1. SAN DIEGO, June 21, 2021 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. ("Biosplice"), a clinical-stage biotechnology company pioneering therapeutics based on alternative pre-mRNA splicing for major diseases, announced today the addition of Dave Johnson, most recently Founder and CEO of VelosBio, as an independent director to its board.

    "Mr. Johnson's vast experience ushering drugs from pre-clinical development through product launch will provide invaluable guidance as we accelerate our oncology program, complete the clinical development of lorecivivint, our knee osteoarthritis drug candidate, and broaden the applicability of our alternative splicing platform," said Cevdet Samikoglu, CEO of Biosplice.

    Dave Johnson brings more than 25 years…

    SAN DIEGO, June 21, 2021 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. ("Biosplice"), a clinical-stage biotechnology company pioneering therapeutics based on alternative pre-mRNA splicing for major diseases, announced today the addition of Dave Johnson, most recently Founder and CEO of VelosBio, as an independent director to its board.

    "Mr. Johnson's vast experience ushering drugs from pre-clinical development through product launch will provide invaluable guidance as we accelerate our oncology program, complete the clinical development of lorecivivint, our knee osteoarthritis drug candidate, and broaden the applicability of our alternative splicing platform," said Cevdet Samikoglu, CEO of Biosplice.

    Dave Johnson brings more than 25 years of biopharmaceutical experience. He most recently held the position as Founder and CEO of VelosBio, a clinical-stage, oncology-focused biopharmaceutical company advancing novel antibody-drug-conjugate and bispecific antibody technologies, acquired by Merck for $2.75 billion. From 2013 to 2016, Mr. Johnson rose to Chief Executive Officer of Acerta Pharma, an oncology-focused pharmaceutical company, where he spearheaded acalabrutinib from early to late-stage global clinical development. His term at Acerta concluded in an acquisition of the company by AstraZeneca, a deal valued at up to $7 billion.

    Earlier in his career, he held positions of increasing responsibility at Calistoga (acq. by Gilead), Gloucester (acq. by Celgene), Favrille, Millennium (acq. by Takeda), Immunex (acq. by Amgen), and Hoffman-La Roche.   Mr. Johnson also currently serves as Chairman of Aura Biosciences, Inc. and as a director of Zentalis Pharmaceuticals (NASDAQ:ZNTL).

    Learn more about Biosplice's Board of Directors at https://www.biosplice.com/board-of-directors.

    About Biosplice

    Biosplice is developing first-in-class, small-molecule therapeutics based on pioneering science of alternative pre-mRNA splicing. Stemming from foundational discoveries in Wnt pathway modulation, Biosplice has elucidated novel biology linking CLK/DYRK kinases to the therapeutic regulation of alternative splicing. Alternative splicing is an essential biological mechanism that regulates the diversification of proteins in a cell, which, in turn, determines cell type and function. Biosplice's target class governs the selection of tissue-specific mRNA splice sites, making them attractive, druggable targets within the cellular "command and control" center.

    Biosplice's drugs in clinical development include lorecivivint for osteoarthritis (in Phase 3), cirtuvivint for numerous cancers, and a broad pipeline that ranges from Alzheimer's disease to other degenerative conditions. Learn more at https://www.biosplice.com.

    Corporate Contact:

    Erich Horsley

    Biosplice Therapeutics, Inc.



    858-365-0200



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  2. NEW YORK and SAN DIEGO, May 28, 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 and Melissa Epperly, MBA, Chief Financial Officer of Zentalis, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 2:30 p.m. ET.

    A live webcast from the Jefferies fireside chat will be accessible through the Investors section of the Company's website at www.zentalis.com. Following the event, an archived webcast will be available on the…

    NEW YORK and SAN DIEGO, May 28, 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 and Melissa Epperly, MBA, Chief Financial Officer of Zentalis, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 2:30 p.m. ET.

    A live webcast from the Jefferies fireside chat will be accessible through the Investors section of the Company's website at www.zentalis.com. Following the event, an archived webcast 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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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 March 31, 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

    Solebury Trout

    1.646.378.2949

    soleburytrout.com

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  3. Reported robust initial results from the Phase 1 monotherapy dose escalation trial of its WEE1 inhibitor, ZN-c3, demonstrating single-agent activity and Exceptional Responses in heavily pre-treated patients

    Announced clinical collaboration with GlaxoSmithKline (GSK) to evaluate ZN-c3 in combination with niraparib, a PARP inhibitor

    Upcoming milestone review of its clinical product candidates ZN-c5 and ZN-c3

    NEW YORK and SAN DIEGO, May 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 financial results for the first quarter ended March 31…

    Reported robust initial results from the Phase 1 monotherapy dose escalation trial of its WEE1 inhibitor, ZN-c3, demonstrating single-agent activity and Exceptional Responses in heavily pre-treated patients

    Announced clinical collaboration with GlaxoSmithKline (GSK) to evaluate ZN-c3 in combination with niraparib, a PARP inhibitor

    Upcoming milestone review of its clinical product candidates ZN-c5 and ZN-c3

    NEW YORK and SAN DIEGO, May 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 financial results for the first quarter ended March 31, 2021 and highlighted recent corporate accomplishments.

    "This quarter, we have made tremendous progress advancing the clinical development of one of our lead programs, ZN-c3, underscored by strong data recently presented in a late-breaking session at AACR," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "These initial results from the Phase 1 monotherapy trial not only demonstrated signals of single-agent efficacy and a superior safety profile compared to other WEE1 inhibitors in development, but also generated multiple confirmed Exceptional Responses across differing solid tumor types. With the recommended dose selected, we look forward to pursuing many planned trials with ZN-c3 this year and exploring its best-in-class potential both as a monotherapy and in combination."

    Continued Dr. Sun, "In parallel, we continue to make great headway with the development of our additional differentiated oncology candidates – ZN-c5, ZN-d5 and ZN-e4 – with numerous trials on track to initiate in 2021. Looking ahead to our catalyst-rich year, we remain focused on executing on our clinical strategy and creating value for our stakeholders, in hopes of delivering innovative treatments to help improve the lives of cancer patients."

    Program Highlights:

    • In April 2021, Zentalis reported initial results from the Phase 1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in a late-breaking session at the American Association of Cancer Research (AACR) Annual Meeting, which was further discussed at a webcast event with Key Opinion Leaders.
      • ZN-c3 generated three Exceptional Responses in heavily pretreated patients with ovarian cancer, colorectal cancer and non-small cell lung cancer, as well as two unconfirmed Partial Responses in patients with uterine serous carcinoma;
      • Showcased favorable safety results with a wide therapeutic window;
      • A Unique Predictive Biomarker was identified for the Exceptional Responders, with plans to further investigate the biomarker in this patient population;
      • Selected Recommended Phase 2 Dose for ZN-c3 to be 300 mg QD with continuous dosing.



    • In April 2021, we entered into a Clinical Trial Collaboration and Supply Agreement with GSK to investigate the combination of ZN-c3, our oral WEE1 inhibitor, and niraparib, GSK's poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. The Company expects to initiate a Phase 1b trial with this combination in the second half of 2021.



    • Zentera Therapeutics, Zentalis' majority-owned joint venture, filed four Clinical Trial Applications (CTAs, China equivalent of IND) and three have been approved in China to date for ZN-c5, ZN-c3, and ZN-c3 in combination. A fourth CTA was submitted earlier this month for ZN-d5.



    • In February 2021, Zentalis entered into a strategic collaboration with Tempus to leverage its patient-derived organoid biological modeling platform to aid Zentalis in discovering and developing novel oncology therapies. The collaboration will assist in the validation of Zentalis' mechanistic discoveries, initially focusing on its WEE1 inhibitor, ZN-c3, across patient tumor populations.

    Anticipated Milestones:

    • The Company plans to report interim results from numerous ongoing trials with ZN-c5 and to share guidance on future development plans for this product candidate in the second quarter of 2021.
    • Zentalis expects to initiate several studies in the coming months, including:
      • A Phase 2 trial of ZN-c3 in uterine serous carcinoma in the third quarter of 2021;
      • A Phase 1/2 trial of ZN-c3 in combination with chemotherapy in osteosarcoma in the third quarter of 2021; and
      • A Phase 1/2 trial of ZN-c3 in combination with GSK's niraparib in ovarian cancer in the second half of 2021.

    Corporate Highlights:

    • In February 2021, the Company appointed Enoch Kariuki, Pharm.D., to the Board of Directors. Dr. Kariuki most recently served as Chief Financial Officer at VelosBio and has over a decade of experience in life sciences investment banking, strategic advising and business development.

    First Quarter 2021 Financial Results

    • Cash and Marketable Securities Position: As of March 31, 2021, Zentalis had cash, cash equivalents and marketable securities of $298.4 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the August 2020 follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.



    • Research and Development Expenses: Research and development expenses for the three months ended March 31, 2021 were $38.4 million, compared to $13.3 million for the three months ended March 31, 2020. The increase of $25.1 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials for each of ZN-c5, ZN-c3, ZN-d5 and ZN-e4. In addition, in the three months ended March 31, 2021, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials. Unallocated research and development expenses increased by $14.0 million primarily due to $6.6 million of additional employee related costs, of which $3.0 million was driven by non-cash stock-based compensation from incentive grants and increased headcount to support our platform development. Expenses attributable to collaborations and strategic alliances increased by $3.0 million while allocated expenses, including software, supplies and insurance increased by $2.4 million and outside services increased by $2.0 million to support our growth.



    • General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2021 were $11.9 million, compared to $3.1 million during the three months ended March 31, 2020. This increase of $8.8 million was primarily attributable to an increase of $8.3 million in employee-related costs, of which $6.4 million was driven by non-cash stock-based compensation from incentive grants, and from increased headcount to support our growth. Consulting and outside services increased by $0.7 million, and fees increased by $0.3 million to support the increased operations of the organization. Insurance costs increased by $0.7 million due to operating as a public company offset by allocated expenses.



    • Net Loss: Net loss was $50.4 million for three months ended March 31, 2021, compared to $16.2 million for the three months ended March 31, 2020. The increase of $34.2 million was primarily the result of the increases in research and development and general and administrative expenses discussed above.



    • Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

    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-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor for advanced solid tumors, 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-c5, ZN-c3 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, plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones, activities in connection with our collaboration with Tempus, the anticipated impact of the COVID-19 pandemic on our business and operating results, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Rebecca John

    Solebury Trout

    1.646.378.2935

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



       Zentalis Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per unit and per share amounts)

     Three Months Ended

    March 31,
     2021 2020
    Operating Expenses   
    Research and development$38,394   $13,258  
    General and administrative11,953   3,141  
    Total operating expenses50,347   16,399  
    Operating loss(50,347)  (16,399) 
    Other Income (Expense)   
    Interest income143   164  
    Other expense(44)    
    Net loss before income taxes(50,248)  (16,235) 
    Income tax expense196     
    Net loss(50,444)  (16,235) 
    Net loss attributable to noncontrolling interests(543)  (109) 
    Net loss attributable to Zentalis$(49,901)  $(16,126) 
    Net loss per common share outstanding, basic and diluted$(1.24)    
    Net loss per Class A common unit outstanding, basic and diluted   $(2.88) 
    Common shares/units used in computing net loss per share/Class A common unit, basic and diluted40,359   5,601  



    Zentalis Pharmaceuticals, Inc.

    Selected Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)

     As of

    March 31,
     As of

    December 31,
     2021 2020
    Cash, cash equivalents and marketable securities$298,381  $338,505 
    Working capital (1)273,557  316,503 
    Total assets328,353  365,555 
    Total liabilities35,715  32,178 
    Total Zentalis equity292,638  333,377 
        
    (1) The Company defines working capital as current assets less current liabilities. 
        

     



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  4. Completed successful initial public offering and raised $46 million in gross proceeds
    ---
    Appointed four new independent board of directors to strengthen leadership team
    ---
    Signed a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer
    ---
    Presented positive pre-clinical lysosomal storage target data at annual WorldSymposium™
    ---
    Expect to complete proof of concept animal studies and begin IND-enabling trials in the second half of 2021

    BETHESDA, Md., May 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on redefining drug discovery by identifying allosteric sites that have never…

    Completed successful initial public offering and raised $46 million in gross proceeds

    ---

    Appointed four new independent board of directors to strengthen leadership team

    ---

    Signed a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer

    ---

    Presented positive pre-clinical lysosomal storage target data at annual WorldSymposium™

    ---

    Expect to complete proof of concept animal studies and begin IND-enabling trials in the second half of 2021

    BETHESDA, Md., May 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on redefining drug discovery by identifying allosteric sites that have never been targeted previously and discovering molecules that can bind stabilize and restore functional activity to misfolded enzymes, today announced its financial results as of and for the first quarter ended March 31, 2021 and provided a corporate update.

    "We were thrilled to complete our IPO in March on the Nasdaq Global Market Exchange," stated Sal Calabrese, Chief Financial Officer of Gain. "The Company now has sufficient financial resources to fund its research and development programs for the foreseeable future. The recent addition of four deeply talented and experienced independent board members provides us with a seasoned leadership team that can help advance the Company towards a clinical stage biopharmaceutical organization."

