTIVE-U trial (2H24).Continue enrollment of the ongoing Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (TACTIVE-U; ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522).Continue enrollment and evaluate preliminary data from the ongoing clinical trial with vepdegestrant plus Pfizer’s novel CDK4 inhibitor atirmociclib (TACTIVE-K; ClinicalTrials.gov Identifier: NCT06206837) to inform the study design for the planned Phase 3 first line combination trial with either atirmociclib or palbociclib, with planned initiation in 2025. Pipeline Continue enrollment in the single ascending dose portion of the Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2 degrader ARV-102 and begin enrolling the multiple ascending dose portion by the end of 2024.Continue enrollment in the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with PROTAC BCL6 degrader ARV-393. Financial Guidance Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027. Second Quarter Financial ResultsCash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of June 30, 2024, cash, cash equivalents, restricted cash and marketable securities were $1,234.2 million as compared with $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents, restricted cash and marketable securities of $32.3 million for the six months ended June 30, 2024 was primarily related to cash used in operations of $36.0 million (net of $150.0 million received from the Novartis agreements), unrealized losses on marketable securities of $0.7 million and the purchase of lab equipment and leasehold improvements of $0.8 million, partially offset by proceeds from the exercise of stock options of $5.3 million. Research and Development Expenses: Research and development expenses were $93.7 million for the quarter ended June 30, 2024, as compared with $103.4 million for the quarter ended June 30, 2023. The decrease in research and development expenses of $9.7 million for the quarter was primarily due to decreases in expenses related to our ER program (which includes the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer) of $6.6 million and our platform and exploratory programs of $5.7 million, partially offset by an increase in our AR program (which includes ARV-766 and bavdegalutamide (ARV-110)) of $2.6 million. General and Administrative Expenses: General and administrative expenses were $31.3 million for the quarter ended June 30, 2024, as compared with $25.7 million for the quarter ended June 30, 2023. The increase in general and administrative expenses of $5.6 million for the quarter was primarily due to an increase in personnel and infrastructure related costs of $4.0 million and professional fees of $1.6 million. Revenues: Revenues were $76.5 million for the quarter ended June 30, 2024, as compared with $54.5 million for the quarter ended June 30, 2023. Revenue for the quarter is related to the license agreement and the asset purchase agreement with Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, and revenue related to our Oerth Bio joint venture. The increase in revenue of $22.0 million was primarily due to revenue from the Novartis agreements, which were entered into during the quarter, of $45.4 million, offset by a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $22.2 million and a decrease of $1.3 million of previously constrained deferred revenue related to our Oerth Bio joint venture. About VepdegestrantVepdegestrant 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 (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC® (PROteolysis Targeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102, targeting LRRK2 for neurodegenerative disorders; and ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. Forward-Looking StatementsThis 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 expected timing in connection with the completion of enrollment and readout of topline data from the VERITAC-2 clinical trial, submission of Arvinas’ first new drug application filing and transition to a commercial-stage company, assuming regulatory approval, the availability and timing of data from other clinical trials, the receipt of milestone and royalty payments in connection with the transaction with Novartis and the future development, potential marketing approval and commercialization of ARV-766, the potential of Arvinas’ PROTAC protein degrader platform and its potential to deliver new treatments, Arvinas’ and Pfizer’s plans to determine the recommended palbociclib dose to be combined with vepdegestrant in the planned Phase 3 combination trials in patients with ER+/HER2- locally advanced or metastatic breast cancer, and statements regarding Arvinas’ cash, cash equivalents, restricted cash and marketable securities. All statements, other than statements of historical fact, 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 these forward-looking statements, and you should not place undue reliance on such 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’s performance of the respective obligations with respect to Arvinas’ 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 other product candidates and including whether Arvinas initiates and completes clinical trials for its product candidates and receive results from its clinical trials on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas’ and Novartis’ performance of their respective obligations under the license agreement; whether Novartis will be able to successfully conduct and complete clinical development, obtain marketing approval for and commercialize ARV-766; Arvinas’ ability to 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, 2023 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. ContactsInvestors:Jeff Boyle+1 (347) 247-5089Jeff.Boyle@arvinas.com Media:Kirsten Owens+1 (203) 584-0307Kirsten.Owens@arvinas.com Arvinas, Inc.Condensed Consolidated Balance Sheets (Unaudited) (dollars and shares in millions, except per share amounts)June 30,2024December 31,2023Assets Current assets: Cash and cash equivalents$154.8 $311.7 Restricted cash 5.5 5.5 Marketable securities 1,073.9 949.3 Other receivables 10.0 7.2 Prepaid expenses and other current assets 12.5 6.5 Total current assets 1,256.7 1,280.2 Property, equipment and leasehold improvements, net 9.8 11.5 Operating lease right of use assets 1.5 2.5 Collaboration contract asset and other assets 11.6 10.4 Total assets$1,279.6 $1,304.6 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued liabilities$78.1 $92.2 Deferred revenue 267.9 163.0 Current portion of operating lease liabilities 1.2 1.9 Total current liabilities 347.2 257.1 Deferred revenue 331.3 386.2 Long term debt 0.7 0.8 Operating lease liabilities 0.2 0.5 Total liabilities 679.4 644.6 Stockholders’ equity: Preferred stock, $0.001 par value, zero shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively — — Common stock, $0.001 par value; 68.6 and 68.0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 0.1 0.1 Accumulated deficit (1,437.3) (1,332.7)Additional paid-in capital 2,041.2 1,995.7 Accumulated other comprehensive loss (3.8) (3.1)Total stockholders’ equity 600.2 660.0 Total liabilities and stockholders’ equity$1,279.6 $1,304.6 Arvinas, Inc.Condensed Consolidated Statements of Operations (Unaudited) Three Months EndedJune 30,Six Months EndedJune 30,(dollars and shares in millions, except per share amounts) 2024 2023 2024 2023 Revenue$76.5 $54.5 $101.8 $87.0 Operating expenses: Research and development 93.7 103.4 178.0 198.6 General and administrative 31.3 25.7 55.6 50.7 Total operating expenses 125.0 129.1 233.6 249.3 Loss from operations (48.5) (74.6) (131.8) (162.3)Interest and other income 13.5 9.0 27.5 15.5 Net loss before income taxes and loss from equity method investment (35.0) (65.6) (104.2) (146.8)Income tax (expense) benefit (0.2) 0.3 (0.3) 0.7 Loss from equity method investment — (1.3) — (2.4)Net loss$(35.2)$(66.6)$(104.6)$(148.5)Net loss per common share, basic and diluted$(0.49)$(1.25)$(1.46)$(2.78)Weighted average common shares outstanding, basic and diluted 71.9 53.4 71.7 53.4