Core Insights - Bolt Biotherapeutics is advancing its Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody™ ISAC candidate targeting claudin 18.2, with initial strong immune responses observed [1][4] - The company plans to modify the clinical trial protocol to allow for step-up dosing, which has been effective in commercial applications for T-cell engagers [1] - Initial clinical data for BDC-4182 is now expected to be reported in Q3 2026 [2][6] - To conserve capital and extend its cash runway into 2027, the company is implementing a workforce reduction of approximately 50% [2][6] - The CEO expressed gratitude to affected employees and emphasized the strategic focus on advancing BDC-4182 and supporting ISAC collaborations to enhance shareholder value [3] Company Overview - Bolt Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer treatment [4] - The company's pipeline includes BDC-4182, which is currently in a Phase 1 trial involving patients with gastric and gastroesophageal cancer [4] - Bolt has strategic collaborations with Genmab and Toray centered around its Boltbody™ ISAC platform technology and expertise in myeloid biology [4]

Group 1 - Bolt Biotherapeutics reported a quarterly loss of $4.46 per share, which was better than the Zacks Consensus Estimate of a loss of $6.4, and an improvement from a loss of $11.2 per share a year ago, resulting in an earnings surprise of +30.31% [1] - The company generated revenues of $1.8 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 73.46%, compared to $1.27 million in the same quarter last year [2] - Over the last four quarters, Bolt Biotherapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Group 2 - The stock has underperformed, losing about 47.5% since the beginning of the year, while the S&P 500 has gained 10% [3] - The current consensus EPS estimate for the upcoming quarter is -$5.70 on revenues of $0.9 million, and for the current fiscal year, it is -$23.00 on revenues of $4.02 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the bottom 41% of over 250 Zacks industries, indicating potential challenges for the stock's performance [8]

PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Bolt Biotherapeutics, Inc. show total assets decreased to $75.5 million by June 30, 2025, with a net loss of $19.6 million for the six months ended June 30, 2025, and significant "going concern" uncertainty [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $75.5 million from $99.6 million, total liabilities decreased to $36.7 million, and stockholders' equity declined to $38.8 million due to an accumulated deficit of $447.0 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,601 | $7,205 | | Short-term & Long-term investments | $38,893 | $62,998 | | Total current assets | $38,336 | $50,814 | | Total assets | $75,499 | $99,632 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $12,310 | $15,856 | | Total liabilities | $36,657 | $42,434 | | Accumulated deficit | $(447,004) | $(427,403) | | Total stockholders' equity | $38,842 | $57,198 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, net loss improved to $8.6 million from $21.2 million in Q2 2024, and for the six months ended June 30, 2025, net loss was $19.6 million, down from $32.0 million, primarily due to reduced operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,804 | $1,275 | $3,026 | $6,549 | | Research and development | $7,498 | $15,433 | $17,010 | $31,962 | | General and administrative | $3,516 | $4,874 | $7,341 | $10,711 | | Restructuring charges | $0 | $3,565 | $0 | $3,565 | | Loss from operations | $(9,210) | $(22,597) | $(21,325) | $(39,689) | | Net loss | $(8,561) | $(21,195) | $(19,601) | $(32,006) | | Net loss per share | $(4.46) | $(11.12) | $(10.22) | $(16.80) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $57.2 million at year-end 2024 to $38.8 million by June 30, 2025, primarily due to a $19.6 million net loss - For the six months ended June 30, 2025, the **total stockholders' equity decreased by $18.4 million**, mainly driven by a **net loss of $19.6 million**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to $23.0 million for the six months ended June 30, 2025, from $32.9 million in 2024, with total cash increasing by $2.4 million to $11.4 million Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(22,962) | $(32,893) | | Net cash provided by investing activities | $25,344 | $28,206 | | Net cash provided by financing activities | $14 | $79 | | **Net increase (decrease) in cash** | **$2,396** | **$(4,608)** | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Key notes highlight substantial doubt about the company's going concern ability, with cash projected to last only through mid-2026, details on a 1-for-20 reverse stock split, collaboration revenues, and a May 2024 restructuring - The company has concluded there is **substantial doubt about its ability to continue as a going concern**, as its cash and marketable securities of **$48.5 million** as of June 30, 2025, may only be sufficient to fund operations through mid-2026[26](index=26&type=chunk) - On June 6, 2025, the company executed a **1-for-20 reverse stock split** of its common stock, with all share and per-share data retrospectively adjusted[30](index=30&type=chunk) - In May 2024, the company initiated a restructuring plan, reducing its workforce by approximately **50%** and recording a total charge of **$3.6 million**[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on novel immunotherapies, a strategic restructuring in May 2024, and a significant reduction in operating expenses and net loss for H1 2025, while reiterating substantial doubt about its going concern ability [Overview and Recent Developments](index=28&type=section&id=Overview%20and%20Recent%20Developments) The company, a clinical-stage biopharmaceutical firm, is prioritizing BDC-4182 and BDC-3042 programs following a May 2024 restructuring that reduced the workforce by 50% and discontinued a program, with a 1-for-20 reverse stock split completed in June 2025 - The company is prioritizing its pipeline on **BDC-4182**, a next-generation Boltbody™ ISAC targeting claudin 18.2, which entered a Phase 1 trial in April 2025[99](index=99&type=chunk) - A strategic restructuring in May 2024 involved a **50% workforce reduction** and discontinuation of the trastuzumab imbotolimod program to focus on key assets[101](index=101&type=chunk) - A **1-for-20 reverse stock split** of common stock became effective on June 6, 2025[107](index=107&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, collaboration revenue decreased by $3.5 million, R&D expenses fell by $15.0 million, and G&A expenses decreased by $3.4 million, resulting in an improved net loss of $19.6 million from $32.0 million in the prior year Comparison of Operating Results (in thousands) | Item | Six Months 2025 | Six Months 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $3,026 | $6,549 | $(3,523) | | Research and development | $17,010 | $31,962 | $(14,952) | | General and administrative | $7,341 | $10,711 | $(3,370) | | Net loss | $(19,601) | $(32,006) | $12,405 | - The decrease in R&D expenses for the first six months of 2025 was primarily due to a **$6.3 million reduction in personnel-related costs** and a **$3.9 million decrease in clinical expenses** related to the discontinued development of trastuzumab imbotolimod[133](index=133&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) With an accumulated deficit of $447.0 million, the company's $48.5 million in cash and marketable securities are projected to fund operations only through mid-2026, leading to substantial doubt about its going concern ability and necessitating additional capital - The company's cash, cash equivalents, and marketable securities of **$48.5 million** as of June 30, 2025, are projected to fund operations only through mid-2026[137](index=137&type=chunk) - Due to significant uncertainty and limited cash runway, management has concluded there is **substantial doubt about the company's ability to continue as a going concern**[137](index=137&type=chunk)[143](index=143&type=chunk) - Net cash used in operating activities decreased to **$23.0 million** for the first six months of 2025 from **$32.9 million** in the comparable 2024 period, reflecting reduced operating expenses[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Bolt Biotherapeutics is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Bolt Biotherapeutics is **not required to provide quantitative and qualitative disclosures about market risk**[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's **disclosure controls and procedures were effective** as of the end of the period, June 30, 2025[152](index=152&type=chunk) - No changes occurred in the **internal control over financial reporting** during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[153](index=153&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its financial condition, results of operations, or cash flows - As of the filing date, there are **no pending claims or actions against the company** that are expected to have a material adverse effect[155](index=155&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company highlights new risk factors related to potential adverse effects from international trade policies, including tariffs and sanctions, and U.S. healthcare reform, such as the OBBBA, on its business and product commercialization - A new risk factor highlights that **international trade policies**, including tariffs and sanctions, could adversely affect the business, given its reliance on third-party suppliers in countries like South Korea, China, and in Europe[157](index=157&type=chunk)[158](index=158&type=chunk) - The company identifies risks from **U.S. healthcare reform**, including the Inflation Reduction Act (IRA) and the newly enacted "H.R.1: One Big Beautiful Bill Act" (OBBBA), which could hinder the commercial success and profitability of its products[162](index=162&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were **no recent sales of unregistered securities**[166](index=166&type=chunk) [Item 3. Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[167](index=167&type=chunk) [Item 4. Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[168](index=168&type=chunk) [Item 5. Other Information](index=46&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - None[169](index=169&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including the Certificate of Amendment for the reverse stock split, bylaws, and certifications - Exhibits filed include certifications by the CEO/CFO and Principal Accounting Officer, and documents related to the company's incorporation and bylaws[171](index=171&type=chunk)

Introduction and Business Update This section details the CEO's strategic updates on BDC-4182 and BDC-3042, along with recent operational highlights and anticipated milestones [CEO Statement and Strategic Focus](index=1&type=section&id=CEO%20Statement%20and%20Strategic%20Focus) The CEO highlighted BDC-4182's Phase 1 study for gastric and gastroesophageal cancer, with H1 2026 data expected, and the active search for a partner for BDC-3042, which showed a partial response - BDC-4182, a next-generation Boltbody™ ISAC, is now in a Phase 1 dose-escalation study for patients with gastric and gastroesophageal cancer, with initial data anticipated in the first half of 2026[2](index=2&type=chunk) - Bolt Biotherapeutics is seeking a partner for further development of BDC-3042, a dectin-2 agonist antibody, which demonstrated a **partial response (PR)** at the highest dose tested in lung cancer patients[2](index=2&type=chunk) [Recent Highlights and Anticipated Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Anticipated%20Milestones) Key highlights include the initiation of the BDC-4182 Phase 1 study, a cash balance of $48.5 million expected to fund operations through mid-2026, ongoing collaborations with Genmab and Toray, and the continued search for a partner for BDC-3042 after completing its Phase 1 dose escalation - Next-generation claudin 18.2 ISAC BDC-4182 is now in a Phase 1 dose-escalation study, open for enrollment for patients with gastric and gastroesophageal cancer[4](index=4&type=chunk)[5](index=5&type=chunk) - Cash, cash equivalents, and marketable securities totaled **$48.5 million** as of June 30, 2025, anticipated to fund key milestones and operations through mid-2026[4](index=4&type=chunk)[5](index=5&type=chunk) - Collaborations with Genmab and Toray are progressing, advancing multiple development candidates and continuing research on additional programs[5](index=5&type=chunk) - Bolt is actively seeking a partner for BDC-3042 development following the completion of its Phase 1 dose-escalation clinical study[5](index=5&type=chunk) Financial Performance This section presents key financial highlights, including revenue, expenses, and operational loss, along with detailed consolidated statements of operations, balance sheets, and cash flows [Key Financial Highlights](index=2&type=section&id=Key%20Financial%20Highlights) For Q2 2025, collaboration revenue increased to $1.8 million, R&D and G&A expenses significantly decreased, and the loss from operations reduced to $9.2 million from $22.6 million in Q2 2024 Q2 2025 vs Q2 2024 Financial Performance | Financial Metric (Q2 2025 vs Q2 2024) | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :------------------------------------ | :-------------------- | :-------------------- | :----------- | | Collaboration Revenue | $1.8 | $1.3 | +$0.5 (+38.5%) | | Research and Development (R&D) Expenses | $7.5 | $15.4 | -$7.9 (-51.3%) | | General and Administrative (G&A) Expenses | $3.5 | $4.9 | -$1.4 (-28.6%) | | Restructuring Charges | $0.0 | $3.6 | -$3.6 (-100%) | | Loss from Operations | ($9.2) | ($22.6) | +$13.4 (+59.3%) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statements of operations show a net loss of $8.561 million for Q2 2025, an improvement from $21.195 million in Q2 2024, with the six-month net loss also improving to $19.601 million from $32.006 million Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Collaboration revenue | $1,804 | $1,275 | $3,026 | $6,549 | | Research and development | $7,498 | $15,433 | $17,010 | $31,962 | | General and administrative | $3,516 | $4,874 | $7,341 | $10,711 | | Restructuring charges | $— | $3,565 | $— | $3,565 | | Total operating expense | $11,014 | $23,872 | $24,351 | $46,238 | | Loss from operations | $(9,210) | $(22,597) | $(21,325) | $(39,689) | | Net loss | $(8,561) | $(21,195) | $(19,601) | $(32,006) | | Net loss per share, basic and diluted | $(4.46) | $(11.12) | $(10.22) | $(16.80) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $75.499 million from $99.632 million, with total liabilities and stockholders' equity also showing corresponding decreases