Mersana Therapeutics(MRSN)
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Mersana Therapeutics(MRSN) - 2020 Q3 - Earnings Call Transcript
2020-11-09 17:58
Financial Data and Key Metrics Changes - The company ended Q3 2020 with approximately $271 million in cash and cash equivalents, compared to approximately $100 million at the end of 2019 [38] - Net cash used in operating activities in Q3 2020 was $20.2 million [38] - Net loss for Q3 2020 was $22.5 million or $0.33 per share, compared to a net loss of $16.8 million or $0.35 per share for the same period in 2019 [42] Business Line Data and Key Metrics Changes - Collaboration revenue in Q3 2020 was immaterial, down from $0.8 million in Q3 2019, primarily due to the completion of research services associated with a previous agreement [40] - Research and development expenses increased to approximately $16.5 million in Q3 2020 from $13.7 million in Q3 2019, driven by increased manufacturing activities and clinical expenses for XMT-1536 and XMT-1592 [41] - General and administrative expenses rose to approximately $5.9 million in Q3 2020 from $4.4 million in Q3 2019, mainly due to increased consulting fees and facility-related costs [42] Market Data and Key Metrics Changes - The company reported encouraging data from the XMT-1536 Phase 1 study, with an overall response rate of 34% and a disease control rate of 79% among late-stage ovarian cancer patients [14][15] - The FDA granted Fast Track Designation for XMT-1536, highlighting the high unmet medical need for treatments in platinum-resistant ovarian cancer [21] Company Strategy and Development Direction - The company plans to hold an Analyst and Investor Day around year-end to provide updates on XMT-1536 and its development candidates [25][44] - There is a focus on exploring combination therapies for XMT-1536 in earlier lines of ovarian cancer treatment [49] - The company is also advancing its B7-H4 DolaLock ADC development candidate, which targets both tumor cells and immunosuppressive tumor-associated macrophages [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of XMT-1536 and its potential to address significant unmet medical needs in ovarian cancer [46] - The company acknowledged the challenges posed by the COVID-19 pandemic but emphasized its commitment to advancing its clinical programs [6][46] Other Important Information - The company is preparing to meet with the FDA to discuss the path to registration for XMT-1536 [23] - The company has initiated new international sites for the lung adenocarcinoma cohort in the expansion portion of the Phase 1 study [27] Q&A Session Summary Question: Can you talk about your thoughts and strategy for 1536 in earlier lines of ovarian cancer and in combination settings? - The company is working on a plan for 1536 and will share it at the analyst and investor meeting around year-end, highlighting opportunities for combination therapies [49] Question: Can you talk about how you're thinking about the lung cancer opportunity for 1536 and 1592? - The company has characterized NaPi2b expression in lung adenocarcinoma and is encouraged by early data, continuing to recruit patients for further insights [50][51] Question: What do you think is the minimum meaningful durability of response for 1536? - The company is gathering data to determine overall durability of response and will assess it based on FDA interactions and totality of data [56] Question: How important is the delta in terms of response rate between NaPi2b high and NaPi2b low? - The company is encouraged by the overall response rate and is focused on understanding how patient selection impacts outcomes [60] Question: Are there newer or preclinical models where you think you can differentiate yourself from some of the other approaches in the STING program? - The company is excited about the data from its Immunosynthen platform and will provide more details at the upcoming webinar [66][68] Question: What is going to change over the next two months that prevents you from outlining data disclosure plans today for 1592? - The company prefers to wait for more information from ongoing dose escalation before outlining data disclosure plans [72] Question: Have the U.S. sites picked up in terms of enrollment for 1536? - The company has seen a pickup in enrollment across all sites, with international sites contributing positively [74] Question: How should we think about expenses rounding out the year and into 2021? - The company reiterated that its current cash position provides more than two years of runway on its operating plan [75]
Mersana Therapeutics(MRSN) - 2020 Q3 - Quarterly Report
2020-11-09 14:00
