Core Viewpoint - Rosen Law Firm has announced a class action lawsuit on behalf of investors who purchased securities of Jasper Therapeutics, Inc. during the specified Class Period from November 30, 2023, to July 3, 2025, due to alleged misleading statements and failures to disclose critical information [1][5]. Group 1: Lawsuit Details - The lawsuit claims that Jasper Therapeutics lacked necessary controls and procedures for third-party manufacturers, which could lead to non-compliance with cGMP regulations [5]. - It is alleged that this failure increased the risk of confounding results in ongoing studies, negatively impacting the regulatory and commercial prospects of Jasper's products, particularly briquilimab [5]. - The lawsuit asserts that Jasper's business and financial prospects were overstated, and public statements made by the defendants were materially false and misleading [5]. Group 2: Class Action Participation - Investors who purchased Jasper Therapeutics securities during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - To join the class action, interested parties can visit the provided link or contact the law firm directly for more information [3][6]. - A lead plaintiff must be appointed by November 18, 2025, to represent the interests of other class members in the litigation [1][3]. Group 3: Rosen Law Firm Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements and has recovered hundreds of millions of dollars for investors [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability and experience in handling such cases [4].

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces that an investor filed a class action lawsuit on behalf of purchasers of securities of Jasper Therapeutics, Inc. (NASDAQ: JSPR), between November 30, 2023 and July 3, 2025, both dates inclusive (the "Class Period†). Jasper is a clinical-stage biotechnology company. For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investigat. ...

Core Viewpoint - A class action lawsuit has been filed against Jasper Therapeutics, Inc. for allegedly misleading investors regarding the commercial prospects of its lead product candidate, briquilimab [1][2]. Group 1: Allegations - The lawsuit claims that Jasper Therapeutics failed to disclose critical information about its manufacturing controls and procedures, which were necessary to ensure compliance with cGMP regulations [2]. - The lack of proper controls increased the risk of confounding results in ongoing studies, negatively impacting the regulatory and commercial prospects of the company's products, including briquilimab [2]. - This situation heightened the likelihood of disruptive cost-reduction measures, leading to an overstatement of the company's business and financial prospects [2]. Group 2: Stock Price Impact - Following the revelation of these issues on July 7, 2025, Jasper's stock price plummeted by $3.73 per share, representing a 55.1% decline, closing at $3.04 per share [3]. Group 3: Class Action Participation - Shareholders who purchased Jasper Therapeutics securities between November 30, 2023, and July 3, 2025, may be eligible to participate in the class action [1][4]. - Interested shareholders can contact Robbins LLP to serve as lead plaintiff or remain as absent class members without participating in the case [4].

Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - AGM Group Holdings Inc. (AGMH) increased by 185% to $6.36 [3] - AlphaVest Acquisition Corp (ATMV) rose by 77% to $26.80 [3] - Brera Holdings PLC (BREA) saw a 20% increase to $30.00 [3] - Asset Entities Inc. (ASST) gained 18% to $4.54 [3] - 22nd Century Group, Inc. (XXII) also increased by 18% to $2.08 [3] - Millennium Group International Holdings Limited (MGIH) rose by 16% to $2.84 [3] - Robo.ai Inc. (AIIO) increased by 11% to $2.17 [3] - Butterfly Network, Inc. (BFLY) saw a 10% rise to $2.10 [3] - GrafTech International Ltd. (EAF) increased by 9% to $13.91 [3] - Cardlytics, Inc. (CDLX) rose by 8% to $2.99 [3] Premarket Losers - ECD Automotive Design, Inc. (ECDA) decreased by 14% to $3.70 [4] - Champions Oncology, Inc. (CSBR) fell by 8% to $6.11 [4] - Beam Global (BEEM) saw an 8% decline to $2.79 [4] - Fathom Holdings Inc. (FTHM) decreased by 8% to $2.19 [4] - Ventyx Biosciences, Inc. (VTYX) fell by 7% to $2.20 [4] - SciSparc Ltd. (SPRC) decreased by 6% to $4.35 [4] - Lightwave Logic, Inc. (LWLG) fell by 6% to $3.45 [4] - Jasper Therapeutics, Inc. (JSPR) decreased by 6% to $2.43 [4] - StableX Technologies, Inc. (SBLX) fell by 5% to $5.67 [4] - Galecto, Inc. (GLTO) decreased by 5% to $2.70 [4]

