Form 8-K
8-K — Verastem, Inc.
Accession: 0001104659-26-057126
Filed: 2026-05-07
Period: 2026-05-07
CIK: 0001526119
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — tm2613842d1_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (tm2613842d1_ex99-1.htm)
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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):
May 7, 2026
Verastem,
Inc.
(Exact Name of Registrant as Specified in
Charter)
Delaware
001-35403
27-3269467
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
117 Kendrick Street, Suite 500, Needham, MA
02494
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s telephone number, including
area code: (781) 292-4200
(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:
¨ 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 per share
VSTM
The Nasdaq Capital Market
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 May 7, 2026, Verastem, Inc.
posted its updated corporate presentation on its website, a copy of which is furnished hereto as Exhibit 99.1 to this Current Report
on Form 8-K.
Item 9.01 Financial Statements and Exhibits
Exhibit No.
Description
99.1
Corporate Presentation,
dated May 7, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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.
VERASTEM, INC.
Dated: May 7, 2026
By:
/s/ Daniel W. Paterson
Daniel W. Paterson
Chief Executive Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2613842d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
Delivering Novel
Therapies for
RAS/MAPK Pathway-Driven Cancers
C O R P O R A T E P R E S E N T A T I O N
M A Y 2 0 2 6
2
FORWARD-LOOKING STATEMENTS
This presentation includes forward-looking statements about, among other things, Verastem Oncology’s (the “Company”) programs and product candidates, strategy, future plans and prospects, including statements related to the approval and commercialization of AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) as a treatment for adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant-type (mt) recurrent Low-Grade Serous Ovarian Cancer (LGSOC), the expected outcome and benefits of collaborations, including with GenFleet Therapeutics (Shanghai), Inc. (GenFleet), including the conduct of a Phase 1/2a study and subsequent studies with respect to VS-7375, the potential of the results of the RAMP 301 Phase 3 trial to confirm the results of the RAMP 201 study specific to KRAS mutant patients and to expand the indication for AVMAPKI FAKZYNJA CO-PACK regardless of KRAS mutation status, the structure and potential clinical value of our completed, planned and pending clinical trials, the potential clinical value of various of the Company's clinical trials, including the RAMP 201, RAMP 201J, RAMP 205, RAMP 301 and VS-7375 trials, the timing of commencing and completing trials,
including topline data reports, our interactions with regulators, the timeline and indications for clinical development, regulatory submissions and the potential for and timing of commercialization of our product candidates and potential for additional development programs involving the Company’s lead compound and the potential market opportunities thereof; and the estimated addressable markets for, and anticipated market opportunities of our drug candidates. The words "anticipate," "believe," "estimate," "expect," "may," "plan," "target," "potential," "would," "could," "should," "continue," “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks related to the development and successful commercialization of our product candidates; obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercialization of a new product; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of Verastem's clinical trials, including, but not limited to Verastem's ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Verastem's trials; any delays or failures enrollment and the occurrence of adverse safety events; our ability to successfully commercialize AVMAPKI FAKZYNJA CO-PACK in the U.S. including our ability to generate market demand for and acceptance of AVMAPKI FAKZYNJA CO-PACK; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms or to fund operations from revenues generated by the sales of AVMAPKI FAKZYNJA CO-PACK; actions or advice of regulatory agencies to maintain regulatory approval of AVMAPKI FAKZYNJA CO-PACK; the impact of current and future healthcare reforms, including those affecting the delivery of or payment for healthcare products and services; uncertainties related to the activities and initiatives of the current U.S. presidential administration, including regulatory and policy changes that may adversely affect our business; risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; decisions by regulatory authorities regarding trial design, labeling and other matters that could affect the timing, availability or commercial potential of our product candidates; whether preclinical testing of our product candidates and preliminary or interim data from clinical trials will be predictive of the results or success of ongoing or later clinical trials; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that the market opportunities of our drug candidates are based on internal and third-party estimates which may prove to be incorrect; that third-party payors (including government agencies) may not reimburse; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; the risks that we will not satisfy our post-marketing requirements and commitments established and agreed to as part of the FDA's approval of AVMAPKI FAKZYNJA CO-PACK; that our marketed product candidates may cause adverse safety events and/or unexpected concerns may arise from additional data or analysis, or result in unmanageable safety profiles as compared to their levels of efficacy; that we may not be able to confirm the results from the RAMP 201 study or expand the approved indication for AVMAPKI FAKZYNJA CO-PACK; that our product candidates may experience manufacturing or supply interruptions or failures; that any of our third-party contract research organizations, contract manufacturing organizations, clinical sites, or contractors, among others, who we rely on may fail to fully perform; that we face substantial competition, which may result in others developing or commercializing products before or more successfully than we do which could result in reduced market share or market potential for our product candidates; that we may be unable to successfully initiate or complete the clinical development and eventual commercialization of our product candidates; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that we may not attract and retain high quality personnel; that we or Pfizer, Inc. may fail to
fully perform under the license agreement covering certain Pfizer FAK inhibitors, including defactinib; that we or Chugai Pharmaceutical Co., Ltd. may fail to fully perform under the avutometinib license agreement; that we or GenFleet may fail to fully perform under the collaboration and option agreement covering VS-7375 and other assets we may decide to option in; that our total addressable and target markets for our product candidates might be smaller than we are presently estimating; that we or Secura Bio, Inc. may fail to fully perform under the asset purchase agreement with Secura Bio, Inc., including in relation to milestone payments; that we may not be able to establish new or expand on existing collaborations or partnerships, including with respect to in-licensing of our product candidates, on favorable terms, or at all; that we may be unable to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that we may not pursue or submit regulatory filings for our product candidates; that, due to the current presidential administration's significant reduction in the FDA's workforce and potential reductions to the FDA's budget, we may experience a material impact to the FDA's ability to engage in a variety of activities that may affect our business, including routine regulatory and oversight activities; and that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients.
Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC) on March 04, 2026, and in any subsequent filings with the SEC, which are available at www.sec.govand www.verastem.com.The forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements whether as a result of new information, future events or otherwise, except as required by law. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential
investors, and others should give careful consideration to these risks and uncertainties.
USE OF NON-GAAP FINANCIAL MEASURES
This presentation contains references to our non-GAAP operating expense, a financial measure that is not calculated in accordance with generally accepted accounting principles in the US (GAAP). This non-GAAP financial measure excludes certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses this measure, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, this non-GAAP financial measure is unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between this non-GAAP financial measure and the most comparable GAAP financial measure are included in the footnotes to the slides in this presentation on which such non-GAAP number appears.
THIRD-PARTY SOURCES
Certain information contained in this presentation, including industry and market data and other statistical information, relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own
internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions.
Disclaimers
3
OUR COMMERCIAL
PRODUCTS
MONOTHERAPY & COMBINATION APPROACHES
RAS: Rat Sarcoma Virus; MAPK: Mitogen-Activated Protein Kinase; RAF: Rapidly Accelerated Fibrosarcoma; MEK: Mitogen-Activated Extracellular Signal-regulated Kinase; FAK: focal adhesion kinase;
KRAS: Kirsten Rat Sarcoma Virus
Please see the full Prescribing Information for more information
OUR FOCUS
To expeditiously develop and deliver transformative therapies that truly change outcomes
for people living with RAS/MAPK pathway-driven cancers.
Avutometinib
RAF/MEK Clamp
Defactinib
FAK Inhibitor
VS-7375
KRAS G12D (ON/OFF)
Inhibitor
Verastem Oncology: Tackling Challenging Cancers with Novel Therapies
4
FDA: Food and Drug Administration
CLINICAL-TO-COMMERCIAL SUCCESS
in bringing novel RAS/MAPK
pathway-targeted therapies
from development to FDA
approval to
commercialization
INNOVATIVE
PIPELINE
with a potential best-in-class KRAS G12D asset
targeting the most
prevalent KRAS mutation in
human cancers
SCALABLE
ORGANIZATION
to maximize future
oncology development
programs and launches
Well Positioned to Deliver Continued Commercial Success and a Potential
Best-in-Class Treatment for Long-term Growth
OUR ADVANTAGE:
4
5
TARGET
RAS DIRECTLY
TARGET THE
PATHWAY
DOWNSTREAM
TARGET THE PARALLEL
PATHWAY THAT
DRIVES RESISTANCE
First novel/novel
combination therapy,
targeting the
RAS/MAPK pathway,
approved in oncology
Precision Targeting of RAS/MAPK-Driven Cancers Differentiates Our Science
OUR SCIENTIFIC STRATEGY:
EGF: Epidermal Growth Factor; EGRF: Epidermal Growth Factor Receptor; ERK: Extracellular Signal-regulated Kinase; PI3K: Phosphatidylinositol 3-Kinase; AKT: Protein Kinase B; mTOR: Mammalian
Target of Rapamycin; YAP: Yes-Associated Protein; TEAD: Transcriptional Enhanced Associate Domain; MYC: Myelocytomatosis oncogene
ICT: investigator choice of treatment; LGSOC: Low-grade Serous Ovarian Cancer; mPDAC: metastatic Pancreatic Ductal Adenocarcinoma; mNSCLC: metastatic Non-small cell lung cancer; mCRC: 6
metastatic colorectal cancer; FAKi: focal adhesion kinase inhibitor; Gem: Gemcitabine. NabP: nab-paclitaxel; EGFR: epidermal growth factor receptor
Not shown: *GenFleet Therapeutics has an ongoing Phase 1/2 and Phase 3 clinical trials in China with VS-7375, known as GFH375 in China. GenFleet retains greater China rights. Verastem has two
undisclosed assets at discovery phase targeting RAS/MAPK pathway-driven cancers as part of the GenFleet collaboration.