    Eric Richman, Chief Executive Officer of Gain, added, "We look forward to a very active 2021 and plan to meet several important milestones that will help us advance our SEE-Tx supercomputing platform technology to identify novel allosteric binding sites on misfolded proteins. Our lead pipeline candidates in lysosomal storage and CNS diseases are currently completing animal proof-of-concept studies, and we anticipate moving these into IND-enabling trials towards the end of 2021. We are confident that our Company is on the right path to achieve our mission in redefining drug discovery and develop novel therapies for devastating conditions with significant unmet medical need."

    Business and Recent Developments

    • Multi-target collaboration agreement. In April 2021, the Company announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology.

       
    • Presentation of data at the International Association of Parkinsonism and Related Disorders 2021 World Congress. In April 2021, the Company announced the presentation of a poster at the International Association of Parkinsonism and Related Disorders (IAPRD) 2021 World Congress being held virtually May 1-4, 2021. The poster highlights data demonstrating the potential of the Company's structurally targeted allosteric regulators (STARs) to restore relevant biological function in vitro and improve motor deficits in an in vivo model of Parkinson's disease.

       
    • Completed Successful IPO. In March 2021, the Company completed an oversubscribed initial public offering (IPO) of 4,181,818 shares of common stock at a public offering price of $11.00 per share, including the full exercise by the underwriters of their overallotment option to purchase 545,454 additional shares of common stock. Gain Therapeutics, Inc received gross proceeds of approximately $46 million in the offering. This financing strengthened the Company's balance sheet it with significant funding to advance its therapeutics programs and pipeline expansion.



    • Presented pre-clinical data at the 17th Annual WorldSymposium. In February 2021, the Company presented positive pre-clinical data supportive of in vitro engagement for Gaucher disease, GM1 gangliosidosis, and Morquio B programs at the 17th Annual WorldSymposium™.

       
    • Appointed new members to the board of directors with deep financial, clinical development and regulatory experience. In February 2021, the Company strengthened the leadership team with the appointment of four industry leaders to the Company's Board of Directors. Dov Goldstein, M.D., Gwen Melincoff, Claude Nicaise, M.D., and Hans Peter Hasler.

    Financial Results

    For the first quarter ended March 31, 2021, compared to same period of 2020:

    • Research and development expenses were $1,422 thousand compared to $417 thousand.
    • General and administrative expenses were $1,051 thousand compared to $102 thousand.
    • Total operating expenses increased to $2,472 thousand compared to $519 thousand.
    • Net loss was $2,450 thousand compared to $584 thousand.
    • Basic and diluted net loss per share was $0.50, compared to basic and diluted net loss per share of $0.29.

    Cash and cash equivalents were $46.59 million as of March 31, 2021 compared to $7.49 million at December 31, 2020. The increase was primarily the result of the completion of the Company's initial public offering, from which the Company received aggregate net proceeds of $42.6 million.

    Gain Therapeutics, Inc. was incorporated under the laws of the state of Delaware (U.S.) on June 26, 2020. On July 20, 2020, the Company consummated a Corporate Reorganization pursuant to which all of the issued and outstanding common and preferred stock of GT Gain Therapeutics SA, a Swiss company formed in 2017, were exchanged for common stock or preferred stock, as applicable, of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.

    Operating Results

    The Company incurred research and development expenses of $1,422 thousand for the three-month period ended March 31, 2021 compared to $417 thousand for the same period of 2020, an increase of $1,005 thousand. The increase in research and development expenses was primarily attributable to increases in outside services as we continue to expand our research and development activities, including external collaborations, chemical synthesis, toxicology studies, in vitro ADME and model studies, and in vivo. pharmacology and pharmacokinetic studies, as well as increases in payroll, payroll-related expenses and stock-based compensation.

    General and administrative expenses were $1,051 thousand for the three-month period ended March 31, 2021 compared to $102 thousand for the same period of 2020, an increase of $949 thousand. The increase is primarily due to increases in personnel-related costs, including stock based compensation, as a result of senior management hires, increase in expenses for legal fees relating to patent and corporate matters, professional fees for accounting, professional services and investor relations as we continue to expand our business and build management infrastructure.

    As a result of the above net loss was $2,450 thousand for the three-month period ended March 31, 2021, compared to $584 thousand for the same period of 2020. The increase in net loss was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company's infrastructure as a publicly traded company.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our prospectus filed with the Securities and Exchange Commission under the caption "Risk Factors."



    Gain Therapeutics, Inc.

    CONSOLIDATED BALANCE SHEETS (unaudited)

     March 31,

    2021
     December 31,

    2020
    Assets     
    Current assets:     
    Cash and cash equivalents$46,593,604  $7,492,910 
    Restricted cash 11,129   11,371 
    Accounts receivable 4,486   8,548 
    Prepaid expenses and other current assets 774,809   257,011 
    Deferred offering costs -   1,217,988 
    Total current assets$47,384,028  $8,987,828 
          
    Non-current assets:     
    Property and equipment, net 54,717   29,633 
    Operating lease - right of use assets 499,017   523,080 
    Restricted cash 31,554   - 
    Long-term deposits 12,008   12,152 
    Other non-current assets 59,740   51,665 
    Total non-current assets$657,036  $616,530 
    Total Assets$48,041,064  $9,604,358 
            
    Current liabilities:     
    Accounts payable 881,753   961,516 
    Operating lease liability - current 121,419   122,756 
    Other current liabilities 1,096,334   767,380 
    Tax provision 4,526   1,070 
    Deferred income 178,418   239,483 
    Loans - short term 44,287   22,626 
    Total current liabilities$2,326,737  $2,114,831 
          
    Non-current liabilities:     
    Defined benefit pension plan 194,465   171,558 
    Operating lease liability - non-current 377,598   400,324 
    Loans - long term 678,255   715,656 
    Total non-current liabilities$1,250,318  $1,287,538 
          
    Stockholders' equity     
    Series A Preferred Stock: $0.0001 par value, nil and 1,185,879 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively -   118 
    Series B Preferred Stock: $0.0001 par value, nil and 2,965,600 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively -   297 
    Common Stock, $0.0001 par value: 11,876,460 and 7,694,642 issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 1,188   354 
    Additional paid-in capital 54,104,982   13,388,771 
    Accumulated other comprehensive loss (156,861)  (152,698)
    Accumulated deficit (7,034,853)  (3,457,171)
    Loss of the period (2,450.447)  (3,577,682)
    Total Stockholders' equity$44,464,009  $6,201,989 
    Total Liabilities and Stockholders' equity$48,041,064  $9,604,358 



    Gain Therapeutics, Inc

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited)

     For Three Months Ended March 31,
      2021  2020
    Revenues:     
    Other income 5,269  6,673
    Total revenues $5,269 $6,673
          
    Operating expenses:     
    Research and development (1,421,509)  (417,259)
    General and administrative (1,050,675)  (101,674)
    Total operating expenses (2,472,184)  (518,933)
          
    Loss from operations$(2,466,915) $(512,260)
          
    Other income (expense):     
    Interest income/(expenses), net 1,408  (1,747)
    Foreign exchange gain/(loss), net 18,539  (68,914)
    Loss before income tax$(2,446,968) $(582,921)
          
    Income tax (3,479)  (1,347)
          
    Net Loss$(2,450,447) $(584,268)
          
    Net loss per shares:     
    Net loss per share attributable to common stockholders - basis and diluted$(0.50) $(0.29)
    Weighted average common shares - basic and diluted 4,868,915  1,981,765





    Gain Therapeutics, Inc

    CONSOLIDATED STATEMENTS OF CASH FLOWS

    (unaudited)

     For Three Months Ended March, 31
      2021  2020 
      USD  USD 
    Operating activities:      
    Net loss$(2,450,447) $(584,268) 
      -    
    Adjustments to reconcile net loss to net cash used in operating activities:    
    Depreciation 3,403  2,101 
    Stock based compensation 110,725  - 
    Changes in operating assets and liabilities:      
    Account receivables and other currents assets (513,738)  62,947 
    Other non current assets (8,075)    
    Account payables and other current liabilities 82,927  (184,920) 
    Tax payable 3,456  (2,355) 
    Pension liability 22,907  8,085 
    Deferred income (61,065)  (54,406) 
    Total changes in operating assets and liabilities (473,588)  (170,649) 
    Net cash used in operating activities$(2,809,907) $(752,816) 
           
    Cash flows from investing activities:      
    Purchase of computers and office equipment (28,488)  (4,897) 
    Net cash used in investing activities $(28,488) $(4,897) 
           
    Cash flow from financing activities:      
    Proceeds from long-term debts -  284,598 
    Proceeds from issuance of Series A Preferred Stock, net of issuance costs -  1,108,097 
    Proceeds from issuance of common shares upon completion of initial public offering, net of offering costs 42,629,998  - 
    Payments of deferred offering costs (639,693)    
    Net cash provided by financing activities$41,990,305 $1,392,695 
    Effect of exchange rate changes (19,904)  (3,573) 
    Net increase in cash, cash equivalents and restricted cash$39,132,006 $631,409 
    Cash, cash equivalents and restricted cash at beginning of period7,504,281  313,700 
    Cash, cash equivalents and restricted cash at end of period$46,636,287 $945,109 
           

    SOURCE: Gain Therapeutics, Inc.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    Gain Therapeutics Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366



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  5. Collaboration to use Gain's proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) computational platform technology to identify new and previously difficult-to-drug oncology targets

    BETHESDA, Md., April 20, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain") today announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. SEE-Tx applies a proprietary computational algorithm and supercomputer processing to the published 3D structure of proteins to discover new binding sites…

    Collaboration to use Gain's proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) computational platform technology to identify new and previously difficult-to-drug oncology targets

    BETHESDA, Md., April 20, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain") today announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. SEE-Tx applies a proprietary computational algorithm and supercomputer processing to the published 3D structure of proteins to discover new binding sites with the ability to modulate protein function. The intended output is newly-discovered targets or target protein interactions that can then be drugged for therapeutic benefit to intervene on protein misfolding.

    "We are pleased to enter into a relationship with Zentalis, an oncology company at the forefront of developing differentiated treatments for patients," said Eric Richman, Chief Executive Officer at Gain. "Our unique algorithm, based on a patented method to analyze molecular dynamics and powered by supercomputers, is designed to enable discovery of novel targets in various therapeutic areas. Zentalis' team brings extensive industry experience and a proven track record in the discovery and clinical development of innovative cancer therapies, which will be beneficial as we work to further validate SEE-Tx for use in combating cancers and other devastating diseases. Together, we are looking forward to changing the way the industry thinks about drug discovery in oncology."

    Prof. Xavier Barril, Chief Scientific Officer of Gain, added, "Over the past several decades, the evidence linking protein misfolding and cancer has continued to grow, with chaperones that mediate protein folding being identified as critical modulators of proper cellular function. Of particular note, while most proteins have a half-life of one to two hours, many oncogenes have half-lives of just a few minutes, meaning that they are continually being synthesized, folded and degraded, offering significant opportunities for misfolding. We are excited to collaborate with Zentalis with its promising pipeline of oncology therapeutic candidates. Zentalis sees the potential of our SEE-Tx platform technology to address this challenge in cancer."

    Under the terms of the agreement, Gain will pursue binding site identification on target proteins that will be selected and agreed upon by both parties. Next, Gain will identify and determine the potential suitability of these sites as drug targets, as well as their prospective therapeutic use. Selected compounds will be tested in the lab by Zentalis against the target protein to confirm binding and action to identify and characterize novel compounds for development.

    About SEE-Tx™

    SEE-Tx is the first proprietary technology platform exclusively designed use the 3D structure of proteins to systematically identify allosteric binding sites never described previously and predict their druggability. Powered by supercomputers, its novel algorithm orchestrates molecular modeling at a speed and efficiency that has the potential to redefine drug discovery.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    Gain Therapeutics Media Contact:

    Cait Williamson, Ph.D.

    LifeSci Communications

    +1 646-751-4366



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  6. NEW YORK and SAN DIEGO, April 12, 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 a clinical collaboration agreement with GlaxoSmithKline ("GSK") in which Zentalis will evaluate the combination of ZN-c3, Zentalis' oral WEE1 inhibitor product candidate, and ZEJULA (niraparib), GSK's poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. Zentalis is currently conducting clinical studies with ZN-c3 both as a monotherapy and in combination with certain standard of care therapies.

    "This clinical collaboration…

    NEW YORK and SAN DIEGO, April 12, 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 a clinical collaboration agreement with GlaxoSmithKline ("GSK") in which Zentalis will evaluate the combination of ZN-c3, Zentalis' oral WEE1 inhibitor product candidate, and ZEJULA (niraparib), GSK's poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. Zentalis is currently conducting clinical studies with ZN-c3 both as a monotherapy and in combination with certain standard of care therapies.

