Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage
biopharmaceutical company focused on the discovery, development,
and commercialization of novel treatments for patients suffering
from serious hematologic diseases, today reported financial results
for the second quarter ending June 30, 2023, and provided an update
on recent program and corporate developments.
“This was a landmark quarter for our company, as
we presented positive initial data from the BEACON study at EHA,
which showed the promise of bitopertin as a potential treatment for
EPP. The BEACON data catalyzed the successful completion of an
upsized public offering, which provides runway well beyond key
read-outs across our portfolio and positions us to advance
bitopertin into late-stage development,” said John Quisel, J.D.,
Ph.D., President and Chief Executive Officer of Disc. “We continue
to make excellent progress across our portfolio and look forward to
providing updated results from BEACON and our other studies at the
end of the year.”
Recent Business Highlights and Upcoming
Milestones:
Bitopertin: GlyT1 Inhibitor (Heme
Synthesis Modulator)
Bitopertin is an investigational,
clinical-stage, orally-administered inhibitor of glycine
transporter 1 (GlyT1) that is designed to modulate heme
biosynthesis. GlyT1 is a membrane transporter expressed on
developing red blood cells and is required to supply sufficient
glycine for heme biosynthesis and support erythropoiesis. Disc is
planning to develop bitopertin as a potential treatment for a range
of hematologic diseases including erythropoietic porphyrias, where
it has potential to be the first disease-modifying therapy.
- Presented
positive initial data from BEACON, an open-label Phase 2 clinical
study of bitopertin in patients with EPP and X-linked
protoporphyria (XLP), demonstrating:
- Consistent and
dose-dependent reductions of protoporphyrin IX (PPIX), the
disease-causing metabolite in EPP
- Marked
improvements in sunlight tolerance and quality of life
- Bitopertin was
well-tolerated, with no meaningful changes in hemoglobin
- Continued
enrollment for AURORA, a Phase 2 randomized, placebo-controlled
clinical study of bitopertin in adults with EPP. Disc expects to
have data by year-end 2023, to be presented in early 2024.
- Initiated and
enrolled first patient in an NIH-sponsored Phase 1/2 study of
bitopertin in patients with Diamond-Blackfan Anemia in July
2023
DISC-0974: Anti-Hemojuvelin Antibody
(Hepcidin Suppression)
DISC-0974 is an investigational anti-hemojuvelin
monoclonal antibody (mAb) and is designed to suppress hepcidin
production and increase serum iron levels in patients suffering
from anemia of inflammation.
- Enrollment ongoing for a Phase 1b/2
clinical study of patients with anemia of chronic kidney disease
who are not receiving dialysis (NDD-CKD); initial data expected by
year-end 2023
- Continued enrollment in a Phase
1b/2 clinical study in MF patients with severe anemia on stable
background therapy; initial data expected by year-end 2023
MWTX-003: Anti-TMPRSS6 Antibody
(Hepcidin Induction)
MWTX-003 is an investigational, anti-TMPRSS6
(Transmembrane Serine Protease 6, also known as Matriptase-2)
monoclonal antibody designed to increase hepcidin production and
suppress serum iron.
- Continued
technology transfer and study preparation activities for MWTX-003.
Disc plans to initiate a Phase 1 study in healthy volunteers during
the second half of 2023.
- Disc plans to
develop MWTX-003 initially as a treatment for polycythemia vera as
well as other indications.
Corporate:
- Completed an upsized public
offering of common stock and pre-funded warrants in June 2023 for
$157.8 million in gross proceeds.
Second Quarter 2023 Financial
Results:
- Cash Position:
Cash and cash equivalents were $377.6 million as of June 30, 2023,
which are expected to fund our operational plans well into
2026.
- Research and Development
Expenses: R&D expenses were $12.1 million for the
quarter ended June 30, 2023, as compared to $7.7 million for the
quarter ended June 30, 2022. The increase in R&D expenses were
primarily driven by the progression of Disc’s portfolio, including
bitopertin’s ongoing two Phase 2 clinical studies, increased
headcount, and costs related to technology transfer and study
preparations for MWTX-003.
- General and Administrative
Expenses: G&A expenses were $5.2 million for the
quarter ended June 30, 2023, as compared to $4.3 million for the
same period in 2022. The increase in G&A expenses was primarily
due to increased headcount.
- Net Loss: Net loss
was $15.9 million for the quarter ended June 30, 2023, as compared
to $9.6 million for the second quarter of 2022. The increase was
primarily due to higher operating costs in the current period to
support the continued advancement of our pipeline.
About Disc Medicine
Disc Medicine (NASDAQ:IRON) is a clinical-stage
biopharmaceutical company committed to discovering, developing, and
commercializing novel treatments for patients who suffer from
serious hematologic diseases. We are building a portfolio of
innovative, potentially first-in-class therapeutic candidates that
aim to address a wide spectrum of hematologic diseases by targeting
fundamental biological pathways of red blood cell biology,
specifically heme biosynthesis and iron homeostasis. For more
information, please visit www.discmedicine.com.
Available Information
Disc announces material information to the
public about the Company, its products and services, and other
matters through a variety of means, including filings with the U.S.
Securities and Exchange Commission (SEC), press releases, public
conference calls, webcasts and the investor relations section of
the Company website at ir.discmedicine.com in order to achieve
broad, non-exclusionary distribution of information to the public
and for complying with its disclosure obligations under Regulation
FD.
