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Aerovate Therapeutics(AVTE) - 2025 Q2 - Quarterly Report
2025-08-13 20:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ 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: 001-40544 Jade Biosciences, Inc. (Exact name of registrant as specified in its charter) Nevada 8 ...
Aerovate Therapeutics(AVTE) - 2025 Q2 - Quarterly Results
2025-08-13 20:14
[Executive Summary and Q2 2025 Highlights](index=1&type=section&id=Executive%20Summary) Jade Biosciences' Q2 2025 highlights include a reverse merger, significant financing, and JADE101 pipeline advancement [Q2 2025 Highlights and Strategic Direction](index=1&type=section&id=Q2%202025%20Highlights%20and%20Strategic%20Direction) Jade Biosciences reported a productive second quarter, marked by the closing of a reverse merger and significant financing, advancing its pipeline, particularly JADE101, towards clinical-stage development - Closed a reverse merger and significant financing during the quarter[2](index=2&type=chunk) - Continued to advance a pipeline aimed at delivering potentially best-in-class therapies for systemic and organ-specific autoimmune diseases[2](index=2&type=chunk) - Presented compelling preclinical data on JADE101, supporting its potential as a best-in-class disease-modifying therapy for IgA nephropathy (IgAN)[2](index=2&type=chunk) - Anticipates transitioning into a clinical-stage company in the coming months[2](index=2&type=chunk) [Pipeline and Corporate Updates](index=1&type=section&id=Pipeline%20and%20Corporate%20Updates) Jade Biosciences provided pipeline updates for JADE101 and JADE201, alongside a key corporate appointment [JADE101 Program Update](index=1&type=section&id=JADE101%3A%20potentially%20best-in-class%20anti-APRIL%20monoclonal%20antibody%20for%20IgA%20nephropathy%20%28IgAN%29) Jade Biosciences provided a comprehensive update on JADE101, its lead candidate for IgA nephropathy, highlighting strong preclinical data and outlining the plan for its Phase 1 clinical trial [Preclinical Data and Mechanism](index=1&type=section&id=JADE101%20Preclinical%20Data) Preclinical data for JADE101 demonstrated ultra-high APRIL binding affinity, potent inhibition of APRIL signaling, and sustained IgA suppression, supporting its potential for best-in-class activity and convenient dosing - Presented preclinical data for JADE101 at the 62nd European Renal Association Congress[4](index=4&type=chunk)[5](index=5&type=chunk) - JADE101 showed **ultra-high APRIL binding affinity (~50 femtomolar KD, >750-fold higher than sibeprenlimab)** and potent, complete inhibition of APRIL signaling in vitro[5](index=5&type=chunk) - Demonstrated deep, sustained IgA suppression with an extended half-life of approximately **27 days** after a single **30 mg/kg intravenous dose** in non-human primates (NHPs)[5](index=5&type=chunk) - Pharmacokinetic (PK) profile in NHPs supports potential for convenient, infrequent subcutaneous dosing (no more than every eight weeks) in clinical settings[5](index=5&type=chunk) - Binds a unique epitope on trimeric APRIL protein, selected to avoid high molecular weight immune complexes, aiming for predictable PK and reduced immunogenicity risk[5](index=5&type=chunk) [Clinical Development Plan](index=1&type=section&id=JADE101%20Clinical%20Development%20Plan) The Phase 1 clinical trial for JADE101 is set to begin in Q3 2025, with interim data expected in the first half of 2026 to inform later-stage studies - Phase 1 healthy-volunteer study of JADE101, administered as a subcutaneous injection, is expected to begin in the **third quarter of 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) - Interim, biomarker-rich data are anticipated in the **first half of 2026**, intended to guide dose and dose interval selection for later-stage JADE101 studies in IgAN patients[4](index=4&type=chunk)[5](index=5&type=chunk) [JADE201 Program Update](index=2&type=section&id=JADE201%3A%20development%20candidate%20from%20the%20JADE-002%20antibody%20discovery%20program) JADE201, a development candidate from the JADE-002 program, is on track to enter the clinic in the first half of 2026, with potential applications in multiple systemic autoimmune diseases - JADE201, the development candidate from the JADE-002 antibody