1. WILMINGTON, Del., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that members of its management team will participate in two upcoming virtual investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference
      Fireside chat at 11:45 a.m. ET on Thursday, September 9, 2021
    • H.C. Wainwright 23rd Annual Global Investment Conference
      Corporate presentation at 7:00 a.m. ET on Monday, September 13, 2021

    A live webcast of the Morgan Stanley fireside chat and H.C. Wainwright presentation can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations

    WILMINGTON, Del., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that members of its management team will participate in two upcoming virtual investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference

      Fireside chat at 11:45 a.m. ET on Thursday, September 9, 2021
    • H.C. Wainwright 23rd Annual Global Investment Conference

      Corporate presentation at 7:00 a.m. ET on Monday, September 13, 2021

    A live webcast of the Morgan Stanley fireside chat and H.C. Wainwright presentation can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations, where a replay of the events will also be available for a limited time.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Investor Contact:

    Stacey Jurchison

    Executive Director, Corporate Affairs

    sjurchison@preludetx.com

    Melissa Forst

    Argot Partners

    212.600.1902

    prelude@argotpartners.com

    Media Contact:

    Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  2. - Data from Dose Escalation Portion of Phase 1 Trials of Lead Oral PRMT5 Inhibitors PRT543 and PRT811 to be Presented in 4Q21 –

    - Enrollment Ongoing in Multiple Expansion Cohorts in Phase 1 Trial of PRT543; Dose Expansion Portion of Phase 1 Trial of PRT811 Expected to Commence in 3Q21 –

    - Dose Escalation Portion of Phase 1 Trials of Oral and IV Formulations of MCL1 Inhibitor PRT1419 Ongoing –

                      -Strong Cash Position of $343 Million to Support Clinical and Discovery Pipeline Advancement –

    WILMINGTON, Del., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the second quarter ended June 30, 2021 and provided an update…

    - Data from Dose Escalation Portion of Phase 1 Trials of Lead Oral PRMT5 Inhibitors PRT543 and PRT811 to be Presented in 4Q21 –

    - Enrollment Ongoing in Multiple Expansion Cohorts in Phase 1 Trial of PRT543; Dose Expansion Portion of Phase 1 Trial of PRT811 Expected to Commence in 3Q21 –

    - Dose Escalation Portion of Phase 1 Trials of Oral and IV Formulations of MCL1 Inhibitor PRT1419 Ongoing –

                      -Strong Cash Position of $343 Million to Support Clinical and Discovery Pipeline Advancement –

    WILMINGTON, Del., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the second quarter ended June 30, 2021 and provided an update on recent clinical and development pipeline progress.

    "Prelude's second quarter was marked by solid operational execution, continued innovation, and organizational growth. We made meaningful progress advancing our pipeline of novel, internally discovered precision oncology therapeutics aimed at addressing several cancers with high unmet need," said Kris Vaddi, PhD, Chief Executive Officer. "Our ongoing clinical programs, including the Phase 1 trials of PRT543 and PRT811, for which we expect to present clinical data in the fourth quarter, and PRT1419 are advancing as planned. In addition, we continue to maintain focus on the advancement of our preclinical and discovery programs, with an IND application submission for PRT2527, our CDK9 inhibitor, and initiation of IND-enabling studies for our discovery programs expected by year end."

    Recent Highlights and Upcoming Milestones

    PRT543

    • Dose Expansion Portion of Phase 1 Trial Ongoing; Data from Dose Escalation Portion to be Presented at the AACR-NCI-EORTC Annual Meeting: The Company will present data from the dose escalation portion of the Phase 1 trial in unselected patient populations, including safety, PK and PD data and markers of target engagement, at the AACR-NCI-EORTC Annual Meeting in October. PRT543 is designed to be a potent and selective inhibitor of PRMT5. Patient enrollment is continuing in specific biomarker-selected solid tumor and hematologic malignancy expansion cohorts representing cancers of high unmet need, including adenoid cystic carcinoma (ACC), spliceosome mutated and HRD+ solid tumors and spliceosome-mutated myeloid malignancies. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.   

    PRT811

    • Dose Expansion Portion of Phase 1 Trial Expected to Commence in 3Q21; Data from Dose Escalation Portion to be Presented at the AACR-NCI-EORTC Annual Meeting: The Company will present data from the dose escalation portion of the Phase 1 trial in unselected patient populations, including safety, PK and PD data and markers of target engagement, at the AACR-NCI-EORTC Annual Meeting in October. PRT811 is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor. Prelude anticipates beginning the dose expansion portion of the Phase 1 trial in the third quarter in selected patients with central nervous system cancers, including high grade gliomas and CNS metastatic cancers. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.      

    PRT1419

    • Oral Formulation: Dose Escalation Portion of Phase 1 Trial Ongoing. The dose escalation portion of the Company's first-in-human Phase 1 study of oral PRT1419, the Company's third clinical candidate, in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419 is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.



    • IV Formulation: Dose Escalation Portion of Phase 1 Trial is Now Underway. The Phase 1 trial of an intravenous (IV) formulation of PRT1419, which leverages the optimized physicochemical properties of PRT1419, is now underway in patients with solid tumors.

    Discovery Programs

    • Earlier-Stage Candidates Expected to Advance in 2021. The Company remains on track to submit an Investigational New Drug (IND) application in 2021 for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. In addition, the Company continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, by the end of the year.

    Corporate Updates

    • Martin Babler Appointed to Board of Directors. In July 2021, the Company announced the appointment of Martin Babler to its Board of Directors. Mr. Babler brings to Prelude over 25 years of pharmaceutical and biotech experience, most recently serving as President and Chief Executive Officer of Principia Biopharma until its acquisition by Sanofi S.A. in October 2020. Mr. Babler will serve as a member of the audit committee of the Board.