Core Viewpoint - Jasper Therapeutics, Inc. has announced a public offering of common stock and warrants to raise approximately $30 million to support the development of briquilimab, a novel antibody therapy targeting mast cell driven diseases [1][3]. Group 1: Offering Details - The offering includes 11,670,707 shares of common stock priced at $2.43 per share, along with common warrants to purchase the same number of shares [1]. - Additionally, the offering includes pre-funded warrants for 675,000 shares, priced at $2.43 minus a nominal exercise price of $0.0001 per share [1][2]. - The gross proceeds from the offering are expected to be around $30 million, before deducting underwriting discounts and commissions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for the advancement of briquilimab's preclinical and clinical development programs, as well as for general corporate purposes, including capital expenditures and working capital [3]. Group 3: Company Overview - Jasper Therapeutics is focused on developing briquilimab as a treatment for chronic mast cell diseases, including chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [7]. - Briquilimab is a targeted aglycosylated monoclonal antibody that inhibits signaling through the KIT receptor, leading to the depletion of mast cells and addressing the inflammatory response in these diseases [7]. - The company is currently conducting clinical studies demonstrating the efficacy and safety of briquilimab in patients with CSU and CIndU [7].

REDWOOD CITY, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper”), a clinical-stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting KIT (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, announced today that it intends to offer and sell in an underwritten public offering, subject to market and other conditions, shares of its common ...

Jasper Therapeutics (JSPR) 2025 Conference September 03, 2025 01:00 PM ET Speaker0Welcome to the Cantor Global Healthcare Conference. I am Pete Stavropoulos, a biotech analyst with Cantor. With us we have Jasper Therapeutics, a company I cover. I'm pleased to introduce Ron Martell, the CEO. So welcome, Ron.And now let's start off with an introduction of yourself and a brief description of Jasper for those not familiar.Speaker1Pete, well, on behalf of all of my colleagues at Jasper, we'd really like to thank ...

