Core Insights - Biotech and healthcare stocks experienced significant movements in after-hours trading, driven by corporate updates and investor anticipation [1] Company Updates - Butterfly Network, Inc. (BFLY) shares increased by 6.04% to $2.81 after a 14.22% rise to $2.65 at market close, following the announcement of CEO Joseph DeVivo and Interim CFO Megan Carlson's participation in the 8th Annual Evercore Healthcare Conference [2] - Citius Pharmaceuticals Inc. (CTXR) saw a 7.90% increase to $1.23 after a 15.15% rally to $1.14, attributed to a deeper collaboration with Verix for the commercialization of LYMPHIR, an FDA-approved immunotherapy expected to launch in Q4 2025 [3] - ProQR Therapeutics N.V. (PRQR) rose 6.80% to $2.20 after a flat close at $2.06, with no specific news indicating that the movement may be due to investor sentiment [4] - Perrigo Company plc (PRGO) advanced 3.97% to $13.14, building on a 3.10% gain at the close, reflecting steady investor interest despite no new announcements [4] - Tempest Therapeutics, Inc. (TPST) added 4.86% to $3.67 after reversing a decline, following the announcement of plans to acquire CAR-T programs from Factor Bioscience, expected to close in early 2026 [5] - Iterum Therapeutics plc (ITRM) rose 2.77% to $0.3969 after a 4.38% gain at the close, with no new updates released [6] - Processa Pharmaceuticals, Inc. (PCSA) edged up 1.86% to $0.26 despite a steep decline at the close, with no news issued [6]

Core Insights - Citius Oncology is enhancing its commercial strategy for the launch of LYMPHIR, a novel immunotherapy for cutaneous T-cell lymphoma, through a collaboration with Verix and its Tovana platform, which utilizes AI and machine learning for salesforce targeting and engagement [1][2][3] Company Overview - Citius Oncology, a subsidiary of Citius Pharmaceuticals, focuses on developing and commercializing innovative oncology therapies, with LYMPHIR being its primary asset approved by the FDA in August 2024 for treating relapsed or refractory Stage I-III cutaneous T-cell lymphoma [1][34][36] - The company aims to penetrate a market estimated to exceed $400 million, which is currently underserved by existing therapies [34] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy indicated for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy [10][34] - The drug works by binding to IL-2 receptors on cancer cells, leading to cell death through inhibition of protein synthesis [6][7] Collaboration and Technology - The partnership with Verix aims to leverage the Tovana platform for real-time analytics and data-driven decision-making, enhancing the efficiency of Citius Oncology's commercial team [2][4][5] - The Tovana platform integrates advanced analytics and real-world claims data to refine targeting and support predictive intelligence in sales and marketing [2][4] Market Strategy - Citius Oncology is focused on capital efficiency and sustainable value creation for shareholders while facilitating access to care for patients with cutaneous T-cell lymphoma [5] - The company has established foundational launch activities, including distribution partnerships and reimbursement codes, to support the commercialization of LYMPHIR [4][5]

Core Insights - U.S. stock futures showed slight gains, with Dow futures up approximately 0.1% [1] Company Performance - PACCAR Inc reported a significant decline in shares, falling 18.3% to $7.64 in pre-market trading after disappointing third-quarter results [1] - The company's quarterly earnings were $1.12 per share, missing the analyst consensus estimate of $1.17 per share [1] - PACCAR's quarterly sales were reported at $6.107 billion, also below the analyst consensus estimate of $6.371 billion [1] Other Stocks Movement - Neuphoria Therapeutics Inc shares plummeted 65.3% to $5.35 after its AFFIRM-1 trial for social anxiety failed to meet endpoints [4] - Citius Pharmaceuticals Inc shares fell 18.2% to $1.48 following a $6 million registered direct offering announcement [4] - Galapagos NV shares declined 15.4% to $28.99 as the company plans to wind down its Cell Therapy Business [4] - Silvercorp Metals Inc shares decreased by 9.9% to $6.35 in pre-market trading [4] - Other notable declines included Theravance Biopharma Inc down 8.6% to $13.07 and Pacira Biosciences Inc down 8.3% to $21.10 [4]

