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
proprietary Dolaflexin® platform, today reported business
highlights and financial results for the quarter ended June 30,
2017.
“In this quarter, we achieved an important milestone with the
successful completion of our initial public offering, raising $75
million in gross proceeds to continue to progress our novel ADC
pipeline. Our lead oncology drug candidate XMT-1522 is currently
enrolling patients in a Phase 1 trial and we continue to expect to
report interim results around the end of this year. We also remain
on track to file our second IND shortly and begin clinical studies
in early 2018 for XMT-1536, our potential first in class NaPi2b
ADC,” said Anna Protopapas, President and CEO of Mersana
Therapeutics. “These efforts, as well as significant partnerships
with leading pharmaceutical companies, Merck KGaA and Takeda,
continue to demonstrate the ability of our proprietary Dolaflexin
platform to generate promising drug candidates to help patients
with devastating cancers.”
Platform and Pipeline Highlights
XMT-1522: XMT-1522 is a Dolaflexin-based HER2-targeted
ADC targeting tumors not addressed by currently approved HER2
therapies.
- Enrollment of the Phase 1 dose escalation study of XMT-1522
continues in patients with advanced tumors expressing HER2,
including breast cancer, non-small-cell-lung-cancer (NSCLC) and
gastric cancer with interim safety results expected around the end
of 2017.
- In June 2017, Mersana presented a Trials in Progress abstract
on Phase 1 trial design of its lead program, XMT-1522, a novel
HER2-targeted ADC, at the 2017 American Society of Clinical
Oncology (ASCO) annual meeting in Chicago, IL.
- In April 2017, at the American Association for Cancer Research
(AACR) Annual Meeting, Mersana presented preclinical data on the
biodistribution of XMT-1522 in mice carrying HER2-expressing
tumors, providing in vivo proof-of-concept of Mersana’s proprietary
DolaLock payload technology. In this study, there was exposure to
both the primary ADC payload release product and its active
metabolite in the tumor for two weeks after a single dose of
XMT-1522, with minimal exposure to either payload in normal
tissues. The results presented support the potential of Mersana’s
Dolaflexin ADC platform to provide a greater therapeutic index by
simultaneously improving efficacy via greater payload delivery and
tolerability through the DolaLock payload technology.
- Also at the AACR Annual Meeting in April 2017, Mersana
presented preclinical data supporting the activity of XMT-1522 as
monotherapy and in combination with immune checkpoint inhibitors in
NSCLC models. We believe these data support the enrollment of NSCLC
patients in the XMT-1522 early development program and its
potential synergistic effect with checkpoint inhibitors.
XMT-1536: XMT-1536 is a potential first-in-class
Dolaflexin ADC targeting NaPi2b-expressing tumors.
- The Phase 1 study of XMT-1536, a potential first in class
NaPi2b ADC, remains on track for initiation of clinical trials in
early 2018, with the in-life portion of the Good Laboratory
Practice (GLP) toxicology studies now successfully completed.
Recent Corporate Highlights
- In July 2017, Mersana completed its initial public offering,
raising approximately $75.0 million in gross proceeds through the
sale of 5,000,000 shares of its common stock at an offering price
of $15.00 per share.
Second Quarter 2017 Financial Results
- Cash, cash equivalents and marketable securities as of June 30,
2017 were $77.2 million, compared with $100.3 million as of
December 31, 2016. Cash, cash equivalents and marketable securities
as of June 30, 2017 did not include net proceeds of approximately
$67.5 million from the Company's initial public offering, as
described above. The Company expects that its cash, cash
equivalents and marketable securities will enable it to fund its
operating plan through at least mid-2019.
- Research and development expenses for the quarter were
approximately $10.6 million, compared to $8.2 million for the same
period in 2016. The increase was primarily due to additional
personnel and external costs associated with continued clinical
development of the Company’s lead program XMT-1522 and IND-enabling
studies and manufacturing activities associated with its second
program, XMT-1536, which is expected to enter clinical development
in early 2018.
- General and administrative expenses for the quarter were
approximately $2.2 million, compared to $1.8 million for the same
period in 2016. The increase was primarily due to additional
personnel expense as the Company builds the infrastructure to
support the growth of research and development organization and
increased professional fees as the Company prepared to operate as a
publicly traded company.
- Net loss for the quarter was $8.9 million, or $6.33 per share,
compared to a net loss of $3.8 million, or $3.00 per share, for the
same period in 2016.