Condensed Consolidated Balance Sheets | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $9,601 | $7,205 | | Short-term investments | $25,168 | $40,118 | | Total current assets | $38,336 | $50,814 | | Total assets | $75,499 | $99,632 | | Total current liabilities | $12,310 | $15,856 | | Total liabilities | $36,657 | $42,434 | | Total stockholders' equity | $38,842 | $57,198 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities improved to $22.962 million, with net cash provided by investing activities at $25.344 million, leading to a net increase in cash of $2.396 million and an ending balance of $11.366 million Condensed Consolidated Statements of Cash Flows | Cash Flow Item (Six Months Ended June 30, in thousands) | 2025 | 2024 | | :------------------------------------------------------ | :------------ | :------------ | | Net cash used in operating activities | $(22,962) | $(32,893) | | Net cash provided by investing activities | $25,344 | $28,206 | | Net cash provided by financing activities | $14 | $79 | | NET INCREASE (DECREASE) IN CASH | $2,396 | $(4,608) | | Cash, cash equivalents and restricted cash at end of period | $11,366 | $7,967 | Other Corporate Developments This section outlines other corporate developments, specifically the one-for-twenty reverse stock split and its impact on Nasdaq compliance [Reverse Stock Split](index=2&type=section&id=Reverse%20Stock%20Split) On June 6, 2025, Bolt Biotherapeutics effected a one-for-twenty reverse stock split, which helped the company regain compliance with Nasdaq's minimum bid price requirement by June 24, 2025 - A **one-for-twenty (1:20) reverse stock split** of outstanding common stock was effected on June 6, 2025[7](index=7&type=chunk) - The reverse stock split contributed to Bolt Biotherapeutics regaining compliance with Nasdaq's minimum bid price requirement on June 24, 2025[7](index=7&type=chunk) Company and Platform Information This section provides an overview of the Boltbody™ ISAC platform technology and details about Bolt Biotherapeutics, Inc., its pipeline, and collaborations [About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform](index=2&type=section&id=About%20the%20Boltbody%E2%84%A2%20Immune-Stimulating%20Antibody%20Conjugate%20(ISAC)%20Platform) The Boltbody ISAC platform combines tumor-targeting antibodies with proprietary immune stimulants to recruit and activate myeloid cells, aiming to generate robust anti-cancer immune responses - The Boltbody ISAC platform utilizes tumor-targeting antibodies, non-cleavable linkers, and proprietary immune stimulants to recruit and activate myeloid cells, aiming to generate a productive anti-cancer immune response[8](index=8&type=chunk) - Activated myeloid cells release cytokines and chemokines, attracting other immune cells and lowering the activation threshold for an immune response, promoting durable therapeutic responses[8](index=8&type=chunk) [About Bolt Biotherapeutics, Inc.](index=2&type=section&id=About%20Bolt%20Biotherapeutics,%20Inc.) Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel cancer immunotherapies, with a pipeline including BDC-4182 in Phase 1 and BDC-3042 seeking a partner, alongside strategic collaborations with Genmab and Toray - Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for cancer, built on expertise in myeloid biology and cancer drug development[9](index=9&type=chunk)[11](index=11&type=chunk) - The pipeline includes BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2, currently in a Phase 1 dose escalation trial[11](index=11&type=chunk) - The company is seeking to partner its Dectin-2 agonist, BDC-3042, that recently completed a first-in-human Phase 1 dose escalation trial, and has strategic collaborations with Genmab and Toray[11](index=11&type=chunk) Legal and Contact Information This section includes important disclosures regarding forward-looking statements and provides contact information for investor relations and media inquiries [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements, subject to substantial risks and uncertainties, which may cause actual results to differ materially, and the company disclaims any obligation to update them except as required by law - The press release contains forward-looking statements about the company and its industry, involving substantial risks and uncertainties based on current beliefs and assumptions[12](index=12&type=chunk) - These statements, identifiable by terms like "anticipate" or "expect," involve known and unknown risks that may cause actual results to differ materially, including those related to product candidate development, clinical trials, regulatory approvals, and collaborations[12](index=12&type=chunk) - The company assumes no obligation to update these forward-looking statements, except as required by law, and refers readers to its SEC filings for further information on factors that could cause actual results to differ[12](index=12&type=chunk) [Investor Relations and Media Contact](index=3&type=section&id=Investor%20Relations%20and%20Media%20Contact) Matthew DeYoung of Argot Partners is the primary contact for investor relations and media inquiries for Bolt Biotherapeutics - For investor relations and media inquiries, contact Matthew DeYoung at Argot Partners, via phone (212) 600-1902 or email boltbio@argotpartners.com[13](index=13&type=chunk)

