SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage
biopharmaceutical company focused on developing life-changing
medicines for patients with severe rare diseases and cancer, today
reported third quarter financial results for the period ended
September 30, 2023 and provided an update on recent business
highlights.
“We continue to work closely with the FDA as they complete their
review of our nirogacestat NDA and are ready to serve the desmoid
tumor community following an approval,” said Saqib Islam, Chief
Executive Officer of SpringWorks. “We are also on track to report
topline data from our Phase 2b ReNeu trial of mirdametinib in
patients with NF1-PN, which, if positive, would position us to file
an NDA in the first half of 2024. Together, these anticipated
milestones position us to have two medicines approved to treat
patients with two distinct devastating diseases. In addition to
these near-term events, we continue to advance our broader targeted
oncology pipeline, which includes rare oncology, BCMA combinations
in multiple myeloma, and biomarker-defined metastatic solid tumor
programs, and look forward to providing further updates on our
progress over the coming months.”
Recent Business Highlights and Upcoming
Milestones
Rare Oncology
- The Prescription Drug User Fee Act (PDUFA) target action date
for the New Drug Application (NDA) for nirogacestat for the
treatment of adults with desmoid tumors is November 27, 2023.
SpringWorks expects to file a Marketing Authorisation Application
for nirogacestat with the European Medicines Agency (EMA) in the
first half of 2024.
- In November 2023, additional data from the Phase 3 DeFi trial
evaluating the impact of nirogacestat on functional status in
patients with desmoid tumors were presented at the 2023 Connective
Tissue Oncology Society (CTOS) Annual Meeting. Statistically
significant and clinically meaningful improvements in physical and
role functioning were observed in patients receiving nirogacestat
compared with those who received placebo by Cycle 10 across the
three prespecified assessment tools evaluated. Patients receiving
nirogacestat were five times more likely to have a clinically
meaningful improvement in physical functioning and two times more
likely to have a clinically meaningful improvement in role
functioning compared to placebo at Cycle 10. These improvements
began as early as Cycle 2 (the first post-treatment timepoint) and
were sustained through Cycle 24 (the final assessment).
Improvements in functioning were consistent with the improvements
in pain measures, disease-related symptoms, and overall
health-related quality of life that were previously reported with
nirogacestat.
- The ongoing Phase 2 trial evaluating nirogacestat as a
monotherapy in patients with recurrent ovarian granulosa cell
tumors is fully enrolled. SpringWorks expects to report initial
data from the trial in 2024.
- SpringWorks expects to present topline data from the pediatric
and adult cohorts of the Phase 2b ReNeu trial evaluating
mirdametinib, an investigational MEK inhibitor, in NF1-associated
plexiform neurofibromas (NF1-PN) in the fourth quarter of 2023. If
these data are positive, SpringWorks plans to submit an NDA to the
FDA for mirdametinib for the treatment of NF1-PN in the first half
of 2024.
B-cell Maturation Antigen (BCMA) Combinations in
Multiple Myeloma
- SpringWorks continues to evaluate nirogacestat as part of
several BCMA combination therapy regimens across treatment lines in
collaboration with industry leaders.
- In September 2023, the first patient was dosed in the
Regeneron-sponsored Phase 1b study arm evaluating nirogacestat in
combination with Regeneron's linvoseltamab, a bispecific antibody
targeting BCMA and CD3.
Biomarker-Defined Metastatic Solid Tumors
- The dose expansion portion of the Phase 1b trial evaluating
brimarafenib (BGB-3245) is ongoing in adult patients with RAF
mutant solid tumors. Brimarafenib is an investigational, selective
RAF dimer inhibitor being developed by MapKure, LLC, a joint
venture between SpringWorks and BeiGene, Ltd.
- Patients continue to be enrolled in the dose escalation phase
of the SpringWorks-sponsored Phase 1/2a combination study of
brimarafenib and mirdametinib.
- In August 2023, MapKure filed an Investigational New Drug
Application (IND) for a combination study of brimarafenib with
panitumumab, a monoclonal antibody targeting EGFR, in colorectal
and pancreatic cancer patients with known MAPK pathway mutations
and expects to initiate a Phase 1/2a study in the first quarter of
2024. Amgen Inc. is supplying panitumumab pursuant to a clinical
trial collaboration agreement with MapKure.
- Dose expansion cohort is ongoing in the BeiGene-sponsored Phase
1b/2 trial evaluating mirdametinib in combination with BeiGene’s
RAF dimer inhibitor, lifirafenib, in adult patients with NRAS
mutant solid tumors.
