Catalysts lie ahead for both of these companies.Technology stocks have led general market gains, with chip companies and software giants soaring amid excitement about the new bull market. This sort of environment favors growth stocks, so it's not surprising to see these sorts of players stand out. But if you're looking for growth, you can find it in another industry as well. I'm talking about biotech, an area bursting with innovation and potentially game-changing products.Today many of these players are tra ...

SAN CARLOS, Calif., April 19, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that on April 18, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 79,310 shares of Iovance's common stock to thirty-seven new, non-executive ...

Let's find out if this biotech can keep up its recent momentum.Is this the start of a comeback for Iovance Biotherapeutics (IOVA -0.08%)? Though the small-cap biotech has significantly trailed the broader market in the past five years, its shares are up by 50% since 2024 started. Iovance is making progress on several fronts (more on that below).It's no wonder that many investors are increasingly excited about the company's direction. But should long-term investors put their hard-earned money into this stock ...

Monty Rakusen Iovance Biotherapeutics (NASDAQ:IOVA) is going through a favorable moment which began in the second half of February following an accelerated FDA approval for its melanoma drug Amtagvi and the pricing of an underwritten offering. By analyzing the company foundations, we can underline that, beyond the approval by the regulator, there is an unsatisfied market demand regarding metastatic melanoma and that the company has developed and integrated its production capacity internally. It is also ...

Iovance Biotherapeutics (IOVA) is a commercial-stage pharmaceutical company primarily focused on developing and marketing novel T cell-based cancer immunotherapies.Currently, Iovance has two cancer drugs in its portfolio — Amtagvi and Proleukin. While Proleukin is approved to treat two cancer indications, namely metastatic renal cell carcinoma (mRCC) and metastatic melanoma, Amtagvi is approved for advanced melanoma indication.The company is developing its pipeline candidates, consisting of tumor-infiltrati ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transaction period from __________ to __________ Commission file number: 001-36860 IOVANCE BIOTHERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) | D ...

Financial Data and Key Metrics Changes - Revenue for Q3 2023 was $469,000, and for the nine months ended September 30, 2023, it was $707,000, compared to no revenue for the same periods in 2022 [35] - Net loss for Q3 2023 was $113.8 million or $0.46 per share, compared to a net loss of $99.6 million or $0.63 per share for Q3 2022 [60] - Research and development expenses increased to $87.5 million for Q3 2023, up from $72.5 million in Q3 2022 [61] Business Line Data and Key Metrics Changes - The company has provided TIL therapy to over 600 patients with a manufacturing success rate exceeding 90% [23] - Approximately 30 Authorized Treatment Centers (ATCs) have completed pre-approval onboarding steps to establish their TIL service line capabilities [24] Market Data and Key Metrics Changes - The advanced melanoma population in Germany, France, the U.K., and Canada is slightly larger than that in the U.S., indicating a significant market opportunity for Lifileucel [20] - More than 3/4 of advanced melanoma patients are currently insured through commercial, Medicare Advantage, and Medicare IPPS exempt segments [26] Company Strategy and Development Direction - The company aims to secure FDA approval for Lifileucel and plans to submit additional marketing applications in Europe and other regions [5][6] - The company is expanding its TIL therapy pipeline with 7 active clinical trials, including registrational trials for melanoma and lung cancer [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for Lifileucel to redefine treatment for advanced melanoma patients with no approved options [5] - The company expects to manage cash burn in the range of $320 million to $340 million for 2024, excluding one-time expenses [34][63] Other Important Information - The company had a cash position of approximately $428 million as of September 30, 2023, expected to fund operations into 2025 [9][59] - The company plans to integrate Proleukin into its treatment regimen, which is anticipated to lower clinical trial expenses and future costs associated with Lifileucel [46] Q&A Session Summary Question: Impact of a single-arm study on EU approval and reimbursement - Management indicated that the single-arm data should be sufficient for early access programs in major EU countries, with the TILVANCE-301 study providing randomized controlled trial data for reimbursement [64][65] Question: Increase in the number of authorized treatment centers - The increase in ATCs was driven by high demand from treatment centers and the extended preparation time due to the FDA delay [66] Question: Status of the review process and potential approval timeline - Management expects the BLA for Lifileucel to be approved potentially before the PDUFA date in February 2024, based on the FDA's history of approving products with unmet medical needs [72][73] Question: Manufacturing capacity and onboarding of additional centers - The company anticipates onboarding approximately 50 ATCs within 90 days of the PDUFA date, with the potential to exceed that number depending on capacity [74][75] Question: Updates on lung cancer data and future presentations - Management is focused on gathering more patient data before presenting updated lung cancer results, aiming for significant findings before sharing at a medical meeting [76] Question: Strategic portfolio prioritization and ongoing studies - Management confirmed that all ongoing studies continue, with a focus on high-priority studies like LUN-202 and TILVANCE-301, while still evaluating other programs [79][82] Question: Long-term follow-up data and patient outcomes - Management highlighted the long-term durability of responses in patients treated with Lifileucel, indicating no detrimental impact from subsequent therapies [83]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ 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 001-36860 (650) 260-7120 (Registrant's telephone number, including area code) Indicate by check mark whether the registran ...

