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 third quarter 2023.
“Morphic presented a comprehensive set of
positive results from the 12-week induction phase of the EMERALD-1
study of MORF-057 in UC, showing consistent efficacy
across-the-board for patients, while demonstrating no safety
signals. These results are particularly impressive, given that
enrollment was skewed towards the severe end of the spectrum of
moderately-to-severely active UC. Notably, we continue to observe
improvement in these difficult to treat patients beyond the
induction phase of the study in 44-week data presented recently,”
commented Bruce Rogers, PhD, President of Morphic Therapeutic. “The
Phase 2a study of MORF-057 clearly signaled everything we believed
it would at this point in development and we are excited to
continue enrolling patients in our ongoing EMERALD-2 Phase 2b
study. On a separate note, what the company continues to
accomplish, while Praveen is on medical leave, is a testament to
the quality the team that he put in place, and we are all wishing
him the very best in his continued recovery.”
Third Quarter 2023 and Recent Corporate
Highlights
Chief Executive Officer of Morphic Therapeutic,
Praveen Tipirneni, MD, continues to improve while remaining on a
medical leave of absence after suffering an emergent medical event
in late September. Dr. Tipirneni is expected to return after he
recovers.
In the EMERALD-1 Phase 2a trial of MORF-057 in
UC, additional positive data, presented at UEGW 2023 and in a
company conference call, indicate that in a
moderately-to-severely-active UC population with severe disease
burden, MORF-057:
- Continues to be
generally well tolerated with no safety signal observed to
date
- Achieved primary
endpoint with high statistical significance in reduction of RHI of
6.4 points (p=0.0019)
- Showed clinical
improvement consistently across key measures at week 12, including
remission and response (mMCS remission of 25.7%; mMCS response of
45.7%)
- Demonstrated RHI
change ≥7 points in 48.6% of patients and RHI remission in 22.9% of
patients
- Led to clinical
improvement in mMCS within the 12-week induction period for 76% of
patients, including advanced therapy-experienced patients
- PK/PD results
confirm those seen in healthy volunteer studies
- Median RO
>99% and sustained saturation at week 12
- Predicted
lymphocyte subset changes observed, consistent with engagement of
α4β7
- Demonstrated
deepening of clinical effect beyond the 12-week induction period,
with symptomatic remission rates continuing to increase out to 44
weeks in both advanced treatment-naïve and advanced
treatment-experienced patients
Ongoing MORF-057 EMERALD Phase 2 Development
Program Updates
- Continued the
40-week maintenance phase of the EMERALD-1 study as planned
- EMERALD-2 global
Phase 2b randomized, double-blind, placebo-controlled trial of
MORF-057 in patients with moderate-to-severe UC continues to enroll
as projected
- 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
- The Phase 2b
study of MORF-057 in Crohn’s Disease is anticipated to begin in the
first half of 2024
MORF-057 Preclinical Studies
- Presented
preclinical data on rational selection of combination therapy for
inflammatory bowel disease (IBD) treatment using an established
clinical mode at UEGW 2023
- This study
explored preclinical combination models in UC and preliminarily
examined the potential utility and rationale of combining
anti-inflammatory mechanisms with α4β7 integrin inhibition in
IBD
Pipeline Programs
- Continued
late-stage preclinical work in the MORF-088 small molecule αvβ8
inhibitor program, with initiation of clinical trials anticipated
in the first half of 2024
- αvβ8 inhibition
holds promise as a novel mechanism to treat myelofibrosis, a rare
blood cancer, because the αvβ8 integrin is an activator of TGF-β
which is believed to play a central role in the pathogenesis of
myelofibrosis
Financial Results for the Third Quarter
2023
- Net loss for the
quarter ended September 30, 2023, was $36.2 million or $0.73 per
share compared to net income of $30.0 million or $0.78 per share
for the same quarter last year
- Revenue was $0
million for the quarter ended September 30, 2023, compared to $2.1
million for the same quarter last year due to the conclusion of the
Company’s research and development collaborations with AbbVie and
Janssen
- Research and
development expenses were $34.4 million for the quarter ended
September 30, 2023, as compared to $25.2 million for the same
quarter last year. The increase was primarily attributable to
higher manufacturing and development costs along with higher
pre-clinical and phase 2 clinical trial costs to support our lead
product candidate, MORF-057
- General and
administrative expenses were $10.4 million for the quarter ended
September 30, 2023, compared to $8.3 million for the same quarter
last year. The increase was due to increased non-cash stock-based
compensation expenses and higher payroll costs
As of September 30, 2023, Morphic had cash, cash
equivalents and marketable securities of $725.1 million, compared
to $731.4 million as of June 30, 2023. Based on its current
operating plan, Morphic believes its existing cash, cash
equivalents and marketable securities as of September 30, 2023,
will be sufficient to fund operating expenses and capital
expenditure requirements into the second half of 2027.
