Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in the biotech sector and has compiled detailed reports on more than 1,000 companies [1]

Core Insights - IBRX's MSCI ESG rating has been downgraded from BBB to B as of August 26, 2025 [1] Summary by Category - **Company Rating Change** - IBRX's MSCI ESG rating was downgraded from BBB to B [1]

Core Insights - ImmunityBio reported a significant increase in revenue for Q2 2025, reaching $26.4 million, surpassing analyst expectations of $23.15 million, driven by strong sales of its immunotherapy product ANKTIVA [1][2] - The company narrowed its net loss per share to ($0.10), an improvement from the projected ($0.11) and a substantial reduction from ($0.20) a year prior, indicating better financial performance [1][2] Financial Performance - Revenue for Q2 2025 increased by 2,540% year-over-year from $1.0 million in Q2 2024 [2] - The GAAP revenue saw a 60% increase compared to Q1 2025, primarily due to rising sales of ANKTIVA for bladder cancer [5] - ANKTIVA unit sales surged 246% in the first half of 2025 compared to the second half of 2024, following the assignment of a J-code for easier reimbursement [5] - Research and Development expenses were reported at $52.4 million, reflecting the company's commitment to pipeline development [2] Business Focus and Strategy - ImmunityBio is focused on ramping up commercial sales of ANKTIVA for bladder cancer and expanding into global markets while investing in a diverse pipeline [4] - The company is pursuing regulatory approvals and maintaining robust sales growth for ANKTIVA, alongside advancing other product candidates into late-stage trials [4] - Recent regulatory developments include approval from the UK MHRA for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer, while facing challenges from the FDA regarding a supplemental application [6] Pipeline Development - ImmunityBio launched a pivotal randomized trial for non-small cell lung cancer (NSCLC) combining its proprietary N-803 with BeOne Medicines' tislelizumab [7] - The company is expanding clinical trials into Europe and Asia and has received FDA support for its lymphopenia program [7] - Strategic collaborations with BeOne Medicines and the Serum Institute of India are enhancing manufacturing capabilities for bladder cancer therapies [8] Future Outlook - Management did not provide explicit guidance for the next quarter or fiscal 2025 but emphasized priorities around expanding ANKTIVA's market reach and advancing regulatory filings [9] - The company raised $80 million in equity in July 2025, which may extend its cash runway amid ongoing cash burn and fundraising needs [9][10]

Core Insights - ImmunityBio reported a quarterly loss of $0.1 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.2 per share a year ago [1] - The company achieved revenues of $26.43 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 0.10%, and significantly up from $1.05 million year-over-year [2] - ImmunityBio shares have declined approximately 5.9% year-to-date, contrasting with the S&P 500's gain of 7.6% [3] Earnings Outlook - The earnings outlook for ImmunityBio is mixed, with the current consensus EPS estimate at -$0.10 on revenues of $27.17 million for the upcoming quarter, and -$0.45 on revenues of $96.77 million for the current fiscal year [7] - The company's Zacks Rank is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which ImmunityBio belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, suggesting potential challenges ahead [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact ImmunityBio's stock performance [5]

Product Approval and Commercialization - ANKTIVA has been approved by the U.S. FDA and the MHRA for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors[317]. - ANKTIVA began commercial distribution in May 2024, with marketing authorization granted in the UK in July 2025[322][323]. - The UK’s MHRA approved the marketing authorization application of ANKTIVA in combination with BCG for treating BCG-unresponsive NMIBC with CIS[333]. - The company has begun generating revenue from its approved product ANKTIVA since May 2024, but significant revenue generation is expected to take time[404]. Financial Performance - Q2 2025 revenue reached $26.4 million, a 60% increase from Q1 2025, with year-to-date sales totaling $42.9 million[333]. - Product revenue, net increased by $25.4 million to $26.4 million for the three months ended June 30, 2025, representing a 2569% increase compared to the same period in 2024[364]. - Total revenue for the three months ended June 30, 2025, was $26.4 million, up from $1.0 million in 2024, marking a 2424% increase[363]. - Product revenue, net increased by $41.9 million to $42.93 million for the six months ended June 30, 2025, representing a 4236% increase compared to the same period in 2024[374]. - Total revenue reached $42.94 million, a significant increase of $41.86 million or 3851% from $1.09 million in the prior year[373]. Research and Development - The company is exploring ANKTIVA's potential in multiple oncology indications, including lung, colorectal, prostate, and ovarian cancers, as well as GBM and NHL[324]. - Data from clinical trials suggest ANKTIVA may enhance the activity of therapeutic mAbs, including CPIs like pembrolizumab, across various tumor types[325]. - The company is developing next-generation therapies, including cytokine fusion proteins, DNA and vaccine vectors, and cell therapies[326]. - The company expects research and development expenses to increase significantly in the foreseeable future due to ongoing clinical trials and product development[368]. - The company has incurred significant expenses related to ongoing clinical trials and operations, with expectations of continued high operating expenses[336]. Financial Position and Cash Flow - As of June 30, 2025, the company had a cash position of $153.7 million, with an additional $80 million equity financing closed in July 2025[333]. - The company reported an accumulated deficit of $3.6 billion as of June 30, 2025, with net losses of $222.2 million and $268.7 million for the six months ended June 30, 2025, and 2024, respectively[337]. - The company has $565.6 million available for use under its $750 million shelf registration statement filed in 2023[384]. - For the six months ended June 30, 2025, net cash used in operating activities was $165.7 million, consisting of a net loss of $222.2 million and $27.7 million of cash used in net working capital[395]. - The company reported a net change in cash and cash equivalents of $(5.8) million for the six months ended June 30, 2025[394]. Strategic Initiatives and Collaborations - The company aims to implement an integrated discovery ecosystem to regularly add neoepitopes and formulate new product candidates[311]. - The company has entered into strategic collaborations to leverage partners' expertise and expand market access for its approved products[339]. - The company is seeking to expand the BCG-unresponsive NMIBC guidelines to include papillary-only disease, with a review expected in August 2025[334]. - The company is evaluating its go-to-market strategy for the UK in light of the U.S. Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025[420]. Operational Commitments and Obligations - The company committed to spend an aggregate of $1.52 billion on operational expenses for the Dunkirk Facility during the initial 10-year term, with an additional $1.50 billion if the lease is renewed[422]. - The maximum amount payable related to contractual commitments for development, regulatory, and commercial milestones is $88.2 million as of June 30, 2025[422]. - The company has material cash requirements to pay related-party affiliates and third parties under various contractual obligations[412]. - The company is obligated to make payments to Oberland associated with revenue interest liability, which do not have a fixed repayment schedule[414]. Future Outlook and Funding Needs - The company anticipates substantial additional funding will be required to support ongoing operations and commercialization efforts[405]. - The company may need to raise additional funds through public or private equity offerings, debt financings, or strategic partnerships to meet future cash needs[409]. - The company expects to incur approximately $304.0 million in contingent consideration to prior Altor stockholders if worldwide net sales of ANKTIVA exceed $1.0 billion before December 31, 2026[392].

