Mersana Therapeutics Provides Business Update and Announces First Quarter 2022 Financial Results
May 09 2022 - 7:00AM
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 provided a business update
and reported financial results for the first quarter ended March
31, 2022.
“We believe that UpRi holds the potential to
transform the treatment paradigm for patients with ovarian cancer.
Our development strategy is designed to advance UpRi from
platinum-resistant ovarian cancer with our potential UPLIFT data
readout in 2023 into earlier lines of treatment with our UP-NEXT
and UPGRADE trials,” said Anna Protopapas, President and Chief
Executive Officer of Mersana Therapeutics. “With a strengthened
balance sheet and preparations to move XMT-1660 and XMT-2056 into
the clinic in the near term, we look forward to delivering clinical
data across all three of our platforms and building a leading ADC
company.”
Strategic Goals, Recent Developments and
Anticipated Milestones
- Build
UpRi, a Dolaflexin ADC targeting NaPi2b, into a Foundational
Medicine in Ovarian Cancer:
-
Presented Analysis Supporting UPLIFT Trial Dose:
An analysis from nearly 100 patients in the expansion cohort of the
Phase 1 Upifitamab Rilsodotin (UpRi) clinical trial based on a June
10, 2021 data cut was presented at the 2022 Society of Gynecologic
Oncology (SGO) Annual Meeting on Women’s Cancer. This analysis
supported the decision to select 36mg/m2 as the dose for UPLIFT,
given the observed efficacy in both the evaluable and intent to
treat populations, fewer adverse events (AEs) including Grade 3 or
higher AEs, longer duration of treatment, and fewer
discontinuations relative to the higher dose group.
-
Expecting to Complete Enrollment in UPLIFT Registration
Trial in 3Q 2022: UPLIFT is enrolling up to 180 patients
with platinum-resistant ovarian cancer, including approximately 100
patients with high NaPi2b expression. The trial’s primary endpoint
will evaluate efficacy in the NaPi2b high population.
-
Advancing Toward Initiation of Patient Screening in UP-NEXT
Trial in 2Q 2022: UP-NEXT is a Phase 3 clinical trial of
UpRi as monotherapy maintenance following treatment with platinum
doublets in recurrent platinum-sensitive ovarian cancer. This trial
has the potential to serve as a post-approval confirmatory trial,
supporting the expansion of UpRi into earlier lines of
therapy.
-
Enrolling UPGRADE Combination Trial: UPGRADE, the
company’s Phase 1/2 umbrella trial of UpRi in combination with
other agents, is currently dose escalating UpRi in combination with
carboplatin. Mersana expects to disclose interim data from this
cohort in Q4 2022, with a primary focus on safety and tolerability.
UPGRADE is intended to inform the further development of UpRi in
combination with other therapies used in platinum-sensitive ovarian
cancer.
- Build
Out Pipeline of Highly Impactful Cancer Medicines
- Planning
to Initiate Phase 1 Clinical Trial of XMT-1660 in
Mid-2022: XMT-1660 is a B7-H4-directed Dolasynthen ADC
with a precise and target-optimized drug-to-antibody ratio (DAR) of
6 and Mersana’s clinically validated DolaLock microtubule inhibitor
payload with controlled bystander effect. In April, the company
presented preclinical data at the American Association for Cancer
Research (AACR) Annual Meeting demonstrating that a single dose of
XMT-1660 had anti-tumor activity in xenograft models of both
triple-negative breast cancer and estrogen receptor positive breast
cancer. The data presented also demonstrated that higher B7-H4
expression was associated with greater anti-tumor activity of
XMT-1660, consistent with its targeted effect. In its Phase 1
clinical trial, the company expects to investigate XMT-1660 in
B7-H4-expressing tumors such as breast, endometrial and ovarian
cancers.