    • Michele Porreca Appointed as Chief People Officer. Prelude today announced the recent appointment of Michele Porreca as Chief People Officer. In this newly created role, she will lead all aspects of the Company's human resources management, including, talent management and strategy, organizational effectiveness, total rewards, culture, inclusion, and employee communications. Ms. Porreca brings to Prelude over 20 years of human resources experience, most recently serving as Chief Human Resources Officer at Nabriva Therapeutics.

    Second Quarter 2021 Financial Results

    • Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021 were $343.1 million.



    • Research and Development (R&D) Expenses: For the second quarter of 2021, R&D expense increased by $12.6 million to $22.4 million for the three months ended June 30, 2021 from $9.8 million for the three months ended June 30, 2020. The increase was mainly due to increased clinical research costs for the PRT543, PRT811 and PRT1419 (Oral and IV) programs, and increased chemistry, manufacturing and other costs for those trials.



    • General and Administrative (G&A) Expenses: For the second quarter of 2021, G&A expense increased by $3.9 million to $5.5 million for the three months ended June 30, 2021 from $1.6 million for the three months ended June 30, 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in the Company's professional fees as a result of expanded operations to support research and development efforts as well as incurred additional costs to operate as a public company.



    • Net Loss: For the second quarter of 2021, net loss was $26.9 million, or $0.58 per share, compared with a net loss of $11.4 million, or $5.50 per share, for the same period in 2020.



    • Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into mid-2023.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    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, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543, PRT811 and PRT1419, the timing of IND-related activities for PRT2527 and PRT-SCA2 and the potential benefits of the Company's product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company 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 the Company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents the Company 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 the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    STATEMENTS OF OPERATIONS

    (UNAUDITED)

      Three Months Ended June 30, 
    (in thousands, except share and per share data) 2021  2020 
    Operating expenses:        
    Research and development $22,409  $9,776 
    General and administrative  5,513   1,660 
    Total operating expenses  27,922   11,436 
    Loss from operations  (27,922)  (11,436)
    Other income, net  1,057   28 
    Net loss $(26,865) $(11,408)
    Per share information:        
    Net loss per share of common stock, basic and diluted $(0.58) $(5.50)
    Weighted average common shares outstanding, basic

    and diluted
      46,057,112   2,074,108 
             



    BALANCE SHEETS


    (UNAUDITED)

    (in thousands, except share data) June 30,

    2021
      December 31,

    2020
     
    Assets        
    Current assets:        
    Cash and cash equivalents $343,119  $218,309 
    Prepaid expenses and other current assets  1,456   2,500 
    Total current assets  344,575   220,809 
    Property and equipment, net  3,109   2,480 
    Right-of-use asset  1,897    
    Deferred offering costs     301 
    Total assets $349,581  $223,590 
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $6,844  $3,920 
    Accrued expenses and other current liabilities  6,430   7,455 
    Operating lease liability  1,403    
    Total current liabilities  14,677   11,375 
    Other liabilities     32 
    Operating lease liability  543    
    Total liabilities  15,220   11,407 
             
    Stockholders' equity:        
    Voting common stock, $ par value: shares authorized; 35,636,695 and 32,595,301 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively  4   3 
    Non-voting common stock, $ par value; shares authorized; and shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively  1   1 
    Additional paid-in capital  489,947   319,605 
    Accumulated deficit  (155,591)  (107,426)
    Total stockholders' equity  334,361   212,183 
    Total liabilities and stockholders' equity $349,581  $223,590 
             

    Contact

    Investors: Melissa Forst

    Media: Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  3. WILMINGTON, Del., July 19, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the appointment of Martin Babler to its Board of Directors. Mr. Babler brings to Prelude over 25 years of pharmaceutical and biotech experience, most recently serving as President and Chief Executive Officer of Principia Biopharma until its acquisition by Sanofi S.A. in October 2020. Mr. Babler will serve as a member of the Audit Committee of the Board.

    "We are delighted to welcome Martin, a deeply experienced industry leader, to the Prelude Therapeutics Board of Directors," said Kris Vaddi, PhD, Chief Executive Officer. "We look forward to leveraging his vast expertise as we continue to…

    WILMINGTON, Del., July 19, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the appointment of Martin Babler to its Board of Directors. Mr. Babler brings to Prelude over 25 years of pharmaceutical and biotech experience, most recently serving as President and Chief Executive Officer of Principia Biopharma until its acquisition by Sanofi S.A. in October 2020. Mr. Babler will serve as a member of the Audit Committee of the Board.

    "We are delighted to welcome Martin, a deeply experienced industry leader, to the Prelude Therapeutics Board of Directors," said Kris Vaddi, PhD, Chief Executive Officer. "We look forward to leveraging his vast expertise as we continue to advance our novel pipeline of internally discovered therapeutics aimed at addressing several cancers with high unmet need."

    "It is a privilege to join the Board at this exciting time in the Company's evolution," said Mr. Babler. "I look forward to working alongside the talented Board and leadership team as the Company continues to strive toward delivering meaningful new therapies to patients with cancer."

