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Arrowhead Pharmaceuticals, Inc. (ARWR) 2024 Summer Series R&D Webinar: Obesity/Metabolic - ARO-INHBE Conference (Transcript)
Seeking Alpha· 2024-08-14 22:59
Core Insights - Arrowhead Pharmaceuticals is conducting a Summer Series of R&D webinars, focusing on various therapeutic areas, with the current session dedicated to obesity and metabolic diseases [4][5][6] - The company has a broad pipeline of 14 clinical-stage assets, including programs targeting obesity, leveraging its proprietary RNAi technology [7][8] - The discussion emphasizes the need for diverse treatment options for obesity, recognizing it as a complex disease rather than a singular condition [11][23] Company Overview - Arrowhead Pharmaceuticals operates an RNAi therapeutics platform with a focus on delivering treatments to various tissue types, including adipose tissue [7][8] - The company is advancing two key programs: ARO-INHBE and ARO-ALK7, both targeting mechanisms related to obesity [24][42] - The TRiM platform is designed to enhance the delivery of RNA therapies specifically to adipose tissue, aiming for deep and durable gene silencing [35][36] Research and Development Focus - The webinar features expert insights on the obesity landscape, highlighting unmet needs and the importance of innovative treatments [10][11] - ARO-INHBE targets the INHBE gene, which is linked to energy regulation and fat storage, while ARO-ALK7 focuses on the ALK7 receptor, which influences adipocyte behavior [24][42] - Preclinical studies show that silencing INHBE and ALK7 leads to significant reductions in body weight gain and fat mass without affecting lean muscle mass [30][48] Clinical Trial Plans - Arrowhead plans to initiate Phase 1/2a clinical trials for ARO-INHBE and ARO-ALK7 in healthy volunteers with obesity, assessing safety and efficacy [55][56] - The trials will include various cohorts to evaluate the effects of these therapies in combination with existing treatments like tirzepatide [57][58] - Primary endpoints will focus on gene target silencing and changes in body composition, alongside metabolic parameters [58]
Arrowhead Pharmaceuticals, Inc. (ARWR) 2024 Summer Series R&D Webinar: Obesity/Metabolic - ARO-INHBE Conference (Transcript)
2024-08-14 22:59
Summary of Arrowhead Pharmaceuticals, Inc. R&D Webinar on Obesity/Metabolic Company Overview - **Company**: Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) - **Focus**: RNAi therapeutics platform with a pipeline of 14 clinical-stage assets across various therapeutic areas, including obesity and metabolic diseases [7][8] Key Themes and Insights Industry Context - **Obesity as a Disease**: The understanding of obesity is evolving; it is now recognized as a complex disease rather than merely a result of overeating [11][12][23] - **Need for Diverse Treatments**: There is a call for a variety of treatment options, including nutritional, pharmacological, and surgical therapies, to effectively address obesity [12][23] Scientific Insights - **Obesity Mechanisms**: New insights suggest that obesity may not just be a single disease but rather multiple subtypes, each requiring tailored treatments [14][15] - **Pharmacotherapy Advances**: Recent pharmacotherapies have shown promise, but there remains a significant portion of patients who do not respond effectively to current treatments [13][18][19] Pipeline Developments - **ARO-INHBE Program**: A new clinical program targeting the INHBE gene, which is linked to energy homeostasis and fat storage. Preclinical studies show that silencing this gene can lead to reduced body weight gain and improved metabolic profiles [24][28][30] - **ARO-ALK7 Program**: Another program targeting the ALK7 receptor, which is involved in lipid metabolism. Preclinical data indicate that silencing ALK7 can also reduce body weight gain without affecting lean muscle mass [42][46][48] TRiM Platform - **Adipose Tissue Targeting**: Arrowhead's TRiM platform aims to deliver RNA therapies directly to adipose