Core Points - NeOnc Technologies Holdings, Inc. is a clinical-stage biotechnology company focused on developing treatments for brain and central nervous system cancers [1][4] - The company will have its Executive Chairman, Amir Heshmatpour, featured in a live interview on July 24, 2025, at 11:00 a.m. ET [1] - NeOnc has executed a Sub-License Agreement with its Abu Dhabi subsidiary, NuroCure, as part of a $50 million strategic partnership with Quazar Investment [2] - The company has been included in the Russell Microcap Index, which is part of its strategy to attract institutional capital and enhance market liquidity [3] Company Overview - NeOnc Technologies is dedicated to developing and commercializing therapeutics that address challenges in overcoming the blood-brain barrier [4] - The company's NEO™ drug development platform has produced a portfolio of novel drug candidates with patent protections extending to 2038 [4] - NeOnc's NEO100™ and NEO212™ therapeutics are currently in Phase II human clinical trials and have received FDA Fast-Track and Investigational New Drug (IND) status [4]

Core Insights - NeOnc Technologies Holdings, Inc. has received formal approval from its Board of Directors for a strategic transaction with Quazar Investment, marking a significant step towards closing the deal [1][2][3] Company Overview - NeOnc Technologies is a clinical-stage biotechnology company focused on developing treatments for brain and central nervous system cancers, utilizing its NEO™ drug development platform [5] - The company’s proprietary chemotherapy agents, including NEO100™ and NEO212™, are currently in Phase II clinical trials and have received FDA Fast-Track and Investigational New Drug (IND) status [5] Strategic Partnership - The Board's unanimous approval allows NeOnc to participate in a $50 million equity investment and expansion into the MENA region under a non-binding term sheet with Quazar [2][3] - Quazar plans to lead a capital formation round priced at $25 per share, with 70% of proceeds allocated to acquiring NeOnc common stock and 30% for clinical trials and infrastructure development in the UAE and MENA region [3] Transaction Milestones - The transaction requires NeOnc to meet five milestones, with the current Board approval being the first of these [2][4] - NeOnc has 120 days to satisfy the remaining conditions necessary for closing the transaction [4] Future Developments - The strategic partnership aims to establish a strong operational presence in the MENA region and accelerate the clinical development of NeOnc's core assets [3] - Key future actions include the legal formation of NuroMENA and NuroCure in Abu Dhabi, execution of a Sub-License Agreement, finalization of offering documents, and approval of a comprehensive business plan [8]

Core Insights - NeOnc Technologies Holdings, Inc. has been included in the Russell Microcap® Index, which is a significant recognition of the company's growth and commitment to shareholder value [1][3] - The Russell Microcap® Index includes companies with an average market capitalization of approximately $640 million, covering stocks ranging from about $30 million to $3 billion [3][4] - NeOnc is focused on advancing its Phase II clinical trials for CNS cancers and expanding into the MENA region through a proposed partnership with Quazar [3] Company Overview - NeOnc Technologies Holdings, Inc. is a clinical-stage biopharmaceutical company dedicated to developing treatments for central nervous system cancers and disorders [1][6] - The company utilizes the NEO™ drug development platform, which has produced a portfolio of novel drug candidates with patent protections extending to 2038 [6] - NeOnc's therapeutics, NEO100™ and NEO212™, are currently in Phase II human clinical trials and have received FDA Fast-Track and Investigational New Drug (IND) status [6] Industry Context - The Russell US Indexes reconstitution ranks the 4,000 largest US stocks by total market capitalization, and membership in the Russell Microcap® Index is valid for one year [2][4] - Russell indexes are widely utilized by investment managers and institutional investors, serving as benchmarks for approximately $10.6 trillion in assets as of June 2024 [4]

Core Insights - NeOnc Technologies Holdings, Inc. has signed a non-binding term sheet with Quazar Investment to establish a new investment and clinical platform in the MENA region [1][2] - The partnership aims to leverage the UAE's clinical trial infrastructure to advance NeOnc's late-stage drug candidates [3][7] Investment and Structure - The term sheet outlines the formation of NuroMENA Holdings Ltd, which will oversee the establishment of NuroCure, an Abu Dhabi-based subsidiary responsible for clinical trials [2][5] - A proposed equity investment of $50 million is contingent upon NeOnc meeting specific conditions within 120 days [4][8] Clinical Development - NuroCure will initiate clinical trials for NEO100 and NEO212, targeting aggressive brain cancers such as Diffuse Intrinsic Pontine Glioma and glioblastoma multiforme [7][9] - The partnership is positioned to enhance NeOnc's clinical programs through collaboration with Cleveland Clinic Abu Dhabi [3][10] Financial Strategy - Quazar will lead a capital formation round of up to $50 million, with 70% allocated for acquiring NeOnc common stock and 30% for clinical trial and infrastructure development [8][10] - The investment strategy includes executing a Sub-License Agreement for NEO100 and NEO212, facilitating clinical efforts in the region [5][11] Company Background - NeOnc Technologies is focused on developing therapeutics for central nervous system cancers, with a robust patent portfolio extending to 2038 [11] - The company's drug candidates, NEO100 and NEO212, are currently in Phase II clinical trials under FDA Fast-Track status [11]

