• Offered extra knowledge from XMT-1536 Part 1 examine at ESMO demonstrating compelling and constant exercise and tolerability profile in ovarian most cancers
  • Obtained FDA Quick Monitor Designation for XMT-1536 for patients with heavily-pretreated ovarian cancer
  • Ended Q3 2020 with $271 million in money

CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical firm targeted on discovering and growing a pipeline of antibody-drug conjugates (ADCs) focusing on cancers in areas of excessive unmet medical want, right now reported monetary outcomes and supplied a enterprise replace for the third quarter ended September 30, 2020.

“Throughout the quarter, we offered an replace from the ovarian most cancers cohort of the XMT-1536 Part 1 examine at ESMO, which confirmed continued vital anti-tumor exercise in very late-stage ovarian most cancers sufferers with response charges far exceeding normal of care and a differentiated tolerability profile. We’re very inspired by the potential of this promising remedy for individuals with ovarian most cancers, and we stay up for offering a further replace on this program at an Analyst and Investor day round year-end,” stated Anna Protopapas, President and Chief Government Officer of Mersana Therapeutics. “We’ve additionally made nice progress in advancing a deep pipeline of therapies derived from our a number of revolutionary ADC platforms. XMT-1592, a Dolasynthen ADC focusing on NaPi2b, is actively enrolling sufferers in a Part 1 dose escalation examine. We’ve continued to advance our B7-H4 and first Immunosynthen STING-agonist ADC improvement candidates and stay up for sharing the info units supporting the scientific improvement of those promising molecules.”

Current Highlights and Updates

Scientific Programs

  • Reported optimistic incremental interim knowledge from the ovarian most cancers cohort of the XMT-1536 Part 1 enlargement examine at the European Society of Medical Oncology (ESMO) Digital Congress. These knowledge confirmed a security profile according to beforehand reported enlargement knowledge with out extreme neutropenia, peripheral neuropathy, or ocular toxicities; continued promising antitumor exercise in ovarian most cancers with 2/29 (7%) who achieved confirmed full responses (CRs) and eight/29 (28%) who achieved confirmed partial responses (PRs) for an goal response fee (ORR) of 34%; and continued assist for a NaPi2b biomarker-based affected person choice technique based mostly on depth, time on examine and high quality of response. The Firm has exceeded its recruitment aim of 40-45 sufferers within the ovarian most cancers cohort of the XMT-1536 Part 1 enlargement examine and can proceed to enroll sufferers all through the rest of 2020.
  • XMT-1536 granted Quick Monitor Designation underscoring the excessive unmet medical want in ovarian most cancers. In August 2020, the U.S. Meals and Drug Administration (FDA) granted Quick Monitor Designation for XMT-1536 for the remedy of sufferers with platinum-resistant high-grade serous ovarian most cancers who’ve acquired as much as three prior traces of systemic remedy or sufferers who’ve acquired 4 prior traces of systemic remedy no matter platinum standing.
  • Mersana plans to host a digital Analyst and Investor Day occasion to supply an replace on the ovarian most cancers cohort of the XMT-1536 Part 1 enlargement examine and the path ahead in ovarian most cancers round 12 months finish. The Firm anticipates that the year-end disclosure will embrace efficacy knowledge from roughly 40-45 RECIST evaluable sufferers, security knowledge from roughly 65-70 sufferers, and roughly three months of affected person comply with up for the reason that final knowledge cutoff date of August 18, 2020. As well as, the Firm will evaluate its plans for the registration-enabling examine and description its lifecycle administration technique for XMT-1536.
  • New worldwide websites added to assist enrollment of the NSCLC adenocarcinoma patient cohort of the XMT-1536 Part 1 enlargement examine. Within the third quarter of 2020 the Firm noticed a rise in enrollment within the lung most cancers cohort in parallel with the latest opening of worldwide websites that had been delayed due to COVID-19. The Firm will proceed to recruit the enlargement cohort and expects to debate its knowledge disclosure plans for the NSCLC adenocarcinoma affected person cohort in early January 2021.
  • Part 1 dose escalation examine of XMT-1592, a Dolasynthen ADC targeting NaPi2b, continuing to greater dose ranges. XMT-1592 is the Firm’s first scientific candidate created utilizing its new Dolasynthen ADC platform. In preclinical research, XMT-1592 confirmed 4 instances higher efficacy in a patient-derived lung tumor mannequin compared to XMT-1536, the Firm’s Dolaflexin ADC that has already proven success when focused to NaPi2b within the clinic. The Firm continues to dose escalate and expects to debate its knowledge disclosure plans for XMT-1592 in early January 2021.

