Acumen Pharmaceuticals(ABOS)
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Acumen Pharmaceuticals(ABOS) - 2023 Q3 - Earnings Call Presentation
2023-11-13 21:32
Q3 2023 Financial Results & Business Update November 13, 2023 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking stateme ...
Acumen Pharmaceuticals(ABOS) - 2023 Q3 - Earnings Call Transcript
2023-11-13 21:29
Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q3 2023 Earnings Conference Call November 13, 2023 08:00 AM ET Company Participants Alex Braun - Head-IR Daniel O'Connell - CEO Eric Siemers - Chief Medical Officer Matt Zuga - CFO & Chief Business Officer Conference Call Participants Thomas Shrader - BTIG Pete Stavropoulos - Cantor Fitzgerald Colin Bristow - UBS Presentation Operator Good day, ladies and gentlemen. Thank you for standing by. Welcome to Acumen Pharma Third Quarter 2023 Conference Call and Webcast ...
Acumen Pharmaceuticals(ABOS) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited financial statements show total assets increased to **$286.4 million** due to a public offering, with a **$35.9 million** net loss for the first nine months of 2023 Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $94,917 | $130,101 | | Marketable securities (short & long-term) | $187,787 | $63,341 | | **Total assets** | **$286,371** | **$196,587** | | Total liabilities | $6,098 | $7,812 | | **Total stockholders' equity** | **$280,273** | **$188,775** | Condensed Statement of Operations Highlights (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Research and development | $29,025 | $21,615 | | General and administrative | $13,627 | $9,374 | | **Loss from operations** | **($42,652)** | **($30,989)** | | **Net loss** | **($35,874)** | **($29,990)** | | Net loss per common share | ($0.79) | ($0.74) | Condensed Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,750) | ($23,950) | | Net cash (used in) provided by investing activities | ($122,864) | $59,605 | | Net cash provided by (used in) financing activities | $122,619 | ($277) | - In July 2023, the company completed a public offering, issuing 16,774,193 shares of common stock at **$7.75 per share**, resulting in net proceeds of **$122.3 million** after expenses[31](index=31&type=chunk) - Subsequent to the quarter end, the company entered a license agreement with Halozyme for ENHANZE® technology and a Loan and Security Agreement for up to **$50.0 million** in term loans[80](index=80&type=chunk)[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses ACU193's clinical progress, a **38%** rise in operating expenses, and strengthened liquidity from recent financing, extending cash runway to 2026 - The company announced **positive topline results** from its **Phase 1 INTERCEPT-AD trial** for ACU193 in July 2023, meeting primary objectives for safety and tolerability and showing evidence of target engagement in the brain, with plans to initiate a **Phase 2/3 clinical study** in the first half of 2024[89](index=89&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) Comparison of Operating Expenses (Nine Months Ended Sep 30, in thousands) | Expense Category | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $29,025 | $21,615 | $7,410 | 34% | | General and administrative | $13,627 | $9,374 | $4,253 | 45% | | **Total operating expenses** | **$42,652** | **$30,989** | **$11,663** | **38%** | - The **$7.4 million** increase in R&D expenses was primarily driven by higher personnel costs, services from contractors and consultants, and costs associated with planning for the upcoming Phase 2 clinical trial[116](index=116&type=chunk) - The **$4.3 million** increase in G&A expenses was mainly due to a **$3.5 million** rise in personnel costs, which included a **$1.6 million** increase in non-cash stock compensation, along with higher consulting and professional fees[117](index=117&type=chunk) - As of September 30, 2023, the company had **$282.7 million** in cash, cash equivalents, and marketable securities, with capital expected to fund operations and expenditures into the **second half of 2026** after a subsequent **$30.0 million** loan tranche received in November 2023[99](index=99&type=chunk)[121](index=121&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Acumen Pharmaceuticals is not required to provide market risk disclosures - Acumen Pharmaceuticals is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a "smaller reporting company" under SEC regulations[140](index=140&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed effective disclosure controls and no material changes to internal controls over financial reporting as of September 30, 2023 - Based on an evaluation as of September 30, 2023, the company's management, including the principal executive and financial officers, concluded that disclosure controls and procedures were **effective**[142](index=142&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, these controls[144](index=144&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would adversely affect its business - As of the filing date, the company is not subject to any material legal proceedings[148](index=148&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been no material changes to the risk factors as described in the company's Annual Report on Form 10-K for the year ended December 31, 2022[149](index=149&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reports no unregistered equity sales or repurchases, with no material change in the planned use of IPO proceeds - The company reports no unregistered sales of equity securities or issuer purchases of its equity securities for the period[149](index=149&type=chunk)[150](index=150&type=chunk) - There has been no material change in the planned use of the **$168.6 million** in net proceeds from the company's IPO, which closed in July 2021[150](index=150&type=chunk) [Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[151](index=151&type=chunk) [Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[151](index=151&type=chunk) [Other Information](index=28&type=section&id=Item%205.%20Other%20Information) The company secured up to **$50.0 million** in term loans via a Loan and Security Agreement on November 10, 2023, for working capital - On November 10, 2023, the company entered into a Loan and Security Agreement providing up to **$50.0 million** in term loans[152](index=152&type=chunk) - The loan consists of a first tranche of **$30.0 million** funded at closing and a second tranche of up to **$20.0 million** available subject to lender review and approval[152](index=152&type=chunk) - The loan bears a variable interest rate, matures on **November 1, 2027** (extendable to **2028**), and is secured by substantially all company assets, excluding intellectual property[153](index=153&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and XBRL documents - The report includes a list of exhibits filed, such as officer certifications under Sections 302 and 906 of the Sarbanes-Oxley Act and XBRL data files[158](index=158&type=chunk)
Acumen Pharmaceuticals(ABOS) - 2023 Q2 - Earnings Call Transcript
2023-08-11 13:52
Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q2 2023 Earnings Conference Call August 8, 2023 8:00 AM ET Company Participants Alex Braun - Head-Investor Relations Dan O'Connell - Chief Executive Officer Eric Siemers - Chief Medical Officer Matt Zuga - Chief Financial Officer & Chief Business Officer Conference Call Participants Colin Bristow - UBS Paul Matteis - Stifel Tom Shrader - BTIG Pete Stavropoulos - Cantor Fitzgerald Charlie Yang - Bank of America Operator Thank you for standing by, and welcome to the ...