Financial Data and Key Metrics Changes - As of June 30, 2023, the company had $317.3 million in cash, cash equivalents, investments, and restricted cash, down from $478.3 million as of December 31, 2022, primarily due to cash used for the acquisition of Proleukin [7] - The net loss for the second quarter ended June 30, 2023, was $106 million or $0.47 per share, compared to a net loss of $99.3 million or $0.63 per share for the same period in 2022 [123] - Revenue for the second quarter and six months ended June 30, 2023, was $0.2 million, comprised entirely of Proleukin product sales, marking the first revenue recognition for the company [123] Business Line Data and Key Metrics Changes - Research and development expenses increased to $85.8 million for the second quarter of 2023, up from $73.4 million in the same period of 2022, driven by growth in the internal R&D team and the initiation of the Phase 3 TILVANCE-301 trial [27] - Selling, general, and administrative expenses decreased to $21.9 million for the second quarter of 2023, down from $26.3 million in the same period of 2022, primarily due to the capitalization of expenses related to the Proleukin acquisition [152] Market Data and Key Metrics Changes - The company is preparing for the commercial launch of lifileucel, with a PDUFA date set for November 25, 2023, and anticipates significant revenue from Proleukin following the launch [113][101] - The market access team is engaging key national and regional payers, expecting coverage consistent with the label and similar to recent CAR-T therapies [105] Company Strategy and Development Direction - The company aims to establish TIL therapy as a new paradigm in cancer treatment, integrating Proleukin into its offerings to enhance the TIL regimen [101] - The company is focused on expanding its clinical pipeline, with seven active clinical trials aimed at solid tumors, including ongoing studies in melanoma and non-small cell lung cancer [114] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the prospects for approval of lifileucel, citing strong clinical data and positive interactions with the FDA [4] - The company noted significant pent-up demand for lifileucel, supported by an expanded access program and ongoing engagement with patient advocacy groups [36] Other Important Information - The company has successfully provided TIL therapy for over 600 patients with a manufacturing success rate exceeding 90% [103] - The company plans to report detailed data from its IOV-COM-202 trial at the upcoming World Congress on Lung Cancer [102] Q&A Session All Questions and Answers Question: Can you provide an update on the cash runway and any internal changes? - Management indicated that the cash runway extends to the end of 2024, influenced by the recent $161 million capital raise and anticipated revenues from Proleukin and lifileucel [10] Question: What is the anticipated demand for lifileucel upon launch? - Management noted significant pent-up demand and plans to prioritize patient populations based on characteristics during the initial launch phase [18] Question: How is the onboarding process for treatment centers progressing? - The onboarding process is on track, with a goal to onboard 40 authorized treatment centers within the first 90 days post-approval [104] Question: What are the expectations regarding the FDA's review process for lifileucel? - Management reported that the FDA has not identified any major review issues and does not plan to hold an advisory committee meeting [113][137] Question: Can you elaborate on the expected efficacy benchmarks for the lung cancer trials? - Management highlighted that the overall response rate (ORR) in the lung cancer trials is promising, with specific benchmarks set against existing therapies [149]

PART I FINANCIAL INFORMATION This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for Iovance Biotherapeutics, Inc. as of June 30, 2023, and for the three and six-month periods then ended. It includes the balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies and events, such as the recent acquisition of Proleukin® [Financial Statements](index=6&type=section&id=Financial%20Statements) This section provides the unaudited condensed consolidated balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $230,010 | $231,731 | | Total Current Assets | $274,878 | $479,116 | | Intangible assets, net | $235,511 | $0 | | Total Assets | $757,293 | $663,982 | | **Liabilities & Equity** | | | | Total Current Liabilities | $88,643 | $91,485 | | Total Liabilities | $178,724 | $164,344 | | Total Stockholders' Equity | $578,569 | $499,638 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $238 | $0 | $238 | $0 | | Research and development | $86,347 | $73,406 | $169,081 | $141,706 | | Selling, general and administrative | $21,927 | $26,328 | $50,049 | $49,741 | | Loss from operations | ($110,086) | ($99,734) | ($220,942) | ($191,447) | | Net Loss | ($106,528) | ($99,349) | ($213,898) | ($190,956) | | Net Loss Per Share | ($0.47) | ($0.63) | ($0.98) | ($1.21) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($193,767) | ($151,437) | | Net cash (used in) provided by investing activities | ($3,383) | $182,279 | | Net cash provided by (used in) financing activities | $259,197 | ($650) | | Net increase in cash, cash equivalents and restricted cash | $58,279 | $30,192 | [Note 1: General Organization, Business and Liquidity](index=15&type=section&id=NOTE%201.