    "This clinical collaboration and supply agreement with GSK allows us to investigate the broader potential of our WEE1 inhibitor when used as part of a combination treatment with niraparib, a PARP inhibitor," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals. "As demonstrated in our preclinical studies, ZN-c3 is designed to have significant advantages over other investigational WEE1 inhibitor therapies. We believe this combination has the potential to meaningfully improve the outcomes for patients with ovarian cancer."

    PARP inhibitors prevent DNA damage repair in cancer cells. Similar to PARP, WEE1 plays a role in cellular regulation and repair, allowing cells with DNA damage to repair and survive. Inhibition of WEE1 causes dysregulation of DNA replication and subsequently induces apoptosis. Based on these complementary mechanisms of action, the use of WEE1 and PARP inhibitors could potentially have synergistic anti-tumor activity.

    More than 300,000 women worldwide are diagnosed with ovarian cancer each year, leading to over 180,000 fatalities1. While substantial progress has been made in the treatment of this disease, there is an urgency to address the remaining unmet need through the development of innovative combination treatments.

    Under the terms of the non-exclusive collaboration, Zentalis is responsible for conducting the study with GSK providing all required doses of niraparib. Zentalis maintains full ownership of ZN-c3.

    1www.cancerresearch.org

    About ZN-c3

    ZN-c3 is an 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. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and reported initial data from the Phase 1 portion at the AACR Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 1/2 trial in combination with GSK's niraparib in patients with advanced ovarian cancer, a Phase 1/2 trial in combination with chemotherapy in osteosarcoma and a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.

    About ZEJULA (niraparib)

    GSK's ZEJULA (niraparib) is an FDA and EMA-approved oral, once-daily poly (ADP-ribose) polymerase inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including Phase III studies in ovarian and non-ovarian indications.

    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-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor for advanced solid tumors, 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-c5, ZN-c3 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 activities in connection with our clinical collaboration agreement with GlaxoSmithKline. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the quarterly period ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931



    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  7. ZN-c3 demonstrated single agent activity, generating Exceptional Responses in a range of heavily pre-treated solid tumors

    ZN-c3 was safe and well-tolerated

    Identified recommended Phase 2 dose for ZN-c3 to be 300 mg QD with continuous dosing

    Announces plan to start Phase 1/2 osteosarcoma trial in Q3 2021

    Company to host webcast event with key opinion leaders on Monday, April 12 at 4:00 p.m. EDT

    NEW YORK and SAN DIEGO, April 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 initial efficacy and safety data from the Phase 1 dose-escalation…

    ZN-c3 demonstrated single agent activity, generating Exceptional Responses in a range of heavily pre-treated solid tumors

    ZN-c3 was safe and well-tolerated

    Identified recommended Phase 2 dose for ZN-c3 to be 300 mg QD with continuous dosing

    Announces plan to start Phase 1/2 osteosarcoma trial in Q3 2021

    Company to host webcast event with key opinion leaders on Monday, April 12 at 4:00 p.m. EDT

    NEW YORK and SAN DIEGO, April 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 initial efficacy and safety data from the Phase 1 dose-escalation portion of its ongoing Phase 1/2 clinical trial of ZN-c3 in patients with advanced solid tumors who are refractory to or ineligible for standard therapy or for whom no standard therapy is available. Initial results showed that monotherapy ZN-c3 use resulted in Exceptional Responses in heavily pre-treated patients in a range of solid tumors, including Partial Responses (PRs) in ovarian cancer, colorectal cancer, non-small cell lung carcinoma and uterine serous carcinoma. Data were reviewed as a late-breaking abstract during the American Association of Cancer Research (AACR) Annual Meeting, being held virtually April 10-15, 2021 and May 17-21, 2021.

    "The initial clinical data on our WEE1 inhibitor are extremely promising and showcase ZN-c3's strong potential to improve outcomes in patients with advanced solid tumors who have exhausted available treatment options," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Our WEE1 candidate, which we believe is potentially a best-in-class small molecule, demonstrated favorable safety results with a wide therapeutic window, and resulted in Partial Responses in five patients with a range of cancers. Having identified a recommended dose for future studies, we look forward to advancing clinical trials in a larger number of patients, as well as novel biomarkers that may help select patients who are likely to respond to treatment with ZN-c3. We are looking to make Exceptional Responses commonplace."

    Initial Efficacy and Safety Data

    In the Phase 1 dose-escalation trial, ZN-c3 was dosed starting at 25 mg and going as high as 450 mg QD in patients with advanced or metastatic solid tumors. At the time of the data cutoff on February 12, 2021, 55 patients were evaluated for safety, the primary endpoint. The study remains ongoing and based on the data presented at AACR, ZN-c3 generated 5 Partial Responses.

    Best Overall Responses:

    • Two confirmed PRs in ovarian cancer and colorectal cancer (CRC) patients
      • After receiving 18 prior lines of therapy, 11 prior lines in the advanced metastatic setting, a patient with Stage IV ovarian cancer had a RECIST-confirmed PR with a 56% reduction in overall target lesions. The patient also experienced a large rapid drop in CA-125 from 610 kU/L at baseline to 125 kU/L within 4 weeks on treatment, with her CA-125 level normalizing 3 weeks later. The patient was on study for 186 days and remains on study drug.
      • After receiving 5 prior lines of therapy in the advanced metastatic setting, a patient with Stage IV CRC had a RECIST-confirmed PR with a 42% reduction in overall target lesions, as well as a rapid decrease in CEA tumor marker from 327 ng/mL at baseline to <50 ng/mL after 3 weeks on treatment. The patient remained on study for 169 days until clinical disease progression.
    • In addition, three unconfirmed PRs—one in non-small cell lung carcinoma (NSCLC) and two in uterine serous carcinoma (USC) patients
      • After receiving 3 prior lines of therapy in the advanced metastatic setting, a patient with Stage IV NSCLC had an unconfirmed (per RECIST) PR with a 50% reduction in overall target lesions. The patient was on study for 145 days and remains on study drug.

    ZN-c3 was generally well-tolerated as a single agent. As of the cutoff date, the most common treatment-related adverse events were mainly Grade 1/2, including nausea (49.0% of patients), diarrhea (32.7% of patients), fatigue (29.0% of patients) and vomiting (29.0% of patients) across all doses. Significant hematological adverse events were limited; treatment-related white blood cell count decrease / neutropenia (7.2% all Grades, 3.6% Grade ≥3), anemia (7.2% all Grades, 5.4% Grade ≥3) and thrombocytopenia (7.2% all Grades, 3.6% Grade ≥3).

    Results from this study indicate that an oral dose of 300 mg QD with continuous dosing is the recommended Phase 2 dose of ZN-c3 when used as a monotherapy. The 300 mg QD dose demonstrated high plasma exposure levels, while minimizing adverse events. In addition, the pharmacodynamic marker of pCDK1 levels in skin punch biopsies showed active target engagement at relevant pharmacological doses. The Company initiated the Phase 1 expansion portion of the trial with the 300 mg QD dose earlier in 2021 and is exploring this candidate's potential in combination trials including in ovarian cancer and osteosarcoma. Using this recommended dose, Zentalis will also coordinate with Zentera Therapeutics, Zentalis' majority-owned joint venture, to initiate a Phase 1b trial investigating ZN-c3 as a single agent in China.

    "WEE1 is a promising target for cancer therapy, and this dataset provides further validation on the importance of candidates like ZN-c3 that are designed to inhibit the DNA damage checkpoint, resulting in tumor cell death," said Dr. Anthony Tolcher, CEO, Founder and Director of Clinical Research at NEXT Oncology. "ZN-c3 was shown to be tolerable in this heavily pretreated patient population. Furthermore, this candidate's early signals of anti-tumor activity are very exciting, and I am even more optimistic that WEE1 inhibition may become an important treatment approach for a wide range of cancers."

    KOL Webcast Event:

    Zentalis will host a webcast event with key opinion leaders Monday, April 12, 2021 at 4:00 p.m. EDT. To register and access the event, the webcast link is available on the Investors & Media section of the Zentalis website at www.zentalis.com.

    About ZN-c3

    ZN-c3 is an 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. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and reported initial data from the Phase 1 portion at the AACR Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 1/2 in combination with chemotherapy in osteosarcoma and a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.

    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-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor for advanced solid tumors, 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-c5, ZN-c3 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, plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones, and 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 following: the outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; interim, initial, "topline", and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  8. Initiated multiple early-stage clinical trials evaluating its oral SERD, ZN-c5, WEE1 inhibitor, ZN-c3 and BCL-2 inhibitor, ZN-d5

    Announced strategic collaboration with Tempus to expand and strengthen the Company's research and development capabilities

    The Company's majority-owned joint venture, Zentera Therapeutics, submitted two Investigational New Drug (IND) applications in China ahead of schedule

    Presenting clinical data from the Phase 1 monotherapy trial of ZN-c3 in a late-breaking session at the upcoming AACR 2021 Annual Meeting

    NEW YORK and SAN DIEGO, March 25, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics…

    Initiated multiple early-stage clinical trials evaluating its oral SERD, ZN-c5, WEE1 inhibitor, ZN-c3 and BCL-2 inhibitor, ZN-d5

    Announced strategic collaboration with Tempus to expand and strengthen the Company's research and development capabilities

    The Company's majority-owned joint venture, Zentera Therapeutics, submitted two Investigational New Drug (IND) applications in China ahead of schedule

    Presenting clinical data from the Phase 1 monotherapy trial of ZN-c3 in a late-breaking session at the upcoming AACR 2021 Annual Meeting

    NEW YORK and SAN DIEGO, March 25, 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 fourth quarter and full year ended December 31, 2020 and highlighted recent corporate accomplishments.

    "2020 was a pivotal year for Zentalis, marked by the advancement of our broad pipeline, multiple clinical and strategic collaborations, as well as successful public offerings," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "With the initiation of numerous studies at the end of 2020, our internally discovered candidates are now being investigated in a combined total of seven ongoing clinical trials, further exploring their potential to address a range of cancers. We believe our collaborations with global innovators in the biopharmaceutical and technology industries provide us with the resources needed to evaluate the full potential of our differentiated product candidates in the clinic as both monotherapies and in combinations."

    Continued Dr. Sun, "Looking to the year ahead, we are strongly positioned to reach our upcoming milestones, starting with our late-breaker presentation discussing data from the Phase 1 portion of the Phase 1/2 monotherapy trial of ZN-c3 at AACR in April. This readout, along with results from our other ongoing trials investigating ZN-c5, ZN-d5 and ZN-e4, is expected to deliver important insights into our clinical and regulatory strategies as we advance our objective of bringing improved therapies to cancer patients in need."

    Program Highlights:

    • Zentalis initiated patient dosing in three combination and monotherapy clinical trials, which included a Phase 1b combination trial with ZN-c5 and abemaciclib (marketed as Verzenio® by Eli Lilly) in ER+/HER2- advanced breast cancer, a Phase 1 combination dose escalation trial with ZN-c3 and chemotherapy in advanced ovarian cancer and a Phase 1 trial with ZN-d5 in acute myeloid leukemia and Non-Hodgkin's lymphoma. Each trial will assess the safety, tolerability and pharmacokinetics of the respective candidate.



    • In February 2021, Zentalis entered into a strategic collaboration with Tempus to leverage its patient-derived organoid biological modeling platform to aid Zentalis in discovering and developing novel oncology therapies. The collaboration will initially aim to validate Zentalis' WEE1 inhibitor, ZN-c3, and its DNA damage response pathway in genetically distinct patient populations.



    • Three abstracts, including a late-breaker oral presentation on ZN-c3, were accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021. Zentalis expects to report clinical data from the Phase 1 portion of its Phase 1/2 monotherapy trial of ZN-c3 in advanced solid tumors.



    • Zentera Therapeutics, Zentalis' majority-owned joint venture, submitted two IND applications in China for ZN-c5 and ZN-c3 in December 2020 and February 2021, respectively. A third IND application for ZN-d5 is expected to be submitted in 2021.

    Corporate Highlights:

    • In February 2021, the Company appointed Enoch Kariuki, Pharm.D., to the Board of Directors. Dr. Kariuki most recently served as Chief Financial Officer at VelosBio and has over a decade of experience in life sciences investment banking, strategic advising and business development.

    Fourth Quarter and Full Year 2020 Financial Results

    • Cash and Marketable Securities Position: As of December 31, 2020, Zentalis had cash, cash equivalents and marketable securities of $338.5 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the August 2020 follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.



    • Research and Development Expenses: Research and development expenses were $29.5 million in the fourth quarter of 2020, compared to $11.9 million for the same period in 2019. This increase of $17.6 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials investigating ZN-c5, ZN-c3 and ZN-d5 in 2020. In addition, in 2020 we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials. Unallocated research and development expenses increased by $10.2 million primarily due to $5.3 million of additional employee related costs, of which $2.6 million was driven by non-cash stock-based compensation from incentive grants and increased headcount to support our platform development, $1.6 million of facilities and other allocated overhead expenses, $3.0 million of consulting, supplies and outside services, and decreased federal grant reimbursements of $0.3 million.

    Research and development expenses for the full year were $84.9 million, compared with $38.4 million in 2019.

