WILMINGTON, Del., May 01, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, announced today that the Company will participate in the Citizens Life Sciences Conference taking place in New York on May 7, 2025. On Wednesday, May 7, 2025, at 11:00 a.m. ET, Kris Vaddi, Ph.D., Chief Executive Officer of Prelude, Jane Huang, M.D., President and Chief Medical Officer, and Peggy Scherle, Ph.D., Chief Scientific Officer will participate i ...

Preclinical data elucidating the mechanism of action of PRT3789, Prelude’s first-in-class, highly selective SMARCA2 degrader currently in early clinical development Highlights from Prelude’s efforts to discover and develop selective KAT6A degraders, including preclinical data, demonstrating potential for a differentiated efficacy and safety profile WILMINGTON, Del., April 25, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announc ...

Prelude Therapeutics Incorporated (PRLD) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.S ...

Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $127.2 million, compared to a net loss of $121.8 million for the year ended December 31, 2023[163]. - As of December 31, 2024, the company had an accumulated deficit of $583.6 million and does not expect to generate revenue from product sales for several years[163]. - The company's cash, cash equivalents, and marketable securities were $133.6 million as of December 31, 2024[164]. - The company expects to continue incurring operating losses for the foreseeable future as it advances product candidates through clinical development[165]. Research and Development - The company expects to incur significant research and development expenses related to ongoing clinical trials and potential commercialization efforts[165]. - Future capital requirements will depend on the progress and results of preclinical studies and clinical trials for current or future product candidates[173]. - The company will require additional capital to complete planned clinical development programs and may face delays or reductions in research programs if adequate funds are not available[174]. - The company is highly dependent on the success of its product candidates, which are currently in early clinical development, with no products approved for sale in any jurisdiction[178]. - The company faces significant risks related to the lengthy and expensive drug development process, with high failure rates in clinical trials[181]. Regulatory and Compliance Risks - Delays in obtaining regulatory approvals or completing clinical trials could materially adversely affect the company's business and financial condition[180]. - The company has no assurance that its product candidates will achieve success in clinical trials or obtain regulatory approval, which could hinder profitability[179]. - The FDA approval process is expensive and uncertain, with only a small percentage of drugs successfully completing the regulatory approval process[203]. - The company has not obtained FDA approval for any product, which may impede its ability to generate revenues and adversely affect its financial condition[208]. - Regulatory authorities may require additional studies or impose restrictions that could delay or prevent marketing approval[206]. Market and Competitive Landscape - The market opportunities for the company's product candidates may be smaller than estimated, affecting revenue potential and profitability[162]. - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may have greater financial resources and expertise[290]. - The commercial opportunity could be reduced if competitors develop safer, more effective, or less expensive products[293]. Intellectual Property Risks - The patent application process is complex and costly, with uncertainty regarding the issuance and enforceability of patents, which could affect competitive advantage[329]. - The company faces potential challenges to its patents, which could lead to reduced scope or invalidation, impacting its ability to commercialize products[334]. - The complexity and uncertainty of European patent laws have increased, particularly with the introduction of the unitary patent system in early 2023, which may impact existing patents significantly[351]. Operational and Management Challenges - The company currently lacks a marketing and sales organization and has no experience in commercializing products, which may hinder revenue generation[284]. - Establishing sales and marketing capabilities is expected to be costly and time-consuming, potentially delaying product launches[285]. - The company is highly dependent on key personnel, including its CEO, and may struggle to retain qualified employees due to intense competition in the biotechnology sector[302][304]. Financial and Economic Risks - Unstable market conditions and economic downturns could adversely affect the company's ability to raise capital and meet commitments[177]. - Changes in tax laws, such as those from the Tax Cuts and Jobs Act, could materially affect cash flow and financial performance, with potential one-time charges and increased future tax expenses[325]. - The company's investment portfolio is subject to market, interest, and credit risks, which may lead to declines in value due to economic conditions and market instability[328]. Compliance with Healthcare Laws - The company may incur substantial costs to ensure compliance with various healthcare laws and regulations, which could adversely affect its financial condition[238]. - Non-compliance with healthcare laws may expose the company to criminal, civil, and administrative penalties, as well as reputational harm and diminished profits[237]. - The Inflation Reduction Act allows the U.S. Department of Health and Human Services to negotiate drug prices, which could adversely affect the company's revenues starting in 2026[243]. Supply Chain and Manufacturing Risks - The company does not have manufacturing facilities and depends on third-party suppliers for preclinical and clinical supplies, increasing the risk of insufficient quantities or quality issues[263]. - The company is dependent on a sole supplier for certain components, which could result in delays if disruptions occur[266]. - The company’s reliance on third-party manufacturers increases the risk of not having sufficient quantities of products at acceptable costs or quality[262]. Cybersecurity and Data Protection - The company may face significant costs and operational disruptions due to cybersecurity threats and data breaches, which could impact business continuity and reputation[311][313]. - Compliance with health and data protection laws, including GDPR and CCPA, is critical, with potential penalties for non-compliance reaching up to EUR 20 million or 4% of annual worldwide gross revenue[317][318]. Future Growth and Strategic Transactions - Strategic transactions, including acquisitions and partnerships, may increase expenses and present management distractions, potentially affecting operations and financial results[327]. - Future growth may lead to difficulties in managing operations, requiring improvements in managerial and operational systems[307].