tissue, which is crucial for metabolic disease treatment. The platform has shown effective gene silencing in adipocytes [35][36][39] - **Efficacy and Safety**: The TRiM platform demonstrated significant knockdown of target proteins in both mouse and non-human primate models, with a favorable safety profile [41][40] Clinical Trial Plans - **Phase 1/2a Studies**: Plans for clinical trials of ARO-INHBE and ARO-ALK7 in healthy volunteers with obesity, focusing on gene target knockdown and metabolic outcomes [55][56] - **Combination Studies**: Both programs will explore the effects of combining their therapies with existing treatments like tirzepatide to enhance efficacy [57] Market Considerations - **Long-term Health Outcomes**: The focus is shifting from weight loss as a primary goal to improving long-term health outcomes, which is increasingly recognized by payers and the healthcare system [60][61] - **Genetic and Biological Support**: The underlying genetics and biology of the INHBE and ALK7 pathways support their exploration as therapeutic targets for obesity [62] Conclusion - Arrowhead Pharmaceuticals is positioned to leverage its innovative RNAi platform and emerging understanding of obesity to develop novel therapies that address the multifaceted nature of the disease, with a strong emphasis on improving patient outcomes and maintaining lean mass during treatment [59][62]
Arrowhead Pharmaceuticals(ARWR) - 2024 Q3 - Earnings Call Transcript
2024-08-09 01:08
Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) Q3 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Company Participants Vince Anzalone - VP, IR Chris Anzalone - President and CEO Bruce Given - Interim Chief Medical Scientist Andy Davis - Senior Vice President and Head of Global Cardiometabolic Franchise Ken Myszkowski - CFO James Hamilton - Chief Discovery and Translational Medicine Patrick O'Brien - COO and General Counsel Conference Call Participants Maury Raycroft - Jefferies Ellie Merle - UBS Luca ...
Arrowhead Pharmaceuticals(ARWR) - 2024 Q3 - Quarterly Results
2024-08-08 20:04
EXHIBIT 99.1 PRESS RELEASE August 8, 2024 Arrowhead Pharmaceuticals Reports Fiscal 2024 Third Quarter Results – Conference Call and Webcast Today, August 8, 2024 at 4:30 p.m. ET PASADENA, Calif., August 8, 2024 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2024 third quarter ended June 30, 2024. The Company is hosting a conference call today, August 8, 2024, at 4:30 p.m. ET to discuss the results. "Arrowhead had a very productive quarter with several high- ...
Arrowhead Pharmaceuticals(ARWR) - 2024 Q3 - Quarterly Report
2024-08-08 20:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 _____________________________________ FORM 10-Q _____________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38042 _____________________________________ ARROWHEAD PHAR ...
Double-Up Delights: 7 Stocks Poised to Soar 100% by 2025
InvestorPlace· 2024-05-14 11:08
If you’re wondering what stocks to buy this month, look no further. Every investor wants their stock picks to double in price. Yet, the reality is that the average annual S&P 500 return is approximately 10%. At that rate the law of 72 states that an investor can expect their capital to double roughly every 7 years. Thus, those seeking 100% returns by 2025 will have to take some risks. There is effectively zero chance that an average strategy will double an investor’s returns within that time frame. That doe ...
Arrowhead Pharmaceuticals(ARWR) - 2024 Q2 - Earnings Call Transcript
2024-05-10 01:23
Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) Q2 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Vince Anzalone - VP, IR Chris Anzalone - President and CEO Bruce Given - Chief Medical Scientist James Hamilton - Chief Discovery & Translational Medicine Ken Myszkowski - CFO Conference Call Participants Luca Issi - RBC Capital Edward Tenthoff - Piper Sandler Maury Raycroft - Jefferies Brendan Smith - TD Cowen William Pickering - Bernstein Patrick Trucchio - H.C. Wainwright & Company O ...
