false
0001442836
0001442836
2024-01-05
2024-01-05
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): January 5,
2024
MERSANA THERAPEUTICS, INC.
(Exact name of registrant as specified in its
charter)
Delaware |
|
001-38129 |
|
04-3562403 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
840
Memorial Drive Cambridge,
Massachusetts |
|
02139 |
(Address of Principal Executive Offices)
|
|
(Zip
Code) |
Registrant’s telephone number, including
area code: (617) 498-0020
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b)
of the Act:
Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which registered |
Common Stock, $0.0001 par value |
MRSN |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 7.01 | Regulation FD Disclosure. |
On January 5, 2024, Mersana
Therapeutics, Inc. (the “Company”) posted an updated corporate presentation on the Company’s website. To
access the presentation, investors should visit the “Events & Presentations” page under the “Investors & Media”
section of the Company’s website at ir.mersana.com.
The information furnished
in this Item 7.01 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
to be incorporated by reference in any filing by the Company with the Securities and Exchange Commission under the Securities Act of 1933,
as amended, or the Exchange Act, regardless of any general incorporation language contained in such
a filing, except as expressly set forth by specific reference in such a filing.
Additionally,
on January 5, 2024, the Company issued a press release announcing business updates and expected 2024 milestones, a copy of which is filed
as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 8.01 by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
MERSANA THERAPEUTICS, INC. |
|
|
|
Date: January 5, 2024 |
By: |
/s/ Brian DeSchuytner |
|
|
Brian DeSchuytner |
|
|
Senior Vice President, Chief Operating Officer and Chief Financial Officer |
Exhibit 99.1
Mersana Therapeutics Announces Business Updates,
Expected 2024 Milestones and Upcoming Presentation at the 42nd Annual J.P. Morgan Healthcare Conference
| · | Enrollment in dose escalation and backfill cohorts continuing in Phase 1 clinical trial of XMT-1660, Dolasynthen B7-H4 ADC; expect
to initiate expansion in Q2 2024 and announce initial clinical data in mid-2024 |
| · | Phase 1 clinical trial of XMT-2056, Immunosynthen HER2 ADC, restarting; plan to advance dose escalation in 2024 |
| · | Expect capital resources will support current operating plan commitments into 2026 |
| · | Company to webcast presentation from 42nd Annual J.P. Morgan Healthcare Conference at 2:15 p.m. Eastern Time (ET)/11:15 a.m. Pacific
Time (PT) on January 11, 2024 |
CAMBRIDGE,
Mass., January 5, 2024 – 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 announced business updates, its expected 2024 milestones and its upcoming presentation at the 42nd Annual J.P. Morgan Healthcare
Conference.
“Mersana’s
next-generation ADC platforms are designed to overcome key limitations of traditional ADCs,” said Martin Huber, M.D., President
and Chief Executive Officer of Mersana Therapeutics. “We gained important new learnings in 2023 that affirmed the differentiation
of both Dolasynthen, our next-generation cytotoxic ADC platform, and Immunosynthen, our STING-agonist ADC platform.
“In 2024, we plan to demonstrate over several data presentations
how Dolasynthen’s preclinical differentiation translates into the clinic. These presentations will include initial clinical data
from our ongoing Phase 1 clinical trial of XMT-1660. We also are looking forward to progressing dose escalation in our Phase 1 clinical
trial of XMT-2056 as we strive to advance ADCs beyond cytotoxics by enabling targeted innate immune stimulation via our Immunosynthen
platform,” Dr. Huber continued. “With these programs in motion, multiple collaborations in place and a strong balance
sheet, Mersana is well positioned to meaningfully advance its mission to discover and develop life-changing ADCs for patients fighting
cancer.”
Business Updates and Expected Milestones
| · | XMT-1660: Mersana continues to advance its Phase 1 clinical trial of XMT-1660, the company’s lead Dolasynthen ADC candidate
targeting B7-H4. The trial is currently enrolling patients in dose escalation at dose level 6 as well as in backfill cohorts to optimize
dose and schedule. Mersana plans to initiate tumor-specific expansion cohorts in the second quarter of 2024 and share initial dose escalation
and backfill cohort data in mid-2024. |
| · | XMT-2056: Mersana is restarting its Phase 1 clinical trial of XMT-2056, the company's lead Immunosynthen ADC candidate targeting
a novel HER2 epitope. The company plans to advance dose escalation in 2024. XMT-2056 is wholly owned by Mersana. GSK plc has an exclusive
global license option to co-develop and commercialize the candidate. |
| · | Additional
Upcoming Data Presentations: In the first half of 2024, Mersana expects to present data at multiple scientific meetings demonstrating
Dolasynthen’s differentiation from first-generation cytotoxic ADC platforms. The presentations will include clinical data from two discontinued ADC candidates, XMT-1592 and XMT-1536 (UpRi). |
| · | Collaborations: Mersana continues to advance its collaborations with Janssen Biotech, Inc. and Merck KGaA, Darmstadt,
Germany. The collaboration and license agreement with Janssen focuses on discovering novel Dolasynthen ADCs for up to three targets. The
collaboration and license agreement with Merck KGaA, Darmstadt, Germany focuses on discovering novel Immunosynthen ADCs for up to two
targets. In 2023, Mersana received development milestone payments from both collaborations. |
| · | Financial Resources: Mersana’s cash, cash equivalents and marketable securities as of September 30, 2023 were $241.0
million. The company continues to expect that its available funds will be sufficient to support its current operating plan commitments
into 2026. |
Upcoming J.P. Morgan Healthcare Conference Presentation and Webcast
Mersana President and CEO Dr. Martin Huber will present at the
42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 2:15 p.m. Eastern Time/11:15 a.m. Pacific
Time. A live webcast of this event will be available on the Investors & Media section of Mersana’s website at www.mersana.com.
An archived replay will be available for approximately 90 days following the event.
About Mersana Therapeutics
Mersana
Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven
by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and
immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with
the potential to treat a range of cancers. Its pipeline includes 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). Mersana routinely posts information that may be useful
to investors on the “Investors & Media” section of its website at www.mersana.com.
Forward-Looking Statements
This 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 Mersana’s strategic priorities; its plans regarding the clinical development of XMT-1660 and XMT-2056, including with
respect to the resumption of Mersana’s Phase 1 clinical trial of XMT-2056 and the progress and design of the clinical trials of
these product candidates; Mersana’s planned data presentations, including with respect to its Phase 1 clinical trial of XMT-1660;
Mersana’s cash runway; Mersana’s collaborations with third parties; and the development and potential of Mersana’s product
candidates, platforms, technology and pipeline of ADC candidates. 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 advancement, progression
and completion of clinical trials and in the clinical development of Mersana’s product candidates, including XMT-1660 and XMT-2056;
the risk that Mersana may face delays in resuming its Phase 1 clinical trial of XMT-2056; the risk that Mersana may not realize the intended
benefits of its platforms, technology and collaborations; 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 November 7, 2023, 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.
###
Contact:
Jason Fredette
617-498-0020
jason.fredette@mersana.com
v3.23.4
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Mersana Therapeutics (NASDAQ:MRSN)
Historical Stock Chart
From Apr 2024 to May 2024
Mersana Therapeutics (NASDAQ:MRSN)
Historical Stock Chart
From May 2023 to May 2024