%20GENERAL%20ORGANIZATION%2C%20BUSINESS%20AND%20LIQUIDITY) This note details the company's core business, strategic developments, and assessment of its liquidity position - The company is a biopharmaceutical firm focused on developing and delivering tumor-infiltrating lymphocyte (TIL) therapies for solid tumor cancers. Its lead product candidate is lifileucel for advanced melanoma[32](index=32&type=chunk) - In **May 2023**, the company acquired the worldwide rights to Proleukin® (aldesleukin), a commercialized IL-2 product, to secure its supply chain and create a new revenue source[32](index=32&type=chunk) - The FDA accepted the Biologics License Application (BLA) for lifileucel in advanced melanoma in **May 2023**, granted it Priority Review, and set a PDUFA target action date of **November 25, 2023**[33](index=33&type=chunk) - As of **June 30, 2023**, the company had **$317.3 million** in cash, cash equivalents, investments, and restricted cash. Management believes it has sufficient capital to fund operations for at least the next twelve months, including proceeds from a **July 2023** public offering[37](index=37&type=chunk)[38](index=38&type=chunk) [Note 4: Proleukin® Acquisition](index=26&type=section&id=NOTE%204.%20PROLEUKIN%C2%AE%20ACQUISITION) This note describes the financial details and accounting treatment of the Proleukin® acquisition - On **May 18, 2023**, the company completed the acquisition of the worldwide rights to Proleukin® from Clinigen for an upfront payment of **£166.9 million** (approx. **$207.2 million**) plus inventory costs[81](index=81&type=chunk)[82](index=82&type=chunk) - The transaction was accounted for as an asset acquisition, with the total cost of **$222.7 million** allocated primarily to developed technology (**$232.7 million**) and inventory (**$9.7 million**), offset by a deferred tax liability (**$20.4 million**)[83](index=83&type=chunk)[84](index=84&type=chunk) - The agreement includes a potential milestone payment of **£41.7 million** (approx. **$50.0 million**) upon the first approval of lifileucel in advanced melanoma, as well as future sales-based deferred consideration and earnout payments[84](index=84&type=chunk) [Note 10: Stockholders' Equity](index=30&type=section&id=NOTE%2010.%20STOCKHOLDERS%27%20EQUITY) This note outlines changes in stockholders' equity, including capital raises and stock-based compensation - During the **six months ended June 30, 2023**, the company received approximately **$260.1 million** in net proceeds from the sale of **36,080,226 shares** through its "at the market" (ATM) offering program at a weighted average price of **$7.35 per share**[103](index=103&type=chunk) - In **June 2023**, stockholders approved an amendment to the 2018 Equity Incentive Plan, increasing the number of shares available for issuance from **20.7 million** to **29.7 million**[113](index=113&type=chunk) - Stock-based compensation expense was **$16.7 million** for **Q2 2023** and **$32.4 million** for the **six months ended June 30, 2023**, a decrease from **$22.5 million** and **$44.7 million** in the respective prior-year periods[129](index=129&type=chunk) [Note 13: Legal Proceedings](index=47&type=section&id=NOTE%2013.%20LEGAL%20PROCEEDINGS) This note provides an overview of the company's ongoing legal disputes and related developments - The company is involved in a stockholder derivative complaint filed in December 2020, alleging excessive compensation for certain non-executive directors. A proposed settlement has been submitted to the court[165](index=165&type=chunk) - Two lawsuits filed by Solomon Capital, LLC and related plaintiffs are ongoing, alleging breach of contract and other claims related to financing activities in 2012. The company is vigorously defending these claims and has asserted counterclaims[166](index=166&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) [Note 15: Subsequent Events](index=51&type=section&id=NOTE%2015.%20SUBSEQUENT%20EVENTS) This note discloses significant events that occurred after the reporting period, impacting the company's financial position - On **July 13, 2023**, the company closed a public offering of **23,000,000 shares** of its common stock at **$7.50 per share**, generating estimated net proceeds of approximately **$161.4 million**[179](index=179&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations. It details the business strategy, focusing on the development of TIL therapies and the recent acquisition of Proleukin®. The discussion covers the progress of key clinical trials, an analysis of financial results for the three and six months ended June 30, 2023, compared to the prior year, and an assessment of liquidity and capital resources [Overview and Clinical Development](index=33&type=section&id=Overview%20and%20Clinical%20Development) This section outlines the company's strategic focus, lead product candidates, and progress in key clinical trials - The company's lead product candidate, lifileucel, is under FDA review for advanced melanoma, with