[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited financial statements reflect increased assets from financing activities and a higher net loss, primarily due to prior year's deferred revenue recognition [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | | September 30, 2020 | December 31, 2019 | |:---|:---:|:---:| | **Assets** | | | | Cash and cash equivalents | $270,936 | $62,351 | | Total current assets | $274,934 | $101,326 | | Total assets | $290,128 | $107,541 | | **Liabilities and stockholders' equity** | | | | Total current liabilities | $21,070 | $24,070 | | Total liabilities | $36,820 | $29,223 | | Total stockholders' equity | $253,308 | $78,318 | | Total liabilities and stockholders' equity | $290,128 | $107,541 | - The significant increase in cash and cash equivalents from **$62.4 million** at the end of 2019 to **$270.9 million** as of September 30, 2020, was primarily driven by proceeds from stock offerings[14](index=14&type=chunk)[27](index=27&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | |:---|:---:|:---:|:---:|:---:| | Collaboration revenue | $11 | $844 | $817 | $42,081 | | Research and development | $16,546 | $13,701 | $44,179 | $42,610 | | General and administrative | $5,881 | $4,436 | $15,988 | $13,072 | | **Net loss** | **($22,489)** | **($16,792)** | **($59,203)** | **($11,962)** | | **Net loss per share** | **($0.33)** | **($0.35)** | **($1.00)** | **($0.28)** | - The net loss for the nine months ended September 30, 2020, was significantly higher than the same period in 2019, primarily because the 2019 period included the recognition of **$39.97 million** in deferred revenue from the terminated Takeda partnership[26](index=26&type=chunk)[64](index=64&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | | Nine Months Ended September 30, 2020 | Nine Months Ended September 30, 2019 | |:---|:---:|:---:| | Net cash used in operating activities | ($57,377) | ($55,168) | | Net cash provided by (used in) investing activities | $37,215 | ($43,793) | | Net cash provided by financing activities | $228,747 | $97,473 | | **Increase (decrease) in cash** | **$208,585** | **($1,488)** | - Net cash from financing activities was **$228.7 million** for the first nine months of 2020, mainly from a public offering (**$164.0 million**) and at-the-market (ATM) facility proceeds (**$63.0 million**)[22](index=22&type=chunk)[174](index=174&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical firm focused on developing Antibody Drug Conjugates (ADCs) with proprietary platforms like Dolaflexin, Dolasynthen, and Immunosynthen. Key product candidates are XMT-1536 and XMT-1592, both targeting NaPi2b[24](index=24&type=chunk)[25](index=25&type=chunk) - Collaboration agreements with Takeda were terminated in Q1 2019, leading to the recognition of the remaining **$39.97 million** in deferred revenue during that period[64](index=64&type=chunk) - In August 2020, the company amended its loan and security agreement with Silicon Valley Bank (SVB), allowing for borrowing up to **$30.0 million** in term loans. An initial **$5.2 million** was drawn to repay the existing balance[78](index=78&type=chunk) - The company raised approximately **$63.0 million** in net proceeds from its at-the-market (ATM) facility in April 2020 and an additional **$164.0 million** from a follow-on public offering in June 2020[89](index=89&type=chunk)[91](index=91&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses ADC platform development, noting decreased collaboration revenue, increased operating expenses, and strengthened liquidity from recent equity offerings [Overview](index=25&type=section&id=Overview) - Mersana is a clinical-stage biopharmaceutical company developing proprietary Antibody Drug Conjugates (ADCs) like Dolaflexin and Dolasynthen to improve efficacy, safety, and tolerability over existing therapies[121](index=121&type=chunk) - The lead product candidate, XMT-1536, targets NaPi2b and is in a Phase 1 clinical trial for ovarian cancer and NSCLC adenocarcinoma. A second candidate, XMT-1592, also targeting NaPi2b using the Dolasynthen platform, initiated a Phase 1 dose escalation study in Q2 2020[124](index=124&type=chunk)[125](index=125&type=chunk) [Impact of COVID-19 on Our Business](index=26&type=section&id=Impact%20of%20COVID-19%20on%20Our%20Business) - The company has implemented work-from-home for non-lab employees and staggered schedules for lab staff to mitigate COVID-19 risks[136](index=136&type=chunk) - Patient enrollment continues for XMT-1536 and XMT-1592 trials, with measures like remote monitoring implemented. The company is initiating additional clinical sites to mitigate potential regional impacts from COVID-19[136](index=136&type=chunk) - Manufacturing operations through contract partners have not experienced COVID-related delays, and the company believes it