Discovery & Platform Progress

  • Mersana to current preclinical knowledge supporting its first Immunosynthen improvement candidate in November 2020. Immunosynthen, the Firm’s novel STING-agonist ADC platform, has generated preclinical knowledge throughout a number of targets and fashions displaying full regression of tumors in vivo after a single, well-tolerated dose, according to elevated cytokine expression and immune cell infiltration throughout the tumor, and immune reminiscence. The Firm plans to current extra preclinical mechanistic knowledge supporting the focused twin activation of the STING pathway in tumor cells and tumor-resident immune cells on the Society for Immunotherapy of Most cancers (SITC) digital assembly in November. As well as, the Firm will host a webinar on November 16, 2020 the place it plans to evaluate the therapeutic rationale for the event of STING-agonist ADCs together with preclinical mechanistic knowledge displaying STING activation in each tumor cells and tumor-resident immune cells, the event and optimization of the Immunosynthen platform, and preclinical knowledge supporting the Firm’s Immunosynthen ADC pipeline in addition to the Investigational New Drug timeline for the Firm’s first improvement candidate.
  • Mersana on observe disclose its first-in-class ADC focusing on B7-H4 improvement candidate and supporting knowledge round 12 months finish. B7-H4 is expressed on each tumor cells and immunosuppressive tumor-associated macrophages (TAMs). This offers the potential for each a direct, cytotoxic antitumor impact in addition to for extra payload supply to the tumor microenvironment that may additional contribute to immunogenic cell dying, dendritic cell activation, and stimulation of an immune response according to the options of the Firm’s distinctive DolaLock payload. IND-enabling research are ongoing, and the Firm plans to reveal its improvement candidate and supporting knowledge at a digital Analyst and Investor Day round 12 months finish.

Company

  • New addition to Government Administration Staff. In August 2020, the Firm introduced the appointment of Chuck Miller as Senior Vice President of Regulatory Affairs. Mr. Miller was most lately Vice President of Regulatory Technique and Labeling at TESARO, Inc earlier than its acquisition by GSK. Previous to that, he labored as Government Director of Regulatory Affairs at Cubist, earlier than its acquisition by Merck.
  • Refinancing of SVB Debt Settlement. In August 2020, the Firm entered right into a second modification of its debt settlement with Silicon Valley Financial institution. The modification offers for an elevated dedication quantity and an extension of the interest-only fee interval into 2022. The Firm is now not required to take care of a minimal liquidity ratio.

Upcoming Occasions

  • Mersana will give a company presentation on the twenty ninth Annual Credit score Suisse Digital Healthcare Convention scheduled for Thursday, November 11, 2020 at 11:00 a.m. ET.
  • Mersana will current preclinical knowledge from its novel Immunosynthen STING-agonist ADC platform on the thirty fifth Annual Assembly of the Society for Immunotherapy of Most cancers (SITC) as an on-demand poster show obtainable from November 11 – 14, 2020.
  • Mersana will host an Immunosynthen STING-Agonist ADC Platform webinar on Monday, November 16, 2020 at 8:00 a.m. ET.

