ZNTL Zentalis Pharmaceuticals Inc.

75.8
-1.73  -2%
Previous Close 77.53
Open 76.16
52 Week Low 34.48
52 Week High 87.19
Market Cap $3,434,160,235
Shares 45,305,544
Float 30,846,051
Enterprise Value $3,146,609,826
Volume 170,241
Av. Daily Volume 240,454
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Upcoming Catalysts

Drug Stage Catalyst Date
ZN-e4
Non-small cell lung cancer
Phase 1
Phase 1
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ZN-c3-003 with gemcitabine (chemotherapy)
Osteosarcoma
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
ZN-c3
Uterine serous carcinoma
Phase 2
Phase 2
Phase 2 initiation of dosing announced August 2, 2021. Enrollment ongoing.
ZN-d5
Acute Myeloid Leukemia
Phase 1
Phase 1
Phase 1 trial initiation announced January 6, 2021.
ZN-c5
ER+/HER2- breast cancer
Phase 1/2
Phase 1/2
Phase 2 monotherapy trial to be initiated 1H 2021.
ZN-c3 and ZEJULA (Niraparib)
Ovarian cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial to commence 2H 2021.
ZN-c5 and abemaciclib
ER+/HER2- advanced breast cancer
Phase 1b
Phase 1b
Phase 1b trial initiation announced January 6, 2021.

Latest News

  1. NEW YORK and SAN DIEGO, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZN-c3, the Company's oral WEE1 inhibitor product candidate, for the treatment of recurrent or persistent uterine serous carcinoma (USC) in adult women.

    "USC is a devastating endometrial cancer marked by low survival rates and high rates of recurrence. Receiving Fast Track designation for ZN-c3 is an important milestone, as it underscores the need for novel, effective treatment…

    NEW YORK and SAN DIEGO, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZN-c3, the Company's oral WEE1 inhibitor product candidate, for the treatment of recurrent or persistent uterine serous carcinoma (USC) in adult women.

    "USC is a devastating endometrial cancer marked by low survival rates and high rates of recurrence. Receiving Fast Track designation for ZN-c3 is an important milestone, as it underscores the need for novel, effective treatment options for this aggressive and often fatal disease," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "ZN-c3, our potentially first- and best-in-class oral WEE1 inhibitor, is a notable clinical advancement in DNA damage response and synthetic lethality and is currently being evaluated in a potentially registrational Phase 2 trial in USC. We are grateful for the opportunity to have more frequent interactions with the FDA as we continue to quickly advance the development of this promising candidate for patients in need."

    Fast Track designation aims to facilitate the development and accelerate the review of new therapeutics that are intended to treat serious or life-threatening conditions and that potentially address an unmet medical need. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.

    About Uterine Serous Carcinoma

    Uterine serous carcinoma is an aggressive variant of endometrial cancer that accounts for less than 10% of all endometrial cancers, yet 80% of endometrial cancer–related deaths. In the U.S., ~6,500 women are diagnosed annually, with ~70% presenting with Stage III or IV disease at diagnosis. Currently, the standard of care for treating USC is staging surgery together with chemotherapy or radiotherapy; yet, the recurrence rates post-surgery are extremely high and result in low patient survival rates. There remains an urgent medical need for transformative therapies that target the USC pathway.

    About ZN-c3

    ZN-c3 is a potentially first-in-class and best-in-class oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage response protein, aims to generate sufficient DNA damage in cancer cells, causing cell death, thereby preventing tumor growth and potentially causing tumor regression. ZN-c3 has broad potential as a monotherapy and in combination. We are currently evaluating this candidate in several ongoing and planned studies, including two potentially registrational monotherapy trials in USC and a biomarker-driven setting, as well as combination studies, including in combination with chemotherapy in patients with advanced ovarian cancer. We also received orphan drug and rare pediatric disease designations from the FDA for pediatric osteosarcoma and have initiated a Phase 1/2 trial in combination with chemotherapy.

    About Zentalis Pharmaceuticals

    Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company is developing a broad pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a WEE1 inhibitor for advanced solid tumors, ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for hematologic malignancies, and ZN-e4, an EGFR inhibitor for non-small cell lung carcinoma (NSCLC). Zentalis has licensed ZN-c3, ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the development, potential, safety, efficacy, and regulatory and clinical progress of our product candidates, including without limitation ZN-c3, in the Unites States and globally, potential eligibility of ZN-c3 for a rare pediatric disease priority voucher and plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to the important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.



