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]

Citius Oncology, Inc. Reports Fiscal Third Quarter 2025 Financial Results and Provides Business Update Exhibit 99.1 LYMPHIR commercial availability planned for the fourth quarter of 2025 $12.5 million in gross financings raised during the quarter by Citius Pharmaceuticals, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., August 12, 2025 -- Citius Oncology, Inc. ("Citius Oncology" or the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2025 OR ☐ 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 001-41534 Citius Oncology, Inc. (Exact name of registrant as specified in its charter) | Delaware | 99 ...

LYMPHIR commercial availability planned for the fourth quarter of 2025 $12.5 million in gross financings raised during the quarter by Citius Pharmaceuticals, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introductionCRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercia ...

Company Overview - Citius Oncology, Inc. is a platform focused on developing and commercializing novel targeted oncology therapies, with its primary asset, LYMPHIR, approved by the FDA for treating adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL) [5] - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [5] - Citius Pharmaceuticals, Inc. owns 92% of Citius Oncology and is dedicated to developing first-in-class critical care products [6] Recent Offering - Citius Oncology announced the closing of a public offering of 6,818,182 shares of common stock at a price of $1.32 per share, generating gross proceeds of approximately $9.0 million [1][2] - The offering included warrants to purchase shares at the same exercise price of $1.32, which are immediately exercisable and expire five years from issuance [1] Use of Proceeds - The net proceeds from the offering will primarily support the commercialization of LYMPHIR, including milestone and royalty payments under existing license agreements, as well as for working capital and general corporate purposes [2] Regulatory Information - The securities were offered under a registration statement filed with the U.S. Securities and Exchange Commission (SEC), which was declared effective on July 16, 2025 [3]

Core Viewpoint - Citius Oncology, Inc. has announced a public offering of 6,818,182 shares of common stock at a price of $1.32 per share, aiming to raise approximately $9.0 million in gross proceeds to support the commercialization of its product LYMPHIR and for general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes warrants to purchase shares at an exercise price of $1.32, which will be immediately exercisable and expire five years from issuance [1]. - Maxim Group LLC is acting as the sole placement agent for this offering [2]. - The offering is expected to close on or about July 17, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily support the commercialization of LYMPHIR, including milestone and royalty payments under existing license agreements, as well as working capital and general corporate purposes [2]. Group 3: Company Overview - Citius Oncology, Inc. 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 [5]. - Citius Pharmaceuticals, Inc. owns 92% of Citius Oncology and is dedicated to developing first-in-class critical care products, with a late-stage pipeline that includes Mino-Lok® and CITI-002 [6].

Core Insights - Citius Oncology has executed a distribution services agreement with Cencora to enhance its commercial infrastructure for the FDA-approved immunotherapy LYMPHIR [1][2][3] - The agreement aims to expand Citius Oncology's distribution network, ensuring product availability upon launch and supporting long-term scalability [2][3] - LYMPHIR is indicated for relapsed or refractory cutaneous T-cell lymphoma (CTCL) and is a targeted immune therapy that has shown antitumor activity [4][5] Company Overview - Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, focusing on developing and commercializing novel targeted oncology therapies [29][30] - The FDA approved LYMPHIR in August 2024, with an estimated initial market exceeding $400 million, indicating significant growth potential in an underserved market [29][30] - Citius Pharmaceuticals also has a late-stage pipeline that includes other critical care products, demonstrating a diverse portfolio [30] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a recombinant fusion protein that targets IL-2 receptors, leading to cell death in tumors expressing these receptors [4][5] - The product is indicated for adult patients with r/r Stage I-III CTCL after at least one prior systemic therapy [8][29] - The drug has received regulatory approval in Japan for CTCL and peripheral T-cell lymphoma (PTCL) prior to its FDA approval [5]