Asset Disease Phase Key Milestones
Avutometinib, RAF/MEK Clamp + Defactinib, FAKi
Recurrent LGSOC Avutometinib
+ Defactinib
Expect to report topline readout
of primary endpoint by mid-2027
Recurrent LGSOC Avutometinib
+ Defactinib vs ICT
Expect to report an update on
the expansion cohort in Q2’26 1L mPDAC Avutometinib
+ Defactinib + Gem/NabP
VS-7375, oral KRAS G12D (ON/OFF) inhibitor
Ongoing enrollment; expect to
report early data in 1H’26; report
update in 2H’26
KRAS G12D-mutated
solid tumors (advanced solid
tumors)
VS-7375 monotherapy +
various combinations
Expect FPI in mid-2026 2L mPDAC; 1L PDAC
combination
VS-7375 monotherapy
+ EGFR combination
Expect FPI in mid-2026
2L/3L advanced NSCLC; 2L+
asymptomatic untreated brain
mets
VS-7375 monotherapy
Expect FPI in mid-2026 2L+ mCRC; 1L mCRC
combination
VS-7375 combinations
w/ EGFR & Chemotherapy
TARGET-D 101: Phase 1/2
dose escalation & expansion
TARGET-D 202: Phase 2 registration directed trial
TARGET-D 203: Phase 2 registration directed trial
TARGET-D 201: Phase 2 registration directed trial
RAMP 201: Phase 2 Registration Directed Trial;
Accelerated FDA Approval May 2025
RAMP 301: Phase 3 International Confirmatory Trial
RAMP 205: Phase 1/2 Trial
Multi-Faceted & Targeted Approaches to Address RAS/MAPK-Driven Cancers
OUR PIPELINE:
7
MAXIMIZE COMMERCIAL LAUNCH
EXECUTION OF AVMAPKI® FAKZYNJA®
CO-PACK FOR BROAD HCP ADOPTION
Commercial Product and Pipeline Positioned to Deliver Long-Term
Shareholder Value
OUR 2026 PRIORITIES:
CONTINUE EXECUTION OF RAMP 301
CONFIRMATORY PHASE 3 TRIAL
IN RECURRENT LGSOC
MAINTAIN STRONG BALANCE SHEET
HCP: Healthcare professional
GENERATE MONOTHERAPY &
COMBINATION DATA WITH VS-7375 TO
INFORM REGISTRATION PATH IN KRAS
G12D-MUTATED SOLID TUMORS
8
1H2026 Mid-2026 2H 20206
Continued strong execution of product commercialization throughout 2026 building upon
successful product launch
Q2 2026: Report an update on the safety & efficacy of the
expansion cohort with six months of follow-up on all
patients
RAMP 205 1L PDAC
Avutometinib + Defactinib +
Gem/NabP
2H 2026: Report update on
TARGET-D 101
1H 2026: Report early data from the
TARGET-D 101 Phase 1/2 trial
VS-7375 TARGET-D 101
Dose escalation & expansion
Monotherapy & Combinations
(advanced solid tumors)
Expect FPI in mid-2026
VS-7375 TARGET-D 201
2L mPDAC monotherapy +
combination; 1L mPDAC
combination
Expect FPI in mid-2026
VS-7375 TARGET-D 202
2L/3L advanced NSCLC
monotherapy; 2L+ asymptomatic
untreated brain mets
Expect FPI in mid-2026
VS-7375 TARGET-D 203
2L+ mCRC combination; 1L mCRC
combination
Milestones for 2026
OUR MILESTONES:
FPI: First Patient In.
9
Commercially Launched
in the U.S. for KRAS-mutated
Recurrent LGSOC
FDA APPROVAL DATE: MAY 8, 2025
10
70% of LGSOC Tumors are Driven by the RAS/MAPK Pathway;
~30% of These Have a KRAS Mutation1,2,3,4
• Avutometinib inhibits MEK kinase activity while
blocking the compensatory reactivation of MEK
by upstream RAF5,6,7
• Blocking RAF and/or MEK activates FAK, a key
mediator of drug resistance8,9
• Defactinib, a FAK inhibitor, inhibits parallel
pathway signaling10,11,12
• Together, avutometinib plus defactinib offer
more complete blockade of the signaling that
drives the growth of RAS/MAPK pathway-dependent tumors
RAF-MEK
Complex
The Combination of Avutometinib and Defactinib
Induces Deeper Inhibition of Tumor Growth
1. AACR Genie v16.1; 2. Cheasley et al., J Pathol 2021; 3. Thomson et al., Gynecol Oncol 2023;
4. Gershenson et al., Gynecol Oncol 2022; 5. Coma et al., AACR 2022; 6. Ishii et al., Cancer Res, 2013;
7. Lito et al., Cancer Cell, 2014; 8. Lubrano et al., AACR 2024; 9. Banerji et al., AACR 2020; 10. Jones et al.,
Invest New Drugs 2015; 11. McNamara et al., Gynecol Oncol 2024; 12. Banerjee et al., ASCO 2023
ERK: Extracellular Signal-regulated Kinase; FAK: Focal Adhesion Kinase; MEK, Mitogen-Activated
Extracellular Signal-regulated Kinase; mTOR: Mammalian Target of Rapamycin; P: Phosphate; PI3K:
Phosphatidylinositol 3-Kinase; RAF: Rapidly Accelerated Fibrosarcoma; RAS: Rat Sarcoma Virus; RhoA: Ras
Homolog Family Member A; RTK: Receptor Tyrosine Kinase; YAP: Yes-Associated Protein.yes
11
High Unmet Need for an Effective and
Tolerable Therapy in Recurrent LGSOC
• U.S. annual incidence: ~1,000-2,0001
and
prevalence: 6,000-8,0002
• Affects younger women with bimodal peaks
of diagnosis between the ages of 20-30 and
50-60
– Disproportionately impacts health, fertility, and
long-term quality of life3,4
• 80-90% of patients will experience a
recurrence5
• Standard of care offers low to moderate
response rates (6-13%)6,7,8
When you get told that you have a recurrence,
the mental load is a lot. You’re thinking, okay,
what did I have to do for treatment the first
time? Now I have to repeat that. And will there
even be something available for me to take for a
second, or a third recurrence? - Amanda, real patient living with recurrent LGSOC;
diagnosed at 26 with LGSOC
1.Verastem DOF; 2. US Cancer Statistics. Accessed 2024; 3. Slomovitz Gynecol Oncol 2020;
4. Manning-Geist B et al. Clin Cancer Res 2022;28(20):4456-4465; 5. Babaier 2022/p1/para1/ln6,7;
6. Gershenson Gynecol Oncol 2022; 7. Slomovitz Gynecol Oncol 2020; 8. Monk 2020/p3758/table2/footnote-b; 11
12
Driving Impact in the First Year of Launch
N E T P R O D U C T R E V E N U E
S I N C E L A U N C H
$11.2M
$17.5M
$2.1M
$30.9M
FY25
$18.7M
Q2’25* Q3’25 Q4’25 Q1’26
400+
unique U.S. prescribers through April 2026
60/40
of prescription split between GynOncs and MedOncs
65%
of commercially eligible patients
are using our copay program
12-14
days to fill prescriptions
$18. 7M in Net Product Revenue in Q1’26
Achieved ~$50M in AVMAPKI FAKZYNJA CO-PACK
Net Product Revenue Since Launch in May 2025
*Not a full quarter; May 8, 2025 FDA approval
Verastem DOF; US dollars in millions. Refer to press release issued on May 7, 2026 for full financial details.
