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 first quarter ending March 31, 2023 and provided an update
on recent program and corporate developments.
“We have had an excellent start to 2023 with each of our
development programs on-track; multiple clinical studies ongoing,
including new indications such as CKD anemia and Diamond-Blackfan
anemia; and growing our pipeline by in-licensing a third, Phase-1
ready program,” said John Quisel, J.D., Ph.D., President and Chief
Executive Officer of Disc. “We are positioned to deliver a series
of important catalysts across our portfolio through the rest of
2023 and into next year, beginning with the presentation of initial
data from the BEACON study at EHA.”
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.
- Continued enrollment of BEACON, an open-label Phase 2 clinical
study of bitopertin in patients with EPP and X-linked
protoporphyria (XLP).
- Interim data will be presented at EHA Congress on June 9, 2023,
with an accompanying management call at 7:30 am ET the same
day.
- Disc expects topline data from BEACON by end of 2023.
- Continued enrollment for AURORA, a Phase 2 randomized,
placebo-controlled clinical study of bitopertin in adults with EPP.
Disc expects topline data from AURORA by end of 2023.
- Received a positive opinion on Orphan Designation for
bitopertin for treatment of EPP from the European Committee for
Orphan Medical Products in January 2023. Orphan Drug Designation
was previously granted by the FDA in 2022.
- Announced a collaboration with NIH to study bitopertin in
patients with Diamond-Blackfan Anemia in March 2023; the study is
expected to initiate mid-year 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.
- Initiated and enrollment is ongoing for a Phase 1b/2 clinical
study of patients with anemia of chronic kidney disease who are not
receiving dialysis (NDD-CKD) in February 2023; interim data
expected by end of 2023
- Continued enrollment in a Phase 1b/2 clinical study in MF
patients with severe anemia on stable background therapy; interim
data expected by end of 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.
- Entered into an exclusive licensing agreement with Mabwell
Therapeutics in January 2023 to obtain an exclusive license to
rights outside of Greater China for a portfolio of monoclonal
antibodies targeting TMPRSS6 including a Phase 1-ready drug
candidate, MWTX-003.
- The IND was accepted in November 2022 and Disc plans to
initiate a Phase 1 study of MWTX-003 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 a $62.5 million registered direct offering of our
common stock led by Bain Capital Life Sciences, with participation
from Access Biotechnology and OrbiMed, in February 2023.
First Quarter 2023 Financial Results:
- Cash Position: Cash and cash equivalents were
$236.4 million as of March 31, 2023 compared to $194.6 million as
of December 31, 2022. The increase was due to $62.5 million in
gross proceeds from a registered direct offering led by Bain
Capital Life Sciences in February 2023, as well as $15.0 million in
gross proceeds from ATM offerings completed in Q1 2023. Disc
expects its cash and cash equivalents to fund its operational plans
into 2025.
- Research and Development Expenses: R&D
expenses were $20.2 million for the quarter ending March 31, 2023,
as compared to $7.8 million for the quarter ending March 31, 2022.
The increase in R&D expenses were primarily driven by a
one-time $10.0 million upfront payment under the Mabwell license
agreement and the progression of Disc’s portfolio, including
increased headcount, the advancement of DISC-0974 into an
additional Phase 1b/2 clinical study, and bitopertin’s ongoing two
Phase 2 clinical studies.
- General and Administrative Expenses: G&A
expenses were $4.9 million for the quarter ending March 31, 2023,
as compared to $2.1 million for the same period in 2022. The
increase in G&A expenses was primarily due to increased
headcount and legal and market research costs.
- Net Loss: The net loss was $22.8 million for
the first quarter of 2023, as compared to $9.9 million for the
first quarter of 2022. The increase was primarily due to higher
operating costs in the current period to support the continued
advancement of the Company’s 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 anticipated 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 into 2025. 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 and
other documents filed by Disc from time to time with the Securities
and Exchange Commission, as well as discussions of potential risks,
uncertainties, and other important factors in Disc’s subsequent
filings with the Securities and Exchange Commission. 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 Ended March 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
$ |
20,180 |
|
|
$ |
7,821 |
|
|
General and administrative |
|
|
4,945 |
|
|
|
2,139 |
|
|
Total operating expenses |
|
|
25,125 |
|
|
|
9,960 |
|
|
Loss from operations |
|
|
(25,125 |
) |
|
|
(9,960 |
) |
|
Other income (expense), net |
|
|
2,367 |
|
|
|
107 |
|
|
Income tax expense |
|
|
(23 |
) |
|
|
— |
|
|
Net loss |
|
$ |
(22,781 |
) |
|
$ |
(9,853 |
) |
|
Weighted-average common shares
outstanding-basic and diluted |
|
|
18,954,914 |
|
|
|
923,750 |
|
|
Net loss per share-basic and
diluted |
|
$ |
(1.20 |
) |
|
$ |
(10.67 |
) |
|
|
|
|
|
|
|
DISC MEDICINE, INC. |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(In thousands) |
|
(Unaudited) |
|
|
|
March 31, |
|
December 31, |
|
|
|
2023 |
|
2022 |
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
236,422 |
|
$ |
194,611 |
|
Other current assets |
|
|
5,716 |
|
|
3,880 |
|
Total current assets |
|
|
242,138 |
|
|
198,491 |
|
Non-current assets |
|
|
1,642 |
|
|
1,714 |
|
Total assets |
|
$ |
243,780 |
|
$ |
200,205 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
$ |
9,980 |
|
$ |
22,578 |
|
Non-current liabilities |
|
|
945 |
|
|
1,027 |
|
Total liabilities |
|
|
10,925 |
|
|
23,605 |
|
Total stockholders’ equity |
|
|
232,855 |
|
|
176,600 |
|
Total liabilities and
stockholders’ equity |
|
$ |
243,780 |
|
$ |
200,205 |
|
Media Contact
Peg RusconiVerge Scientific
Communicationsprusconi@vergescientific.com
Investor Relations Contact
Suzanne Messere Stern Investor
Relationssuzanne.messere@sternir.com
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