[Corporate Update and Business Highlights](index=1&type=section&id=Corporate%20Update%20and%20Business%20Highlights) The company provided updates on briquilimab's clinical efficacy and ongoing investigation into atypical results, alongside a significant corporate restructuring to focus on mast cell-driven diseases [Management Commentary](index=1&type=section&id=Management%20Commentary) Management expressed confidence in briquilimab's potential for mast cell-driven diseases, while addressing an ongoing investigation into atypical efficacy results in specific BEACON study cohorts - The CEO highlighted strong data showing briquilimab's potential, with complete responses in **89% of patients** in certain BEACON study cohorts, **73%** in an open-label extension, and **92%** in the SPOTLIGHT CIndU study[2](index=2&type=chunk) - An investigation is underway for two BEACON study cohorts (**240mg Q8W** and **240mg/180mg Q8W**) that did not show expected efficacy. The company is exploring various causes and plans to redose affected patients and enroll new ones, with an update expected later in the year[2](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Robust efficacy data for briquilimab in CSU and CIndU was presented, though an investigation into anomalous BEACON study results has delayed the Phase 2b CSU study and paused asthma trial enrollment Briquilimab Efficacy Data Highlights | Study/Cohort | Indication | Key Efficacy Result | | :--- | :--- | :--- | | BEACON (240mg & 360mg single-dose) | CSU | 89% (8 of 9) achieved complete response (UAS7=0) | | Open-Label Extension (180mg Q8W) | CSU | 73% (8 of 11) maintained complete response at 12 weeks | | SPOTLIGHT (180mg) | CIndU | 92% (11 of 12) achieved complete response | - An investigation was initiated for the **240mg Q8W** and **240mg/180mg Q8W** BEACON cohorts due to an atypical absence of UAS7 reduction. The company is assessing potential product lot variability, as all **10 patients** dosed from one specific lot failed to show a response[6](index=6&type=chunk) - Due to the ongoing investigation, the planned Phase 2b CSU study is now expected to commence in **mid-2026**. Enrollment in the ETESIAN asthma study has been halted pending the investigation's outcome[6](index=6&type=chunk) - Across studies, briquilimab was reported to be well-tolerated with no dose-limiting toxicities. Any adverse events were generally low-grade and did not lead to discontinuations[3](index=3&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Jasper implemented a significant corporate restructuring, including a **50% workforce reduction**, to preserve capital and focus resources on its core urticaria programs - The company executed a corporate restructuring, reducing its workforce by approximately **50%** to focus resources on its urticaria programs and preserve capital[6](index=6&type=chunk) - All non-mast cell focused clinical and preclinical programs, including investigator-sponsored trials and the SCID clinical program, have been halted[6](index=6&type=chunk) - As part of the reorganization, Dr. Edwin Tucker stepped down as Chief Medical Officer and was succeeded on an interim basis by Dr. Daniel Adelman[6](index=6&type=chunk) [Second Quarter Fiscal 2025 Financial Results](index=2&type=section&id=Second%20Quarter%20Fiscal%202025%20Financial%20Results) The company reported a widened net loss for Q2 2025, driven by increased R&D expenses, with a significant decrease in cash and total assets [Financial Highlights](index=2&type=section&id=Financial%20Highlights) For the second quarter of 2025, Jasper Therapeutics reported a net loss of **$26.7 million** and ended the period with **$39.5 million** in cash and cash equivalents Q2 2025 Financial Summary | Metric | Amount | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $39.5 million | | Research and development expense | $21.2 million | | General and administrative expense | $5.9 million | | Net loss | $26.7 million | | Net loss per share | $1.74 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's net loss widened to **$26,723 thousand** for the three months ended June 30, 2025, from **$14,583 thousand** in the same period of 2024, primarily due to a substantial increase in research and development expenses to **$21,196 thousand** from **$11,296 thousand** year-over-year Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | $37,353 | $21,594 | | General and administrative | $5,880 | $4,697 | $11,525 | $9,471 | | **Total operating expenses** | **$27,076** | **$15,993** | **$48,878** | **$31,065** | | Loss from operations | $(27,076) | $(15,993) | $(48,878) | $(31,065) | | **Net loss** | **$(26,723)** | **$(14,583)** | **$(47,964)** | **$(28,311)** | | Net loss per share | $(1.74) | $(0.97) | $(3.16) | $(2.00) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Jasper Therapeutics had total assets of **$46,466 thousand**, a significant decrease from **$79,899 thousand** at the end of 2024, primarily due to reduced cash and cash equivalents Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,510 | $71,637 | | Total current assets | $42,966 | $75,811 | | **Total assets** | **$46,466** | **$79,899** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $20,500 | $15,237 | | **Total liabilities** | **$22,965** | **$18,225** | | **Total stockholders' equity** | **$23,501** | **$61,674** | [About Jasper](index=2&type=section&id=About%20Jasper) Jasper is a clinical-stage biotechnology company focused on developing briquilimab for mast cell-driven diseases like CSU, CIndU, and asthma - Jasper is a clinical-stage biotechnology company focused on developing briquilimab, a monoclonal antibody targeting the c-Kit receptor to deplete mast cells[5](index=5&type=chunk) - The company's primary therapeutic areas of focus are mast cell-driven diseases, including chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma[5](index=5&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements regarding clinical development and timelines, which are subject to numerous risks and uncertainties - This report contains forward-looking statements regarding briquilimab's potential, clinical trial timelines, and the expected completion of investigations. These statements are subject to numerous risks and uncertainties[7](index=7&type=chunk) - Key risks include potential failures in clinical development, inconclusive investigation results, inability to raise capital, and the possibility that prior trial results may not be replicated in future studies[7](index=7&type=chunk)