    Prior to joining Principia Biopharma, Mr. Babler served as President and Chief Executive Officer of Talima Therapeutics from 2007 to 2011. From 1998 to 2007, he held several positions at Genentech, Inc., most notably as Vice President, Immunology Sales and Marketing. While at Genentech, he also helped to build and led the Commercial Development organization and led the Cardiovascular Marketing organization. Mr. Babler previously served at Eli Lilly and Company in positions focused on sales, sales management, global marketing, and business development. He presently serves on the Board of Directors of Neoleukin Therapeutics, Inc., Omega Alpha SPAC, and on the Emerging Companies Section Governing Board of the Biotechnology Innovation Organization. Mr. Babler received a Swiss Federal Diploma in Pharmacy from the Federal Institute of Technology in Zurich and completed the Executive Development Program at the Kellogg Graduate School of Management at Northwestern University.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    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, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543, PRT811 and PRT1419, the timing of IND-related activities for PRT2527 and PRT-SCA2 and the potential benefits of the Company's product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company 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 the Company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents the Company 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 the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact

    Investors: Melissa Forst

    Media: Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  4. WILMINGTON, Del., June 02, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that members of its management team will participate in two upcoming virtual investor conferences:

    • 42nd Annual Goldman Sachs Global Healthcare Conference

    Fireside chat at 8:00 a.m. ET on Wednesday, June 9, 2021

    • JMP Securities Life Sciences Conference

    Corporate presentation at 10:00 a.m. ET on Wednesday, June 16, 2021

    A live webcast of the Goldman Sachs fireside chat and JMP Securities presentation can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations, where a replay of…

    WILMINGTON, Del., June 02, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that members of its management team will participate in two upcoming virtual investor conferences:

    • 42nd Annual Goldman Sachs Global Healthcare Conference

    Fireside chat at 8:00 a.m. ET on Wednesday, June 9, 2021

    • JMP Securities Life Sciences Conference

    Corporate presentation at 10:00 a.m. ET on Wednesday, June 16, 2021

    A live webcast of the Goldman Sachs fireside chat and JMP Securities presentation can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations, where a replay of the events will also be available for a limited time.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Contact

    Investors: Melissa Forst

    Media: Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  5. - Enrollment Now Underway in Multiple Solid Tumor and Hematologic Malignancy Expansion Cohorts in Phase 1 Trial of Oral PRMT5 Inhibitor PRT543 -

    - Initial Clinical Data Readouts for Lead Oral PRMT5 Inhibitors PRT543 and PRT811 Expected in 2H21 -

    - Dose Escalation Ongoing in Phase 1 Trial of Oral MCL1 Inhibitor PRT1419, with Dose Expansion Cohorts on Track to be Added in 2H21 -

    WILMINGTON, Del., May 11, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent clinical and development pipeline progress.

    "With several novel, internally discovered therapeutics now advancing…

    - Enrollment Now Underway in Multiple Solid Tumor and Hematologic Malignancy Expansion Cohorts in Phase 1 Trial of Oral PRMT5 Inhibitor PRT543 -

    - Initial Clinical Data Readouts for Lead Oral PRMT5 Inhibitors PRT543 and PRT811 Expected in 2H21 -

    - Dose Escalation Ongoing in Phase 1 Trial of Oral MCL1 Inhibitor PRT1419, with Dose Expansion Cohorts on Track to be Added in 2H21 -

    WILMINGTON, Del., May 11, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent clinical and development pipeline progress.

    "With several novel, internally discovered therapeutics now advancing in clinical trials, our pipeline products are off to a strong start in 2021 and we expect this momentum to carry us through multiple key inflection points," said Kris Vaddi, PhD, Chief Executive Officer. "We initiated numerous expansion cohorts for PRT543, our novel PRMT5 inhibitor, in the ongoing Phase 1 trial in patients with advanced solid tumors and hematologic malignancies. We expect to present initial clinical data for both PRT543 and PRT811, our brain penetrant PRMT5 inhibitor, in the second half of the year."

    Dr. Vaddi added, "We continue to enroll the dose escalation portion of our Phase 1 trial of oral PRT1419, our MCL1 inhibitor, and plan to initiate dose expansion and combination cohorts in the second half of the year. Beyond our clinical pipeline, we remain focused on the advancement of our preclinical programs, and expect to submit an IND application for PRT2527, our CDK9 inhibitor, by year end. We are steadfast in our mission to develop novel therapeutic options for several cancers with high unmet need, and we look forward to providing updates on our continued progress as these programs mature."

    Recent Highlights and Upcoming Milestones

    PRT543

    • Enrollment Ongoing in Phase 1 Dose Expansion Cohorts. Patient enrollment is underway in additional solid tumor and hematologic malignancy expansion cohorts of the Company's Phase 1 trial of PRT543, which is designed to be a potent and selective inhibitor of PRMT5. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.



    • Preclinical Data Featured at the 2021 AACR Annual Meeting. Three preclinical presentations on PRT543 were featured at the American Association for Cancer Research (AACR) Annual Meeting in April 2021. A copy of each poster is available in the Publications section of the Prelude Therapeutics website.

    PRT811

    • Phase 1 Dose Expansion Cohorts Remain on Track to Begin in Mid-2021. The dose escalation portion of the Company's Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, remains ongoing in patients with advanced solid tumors, including gliomas. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish a recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers, including glioblastoma multiforme (GBM), with initial clinical data expected by the end of 2021.

    PRT1419

    • Oral Formulation: Planned Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company's first-in-human Phase 1 study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, is ongoing. PRT1419, which is the Company's third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.



    • IND Application Cleared. In March 2021, the Company announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the coming months in patients with solid tumors.



    • Data on Preclinical Characterization Featured at the 2021 AACR Annual Meeting. Data on the preclinical characterization of PRT1419 was featured at the AACR Annual Meeting in April 2021. A copy of the poster is available in the Publications section of the Prelude Therapeutics website.

    Discovery Programs

    • Advancement of Earlier-Stage Candidates Expected in 2021. The Company remains on track to submit an IND application in 2021 for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. Prelude also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.



    • Preclinical Data on SMARCA2 Protein Degradation Featured at the 2021 AACR Annual Meeting. A poster presentation on the Company's SMARCA2 protein degradation program was featured at the AACR Annual Meeting in April 2021. A copy of the poster is available in the Publications section of the Prelude Therapeutics website.