Core Insights - Bolt Biotherapeutics is advancing its clinical-stage immunotherapy pipeline, particularly focusing on BDC-4182, a next-generation Boltbody™ ISAC targeting claudin 18.2, currently in a Phase 1 dose-escalation study for gastric and gastroesophageal cancer [2][6][9] - The company reported a cash balance of $48.5 million as of June 30, 2025, which is expected to fund key milestones through mid-2026 [5][6] - Collaboration revenue for the second quarter of 2025 was $1.8 million, an increase from $1.3 million in the same quarter of 2024, indicating growth in R&D collaborations [6][11] Business Update - The Phase 1 study for BDC-4182 opened for enrollment in early 2025, with initial data expected in the first half of 2026 [2][6] - The company is seeking a partner for the further development of BDC-3042, which has shown activity in lung cancer patients [2][6] - Collaborations with Genmab and Toray are progressing, focusing on multiple development candidates and research programs [6][9] Financial Results - Total collaboration revenue for the quarter ended June 30, 2025, was $1.8 million, compared to $1.3 million for the same quarter in 2024 [6][11] - Research and Development (R&D) expenses decreased to $7.5 million in Q2 2025 from $15.4 million in Q2 2024, primarily due to reduced salary and clinical expenses [6][11] - General and Administrative (G&A) expenses also decreased to $3.5 million in Q2 2025 from $4.9 million in Q2 2024, reflecting cost management efforts [6][11] Operational Highlights - The company executed a one-for-twenty reverse stock split on June 6, 2025, which helped regain compliance with Nasdaq's minimum bid price requirement [7] - The Boltbody™ ISAC platform combines tumor-targeting antibodies with immune stimulants to enhance anti-cancer responses [8][9] - The company’s pipeline includes BDC-4182 and BDC-3042, with ongoing efforts to establish partnerships for further development [9]

Financial Performance - Bolt Biotherapeutics reported a quarterly loss of $0.29 per share, better than the Zacks Consensus Estimate of a loss of $0.34, and compared to a loss of $0.28 per share a year ago, indicating an earnings surprise of 14.71% [1] - The company posted revenues of $1.22 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 19.45%, but down from $5.27 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates just once and topped consensus revenue estimates three times [2] Stock Performance - Since the beginning of the year, Bolt Biotherapeutics shares have declined by approximately 33.1%, while the S&P 500 has decreased by 3.8% [3] - The current Zacks Rank for Bolt Biotherapeutics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.34 on revenues of $0.99 million, and for the current fiscal year, it is -$1.27 on revenues of $3.79 million [7] - The estimate revisions trend for Bolt Biotherapeutics is mixed, and future stock movements will depend on management's commentary during the earnings call [3][4] Industry Context - The Medical - Biomedical and Genetics industry, to which Bolt Biotherapeutics belongs, is currently in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Summary of Bolt Biotherapeutics Conference Call Company Overview - **Company**: Bolt Biotherapeutics (BOLT) - **Focus**: Development of immuno-oncology therapeutics, specifically targeting cancer through innovative antibody platforms Key Points Discussed Financial Overview - As of March 31, cash, cash equivalents, and marketable securities totaled **$58 million** [4] - Funding expected to support key milestones, including the Phase 1 trial for BDC3042 through mid-2026 [4] Clinical Programs - **BDC3042**: A first-in-class dectin-2 agonist antibody aimed at treating cancer - Phase 1 trial results presented at the American Association for Cancer Research (AACR) Annual Meeting [4][25] - **Enrollment**: 17 patients, including those with non-small cell lung cancer (NSCLC) [26] - **Safety Profile**: Well tolerated with no grade 4 or 5 adverse events reported [28] - **Efficacy**: Evidence of tumor size reduction in patients with prior treatments, particularly in NSCLC [31][37] - **BDC4182**: A next-generation immune-stimulating antibody conjugate (ISAC) targeting claudin 18.2 - Enrollment for the first-in-human Phase 1 study has opened in Australia [42] - Targeting advanced gastric and gastroesophageal cancers [50] Mechanism of Action - **BDC3042**: Engages and activates dectin-2 on tumor-associated macrophages (TAMs), converting them into tumor-destructive cells [11][12] - **Clinical Observations**: