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Response to the FDA Partial Clinical Hold Submitted This Week
Strong Balance Sheet with a cash position of $97M to close Q2
CAMBRIDGE, Mass., Aug. 14, 2018 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin® and other proprietary platforms, today reported financial results and a business update for the second quarter ended June 30, 2018.
“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 FDA this week and are optimistic that, based on communications with the FDA, we are aligned on a path to lifting the hold.”
Clinical Program Status of XMT-1522
As reported on July 19, 2018, the U.S. Food and Drug Administration (FDA) placed the Phase 1 study of XMT-1522 on partial clinical hold following a report to the FDA of a Grade 5 Serious Adverse Event (patient death) in dose level 7 of the XMT-1522 Phase 1 trial. The company continues to dose patients who had started treatment prior to the hold and continue to participate in the trial consistent with the protocol.
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
Discovery & Platform Progress
Upcoming 2018 Events
Mersana Therapeutics will host a conference call and webcast at 8:00 am ET on August 15 to report financial results for the second quarter 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2895337. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.
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.
About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms to develop highly targeted drugs with increased tolerability and expanded opportunities to deliver meaningful clinical benefit to patients. Mersana’s first product candidate XMT-1522 is in Phase 1 clinical trials in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer. Mersana’s second product candidate, XMT-1536, is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC and other rare 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 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 U.S. Securities and Exchange Commission (SEC) including, without limitation, the company’s Annual Report on Form 10-K filed on March 28, 2018 and subsequent SEC filings. Except as required by law, the company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
Mersana Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||96,509||$||125,216|
|Working capital (1)||70,309||85,662|
|Total stockholders' equity||45,693||69,994|
|(1) The company defines working capital as current assets less current liabilities. See the company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.|
Mersana Therapeutics, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
|Three months ended||Six months ended|
|June 30,||June 30,||June 30,||June 30,|
|Research and development||12,663||10,627||24,919||20,733|
|General and administrative||4,231||2,204||7,801||4,501|
|Total operating expenses||16,894||12,831||32,720||25,234|
|Net income (loss)||$||(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|
Media Contact Paul Kidwell firstname.lastname@example.org 617-680-1088 Investor Contact Stern Investor Relations, Inc. Christina Tartaglia email@example.com 212-362-1200