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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 9, 2024
Edgewise Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-40236 |
|
82-1725586 |
(State or other jurisdiction
of incorporation)
|
|
(Commission
File Number)
|
|
(IRS
Employer
Identification No.) |
1715
38th St.
Boulder,
CO 80301
(Address of principal executive offices) (Zip Code)
(720)
262-7002
(Registrant’s telephone number, including
area code)
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 per share |
|
EWTX |
|
The
Nasdaq Global Select 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 x
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 2.02 | Results of Operations and Financial Condition. |
On May 9, 2024,
Edgewise Therapeutics, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2024.
The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information
furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed “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,
and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except
as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 |
Financial Statements
and 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.
| |
EDGEWISE THERAPEUTICS, INC. |
| |
By: |
/s/ R. Michael Carruthers |
| |
|
R. Michael Carruthers |
| |
|
Chief Financial Officer |
Date: May 9, 2024
Exhibit 99.1
Edgewise Therapeutics Reports First Quarter
2024 Financial Results and Recent Business Highlights
– Announced positive two-year topline
results of sevasemten ARCH open label trial and
advanced GRAND CANYON pivotal cohort in Becker –
–Positive interim topline data
for DUNE trial of sevasemten in Becker –
–
Expanded Phase 2 LYNX trial of sevasemten in Duchenne –
– Anticipated to overenroll
Phase 2 FOX trial in Duchenne boys previously treated with gene therapy –
– Initiated Phase 2 CIRRUS-HCM
trial of EDG-7500 in patients with obstructive HCM –
Boulder, Colo.,
(May 9, 2024) – Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical
company, today reported financial results for the first quarter of 2024 and recent business highlights.
“2024 is off
to a great start with tremendous progress on our skeletal and cardiac muscle programs,” said Kevin Koch, Ph.D., President
and Chief Executive Officer of Edgewise. “Most recently, we initiated our Phase 2 CIRRUS-HCM trial of EDG-7500 and announced positive
2-year topline data from our ARCH open label trial in Becker. We expect significant catalysts on our programs throughout this year including
data from the CANYON and CIRRUS studies.”
Recent Highlights
Musculoskeletal Program / Sevasemten
Becker Muscular Dystrophy (Becker)
Sevasemten is
an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies including Becker and
Duchenne muscular dystrophy. There are currently no approved therapies for individuals with Becker, a serious genetic, progressive neuromuscular
disorder with significant unmet need.
ARCH open-label trial in Becker: The
Company announced positive two-year topline results from the ARCH trial, an open label, single-center trial assessing safety,
tolerability, impact on muscle damage biomarkers, pharmacokinetics (PK) and functional measures with sevasemten in adults with
Becker. The ARCH trial evaluated sevasemten administered daily over two years in adults with Becker. Sevasemten was
well-tolerated in all 12 participants with no discontinuations or dose reductions due to adverse events. During two years
of sevasemten treatment, participants’ North Star Ambulatory Assessment (NSAA) scores
stabilized and continued to diverge relative to declines reported across multiple Becker natural history studies.1, 2,3
In addition, significant decreases in key biomarkers of muscle damage including creatine kinase (CK) and fast skeletal muscle
troponin I (TNNI2) were observed in participants treated with sevasemten, which are consistent with prior observations. The
positive results from the two-year ARCH trial further support the hypothesis that a reduction in contraction-induced muscle damage
has the potential to preserve and improve muscle function and disease progression in Becker.
CANYON Phase 2 placebo-controlled trial in
adults with Becker: CANYON, the largest interventional Becker trial to date, includes 40 adults and 29 adolescents with a sevasemten
treatment period of 12 months. The primary endpoint of CANYON is change in CK over the treatment period with additional measures collected,
including NSAA, 100-meter timed test, biomarkers of muscle damage and MRI. The Company expects to report CANYON data in the fourth quarter
of 2024.
GRAND CANYON,
a global pivotal cohort in Becker: GRAND CANYON, an expansion of the CANYON placebo-controlled trial, is a multicenter, randomized,
double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. The primary endpoint
of GRAND CANYON is change in NSAA. In addition, other functional assessments, biomarkers of muscle damage and safety will be assessed.
GRAND CANYON is an 18-month cohort anticipated to recruit approximately 120 individuals with Becker, aged between 18 and 50 years old
and a NSAA score between 5 and 32, at up to 50 sites in 10 countries. Data from GRAND CANYON, if positive, could support a marketing
application. To learn more, go to clinicaltrials.gov (NCT05291091) or the GRAND CANYON microsite: https://www.beckergcstudy.com.