Enhanced immune response noted, particularly in patients previously treated with checkpoint inhibitors [12][60] Preclinical Data - BDC3042 shows promising preclinical results, indicating potential for broad applicability across various cancer types [15][18] - Evidence of tumor regression in preclinical models, supporting the mechanism of action [19][20] Market Potential - BDC4182 aims to capture a broader market by targeting not only high expressers of claudin 18.2 but also moderate and low expressers [44][81] - The approved drug for claudin 18.2 currently addresses about **38%** of the gastric cancer market [81] Collaboration and Partnerships - Ongoing discussions for partnerships to accelerate the development of BDC3042, with a goal to secure a non-binding term sheet by June 6 [39] - Collaboration with Genmab and Toray to advance multiple development programs [52][53] Future Outlook - Anticipated updates on patient recruitment for BDC4182 and partner selection for BDC3042 by fall [54] - Emphasis on efficiency in the current biotech financing environment to develop product candidates that could improve patient outcomes [54] Additional Insights - The conference highlighted the importance of safety and tolerability in early-phase trials, especially for heavily pretreated patients [28][37] - The potential for BDC3042 to be effective in combination with other therapies, particularly in immunogenic tumors like NSCLC [60][61] - The company is focused on differentiating its ISAC platform from competitors by improving linker payloads and reducing immunogenicity [95][96] This summary encapsulates the critical aspects of the conference call, providing insights into Bolt Biotherapeutics' current status, clinical programs, and future directions in the oncology space.

Financial Performance - Net losses for the three months ended March 31, 2025, were $11.0 million, compared to $10.8 million for the same period in 2024, with an accumulated deficit of $438.4 million as of March 31, 2025[98]. - Collaboration revenue decreased to $1.2 million in Q1 2025 from $5.3 million in Q1 2024, a decline of 77% due to the completion of performance obligations under the Amended Innovent Agreement[120]. - Net loss for Q1 2025 was $11.0 million, slightly higher than the $10.8 million loss in Q1 2024, indicating a 2% increase in losses year-over-year[125]. - Net cash used in operating activities was $13.4 million in Q1 2025 compared to $16.8 million in Q1 2024, a decrease of 20%[128]. - Cash and cash equivalents, along with marketable securities, totaled $58.0 million as of March 31, 2025, expected to fund operations through mid-2026[125]. - The accumulated deficit reached $438.4 million as of March 31, 2025, reflecting ongoing financial challenges[125]. - The company anticipates continuing to incur net losses and has substantial doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[125]. Revenue Sources - The company has not recorded any revenue from product sales, with revenue solely derived from collaborations with Toray, Genmab, and Innovent[96]. - Collaboration revenue is expected to fluctuate based on the timing and outcome of development activities and payments from collaboration partners[106]. Research and Development - BDC-3042, a dectin-2 agonist antibody program, received FDA IND clearance in July 2023 and began dosing patients in a Phase 1 study in October 2023, with favorable results reported in April 2025[92]. - BDC-4182, targeting claudin 18.2, is expected to begin its first-in-human Phase 1 trial in the second quarter of 2025, following positive preclinical results[93]. - Research and development expenses were $9.5 million in Q1 2025, down from $16.5 million in Q1 2024, reflecting a 43% reduction primarily due to lower personnel-related costs and discontinued clinical development[121]. Operational Changes - The restructuring plan announced in May 2024 resulted in a workforce reduction of approximately 50 employees, or 50% of the workforce, with total restructuring charges estimated at $3.6 million[94]. - General and administrative expenses decreased to $3.8 million in Q1 2025 from $5.8 million in Q1 2024, a reduction of 35% attributed to restructuring and lower consulting costs[122]. - The establishment of a wholly-owned subsidiary in Australia in October 2024 aims to enhance research and development capabilities and strengthen partnerships in the Australian life sciences market[97]. Future Outlook - The company anticipates continued significant operating losses as it conducts ongoing and planned clinical trials and research and development programs[98]. - Future capital requirements will depend on various factors, including clinical trial costs and the success of collaborations, with significant uncertainty regarding funding availability[134]. - Macroeconomic factors, including inflation and interest rates, are anticipated to impact the company's business and financial condition[100].