- In September 2023, preclinical data were published in Molecular
Cancer Therapeutics characterizing SWTX-143, a TEAD inhibitor tool
compound, and describing the potential of TEAD inhibitors to treat
multiple Hippo-mutant solid tumor types. SpringWorks plans to file
an IND for SW-682, the Company's TEAD inhibitor development
candidate, in the fourth quarter of 2023.
General Corporate
- In September 2023, SpringWorks appointed Tai-An Lin, Ph.D., as
Chief Scientific Officer. Dr. Lin brings more than 25 years of
biotechnology and global pharmaceutical experience in advancing
drug discovery programs from target identification through early
clinical trials across the therapeutic areas of oncology,
immuno-oncology, and immunology.
Third Quarter 2023
Financial Results
- Research and Development (R&D) Expenses:
R&D expenses were $37.5 million for the third quarter, compared
to $36.1 million for the comparable period of 2022. The increase in
R&D expenses was primarily attributable to an increase in
internal costs driven by the growth in employee costs associated
with increases in the number of personnel, including an increase in
stock-based compensation expense, partially offset by a decrease in
external costs related to drug manufacturing, clinical trials and
other research.
- General and Administrative (G&A) Expenses:
G&A expenses were $46.5 million for the third quarter, compared
to $35.7 million for the comparable period of 2022. The increase in
G&A expenses was largely attributable to commercial readiness
activities to support the U.S. launch of nirogacestat, if approved,
for the treatment of adults with desmoid tumors.
- Net Loss Attributable to Common Stockholders:
SpringWorks reported a net loss of $79.4 million, or $1.27 per
share, for the third quarter of 2023. This compares to a net loss
of $72.4 million, or $1.37 per share, for the comparable period of
2022.
- Cash Position: Cash, cash equivalents and
marketable securities were $422.4 million as of September 30,
2023.
About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company
applying a precision medicine approach to acquiring, developing and
commercializing life-changing medicines for patients living with
severe rare diseases and cancer. SpringWorks has a differentiated
targeted oncology pipeline spanning solid tumors and hematological
cancers, including two late-stage clinical trials in rare tumor
types as well as several programs addressing highly prevalent,
genetically defined cancers. SpringWorks’ strategic approach and
operational excellence in clinical development have enabled it to
rapidly advance its two lead product candidates into late-stage
clinical trials while simultaneously entering into multiple
shared-value partnerships with innovators in industry and academia
to unlock the full potential for its portfolio and create more
solutions for patients with cancer. For more information, For more
information, visit www.springworkstx.com and
follow @SpringWorksTx on X (formerly Twitter), LinkedIn, and
YouTube.
SpringWorks uses its website as a means of disclosing material
non-public information and for complying with its disclosure
obligations under Regulation FD. Such disclosures will be included
on SpringWorks' website in the Investors & Media section.
Accordingly, investors should monitor such portions of the
SpringWorks website, in addition to following press releases, SEC
filings and public conference calls and webcasts.
Forward-Looking Statements
This presentation contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, 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, the potential for nirogacestat to
become an important new treatment for adult patients with desmoid
tumors, expectations regarding the timing and results of the FDA’s
review of the NDA for nirogacestat, including the FDA's PDUFA
target action date for the NDA, and the adequacy of the data
contained in the NDA to serve as the basis for an approval of
nirogacestat for the treatment of adults with desmoid tumors, our
plans to submit a Marketing Authorisation Application for
nirogacestat with the European Medicines Agency in the first half
of 2024, expectations regarding the timing of initial data from the
Phase 2 trial evaluating nirogacestat as a monotherapy in patients
with recurrent ovarian granulosa cell tumors, expectations
regarding the timing and results of topline data from the Phase 2b
ReNeu trial, the potential for the results of the Phase 2b ReNeu
trial to support an NDA submission for mirdametinib, the potential
for mirdametinib to become an important new treatment for patients
with NF1-PN, our plans for seeking regulatory approval for and
making mirdametinib available for NF1-PN patients, if approved, our
plans to file an IND for SW-682 in the fourth quarter of 2023, our
