Prelude Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Prelude Therapeutics (Nasdaq: PRLD) reported Q2 2025 financial results and provided updates on its clinical pipeline. The company's oral SMARCA2 degrader PRT7732 is currently enrolling its seventh dosing cohort at 125mg, with preliminary data expected by year-end 2025. Prelude has completed Phase 1 study of PRT3789, its IV SMARCA2 degrader, but decided to pause its development to focus resources on PRT7732.
The company reported $77.3 million in cash and equivalents as of June 30, 2025, providing runway into Q2 2026. Q2 net loss was $31.2 million ($0.41 per share), improved from $34.7 million ($0.46 per share) in Q2 2024. The company remains on track to file an IND for its oral KAT6A degrader program in H1 2026.
Positive
- Cash runway extended into Q2 2026 with $77.3M in cash and equivalents
- PRT7732 oral SMARCA2 degrader advancing to seventh dose cohort
- Reduced net loss to $31.2M from $34.7M year-over-year
- On track for KAT6A degrader IND filing in H1 2026
Negative
- Discontinuation of PRT3789 IV SMARCA2 degrader program
- R&D expenses remain high at $25.8M despite decrease from prior year
- Operating loss of $32.2M in Q2 2025
Insights
Prelude's strategic focus on oral SMARCA2 degrader PRT7732 over IV PRT3789 reflects resource prioritization with critical data expected by year-end.
Prelude is making significant progress with PRT7732, its oral SMARCA2 degrader, which has reached the seventh dosing cohort (125mg) in Phase 1 trials. This accelerated enrollment pace is encouraging, as the company is targeting an aggressive timeline to deliver preliminary data by year-end 2025. The strategic decision to pause PRT3789 (IV formulation) development and focus solely on PRT7732 represents a critical pivot. While management indicated PRT3789 demonstrated proof-of-concept for the SMARCA2 degradation mechanism, they've determined the oral PRT7732 program offers superior characteristics, including once-daily dosing convenience and >90% target degradation.
The company's target indication focuses on SMARCA4-mutated cancers, which represent approximately 10% of non-small cell lung cancers and 5% of all cancers. These patients typically respond poorly to standard chemoimmunotherapy and lack eligibility for many targeted therapies, creating a substantial unmet need. The potential therapeutic value of selective SMARCA2 degradation in these populations remains scientifically sound - when SMARCA4 is mutated, cancer cells become dependent on SMARCA2, creating a synthetic lethality opportunity.
Prelude is also advancing a KAT6A degrader program with IND filing expected in H1 2026. Their preclinical data suggests selective KAT6A degradation could improve efficacy and tolerability compared to non-selective KAT6A/B inhibitors in ER+ breast cancer. The company's precision ADC pipeline utilizing SMARCA2/4 dual degrader payloads and mCALR-targeted ADCs for myelofibrosis represents additional opportunities, though these remain in earlier research stages.
Prelude's financial position remains stable with $77.3M cash providing runway into Q2 2026, though strategic program prioritization signals resource constraints.
Prelude's financial situation shows mixed signals in Q2 2025. The company reported
The decision to pause PRT3789 development despite showing proof-of-concept indicates capital constraint pressures. Management explicitly cited "capital needs to continue to advance both agents" as a factor in the decision, signaling prudent but necessary resource allocation.
Quarterly expenses showed meaningful decreases compared to the prior year period. R&D expenses fell to
The cash burn rate remains substantial relative to available resources. With
PRT7732, once daily oral SMARCA2 degrader, currently enrolling at the seventh dosing cohort (125 mg); Company to provide an update with preliminary clinical data, including PK/PD, safety and initial clinical activity by year end 2025
Phase 1 study of PRT3789, a once weekly IV SMARCA2 degrader, has been completed; Company to provide final data by year end 2025
Prelude is advancing a development candidate for its oral KAT6A degrader program and remains on track to file an IND in the first half of 2026
Current cash runway into the second quarter of 2026 with
WILMINGTON, Del., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for second quarter ended June 30, 2025, and provided an update on its clinical development pipeline and other corporate developments.