Summary of Key Points Core Viewpoint - U.S. stock futures showed slight gains, with the Dow futures increasing by approximately 0.1% on Tuesday, while several companies experienced significant declines in pre-market trading due to disappointing earnings or other negative news [1]. Company-Specific Summaries - **PACCAR Inc (NASDAQ:PCAR)**: - Shares fell 18.3% to $7.64 after reporting third-quarter earnings of $1.12 per share, missing the analyst consensus estimate of $1.17 per share. - Quarterly sales were reported at $6.107 billion, also below the consensus estimate of $6.371 billion [1]. - **Neuphoria Therapeutics Inc (NASDAQ:NEUP)**: - Shares dropped 65.3% to $5.35 following the failure of its AFFIRM-1 trial for social anxiety to meet endpoints [4]. - **Citius Pharmaceuticals Inc (NASDAQ:CTXR)**: - Shares decreased by 18.2% to $1.48 after announcing a $6 million registered direct offering [4]. - **Galapagos NV – ADR (NASDAQ:GLPG)**: - Shares declined 15.4% to $28.99 as the company announced plans to wind down its Cell Therapy Business as part of a transformation strategy [4]. - **Silvercorp Metals Inc (NYSE:SVM)**: - Shares fell 9.9% to $6.35 in pre-market trading [4]. - **Theravance Biopharma Inc (NASDAQ:TBPH)**: - Shares decreased by 8.6% to $13.07 [4]. - **Pacira Biosciences Inc (NASDAQ:PCRX)**: - Shares dipped 8.3% to $21.10; the company is set to present new data from a Phase 1 clinical trial for a gene therapy candidate at an upcoming meeting [4]. - **Coeur Mining Inc (NYSE:CDE)**: - Shares fell 8.2% to $20.22 after a previous gain of 5% on Monday [4]. - **Endeavour Silver Corp (NYSE:EXK)**: - Shares declined 8.2% to $8.57 [4]. - **Sibanye Stillwater Ltd (NYSE:SBSW)**: - Shares fell 8.1% to $10.67 [4]. - **First Majestic Silver Corp (NYSE:AG)**: - Shares declined 7.9% to $13.22 [4]. - **Hycroft Mining Holding Corporation (NYSE:HYMC)**: - Shares dipped 7.7% to $8.03 [4]. - **Harmony Gold Mining Company Ltd (NYSE:HMY)**: - Shares declined 6.8% to $18.85 [4]. - **Pan American Silver Corp (NYSE:PAAS)**: - Shares fell 6.6% to $36.80 [4].

Core Insights - Citius Pharmaceuticals and Citius Oncology will participate in three investor conferences in October 2025, providing opportunities for one-on-one meetings with management [1][2][3]. Company Overview - Citius Pharmaceuticals, Inc. is focused on developing first-in-class critical care products, with FDA approval for LYMPHIR, a targeted immunotherapy for cutaneous T-cell lymphoma, received in August 2024 [4]. - Citius Pharmaceuticals' late-stage pipeline includes Mino-Lok, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, with successful trial completions in 2023 [4]. - Citius Pharmaceuticals owns 79% of Citius Oncology, which specializes in novel targeted oncology therapies [4][5]. Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, indicating significant growth potential [5]. - Citius Oncology has robust intellectual property protections, including orphan drug designation and pending patents, which enhance its competitive positioning in the oncology market [5][6].

Core Insights - Citius Oncology has finalized an exclusive agreement with EVERSANA to support the commercialization of LYMPHIR, an FDA-approved therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), expected to launch in Q4 2025 [1][4][27] Company Overview - Citius Oncology is a subsidiary of Citius Pharmaceuticals, focused on developing and commercializing targeted oncology therapies. The company’s primary asset, LYMPHIR, received FDA approval in August 2024 for treating adults with relapsed or refractory CTCL after at least one prior systemic therapy [27][28] - Citius Oncology estimates the initial market for LYMPHIR exceeds $400 million and is growing, indicating a significant opportunity in an underserved market [27] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy indicated for adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy. It works by binding to IL-2 receptors on malignant T-cells, leading to cell death [6][8][27] - The therapy has demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes and exhibit antitumor activity [7] Commercialization Strategy - Under the Master Service Agreement, EVERSANA will provide an integrated suite of pre- and post-launch operations services, including medical information, pharmacovigilance, revenue cycle management, and data analytics [2][3] - This partnership is expected to enhance Citius Oncology's operational readiness and market access for LYMPHIR, aligning with investor expectations [4][29] Market Context - Cutaneous T-cell lymphoma is the most common type of cutaneous lymphoma, with a significant impact on patients' quality of life due to severe symptoms. The disease primarily affects men aged 50 to 60 [5][27] - Current treatment options for advanced CTCL are limited, with no curative therapies available other than allogeneic stem cell transplantation for a small fraction of patients [5]