Third Quarter 2020 Monetary Outcomes

Money and money equivalents as of September 30, 2020, have been $270.9 million, in comparison with $99.8 million in money, money equivalents and marketable securities as of December 31, 2019. Web money utilized in working actions within the third quarter of 2020 was $20.2 million.

The Firm expects that its money and money equivalents will allow it to fund its present working plan commitments for greater than two years. As well as, the Firm has the choice to attract extra funds by the debt financing settlement with Silicon Valley Financial institution.

  • Collaboration income for the third quarter of 2020 was immaterial, in comparison with $0.8 million for a similar interval in 2019. The lower in collaboration income was primarily a results of the completion of analysis providers related to a goal included within the Merck KGaA settlement within the third quarter of 2019.
  • Analysis and improvement bills for the third quarter of 2020 have been roughly $16.5 million, in comparison with $13.7 million for a similar interval in 2019. The distinction was primarily on account of a rise in manufacturing actions for XMT-1536 and our discovery stage applications, a rise in XMT-1536 and XMT-1592 scientific bills, elevated headcount and an elevated valuation of stock-based awards, a rise in consulting {and professional} charges and development of companion diagnostics improvement efforts for the NaPi2b biomarker. The rise was partially offset by a lower in preclinical improvement and manufacturing bills for XMT-1592 and discontinuation of XMT-1522.
  • Common and administrative bills for the third quarter of 2020 have been roughly $5.9 million, in comparison with $4.4 million throughout the identical interval in 2019 primarily on account of a rise in consulting {and professional} charges, a rise in valuation of stock-based awards, and a rise in facility-related prices because of the extension of the Firm’s lease in March 2020.
  • Web loss for the third quarter of 2020 was $22.5 million, or $0.33 per share, in comparison with a internet lack of $16.8 million, or $0.35 per share, for a similar interval in 2019. Weighted common widespread shares excellent for the quarters ended September 30, 2020 and September 30, 2019, have been 68,419,192 and 47,833,607, respectively.

Convention Name Particulars
Mersana Therapeutics will host a convention name and webcast right now at 8:00 a.m. ET to report monetary outcomes for the third quarter of 2020 and supply sure enterprise updates. To entry the decision, please dial 877-303-9226 (home) or 409-981-0870 (worldwide) and supply the Convention ID 7953159. A stay webcast of the presentation will likely be obtainable on the Traders & Media part of the Mersana web site at www.mersana.com.

About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical firm utilizing its differentiated and proprietary ADC platforms to quickly develop novel ADCs with optimum efficacy, security and tolerability to meaningfully enhance the lives of individuals combating most cancers. Mersana’s lead product candidate, XMT-1536, is within the enlargement portion of a Part 1 proof-of-concept scientific examine in sufferers with ovarian most cancers and NSCLC adenocarcinoma. XMT-1592, Mersana’s second ADC product candidate focusing on NaPi2b-expressing tumors, was created utilizing Mersana’s customizable and homogeneous Dolasynthen platform and is within the dose escalation portion of a Part 1 proof-of-concept scientific examine. The Firm’s early stage applications embrace a B7-H4 focusing on ADC, in addition to a STING-agonist ADC developed utilizing the Firm’s Immunosynthen platform. As well as, a number of companions are utilizing Mersana’s Dolaflexin platform to advance their ADC pipelines.