plans to report additional clinical data of nirogacestat in
combination with BCMA-directed therapies and to initiate additional
planned Phase 1 collaborator studies, our expectations regarding
the potential for the Phase 1b dose expansion phase of brimarafenib
and the Phase 1b/2 dose expansion phase of mirdametinib with
lifirafenib, expectations to initiate a Phase 1/2a study of
brimarafenib with panitumumab, expectations about whether our
patents or market exclusivity for our lead assets will adequately
protect SpringWorks against competition, as well as relating to
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 press release 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
press release, including, without limitation, risks relating to:
(i) the success and timing of our product development activities,
including the initiation and completion of SpringWorks’ clinical
trials, (ii) the fact that topline data or interim data from our
clinical studies may not be predictive of the final or more
detailed results of such study, or the results of other ongoing or
future studies, (iii) the success and timing of our collaboration
partners’ ongoing and planned clinical trials, (iv) the timing of
our planned regulatory submissions and interactions and the timing
and outcome of decisions made by the FDA, EMA, and other regulatory
authorities, investigational review boards at clinical trial sites
and publication review bodies; (v) whether FDA, EMA, or other
regulatory authorities will require additional information or
further studies, or may fail or refuse to approve or may delay
approval of our product candidates, including nirogacestat and
mirdametinib, (vi) our ability to obtain and maintain regulatory
approval of any of our product candidates, (vii) our plans to
research, discover and develop additional product candidates,
(viii) our ability to enter into collaborations for the development
of new product candidates and our ability to realize the benefits
expected from such collaborations, (ix) our ability to maintain
adequate patent protection and successfully enforce patent claims
against third parties, (x) the adequacy of our cash position to
fund our operations through any time period indicated herein, (xi)
our ability to establish manufacturing capabilities, and our and
our collaboration partners’ abilities to manufacture our product
candidates and scale production, and (xii) 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” in Item 1A of Part II of SpringWorks’ Quarterly Report on
Form 10-Q for the quarter ended September 30, 2023, as well as
discussions of potential risks, uncertainties and other important
factors in SpringWorks’ subsequent filings.
SpringWorks Therapeutics, Inc.Condensed Consolidated
Statements of Operations(Unaudited) |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(in thousands, except share and per-share
data) |
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
37,453 |
|
|
|
36,067 |
|
|
|
106,835 |
|
|
|
108,194 |
|
General and administrative |
|
46,546 |
|
|
|
35,673 |
|
|
|
137,715 |
|
|
|
94,026 |
|
Total operating expenses |
|
83,999 |
|
|
|
71,740 |
|
|
|
244,550 |
|
|
|
202,220 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(83,999 |
) |
|
|
(71,740 |
) |
|
|
(244,550 |
) |
|
|
(202,220 |
) |
Interest and other income
(expense): |
|
|
|
|
|
|
|
Other expense, net |
|
(76 |
) |
|
|
(74 |
) |
|
|
(373 |
) |
|
|
(291 |
) |
Interest income, net |
|
5,662 |
|
|
|
912 |
|
|
|
17,344 |
|
|
|
1,482 |
|
Total interest and other income |
|
5,586 |
|
|
|
838 |
|
|
|
16,971 |
|
|
|
1,191 |
|
Equity investment loss |
|
(1,024 |
) |
|
|
(1,486 |
) |
|
|
(3,203 |
) |
|
|
(2,210 |
) |
Net loss |
$ |
(79,437 |
) |
|
$ |
(72,388 |
) |
|
$ |
(230,782 |
) |
|
$ |
(203,239 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(1.27 |
) |
|
$ |
(1.37 |
) |
|
$ |
(3.70 |
) |
|
$ |
(4.04 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
62,521,772 |
|
|
|
52,900,819 |
|
|
|
62,386,496 |
|
|
|
50,298,015 |
|
SpringWorks Therapeutics, Inc.Selected Balance Sheet
Data(Unaudited) |
|
September 30, 2023 |
|
December 31, 2022 |
(in
thousands) |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
422,419 |
|
|
$ |
597,006 |
|
Working Capital (1) |
|
382,100 |
|
|
|
548,711 |
|
Total assets |
|
467,654 |
|
|
|
630,242 |
|
Total liabilities |
|
72,755 |
|
|
|
72,050 |
|
Accumulated deficit |
|
(800,712 |
) |
|
|
(569,930 |
) |
Total stockholders’
equity |
|
394,899 |
|
|
|
558,192 |
|
(1) We define Working Capital as current
assets less current liabilities.Contacts:Kim
DiamondVice President, Communications and Investor RelationsPhone:
203-561-1646Email: kdiamond@springworkstx.com
Samantha Hilson SandlerSenior Director, Investor RelationsPhone:
203-461-5501Email: samantha.sandler@springworkstx.com
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