Core Viewpoint - Citius Oncology, Inc. has successfully closed a registered direct offering and concurrent private placement, raising approximately $9.0 million through the sale of 5,142,858 shares of common stock and warrants [1][2]. Group 1: Offering Details - The effective offering price for each share of common stock and accompanying warrant was $1.75, with warrants having an exercise price of $1.84 per share [1]. - The warrants will be exercisable six months from the date of issuance and will expire on the five and one-half year anniversary from the date of issuance [1]. - Maxim Group LLC acted as the sole placement agent for the offering, which was conducted under a registration statement filed with the SEC [3]. Group 2: Company Overview - Citius Oncology is focused on developing and commercializing novel targeted oncology therapies, with its primary asset, LYMPHIR, approved by the FDA for treating relapsed or refractory CTCL [5]. - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [5]. - Citius Pharmaceuticals, the parent company, also has a late-stage pipeline including Mino-Lok® and CITI-002 (Halo-Lido) [6].

Core Viewpoint - Citius Oncology, Inc. has entered into a securities purchase agreement to raise approximately $9.0 million through a registered direct offering and a concurrent private placement, involving the sale of 5,142,858 shares of common stock and unregistered warrants [1][2]. Group 1: Offering Details - The effective offering price for each share of common stock and accompanying warrant is set at $1.75, with warrants having an exercise price of $1.84 per share, exercisable six months from issuance and expiring five and a half years later [1][2]. - The offering is expected to close around September 10, 2025, pending customary closing conditions [2]. Group 2: Company Background - Citius Oncology focuses on developing and commercializing novel targeted oncology therapies, with its primary asset, LYMPHIR, approved by the FDA for treating adults with relapsed or refractory CTCL [5]. - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, supported by robust intellectual property protections [5]. - Citius Pharmaceuticals, the parent company, is dedicated to first-in-class critical care products, with a late-stage pipeline that includes Mino-Lok® and CITI-002 (Halo-Lido) [6].

Core Insights - Citius Oncology has launched an innovative AI platform to enhance its commercial strategies and support the upcoming launch of LYMPHIR™, a novel therapy for cutaneous T-cell lymphoma (CTCL) [1][2][5] - The AI platform utilizes machine learning to identify treatment patterns and target prescribers effectively, thereby improving patient care and clinical decision-making [2][4][5] - LYMPHIR is a targeted immune therapy approved by the FDA in August 2024 for relapsed or refractory CTCL, with a market potential exceeding $400 million [6][7][32] Group 1: AI Platform and Commercial Strategy - The proprietary AI platform is designed to refine targeting and enhance the efficiency of the salesforce by providing data-informed engagement with healthcare providers [1][3] - It continuously learns from real-world data and marketing performance analytics, delivering predictive insights for tailored customer journeys [4] - The platform aims to optimize the commercial infrastructure and accelerate healthcare provider education [5] Group 2: Product Overview and Market Potential - LYMPHIR is indicated for adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy [10] - The therapy is a recombinant fusion protein that targets IL-2 receptors on tumor cells, leading to cell death and enhanced antitumor activity [6] - Citius Oncology estimates the initial market for LYMPHIR to exceed $400 million, indicating significant growth potential in an underserved market [32]