    • General and Administrative Expenses: General and administrative expenses for the fourth quarter were $10.7 million, compared to $3.0 million for the same period in 2019. This increase of $7.7 million was primarily attributable to an increase of $7.3 million in employee-related costs, of which $5.1 million was driven by non-cash stock-based compensation from incentive grants issued during the year and increased headcount to support our growth. The remaining increase in spend was primarily driven by professional service fees for legal services of $0.6 million, consulting and other outside services of $0.7 million, and insurance costs of $0.6 million, which were offset by allocated overhead expenses.

    General and administrative expenses for the full year were $33.9 million, compared with $8.5 million in 2019.

    • Net Loss: The Company's net loss for the fourth quarter of 2020 was $40.4 million, compared to a net loss of $14.5 million for the same period in 2019.

    The Company's net loss for the full year 2020 was $118.5 million, compared to a net loss of $46.4 million for the same period in 2019.

    • Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

    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-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor for advanced solid tumors, 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-c5, ZN-c3 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, plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones, activities in connection with our collaboration with Tempus, the anticipated impact of the COVID-19 pandemic on our business and operating results, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931



    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

        Zentalis Pharmaceuticals, Inc. (Successor to Zentalis Pharmaceuticals, LLC)

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per unit and per share amounts)

     Three months ended December 31, Year ended December 31,
     2020 2019 2020 2019
    Operating Expenses       
    Research and development$29,521   $11,869   $84,901   $38,386  
    General and administrative10,724   3,036   33,886   8,459  
    Total operating expenses40,245   14,905   118,787   46,845  
    Operating loss(40,245)  (14,905)  (118,787)  (46,845) 
    Other Income (Expense)       
    Investment and other income (expense), net315   359   683   482  
    Net loss before income taxes(39,930)  (14,546)  (118,104)  (46,363) 
    Income tax expense426      444   15  
    Net loss(40,356)  (14,546)  (118,548)  (46,378) 
    Net loss attributable to noncontrolling interests(53)  (40)  (707)  (715) 
    Net loss attributable to Zentalis$(40,303)  $(14,506)  $(117,841)  $(45,663) 
    Net loss per common share outstanding, basic and diluted$(1.01)  $   $(4.19)  $  
    Net loss per Class A common unit outstanding, basic and diluted$   $(2.59)  $   $(8.16) 
    Common shares/units used in computing net loss per share/Class A common unit, basic and diluted39,936   5,601   28,113   5,597  



    Zentalis Pharmaceuticals, Inc. (Successor to Zentalis Pharmaceuticals, LLC)


    Selected Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)

     December 31,
     2020 2019
    Cash, cash equivalents and marketable securities$338,505  $67,246  
    Working capital (1)316,503  53,994  
    Total assets365,555  87,481  
    Total liabilities32,178  19,060  
    Convertible preferred units  141,706  
    Total Zentalis equity (deficit)333,377  (73,285) 
        
    (1) The Company defines working capital as current assets less current liabilities. 
        


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  9. NEW YORK and SAN DIEGO, March 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 that three abstracts have been accepted for presentation, including a late-breaker on its WEE1 inhibitor, ZN-c3, at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021. The meeting will be held virtually on April 10-15 and May 17-21, 2021.

    "The important data we are presenting at AACR supports the ability of our Integrated Discovery Engine to develop differentiated oncology therapeutic candidates across diverse cancer targets and types…

    NEW YORK and SAN DIEGO, March 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 that three abstracts have been accepted for presentation, including a late-breaker on its WEE1 inhibitor, ZN-c3, at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021. The meeting will be held virtually on April 10-15 and May 17-21, 2021.

    "The important data we are presenting at AACR supports the ability of our Integrated Discovery Engine to develop differentiated oncology therapeutic candidates across diverse cancer targets and types," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals. "We especially look forward to presenting clinical data from our ongoing Phase 1 monotherapy trial of our WEE1 inhibitor, ZN-c3, selected for a late-breaking session. In addition, results from two cell-based studies of ZN-c3, and our EGFR inhibitor, ZN-e4, demonstrated impressive selectivity and tolerability, which we believe positions these candidates to improve upon the constraints of existing products."

    Late-Breaker Oral Presentation:

    Title: Clinical activity of a single-agent ZN-c3, an oral WEE1 inhibitor, in a Phase 1 dose-escalation trial in patients with advanced solid tumors

    Session: Early Clinical Trials with New Anticancer Agents

    Presentation Number: CT016

    Date/Time: Saturday, April 10, 2021 at 1:30 p.m. EDT

    Poster Presentations:

    Title: Discovery of ZN-c3, a potent Wee-1 inhibitor with a differentiated pharmacologic and kinase selectivity profile

    Session: Molecular and Cellular Biology / Genetics

    Abstract ID: 1965

    Date/Time: Available starting on Saturday, April 10, 2021 at 8:30 a.m. EDT

    Title: Discovery of ZN-e4, an irreversible EGFR-TKI with potent anti-tumor activity in EGFR mutant non-small-cell lung cancer

    Session: Oncogene Growth Factors and their Receptors

    Abstract ID: 2423

    Date/Time: Available starting on Saturday, April 10, 2021 at 8:30 a.m. EDT

    The poster presentation abstracts are currently available on the AACR Annual Meeting 2021 website at www.aacr.org/meeting/aacr-annual-meeting-2021/.

    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-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor for advanced solid tumors, 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-c5, ZN-c3 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, plans and timing for the release of data from our clinical trials and preclinical studies, and 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 following: the outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  10. NEW YORK and SAN DIEGO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL) today announced a strategic collaboration with Tempus to leverage the company's patient-derived organoid biological modeling platform to strengthen Zentalis' discovery and research capabilities.

    Zentalis CEO Anthony Sun commented, "We are thrilled to be entering into this collaboration with Tempus and its unique platform to help us discover and develop novel therapies aimed at a variety of cancers. This partnership provides Zentalis with access to Tempus' one-of-a-kind resource to help validate our mechanistic discoveries, beginning with our WEE1 inhibitor, and ultimately to expand our growing product pipeline."

    Tempus' proprietary platform…

    NEW YORK and SAN DIEGO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL) today announced a strategic collaboration with Tempus to leverage the company's patient-derived organoid biological modeling platform to strengthen Zentalis' discovery and research capabilities.

    Zentalis CEO Anthony Sun commented, "We are thrilled to be entering into this collaboration with Tempus and its unique platform to help us discover and develop novel therapies aimed at a variety of cancers. This partnership provides Zentalis with access to Tempus' one-of-a-kind resource to help validate our mechanistic discoveries, beginning with our WEE1 inhibitor, and ultimately to expand our growing product pipeline."

    Tempus' proprietary platform has the ability to grow and recapitulate tumors both genetically and functionally, some of which can be used for DNA repair profiling and research on potential therapeutic sensitivity. In harnessing Tempus' cutting-edge approach, the collaboration will initially aim to validate Zentalis' WEE1 inhibitor, ZN-c3, and its DNA damage response pathway in genetically distinct patient populations. The platform will also be used to investigate additional novel targets of cancer pathways that may be identified by Zentalis, as well as support the study of Zentalis' current product candidates across various indications.

    "We believe that our library of patient-derived organoids is well positioned to better identify patient populations that could benefit from Zentalis' WEE1 inhibitor, ZN-c3," said Marc Yoskowitz, Chief Strategy Officer of Tempus. "We look forward to applying the full potential of our platform to address the ever-increasing unmet needs of cancer patients."

    Zentalis retains full ownership of its therapeutic candidates.

    About ZN-c3

    ZN-c3 is an 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. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and expects to report data from the Phase 1 portion at the AACR Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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, and activities in connection with our collaboration with Tempus. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931



    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  11. NEW YORK and SAN DIEGO, Feb. 24, 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 initial clinical data from the Phase 1 portion of its Phase 1/2 monotherapy trial of ZN-c3, the Company's WEE1 inhibitor, in advanced solid tumors has been selected for presentation at the upcoming virtual American Association for Cancer Research (AACR) Annual Meeting 2021. AACR is being held April 10-15 and May 17-21.

    About ZN-c3

    ZN-c3 is an oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage…

    NEW YORK and SAN DIEGO, Feb. 24, 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 initial clinical data from the Phase 1 portion of its Phase 1/2 monotherapy trial of ZN-c3, the Company's WEE1 inhibitor, in advanced solid tumors has been selected for presentation at the upcoming virtual American Association for Cancer Research (AACR) Annual Meeting 2021. AACR is being held April 10-15 and May 17-21.

    About ZN-c3

    ZN-c3 is an 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. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and expects to report data from the Phase 1 portion at the AACR Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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, including the presentation of initial clinical data from the Phase 1 portion of our Phase 1/2 clinical trial of ZN-c3 at AACR Annual Meeting 2021, and our ability to meet other key milestones, the anticipated direct and indirect impact of COVID-19 on our business and operations, 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  12. NEW YORK & SAN DIEGO, Feb. 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 the appointment of Enoch Kariuki, PharmD, to its Board of Directors. Dr. Kariuki is a highly accomplished finance executive, bringing over a decade of deep expertise in life sciences investment banking, strategic advising and business development to Zentalis.

    "We are pleased to welcome Enoch to our Board of Directors, and believe his experience as a financial leader in the healthcare sector will offer invaluable perspective for our growing organization," said Dr…

    NEW YORK & SAN DIEGO, Feb. 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 the appointment of Enoch Kariuki, PharmD, to its Board of Directors. Dr. Kariuki is a highly accomplished finance executive, bringing over a decade of deep expertise in life sciences investment banking, strategic advising and business development to Zentalis.

    "We are pleased to welcome Enoch to our Board of Directors, and believe his experience as a financial leader in the healthcare sector will offer invaluable perspective for our growing organization," said Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals. "Over the course of his career, Enoch has played a pivotal role in follow-on offerings and multibillion-dollar mergers and acquisitions, and we look forward to applying his guidance and learnings to Zentalis' corporate financial strategy."

    Dr. Kariuki most recently served as Chief Financial Officer at VelosBio, a clinical-stage oncology-focused biopharmaceutical company, which was acquired by Merck. At VelosBio, he led all finance-related and investor relations functions. Prior to VelosBio, he served as Senior Vice President of Corporate Development at Synthorx. During his tenure, he led the company's IPO as well as business development efforts leading up to its acquisition by Sanofi. Previously, Dr. Kariuki was Vice President at H.I.G. Capital, where he invested in and served on the boards of multiple life sciences companies. Earlier in his career, Dr. Kariuki held various roles in investment banking at Leerink Partners and UBS Investment Bank.

    He completed a Post-Doctoral Fellowship in R&D Strategy and Analytics at Bristol Myers Squibb and was a Pharmacist at CVS Caremark. Dr. Kariuki received an MBA from the Tuck School of Business at Dartmouth College and a PharmD from Texas Southern University.

    "I am honored to join Zentalis' Board and to serve as the Chair of the Audit Committee," commented Enoch Kariuki, PharmD. "I am eager to work closely with the Zentalis team to provide collaborative and meaningful contributions as they navigate bringing potentially differentiated cancer therapeutics to patients."

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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 Dr. Kariuki's expected contributions to our board, our growth strategy and our expectations surrounding the development, potential, safety, efficacy, and regulatory and clinical progress of our product candidates in the Unites States and globally. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  13. NEW YORK and SAN DIEGO, Feb. 05, 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 participate in fireside chats at two upcoming virtual investor conferences.

    Presentation Details:

    Event: Guggenheim Healthcare Talks 2021 Oncology Days
    Date: Friday, February 12, 2021
    Time: 1:30 p.m. EST

    Event: SVB Leerink 10th Annual Global Healthcare Conference
    Date: Wednesday, February 24, 2021
    Time: 10:00 a.m. EST

    Live webcasts from the Guggenheim and SVB Leerink fireside chats will…

    NEW YORK and SAN DIEGO, Feb. 05, 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 participate in fireside chats at two upcoming virtual investor conferences.

    Presentation Details:

    Event: Guggenheim Healthcare Talks 2021 Oncology Days

    Date: Friday, February 12, 2021

    Time: 1:30 p.m. EST

    Event: SVB Leerink 10th Annual Global Healthcare Conference

    Date: Wednesday, February 24, 2021

    Time: 10:00 a.m. EST

    Live webcasts from the Guggenheim and SVB Leerink fireside chats 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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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.

    Investor Contact:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967



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  14. NEW YORK and SAN DIEGO, Jan. 06, 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 Zentalis has initiated patient dosing in three new combination and monotherapy clinical trials:

    • A Phase 1b combination trial with ZN-c5 and abemaciclib (marketed as Verzenio® by Eli Lilly) in ER+/HER2- advanced breast cancer;
    • A Phase 1 combination dose escalation trial with ZN-c3 and chemotherapy in advanced ovarian cancer; and
    • A Phase 1 trial with ZN-d5 in acute myeloid leukemia and Non-Hodgkin's Lymphoma.