    First Quarter 2021 Financial Results

    • Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2021 were $363.0 million.



    • Research and Development (R&D) Expenses: For the first quarter of 2021, R&D expense increased by $7.9 million to $16.5 million. The increase was mainly due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for oral PRT1419, as well as preparation for the anticipated initiation of the Phase 1 trial for IV PRT1419 in the first half of 2021. We also incurred an increase in chemistry, manufacturing, and other costs for those trials.



    • General and Administrative (G&A) Expenses: For the first quarter of 2021, G&A expense increased by $4.3 million to $5.5 million. The increase was primarily due to an increase in personnel related expense due to increases in employee headcount and an increase in the Company's professional fees as it expanded operations to support R&D efforts and incurred additional costs to operate as a public company.



    • Net Loss: For the first quarter of 2021, net loss was $21.3 million, or $0.47 per share, compared with a net loss of $9.5 million, or $5.12 per share, for the same period in 2020.



    • Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2023.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    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, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543, PRT811 and PRT1419, the timing of IND-related activities for PRT2527 and PRT-SCA2 and the potential benefits of the Company's product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company 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 the Company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents the Company 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 the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    STATEMENTS OF OPERATIONS

    (UNAUDITED)

      Three Months Ended March 31, 
    (in thousands, except share and per share data) 2021  2020 
    Operating expenses:        
    Research and development $16,470  $8,536 
    General and administrative  5,497   1,201 
    Total operating expenses  21,967   9,737 
    Loss from operations  (21,967)  (9,737)
    Other income, net  667   226 
    Net loss $(21,300) $(9,511)
    Per share information:        
    Net loss per share of common stock, basic and diluted $(0.47) $(5.12)
    Weighted average common shares outstanding, basic

    and diluted
      45,121,955   1,857,023 

    BALANCE SHEETS

    (UNAUDITED)

    (in thousands, except share data) March 31,

    2021
      December 31,

    2020
     
    Assets        
    Current assets:        
    Cash and cash equivalents $362,990  $218,309 
    Prepaid expenses and other current assets  2,028   2,500 
    Total current assets  365,018   220,809 
    Property and equipment, net  2,627   2,480 
    Right-of-use asset  2,186    
    Deferred offering costs     301 
    Total assets $369,831  $223,590 
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $4,842  $3,920 
    Accrued expenses and other current liabilities  6,179   7,455 
    Operating lease liability  1,403    
    Total current liabilities  12,424   11,375 
    Other liabilities     32 
    Operating lease liability  840    
    Total liabilities  13,264   11,407 
             
    Stockholders' equity:        
    Voting common stock, $ par value: shares authorized; and shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively  4   3 
    Non-voting common stock, $ par value; shares authorized; and shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively  1   1 
    Additional paid-in capital  485,288   319,605 
    Accumulated deficit  (128,726)  (107,426)
    Total stockholders' equity  356,567   212,183 
    Total liabilities and stockholders' equity $369,831  $223,590 

    Contact

    Investors: Melissa Forst

    Media: Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  6. WILMINGTON, Del., May 05, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that Kris Vaddi, PhD, Chief Executive Officer, will present at the BofA Securities 2021 Virtual Health Care Conference on Wednesday, May 12 at 5:00 p.m. ET.

    A live webcast of the presentation chat can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations, where a replay of the presentation will also be available for a limited time.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing…

    WILMINGTON, Del., May 05, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that Kris Vaddi, PhD, Chief Executive Officer, will present at the BofA Securities 2021 Virtual Health Care Conference on Wednesday, May 12 at 5:00 p.m. ET.

    A live webcast of the presentation chat can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations, where a replay of the presentation will also be available for a limited time.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Contact

    Investors: Melissa Forst

    Media: Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  7. – Dose Escalation Portion of Phase 1 Trial of PRT543 Complete; Additional Expansion Cohorts Set to Initiate Early in the Second Quarter –

    – Clinical Data Readouts Expected in 2H21 for Lead PRMT5 Inhibitors PRT543 and PRT811 –

    – Phase 1 Dose-Escalation Study of Oral PRT1419 Ongoing –

    – Preclinical Data from Multiple Programs to be Presented at the Upcoming 2021 AACR Annual Meeting –

    WILMINGTON, Del., March 16, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments.

    "2020 marked a highly transformational…

    – Dose Escalation Portion of Phase 1 Trial of PRT543 Complete; Additional Expansion Cohorts Set to Initiate Early in the Second Quarter –

    – Clinical Data Readouts Expected in 2H21 for Lead PRMT5 Inhibitors PRT543 and PRT811 –

    – Phase 1 Dose-Escalation Study of Oral PRT1419 Ongoing –

    – Preclinical Data from Multiple Programs to be Presented at the Upcoming 2021 AACR Annual Meeting –

    WILMINGTON, Del., March 16, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments.

    "2020 marked a highly transformational year for Prelude with the successful completion of an initial public offering and progress across our three clinical-stage programs," said Kris Vaddi, PhD, Chief Executive Officer of Prelude Therapeutics. "We are firmly committed to bringing novel therapies to patients in areas of high unmet need, and we have entered 2021 with both the momentum and resources that we believe will carry us through several key milestones. Notably, we are pleased to announce the completion of dose escalation activities in our ongoing Phase 1 trial of PRT543, our lead PRMT5 inhibitor, in patients with advanced solid tumors and hematologic malignancies, and that we will soon begin initiating additional expansion cohorts. We look forward to sharing clinical data for this program, as well as for our second PRMT5 inhibitor, PRT811, in the second half of this year."

