Disc Medicine Reports Second Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

Disc Medicine (NASDAQ:IRON) reported Q2 2024 financial results and provided a business update. The company presented positive data for all three programs at the EHA 2024 Congress, demonstrating potential efficacy for bitopertin in EPP and DISC-0974 in anemia of myelofibrosis. Disc plans to provide updates on regulatory interactions for these programs in H2 2024. The company strengthened its financial position through a $178 million common stock offering, ending Q2 with $501 million in cash, expected to fund operations into 2027.

Financial highlights include R&D expenses of $23.5 million, up from $12.1 million in Q2 2023, and G&A expenses of $7.4 million, up from $5.2 million. The net loss for Q2 2024 was $26.4 million, compared to $15.9 million in Q2 2023. Disc Medicine continues to advance its portfolio, with upcoming milestones including regulatory discussions and data readouts in H2 2024.

Positive

• Presented positive data for all three programs at EHA 2024 Congress
• Raised $178 million through common stock offering
• Cash position of $501 million, expected to fund operations into 2027
• Demonstrated potential efficacy for bitopertin in EPP and DISC-0974 in anemia of myelofibrosis
• Advancing regulatory interactions for bitopertin and DISC-0974 in H2 2024

Negative

• Increased net loss to $26.4 million in Q2 2024 from $15.9 million in Q2 2023
• R&D expenses increased to $23.5 million from $12.1 million year-over-year
• G&A expenses rose to $7.4 million from $5.2 million year-over-year

Financial Analyst

Disc Medicine's Q2 2024 results show a strong financial position with $500.9 million in cash and equivalents, bolstered by a $178 million public offering. This runway extends well into 2027, providing ample resources for ongoing clinical trials. However, the net loss widened to $26.4 million from $15.9 million year-over-year, primarily due to increased R&D expenses ($23.5 million, up from $12.1 million). This escalation in spending reflects the company's aggressive pursuit of clinical milestones across its portfolio, which could potentially lead to valuable data readouts in the near future.

Medical Research Analyst

Disc Medicine's pipeline shows promising progress across three key programs. The bitopertin data in EPP and DISC-0974 results in anemia of myelofibrosis demonstrate potential efficacy, while DISC-3405's Phase 1 results provide proof of mechanism. The upcoming regulatory interactions for bitopertin and DISC-0974 in H2 2024 are critical milestones that could accelerate their development paths. The diverse portfolio targeting various hematologic diseases positions Disc well in the competitive landscape, with potential for multiple value-creating catalysts in the near term.

Market Research Analyst

Disc Medicine's recent data presentations at EHA 2024 have significantly boosted investor confidence, as evidenced by the successful $178 million public offering. The company's focus on serious hematologic diseases addresses substantial unmet medical needs, potentially leading to lucrative market opportunities. The planned regulatory interactions in H2 2024 for bitopertin and DISC-0974 could be pivotal for future valuations. With a cash runway extending to 2027, Disc is well-positioned to navigate clinical development risks and capitalize on positive outcomes, making it an intriguing prospect for investors in the biotech sector.

• Presented positive data for all three programs at the European Hematology Association (EHA) 2024 Congress; demonstrated potential efficacy for bitopertin in erythropoietic protoporphyria (EPP) and DISC-0974 in anemia of myelofibrosis (MF), as well as proof of mechanism in a Phase 1 study for DISC-3405
• Plan to provide an update on regulatory interactions for bitopertin in EPP and DISC-0974 in anemia of MF in the second half of 2024
• Strengthened financial position through an underwritten offering of common stock for $178 million in gross proceeds, ending Q2 with $501 million in cash, cash equivalents, and marketable securities that is expected to fund operations well into 2027
  

WATERTOWN, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- 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 ended June 30, 2024.

“The data we presented at EHA this past quarter were highly encouraging and supportive of the therapeutic potential of our entire portfolio,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “These data catalyzed the successful completion of a financing supported by a prestigious group of investors, which provides runway through key readouts across our programs over the next few years. We continue to make great progress and look forward to sharing updates on our regulatory interactions around bitopertin and DISC-0974 in the second half of the year.”