[Preamble](index=1&type=section&id=Preamble) This section introduces the Securities Purchase Agreement, outlining the terms for ImmunityBio, Inc. to issue and sell securities [Securities Purchase Agreement Overview](index=1&type=section&id=Securities%20Purchase%20Agreement%20Overview) This agreement, dated July 24, 2025, details the terms for ImmunityBio, Inc. to issue and sell securities to purchasers under an effective registration statement - The agreement is dated **July 24, 2025**, between ImmunityBio, Inc. and various purchasers[2](index=2&type=chunk) - The Company will issue and sell securities to each Purchaser under the agreement and an effective registration statement[3](index=3&type=chunk) [ARTICLE I. DEFINITIONS](index=1&type=section&id=ARTICLE%20I.%20DEFINITIONS) This article provides a comprehensive list of defined terms essential for the consistent interpretation of the Securities Purchase Agreement [1.1 Definitions](index=1&type=section&id=1.1%20Definitions) This section defines key terms for consistent interpretation of the Securities Purchase Agreement, covering parties, securities, regulatory bodies, and financial instruments - This section defines crucial terms like 'Company', 'Purchaser', 'Securities', 'Common Stock', 'Warrants', 'Closing Date', and 'Commission' (SEC)[5](index=5&type=chunk)[10](index=10&type=chunk)[32](index=32&type=chunk) Key Defined Terms | Term | Definition | | :--- | :--- | | **Company** | ImmunityBio, Inc., a Delaware corporation | | **Purchaser** | Each purchaser identified on the signature pages | | **Closing Date** | Trading Day on which all Transaction Documents are executed and conditions met, no later than July 28, 2025 | | **Common Stock** | Common stock of the Company, par value $0.0001 per share | | **Per Share Purchase Price** | $2.70 (subject to adjustment) | | **Securities** | Collectively, the Shares, the Warrants and the Warrant Shares | | **Warrants** | Common Stock purchase warrants, immediately exercisable, 5-year term | | **Placement Agent** | Piper Sandler & Co. | [ARTICLE II. PURCHASE AND SALE](index=4&type=section&id=ARTICLE%20II.%20PURCHASE%20AND%20SALE) This article details the procedures and conditions for the purchase and sale of securities, including closing, deliveries, and specific requirements [2.1 Closing](index=4&type=section&id=2.1%20Closing) This section outlines the closing procedures for the purchase and sale of securities, including the aggregate amount, settlement method, and remote execution - The Company agrees to sell, and Purchasers agree to buy, up to an aggregate of **$80,000,006.40** of Shares and Warrants[42](index=42&type=chunk) - The Closing Date is the Trading Day when all Transaction Documents are executed and conditions met, but no later than **July 28, 2025**[10](index=10&type=chunk) - The closing will take place remotely by electronic transfer of documentation, with the Company issuing shares registered in Purchasers' names[42](index=42&type=chunk) [2.2 Deliveries](index=4&type=section&id=2.2%20Deliveries) This section specifies the documents and items the Company and each Purchaser must deliver on or prior to the Closing Date - The Company must deliver the executed Agreement, wire instructions, irrevocable instructions to the Transfer Agent for share delivery, a Warrant, and the Base Prospectus and Prospectus[43](index=43&type=chunk) - Each Purchaser must deliver the duly executed Agreement and their Subscription Amount[44](index=44&type=chunk) Company Deliverables to Purchasers | Item | Description | | :--- | :--- | | **Agreement** | Duly executed by the Company | | **Wire Instructions** | On Company letterhead, executed by an officer | | **Transfer Agent Instructions** | Irrevocable instructions for expedited share delivery | | **Warrant** | Registered in Purchaser's name, 100% of Shares, exercise price $3.24 | | **Prospectus** | Base Prospectus and Prospectus (may be delivered per Rule 172) | [2.3 Closing Conditions](index=4&type=section&id=2.3%20Closing%20Conditions) This section details the conditions required for both the Company's and the Purchasers' obligations to close the transaction - Company's obligations are subject to the accuracy of Purchaser representations, performance of Purchaser covenants, and delivery of items per Section 2.2(b)[45](index=45&type=chunk)[46](index=46&type=chunk) - Purchasers' obligations are subject to the accuracy of Company representations, performance of Company covenants, delivery of items per Section 2.2(a), and no suspension of trading in Common Stock or general securities markets, or a Material Adverse Change[47](index=47&type=chunk) [ARTICLE III. REPRESENTATIONS AND WARRANTIES](index=5&type=section&id=ARTICLE%20III.%20REPRESENTATIONS%20AND%20WARRANTIES) This article contains extensive representations and warranties from both the Company and the Purchasers regarding their status, compliance, and the transaction [3.1 Representations and Warranties of the Company](index=5&type=section&id=3.1%20Representations%20and%20Warranties%20of%20the%20Company) The Company provides extensive representations and warranties covering its business, financial condition, legal compliance, and the nature of the securities offered - The Company warrants that its Disclosure Package, Registration Statement, and Prospectus do not contain any untrue statements of material fact or omit material facts, except for information provided by the Placement Agent[49](index=49&type=chunk)[53](index=53&type=chunk) - The Company confirms its proper organization, authorization to enter into the transaction, and that the transaction will not conflict with its organizational documents or applicable laws[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) - The Company represents that the Shares and Warrant Shares are duly authorized, validly issued, fully paid, nonassessable, and free of Liens imposed by the Company, and that it has reserved sufficient Common Stock for their issuance[59](index=59&type=chunk)[121](index=121&type=chunk) [3.1(a) Disclosure Package](index=5&type=section&id=3.1%28a%29%20Disclosure%20Package) The Company represents that the Disclosure Package, at both execution and closing, contains no material misstatements or omissions, excluding Placement Agent information - The Disclosure Package is represented to be free of material misstatements or omissions, both at execution and closing, excluding Placement Agent-provided information[49](index=49&type=chunk) [3.1(b) Issuer Free Writing Prospectuses](index=5&type=section&id=3.1%28b%29%20Issuer%20Free%20Writing%20Prospectuses) The Company affirms that any Issuer Free Writing Prospectuses comply with the Securities Act, are filed as required, and are free of material misstatements or omissions - Issuer Free Writing Prospectuses comply with the Securities Act, are filed as required, and are free of material misstatements, except for Placement Agent Information[50](index=50&type=chunk)[52](index=52&type=chunk) [3.1(c) Registration Statement and Prospectus](index=6&type=section&id=3.1%28c%29%20Registration%20Statement%20and%20Prospectus) The Company confirms its eligibility to use Form S-3, the effectiveness of its Registration Statement, and its material compliance with the Securities Act - The Company meets Form S-3 requirements, the Registration Statement is effective, and no stop order has been issued or threatened by the SEC[53](index=53&type=chunk) - The Registration Statement and Prospectus are materially compliant with the Securities Act and do not contain material misstatements or omissions, excluding Placement Agent Information[53](index=53&type=chunk) [3.1(d) Incorporated Documents](index=6&type=section&id=3.1%28d%29%20Incorporated%20Documents) The Company represents that documents incorporated by reference conformed to Exchange Act requirements and were free of material misstatements when filed - Incorporated documents conformed to Exchange Act requirements and were free of material misstatements when filed[54](index=54&type=chunk) [3.1(e) Organization and Qualification](index=6&type=section&id=3.1%28e%29%20Organization%20and%20Qualification) The Company and its Subsidiaries are duly organized, validly existing, and in good standing, with necessary authority to conduct business in required jurisdictions - The Company and