Disc Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, express or
implied statements regarding Disc’s expectations with respect to
its AURORA Phase 2 and BEACON Phase 2 clinical studies of
bitopertin, and its Phase 1b/2 study of bitopertin in
Diamond-Blackfan Anemia, its Phase 1b/2 clinical study of DISC-0974
in NDD-CKD patients with anemia, its anticipated Phase 1 study of
MWTX-003 and potential development of MWTX-003 as a treatment for
polycythemia vera and other indications, projected timelines for
the initiation and completion of its clinical trials, anticipated
timing of release of data, and other clinical activities; Disc’s
business plans and objectives; and Disc’s beliefs about operating
expenses and that it will have capital to fund Disc well into 2026.
The use of words such as, but not limited to, “believe,” “expect,”
“estimate,” “project,” “intend,” “future,” “potential,” “continue,”
“may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or
“could” or the negative of these terms and other similar words or
expressions that are intended to identify forward-looking
statements. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based on
Disc’s current beliefs, expectations and assumptions regarding the
future of Disc’s business, future plans and strategies, clinical
results and other future conditions. New risks and uncertainties
may emerge from time to time, and it is not possible to predict all
risks and uncertainties. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Disc may not actually achieve the plans,
intentions or expectations disclosed in these forward-looking
statements, and investors should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements as a result of a number of material
risks and uncertainties including but not limited to: the adequacy
of Disc’s capital to support its future operations and its ability
to successfully initiate and complete clinical trials; the nature,
strategy and focus of Disc; the difficulty in predicting the time
and cost of development of Disc’s product candidates; Disc’s plans
to research, develop and commercialize its current and future
product candidates; the timing of initiation of Disc’s planned
preclinical studies and clinical trials; the timing of the
availability of data from Disc’s clinical trials; Disc’s ability to
identify additional product candidates with significant commercial
potential and to expand its pipeline in hematological diseases; the
timing and anticipated results of Disc’s preclinical studies and
clinical trials and the risk that the results of Disc’s preclinical
studies and clinical trials may not be predictive of future results
in connection with future studies or clinical trials and may not
support further development and marketing approval; the other risks
and uncertainties described in the “Risk Factors” section of our
Annual Report on Form 10-K for the year ended December 31, 2022,
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2023 and June 30, 2023, and other documents filed by Disc from time
to time with the SEC, as well as discussions of potential risks,
uncertainties, and other important factors in Disc’s subsequent
filings with the SEC. Any forward-looking statement speaks only as
of the date on which it was made. None of Disc, nor its affiliates,
advisors or representatives, undertake any obligation to publicly
update or revise any forward-looking statement, whether as result
of new information, future events or otherwise, except as required
by law.
DISC MEDICINE, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
$ |
12,100 |
|
|
$ |
7,714 |
|
|
$ |
32,280 |
|
|
$ |
15,535 |
|
General and
administrative |
|
5,228 |
|
|
|
4,301 |
|
|
|
10,173 |
|
|
|
6,440 |
|
Total operating
expenses |
|
17,328 |
|
|
|
12,015 |
|
|
|
42,453 |
|
|
|
21,975 |
|
Loss from
operations |
|
(17,328 |
) |
|
|
(12,015 |
) |
|
|
(42,453 |
) |
|
|
(21,975 |
) |
Other income
(expense), net |
|
1,405 |
|
|
|
2,435 |
|
|
|
3,772 |
|
|
|
2,542 |
|
Income tax
expense |
|
(24 |
) |
|
|
— |
|
|
(47 |
) |
|
|
— |
|
Net loss |
$ |
(15,947 |
) |
|
$ |
(9,580 |
) |
|
$ |
(38,728 |
) |
|
$ |
(19,433 |
) |
Weighted-average
common shares outstanding-basic and diluted |
|
21,484,955 |
|
|
|
944,706 |
|
|
|
20,226,923 |
|
|
|
934,286 |
|
Net loss per
share-basic and diluted |
$ |
(0.74 |
) |
|
$ |
(10.14 |
) |
|
$ |
(1.91 |
) |
|
$ |
(20.80 |
) |
|
|
|
|
|
|
|
|
DISC MEDICINE, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
(Unaudited) |
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
377,602 |
|
$ |
194,611 |
Other
current assets |
|
|
4,131 |
|
|
3,880 |
Total
current assets |
|
|
381,733 |
|
|
198,491 |
Non-current assets |
|
|
2,441 |
|
|
1,714 |
Total
assets |
|
$ |
384,174 |
|
$ |
200,205 |
Liabilities and Stockholders’ Equity |
|
|
|
|
Current
liabilities |
|
$ |
9,683 |
|
$ |
22,578 |
Non-current liabilities |
|
|
3,272 |
|
|
1,027 |
Total
liabilities |
|
|
12,955 |
|
|
23,605 |
Total
stockholders’ equity |
|
|
371,219 |
|
|
176,600 |
Total
liabilities and stockholders’ equity |
|
$ |
384,174 |
|
$ |
200,205 |
Media Contact
Peg Rusconi
Verge Scientific Communications
prusconi@vergescientific.com
Investor Relations Contact
Christina Tartaglia
Stern Investor Relations
christina.tartaglia@sternir.com
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