    "At Zentalis, our primary focus is to rapidly bring…

    NEW YORK and SAN DIEGO, Jan. 06, 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 Zentalis has initiated patient dosing in three new combination and monotherapy clinical trials:

    • A Phase 1b combination trial with ZN-c5 and abemaciclib (marketed as Verzenio® by Eli Lilly) in ER+/HER2- advanced breast cancer;
    • A Phase 1 combination dose escalation trial with ZN-c3 and chemotherapy in advanced ovarian cancer; and
    • A Phase 1 trial with ZN-d5 in acute myeloid leukemia and Non-Hodgkin's Lymphoma.

    "At Zentalis, our primary focus is to rapidly bring novel and transformative medicines to patients diagnosed with a wide variety of cancers," said Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals. "With the initiation of these clinical trials during the fourth quarter of 2020, we are excited to explore the potential benefit of our candidates, either as a monotherapy or in combination, assessing the safety, tolerability and pharmacokinetics of the treatments. These data will provide key insight needed for future trials, laying the foundation to continue to advance the investigation of ZN-c5, ZN-c3 and ZN-d5."   

    For more information on the trials, visit www.clinicaltrials.gov.

    About ZN-c5

    ZN-c5 is an oral selective estrogen receptor degrader (SERD) being developed for the treatment of ER+/HER2- advanced or metastatic breast cancer. This form of breast cancer is reliant on the estrogen receptor for tumor growth and survival. Zentalis is currently conducting a Phase 1/2 clinical trial of ZN-c5 in patients with ER+/HER2- advanced or metastatic breast cancer as a monotherapy. The Company is also investigating ZN-c5 in combination studies, including a Phase 1/2 trial with palbociclib (Ibrance®) through a clinical research collaboration with Pfizer and a Phase 1b trial with abemaciclib (Verzenio®) through a clinical research collaboration with Eli Lilly.

    About ZN-c3

    ZN-c3 is an 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. Zentalis is currently conducting a Phase 1/2 clinical trial of ZN-c3 as a monotherapy in patients with advanced solid tumors, and a Phase 1b clinical trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer.

    About ZN-d5

    ZN-d5 is an oral inhibitor of B-cell lymphoma 2 (BCL-2), in development initially for the treatment of hematologic malignancies. BCL-2 plays a critical role in the regulation of cell death and the overexpression of this protein is frequently detected in numerous cancer types, preventing apoptosis. Zentalis believes a BCL-2 inhibitor will restore the normal apoptosis process. The Company has initiated a Phase 1 trial of ZN-d5 in patients with AML and Non-Hodgkin's Lymphoma.

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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 of 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 following: the outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

     



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  15. NEW YORK and SAN DIEGO, Nov. 12, 2020 (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 participate in two upcoming virtual investor conferences.

    Presentation Details:

    Event: Jefferies Virtual London Healthcare Conference
    Format: Fireside chat
    Date: Thursday, November 19, 2020
    Time: 5:00 p.m. GMT/12:00 p.m. EST

    Event
    : SVB Leerink Oncology 1x1 Day
    Format: One-on-one meetings
    Date: Thursday, November 19, 2020

    A live webcast of the Jefferies fireside chat will be accessible through…

    NEW YORK and SAN DIEGO, Nov. 12, 2020 (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 participate in two upcoming virtual investor conferences.

    Presentation Details:

    Event: Jefferies Virtual London Healthcare Conference

    Format: Fireside chat

    Date: Thursday, November 19, 2020

    Time: 5:00 p.m. GMT/12:00 p.m. EST



    Event
    : SVB Leerink Oncology 1x1 Day

    Format: One-on-one meetings

    Date: Thursday, November 19, 2020

    A live webcast of the Jefferies fireside chat will be accessible through the Investors section of the Company's website at www.zentalis.com. Following the event, an archived webcast 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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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.

    Investor Contact:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

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  16. Announced topline data from the Phase 1 monotherapy dose escalation trial of ZN-c5, its investigational oral SERD, in patients with ER+/HER2- advanced breast cancer; Phase 2 trial expected to initiate in H1 2021

    Entered into a clinical collaboration with Eli Lilly to evaluate ZN-c5 in combination with abemaciclib, a CDK4 and 6 inhibitor

    Raised an additional ~$166.0 million in gross proceeds from recent follow-on offering

    NEW YORK and SAN DIEGO, Nov. 09, 2020 (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…

    Announced topline data from the Phase 1 monotherapy dose escalation trial of ZN-c5, its investigational oral SERD, in patients with ER+/HER2- advanced breast cancer; Phase 2 trial expected to initiate in H1 2021

    Entered into a clinical collaboration with Eli Lilly to evaluate ZN-c5 in combination with abemaciclib, a CDK4 and 6 inhibitor

    Raised an additional ~$166.0 million in gross proceeds from recent follow-on offering

    NEW YORK and SAN DIEGO, Nov. 09, 2020 (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, 2020, and highlighted recent corporate accomplishments.

    "We are proud of the clinical progress we have made this quarter, making meaningful strides in the advancement of our broad oncology pipeline," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "In July, we announced positive topline results from the Phase 1 monotherapy dose escalation trial of our lead candidate, ZN-c5, with a clinical benefit rate of 40%. Based on this candidate's favorable tolerability and encouraging anti-tumor activity, we are preparing to initiate the Phase 2 trial in patients with ER+/HER2- advanced breast cancer in the first half of 2021."

    Continued Dr. Sun, "In addition to our multiple ongoing studies, we remain on track to initiate a Phase 1b trial of ZN-c5 and Verzenio® (abemaciclib) in collaboration with Eli Lilly, as well as a Phase 1 combination trial with ZN-c3 and a chemotherapy agent before year-end. Supported by our recent financing, we maintain a strong position for sustained clinical and strategic growth and look forward to expanding the breadth of our pipeline with the hopes of bringing transformative cancer treatments to patients."

    Program Highlights:

    • In July 2020, Zentalis announced positive topline results from the Phase 1 monotherapy dose escalation trial of ZN-c5 in patients with ER+/HER2- advanced breast cancer. ZN-c5 was well tolerated and showed preliminary efficacy, with a clinical benefit rate of 40%. The Company expects to initiate the Phase 2 monotherapy trial in the first half of 2021.

       
    • In July 2020, the Company entered into a clinical collaboration with Eli Lilly to evaluate the combination of ZN-c5, the Company's oral selective estrogen receptor degrader (SERD) product candidate, and Verzenio® (abemaciclib), Eli Lilly's CDK4 and 6 inhibitor. Zentalis plans to initiate a Phase 1b open label, multicenter trial in patients with ER+/HER2- advanced breast cancer before year-end.



    • In September 2020, Zentalis hosted a virtual meeting with Key Opinion Leaders on its investigational WEE1 inhibitor, ZN-c3, and its potential for the treatment of advanced solid tumors. Currently, the Company is conducting a Phase 1/2 clinical trial of ZN-c3 in patients with advanced solid tumors and expects to report topline results from the Phase 1 portion of this trial in 2021.

    Corporate Highlights:

    • In August 2020, Zentalis closed a follow-on offering of common stock resulting in gross proceeds of approximately $166.0 million.

       
    • In July 2020, the Company appointed Kimberly Blackwell, M.D., to the Board of Directors. Dr. Blackwell is the current Chief Medical Officer of Tempus, as well as a renowned breast cancer researcher who has made significant contributions to the biopharmaceutical industry for more than two decades.

       
    • In September 2020, Zentalis appointed Alexis Pinto, J.D., as Chief Legal Officer. Ms. Pinto joins Zentalis with over 20 years of legal and strategic business development experience in the healthcare industry, most recently at Celgene Corporation.

    Third Quarter 2020 Financial Results

    • Cash and Marketable Securities Position: As of September 30, 2020, Zentalis had cash, cash equivalents and marketable securities of $367.4 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.

       
    • Research and Development Expenses: Research and development expenses were $24.7 million in the third quarter of 2020, compared to $10.7 million for the same period in 2019. This increase of $14.0 million was primarily due to increases in external research and development expenses related to Zentalis' lead product candidates, as the Company advanced its Phase 1/2 clinical trials for ZN-c5 and ZN-c3 and prepared for ZN-d5 development. In addition, in the three months ended September 30, 2020, the Company conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.

       
    • General and Administrative Expenses: General and administrative expenses were $10.1 million in the third quarter of 2020, compared to $1.8 million for the same period in 2019. This increase of $8.3 million was primarily attributable to an increase of $6.5 million in employee-related costs of which $5.0 million was driven by non-cash, stock-based compensation from incentive grants issued during the quarter and increased headcount to support growth. Professional service fees for legal, accounting and consulting services increased by $1.1 million to support the increased operations of the organization, and insurance costs increased by $0.7 million related to operating as a public company.

       
    • Net Loss: The Company's net loss for the third quarter of 2020 was $34.7 million, compared to the net loss of $12.6 million for the same period in 2019.

       
    • Impact from COVID-19 Pandemic: The Company is continuing to monitor how the spread of the COVID-19 pandemic is affecting its employees, business, preclinical studies and clinical trials. The COVID-19 pandemic has caused disruptions to the Company's development plans and research-stage programs, including delayed initiations, suspended enrollment at some clinical sites for new patients, and limited operations at its laboratory facilities. As a result, this pandemic may continue to impact Zentalis' business, revenues, results of operations and financial condition.

    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, including ZN-c5, an oral selective estrogen receptor degrader for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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, activities in connection with our collaborations with Eli Lilly, the anticipated direct and indirect impact of COVID-19 on our business and operations, 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931



    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967





    Zentalis Pharmaceuticals, Inc. (Successor to Zentalis Pharmaceuticals, LLC)

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per unit and per share amounts)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2020 2019 2020 2019
    Operating Expenses       
    Research and development$24,670  $10,739  $55,380  $26,517 
    General and administrative10,097  1,844  23,162  5,423 
    Total operating expenses34,767  12,583  78,542  31,940 
    Operating loss(34,767) (12,583) (78,542) (31,940)
    Other Income (Expense)       
    Investment and other income, net120  12  368  123 
    Net loss before income taxes(34,647) (12,571) (78,174) (31,817)
    Income tax expense18  1  18  15 
    Net loss(34,665) (12,572) (78,192) (31,832)
    Net loss attributable to noncontrolling interests(110) (228) (654) (675)
    Net loss attributable to Zentalis$(34,555) $(12,344) $(77,538) $(31,157)
    Net loss per common share outstanding, basic and diluted$(0.91) $  $(3.21) $ 
    Net loss per Class A common unit outstanding, basic and diluted$  $(2.20) $  $(5.56)
    Common shares/units used in computing net loss per share/Class A common unit, basic and diluted37,959  5,601  24,143  5,601 





    Zentalis Pharmaceuticals, Inc. (Successor to Zentalis Pharmaceuticals, LLC)

    Selected Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)

     As of As of
     September 30, December 31,
     2020 2019
        
    Cash, cash equivalents and marketable securities$367,436  $67,246 
    Working capital (1)348,830  53,994 
    Total assets393,233  87,481 
    Total liabilities27,400  19,060 
    Convertible preferred units  141,706 
    Total Zentalis equity (deficit)365,833  (73,285)
        
    (1) The Company defines working capital as current assets less current liabilities.
     

     

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  17. NEW YORK and SAN DIEGO, Sept. 11, 2020 (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 it will host a Key Opinion Leader (KOL) virtual meeting on its clinical candidate ZN-c3, the Company's WEE1 inhibitor, and its potential in the treatment of advanced solid tumors on Thursday, September 24, 2020 from 12:00 p.m. to 1:30 p.m. EDT.

    The virtual event will feature presentations by KOL Kwok-Kin Wong, MD, PhD, Professor of Oncology, Department of Medicine at the NYU Grossman School of Medicine and Director of the Division of Hematology and Medical…

    NEW YORK and SAN DIEGO, Sept. 11, 2020 (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 it will host a Key Opinion Leader (KOL) virtual meeting on its clinical candidate ZN-c3, the Company's WEE1 inhibitor, and its potential in the treatment of advanced solid tumors on Thursday, September 24, 2020 from 12:00 p.m. to 1:30 p.m. EDT.

    The virtual event will feature presentations by KOL Kwok-Kin Wong, MD, PhD, Professor of Oncology, Department of Medicine at the NYU Grossman School of Medicine and Director of the Division of Hematology and Medical Oncology Chief at The Perlmutter Cancer Center at NYU Langone Medical Center and KOL Gordon Mills, MD, PhD, Professor of Cell, Developmental and Cancer Biology, School of Medicine and Director of Precision Oncology and SMMART Trials, Knight Cancer Institute at Oregon Health & Science University. The Zentalis management team will also provide an overview of the ongoing clinical development strategy of ZN-c3.

    The inhibition of WEE1 aims to generate sufficient DNA damage to cancer cells, resulting in programmed cell death and prevention of tumor growth. ZN-c3 is designed to have a best-in-class product profile with significant advantages over other investigational WEE1 inhibitor therapies, including good solubility, target selectivity and pharmacokinetic properties. The Company is currently conducting a Phase 1/2 trial in patients with advanced solid tumors.

