Aerovate Therapeutics(AVTE) - 2025 Q2 - Quarterly Results

Executive Summary and Q2 2025 Highlights Jade Biosciences' Q2 2025 highlights include a reverse merger, significant financing, and JADE101 pipeline advancement Q2 2025 Highlights and Strategic Direction 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] - Continued to advance a pipeline aimed at delivering potentially best-in-class therapies for systemic and organ-specific autoimmune diseases[2] - Presented compelling preclinical data on JADE101, supporting its potential as a best-in-class disease-modifying therapy for IgA nephropathy (IgAN)[2] - Anticipates transitioning into a clinical-stage company in the coming months[2] Pipeline and Corporate Updates Jade Biosciences provided pipeline updates for JADE101 and JADE201, alongside a key corporate appointment JADE101 Program Update 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 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][5] - 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] - 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] - Pharmacokinetic (PK) profile in NHPs supports potential for convenient, infrequent subcutaneous dosing (no more than every eight weeks) in clinical settings[5] - 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] Clinical Development Plan 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][5] - 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][5] JADE201 Program Update 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] - JADE201 has the potential to be evaluated in multiple systemic autoimmune diseases[8] - Further details on JADE201 are expected to be disclosed in the second half of 2025[8] Corporate Developments 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] Second Quarter 2025 Financial Results Jade Biosciences reported its Q2 2025 financial results, detailing a net loss and a robust cash position Financial Summary 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][8] - Net loss totaled $32.1 million for the second quarter of 2025, which includes non-cash stock-based compensation of $4.0 million[8] Condensed Consolidated Balance Sheets 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] - 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] Condensed Consolidated Statements of Operations and Comprehensive Loss 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][16] - 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][16] About Jade Biosciences, Inc. Jade Biosciences is a biotech company developing best-in-class therapies for autoimmune diseases, with JADE101 as its lead About Jade Biosciences, Inc. 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] - Lead candidate, JADE101, targets the cytokine APRIL for the treatment of immunoglobulin A nephropathy[9] - Pipeline also includes JADE201 and an undisclosed antibody discovery program, JADE-003, both in preclinical development[9] - Launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine[9] Forward-Looking Statements This section provides a cautionary disclaimer for forward-looking statements about Jade's future pipeline and financial performance Forward-Looking Statements 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] - 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] - 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] Contact Information Contact details for media and investor inquiries regarding Jade Biosciences Contact Information 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]