Please see the full Prescribing Information for more information
13
Three Key Drivers to Realize Full Benefits of AVMAPKI FAKZYNJA CO-PACK
v
New
Patients
Starts
Use at
First
Recurrence
Help
Patients Stay
on Therapy
Please see the full Prescribing Information for more information
14
Reach among
prescribers who
haven’t prescribed
AVMAPKI FAKZYNJA
CO-PACK
Experience with
AVMAPKI FAKZYNJA
CO-PACK among
current prescribers
Entrenched
prescribing behaviors
Maximizing Benefit with AVMAPKI FAKZYNJA CO-PACK at First Recurrence
Expand Shift Deepen
Substantial Market Opportunity, Growth Potential Ahead
Please see the full Prescribing Information for more information
15
RAMP 201: Demonstrated Durable Results Across Various Efficacy Measures
in Heavily Pretreated Patients With and Without a KRAS Mutation
Avutometinib + Defactinib Regimen: Best Overall Response
82% of All Patients Had a Reduction in Target Lesions,
Regardless of KRAS Status1
All Patients KRAS mt KRAS wt 1
ORR % 31% 44% 17%
DoT, mean 14.5 months 18 months 11 months
DoR, median 31 months 31 months 9 months
PFS, median 13 months 22 months 13 months
61% 70% 50% DCR at 6 or
more months
10% Discontinuation Rate
Due to AEs
1. RAMP 201 data cut off as of June 30, 2024; 2. RAMP 201 Long-Term Efficacy and Safety August 2025 data cut off presented at SGO 2026. ORR: Objective Response Rate; DoT: Duration of Treatment; mDoR:
median Duration of Response; mPFS: media Progression-free Survival; DCR: Disease Control Rate; AE: adverse event
Avutometinib + Defactinib Regimen: Best Overall Response • More than half of responders (56%) remain in response at 24 months • KRAS mt patients: mDoR remains at 31.1 months and mPFS is 19.6 months • KRAS wt patients: mDoR is now 12 months and mPFS is 12.7 months
The discontinuation rate due to
adverse events remains low (12%)
even with extensive follow up
RAMP 201 Long-Term Data
Median Follow-Up
of 2 Years2
:
NEW DATA
16
OS
PFS by RECIST v1.1
per INV assessment
ORR
DoR
DCR
Safety
Pharmacokinetics
PROs a Unless otherwise specified, all tumor
response-based endpoints will be
analyzed using both BICR and INV
assessments
*US FDA analysis plan will evaluate PFS independently in KRAS-mt and KRAS wt LGSOC; BID: twice a day; BIW: twice a week; DCR: disease control rate; DoR: duration of response; INV: investigator;
KRAS: kirsten rat sarcoma virus; MEKi: MEK inhibitor; mt: mutant; PO: per oral; pts, patients; ORR: objective response rate; OS: overall survival; PD: progressive disease; PFS: progression-free survival;
PROs: patient-reported outcomes; RECIST: response evaluation criteria in solid tumors; wt: wild type. BICR: blinded independent central radiological review
• Expect to report topline primary endpoint of PFS by mid-2027
• Similar entry criteria to RAMP 201 patient population, KRAS mt and KRAS wt recurrent LGSOC
• Study sites include the U.S., Canada, UK, Europe, Australia, New Zealand, Japan and South Korea
• Recurrent disease after prior
platinum therapy
• Documented KRAS mutation status
• Measurable disease per RECIST v1.1
• Confirmed LGSOC diagnosis
• Prior MEKi allowed
• Prior bevacizumab allowed
RAMP 301 (GOG-3907/ENGOT-ov81/GTG-UK): NCT06072781
Pegylated Liposomal Doxorubicin
Paclitaxel
Letrozole
Anastrozole
Investigator’s Choice
n = 135
Avutometinib 3.2 mg PO BIW
Defactinib 200 mg BID
3 weeks on, 1 week off
Avutometinib + Defactinib
n = 135
May cross over upon
BICR-confirmed PD
PFS (BICR by RECIST v1.1)
Hierarchical Evaluation of PFS*:
KRAS mutant LGSOC
All recurrent LGSOC
KRAS wt LGSOC
Primary Endpoint:
Secondary Endpointsa 1:1 Randomization
n = 270
Stratification Factors: • KRAS mutation status
(wt vs. mt) • Geography (N.
America/EU) vs. ROW
• Number of prior
therapies (1-3 vs.
4 or more)
Inclusion Criteria
RAMP 301: International Phase 3 Confirmatory Trial of
Avutometinib + Defactinib in Recurrent LGSOC
17
U.S.
Secured FDA
Accelerated Approval
in KRAS-mutated
recurrent LGSOC.
2029
2025
RAMP 301: topline data
expected in mid-2027.
U.S. Label Expansion
Leverage the RAMP 301
results to confirm the initial
indication and expand the
indication regardless of
KRAS mutation status.
Japan:
Leverage the results from
RAMP 201J & RAMP 301 for
potential approval in both
KRAS mutant and
wild type recurrent LGSOC.
Europe:
Leverage results from
RAMP 301 for potential
approval in both KRAS
mutant and wild type
recurrent LGSOC.
2028
2027
KRAS MT represents ~33% of the population, while the WT represents 67% and therefore there are many more addressable patients.