- Planning
to Initiate Phase 1 Clinical Trial of XMT-2056 in
Mid-2022: XMT-2056, the company’s first Immunosynthen
STING agonist ADC, targets a novel epitope of HER2 and is designed
to offer a differentiated and complementary therapeutic approach to
existing and emerging solid tumor treatments. In April, the company
presented preclinical data at the AACR Annual Meeting demonstrating
that XMT-2056 had robust anti-tumor activity as a monotherapy in
both high and low HER-2 expressing models. The data showed
XMT-2056’s complementary mechanism of action also resulted in
increased efficacy across a number of models in combination with
trastuzumab, pertuzumab, anti-PD-1 and trastuzumab deruxtecan. In
its Phase 1 clinical trial, the company expects to investigate
XMT-2056 in HER2-expressing tumors such as breast, gastric and
non-small-cell lung cancers.
-
Maintaining Pipeline Prioritization Discipline:
Based on the lower prevalence of the NaPi2b biomarker in non-small
cell lung cancer, the increasingly competitive nature of this
indication and the company’s commitment to remain financially
disciplined, Mersana has decided to discontinue the development of
XMT-1592. Additionally, the company has decided to defer certain
investments in its preclinical pipeline, including two of its
earlier-stage candidates, XMT-2068 and XMT-2175.
- Build
Mersana with Strategic Partners:
-
Announced New Collaboration with Janssen: In
February, the company announced a research collaboration and
license agreement with Janssen Biotech, Inc. to discover novel ADCs
for up to three targets by leveraging Mersana’s Dolasynthen
platform and ADC expertise and Janssen’s antibodies. As part of the
agreement, Mersana received a $40.0 million upfront payment and has
the potential to receive more than $1.0 billion in total milestone
payments and mid-single-digit to low-double-digit percentage
royalties on future net sales.
First Quarter 2022 Financial
Results
- Net cash used in operating
activities in the first quarter of 2022 was $8.0 million. Cash and
cash equivalents as of March 31, 2022, were $230.1 million,
compared to $177.9 million in cash and cash equivalents as of
December 31, 2021. This increase reflects the receipt of the $40.0
million upfront payment from Janssen and proceeds from the sale of
Mersana common stock through its at-the-market (ATM) equity
offering program, partially offset by operating spend. The company
expects that its available funds will be sufficient to support its
operating plan commitments well into the second half of 2023.
- Research and
development (R&D) expenses for the first quarter of 2022 were
$35.8 million, compared to $27.4 million for the same period in
2021. Included in first quarter 2022 R&D expenses was $2.9
million in non-cash stock-based compensation. The year-over-year
increase in R&D expenses was primarily related to greater
headcount, preparations for the clinical advancement of XMT-1660
and XMT-2056, and increased UpRi manufacturing and clinical
costs.
- General and administrative (G&A)
expenses for the first quarter of 2022 were $12.8 million, compared
to $7.2 million during the same period in 2021. Included in first
quarter 2022 G&A expenses was $2.6 million in non-cash
stock-based compensation. The year-over-year increase in G&A
expenses was primarily related to an increase in consulting and
professional fees, and increased headcount.
- Net loss for the first quarter of
2022 was $47.3 million, or $0.59 per share, compared to a net loss
of $34.7 million, or $0.50 per share, for the same period in
2021.
Conference Call ReminderMersana
will host a conference call today at 8:00 a.m. ET to discuss its
financial results for the first quarter of 2022 and business
updates. To access the call, please dial 877-303-9226 (domestic) or
409-981-0870 (international) and provide the Conference ID 4289737.
A live webcast of the presentation will be available on the
Investors & Media section of the Mersana website at
www.mersana.com, and a replay of the webcast will be available in
the same location following the conference call for at least 90
days.
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 that is
being studied in UPLIFT, a single-arm registrational trial in
patients with platinum-resistant ovarian cancer, as well as in
UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combination
with other ovarian cancer therapies. Mersana’s early-stage programs
include XMT-1660, a Dolasynthen ADC targeting B7-H4, and 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 platforms to advance their ADC pipelines. Mersana
Therapeutics was recently named among the 2021 Top Places to Work
in Massachusetts by The Boston Globe. Mersana routinely posts
information that may be useful to investors on the “Investors and
Media” section of its website at www.mersana.com.
