PRLD Prelude Therapeutics Incorporated

17.34
-1.58  -8%
Previous Close 18.93
Open 18.75
52 Week Low 15.31
52 Week High 95.375
Market Cap $816,837,295
Shares 47,093,531
Float 7,203,248
Enterprise Value $503,172,239
Volume 288,665
Av. Daily Volume 552,037
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Upcoming Catalysts

Drug Stage Catalyst Date
PRT811
Solid Tumors and Recurrent High-Grade Gliomas
Phase 1
Phase 1
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PRT543
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
PRT2527
Solid tumors and hematological malignancies
Phase 1
Phase 1
IND application and Phase 1 trial to commence by year-end 2021.
PRT1419
Hematologic malignancies
Phase 1
Phase 1
Phase 1 dose escalation trial is ongoing.

Latest News

  1. – Lead oral PRMT5 inhibitors PRT543 and PRT811 demonstrate favorable safety profile, evidence of preliminary clinical activity including durable responses and high levels of target inhibition of PRMT5 in Phase 1 dose escalation in unselected patients –

    – CDK9 inhibitor PRT2527 demonstrates strong efficacy in hematological malignancies and solid tumor models with MYC dysregulation in preclinical studies –

    WILMINGTON, Del., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the presentation of data from multiple pipeline programs, including the dose escalation portions of the Company's ongoing Phase 1 trials of lead oral protein arginine methyltransferase…

    – Lead oral PRMT5 inhibitors PRT543 and PRT811 demonstrate favorable safety profile, evidence of preliminary clinical activity including durable responses and high levels of target inhibition of PRMT5 in Phase 1 dose escalation in unselected patients –

    – CDK9 inhibitor PRT2527 demonstrates strong efficacy in hematological malignancies and solid tumor models with MYC dysregulation in preclinical studies –

    WILMINGTON, Del., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (NASDAQ:PRLD), a clinical-stage precision oncology company, today announced the presentation of data from multiple pipeline programs, including the dose escalation portions of the Company's ongoing Phase 1 trials of lead oral protein arginine methyltransferase 5 (PRMT5) inhibitors PRT543 and PRT811. These data will be featured at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics being held October 7-10, 2021.

    "We are encouraged by the Phase 1 dose escalation data for our lead oral PRMT5 inhibitors, PRT543 and PRT811, both of which demonstrated favorable safety profiles, dose-dependent increases in pharmacokinetic parameters, target engagement, and achieved degrees of PRMT5 inhibition required for efficacy in preclinical models at well tolerated doses. We are also encouraged by the preliminary clinical activity observed with both molecules in multiple tumor types, including durable responses in cancers with high unmet need. Importantly, our brain penetrant molecule, PRT811, demonstrated a very high level of systemic PRMT5 inhibition at well tolerated doses and without central nervous system adverse events, which expands the potential clinical utility of this molecule," said Kris Vaddi, Ph.D., Chief Executive Officer. "We are leveraging insights from these data as we move forward through the expansion cohorts in selected patient populations, and we anticipate a cadence of data from these cohorts throughout 2022."

      

    Dr. Vaddi added, "With respect to PRT2527, our potent and selective CDK9 inhibitor, we are encouraged by preclinical findings which support its potential in solid tumors and hematological malignancies demonstrating dysregulation of MYC gene expression. We remain on track to submit an IND application and initiate a Phase 1 clinical trial by year-end."

    Summary of Data Presented

    A copy of each poster will be available in the Publications section of the Prelude Therapeutics website.

    PRT543

    Title: A phase 1 dose-escalation study of protein arginine methyltransferase 5 (PRMT5) inhibitor PRT543 in patients with advanced solid tumors and lymphoma 

    Presenter: Meredith McKean, M.D., MPH, Sarah Cannon Research Institute, Tennessee Oncology

    Poster: P039

    • As of an August 6, 2021 data cutoff date, the dose escalation portion of the ongoing Phase 1 trial of PRT543, which is designed to be a potent and selective inhibitor of PRMT5, enrolled a total of 49 patients across 18 unselected advanced solid tumors and lymphoma. Patients enrolled received an average of three prior lines of therapy. PRT543 demonstrated target engagement and inhibition of PRMT5 functional activity as evidenced by a 69% reduction in serum symmetric dimethylarginine (sDMA) at a dose of 45 mg/5x per week. In addition, PRT543 demonstrated signs of preliminary clinical activity, including a durable complete response (CR) maintained for over 18 months in a patient with HRD+ ovarian cancer who remains on treatment, and prolonged stable disease (SD) persisting for over six months in five patients, including four patients with adenoid cystic carcinoma (ACC) and one patient with uveal melanoma. PRT543 was generally well tolerated: the most common grade 3 or higher treatment-related adverse events (AE) occurring in at least 5% of patients were thrombocytopenia (27%) and anemia (12%), both of which were reversible upon treatment interruption. Patients were largely able to remain on therapy with few AE-related dose interruptions (27%), reductions (22%), or discontinuations (4%).