Potential for Label and Geographic Expansion
AVMAPKI FAKZYNJA CO-PACK Future Commercial Opportunity
18
VS-7375,
Oral KRAS G12D
(ON/OFF) Inhibitor
19 Ref: Lee et al Nature, Dec 2022 for epidemiology; 1: VSTM DOF, based on internal estimates; 2: McIntyre et al., Cancer Cell 2024, 42:1614-1629 and Hafezi S et al., Int J Mol Sci
2021, 22(19):10219; 3: Judd J, Abdel Karim N, Khan H, et al. Mol Cancer Ther. 2021;20(12):2577-2584;4: Lee J, et al. J Clin Med. 2020;9(12):3863; BTC: biliary tract cancers
KRAS G12D: The Most Prevalent KRAS Mutation in Cancer with Poor
Prognosis and High Unmet Need
PANCREATIC
40%
KRAS G12D
mutation in
pancreatic cancer
correlates with
worse outcomes,
shorter survival,
and a higher risk of
progression2
LUNG
5%
KRAS G12D
mutation is a
significant driver in
lung cancer,
especially among
non-smokers, and
is linked to poor
responses to SOC3
COLORECTAL
15%
KRAS G12D
mutation in CRC is
often linked to
more aggressive
tumors4
TUMOR
AGNOSTIC
16% - Small Bowel
7-15% - BTC
5% - Endometrial
KRAS G12D
mutation appears
across many
cancer types and
remains an unmet
medical need
KRAS G12D Mutation Expression Across Tumor Types
60,000+ New Patients in U.S. Annually1
20
Data in China Phase 1/2 study demonstrate strong monotherapy
response rates in patients with previously treated pancreatic and
lung cancers with manageable tolerability
Pachter et al., Targeting RAS 2nd edition 2025; Ai et al., ASCO 2025; Li et al., World Conference of Lung Cancer 2025; pERK: phosphorylated Extracellular signal-regulated
Kinase; GEF: Guanine nucleotide exchange factor GAP: GTPase-activating protein
VS-7375: Potential Best-in-Class G12D Inhibitor for Advanced KRAS G12D-Mutated Cancers
Differentiated Profile vs. Other RAS Inhibitors
• Dual potent inhibition of both ON and OFF states of KRAS G12D – Correlates with better in vivo efficacy and durability vs. ON-only
RAS inhibitors • High affinity for KRAS G12D with long residence time (18-24 hours) – Correlates with more rapid and durable suppression of pERK signaling
vs. RMC-9805 in tumor cell lines
• Selective inhibition of KRAS G12D – Spares T cell proliferation in contrast to RAS-Multi inhibitor, which
impairs T cell proliferation
• Once daily oral dosing in patients – Achieves exposures corresponding to maximal tumor regressions
across preclinical models
RMC-6236 and RMC-9805 are assets developed by Revolution Medicine; AMG410 is an asset developed by Amgen; AZD0022 is an asset developed by AstraZeneca. 21
VS-7375: Best-in-Class Preclinical Profile
LS513 Colorectal Cancer Model
Better Efficacy and Durability than G12D ON and Pan-RAS
ON Inhibitors in KRAS G12D Mutant Tumor Models
Isolated CD3+ T cells from PBMCs from triplicate
human donors were cultured with anti-human
CD3/CD28 beads and treated for 3 days
Variant-Selective KRAS
Inhibitors Spare T Cell
Proliferation in Contrast to
RAS-Multi Inhibitor
Assay VS-7375
IC50 (nM)
KRAS G12D
State
RAF1
binding 2 1 GppNHp-bound
(ON/active)
Nucleotide
exchange 6 1 GDP-bound
(OFF/inactive)
Assay VS-7375
KD (pM)
KRAS G12D
State
18 SPR affinity GppNHp-bound
(ON/active)
12 SPR affinity GDP-bound
(OFF/inactive)
Functional Assays
Potent Dual ON/OFF Inhibitor
of KRAS G12D
Long Residence time (18-24 hours)
for VS-7375 vs ~1 hour for AZD0022
(G12Di) or AMG410 (pan-RASi)
KP4 Pancreatic Cancer Model LU0876 NSCLC PDX Model
Binding Assays
CD8+
CD4+
22
GFH375/VS-7375 Confers Single Agent Anti-Tumor Activity in Patients with
Previously Treated PDAC and NSCLC
PDAC
• 58.3% ORR (n=12) in 2L; 40.7% ORR (n=59) in all evaluable pts at 600 mg QD* • mPFS and mOS has not been reached for 2L PDAC pts. Median follow up time was 5.65 months. C -PR confirmed → -On treatment
NSCLC
• 68.8% ORR (n=16) at 600 mg QD; 57.7% ORR (n=26) evaluable pts* • Among the 5 pts with baseline brain metastases, 2 achieved PR
Ongoing Trials by GenFleet in China • Initiated registrational Phase 3 trial in previously treated KRAS G12D-mutated PDAC at 600 mg QD versus investigator choice of chemotherapy
• Ongoing Phase 1b/2 trial of GFH375 in combination with cetuximab or
chemotherapy. The chemotherapy combination will be conducted 1L PDAC. • Ongoing Phase 1/2 trial in G12D solid tumors
Manageable Safety Profile
• GFH375 presented a manageable safety profile at 600mg QD in
heavily previously treated KRAS G12D mutant NSCLC & PDAC patients
• NSCLC: 4.2% of patients discontinued treatment due to TRAEs.
Dose intensity = 90%. • PDAC: 3% of patients discontinued treatment due to TRAEs.
