Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage
biopharmaceutical company focused on discovering and developing a
pipeline of antibody-drug conjugates (ADCs) targeting cancers in
areas of high unmet medical need, today reported financial results
for the first quarter ended March 31, 2021 and provided a business
update.
“The recent initiation of UPLIFT, a single-arm
registrational strategy evaluating UpRi in platinum-resistant
ovarian cancer, speaks to the team’s commitment to achieving key
milestones and dedication to developing therapies for people living
with cancer. We believe UpRi has demonstrated promising activity
and a differentiated tolerability profile in studies to date in
patients with heavily-pretreated ovarian cancer and limited
options. UPLIFT has been designed to increase the potential for
label differentiation, speed to market, and the probability of
success. We also remain on track to initiate the UPGRADE umbrella
combination study in the third quarter of 2021 as a first step in
bringing UpRi to patients in earlier lines of therapy and
establishing UpRi as a foundational medicine in ovarian cancer,”
said Anna Protopapas, President and Chief Executive Officer of
Mersana Therapeutics. “We are excited to continue this productive
year by building out our maturing pipeline of innovative ADC
candidates with the potential to address unmet medical needs across
multiple different tumor types.”
Recent Highlights and Anticipated
Milestones
Upifitamab Rilsodotin (UpRi, previously
XMT-1536), first-in-class Dolaflexin ADC targeting NaPi2b:
- Initiated UPLIFT, a
single-arm registration strategy in platinum-resistant ovarian
cancer. In April 2021, the Company announced the
initiation of patient dosing in UPLIFT, a single-arm registration
strategy evaluating the safety and efficacy of UpRi in patients
with platinum-resistant ovarian cancer who have received up to four
lines of therapy. Consistent with the bevacizumab label, patients
previously treated with three or four lines of therapy may enroll
without regard to prior bevacizumab treatment. There is no
exclusion for patients with baseline peripheral neuropathy.
Patients may enroll without regard to NaPi2b expression; however,
the role of the biomarker will be evaluated. The primary endpoint
will be the objective response rate (ORR) in the high NaPi2b
population and the secondary endpoints will be the ORR regardless
of NaPi2b expression, as well as duration of response and safety.
UPLIFT is an amendment to the ongoing multinational, multi-center,
open label study protocol, and the Company expects to enroll
approximately 100 patients with high NaPi2b expression and up to
180 patients overall.
- In April 2021, the Company
announced its plans to use Tumor Proportion Score (TPS) greater
than or equal to 75% as the predefined threshold for high NaPi2b
expression in UPLIFT. In the ovarian cancer
expansion study data presented to date, TPS ≥ 75% resulted in an
objective response rate (ORR) of 39% in high NaPi2b patients
relative to an ORR of 28% in the overall population. As part of its
diagnostic development plan, the Company evaluated TPS methodology
in the expansion portion of the Phase 1 study in ovarian cancer and
demonstrated that TPS captures a broad dynamic range of expression
values, enriches for response, and offers reproducibility
advantages across commercial labs. The Company also disclosed the
steps it has taken to develop a robust, predictive and reproducible
commercial diagnostic assay which will be used in a prospectively
defined retrospective analysis in UPLIFT.
- UPGRADE combination dose
escalation umbrella study in ovarian cancer expected to initiate in
the third quarter of 2021. The Company plans to
initiate the UPGRADE study in the third quarter of 2021 to evaluate
the combination of UpRi with other agents, starting with a platinum
combination. The Phase 1, open-label, dose-escalation portion of
the study will determine the maximum tolerated dose (MTD) and
safety and tolerability of a once-every-four-week (Q4W)
administration of UpRi in combination with Q4W administration of
carboplatin for six cycles followed by UpRi monotherapy in
platinum-sensitive patients with high-grade serous ovarian cancer
who have received 1-2 prior platinum-based regimens. Patients will
not be preselected for NaPi2b expression; however, archival or
fresh tissue will be required for retrospective assessment of
expression. Upon completion of the dose-escalation portion of the
study, the Company plans to initiate the expansion portion in
combination with carboplatin for six cycles followed by UpRi
monotherapy to assess feasibility as well as efficacy to inform
next steps in this broader and less heavily-pretreated patient
population.
- NSCLC adenocarcinoma cohort
of the expansion portion of Phase 1 study continues to enroll
patients. The Company is on track to recruit approximately
40 patients in the expansion phase of the study. The Company plans
to report interim data in the second half of 2021.
XMT-1592, first Dolasynthen ADC targeting
NaPi2b:
- Phase 1 dose escalation
study of XMT-1592 is ongoing, with interim data anticipated in the
second half of 2021. The Company has exceeded the maximum
tolerated dose and continues to further explore dose and schedule.
The Company plans to disclose interim data in the second half of
2021 and further outline the XMT-1592 development plan in NSCLC in
the fourth quarter of 2021.
XMT-1660, first-in-class Dolasynthen ADC
targeting B7-H4:
- Investigational New Drug
(IND)-enabling studies of XMT-1660 ongoing with Phase 1 studies
expected to start in early 2022. B7-H4 is expressed in
high unmet need tumors such as breast, endometrial and ovarian.
