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 third quarter ended September 30, 2021 and provided a
business update.
“We have made significant progress towards our
vision of building UpRi into a foundational medicine in ovarian
cancer and advancing a diverse pipeline addressing areas of high
unmet medical need. Over the course of next year, we expect UPLIFT
to be fully enrolled, UP-NEXT to be initiated and enrolling,
UPGRADE to be charting the path in combinations and to have
multiple assets in the clinic addressing a diverse set of targets,”
said Anna Protopapas, President and Chief Executive Officer of
Mersana Therapeutics. “Our promising pipeline assets are generated
by our innovative platforms Dolaflexin, Dolasynthen and
Immunosynthen, which act as efficient product engines creating
value now and into the future.”
Recent Highlights and Anticipated
Milestones
Upifitamab Rilsodotin (UpRi), first-in-class
Dolaflexin ADC targeting NaPi2b:
- Reported updated interim
data in almost 100 patients from the UpRi ovarian cancer expansion
cohort. Data continued to demonstrate a clinically
meaningful and consistent profile for UpRi with a confirmed
objective response rate (ORR) of 34% in the two-thirds of patients
with NaPi2b high ovarian cancer. Data continued to show a
differentiated tolerability profile for UpRi without the severe
neutropenia, neuropathy and ocular toxicities seen with other ADC
platforms. These data support the potential for UpRi to demonstrate
a clinically meaningful benefit in the ongoing
registration-enabling UPLIFT study in platinum-resistant ovarian
cancer, a setting in which the single-agent chemotherapy standard
of care has an ORR of no more than 12% and carries substantial
toxicities.
- Introduced UP-NEXT, a Phase
3 study of UpRi monotherapy maintenance, informed by FDA
feedback. UP-NEXT is designed to establish UpRi as a
maintenance agent following treatment with platinum doublets in
platinum-sensitive ovarian cancer. Watch-and-wait remains the
standard of care for patients who have previously received or are
poorly served by existing maintenance agents, as well as patients
who achieve only stable disease to platinum doublets. UP-NEXT is
designed to provide data to address these unmet needs. The Company
plans to provide more details on the final design of UP-NEXT and
expects to initiate the study in 2022.
- UPLIFT, a single-arm
registration study in platinum-resistant ovarian cancer, continues
to enroll. UPLIFT is enrolling a broader population of
patients with platinum-resistant ovarian cancer than other studies
in this indication through more flexible inclusion criteria with
respect to lines of therapy and underlying comorbidities, the use
of a robust diagnostic assay capturing two-thirds of the patients
as NaPi2b high for the primary endpoint, as well as a secondary
endpoint in the overall population. The Company plans to enroll
approximately 100 patients with high NaPi2b expression and up to
180 patients overall and expects the study to be substantially
enrolled during the summer of 2022.
- Enrollment continues in
UPGRADE, the Company’s Phase 1 combination umbrella study.
UPGRADE is a Phase 1 dose-escalation study evaluating the
combination of carboplatin with UpRi followed by UpRi continued
until progression. The dose escalation portion of the study is
intended to determine the recommended Phase 2 dose in combination
with carboplatin. The expansion portion of the study is intended to
provide proof of concept for a potential new standard of care for
platinum-sensitive ovarian cancer earlier in the disease by
demonstrating that the combination of platinum and UpRi followed by
UpRi continuation could result in improved efficacy and
tolerability with the ultimate goal of improved clinical benefit
for patients. The study will inform further development of UpRi in
this broader and earlier line patient population.
- Completed enrollment and
evaluation of UpRi in the NSCLC adenocarcinoma expansion
cohort. The Company observed modest single-agent activity
that did not meet its internal threshold for advancement and has
decided to deprioritize further clinical evaluation of UpRi in this
indication. The safety profile of UpRi in lung adenocarcinoma was
generally consistent with the favorable profile observed with UpRi
at the 36 mg/m2 dose level selected for further advancement in
ovarian cancer.
XMT-1592, first Dolasynthen ADC targeting
NaPi2b:
- Phase 1 dose escalation
study of XMT-1592 is ongoing. The Company continues dose
exploration in order to determine the recommended Phase 2 dose and
expects this to continue into 2022. The Company plans to provide
further details of the XMT-1592 development plan alongside its 2022
milestones and goals early next 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
could 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-in-class HER2-targeted
Immunosynthen STING-agonist ADC:
- Presented new preclinical
data for XMT-2056 at the 2021 AACR-NCI-EORTC Virtual International
Conference on Molecular Targets and Cancer Therapeutics (Triple
Meeting) in October 2021. In vitro and in vivo studies
demonstrate that Immunosynthen STING-agonist ADCs activate the
STING pathway in both tumor-resident immune cells and tumor cells,
offering the potential for an increased therapeutic index and an
advantage over other innate immune activating pathways. The Company
developed XMT-2056 based on a differentiated anti-HER2 antibody
that binds a novel epitope, providing the opportunity for
combinations with well-established anti-HER2 therapies. In
preclinical models, XMT-2056 showed efficacy in combination with
trastuzumab. In both high and low HER2 models, XMT-2056
demonstrated increased efficacy in comparison to benchmark agents
such as a trastuzumab-TLR7/8 agonist ADC as well as a small
molecule systemically-administered STING agonist. XMT-2056 was
generally well-tolerated in non-human primate studies with no
clinical signs and no adverse findings in clinical pathology or
histopathology after single and repeat IV doses. The Company plans
to initiate a Phase 1 study of XMT-2056 in early 2022.