DUNE
Phase 2 Exercise Challenge trial in adults with Becker, LGMD2I or McArdle disease:
The Company continues to advance the DUNE Phase 2 Exercise Challenge study. This 16-week randomized, double-blind, placebo-controlled
study with an open label extension to 78 weeks, assesses safety, PK, and biomarker response to exercise in adults with Becker, limb-girdle
muscular dystrophy type 2I (LGMD2I) or McArdle disease. Unlike Becker, LGMD2I is a muscular dystrophy
caused by a dysfunctional dystroglycan complex while McArdle is caused by deficiencies in glycogen mobilization leading to metabolic crisis
and injury of skeletal muscle.
The study was designed with a
3-week screening period, which included a controlled exercise challenge and subsequent biomarker analysis, principally CK and TNNI2, followed
by a 16-week double-blind period in which participants were randomized 2:1 to receive once-daily treatment with sevasemten (15 mg) or
matching placebo. At week 12, participants underwent a second controlled exercise challenge to determine whether treatment with sevasemten
conferred protection against exercise induced muscle damage.
Topline
interim results showed that sevasemten was well tolerated across all 21 participants (Becker (n=9), LGMD2I (n=9) and McArdle (n=3)). Biomarker
reductions in the Becker cohort were consistent with results observed in the ARCH trial, including statistically significant decreases
in TNNI2 and CK versus patients on placebo; sevasemten treatment significantly reduced mean CK by 45% (p<0.05 vs placebo) and TNNI2
by 89% (p<0.05 vs placebo). Over the 24 hours post-exercise, sevasemten treatment also significantly reduced biomarkers of muscle damage
associated with exercise with a mean post-exercise reduction of CK of 49% (p<0.001 vs placebo) and TNNI2 of 75% (p=0.07 vs placebo).
Biomarker data from the LGMD2I and McArdle cohorts
are currently inconclusive and would likely require additional participants to interpret any response. The Company, in partnership with
Dr. John Vissing, the lead investigator for DUNE, are continuing to compile and analyze the data which will be presented in full at a
future medical meeting.
DUNE represents the first placebo-controlled trial
with sevasemten in individuals with Becker. The preliminary data from DUNE, combined with the 2-year observations from ARCH, continue
to support the hypothesis that protecting fast muscle fibers with sevasemten limits contraction-induced muscle damage and offers the potential
to halt disease progression in individuals with Becker.
Duchenne Muscular Dystrophy
LYNX Phase 2
trial in boys with Duchenne: LYNX is a 2-part multi-center, dose-finding Phase 2 trial to evaluate the effect of sevasemten
on safety, PK, and biomarkers of muscle damage in over 60 children aged 4 to 9 years with Duchenne treated with oral, once-daily sevasemten.
The trial will also explore changes in functional measures such as NSAA, stride velocity 95th centile (SV95%) and self-reported/caregiver-reported
outcomes. Part A of the trial will include a 12-week, randomized, double-blind, placebo-controlled dose ranging study period, followed
by Part B, a 92-week open-label extension. Dosing in Part B was adjusted to a previously studied dose, based on the interim analysis of
the higher dose for safety as well as assessment of biomarkers of muscle damage in that cohort.
LYNX was designed to identify a Phase 3 dose of
sevasemten that will reduce biomarkers of muscle damage and has the potential to provide functional benefit to individuals with Duchenne.
To date, across five cohorts, sevasemten achieved exposures predicted to provide benefit based on preclinical models and was observed
to be safe and well tolerated. Moreover, decreases in biomarkers of muscle damage with sevasemten treatment were observed. This observation
provides confidence that exposures are achieving target levels and the Company is initiating a 6th cohort to validate observations thus
far.
The Company plans
to report LYNX data, including safety, PK, changes in biomarkers of muscle damage and functional changes in NSAA and SV95 in the fourth
quarter of 2024. The Company will rely on LYNX data, along with data from the FOX trial of Duchenne boys previously
treated with gene therapy, to guide the design and powering of a Phase 3 trial in Duchenne, planned to be initiated in the first
half of 2025. For more information on LYNX go to clinicaltrials.gov to learn more about this trial (NCT05540860).
FOX Phase 2
trial in boys with Duchenne (previously treated with gene therapy): The Company is advancing FOX, a Phase 2 placebo-controlled
trial to assess the effect of sevasemten over 12 weeks on safety, PK and biomarkers of muscle damage in children and adolescents aged
6 to 14 years with Duchenne who have been previously treated with gene therapy. The trial will also explore changes in functional measures
such as NSAA, SV95% and self-reported/caregiver-reported outcomes. The Company expects to substantially overenroll the trial from the
original plan of 24 participants. There has been exceptional enthusiasm from the Duchenne community for this trial, evident in the Company’s
ability to complete the trial’s enrollment within two months. Go to clinicaltrials.gov to learn more about this trial (NCT06100887).
