Disc Medicine Reports First Quarter 2024 Financial Results and Provides Business Update
May 09 2024 - 8:00AM
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 ended March 31, 2024.
“The topline data from AURORA, presented in
April, strengthened our belief that bitopertin is active. These
data confirmed that bitopertin significantly reduced toxic PPIX in
EPP patients and led to reduced phototoxic pain reactions and
improved quality of life. We look forward to building upon this and
sharing additional data from the AURORA and BEACON studies in June
as we move towards regulatory interactions in the second half of
the year,” said John Quisel, J.D., Ph.D., President and Chief
Executive Officer of Disc. “We also look forward to our additional
readouts of updated data for DISC-0974 in anemia of myelofibrosis
and initial data on DISC-3405 in healthy volunteers, both in
June.”
Recent Business Highlights and Upcoming
Milestones:
Bitopertin: GlyT1 Inhibitor (Heme
Synthesis Modulator)
- Presented results from the phase 2
AURORA trial in April 2024, showing:
- Significant, dose-dependent, and
sustained reductions in whole blood protoporphyrin IX (PPIX)
levels
- Improvement on measures of light
tolerance, including the precedented regulatory endpoint of
cumulative time in light on days without pain, but did not meet
statistical significance due to a benefit in the placebo arm that
was greater than expected
- Dose-dependent reductions in
phototoxic reactions with pain, reaching statistical significance
for the 60 mg group
- Dose-dependent improvements in the
Patient Global Impression of Change, with statistical significance
at the 60 mg dose group compared to placebo
- Bitopertin was generally
well-tolerated with stable hemoglobin at both dose levels
- Additional
analyses from the AURORA and BEACON trials to be presented in Q2
2024
- Regulatory
interactions to define optimal registrational endpoints moving
forward in EPP expected to occur in the second half of 2024
- Received FDA
Rare Pediatric Disease Designation (RPD) in May 2024 for the
treatment of EPP
DISC-0974: Anti-Hemojuvelin Antibody
(Hepcidin Suppression)
- Updated phase 1b/2 data from
DISC-0974 in anemia in MF patients will be presented in Q2 2024,
including safety and changes in hepcidin, iron, and hemoglobin
levels for additional patients, as well as longer follow-up for
patients included in the data set presented at the 2023 American
Society of Hematology Annual Meeting
- Updated phase 1b/2 data from
DISC-0974 in anemia in non-dialysis-dependent chronic kidney
disease (NDD-CKD) is expected to be shared in the second half of
2024
DISC-3405: Anti-TMPRSS6 Antibody
(Hepcidin Induction)
- Initial
pharmacokinetic and pharmacodynamic data from SAD cohorts expected
to be presented in Q2 2024
First Quarter 2024 Financial
Results:
- Cash Position:
Cash and cash equivalents were $342.6 million as of March 31, 2024,
which are expected to fund our operational plans well into
2026.
- Research and Development
Expenses: R&D expenses were $23.7 million for the
quarter ended March 31, 2024, as compared to $20.2 million for the
quarter ended March 31, 2023. 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, and increased headcount.
- General and Administrative
Expenses: G&A expenses were $7.8 million for the
quarter ended March 31, 2024, as compared to $4.9 million for the
quarter ended March 31, 2023. The increase in G&A expenses was
primarily due to increased headcount.
- Net Loss: Net loss
was $26.9 million for the quarter ended March 31, 2024, as compared
to $22.8 million for the quarter ended March 31, 2023.
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, its phase 1b/2 clinical studies
of DISC-0974 in patients with MF and NDD-CKD patients with anemia,
its initial SAD data in 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; 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, Quarterly Report for the quarter
ended March 31, 2024, 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 March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
23,704 |
|
|
$ |
20,180 |
|
General and
administrative |
|
|
7,758 |
|
|
|
4,945 |
|
Total operating expenses |
|
|
31,462 |
|
|
|
25,125 |
|
Loss from operations |
|
|
(31,462 |
) |
|
|
(25,125 |
) |
Other income (expense),
net |
|
|
4,518 |
|
|
|
2,367 |
|
Income tax expense |
|
|
(5 |
) |
|
|
(23 |
) |
Net loss |
|
$ |
(26,949 |
) |
|
$ |
(22,781 |
) |
Weighted-average common shares
outstanding-basic and diluted |
|
|
24,809,869 |
|
|
|
18,954,914 |
|
Net loss per share-basic and
diluted |
|
$ |
(1.09 |
) |
|
$ |
(1.20 |
) |
|
|
|
|
|
|
|
|
|
|
DISC MEDICINE, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
(Unaudited) |
|
|
March 31, |
|
December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
342,615 |
|
|
$ |
360,382 |
|
Other current assets |
|
|
9,333 |
|
|
|
5,280 |
|
Total current assets |
|
|
351,948 |
|
|
|
365,662 |
|
Non-current assets |
|
|
2,234 |
|
|
|
2,334 |
|
Total assets |
|
$ |
354,182 |
|
|
$ |
367,996 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
$ |
14,852 |
|
|
$ |
21,439 |
|
Non-current liabilities |
|
|
1,259 |
|
|
|
1,436 |
|
Total liabilities |
|
|
16,111 |
|
|
|
22,875 |
|
Total stockholders’
equity |
|
|
338,071 |
|
|
|
345,121 |
|
Total liabilities and
stockholders’ equity |
|
$ |
354,182 |
|
|
$ |
367,996 |
|
Media Contact
Peg RusconiVerge Scientific
Communicationsprusconi@vergescientific.com
Investor Relations Contact
Christina TartagliaStern Investor
Relationschristina.tartaglia@sternir.com
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