Core Insights - Prelude Therapeutics announced the first clinical data for PRT3789, a novel SMARCA2 degrader, targeting patients with advanced solid tumors having a SMARCA4 mutation [1][2] - The company is conducting a Phase 1 clinical trial to evaluate the safety, tolerability, and clinical activity of PRT3789, with enrollment on track and dose escalation expected to conclude by the end of 2024 [1][2] Clinical Trial Details - As of March 7, 2024, 40 patients have been enrolled in the trial, with 55% having loss-of-function mutations [2] - Dose escalation has progressed through 6 levels, ranging from 24 mg to 212 mg, with no dose-limiting toxicities (DLTs) or serious adverse events (SAEs) reported [2] - Common adverse events include nausea (25%), constipation and dyspnea (17.5% each), decreased appetite and fatigue (15% each), and anemia (12.5%) [2] Clinical Activity Observations - Clinical activity noted includes RECIST partial responses, tumor shrinkage, and prolonged stable disease in patients with advanced esophageal cancer and non-small cell lung cancer (NSCLC) [2] - Dose-related increases in area under the curve (AUC) and decreases in SMARCA2 levels were observed, with minimal effects on SMARCA4 levels [2] Upcoming Events - Prelude Therapeutics will host an investor webcast on September 13, 2024, to discuss the findings and provide updates on the clinical trial [1][4] - Updated data will be presented at the European Society of Medical Oncology (ESMO) Congress 2024 [3] Company Overview - Prelude Therapeutics is focused on developing innovative precision oncology medicines, including first-in-class SMARCA2 degraders and a CDK9 inhibitor [5] - The company aims to address high unmet needs in cancer treatment through targeted protein degradation and next-generation therapies [5]

Financial Performance - The company reported a net loss of $66.2 million for the six months ended June 30, 2024, compared to a net loss of $58.1 million for the same period in 2023, resulting in an accumulated deficit of $522.6 million as of June 30, 2024[70]. - Net loss for the three months ended June 30, 2024 was $34.740 million, compared to a net loss of $30.431 million for the same period in 2023, reflecting a 14.0% increase in losses[79]. - Total operating expenses for the six months ended June 30, 2024 were $71.507 million, up from $61.513 million in the same period of 2023, marking a 16.0% increase[85]. - Research and development expenses increased from $24.966 million in Q2 2023 to $29.509 million in Q2 2024, representing a 18.1% increase[79]. - General and administrative expenses rose from $7.432 million in Q2 2023 to $7.655 million in Q2 2024, a 3.0% increase[79]. - Research and development expenses for the six months ended June 30, 2024 totaled $56.918 million, up from $46.800 million in the same period of 2023, a 21.6% increase[86]. - The company has incurred recurring losses primarily due to research and development activities and negative cash flows from operations[70]. - The company plans to continue incurring significant expenses and operating losses for the foreseeable future as it seeks regulatory approval for its product candidates[70]. Revenue Generation - The company has not recognized any revenue from product sales to date and does not expect to generate revenue in the foreseeable future[71]. - The company has not yet commercialized any product and does not expect to generate revenue from product sales for several years[90]. Research and Development - The company is advancing its first-in-class SMARCA2 degrader, PRT3789, which is currently in Phase 1 clinical development, with expectations to conclude monotherapy dose escalation in 2024[67]. - PRT2527, a selective CDK9 inhibitor, has completed a Phase 1 multi-dose escalation study, showing high levels of target inhibition and a favorable safety profile, with further development planned in hematologic malignancies[68]. - The company expects to present interim Phase 1 data for PRT3789 at the European Society of Medical Oncology (ESMO) Congress 2024 on September 13, 2024[67]. - The company has received IND clearance for its lead oral molecule, PRT7732, which is expected to enter Phase 1 clinical development in the second half of 2024[68]. - The company anticipates significant increases in research and development expenses as it advances its product candidates through clinical trials and prepares for regulatory filings[74]. Cash Flow and Financing - As of June 30, 2024, the company had $179.8 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2026[92]. - The company reported a net cash used in operating activities of $54.848 million for the six months ended June 30, 2024, compared to $57.802 million for the same period in 2023[98]. - Cash used in operating activities for the six months ended June 30, 2024, was $54.8 million, compared to $57.8 million for the same period in 2023, reflecting a net loss of $66.2 million in 2024 and $58.1 million in 2023[99]. - Net cash provided by investing activities for the six months ended June 30, 2024, was $57.3 million, primarily from $71.4 million in proceeds from maturities of marketable securities, while net cash used in investing activities in 2023 was $57.4 million[100]. - Net cash provided by financing activities for the six months ended June 30, 2024, was primarily from proceeds received from the issuance of common stock under the employee stock purchase plan, while in 2023 it was $111.1 million from the sale of common stock and pre-funded warrants[101]. - The company plans to raise up to $400 million through a shelf registration statement filed in May 2024 to support ongoing operations and growth strategies[95]. Accounting and Reporting - The company entered into a license agreement with Pathos AI, Inc. in May 2024, granting an exclusive, sublicensable, worldwide license for its PRMT5 inhibitor, PRT811, which will be accounted for under ASC 606[102]. - The company recognizes revenue when the customer obtains control of promised goods or services, reflecting the consideration expected in exchange for those goods or services[102]. - The company has elected to take advantage of exemptions under the JOBS Act, allowing it to delay the adoption of certain accounting standards until they apply to private companies[104]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[106]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company, including presenting only the two most recent fiscal years of audited financial statements[106]. - There were no material changes to the company's critical accounting policies and estimates during the three months ended June 30, 2024[103]. - The company is not required to provide quantitative and qualitative disclosures about market risk for the period ending June 30, 2024, as a smaller reporting company[107].

