Question-and-Answer SessionI'm sure we have a lot to talk about in terms of some of the updates from this week, but maybe just level set expectations in terms of what you see as the key priorities for the company right now.Dr. Christopher AnzaloneChairman, CEO & President Sure. We have a really busy 6 to 9 months ahead of us in essentially chronological order. I think what you're going to see is we will bring MAPT to the clinic. That's going to be our first CNS drug that is administered via a subcu injectio ...

Arrowhead Pharmaceuticals (ARWR) 2025 Conference September 04, 2025 09:10 AM ET Company ParticipantsPrakhar Agrawal - Managing DirectorChristopher Anzalone - President, CEO & Chairman of BoardPrakhar AgrawalGood. Right. Welcome everyone. Day two of Cantor's Global Healthcare Conference. My name is Prakhar Gwal, Biotech Analyst at Cantor.For the next session, we have the team of Arrowhead and representing Arrowhead, we have Chris Antalone, President, Chairman and CEO of the company. Chris, appreciate your ti ...

PresentationVery much and welcome again to the Citi Biopharma Conference in Boston. Happy to have with me, Arrowhead Pharmaceuticals. I guess if you could start out, introduce yourself, and introduce the company, tell a little bit about the history and bring it up to speed.Dr. Christopher AnzaloneChairman, CEO & President Thanks very much. And again, thanks for having us. I'm Chris Anzalone, President and CEO of Arrowhead Pharmaceuticals. We are an RNAi company. I've been around for some time and have devel ...

Arrowhead Pharmaceuticals (ARWR) Conference September 03, 2025 01:00 PM ET Company ParticipantsChristopher Anzalone - President, CEO & Chairman of BoardConference Call ParticipantsDavid Lebowitz - Senior Research Analyst - BiotechnologyDavid LebowitzVery much, and welcome again to the, Citi Biopharma conference in Boston. Happy to have with me Arrowhead Pharmaceuticals. I guess if you could start out, introduce yourself and introduce the company, tell a little bit about the history and bring us up to speed. ...

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Core Viewpoint - Arrowhead Pharmaceuticals reported significant misses in both GAAP revenue and earnings for Q3 FY2025, highlighting ongoing financial volatility despite progress in its clinical pipeline [1][5][6] Financial Performance - Q3 FY2025 GAAP revenue was $27.8 million, missing analyst estimates of $46.8 million by nearly 41% [5] - GAAP earnings per share for Q3 FY2025 were $(1.26), falling short of the $(0.95) forecast by $0.31 [1][5] - Operating loss for Q3 FY2025 was $(165.6 million), an improvement of 6% compared to $(176.1 million) in Q3 FY2024 [2][6] - Research and development expenses increased by 6.6% year-over-year to $162.4 million [2][6] - Total cash resources rose to $900.4 million, a 32.1% increase from $681.0 million in Q3 FY2024 [2][7] Company Overview and Strategy - Arrowhead Pharmaceuticals focuses on RNA interference (RNAi) therapeutics, targeting diseases with significant unmet needs using its TRiMTM platform [3][4] - The company is advancing its drug pipeline with an emphasis on late-stage development and regulatory approvals, while building strategic partnerships with larger pharmaceutical companies [4] Product Pipeline Progress - Plozasiran, Arrowhead's leading RNAi candidate, received NDA acceptance from the FDA for familial chylomicronemia syndrome, with a PDUFA target date of November 18, 2025 [8][11] - Phase 3 studies for severe hypertriglyceridemia are ongoing, with data expected in mid-2026 [8][11] - Zodasiran, targeting rare cholesterol disorders, has commenced its Phase 3 trial [12] - The obesity portfolio includes ARO-INHBE and ARO-ALK7, which are in Phase 1/2 studies [13] Strategic Partnerships and Milestones - Visirna, a subsidiary, entered a deal with Sanofi for rights to four cardiometabolic programs, resulting in immediate payments of $130 million and potential milestones of up to $265 million [9] - The company anticipates additional milestone payments from Sarepta Therapeutics, totaling up to $200 million by the end of 2025 [9] Commercial Readiness - Arrowhead is preparing for the potential launch of plozasiran by expanding its U.S. sales force and engaging with payers [10] - The company is focused on rare disease awareness and patient identification, crucial for the target population of plozasiran [10] Outlook and Guidance - Management indicated that Arrowhead is funded through 2028, focusing on regulatory approval for plozasiran and commercialization efforts [15] - Key near-term catalysts include pivotal SHTG data readout in mid-2026 and potential partnership milestones within the next twelve months [15]