Received Orphan
Drug from the European Medicines Agency (EMA) and Fast Track from the U.S. Food & Drug Administration (FDA): The EMA granted
Orphan Drug Designation (ODD) for sevasemten for the treatment of Becker and for the treatment of Duchenne in April 2024. The FDA granted
sevasemten Fast Track designation for the treatment of Duchenne in February 2024. The FDA previously granted ODD for the treatment of
Duchenne and Becker, Rare Pediatric Disease Designation for the treatment of Duchenne and Fast Track designation for sevasemten for the
treatment of Becker.
Cardiovascular Program / EDG-7500
EDG-7500 is a novel oral, selective, cardiac
sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated
with hypertrophic cardiomyopathy (HCM) and other diseases of diastolic dysfunction. Preclinical data in models of both obstructive
and non-obstructive HCM suggest the ability to drive a broadly effective clinical response at a low risk of decreasing left
ventricular ejection fraction below normal at all doses tested. Based on EDG-7500’s self-limiting effect on systolic
contraction observed in preclinical models, the Company plans to investigate fixed-dose regimens of EDG-7500, thus potentially
avoiding intensive safety monitoring of patients on current therapy.
Phase 2 CIRRUS-HCM
trial of EDG-7500: In April 2024, the first patient was dosed in CIRRUS-HCM, a multi-center, two-part, open-label trial of
EDG-7500 in patients with obstructive HCM at up to 20 clinical sites in the U.S. The trial will evaluate the safety, tolerability, PK
and pharmacodynamics of EDG-7500 in up to thirty adults with obstructive HCM. Participants enrolled in this trial will receive EDG-7500
as a single oral dose and will have the option of then receiving multiple oral doses for 28 days. To learn more about this trial (NCT06347159),
go to clinicaltrials.gov.
Phase 1 Trial
of EDG-7500: The Company is continuing the randomized, placebo-controlled, single and multiple ascending dose Phase 1 trial
evaluating safety, tolerability, PK and pharmacodynamics in healthy adults. To learn more about this trial (NCT06011317), go to
clinicaltrials.gov.
The Company
expects to report data from the single dose arm of CIRRUS-HCM and the Phase 1 trial of EDG-7500 in healthy volunteers in the third quarter
of 2024. Furthermore, the Company expects to initiate a 28-day trial in patients with obstructive and non-obstructive HCM in the second
half of 2024. The Company also expects to begin an open-label extension trial of EDG-7500 in the fourth quarter of 2024.
Strengthened Engagement with the Scientific
and Patient Communities
Musculoskeletal Program / sevasemten
The Company continued its education and outreach
on its musculoskeletal program with the medical and patient communities, including presentations at the Muscular Dystrophy Association
Clinical and Scientific Conference, the American Academy of Neurology 2024 Annual Meeting and the 8th International Myology
Congress. The Company continues to sponsor and participate in numerous other clinician and patient-focused events.
Cardiovascular Program / EDG-7500
The Company sponsored
and attended several cardiovascular-focused conferences, building relationships with the medical and patient communities. During the quarter,
the Company presented preclinical data on the effects of EDG-7500 in a model of non-obstructive HCM at the American College of Cardiology's
2024 Annual Scientific Session.
First Quarter Financial Results
Cash, cash equivalents
and marketable securities were approximately $532.8 million as of March 31, 2024.
Research and
development (R&D) expenses were $27.7 million for both the first quarter of 2024 and for the immediately preceding
quarter. During the first quarter of 2024 there was an additional $1.8 million in clinical trial expenses for the sevasemten and EDG-7500
clinical programs from increasing clinical trial enrollment, and $0.3 million of higher personnel-related costs. These increases were
offset by a $1.1 million decrease in drug discovery and preclinical costs, a $0.8 million decrease in costs related to the formulation,
manufacture and clinical supply of our drug product candidates, and a $0.2 million decrease in other allocated costs.
General and Administrative
(G&A) expenses were $7.1 million for the first quarter of 2024, compared to $6.2 million for the immediately
preceding quarter. The increase of $0.9 million was primarily driven by $0.6 million in increased professional and consulting costs and
$0.3 million in personnel-related costs.
Net loss and
net loss per share for the first quarter of 2024 was $28.5 million or $0.33 per share, compared to $30.1 million or $0.47
per share for the immediately preceding quarter.
About Edgewise
Therapeutics
Edgewise Therapeutics
is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions.
The Company’s deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered
skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere
modulator for the treatment of hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical
development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious
muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, X (formerly Twitter), Facebook,
Instagram and Threads.
References
[1] Bello L, et al. Functional changes in Becker
muscular dystrophy: implications for clinical trials in dystrophinopathies. Sci Rep. 2016;6:32439. doi:10.1038/srep32439
[2] van de Velde NM, et al. Selection approach
to identify the optimal biomarker using quantitative muscle MRI and functional assessments in Becker muscular dystrophy. Neurology. 2021;97(5):e513-e522.
doi: 10.1212/WNL.0000000000012233.
