MERSANA THERAPEUTICS, INC. Item 2.02 Results of Operations and Financial Condition.
The information in this Item 2.02 is unaudited and preliminary and does not
present all information necessary for an understanding of the Company's
financial condition as of
The information furnished in this Item 2.02 shall not be deemed to be "filed"
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the "Exchange Act"), or otherwise subject to the liabilities of that section,
nor shall such information be deemed incorporated by reference in any filing by
the Company with the
Item 7.01 Regulation FD Disclosure.
On
The information furnished under this Item 7.01, including Exhibit 99.1, shall
not be deemed "filed" for purposes of Section 18 of the Exchange Act or
otherwise subject to the liabilities of that section, nor shall such information
be deemed incorporated by reference in any filing by the Company with the
Item 8.01. Other Events.
Strategic Objectives, 2022 Accomplishments and Expected 2023 Milestones
On
Strategic Objective: Establish Upifitamab Rilsodotin ("UpRi") as a Foundational Medicine in Ovarian Cancer
2022 Accomplishments
· Completed enrollment in UPLIFT, the company's single-arm registrational trial
of UpRi in platinum-resistant ovarian cancer
· Initiated Phase 3 UP-NEXT clinical trial of UpRi as a maintenance monotherapy
in recurrent platinum-sensitive ovarian cancer
· Neared completion of dose escalation in Phase 1 UPGRADE-A trial of UpRi in
combination with carboplatin in platinum-sensitive ovarian cancer
· Announced that the European Commission has designated UpRi as an orphan
medicinal product for the treatment of ovarian cancer
Expected Milestones
· Report top-line data from UPLIFT in mid-2023
· Assuming positive data, submit a biologics license application ("BLA") to the
· Prepare for potential
· Significantly advance enrollment of UP-NEXT in 2023
· Initiate dose expansion portion of UPGRADE-A in the first quarter of 2023 and
report interim data from UPGRADE-A in the second half of 2023
Strategic Objective: Advance Clinical-Stage Pipeline
2022 Accomplishments
· XMT-1660: Initiated multicenter Phase 1 clinical trial in patients with
previously treated breast, endometrial and ovarian cancers
· XMT-1660: Announced Fast Track designation for the treatment of adult patients
with advanced or metastatic triple-negative breast cancer
· XMT-2056: Announced FDA orphan drug designation for the treatment of gastric
cancer
Expected Milestones
· XMT-1660: Complete dose escalation portion of Phase 1 clinical trial in 2023
· XMT-2056: Initiate Phase 1 clinical trial in the first quarter of 2023
Strategic Objective: Position Mersana as the Antibody-Drug Conjugate ("ADC") Partner-of-Choice
2022 Accomplishments
· Entered into the following agreements that collectively provided Mersana with
$170 million in upfront payments and an opportunity for more than $3 billion in
milestones, plus royalties:
· An Immunosynthen research collaboration and license agreement with Merck
KGaA, Darmstadt, Germany for two targets, which includes a $30 million
upfront payment to Mersana and the potential for up to $800 million in total
potential milestones, plus tiered royalties up to the low double-digits on
net sales
· A collaboration, option and license agreement with GlaxoSmithKline plc
("GSK") for the co-development and commercialization of XMT-2056, which
provided Mersana with a $100 million upfront option purchase fee and the
potential to receive up to $1.36 billion in the form of an additional option
exercise fee and milestone payments, plus an option for Mersana to retain a
U.S. profit share and tiered royalties on net sales outside of the United
States or to receive tiered royalties up to the mid-twenties on global net
sales
· A Dolasynthen research collaboration and license agreement with Janssen
Biotech, Inc. for three targets, which provided Mersana with a $40 million
upfront payment and the potential to receive over $1 billion in total
potential milestones, plus tiered royalties up to the low double-digits on
net sales
Expected Milestones
· Pursue impactful new collaborations
· Execute against existing collaboration agreements
Additionally, the Company announced that as of
Forward-Looking Statements
This Current Report on Form 8-K (this "Report") 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 Report include, but are not limited to, statements concerning
the therapeutic potential of the Company's product candidates; the potential of
the Company's platforms and technology; the design, progression, timing and
objectives of the Company's clinical trials and the release of data from those
trials, including UPLIFT; the Company's potential BLA submission for UpRi and,
if approved, potential
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press Release issued by the Company onJanuary 6, 2023 . Cover Page Interactive Data File (embedded within the Inline XBRL 104 document).
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