B7-H4 is expressed on both tumor cells and immunosuppressive
tumor-associated macrophages (TAMs). This provides the potential
for both a direct, cytotoxic antitumor effect as well as for
additional payload delivery to the tumor microenvironment that can
further contribute to immunogenic cell death, dendritic cell
activation, and stimulation of an immune response consistent with
the features of the Company’s unique DolaLock payload. In a poster
presented at the Virtual 2021 American Association for Cancer
Research (AACR) Annual Meeting in April, the Company presented
preclinical data demonstrating XMT-1660’s superior efficacy
compared to other potential candidate B7-H4 ADCs, covering a range
of drug-to-antibody ratios, in multiple triple-negative breast
cancer models as well as a ER+/HER2- breast cancer model. These
data further support the clinical development of XMT-1660 for the
treatment of B7-H4-expressing tumors.
XMT-2056, first Immunosynthen
STING-agonist ADC:
-
IND-enabling studies of XMT-2056 ongoing with Phase 1
studies expected to start in early 2022. In April 2021,
the Company presented two posters at AACR highlighting preclinical
efficacy of XMT-2056 as well as mechanistic data representative of
the Immunosynthen platform. These data demonstrated the
differentiation of XMT-2056 and its ability to induce robust
anti-tumor immune activity, with only minimal increases in systemic
cytokine levels, and a significant benefit over the benchmark
IV-administered free STING-agonist in mice. Preclinical mechanistic
data suggests that the tumor cell-intrinsic STING pathway can be
activated in the presence of cues from immune cells, a potential
key differentiator from other innate immune activation approaches.
Further, in vitro studies showed that blocking Type III interferons
(IFNs) inhibits the production of key cytokines and cancer cell
killing induced by STING-agonist ADC treatment, pointing to a
potentially important role for Type III IFNs in anti-tumor immune
responses downstream of STING pathway activation in tumor cells.
The Company plans to disclose the target for the XMT-2056 in the
fourth quarter of 2021.
Corporate
- Appointed Alejandra
Carvajal as Senior Vice President and Chief Legal Officer.
Ms. Carvajal was most recently the Chief Legal Officer, General
Counsel & Secretary at Momenta Pharmaceuticals, where she led
the company’s legal operations through both business restructuring
and successful execution of an acquisition by Johnson & Johnson
for $6.5 billion. She also served as a key strategic legal partner
in the company’s financing, business development, and contractual
decision-making efforts. Prior to joining Momenta, Ms. Carvajal
served as the Vice President, General Counsel at Cerulean Pharma.
Previously, she worked at Millennium Pharmaceuticals in several
positions of increasing seniority.
- Appointed Allene Diaz to
Board of Directors. Ms. Diaz has over thirty years of
experience in the pharmaceutical industry most recently serving as
Senior Vice President of R&D portfolio management and decision
sciences at GlaxoSmithKline. She previously held senior strategic
product planning and commercial roles at Tesaro and Merck KGaA. She
has contributed to the development, launch and commercialization of
multiple global cancer therapies. Ms. Diaz is currently on the
board of both BCLS Acquisition Corporation and Allena
Pharmaceuticals, having previously served as a non-executive
director at Erytech for three years before her current board
positions.
Upcoming Events
- Mersana will participate in a
virtual presentation at the Jefferies Healthcare Conference
scheduled for June 1-4, 2021.
- A Trial in Progress poster
detailing the design of the UPLIFT single-arm registration strategy
evaluating UpRi in platinum resistant ovarian cancer will be
presented at the American Society of Clinical Oncology (ASCO)
Virtual Annual Meeting scheduled for June 4-8, 2021.
First Quarter 2021 Financial
Results
Cash and cash equivalents as of March 31, 2021,
were $228.4 million, compared to $255.1 million in cash and cash
equivalents as of December 31, 2020. In addition, the Company has
the option to draw additional funds through its debt financing
agreement with Silicon Valley Bank.
Net cash used in operating activities in the
first quarter of 2021 was $27.0 million. The Company expects that
its available funds will be sufficient to support its operating
plan commitments for approximately two years.
- Research and development expenses
for the first quarter of 2021 were approximately $27.4 million,
compared to $12.2 million for the same period in 2020. The
difference was primarily due to an increase in UpRi and XMT-1592
manufacturing, clinical and regulatory expenses, an increase in
manufacturing activities for preclinical and discovery stage
programs and an increase in headcount. Non-cash stock-based
compensation expense included in research and development expenses
increased by $1.5 million, primarily related to an increase in the
valuation of stock-based awards as a result of stock
appreciation.
- General and administrative expenses
for the first quarter of 2021 were approximately $7.2 million,
compared to $4.9 million during the same period in 2020 primarily
due to an increase in headcount and consulting and professional
fees. Non-cash stock-based compensation expense included in general
and administrative expenses increased by $0.9 million, primarily
related to an increase in the valuation of stock-based awards as a
result of stock appreciation.
- Net loss for the first quarter of
2021 was $34.7 million, or $0.50 per share, compared to net loss of
$16.9 million, or $0.35 per share, for the same period in 2020.
