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 third quarter ended September 30, 2023, and provided an
update on recent program and corporate developments.
“We made tremendous progress this quarter in
advancing our portfolio, including a major milestone of completing
enrollment of both BEACON and AURORA studies within a year, as well
as advancing our third development program into the clinic,” said
John Quisel, J.D., Ph.D., President and Chief Executive Officer of
Disc. “We’re looking forward to the ASH 2023 meeting in December,
when we will be presenting updated interim data from BEACON, as
well as initial data for DISC-0974 in MF and CKD.”
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.
- Completed
enrollment for both BEACON, an open-label Phase 2 clinical study of
bitopertin in patients with EPP and X-linked protoporphyria (XLP),
and AURORA a Phase 2 randomized, placebo-controlled clinical study
of bitopertin in adults with EPP
- Expanded
enrollment of BEACON to include adolescents (ages 12-18)
- Updated BEACON data from all
patients and with longer duration of therapy will be presented at
ASH 2023, including measures of protoporphyrin IX (PPIX),
photosensitivity, quality of life, safety, and tolerability, as
well as preliminary analysis of the precedented pivotal endpoint,
cumulative time in light over 6 months on days without pain
- Topline AURORA
data is expected to be presented in early 2024
DISC-0974: Anti-Hemojuvelin Antibody
(Hepcidin Suppression)
DISC-0974 is an investigational anti-hemojuvelin
monoclonal antibody and is designed to suppress hepcidin production
and increase serum iron levels in patients suffering from anemia of
inflammation.
- Ongoing enrollment and dose
escalation in a Phase 1b/2 clinical study in MF patients with
severe anemia on stable background therapy; initial data from 10-20
patients in the dose-escalation phase of the study, including
safety and changes in hepcidin, iron, and hemoglobin levels, will
be presented at ASH 2023
- Ongoing enrollment and dose
escalation in a Phase 1b/2 clinical study of patients with anemia
of chronic kidney disease who are not receiving dialysis (NDD-CKD);
initial data from the 28 mg cohort will be presented as part of a
management call in December
DISC-3405: Anti-TMPRSS6 Antibody
(Hepcidin Induction)
DISC-3405 is an investigational, anti-TMPRSS6
(Transmembrane Serine Protease 6, also known as Matriptase-2)
monoclonal antibody designed to increase hepcidin production and
restrict serum iron.
- Initiated a
Phase 1 study in healthy volunteers in October 2023
- Received FDA
fast track designation in September 2023 for DISC-3405 for the
treatment of PV
Third Quarter 2023 Financial
Results:
- Cash Position:
Cash and cash equivalents were $370.5 million as of September 30,
2023, which are expected to fund our operational plans well into
2026.
- Research and Development
Expenses: R&D expenses were $14.4 million for the
quarter ended September 30, 2023, as compared to $7.9 million for
the quarter ended September 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 and drug manufacturing, study initiation for DISC-3405, and
increased headcount.
- General and Administrative
Expenses: G&A expenses were $4.5 million for the
quarter ended September 30, 2023, as compared to $2.6 million for
the same period in 2022. The increase in G&A expenses was
primarily due to increased headcount.
- Net Loss: Net loss
was $14.1 million for the quarter ended September 30, 2023, as
compared to $16.2 million for the third quarter of 2022. Although
operating expenses increased in the current period relative to the
prior period due to increased product development activities, these
increases were offset by increased interest income and the absence
of the change in fair value of the derivative liability related to
a one-time share issuance obligation to F. Hoffmann-La Roche Ltd
and Hoffmann-La Roche Inc. in connection with the bitopertin
license agreement which was settled in late 2022.
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 the results
thereof, and its Phase 1b/2 study of bitopertin in Diamond-Blackfan
Anemia, its Phase 1b/2 clinical studies of DISC-0974 in patients
with MF and NDD-CKD patients with anemia, its Phase 1 clinical
study of DISC-3405 in healthy volunteers; projected timelines for
the initiation and completion of its clinical trials, anticipated
timing of release of data, and other clinical activities; and
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; that enrollment timelines of both the BEACON
and AURORA studies may not necessarily be predictive of future
enrollment timelines; the timing of initiation of Disc’s planned
clinical trials; Disc’s ability to retain and recognize the
intended incentives conferred by Fast Track Designation for its
product candidates including DISC-3405; 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 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 September 30, |
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
14,419 |
|
|
$ |
7,886 |
|
|
$ |
46,699 |
|
|
$ |
23,421 |
|
General and administrative |
|
|
4,539 |
|
|
|
2,593 |
|
|
|
14,712 |
|
|
|
9,033 |
|
Total operating expenses |
|
|
18,958 |
|
|
|
10,479 |
|
|
|
61,411 |
|
|
|
32,454 |
|
Loss from operations |
|
|
(18,958) |
|
|
|
(10,479) |
|
|
|
(61,411) |
|
|
|
(32,454) |
|
Other income (expense), net |
|
|
4,856 |
|
|
|
(5,671) |
|
|
|
8,628 |
|
|
|
(3,129) |
|
Income tax expense |
|
|
(20) |
|
|
|
— |
|
|
|
(67) |
|
|
|
— |
|
Net loss |
|
$ |
(14,122) |
|
|
$ |
(16,150) |
|
|
$ |
(52,850) |
|
|
$ |
(35,583) |
|
Weighted-average common shares outstanding-basic and diluted |
|
|
24,316,817 |
|
|
|
960,317 |
|
|
|
21,605,202 |
|
|
|
943,058 |
|
Net loss per share-basic and diluted |
|
$ |
(0.58) |
|
|
$ |
(16.82) |
|
|
$ |
(2.45) |
|
|
$ |
(37.73) |
|
|
|
|
|
|
|
|
|
|
|
DISC MEDICINE, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
(Unaudited) |
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
370,541 |
|
|
$ |
194,611 |
|
Other current assets |
|
|
3,722 |
|
|
|
3,880 |
|
Total current assets |
|
|
374,263 |
|
|
|
198,491 |
|
Non-current assets |
|
|
2,234 |
|
|
|
1,714 |
|
Total assets |
|
$ |
376,497 |
|
|
$ |
200,205 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
$ |
14,416 |
|
|
$ |
22,578 |
|
Non-current liabilities |
|
|
3,107 |
|
|
|
1,027 |
|
Total liabilities |
|
|
17,523 |
|
|
|
23,605 |
|
Total stockholders’ equity |
|
|
358,974 |
|
|
|
176,600 |
|
Total liabilities and stockholders’ equity |
|
$ |
376,497 |
|
|
$ |
200,205 |
|
|
Media Contact
Peg RusconiVerge Scientific
Communicationsprusconi@vergescientific.com
Investor Relations Contact
Christina TartagliaStern Investor
Relationschristina.tartaglia@sternir.com
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