      Patient enrollment is ongoing in specific biomarker-selected solid tumor and hematologic malignancy expansion cohorts. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.

    "Preliminary findings support that PRT543 could represent a much-needed treatment option across multiple malignancies," said Dr. McKean. "Of note, preliminary clinical activity observed in heavily pre-treated patients with historically difficult to treat disease, including a durable CR in a patient with HRD+ ovarian cancer, offers support for the continued assessment of this promising agent."

    PRT811

    Title: A phase 1 dose-escalation study of protein arginine methyltransferase 5 (PRMT5) brain-penetrant inhibitor PRT811 in patients with advanced solid tumors, including recurrent high-grade gliomas 

    Presenter: Gerald S. Falchook, M.D., Sarah Cannon Research Institute at HealthONE

    Poster: P044

    • As of an August 13, 2021 data cutoff date, the dose escalation portion of the ongoing Phase 1 trial of PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, enrolled a total of 45 patients, including 27 patients across 16 unselected advanced solid tumors and 18 patients with high-grade gliomas, including 17 patients with glioblastoma multiforme (GBM). PRT811 demonstrated dose dependent inhibition of PRMT5 activity as evidenced by an 83% reduction in serum sDMA at a dose of 600 mg daily (QD). In addition, PRT811 demonstrated signs of preliminary clinical activity, including an IDH1 mutated GBM patient who experienced a partial response (PR) that evolved into a durable CR for more than 13 months and remains on treatment. In addition, a patient with splicing-mutant (SF3B1) uveal melanoma demonstrated SD for more than six months with a 25% tumor regression and remains on treatment. At a post data-cutoff on September 20, 2021, one additional patient (800 mg QD) with SF3B1 uveal melanoma had an unconfirmed PR and 47% decrease in target lesion, and a patient with triple negative breast cancer (800 mg QD) who demonstrated a 27% decrease in target lesions. Both patients continue treatment. PRT811 was generally well-tolerated; the most common grade 3 or higher treatment-related AE was thrombocytopenia (7%), which was reversible upon treatment interruption. Patients were largely able to remain on therapy with few AE-related dose interruptions (13%), reductions (4%), or discontinuations (3%). 

    The study remains ongoing, and the Company expects to commence enrollment in the expansion portion of the trial in the fourth quarter. Data from the expansion cohorts are expected to be presented at medical meetings throughout 2022.

    "Patients with high-grade gliomas and uveal melanoma have limited treatment options and face a particularly poor prognosis," said Dr. Falchook. "I am encouraged by the initial data from the dose escalation portion of the study, which include a patient with recurrent GBM harboring an IDH1 mutation whose durable initial PR subsequently evolved into a CR, as well as a patient with splicing-mutant uveal melanoma and a patient with triple negative breast cancer who both experienced decreases in their target lesions and remain on therapy. Given the role of PRMT5 in DNA damage response, the results thus far provide impetus for the continued evaluation of PRT811 within this patient population."

    Preclinical Data

    Title: PRT2527 is a potent and selective CDK9 inhibitor that demonstrates anti-cancer activity in preclinical models of hematological malignancies and solid tumors with MYC amplification

    Presenter: Yang Zhang, Ph.D., Prelude Therapeutics

    Poster: P237

    • This study sought to assess PRT2527, which is designed to be a potent and selective CDK9 inhibitor, in preclinical models of multiple hematological malignancies and solid tumors. Treatment with PRT2527 was shown to deplete oncogenic drivers with short half-lives such as MYC and MCL1 and induce apoptosis. Intermittent intravenous administration of PRT2527 demonstrated strong efficacy in hematological malignancies and solid tumor models with MYC dysregulation. The Company remains on track to submit an Investigational New Drug (IND) application for PRT2527 and initiate a Phase 1 clinical trial by the end of the year.

    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 and PRT811, the timing of IND-related activities for PRT2527 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.

    Investor Contacts:

    Stacey Jurchison

    Executive Director, Corporate Affairs

    sjurchison@preludetx.com

    Melissa Forst

    Argot Partners

    212.600.1902

    prelude@argotpartners.com

    Media Contact:

    Paige Donnelly

    Argot Partners

    212.600.1902

    prelude@argotpartners.com



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  2. 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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  3. - 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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  4. 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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  5. 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…

    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



    Primary Logo

    View Full Article Hide Full Article
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