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) Citius Pharmaceuticals reported improved Q3 2025 financials, is preparing for LYMPHIR™ launch, and secured significant capital [Fiscal Third Quarter 2025 Financial Highlights](index=1&type=section&id=FISCAL%20THIRD%20QUARTER%202025%20FINANCIAL%20RESULTS) Citius Pharmaceuticals reported an improved net loss and EPS for Q3 2025 compared to Q3 2024, driven by reduced R&D, G&A, and stock-based compensation expenses. The company ended the quarter with $6.1 million in cash and cash equivalents, bolstered by recent equity and debt financings Fiscal Third Quarter 2025 Financial Performance (YoY) | Metric | Q3 2025 (Millions) | Q3 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | R&D expenses | $1.6 | $2.8 | ↓ $1.2 |\n| G&A expenses | $4.4 | $4.8 | ↓ $0.4 |\n| Stock-based compensation | $2.7 | $3.1 | ↓ $0.4 |\n| Net loss | $(9.2) | $(10.6) | ↑ $1.4 |\n| Net Loss Per Share (EPS) | $(0.80) | $(1.57) | ↑ $0.77 | - Cash and cash equivalents stood at **$6.1 million** as of June 30, 2025. The company received net proceeds of **$16.5 million** from equity issuance and **$1 million** from a note payable during the nine months ended June 30, 2025[4](index=4&type=chunk) - Citius Oncology completed a public offering on July 17, 2025, generating approximately **$7.4 million** in net proceeds[4](index=4&type=chunk) [Strategic Priorities and LYMPHIR Launch](index=1&type=section&id=Strategic%20Priorities%20and%20LYMPHIR%20Launch) Citius Pharmaceuticals is transitioning from a development-stage enterprise to a commercial organization, with final preparations underway for the planned U.S. launch of LYMPHIR™ in Q4 2025. The company has completed major launch-enabling activities and continues to advance its pipeline product, Mino-Lok - Citius is operationally positioned to transition from a development-stage enterprise to a **fully integrated commercial organization**[2](index=2&type=chunk) - Final preparations are underway for the planned U.S. launch of LYMPHIR™ in the **fourth quarter of 2025**[2](index=2&type=chunk) - Major launch-enabling activities for LYMPHIR, including commercial-scale manufacturing, labeling, packaging, and distribution services agreements, have been completed[3](index=3&type=chunk) - The company remains focused on advancing Mino-Lok and is engaging with the U.S. Food and Drug Administration (FDA) to determine the best path forward for this antibiotic lock solution[3](index=3&type=chunk) [Financing Activities](index=1&type=section&id=Financing%20Activities) During the fiscal third quarter and shortly thereafter, Citius Pharmaceuticals and its subsidiary Citius Oncology raised significant capital to support commercialization activities and corporate operations, including pre-launch initiatives for LYMPHIR - Citius Pharmaceuticals raised **$12.5 million** in gross financings during the quarter[1](index=1&type=chunk) - In June 2025, the company completed a **$6 million** registered direct offering, with potential for an additional **$9.8 million** upon full warrant exercise[3](index=3&type=chunk) - In July 2025, Citius Oncology strengthened its capital position with **$9 million** in gross proceeds from a public offering[3](index=3&type=chunk) [Company Overview](index=2&type=section&id=About%20Citius%20Pharmaceuticals%2C%20Inc.) Citius Pharmaceuticals is a late-stage biopharmaceutical company focused on critical care products, with FDA-approved LYMPHIR™ and an 84% stake in Citius Oncology [About Citius Pharmaceuticals](index=2&type=section&id=About%20Citius%20Pharmaceuticals) Citius Pharmaceuticals is a late-stage biopharmaceutical company focused on developing and commercializing first-in-class critical care products. Its lead product, LYMPHIR™, received FDA approval in August 2024, and the company holds an 84% ownership stake in its oncology subsidiary, Citius Oncology - Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of **first-in-class critical care products**[6](index=6&type=chunk) - LYMPHIR™ was approved by the FDA in **August 2024** for an initial indication in the treatment of cutaneous T-cell lymphoma[6](index=6&type=chunk) - Citius Pharma owns **84%** of Citius Oncology[6](index=6&type=chunk) [Product Pipeline](index=2&type=section&id=Product%20Pipeline) Beyond LYMPHIR, Citius Pharma's late-stage pipeline includes Mino-Lok®, an antibiotic lock solution that successfully met its primary and secondary endpoints in a Phase 3 trial, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoids, which completed a Phase 2b trial. The company is actively engaging with the FDA for next steps on both programs - Mino-Lok® is an antibiotic lock solution designed to salvage catheters in patients with catheter-related bloodstream infections. Its Pivotal Phase 3 Trial was completed in **2023** and met primary and secondary endpoints[6](index=6&type=chunk) - CITI-002 (Halo-Lido) is a topical formulation for the relief of hemorrhoids, for which a Phase 2b trial was completed in **2023**[6](index=6&type=chunk) - Citius Pharma is actively engaged with the FDA to outline next steps for both the Mino-Lok and Halo-Lido programs[6](index=6&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) Citius Pharmaceuticals reported changes in its balance sheet, statements of operations, and cash flows, reflecting increased assets and liabilities, reduced net loss for Q3, and improved cash from financing activities [Condensed Consolidated Balance Sheets](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, Citius