“From the discovery of first-in-class highly selective SMARCA2 degraders through Phase 1 studies in biomarker selected population of patients, Prelude demonstrated exemplary execution of our SMARCA2 program to deliver a potentially novel treatment option for patients with aggressive cancers harboring SMARCA4 deletion,” stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. “This past quarter, we completed our Phase 1 dose escalation of PRT3789 (IV), both as monotherapy and in combination with docetaxel. With the knowledge and experience gained through PRT3789 clinical development, we were able to expeditiously advance our oral program, PRT7732, which began in the fourth quarter of 2024. I am pleased with the progress made to date with PRT7732, which is currently enrolling our seventh dose cohort of 125 mg.”
Vaddi continued, “We’ve decided to pause further development of PRT3789, and focus solely on PRT7732 as our go-forward strategy for our SMARCA2 Program. While PRT3789 demonstrated initial proof of concept for the mechanism, a number of considerations – including the potential need for higher target coverage throughout the dosing interval, and capital needs to continue to advance both agents – contributed to this decision. The clinical profile observed to date with PRT7732 including oral once daily dosing, safety and tolerability, oral exposures, and >
Continued Vaddi, “We’ve made significant progress across our core research and development organization, while employing disciplined capital management through resource allocation and headcount management throughout the Company. Notably, we’ve continued to advance our KAT6A degrader program, on track for IND filing in the first half of 2026, presented preclinical data on mCALR-targeted ADCs and continued progress with our partner AbCellera related to precision ADCs.”
Clinical Program Updates and Upcoming Milestones
SMARCA2 Degrader Development Program
PRT3789 – A first-in-class, highly selective, intravenous SMARCA2 degrader
PRT3789 is designed to treat patients with a SMARCA4 mutation. Patients with SMARCA4-mutated cancer, a particularly aggressive form of the disease, have a very poor clinical prognosis. Approximately
PRT3789 has completed Phase 1 clinical development in patients with biomarker selected SMARCA4-mutated cancers. The Company anticipates providing updated data from the Phase 1 study by year-end 2025. Based on the totality of the data and available resources, the Company would only advance the program in the context of a partnership and will be focusing internal resources solely on PRT7732.
PRT7732 – A potent, highly selective and orally bioavailable SMARCA2 degrader
PRT7732 is a highly selective and orally bioavailable SMARCA2 degrader with a distinct chemical composition to PRT3789. In the fourth quarter of 2024, the Company initiated and enrolled the first patients in a phase 1 multi-dose escalation trial of PRT7732 (NCT06560645) in biomarker selected SMARCA4 mutated cancers. Enrollment continues to advance rapidly, and the Company is currently enrolling patients in the seventh dose escalation cohort (125 mg once daily). The Company expects to provide an initial first-in-human data update including PK/PD, safety and an initial look at clinical activity at biologically relevant doses by year end 2025.
Highly selective KAT6A oral degrader program
KAT6 is an emerging and recently validated target in the treatment of ER+ breast cancer and other malignancies. Prelude discovered and is developing the industry’s first – based on currently published patents and literature – highly potent, selective and orally bioavailable KAT6A selective degraders. The Company is now advancing a development candidate and remains on track to file an IND in the first 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 recently presented preclinical data validating this hypothesis at the AACR Annual Meeting 2025. The presentation can be found at Publications - Prelude Therapeutics.
Precision ADCs with SMARCA2/4 dual degrader payload
Prelude is developing potent SMARCA2/4 dual degraders that robustly inhibit cancer cell growth and induce cell death across multiple cancer types as payloads for precision ADCs. The Company presented the first preclinical data from its precision ADC platform at the 36th EORTC-NCI-AACR Symposium in October. These data demonstrated that SMARCA2/4 degrader antibody conjugates have potential for significantly better in vivo efficacy and tolerability when compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. The presentation can be found at Publications - Prelude Therapeutics.