Financial Performance - Prelude Therapeutics reported a net loss of $127.2 million for the year ended December 31, 2024, compared to a net loss of $121.8 million for the prior year, resulting in a loss per share of $1.68[20]. - The total operating expenses for the year ended December 31, 2024, were $146.7 million, up from $132.3 million in 2023[24]. - General and administrative (G&A) expenses decreased slightly to $28.7 million in 2024 from $28.9 million in 2023[19]. - Research and development (R&D) expenses increased to $118.0 million in 2024 from $103.4 million in 2023, driven by a higher number of patients enrolled in clinical trials[18]. Cash and Assets - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $133.6 million, providing a runway into the second quarter of 2026[17]. - Total assets decreased from $277,665,000 in 2023 to $175,515,000 in 2024, a decline of approximately 36.8%[26]. - Current assets fell from $235,589,000 in 2023 to $135,895,000 in 2024, representing a decrease of about 42.4%[26]. - Cash and cash equivalents decreased significantly from $25,291,000 in 2023 to $12,474,000 in 2024, a drop of approximately 50.7%[26]. Liabilities and Equity - Total liabilities increased from $40,575,000 in 2023 to $44,056,000 in 2024, an increase of about 8.7%[26]. - Stockholders' equity declined from $237,090,000 in 2023 to $131,459,000 in 2024, a decrease of approximately 44.6%[26]. - Accumulated deficit increased from $(456,390,000) in 2023 to $(583,563,000) in 2024, reflecting a worsening of about 27.8%[26]. - Additional paid-in capital rose from $693,252,000 in 2023 to $714,982,000 in 2024, an increase of approximately 3.2%[26]. - Accounts payable increased from $4,580,000 in 2023 to $7,732,000 in 2024, a rise of about 68.8%[26]. - Operating lease liability increased from $1,481,000 in 2023 to $2,492,000 in 2024, an increase of approximately 68.1%[26]. - Total current liabilities rose from $21,829,000 in 2023 to $25,641,000 in 2024, an increase of about 17.5%[26]. Clinical Development - Prelude initiated a Phase 2 clinical trial for PRT3789 in combination with KEYTRUDA® in patients with SMARCA4-mutated cancers[5]. - PRT3789 demonstrated partial responses in 5 out of 32 patients with advanced NSCLC or esophageal cancer, indicating anti-tumor activity[7]. - The company is nearing completion of monotherapy dose escalation for PRT3789, currently at a 665 mg once weekly IV dose[4]. - Prelude expects to provide an interim data update for PRT7732 in the second half of 2025, which is currently in Phase 1 clinical development[10]. - The company plans to update its discovery pipeline in the first half of 2025, reflecting ongoing research and development efforts[2].

