false 0001816736 0001816736 2023-08-11 2023-08-11












Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2023




(Exact name of registrant as specified in its charter)




Delaware   001-39438   85-1612845
(State or other jurisdiction
of incorporation)
File Number)
  (IRS Employer
Identification No.)


321 Arsenal Street, Suite 101, Watertown, MA 02472   02472
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 674-9274


(Former Name or Former Address, if Changed Since Last Report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4© under the Exchange Act (17 CFR 240.13e-4©)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class




Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   IRON   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.




Item 2.02

Results of Operations and Financial Condition.

On August 11, 2023, Disc Medicine, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2023 and provided a corporate update. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

The following exhibit relating to Item 2.02 of this Current Report on Form 8-K shall be deemed to be furnished and not filed:




99.1    Press Release issued by Disc Medicine, Inc. on August 11, 2023
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: August 11, 2023     By:  

/s/ John Quisel

    Name:   John Quisel, J.D. Ph.D.
    Title:   Chief Executive Officer

Exhibit 99.1



Disc Medicine Reports Second Quarter 2023 Financial Results and Provides Business Update



Presented positive initial safety and efficacy data from BEACON trial at the European Hematology Association (EHA) Congress in June 2023; data from all patients in BEACON to be presented year-end 2023



Initiated phase 1/2 study of bitopertin in patients with Diamond-Blackfan Anemia who have failed corticosteroid treatment



Enrolling patients in two separate Phase 1b/2 studies for DISC-0974, one in patients with anemia of chronic kidney disease who are not receiving dialysis (NDD-CKD) and one in patients with myelofibrosis and anemia; initial data from both trials expected by year-end 2023



Strengthened financial position through $158 million upsized public offering; ended Q2 with approximately $378 million in cash that is expected to fund operations well into 2026

WATERTOWN, Mass. (August 11, 2023) – 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 ending June 30, 2023, and provided an update on recent program and corporate developments.

“This was a landmark quarter for our company, as we presented positive initial data from the BEACON study at EHA, which showed the promise of bitopertin as a potential treatment for EPP. The BEACON data catalyzed the successful completion of an upsized public offering, which provides runway well beyond key read-outs across our portfolio and positions us to advance bitopertin into late-stage development,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We continue to make excellent progress across our portfolio and look forward to providing updated results from BEACON and our other studies at the end of the year.”

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.



Presented positive initial data from BEACON, an open-label Phase 2 clinical study of bitopertin in patients with EPP and X-linked protoporphyria (XLP), demonstrating:



Consistent and dose-dependent reductions of protoporphyrin IX (PPIX), the disease-causing metabolite in EPP



Significant improvements in sunlight tolerance and quality of life



Bitopertin was well-tolerated, with no meaningful changes in hemoglobin



Continued enrollment for AURORA, a Phase 2 randomized, placebo-controlled clinical study of bitopertin in adults with EPP. Disc expects to have data by year-end 2023, to be presented in early 2024.



Initiated and enrolled first patient in an NIH-sponsored Phase 1/2 study of bitopertin in patients with Diamond-Blackfan Anemia in July 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.



Enrollment ongoing for a Phase 1b/2 clinical study of patients with anemia of chronic kidney disease who are not receiving dialysis (NDD-CKD); initial data expected by year-end 2023



Continued enrollment in a Phase 1b/2 clinical study in MF patients with severe anemia on stable background therapy; initial data expected by year-end 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.



Continued technology transfer and study preparation activities for MWTX-003. Disc plans to initiate a Phase 1 study 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.




Completed an upsized public offering of common stock and pre-funded warrants in June 2023 for $157.8 million in gross proceeds.

Second Quarter 2023 Financial Results:



Cash Position: Cash and cash equivalents were $377.6 million as of June 30, 2023, which are expected to fund our operational plans well into 2026.



Research and Development Expenses: R&D expenses were $12.1 million for the quarter ended June 30, 2023, as compared to $7.7 million for the quarter ended June 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, increased headcount, and costs related to technology transfer and study preparations for MWTX-003.



General and Administrative Expenses: G&A expenses were $5.2 million for the quarter ended June 30, 2023, as compared to $4.3 million for the same period in 2022. The increase in G&A expenses was primarily due to increased headcount.



Net Loss: Net loss was $15.9 million for the quarter ended June 30, 2023, as compared to $9.6 million for the second quarter of 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 its Phase 1b/2 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 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; 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, 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.





(In thousands, except share and per share amounts)



     Three Months Ended June 30,     Six Months Ended June 30,  
     2023     2022     2023     2022  

Operating expenses:


Research and development

   $ 12,100     $ 7,714     $ 32,280     $ 15,535  

General and administrative

     5,228       4,301       10,173       6,440  













Total operating expenses

     17,328       12,015       42,453       21,975  













Loss from operations

     (17,328     (12,015     (42,453     (21,975

Other income (expense), net

     1,405       2,435       3,772       2,542  

Income tax expense

     (24     —         (47     —    













Net loss

   $ (15,947   $ (9,580   $ (38,728   $ (19,433













Weighted-average common shares outstanding-basic and diluted

     21,484,955       944,706       20,226,923       934,286  













Net loss per share-basic and diluted

   $ (0.74   $ (10.14   $ (1.91   $ (20.80















(In thousands)



     June 30,      December 31,  
     2023      2022  



Cash and cash equivalents

   $ 377,602      $ 194,611  

Other current assets

     4,131        3,880  







Total current assets

     381,733        198,491  

Non-current assets

     2,441        1,714  







Total assets

   $ 384,174      $ 200,205  







Liabilities and Stockholders’ Equity


Current liabilities

   $ 9,683      $ 22,578  

Non-current liabilities

     3,272        1,027  







Total liabilities

     12,955        23,605  

Total stockholders’ equity

     371,219        176,600  







Total liabilities and stockholders’ equity

   $ 384,174      $ 200,205  









Media Contact

Peg Rusconi

Verge Scientific Communications


Investor Relations Contact

Christina Tartaglia

Stern Investor Relations