Summary of Citius Pharmaceuticals (CTXR) Conference Call Company Overview - Citius Pharmaceuticals operates two companies: Sidious Pharmaceuticals and Sidious Oncology, with Sidious Oncology being a subsidiary focused on cancer treatment [3][4] - Sidious Oncology has an approved drug, LENFIR, for cutaneous T cell lymphoma (CTCL) and plans to launch it within the year [4][9] Key Products and Developments - **LENFIR**: - Approved for CTCL, with a market size of approximately $400 million [9] - Offers 12 years of BLA exclusivity as the first new systemic treatment since 2018 [9][36] - Clinical trial results show a 36% objective response rate and an 84.4% reduction in skin burden [24][25] - Expected to add to the market rather than take market share due to the nature of oncological treatments [10] - **Miniloc**: - An antibiotic lock solution for infected central venous catheters, completing a Phase III trial [5][37] - Unique in its ability to clear biofilm from catheters, with a significant market opportunity [39][42] - Results showed a p-value of 0.0006, indicating a superior outcome compared to standard care [45] - **Hemorrhoid Drug**: - A cream formulation combining halobetasol and lidocaine, currently in Phase 2b trials [48] - Aims to monetize through partnerships after demonstrating efficacy [48] Management and Investment - The management team has significant personal investments totaling $26.5 million, indicating strong commitment [7][51] - Experienced professionals lead the company, including former executives from major pharmaceutical firms [18][19] Market Strategy and Sales - A small prescriber base for CTCL, with only 25 representatives needed to cover the market [32][33] - The pricing for LENFIR is projected between $325,000 and $350,000 for a course of therapy [30] - Plans to establish a patient services hub and a sales force to support the launch of LENFIR [15][16] Regulatory and Competitive Landscape - Miniloc has received QIDP designation, reducing NDA review time and providing extended market exclusivity [46] - Competitive advantages include a unique mechanism of action for LENFIR and a lack of existing treatments for peripheral T cell lymphoma [26][30] Conclusion - Citius Pharmaceuticals is positioned to launch LENFIR, with a strong management team and significant investment backing. The company is exploring additional market opportunities and preparing for regulatory interactions to advance its product pipeline [50][51]

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%2E%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for March 31, 2025, reveal a $14.4 million net loss and negative working capital, raising substantial doubt about the company's going concern [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows increased assets and liabilities, leading to a decrease in total stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Total Current Assets | $18,039 | $10,969 | | Total Assets | $91,439 | $84,369 | | **Liabilities & Equity** | | | | Total Current Liabilities | $49,740 | $32,700 | | Total Liabilities | $55,797 | $38,229 | | Total Stockholders' Equity | $35,643 | $46,140 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no revenue for the six months ended March 31, 2025, with net loss increasing to $14.4 million due to higher operating expenses Statement of Operations Summary (in thousands) | Metric | Six Months Ended Mar 31, 2025 | Six Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Total Operating Expenses | $13,866 | $9,275 | | Net Loss | $(14,395) | $(9,563) | | Net Loss Per Share | $(0.20) | $(0.14) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Total stockholders' equity decreased to $35.6 million at March 31, 2025, primarily due to the period's net loss - Total stockholders' equity declined to **$35.6 million** at March 31, 2025, from **$46.1 million** at September 30, 2024, primarily due to the period's net loss[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities was zero for the six months ended March 31, 2025, with expenditures funded by the parent company - Net cash provided by operating activities for the six months ended March 31, 2025 was **zero**, with the cash balance remaining at **$112**[21](index=21&type=chunk) - The company's expenditures are paid by its parent, Citius Pharma, and reflected in the 'due to related party' account, explaining the lack of cash flow from operations[63](index=63&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's focus on LYMPHIR, merger, accounting policies, going concern uncertainty, reliance on parent funding, license agreements, and manufacturing commitments - There is **substantial doubt** about the Company's ability to continue as a going concern, given its net loss of **$14.4 million** for the six months ended March 31, 2025, negative working capital of **$31.7 million**, and reliance on funding from Citius Pharma, which is only secured through **May 2025**[38](index=38&type=chunk) - Following FDA approval of LYMPHIR, milestone payments became due. As of March 31, 2025, a balance of **$22.5 million** is owed to