Mersana Therapeutics(MRSN)

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Mersana Therapeutics(MRSN) - 2022 Q2 - Earnings Call Presentation
2022-08-09 00:04
Accelerating ADC Innovation …because patients are waiting August 2022 Legal Disclaimer This presentation contains "forward-looking" statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions, although not a ...
Mersana Therapeutics(MRSN) - 2022 Q2 - Quarterly Report
2022-08-08 21:07
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, 2022 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 001-38129 Mersana Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or org ...
Mersana Therapeutics (MRSN) Investor Presentation - Slideshow
2022-06-10 17:04
Accelerating ADC Innovation …because patients are waiting June 2022 Legal Disclaimer This presentation contains "forward-looking" statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions, although not all ...
Mersana Therapeutics(MRSN) - 2022 Q1 - Earnings Call Transcript
2022-05-09 15:19
Mersana Therapeutics, Inc. (NASDAQ:MRSN) Q1 2022 Earnings Conference Call May 9, 2022 8:00 AM ET Company Participants Jason Fredette - Senior Vice President, Investor Relations and Corporate Communications Anna Protopapas - President, CEO & Director Arvin Yang - Senior VP & Chief Medical Officer Tim Lowinger - Chief Science & Technology Officer Brian DeSchuytner - Senior VP & CFO Conference Call Participants Jonathan Chang - SVB Leerink Boris Peaker - Cowen Daniel Wolle - JPMorgan Colleen Kusy - Baird David ...
Mersana Therapeutics(MRSN) - 2022 Q1 - Quarterly Report
2022-05-09 12:58
[PART I – FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents unaudited financial statements, management's discussion and analysis, market risk, and internal controls [Item 1. Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, showing increased cash and a wider net loss due to higher R&D and G&A expenses, with key details in the notes [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The financial statements show increased cash to $230.1 million and a wider net loss of $47.3 million due to higher R&D and G&A expenses Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $230,057 | $177,947 | | Total current assets | $241,470 | $188,898 | | Total assets | $258,267 | $206,111 | | **Liabilities & Equity** | | | | Total current liabilities | $56,463 | $47,523 | | Deferred revenue, noncurrent | $25,620 | $— | | Total liabilities | $117,741 | $84,370 | | Total stockholders' equity | $140,526 | $121,741 | Condensed Consolidated Statement of Operations (in thousands) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Collaboration revenue | $2,036 | $11 | | Research and development | $35,806 | $27,415 | | General and administrative | $12,782 | $7,208 | | **Net loss** | **$(47,258)** | **$(34,693)** | | Net loss per share | $(0.59) | $(0.50) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,955) | $(27,022) | | Net cash used in investing activities | $(329) | $(114) | | Net cash provided by financing activities | $60,394 | $472 | | **Increase (decrease) in cash** | **$52,110** | **$(26,664)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's ADC focus, the Janssen collaboration, ATM equity financing, debt facilities, and stock-based compensation - The company's lead product candidate, **upifitamab rilsodotin (UpRi)**, is a first-in-class ADC targeting NaPi2b for ovarian cancer, currently in a registrational trial (UPLIFT) and a combination trial (UPGRADE)[30](index=30&type=chunk) - In February 2022, the company entered a research collaboration with Janssen, receiving a **$40.0 million upfront payment**, and recognized **$1.7 million** in collaboration revenue for the quarter[52](index=52&type=chunk)[65](index=65&type=chunk) - During Q1 2022, the company sold **11.7 million shares** for **$54.8 million** net proceeds, fully utilizing its 2020 ATM program, and established a new **$100.0 million** 2022 ATM program, selling **1.4 million shares** for **$5.8 million** net proceeds[92](index=92&type=chunk)[93](index=93&type=chunk) - The company's New Credit Facility provides for up to **$100.0 million** in term loans, with **$25.0 million** outstanding as of March 31, 2022[86](index=86&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $2,933 | $2,301 | | General and administrative | $2,552 | $1,738 | | **Total** | **$5,485** | **$4,039** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Q1 2022 net loss increase to $47.3 million due to higher R&D and G&A, strong liquidity, and the discontinuation of XMT-1592 development [Overview](index=25&type=section&id=Overview) This