Pharmaceuticals reported an increase in total assets, primarily driven by higher cash and inventory. Total liabilities also increased significantly, mainly due to a rise in accounts payable and accrued expenses, while total equity saw a decrease Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 | Sept 30, 2024 | Change (Absolute) | | :-------------------------- | :------------ | :------------ | :---------------- | | Cash and cash equivalents | $6,089,126 | $3,251,880 | ↑ $2,837,246 |\n| Inventory | $17,208,967 | $8,268,766 | ↑ $8,940,201 |\n| Total Current Assets | $24,611,269 | $14,220,646 | ↑ $10,390,623 |\n| Total Assets | $127,676,859 | $116,651,751 | ↑ $11,025,108 |\n| Accounts payable | $10,094,042 | $4,927,211 | ↑ $5,166,831 |\n| Accrued expenses | $8,523,675 | $17,027 | ↑ $8,506,648 |\n| Total Current Liabilities | $51,842,452 | $35,814,803 | ↑ $16,027,649 |\n| Total Liabilities | $60,115,929 | $42,549,921 | ↑ $17,566,008 |\n| Total Equity | $67,560,930 | $74,101,830 | ↓ $6,540,900 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the three months ended June 30, 2025, Citius Pharma reported a reduced net loss and improved EPS compared to the prior year, primarily due to lower operating expenses. However, for the nine-month period, while operating expenses slightly decreased, the net loss increased, and EPS improved due to a higher weighted average common shares outstanding Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric | 2025 | 2024 | Change (Absolute) | | :---------------------------------------- | :------------ | :------------ | :---------------- | | Research and development | $1,621,325 | $2,763,865 | ↓ $1,142,540 |\n| General and administrative | $4,447,008 | $4,808,551 | ↓ $361,543 |\n| Stock-based compensation – G&A | $2,719,674 | $3,061,763 | ↓ $342,089 |\n| Total Operating Expenses | $8,788,007 | $10,634,179 | ↓ $1,846,172 |\n| Operating Loss | $(8,788,007) | $(10,634,179) | ↑ $1,846,172 |\n| Net Loss | $(9,203,872) | $(10,573,336) | ↑ $1,369,464 |\n| Net Loss Per Share - Basic and Diluted | $(0.80) | $(1.57) | ↑ $0.77 | Condensed Consolidated Statements of Operations (Nine Months Ended June 30) | Metric | 2025 | 2024 | Change (Absolute) | | :---------------------------------------- | :------------ | :------------ | :---------------- | | Research and development | $7,514,888 | $8,991,673 | ↓ $1,476,785 |\n| General and administrative | $14,626,882 | $12,755,190 | ↑ $1,871,692 |\n| Stock-based compensation – G&A | $7,946,529 | $9,198,340 | ↓ $1,251,811 |\n| Total Operating Expenses | $30,088,299 | $30,945,203 | ↓ $856,904 |\n| Operating Loss | $(30,088,299) | $(30,945,203) | ↑ $856,904 |\n| Net Loss | $(30,996,623) | $(28,348,675) | ↓ $2,647,948 |\n| Net Loss Per Share - Basic and Diluted | $(3.27) | $(4.37) | ↑ $1.10 | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the nine months ended June 30, 2025, Citius Pharmaceuticals significantly reduced cash used in operating activities and increased cash provided by financing activities, resulting in a positive net change in cash and cash equivalents, a notable improvement from the prior year's negative change Condensed Consolidated Statements of Cash Flows (Nine Months Ended June 30) | Metric | 2025 | 2024 | Change (Absolute) | | :-------------------------------------- | :------------- | :------------- | :---------------- | | Net Cash Used In Operating Activities | $(14,671,948) | $(22,288,687) | ↑ $7,616,739 |\n| Net Cash Provided By Financing Activities | $17,509,194 | $13,718,951 | ↑ $3,790,243 |\n| Net Change in Cash and Cash Equivalents | $2,837,246 | $(8,569,736) | ↑ $11,406,982 |\n| Cash and Cash Equivalents - End of Period | $6,089,126 | $17,911,192 | ↓ $11,822,066 | - Net proceeds from common stock offerings increased to **$16.5 million** in 2025 from **$13.7 million** in 2024[15](index=15&type=chunk) [Additional Information](index=2&type=section&id=Additional%20Information) This section provides important disclaimers regarding forward-looking statements and contact details for investor and media inquiries [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section contains standard forward-looking statements that are subject to various risks and uncertainties, which could negatively impact the company's business, operating results, financial condition, and stock price. Investors are cautioned not to place undue reliance on these statements - The press release contains forward-looking statements based on expectations and beliefs concerning future events, identifiable by words such as 'will,' 'anticipate,' 'estimate,' 'expect,' 'plan,' 'should,' and 'may'[7](index=7&type=chunk) - These statements are subject to risks and uncertainties, including the need for substantial additional funds, ability to commercialize LYMPHIR, compliance with Nasdaq standards, financing agreements, market acceptance, R&D risks, dependence on third-party suppliers, government regulation, and competition[7](index=7&type=chunk) - Readers are cautioned not to place undue reliance on these forward-looking statements, as they do not constitute guarantees of future performance[7](index=7&type=chunk) [Investor and Media Contact](index=2&type=section&id=Investor%20Contact) Contact information for investor and media inquiries is provided for direct communication with company representatives - Investor Contact: Ilanit Allen, ir@citiuspharma.com, **908-967-6677 x113**[8](index=8&type=chunk) - Media Contact: Greg Salsburg, Greg@STiR-communications.com[8](index=8&type=chunk)