Corporate:
- Increased financial
flexibility with additional access to capital. The Company
entered into a new credit facility at favorable terms for up to
$100 million with Oxford and Silicon Valley Bank of which $60
million is available immediately, with remaining balance primarily
available upon achievement of certain pipeline and UpRi related
milestones. In connection with this new facility, the Company
retired the prior debt financing agreement with Silicon Valley
Bank.
-
Strengthened leadership team with key
appointments. In August 2021, the Company announced the
appointment of Tushar Misra, Ph.D., as Chief Manufacturing Officer.
Dr. Misra was most recently EVP, Head of Technical Development
& Manufacturing at Laronde and has held senior leadership
positions at Wave Life Sciences, Takeda Pharmaceuticals and
Sunovion Pharmaceuticals. In October, the Company appointed Mohan
Bala, Ph.D., as SVP, Strategic Product Planning & Program
Leadership. Dr. Bala was most recently Chief Operating Officer at
Constellation Pharmaceuticals and has over 20 years of clinical
development and commercialization experience.
Upcoming Events
- Mersana plans to present a poster
entitled, “STING-agonist ADCs targeting tumor-associated antigens
coordinate immune-mediated killing of antigen-negative cancer
cells,” at the 36th Annual Meeting of the Society for
Immunotherapy of Cancer (SITC) during the live poster display
session available from November 12 – 13, 2021.
- Mersana plans to give a corporate
presentation at the 2021 Stifel Virtual Healthcare Conference
scheduled for November 17, 2021.
- Mersana plans to participate in a
fireside chat at the Evercore ISI 4th Annual HealthconX scheduled
for December 1, 2021.
Third Quarter 2021 Financial
Results
Cash and cash equivalents as of September 30,
2021, were $191.7 million, compared to $255.1 million in cash and
cash equivalents as of December 31, 2020. Net cash used in
operating activities in the third quarter of 2021 was $36.1
million.
The Company expects that its available funds
will be sufficient to support its operating plan commitments into
the first half of 2023.
- Research and development expenses
for the third quarter of 2021 were $35.3 million, compared to $16.5
million for the same period in 2020. The difference was primarily
due to an increase in manufacturing, clinical and regulatory
expenses, an increase in headcount and advancement of diagnostic
development efforts for the NaPi2b biomarker. Non-cash stock-based
compensation expense included in these research and development
expenses increased by $1.7 million.
- General and administrative expenses
for the third quarter of 2021 were $10.1 million, compared to $5.9
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 these general and
administrative expenses increased by $1.4 million.
- Net loss for the third quarter of
2021 was $45.5 million, or $0.63 per share, compared to net loss of
$22.5 million, or $0.33 per share, for the same period in 2020.
Weighted average common shares outstanding for the quarters ended
September 30, 2021 and September 30, 2020 were 71,753,004 and
68,419,192, respectively.
Conference Call DetailsMersana
Therapeutics will host a conference call today at 8:00 a.m. ET to
report financial results for the third 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 2116349. 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.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 and targeting a novel epitope of human epidermal growth
factor receptor 2 (HER2). 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 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 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 Oxford
Finance and 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 August 6, 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)
|
September 30, 2021 |
|
December 31, 2020 |
|
|
|
|
Cash and cash equivalents |
$ |
191,707 |
|
|
$ |
255,094 |
|
Working capital(1) |
155,334 |
|
|
228,577 |
|
Total assets |
217,586 |
|
|
273,399 |
|
Total stockholders'
equity |
155,549 |
|
|
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 |
|
Nine months ended |
|
September 30, 2021 |
|
September 30, 2020 |
|
September 30, 2021 |
|
September 30, 2020 |
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
11 |
|
|
$ |
11 |
|
|
$ |
32 |
|
|
$ |
817 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
35,275 |
|
|
16,546 |
|
|
94,645 |
|
|
44,179 |
|
General and administrative |
10,124 |
|
|
5,881 |
|
|
26,214 |
|
|
15,988 |
|
Total operating expenses |
45,399 |
|
|
22,427 |
|
|
120,859 |
|
|
60,167 |
|
Total other income (expense),
net |
(83 |
) |
|
(73 |
) |
|
(250 |
) |
|
147 |
|
Net loss |
$ |
(45,471 |
) |
|
$ |
(22,489 |
) |
|
$ |
(121,077 |
) |
|
$ |
(59,203 |
) |
Net loss per
share attributable to common stockholders — basic and
diluted |
$ |
(0.63 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.73 |
) |
|
$ |
(1.00 |
) |
Weighted-average number of
common shares used in net loss per share attributable to common
stockholders — basic and diluted |
71,753,004 |
|
|
68,419,192 |
|
|
70,129,236 |
|
|
59,086,202 |
|
Contact:Investor & Media ContactSarah
Carmody, 617-844-8577scarmody@mersana.com
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