Mersana Therapeutics Announces Third Quarter 2018 Financial Results and Provides Business Updates
November 13 2018 - 7:00AM
XMT-1536 Phase 1 Dose Escalation Ongoing with
Data Expected in the First Half of 2019
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 third quarter ended
September 30, 2018.
“We continue to make significant strides towards
building a leadership position in ADCs. In the third quarter,
we progressed our Phase 1 dose escalation trial of XMT-1536 for
solid tumors expressing NaPi2b and resumed enrollment on our new
protocol for the Phase 1 dose escalation trial of XMT-1522 for
HER2-expressing cancers,” said Anna Protopapas, President and CEO
of Mersana Therapeutics. “In addition to advancing our two clinical
programs, we have developed innovative new platforms that are
enabling us to greatly expand the reach of our therapeutics and the
productivity of our discovery engine.”
Recent Highlights and
Updates
Clinical Programs
- Continued evaluation of
once every four week schedule in the Phase 1 dose escalation study
of XMT-1536 for the treatment of NaPi2b-expressing.
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. XMT-1536 has previously been
studied on a once every three week schedule and this quarter we
initiated evaluation of a once every four week dosing
regimen. This dosing regimen has thus far been well tolerated
and, based on the results of this cohort, the company has advanced
the study to the next higher dosing level. A phase 2
recommended dose on XMT-1536 is expected in the first half of
2019. Additional data may be shared before selection of a
phase 2 dose as it matures and informs our expansion and phase 2
plans.
- Resumed enrollment of Phase
1 dose escalation study of XMT-1522 for the treatment of
HER2-expressing cancers. As reported on September 17,
2018, the U.S. Food and Drug Administration (FDA) lifted the
partial clinical hold on the Phase 1 study of XMT-1522 and the
trial has resumed enrollment. The company expects to select a phase
2 dose in mid2019.
- Presented preclinical data
on XMT-1536, a NaPi2b-targeting ADC, at the International
Association for the Study of Lung Cancer 19th World Conference on
Lung Cancer (IASLC WCLC 2018). In a poster titled “MERS67
is a Novel anti-NaPi2b Antibody and Demonstrates Differential
Expression Patterns in Lung Cancer Histologic Subtypes,” Mersana
demonstrated that proprietary immunohistochemistry reagent MERS67
has the ability to quantify NaPi2b expression in lung
adenocarcinoma (ACA). These data indicate potential uses of MERS67
in characterizing and selecting patients for the XMT1536 clinical
trial.
Discovery & Platform Progress
- Substantially advanced
research on new ADC platforms. The Company intends to
present data on two new platforms at the EORTC-NCI-AACR Molecular
Targets and Cancer Therapeutics Symposium from November 13-16,
2018, in Dublin, Ireland.• The first abstract, titled
“Discovery of the novel, homogeneous payload platform Dolasynthen
for Antibody-Drug Conjugates” characterizes Dolasynthen, a
next-generation platform allowing for drug homogeneity and precise
control of Drug-to- Antibody ratio.• The second abstract,
titled "Indole-Biaryl Pyrrolobenzodiazepines (I-BiPs): A potent and
well-tolerated class of DNA mono-alkylating payload for
antibody-drug conjugates (ADCs)” characterizes Alkymer, a DNA
damaging platform demonstrating superiority in both efficacy and
tolerability to existing DNA damaging platforms.
- Performed additional
preclinical studies demonstrating the potential of XMT-1522 in
NSCLC. The Company intends to present preclinical data on
XMT-1522 at the EORTC-NCI-AACR Molecular Targets and Cancer
Therapeutics Symposium. The abstract, titled “Target
Expression/Efficacy Relationship of XMT-1522, a HER2-targeting
Antibody Drug Conjugate (ADC), in an Unselected Series of Non-small
Cell Lung Cancer (NSCLC) Primary Human Carcinoma Xenografts”
demonstrates deep and durable responses with XMT-1522 treatment
across a broad range of patient derived NSCLC xenografts.
Upcoming Events
- The Company will give a corporate
presentation at the Credit Suisse Healthcare Conference on November
14, 2018, in Scottsdale, AZ.
- The Company is participating in the
9th Annual World ADC meeting from November 12-15, 2018, in San
Diego, CA. Tim Lowinger, the company’s Chief Scientific
Officer, will be chairing the meeting.
- The Company will present three data
abstracts at the EORTC-NCI-AACR Molecular Targets and Cancer
Therapeutics Symposium from November 13-16, 2018, in Dublin,
Ireland.
Financial Results
- Cash, cash equivalents and
marketable securities as of September 30, 2018, were $86.1 million,
compared to $125.2 million as of December 31, 2017. The company
expects that its cash, cash equivalents and marketable securities
will enable it to fund its operating plan into 2020.