its Subsidiaries are duly organized, validly existing, and in good standing, with authority to conduct business[55](index=55&type=chunk) [3.1(f) Authorization; Enforcement](index=6&type=section&id=3.1%28f%29%20Authorization%3B%20Enforcement) The Company has the corporate power and authority to execute and consummate the transactions, and the Transaction Documents are valid and binding obligations - The Company has the corporate power and authority, and has duly authorized, the execution and consummation of the transactions[56](index=56&type=chunk) - The Transaction Documents are valid and binding obligations, enforceable against the Company, subject to standard legal limitations[56](index=56&type=chunk) [3.1(g) No Conflicts](index=7&type=section&id=3.1%28g%29%20No%20Conflicts) The Company represents that the transaction will not conflict with its organizational documents, result in defaults, or violate laws, unless without Material Adverse Change - The transaction will not conflict with organizational documents, create Liens, or violate laws, unless such effects would not result in a Material Adverse Change[57](index=57&type=chunk) [3.1(h) Filings, Consents and Approvals](index=7&type=section&id=3.1%28h%29%20Filings%2C%20Consents%20and%20Approvals) The Company states that no governmental or third-party consents are required for the transaction, other than specific SEC filings, listing notices, and state securities law filings - Required approvals include SEC filings (Prospectus), Trading Market listing notices, state securities law filings, and other consents obtained before closing[58](index=58&type=chunk) [3.1(i) Issuance of the Securities; Registration](index=7&type=section&id=3.1%28i%29%20Issuance%20of%20the%20Securities%3B%20Registration) The Company represents that the Shares and Warrant Shares are duly authorized, validly issued, fully paid, nonassessable, and free of Company-imposed Liens - Shares and Warrant Shares are duly authorized, validly issued, fully paid, nonassessable, and free of Company-imposed Liens[59](index=59&type=chunk) - The Company has reserved the maximum number of Common Stock shares for this agreement and Warrants[59](index=59&type=chunk) - The Registration Statement is effective, complies with the Securities Act, and the Company is eligible to use Form S-3[59](index=59&type=chunk) [3.1(j) Ineligible Issuer Status](index=8&type=section&id=3.1%28j%29%20Ineligible%20Issuer%20Status) The Company confirms it is not an 'ineligible issuer' as defined by SEC rules in connection with the offering of the Securities - The Company is not an 'ineligible issuer' under SEC Rules 164, 405, and 433 for this offering[60](index=60&type=chunk) [3.1(k) Statistical and Market-Related Data](index=8&type=section&id=3.1%28k%29%20Statistical%20and%20Market-Related%20Data) The Company asserts that all statistical and market-related data in its disclosure documents is based on reliable and accurate sources - Statistical and market data in disclosure documents are based on reliable and accurate sources[61](index=61&type=chunk) [3.1(l) Disclosure Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting](index=8&type=section&id=3.1%28l%29%20Disclosure%20Controls%20and%20Procedures%3B%20Deficiencies%20in%20or%20Changes%20to%20Internal%20Control%20Over%20Financial%20Reporting) The Company maintains effective disclosure controls and internal control over financial reporting, with no significant deficiencies or material changes since the last audited fiscal year - The Company maintains effective disclosure controls and internal control over financial reporting, compliant with Exchange Act and GAAP[62](index=62&type=chunk) - No significant deficiencies, material weaknesses, or material changes in internal control over financial reporting since the last audited fiscal year[62](index=62&type=chunk) [3.1(m) No Applicable Registration or Other Similar Rights](index=8&type=section&id=3.1%28m%29%20No%20Applicable%20Registration%20or%20Other%20Similar%20Rights) The Company confirms no persons hold registration or similar rights for other securities in this offering, except for duly waived rights - No outstanding registration or similar rights exist for other securities in this offering, except for duly waived rights[63](index=63&type=chunk) [3.1(n) No Material Adverse Change](index=8&type=section&id=3.1%28n%29%20No%20Material%20Adverse%20Change) Since the last reported dates, there has been no Material Adverse Change in the Company's condition, earnings, business, or ability to consummate the transactions - No Material Adverse Change in the Company's condition, earnings, business, or ability to consummate transactions since the last reported dates[64](index=64&type=chunk) - No material liabilities incurred outside the ordinary course of business, nor material changes in capital stock or indebtedness[64](index=64&type=chunk) [3.1(o) Independent Accountants](index=8&type=section&id=3.1%28o%29%20Independent%20Accountants) Ernst & Young LLP and Deloitte & Touche LLP are confirmed as independent registered public accounting firms, compliant with SEC and PCAOB requirements - Ernst & Young LLP and Deloitte & Touche LLP are independent registered public accounting firms, compliant with SEC and PCAOB rules[65](index=65&type=chunk) [3.1(p) Financial Statements](index=9&type=section&id=3.1%28p%29%20Financial%20Statements) The financial statements and interactive data in disclosure documents fairly present the Company's financial position and results in conformity with GAAP and SEC rules - Financial statements fairly present the Company's consolidated financial position and results, prepared in conformity with GAAP[66](index=66&type=chunk) - Interactive data in XBRL is fairly presented and prepared in accordance with SEC rules[66](index=66&type=chunk) [3.1(q) Company's Accounting System](index=9&type=section&id=3.1%28q%29%20Company%27s%20Accounting%20System) The Company maintains adequate books, records, and internal accounting controls for proper financial reporting and asset accountability, with XBRL data prepared per SEC rules - The Company maintains adequate books, records, and internal accounting controls for proper financial reporting and asset accountability[67](index=67&type=chunk) - XBRL data is prepared in material respects according to SEC rules and guidelines[67](index=67&type=chunk) [3.1(r) Capitalization and Other Capital Stock Matters](index=9&type=section&id=3.1%28r%29%20Capitalization%20and%20Other%20Capital%20Stock%20Matters) The Company's capitalization is as disclosed, with all issued Common Stock duly authorized, validly issued, fully paid, and nonassessable - Company's capitalization is as disclosed, and all issued Common Stock is duly authorized, validly issued, fully paid, and nonassessable[68](index=68&type=chunk) - No outstanding options, warrants, or other rights to purchase capital stock exist beyond those disclosed or duly waived[68](index=68&type=chunk) - All subsidiary equity is owned by the Company, free of security interests[68](index=68&type=chunk) [3.1(s) Stock Exchange Listing](index=9&type=section&id=3.1%28s%29%20Stock%20Exchange%20Listing) The Common Stock is registered under the Exchange Act and listed on the Nasdaq Global Select Market, with the Company in material compliance with listing requirements - Common Stock is registered under the Exchange Act and listed on Nasdaq Global Select Market[69](index=69&type=chunk) - The Company is in material compliance with Nasdaq listing requirements and has not initiated or been notified of delisting actions[69](index=69&type=chunk) [3.1(t) Non-Contravention of Existing Instruments](index=10&type=section&id=3.1%28t%29%20Non-Contravention%20of%20Existing%20Instruments) Neither the Company nor its Subsidiaries are in violation of organizational documents, laws, or agreements, unless such violations would not lead to a Material Adverse Change - Neither the Company nor its Subsidiaries are in violation of organizational documents, laws, or agreements, unless such violations would not lead to a Material Adverse Change[70](index=70&type=chunk) [3.1(u) No Further Authorizations or Approvals Required](index=10&type=section&id=3.1%28u%29%20No%20Further%20Authorizations%20or%20Approvals%20Required) The Company's execution and performance of the transaction