UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 28, 2025 Jade Biosciences, Inc. (Exact name of Registrant as specified in its charter) Nevada 001-40544 83-1377888 (State or other jurisdiction of incorporation) (Commission File Number) 221 Crescent St., Building 23 Suite 105 Waltham, MA 02453 (Address of principal executive offices) (Zi ...

Product Development - AV-101, the only product candidate in development, did not meet primary or secondary endpoints in the Phase 2b/Phase 3 IMPAHCT study, leading to the decision to halt its development[76][78]. - The successful development of future product candidates remains highly uncertain, with no estimated timelines or costs available[99]. Workforce and Expenses - As of March 31, 2025, approximately 92% of the workforce has been terminated, resulting in costs of approximately $6.5 million related to severance benefits[79]. - Research and development expenses have been incurred for shutting down clinical trials and operations following the halt of AV-101 development[98]. - Research and development expenses for Q1 2025 were $0.0 million, a decrease of $20.1 million compared to $20.1 million in Q1 2024, primarily due to the discontinuation of clinical operations[104]. - General and administrative expenses for Q1 2025 were $3.4 million, down from $4.5 million in Q1 2024, reflecting a decrease of $1.2 million mainly from reduced headcount-related costs[105]. - Total operating expenses for Q1 2025 were $3.4 million, a significant decrease of $21.2 million from $24.6 million in Q1 2024[103]. - Net loss for Q1 2025 was $2.5 million, compared to a net loss of $23.2 million in Q1 2024, representing an improvement of $20.7 million[103]. Financial Position - Cash and cash equivalents and short-term investments as of March 31, 2025, totaled $76.2 million, expected to fund operations for at least the next twelve months[110]. - Net cash used in operating activities for Q1 2025 was $2.4 million, a significant reduction from $23.7 million in Q1 2024[119]. - Net cash provided by investing activities for Q1 2025 was $12.9 million, compared to $8.8 million in Q1 2024[121]. - The company has received aggregate net proceeds of $79.8 million from the sale of convertible preferred stock and $5.0 million from convertible promissory notes to related parties since inception[107]. - As of March 31, 2025, approximately $6.0 million of shares remain available for sale under the At-the-Market Offering Program[109]. - The company’s future capital requirements will depend on the costs and timing of the Merger and any future product development efforts[111]. Merger and Corporate Actions - A merger agreement was entered into on October 30, 2024, with Jade Biosciences, Inc., involving a two-step merger process[80][82]. - The merger is expected to qualify as a tax-free reorganization under Section 368(a) of the Internal Revenue Code[80]. - The merger is subject to closing conditions, including stockholder approvals and Nasdaq's approval for listing shares[86]. - A special cash dividend of $69.6 million, or approximately $2.40 per share, was declared, payable to stockholders of record as of April 25, 2025[92]. - An "at-the-market" offering program was established to sell up to $75.0 million of common stock, generating $67.9 million in net proceeds as of March 31, 2025[95]. Market Risks and Economic Factors - The company does not believe that interest rate fluctuations have had a material effect on its results of operations during the three months ended March 31, 2025 and 2024[127]. - The company is exposed to market risk related to changes in foreign currency exchange rates but does not currently hedge this risk, believing it has not materially affected operations during the three months ended March 31, 2025 and 2024[128]. - Inflation has generally increased the company's cost of labor and research and development contract costs, but it does not believe inflation has had a material impact on its financial position or results of operations to date[129]. - The company may experience some effects from rising inflation rates in the near future, particularly on clinical trial costs and labor costs to attract and retain qualified personnel[129].

Core Viewpoint - Aerovate Therapeutics, Inc. has declared a special cash dividend of $69.6 million, approximately $2.40 per share, in connection with its merger with Jade Biosciences, Inc. [1] Company Overview - Aerovate Therapeutics is a biotechnology company focused on improving the lives of patients with rare cardiopulmonary diseases [5] - Jade Biosciences is developing therapies for autoimmune diseases, with its lead asset targeting IgA nephropathy [6] Dividend Details - The cash dividend will be payable to stockholders of record as of April 25, 2025, with a payment date scheduled for April 29, 2025 [1] - The estimated per share dividend is based on 28,985,019 shares of Aerovate's common stock outstanding as of April 9, 2025 [1] Merger Information - The payment of the cash dividend is contingent upon the closing of the merger, expected to occur around April 28, 2025, pending stockholder approval [3] - A special meeting for Aerovate's stockholders to vote on the merger is scheduled for April 16, 2025 [3]

