Mersana Therapeutics Provides Business Update and Announces Third Quarter 2022 Financial Results
07 November 2022 - 11:00PM
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 third quarter ended
September 30, 2022.
“The year 2022 has already been an incredibly
productive period for Mersana as we have advanced UpRi, expanded
our clinical pipeline and strengthened our balance sheet with two
notable partnerships,” said Anna Protopapas, President and Chief
Executive Officer of Mersana Therapeutics. “With significant
support from global investigators, we were able to
enroll approximately 270 patients in UPLIFT within just
one year, positioning us for a planned top-line data readout and
potential BLA submission next year. We also initiated UP-NEXT, our
randomized Phase 3 clinical trial that has the potential to be our
post-approval confirmatory trial in the United States, support
approvals in other countries and bring UpRi into an earlier disease
setting. Additionally, we view our recent collaborations as a
reflection of the progress we have made in advancing our three
innovative platforms and our position as a partner of choice within
the ADC field. We believe these accomplishments strengthen our
foundation and will enable us to enter 2023 with momentum.”
Strategic Goals, Recent Developments and
Anticipated Milestones
- Build Upifitamab Rilsodotin
(UpRi), a First-in-Class NaPi2b-Targeting ADC, into a Foundational
Medicine in Ovarian Cancer
- Completed Enrollment in UPLIFT Registrational
Trial: UpRi is a first-in-class NaPi2b-targeting ADC with
a novel scaffold-linker-payload that enables high
drug-to-antibody ratio and controlled bystander effect. The
trial’s primary endpoint is the objective response rate (ORR) in
the NaPi2b positive population, and secondary endpoints include the
ORR in the overall population, as well as duration of objective
response and incidence and severity of adverse events. While
analysis of patient biopsies is ongoing, the company has already
exceeded its minimum targeted number of NaPi2b-positive patients
necessary for the primary endpoint analysis. The company plans to
report topline data from the trial in mid-2023 and, assuming
positive data, submit a potential BLA for UpRi for the treatment of
patients with platinum-resistant ovarian cancer to the U.S. Food
and Drug Administration (FDA) by the end of 2023.
- Initiated Patient Enrollment and Dosing in UP-NEXT
Trial: Patient dosing is now underway in UP-NEXT, the
company’s Phase 3 clinical trial of UpRi as monotherapy maintenance
following treatment with platinum doublets in recurrent
platinum-sensitive ovarian cancer. If successful, UP-NEXT could
serve as a post-approval confirmatory trial in the United States,
support potential approvals outside of the United States and
support UpRi’s expansion into earlier lines of therapy.
- Nearing Completion of Dose Escalation
in UPGRADE-A Trial: The dose escalation portion of
UPGRADE-A, the company’s Phase 1/2 trial of UpRi in combination
with carboplatin, is now nearly complete. The company expects to
enter the dose expansion portion of UPGRADE-A in the first quarter
of 2023 and plans to present data from the trial in the second half
of 2023.
- Build a Pipeline of Highly Impactful Cancer
Medicines
- Initiated Phase 1 Patient Dosing and Received Fast
Track Designation for
XMT-1660: XMT-1660 is a B7-H4-directed Dolasynthen
ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6)
and Mersana’s clinically validated DolaLock microtubule inhibitor
payload with controlled bystander effect. The company has initiated
patient dosing in its multicenter Phase 1 trial investigating
XMT-1660 in patients with breast, endometrial and ovarian cancers.
The FDA has granted Fast Track designation to XMT-1660 for the
treatment of adult patients with advanced or metastatic
triple-negative breast cancer.
- Readying for Initiation of XMT-2056 Phase 1
Trial: XMT-2056 is a systemically administered
Immunosynthen STING agonist ADC (DAR 8) that is designed to target
a novel HER2 epitope and locally activate STING signaling in both
tumor-resident immune cells and in tumor cells, providing the
potential to treat patients with HER2-high or -low tumors as
monotherapy or in combination with standard-of-care agents. The
company expects to initiate a multicenter Phase 1 open-label trial
of XMT-2056 in previously treated patients with advanced/recurrent
solid tumors expressing HER2, including breast, gastric, colorectal
and non-small-cell lung cancers later in the fourth quarter of
2022.
- Build Mersana with Strategic Partners
- Received $100 Million
Upfront Option Purchase Fee from GSK: In August 2022,
Mersana announced a global collaboration providing GSK plc an
exclusive option to co-develop and commercialize XMT-2056. Under
the terms of the agreement, Mersana received an upfront option
purchase fee of $100 million. Mersana is also eligible to receive
up to $1.36 billion in the form of an option exercise payment and
development, regulatory and commercial milestone payments if GSK
exercises its option. Mersana has retained options to profit-share
and to co-promote in the United States. If it exercises its
profit-share option, Mersana will be eligible to receive tiered
royalties on net sales outside of the United States. If Mersana
does not elect to profit-share, it is eligible to receive
double-digit tiered royalties on global net sales.
