Full Press Release Details
Presentation December 2019 NASDAQ: SWTX
Statements This presentation may contain "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995 relating to our business, operations,
and financial conditions, including but not limited to current beliefs, expectations
and assumptions regarding the future of our business, future plans and strategies, our
development plans, our preclinical and clinical results and other future conditions.
Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate,"
"estimate," "intend," "plan," "would," "should" and "could," and similar expressions
or words, identify forward-looking statements. New risks and uncertainties may emerge
from time to time, and it is not possible to predict all risks and uncertainties. Any
forward-looking statements in this presentation are based on management's current expectations
and beliefs and are subject to a number of risks, uncertainties and important factors
that may cause actual events or results to differ materially from those expressed or
implied by any forward-looking statements contained in this presentation, including,
without limitation, statements regarding: (i) the success and timing of our ongoing DeFi
and ReNeu clinical trials, (ii) the success and timing of our product development activities
and initiating clinical trials, (iii) the success and timing of our collaboration partner's
ongoing and planned clinical trials, (iv) our ability to obtain and maintain regulatory
approval of any of our product candidates, (v) our plans to research, discover and develop
additional product candidates, (vi) our ability to enter into collaborations for the
development of new product candidates, (vii) our ability to establish manufacturing capabilities,
and our and our collaboration partners' abilities to manufacture our product candidates
and scale production, and, (viii) our ability to meet any specific milestones set forth
herein. Except as required by applicable law, we do not plan to publicly update or revise
any forward-looking statements contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise. Although we believe the expectations
reflected in such forward-looking statements are reasonable, we can give no assurance
that such expectations will prove to be correct. Accordingly, readers are cautioned not
to place undue reliance on these forward-looking statements. For further information
regarding the risks, uncertainties and other factors that may cause differences between
SpringWorks' expectations and actual results, you should review the "Risk Factors" section(s)
of our filings with the Securities and Exchange Commission. Certain information contained
in this presentation relates to or is based on studies, publications, surveys and other
data obtained from third-party sources and our own internal estimates and research. While
SpringWorks believes these third-party sources to be reliable as of the date of this
presentation, we have not independently verified, and make 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. Finally, while we believe our own internal research
is reliable, such research has not been verified by any independent source. PROPRIETARY
Therapeutics is a Clinical-Stage Targeted Oncology Company ? Two late-stage rare oncology
programs commenced potentially registrational trials in 2019, each supported by strong
clinical data Grady NF1 patient ? Three programs addressing large opportunities in genetically
defined cancers in collaboration with industry leaders Dana Desmoid patient ? Leveraging
strong development capabilities and shared-value partnerships to enhance portfolio value
and become the partner of choice for industry leaders Sheila NF1 patient ? Led by an
experienced management team with deep expertise in drug development and commercialization
? Well-capitalized to execute important value-driving milestones across both standalone
and partnered programs Emmie NF1 patient Our ambition is to ignite the power of promising
science to unleash new possibilities for patients PROPRIETARY & CONFIDENTIAL 3
Leadership Advancing Transformative Therapies Leadership Team Saqib Islam, J.D. Chief
Executive Officer Jens Renstrup, M.D., MBA Chief Medical Officer Badreddin Edris, Ph.D.