Core Viewpoint - Aerovate Therapeutics, Inc. expects to declare a cash dividend of approximately $67.6 to $69.6 million to pre-Merger stockholders in connection with its merger with Jade Biosciences, Inc. [1][2] Company Overview - Aerovate Therapeutics is a biotechnology company focused on improving the lives of patients with rare cardiopulmonary diseases [4] - Jade Biosciences is developing therapies for autoimmune diseases, with its lead asset targeting immunoglobulin A nephropathy [5] Merger Details - The cash dividend is contingent upon the approval of Aerovate's board of directors and is expected to be announced later in April 2025 [2] - A special meeting for Aerovate's stockholders to vote on the merger is scheduled for April 16, 2025, with the closing expected by April 30, 2025 [2][3] Financial Information - As of April 4, 2025, there are 28,985,019 shares of Aerovate's common stock outstanding [1]

Development and Clinical Trials - Aerovate Therapeutics halted the development of AV-101 after the Phase 2b trial did not meet its primary endpoint for improvement in pulmonary vascular resistance (PVR) compared to placebo[22]. - The Phase 2b trial results showed no meaningful improvements in the secondary endpoint of change in six-minute walk distance (6MWD) across all dose groups[38]. - The company has halted enrollment in the Phase 3 clinical trial for AV-101 and is not currently pursuing further clinical development of this product[198]. - The biotechnology and pharmaceutical industries are characterized by intense competition, with the company halting enrollment in the Phase 3 study of AV-101 in PAH as of June 2024[60]. Workforce and Financial Impact - Approximately 92% of Aerovate's workforce, totaling 47 individuals, were terminated as part of the Workforce Reduction Plan, incurring costs of approximately $6.7 million[23]. - The company is undertaking a comprehensive review of strategic alternatives, which may include the merger or other transactions to maximize shareholder value[198]. - If the merger is not completed, the company may face significant costs, including legal and accounting fees, which will reduce cash available for business operations[199]. - The company may incur a termination fee of $2.34 million to Jade or vice versa, depending on the circumstances of the merger agreement termination[212]. Merger Agreement and Financial Projections - Aerovate entered into a Merger Agreement with Jade Biosciences, with the intention of merging and creating a surviving corporation[24]. - A cash dividend of approximately $65.0 million is expected to be declared to pre-Merger stockholders upon the closing of the merger[25]. - The Concurrent Investment prior to the merger is expected to raise approximately $300.0 million, reflecting the conversion of previously issued $95 million of convertible notes[30]. - The merger could result in Jade's securityholders owning approximately 34.0% of the company's common stock on a fully-diluted basis, while the company's securityholders would own about 1.6%[195]. - The completion of the merger is subject to stockholder approvals, and failure to obtain these approvals may delay or prevent the merger[197]. Intellectual Property and Patent Strategy - Aerovate's intellectual property portfolio includes six U.S. patents and 19 foreign patent applications, with expiration expected between May 14, 2040, and February 15, 2042[45]. - The company has multiple patents related to AV-101, with expiration dates projected for May 14, 2040, in various jurisdictions including the US, Europe, China, and Japan[46][47]. - The intellectual property strategy includes proprietary patent rights for drug products, treatment methods, and innovative manufacturing processes[48]. - The company has conducted freedom to operate analyses to ensure its ability to operate within the complex patent landscape of inhalable kinase inhibitors[50]. Regulatory Environment - The FDA regulates pharmaceutical products extensively, impacting all stages from research to marketing[63]. - The FDA requires extensive preclinical and clinical testing before a new drug can be marketed, which can take many years[66]. - An IND application must become effective within 30 days unless the FDA raises safety concerns, which can delay clinical trials[68]. - The FDA has a goal of responding to standard NDAs within ten months and six months for priority reviews after acceptance for filing[80]. - Approval of a product may include limitations on its indicated uses and may require post-market studies to monitor safety and efficacy[84]. Market and Competitive Landscape - The global sales for PAH products in 2023 were estimated at $6.2 billion, highlighting the market potential despite the high five-year survival rate of 61% to 65% for PAH patients[35]. - Key competitive factors for the company's products include efficacy, safety, convenience, price, and reimbursement availability[62]. - The company faces risks related to third-party patent infringements, which could require obtaining licenses or ceasing commercialization of infringing products[59]. Corporate Governance and Compliance - The company is classified as an "emerging growth company" and will retain this status until it meets certain revenue or market value thresholds, including total annual gross revenue of at least $1.235 billion or a market value exceeding $700 million[184]. - The company is subject to various financial disclosure and securities trading regulations as a public entity, including oversight by the SEC and compliance with Nasdaq regulations[174]. - The company must comply with the Foreign Corrupt Practices Act, which prohibits corrupt payments to foreign officials to obtain or retain business[175]. - The company is subject to numerous data privacy and security laws, including HIPAA and GDPR, which govern the handling of personal information and health-related data[173]. Employee Relations and Culture - The company is committed to fostering a diverse workforce and a culture of inclusion, aiming to empower employees for professional growth and long-term job satisfaction[180]. - The company has objectives focused on recruiting, retaining, and incentivizing employees to enhance stockholder value and achieve business goals[179]. Legislative and Policy Changes - The Inflation Reduction Act of 2022 may affect the healthcare industry by reducing out-of-pocket costs for Medicare beneficiaries and allowing government negotiation of drug prices[168]. - The pricing and reimbursement landscape in the EU allows member states to control prices and reimbursement for medicinal products, often requiring evidence of cost-effectiveness[155].