Arrowhead Pharmaceuticals(ARWR) - 2024 Q2 - Quarterly Results
2024-05-09 20:11
Financial Performance - Arrowhead Pharmaceuticals reported a revenue of $146.3 million for the three months ended March 31, 2024, compared to $0 for the same period in 2023[9]. - The net loss attributable to Arrowhead Pharmaceuticals was $125.3 million, compared to a net income of $48.7 million in the same quarter last year[9]. Operating Expenses - Operating expenses increased to $126.2 million in Q2 2024, up from $98.1 million in Q2 2023, with research and development expenses rising to $101.1 million[9]. Clinical Trials and Studies - In the Phase 2 SHASTA-2 study, plozasiran demonstrated placebo-adjusted triglyceride reductions of -49%, -53%, and -57% at week 24, with 90.6% of patients achieving triglyceride levels below 500 mg/dL[4]. - The company dosed the first subjects in two Phase 1/2a clinical trials for ARO-CFB and ARO-DM1, targeting complement factor B and dystrophia myotonica protein kinase, respectively[6]. - Arrowhead plans to begin the regulatory submission process and refine its commercial strategy as it approaches completion of the PALISADE Phase 3 study of plozasiran[2]. Milestone Payments and Funding - The company received a $50 million milestone payment from Royalty Pharma plc following the completion of enrollment in the Phase 3 OCEAN(a) trial of olpasiran[4]. - The company strengthened its balance sheet with a registered offering of common stock, raising approximately $450 million[7]. Cash Resources - Total cash resources (cash and investments) increased to $523.1 million as of March 31, 2024, compared to $403.6 million as of September 30, 2023[9]. Expanded Access Program - Arrowhead initiated an Expanded Access Program for plozasiran for patients with familial chylomicronemia syndrome[5].
Arrowhead Pharmaceuticals(ARWR) - 2024 Q2 - Quarterly Report
2024-05-09 20:09
Financial Performance - The company reported a net loss of $125.3 million for the three months ended March 31, 2024, compared to a net income of $48.7 million for the same period in 2023, marking a significant decline [88]. - Total revenue for the three months ended March 31, 2024, decreased by $146.3 million or 100.0% from the same period in 2023, primarily due to decreased revenue recognition from license and collaboration agreements [93]. - The company recorded a net loss per share – diluted of $1.02 for the three months ended March 31, 2024, compared to net income per share – diluted of $0.45 for the same period in 2023 [92]. Cash and Assets - The company had $127.7 million in cash, cash equivalents, and restricted cash as of March 31, 2024, an increase from $110.9 million as of September 30, 2023 [89]. - The company had total assets of $955.2 million as of March 31, 2024, compared to $765.6 million as of September 30, 2023 [89]. - Cash, cash equivalents, and restricted cash at the end of the period totaled $127.7 million as of March 31, 2024, compared to $135.0 million at the end of March 31, 2023 [108]. - The net increase in cash, cash equivalents, and restricted cash for the six months ended March 31, 2024, was $16.7 million, down from $27.2 million in the prior year [108]. Research and Development - Research and development expenses increased as the company's pipeline of candidates expanded and progressed through clinical trial phases [88]. - Total research and development expense was $101.1 million for the three months ended March 31, 2024, up from $74.9 million for the same period in 2023, representing a 35% increase [102]. - Candidate costs increased by $7.3 million, or 28%, for the three months ended March 31, 2024, and $10.3 million, or 15%, for the six months ended March 31, 2024 compared to the same period of 2023 [98]. - R&D discovery costs rose by $7.4 million, or 42%, for the three months ended March 31, 2024, and $23.9 million, or 79%, for the six months ended March 31, 2024 compared to the same period of 2023 [99]. - The company continues to develop other clinical candidates for future trials, with candidate costs expected to increase as development progresses [88]. - The company initiated a Phase 1/2a clinical trial of ARO-DM1 for type 1 myotonic dystrophy and filed for clearance to initiate a Phase 1/2a trial of ARO-CFB for complement-mediated renal disease [88]. Expenses - General and administrative expenses totaled $25.1 million for the three months ended March 31, 2024, an increase of $1.8 million, or 8%, compared to $23.2 million for the same period in 2023 [101]. - Salaries increased by $8.5 million, or 52%, for the three months ended March 31, 2024, and $16.4 million, or 53%, for the six months ended March 31, 2024 compared to the same period in 2023 [99]. - Facilities-related expenses increased by $2.5 million, or 72%, for the three months ended March 31, 2024, compared to the same period of 2023 [99]. - Depreciation and amortization expense increased by $1.8 million, or 81%, for the three months ended March 31, 2024, compared to the same period of 2023 [99]. - Other expense increased by $0.3 million and $2.8 million for the three and six months ended March 31, 2024, respectively, compared to the same periods of 2023 [105]. Cash Flow - Cash flow used in operating activities for the six months ended March 31, 2024, was $210.2 million, compared to $107.2 million for the same period in 2023, reflecting increased ongoing expenses related to research and development and administrative costs [108]. - Cash used in investing activities amounted to $204.1 million for the six months ended March 31, 2024, primarily due to capital expenditures of $102.7 million and investment purchases of $310.0 million, offset by proceeds from sales and maturities of investments of $208.6 million [108]. - Cash provided by financing activities was $431.0 million for the six months ended March 31, 2024, mainly from the issuance of common stock and stock option exercises, compared to $251.1 million in the same period in 2023 [108]. Other Information - The company completed enrollment in Amgen's Phase 3 OCEAN trial of olpasiran, triggering a $50.0 million milestone payment, which was received in Q3 of fiscal 2024 [88]. - There has been no material change in the Company's contractual obligations from the previous reporting period [109]. - The Company's exposure to market risk has not materially changed from the previous reporting period [110].