has sufficient inventory of XMT-1536 and XMT-1592 for ongoing clinical studies[136](index=136&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Comparison of Results for the Three Months Ended September 30 (in thousands) | | 2020 | 2019 | Dollar Change | |:---|:---:|:---:|:---:| | Collaboration revenue | $11 | $844 | ($833) | | Research and development | $16,546 | $13,701 | $2,845 | | General and administrative | $5,881 | $4,436 | $1,445 | | **Net loss** | **($22,489)** | **($16,792)** | **($5,697)** | - R&D expense for Q3 2020 increased by **$2.8 million** year-over-year, primarily due to a **$2.7 million** increase in manufacturing, clinical, and regulatory activities for XMT-1536[150](index=150&type=chunk)[151](index=151&type=chunk) Comparison of Results for the Nine Months Ended September 30 (in thousands) | | 2020 | 2019 | Dollar Change | |:---|:---:|:---:|:---:| | Collaboration revenue | $817 | $42,081 | ($41,264) | | Research and development | $44,179 | $42,610 | $1,569 | | General and administrative | $15,988 | $13,072 | $2,916 | | **Net loss** | **($59,203)** | **($11,962)** | **($47,241)** | - The significant decrease in collaboration revenue for the nine-month period was primarily due to the recognition of **$40.0 million** in deferred revenue in Q1 2019 from the terminated Takeda agreements[159](index=159&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2020, the company had cash and cash equivalents of **$270.9 million**[170](index=170&type=chunk) - The company significantly boosted its liquidity in 2020 by raising net proceeds of **$63.0 million** from its ATM facility in April and **$164.0 million** from a follow-on offering in June[166](index=166&type=chunk) - Management believes that currently available funds are sufficient to fund the company's operating plan and cash flow requirements for more than two years[176](index=176&type=chunk) Cash Flow Summary for Nine Months Ended September 30 (in thousands) | | 2020 | 2019 | |:---|:---:|:---:| | Net cash used in operating activities | ($57,377) | ($55,168) | | Net cash provided by (used in) investing activities | $37,215 | ($43,793) | | Net cash provided by financing activities | $228,747 | $97,473 | [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its short-term investments, with no material impact expected from a 1% rate change - The company's main market risk is interest rate sensitivity on its investments in U.S. Treasury obligations, commercial paper, and corporate bonds[183](index=183&type=chunk) - Due to the short-term duration of the investment portfolio, management believes a **1%** change in interest rates would not materially impact the portfolio's fair market value[183](index=183&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective as of September 30, 2020[186](index=186&type=chunk) - No changes occurred during the quarter ended September 30, 2020, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[187](index=187&type=chunk) [PART II - OTHER INFORMATION](index=38&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently party to any claim or litigation that is expected to have a material adverse effect on its business[189](index=189&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the company's risk factors since previous disclosures in its Annual Report and Q1 2020 Quarterly Report - There have been no material changes to the company's risk factors since those disclosed in the Annual Report on Form 10-K filed on February 28, 2020, and the Q1 2020 Form 10-Q filed on May 8, 2020[190](index=190&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the amended loan agreement, officer certifications, and iXBRL financial data - The exhibits filed with this report include the Second Amendment to the Loan and Security Agreement with Silicon Valley Bank, CEO and CFO certifications, and financial statements formatted in Inline eXtensible Business Reportable Language (iXBRL)[191](index=191&type=chunk)
Mersana Therapeutics(MRSN) - 2020 Q2 - Earnings Call Transcript
2020-08-07 18:04
Mersana Therapeutics, Inc. (NASDAQ:MRSN) Q2 2020 Earnings Conference Call August 7, 2020 8:00 AM ET Company Participants Sarah Carmody ??? Executive Director, Investor Relations and Corporate Communications Anna Protopapas ??? President and Chief Executive Officer Tim Lowinger ??? Chief Science and Technology Officer Brian DeSchuytner ??? Senior Vice President Finance and Product Strategy Conference Call Participants Jonathan Chang ??? SVB Leerink Boris Peaker ??? Cowen Tom Shrader ??? BTIG Mike Ulz ??? Bai ...
Mersana Therapeutics(MRSN) - 2020 Q2 - Quarterly Report
2020-08-07 12:50
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-38129 Mersana Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 04-3562403 (I. ...