a PDUFA target action date of **November 25, 2023**. A Phase 3 confirmatory trial, TILVANCE-301, is underway in frontline advanced melanoma[183](index=183&type=chunk) - Registrational strategies are being pursued for lifileucel in advanced cervical cancer and for TIL therapy LN-145 in metastatic non-small cell lung cancer (NSCLC)[184](index=184&type=chunk) - Preliminary analysis of the IOV-LUN-202 trial in **23 NSCLC patients** showed an objective response rate of **26.1%**. The company plans to enroll a total of approximately **120 patients** in this registrational trial[191](index=191&type=chunk) - The company is advancing next-generation approaches, including its first genetically modified TIL therapy (IOV-4001), a shorter manufacturing process, and a novel IL-2 analog (IOV-3001)[184](index=184&type=chunk)[192](index=192&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) This section analyzes the company's revenues, costs, and net loss for the current and prior reporting periods Comparison of Costs and Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $238 | $0 | $238 | $0 | | Cost of sales | $2,050 | $0 | $2,050 | $0 | | Research and development | $86,347 | $73,406 | $169,081 | $141,706 | | Selling, general and administrative | $21,927 | $26,328 | $50,049 | $49,741 | - **Revenue & Cost of Sales:** The company recorded its first product revenue of **$0.2 million** and cost of sales of **$2.1 million** in **Q2 2023**, following the acquisition of Proleukin® in **May 2023**[227](index=227&type=chunk)[229](index=229&type=chunk) - **R&D Expense Increase:** R&D expenses rose by **18%** in **Q2 2023** YoY, primarily due to increased payroll from hiring, higher clinical trial costs for the Phase 3 TILVANCE-301 trial, and increased manufacturing costs related to commercial readiness activities at the iCTC facility[231](index=231&type=chunk) - **SG&A Expense Decrease:** SG&A expenses decreased by **17%** in **Q2 2023** YoY, mainly due to a **$4.2 million** decrease in legal fees (as some costs were capitalized for the Proleukin acquisition) and a **$1.2 million** decrease in stock-based compensation[233](index=233&type=chunk) - **Net Loss Increase:** Net loss increased to **$106.5 million** in **Q2 2023** from **$99.3 million** in **Q2 2022**, driven by the expansion of R&D activities, clinical trials, and pre-commercialization efforts for lifileucel[237](index=237&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's cash position, funding sources, and ability to meet its operational and capital needs - The company has historically funded operations through equity offerings. It began generating revenue from Proleukin® sales in **Q2 2023** but does not expect material revenue in the next 12 months[238](index=238&type=chunk) - Management believes existing capital, including the **$161.4 million** net proceeds from the **July 2023** public offering, is sufficient to fund operations and capital expenditures for at least the next twelve months[238](index=238&type=chunk) - Net cash used in operating activities increased to **$193.8 million** for the **six months ended June 30, 2023**, up from **$151.4 million** in the prior-year period, due to higher net loss and increased operational activities[244](index=244&type=chunk) - Net cash provided by financing activities was **$259.2 million** for the first **six months of 2023**, primarily from **$260.1 million** in net proceeds from the "at the market" offering program[247](index=247&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily interest rate risk and foreign currency exchange risk. Interest rate risk is considered minimal due to the investment portfolio's focus on short-term U.S. government securities. Foreign currency risk has increased following the acquisition of Proleukin®, with exposure mainly to the Great Britain Pound - Interest rate risk is limited as a significant portion of investments are in short-term U.S. government debt securities, with the primary objective being principal preservation[252](index=252&type=chunk) - Foreign currency exchange risk has emerged following the Proleukin® acquisition due to foreign subsidiaries and sales denominated in foreign currencies. The most significant exposure is to the Great Britain Pound[255](index=255&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) This section provides management's conclusion on the effectiveness of the company's disclosure controls and procedures. As of June 30, 2023, these controls were deemed effective. It also notes that internal controls were implemented during the quarter related to the Proleukin® acquisition - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective as of **June 30, 2023**[257](index=257&type=chunk) - During the quarter, the company implemented new internal controls over financial reporting related to revenue and inventory processes resulting from the Proleukin® acquisition[258](index=258&type=chunk) PART II OTHER INFORMATION This part covers legal proceedings, comprehensive risk factors, and other required disclosures [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the information on legal proceedings from Note 13 of the Condensed Consolidated Financial Statements, which details ongoing