Financial Performance - Prelude Therapeutics reported a net loss of $34.7 million, or $0.46 per share, for Q2 2024, compared to a net loss of $30.4 million, or $0.54 per share, in the same period last year[12]. - Total operating expenses for Q2 2024 were $37.2 million, up from $32.4 million in the prior year period[16]. - Accumulated deficit increased significantly from $456,390,000 to $522,561,000, reflecting a rise of about 14.5%[19]. - Total stockholders' equity decreased from $237,090,000 to $182,276,000, a decline of approximately 23.1%[19]. Research and Development - Research and Development (R&D) expenses increased to $29.5 million in Q2 2024 from $25.0 million in the prior year period, primarily due to increased chemistry, manufacturing, and controls (CMC) expenses[10]. - The interim Phase 1 data for PRT3789, a first-in-class SMARCA2 degrader, is scheduled for oral presentation at the ESMO Congress on September 13, 2024[6]. - Prelude has received IND authorization for PRT7732, its first-in-class oral SMARCA2 degrader, which is expected to enter Phase 1 clinical development in the second half of 2024[8]. - PRT2527, a selective CDK9 inhibitor, is on track to present interim Phase 1 data in Q4 2024, with ongoing dose escalation in both lymphoid and myeloid malignancies[9]. - The company is collaborating with Merck to evaluate PRT3789 in combination with KEYTRUDA® in patients with SMARCA4-mutated cancers, with a Phase 2 trial anticipated to start in Q4 2024[7]. - The company is advancing its clinical programs with a focus on the SMARCA pathway, aiming to address high unmet medical needs in cancer treatment[2]. Cash and Assets - As of June 30, 2024, the company had $179.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2026[10]. - Total current assets decreased from $235,589,000 on December 31, 2023, to $182,714,000 on June 30, 2024, a decline of approximately 22.4%[18]. - Cash and cash equivalents increased from $25,291,000 to $27,828,000, representing an increase of about 10.1%[18]. - Marketable securities decreased from $207,644,000 to $152,016,000, a drop of about 26.8%[18]. Liabilities and Equity - Total liabilities rose from $40,575,000 to $42,015,000, an increase of approximately 3.6%[19]. - Accounts payable increased from $4,580,000 to $6,170,000, an increase of approximately 34.7%[18]. - Accrued expenses and other current liabilities decreased from $15,768,000 to $11,426,000, a decline of about 27.5%[18]. - Additional paid-in capital increased from $693,252,000 to $705,122,000, an increase of approximately 1.3%[19]. - Operating lease right-of-use asset slightly decreased from $30,412,000 to $29,574,000, a reduction of about 2.8%[18]. Educational Initiatives - Prelude has launched an educational video series on SMARCA biology and the development of SMARCA2 degraders, available on its website[5].