    Investor Contact:

    Alexandra Roy

    Solebury Trout

    Media Contact:

    Julia Deutsch

    Solebury Trout



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  2. Initiated a Phase 1/2 trial of ZN-c3 in combination with gemcitabine for patients with relapsed or refractory osteosarcoma

    Enrollment ongoing in the potentially registrational Phase 2 trial of ZN-c3 in patients with uterine serous carcinoma (USC)

    Published seminal research on the discovery of ZN-c3 in the Journal of Medicinal Chemistry

    Announces the Company's virtual R&D day will be hosted on Thursday, December 16, 2021 at 11:00 a.m. EST

    NEW YORK and SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers…

    Initiated a Phase 1/2 trial of ZN-c3 in combination with gemcitabine for patients with relapsed or refractory osteosarcoma

    Enrollment ongoing in the potentially registrational Phase 2 trial of ZN-c3 in patients with uterine serous carcinoma (USC)

    Published seminal research on the discovery of ZN-c3 in the Journal of Medicinal Chemistry

    Announces the Company's virtual R&D day will be hosted on Thursday, December 16, 2021 at 11:00 a.m. EST

    NEW YORK and SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the third quarter ended September 30, 2021 and highlighted recent corporate accomplishments.

    "This past quarter, Zentalis continued to execute on its clinical development strategy, and we are pleased with the progress we have made to advance our lead program, ZN-c3, a potentially best-in-class WEE1 inhibitor," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Most recently, we initiated a Phase 1/2 trial with ZN-c3 in combination with gemcitabine in patients with osteosarcoma, further supporting the broad potential of ZN-c3 in combination therapy settings. Before year-end, we plan to have a total of six ongoing trials investigating our WEE1 inhibitor and look forward to initiating our potentially registrational biomarker-driven Phase 2 trial shortly. Additionally, the foundational research on the discovery of ZN-c3 was published in the peer-reviewed Journal of Medicinal Chemistry, which reviews our objectives for designing ZN-c3 as a potentially safer and more selective WEE1 inhibitor and in turn, overcoming limitations seen with other candidates in development."

    Continued Dr. Sun, "We remain on track with our anticipated clinical milestones and are eager to provide future updates on these efforts. Looking ahead, we are excited to host a virtual R&D Day on December 16, during which our management team and key opinion leaders will provide a review of new preclinical science across multiple programs and share clinical updates on ZN-d5 and ZN-e4."

    Program Highlights:

    • In September 2021, Zentalis dosed the first patient in the Phase 1/2 study of ZN-c3 in combination with gemcitabine, a chemotherapy used to treat certain malignant tumors, in patients with relapsed or refractory osteosarcoma. Zentalis recently received orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA) for pediatric osteosarcoma. Zentalis expects to report initial results from this trial in the second half of 2022.
    • Enrollment is ongoing in the potentially registrational Phase 2 trial of ZN-c3 in women with recurrent or persistent USC. Following an end-of-Phase 1 meeting in July 2021, the FDA agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 study design in USC.
    • In September 2021, research on the discovery of ZN-c3 was published in the Journal of Medicinal Chemistry. The paper reviews Zentalis' objectives in designing ZN-c3 as a potentially safer and more selective WEE1 inhibitor, overcoming limitations seen with other WEE1 inhibitors.
    • In September 2021, Zentalis presented six poster presentations on the candidates: ZN-c3, a WEE1 inhibitor; ZN-c5, an oral selective SERD and ZN-d5, a BCL-2 inhibitor at the European Society for Medical Oncology (ESMO) Congress.

    Zentera Highlights:

    • In August 2021, Zentera, a Shanghai-based clinical-stage biopharmaceutical company formed by Zentalis, announced the completion of a $75 million Series B financing. Zentera plans to use the proceeds to advance the clinical development in China of three of Zentalis' product candidates (ZN-c3, ZN-c5 and ZN-d5), as well as expand its pipeline through additional business development opportunities for China and global development.
    • Zentera received CTA acceptances in China for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5 and four clinical trials are ongoing.

    Corporate Highlights:

    • In July 2021, Zentalis closed an underwritten follow-on offering of 3,565,000 shares of its common stock at a public offering price of $48.50 per share. The total net proceeds were approximately $162.2 million, after deducting underwriting discounts and commissions and offering expenses payable by Zentalis.

