– Initiated the Phase 1/1b CLARITY-101 clinical trial of DMR-001 in patients with mutant calreticulin (mutCALR)-driven essential thrombocythemia (ET) and myelofibrosis (MF) –
– Presented DMR-001 preclinical data at the European Hematology Association (EHA) 2026 Congress, showcasing best-in-class potential –
– Appointed biotech veteran Dr. Andrew Cheng to the Board of Directors –
– Strong financial position with $540.5 million in cash and cash equivalents as of June 30, 2026, expected to fund operations into the second half of 2029 –
WALTHAM, Mass., Aug. 10, 2026 (GLOBE NEWSWIRE) — Damora Therapeutics, Inc. (NASDAQ: DMRA), a biotechnology company working to fundamentally redefine care for patients with blood disorders, today announced its operating and financial results for the quarter ended June 30, 2026, and recent corporate highlights.
“Following the recent achievement of our first major clinical milestone – the initiation of the CLARITY-101 trial of DMR-001 in patients with mutCALR-driven myeloproliferative neoplasm (MPNs) – we are moving with urgency to advance development of this potentially best-in-class long-acting anti-mutCALR antibody because we know patients are waiting,” said Jennifer Jarrett, President and Chief Executive Officer of Damora Therapeutics. “At the EHA 2026 Congress in June, we presented preclinical data that showed clear differentiation for DMR-001, including best-in-class potency across both major mutation subtypes and a half-life predicted to enable convenient, once-monthly subcutaneous dosing. Advancing from the presentation of these data into the clinic within weeks reflects the pace we intend to keep, and we’re eager to present initial clinical evidence of DMR-001’s unique potential beginning in mid-2027.”
Recent Business Highlights
- Initiated the global Phase 1/1b CLARITY-101 trial to evaluate the safety, tolerability and efficacy of DMR-001 in patients with mutCALR-driven ET and MF, based on receipt of health authority approval. The Phase 1 dose escalation portion of the trial is designed to rapidly identify a recommended dose for expansion cohorts, with a starting dose of 100 mg (subcutaneous, monthly) expected to be in the range of anticipated therapeutic exposure and an adaptive Bayesian design enabling cohort enrichment. The planned Phase 1b expansion portion of the trial will further evaluate the safety and efficacy of DMR-001 in additional populations and settings, including in early-line disease and in combination with other therapies. Read the press release here.
- Presented DMR-001 preclinical data at the EHA 2026 Congress (Abstract PF873), highlighting its best-in-class potential. In head-to-head preclinical studies versus a reference anti-mutCALR antibody, DMR-001 showed up to 30-fold higher binding affinity for mutCALR, 26-fold greater inhibition of cellular proliferation in Type 2 mutCALR, and five-fold longer half-life in non-human primates. Based on these data, DMR-001 is predicted to have robust activity across mutCALR subtypes with convenient once-monthly subcutaneous dosing. See the poster presentation here.
- Appointed Andrew Cheng, M.D., Ph.D., to the Board of Directors. Dr. Cheng has served as President, Chief Executive Officer and Chairman of the Board of Avere Therapeutics since 2026. He previously served as President and Chief Executive Officer of Akero Therapeutics, Inc. from 2018 until its acquisition by Novo Nordisk in December 2025, where he also served on the board of directors. Prior to Akero, Dr. Cheng spent nearly two decades at Gilead Sciences, Inc., including as Senior Vice President from 2009 to 2015, Executive Vice President from 2015 to 2018, and Chief Medical Officer in 2018. Dr. Cheng has served on the board of directors of Vera Therapeutics, Inc. since 2017, where he chairs the nominating and corporate governance committee. Dr. Cheng received his M.D. and Ph.D. from Columbia University College of Physicians and Surgeons and completed his internal medicine residency at the University of California, Los Angeles.
Anticipated Milestones
- DMR-002 (Fc enhanced, half-life extended anti-mutCALR monoclonal antibody): first regulatory submission expected in the second half of 2026
- DMR-003 (T-cell engager anti-mutCALR/CD3 bispecific antibody): first regulatory submission expected in 2027
- Two clinical proof-of-concept datasets for DMR-001 (Fc null, half-life extended anti-mutCALR monoclonal antibody) anticipated beginning mid-2027
Second Quarter 2026 Financial Results
Financial results for the second quarter of 2026 follow the acquisition of rights to the Company’s anti-mutCALR portfolio, appointment of new board and executive leadership, and the renaming of the Company, together completed in the first quarter of 2026.