Third Quarter 2022 Financial
Results
- Net cash provided by operating activities in the third quarter
of 2022, including the impact of the aforementioned $100 million
upfront payment from GSK, was $54.6 million.
- Cash, cash equivalents and marketable securities as of
September 30, 2022, were $290.1 million, compared to cash and cash
equivalents of $177.9 million as of December 31, 2021. Mersana
expects that its available funds will be sufficient to support its
operating plan commitments into the first half of 2024.
- Collaboration revenue for the third quarter of 2022 was $5.6
million, compared to an immaterial amount for the same period in
2021. The year-over-year increase was primarily related to the
company’s recent collaboration agreements with Janssen and
GSK.
- Research and development (R&D) expenses for the third
quarter of 2022 were $50.6 million, compared to $35.3 million for
the same period in 2021. Included in third quarter 2022 R&D
expenses were $2.9 million in non-cash stock-based compensation
expenses. The year-over-year increase in R&D expenses was
primarily related to higher manufacturing and clinical costs
related to UpRi and to an increase in headcount.
- General and administrative (G&A) expenses for the third
quarter of 2022 were $14.6 million, compared to $10.1 million
during the same period in 2021. Included in third quarter 2022
G&A expenses were $2.5 million in non-cash stock-based
compensation expenses. The year-over-year increase in G&A
expenses was primarily related to increases in consulting and
professional fees, and in headcount.
- Net loss for the third quarter of 2022 was $59.8 million, or
$0.61 per share, compared to a net loss of $45.5 million, or $0.63
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
business updates and its financial results for the third quarter of
2022. To access the call, please dial 646-307-1963 (domestic) or
800-715-9871 (international) and provide the Conference ID 9941053.
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 approximately
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; UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi
in combination with other ovarian cancer therapies; and UP-NEXT, a
Phase 3 clinical trial of UpRi as monotherapy maintenance following
treatment with platinum doublets in recurrent platinum-sensitive
ovarian cancer. Mersana is also advancing XMT-1660, a Dolasynthen
ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a
novel epitope of human epidermal growth factor receptor 2 (HER2),
in addition to other earlier-stage assets. In addition, multiple
partners are using Mersana’s platforms to advance their ADC
pipelines. Mersana Therapeutics was 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
& 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 and
the release of data from those trials, including UPLIFT; Mersana’s
potential BLA submission for UpRi; Mersana’s anticipated initiation
of its Phase 1 clinical trial of XMT-2056 and the dose expansion
portion of its UPGRADE trial; the ability of trial results to
support marketing approvals or other objectives; the development
and potential of Mersana’s pipeline of ADC candidates; Mersana’s
expected cash runway; GSK’s potential exercise of its option for a
license to co-develop and commercialize XMT-2056; Mersana’s options
to share in U.S. profits and losses and/or to co-promote licensed
products pursuant to its agreement with GSK; and potential option
exercise, 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, including that GSK may not exercise its option for
a license; 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 and its collaborators’ 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; the risk that any of Mersana’s collaborators fail to
make any payments owed to Mersana; 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (“SEC”) on August 8, 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)
|
|
|
|
|
September 30,2022 |
|
December 31,2021 |
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
290,126 |
|
$ |
177,947 |
Working capital(1) |
211,243 |
|
141,375 |
Total assets |
314,850 |
|
206,111 |
Total stockholders'
equity |
90,229 |
|
121,741 |
|
|
|
|
(1) The Company
defines working capital as current assets less current
liabilities. . |
|
|
Mersana Therapeutics,
Inc.Condensed Consolidated Statement of
Operations(in thousands, except share and per
share data, and unaudited)
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
September 30,2022 |
|
September 30,2021 |
|
September
30,2022 |
|
September 30,2021 |
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
5,573 |
|
|
$ |
11 |
|
|
$ |
11,893 |
|
|
$ |
32 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
50,639 |
|
|
35,275 |
|
|
127,676 |
|
|
94,645 |
|
General and administrative |
14,573 |
|
|
10,124 |
|
|
42,158 |
|
|
26,214 |
|
Total operating expenses |
65,212 |
|
|
45,399 |
|
|
169,834 |
|
|
120,859 |
|
Total other income (expense),
net |
(172 |
) |
|
(83 |
) |
|
(1,347 |
) |
|
(250 |
) |
Net loss |
|
(59,811 |
) |
|
|
(45,471 |
) |
|
|
(159,288 |
) |
|
|
(121,077 |
) |
Net loss per share — basic and
diluted |
$ |
(0.61 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.75 |
) |
|
$ |
(1.73 |
) |
Weighted-average number of
common shares — basic and diluted |
97,641,936 |
|
|
71,753,004 |
|
|
91,173,989 |
|
|
70,129,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:Jason Fredette
617-498-0020jason.fredette@mersana.com
Mersana Therapeutics (NASDAQ:MRSN)
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