Core Insights - NeOnc Technologies Holdings, Inc. has appointed Dr. Josh Neman as Chief Clinical Officer to enhance its clinical development strategy and accelerate clinical trials, particularly for its lead asset NEO100, which is nearing completion of Phase 2a ahead of schedule [1][5]. Company Overview - NeOnc Technologies is a clinical-stage biopharmaceutical company focused on innovative therapies for central nervous system cancers, with lead programs including NEO100 and NEO212 designed to bypass the blood-brain barrier [6]. Leadership Appointment - Dr. Neman joins from the Keck School of Medicine at USC, where he has significant experience in cancer neuroscience and has led various cancer research initiatives [2][3]. - His expertise in brain tumor biology and clinical leadership is expected to be instrumental in advancing NeOnc's mission to improve treatment outcomes for patients with life-threatening cancers [5]. Clinical Trials and Development - NeOnc is currently conducting four clinical trials, with NEO100's Phase 2a trial achieving full enrollment ahead of schedule [5]. - The company aims to integrate AI and quantum computing into its drug delivery platform, enhancing its precision therapies [5]. Research and Innovation - NeOnc's proprietary formulations and extensive patent portfolio (176 patents worldwide) reflect its strong potential for commercialization in the CNS cancer treatment market [6].

[Part I - Financial Information](index=5&type=section&id=Part%20I%20-%20Financial%20Information) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's Q1 2025 financials show a soaring net loss and a 'going concern' warning despite increased cash from financing [Condensed Consolidated Balance Sheet](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) The balance sheet reflects increased cash and total assets, but liabilities more than doubled, widening the shareholders' deficit **Balance Sheet Highlights (Unaudited)** | Financial Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,439,210 | $64,893 | | Total Assets | $8,441,691 | $3,417,241 | | **Liabilities & Equity** | | | | Accounts payable | $4,025,244 | $2,917,801 | | Accrued advisory fee - related party | $8,828,565 | $0 | | Total Current Liabilities | $18,065,336 | $8,922,202 | | Accumulated deficit | ($88,610,432) | ($50,608,445) | | Total Shareholders' Deficit | ($9,623,645) | ($5,504,961) | [Condensed Consolidated Statement of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) The Q1 2025 net loss surged to $38.0 million due to significant one-time, non-cash expenses related to the NASDAQ listing **Statement of Operations Summary (Unaudited)** | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $39,990 | $43,000 | | Research and development | $998,222 | $614,517 | | Share based compensation | $23,073,745 | $0 | | Advisory fees | $11,737,806 | $0 | | **Total Operating Expenses** | **$37,616,803** | **$1,594,483** | | **Loss From Operations** | **($37,576,813)** | **($1,551,483)** | | **Net Loss** | **($38,001,987)** | **($2,938,976)** | | Net loss per share | ($2.10) | ($0.18) | [Condensed Consolidated Statement of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) Financing activities provided $11.0 million in cash, offsetting operating cash use and resulting in a net cash increase of $5.4 million **Cash Flow Summary (Unaudited)** | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,650,055) | $145,747 | | Net cash provided by (used in) financing activities | $11,024,372 | ($172,595) | | **Net increase (decrease) in cash** | **$5,374,317** | **($26,848)** | | **Cash and cash equivalents - end of period** | **$5,439,210** | **$5,014** | [Note 1 – Business Description and Liquidity](index=9&type=section&id=Note%201%20%E2%80%93%20Description%20of%20Business%20and%20Liquidity) The company is a clinical-stage biopharma firm facing substantial doubt about its ability to continue as a going concern - The company's lead product, NEO100, is in clinical trials for treating glioblastoma and has received **Orphan Drug and Fast Track designation** from the FDA[21](index=21&type=chunk) - The company raised **$11.6 million in gross proceeds** from a common stock sale, which was released from escrow upon its NASDAQ listing on March 26, 2025[22](index=22&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern**, as it lacks sufficient capital to fund operations for the next 12 months[23](index=23&type=chunk)[24](index=24&type=chunk) [Note 3 & 4 – Related Party Transactions and Loans](index=14&type=section&id=Note%203%20%E2%80%93%20Related%20party%20transactions) Significant