Ahead-Trying Statements
This press launch incorporates “forward-looking” statements throughout the that means of federal securities legal guidelines. These forward-looking statements usually are not statements of historic info and are based mostly on administration’s beliefs and assumptions and on data at the moment obtainable to administration. Ahead-looking statements embrace data regarding the Firm’s enterprise technique and the design, development and timing of its scientific trials. Ahead-looking statements usually could be recognized by phrases resembling “goals,” “anticipates,” “believes,” “contemplates,” “continues,” “might,” “estimates,” “expects,” “aim,” “intends,” “might,” “on observe,” “plans,” “potential,” “potential,” “predicts,” “initiatives,” “seeks,” “ought to,” “goal,” “will,” “would” or related expressions and the negatives of these phrases. Ahead-looking statements signify administration’s beliefs and assumptions solely as of the date of this press launch. The Firm’s operations contain dangers and uncertainties, lots of that are outdoors its management, and any considered one of which, or mixture of which, might materially have an effect on its outcomes of operations and whether or not the forward-looking statements finally show to be appropriate. Elements that will materially have an effect on the Firm’s outcomes of operations and whether or not these forward-looking statements show to be appropriate embrace, amongst different issues, that preclinical testing is probably not predictive of the outcomes or success of ongoing or later preclinical or scientific trials, that the event and testing of the Firm’s product candidates and new platforms will take longer and/or price greater than deliberate, and that the identification of latest product candidates will take longer than deliberate, in addition to these listed within the Firm’s Annual Report on Type 10-Okay filed on February 28, 2020, with the Securities and Trade Fee (“SEC”), the Firm’s Quarterly Report on Type 10-Q filed on Could 8, 2020, with the SEC and subsequent SEC filings. As well as, whereas we count on that the COVID-19 pandemic would possibly adversely have an effect on the Firm’s preclinical and scientific improvement efforts, enterprise operations and monetary outcomes, the extent of the influence on the Firm’s operations and the worth of and marketplace for the Firm’s widespread inventory will rely on future developments which can be extremely unsure and can’t be predicted with confidence at the moment, resembling the last word period of the pandemic, journey restrictions, quarantines, bodily distancing and enterprise closure necessities within the U.S. and in different nations, and the effectiveness of actions taken globally to include and deal with the illness. Besides as required by legislation, the Firm assumes no obligation to replace these forward-looking statements publicly, or to replace the explanations precise outcomes might differ materially from these anticipated within the forward-looking statements, even when new data turns into obtainable sooner or later.

Mersana Therapeutics, Inc.
Chosen Condensed Consolidated Steadiness Sheet Information
(in hundreds)
(unaudited)

    September 30,
2020
  December 31,
2019
             
Money, money equivalents and marketable securities $ 270,936   $ 99,790
Working capital (1)   253,864     77,256
Whole belongings   290,128     107,541
Whole stockholders’ fairness   253,308     78,318
             
             
(1) The Firm defines working capital as present belongings much less present liabilities. See the Firm’s condensed consolidated monetary statements for additional element concerning its present belongings and present liabilities.
 

Mersana Therapeutics, Inc.
Condensed Consolidated Assertion of Operations
(in hundreds, besides share and per share knowledge)
(unaudited)

  Three months ended   9 months ended
  September 30,   September 30,   September 30,   September 30,
    2020       2019       2020       2019  
                       
Collaboration income $ 11     $ 844     $ 817     $ 42,081  
Working bills:                      
Analysis and improvement   16,546       13,701       44,179       42,610  
Common and administrative   5,881       4,436       15,988       13,072  
Whole working bills   22,427       18,137       60,167       55,682  
Different revenue (expense), internet   (73 )     501       147       1,639  
Web loss $ (22,489 )   $ (16,792 )   $ (59,203 )   $ (11,962 )
Different complete revenue (loss):                      
Unrealized acquire (loss) on marketable securities   (2 )     17       (25 )     36  
Complete loss $ (22,491 )   $ (16,775 )   $ (59,228 )   $ (11,926 )
Web loss per share attributable to widespread stockholders — primary and diluted $ (22,489 )   $ (16,792 )   $ (59,203 )   $ (11,962 )
Web loss per share attributable to widespread stockholders – primary and diluted $ (0.33 )   $ (0.35 )   $ (1.00 )   $ (0.28 )
Weighted-average variety of widespread shares utilized in internet loss per share attributable to widespread stockholders — primary and diluted   68,419,192       47,833,607       59,086,202       42,011,340  
                               

Contact:
Investor & Media Contact
Sarah Carmody, 617-844-8577
scarmody@mersana.com



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