7 Biotech Stocks to Buy as Sector Rotation Ramps Up
InvestorPlace· 2024-03-13 18:25
Core Viewpoint - The technology sector may face a slowdown, prompting a potential shift towards biotech stocks, which have not received the same attention despite their innovation potential [1] Group 1: Crispr Therapeutics (CRSP) - Crispr Therapeutics is utilizing the CRISPR gene-editing platform to develop medicines, with expected revenue of $105.82 million in fiscal 2024, down 71.5% from $371.21 million in 2023, but projected to rise to $405.2 million by 2025, a 9.2% increase from 2023 [2] - The gene editing market is anticipated to reach $15.8 billion by 2031, up from a valuation of $1.89 billion in 2022 [2] Group 2: Halozyme (HALO) - Halozyme develops oncology therapies and has seen its stock gain over 12% since the start of the year, with expected revenue of $954.58 million for the current fiscal year, a 15.1% increase from $829.25 million last year [5] - Analysts project earnings per share (EPS) of $3.68 for this year, up from $2.77 in 2023, with a forecast of $4.58 for 2025 [5] Group 3: SpringWorks Therapeutics (SWTX) - SpringWorks focuses on targeted oncology and is expected to achieve revenue of $87.34 million this fiscal year, a 1,503.5% increase from $5.45 million last year, with projections of $256.3 million in 2025 [7] - Analysts rate shares a unanimous strong buy with an average price target of $66.33, implying a 33% increase [8] Group 4: Cytokinetics (CYTK) - Cytokinetics develops muscle activators and inhibitors, with projected sales of $6.57 million this year, a 12.7% decline from $7.53 million last year, but expected to rise to $146.24 million by 2025, a 2,126% increase from 2024 [9] - Analysts rate shares a strong buy with an average price target of $94.63, indicating nearly 47% growth potential [10] Group 5: Jazz Pharmaceuticals (JAZZ) - Jazz Pharmaceuticals, known for its product Xyrem, is expected to report revenue of $4.11 billion for the current fiscal year, a 7.2% increase from $3.83 billion last year, with projections of $4.4 billion in 2025 [11] - Analysts rate shares a strong buy with a forecast price of $183.82, suggesting almost 59% upside potential [12] Group 6: Viking Therapeutics (VKTX) - Viking Therapeutics has gained 267% in equity value since January, focusing on therapeutics for metabolic disorders, although no sales forecast is provided [13] - Analysts unanimously rate VKTX a strong buy with an average price target of $102.43, implying nearly 53% upside potential [14] Group 7: Arrowhead Pharmaceuticals (ARWR) - Arrowhead Pharmaceuticals specializes in RNA-based therapeutics, with expected sales of $139 million this fiscal year, a 42.2% decline from $240.74 million last year, but projected to reach $157.94 million in 2025 [15] - The consensus view for ARWR stock is a moderate buy, with an average price target of $53.70, indicating 88% upside potential [16]