Dr. Reddy's and **$5.9 million** is owed to Eisai, with a payment plan established for the latter[44](index=44&type=chunk)[45](index=45&type=chunk) - The company has minimum purchase commitments of approximately **$17.3 million** for drug substance and **$4.5 million** for finished drug products for calendar years **2025** and **2026**[58](index=58&type=chunk)[59](index=59&type=chunk) - On April 7, 2025, the company increased its authorized shares of common stock from **100 million** to **400 million**[52](index=52&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A discusses LYMPHIR commercialization, increased net loss due to higher expenses, and critical liquidity challenges with parent funding expiring soon [Results of Operations](index=20&type=section&id=RESULTS%20OF%20OPERATIONS) For the six months ended March 31, 2025, the company reported no revenue and a $14.4 million net loss, driven by increased R&D and G&A expenses Comparison of Operating Results (Six Months Ended March 31) | Account (in thousands) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $4,404 | $2,497 | +$1,907 | | General and administrative | $5,565 | $2,903 | +$2,662 | | Stock-based compensation | $3,897 | $3,874 | +$23 | | **Net loss** | **$(14,395)** | **$(9,563)** | **+$(4,832)** | - The increase in R&D expenses was primarily related to costs for a drug substance batch needed for a pre-license inspection of the manufacturer[88](index=88&type=chunk) - The increase in G&A expenses was driven by pre-commercial and commercial launch activities for LYMPHIR, including market research, marketing, and distribution[89](index=89&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) The company faces a severe liquidity crisis with minimal cash, negative working capital, and reliance on parent funding expiring in May 2025 - As of March 31, 2025, the company had **$112** in cash, an accumulated deficit of **$53.7 million**, and negative working capital of approximately **$31.7 million**[93](index=93&type=chunk) - Funding from parent company Citius Pharma is only expected to sustain operations through **May 2025**, creating an immediate need to raise additional capital[96](index=96&type=chunk) - Significant financial obligations for **2025** include a **$22.5 million** milestone payment to Dr. Reddy's, a structured payment plan to Eisai, and minimum purchase commitments of **$11.9 million** for drug substance and **$2.9 million** for finished drug products[99](index=99&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that this section is not applicable, indicating no significant exposure to market risks at its current stage - The company has determined that disclosures about market risk are not applicable[102](index=102&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[104](index=104&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[105](index=105&type=chunk) [PART II. OTHER INFORMATION](index=24&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings to disclose for the period - The company reported no legal proceedings[108](index=108&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) Substantial doubt exists about the company's going concern due to losses and limited parent funding, alongside a recent Nasdaq non-compliance notice - The independent registered public accounting firm's report includes an explanatory paragraph stating there is **substantial doubt** about the company's ability to continue as a going concern[110](index=110&type=chunk) - The company expects to have sufficient funds to continue operations only through **May 2025** and will need to raise additional capital to support operations beyond that date[111](index=111&type=chunk) - On April 23, 2025, the company received a non-compliance notice from Nasdaq because its stock price closed below **$1.00** for **30 consecutive business days**. It has until **October 20, 2025**, to regain compliance[65](index=65&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - The company reported no unregistered sales of equity securities[112](index=112&type=chunk) [Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - The company reported no defaults upon senior securities[113](index=113&type=chunk) [Mine Safety Disclosures](index=24&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's business operations - The company states that mine safety disclosures are not applicable[114](index=114&type=chunk) [Other Information](index=24&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated any plan for the purchase or sale of company securities during the quarter - During the quarter ended March 31, 2025, none of the company's directors or officers adopted or terminated any plan for the purchase or sale of the company's securities[115](index=115&type=chunk) [Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q report, including stock amendment and officer certifications - Key exhibits filed with this report include the Certificate of Amendment to the Certificate of Incorporation, and certifications from the Principal Executive and Financial Officers[116](index=116&type=chunk)