will not conflict with existing agreements, organizational documents, or laws, unless without Material Adverse Change - The transaction will not conflict with existing agreements, organizational documents, or laws, unless such conflicts would not result in a Material Adverse Change[71](index=71&type=chunk) [3.1(v) No Material Actions or Proceedings](index=10&type=section&id=3.1%28v%29%20No%20Material%20Actions%20or%20Proceedings) No undisclosed material legal or governmental proceedings are pending or threatened against the Company, its Subsidiaries, or their officers/directors - No undisclosed material legal or governmental proceedings are pending or threatened against the Company or its Subsidiaries[72](index=72&type=chunk) [3.1(w) Intellectual Property Rights](index=10&type=section&id=3.1%28w%29%20Intellectual%20Property%20Rights) The Company and its Subsidiaries own or license adequate Intellectual Property Rights, do not materially infringe on third-party IPR, and maintain confidentiality - The Company and Subsidiaries own or license adequate Intellectual Property Rights for their business[73](index=73&type=chunk) - No material infringement of third-party IPR, and no undisclosed third-party rights or claims against the Company's IPR[73](index=73&type=chunk) - Reasonable steps taken to maintain confidentiality of IPR, and relevant personnel have signed invention assignment agreements[74](index=74&type=chunk) [3.1(x) All Necessary Permits, etc.](index=11&type=section&id=3.1%28x%29%20All%20Necessary%20Permits%2C%20etc.) The Company and its Subsidiaries possess all valid and current permits required by regulatory agencies to conduct their businesses and are in compliance - The Company and Subsidiaries hold all necessary permits for their operations and are in compliance with them[75](index=75&type=chunk) [3.1(y) Title to Properties](index=11&type=section&id=3.1%28y%29%20Title%20to%20Properties) The Company and its Subsidiaries have good and marketable title to owned properties, free of material Liens, and hold leased properties under valid leases - The Company and Subsidiaries have good and marketable title to owned properties, free of material Liens[76](index=76&type=chunk) - Leased properties are held under valid and enforceable leases[76](index=76&type=chunk) [3.1(z) Tax Law Compliance](index=11&type=section&id=3.1%28z%29%20Tax%20Law%20Compliance) The Company and its Subsidiaries have filed all required tax returns and paid taxes, or requested extensions, without material adverse impact - The Company and Subsidiaries have filed all required tax returns and paid taxes, or requested extensions, without material adverse impact[77](index=77&type=chunk) - No material unpaid tax liabilities or adverse tax deficiencies are known[77](index=77&type=chunk) [3.1(aa) Company Not an "Investment Company."](index=11&type=section&id=3.1%28aa%29%20Company%20Not%20an%20%22Investment%20Company.%22) The Company represents that it is not, and will not become, an 'investment company' requiring registration under the Investment Company Act of 1940 - The Company is not and will not be required to register as an 'investment company' under the Investment Company Act of 1940[78](index=78&type=chunk) [3.1(bb) Insurance](index=11&type=section&id=3.1%28bb%29%20Insurance) The Company and its Subsidiaries maintain adequate and customary insurance policies and expect to renew coverage without a Material Adverse Change - The Company and Subsidiaries maintain adequate and customary insurance coverage from reputable institutions[78](index=78&type=chunk) - No reason to believe existing insurance cannot be renewed or comparable coverage obtained without a Material Adverse Change[78](index=78&type=chunk) [3.1(cc) Related Party Transactions](index=12&type=section&id=3.1%28cc%29%20Related%20Party%20Transactions) The Company confirms that all required related-party transactions are accurately described in the Registration Statement, Disclosure Package, and Prospectus - All required related-party transactions are accurately described in the disclosure documents[79](index=79&type=chunk) [3.1(dd) FINRA Matters](index=12&type=section&id=3.1%28dd%29%20FINRA%20Matters) The Company represents that information provided to the Placement Agent is FINRA-compliant and meets Form S-3 requirements under FINRA Rule 5110(h)(1)(C) - Information provided to Placement Agent is true, complete, correct, and FINRA-compliant[80](index=80&type=chunk) - The Company meets Form S-3 requirements under FINRA Rule 5110(h)(1)(C)[80](index=80&type=chunk) [3.1(ee) No Unlawful Contributions or Other Payments](index=12&type=section&id=3.1%28ee%29%20No%20Unlawful%20Contributions%20or%20Other%20Payments) The Company, its Subsidiaries, and their agents have not made any unlawful contributions or payments requiring disclosure - No unlawful contributions or payments made by the Company, Subsidiaries, or their agents[81](index=81&type=chunk) [3.1(ff) Compliance with Environmental Laws](index=12&type=section&id=3.1%28ff%29%20Compliance%20with%20Environmental%20Laws) The Company and its Subsidiaries comply with Environmental Laws, hold necessary permits, and have no material associated costs or liabilities - The Company and Subsidiaries comply with Environmental Laws and hold necessary permits, without material noncompliance or liabilities[82](index=82&type=chunk) [3.1(gg) ERISA Compliance](index=12&type=section&id=3.1%28gg%29%20ERISA%20Compliance) Each employee benefit plan sponsored by the Company or its Controlled Group is maintained in material compliance with its terms, ERISA, and the Code - Employee benefit plans are maintained in material compliance with ERISA and the Code[83](index=83&type=chunk) [3.1(hh) Brokers](index=12&type=section&id=3.1%28hh%29%20Brokers) Except for the Placement Agency Agreement, the Company is not party to any agreement giving rise to brokerage commissions or finder's fees for this offering - No brokerage commissions or finder's fees are due, other than those under the Placement Agency Agreement[84](index=84&type=chunk) [3.1(ii) No Outstanding Loans or Other Extensions of Credit](index=12&type=section&id=3.1%28ii%29%20No%20Outstanding%20Loans%20or%20Other%20Extensions%20of%20Credit) The Company has no outstanding personal loans or other extensions of credit to its directors or executive officers, except as permitted by the Exchange Act - No outstanding personal loans to directors or executive officers, except as permitted by Exchange Act Section 13(k)[85](index=85&type=chunk) [3.1(jj) Compliance with Laws](index=12&type=section&id=3.1%28jj%29%20Compliance%20with%20Laws) The Company and its Subsidiaries comply with all applicable laws, rules, and regulations, without material adverse impact - The Company and Subsidiaries comply with all applicable laws, rules, and regulations, without material adverse impact[86](index=86&type=chunk) [3.1(kk) Dividend Restrictions](index=13&type=section&id=3.1%28kk%29%20Dividend%20Restrictions) No undisclosed restrictions exist on subsidiary dividends, distributions, loan repayments, or asset transfers to the Company or other subsidiaries - No undisclosed restrictions on subsidiary dividends, distributions, loan repayments, or asset transfers to the Company[87](index=87&type=chunk) [3.1(ll) Anti-Corruption and Anti-Bribery Laws](index=13&type=section&id=3.1%28ll%29%20Anti-Corruption%20and%20Anti-Bribery%20Laws) Neither the Company, its Subsidiaries, nor associated persons have violated anti-bribery or anti-corruption laws, including the FCPA, and policies ensure compliance - No violations of anti-bribery or anti-corruption laws, including FCPA, by the Company, Subsidiaries, or associated persons[88](index=88&type=chunk) - The Company maintains policies and procedures to ensure FCPA compliance[88](index=88&type=chunk) [3.1(mm) Money Laundering Laws](index=13&type=section&id=3.1%28mm%29%20Money%20Laundering%20Laws) The Company and its Subsidiaries' operations comply with applicable anti-money laundering laws, with no related pending or threatened actions - Operations comply with applicable anti-money laundering laws, and no related actions are pending or threatened[89](index=89&type=chunk) [3.1(nn) Regulatory Matters](index=13&type=section&id=3.1%28nn%29%20Regulatory%20Matters) The Company and its Subsidiaries