    Dr. Wong's research, teaching and clinical activities focus on understanding the genetic alterations driving lung tumor formation and the testing of new targeted and immune lung cancer therapies. The unique models used in Dr. Wong's laboratory allow scientists to investigate the efficacy of new targeted therapeutics and immunotherapeutics. Dr. Wong and his team continue to lead the search for curative treatments for patients with advanced lung cancer.

    Dr. Mills is responsible for the implementation of an integrated program of tumor analysis, decision-making and implementation of novel precision oncology trials. His key goal is to use serial tumor and liquid biopsies to evaluate and target adaptive responses in real time to interdict cancer evolution. Dr. Mills has published more than 1,000 papers and holds more than 20 patents.

    The live webcast of the event will be accessible from the Investors page of Zentalis' website, www.zentalis.com. The archived webcast and presentation will be available on the Company's website after the event.

    About ZN-c3

    ZN-c3 is an 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. Zentalis is currently conducting a Phase 1/2 clinical trial of ZN-c3, and expects to initiate a Phase 1b clinical trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer in the second half of 2020.

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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 clinical development strategy and goals, the potential of our product candidates, including without limitation ZN-c3 and upcoming meetings 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 following: the outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

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  18. NEW YORK and SAN DIEGO, Sept. 10, 2020 (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 participate in two upcoming virtual investor conferences.

    Presentation Details:

    Event: Morgan Stanley 18th Annual Global Healthcare Conference
    Date: Thursday, September 17, 2020
    Time: 8:45 a.m. ET

    Event: Cantor Fitzgerald Virtual Global Healthcare Conference
    Date: Thursday, September 17, 2020
    Time: 10:00 a.m. ET

    Live webcasts from the Morgan Stanley and Cantor fireside chats will be accessible…

    NEW YORK and SAN DIEGO, Sept. 10, 2020 (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 participate in two upcoming virtual investor conferences.

    Presentation Details:

    Event: Morgan Stanley 18th Annual Global Healthcare Conference

    Date: Thursday, September 17, 2020

    Time: 8:45 a.m. ET

    Event: Cantor Fitzgerald Virtual Global Healthcare Conference

    Date: Thursday, September 17, 2020

    Time: 10:00 a.m. ET

    Live webcasts from the Morgan Stanley and Cantor fireside chats 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, including  ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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.

    Investor Contact:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

    Primary Logo

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  19. NEW YORK and SAN DIEGO, Sept. 01, 2020 (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 the appointment of Alexis Pinto as Chief Legal Officer. Ms. Pinto joins Zentalis with over 20 years of legal and strategic business development experience in the healthcare industry, most recently at Celgene Corporation.

    "We are thrilled to welcome Alexis to Zentalis, as her depth of knowledge in deal-making and leading legal teams within the life science sector will be a great asset to the Company," said Dr. Anthony Sun, Chairman and Chief Executive Officer at…

    NEW YORK and SAN DIEGO, Sept. 01, 2020 (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 the appointment of Alexis Pinto as Chief Legal Officer. Ms. Pinto joins Zentalis with over 20 years of legal and strategic business development experience in the healthcare industry, most recently at Celgene Corporation.

    "We are thrilled to welcome Alexis to Zentalis, as her depth of knowledge in deal-making and leading legal teams within the life science sector will be a great asset to the Company," said Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals. "Alexis will be responsible for the legal function across the organization, in addition to advising the Zentalis team on all legal affairs related to our growing pipeline of differentiated oncology candidates."

    Ms. Pinto most recently served as Corporate Vice President & Corporate Secretary at Celgene Corporation, where she transformed the legal support provided to the Business Development and Global Alliance Management groups, and served as lead counsel on critical, high-value transactions, including the acquisition of Celgene by Bristol Myers Squibb Company. Prior to joining Celgene, she was Managing Counsel of Corporate Transactions at Merck & Co., Inc., where she led, structured and managed complex sales, acquisitions, licensing and joint venture transactions, including the divestiture of Merck's consumer care business to Bayer AG. Over her 18-year tenure at Merck, Ms. Pinto held numerous positions of increasing responsibility and scope, starting out as a labor and employment attorney and progressing into licensing, vaccines, mergers and acquisitions and business development roles. She earned her J.D. from the University of Virginia School of Law and her B.A. from the University of Virginia.

    "I am honored to join an organization that is committed to developing best-in-class therapeutics that have the potential to revolutionize the lives of cancer patients," commented Alexis Pinto, J.D., Chief Legal Officer at Zentalis Pharmaceuticals. "Over the past year, Zentalis has made impressive strides on both the corporate and clinical fronts, and I look forward to working with the management team and board to further build the legal framework necessary to reach the Company's future milestones."

    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, including  ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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, commercialization, potential, safety, efficacy, and regulatory and clinical progress of our product candidates, and the impact of management changes. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

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  20. Closed initial public offering (IPO) of common stock, raising gross proceeds of ~$190.0 million

    Raised an additional ~$144.4 million in gross proceeds from recent follow-on offering

    Completed a $20.0 million Series A financing to establish Zentera Therapeutics, a majority-owned Chinese joint venture

    Entered into strategic collaborations with Eli Lilly and Tavros Therapeutics to further advance oncology pipeline

    NEW YORK and SAN DIEGO, Aug. 13, 2020 (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 second quarter ended June…

    Closed initial public offering (IPO) of common stock, raising gross proceeds of ~$190.0 million



    Raised an additional ~$144.4 million in gross proceeds from recent follow-on offering



    Completed a $20.0 million Series A financing to establish Zentera Therapeutics, a majority-owned Chinese joint venture



    Entered into strategic collaborations with Eli Lilly and Tavros Therapeutics to further advance oncology pipeline

    NEW YORK and SAN DIEGO, Aug. 13, 2020 (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 second quarter ended June 30, 2020, and highlighted recent corporate accomplishments.

    "This quarter and year as a whole have been marked by immense growth and business development opportunities," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Following the successful completion of our IPO at the height of market uncertainty in early April and our recent follow-on offering in August, we believe that we are well-positioned financially to deliver on an even greater number of upcoming key milestones as disclosed in the follow-on prospectus. Furthermore, we are pleased to have recently completed a Series A financing to establish Zentera Therapeutics, our majority-owned Chinese joint venture, as well as enter into two strategic collaborations with Eli Lilly and Tavros Therapeutics. These opportunities will allow us to continue exploring the potential of our oncology candidates in both the United States and globally, and work toward the discovery of innovative therapies to address unmet needs for cancer patients."

    Dr. Sun added, "Last month, we announced topline results from the Phase 1 monotherapy dose escalation trial of our oral SERD, ZN-c5, showcasing this candidate's favorable tolerability profile and high exposure levels, while also demonstrating preliminary efficacy. As we look ahead, our highly motivated team remains focused on driving our pipeline forward to achieve our upcoming clinical goals, which include initiating a Phase 1b combination study with our oral SERD, ZN-c5, and Eli Lilly's abemaciclib, and initiating a Phase 1 combination dose escalation study with our WEE1 inhibitor, ZN-c3, and a chemotherapy agent in the second half of 2020."

    Program Highlights:

    • In July 2020, the Company entered into a clinical collaboration with Eli Lilly and Company to evaluate the combination of ZN-c5, the Company's oral selective estrogen receptor degrader (SERD) product candidate, and Verzenio® (abemaciclib), Eli Lilly's CDK4 and 6 inhibitor, in patients with ER+/HER2- advanced breast cancer. Zentalis maintains full ownership of ZN-c5.

       
    • In July 2020, Zentalis announced topline results from the Phase 1 monotherapy dose escalation trial of ZN-c5 in patients with ER+/HER2- advanced breast cancer. As of June 30, 2020, fifteen patients had been enrolled, with three patients at each dose level: 50 mg, 75 mg, 100 mg, 150 mg and 300 mg. With a median of four prior lines of therapy, six out of the fifteen patients showed stable disease for 24 weeks, demonstrating a clinical benefit rate of 40%. ZN-c5 was well tolerated with no dose-limiting toxicities reported. The Company expects to initiate the Phase 2 monotherapy trial in the first half of 2021.

       
    • Zentalis is currently conducting a Phase 1/2 clinical trial of its WEE1 inhibitor ZN-c3 in patients with advanced solid tumors. Based on data from 22 patients dosed in the Phase 1 monotherapy dose escalation portion of the ongoing Phase 1/2 clinical trial as of June 19, 2020, ZN-c3 has been observed to be well tolerated with no dose limiting toxicities reported. Zentalis expects to report topline results from the Phase 1 portion of this trial in 2021.

       
    • In May 2020, Zentalis reported the closing of a $20.0 million Series A financing, before issuing costs of $1.6 million, to establish its majority-owned Chinese joint venture, Zentera Therapeutics, a biopharmaceutical company with headquarters in Shanghai, China. The proceeds will be used to develop and commercialize three Zentalis-discovered cancer therapies, in addition to potential future candidates. 

       
    • In May 2020, the Company finalized a strategic collaboration with Tavros Therapeutics in which Tavros' functional genomic discovery platform will be leveraged to discover next generation targeted small molecule drug candidates to expand Zentalis' oncology pipeline.

       
    • In April 2020, the FDA cleared the Company's fourth oncology IND application for ZN-d5, an investigational oral selective inhibitor of B-cell lymphoma 2 (BCL-2) initially in development for the treatment of hematologic malignancies. Zentalis plans to initiate a Phase 1 trial of ZN-d5 in patients with acute myeloid leukemia or B-cell lymphoma in the first half of 2021.

    Corporate Highlights:

    • In April 2020, the Company completed its IPO of common stock that yielded gross proceeds of approximately $190.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Zentalis.

       
    • In August 2020, Zentalis closed a follow-on offering of common stock resulting in gross proceeds of approximately $144.4 million.

       
    • In July 2020, the Company appointed Kimberly Blackwell, M.D., to the Board of Directors. Dr. Blackwell is the current Chief Medical Officer of Tempus, as well as a renowned breast cancer researcher who has made significant contributions to the biopharmaceutical industry for more than two decades.

    Second Quarter 2020 Financial Results

    • Cash and Marketable Securities Position: As of June 30, 2020, Zentalis had cash, cash equivalents and marketable securities of $233.2 million. We expect that the Company's existing cash, cash equivalents and marketable securities, together with the net proceeds of approximately $135.0 million from the follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.

       
    • Research and Development Expenses: Research and development expenses were $17.5 million in the second quarter of 2020, compared to $8.7 million for the same period in 2019. This increase of $8.8 million was primarily due to increases in external research and development expenses related to Zentalis' lead product candidates, as the Company advanced its Phase 1/2 clinical trials for ZN-c5 and ZN-c3. In addition, in the three months ended June 30, 2020, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.

       
    • General and Administrative Expenses: General and administrative expenses were $9.9 million in the second quarter of 2020, compared to $1.9 million for the same period in 2019. This increase of $8.0 million was primarily attributable to an increase of $5.9 million in employee-related costs of which $5.2 million was driven by non-cash stock-based compensation from incentive grants issued during the quarter and increased headcount to support growth. Professional service fees for legal, accounting and consulting services increased by $1.0 million to support the increased operations of the organization, insurance costs increased by $0.7 million related to operating as a public company, and facilities and other allocable overhead expenses increased by $0.4 million.

       
    • Net Loss: The Company's net loss for the second quarter of 2020 was $27.3 million, compared to the net loss of $10.6 million for the same period in 2019.

       
    • Impact from COVID-19 Pandemic: The Company is continuing to monitor how the spread of the COVID-19 pandemic is affecting its employees, business, preclinical studies and clinical trials. The COVID-19 pandemic has caused disruptions to the Company's development plans and research-stage programs, including delayed initiations, suspended enrollment at some clinical sites for new patients, and limited operations at its laboratory facilities. As a result, this pandemic may continue to impact Zentalis' business, revenues, results of operations and financial condition.

    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, including ZN-c5, an oral selective estrogen receptor degrader for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. 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, commercialization, 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, activities in connection with our collaborations with Eli Lilly and Tavros Therapeutics, the anticipated direct and indirect impact of COVID-19 on our business and operations, 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931



    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

       Zentalis Pharmaceuticals, Inc. (Successor to Zentalis Pharmaceuticals, LLC)

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per unit and per share amounts)

     Three Months Ended

    June 30,
     Six Months Ended

    June 30,
    Operating Expenses 2020   2019   2020   2019 
    Research and development$   17,452  $ 8,689  $ 30,710  $ 15,778 
    General and administrative 9,924   1,946   13,065   3,579 
    Total operating expenses 27,376   10,635   43,775   19,357 
    Operating loss (27,376)  (10,635)  (43,775)  (19,357)
    Other Income (Expense)       
    Investment and other income, net 84   49   248   111 
    Income tax expense -   11   -   14 
    Net loss (27,292)  (10,597)  (43,527)  (19,260)
    Net loss attributable to noncontrolling interests (435)  (127)  (544)  (447)
    Net loss attributable to Zentalis$(26,857) $(10,470) $(42,983) $  (18,813)
    Net loss per common share outstanding, basic and diluted$   (0.78) $ -  $   (2.53) $ - 
    Net loss per Class A common unit outstanding, basic and diluted$   -  $  (1.87) $   -  $   (3.36)
    Common shares/units used in computing net loss per share/Class A common unit, basic and diluted 34,353   5,601   16,978   5,601 





    Zentalis Pharmaceuticals, Inc. (Successor to Zentalis Pharmaceuticals, LLC)

    Selected Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)

     As of As of
     June 30, December  31,
      2020  2019 
    Cash, cash equivalents and marketable securities$  233,191 $  67,246 
    Working capital (1)   222,914    53,994 
    Total assets   257,217    87,481 
    Total liabilities   19,292  19,060 
    Convertible preferred units   -  141,706 
    Total Zentalis Equity (Deficit)$   213,224 $   (80,106)
        
    (1) The Company defines working capital as current assets less current liabilities. 