    Dr. Vaddi added, "The ongoing Phase 1 trial of our third clinical candidate, PRT1419, an MCL1 inhibitor, also continues to progress, with the addition of dose expansion cohorts expected in the second half of the year. Finally, the continued advancement of our preclinical programs remains a high priority for us in 2021, with the anticipated submission of an IND application for PRT2527, our CDK9 inhibitor, in the second half of this year."

    Recent Highlights and Upcoming Milestones

    PRT543

    • Phase 1 Dose Escalation Complete; Additional Expansion Cohorts to Open in the Second Quarter. The Company today announced that the dose escalation portion of the Phase 1 trial of its lead product candidate, PRT543, is now complete, and that a recommended expansion dose with adequate safety, pharmacokinetics, and target engagement profile has been established. PRT543 is designed to be a potent, selective, and oral inhibitor of PRMT5. The dose expansion portion of the Phase 1 trial is currently open for the patient cohort with adenoid cystic carcinoma, and will be open for additional patient cohorts with solid tumor and hematologic malignancies early in the second quarter. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.



    • Preclinical Data to be Featured at the 2021 AACR Annual Meeting. Three preclinical presentations on PRT543 will be featured at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held April 10-15, 2021 in a virtual setting. A copy of the posters, titled "PRMT5 inhibition downregulates MYB and NOTCH1 signaling, key molecular drivers of adenoid cystic carcinoma" (abstract 1138), "PRMT5 inhibition epigenetically regulates DNA damage response pathways in cancer cells and sensitizes to chemotherapy and PARP inhibition" (abstract 1185), and "PRMT5 inhibition regulates alternative splicing and DNA damage repair pathways in SF3B1 R625C expressing uveal melanoma cells" (abstract 1137), will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.

    PRT811

    • Phase 1 Dose Expansion Cohorts Expected to Commence in Mid-2021. The dose escalation portion of the Company's Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with advanced solid tumors, including glioblastoma multiforme (GBM), remains ongoing. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish the recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers including GBM, with initial clinical data expected by the end of 2021.

    PRT1419

    • Oral Formulation: Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company's first-in-human Phase 1 open-label, multicenter, dose-escalation study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419, which is the Company's third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.



    • IV Formulation: IND Application Cleared. Prelude today announced the recent U.S. Food and Drug Administration (FDA) clearance of the Company's Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the first half of 2021 in patients with solid tumors.



    • Data on Preclinical Characterization to be Featured at the 2021 AACR Annual Meeting. Data on the preclinical characterization of PRT1419 will be featured during a poster session at the 2021 AACR Annual Meeting. A copy of the poster, titled "Preclinical characterization of PRT1419, a potent, selective and orally available inhibitor of MCL1" (abstract 983), will be available in the Publication section of the Prelude Therapeutics website following the conclusion of the meeting.

    Discovery Programs

    • Advancement of Earlier-Stage Candidates Expected in 2021. Prelude remains on track to submit an IND application for PRT2527, which is designed to be a potent and selective CDK9 inhibitor, in 2021. The Company also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.



    • Preclinical Data on SMARCA2 Protein Degradation to be Featured at the 2021 AACR Annual Meeting. A poster presentation on Prelude's SMARCA2 protein degradation program, titled "Potent SMARCA2 targeted degraders induce genetic synthetic lethality in SMARCA4 deleted cancer" (abstract 1139), will be presented at the 2021 AACR Annual Meeting. A copy of the poster will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.

    Corporate

    • Completed Successful Upsized Public Offering of $172.5 Million. In January 2021, the Company announced the closing of its upsized public offering of 2,583,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share, which includes the exercise in full of the underwriters' option to purchase an additional 375,000 shares of its voting common stock. The aggregate gross proceeds from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude.

    Fourth Quarter and Full Year 2020 Financial Results

    • Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $218.3 million.



    • Research and Development (R&D) Expenses: For the fourth quarter of 2020, R&D expense increased to $14.6 million from $8.8 million for the prior year period, and for the full year increased to $48.2 million compared to $24.3 million for 2019. The fourth quarter and full year increases were primarily due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for PRT1419, which began in the third quarter of 2020. The Company also incurred an increase in chemistry, manufacturing, and other costs for those trials.



    • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2020 increased to $4.9 million from $1.2 million for the prior year period, and for the full year increased to $10.6 million compared to $3.8 million for 2019. The fourth quarter and full year increases were primarily due to an increase in personnel related expense due to increased employee headcount and an increase in professional fees as the Company expanded its operations to support R&D efforts and incurred additional costs associated with operating as a public company.



    • Net Loss: For the fourth quarter of 2020, net loss was $19.3 million, or $0.45 per share, compared with a net loss of $10.0 million, or $5.56 per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $56.9 million, or $4.56 per share, compared with a net loss of $27.6 million, or $16.52 per share, for the year ended December 31, 2019.



    • Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2023.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    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, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543, PRT811 and PRT1419, the timing of IND-related activities for PRT2527 and PRT-SCA2 and the potential benefits of the Company's product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company 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 the Company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents the Company 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 the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

     Year ended December 31, 
    (in thousands, except share and per share data)2020  2019 
    Operating expenses:       
    Research and development$48,177  $24,279 
    General and administrative 10,586   3,830 
    Total operating expenses 58,763   28,109 
    Loss from operations (58,763)  (28,109)
    Other income, net 1,834   539 
    Net loss$(56,929) $(27,570)
    Per share information:       
    Net loss per share of common stock, basic and diluted$(4.56) $(16.52)
    Weighted average common shares outstanding, basic and diluted 12,478,463   1,668,549 