Dose intensity = 93%
600mg QD
(N=16)
All patients
(N=26)
ORR [90% CI] 57.7% [39.8%, 74.2%] 68.8% [41.3%, 89.0%]
DCR [90% CI] 88.5% [72.8%, 96.8%] 93.8% [69.8%, 99.8%]
3L+
(N=47)
2L
(N=12)
All PDAC
(N=59)
40.7% [29.87%, 52.22%] 58.3% [31.52%, 81.90%] 36.2% [24.52%, 49.18%] ORR
[90%CI]
96.6% [89.71%, 99.39%] 100% [77.91, 100%] 95.7% [87.20%, 99.24] DCR
[90%CI]
GFH375 is being developed by GenFleet Therapeutics in China. Source of data: GenFleet presentation at WCLC, ESMO and company event in 2025. *Includes confirmed and
unconfirmed responses. QD: once daily; PR: partial response; TRAE: treatment related adverse events; IL: first-line; 2L: second line; 3L: third-line;
23
Strong Partner Data (GenFleet)1
• Activity in pre-treated PDAC &
NSCLC
• 2L PDAC: 58% ORR (n=12) • 2L+ NSCLC: 69% ORR (n=16) • 300+ patients treated in China
• Enabled U.S. trial start at 400 mg QD
• Ongoing Phase 1/2 & Phase 3 trial in
China • BTD received in China for NSCLC &
PDAC
Ex-US Data Provides Roadmap
U.S. Trial: Emerging Favorable Safety
& Tolerability Profile2
• No drug-related liver toxicity or
neutropenia observed
• Monotherapy: DLT cleared up to
900 mg QD dose level, expansions
ongoing; 1200 mg QD under
evaluation
• Combinations: DLT cleared up to
600 mg QD with cetuximab &
evaluating higher dose; ongoing
combo with GnP; ongoing combo
with Pembro-Platinum-Pemetrexed
Building Clinical Evidence to Become the Preferred Agent for KRAS G12D-mutated Cancers
Path to Accelerated Approval
Continuing Dose Escalation &
Combination Evaluations
• Phase 2 trials designed to support
Accelerated Approval • FPI expected by mid-2026
2L PDAC
2L/3L NSCLC
2L+ CRC
1. GenFleet Therapeutics is developing VS-7375 in China as GFH375. GenFleet presentations at WCLC, ESMO and company event in 2025. Includes confirmed and unconfirmed
responses. 2. As of a January 30, 2026 safety data cutoff from the TARGET-D 101 trial.
DLTs: Dose-limiting Toxicities; ORR: Objective Response Rates; QD: daily dose; FPI: First Patient in. GnP: Gemcitabine and Nab-paclitaxel
24 NCT07020221
D1: 2L+ CRC
VS-7375 600mg QD
+ Cetuximab Ongoing
D2: 1L NSCLC
Carboplatin/Pemetrexed
/Pembrolizumab
D3: 1L PDAC
Gemcitabine/Nab-P
Early Observations Show Manageable Safety & Tolerability
Profile with Promising Anti-Tumor Activity
Enrolling
Monotherapy Combination Therapy
Part B:
Dose Expansion
Part C:
Combination Dose
Escalations Cohorts
Part D:
Combination Dose
Expansions Cohorts
Part A:
Dose Escalation
Solid tumors
Dose Level 2:
600 mg QD
Dose Level 3:
900 mg QD
Dose Level 1:
400 mg QD
Dose Level 4:
1200 mg QD
Dose-Level Cleared
The study is dosing with meals and using prophylactic anti-emetics
Dose
Selection
Dose
Selection
Dose
Selection
C1: 2L+ Solid Tumors
VS-7375 900mg QD +
Cetuximab Ongoing
C2: 1L NSCLC
Carboplatin/
Pemetrexed/
Pembrolizumab
C3: 2L PDAC
Gemcitabine +
Nab-Paclitaxel
Cohort B3:
2L+ Tumor Agnostic
Solid Tumors
Cohort B2:
2L/3L NSCLC
Cohort B1:
2L PDAC
25 VSTM DOF April 2026; AUCss: area under the curve at steady state
400 mg 600 mg 900 mg
10
100
1000
10000
900 mg QD of VS-7375 Achieves the Targeted Human AUCss in All Patients
Corresponding to Maximal Tumor Regression across Mouse Models VS-7375 (ng*h/mL)
600mg QD
VS-7375-101
(TARGET-D 101)
n=11 n=49 n=8
GenFleet Study
400mg QD 600mg QD 900mg QD
Equivalent exposure to mice at 100 mg/kg
(PR in almost all mice in 4 tumor models)
Equivalent exposure to mice at 10 mg/kg
(Tumor regression in sensitive tumor models)
Equivalent exposure to mice at 30 mg/kg
(Tumor regression in all tumor models)
26
Monotherapy Dose Escalation Cohorts (All dose levels)
N=231
; mDoT, median (range): 1.6 (0.7-5.6) months (TRAEs)
Gr. 1, n (%) Gr. 2, n (%) Gr. 3, n (%) Gr. ≥4, n (%) All Gr., n (%) System Organ Class
Preferred Term
Gastrointestinal
Nausea 11 (48) 1 (4) 0 (0) 0 (0) 12 (52)
Diarrhea 7 (30) 1 (4) 1 (4) 0 (0) 9 (39)
Vomiting 6 (26) 0 (0) 0 (0) 0 (0) 6 (26)
Abdominal pain 0 (0) 1 (4) 0 (0) 0 (0) 1 (4)
Abdominal distention 2 (9) 0 (0) 0 (0) 0 (0) 2 (9)
Flatulence 2 (9) 0 (0) 0 (0) 0 (0) 2 (9)
General
Fatigue 6 (26) 1 (4) 0 (0) 0 (0) 7 (30)
Edema peripheral 1 (4) 0 (0) 0 (0) 0 (0) 1 (4)
Investigations
AST increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
ALT increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Blood bilirubin increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
GGT increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
ALP increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Amylase increased 1 (4) 1 (4) 1 (4) 0 (0) 3 (13)