Financial Data and Key Metrics Changes - The net loss for Q3 2025 was $175.2 million, or a loss of $1.26 per share, compared to a net loss of $170.8 million, or a loss of $1.38 per share in Q3 2024 [35] - Revenue for Q3 2025 was $27.8 million, primarily from the collaboration agreement with Sarepta, with $20 million from initial consideration and $7 million from reimbursement of collaboration costs [35][36] - Total operating expenses for Q3 2025 were $193.3 million, an increase from $176.1 million in the prior year, driven by higher R&D costs and SG&A expenses [37][38] - Cash and investments totaled $900.4 million as of June 30, 2025 [38] Business Line Data and Key Metrics Changes - The company achieved full enrollment in Phase 3 studies for clozaran, targeting severe hypertriglyceridemia, with approximately 2,200 patients enrolled across 24 countries [9][24] - The Phase 3 study for zodasiran began with the first patients enrolled in July 2025, targeting homozygous familial hypocholesterolemia [10][27] - The company is on track to meet its 2025 initiative of having 20 individual drug candidates in clinical studies or at market, with nine partnered and 11 wholly owned candidates [16] Market Data and Key Metrics Changes - The collaboration with Sarepta is expected to continue, providing capital to fund internal programs, despite Sarepta's recent setbacks [6] - The company is preparing for the US launch of clozaran, with a PDUFA date set for November 18, 2025, and has engaged with payers representing over 85% of US covered lives [29][30] Company Strategy and Development Direction - The company aims to create value through novel medicines, generate capital for development, and build a growth engine [7] - The focus is on expanding the cardiometabolic franchise and addressing unmet medical needs in various patient populations [14][31] - The company is building a commercial organization to support the launch of its products, particularly clozaran and zodasiran [21][40] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging biotech market but emphasized their commitment to serving patients and creating shareholder value [7] - The company is optimistic about the upcoming regulatory submissions and the potential for multiple product launches between late 2025 and 2028 [12][16] - Management expressed confidence in the collaboration with Sarepta and the potential for significant future milestones [6][36] Other Important Information - The company has made significant progress in sourcing new capital, including a $130 million upfront payment from Sanofi for rights to develop clozaran in Greater China [18][36] - The company expects to achieve a $100 million milestone payment from Sarepta and anticipates a second milestone of $200 million by the end of the year [36][38] Q&A Session Summary Question: How does the company view competitors' programs in triglyceride reduction? - Management stated that they focus on their own studies and have had positive data in their Phase 2 and Phase 3 studies, expecting to demonstrate best-in-class triglyceride reduction [44][46] Question: What are the baseline demographics for the Phase III studies? - Management confirmed that their baseline demographics are similar to those published by competitors, but emphasized the importance of focusing on adjudicated cases of pancreatitis rather than abdominal pain [52][56] Question: How does clozaran address unmet clinical needs? - Management highlighted that clozaran offers deep triglyceride reduction and is the only agent in a registrational Phase 3 study that has shown a statistically significant reduction in acute pancreatitis risk [61][62] Question: What is the expected pricing strategy for clozaran? - Management indicated that they expect clozaran to be priced higher than treatments for severe hypertriglyceridemia, but specific pricing details are still under consideration [65] Question: What is the expected timeline for the auto-injector for clozaran? - Management stated that the initial presentation will be a prefilled syringe, with development underway for an auto-injector expected to be available at launch or soon thereafter [88][89]

[Overview and Recent Developments](index=1&type=section&id=Overview%20and%20Recent%20Developments) [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO highlighted strong execution across discovery, clinical, regulatory, and business development, preparing for the potential commercial launch of plozasiran by November 18, 2025, and maintaining a strong balance sheet to advance its pipeline of innovative medicines - The company's pipeline has matured, with **four Arrowhead-discovered candidates** now in pivotal Phase 3 studies[2](index=2&type=chunk) - Arrowhead is building out its commercial capabilities to be launch-ready for plozasiran, pending regulatory approval on its **November 18, 2025, PDUFA date**[2](index=2&type=chunk) - Management expressed confidence in the company's **strong