Cash Position: Cash and cash equivalents were approximately $540.5 million as of June 30, 2026. The Company anticipates that its cash and cash equivalents will be sufficient to fund operations into the second half of 2029. Net cash used in operating activities was $21.9 million for the second quarter of 2026.
R&D Expenses: Research and development expenses were $25.5 million for the three months ended June 30, 2026, compared to $1.5 million for the three months ended June 30, 2025. The increase was primarily driven by increased preclinical research, manufacturing and personnel costs, including non-cash stock-based compensation charges of $4.5 million related to a warrant obligation pursuant to the Antibody Discovery and Option Agreement that the Company has with Paragon Therapeutics and $1.5 million related to personnel.
G&A Expenses: General and administrative expenses were $9.5 million for the three months ended June 30, 2026, compared to $2.0 million for the three months ended June 30, 2025. The increase was primarily driven by increased personnel costs, along with increased professional fees. Non-cash stock-based compensation (personnel-related) increased by $4.5 million for the three months ended June 30, 2026.
Total Other Income: Other income was $4.1 million for the three months ended June 30, 2026, compared to less than $0.1 million for the three months ended June 30, 2025. The increase of $4.1 million was due to increased interest income because of the recent financings.
Net Loss: Net loss for the three months ended June 30, 2026, was $31.2 million, compared to $3.4 million for the three months ended June 30, 2025.
About Damora Therapeutics
Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with blood disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized therapies with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes. For more information, visit www.damoratx.com or follow us on LinkedIn.
Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its assets, pipeline and business including, without limitation, the timing for regulatory submissions for DMR-002 and DMR-003, the expected timing for Phase 1 data for DMR-001, the Company’s belief that its portfolio of assets have best-in-class potential, and the length of time that the Company believes its existing cash and cash equivalents will fund its operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the headings “Risk Factors,” “Cautionary Information Regarding Forward-Looking Statements” or “Cautionary Statement Regarding Forward-Looking Statements” in the Company’s most recent filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The Company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.
Investor/Media Contact:
Jim Baker
Chief Corporate Affairs Officer
Investors: [email protected]
Media: [email protected]
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DAMORA THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) |
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| June 30, | December 31, | ||||||
| 2026 | 2025 | ||||||
| Assets | (unaudited) | ||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 540,515 | $ | 257,624 | |||
| Prepaid expenses and other current assets | 3,073 | 2,799 | |||||
| Total current assets | 543,588 | 260,423 | |||||
| Other assets, noncurrent | 48 | 104 | |||||
| Total assets | $ | 543,636 | $ | 260,527 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 3,482 | $ | 444 | |||
| Accrued expenses and other current liabilities | 8,879 | 2,401 | |||||
| Paramora warrant obligation | 9,527 | — | |||||
| Related party accounts payable and other current liabilities | 5,662 | 17,221 | |||||
| Total current liabilities | 27,550 | 20,066 | |||||
| Other liabilities, noncurrent | 27 | 81 | |||||
| Total liabilities | $ | 27,577 | $ | 20,147 | |||
| Total stockholders’ equity | 516,059 | 240,380 | |||||
| Total liabilities and stockholders’ equity | $ | 543,636 | $ | 260,527 | |||
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DAMORA THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited) |
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| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 25,540 | $ | 1,465 | $ | 49,317 | $ | 2,143 | |||||||
| General and administrative | 9,454 | 1,956 | 16,488 | 3,877 | |||||||||||
| Total operating expenses | 34,994 | 3,421 | 65,805 | 6,020 | |||||||||||
| Loss from operations | (34,994 | ) | (3,421 | ) | (65,805 | ) | (6,020 | ) | |||||||
| Other income (expense), net | |||||||||||||||
| Interest income, net | 4,059 | 50 | 7,129 | 124 | |||||||||||
| Foreign currency transaction gain (loss), net | 16 | (62 | ) | 16 | (68 | ) | |||||||||
| Total other income, net | 4,075 | (12 | ) | 7,145 | 56 | ||||||||||
| Loss before income tax expense | (30,919 | ) | (3,433 | ) | (58,660 | ) | (5,964 | ) | |||||||
| Income tax expense | (255 | ) | (4 | ) | (297 | ) | (6 | ) | |||||||
| Net loss | $ | (31,174 | ) | $ | (3,437 | ) | $ | (58,957 | ) | $ | (5,970 | ) | |||