Recent Business Highlights and Upcoming Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

• Presented updated results from AURORA showing that bitopertin had a meaningful impact on key aspects of EPP, and providing a range of potential efficacy endpoints
• End of Phase 2 meeting to discuss optimal registrational endpoints moving forward in EPP is expected to occur in the second half of 2024

DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

• Presented updated Phase 1b data from DISC-0974 in anemia of MF patients demonstrating a durable hemoglobin response in the majority of patients and a positive impact on transfusion burden across a broad range of participants
• Plan for interactions with regulators in the second half of 2024 to determine the optimal Phase 2 study design in anemia of MF
• Updated Phase 1b 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)

• Presented initial data from the single-ascending dose (SAD) cohorts of the ongoing Phase 1 study in healthy volunteers, which demonstrated proof of mechanism with substantial increases in hepcidin levels and sustained reductions in serum iron supportive of monthly subcutaneous dosing, as well as positive impact on hematologic parameters at the highest dose
• Data from the multiple ascending dose (MAD) cohorts of this study expected to be shared in the second half of 2024

Corporate

• Completed an underwritten public offering of common stock in June 2024 for $178.0 million in gross proceeds
  

Second Quarter 2024 Financial Results:

• Cash Position: Cash, cash equivalents, and marketable securities were $500.9 million as of June 30, 2024, which are expected to fund our operational plans well into 2027.
• Research and Development Expenses: R&D expenses were $23.5 million for the quarter ended June 30, 2024, as compared to $12.1 million for the quarter ended June 30, 2023. The increase in R&D expenses were primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, and advancing our DISC-0974 and DISC-3405 programs in the clinic, and increased headcount.
• General and Administrative Expenses: G&A expenses were $7.4 million for the quarter ended June 30, 2024, as compared to $5.2 million for the quarter ended June 30, 2023. The increase in G&A expenses was primarily due to increased headcount.
• Net Loss: Net loss was $26.4 million for the quarter ended June 30, 2024, as compared to $15.9 million for the quarter ended June 30, 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 trials of bitopertin and the results thereof, its Phase 1b/2 clinical trial of DISC-0974 in patients with MF and NDD-CKD patients with anemia, its initial SAD data in its Phase 1 clinical trial of DISC-3405 in healthy volunteers; and projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; and Disc’s belief about operating expenses and that it will have capital to fund Disc well into 2027. 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 2023, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 and June 30, 2024, and other documents filed by Disc from time to time with the Securities and Exchange Commission (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,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	23,485			$	12,100			$	47,189			$	32,280
General and administrative			7,367				5,228				15,125				10,173
Total operating expenses			30,852				17,328				62,314				42,453
Loss from operations			(30,852	)			(17,328	)			(62,314	)			(42,453	)
Other income (expense), net			4,560				1,405				9,078				3,772
Income tax expense			(60	)			(24	)			(65	)			(47	)
Net loss		$	(26,352	)		$	(15,947	)		$	(53,301	)		$	(38,728	)
Weighted-average common shares outstanding-basic and diluted	​		25,649,043				21,484,955				25,229,456				20,226,923
Net loss per share-basic and diluted		$	(1.03	)		$	(0.74	)		$	(2.11	)		$	(1.91	)

DISC MEDICINE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
		June 30,				December 31,
		2024				2023
Assets
Cash, cash equivalents, and marketable securities		$	500,945			$	360,382
Other current assets			7,296				5,280
Total current assets			508,241				365,662
Non-current assets			1,976				2,334
Total assets		$	510,217			$	367,996
Liabilities and Stockholders’ Equity
Current liabilities		$	20,310			$	21,439
Non-current liabilities			1,078				1,436
Total liabilities			21,388				22,875
Total stockholders’ equity			488,829				345,121
Total liabilities and stockholders’ equity		$	510,217			$	367,996

Media Contact

Peg Rusconi
Verge Scientific Communications
prusconi@vergescientific.com

Investor Relations Contact

Christina Tartaglia
Stern Investor Relations
christina.tartaglia@sternir.com

FAQ

What were Disc Medicine's (IRON) Q2 2024 financial results?

Disc Medicine reported a net loss of $26.4 million, R&D expenses of $23.5 million, and G&A expenses of $7.4 million for Q2 2024. The company ended the quarter with $500.9 million in cash, cash equivalents, and marketable securities.

What clinical progress did Disc Medicine (IRON) report in Q2 2024?

Disc Medicine presented positive data for all three programs at the EHA 2024 Congress, showing potential efficacy for bitopertin in EPP and DISC-0974 in anemia of myelofibrosis, as well as proof of mechanism for DISC-3405 in a Phase 1 study.

How much funding did Disc Medicine (IRON) raise in Q2 2024?

Disc Medicine completed an underwritten public offering of common stock in June 2024, raising $178 million in gross proceeds.

What are the upcoming milestones for Disc Medicine (IRON) in 2024?

Disc Medicine plans to provide updates on regulatory interactions for bitopertin in EPP and DISC-0974 in anemia of myelofibrosis in the second half of 2024. The company also expects to share updated Phase 1b data for DISC-0974 in anemia of NDD-CKD and data from the MAD cohorts of the DISC-3405 Phase 1 study.