hold all necessary regulatory Authorizations for their business, which are valid, with no material violations or revocation notices - The Company and Subsidiaries hold all necessary regulatory Authorizations (e.g., from FDA, EMA) for their business[90](index=90&type=chunk) - Authorizations are valid, and no material violations or revocation notices have been received[90](index=90&type=chunk) [3.1(oo) Health Care Laws](index=13&type=section&id=3.1%28oo%29%20Health%20Care%20Laws) The Company and its Subsidiaries comply with all applicable healthcare laws, including FDA regulations, anti-kickback statutes, and HIPAA, without material noncompliance - The Company and Subsidiaries comply with all applicable healthcare laws, including FDA regulations, anti-kickback statutes, and HIPAA, without material noncompliance[91](index=91&type=chunk)[92](index=92&type=chunk) - No FDA Form 483s, warning letters, or notices of material noncompliance received[92](index=92&type=chunk) - All material reports and filings with regulatory authorities were complete and accurate[92](index=92&type=chunk) [3.1(pp) Clinical Trials](index=14&type=section&id=3.1%28pp%29%20Clinical%20Trials) Preclinical studies and clinical trials comply with protocols and Applicable Laws, with accurate results and no undisclosed issues or termination notices - Preclinical studies and clinical trials comply with protocols and Applicable Laws[93](index=93&type=chunk) - Descriptions of study results are accurate and complete in all material respects[93](index=93&type=chunk) - No notices received for termination or modification of trials, and no undisclosed data questions reported results[93](index=93&type=chunk) [3.1(qq) Certain FDA Matters](index=14&type=section&id=3.1%28qq%29%20Certain%20FDA%20Matters) Neither the Company, its Subsidiaries, nor key personnel are excluded, suspended, or debarred from Federal Health Care Programs or by the FDA - No exclusion, suspension, or debarment from Federal Health Care Programs or by FDA for the Company, Subsidiaries, or their key personnel[94](index=94&type=chunk) [3.1(rr) Manufacturing](index=14&type=section&id=3.1%28rr%29%20Manufacturing) The Company's manufacturing facilities and operations, and those of its suppliers, comply materially with all Applicable Laws - Manufacturing facilities and operations, including suppliers, comply materially with Applicable Laws[95](index=95&type=chunk) [3.1(ss) Sanctions](index=14&type=section&id=3.1%28ss%29%20Sanctions) Neither the Company, its Subsidiaries, nor associated persons are subject to Sanctions, and proceeds will not be used in violation of Sanctions - Neither the Company, Subsidiaries, nor associated persons are subject to or target of Sanctions[96](index=96&type=chunk)[97](index=97&type=chunk) - Proceeds will not be used to fund activities in sanctioned countries or in violation of Sanctions[97](index=97&type=chunk) - No knowing dealings with sanctioned persons or countries in the past five years[97](index=97&type=chunk) [3.1(tt) Sarbanes-Oxley](index=15&type=section&id=3.1%28tt%29%20Sarbanes-Oxley) The Company is in material compliance with all applicable provisions of the Sarbanes-Oxley Act of 2002 and its promulgated rules and regulations - The Company is in material compliance with the Sarbanes-Oxley Act of 2002[98](index=98&type=chunk) [3.1(uu) Duties, Transfer Taxes, Etc.](index=15&type=section&id=3.1%28uu%29%20Duties%2C%20Transfer%20Taxes%2C%20Etc.) No stamp, issuance, transfer, capital gains, income, withholding, or other taxes are payable by the Placement Agent in the U.S. for this transaction - No stamp, issuance, transfer, capital gains, income, withholding, or other taxes are payable by the Placement Agent in the U.S. for this transaction[99](index=99&type=chunk) [3.1(vv) Cybersecurity](index=15&type=section&id=3.1%28vv%29%20Cybersecurity) No material security breach or compromise of IT Systems and Data has occurred, and backup and disaster recovery technology are industry-standard - No material security breach or compromise of IT Systems and Data, and no notification of such events[100](index=100&type=chunk) - Backup and disaster recovery technology are consistent with industry standards[100](index=100&type=chunk) [3.1(ww) Compliance with Data Privacy Laws](index=15&type=section&id=3.1%28ww%29%20Compliance%20with%20Data%20Privacy%20Laws) The Company and its Subsidiaries materially comply with Privacy Laws (HIPAA, GDPR), have implemented data privacy policies, and have received no related notices of liability - The Company and Subsidiaries are in material compliance with Privacy Laws (HIPAA, GDPR)[101](index=101&type=chunk) - Policies and procedures for data privacy and security are in place and complied with[101](index=101&type=chunk) - No notices of liability, violations, or investigations related to Privacy Laws[101](index=101&type=chunk) [3.1(xx) Disclosure](index=15&type=section&id=3.1%28xx%29%20Disclosure) The Company affirms that summaries of Common Stock and Warrants terms, and descriptions of laws/documents in disclosure materials, are accurate, complete, and fair - Summaries of Common Stock and Warrants terms, and descriptions of laws/documents in disclosure materials, are accurate, complete, and fair[102](index=102&type=chunk) [3.2 Representations and Warranties of the Purchasers](index=16&type=section&id=3.2%20Representations%20and%20Warranties%20of%20the%20Purchasers) Each Purchaser makes specific representations regarding their organizational status, authority, accredited investor status, investment experience, and confidentiality - Each Purchaser is an entity or individual duly organized/formed, with full authority to enter and consummate the transactions[103](index=103&type=chunk) - Each Purchaser is an 'accredited investor' as defined in Rule 501(a) under the Securities Act[105](index=105&type=chunk) - Purchasers are acquiring Securities as principal for their own account, have evaluated investment risks, and have had access to Company information[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [3.2(a) Organization; Authority](index=16&type=section&id=3.2%28a%29%20Organization%3B%20Authority) Each Purchaser is duly organized and authorized to enter into and consummate the transactions, which constitute valid and binding obligations - Each Purchaser is duly organized and authorized to enter into and consummate the transactions[103](index=103&type=chunk) - Transaction Documents are valid and binding obligations of each Purchaser, subject to standard legal limitations[103](index=103&type=chunk) [3.2(b) Understandings or Arrangements](index=16&type=section&id=3.2%28b%29%20Understandings%20or%20Arrangements) Each Purchaser represents that it is acquiring the Securities as principal for its own account, without distribution arrangements, and in the ordinary course of business - Purchaser is acquiring Securities as principal for its own account, without distribution arrangements, and in the ordinary course of business[104](index=104&type=chunk) [3.2(c) Purchaser Status](index=16&type=section&id=3.2%28c%29%20Purchaser%20Status) Each Purchaser confirms its status as an 'accredited investor' under Rule 501(a) of the Securities Act at all relevant times - Each Purchaser is and will remain an 'accredited investor' under Rule 501(a) of the Securities Act[105](index=105&type=chunk) [3.2(d) Experience of Such Purchaser](index=16&type=section&id=3.2%28d%29%20Experience%20of%20Such%20Purchaser) Each Purchaser possesses sufficient knowledge and experience to evaluate investment risks and can bear the economic risk, including complete loss - Purchaser has sufficient knowledge and experience to evaluate investment risks and can bear the economic risk, including complete loss[106](index=106&type=chunk) [3.2(e) Access to Information](index=16&type=section&id=3.2%28e%29%20Access%20to%20Information) Each Purchaser reviewed transaction documents and public filings, had access to Company information, and acknowledges the Placement Agent's role - Purchaser reviewed Transaction Documents and public filings, and had access to Company information for informed decision-making[107](index=107&type=chunk) - Placement Agent has not provided investment advice, and may have non-public information not shared with Purchaser[107](index=107&type=chunk) [3.2(f) Certain Transactions and Confidentiality](index=16&type=section&id=3.2%28f%29%20Certain%20Transactions%20and%20Confidentiality) Each Purchaser has not engaged in certain Company securities transactions from term sheet receipt until agreement execution and has maintained confidentiality - Purchaser has not engaged in purchases or Short Sales of Company securities from term sheet receipt until agreement execution[108](index=108&type=chunk) - Purchaser has maintained confidentiality of transaction disclosures[109](index=109&type=chunk) [ARTICLE IV. OTHER AGREEMENTS OF THE PARTIES](index=17&type=section&id=ARTICLE%20IV.