    Third Quarter 2021 Financial Results

    • Cash and Marketable Securities Position: As of September 30, 2021, Zentalis had cash, cash equivalents and marketable securities of $366.8 million. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2021 will be sufficient to fund our operating expenses and capital expenditures requirements into the third quarter of 2023.

    • Research and Development Expenses: Research and development expenses for the three months ended September 30, 2021 were $54.0 million, compared to $24.7 million for the three months ended September 30, 2020. The increase of $29.3 million was primarily due to increases in external research and development expenses related to our clinical product candidates, as we advanced our clinical pipeline.

    • General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2021 were $8.9 million, compared to $10.1 million during the three months ended September 30, 2020. This decrease of $1.2 million was primarily attributable to a decrease of $0.6 million in legal fees and an increase in allocable overhead expenses to research and development expenses of $1.7 million, offset by an increase of $1.1 million of facilities and related permits/fees and licenses expenses.

    • Net Loss: Net loss was $10.5 million for the three months ended September 30, 2021, compared to $34.7 million for the three months ended September 30, 2020. The $24.2 million decrease in net loss was primarily the result of the gain on deconsolidation of Zentera recognized during the three months ended September 30, 2021, partially offset by increases in research and development expenses discussed above.

    About Zentalis Pharmaceuticals

    Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company is developing a broad pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a WEE1 inhibitor for advanced solid tumors, ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for hematologic malignancies, and ZN-e4, an EGFR inhibitor for non-small cell lung carcinoma (NSCLC). Zentalis has licensed ZN-c3, ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the development, potential, safety, efficacy, and regulatory and clinical progress of our product candidates in the Unites States and globally, plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones, our participation in upcoming events and presentations, and the sufficiency of our cash and cash equivalents. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the COVID-19 pandemic has adversely impacted and may continue to adversely impact our business, including our preclinical studies and clinical trials; our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of our lead product candidates; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel; significant costs as a result of operating as a public company and risks related to our ceasing to qualify as an emerging growth company after December 31, 2021; and the other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Investor Contact:

    Alexandra Roy

    Solebury Trout

    Media Contact:

    Julia Deutsch

    Solebury Trout

    Zentalis Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2021 2020 2021 2020
    Operating Expenses       
    Research and development$53,998  $24,670  $137,162  $55,380 
    General and administrative8,872  10,097  31,187  23,162 
    Total operating expenses62,870  34,767  168,349  78,542 
    Operating loss(62,870) (34,767) (168,349) (78,542)
    Other Income (Expense)       
    Investment and other income, net99  120  313  368 
    Gain on deconsolidation of Zentera51,582    51,582   
    Net loss before income taxes(11,189) (34,647) (116,454) (78,174)
    Income tax expense (benefit)(697) 18  (456) 18 
    Net loss(10,492) (34,665) (115,998) (78,192)
    Net loss attributable to noncontrolling interests(6,301) (110) (7,332) (654)
    Net loss attributable to Zentalis$(4,191) $(34,555) $(108,666) $(77,538)
    Net loss per common share outstanding, basic and diluted$(0.09) $(0.91) $(2.59) $(3.21)
    Common shares used in computing net loss per share, basic and diluted44,609  37,959  41,918  24,143 
                

    Zentalis Pharmaceuticals, Inc.

    Selected Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)

     As of

    September 30,
     As of

    December 31,
     2021 2020
    Cash, cash equivalents and marketable securities$366,791  $338,505 
    Working capital (1)338,150  316,503 
    Total assets435,081  365,555 
    Total liabilities41,085  32,178 
    Total Zentalis equity$393,996  $333,377 
        

    (1) The Company defines working capital as current assets less current liabilities.



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  3. NEW YORK and SAN DIEGO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that Anthony Sun, MD, Chairman and Chief Executive Officer of Zentalis, will present at two upcoming investor conferences.

    Presentation Details:

    Event: Stifel 2021 Virtual Healthcare Conference
    Date/Time: Wednesday, November 17th, 2021 at 8:40 a.m. EST
    Format: Corporate Presentation

    Event: Jefferies London Healthcare Conference
    Date/Time: Available starting on Thursday, November 18th, 2021 at 8:00 a.m. GMT, 3:00 a.m. EST
    Format: On Demand Corporate Presentation

    NEW YORK and SAN DIEGO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that Anthony Sun, MD, Chairman and Chief Executive Officer of Zentalis, will present at two upcoming investor conferences.