      December 31, 
    (in thousands, except share and per share data) 2020  2019 
    Assets        
    Current assets:        
    Cash and cash equivalents $218,309  $18,879 
    Prepaid expenses and other current assets  2,500   1,345 
    Total current assets  220,809   20,224 
    Property and equipment, net  2,480   1,647 
    Deferred offering costs 301    
    Total assets $223,590  $21,871 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)        
    Current liabilities:        
    Capital lease obligation $  $258 
    Accounts payable  3,920   1,974 
    Accrued expenses and other current liabilities  7,455   2,603 
    Total current liabilities  11,375   4,835 
    Other liabilities 32   5 
    Total liabilities  11,407   4,840 
    Convertible preferred stock, $0.0001 par value:        
    Series A convertible preferred stock: No shares and 13,574,008 shares authorized at December 31, 2020 and 2019, respectively; No shares and 11,736,119 shares issued and outstanding at December 31, 2020 and 2019, respectively     36,595 
    Series B convertible preferred stock: No shares and 18,500,000 shares authorized at December 31, 2020 and 2019, respectively; No shares and 7,628,846 shares issued and outstanding at December 31, 2020 and 2019, respectively     29,848 
    Series C convertible preferred stock: No shares authorized, issued or outstanding at December 31, 2020 and 2019      
    Total convertible preferred stock     66,443 
             
    Stockholders' equity:        
    Voting common stock, $0.0001 par value: 487,149,741 and 42,000,000 shares authorized at December 31, 2020 and 2019, respectively; 32,595,301and 3,161,653 shares issued and outstanding at December 31, 2020 and 2019, respectively 3    
    Non-voting common stock, $0.0001 par value: 12,850,259 and no shares authorized at December 31, 2020 and 2019, respectively; 11,110,371 and no shares issued and outstanding at December 31, 2020 and 2019, respectively 1    
    Additional paid-in capital  319,605   1,085 
    Accumulated deficit  (107,426)  (50,497)
    Total stockholders' equity (deficit)  212,183   (49,412)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $223,590  $21,871 

    Contact

    Investors: Melissa Forst

    Media: Deborah Elson

    Argot Partners

    212.600.1902

    prelude@argotpartners.com 



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  8. WILMINGTON, Del., March 03, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that members of its management team will participate in three upcoming virtual investor conferences:

    • Barclays Global Healthcare Conference
      Fireside chat at 8:35 a.m. ET on Wednesday, March 10, 2021
    • Morgan Stanley Virtual Healthcare Corporate Access Day
      1x1 meetings on Tuesday, March 16, 2021
    • Oppenheimer 31st Annual Healthcare Conference
      Corporate presentation at 3:50 p.m. ET on Wednesday, March 17, 2021

    A live webcast of the Barclays fireside chat and Oppenheimer presentation can be accessed under "Events & Presentations" in the Investor Section of the…

    WILMINGTON, Del., March 03, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that members of its management team will participate in three upcoming virtual investor conferences:

    • Barclays Global Healthcare Conference

      Fireside chat at 8:35 a.m. ET on Wednesday, March 10, 2021
    • Morgan Stanley Virtual Healthcare Corporate Access Day

      1x1 meetings on Tuesday, March 16, 2021
    • Oppenheimer 31st Annual Healthcare Conference

      Corporate presentation at 3:50 p.m. ET on Wednesday, March 17, 2021

    A live webcast of the Barclays fireside chat and Oppenheimer presentation can be accessed under "Events & Presentations" in the Investor Section of the Company's website, https://investors.preludetx.com/news-and-events/events-and-presentations, where a replay of the events will also be available for a limited time.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Contact

    Melissa Forst

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  9. WILMINGTON, Del., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated ("Prelude" or "the Company") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the closing of its upsized public offering of 2,583,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share, which includes the exercise in full of the underwriters' option to purchase an additional 375,000 shares of its voting common stock. The aggregate gross proceeds from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude.

    Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities…

    WILMINGTON, Del., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated ("Prelude" or "the Company") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the closing of its upsized public offering of 2,583,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share, which includes the exercise in full of the underwriters' option to purchase an additional 375,000 shares of its voting common stock. The aggregate gross proceeds from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude.

    Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities and Barclays acted as joint book-running managers for the offering.

    A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (the "SEC") on January 6, 2021. The offering was made only by means of a prospectus. A copy of the final prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at prospectus@morganstanley.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526 or by email at prospectus-ny@ny.email.gs.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001 Attn: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at Barclaysprospectus@broadridge.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). Prelude's diverse clinical pipeline also includes PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. These forward-looking statements include, but are not limited to, any statements regarding the development of Prelude's product candidates for certain indications. Such forward-looking statements are subject to various risks, uncertainties, assumptions, or changes in circumstances that are difficult to predict or quantify, including risks resulting from COVID-19. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors include but are not limited to those described under "Risk Factors" in Prelude's periodic filings with the SEC, as well as the risks identified in the registration statement and prospectus relating to the offering. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in the registration statement. Prelude undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

    Contact

    Investors: Melissa Forst

    Media: Joshua Mansbach

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  10. WILMINGTON, Del., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Wilmington, DE – January 7, 2021 – Prelude Therapeutics Incorporated ("Prelude" or "the Company") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the pricing of its upsized public offering of 2,208,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share. The aggregate gross proceeds from this offering are expected to be $150.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude. In addition, Prelude has granted the underwriters a 30-day option to purchase up to an additional 375,000 shares of voting common stock at…

    WILMINGTON, Del., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Wilmington, DE – January 7, 2021 – Prelude Therapeutics Incorporated ("Prelude" or "the Company") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the pricing of its upsized public offering of 2,208,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share. The aggregate gross proceeds from this offering are expected to be $150.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude. In addition, Prelude has granted the underwriters a 30-day option to purchase up to an additional 375,000 shares of voting common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about January 11, 2021, subject to the satisfaction of customary closing conditions.

    Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities and Barclays are acting as joint book-running managers for the offering.

    A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (the "SEC") on January 6, 2021. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at prospectus@morganstanley.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526 or by email at prospectus-ny@ny.email.gs.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001 Attn: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at Barclaysprospectus@broadridge.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). Prelude's diverse clinical pipeline also includes PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. These forward-looking statements include, but are not limited to, any statements regarding the development of Prelude's product candidates for certain indications, and statements regarding the completion and anticipated proceeds of the offering. Such forward-looking statements are subject to various risks, uncertainties, assumptions, or changes in circumstances that are difficult to predict or quantify, including risks resulting from COVID-19. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors include but are not limited to those described under "Risk Factors" in Prelude's periodic filings with the SEC, as well as the risks identified in the registration statement and prospectus relating to the offering. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in the registration statement. Prelude undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

    Contact

    Investors: Melissa Forst

    Media: Joshua Mansbach

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  11. WILMINGTON, Del., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated ("Prelude" or "the Company") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that it has commenced a public offering of 1,750,000 shares of its common stock pursuant to a registration statement on Form S-1 filed with the Securities and Exchange Commission ("SEC"). All shares of common stock to be sold in the offering will be sold by Prelude. In addition, Prelude expects to grant the underwriters a 30-day option to purchase up to an additional 262,500 shares of common stock at the public offering price, less underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or…

    WILMINGTON, Del., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated ("Prelude" or "the Company") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced that it has commenced a public offering of 1,750,000 shares of its common stock pursuant to a registration statement on Form S-1 filed with the Securities and Exchange Commission ("SEC"). All shares of common stock to be sold in the offering will be sold by Prelude. In addition, Prelude expects to grant the underwriters a 30-day option to purchase up to an additional 262,500 shares of common stock at the public offering price, less underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities and Barclays are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the SEC and has not yet become effective. The proposed offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at prospectus@morganstanley.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526 or by email at prospectus-ny@ny.email.gs.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001 Attn: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at Barclaysprospectus@broadridge.com.

    These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). Prelude's diverse clinical pipeline also includes PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. These forward-looking statements include, but are not limited to, any statements regarding the development of Prelude's product candidates for certain indications, statements regarding the terms of the proposed public offering, including our expectations with respect to granting the underwriters a 30-day option to purchase additional shares, and the completion, timing and size of the proposed public offering. Such forward-looking statements are subject to various risks, uncertainties, assumptions, or changes in circumstances that are difficult to predict or quantify, including risks resulting from COVID-19. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors include but are not limited to those described under "Risk Factors" in Prelude's periodic filings with the SEC, as well as the risks identified in the registration statement and preliminary prospectus relating to the offering. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in the registration statement. Prelude undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

    Contacts

    Investors: Melissa Forst

    Media: Joshua Mansbach

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  12. - Completed Initial Public Offering of Common Stock, Raising Gross Proceeds of ~$181.9M -

    - Partial Response Confirmed in Glioblastoma Multiforme Patient in Phase 1 Trial of PRT811 -

    - Durable Complete Response Ongoing in HRD+ High Grade Serous Ovarian Cancer Patient in Phase 1 Trial of PRT543 -

    WILMINGTON, Del., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated ("Prelude", "the Company", "we") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the third quarter ended September 30, 2020 and provided an update on recent developments.

    "Prelude has evolved substantially to become a clinical-stage precision oncology company with multiple small molecule oral agents…

    - Completed Initial Public Offering of Common Stock, Raising Gross Proceeds of ~$181.9M -

    - Partial Response Confirmed in Glioblastoma Multiforme Patient in Phase 1 Trial of PRT811 -

    - Durable Complete Response Ongoing in HRD+ High Grade Serous Ovarian Cancer Patient in Phase 1 Trial of PRT543 -

    WILMINGTON, Del., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated ("Prelude", "the Company", "we") (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced its financial results for the third quarter ended September 30, 2020 and provided an update on recent developments.

    "Prelude has evolved substantially to become a clinical-stage precision oncology company with multiple small molecule oral agents currently advancing through clinical trials," said Kris Vaddi, PhD, Chief Executive Officer, Prelude Therapeutics. "We continue to make great progress in advancing the clinical development of our lead PRMT5 inhibitors, PRT543 and PRT811, and believe we are well-positioned for continued success with the execution of these programs. We look forward to sharing additional data from each program in 2021."

    Dr. Vaddi added, "Beyond our PRMT5 program, we recently advanced our third product candidate, MCL1 inhibitor PRT1419, into the clinic for patients with hematologic malignancies, while our discovery engine continues to generate a diverse and robust pipeline. On the heels of our recent initial public offering resulting in gross proceeds of $181.9 million, we look forward to achieving additional clinical and regulatory milestones in the coming quarters."

    Clinical Program Highlights

    PRT543

    • Dose Expansion Portion of Phase 1 Trial to Commence by Year-End. The Company remains on track to commence the expansion portion of its Phase 1 trial of its lead product candidate, PRT543, which is designed to be a potent, selective, and oral inhibitor of PRMT5, in select solid tumor cohorts during the fourth quarter of 2020 and in select myeloid malignancy cohorts in early 2021. The expansion cohorts will include patients with adenoid cystic carcinoma (ACC), myelofibrosis (MF), genomically-selected myelodysplastic syndrome (MDS), and homologous recombination deficient positive (HRD+) tumors. Preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability, including a durable confirmed complete response (CR) in a patient with HRD+ high grade serous ovarian cancer who had received seven prior lines of therapy. The Company anticipates obtaining initial clinical data from these expansion cohorts in the first half of 2021 and presenting these data at medical meetings in 2021.