Workforce Reduction and Costs - The company halted the development of AV-101 for pulmonary arterial hypertension (PAH) after the Phase 2b trial did not meet its primary endpoint, resulting in the termination of nearly 90% of its workforce by September 30, 2024[83][84]. - The company incurred approximately $6.4 million in costs related to the Workforce Reduction Plan, primarily for one-time severance benefits[84]. Financial Performance - Total operating expenses for the three months ended September 30, 2024, were $17.4 million, a decrease of $3.96 million compared to $21.37 million for the same period in 2023[104]. - Research and development expenses decreased to $10.3 million for the three months ended September 30, 2024, down from $16.9 million in the same period in 2023, primarily due to reductions in contract manufacturing and clinical trial costs[104]. - The net loss for the three months ended September 30, 2024, was $16.2 million, an improvement of $3.3 million compared to a net loss of $19.6 million in the same period in 2023[104]. - General and administrative expenses for the nine months ended September 30, 2024, were $16.5 million, an increase of $3.6 million compared to $12.9 million for the same period in 2023[109]. - Research and development expenses for the nine months ended September 30, 2024, were $51.7 million, up from $46.4 million in 2023, reflecting an increase of $5.3 million[108]. - Total operating expenses for the nine months ended September 30, 2024, were $68.2 million, compared to $59.3 million for the same period in 2023, marking an increase of $8.9 million[107]. - Net loss for the nine months ended September 30, 2024, was $64.2 million, compared to a net loss of $55.1 million in 2023, representing an increase of $9.1 million[121]. - Other income for the nine months ended September 30, 2024, was $4.0 million, a decrease of $0.2 million from $4.2 million in 2023[110]. Cash and Financing Activities - Cash and cash equivalents and short-term investments as of September 30, 2024, totaled $88.7 million, expected to fund operations for at least twelve months[114]. - The company has received aggregate net proceeds of $79.8 million from the sale of convertible preferred stock and $5.0 million from convertible promissory notes to related parties since inception[111]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $60.1 million, compared to $42.0 million in 2023, indicating an increase in cash outflow[121]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $24.9 million, down from $45.5 million in 2023[126]. Future Operations and Revenue - The company currently has no products approved for sale and does not anticipate generating revenue in the near future[96]. - The successful development of any future product candidates remains highly uncertain, impacting the company's ability to generate future revenue[100]. - The company entered into a Merger Agreement on October 30, 2024, which is expected to significantly impact future operations[112]. Economic Factors - The company has opted out of the extended transition period under the JOBS Act, meaning it will adopt new or revised accounting standards at the same time as public companies[131]. - The company does not believe that interest rate fluctuations have had a material effect on its results of operations during the nine months ended September 30, 2024 and 2023[134]. - The company is exposed to foreign currency exchange rate fluctuations due to contracts with vendors outside the United States, but does not currently hedge this risk[135]. - Inflation has generally increased the company's cost of labor and research and development contract costs, but it does not believe inflation has had a material impact on its financial position or results of operations to date[136]. Accounting and Reporting - The company reflects research and development expenses in its consolidated financial statements by matching those expenses with the period in which services are expended[130].

