Mersana Therapeutics Announces Second Quarter 2019 Financial Results and Provides Business Updates
Patient Dosing in XMT-1536 Phase 1 Expansion Study Expected to Commence in Third Quarter 2019
Ended Second Quarter 2019 with
“In the second quarter, we reported encouraging clinical activity and tolerability for our first-in-class, wholly-owned ADC candidate, XMT-1536, in heavily pretreated cancer patients without selection for NaPi2b expression,” said Anna Protopapas, President and CEO of
Recent Highlights and Updates
• Presented interim Phase 1 data for XMT-1536 at the 2019
- The most common treatment-related adverse events (TRAEs) were Grade 1-2 nausea, fatigue, and headache, and the most frequent Grade 3 TRAE was transient AST elevation without associated changes in bilirubin.
- In patients with tumor types selected for the planned expansion phase (platinum-resistant ovarian cancer and NSCLC adenocarcinoma) treated at ≥20 mg/m2 (N=18), three (17%) achieved partial responses (PRs) and eight (44%) achieved stable disease (SD) for a disease control rate (DCR) of 11/18 (61%), and a treatment duration lasting beyond 16 weeks in 9 patients (50%).
- In ovarian cancer patients treated at ≥30 mg/m2 (N=7), two (28%) achieved partial responses (PRs) and three (43%) achieved stable disease (SDs) for a disease control rate (DCR) of 5/7 (71%), and three of these patients (43%) were treated on study for more than 16 weeks.
• The Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing cancers remains ongoing. The Company continues to evaluate patients in the 36 mg/m2 once-every-four-week dosing cohort and the maximum tolerated dose has not yet been reached. The Company expects to select a dose and initiate expansion cohorts in the third quarter of 2019.
• Site initiation continues for the dose expansion portion of the XMT-1536 Phase 1 study. Mersana continues to add sites in anticipation of dosing patients in the expansion groups in the third quarter of 2019. In the first group, the Company plans to enroll platinum-resistant ovarian cancer patients who have failed standard therapy. The second patient group will enroll NSCLC adenocarcinoma patients who have failed front line platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 therapy.
Discovery & Platform Progress
• Mersana expects to disclose its next ADC clinical candidate around year end, further strengthening its scientific leadership in ADC development. The Company is targeting the filing of its next Investigational New Drug (IND) application with the
• Completed non-dilutive debt financing for additional financial flexibility. On
• Added significant strategic and operational expertise in oncology to Mersana’s leadership team. On
• The Company will give a corporate presentation on
• The Company will give a corporate presentation on
• The Company will give a corporate presentation at the
• The Company will present preclinical data from its proprietary, novel Immunosynthen platform at the upcoming 10th Annual World ADC conference on
2019 Financial Results
• Cash, cash equivalents and marketable securities as of
Second Quarter 2019
• Collaboration revenue for the second quarter 2019 was approximately
• Research and development expenses for the second quarter 2019 were approximately
• General and administrative expenses for the second quarter 2019 remained flat at
• Net loss for the second quarter 2019 was
XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen expressed in the majority of non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC adenocarcinoma and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.
Mersana Therapeutics is a clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms and its modular Synthemer scaffold to develop highly targeted drugs with increased tolerability and expanded opportunities to deliver meaningful clinical benefit to cancer patients. Mersana’s lead product candidate, XMT-1536, is in a Phase 1 clinical trial in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC adenocarcinoma, and other cancers. In addition, multiple partners are using Mersana’s platform to advance their ADC pipelines.
This press release 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 trials. Forward-looking statements generally can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward-looking statements represent management’s beliefs and assumptions only as of the date of this press release. The Company’s operations involve risks and uncertainties, many of which are outside its control, and any one of which, or combination of which, could materially affect its results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that may materially affect the Company’s results of operations and whether these forward-looking statements prove to be correct include, among other things, that preclinical testing may not be predictive of the results or success of ongoing or later preclinical or clinical trials, that the development and testing of the Company’s product candidates and new platforms will take longer and/or cost more than planned and that the identification of new product candidates will take longer than planned, as well as those listed in the Company’s Annual Report on Form 10-K filed on
Selected Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and marketable securities||$||128,177||$||70,131|
|Working capital (1)||107,699||4,880|
|Total stockholders' equity||108,514||8,795|
|(1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
|Three months ended||Six months ended|
|June 30,||June 30,||June 30,||June 30,|
|Research and development||13,766||12,663||28,909||24,919|
|General and administrative||4,192||4,231||8,635||7,801|
|Total operating expenses||17,958||16,894||37,544||32,720|
|Other income (expense), net||685||349||1,137||709|
|Net income (loss)||$||(17,071||)||$||(12,354||)||$||4,830||$||(24,756||)|
|Other comprehensive income (loss):|
|Unrealized gain on marketable securities||11||72||19||59|
|Comprehensive income (loss)||$||(17,060||)||$||(12,282||)||$||4,849||$||(24,697||)|
|Net income (loss) per share attributable to common stockholders — basic and diluted||$||(17,071||)||$||(12,354||)||$||4,830||$||(24,756||)|
|Net income (loss) per share attributable to common stockholders — basic||$||(0.36||)||$||(0.54||)||$||0.12||$||(1.08||)|
|Net income (loss) per share attributable to common stockholders — diluted||$||(0.36||)||$||(0.54||)||$||0.12||$||(1.08||)|
|Weighted-average number of common shares used in net income (loss) per share attributable to common stockholders — basic||47,708,085||22,966,314||39,051,958||22,891,831|
|Weighted-average number of common shares used in net income (loss) per share attributable to common stockholders — diluted||47,708,085||22,966,314||40,184,374||22,891,831|
Investor & Media Contact
Source: Mersana Therapeutics, Inc.