Mersana Therapeutics (MRSN) Presents XMT-1536 Interim Expansion Data from Phase 1 Study - Slideshow
2020-05-29 17:42
XMT-1536 Interim Expansion Data from Phase 1 Study May 27, 2020 Legal Disclaimer This presentation contains "forward-looking" statements within the meaning of federal securities laws. These forward-looking statements are not statements of historical facts and are based on management's beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning the Company's business strategy and the design, progression and timing of its clinical tri ...
Mersana Therapeutics (MRSN) Presents At ASCO 2020 - Slideshow
2020-05-29 17:31
XMT-1536 临床试验结果 - XMT-1536 是一种新型的 NaPi2b 靶向抗体药物偶联物 (ADC),用于治疗既往接受过治疗的转移性卵巢癌 (OC) 或非小细胞肺癌 (NSCLC) 患者[1] - 在铂耐药性卵巢癌 (OC) 患者中,标准治疗(如单药聚乙二醇脂质体阿霉素和拓扑替康)的疗效有限,缓解率为 4% 至 12%,中位无进展生存期为 3 至 4 个月[1] - 在 NSCLC 腺癌患者中,尽管治疗选择有所进展,但临床结果仍然较差,二线和后续化疗的缓解率为 12% 至 20%[1] - 最大耐受剂量 (MTD) 确定为 43 mg/m2,这是目前正在扩展中评估的剂量[1] 安全性与耐受性 - 大多数治疗相关不良事件 (TRAE) 为 1 级或 2 级[1] - 28 名患者 (82%) 报告了至少 1 起治疗相关不良事件 (TRAE)[1] - 常见的 TRAE(≥20%)包括疲劳、恶心、呕吐、发热、食欲下降、腹泻、AST 升高(短暂性)[1] - 没有报告 4 级或 5 级 TRAE[1] - 没有报告 ≥3 级(严重)的中性粒细胞减少症、周围神经病变或眼部毒性[1] - 18 起严重不良事件 (SAE) 在 10 名患者 (29%) 中报告[1] 疗效 - 在铂耐药性 OC 患者中观察到抗肿瘤活性[1] - 在 20 名可评估的卵巢癌患者中,完全缓解 (CR) 为 2 例 (10%)[1] - 在铂耐药性 OC 患者中,客观缓解率 (ORR) 为 35%(不包括 1 名未确认 PR 的患者)[1] - 疾病控制率 (DCR) 为 80%[1]
Mersana Therapeutics(MRSN) - 2020 Q1 - Earnings Call Transcript
2020-05-08 17:59
Mersana Therapeutics, Inc. (NASDAQ:MRSN) Q1 2020 Earnings Conference Call May 8, 2020 8:00 AM ET Company Participants Sarah Carmody ??? Executive Director-Investor Relations and Corporate Communications Anna Protopapas ??? President and Chief Executive Officer Dirk Huebner ??? Chief Medical Officer Tim Lowinger ??? Chief Science and Technology Officer Brian DeSchuytner ??? Senior Vice President-Finance and Product Strategy Eva Jack ??? Chief Business Officer Conference Call Participants Jonathan Chang ??? S ...
Mersana Therapeutics(MRSN) - 2020 Q1 - Quarterly Report
2020-05-08 13:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-38129 Mersana Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or o ...
Mersana Therapeutics (MRSN) Investor Presentation - Slideshow
2020-03-05 17:00
T H E R A P E U T I C S Accelerating ADC Innovation …because patients are waiting March 2020 Legal Disclaimer This presentation contains "forward-looking" statements within the meaning of federal securities laws. These forward-looking statements are not statements of historical facts and are based on management's beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning the Company's business strategy and the design, progression a ...
Mersana Therapeutics(MRSN) - 2019 Q4 - Earnings Call Transcript
2020-02-28 18:09
Mersana Therapeutics, Inc. (NASDAQ:MRSN) Q4 2019 Results Conference Call February 28, 2020 8:00 AM ET Company Participants Sarah Carmody - Executive Director, IR and Corporate Communications Anna Protopapas - CEO Brian DeSchuytner - SVP, Finance and Product Strategy Conference Call Participants Jonathan Chang - SVB Leerink Boris Peaker - Cowen Debjit Chattopadhyay - H.C. Wainwright Jessica Fye - JP Morgan Mike Ulz - Baird David Nierengarten - Wedbush Securities Operator Good morning, and welcome to Mersana ...