Chief Business Officer Frank Perier, MBA Chief Financial Officer Mary Smith, Ph.D. Senior
Vice President, Clinical Research and Development Board of Directors Daniel S. Lynch
Chairman of the Board Alan Fuhrman Amplyx Pharmaceuticals, Chief Financial Officer Saqib
Islam, J.D. SpringWorks Therapeutics, Chief Executive Officer Freda Lewis-Hall, M.D.,
DFAPA Pfizer, Executive Vice President Jeffrey Schwartz Bain Capital Life Sciences, Managing
Director Stephen Squinto, Ph.D. OrbiMed, Executive Partner PROPRIETARY & CONFIDENTIAL
Diversified Pipeline of Targeted Oncology Programs as Standalone and Combination Therapies
Key Anticipated Partner / Note: Nirogacestat = PF-03084014 and Mirdametinib = PD-0325901
(both in-licensed from Pfizer). * Received Orphan Drug, Fast Track and Breakthrough Therapy
Designations. Received Orphan Drug and Fast Track Designations. (1) Being developed
by MapKure, LLC, jointly owned by SpringWorks and BeiGene. PROPRIETARY & CONFIDENTIAL
5 Nirogacestat Desmoid Tumors* Gamma secretase inhibitor (GSI) Preclinical Phase 1 Phase
2 Phase 3 MilestonesCollaborator Phase 3 trial update: 2H20 P H AS E 3 Nirogacestat +
Belantamab Mafodotin Relapsed/Refractory Multiple Myeloma GSI + BCMA-targeted ADC Phase
1b trial initiation: 1Q20 P H AS E 1 B Mirdametinib NF1-Associated Plexiform Neurofibromas
(NF1-PN) MEK 1/2 inhibitor (MEKi) Phase 2b trial update: 4Q20-1Q21 P H AS E 2
B Mirdametinib + Lifirafenib RAS/RAF Mutant and Other MAPK Pathway Aberrant Solid Tumors
MEKi + RAF dimer inhibitor Phase 1b trial update: 2020 P H AS E 1 B BGB-3245 (1) RAF
Mutant Solid Tumors RAF fusion and dimer inhibitor Phase 1 trial initiation: 1Q20 P R
E C L I N I C AL Collaborator Asset
Potentially Registrational Trials Ongoing in Rare Oncology Indications Dana Kendall Nirogacestat
Gamma Secretase Inhibitor Desmoid Tumors Mirdametinib MEK Inhibitor NF1-Associated Plexiform
Neurofibromas ? Clinical activity and tolerability observed in Ph2 trial in whom were
heavily pre-treated) in Ph1 and Ph2 trials Designations and Orphan Drug Designation from
both FDA Designation from both FDA and European Commission trial (DeFi) and is supported
by precedent data PN patients of all ages (pediatrics, adolescents and adults) PROPRIETARY
& CONFIDENTIAL 6 Disease Manifestation ? Highly morbid disease that can cause severe
pain,? Aggressive tumor growth that can lead to severe pain and disfigurement, and incapacitating
loss of physical functionfunctional impairment, most often manifesting in children Current
Treatments ? Currently no FDA approved therapies? Currently no FDA approved therapies
? Off-label treatment options provide inconsistent clinical benefit? Opportunity for
differentiated profile vs. other MEK inhibitors Existing Data ? Generally well tolerated
in over 200 subjects ? Clinical activity observed in desmoid tumor patients (most ofadolescents
and adults with NF1-PN Regulatory Designations ? Received FDA Fast Track and Breakthrough
Therapy? Received Fast Track Designation from FDA and Orphan Drug and European Commission
Ongoing Trial ? Progression-free survival is primary endpoint in ongoing Ph3? Potentially
registrational Ph2b trial (ReNeu) is enrolling NF1-Potential to become the first approved
therapy in an orphan oncology indication with substantial morbidity Potentially best-in-class
program for large orphan oncology indication with no approved treatments
Programs Addressing Large, Genetically Defined Cancers in Collaboration with Industry
Leaders Mutations/Fusions BRAF Primary & Class 2/3 Mutations /3 Mutations F Fusions
V600 Expecting to have three programs in large cancer indications in the clinic by 1Q20,
each supported by strong preclinical activity in the selected biomarker settings PROPRIETARY
& CONFIDENTIAL 7 (1) Includes colorectal, biliary tract and pancreatic tumors. (2)
Program being developed by MapKure, LLC, jointly owned by SpringWorks and BeiGene. Mirdametinib
+ Lifirafenib Nirogacestat + Belantamab Mafodotin BGB-3245 Non-Small Cell Lung Endometrial
Selected GI Tumors (1) Refractory/Relapsed Multiple Myeloma Solid Tumors with BRAF (Tissue