discovery program, remains on track to enter the clinic in the **first half of 2026**[8](index=8&type=chunk) - JADE201 has the potential to be evaluated in multiple systemic autoimmune diseases[8](index=8&type=chunk) - Further details on JADE201 are expected to be disclosed in the **second half of 2025**[8](index=8&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate) Jade Biosciences announced the appointment of Brad Dahms as its new Chief Financial Officer - Appointed Brad Dahms as Chief Financial Officer (CFO), an accomplished biopharmaceutical executive with extensive experience in CFO and senior leadership roles[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Jade Biosciences reported its Q2 2025 financial results, detailing a net loss and a robust cash position [Financial Summary](index=2&type=section&id=Financial%20Summary) Jade Biosciences reported a net loss of $32.1 million for Q2 2025, supported by $220.9 million in cash and cash equivalents, with R&D and G&A expenses totaling $22.5 million and $5.2 million respectively Q2 2025 Key Financial Metrics | Metric | Q2 2025 (in millions) | | :------------------------------------ | :-------------------- | | Cash & Cash Equivalents (as of June 30, 2025) | $220.9 | | Research and Development (R&D) expenses | $22.5 | | General and Administrative (G&A) expenses | $5.2 | | Other expenses, net | $4.4 | | Net loss | $(32.1) | | Shares Outstanding (as of June 30, 2025) | 52.6 | - Cash and cash equivalents of **$220.9 million** as of June 30, 2025, supports cash runway through the **end of 2027**, including multiple clinical inflection points[4](index=4&type=chunk)[8](index=8&type=chunk) - Net loss totaled **$32.1 million** for the second quarter of 2025, which includes non-cash stock-based compensation of **$4.0 million**[8](index=8&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The balance sheet shows a significant increase in cash and total assets, and a shift from a stockholders' deficit to a positive equity position, primarily driven by recent financing activities Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $220,942 | $69,386 | +$151,556 | | Other assets | $3,026 | $3,413 | -$387 | | Total assets | $223,968 | $72,799 | +$151,169 | | Total liabilities | $22,412 | $119,596 | -$97,184 | | Total convertible preferred stock and stockholders' equity (deficit) | $201,556 | $(46,797) | +$248,353 | - Cash and cash equivalents increased by **$151.6 million** from December 31, 2024, to June 30, 2025[14](index=14&type=chunk) - Total liabilities decreased significantly by **$97.2 million**, while total stockholders' equity shifted from a deficit of **$(46.8) million** to a positive **$201.6 million**[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) The company reported a net loss of $32.1 million for Q2 2025 and $70.3 million for the six months ended June 30, 2025, driven by increased R&D and G&A expenses, and a significant expense from the change in fair value of convertible notes Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Period from June 18, 2024 (Inception) Through June 30, 2024 | | :-------------------------------------------------------------------------------- | :------------------------------- | :----------------------------- | :---------------------------------------------------------- | | Research and development | $22,547 | $42,570 | $78 | | General and administrative | $5,231 | $8,592 | $512 | | Total operating expenses | $27,778 | $51,162 | $590 | | Loss from operations | $(27,778) | $(51,162) | $(590) | | Interest income | $1,828 | $2,443 | — | | Change in fair value of Convertible Notes payable | $(6,184) | $(21,584) | — | | Total other expense, net | $(4,356) | $(19,141) | — | | Net loss | $(32,134) | $(70,303) | $(590) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.86) | $(3.45) | $(0.19) | - Research and development expenses increased substantially to **$22.5 million** for Q2 2025 and **$42.6 million** for the six months ended June 30, 2025, reflecting active pipeline development[8](index=8&type=chunk)[16](index=16&type=chunk) - Other expenses, net, for Q2 2025 included a **$6.2 million** expense from the change in fair value of convertible notes, partially offset by **$1.8 million** in interest