%20OTHER%20AGREEMENTS%20OF%20THE%20PARTIES) This article outlines additional covenants and agreements between the Company and Purchasers, covering share issuance, information, and market conduct [4.1 Shares and Warrant Shares](index=17&type=section&id=4.1%20Shares%20and%20Warrant%20Shares) Shares will be issued free of legends, and Warrant Shares will also be legend-free if exercised under an effective registration statement or via cashless exercise - Shares will be issued free of legends[112](index=112&type=chunk) - Warrant Shares will be issued free of legends if exercised under an effective registration statement or via cashless exercise[112](index=112&type=chunk) - The Company will use commercially reasonable efforts to keep the registration statement for Warrant Shares effective[112](index=112&type=chunk) [4.2 Furnishing of Information](index=17&type=section&id=4.2%20Furnishing%20of%20Information) The Company covenants to timely file all reports required under the Exchange Act until Purchasers no longer own Securities or Warrants expire - The Company will timely file all Exchange Act reports until Purchasers no longer own Securities or Warrants expire[113](index=113&type=chunk) [4.3 Integration](index=17&type=section&id=4.3%20Integration) The Company agrees not to sell or offer any security that would be integrated with this offering, requiring shareholder approval, without obtaining such approval - The Company will not sell or offer securities that would be integrated with this offering, requiring shareholder approval, without obtaining such approval[114](index=114&type=chunk) [4.4 Securities Laws Disclosure; Publicity](index=17&type=section&id=4.4%20Securities%20Laws%20Disclosure%3B%20Publicity) The Company will issue a press release and file a Form 8-K disclosing material terms, after which confidentiality obligations terminate - The Company will issue a press release and file a Form 8-K disclosing material terms of the transaction[115](index=115&type=chunk) - Upon press release, all material non-public information delivered to Purchasers will be publicly disclosed, and confidentiality obligations will terminate[116](index=116&type=chunk) - The Company will not publicly disclose Purchaser names without prior written consent, except as legally required[116](index=116&type=chunk) [4.5 Shareholder Rights Plan](index=18&type=section&id=4.5%20Shareholder%20Rights%20Plan) The Company agrees that no Purchaser will be deemed an 'Acquiring Person' under any anti-takeover plan by virtue of receiving Securities - No Purchaser will be deemed an 'Acquiring Person' under any anti-takeover plan by virtue of receiving Securities[117](index=117&type=chunk) [4.6 Non-Public Information](index=18&type=section&id=4.6%20Non-Public%20Information) The Company will not provide material non-public information without Purchaser consent and confidentiality, and will file any inadvertent disclosures on Form 8-K - The Company will not provide material non-public information to Purchasers without their consent and confidentiality agreement[118](index=118&type=chunk) - If material non-public information is inadvertently provided, Purchasers have no duty of confidentiality or duty not to trade, subject to applicable law[118](index=118&type=chunk) - Any material non-public information in notices will be simultaneously filed with the SEC on Form 8-K[118](index=118&type=chunk) [4.7 Use of Proceeds](index=18&type=section&id=4.7%20Use%20of%20Proceeds) Net proceeds from the sale of Securities will be used for working capital, explicitly excluding debt satisfaction (except ordinary course), stock redemption, or illegal activities - Net proceeds from the sale of Securities will be used for working capital purposes[119](index=119&type=chunk) - Proceeds will not be used for debt satisfaction (except ordinary course), redemption of Common Stock, inconsistent litigation settlement, or in violation of FCPA/OFAC[119](index=119&type=chunk) [4.8 Indemnification of Purchasers](index=19&type=section&id=4.8%20Indemnification%20of%20Purchasers) The Company will indemnify Purchaser Parties against losses from Company breaches or stockholder actions, with payments made periodically - The Company will indemnify Purchaser Parties against losses from Company breaches of representations, warranties, covenants, or agreements[120](index=120&type=chunk) - Indemnification also covers actions by Company stockholders, unless based on Purchaser's breach, fraud, gross negligence, or willful misconduct[120](index=120&type=chunk) - Indemnification payments will be made periodically, and the Company has the right to assume defense[120](index=120&type=chunk) [4.9 Reservation of Common Stock](index=19&type=section&id=4.9%20Reservation%20of%20Common%20Stock) The Company has reserved and will continue to reserve sufficient Common Stock shares, free of preemptive rights, for the issuance of Shares and Warrant Shares - The Company has reserved and will continue to reserve sufficient Common Stock for Shares and Warrant Shares issuance, free of preemptive rights[121](index=121&type=chunk) [4.10 Listing of Common Stock](index=19&type=section&id=4.10%20Listing%20of%20Common%20Stock) The Company will use reasonable best efforts to maintain Common Stock listing on the principal Trading Market and apply to list all Shares and Warrant Shares - The Company will maintain Common Stock listing on the principal Trading Market[122](index=122&type=chunk) - Concurrently with Closing, the Company will apply to list all Shares and Warrant Shares on the Trading Market[122](index=122&type=chunk) - The Company will maintain eligibility for electronic transfer through the Depository Trust Company[122](index=122&type=chunk) [4.11 Equal Treatment of Purchasers](index=20&type=section&id=4.11%20Equal%20Treatment%20of%20Purchasers) The Company commits to offering the same consideration to all parties for any amendment, waiver, or modification of the Transaction Documents - The Company will offer the same consideration to all parties for any amendment or waiver of Transaction Documents[123](index=123&type=chunk) - This ensures Purchasers are treated as a class and not construed as acting in concert[123](index=123&type=chunk) [4.12 Certain Transactions and Confidentiality](index=20&type=section&id=4.12%20Certain%20Transactions%20and%20Confidentiality) Purchasers will not engage in certain Company securities transactions or disclose confidential information until public announcement, after which restrictions cease - Purchasers will not engage in purchases or Short Sales of Company securities from agreement execution until public announcement[124](index=124&type=chunk) - Purchasers will maintain confidentiality of the transaction's existence and terms until public disclosure[124](index=124&type=chunk) - After public disclosure, Purchasers are not restricted from trading and have no further duty of confidentiality[124](index=124&type=chunk) [4.13 Exercise Procedures](index=20&type=section&id=4.13%20Exercise%20Procedures) The Warrant's Notice of Exercise form outlines all required procedures for Purchasers to exercise Warrants, and the Company will honor exercises - The Notice of Exercise form sets forth all required procedures for Warrant exercise; no additional requirements[125](index=125&type=chunk) - The Company will honor Warrant exercises and deliver Warrant Shares according to Transaction Documents[125](index=125&type=chunk) [4.14 Agreement Not to Offer or Sell Additional Shares](index=20&type=section&id=4.14%20Agreement%20Not%20to%20Offer%20or%20Sell%20Additional%20Shares) The Company will not issue or announce additional Common Stock or Equivalents for 45 days post-Closing, with specific 'Exempt Issuance' exceptions - The Company will not issue or announce additional Common Stock or Equivalents, or file related registration statements, for **45 days** post-Closing Date[126](index=126&type=chunk) - Exempt Issuances include the Shares/Warrants/Warrant Shares, sales under the Open Market Sale Agreement (after **August 7, 2025**), employee benefit plan issuances, exercises of existing securities, and securities issued in approved acquisitions/strategic transactions[126](index=126&type=chunk) [ARTICLE V. MISCELLANEOUS](index=21&type=section&id=ARTICLE%20V.