Financial Performance - Collaboration revenue for Q1 2025 was $1.2 million, a decrease of 77% from $5.3 million in Q1 2024[14] - Loss from operations for Q1 2025 was $12.1 million, compared to a loss of $17.1 million in Q1 2024, representing a 29% improvement[14] - Net loss for Q1 2025 was $11.0 million, compared to a net loss of $10.8 million in Q1 2024[14] - Net loss for Q1 2025 was $11,040,000, compared to a net loss of $10,811,000 in Q1 2024, representing an increase in loss of approximately 2.1%[18] Expenses - Research and Development (R&D) expenses decreased to $9.5 million in Q1 2025 from $16.5 million in Q1 2024, reflecting a reduction of 42%[14] - General and Administrative (G&A) expenses were $3.8 million in Q1 2025, down 35% from $5.8 million in Q1 2024[14] - Cash used in operating activities decreased to $13,365,000 in Q1 2025 from $16,751,000 in Q1 2024, a reduction of about 20.5%[18] - Depreciation and amortization expenses decreased to $399,000 in Q1 2025 from $458,000 in Q1 2024, a decline of about 12.9%[18] - Stock-based compensation expense significantly decreased to $709,000 in Q1 2025 from $2,302,000 in Q1 2024, a reduction of approximately 69.1%[18] - Changes in accounts payable and accrued expenses improved, decreasing to $2,511,000 in Q1 2025 from $3,544,000 in Q1 2024, a decrease of about 29.0%[18] Cash and Assets - Cash balance as of March 31, 2025, was $58.0 million, expected to fund operations through mid-2026[5] - Total assets decreased to $85.9 million as of March 31, 2025, from $99.6 million at the end of 2024[16] - Cash, cash equivalents, and restricted cash at the end of Q1 2025 totaled $10,156,000, up from $6,027,000 at the end of Q1 2024, an increase of about 68.5%[18] - Total cash and cash equivalents increased to $8,391,000 in Q1 2025 from $4,262,000 in Q1 2024, marking a growth of approximately 96.5%[18] Investment Activities - Net cash provided by investing activities increased to $14,551,000 in Q1 2025, compared to $10,203,000 in Q1 2024, reflecting a growth of approximately 42.9%[18] - Maturities of marketable securities decreased to $14,580,000 in Q1 2025 from $33,261,000 in Q1 2024, a decline of approximately 56.2%[18] - The company reported a gain on the sale of property and equipment amounting to $288,000 in Q1 2025, with no comparable figure in Q1 2024[18] Clinical Development - BDC-3042 Phase 1 dose-escalation study demonstrated a favorable safety profile and dose-dependent biological activity[5] - BDC-4182 Phase 1 study for gastric and gastroesophageal cancer opened for enrollment in April 2025[6] - Bolt Biotherapeutics is seeking a partner to accelerate the development of BDC-3042[5]

Core Insights - Bolt Biotherapeutics reported financial results for Q1 2025, highlighting advancements in their immunotherapy pipeline and a cash balance of $58 million to fund operations through mid-2026 [1][4][10]. Business Update - The company is advancing its pipeline of novel immunotherapies, with promising early clinical data for BDC-3042 presented at AACR 2025 and the opening of enrollment for BDC-4182 [2][4]. - BDC-3042, a proprietary agonist antibody targeting dectin-2, showed a favorable safety profile and anti-tumor activity in a Phase 1 study for patients with metastatic solid tumors [5]. - BDC-4182, targeting claudin 18.2, has opened for enrollment and demonstrated complete regressions in preclinical models [5]. Financial Performance - Collaboration revenue decreased to $1.2 million in Q1 2025 from $5.3 million in Q1 2024, primarily due to the completion of performance obligations under a previous agreement [10]. - Research and Development (R&D) expenses were $9.5 million in Q1 2025, down from $16.5 million in Q1 2024, attributed to reduced clinical expenses and restructuring [10]. - General and Administrative (G&A) expenses also decreased to $3.8 million from $5.8 million year-over-year [10]. - The net loss for Q1 2025 was $11.0 million, compared to a net loss of $10.8 million in Q1 2024 [12]. Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $58 million, expected to support operations through mid-2026 [4][10].