    PRT811

    • Dose Escalation Ongoing in Phase 1 Trial in Patients with Advanced Solid Tumors and Recurrent High-Grade Gliomas. The dose escalation portion of the Company's Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with advanced solid tumors, including glioblastoma multiforme (GBM) and primary central nervous system lymphomas (PCNSL), remains ongoing. To date, the trial has demonstrated early signs of clinical activity and tolerability. The previously disclosed refractory GBM patient whose tumor had demonstrated a 66% reduction on monotherapy PRT811 has subsequently undergone a follow-up MRI at week 16 confirming a partial response (PR) per RANO (response assessment in neuro-oncology) criteria. The Company expects to commence the dose expansion portion of the trial in the first half of 2021, with data expected by the end of 2021.

    PRT1419

    • Dosed First Patient in Phase 1 Trial of MCL1 Inhibitor PRT1419 for the Treatment of Relapsed/Refractory Hematologic Malignancies. In September 2020, Prelude announced dosing of the first patient in its first-in-human Phase 1 open-label, multicenter, dose-escalation study of PRT1419 in patients with relapsed/refractory hematologic malignancies. PRT1419, the Company's third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor.

    Corporate Update

    • Completed Initial Public Offering (IPO). In September 2020, Prelude closed its IPO of 9,573,750 shares of common stock, including the full exercise of the underwriters' option to purchase up to 1,248,750 additional shares of common stock, at a public offering price of $19.00 per share. Aggregate gross proceeds to Prelude were approximately $181.9 million, before deducting underwriting discounts and commissions and other offering expenses of $15.3 million.
    • Strengthened Board of Directors with Two New Appointments. In August 2020, the Company announced the appointment of Mardi C. Dier and Victor Sandor, M.D., both highly accomplished industry veterans, to its Board of Directors.

    Third Quarter 2020 Financial Results

    • Cash and cash equivalents: Cash and cash equivalents as of September 30, 2020 were $234.8 million.
    • Research and Development (R&D) Expenses: For the third quarter of 2020, R&D expenses increased by $9.8 million to $15.3 million compared to $5.5 million for the third quarter of 2019. The increase was mainly due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for PRT1419, which began in the third quarter of 2020. Prelude also incurred an increase in chemistry, manufacturing, and other costs for those trials. 
    • General and Administrative (G&A) Expenses: For the third quarter of 2020, G&A expenses increased by $1.5 million to $2.9 million compared to $1.4 million for the third quarter of 2019. The increase was primarily due to an increase in personnel related expense due to increases in employee headcount and an increase in professional fees as Prelude expanded its operations to support its research and development efforts and incurred additional costs to operate as a public company.
    • Net Loss: For the third quarter of 2020, net loss was $16.8 million, or $5.25 per share, compared to a net loss of $6.7 million, or $3.93 per share, for the third quarter of 2019.

    About Prelude Therapeutics

    Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company's lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company's diverse clinical pipeline also includes PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

    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, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543 and PRT811 and the potential benefits of the Company's product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company 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 the Company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents the Company 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 the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.





    Statements of Operations

    (unaudited)

      Three Months Ended September 30, 
    (in thousands, except share and per share data) 2020  2019 
    Operating expenses:        
    Research and development $15,293  $5,490 
    General and administrative  2,851   1,394 
    Total operating expenses  18,144   6,884 
    Loss from operations  (18,144)  (6,884)
    Other income, net  1,384   150 
    Net loss $(16,760) $(6,734)
    Per share information:        
    Net loss per share of common stock, basic and diluted $(5.25) $(3.93)
    Weighted average common shares outstanding, basic and diluted  3,194,471   1,713,371 





    Balance Sheets

    (unaudited)

    (in thousands, except share data) September 30,

    2020
       December 31,

    2019
     
    Assets       
    Current assets:       
    Cash and cash equivalents$234,792  $18,879 
    Prepaid expenses and other current assets 3,269   1,345 
    Total current assets 238,061   20,224 
    Property and equipment, net 1,620   1,647 
    Total assets$239,681  $21,871 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)       
    Current liabilities:       
    Capital lease obligation$  $258 
    Accounts payable 5,074   1,974 
    Accrued expenses and other current liabilities 6,285   2,603 
    Total current liabilities 11,359   4,835 
    Other liabilities 15   5 
    Total liabilities 11,374   4,840 
    Convertible preferred stock, $0.0001 par value:       
    Series A convertible preferred stock: No shares and 13,574,008 shares

    authorized at September 30, 2020 and December 31, 2019, respectively; no shares and 11,736,119 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
        36,595 
    Series B convertible preferred stock: No shares and 18,500,000 shares

    authorized at September 30, 2020 and December 31, 2019; No shares and 7,628,846 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
        29,848 
    Series C convertible preferred stock: no shares authorized, issued or outstanding at September 30, 2020 and December 31, 2019     
    Total convertible preferred stock    66,443 
    Stockholders' equity (deficit):       
    Voting common stock, $0.0001 par value: 487,149,741 and 42,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 32,593,010 and 3,161,653 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 3    
    Non-voting common stock, $0.0001 par value; 12,850,259 and no shares

    authorized at September 30, 2020 and December 31, 2019, respectively; 11,110,371 and no shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
     1    
    Additional paid-in capital 316,479   1,085 
    Accumulated deficit (88,176)  (50,497)
    Total stockholders' equity (deficit) 228,307   (49,412)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$239,681  $21,871 



    Contact

    Investors: Melissa Forst

    Media: Joshua Mansbach

    Argot Partners

    212.600.1902

    prelude@argotpartners.com

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