Prelude Therapeutics (PRLD) 2025 Conference June 05, 2025 03:10 PM ET Speaker0 Alright. Welcome, everyone, to Jeffrey twenty twenty five Healthcare Global Conference. And then my name is Roger Song, one of the senior analysts cover SMICAP biotech in The US. It's my pleasure to have the next fireside chat with Peru Therapeutics. We have the whole team here. We have the CEO, Chris, and then President, then CMO, Jim, and then the CSO, Peggy. Welcome, everyone. Thanks. Awesome. Great. Yeah. Speaker1 Thanks, Rog ...

Prelude Therapeutics (PRLD) 2025 Conference May 07, 2025 11:00 AM ET Speaker0 I've been working on it for a awhile but now we have two molecules, one an IV and one an oral agent, both in the clinic that are targeting a very unique pathway called SMARK pathway, desired SMARK2 degraders, and there is a high unmet need in patients who have this mutation since SMARK4, a related family member that results in pretty aggressive cancers across multiple cancer types. So we've made a lot of progress. We demonstrated ...

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 March 31, 2025 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) Registrant's telephone number, inc ...

Exhibit 99.1 Prelude Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update PRT3789 monotherapy and combination with docetaxel escalation enrollment is complete and the Company plans to present updated results in the second half of 2025 Enrollment of the Phase 1 study of Prelude's once daily, oral SMARCA2 degrader, PRT7732 is advancing rapidly, and an initial data update is anticipated in the second half of 2025 Current cash runway into the second quarter of 2026 with $103.1 ...

PRT3789 monotherapy and combination with docetaxel escalation enrollment is complete and the Company plans to present updated results in the second half of 2025 Enrollment of the Phase 1 study of Prelude's once daily, oral SMARCA2 degrader, PRT7732 is advancing rapidly, and an initial data update is anticipated in the second half of 2025 Current cash runway into the second quarter of 2026 with $103.1 million in cash, cash equivalents, restricted cash and marketable securities as of March 31, 2025 WILMINGTON ...

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].