Acumen Pharmaceuticals(ABOS) - 2023 Q2 - Earnings Call Presentation
2023-08-09 16:14
Q2 2023 Financial Results & Business Update August 8, 2023 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking stateme ...
Acumen Pharmaceuticals(ABOS) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ___________________________ FORM 10-Q ___________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR o 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: 001-40551 ___________________________ Acumen Pharmaceuticals, ...
Acumen Pharmaceuticals(ABOS) - 2023 Q1 - Earnings Call Transcript
2023-05-14 06:22
Financial Data and Key Metrics Changes - As of March 31, 2023, the company had approximately $184 million in cash and marketable securities, with expectations that this cash will last through 2025 [16] - R&D expenses for Q1 2023 were approximately $8.7 million, an increase attributed to heightened activity in the ongoing INTERCEPT-AD trial [16] - G&A expenses were $4.4 million, reflecting an increase due to higher headcount to support the INTERCEPT-AD trial, leading to a loss from operations of $13.1 million for the quarter [16] Business Line Data and Key Metrics Changes - The completion of enrollment in the Phase I INTERCEPT-AD trial for ACU193 was highlighted, with top-line results expected in Q3 2023 [6][7] - The company is preparing for Phase II/III activities, anticipating successful results from the Phase I study, with an end-of-Phase II meeting with the FDA expected in Q4 [8] Market Data and Key Metrics Changes - The evolving Alzheimer's landscape is noted, with positive momentum anticipated from upcoming outcomes related to lecanemab and donanemab, which may influence market access and uptake for ACU193 [8][9] Company Strategy and Development Direction - The company aims to develop ACU193 as a next-generation therapeutic for Alzheimer's patients, focusing on selective targeting of toxic A-beta oligomers [6][9] - There is an emphasis on the importance of the INTERCEPT-AD trial data for finalizing the design of subsequent studies, including dose selection [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of ACU193 to have lower rates of ARIA-E compared to existing therapies, while also highlighting the need for further research to validate these claims [15] - The company is optimistic about the upcoming top-line data from the INTERCEPT-AD trial, which is expected to provide critical insights into safety and efficacy [16] Other Important Information - The company presented findings at AD/PD regarding the utility of a human in vitro model for understanding A-beta oligomers' role in Alzheimer's pathogenesis [12][13] - Management discussed the complexities of conducting head-to-head trials with other A-beta antibodies, indicating that such studies may not be required by regulatory agencies [27][28] Q&A Session Summary Question: Scenarios for Phase II study design - Management indicated that various factors, including primary outcomes and biomarkers, will be considered to decide whether to expand the study to Phase III [20][21] Question: Target engagement and oligomer concentrations - Management acknowledged the ongoing learning about toxic species and emphasized that clinical data will ultimately provide the necessary proof of ACU193's effectiveness [24] Question: Inclusion of comparator or combination arms in trials - Management noted that head-to-head trials are complex and not expected to be required, while also discussing the potential for combination therapies in future studies [27][28][43] Question: Cash runway and financing needs - Management expressed confidence that current cash will last through 2025, but acknowledged that financing may be necessary for future trials beyond that point [30] Question: Updates on PK/PD or safety before Q3 - Management stated that no new disclosures are anticipated prior to the topline results in Q3, but they are comfortable with the current safety profile [39]
Acumen Pharmaceuticals(ABOS) - 2023 Q1 - Quarterly Report
2023-05-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ___________________________ FORM 10-Q ___________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR o 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: 001-40551 ___________________________ Acumen Pharmaceuticals ...
Acumen Pharmaceuticals(ABOS) - 2022 Q4 - Earnings Call Presentation
2023-03-27 15:06
1 FY 2022 Financial Results & Business Update March 27, 2023 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen's goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as "believes," "expects," "anticipates," "could," "would," "seeks," "aims," "plans," "potential, ...
Acumen Pharmaceuticals(ABOS) - 2022 Q4 - Earnings Call Transcript
2023-03-27 15:05
Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q4 2022 Earnings Conference Call March 27, 2023 8:00 AM ET Company Participants Alex Braun - Head IR Daniel O'Connell - President and Chief Executive Officer Eric Siemers - , Chief Medical Officer Matt Zuga - Chief Financial Officer and Chief Business Office Conference Call Participants Paul Matteis - Stifel Tom Shrader - BTIG Judah Frommer - Credit Suisse Operator Thank you for standing by. Welcome to Acumen Pharmaceuticals Full Year 2022 Conference Call and Webca ...