Prelude will sponsor the clinical trial and Merck will provide KEYTRUDA. WILMINGTON, Del., July 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD) ("Prelude" or the "Company"), a clinical-stage precision oncology company, today announced that it has entered into a clinical trial collaboration and supply agreement (the "Agreement") with Merck (known as MSD outside of the US and Canada). Under the terms of the Agreement, the Phase 2 clinical study will evaluate PRT3789, the Company' ...

On Wednesday, June 12th, at 10:40 a.m. ET, Dr. Vaddi will provide a corporate presentation. The live webcast of the presentation can be accessed here. For more information, visit Prelude's website under Events and Presentations. All webcast recordings will be archived and available on the Company's website for 90 days. About Prelude Therapeutics Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's div ...

Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's diverse pipeline is comprised of highly differentiated, potentially best-in-class proprietary small molecule compounds aimed at addressing clinically validated pathways for cancers with selectable underserved patients. Prelude's pipeline includes three candidates currently in clinical development: an IV administered, potent and highly selective SMAR ...

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, 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 | | --- | ...

Exhibit 99.1 Prelude Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update First-in-class IV SMARCA2 degrader, PRT3789 and potentially best-in-class CDK9 inhibitor, PRT2527 remain on track to generate initial proof-of-concept data in 2024 New preclinical data presented at AACR 2024 included first characterization of PRT7732, a highly-selective, orally bioavailable SMARCA2 degrader Operational leadership capabilities further strengthened by recent hires Chief Business Office ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 other ju ...

Financial Performance - The company reported a net loss of $88.8 million for the nine months ended September 30, 2023, compared to a net loss of $86.8 million for the same period in 2022, resulting in an accumulated deficit of $423.3 million[86]. - The company reported a net loss of $30.6 million for Q3 2023, compared to a net loss of $30.0 million in Q3 2022, an increase of 2.2%[100]. - Net cash used in operating activities for the nine months ended September 30, 2023, was $83.5 million, compared to $60.8 million for the same period in 2022, an increase of 37.4%[116]. - Total operating expenses for the nine months ended September 30, 2023, were $94.9 million, compared to $90.2 million in the same period of 2022, an increase of 5.5%[104]. Cash and Financing - As of September 30, 2023, the company had $230.5 million in cash, cash equivalents, and marketable securities[89]. - The company generated $111.2 million in net cash from financing activities during the nine months ended September 30, 2023, primarily from the sale of common stock and pre-funded warrants[121]. - The company plans to finance operations through equity sales, debt financing, or collaborations, as it requires substantial additional capital to support ongoing operations[88]. - The company expects to finance operations through equity offerings, debt financings, and collaborations, as it has not yet commercialized any products[115]. Research and Development - The company is focusing resources on its first-in-class SMARCA2 degrader compounds and a selective CDK9 inhibitor, with plans to demonstrate clinical proof-of-concept in 2024[76]. - A Phase 1 multi-dose escalation clinical trial of the SMARCA2 degrader, PRT3789, is ongoing, with initial data expected to be shared in mid-2024[80]. - The CDK9 candidate, PRT2527, has shown high levels of target inhibition and potential for better tolerability compared to existing CDK9 inhibitors, with proof-of-concept data expected in 2024[83]. - The company has received IND clearance for PRT3645, a brain-penetrant CDK4/6 inhibitor, and is currently conducting a Phase 1 trial[85]. - Research and development expenses increased from $22.9 million in Q3 2022 to $26.3 million in Q3 2023, a rise of 15%[99]. - For the nine months ended September 30, 2023, research and development expenses totaled $73.1 million, up from $67.0 million in the same period of 2022, reflecting an increase of 9%[105]. Administrative Expenses - General and administrative expenses decreased from $7.5 million in Q3 2022 to $7.1 million in Q3 2023, a decline of 5.3%[101]. - Other income, net rose significantly from $0.4 million in Q3 2022 to $2.8 million in Q3 2023, an increase of 600%[102]. Company Classification - The company qualifies as an "emerging growth company" and may rely on reduced reporting requirements until it reaches total annual gross revenues of at least $1.235 billion or a market value exceeding $700 million[127]. - The company is classified as a "smaller reporting company" with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million[129]. - If the company remains a smaller reporting company after ceasing to be an emerging growth company, it can continue to rely on certain disclosure exemptions[129]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[130].