Core Insights - Prelude Therapeutics has demonstrated clinical proof-of-concept for PRT3789, a selective SMARCA2 degrader, showing safety and anti-tumor activity in patients with SMARCA4-deficient cancers [1][2] - The company is advancing its clinical pipeline, with ongoing studies for both PRT3789 and PRT7732, and plans to present additional results in the second half of 2025 [1][2] - Prelude reported a cash position of $133.6 million as of December 31, 2024, which is expected to fund operations into the second quarter of 2026 [1][18] Clinical Development Updates - PRT3789 is in Phase 1 clinical development targeting patients with SMARCA4 mutations, which are associated with poor clinical outcomes [3][4] - The company is nearing completion of monotherapy dose escalation for PRT3789 and is also conducting combination studies with docetaxel [4][9] - A Phase 2 trial evaluating PRT3789 in combination with KEYTRUDA® for SMARCA4-mutated cancers has been initiated [5] Clinical Trial Results - Interim data from the PRT3789 trial indicated that it was generally safe and well-tolerated, with partial responses observed in 5 out of 32 patients with advanced NSCLC or esophageal cancer [7][8] - Among patients treated at doses of 283 mg or higher, 3 out of 13 had confirmed partial responses, and tumor shrinkage was noted in both Class 1 and Class 2 SMARCA4 mutations [8] - The combination of PRT3789 with docetaxel has shown an acceptable safety profile in early cohorts [9] Financial Performance - For the year ended December 31, 2024, Prelude reported a net loss of $127.2 million, or $1.68 per share, compared to a net loss of $121.8 million, or $2.02 per share, in the prior year [21][25] - Research and development expenses increased to $118.0 million from $103.4 million in the previous year, driven by higher patient enrollment in clinical trials [19][25] - General and administrative expenses slightly decreased to $28.7 million from $28.9 million, primarily due to a reduction in stock-based compensation [20][25] Corporate Developments - In February 2025, the company appointed Bryant D. Lim as the permanent Chief Financial Officer [14] - Prelude plans to participate in the Barclays 27th Annual Global Healthcare Conference on March 11, 2025, featuring key executives [15]

WILMINGTON, Del., March 05, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, announced today that the Company will participate in the Barclays 27th Annual Global Healthcare Conference, taking place in Miami, FL on March 11, 2025. On Tuesday, March 11, 2025, at 12:30 p.m. ET, Kris Vaddi, Ph.D., Chief Executive Officer of Prelude, Jane Huang, M.D., President and Chief Medical Officer, and Bryant Lim, Chief Financial Officer will ...

Core Viewpoint - Prelude Therapeutics Incorporated (PRLD) has experienced significant selling pressure, resulting in a 31.5% decline in stock price over the past four weeks, but analysts anticipate better earnings than previously predicted, indicating potential for recovery [1]. Group 1: Stock Performance and Technical Indicators - PRLD's stock is currently in oversold territory, with a Relative Strength Index (RSI) reading of 18.71, suggesting a possible reversal in trend [5]. - The RSI is a momentum oscillator that helps identify oversold conditions when the reading falls below 30, indicating potential entry opportunities for investors [2][3]. Group 2: Earnings Estimates and Analyst Sentiment - There has been a consensus among sell-side analysts to raise earnings estimates for PRLD, leading to a 1.6% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [6]. - PRLD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7].

Core Viewpoint - Prelude Therapeutics Incorporated (PRLD) has experienced a significant decline of 39.1% over the past four weeks, but it is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) for PRLD is currently at 25.3, indicating that the heavy selling pressure may be exhausting, suggesting a possible bounce back towards previous supply and demand equilibrium [3] - Stocks are generally considered oversold when their RSI falls below 30, and the RSI helps identify potential entry points for investors looking to benefit from a rebound [2] Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that earnings estimates for PRLD will improve, with a 0.5% increase in the consensus EPS estimate over the last 30 days [4] - An upward trend in earnings estimate revisions typically correlates with price appreciation in the near term, indicating a favorable outlook for PRLD [4] - PRLD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate trends and EPS surprises, further supporting the potential for a turnaround [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39527 PRELUDE THERAPEUTICS INCORPORATED (Exact Name of Registrant as Specified in its Charter) Delaware 81-1384762 (State or ...