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  21. NEW YORK and SAN DIEGO, July 29, 2020 (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 the pricing of an underwritten public offering of 4,125,000 shares of its common stock at a public offering price of $35.00 per share, for total gross proceeds of approximately $144.4 million, before deducting underwriting discounts and commissions and offering expenses payable by Zentalis. The offering is expected to close on August 3, 2020, subject to customary closing conditions. In addition, Zentalis has granted the underwriters a 30-day option to purchase up…

    NEW YORK and SAN DIEGO, July 29, 2020 (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 the pricing of an underwritten public offering of 4,125,000 shares of its common stock at a public offering price of $35.00 per share, for total gross proceeds of approximately $144.4 million, before deducting underwriting discounts and commissions and offering expenses payable by Zentalis. The offering is expected to close on August 3, 2020, subject to customary closing conditions. In addition, Zentalis has granted the underwriters a 30-day option to purchase up to an additional 618,750 shares of its common stock at the public offering price, less underwriting discounts and commissions.

    Morgan Stanley, Jefferies, SVB Leerink and Guggenheim Securities are acting as joint book-running managers for the offering.

    A registration statement relating to the securities being sold in the offering has been filed and was declared effective by the U.S. Securities and Exchange Commission on July 29, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting:

    Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: 877-821-7388 or via email: , SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by emailing , Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at .

    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 the registration or qualification under the securities laws of such state or jurisdiction.

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on social media: @ZentalisP and LinkedIn.

    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 the completion and anticipated proceeds of the proposed offering. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.2967

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  22. NEW YORK and SAN DIEGO, July 27, 2020 (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 the commencement of a proposed underwritten public offering of 3,750,000 shares of its common stock. All shares of common stock to be sold in the proposed offering will be sold by Zentalis. Zentalis also expects to grant the underwriters a 30-day option to purchase up to an additional 562,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

    Morgan Stanley, Jefferies, SVB Leerink and Guggenheim Securities are acting…

    NEW YORK and SAN DIEGO, July 27, 2020 (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 the commencement of a proposed underwritten public offering of 3,750,000 shares of its common stock. All shares of common stock to be sold in the proposed offering will be sold by Zentalis. Zentalis also expects to grant the underwriters a 30-day option to purchase up to an additional 562,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

    Morgan Stanley, Jefferies, SVB Leerink and Guggenheim Securities are acting as joint book-running managers for the offering.

    The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to this offering, when available, may be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: 877-821-7388 or via email: , SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by emailing , Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at .

    A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy these securities 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 Zentalis Pharmaceuticals, Inc.

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on social media: @ZentalisP and LinkedIn.

    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 the completion, timing, terms and and size of the proposed offering and our expectations with respect to granting the underwriters a 30-day option to purchase additional shares. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

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    1.646.378.2931

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    Julia Deutsch

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  23. NEW YORK & SAN DIEGO, July 27, 2020 (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 a clinical collaboration agreement with Eli Lilly and Company (NYSE:LLY, "Lilly"))) in which Zentalis will evaluate the combination of ZN-c5, the Company's oral selective estrogen receptor degrader (SERD) product candidate, and Verzenio® (abemaciclib), Lilly's CDK4 and 6 inhibitor, in patients with ER+/HER2- advanced breast cancer.

    "This is a new, separate study, that allows us to evaluate the potential of our compound in combination with Lilly's CDK4 and 6 inhibitor…

    NEW YORK & SAN DIEGO, July 27, 2020 (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 a clinical collaboration agreement with Eli Lilly and Company (NYSE:LLY, "Lilly"))) in which Zentalis will evaluate the combination of ZN-c5, the Company's oral selective estrogen receptor degrader (SERD) product candidate, and Verzenio® (abemaciclib), Lilly's CDK4 and 6 inhibitor, in patients with ER+/HER2- advanced breast cancer.

    "This is a new, separate study, that allows us to evaluate the potential of our compound in combination with Lilly's CDK4 and 6 inhibitor," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals. "Among its approved indications, abemaciclib is prescribed in combination with hormonal therapy, including fulvestrant, the only FDA-approved SERD, to treat patients with ER+/HER2- advanced or metastatic breast cancer following endocrine therapy. We have designed ZN-c5 to overcome the limitations of existing hormonal therapies, potentially improving outcomes for breast cancer patients."

    Under the terms of the non-exclusive collaboration, Zentalis is responsible for conducting the study with Lilly providing all required doses of abemaciclib. Zentalis maintains full ownership of ZN-c5.

    About ZN-c5

    Zentalis' lead product candidate, ZN-c5, is an oral, small molecule SERD being developed for the treatment of ER+/HER2- advanced or metastatic breast cancer. Zentalis is currently conducting a Phase 1/2 clinical trial of ZN-c5 in patients with ER+/HER2- advanced or metastatic breast cancer, both as a monotherapy and in combination with palbociclib (marketed as Ibrance® by Pfizer) as part of a clinical collaboration with Pfizer. 

    About Verzenio® (abemaciclib)

    Lilly's Verzenio (abemaciclib) is an FDA-approved inhibitor of cyclin-dependent kinases CDK4 and 6, which are activated by binding to D-cyclins. Verzenio is indicated for the treatment of HR+/HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; or in combination with fulvestrant for women with disease progression following endocrine therapy; or as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

    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, including  ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on social media: @ZentalisP and LinkedIn.

    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 our collaboration with Lilly, and the development, commercialization, potential, safety, efficacy, and regulatory and clinical progress of our product candidates. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    m

    Media Contact:

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  24. NEW YORK and SAN DIEGO, July 01, 2020 (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 the appointment of Kimberly Blackwell, M.D. to its Board of Directors. Dr. Blackwell is a renowned breast cancer researcher who has made significant contributions to the biopharmaceutical industry for more than two decades. 

    "We are delighted to welcome Kim, a biopharma veteran with extensive experience in oncology research, to our Board of Directors," said Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals. "Throughout her career…

    NEW YORK and SAN DIEGO, July 01, 2020 (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 the appointment of Kimberly Blackwell, M.D. to its Board of Directors. Dr. Blackwell is a renowned breast cancer researcher who has made significant contributions to the biopharmaceutical industry for more than two decades. 

    "We are delighted to welcome Kim, a biopharma veteran with extensive experience in oncology research, to our Board of Directors," said Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals. "Throughout her career, she has led numerous clinical programs, mainly in breast cancer, that have resulted in successful regulatory approvals. This impressive background will be vital in helping us bring potentially life changing treatments to patients with a range of cancers."

    Dr. Blackwell is currently the Chief Medical Officer of Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. Prior to Tempus, she was Vice President of Early Phase Oncology and Immuno-oncology at Eli Lilly, where she led the clinical development teams in advancing early stage therapeutics. Throughout her 24 year tenure at Duke Cancer Institute, Dr. Blackwell directed the Women's Cancer Program, Strategic Collaborations, and the Precision Medicine Initiative. In addition, she has served as the principal or co-principal investigator on over 50 cancer clinical trials. Dr. Blackwell's innovative work in developing non-chemotherapy based approaches for the treatment of breast cancer led to her inclusion on TIME magazine's 2013 list of the 100 most influential people in the world. She received her undergraduate degree in bioethics from Duke University and holds an M.D. from Mayo Clinic School of Medicine.

    "As a previous member of the Scientific Advisory Board, I am honored by the opportunity to expand my role at Zentalis," said Dr. Kimberly Blackwell. "I look forward to continuing to assist the Zentalis team and its distinguished Board of Directors in building and evolving its potentially best-in-class oncology pipeline, with the goal of making a meaningful difference in patients' lives."

    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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on social media: @ZentalisP and LinkedIn.

    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, commercialization, potential, safety, efficacy, and regulatory and clinical progress of our product candidates. 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

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  25. NEW YORK and SAN DIEGO, June 15, 2020 (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 Ahmed Samatar, Ph.D., Senior Vice President of Oncology Research at Zentalis, will present preclinical data on ZN-c5 at the upcoming American Association of Cancer Research (AACR) Virtual Annual Meeting II taking place June 22-24th.

    The preclinical data demonstrated that ZN-c5, the Company's oral selective estrogen receptor degrader (SERD) product candidate, had antitumor activity in human tumor breast cancer xenograft models. ZN-c5 also displayed excellent…

    NEW YORK and SAN DIEGO, June 15, 2020 (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 Ahmed Samatar, Ph.D., Senior Vice President of Oncology Research at Zentalis, will present preclinical data on ZN-c5 at the upcoming American Association of Cancer Research (AACR) Virtual Annual Meeting II taking place June 22-24th.

    The preclinical data demonstrated that ZN-c5, the Company's oral selective estrogen receptor degrader (SERD) product candidate, had antitumor activity in human tumor breast cancer xenograft models. ZN-c5 also displayed excellent oral bioavailability across several preclinical species. ZN-c5 is currently being evaluated in a Phase 1/2 clinical trial in patients with ER+/HER2- advanced or metastatic breast cancer both as a single agent and in combination studies.

    Poster Presentation Details:

    Title: Discovery of ZN-c5, a novel potent and oral selective estrogen receptor degrader

    Session: PO.EN02.01 - Molecular, Preclinical, and Clinical Endocrinology 2

    Abstract ID: 4373 / 16

    Date/Time: Monday, June 22, 2020, 9:00 AM – 6:00 PM EDT

    The poster presentation will be available immediately following the virtual presentation in the "Supporting Presentations" section on the Zentalis 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, including ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast cancer, ZN-c3, a WEE1 inhibitor, ZN-d5, a BCL-2 inhibitor and ZN-e4, an EGFR inhibitor. Zentalis has operations in both New York and San Diego.

    For more information, please visit www.zentalis.com. Follow Zentalis on social media: @ZentalisP and LinkedIn.

    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 the Company's clinical development of ZN-c5. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause 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 outbreak of the novel coronavirus disease, COVID-19, has adversely impacted and may continue to adversely impact Zentalis' business, including its preclinical studies and clinical trials; Zentalis' limited operating history, which may make it difficult to evaluate its current business and predict its future success and viability; Zentalis has and expects to continue to incur significant losses; Zentalis' need for additional funding, which may not be available; Zentalis' substantial dependence on the success of its lead product candidate; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of Zentalis' 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; Zentalis' product candidates may cause serious adverse side effects; inability to maintain Zentalis' collaborations, or the failure of these collaborations; Zentalis' reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; Zentalis' ability to attract, retain and motivate qualified personnel; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Zentalis' Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Zentalis' other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Zentalis may elect to update such forward-looking statements at some point in the future, Zentalis disclaims any obligation to do so, even if subsequent events cause management's views to change.

    Investor Contact:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

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  26. NEW YORK and SAN DIEGO, May 28, 2020 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental pathways of cancers, today announced that Anthony Sun, MD, Chairman and Chief Executive Officer of Zentalis, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 1:30 p.m. ET.

    A live webcast of the fireside chat will be accessible through the Investors section of the Company's website at www.zentalis.com. Following the event, an archived webcast will be available on the Zentalis website.

    About Zentalis Pharmaceuticals

    Zentalis Pharmaceuticals…

    NEW YORK and SAN DIEGO, May 28, 2020 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental pathways of cancers, today announced that Anthony Sun, MD, Chairman and Chief Executive Officer of Zentalis, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 1:30 p.m. ET.

    A live webcast of the fireside chat will be accessible through the Investors section of the Company's website at www.zentalis.com. Following the event, an archived webcast will be available on the Zentalis website.

    About Zentalis Pharmaceuticals

    Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental biological pathways in cancer. In addition to its lead program, ZN-c5, an oral selective estrogen receptor degrader (SERD) for estrogen-receptor-positive, HER2-negative breast cancer, the Company is developing a broad pipeline of oncology candidates, targeting areas of major unmet medical need. The Company has offices in New York and San Diego. For more information, please visit www.zentalis.com.

    Contacts

    Investor Contact:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

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    1.646.378.2967

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  27. NEW YORK, SAN DIEGO and DURHAM, N.C., May 28, 2020 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL) and Tavros Therapeutics, Inc., today announced a strategic collaboration to apply Tavros' functional genomic discovery platform to develop next generation targeted small molecule drug candidates, initially to expand Zentalis' oncology pipeline.

