Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company
developing a new generation of oral integrin therapies for the
treatment of serious chronic diseases, today reported corporate
highlights and financial results for the first quarter 2024.
“Morphic continues to execute our strategy with
the EMERALD-2 phase 2b study in ulcerative colitis (UC) recruiting
on target, and we are excited to begin enrollment in the GARNET
phase 2 study in patients with moderate to severe Crohn’s disease
(CD),” commented Praveen Tipirneni, CEO of Morphic Therapeutic. “We
look forward to continued progress both with MORF-057 and our
earlier-stage pipeline, including our program in pulmonary
hypertensive diseases. Morphic is well positioned as the EMERALD-2
data approaches and GARNET commences, with a strong cash position
and a strengthened leadership team following the addition of Dr.
Simon Cooper as Chief Medical Officer.”
First Quarter 2024 and Recent Corporate
Highlights
Updates to ongoing MORF-057 EMERALD Phase 2
Development Program
- Enrollment
continues on track for EMERALD-2 global phase 2b randomized,
double-blind, placebo-controlled trial of MORF-057 in patients with
moderate-to-severe UC
- The primary
endpoint of EMERALD-2 is the clinical remission rate as measured by
mMCS at 12 weeks and is expected to report in the first half of
2025
- Anticipate the
first patient to be dosed in GARNET phase 2 study of MORF-057 in
patients with moderate to severe CD in the second quarter of 2024
- The primary
endpoint of GARNET is the proportion of patients with endoscopic
response (≥50% reduction) at week 14 as determined using the Simple
Endoscopic Activity Score for CD (SES-CD)
Key Additions to Morphic Leadership Team
- Appointed Simon
Cooper, M.B.B.S., to the role of Chief Medical Officer
- Dr. Cooper
brings successful and highly relevant therapeutic area drug
development experience, having played a key role in the development
of risankizumab in multiple indications including UC and CD at
AbbVie. Dr. Cooper also held the role of Vice President, Global
Project Head for the sarilumab program at Sanofi and led the
submission of secukinumab in psoriasis at Novartis
- Dr. Cooper has
served as Chief Medical Officer of Keros Therapeutics, Kadmon
Holdings and Anokion, and held roles of increasing responsibility
at research and development organizations including Wyeth Research,
Napp Pharmaceutical Research, Roche, Human Genome Sciences and
MedImmune
- Dr. Cooper holds
a Bachelor of Medicine and a Bachelor of Surgery from the
University of Newcastle upon Tyne Medical School
Financial Results for the First Quarter
2024
- Net loss for the
quarter ended March 31, 2024, was $45.3 million or $0.91 per share
compared to net loss of $36.1 million or $0.90 per share for the
same quarter last year
- Research and
development expenses were $42.4 million for the quarter ended March
31, 2024, as compared to $30.4 million for the same quarter last
year. The increase was primarily attributable to higher development
costs along with increased clinical trial costs to support phase 2
clinical studies and development activities for MORF-057, as well
as other research costs to support early development
candidates
- General and
administrative expenses were $11.2 million for the quarter ended
March 31, 2024, compared to $9.3 million for the same quarter last
year. The increase was primarily attributable to increased non-cash
stock-based compensation expenses
Based on its current operating plan, Morphic
believes its existing cash, cash equivalents and marketable
securities as of March 31, 2024, will be sufficient to fund
operating expenses and capital expenditure requirements into the
second half of 2027.
About MORF-057
Morphic is developing MORF-057 as a selective,
oral small molecule inhibitor of the α4β7 integrin for patients
with inflammatory bowel disease (IBD). α4β7 has been clinically
validated as a target for the treatment of IBD by the success of
the approved injectable antibody therapeutic vedolizumab. MORF-057,
like vedolizumab, is designed to block the interactions between
α4β7 on the surface of lymphocytes and the mucosal endothelial cell
ligand MAdCAM-1, substantially reducing lymphocyte migration from
the bloodstream into intestinal mucosal tissues and avoiding
inflammation that is associated with IBD.
About the EMERALD-1 Study
EMERALD-1 is an open-label multi-center phase 2a
trial designed to evaluate the efficacy, safety, and tolerability
of MORF-057 in adults with moderate to severe ulcerative colitis.
The primary endpoint of EMERALD-1, change in Robarts Histopathology
Index (RHI) from baseline at twelve weeks, was achieved with
statistical significance. RHI is a validated instrument that
measures histological disease activity in ulcerative colitis.
Patients were eligible to continue for an additional 40 weeks of
maintenance therapy followed by a 52-week assessment as well as an
open-label extension period. Secondary and additional outcome
measures in the EMERALD-1 study include change in the modified Mayo
clinic score, safety, pharmacokinetic parameters and key
pharmacodynamic measures including α4β7 receptor occupancy and
lymphocyte subset trafficking.
About the EMERALD-2 Study
EMERALD-2 is a global phase 2b randomized,
double-blind, placebo-controlled trial of MORF-057 that is
currently enrolling patients with moderate-to-severe ulcerative
colitis. The primary endpoint of EMERALD-2 is clinical remission
rate as measured by the Modified Mayo Clinic Score (mMCS) at 12
weeks. EMERALD-2 will also measure several secondary and
exploratory endpoints based on the mMCS as well as histologic,
pharmacokinetic and pharmacodynamic measures, and safety
parameters. Patients in the EMERALD-2 study will be randomized to
receive either 200 mg BID (twice daily) MORF-057, 100 mg BID
MORF-057, a QD (once daily) dose of MORF-057, or a placebo dose.
