Disc Medicine Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
21 March 2024 - 11:00PM
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 fourth quarter and full year ended December 31, 2023, and
provided an update on recent program and corporate developments.
“The past year has been truly remarkable for
Disc and marks another important chapter in our company’s story.
During 2023, we provided the first evidence of the therapeutic
potential of our programs, with positive read-outs in patients for
both bitopertin and DISC-0974. In addition, we advanced a third
program, DISC-3405, into the clinic and fortified our balance
sheet, so we can execute our strategy with confidence,” said John
Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc.
“These achievements have positioned us well for 2024, which
promises to be another transformational year, and I want to express
my deep gratitude to our team for their determination and hard
work. We’re looking forward to sharing AURORA data in the coming
weeks, as well as updated data for DISC-0974 in MF and initial data
for DISC-3405 in healthy volunteers in the first half of this
year.”
Recent Business Highlights and Upcoming
Milestones:
Bitopertin: GlyT1 Inhibitor (Heme
Synthesis Modulator)
- Completed
enrollment of its phase 2 program of bitopertin in erythropoietic
porphyrias:
- BEACON, an
open-label phase 2 clinical study of bitopertin in patients with
EPP and X-linked protoporphyria (XLP), which was expanded to
include adolescents
- AURORA a phase 2
randomized, placebo-controlled clinical study of bitopertin in
adults with EPP
- Presented positive results from the
phase 2 BEACON trial at ASH 2023, showing:
- Significant, sustained reductions in
whole blood protoporphyrin IX (PPIX) levels >40%
- Robust and consistent improvements
across all measures of sunlight tolerance, including >3x
improvement over historical control of precedented pivotal
endpoint
- Bitopertin was generally
well-tolerated with stable hemoglobin at both dose levels
- Topline AURORA
data planned for press release and corporate presentation in
March/April 2024
DISC-0974: Anti-Hemojuvelin Antibody
(Hepcidin Suppression)
- Presented positive, initial data
from ongoing phase 1b/2 clinical study in MF patients with severe
anemia at ASH 2023:
- Treatment at initial dose levels (14
mg, 28 mg, 50 mg) resulted in substantial, dose-dependent decreases
in hepcidin and increases in serum iron
- Hematologic activity was observed in
MF patients, regardless of concomitant JAK inhibitor use. Four of
seven (57%) evaluable non-transfusion-dependent (NTD) patients
reached a >1.5g/dL hemoglobin increase and one of two
transfusion-dependent (TD) patients achieved transfusion
independence.
- DISC-0974 was generally
well-tolerated
- Enrollment and dose escalation is
ongoing
- Presented initial data from the 28
mg cohort of the ongoing phase 1b/2 clinical study of patients with
anemia of chronic kidney disease who are not receiving dialysis
(NDD-CKD)
- Data demonstrated meaningful
reductions in serum hepcidin and corresponding increases in serum
iron with a similar PK/PD profile as seen in Disc’s healthy
volunteer study
- Enrollment and dose escalation is
ongoing
- Updated phase 1b/2 data from
DISC-0974 in anemia in MF patients is expected to be presented in
the first half of 2024
- Updated phase 1b/2 data from
DISC-0974 in anemia in NDD-CKD is expected to be shared in the
second half of 2024
- Received FDA
fast track designation in February 2024 for DISC-0974 for the
treatment of anemia in NDD-CKD
DISC-3405: Anti-TMPRSS6 Antibody
(Hepcidin Induction)
- Initiated a
phase 1 SAD / MAD study in healthy volunteers in October 2023
- Initial SAD data
expected to be presented in the first half of 2024
- Received FDA
orphan drug designation in February 2024 for DISC-3405 for the
treatment of PV
Corporate:
- As the company enters late-stage
development and begins planning for commercialization, Disc
expanded its leadership team with the appointments of industry
veterans Jean Franchi as Chief Financial Officer and Pamela
Stephenson as Chief Commercial Officer, and the promotion of
Jonathan Yu to Chief Operating Officer
Full Year 2023 Financial
Results:
- Cash Position:
Cash and cash equivalents were $360.4 million as of December 31,
2023, which are expected to fund our operational plans well into
2026, compared to $194.6 million as of December 31, 2022. The
increase was primarily due to the completion of a registered direct
offering in February 2023 and a publicly marketed follow-on
offering in June 2023.
- Research and Development
Expenses: R&D expenses were $69.3 million for the full
year ended December 31, 2023, as compared to $33.4 million for the
full year ended December 31, 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, phase 1 study initiation for DISC-3405, and
increased headcount.
- General and Administrative
Expenses: G&A expenses were $21.9 million for the full
year ended December 31, 2023, as compared to $14.0 million for the
full year ended December 31, 2022. The increase in G&A expenses
was primarily due to increased headcount and increased costs as a
public company.
- Net Loss: Net loss
was $76.4 million for the full year ended December 31, 2023, as
compared to $46.8 million for the full year ended December 31,
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 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; Disc’s business plans, objectives and
expected contributions of management; 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 and DISC-0974; Disc’s
ability to retain and recognize the intended incentives conferred
by Orphan Drug Designation for DISC-3405 and bitopertin; 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, 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) |
|
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
69,264 |
|
|
$ |
33,437 |
|
General and administrative |
|
|
21,861 |
|
|
|
14,038 |
|
Total operating expenses |
|
|
91,125 |
|
|
|
47,475 |
|
Loss from operations |
|
|
(91,125 |
) |
|
|
(47,475 |
) |
Other income (expense), net |
|
|
14,795 |
|
|
|
648 |
|
Income tax expense |
|
|
(99 |
) |
|
|
— |
|
Net loss |
|
$ |
(76,429 |
) |
|
$ |
(46,827 |
) |
Weighted-average common shares
outstanding-basic and diluted |
|
|
22,315,877 |
|
|
|
1,039,490 |
|
Net loss per share-basic and
diluted |
|
$ |
(3.42 |
) |
|
$ |
(45.05 |
) |
|
|
|
|
|
|
|
|
|
|
DISC MEDICINE, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
|
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
360,382 |
|
|
$ |
194,611 |
|
Other current assets |
|
|
5,280 |
|
|
|
3,880 |
|
Total current assets |
|
|
365,662 |
|
|
|
198,491 |
|
Non-current assets |
|
|
2,334 |
|
|
|
1,714 |
|
Total assets |
|
$ |
367,996 |
|
|
$ |
200,205 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
$ |
21,439 |
|
|
$ |
22,578 |
|
Non-current liabilities |
|
|
1,436 |
|
|
|
1,027 |
|
Total liabilities |
|
|
22,875 |
|
|
|
23,605 |
|
Total stockholders’ equity |
|
|
345,121 |
|
|
|
176,600 |
|
Total liabilities and
stockholders’ equity |
|
$ |
367,996 |
|
|
$ |
200,205 |
|
Media Contact
Peg RusconiVerge Scientific
Communicationsprusconi@vergescientific.com
Investor Relations Contact
Christina TartagliaStern Investor
Relationschristina.tartaglia@sternir.com
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