balance sheet**, believing it provides sufficient financial resources to advance multiple new medicines through clinical and regulatory processes[2](index=2&type=chunk) [Key Corporate and Clinical Updates](index=1&type=section&id=Key%20Corporate%20and%20Clinical%20Updates) Arrowhead announced significant business and clinical milestones, including a major asset purchase agreement with Sanofi for plozasiran in Greater China, a $100 million milestone payment from Sarepta for ARO-DM1, and progress in multiple Phase 3 studies for plozasiran and zodasiran, alongside initiating a Phase 1/2a trial for its obesity candidate, ARO-ALK7 - Visirna Therapeutics, an Arrowhead subsidiary, signed an asset purchase agreement with Sanofi for plozasiran in Greater China, including a **$130 million upfront payment** and up to **$265 million in potential approval milestones**[3](index=3&type=chunk) - Earned a **$100 million milestone payment** from Sarepta Therapeutics for ARO-DM1, a treatment for type 1 myotonic dystrophy, with an additional **$200 million milestone** anticipated by the end of 2025[3](index=3&type=chunk) - Completed enrollment in **three global Phase 3 studies** for plozasiran in severe hypertriglyceridemia, with topline data expected in **mid-2026**[3](index=3&type=chunk) - Dosed the first subject in the YOSEMITE Phase 3 trial of zodasiran for homozygous familial hypercholesterolemia (HoFH), marking the company's **fourth candidate to reach late-stage studies**[4](index=4&type=chunk) - Initiated a **Phase 1/2a clinical trial of ARO-ALK7**, an investigational RNAi therapeutic for obesity, with a novel mechanism of action aimed at preserving lean muscle mass[4](index=4&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) [Q3 2025 Operating Results](index=3&type=section&id=Q3%202025%20Operating%20Results) For the third quarter ended June 30, 2025, Arrowhead reported revenue of $27.8 million, compared to no revenue in the same period last year, resulting in a net loss attributable to the company of $175.2 million, or ($1.26) per share, an increase from a net loss of $170.8 million, or ($1.38) per share, in Q3 2024, driven by higher R&D and G&A expenses that offset the newly generated revenue Q3 2025 vs Q3 2024 Operating Summary | Metric | Q3 2025 (in thousands) | Q3 2024 (in thousands) | | :--- | :--- | :--- | | Revenue | $27,767 | $0 | | Research and development | $162,368 | $152,431 | | General and administrative | $30,949 | $23,710 | | Total operating expenses | $193,317 | $176,141 | | Operating loss | ($165,550) | ($176,141) | | Net loss attributable to Arrowhead | ($175,241) | ($170,793) | | Net loss per share - Diluted | ($1.26) | ($1.38) | [Financial Position](index=4&type=section&id=Financial%20Position) As of June 30, 2025, Arrowhead's financial position strengthened year-over-year, with total cash resources increasing to $900.4 million from $681.0 million, total assets growing to $1.38 billion, total liabilities decreasing to $860.8 million, and total stockholders' equity significantly increasing to $522.3 million Financial Position Summary as of June 30 | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Total cash resources | $900,372 | $680,961 | | Total Assets | $1,380,612 | $1,139,802 | | Total Liabilities | $860,806 | $948,739 | | Total Arrowhead Stockholders' Equity | $522,313 | $185,444 | | Shares Outstanding | 138,144 | 124,376 | [Corporate Information and Forward-Looking Statements](index=4&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) [About Arrowhead Pharmaceuticals](index=4&type=section&id=About%20Arrowhead%20Pharmaceuticals) Arrowhead Pharmaceuticals is a biopharmaceutical company that develops RNA interference (RNAi) therapeutics to treat intractable diseases by silencing the genes that cause them, utilizing a broad portfolio of RNA chemistries and delivery methods to induce rapid, deep, and durable knockdown of target genes - The company's core technology is **RNA interference (RNAi)**, a natural cellular mechanism that inhibits gene expression to affect protein production[10](index=10&type=chunk) - Arrowhead's therapies are designed to **silence specific genes** that cause intractable diseases by leveraging this natural pathway of gene silencing[10](index=10&type=chunk) [Conference Call Information](index=4&type=section&id=Conference%20Call%20Information) The company hosted a conference call and live audio webcast on August 7, 2025, to discuss its fiscal 2025 third-quarter financial results, with a replay of the webcast available on the company's investor relations website - A conference call and webcast were held on **August 7, 2025, at 4:30 p.m. ET** to discuss the financial results[1](index=1&type=chunk)[8](index=8&type=chunk) - Analysts wishing to participate in the call were required to **pre-register** to receive a dial-in number