Core Viewpoint - Jasper Therapeutics is focused on developing briquilimab, a novel antibody therapy targeting mast cell-driven diseases, with promising clinical results reported for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [1][2]. Clinical Development - Briquilimab demonstrated a complete response rate of 89% in the BEACON study for CSU patients receiving 240 mg and 360 mg single doses [2][3]. - In the open-label extension study, 73% of patients maintained a complete response at 12 weeks with 180 mg dosed every 8 weeks [3]. - The SPOTLIGHT study showed a 92% complete response rate in CIndU patients at the 180 mg dose, with rapid onset of action observed [3]. Safety and Tolerability - Briquilimab has shown a favorable safety profile, with no dose-limiting toxicities reported and adverse events being low grade and infrequent [3][4]. - Ongoing investigations are being conducted to understand the lack of UAS7 reduction in certain cohorts, with no safety signals observed that would impede further dosing [3][6]. Financial Performance - For the second quarter of fiscal 2025, Jasper reported a net loss of $26.7 million, with a basic and diluted net loss per share of $1.74 [6][10]. - Research and development expenses for the quarter were $21.2 million, while general and administrative expenses totaled $5.9 million [6][10]. Corporate Restructuring - The company implemented a workforce reduction of approximately 50% to focus resources on its urticaria programs and preserve capital [6]. - Non-mast cell focused clinical and preclinical programs have been halted to concentrate on briquilimab development [6]. Cash Position - As of June 30, 2025, Jasper had cash and cash equivalents totaling $39.5 million, down from $71.6 million at the end of 2024 [6][13].