Weighted average common shares outstanding for the quarters ended
March 31, 2021 and March 31, 2020 were 68,987,857 and
47,988,630, respectively.
Conference Call DetailsMersana
Therapeutics will host a conference call and webcast today at 4:30
p.m. ET to report financial results for the first quarter 2021 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 5046849. A live webcast of the presentation will
be available on the Investors & Media section of the Mersana
website at www.mersana.com.
About Mersana
TherapeuticsMersana Therapeutics is a clinical-stage
biopharmaceutical company using its differentiated and proprietary
ADC platforms to rapidly develop novel ADCs with optimal efficacy,
safety and tolerability to meaningfully improve the lives of people
fighting cancer. Mersana’s lead product candidate, upifitamab
rilsodotin (UpRi), is a Dolaflexin ADC targeting NaPi2b and is
being studied in UPLIFT, a single-arm registration strategy in
patients with platinum-resistant ovarian cancer, as well as in the
expansion portion of a Phase 1 proof-of-concept clinical study in
patients with NSCLC adenocarcinoma. XMT-1592, Mersana’s second ADC
product candidate targeting NaPi2b-expressing tumors, was created
using Mersana’s customizable and homogeneous Dolasynthen platform
and is in the dose escalation portion of a Phase 1 proof-of-concept
clinical study. The Company’s early-stage programs include
XMT-1660, a Dolasynthen ADC targeting B7-H4, as well as XMT-2056, a
STING-agonist ADC developed using the Company’s Immunosynthen
platform. In addition, multiple partners are using Mersana’s
Dolaflexin platform to advance their ADC pipelines.
Forward-Looking StatementsThis
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 and the
release of data from those trials, the ability of the single-arm
UPLIFT cohort to enable registration, the development and potential
of our pipeline of innovative ADC candidates, expectations
regarding future clinical trial results, including with respect to
the timing of the commencement and future disclosures, and the
sufficiency of the Company’s cash on hand and funds available
through its debt financing agreement with Silicon Valley Bank.
Forward-looking statements generally can be identified by terms
such as “aims,” “anticipates,” “believes,” “contemplates,”
“continues,” “could,” “designed to,” “efforts,” “estimates,”
“expects,” “goal,” “intends,” “may,” “on track,” “opportunity,”
“plans,” “poised for,” “possible,” “potential,” “predicts,”
“projects,” “promises to be,” “seeks,” “should,” “strategy,”
“target,” “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 the results of our
ongoing or future clinical studies may be inconclusive with respect
to the efficacy of our product candidates, that we may not meet
clinical endpoints with statistical significance or there may be
safety concerns or adverse events associated with our product
candidates, that preclinical testing or early clinical results may
not be predictive of the results or success of ongoing or later
preclinical or clinical studies, that the identification,
development and testing of the Company’s product candidates and new
platforms will take longer and/or cost more than planned, and that
our clinical studies may not be initiated or completed on schedule,
if at all, as well as those listed in the Company’s Annual Report
on Form 10-K filed on February 26, 2021, with the Securities and
Exchange Commission (“SEC”), and subsequent SEC filings. In
addition, while we expect that the COVID-19 pandemic might
adversely affect the Company’s preclinical and clinical development
efforts, business operations and financial results, the extent of
the impact on the Company’s operations and the value of and market
for the Company’s common stock will depend on future developments
that are highly uncertain and cannot be predicted with confidence
at this time, such as the ultimate duration of the pandemic, travel
restrictions, quarantines, physical distancing and business closure
requirements in the U.S. and in other countries, and the
effectiveness of actions taken globally to contain and treat the
disease. 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.
Mersana Therapeutics,
Inc.Selected Condensed Consolidated Balance Sheet
Data(in
thousands)(unaudited)
|
March 31, 2021 |
|
December 31, 2020 |
|
|
|
|
Cash and cash equivalents |
$ |
228,430 |
|
|
$ |
255,094 |
|
Working capital(1) |
197,033 |
|
|
228,577 |
|
Total assets |
247,911 |
|
|
273,399 |
|
Total stockholders'
equity |
197,938 |
|
|
228,087 |
|
|
|
|
|
(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 |
|
March 31, 2021 |
|
March 31, 2020 |
|
|
|
|
Collaboration revenue |
$ |
11 |
|
|
$ |
11 |
|
Operating expenses: |
|
|
|
Research and development |
27,415 |
|
|
12,219 |
|
General and administrative |
7,208 |
|
|
4,936 |
|
Total operating expenses |
34,623 |
|
|
17,155 |
|
Total other income (expense),
net |
(81 |
) |
|
218 |
|
Net loss |
$ |
(34,693 |
) |
|
$ |
(16,926 |
) |
Net loss per
share attributable to common stockholders — basic and
diluted |
$ |
(0.50 |
) |
|
$ |
(0.35 |
) |
Weighted-average number of
common shares used in net loss per share attributable to common
stockholders — basic and diluted |
68,987,857 |
|
|
47,988,630 |
|
|
|
|
|
|
|
Contact:Investor & Media ContactSarah
Carmody, 617-844-8577scarmody@mersana.com
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