Lipase increased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Blood & lymphatic/ investigations
Anemia 1 (4) 1 (4) 0 (0) 0 (0) 2 (9)
Neutropenia 1 (4) 1 (4) 0 (0) 0 (0) 2 (9) 2 WBC decreased 0 (0) 1 (4) 0 (0) 0 (0) 1 (4)
Platelet decreased 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Metabolism and nutrition
Decreased appetite 2 (9) 1 (4) 0 (0) 0 (0) 3 (13)
Nervous system
Dizziness 1 (4) 0 (0) 0 (0) 0 (0) 1 (4)
Headache 1 (4) 0 (0) 0 (0) 0 (0) 1 (4)
Skin & subcutaneous tissue
Rash maculo-papular 1 (4) 0 (0) 0 (0) 0 (0) 1 (4)
VSTM DOF, Jan. 30. 2026 cutoff; mDOT: median Duration of
Treatment; AST: AspartateAminotransferase; ALT: Alanine
Aminotransferase;GGT: Gammaglutamyl transferase; ALP:
AlkalinePhosphatase; WBC: White Blood Count; Gr: Grade
1. 9 patients at 400mg, 9 patients at 600mg, 5 patients at 900mg
2. Included neutropenia and neutrophil count decreased
• No drug-related liver function test
abnormalities were reported in any
patient across any of the dose levels
evaluated
• No neutropenia >Grade 2
was reported
• Rates of nausea, vomiting and
diarrhea, using standard prophylactic
anti-nausea agents and rapid
institution of over-the-counter anti-diarrheals, are lower than those
reported by our partner in China
VS-7375 Safety/
Tolerability Profile
27
*All A1 pts with SD allowed to crossover to cetuximab combo if A1 fails to meet efficacy threshold
Maximizing the Opportunity in PDAC Through VS-7375
Monotherapy and EGFR Combination Strategies
R 1:1 randomization
Part A: 2L PDAC
Cohort
A1
Cohort
A2
VS-7375 900 mg
monotherapy
(N=20)
VS-7375 900 mg +
Cetuximab
(N=20)
Cohort
B1
Cohort
B2
VS-7375 900 mg
monotherapy
(N=60)
VS-7375 900 mg +
Cetuximab
(N=60)
Part B: 2L PDAC Expansion
Cohort(s) that meet
efficacy threshold* Part C: 1L PDAC
VS-7375 900 mg + Cetuximab
(N=25)
Study Population Key Endpoints Next Key Milestone
FPI Expected
Mid-2026
Part A, B, C:
Primary: ORR by BICR
Secondary: DOR
Part A & B: 2L KRAS
G12D-mutated PDAC
Part C: 1L KRAS
G12D-mutated PDAC
EGFR: Epidermal Growth Factor Receptor
28
Evaluating VS-7375 Monotherapy in Advanced
NSCLC, Including Patients with Brain Metastases
Cohort A:
Confirm
900 mg QD is the
go-forward dose
Part A: 2L/3L NSCLC
VS-7375 900 mg QD
(N=20) Cohort B: Preferred dose of VS-7375
(N=60)
Part B: 2L/3L NSCLC
Part C: 2L/3L/4L
VS-7375 900 mg QD
with asymptomatic untreated brain
metastasis
(N=25)
Next Key
Milestone Study Population Key Endpoints
FPI Expected
in Mid-2026
Primary: ORR by BICR
Secondary: DOR
• Prior treatment with platinum-based chemo and ICI • At least 1 and no more than 2
prior systemic lines of therapy
Parts
A & B:
Intracranial ORR by
mRECIST v1.1 by BICR
Received at least 1 and no more
than 3 prior systemic lines
of therapy
Part C:
29
#No prior TAS-102 (trifluridine and tipiracil) or regorafenib. VEGFi as appropriate.
Advancing a VS-7375 Combination Strategy with
EGFR Inhibitors and Chemotherapy in Metastatic CRC
Cohort
A1:
R Confirm
900 mg QD is the
go-forward dose
2:1 randomization
Cohort
A2:
Part A: 2L+ CRC
VS-7375 900 + Cetuximab or
Panitumumab
(N=40)
VS-7375 900 mg monotherapy
(N=20)
Cohort B:
Preferred Regimen:
VS-7375 + Cetuximab or
Panitumumab
OR
VS-7375 monotherapy
(N=60)
Part C: 1L CRC
VS-7375 + Cetuximab + mFOLFOX6
(N=30)
Part B: 2L+ CRC
mFOLFOX: modified oxaliplatin, leucovorin, and 5-fluorouracil; VEGFI: vascular endothelial Growth Factor
Study Population Key Endpoints Next Key Milestone
FPI Expected in
Mid-2026
Primary: ORR by
BICR
Secondary: DOR
Prior SoC: fluoro-pyrimidine, irinotecan,
oxaliplatin, VEGFi#
Part
A, B:
Safety/Tolerability No prior tx for
metastatic disease Part C:
30
Development Focus on Highest Unmet Need Populations to Expedite
Regulatory Submissions
Complete single-agent
and combination dose
expansion cohorts
1H INTO
2H 2026
Initiate single-agent and
combination Phase 2
registration-directed studies
2H 2026
Pursue regulatory
approvals 2027 +
Topline Data from RAMP 205:
Avutometinib + Defactinib
+ Standard of Care in First-Line
Metastatic Pancreatic Cancer
32
Historical Gem/Nab mPFS
RAMP 205: Data Presented At ASCO 2025
Trial Status: • Dose Level 1 (DL1) chosen as RP2D for
expansion phase
– Avutometinib: 2.4 MG, Defactinib: 200 mg – Day 1-8-15, Gem: 800 mg NabP: 125mg
• Completed enrollment of 29 patients in
expansion phase
ASCO 2025 Data: • 83% (10/12) confirmed ORR in DL1 with tumor
shrinkage observed in all patients
• Encouraging duration of treatment observed
for DL1
• No new or unexpected AEs observed.