overview details Mersana's ADC strategy, focusing on UpRi's registrational trial, advancing early-stage pipeline, and discontinuing XMT-1592 development - The company's lead ADC, **UpRi**, is in a single-arm registrational trial (UPLIFT) for platinum-resistant ovarian cancer, with enrollment expected in **Q3 2022**[130](index=130&type=chunk) - In May 2022, the company decided to discontinue the development of its second clinical candidate, **XMT-1592**[131](index=131&type=chunk) - Mersana plans to initiate Phase 1 clinical trials for **XMT-1660** (B7-H4 target) and **XMT-2056** (HER2 target) in **mid-2022**[132](index=132&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section analyzes Q1 2022 financial results, showing increased collaboration revenue, an $8.4 million rise in R&D, and a $5.6 million rise in G&A expenses Comparison of Results of Operations (in thousands) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Dollar Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,036 | $11 | $2,025 | | Research and development | $35,806 | $27,415 | $8,391 | | General and administrative | $12,782 | $7,208 | $5,574 | | **Net loss** | **$(47,258)** | **$(34,693)** | **$(12,565)** | - The **$8.4 million** increase in R&D expense was primarily due to a **$3.3 million** rise in employee compensation, a **$2.0 million** increase in manufacturing for preclinical programs, and a **$1.8 million** increase in UpRi activities[157](index=157&type=chunk)[158](index=158&type=chunk) - The **$5.6 million** increase in G&A expense was mainly driven by a **$2.8 million** rise in consulting and professional fees and a **$1.6 million** increase in employee compensation[159](index=159&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) Mersana held $230.1 million in cash as of March 31, 2022, bolstered by $60.6 million from ATM programs, with funds projected to last into H2 2023 - The company held **$230.1 million** in cash and cash equivalents as of March 31, 2022[166](index=166&type=chunk) - During Q1 2022, the company raised **$54.8 million** from its 2020 ATM and **$5.8 million** from its new 2022 ATM, with an additional **$40.0 million** raised post-quarter end through May 5, 2022[163](index=163&type=chunk)[164](index=164&type=chunk) - Net cash used in operating activities decreased to **$8.0 million** for Q1 2022 from **$27.0 million** in Q1 2021, primarily due to **$38.3 million** in deferred revenue from the Janssen Agreement[169](index=169&type=chunk) - Management believes current cash and cash equivalents, plus **$35 million** available borrowings, will fund operations into the **second half of 2023**[174](index=174&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity affecting its cash equivalents and its floating-rate credit facility - The company faces interest rate risk on cash equivalents and its floating-rate New Credit Facility, though a **100 basis point change** is not expected to have a material effect[180](index=180&type=chunk)[181](index=181&type=chunk) - The company is not currently exposed to material foreign currency exchange rate risks, but this may change with increased international vendor contracts[182](index=182&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation as of March 31, 2022, the company's disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded that disclosure controls and procedures were **effective** as of March 31, 2022[184](index=184&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2022[185](index=185&type=chunk) [PART II - OTHER INFORMATION](index=37&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, comprehensive risk factors, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings that would be expected to have a material adverse effect on its business - As of the report date, the company is not party to any **material legal proceedings**[187](index=187&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks including clinical development failure, reliance on UpRi, financial losses, need for capital, third-party dependence, commercialization hurdles, IP challenges, regulatory uncertainty, and broader business risks [Risks Related to Development and Approval](index=37&type=section&id=Risks%20Related%20to%20Development%20and%20Approval%20of%20Our%20ADC%20Product%20Candidates) This subsection highlights inherent uncertainties in drug development, including high failure risk, potential for serious adverse events, and the critical dependence on UpRi's success - The company's early-stage product candidates face a **high risk of failure**, and positive early results do not guarantee future