Mersana Therapeutics Announces Second Quarter 2018 Financial Results and Provides Business Updates
Response to the FDA Partial Clinical Hold Submitted This Week
Strong Balance Sheet with a cash position of
“Our top priority is to resolve the partial clinical hold placed on our novel drug candidate XMT-1522 for HER2 expressing cancers, and to continue advancing XMT-1536 for solid tumors expressing NaPi2b,” said Anna Protopapas, President and CEO of Mersana Therapeutics. “We have submitted our response to the
Clinical Program Status of XMT-1522
As reported on
Clinical Update on XMT-1536
XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer, as well as several other rare tumor types. The company continues to dose patients in its Phase 1 dose escalation study. Upon completing the dose escalation phase and selecting a recommended phase 2 dose (RP2D), the company will move into expansion studies in defined patient populations.
Other Recent Highlights and Updates
Further data on our Clinical Programs
- Presented interim dose escalation data on XMT-1522 in select cancers at the 2018
American Society of Clinical Oncology( ASCO) Annual Meeting. These data showed that as of April 21, 2018, 22 patients had completed the dose limiting toxicity (DLT) evaluation period across 6 dose levels. As of that date, the treatment was well-tolerated, with most adverse events (AEs) for those patients being low grade and manageable; the most common treatment-related AEs were fatigue, nausea, vomiting, anemia, and transient elevations of AST and ALT. As of the date of the ASCOdisclosure, six patients had been dosed at dose level 7 (28.3 mg/m2), but only three had completed the first evaluation period. Of the thirteen patients enrolled at doses of 16 mg/m2 or greater at that time, including the three from dose level 7, eleven had stable disease (SD) or better, including one confirmed partial response (PR).
Discovery & Platform Progress
- The company has progressed its research on new payloads, platforms and new molecules and plans to present preclinical data at a major scientific meeting in the fourth quarter of 2018.
Upcoming 2018 Events
- The company will give a corporate presentation on
August 15, 2018, at the 2018 Wedbush PacGrow Healthcare Conferencein New York City.
- The company will give a corporate presentation at the
H.C. Wainwright Healthcare Conferencein New York Cityfrom September 4 to 6, 2018.
- The company will give a corporate presentation on
September 6, 2018, at the Baird Healthcare Conferencein New York City.
- The company will be presenting preclinical data on XMT-1536 at the
IASLC World Conference on Lung Cancerin Torontoon September 25, 2018. Data will be presented demonstrating preferential expression of NaPi2b in lung adenocarcinoma, as determined using a new immunohistochemical reagent developed by the company, that can be used to detect NaPi2b expression in tissue samples.
- Cash, cash equivalents and marketable securities as of
June 30, 2018, were $96.5 million, compared to $125.2 millionas of December 31, 2017. The company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan for at least the next twelve months.
- Collaboration revenue for the second quarter 2018 was approximately
$4.2 million, compared to $3.7 millionfor the same period in 2017, primarily due to a $1.5 millionmilestone achieved during the three months ended June 30, 2018.
- Research and development expenses for the second quarter 2018 were approximately
$12.6 million, compared to $10.6 millionfor the same period in 2017, driven primarily by an increase in employee-related costs due to increased headcount and clinical and in regulatory expenses due to the progress of XMT-1522 and XMT-1536.
- General and administrative expenses for the second quarter 2018 were approximately
$4.2 million, compared to $2.2 millionfor the same period in 2017, driven primarily by increased employee-related expenses due to increase in headcount and increased consulting and professional fees.
- Net loss for the second quarter 2018 was
$12.4 million, or $0.54per share, compared to a net loss of $8.9 million, or $6.33per share, for the same period in 2017. Weighted average common shares outstanding for the quarter ended June 30, 2018were 22,966,314 and 1,412,308 for the quarter ended June 30, 2017.
The Dolaflexin platform is designed to increase the efficacy, safety, and tolerability of ADCs by overcoming key limitations of existing technologies based on direct conjugation of a payload molecule to an antibody. Dolaflexin consists of Fleximer, a biodegradable, highly biocompatible, water soluble polymer, to which are attached multiple molecules of Mersana’s proprietary auristatin drug payload using a linker specifically optimized for use with Mersana’s polymer. The high water-solubility of the Fleximer polymer compensates for the low solubility of the payload, surrounding the payload and protecting it from aggregation and maintaining stability in circulation. Multiple molecules of this Dolaflexin polymer-drug conjugate can then be attached to an antibody of choice, which significantly increases the payload capacity of the resulting ADC. This approach differs from most other ADC technologies that conjugate the payload directly to the antibody. Using its Dolaflexin platform, Mersana has been able to generate ADCs with a very high Drug-to-Antibody Ratio (DAR), between 12 to 15, while maintaining desirable pharmacokinetics and drug-like properties in animal models. This represents a three to four-fold increase in DAR relative to traditional ADC approaches. The Dolaflexin platform also incorporates DolaLock technology, an engineered controlled bystander effect. AF-HPA, the initial auristatin drug release product, is freely cell permeable and has bystander-killing capabilities. Intra-tumor metabolism then facilitates the conversion of AF-HPA to AF, which is non-cell permeable, highly potent, and “locked” into the tumor. This enhancement improves both the efficacy and tolerability of Mersana’s ADC candidates.
This press release contains “forward-looking” statements within the meaning of federal securities laws. These are not statements of historical facts and are based on management’s beliefs and assumptions and on information currently available. They are subject to risks and uncertainties that could cause the actual results and the implementation of the company’s plans to vary materially, including the risk that our clinical trials will not be completed on schedule, if at all, and the risk that our early encouraging preclinical results for XMT-1522 and XMT-1536 are not necessarily predictive of the results of our ongoing or future discovery programs or clinical studies. These risks are discussed in the company’s filings with the
Selected Condensed Consolidated Balance Sheet Data
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||96,509||$||125,216|
|Working capital (1)||70,309||85,662|
|Total stockholders' equity||45,693||69,994|
|(1) The company defines working capital as current assets less current liabilities. See the company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
|Three months ended||Six months ended|
|June 30,||June 30,||June 30,||June 30,|
|Research and development||12,663||10,627||24,919||20,733|
|General and administrative||4,231||2,204||7,801||4,501|
|Total operating expenses||16,894||12,831||32,720||25,234|
|Net income (loss)||$||(12,354||)||$||(8,946||)||$||(24,756||)||$||(17,008||)|
|Net income (loss) per share attributable to common stockholders — basic and diluted||$||(0.54||)||$||(6.33||)||$||(1.08||)||$||(12.36||)|
|Weighted-average number of common shares used in net loss per share attributable to common stockholders — basic and diluted||22,966,314||1,412,308||22,891,831||1,375,595|
Paul Kidwellpkidwell@mersana.com 617-680-1088 Investor Contact Stern Investor Relations, Inc. Christina Tartagliachristina@sternir.com 212-362-1200
Source: Mersana Therapeutics, Inc.