About MORF-057Morphic 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
StudyEMERALD-1 (MORF-057-201) 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 35 patients enrolled in the main
cohort of the EMERALD-1 study have been treated with 100 mg BID
(twice daily) at sites in the United States and Poland. The primary
endpoint of the trial was the change in Robarts Histopathology
Index (RHI), a validated instrument that measures histological
disease activity in ulcerative colitis at 12 weeks compared to
baseline. Patients will continue for an additional 40 weeks of
maintenance therapy followed by a 52-week assessment. Secondary and
additional pre-specified 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
StudyEMERALD-2 (MORF-057-202) 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 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 Morphic
TherapeuticMorphic 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 StatementsThis 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 technology platform’s ability to discover drug
candidates; Morphic’s plans to develop and commercialize oral
small-molecule integrin therapeutics and any proposed timing
thereof; the execution, timing and completion of the EMERALD-1 and
EMERALD-2 clinical trials; any expectations about safety, efficacy,
timing and ability to commence or complete clinical studies and/or
trials and to obtain regulatory approvals for MORF-057, MORF-088
and other candidates in development; the timing of further data
presentation; the ability of MORF-057 to treat IBD, including
ulcerative colitis, or related indications; the ability of αvβ8
small molecule inhibitors, including MORF-088, to treat
myelofibrosis; the ability for additional integrin targets to treat
pulmonary hypertensive diseases; the company’s cash position and
anticipated runway. 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
Morphic’s actual activities or results to differ significantly from
those expressed in any forward-looking statement, including risks
and uncertainties disclosed in this press release and other risks
set forth in our filings with the Securities and Exchange
Commission, including Morphic’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2022 filed with the SEC on February
23, 2023 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 filed with the SEC on November 3, 2023. These
forward-looking statements speak only as of the date hereof and
Morphic specifically disclaims any obligation to update these
forward-looking statements, 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 September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
Collaboration revenue |
$ |
— |
|
|
$ |
2,055 |
|
|
$ |
521 |
|
|
$ |
64,673 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
34,364 |
|
|
|
25,245 |
|
|
|
100,532 |
|
|
|
77,360 |
|
|
General and administrative |
|
10,384 |
|
|
|
8,303 |
|
|
|
29,244 |
|
|
|
24,128 |
|
|
Total operating expenses |
|
44,748 |
|
|
|
33,548 |
|
|
|
129,776 |
|
|
|
101,488 |
|
|
Loss from operations |
|
(44,748 |
) |
|
|
(31,493 |
) |
|
|
(129,255 |
) |
|
|
(36,815 |
) |
|
Other income: |
|
|
|
|
|
|
|
Interest income, net |
|
8,612 |
|
|
|
1,657 |
|
|
|
18,139 |
|
|
|
2,326 |
|
|
Other income (expense), net |
|
7 |
|
|
|
(156 |
) |
|
|
9 |
|
|
|
(144 |
) |
|
Total other income, net |
|
8,619 |
|
|
|
1,501 |
|
|
|
18,148 |
|
|
|
2,182 |
|
|
Loss before provision for income taxes |
|
(36,129 |
) |
|
|
(29,992 |
) |
|
|
(111,107 |
) |
|
|
(34,633 |
) |
|
Provision for income taxes |
|
(83 |
) |
|
|
(29 |
) |
|
|
(253 |
) |
|
|
(31 |
) |
|
Net loss |
$ |
(36,212 |
) |
|
$ |
(30,021 |
) |
|
$ |
(111,360 |
) |
|
$ |
(34,664 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.73 |
) |
|
$ |
(0.78 |
) |
|
$ |
(2.65 |
) |
|
$ |
(0.91 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and dilutive |
|
49,548,947 |
|
|
|
38,490,910 |
|
|
|
41,979,245 |
|
|
|
37,961,262 |
|
|
|
Morphic Holding, Inc. |
Condensed Consolidated Balance Sheets |
(unaudited) |
(in thousands) |
|
|
September 30, 2023 |
|
December 31, 2022 |
|
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
725,067 |
|
$ |
348,248 |
|
Other current assets |
|
13,030 |
|
|
13,934 |
|
Total current assets |
|
738,097 |
|
|
362,182 |
|
Other assets |
|
5,505 |
|
|
6,407 |
|
Total assets |
$ |
743,602 |
|
$ |
368,589 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities |
$ |
19,298 |
|
$ |
17,126 |
|
Long-term liabilities |
|
1,136 |
|
|
2,344 |
|
Total liabilities |
|
20,434 |
|
|
19,470 |
|
Total stockholders’ equity |
|
723,168 |
|
|
349,119 |
|
Total liabilities and
stockholders’ equity |
$ |
743,602 |
|
$ |
368,589 |
|
|
ContactsMorphic TherapeuticChris
Erdmanchris.erdman@morphictx.com617.686.1718
Morphic (NASDAQ:MORF)
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