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 second quarter ended June 30, 2021 and provided a business
update.
“We have made significant progress in executing
against our goal of establishing UpRi as a foundational therapy in
ovarian cancer. UPLIFT provides the potential to benefit
platinum-resistant patients in desperate need of better options.
UPGRADE is designed to leverage the differentiated profile of UpRi
to evaluate the potential to benefit a substantially larger number
of patients for longer periods earlier in the course of disease,”
said Anna Protopapas, President and Chief Executive Officer of
Mersana Therapeutics. “In parallel, we are continuing to advance
our pipeline of innovative ADCs with the exploration of UpRi in
lung adenocarcinoma and the continued advancement of XMT-1592,
XMT-1660 and XMT-2056.”
Recent Highlights and Anticipated
Milestones
Upifitamab Rilsodotin (UpRi, previously
XMT-1536), first-in-class Dolaflexin ADC targeting NaPi2b:
- Initiated UPGRADE, a Phase
1 combination umbrella study starting with a platinum dose
escalation cohort. The Phase 1, open-label,
dose-escalation portion of the study is designed to determine the
maximum tolerated dose and safety and tolerability of a
once-every-four-week administration of UpRi in combination with
carboplatin for six cycles followed by UpRi monotherapy in patients
with platinum-sensitive 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 to assess both tolerability
and efficacy and inform the further development of UpRi in this
broad and early line patient population.
- Initiated UPLIFT, a
single-arm registration strategy in platinum-resistant ovarian
cancer with new sites starting up in the U.S., European Union and
other countries. UPLIFT is enrolling 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.
The Company expects to enroll approximately 100 patients with high
NaPi2b expression and up to 180 patients overall.
- Ovarian cancer expansion
cohort of Phase 1 UpRi study recently closed enrollment with close
to 100 patients enrolled. The Company expects to provide
an update on the ovarian cancer expansion cohort this year.
- NSCLC adenocarcinoma cohort
of the expansion portion of Phase 1 study continues to enroll
patients. The Company is on track to enroll approximately
45 patients in the expansion phase of the study. The Company plans
to disclose top-line data and determine next steps in this
indication in the fourth quarter of 2021.
XMT-1592, first Dolasynthen ADC targeting
NaPi2b:
- Phase 1 dose escalation
study of XMT-1592 is ongoing with further exploration of dose and
regimen. The Company has exceeded the maximum tolerated
dose and continues to further explore dose and schedule. The
Company plans to disclose top-line data and outline the development
plan in NSCLC adenocarcinoma around the end of the year.
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.
XMT-2056, first Immunosynthen
STING-agonist ADC:
-
IND-enabling studies of XMT-2056 ongoing with Phase 1
studies expected to start in early 2022. The Company plans
to disclose the target and share promising preclinical data for
XMT-2056 at the upcoming virtual 2021 AACR-NCI-EORTC (Triple
Meeting) Molecular Targets and Cancer Therapeutics conference in
October 2021 as part of a plenary session on
antibody-drug-conjugates.
Upcoming Events
- Mersana will participate in a
fireside chat at the BTIG Virtual Biotechnology Conference
scheduled for August 10, 2021.
- Mersana will participate in a
virtual panel presentation at the 2021 Wedbush PacGrow Healthcare
Conference scheduled for August 11, 2021.
Second Quarter 2021 Financial
Results
Cash and cash equivalents as of June 30, 2021,
were $227.4 million, compared to $255.1 million in cash and cash
equivalents as of December 31, 2020. Net cash used in operating
activities in the second quarter of 2021 was $34.5 million.
During the three months ended June 30, 2021, the
Company sold approximately 2.3 million shares of common stock
pursuant to an “at the market” equity offering program and received
net proceeds of $33.3 million, at an average price of approximately
$15 per share.
In addition, the Company has the option to draw
additional funds through its debt financing agreement with Silicon
Valley Bank.
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 second quarter of 2021 were approximately $32.0 million,
compared to $15.4 million for the same period in 2020. The
difference was primarily due to an increase in UpRi manufacturing,
clinical and regulatory expenses, an increase in manufacturing
activities for preclinical and discovery stage programs, an
increase in headcount and advancement of diagnostic development
efforts for the NaPi2b biomarker. Non-cash stock-based compensation
expense included in research and development expenses increased by
$1.7 million, related to growth in headcount and an increase in the
valuation of stock-based awards as a result of stock
appreciation.
- General and administrative expenses
for the second quarter of 2021 were approximately $8.9 million,
compared to $5.2 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 $1.2 million, related to
growth in headcount and an increase in the valuation of stock-based
awards as a result of stock appreciation.
- Net loss for the second quarter of
2021 was $40.9 million, or $0.59 per share, compared to net loss of
$19.8 million, or $0.33 per share, for the same period in 2020.
Weighted average common shares outstanding for the quarters ended
June 30, 2021 and June 30, 2020 were 69,616,467 and 60,748,225,
respectively.
Conference Call DetailsMersana
Therapeutics will host a conference call today at 8:00 a.m. ET to
report financial results for the second 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 3876353. 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
UPGRADE, a Phase 1 umbrella study in combination with other ovarian
cancer therapies. UpRi is also being studied in the expansion
portion of a Phase 1 proof-of-concept clinical study. 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. The
Company routinely posts information that may be useful to investors
on the “Investors and Media” section of our website at
www.mersana.com.
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 or preclinical
studies and the release of data from those studies, 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 Quarterly
Report on Form 10-Q filed on May 10, 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, the
severity of additional strains of the virus, 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)
|
June 30, 2021 |
|
December 31, 2020 |
|
|
|
|
Cash and cash equivalents |
$ |
227,388 |
|
|
$ |
255,094 |
|
Working capital(1) |
192,960 |
|
|
228,577 |
|
Total assets |
253,685 |
|
|
273,399 |
|
Total stockholders'
equity |
195,513 |
|
|
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 |
|
Six months ended |
|
June 30,2021 |
|
June 30,2020 |
|
June 30,2021 |
|
June 30,2020 |
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
11 |
|
|
$ |
796 |
|
|
$ |
21 |
|
|
$ |
807 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
31,955 |
|
|
15,413 |
|
|
59,370 |
|
|
27,632 |
|
General and administrative |
8,883 |
|
|
5,171 |
|
|
16,090 |
|
|
10,106 |
|
Total operating expenses |
40,838 |
|
|
20,584 |
|
|
75,460 |
|
|
37,738 |
|
Total other income (expense),
net |
(86 |
) |
|
2 |
|
|
(167 |
) |
|
219 |
|
Net loss |
$ |
(40,913 |
) |
|
$ |
(19,786 |
) |
|
$ |
(75,606 |
) |
|
$ |
(36,712 |
) |
Net loss per
share attributable to common stockholders — basic and
diluted |
$ |
(0.59 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.09 |
) |
|
$ |
(0.68 |
) |
Weighted-average number of
common shares used in net loss per share attributable to common
stockholders — basic and diluted |
69,616,467 |
|
|
60,748,225 |
|
|
69,303,899 |
|
|
54,368,429 |
|
Contact:Investor & Media ContactSarah
Carmody, 617-844-8577scarmody@mersana.com
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