success[189](index=189&type=chunk)[190](index=190&type=chunk) - With a concentrated pipeline, failure of the lead candidate, **UpRi**, would significantly harm the business and may lead to discontinuing other related candidates[195](index=195&type=chunk) - Patients in clinical trials have experienced **serious adverse events (SAEs)**, including death, which could halt development, prevent approval, or limit commercial potential[191](index=191&type=chunk)[202](index=202&type=chunk) [Risks Related to Financial Position and Need for Capital](index=44&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This subsection details Mersana's financial vulnerabilities, including a history of net losses, the need for substantial additional capital, and restrictive covenants from its credit facility - The company has incurred **net losses since inception**, with a **$47.3 million** net loss for Q1 2022 and an accumulated deficit of **$497.7 million** as of March 31, 2022, anticipating continued substantial losses[208](index=208&type=chunk) - Substantial additional financing is required to achieve company goals; failure to obtain it could lead to delays, limitations, or termination of product development and commercialization efforts[216](index=216&type=chunk) - The company's credit facility imposes **restrictive covenants** that limit operating and financial flexibility, affecting its ability to incur debt, grant liens, make investments, and sell assets[214](index=214&type=chunk)[215](index=215&type=chunk) [Risks Related to Reliance on Third Parties](index=47&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Mersana's business heavily relies on third-party CMOs for manufacturing, CROs for clinical trials, and strategic partners, exposing it to significant operational and financial risks - The company relies entirely on **third-party contract manufacturers** for all product supplies, lacking internal capabilities, which poses risks to supply, quality, and regulatory compliance[223](index=223&type=chunk) - Reliance on **CROs** and other third parties for clinical trials results in less direct control over timing, completion, and data quality[228](index=228&type=chunk) - Dependence on strategic partnerships, such as with **Janssen** or **Merck KGaA**, means partner non-performance or termination could reduce revenue and harm development efforts[232](index=232&type=chunk)[234](index=234&type=chunk) [Risks Related to Commercialization](index=51&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20ADC%20Product%20Candidates) This subsection outlines significant commercialization hurdles, including market acceptance, lack of sales infrastructure, reimbursement challenges, and intense competition from larger companies - Future commercial success depends on achieving significant market acceptance among physicians, patients, and healthcare payors, which remains uncertain[240](index=240&type=chunk) - The company lacks sales, marketing, and distribution infrastructure, and building or outsourcing these capabilities involves significant risks, costs, and potential launch delays[244](index=244&type=chunk)[246](index=246&type=chunk) - Profitable product sales depend on obtaining adequate coverage and reimbursement from third-party payors, who are increasingly focused on cost containment and may impose adverse pricing limitations[249](index=249&type=chunk) - The company faces substantial competition from large pharmaceutical and biotechnology companies possessing greater financial resources and expertise across R&D, manufacturing, and marketing[254](index=254&type=chunk)[256](index=256&type=chunk) [Risks Related to Intellectual Property](index=55&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This subsection details IP risks, including challenges in obtaining and defending patents, reliance on in-licensed IP, and potential for expensive infringement litigation - The company's success relies on obtaining and maintaining patent protection for its technology and product candidates, though the biopharmaceutical patent landscape is highly uncertain[259](index=259&type=chunk) - The company relies on **third-party licenses**, such as from **Recepta** for the NaPi2b antibody, and breaching these agreements could result in loss of IP rights and halted product development[267](index=267&type=chunk)[268](index=268&type=chunk) - The company may face expensive and time-consuming IP lawsuits to protect its rights or defend against infringement claims, potentially leading to loss of patent protection or inability to commercialize products[275](index=275&type=chunk)[278](index=278&type=chunk) [Risks