Following the 12-week induction phase, all patients will receive
MORF-057 for 40 weeks of maintenance dosing. For more information
about the EMERALD clinical trials of MORF-057, please
click here.
About the GARNET Study
GARNET is a global Phase 2b randomized,
double-blind, placebo-controlled trial of MORF-057 in Crohn’s
disease. The primary endpoint of GARNET is the proportion of
participants in endoscopic response (>=50% reduction) at week 14
as determined using Simple Endoscopic Score for Crohn’s Disease, or
SES-CD. The secondary endpoints will include the change in Crohn’s
Disease Activity Index, or CDAI, measures, as well as safety
parameters. Patients enrolled in the GARNET study will be
randomized to receive one of two active doses or a placebo: 200 mg
BID (twice daily), 100 mg BID or a placebo that will cross over to
MORF-057 after the 14-week induction phase. Following the 14-week
induction phase, patients will move to a 38-week maintenance
phase.
About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical
company developing a portfolio of oral integrin therapies for the
treatment of serious chronic diseases, including autoimmune,
cardiovascular, and metabolic diseases, fibrosis, and cancer.
Morphic is also advancing its pipeline and discovery activities in
collaboration with Schrödinger using its proprietary MInT
technology platform which leverages the Company’s unique
understanding of integrin structure and biology. For more
information, visit www.morphictx.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains “forward-looking”
statements within the meaning of the Securities Act of 1933, as
amended, the Securities Exchange Act of 1934, as amended, and of
the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995, including, but not limited to: the MInT
Platform’s ability to discover drug candidates; our plans to
develop and commercialize oral small-molecule integrin therapeutics
and any proposed timing thereof; the initiation, execution and
completion of clinical trials of MORF-057; any expectations about
safety, efficacy, timing and ability to commence or complete
clinical and pre-clinical studies and/or trials and to obtain
regulatory approvals for MORF-057 and other candidates in
development; and the ability of MORF-057 to treat inflammatory
bowel disease, including UC, CD, and other indications. Statements
including words such as “believe,” “plan,” “continue,” “expect,”
“will be,” “develop,” “signal,” “potential,” “anticipate” or
“ongoing” and statements in the future tense are forward-looking
statements. These forward-looking statements involve risks and
uncertainties, as well as assumptions, which, if they do not fully
materialize or prove incorrect, could cause our results to differ
materially from those expressed or implied by such forward-looking
statements. Forward-looking statements are subject to risks and
uncertainties that may cause our actual activities or results to
differ significantly from those expressed in any forward-looking
statement, including risks and uncertainties in this press release
and other risks set forth in our filings with the Securities and
Exchange Commission, including, among others, our or a partner’s
ability to complete a current or future clinical trial of any of
our current or future product candidates, our ability to develop or
obtain regulatory approval for or commercialize any product
candidate, our ability to protect our intellectual property, and
the sufficiency of our cash, cash equivalents and investments to
fund our operations. These forward-looking statements speak only as
of the date hereof and we specifically disclaim any obligation to
update these forward-looking statements or reasons why actual
results might differ, whether as a result of new information,
future events or otherwise, except as required by law.
-Financial Tables to Follow-
Morphic Holding, Inc.Condensed
Consolidated Statements of Operations(unaudited)(in
thousands, except share and per share data) |
|
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
Collaboration revenue |
$ |
— |
|
|
$ |
521 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
42,441 |
|
|
|
30,449 |
|
|
General and administrative |
|
11,163 |
|
|
|
9,277 |
|
|
Total operating expenses |
|
53,604 |
|
|
|
39,726 |
|
|
Loss from operations |
|
(53,604 |
) |
|
|
(39,205 |
) |
|
Other income: |
|
|
|
|
|
|
|
|
Interest income, net |
|
8,390 |
|
|
|
3,100 |
|
|
Other income, net |
|
— |
|
|
|
2 |
|
|
Total other income, net |
|
8,390 |
|
|
|
3,102 |
|
|
Loss before provision for income taxes |
|
(45,214 |
) |
|
|
(36,103 |
) |
|
Provision for income taxes |
|
(80 |
) |
|
|
(32 |
) |
|
Net loss |
$ |
(45,294 |
) |
|
$ |
(36,135 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.91 |
) |
|
$ |
(0.90 |
) |
|
Weighted average common shares outstanding, basic and dilutive |
|
50,009,032 |
|
|
|
40,112,416 |
|
|
|
|
Morphic Holding, Inc.Condensed
Consolidated Balance Sheets(unaudited)(in thousands) |
|
|
|
|
March 31, 2024 |
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
658,766 |
|
$ |
704,349 |
|
Other current assets |
|
17,175 |
|
|
12,579 |
|
Total current assets |
|
675,941 |
|
|
716,928 |
|
Other assets |
|
6,824 |
|
|
5,586 |
|
Total assets |
$ |
682,765 |
|
$ |
722,514 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities |
$ |
17,711 |
|
$ |
24,776 |
|
Long-term liabilities |
|
1,474 |
|
|
716 |
|
Total liabilities |
|
19,185 |
|
|
25,492 |
|
Total stockholders’ equity |
|
663,580 |
|
|
697,022 |
|
Total liabilities and stockholders’ equity |
$ |
682,765 |
|
$ |
722,514 |
|
|
|
ContactsMorphic TherapeuticChris
Erdmanchris.erdman@morphictx.com617.686.1718
Morphic (NASDAQ:MORF)
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