[3] De Wel B, et al. Lessons for future clinical
trials in adults with Becker muscular dystrophy: disease progression detected by muscle magnetic resonance imaging, clinical and patient-reported
outcome measures. Eur J Neurol. 2024:e16282. doi:10.1111/ene.16282. Online ahead of print.
Cautionary Note Regarding Forward-Looking Statements
This press
release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements.
Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding,
Edgewise’s product candidates and programs, including sevasemten and EDG-7500; statements regarding Edgewise’s
expectations relating to its clinical trials, including timing of reporting data (including the CANYON Phase 2 trial, LYNX Phase 2
trial, the single dose arm of CIRRUS-HCM and the Phase 1 trial of EDG-7500 in healthy volunteers); statements regarding the
advancement of Edgewise’s research and development programs; the timing of the initiation of a Phase 3 trial of sevasemten in
Duchenne, a 28-day trial in patients with obstructive and non-obstructive HCM and an open-label extension trial of EDG-7500; the
possibility of data from GRAND CANYON to support a marketing application; statements regarding Edgewise’s pipeline of product
candidates and programs; statements regarding Edgewise’s anticipated milestones; statements regarding potential
overenrollment of the FOX Phase 2 trial; and statements by Edgewise’s President and Chief Executive Officer. Words such as
“believes,” “anticipates,” “plans,” “expects,” “intends,”
“will,” “goal,” “potential” and similar expressions are intended to identify forward-looking
statements. The forward-looking statements contained herein are based upon Edgewise’s current expectations and involve
assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in
any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the
process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating
as an early clinical stage company including the potential for Edgewise’s product candidates to cause serious adverse events;
Edgewise’s ability to develop, initiate or complete clinical trials for, obtain approvals for and commercialize any of its
product candidates; Edgewise’s ability to take advantage of potential benefits associated with designations granted by FDA
and/or to maintain qualifications for applicable designations over time; the timing, progress and results of clinical trials for
sevasemten and EDG-7500; Edgewise’s ability to enroll and maintain patients in clinical trials; Edgewise’s ability to
raise any additional funding it will need to continue to pursue its business and product development plans; the timing, scope and
likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim,
preliminary, topline or expected results; the potential that the outcome of preclinical testing and early clinical trials may not be
predictive of the success of later clinical trials; Edgewise’s ability to develop a proprietary drug discovery platform to
build a pipeline of product candidates; Edgewise’s manufacturing, commercialization and marketing capabilities and strategy;
the size of the market opportunity for Edgewise’s product candidates; the loss of key scientific or management personnel;
competition in the industry in which Edgewise operates; Edgewise’s reliance on third parties; Edgewise’s ability to
obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other
risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in
documents that Edgewise files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements
are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to
update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by
law.
This press release contains hyperlinks to information
that is not deemed to be incorporated by reference into this press release.
Edgewise Therapeutics, Inc.
Condensed Statement of Operations
(in thousands except share and per share amounts, unaudited)
| | |
Three months ended | |
| | |
March 31, 2024 | | |
December 31, 2023 | |
| Operating expenses: | |
| | | |
| | |
| Research and development | |
$ | 27,694 | | |
$ | 27,684 | |
| General and administrative | |
| 7,059 | | |
| 6,178 | |
| Total operating expenses | |
| 34,753 | | |
| 33,862 | |
| Loss from operations | |
| (34,753 | ) | |
| (33,862 | ) |
| Interest income | |
| 6,228 | | |
| 3,719 | |
| Net loss | |
$ | (28,525 | ) | |
$ | (30,143 | ) |
| Net loss per share - basic and diluted | |
$ | (0.33 | ) | |
$ | (0.47 | ) |
| Weighted-average shares outstanding, basic and diluted | |
| 87,567,307 | | |
| 64,774,775 | |
Edgewise Therapeutics, Inc.
Condensed Balance Sheet Data
(in thousands, unaudited)
| | |
March 31, | | |
December 31, | |
| | |
2024 | | |
2023 | |
| Assets | |
| | | |
| | |
| Cash, cash equivalents and marketable securities | |
$ | 532,759 | | |
$ | 318,393 | |
| Other assets | |
| 21,047 | | |
| 21,642 | |
| Total assets | |
$ | 553,806 | | |
$ | 340,035 | |
| Liabilities and stockholders' equity | |
| | | |
| | |
| Liabilities | |
| 18,865 | | |
| 21,205 | |
| Stockholders' equity | |
| 534,941 | | |
| 318,830 | |
| Total liabilities and stockholders' equity | |
$ | 553,806 | | |
$ | 340,035 | |
###
Edgewise
Contacts
Investors:
Michael Carruthers, Chief Financial Officer
ir@edgewisetx.com
Media:
Maureen Franco, VP Corporate Communications
media@edgewisetx.com
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