Initiated enrollment of Phase 1 Study of PRT12396, mutant-selective JAK2V617F inhibitor in patients with polycythemia vera (PV) and myelofibrosis (MF)
The Company expects to file the IND for PRT13722, first-in-class highly-selective oral KAT6A degrader, by mid-2026 with Phase 1 study initiation in ER+ breast cancer anticipated in the 2H 2026
Presented preclinical data demonstrating differentiated profile of PRT13722, at the
Appointed
Current cash runway expected into second quarter of 2028 based on preliminary estimates, driven by previously announced underwritten offering with gross proceeds of
“Through this first quarter of 2026, our company has continued to demonstrate focused execution of the strategic priorities we set forth late last year.” stated
Program Updates and Upcoming Milestones
Mutant selective JAK2V617F JH2 inhibitor program
JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs. Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 “deep pocket” where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.
PRT12396, Prelude’s lead, mutant-selective JAK2V617F inhibitor received IND clearance from the
The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in
Highly selective KAT6A oral degrader program
KAT6 is an emerging and recently validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. The Company has selected a development candidate, PRT13722 and remains on track to file an IND application in mid-2026, and pending clearance, phase 1 study initiation expected in the 2nd half of 2026. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B.
The Company presented preclinical data supporting this hypothesis at the AACR Annual Meeting 2026. The presentation can be found at Publications -
Degrader payloads for next generation DACs
Prelude is leveraging our expertise in targeted protein degradation to discover and develop novel degrader payloads for use with next generation DACs. We have developed highly potent SMARCA2/4 and CDK9 degrader payloads optimized for efficacy, tolerability and developability when coupled to a wide range of different antibodies. Building on our existing DAC partnership with AbCellera, the Company’s payloads and corresponding payload-linkers are available for licensing to additional partners to expand the reach of this new technology.
We have recently published preclinical data demonstrating that next generation DACs using Prelude degrader payloads have potential for significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. These data can be found at: Publications –
Mutated calreticulin (mCALR) DAC discovery program
Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25-35% of patients with MF and essential thrombocythemia (ET). Recently, a mCALR-targeted monoclonal antibody demonstrated robust clinical activity in high-risk ET patients. Prelude is exploring mCALR-targeted DACs using the Company’s proprietary degrader payloads as a differentiated approach for patients with CALR mutations. This early discovery program is wholly owned and controlled by Prelude.
The Company presented the preclinical data from the program at the
Corporate Updates
In
Upcoming Investor Conferences
The Company will participate in the 2026
The Company will also participate in the Goldman Sachs 47th Annual Global Healthcare Conference taking place in
First Quarter 2026 Financial Results?
Cash, Cash Equivalents, Restricted cash and Marketable securities:
Cash, cash equivalents, restricted cash and marketable securities as of
Research and Development (R&D) Expenses:
For the three months ended
General and Administrative (G&A) Expenses:
For the three months ended
Net Loss:
For the three months ended
About
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates, the potential safety, efficacy, benefits and addressable market for Prelude’s product candidates, the expected timeline for clinical trial results for Prelude’s product candidates, and the sufficiency of Prelude’s cash runway into the second quarter of 2028. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in Prelude’s Annual Report on Form 10-K for the year ended
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) | |||||||
| Three Months Ended | |||||||
| (in thousands, except share and per share data) | 2026 | 2025 | |||||
| Revenue | $ | 4,580 | $ | — | |||
| Operating expenses | |||||||
| Research and development | 13,601 | 28,816 | |||||
| General and administrative | 5,156 | 5,790 | |||||
| Total operating expenses | 18,757 | 34,606 | |||||
| Loss from operations | (14,177 | ) | (34,606 | ) | |||
| Other income, net | 3,792 | 2,521 | |||||
| Net loss | $ | (10,385 | ) | $ | (32,085 | ) | |
| Per share information: | |||||||
| Net loss per share of common stock, basic and diluted | $ | (0.13 | ) | $ | (0.42 | ) | |
| Weighted average common shares outstanding, basic and diluted | 82,519,981 | 75,986,281 | |||||
| Comprehensive loss: | |||||||
| Net loss | $ | (10,385 | ) | $ | (32,085 | ) | |
| Unrealized loss on marketable securities, net of tax | (49 | ) | (23 | ) | |||
| Comprehensive loss | $ | (10,434 | ) | $ | (32,108 | ) | |
BALANCE SHEETS
| (in thousands, except share data) | 2026 | 2025 | |||||
| Assets | (unaudited) | ||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 21,756 | $ | 35,256 | |||
| Marketable securities | 59,798 | 67,958 | |||||
| Prepaid expenses and other current assets | 3,039 | 2,478 | |||||
| Total current assets | 84,593 | 105,692 | |||||
| Restricted cash | 3,235 | 3,235 | |||||
| Property and equipment, net | 4,722 | 5,113 | |||||
| Right-of-use asset | 26,778 | 27,165 | |||||
| Prepaid expenses and other non-current assets | 314 | 110 | |||||
| Total assets | $ | 119,642 | $ | 141,315 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,069 | $ | 3,983 | |||
| Accrued expenses and other current liabilities | 5,938 | 12,533 | |||||
| Deferred revenue | 30,952 | 33,734 | |||||
| Operating lease liability | 2,761 | 2,744 | |||||
| Total current liabilities | 41,720 | 52,994 | |||||
| Deferred revenue, net of current portion | — | 1,798 | |||||
| Other liabilities | 2,779 | 2,841 | |||||
| Operating lease liability | 14,960 | 15,045 | |||||
| Total liabilities | 59,459 | 72,678 | |||||
| Commitments (Note 8) | |||||||
| Stockholders’ equity: | |||||||
| Voting common stock, 48,290,087 and 48,225,493 shares issued and outstanding at 2026 and | 5 | 5 | |||||
| Non-voting common stock, authorized; 14,728,135 shares issued and outstanding at both 2026 and | 1 | 1 | |||||
| Additional paid-in capital | 753,664 | 751,684 | |||||
| Accumulated other comprehensive (loss) income | (41 | ) | 8 | ||||
| Accumulated deficit | (693,446 | ) | (683,061 | ) | |||
| Total stockholders’ equity | 60,183 | 68,637 | |||||
| Total liabilities and stockholders’ equity | $ | 119,642 | $ | 141,315 | |||
Investor Contact:
Senior Vice President, Investor Relations
484.639.7235
rdoody@preludetx.com