Related to Regulatory Approval and Other Legal Compliance](index=63&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) This subsection describes the extensive and uncertain regulatory approval process, ongoing compliance requirements, and the complex healthcare laws that govern the company's operations - The regulatory approval process is expensive, time-consuming, and uncertain, and the company, lacking prior experience, may never obtain approval for its candidates[297](index=297&type=chunk) - Any approved product will be subject to extensive ongoing regulation, including **cGMP**, marketing, and safety reporting, with non-compliance risking approval withdrawal or penalties[304](index=304&type=chunk)[307](index=307&type=chunk) - The company's activities are subject to extensive healthcare laws, including **anti-kickback**, **false claims**, **HIPAA**, and **GDPR**, where violations can lead to substantial penalties and reputational harm[333](index=333&type=chunk)[335](index=335&type=chunk)[354](index=354&type=chunk) [General and Business Risks](index=78&type=section&id=Risks%20Related%20to%20our%20Business%20and%20Industry) This subsection covers broader operational risks, including attracting talent, managing growth, product liability, and impacts from the COVID-19 pandemic and geopolitical instability - The company's success depends on attracting and retaining highly qualified senior management and scientific personnel in a competitive market[365](index=365&type=chunk) - The business faces risks from the **COVID-19 pandemic**, potentially disrupting clinical trials, manufacturing, supply chains, and regulatory processes[391](index=391&type=chunk)[392](index=392&type=chunk) - Unfavorable global economic conditions, including **inflation**, and geopolitical events like the **Russia-Ukraine conflict** could adversely affect operations, financial condition, and capital access[398](index=398&type=chunk)[399](index=399&type=chunk) - The company faces an inherent risk of **product liability lawsuits** from clinical testing, potentially resulting in substantial liabilities[369](index=369&type=chunk) [Item 6. Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q. Key documents include the Sales Agreement for the 2022 ATM program, the Research Collaboration and License Agreement with Janssen Biotech, Inc., an amendment to the loan and security agreement, and various officer certifications - This section lists all exhibits filed with the Form 10-Q, including key agreements like the **Janssen collaboration (10.2)**, the **2022 ATM Sales Agreement (10.1)**, and **credit facility amendments (10.4)**[401](index=401&type=chunk)
Mersana Therapeutics(MRSN) - 2021 Q4 - Earnings Call Presentation
2022-02-28 17:20
Accelerating ADC Innovation …because patients are waiting February 2022 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 Mersana Therapeutics, Inc.'s (the "Company's") business strategy and the design, p ...
Mersana Therapeutics(MRSN) - 2021 Q4 - Earnings Call Transcript
2022-02-28 16:25
Mersana Therapeutics, Inc. (NASDAQ:MRSN) Q4 2021 Earnings Conference Call February 28, 2022 8:00 AM ET Company Participants James Salierno - Associate Director, Investor Relations. Anna Protopapas - President & CEO Arvin Yang - Senior Vice President & Chief Medical Officer Brian DeSchuytner - Senior Vice President &Chief Financial Officer Conference Call Participants Jonathan Chang - SVB Leerink Boris Peaker - Cowen Colleen Kusy - Baird Capital Kaveri Pohlman - BTIG Jessica Fye - JPMorgan Operator Good mor ...
Mersana Therapeutics(MRSN) - 2021 Q4 - Annual Report
2022-02-28 14:11
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021. 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 001-38129 Mersana Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 04-3562403 (State ...
Mersana Therapeutics(MRSN) - 2021 Q3 - Earnings Call Transcript
2021-11-09 18:10
Mersana Therapeutics, Inc. (NASDAQ:MRSN) Q3 2021 Earnings Conference Call November 9, 2021 8:00 AM ET Company Participants Sarah Carmody - Executive Director, IR & Corporate Communications Anna Protopapas - President, CEO & Director Arvin Yang - SVP & Chief Medical Officer Timothy Lowinger - Chief Science & Technology Officer Brian DeSchuytner - SVP & CFO Conference Call Participants Boris Peaker - Cowen and Company Kaveri Pohlman - BTIG Daniel Wolle - JPMorgan Chase & Co. Colleen Kusy - Robert W. Baird & C ...
Mersana Therapeutics(MRSN) - 2021 Q3 - Quarterly Report
2021-11-09 14:18
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 September 30, 2021 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 04-356240 ...