and a personalized PIN code[9](index=9&type=chunk) [Safe Harbor Statement](index=4&type=section&id=Safe%20Harbor%20Statement) This press release contains forward-looking statements regarding the company's future financial performance, product pipeline, clinical trial progress, and collaborations, which are based on current expectations and subject to numerous risks and uncertainties that could cause actual results to differ materially, as detailed in the company's SEC filings - The press release includes forward-looking statements concerning projections of **future financial performance**, product pipeline expectations, anticipated regulatory submissions, and clinical program results[12](index=12&type=chunk)[14](index=14&type=chunk) - Actual results may differ due to various risks, including the **safety and efficacy of product candidates**, regulatory decisions, the ability to finance operations, and other uncertainties described in SEC filings[14](index=14&type=chunk)

[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited consolidated financial statements for the quarterly period ended June 30, 2025, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, along with comprehensive notes on accounting policies, agreements, and debt [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights | Account | June 30, 2025 (in thousands) | September 30, 2024 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and restricted cash | $129,793 | $102,685 | | Available-for-sale securities | $770,579 | $578,276 | | Total current assets | $946,923 | $695,471 | | Total Assets | $1,380,612 | $1,139,802 | | **Liabilities & Equity** | | | | Total current liabilities | $194,530 | $103,168 | | Total long-term liabilities | $666,276 | $845,571 | | Stockholders' equity | $522,313 | $185,444 | | Total Liabilities & Equity | $1,380,612 | $1,139,802 | [Consolidated Statements of Operations and Comprehensive (Loss) Income](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) Consolidated Statement of Operations | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Nine Months Ended June 30, 2025 (in thousands) | Nine Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $27,767 | $— | $572,976 | $3,551 | | Research and development | $162,368 | $152,431 | $432,472 | $370,044 | | General and administrative | $30,949 | $23,710 | $86,264 | $72,384 | | Operating (loss) income | $(165,550) | $(176,141) | $54,240 | $(438,877) | | Net (loss) income attributable to Arrowhead | $(175,241) | $(170,793) | $22,119 | $(428,957) | | Diluted (loss) income per share | $(1.26) | $(1.38) | $0.17 | $(3.63) | [Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) - Total stockholders' equity increased from **$191.1 million** at September 30, 2024, to **$519.8 million** at June 30, 2025, primarily driven by the issuance of common stock related to the Sarepta agreement (**$241.4 million**) and net income for the period, offset by net losses in certain quarters[14](index=14&type=chunk) [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statement of Cash Flows | Cash Flow Activity | Nine Months Ended June 30, 2025 (in thousands) | Nine Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $159,061 | $(325,635) | | Net cash used in investing activities | $(201,913) | $(197,149) | | Net cash provided by financing activities | $70,337 | $481,431 | | Net increase (decrease) in cash | $27,485 | $(41,353) | | Cash at end of period | $129,793 | $69,399 | [Notes to Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - The company's pipeline includes multiple candidates in Phase 3 trials, such as plozasiran, zodasiran, olpasiran (Amgen), and fazirsiran (Takeda)[19](index=19&type=chunk) - A global licensing and collaboration agreement was signed with Sarepta Therapeutics on November 25, 2024, which closed on February 7, 2025, with Arrowhead receiving **$325.0 million** from a stock purchase and a **$500.0 million** upfront payment[23](index=23&type=chunk) - The FDA accepted the New Drug Application for plozasiran on January 17, 2025, with a PDUFA action date of November 18, 2025[23](index=23&type=chunk) - Subsequent to the quarter end, on August 1, 2025, the company's majority-owned subsidiary Visirna entered an agreement to sell its rights for plozasiran in Greater China to Sanofi for a **$130.0 million** upfront payment and potential milestones[130](index=130&type=chunk)[132](index=132&type=chunk) - On July 27, 2025, the company triggered a **$100.0 million** milestone payment from Sarepta related to the ARO-DM1 clinical study[133](index=133&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=29&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's financial condition and results of operations, highlighting revenue drivers, expense analysis, and liquidity, with a focus on the Sarepta collaboration and