litigation, including a stockholder derivative lawsuit and two lawsuits from Solomon Capital, LLC - The company incorporates information on legal proceedings from Note 13 of the financial statements, which details the Shumacher derivative lawsuit and the Solomon Capital lawsuits[260](index=260&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive discussion of the risks and uncertainties that could materially affect the company's business, financial condition, and results of operations. The risks are categorized into those related to the business, government regulation, intellectual property, and the company's securities [Risks Related to Our Business](index=46&type=section&id=Risks%20Related%20to%20Our%20Business) This section details risks inherent to the company's operations, product development, manufacturing, and financial sustainability - The company is substantially dependent on the success of its product candidates, particularly lifileucel, and cannot guarantee they will receive regulatory approval or be successfully commercialized[273](index=273&type=chunk) - Manufacturing of TIL therapies is complex and susceptible to product loss, contamination, and scalability issues. Difficulties with the Gen 2 manufacturing process or potency assays could delay or prevent BLA approval[332](index=332&type=chunk)[334](index=334&type=chunk) - The company may need additional financing to fund operations and commercialization. As of **June 30, 2023**, the company had an accumulated deficit of **$1.8 billion**[356](index=356&type=chunk)[269](index=269&type=chunk) - The business faces significant competition from other biotechnology companies developing advanced T-cell therapies, immunotherapies, and novel IL-2 treatments[390](index=390&type=chunk)[392](index=392&type=chunk) [Risks Related to Government Regulation](index=79&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section discusses regulatory challenges, approval processes, and compliance requirements affecting the company's products - The FDA regulatory approval process is lengthy, time-consuming, and uncertain. The BLA for lifileucel was accepted with a PDUFA date of **November 25, 2023**, but approval is not guaranteed[470](index=470&type=chunk) - Even if approved, products will be subject to ongoing regulatory obligations, including potential post-marketing studies (like the TILVANCE-301 confirmatory trial) and REMS, which can be costly and limit commercial prospects[414](index=414&type=chunk)[479](index=479&type=chunk) - Coverage and reimbursement from third-party payors (government and private) are critical for commercial success but may be limited or unavailable, making it difficult to sell products profitably[498](index=498&type=chunk) [Risks Related to Our Intellectual Property](index=87&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses risks related to protecting and enforcing the company's patents and intellectual property rights - The company may be involved in expensive and time-consuming lawsuits to protect its patents or defend against infringement claims, and an adverse result could invalidate or narrow the scope of its patent protection[523](index=523&type=chunk) - Patent law in the biotechnology field is complex and evolving, creating uncertainty about the strength and enforceability of the company's licensed and owned patents[530](index=530&type=chunk) - The company has limited foreign intellectual property rights, which may not be sufficient to prevent competitors from practicing its inventions or selling competing products in markets outside the U.S[541](index=541&type=chunk) [Risks Related to Our Securities](index=91&type=section&id=Risks%20Related%20to%20Our%20Securities) This section highlights factors that could impact the market price and liquidity of the company's common stock - The market price of the company's common stock is likely to be volatile due to factors such as clinical trial results, regulatory developments, and market conditions[546](index=546&type=chunk) - Future sales of common stock, including under the ATM program or other offerings, could cause the stock price to fall and result in substantial dilution to existing stockholders[547](index=547&type=chunk) - Provisions in the company's charter documents and Delaware law could discourage or prevent a change in control, potentially limiting the stock price[561](index=561&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=94&type=section&id=Other%20Items) This concluding section of the report confirms that there were no unregistered sales of securities, defaults upon senior securities, or mine safety disclosures during the period. It also states that no directors or executive officers adopted or terminated a Rule 10b5-1 trading plan in the second quarter of 2023. The section concludes with an index of exhibits filed with the report - There were no unregistered sales of securities, defaults upon senior securities, or mine safety disclosures to report for the period[569](index=569&type=chunk)[570](index=570&type=chunk)[571](index=571&type=chunk) - During the **second quarter of 2023**, no directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or a non-Rule 10b5-1 trading arrangement[572](index=572&type=chunk)