related-party transactions include an $11.3 million advisory fee and a high-interest short-term loan from the Chairman - Upon its NASDAQ listing, the company incurred an **$11.3 million advisory fee** to AFH Holdings, an affiliate, with **$8.8 million remaining payable**[56](index=56&type=chunk) - The Executive Chairman advanced the company $300,000 in February 2025, which was repaid as $600,000 in March 2025, booking a **$300,000 interest expense due to a 100% OID**[63](index=63&type=chunk) [Note 6 – Equity and Financing Agreements](index=16&type=section&id=Note%206%20%E2%80%93%20Common%20and%20Preferred%20Stock) The company raised $11.6 million through a stock sale and secured a $50 million equity purchase agreement for future funding - During Q1 2025, the company sold 727,750 shares of common stock at $16.00 per share, raising **gross proceeds of $11,644,005**[67](index=67&type=chunk)[70](index=70&type=chunk) - The company entered into a **$50 million Equity Purchase Agreement** with Mast Hill Fund, LP, allowing it to sell shares at its discretion[74](index=74&type=chunk)[76](index=76&type=chunk) [Note 8 – Stock-Based Compensation](index=19&type=section&id=Note%208%20%E2%80%93%20Stock-Based%20Compensation) The NASDAQ listing triggered a $23.1 million share-based compensation expense for previously granted RSUs - The NASDAQ listing on March 26, 2025, triggered the vesting condition for outstanding RSUs, leading to the recognition of **$23.1 million in share-based compensation expense** for the quarter[84](index=84&type=chunk)[85](index=85&type=chunk) - As of March 31, 2025, there was approximately **$14.3 million in unamortized stock-based compensation** expected to be recognized over the next 1.8 years[85](index=85&type=chunk) - A total of **3,110,000 RSUs** were granted and outstanding as of March 31, 2025[86](index=86&type=chunk) [Note 9 – Commitments and Contingencies](index=20&type=section&id=Note%209%20%E2%80%93%20Commitments%20and%20Contingencies) Commitments include a $10 million line of credit and two significant, unpaid litigation settlements totaling over $4.6 million - The company has a **$10.0 million line of credit** agreement with HCWG, bearing 10.0% interest, with no amounts borrowed as of March 31, 2025[87](index=87&type=chunk) - A litigation settlement requires a payment of **$4.0 million to Orient EuroPharma Co., Ltd. (OEP)** following the company's IPO, which remains unpaid[93](index=93&type=chunk) - A separate litigation settlement requires a payment of **$600,000 plus accrued interest** to a vendor, which also remains unpaid[94](index=94&type=chunk)[95](index=95&type=chunk) [Management's Discussion and Analysis (MD&A)](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the Q1 2025 net loss to listing-related expenses and reiterates the 'going concern' risk [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Operating expenses surged to $37.6 million due to one-time listing costs, while R&D spending also increased **Comparison of Operating Results (Unaudited)** | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total operating expenses | $37,616,803 | $1,594,483 | $36,022,320 | | Loss from operations | ($37,576,813) | ($1,551,483) | ($36,025,330) | | Net loss | ($38,001,987) | ($2,938,976) | ($35,063,011) | - The increase in operating expenses was primarily driven by a **$23.1 million share-based compensation charge** and an **$11.7 million advisory fee**, both recognized upon the NASDAQ listing[120](index=120&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - Research and development expenses **increased by $383,705** year-over-year due to expanded clinical trial activities[123](index=123&type=chunk)[130](index=130&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Despite raising $11.3 million, current cash is insufficient for the next year, necessitating reliance on future financing - The company ended Q1 2025 with **$5.4 million in cash** after raising approximately **$11.3 million net** from a private placement of common stock[133](index=133&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) - Management confirms a **substantial doubt about the company's ability to continue as a going concern**, as current cash is insufficient to fund operations for the next 12 months[136](index=136&type=chunk) - Future funding sources include a **$10 million line of credit** and a **$50 million equity purchase agreement**[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) [Market Risk Disclosures](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no significant market risk exposure from foreign currency exchange rates or inflation - The company is **not currently exposed to significant market risk** from changes in foreign currency exchange rates or inflation[152](index=152&type=chunk)[153](index=153&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management identified material weaknesses in internal controls, rendering disclosure controls ineffective as of March 31, 2025 - Management concluded that **disclosure controls and procedures were not effective** as of March 31, 2025[156](index=156&type=chunk) - **Material weaknesses were identified** in internal controls related