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 second quarter of 2023.
“Morphic rides a wave of momentum into the 2nd
half of 2023, bolstered by the compelling and consistent dataset
derived from the EMERALD-1 Phase 2a study of MORF-057 in ulcerative
colitis. These data paved the way to a fortress balance sheet,
catalyzing the broader advancement of our pipeline,” commented
Praveen Tipirneni, MD, Chief Executive Officer of Morphic
Therapeutic. “The MORF-057 development program moves ahead with
on-track enrollment of ulcerative colitis patients in the EMERALD-2
Phase 2b study and with the preparation for a Phase 2 trial in
Crohn's Disease, planned to begin in the first half of 2024. Our
robust financial position opens the gates to additional investment
in therapeutic areas beyond IBD, enabled by the MInT Platform.
“In particular, our αvβ8 inhibitor program
continues to stir enthusiasm, buoyed by compelling pre-clinical
data and the potentially central role of TGF-β in the pathogenesis
of myelofibrosis. On the strength of these advancements, we have
formally nominated MORF-088, a selective small molecule inhibitor
of αvβ8, as our development candidate for myelofibrosis and expect
this program to enter the clinic in the first half of 2024.”
Second Quarter 2023 and Recent Corporate
Highlights
In the EMERALD-1 Phase 2a trial of MORF-057 in
UC, topline data indicate that MORF-057:
- Was generally
well tolerated with no safety signal observed
- Achieved the
study’s primary endpoint and demonstrated consistent, clinically
meaningful improvements across secondary and exploratory
measures
- Demonstrated a
statistically significant reduction of 6.4 points (p=0.002) from
baseline at Week 12 in the Robarts Histopathology Index (RHI)
Score
- Achieved 26%
clinical remission as measured by Modified Mayo Clinic Score
(mMCS)
- Demonstrated
positive biomarker results, including the saturation of the α4β7
receptor and α4β7 lymphocyte subset changes consistent with Phase 1
MORF-057 data
Ongoing MORF-057 EMERALD Phase 2 Development
Program Updates
- Continued the
40-week maintenance phase of the EMERALD-1 study as projected with
top-line data anticipated in the first half of 2024
- Patients who
completed the 12-week induction phase of the EMERALD-1 Phase 2a
study were eligible to continue participating in a 40-week
maintenance phase of the EMERALD-1 open-label single-arm study
- Announced
completion of enrollment in the exploratory cohort of the EMERALD-1
study comprised of UC patients who have previously failed treatment
with vedolizumab
- Announced that
the EMERALD-2 global Phase 2b randomized, double-blind,
placebo-controlled trial of MORF-057 in patients with
moderate-to-severe UC continued to ramp-up and 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
- Announced that
the Phase 2b study of MORF-057 in Crohn’s Disease is anticipated to
begin in the first half of 2024
- Announced the
acceptance of a moderated poster presentation of the EMERALD-1
study results at the UEG Week 2023 in October in Copenhagen
MORF-057 Preclinical Studies
- Presented new
biomarker data at Digestive Disease Week 2023, demonstrating
increases in circulating fibroblasts, consistent with previous
findings and adding new support to mechanistic understanding of
MORF-057’s activity in a non-human primate model of UC. These data
further support the ongoing EMERALD Phase 2 clinical trials of
MORF-057 in IBD
Equity Financing
- Morphic
strengthened its balance sheet with a total of approximately $345
million in new capital during the second quarter through:
- $276 million in
gross proceeds from a public offering of 6,133,334 shares of its
common stock at $45 per share, including full exercise of the
underwriters’ overallotment option following the release of the
positive and consistent EMERALD-1 Phase 2a topline data in
ulcerative colitis
- ~$69 million in
gross proceeds through the use of its ATM facility at a
volume-weighted average price of $56.20 per share
Financial Results for the Second Quarter
2023
- Net loss for the
quarter ended June 30, 2023, was $39.0 million or $0.92 per share
compared to net income of $26.8 million or $0.68 per share for the
same quarter last year
- Revenue was $0
million for the quarter ended June 30, 2023, compared to $60.2
million for the same quarter last year due to the conclusion of the
Company’s research and development collaboration with AbbVie
- Research and
development expenses were $35.7 million for the quarter ended June
30, 2023, as compared to $25.7 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 $9.6 million for the quarter ended
June 30, 2023, compared to $8.2 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 June 30, 2023, Morphic had cash, cash
equivalents and marketable securities of $731.4 million, compared
to $421.3 million as of March 31, 2023. Based on its current
operating plan, Morphic believes its existing cash, cash
equivalents and marketable securities as of June 30, 2023, will be
sufficient to fund operating expenses and capital expenditure
requirements into the second half of 2027.