    Presentation Details:

    Event: Stifel 2021 Virtual Healthcare Conference

    Date/Time: Wednesday, November 17th, 2021 at 8:40 a.m. EST

    Format: Corporate Presentation

    Event: Jefferies London Healthcare Conference

    Date/Time: Available starting on Thursday, November 18th, 2021 at 8:00 a.m. GMT, 3:00 a.m. EST

    Format: On Demand Corporate Presentation

    Webcasts from the Stifel and Jefferies corporate presentations will be accessible through the Investors section of the Company's website at www.zentalis.com. Following the events, archived webcasts will be available on the Zentalis website.

    About Zentalis

    Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company is developing a broad pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a WEE1 inhibitor for advanced solid tumors, ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for hematologic malignancies, and ZN-e4, an EGFR inhibitor for non-small cell lung carcinoma (NSCLC). Zentalis has licensed ZN-c3, ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in both New York and San Diego.



    For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our participation in upcoming events and presentations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to the important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Investor Contact:

    Alexandra Roy

    Solebury Trout



    Media Contact:

    Julia Deutsch

    Solebury Trout



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  4. NEW YORK and SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the first patient has been dosed in the Phase 1/2 trial of ZN-c3, the Company's oral WEE1 inhibitor product candidate, in combination with gemcitabine, a chemotherapy used to treat certain malignant tumors, in pediatric and adult patients with relapsed or refractory osteosarcoma.

    "We are thrilled to expand our ZN-c3 program with the initiation of a fourth clinical trial for this candidate, underscoring ZN-c3's potential versatility across a broad range…

    NEW YORK and SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the first patient has been dosed in the Phase 1/2 trial of ZN-c3, the Company's oral WEE1 inhibitor product candidate, in combination with gemcitabine, a chemotherapy used to treat certain malignant tumors, in pediatric and adult patients with relapsed or refractory osteosarcoma.

    "We are thrilled to expand our ZN-c3 program with the initiation of a fourth clinical trial for this candidate, underscoring ZN-c3's potential versatility across a broad range of solid tumors," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Relapsed or refractory patients with osteosarcoma, a rare type of bone cancer, have an extremely poor prognosis, reinforcing the need for novel treatment regimens to combat this highly aggressive disease. With over 50% of osteosarcomas having a mutation in TP53 – potentially resulting in chemoresistance – we believe that inhibiting the DNA damage response protein WEE1 could enhance the efficacy of gemcitabine in this pre-treated population. We are eager to conduct this seminal study evaluating this combination's clinical safety and efficacy and look forward to reporting initial results from this trial in the second half of 2022."

    Zentalis recently received orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration for pediatric osteosarcoma. If ZN-c3 were to obtain approval for the designated indication, it could potentially be eligible for a rare pediatric disease priority voucher upon approval.

    The Phase 1/2 trial (ZN-c3-003) is a dose escalation and dose expansion study, evaluating the clinical activity, safety, pharmacodynamics and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma. The primary efficacy endpoint is event-free survival (EFS) at 18 weeks per RECIST criteria. Secondary endpoints include EFS per RECIST, median overall survival and overall survival at 12 months. More information about the trial is available at www.clinicaltrials.gov: NCT04833582.

    About Osteosarcoma

    Osteosarcoma, while rare, is the most common type of bone cancer and is often associated with a high degree of malignancy, early metastasis, rapid progression, and poor prognosis. This cancer occurs primarily in children, teens and young adults ranging from 10 to 30 years old. The risk of diagnosis decreases in adulthood, but rises again in older adults usually over the age of 60. Approximately 1,000 new cases of osteosarcoma are diagnosed in the United States each year. Treatment typically includes a combination of surgery and chemotherapy, with chemotherapy administered before and after surgery to help lower the risk of relapse. Even though curative therapy is available for the primary tumor, long-term outcomes for osteosarcoma patients continue to be impacted by metastatic progression. In addition, over 50% of osteosarcomas have a mutation in TP53 which portends a poorer prognosis and implies chemoresistance. As no substantive improvements in long-term outcomes have occurred for more than three decades, there remains an urgent need for improved therapies to prevent or treat metastatic disease.