to duties separation, risk processes, major financial transactions, and IT user access management[158](index=158&type=chunk) - The company has begun remediation by **hiring additional financial personnel** and plans to enhance access to accounting literature and third-party professionals[159](index=159&type=chunk) [Part II - Other Information](index=33&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is in default on one settlement payment and disputes another $4.0 million claim following its direct listing - The company is **in default on a settlement agreement to pay a vendor $600,000**, which was due by March 31, 2024, and is now accruing interest[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) - The company has a dispute with OEP regarding a **$4.0 million settlement payment**, which OEP believes is due, but the company disagrees[439](index=439&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including going concern uncertainty, reliance on early-stage products, and internal control weaknesses [Financial and Capital Risks](index=34&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) A history of significant losses and an immediate need for additional capital threaten the company's continued operations - The company has incurred significant losses since inception, with a **net loss of $38.0 million for Q1 2025** and an **accumulated deficit of $88.6 million**[181](index=181&type=chunk) - The independent auditor's report includes a **"going concern" paragraph**, indicating substantial doubt about the company's ability to continue operations[194](index=194&type=chunk) [Product Development and Regulatory Risks](index=34&type=section&id=Risks%20Related%20to%20Product%20Discovery%2C%20Development%20and%20Regulatory%20Approval) Success hinges on a few early-stage products facing a lengthy, expensive, and highly uncertain regulatory approval process - The company's product candidates are in preclinical and clinical stages and **might never receive regulatory approval** or become commercially viable[198](index=198&type=chunk) - The business **substantially depends on its two perillyl acid-based product candidates**, NEO100 and NEO212[202](index=202&type=chunk) - The marketing approval process is **expensive, time-consuming, and uncertain**, and may prevent the company from obtaining approvals for commercialization[237](index=237&type=chunk) [Manufacturing and Third-Party Risks](index=35&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Reliance%20on%20Third%20Parties) The company depends heavily on third-party manufacturers and researchers, creating significant operational and supply chain risks - The company is subject to multiple manufacturing risks and **relies on contract manufacturing organizations (CMOs)** for large-scale production, which it has not yet secured[260](index=260&type=chunk)[262](index=262&type=chunk) - The company **relies on third-party CROs and study sites** to conduct its clinical trials, reducing its direct control over their performance[273](index=273&type=chunk) [Intellectual Property Risks](index=35&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The business relies on licensed intellectual property from USC and faces uncertainty in protecting its patent portfolio - The company's commercial success depends on its ability to **obtain, maintain, and protect its intellectual property rights**, which is highly uncertain[314](index=314&type=chunk) - The company **licenses critical intellectual property from USC** and could lose these rights if it fails to comply with its obligations under the agreement[319](index=319&type=chunk)[342](index=342&type=chunk) [General and Public Company Risks](index=37&type=section&id=General%20Risk%20Factors) Risks include ongoing legal disputes, public company costs, identified material weaknesses, and concentrated ownership - The company is involved in **disputes with former licensees** and is in default on one settlement agreement, which could result in further legal costs[438](index=438&type=chunk)[439](index=439&type=chunk) - As a new public company, it will incur **significantly increased legal and compliance costs**, and its management has limited experience in this environment[387](index=387&type=chunk)[440](index=440&type=chunk) - **Material weaknesses in internal control** have been identified, which could result in a material misstatement of financial statements if not remediated[446](index=446&type=chunk)[447](index=447&type=chunk)[448](index=448&type=chunk) [Unregistered Sales of Equity Securities](index=101&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities) In Q1 2025, the company issued approximately $11.64 million in unregistered common stock through private placements - In March 2025, the company issued a total of 727,750 shares of common stock in private placements, raising **gross proceeds of approximately $11.64 million**[459](index=459&type=chunk)[460](index=460&type=chunk) - In March 2025, **30,000 shares of common stock were issued** to Dawson James Securities, Inc. for advisory services[459](index=459&type=chunk) - In February 2025, **150,000 restricted stock units** were granted to three board members[458](index=458&type=chunk)