Mutated Calreticulin (mCALR)
Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25
Second Quarter 2025 Financial Results
Cash, Cash Equivalents, Restricted Cash and Marketable Securities:
Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2025 were
Research and Development (R&D) Expenses:
For the second quarter of 2025, R&D expense decreased to
General and Administrative (G&A) Expenses:
For the second quarter of 2025, G&A expenses decreased to
Net Loss:
For the three months ended June 30, 2025, net loss was
About Prelude Therapeutics
Prelude Therapeutics is a leading precision oncology company developing innovative medicines in areas of high unmet need for cancer patients. Our pipeline is comprised of several novel drug candidates including first-in-class, highly selective SMARCA2 and KAT6A degraders, and ongoing research into other precision oncology targets. We are also leveraging our expertise in targeted protein degradation to discover, develop and commercialize next generation degrader antibody conjugates (Precision ADCs) with partners. We are on a mission to extend the promise of precision medicine to every cancer patient in need. Our corporate presentation can be found at Events & Presentations - Prelude Therapeutics. For more information, visit preludetx.com.
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 2026. 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 December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.
| PRELUDE THERAPEUTICS INCORPORATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) | ||||||||
| | Three Months Ended June 30, | |||||||
| (in thousands, except share and per share data) | 2025 | 2024 | ||||||
| Operating expenses | ||||||||
| Research and development | 25,784 | 29,509 | ||||||
| General and administrative | 6,410 | 7,655 | ||||||
| Total operating expenses | 32,194 | 37,164 | ||||||
| Loss from operations | (32,194 | ) | (37,164 | ) | ||||
| Other income, net | 963 | 2,424 | ||||||
| Net loss | $ | (31,231 | ) | $ | (34,740 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.41 | ) | $ | (0.46 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 75,993,941 | 75,762,152 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (31,231 | ) | $ | (34,740 | ) | ||
| Unrealized loss on marketable securities, net of tax | (13 | ) | (55 | ) | ||||
| Comprehensive loss | $ | (31,244 | ) | $ | (34,795 | ) | ||
| PRELUDE THERAPEUTICS INCORPORATED BALANCE SHEETS | ||||||||
| (in thousands, except share data) | June 30, 2025 | December 31, 2024 | ||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,752 | $ | 12,474 | ||||
| Marketable securities | 47,464 | 121,140 | ||||||
| Prepaid expenses and other current assets | 3,660 | 2,281 | ||||||
| Total current assets | 76,876 | 135,895 | ||||||
| Restricted cash | 4,044 | 4,044 | ||||||
| Property and equipment, net | 5,956 | 6,767 | ||||||
| Operating lease right-of-use asset | 27,932 | 28,699 | ||||||
| Other assets | 110 | 110 | ||||||
| Total assets | $ | 114,918 | $ | 175,515 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,962 | $ | 7,732 | ||||
| Accrued expenses and other current liabilities | 13,235 | 15,209 | ||||||
| Operating lease liability | 2,711 | 2,492 | ||||||
| Finance lease liability | — | 208 | ||||||
| Total current liabilities | 20,908 | 25,641 | ||||||
| Other liabilities | 2,966 | 3,090 | ||||||
| Operating lease liability | 15,206 | 15,325 | ||||||
| Total liabilities | 39,080 | 44,056 | ||||||
| Commitments | ||||||||
| Stockholders’ equity: | ||||||||
| Voting common stock, | 4 | 4 | ||||||
| Non-voting common stock, | 1 | 1 | ||||||
| Additional paid-in capital | 722,713 | 714,982 | ||||||
| Accumulated other comprehensive (loss) income | (1 | ) | 35 | |||||
| Accumulated deficit | (646,879 | ) | (583,563 | ) | ||||
| Total stockholders’ equity | 75,838 | 131,459 | ||||||
| Total liabilities and stockholders’ equity | $ | 114,918 | $ | 175,515 | ||||
Investor Contact:
Robert A. Doody, Jr.
Senior Vice President, Investor Relations
Prelude Therapeutics Incorporated
484.639.7235
rdoody@preludetx.com
FAQ
What are the key updates for Prelude Therapeutics' (PRLD) SMARCA2 program in Q2 2025?
How much cash does Prelude Therapeutics (PRLD) have and what is their runway?
What was Prelude Therapeutics' (PRLD) net loss in Q2 2025?
When will Prelude Therapeutics (PRLD) file the IND for its KAT6A degrader program?
Why did Prelude Therapeutics (PRLD) pause the development of PRT3789?