%20MISCELLANEOUS) This article covers general provisions including termination, fees, entire agreement, notices, amendments, governing law, and other standard contractual clauses [5.1 Termination](index=21&type=section&id=5.1%20Termination) The Agreement may be terminated by a Purchaser or the Company if the Closing does not occur within five Trading Days, without affecting breach remedies - The Agreement can be terminated by a Purchaser or the Company if Closing doesn't occur within **five Trading Days**[128](index=128&type=chunk) - Termination does not affect the right to sue for breach[128](index=128&type=chunk) [5.2 Fees and Expenses](index=21&type=section&id=5.2%20Fees%20and%20Expenses) Each party is responsible for its own advisory fees, while the Company pays Transfer Agent fees, stamp taxes, and other duties related to Securities delivery - Each party pays its own fees and expenses[129](index=129&type=chunk) - The Company pays Transfer Agent fees, stamp taxes, and other duties related to Securities delivery[129](index=129&type=chunk) [5.3 Entire Agreement](index=21&type=section&id=5.3%20Entire%20Agreement) The Transaction Documents, including exhibits and prospectuses, constitute the entire understanding between the parties, superseding all prior agreements - The Transaction Documents, along with exhibits and prospectuses, form the entire agreement, superseding all prior understandings[130](index=130&type=chunk) [5.4 Notices](index=21&type=section&id=5.4%20Notices) All written notices are effective upon email transmission (timing dependent), courier mailing, or actual receipt, with material non-public information requiring simultaneous Form 8-K filing - Notices must be in writing and are effective upon email transmission (timing dependent), two Trading Days after courier mailing, or actual receipt[131](index=131&type=chunk) - Notices containing material non-public information must be simultaneously filed by the Company on Form 8-K[131](index=131&type=chunk) [5.5 Amendments; Waivers](index=22&type=section&id=5.5%20Amendments%3B%20Waivers) Amendments require written consent from the Company and Purchasers holding at least 50.1% of Shares, with waivers requiring the signature of the party against whom enforcement is sought - Amendments require written consent from the Company and Purchasers holding at least **50.1%** of Shares (or all Purchasers before Closing)[132](index=132&type=chunk) - Waivers require the signature of the party against whom enforcement is sought[132](index=132&type=chunk) - Amendments or waivers disproportionately affecting a Purchaser require that Purchaser's consent[132](index=132&type=chunk) [5.6 Headings](index=22&type=section&id=5.6%20Headings) The headings used in this Agreement are for convenience only and do not constitute a part of the Agreement, nor do they limit or affect its provisions - Headings are for convenience only and do not affect the Agreement's provisions[133](index=133&type=chunk) [5.7 Successors and Assigns](index=22&type=section&id=5.7%20Successors%20and%20Assigns) This Agreement binds parties and their successors/permitted assigns, with Company assignment requiring Purchaser consent and Purchasers able to assign rights to transferees - The Agreement binds parties and their successors/permitted assigns[134](index=134&type=chunk) - Company assignment requires Purchaser consent (except merger); Purchasers can assign rights to Securities transferees who agree to be bound[134](index=134&type=chunk) [5.8 No Third-Party Beneficiaries](index=22&type=section&id=5.8%20No%20Third-Party%20Beneficiaries) The Agreement primarily benefits the parties, but the Placement Agent and Section 4.8 (Indemnification) create specific third-party beneficiaries - The Agreement is for the benefit of the parties and their successors/assigns[134](index=134&type=chunk) - The Placement Agent is a third-party beneficiary of representations and warranties, and Section 4.8 (Indemnification) also creates third-party beneficiaries[134](index=134&type=chunk) [5.9 Governing Law](index=22&type=section&id=5.9%20Governing%20Law) The Transaction Documents are governed by New York law, with exclusive jurisdiction in New York City courts, and the prevailing party reimbursed for legal costs - Governing law is the internal laws of the State of New York[135](index=135&type=chunk) - Exclusive jurisdiction for legal proceedings is in state and federal courts in New York City[135](index=135&type=chunk) - The prevailing party in enforcement actions will be reimbursed for reasonable attorneys' fees and costs[135](index=135&type=chunk) [5.10 Survival](index=22&type=section&id=5.10%20Survival) The representations and warranties contained in this Agreement will survive the Closing and the delivery of the Securities - Representations and warranties survive the Closing and Securities delivery[136](index=136&type=chunk) [5.11 Execution](index=23&type=section&id=5.11%20Execution) The Agreement may be executed in counterparts, with facsimile, electronic mail, or other electronic transmissions of signatures being legally valid - The Agreement may be executed in counterparts, forming one agreement[137](index=137&type=chunk) - Electronic signatures (facsimile, email, e-signatures) are legally valid and binding[137](index=137&type=chunk) [5.12 Severability](index=23&type=section&id=5.12%20Severability) Invalid or unenforceable provisions will not affect the remainder of the Agreement, and parties will seek alternative means to achieve the intended result - Invalid or unenforceable provisions do not affect the remainder of the Agreement[138](index=138&type=chunk) - Parties will seek alternative means to achieve the intended result of any severed provision[138](index=138&type=chunk) [5.13 Rescission and Withdrawal Right](index=23&type=section&id=5.13%20Rescission%20and%20Withdrawal%20Right) Purchasers have the right to rescind or withdraw notices if the Company fails to timely perform obligations, with specific conditions for Warrant exercise rescission - Purchasers have the right to rescind or withdraw notices if the Company fails to timely perform related obligations[139](index=139&type=chunk) - Warrant exercise rescission requires returning Common Stock concurrently with receiving the exercise price and restoring Warrant rights[139](index=139&type=chunk) [5.14 Replacement of Securities](index=23&type=section&id=5.14%20Replacement%20of%20Securities) Mutilated, lost, stolen, or destroyed Securities certificates will be replaced upon satisfactory evidence of loss/destruction and payment of reasonable costs - Mutilated, lost, stolen, or destroyed Securities certificates will be replaced upon satisfactory evidence and payment of costs[140](index=140&type=chunk) [5.15 Remedies](index=23&type=section&id=5.15%20Remedies) Both Purchasers and the Company are entitled to specific performance for breaches, acknowledging that monetary damages may be inadequate - Purchasers and the Company are entitled to specific performance for breaches of Transaction Documents[141](index=141&type=chunk) - Parties agree monetary damages may be inadequate and waive the defense of adequate legal remedy[141](index=141&type=chunk) [5.16 Payment Set Aside](index=23&type=section&id=5.16%20Payment%20Set%20Aside) If any Company payment or Purchaser enforcement proceeds are later invalidated or recovered, the original obligation will be revived and continue in full force - If Company payments or Purchaser enforcement proceeds are later invalidated or recovered, the original obligation is revived[142](index=142&type=chunk) [5.17 Independent Nature of Purchasers' Obligations and Rights](index=24&type=section&id=5.17%20Independent%20Nature%20of%20Purchasers%27%20Obligations%20and%20Rights) Each