Most non-laboratory AEs were Grade 1 or 2 • AEs were generally manageable, allowing
patients to remain on treatment
Dose Level 1: Efficacy Evaluable Population (n=12)
Dose Level 1:
Duration of
Treatment Safety
Population
(n=12)
Historical Gem/Nab mPFS
Source: F_TR_WATERFALL.sas Data Cut: 01 AUG 25;
Source: Program: F_TX_RS_SWIMMER_DL1.sas Data Cut: 25 APR 25;
AE: adverse event; MG: milligram; Gem: gemcitabine; NabP: Nab-paclitaxel
Threshold
for PR Dose Level 1:
Response & Disease Control Rate
as of August 1, 2025
Confirmed ORR, n (%) 83.3% (10/12)
PR, n (%) 10 (83.3)
SD, n (%) 2 (16.7)
PD, n (%) 0
DCR, n (%) ≥ 4 cycles 92% (11/12) Best % Change in Target Lesion Sum of Diameters 40
20
0
-20
-40
-60
-80
-3.3
-14.1
-32.1 -32.9 -32.9
-38.7 -41.3 -42.8
-46.3 -46.3
-50.7
-74.7
SD SD cPR cPR cPR cPR cPR cPR cPR cPR cPR cPR
SD PD
SD PR
SD PR
SD PR PR
PR PR
SD PR PR
SD SD
PR PR
SD PR PR PR
SD SD PR PR
SD SD PR
SD PR PR
PR PR PD
PR PD
PD
PD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Treatment Duration (in months)
Continued Treatment
Financials
33
34
Oberland Finance Credit Facility
• Up to $150M available in a series of notes – $75M principal of notes outstanding
– Remaining $75M available at Company’s option upon achievement of pre-defined milestones
> $25M tranche upon FDA approval of avutometinib and defactinib for treatment of LGSOC
> $50M tranche upon trailing six months revenue of at least $55M
• Floating interest rate, subject to a floor and a cap
• Interest only payments through January 2031
• No financial covenants
Three Months
Ended March 31, 2026
Financial Summary
($ in millions)
Net Product Revenue $18.7M
GAAP Operating Expenses $63.6M
Non-GAAP Operating Expenses $61.5M* As of March 31, 2026
Cash, cash equivalents & short-term investments $181.7M
87.8M** Shares Outstanding
Q1 2026 Financial Results
* Three months ended March 31, 2026 GAAP operating expenses of $63.57M less Q1 2026 stock-based compensation expense of $2.05M = $61.52M Q1 2026 non-GAAP operating expenses.
** Excludes unexercised pre-funded warrants (12.2M shares upon exercise).
35
EU: European Union
Delivering for Long-term Growth
• Established commercial presence with AVMAPKI FAKZYNJA CO-PACK
– RAMP 301: Fully-enrolled Phase 3 confirmatory trial has the potential to expand U.S.
label and can be leveraged for EU/Japan approvals in recurrent LGSOC regardless
of KRAS mutation
• VS-7375 addresses significant opportunity in multiple KRAS G12D solid
tumors with a differentiated profile and best-in-class anti-tumor activity
– Active clinical development program advancing VS-7375 toward registration-directed studies in monotherapy and various combination approaches across
multiple KRAS G12D solid tumors; expect to report early data update in 1H 2026 • Cash runway into 2027 to see key data inflection points – AVMAPKI FAKZYNJA CO-PACK franchise will be self-sustaining in 2H 2026, funding
both commercial operations and avutometinib plus defactinib clinical trials
THANK YOU!
37
AVMAPKI FAKZYNJA CO-PACK: Category 2A Recommendation for KRAS-mutated Recurrent LGSOC
NCCN
Category 3
NCCN
Category 2b
NCCN
Category 2a
NCCN
Category 1
General %
Commercial
Payer Coverage
Binimetinib
• Study stopped early due to futility
• 16% ORR by BICR
• 31% discontinuation rate due to
AEs • Supported by MILO study3
Hormonal therapy
(e.g., Anastrozole, Letrozole)
& chemotherapy
• 6-13% ORR 4
• 17-30% discontinuation rate due
to AEs4
Trametinib
(2-4% US utilization rate1
) • 26% ORR by INV assessment, no BICR5
• 36% discontinuation rate due to AEs5
No category 1
recommendation
Examples of Clinical
Data in LGSOC and
Current NCCN
Guideline Category
Avutometinib + Defactinib
Combination Therapy
KRAS mt recurrent LGSOC
Please see the full Prescribing Information for more information
General source: NCCN; McGivney Global Advisory research and analysis; L.E.K. research and analysis. NCCN categories of preference: Preferred intervention, Other recommended intervention, Useful in certain circumstances.
High-level of evidence generally means large randomized controlled Phased 3 trials; Pie charts represent coverage by all major commercial players; 1. Data on File; 2. GOG 281 trial Gershenson et al., Lancet 2022; 3. MILO Study Monk et al., J Clin Oncol 2020; 4. Supported by GOG 281 and MILO studies2,3 ; 5. Supported by GOG 2812
;AEs: adverse events; BICR: Blinded Independent Central Review Cleaned up
(can just be stored as backup)
38
OB: Orange Book Listed Patent
AVMAPKI FAKZYNJA CO-PACK Patent Portfolio
OB: 7,897,792 Avutometinib COM (expiry 2/9/2027)
OB: 11,400,090 – Avutometinib mono dosing - (expiry 10/29/2038) PTE
OB: 7,928,109 Defactinib COM US (expiry 4/17/2028) PTA PTE (Aug, 2034)
OB: 8,247,411 Defactinib – genus (expiry 4/17/2028)
OB: 11,517,573 A+D combo dosing– (expiry 9/11/2040)
OB: 11,873,296 Avuto polymorph – (expiry 12/29/2042)
PTE (May 2039)
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