About the Dolaflexin Platform
Mersana’s lead platform, Dolaflexin, is designed to increase the
potency and efficacy of ADCs while simultaneously increasing the
safety and tolerability. The backbone of Dolaflexin is
Fleximer®, a biodegradable, biocompatible, highly water soluble
polymer, to which are attached multiple molecules of Mersana’s
proprietary auristatin drug payload. Because of the excellent
physicochemical properties provided by the polymer, ADCs can be
created with drug-antibody ratios of 12-15, significantly higher
than what is achieved with traditional ADC approaches. More
drugs per antibody results has resulted in preclinical trials in
more efficient payload delivery to the tumor cell, particularly for
targets with low expression levels, leading to greater potency and
efficacy. In addition, Mersana’s proprietary auristatin
payload contained in Dolaflexin has been designed with DolaLock
technology, a controlled bystander effect, thereby increasing
tolerability. The initial release product upon
internalization of the ADC is a form of auristatin which is freely
cell permeable and can kill adjacent cells. However, a
metabolic “trigger” has been incorporated into the auristatin
payload such that as it diffuses in the tumor environment it is
converted into a highly active payload, which is no longer freely
cell permeable, resulting in its becoming “locked” into the cell in
which it is formed, thereby increasing tolerability.
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 lead product candidate, XMT-1522, is in
Phase I clinical trials in patients with advanced tumors expressing
HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC)
and gastric cancer patients. The Company expects that its second
product candidate, XMT-1536, will enter clinical trials in early
2018. In addition, multiple partners are using Mersana’s leading
platform to advance their ADC pipelines.
Cautionary Note Regarding Forward-Looking
Statements
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 possible or assumed timing of the
Company’s clinical trials, business strategies and financing
plans.
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 presentation.
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 include, among other things, that preclinical
testing may not be predictive of the results or success of ongoing
or later preclinical or clinical trials and that the development of
the Company’s product candidates will take longer and/or cost more
than planned, as well as those listed in the Company’s Prospectus
filed on June 29, 2017 with the Securities and Exchange Commission
(“SEC”). Except as required by law, the Company assumes no
obligation to update these forward-looking statements publicly, or
to update the reasons actual results could differ materially from
those anticipated in the forward-looking statements, even if new
information becomes available in the future.
Copies of the Company’s Prospectus and other SEC filings are
available by visiting EDGAR on the SEC website at
http://www.sec.gov.
Mersana Therapeutics, Inc
Selected Condensed Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities (1) |
|
$ |
77,232 |
|
|
$ |
100,297 |
|
|
Working
capital (2) |
|
|
|
48,134 |
|
|
|
73,787 |
|
|
Total
Assets |
|
|
|
85,216 |
|
|
|
105,087 |
|
|
Convertible
preferred stock |
|
|
94,450 |
|
|
|
94,450 |
|
|
Total
stockholders' deficit |
|
|
(71,655 |
) |
|
|
(55,619 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Cash,
cash equivalents and marketable securities as of June 30, 2017 did
not include netproceeds of approximately $67.5 million from the
Company's initial public offering of itscommon stock, which was
completed in July 2017. |
|
|
|
|
|
|
|
|
|
|
|
(2) The
Company defines working capital as current assets less current
liabilities. See theCompany's condensed consolidated
financial statements for further detail regarding its currentassets
and current liabilities. |
|
|
|
|
|
|
|
|
|
|
|
Mersana Therapeutics, Inc.
Condensed Consolidated Statement of
Operations
(in thousands, except share and per share
data)
(unaudited)
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2017 |
|
|
June
30, 2016 |
|
|
|
June
30, 2017 |
|
|
June
30, 2016 |
|
Collaboration revenue |
$ |
3,727 |
|
$ |
6,215 |
|
|
$ |
8,017 |
|
$ |
9,913 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development
|
|
10,627 |
|
|
8,171 |
|
|
|
20,733 |
|
|
15,607 |
|
General and administrative |
|
2,204 |
|
|
1,826 |
|
|
|
4,501 |
|
|
3,447 |
|
Total operating expenses |
|
12,831 |
|
|
9,997 |
|
|
|
25,234 |
|
|
19,054 |
|
Other
income |
|
158 |
|
|
16 |
|
|
|
209 |
|
|
20 |
|
Net
loss |
$ |
(8,946 |
) |
$ |
(3,766 |
) |
|
$ |
(17,008 |
) |
$ |
(9,121 |
) |
Net loss
per share attributableto common stockholders —basic and
diluted |
$ |
(6.33 |
) |
$ |
(3.00 |
) |
|
$ |
(12.36 |
) |
$ |
(7.31 |
) |
Weighted-average number ofcommon shares used in netloss per share
attributable tocommon stockholders —basic and diluted |
|
1,412,308 |
|
|
1,254,104 |
|
|
|
1,375,595 |
|
|
1,248,548 |
|
Contacts
Media Contact
Mersana Therapeutics, Inc.
Paul Kidwell, 617-680-1088
paulkidwell@mersana.com
or
Investors Contact
Stern Investor Relations, Inc.
Christina Tartaglia, 212-362-1200
christina@sternir.com
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