Upcoming Morphic Investor and Medical
Meeting Presentations
- Canaccord
Genuity 43rd Annual Growth Conference, Boston
- Corporate
presentation, August 9, 2023
- Wells Fargo
Healthcare Conference, Boston
- Fireside Chat,
September 6, 2023
- UEG Week 2023,
Copenhagen
- EMERALD-1
moderated poster presentation, October 15, 2023
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 (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 Study
EMERALD-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
June 30, 2023 filed with the SEC on August 23, 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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
— |
|
|
$ |
60,236 |
|
|
$ |
521 |
|
|
$ |
62,618 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
35,719 |
|
|
|
25,652 |
|
|
|
66,168 |
|
|
|
52,115 |
|
General and administrative |
|
9,583 |
|
|
|
8,234 |
|
|
|
18,860 |
|
|
|
15,825 |
|
Total operating expenses |
|
45,302 |
|
|
|
33,886 |
|
|
|
85,028 |
|
|
|
67,940 |
|
(Loss) income from
operations |
|
(45,302 |
) |
|
|
26,350 |
|
|
|
(84,507 |
) |
|
|
(5,322 |
) |
Other income: |
|
|
|
|
|
|
|
Interest income, net |
|
6,427 |
|
|
|
482 |
|
|
|
9,527 |
|
|
|
669 |
|
Other income, net |
|
— |
|
|
|
11 |
|
|
|
2 |
|
|
|
12 |
|
Total other income, net |
|
6,427 |
|
|
|
493 |
|
|
|
9,529 |
|
|
|
681 |
|
(Loss) income before provision
for income taxes |
|
(38,875 |
) |
|
|
26,843 |
|
|
|
(74,978 |
) |
|
|
(4,641 |
) |
Provision for income taxes |
|
(138 |
) |
|
|
(2 |
) |
|
|
(170 |
) |
|
|
(2 |
) |
Net (loss) income |
$ |
(39,013 |
) |
|
$ |
26,841 |
|
|
$ |
(75,148 |
) |
|
$ |
(4,643 |
) |
|
|
|
|
|
|
|
|
Net (loss) income per share,
basic |
$ |
(0.92 |
) |
|
$ |
0.70 |
|
|
$ |
(1.82 |
) |
|
$ |
(0.12 |
) |
Net (loss) income per share,
diluted |
$ |
(0.92 |
) |
|
$ |
0.68 |
|
|
$ |
(1.82 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic |
|
42,373,407 |
|
|
|
38,244,547 |
|
|
|
41,249,157 |
|
|
|
37,692,049 |
|
Weighted average common shares
outstanding, diluted |
|
42,373,407 |
|
|
|
39,554,651 |
|
|
|
41,249,157 |
|
|
|
37,692,049 |
|
|
|
|
|
|
|
|
|
Morphic Holding, Inc. |
|
Condensed Consolidated Balance Sheets |
|
(unaudited) |
|
(in thousands) |
|
|
June 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
731,356 |
|
$ |
348,248 |
Other current assets |
|
11,265 |
|
|
13,934 |
Total current assets |
|
742,621 |
|
|
362,182 |
Other assets |
|
6,099 |
|
|
6,407 |
Total assets |
$ |
748,720 |
|
$ |
368,589 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities |
$ |
17,809 |
|
$ |
17,126 |
Long-term liabilities |
|
1,550 |
|
|
2,344 |
Total liabilities |
|
19,359 |
|
|
19,470 |
Total stockholders’ equity |
|
729,361 |
|
|
349,119 |
Total liabilities and
stockholders’ equity |
$ |
748,720 |
|
$ |
368,589 |
|
ContactsMorphic TherapeuticChris
Erdmanchris.erdman@morphictx.com617.686.1718
Morphic (NASDAQ:MORF)
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