- Collaboration revenue for the third
quarter 2018 was approximately $2.2 million, compared to $6.3
million for the same period in 2017, driven primarily by a
reduction of clinical costs in the quarter required to support
Takeda collaboration activities and a change in timelines required
to achieve a phase 2 dose.
- Research and development expenses
for the third quarter 2018 were approximately $15.2 million,
compared to $11.4 million for the same period in 2017, driven
primarily by an increase in clinical and in regulatory expenses due
to the progress of our lead programs and manufacturing costs to
support future clinical development.
- General and administrative expenses
for the third quarter 2018 were approximately $4.4 million,
compared to $2.9 million for the same period in 2017, driven
primarily by increased employee-related expenses due to increase in
personnel costs and increased professional fees.
- Net loss for the third quarter 2018
was $17.1 million, or $0.75 per share, compared to a net loss of
$7.7 million, or $0.35 per share, for the same period in
2017. Weighted average common shares outstanding for the
quarter ended September 30, 2018 were 23,152,019 and 22,242,129 for
the quarter ended September 30, 2017.
Conference Call
Mersana Therapeutics will host a conference call and webcast at
8:00 am ET on November 13 to report financial results for the third
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 8060459. A live
webcast of the presentation will be available on the Investors
& Media section of the Mersana website at www.mersana.com
About Dolaflexin
The Dolaflexin platform is designed to increase
the efficacy, safety, and tolerability of ADCs by overcoming key
limitations of existing technologies. 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 10 to 15, while maintaining desirable pharmacokinetics and
drug-like properties. This represents a three to four-fold increase
in DAR relative to traditional ADC approaches. The Dolaflexin
platform also incorporates the DolaLock technology, an engineered
controlled bystander effect. Auristatin F hydroxypropyl amide
(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 auristatin
F (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 XMT-1522
XMT-1522 is a Dolaflexin ADC targeting
HER2-expressing tumors. XMT-1522 contains a proprietary HER2
antibody which is conjugated with Mersana’s Dolaflexin platform – a
Fleximer polymer linked with a proprietary auristatin payload.
XMT-1522 provides a drug load of approximately 12 molecules per
antibody, specifically designed to improve potency while
simultaneously increasing tolerability. XMT-1522 has the potential
to extend HER2-targeted therapy beyond the current “HER2-positive”
populations into patients with lower levels of HER2 expression.
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 patients.
More information on the ongoing Phase 1 clinical trial can be
found at clinicaltrials.gov.
About XMT-1536
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 highly expressed in the majority of
non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is in
Phase 1 clinical trials in patients with tumors expressing NaPi2b,
including ovarian cancer, non-small cell lung cancer (NSCLC) and
other cancers. More information on the ongoing Phase 1
clinical trial can be found at clinicaltrials.gov.
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 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 patients. The Company’s
second product candidate, XMT-1536, is in Phase 1 clinical trials
in patients with tumors expressing NaPi2b, including ovarian
cancer, NSCLC and other cancers. In addition, multiple partners are
using Mersana’s platform to advance their ADC pipelines.
Forward-Looking Statements
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(in
thousands)(unaudited)
|
September 30, 2018 |
|
December 31, 2017 |
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
86,059 |
|
$ |
125,216 |
Working capital
(1) |
|
58,609 |
|
|
85,662 |
Total Assets |
|
94,378 |
|
|
130,715 |
Total stockholders'
equity |
|
29,854 |
|
|
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)(unaudited)
|
Three months ended |
|
Nine months ended |
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue |
$ |
2,151 |
|
|
$ |
6,267 |
|
|
$ |
9,405 |
|
|
$ |
14,284 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
15,180 |
|
|
|
11,412 |
|
|
|
40,098 |
|
|
|
32,145 |
|
General and
administrative |
|
4,380 |
|
|
|
2,905 |
|
|
|
12,181 |
|
|
|
7,406 |
|
Total operating
expenses |
|
19,560 |
|
|
|
14,317 |
|
|
|
52,279 |
|
|
|
39,551 |
|
Other income |
|
340 |
|
|
|
318 |
|
|
|
1,049 |
|
|
|
527 |
|
Net income (loss) |
$ |
(17,069 |
) |
|
$ |
(7,732 |
) |
|
$ |
(41,825 |
) |
|
$ |
(24,740 |
) |
Net income (loss) per
share attributable to common stockholders — basic and
diluted |
$ |
(0.75 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.82 |
) |
|
$ |
(2.94 |
) |
Weighted-average number
of common shares used in net loss per share attributable to common
stockholders — basic and diluted |
|
23,152,019 |
|
|
|
22,242,129 |
|
|
|
22,979,516 |
|
|
|
8,407,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Media ContactPaul
Kidwellpkidwell@mersana.com617-680-1088
Investor Contact Stern Investor Relations, Inc.
Christina Tartagliachristina@sternir.com212-362-1200
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