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section presents the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show a significant increase in net loss and cash used in operations compared to the prior year, with substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Items (in thousands) | Balance Sheet Items (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,510 | $71,637 | | Total current assets | $42,966 | $75,811 | | Total assets | $46,466 | $79,899 | | **Liabilities & Equity** | | | | Total current liabilities | $20,500 | $15,237 | | Total liabilities | $22,965 | $18,225 | | Accumulated deficit | $(288,833) | $(240,869) | | Total stockholders' equity | $23,501 | $61,674 | - Cash and cash equivalents decreased by **44.8%** from **$71.6 million** at the end of 2024 to **$39.5 million** as of June 30, 2025, reflecting significant cash burn from operations[10](index=10&type=chunk) - Total stockholders' equity declined by **61.9%** to **$23.5 million** from **$61.7 million** at year-end 2024, primarily driven by the net loss incurred during the first six months of 2025[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results (in thousands) | Operating Results (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | $37,353 | $21,594 | | General and administrative | $5,880 | $4,697 | $11,525 | $9,471 | | **Total operating expenses** | **$27,076** | **$15,993** | **$48,878** | **$31,065** | | Loss from operations | $(27,076) | $(15,993) | $(48,878) | $(31,065) | | **Net loss** | **$(26,723)** | **$(14,583)** | **$(47,964)** | **$(28,311)** | - Net loss for the second quarter of 2025 increased by **83.2%** year-over-year to **$26.7 million**, driven by an **87.6%** increase in Research and Development expenses[13](index=13&type=chunk) Per Share Data | Per Share Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss per share, basic and diluted | $(1.74) | $(0.97) | $(3.16) | $(2.00) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,295) | $(27,416) | | Net cash provided by (used in) investing activities | $5 | $(182) | | Net cash provided by financing activities | $6,163 | $47,530 | | **Net (decrease) increase in cash** | **$(32,127)** | **$19,932** | | Cash at beginning of period | $72,054 | $87,304 | | **Cash at end of period** | **$39,927** | **$107,236** | - Net cash used in operating activities increased by **39.7%** to **$38.3 million** for the first six months of 2025, compared to **$27.4 million** in the same period of 2024, reflecting higher operating losses[20](index=20&type=chunk) - Cash from financing activities was significantly lower in the first half of 2025 (**$6.2 million** from ATM offering) compared to the first half of 2024 (**$47.5 million** from an underwritten offering), contributing to the large net decrease in cash[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has concluded that substantial doubt exists about its ability to continue as a going concern, as existing cash and cash equivalents of **$39.5 million** are not sufficient to fund operating plans for at least twelve months from the financial statement issuance date[28](index=28&type=chunk)[30](index=30&type=chunk) - In July 2025, the company implemented a corporate reorganization, including a workforce reduction of approximately **50%**, to extend its cash runway, focusing on briquilimab clinical programs in chronic urticaria and halting other programs, with an estimated cost of **$1.9 million** for the reduction[100](index=100&type=chunk)[101](index=101&type=chunk) - The company operates as a single reportable segment focused on the research and development of therapeutic products for chronic urticaria and asthma, with total program costs of **$25.5 million** for the six months ended June 30, 2025, a **107%** increase from **$12.3 million** in the prior year period[98](index=98&type=chunk)[99](index=99&type=chunk) - The company entered into an Open Market Sale Agreement (ATM Offering) in March 2025, raising net proceeds of approximately **$5.9 million** by June 30, 2025, with **$94.1 million** remaining available under the ATM prospectus as of that date[76](index=76&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing briquilimab for mast cell driven diseases, highlighting recent clinical data, an investigation into a drug product lot, and a subsequent corporate reorganization to extend the cash runway, while reiterating substantial doubt about the company's ability to continue as a going concern [Overview and Recent Developments](index=26&type=section&id=Overview%20and%20Recent%20Developments) - The company is a clinical-stage biotech focused on developing briquilimab, a monoclonal antibody targeting the c-Kit receptor on mast cells for diseases like Chronic Spontaneous Urticaria (CSU), Chronic Inducible Urticaria (CIndU), and asthma[110](index=110&type=chunk)[111](index=111&type=chunk) - An investigation is underway for a specific drug product lot used in the BEACON (CSU) and ETESIAN (asthma) studies, which showed an atypical lack of efficacy in certain patient cohorts, leading to halting enrollment in the ETESIAN study[116](index=116&type=chunk)[119](index=119&type=chunk) - On July 8, 2025, the company implemented a corporate reorganization, reducing its workforce by approximately **50%** to extend its cash runway and focus resources on its chronic urticaria clinical development programs[122](index=122&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Expense Comparison (in thousands) | Expense Comparison (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | +88% | | General and administrative | $5,880 | $4,697 | +25% | | **Total operating expenses** | **$27,076** | **$15,993** | **+69%** | - The **88%** increase in Q2 2025 R&D expenses was driven by a **$9.6 million** rise in program costs, including a **$4.1 million** increase in CRO expenses and a **$5.1 million** increase in CMO manufacturing costs to support clinical programs[143](index=143&type=chunk)[146](index=146&type=chunk) Expense Comparison (in thousands) | Expense Comparison (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $37,353 | $21,594 | +73% | | General and administrative | $11,525 | $9,471 | +22% | | **Total operating expenses** | **$48,878** | **$31,065** | **+57%** | - For the first six months of 2025, R&D expenses grew by **$15.8 million** (**73%**) year-over-year, primarily due to a **$13.2 million** increase in program costs related to advancing the CSU and asthma trials and higher CMO manufacturing expenses[151](index=151&type=chunk)[154](index=154&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had cash and cash equivalents of **$39.5 million**[158](index=158&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern within one year, given recurring losses and the current cash position relative to its operating plan[163](index=163&type=chunk) - The company will need to raise substantial additional funding to continue operations, with future financing potentially coming from equity or debt offerings, collaborations, or other arrangements, though there is no assurance of success[162](index=162&type=chunk)[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risk during the six months ended June 30, 2025 - There have been no material changes to the company's market risk exposure during the first six months of 2025[182](index=182&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[184](index=184&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[185](index=185&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other important information including legal proceedings, updated risk factors, equity sales, other disclosures, and a list of exhibits [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[187](index=187&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section updates and reiterates key risks to the business, including financial concerns about going concern, operational risks from clinical trial delays and reorganization, reliance on third parties, and market-related risks - **Financial Risk:** The company has a history of significant net losses and negative cash flows, expects to incur losses for the foreseeable future, and has substantial doubt about its ability to continue as a going concern[189](index=189&type=chunk)[201](index=201&type=chunk) - **Clinical Development Risk:** Delays in clinical trials are a major risk, highlighted by the investigation into a drug product lot used in the BEACON and ETESIAN studies that demonstrated an atypical absence of efficacy[206](index=206&type=chunk)[208](index=208&type=chunk) - **Operational Risk:** The July 2025 corporate reorganization and **~50%** workforce reduction may have unintended consequences, such as loss of expertise and reduced morale, and may not achieve the anticipated benefits[203](index=203&type=chunk) - **Third-Party Reliance Risk:** The company relies heavily on third parties like CROs to conduct clinical trials, and failures by these parties, such as potential manufacturing variability in the investigated drug lot, could substantially harm the business[221](index=221&type=chunk)[224](index=224&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[242](index=242&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or officers adopted or terminated any Rule 10b5-1 trading plans or other non-Rule 10b5-1 trading arrangements - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the fiscal quarter ended June 30, 2025[245](index=245&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - The report includes a list of exhibits filed, such as corporate governance documents and officer certifications required by the Sarbanes-Oxley Act[246](index=246&type=chunk)