Forward-Looking StatementsThis
press release contains “forward-looking” statements and information
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by words such as
“aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,”
“potential,” “seeks,” “will” and variations of these words or
similar expressions, although not all forward-looking statements
contain these words. Forward-looking statements in this press
release include, but are not limited to, statements concerning the
therapeutic potential of Mersana’s product candidates; the
potential of Mersana’s platforms and technology; the design,
progression, timing and objectives of Mersana’s clinical trials or
preclinical studies and the release of data from those studies and
trials; the completion of enrollment in the UPLIFT clinical trial;
Mersana’s anticipated initiation of its UP-NEXT clinical trial of
UpRi and of its Phase 1 clinical trials of XMT-1660 and XMT-2056;
the timing of the announcement of data from its clinical trials,
including UPLIFT and UPGRADE; the development and potential of
Mersana’s pipeline of ADC candidates; Mersana’s expected cash
runway; and potential milestone and royalty revenues under
Mersana’s collaboration and license agreements. Mersana may not
actually achieve the plans, intentions or expectations disclosed in
these forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a
result of various factors, including, among other things,
uncertainties inherent in research and development, in the
initiation of clinical trials and in the clinical development of
Mersana’s product candidates; the risk that Mersana’s anticipated
clinical trials may not be initiated on schedule, if at all; the
risk that Mersana may not realize the intended benefits of its
platforms, technology and collaborations; whether the outcomes of
preclinical studies will be predictive of clinical trial results;
whether initial or interim results from a clinical trial will be
predictive of the final results of the trial or the results of
future trials; risks to clinical trial site initiation, patient
enrollment and follow-up, as well as to Mersana’s abilities to meet
other anticipated deadlines and milestones, whether presented by
the ongoing COVID-19 pandemic or otherwise; the risk that Mersana’s
projections regarding its expected cash runway are inaccurate or
that its conduct of its business requires more cash than
anticipated; and other important factors, any of which could cause
Mersana’s actual results to differ from those contained in the
forward-looking statements, that are described in greater detail in
the section entitled “Risk Factors” in Mersana’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission (“SEC”)
on February 28, 2022, as well as in other filings Mersana may make
with the SEC in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Mersana expressly disclaims any obligation to update any
forward-looking statements contained herein, whether because of any
new information, future events, changed circumstances or otherwise,
except as otherwise required by law.
Mersana Therapeutics,
Inc.Selected Condensed Consolidated Balance Sheet
Data(in thousands and unaudited)
|
March 31,2022 |
|
December 31,2021 |
|
|
|
|
Cash and cash equivalents |
$ |
230,057 |
|
|
$ |
177,947 |
|
Working capital(1) |
|
185,007 |
|
|
141,375 |
|
Total assets |
|
258,267 |
|
|
206,111 |
|
Total stockholders'
equity |
|
140,526 |
|
|
121,741 |
|
|
|
|
|
(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, and unaudited)
|
Three months ended |
|
March 31,2022 |
|
March 31,2021 |
|
|
|
|
Collaboration revenue |
$ |
2,036 |
|
|
$ |
11 |
|
Operating expenses: |
|
|
|
Research and development |
35,806 |
|
|
27,415 |
|
General and administrative |
12,782 |
|
|
7,208 |
|
Total operating expenses |
48,588 |
|
|
34,623 |
|
Total other income (expense),
net |
(706 |
) |
|
(81 |
) |
Net loss |
$ |
(47,258 |
) |
|
$ |
(34,693 |
) |
Net loss per
share attributable to common stockholders — basic and
diluted |
$ |
(0.59 |
) |
|
$ |
(0.50 |
) |
Weighted-average number of
common shares used in net loss per share attributable to common
stockholders — basic and diluted |
79,928,591 |
|
|
68,987,857 |
|
|
|
|
|
|
|
Contact:Jason Fredette
617-498-0020jason.fredette@mersana.com
Mersana Therapeutics (NASDAQ:MRSN)
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