income[8](index=8&type=chunk)[16](index=16&type=chunk) [About Jade Biosciences, Inc.](index=3&type=section&id=About%20Jade%20Biosciences%2C%20Inc.) Jade Biosciences is a biotech company developing best-in-class therapies for autoimmune diseases, with JADE101 as its lead [About Jade Biosciences, Inc.](index=3&type=section&id=About%20Jade%20Biosciences%2C%20Inc.) Jade Biosciences is a biotechnology company focused on developing best-in-class therapies for autoimmune diseases, with a pipeline including lead candidate JADE101 for IgA nephropathy and other preclinical programs - Focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases[9](index=9&type=chunk) - Lead candidate, JADE101, targets the cytokine APRIL for the treatment of immunoglobulin A nephropathy[9](index=9&type=chunk) - Pipeline also includes JADE201 and an undisclosed antibody discovery program, JADE-003, both in preclinical development[9](index=9&type=chunk) - Launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine[9](index=9&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a cautionary disclaimer for forward-looking statements about Jade's future pipeline and financial performance [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section serves as a cautionary disclaimer, indicating that certain statements about Jade's future pipeline, business, and financial performance are forward-looking and subject to various risks and uncertainties - Includes express or implied statements relating to Jade's expectations, hopes, beliefs, intentions, or strategies regarding the future of its pipeline and business[10](index=10&type=chunk) - Forward-looking statements involve risks and uncertainties that may cause actual results or performance to be materially different, such as trial delays, failure to demonstrate safety/efficacy, unanticipated costs, and regulatory approval issues[10](index=10&type=chunk) - Readers are cautioned not to place undue reliance on these statements, which speak only as of the date they are made, and Jade does not undertake any duty to release public updates or revisions[10](index=10&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) Contact details for media and investor inquiries regarding Jade Biosciences [Contact Information](index=4&type=section&id=Contact%20Information) Contact details for media and investor inquiries regarding Jade Biosciences - For media and investor inquiries, contact Priyanka Shah at Media@JadeBiosciences.com, IR@JadeBiosciences.com, or 908-447-6134[12](index=12&type=chunk)
Aerovate Therapeutics(AVTE) - 2025 Q1 - Quarterly Results
2025-05-14 20:12
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 ...
Aerovate Therapeutics(AVTE) - 2025 Q1 - Quarterly Report
2025-04-25 20:30
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].
Aerovate Therapeutics Stockholders Approve Proposed Merger with Jade Biosciences and All Related Proposals
Prnewswire· 2025-04-21 12:00
—Aerovate Board of Directors approves 1-for-35 reverse stock split— WALTHAM, Mass., April 21, 2025 /PRNewswire/ -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) ("Aerovate") today announced that its stockholders have approved the proposed merger (the "Merger") with Jade Biosciences, Inc. ("Jade"), along with all proposals related to the Merger. The proposals were voted upon at Aerovate's special meeting of stockholders held on April 16, 2025 (the "Special Meeting"), including a reverse stock split of Aerovate' ...
Aerovate Therapeutics Declares Special Cash Dividend in Connection with the Proposed Merger with Jade Biosciences
Prnewswire· 2025-04-09 20:05
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]
Aerovate Therapeutics Announces Range of Expected Cash Dividend in Connection with the Proposed Merger with Jade Biosciences
Prnewswire· 2025-04-07 12:30
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]
Aerovate Therapeutics(AVTE) - 2024 Q4 - Annual Report
2025-03-27 11:30
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].
Aerovate Therapeutics(AVTE) - 2024 Q3 - Quarterly Report
2024-11-12 21:40
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].
INVESTOR ALERT: The M&A Class Action Firm Investigates the Merger of Aerovate Therapeutics, Inc. – AVTE
GlobeNewswire News Room· 2024-11-05 23:53
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]