commercialization preparations [Results of Operations](index=31&type=section&id=Results%20of%20Operations) - Total revenue for the nine months ended June 30, 2025, increased by **$569.4 million** compared to the prior year period, primarily driven by revenue recognition from the Sarepta license agreement, which contributed **$570.3 million**[148](index=148&type=chunk)[154](index=154&type=chunk) Research & Development Expense Breakdown (Nine Months Ended June 30) | Category | 2025 (in thousands) | 2024 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Candidate costs | $243,094 | $185,708 | 31% | | R&D discovery costs | $48,785 | $56,736 | (14)% | | Salaries | $80,583 | $72,048 | 12% | | **Total R&D Expense** | **$432,472** | **$370,044** | **17%** | - The **31% increase** in candidate costs for the nine-month period was due to the progression of the company's pipeline into and through clinical trials, leading to higher manufacturing and clinical trial costs[158](index=158&type=chunk) General & Administrative Expense Breakdown (Nine Months Ended June 30) | Category | 2025 (in thousands) | 2024 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Salaries | $23,152 | $20,087 | 15% | | Professional, outside services, and other | $35,811 | $16,910 | 112% | | **Total G&A Expense** | **$86,264** | **$72,384** | **19%** | - Professional, outside services, and other G&A expenses increased by **112%** for the nine-month period, mainly due to costs associated with commercialization and business development efforts as the company prepares for a product launch[167](index=167&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity Position as of June 30, 2025 | Account | Amount (in millions) | | :--- | :--- | | Cash, cash equivalents and restricted cash | $129.8 | | Available-for-sale securities | $770.6 | - The company expects to have sufficient liquidity to fund its operations through at least the next twelve months from the issuance date of the financial statements, based on its current cash, investments, and operating plan[180](index=180&type=chunk) - During the nine months ended June 30, 2025, net cash provided by operating activities was **$159.1 million**, primarily due to the **$500.0 million** upfront payment from the Sarepta agreement, offset by operating expenses[180](index=180&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=37&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company states there have been no material changes in its exposure to market risk since its last Annual Report on Form 10-K for the fiscal year ended September 30, 2024 - There has been no material change in the Company's exposure to market risk from that described in its Annual Report on Form 10-K for the fiscal year ended September 30, 2024[183](index=183&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=37&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective at a reasonable assurance level, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of the end of the quarter[185](index=185&type=chunk) - There were no changes in the Company's internal control over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[186](index=186&type=chunk) [PART II — OTHER INFORMATION](index=38&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [ITEM 1. LEGAL PROCEEDINGS](index=38&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company reports no material developments in legal proceedings since its last Annual Report on Form 10-K for the fiscal year ended September 30, 2024 - There have been no material developments in the legal proceedings that the Company disclosed in its Annual Report on Form 10-K for the fiscal year ended September 30, 2024[188](index=188&type=chunk) [ITEM 1A. RISK FACTORS](index=38&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company states there have been no material changes to the risk factors identified in its Annual Report on Form 10-K for the fiscal year ended September 30, 2024 - There have been no material changes from the risk factors identified in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2024[189](index=189&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=38&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section reports that there were no unregistered sales of equity securities during the period - None[190](index=190&type=chunk) [ITEM 5. OTHER INFORMATION](index=38&type=section&id=ITEM%205.%20OTHER%20INFORMATION) The company reports that no director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - During the quarter ended June 30, 2025, no director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement[193](index=193&type=chunk) [ITEM 6. EXHIBITS](index=39&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, material agreements, and certifications by the CEO and CFO

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