    About ZN-c3

    ZN-c3 is a potentially first-in-class and best-in-class oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage response protein, aims to generate sufficient DNA damage in cancer cells, causing cell death, thereby preventing tumor growth and potentially causing tumor regression. ZN-c3 has broad potential as a monotherapy and in combination and we are currently evaluating this candidate in several ongoing and planned studies, including two potentially registrational monotherapy trials in USC and a biomarker-driven setting, as well as combination studies such as with chemotherapy in patients with advanced ovarian cancer. We also recently received orphan drug and rare pediatric disease designations from the FDA for pediatric osteosarcoma and have initiated a Phase 1/2 trial in combination with chemotherapy.

    About Zentalis Pharmaceuticals

    Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company is developing a broad pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a WEE1 inhibitor for advanced solid tumors, ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for hematologic malignancies, and ZN-e4, an EGFR inhibitor for non-small cell lung carcinoma (NSCLC). Zentalis has licensed ZN-c3, ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the development, potential, safety, efficacy, and regulatory and clinical progress of our product candidates, including without limitation ZN-c3, in the Unites States and globally, potential eligibility of ZN-c3 for a rare pediatric disease priority voucher and plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to the important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.



    Investor Contact:

    Gitanjali Jain Ogawa

    Solebury Trout

      

    Media Contact:

    Julia Deutsch

    Solebury Trout

      



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  5. NEW YORK and SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that six abstracts have been accepted for poster presentation at the upcoming European Society for Medical Oncology (ESMO) Congress, being held virtually September 16-21, 2021.

    Poster Presentation Details:

    Title: Pharmacodynamic evidence for WEE1 target engagement in surrogate and tumor tissues from a Phase 1 study of the WEE1 inhibitor ZN-c3
    Abstract ID: 3874

    Title: A Phase 1b dose-escalation study of ZN-c3, a WEE1 inhibitor, in combination with chemotherapy…

    NEW YORK and SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that six abstracts have been accepted for poster presentation at the upcoming European Society for Medical Oncology (ESMO) Congress, being held virtually September 16-21, 2021.

    Poster Presentation Details:

    Title: Pharmacodynamic evidence for WEE1 target engagement in surrogate and tumor tissues from a Phase 1 study of the WEE1 inhibitor ZN-c3

    Abstract ID: 3874

    Title: A Phase 1b dose-escalation study of ZN-c3, a WEE1 inhibitor, in combination with chemotherapy in patients with platinum-resistant or -refractory ovarian, peritoneal, or fallopian tube cancer

    Abstract ID: 3912

    Title: A Phase 1/2 dose-escalation and expansion study of ZN-c5, an oral selective estrogen receptor degrader (SERD), as monotherapy and in combination with palbociclib in patients with advanced estrogen receptor (ER)+/HER2- breast cancer

    Abstract ID: 3825

    Title: A Phase 1b dose-escalation study of ZN-c5, an oral selective estrogen receptor degrader (SERD), in combination with abemaciclib in patients with advanced estrogen receptor (ER)+/HER2- breast cancer

    Abstract ID: 3711

    Title: A Phase 1 dose-escalation study of ZN-d5, an BCL-2 inhibitor with improved selectivity, in subjects with advanced non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML)

    Abstract ID: 4102

    Title: Discovery of ZN-d5, a potent BCL-2 inhibitor with improved selectivity for BCL-2

    Abstract ID: 3916

    All posters will be available on the Congress platform beginning September 16, 2021 at 8:30 a.m. CEST. The presentation materials will also be available in the "Supporting Publications" section of Zentalis Pharmaceutical's website at www.zentalis.com.

    About Zentalis Pharmaceuticals

    Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company is developing a broad pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a WEE1 inhibitor for advanced solid tumors, ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for hematologic malignancies, and ZN-e4, an EGFR inhibitor for non-small cell lung carcinoma (NSCLC). Zentalis has licensed ZN-c3, ZN-c5 and ZN-d5 to its majority-owned joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the development, potential, safety, efficacy, and regulatory and clinical progress of our product candidates in the Unites States and globally, and upcoming events and presentations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to the important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.



    Investor Contact:

    Gitanjali Jain Ogawa

    Solebury Trout

     

    Media Contact:

    Julia Deutsch

    Solebury Trout



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