Group 1 - Monteverde & Associates PC is investigating Aerovate Therapeutics, Inc. regarding a proposed merger with Jade Biosciences, where pre-merger Aerovate stockholders are expected to own approximately 1.6% of the combined company, while pre-merger Jade stockholders are expected to own approximately 98.4% [1] - Monteverde & Associates PC has been recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report and has a successful track record in recovering money for shareholders [1][2] - The firm operates from the Empire State Building in New York City and emphasizes its experience in class action securities litigation [2][3] Group 2 - The firm encourages shareholders with concerns regarding the merger to contact them for additional information free of charge [3] - Monteverde & Associates PC highlights the importance of legal representation in class actions and provides contact information for inquiries [4]

Core Insights - Monteverde & Associates PC is investigating Aerovate Therapeutics, Inc. regarding a proposed merger with Jade Biosciences, where pre-merger Aerovate stockholders are expected to own approximately 1.6% of the combined company, while pre-merger Jade stockholders are expected to own approximately 98.4% of the combined entity [1]. Company Overview - Monteverde & Associates PC is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report and has a successful track record in recovering money for shareholders [1][2]. - The firm operates from the Empire State Building in New York City and specializes in class action securities litigation [2]. Legal Context - The firm emphasizes that no company, director, or officer is above the law, indicating a commitment to shareholder rights and legal accountability [3].

Group 1 - Halper Sadeh LLC is investigating Aerovate Therapeutics, Inc. for potential violations related to its merger with Jade Biosciences, where Aerovate stockholders are expected to own approximately 1.6% of the combined company after the transaction closes [1] - Profire Energy, Inc. is being sold to CECO Environmental Corp. for $2.55 per share in cash [2] - The firm may seek increased consideration for shareholders and additional disclosures regarding the proposed transactions [3] Group 2 - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options, with the firm representing investors globally who have experienced securities fraud and corporate misconduct [4]

Financial Performance - The company reported a net loss of $24.8 million for Q2 2024, compared to a net loss of $19.0 million in Q2 2023, representing an increase of $5.8 million[102]. - The company incurred a net loss of $48.0 million for the six months ended June 30, 2024, compared to a net loss of $35.5 million for the same period in 2023[123][124]. - Total operating expenses for the six months ended June 30, 2024, were $50.8 million, compared to $38.0 million for the same period in 2023, reflecting a $12.8 million increase[109]. - Research and development expenses for Q2 2024 were $21.2 million, an increase of $5.2 million from $16.0 million in Q2 2023, primarily due to increased headcount and contract manufacturing costs[103]. - General and administrative expenses for Q2 2024 were $4.9 million, up from $4.3 million in Q2 2023, mainly due to increased headcount-related costs[104]. Workforce and Cost Management - As of July 31, 2024, the company terminated 69% of its workforce, resulting in an estimated cost of $5.6 million primarily for severance benefits[89]. - The company has generated no revenue to date and does not anticipate generating revenue in the near future due to the cessation of product development[93]. Cash Flow and Financing - Net cash used in operating activities for the six months ended June 30, 2024 was $44.1 million, compared to $26.4 million for the same period in 2023, indicating a significant increase in cash outflow[123][124]. - Net cash provided by investing activities for the six months ended June 30, 2024 was $26.8 million, up from $19.4 million in 2023, reflecting improved cash inflow from short-term investments[125]. - Net cash provided by financing activities for the six months ended June 30, 2024 was $24.9 million, a decrease from $45.5 million in 2023, showing reduced capital raised through financing[126]. - The company expects to finance future capital needs through equity offerings, debt financings, or collaborations, but may face challenges in raising funds on favorable terms[118]. Strategic Review and Development - The company is conducting a comprehensive review of strategic alternatives to maximize shareholder value, which may include mergers or acquisitions[88]. - The company may need to delay or limit product development if unable to raise additional funds when needed, which could negatively impact its business plans[118]. - The company halted the development of AV-101 for pulmonary arterial hypertension (PAH) after the Phase 2b trial did not meet its primary endpoint, impacting approximately 70,000 people in the U.S. and Europe[88]. Lease Obligations - The base rent for the Waltham Lease is $43.00 per rentable square foot, totaling approximately $18,000 per month, with annual increases of $1.00 per square foot[119]. - The Foster City Lease has a base rent of $76.80 per rentable square foot, amounting to approximately $22,600 per month, with scheduled annual increases of 3%[120]. - As of June 30, 2024, the company reported no other operating lease obligations, long-term debt obligations, or capital lease obligations[120]. Market Risks - The company is exposed to market risks related to interest rate fluctuations, foreign currency exchange rates, and inflation, but does not believe these have materially affected operations in the recent periods[133][136][137]. - The company has sold 3,462,721 shares under its ATM program, generating $67.9 million in net proceeds, with $6.0 million remaining available for sale[90][91].