Purchaser's obligations are several, not joint, and the agreement does not imply a partnership or group action among Purchasers - Each Purchaser's obligations are several, not joint; no Purchaser is responsible for another's performance[143](index=143&type=chunk) - The agreement does not imply a partnership or group action among Purchasers[143](index=143&type=chunk) - Each Purchaser can independently protect its rights[143](index=143&type=chunk) [5.18 Liquidated Damages](index=24&type=section&id=5.18%20Liquidated%20Damages) The Company's obligation to pay liquidated damages is a continuing obligation until all amounts are paid, regardless of underlying instrument cancellation - The Company's obligation to pay liquidated damages is continuing until all amounts are paid, regardless of instrument cancellation[144](index=144&type=chunk) [5.19 Saturdays, Sundays, Holidays, etc.](index=24&type=section&id=5.19%20Saturdays%2C%20Sundays%2C%20Holidays%2C%20etc.) If a deadline for any action or right falls on a non-Business Day, it may be taken or exercised on the next succeeding Business Day - If a deadline falls on a non-Business Day, the action can be taken on the next Business Day[145](index=145&type=chunk) [5.20 Construction](index=24&type=section&id=5.20%20Construction) The rule of construction against the drafting party will not apply, and all share price and Common Stock references are subject to adjustment for corporate actions - The rule of construction against the drafting party will not apply[146](index=146&type=chunk) - Share prices and Common Stock references are subject to adjustment for stock splits, dividends, and similar transactions[146](index=146&type=chunk) [5.21 WAIVER OF JURY TRIAL](index=24&type=section&id=5.21%20WAIVER%20OF%20JURY%20TRIAL) All parties knowingly, intentionally, and irrevocably waive their right to a trial by jury in any legal proceeding to the greatest extent permitted by law - All parties irrevocably waive their right to a trial by jury in any legal proceeding[147](index=147&type=chunk) [Signature Pages](index=25&type=section&id=Signature%20Pages) This section contains the signature pages for both the Company and the Purchasers, formalizing their agreement to the terms [Company Signature](index=25&type=section&id=Company%20Signature) This page confirms ImmunityBio, Inc.'s agreement to the terms, executed by its Chief Executive Officer, including contact information - ImmunityBio, Inc. signed the agreement through Richard Adcock, CEO[149](index=149&type=chunk) [Purchaser Signatures](index=26&type=section&id=Purchaser%20Signatures) This section details the signature pages for Purchasers, including their subscription amounts, share allocations, and an optional closing acceleration checkbox Purchaser Subscription Details | Purchaser | Subscription Amount | Shares | Warrant Shares (Beneficial Ownership Blocker) | | :--- | :--- | :--- | :--- | | **CVI Investments, Inc.** | $75,000,006 | 27,777,780 | 4.99% | | **Woodline Master Fund LP** | $5,000,000.40 | 1,851,852 | Not specified (checkbox for 4.99% or 9.99% not checked) | - An optional checkbox allows Purchasers to disregard closing conditions and accelerate the closing to the second Trading Day following the agreement date[151](index=151&type=chunk)[154](index=154&type=chunk) [Form of Warrant](index=28&type=section&id=Form%20of%20Warrant) This section indicates that the specific form of the Warrant, detailing terms for purchasing Common Stock, is appended to the agreement [Attached Form of Warrant](index=28&type=section&id=Attached%20Form%20of%20Warrant) This section confirms that the specific form of the Warrant, outlining terms for purchasing Common Stock, is attached to the agreement - The specific form of the Warrant is attached to the agreement[155](index=155&type=chunk)

Group 1 - The article discusses the recent FDA Refusal to File (RTF) letter received by ImmunityBio (IBRX) regarding ANKTIVA's supplemental BLA for papillary-only NMIBC, which led to a negative market reaction [1] - The author emphasizes their long position in IBRX shares, indicating a belief in the company's potential despite recent setbacks [2] - The article is part of a broader investment strategy focused on innovative biotech companies developing breakthrough therapies, highlighting the author's expertise in the healthcare sector [1]

ANKTIVA Mechanism and Applications - ANKTIVA activates NK cells and rescues T cells, serving as a foundational cytokine for universal cancer immunotherapy across multiple tumor types[18] - ANKTIVA, combined with BCG, is approved for bladder cancer and is being investigated in lung cancer, prostate cancer, colon cancer, and hematologic malignancies[20, 22] - ANKTIVA's mechanism overcomes tumor evasion by activating NK cells and rescuing T cells[12] Clinical Trial Results and Regulatory Status - In BCG-unresponsive NMIBC-CIS, ANKTIVA demonstrated a 71% complete response rate[25] - In BCG-unresponsive papillary NMIBC, ANKTIVA showed a disease-free rate of 55.4% at 12 months, 51.1% at 18 months, and 48.3% at 24 months, with 93% cystectomy avoidance[50] - In the NMIBC BCG-naive setting, ANKTIVA + BCG resulted in 100% complete response and disease-free status for at least 9.5 years in 6 out of 6 patients[54, 55] - An interim analysis of a Phase 3 trial in NMIBC BCG-naive patients showed an 84% complete response rate with ANKTIVA + BCG compared to 52% with BCG alone[57] - A BLA submission is planned for the QUILT-3.055 study (N=83) for lung cancer checkpoint progressors[70] Market Access and Launch - ANKTIVA received J-Code 9028 effective January 2025[35] - Market access covers 240 million medical lives as of November 2024[37] Intellectual Property - ImmunityBio has over 700 issued patents worldwide covering its immunotherapy portfolio[75]

Anktiva in Bladder Cancer - Anktiva, combined with BCG, received FDA approval in April 2024 for NMIBC CIS +/- Papillary[29, 30] - In BCG-unresponsive papillary disease, Anktiva + BCG resulted in cystectomy avoidance of 92% at 12 months and 82% at 36 months[34, 41] - The disease-specific overall survival rate at 36 months with Anktiva + BCG was 96%[34, 41] - Treatment-related Grade 3 adverse events occurred in only 3% of NMIBC CIS & papillary subjects treated with Anktiva + BCG, with no Grade 4 or 5 TRAEs[42, 43] - In BCG Naïve NMIBC, 6 out of 6 patients (100%) remained disease-free for ≥ 95 years with Anktiva + BCG[57, 58] - In evaluable patients with CIS BCG Naïve NMIBC receiving Anktiva + BCG, the complete response rate was 86% at any time, 82% at 6 months, and 63% at 12 months[63, 64] - Q1 2025 Anktiva unit sales volume grew 150% over Q4 2024 due to a permanent J-code awarded in January 2025[125] - For the three-month period ending March 31, 2025, ImmunityBio achieved estimated net product revenue of approximately $165 million, surpassing net product revenue of $72 million in the prior quarter, a 129% quarter over quarter increase[125] Lymphopenia and Anktiva's Mechanism - The presentation introduces the concept of lymphopenia (ALC <1,000 Lymphocytes per Microliter) and its negative impact on overall survival in cancer patients[136, 146, 149] - Anktiva is highlighted as a lymphocyte stimulating agent that promotes the proliferation and activation of NK, CD8+, and memory T cells[165, 179, 182] Other Pipeline and Initiatives - ImmunityBio and Serum Institute of India have an exclusive arrangement for global supply of Bacillus Calmette-Guerin (BCG) across all cancer types[72] - A randomized Phase 3 trial (ResQ201A) is underway evaluating Anktiva + Tislelizumab versus Docetaxel in 2nd line NSCLC (N=460)[258, 259] - As of January 2025, the total enrollment in the Lynch Syndrome prevention trial (NCT05419011) is 101 subjects[251]

Core Viewpoint - ImmunityBio (IBRX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - For the fiscal year ending December 2025, ImmunityBio is expected to earn -$0.43 per share, representing a 41.1% change from the previous year's reported number [8]. Analyst Sentiment and Market Position - Analysts have raised their earnings estimates for ImmunityBio, with the Zacks Consensus Estimate increasing by 46.6% over the past three months [8]. - The upgrade to Zacks Rank 2 places ImmunityBio in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].