[Business Update](index=1&type=section&id=Business%20Update) Citius Oncology is transitioning from a development-stage to a commercial-stage company following the FDA approval of its primary asset, LYMPHIR, with immediate focus on disciplined capital deployment for a successful U.S. launch and seeking additional capital - Citius Oncology is advancing its transformation from a development-stage to a commercial-stage organization following the FDA approval of LYMPHIR[2](index=2&type=chunk) - The company is actively engaged in discussions with prospective commercial and strategic partners while also seeking to secure additional capital to ensure financial flexibility for the LYMPHIR launch[3](index=3&type=chunk) [Fiscal Second Quarter 2025 Financial Results](index=1&type=section&id=FISCAL%20SECOND%20QUARTER%202025%20FINANCIAL%20RESULTS%3A) For the second fiscal quarter ended March 31, 2025, Citius Oncology reported a net loss of $7.7 million, driven by higher operating expenses, with critical liquidity of only $112 necessitating additional funding beyond May 2025 [Liquidity and Capital Resources](index=1&type=section&id=Liquidity) As of March 31, 2025, Citius Oncology's cash position was extremely low at $112, dependent on its parent, Citius Pharma, for continued funding and requiring additional capital to support operations beyond May 2025 Liquidity Status as of March 31, 2025 | Metric | Value | | :--- | :--- | | Cash and cash equivalents | $112 | | Common shares outstanding | 71,552,402 | - The company requires additional capital to fund operations beyond May 2025[5](index=5&type=chunk) - Citius Pharma, the parent company, intends to continue funding Citius Oncology until it can raise external capital or generate revenue, with Jefferies LLC retained to evaluate strategic alternatives[4](index=4&type=chunk) [Operating Expenses](index=1&type=section&id=Operating%20Expenses) Operating expenses increased significantly in Q2 2025 compared to the prior year, with R&D expenses more than doubling to $3.1 million and G&A expenses rising to $2.2 million due to pre-commercial and launch activities for LYMPHIR Operating Expenses Comparison (Three Months Ended March 31) | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research and Development (R&D) | $3.1 million | $1.3 million | | General and Administrative (G&A) | $2.2 million | $1.4 million | | Stock-based Compensation | $2.1 million | $2.0 million | - The increase in R&D expenses is mainly related to the cost of a drug substance batch required for a pre-license inspection of the manufacturer[6](index=6&type=chunk) - The rise in G&A expenses was primarily due to pre-commercial and commercial launch activities for LYMPHIR, including market research, marketing, and distribution planning[7](index=7&type=chunk) [Net Loss](index=2&type=section&id=Net%20loss) The company's net loss for Q2 2025 was $7.7 million, or ($0.11) per share, compared to a net loss of $4.8 million, or ($0.07) per share, for Q2 2024, attributed to higher operating expenses Net Loss and EPS Comparison | Period | Net Loss 2025 | EPS 2025 | Net Loss 2024 | EPS 2024 | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended Mar 31 | $7.7 million | ($0.11) | $4.8 million | ($0.07) | | Six Months Ended Mar 31 | $14.4 million | ($0.20) | $9.6 million | ($0.14) | [Financial Statements](index=4&type=section&id=Financial%20Statements) The unaudited condensed consolidated financial statements reflect the company's financial position as of March 31, 2025, and its results of operations and cash flows, showing increased inventory and liabilities, no revenue, and a growing net loss sustained by non-cash financing [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, total assets increased to $91.4 million, driven by a rise in inventory to $15.3 million, while total liabilities grew substantially to $55.8 million, primarily due to increases in accounts payable and accrued expenses, leading to a decline in total stockholders' equity Key Balance Sheet Items (As of March 31, 2025 vs. Sept 30, 2024) | Account | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $112 | $112 | | Inventory | $15,339,253 | $8,268,766 | | Total Assets | $91,439,365 | $84,368,878 | | Total Current Liabilities | $49,740,142 | $32,700,428 | | Total Liabilities | $55,796,733 | $38,228,539 | | Total Stockholders' Equity | $35,642,632 | $46,140,339 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the three months ended March 31, 2025, Citius Oncology generated no revenue and reported total operating expenses of $7.5 million, leading to a net loss of $7.7 million, an increase from the prior year due to higher R&D and G&A spending Statement of Operations Summary (Three Months Ended March 31) | Line Item | 2025 | 2024 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Total Operating Expenses | $7,471,312 | $4,691,546 | | Net Loss | $(7,735,552) | $(4,835,546) | | Net Loss Per Share | $(0.11) | $(0.07) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended March 31, 2025, the company's cash flow statement shows a net loss of $14.4 million with no net change in cash, as operations were sustained by non-cash financing, including increases in inventory, accrued expenses, and amounts due to a related party - Net cash provided by operating activities was zero for the six months ended March 31, 2025, with the cash balance remaining unchanged at **$112**[18](index=18&type=chunk) Key Changes in Operating Assets & Liabilities (Six Months Ended March 31, 2025) | Account | Change (Use)/Source of Cash | | :--- | :--- | | Inventory | $(7,070,487) | | Accrued expenses | $8,722,168 | | Due to related party | $4,352,858 | [About Citius Oncology, Inc.](index=2&type=section&id=About%20Citius%20Oncology%2C%20Inc.) Citius Oncology is a specialty biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies, with its lead product LYMPHIR approved by the FDA for CTCL, targeting an initial market exceeding $400 million - The company's primary asset, LYMPHIR, was approved by the FDA in August 2024 for the treatment of relapsed or refractory CTCL[10](index=10&type=chunk) - Management estimates the initial, underserved market for LYMPHIR is greater than **$400 million**[10](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section serves as a legal disclaimer, cautioning that future-oriented statements are subject to significant risks and uncertainties, primarily the company's need for substantial additional funds to operate beyond May 2025, along with operational risks related to commercialization and supply chain - The company highlights a critical risk: its need for substantial additional funds to continue operations beyond May 2025 and to remain a going concern[11](index=11&type=chunk) - Major operational risks include the ability to commercialize LYMPHIR, dependence on third-party suppliers, and securing cGMP commercial-scale supply[11](index=11&type=chunk)