    "We are pleased to be collaborating with Zentalis, as this aligns with Tavros' goal to improve cancer therapy by uncovering unique and druggable vulnerabilities within tumors," remarked Tavros CEO and co-founder Eoin McDonnell on behalf of Tavros co-founders Kris Wood and Greg Mossinghoff. "The Tavros functional genomic discovery platform employs proven technologies and proprietary know-how…

    NEW YORK, SAN DIEGO and DURHAM, N.C., May 28, 2020 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL) and Tavros Therapeutics, Inc., today announced a strategic collaboration to apply Tavros' functional genomic discovery platform to develop next generation targeted small molecule drug candidates, initially to expand Zentalis' oncology pipeline.

    "We are pleased to be collaborating with Zentalis, as this aligns with Tavros' goal to improve cancer therapy by uncovering unique and druggable vulnerabilities within tumors," remarked Tavros CEO and co-founder Eoin McDonnell on behalf of Tavros co-founders Kris Wood and Greg Mossinghoff. "The Tavros functional genomic discovery platform employs proven technologies and proprietary know-how to significantly increase clinical success, as well as to improve the tolerability and toxicity profile of a new drug." 

    Tavros' strategic approach allows for an unbiased analysis of intricate cellular signaling pathways to discover novel targets, synthetic lethality pairs, mechanisms to overcome cancer resistance, and unique genetic signatures for clinical trials.

    Zentalis CEO Anthony Sun commented, "Tavros and Zentalis share a common goal: to utilize proprietary technologies to discover and develop drugs that are safer, more efficacious and tolerable for patients than existing therapies. Leveraging the unique insights provided by Tavros' technologies coupled with Zentalis' strong medicinal chemistry expertise, we believe this relationship could yield multiple novel drug candidates and combinations that may have the potential to address unmet needs for cancer patients." 

    The transaction terms were structured to build and expand the Tavros discovery platform, with each company given the rights to any new products generated from the platform.

    About Tavros Therapeutics
    Tavros Therapeutics, Inc. is an emerging biotechnology company focused on discovering and developing novel therapies that improve the lives of those affected by cancer. Tavros is led by a team with a deep understanding of the biology of cancer and extensive drug discovery, development and commercialization experience. Through Tavros' pioneering high-throughput functional genomic approaches, it aims to uncover unique vulnerabilities within the tumor and identify drug targets and combinations to address cancers with poor outcomes and high unmet needs. Tavros is located in Durham, North Carolina. For more information, please visit www.tavrostx.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. In addition to its lead program, ZN-c5, an oral selective estrogen receptor degrader (SERD) for estrogen-receptor-positive, HER2-negative breast cancer, Zentalis is developing a broad pipeline of oncology candidates, targeting areas of major unmet medical need. Zentalis has offices in New York and San Diego. For more information, please visit www.zentalis.com.

    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 the collaboration with Tavros and anticipated yield of novel drug candidates, and Zentalis' expectations surrounding the development, commercialization, potential, safety, efficacy, and regulatory and clinical progress of its product candidates. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause 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 outbreak of the novel coronavirus disease, COVID-19, has adversely impacted and may continue to adversely impact Zentalis' business, including its preclinical studies and clinical trials; Zentalis' limited operating history, which may make it difficult to evaluate its current business and predict its future success and viability; Zentalis has and expects to continue to incur significant losses; Zentalis' need for additional funding, which may not be available; Zentalis' substantial dependence on the success of its lead product candidate; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of Zentalis' 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; Zentalis' product candidates may cause serious adverse side effects; inability to maintain Zentalis' collaborations, or the failure of these collaborations, including without limitation the Tavros collaboration; Zentalis' reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; Zentalis' ability to attract, retain and motivate qualified personnel; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Zentalis' Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Zentalis' other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Zentalis may elect to update such forward-looking statements at some point in the future, Zentalis disclaims any obligation to do so, even if subsequent events cause management's views to change.

    Investor Contact:
    Thomas Hoffmann
    Solebury Trout
    1.646.378.2931

    Media Contact:
    Julia Deutsch
    Solebury Trout
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  28. NEW YORK and SAN DIEGO, May 20, 2020 (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 the closing of a $20 million Series A financing of Zentera Therapeutics, a biopharmaceutical company with headquarters in Shanghai, China. Leading the financing is Tybourne Capital Management, a global investment manager headquartered in Asia, and joining the syndicate is OrbiMed Asia, a leading healthcare fund in Asia. Zentalis, through its wholly owned subsidiaries, remains the majority shareholder of Zentera.

    The proceeds from the Series A financing will be used…

    NEW YORK and SAN DIEGO, May 20, 2020 (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 the closing of a $20 million Series A financing of Zentera Therapeutics, a biopharmaceutical company with headquarters in Shanghai, China. Leading the financing is Tybourne Capital Management, a global investment manager headquartered in Asia, and joining the syndicate is OrbiMed Asia, a leading healthcare fund in Asia. Zentalis, through its wholly owned subsidiaries, remains the majority shareholder of Zentera.

    The proceeds from the Series A financing will be used to develop and commercialize three cancer therapies discovered by Zentalis, in addition to potential future candidates, in China. Anthony Sun, MD, CEO of Zentalis, will serve as CEO of Zentera.

    "The launch of Zentera is a key milestone in our global clinical development strategy," commented Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals and Chief Executive Officer at Zentera Therapeutics. "As the second-largest pharmaceutical market in the world, establishing a joint venture in China is the first step toward advancing our product candidates on a global scale. Furthermore, we are building a management team in China of seasoned professionals who are passionate about improving cancer treatment. We would like to thank our partners, Tybourne Capital Management and OrbiMed Asia, for supporting our vision to efficiently advance our best-in-class therapies to markets worldwide."

    Bosun Hau, Managing Director and Co-Head of Private Equity at Tybourne Capital Management, commented, "Over the past few years, we have watched Zentalis' remarkable clinical progress in developing potentially best-in-class candidates for patients with cancer. We are pleased to work with Zentera, as we believe these therapies will greatly benefit patients internationally."

    Dr. David Wang, Partner and Senior Managing Director at OrbiMed Asia, added, "At OrbiMed, we are passionate about investing in innovative solutions that improve the lives of patients. The establishment of this joint venture, which helps to bring potentially life-changing treatments to China, aligns with our values and we are delighted to add Zentera to the OrbiMed family."

    Zentalis' pipeline candidates that will be developed in China by Zentera include its oral SERD (ZN-c5), WEE1 inhibitor (ZN-c3), and BCL-2 inhibitor (ZN-d5), which address unmet medical needs in large patient populations in both solid and liquid tumors. Additional Zentalis candidates may also be developed in China by Zentera.  

    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. In addition to its lead program, ZN-c5, an oral selective estrogen receptor degrader (SERD) for estrogen-receptor-positive, HER2-negative breast cancer, the Company is developing a broad pipeline of oncology candidates, targeting areas of major unmet medical need. The Company has offices in New York and San Diego. For more information, please visit www.zentalis.com.

    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, commercialization, potential, safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated use of the proceeds from the Series A financing, and our presence in China. 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 outbreak of the novel strain of coronavirus disease, COVID-19, could 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our final prospectus under Rule 424(b)(4) filed with the Securities and Exchange Commission on April 6, 2020 could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967

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  29. Completed initial public offering of common stock, raising approximately $190.0 million in gross proceeds

    Fourth oncology Investigational New Drug (IND) application cleared by FDA for ZN-d5, a BCL-2 inhibitor

    NEW YORK and SAN DIEGO, May 15, 2020 (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 first quarter ended March 31, 2020, and highlighted recent corporate accomplishments.

    "2020 has already proven to be a pivotal year for Zentalis. We achieved numerous important corporate and clinical milestones, including the completion…

    Completed initial public offering of common stock, raising approximately $190.0 million in gross proceeds

    Fourth oncology Investigational New Drug (IND) application cleared by FDA for ZN-d5, a BCL-2 inhibitor

    NEW YORK and SAN DIEGO, May 15, 2020 (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 first quarter ended March 31, 2020, and highlighted recent corporate accomplishments.

    "2020 has already proven to be a pivotal year for Zentalis. We achieved numerous important corporate and clinical milestones, including the completion of our initial public offering, positioning Zentalis for continued success," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Becoming a public company during these unprecedented times would not have been possible without the hard work and dedication from our team as well as the continuous support from our new and existing shareholders. From inception, Zentalis has been passionate about improving the lives of cancer patients through the discovery of potential breakthrough medicines, clearing four INDs in just five years. In addition, we look forward to reporting topline data on our oral SERD, ZN-c5, in the second half of 2020 as well as continuing to advance our broad oncology pipeline."

    Recent Accomplishments

    • In April 2020, the Company completed an initial public offering of 10,557,000 shares of common stock at a public offering price of $18.00 per share for gross proceeds of approximately $190.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Zentalis.
       
    • In April 2020, the U.S. Food and Drug Administration (FDA) cleared the Company's IND application for ZN-d5, an investigational oral selective inhibitor of B-cell lymphoma 2 (BCL-2) initially in development for the treatment of hematologic malignancies.

    First Quarter 2020 Financial Results

    • Cash Position: As of March 31, 2020, Zentalis had cash and cash equivalents of $63.7 million. We expect that the Company's existing cash and cash equivalents, together with the net proceeds of $172.4 million from the IPO, will enable the Company to fund its operating expenses and capital expenditure requirements into 2022.

    • Research and Development Expenses: Research and development expenses were $13.3 million in the first quarter of 2020, compared to $7.1 million for the same period in 2019. This increase of $6.2 million was primarily due to increases in external research and development expenses related to our lead product candidates, as the Company advanced Phase 1/2 clinical trials for ZN-c5, ZN-c3 and ZN-e4. In addition, in the three months ended March 31, 2020, Zentalis conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.
       
    • General and Administrative Expenses: General and administrative expenses were $3.1 million in the first quarter of 2020, compared to $1.6 million for the same period in 2019. This increase of $1.5 million was primarily attributable to an increase of $0.6 million in employee-related costs as the Company increased headcount to support growth and an increase of $0.8 million in professional services fees for legal, accounting and consulting services.
       
    • Net Loss: The Company's net loss for the first quarter of 2020 was $16.2 million, compared to the net loss of $8.7 million for the same period in 2019.
       
    • Impact from COVID-19 Pandemic: The Company is closely monitoring how the COVID-19 pandemic is affecting its employees, business, preclinical studies and clinical trials. The COVID-19 pandemic has caused disruptions to the Company's development plans and research-stage programs, including delayed initiations, suspended enrollment at some clinical sites for new patients, and limited operations at our laboratory facilities. As a result, this pandemic may continue to impact Zentalis' business, revenues, results of operations and financial condition.

    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. In addition to its lead program, ZN-c5, an oral selective estrogen receptor degrader (SERD) for estrogen-receptor-positive, HER2-negative breast cancer, the Company is developing a broad pipeline of oncology candidates, targeting areas of major unmet medical need. The Company has offices in New York and San Diego. For more information, please visit www.zentalis.com.

    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, commercialization, potential, safety, efficacy, and regulatory and clinical progress of our product candidates, plans and timing for the initiation of and the release of data from our clinical trials, the anticipated direct and indirect impact of COVID-19 on our business and operations, 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 outbreak of the novel coronavirus disease, COVID-19, 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:

    Thomas Hoffmann

    Solebury Trout

    1.646.378.2931

    Media Contact:

    Julia Deutsch

    Solebury Trout

    1.646.378.2967


       Zentalis Pharmaceuticals, LLC
    Condensed Consolidated Statement of Operations
    (Unaudited)
    (In thousands, except per unit amounts)

      Three Months Ended
    March 31,
    Operating Expenses   2020       2019  
    Research and development $    13,258     $    7,089  
    General and administrative     3,141         1,633  
    Total operating expenses     16,399         8,722  
    Operating loss      (16,399 )        (8,722 )
    Other Income      
    Interest income     164         74  
    Other expense     -          (12 )
    Net loss before income taxes      (16,235 )        (8,660 )
    Income tax expense     -         3  
    Net loss      (16,235 )        (8,663 )
    Net loss attributable to noncontrolling interests      (109 )        (320 )
    Net loss attributable to Zentalis Pharmaceuticals, LLC $    (16,126 )   $    (8,343 )
                   
    Net loss per Class A common unit outstanding, basic and diluted $    (2.88 )   $    (1.49 )
                   
    Shares used in computing net loss per Class A common unit, basic and diluted     5,601         5,594  



    Zentalis Pharmaceuticals, LLC
    Selected Condensed Consolidated Balance Sheet Data
    (Unaudited)
    (In thousands)

      As of   As of
      March 31,   December 31,
        2020       2019  
    Cash and cash equivalents $ 63,650     $ 67,246  
    Working capital (1)   49,070       53,994  
    Total assets   87,629       87,481  
    Total liabilities   20,886       19,060  
    Convertible preferred units   155,934       141,706  
    Total Zentalis Pharmaceuticals, LLC members' deficit $ (95,903 )   $ (80,106 )
           
    (1) The Company defines working capital as current assets less current liabilities.  
           

     

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  30. NEW YORK and SAN DIEGO, April 30, 2020 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ZN-d5, an oral selective inhibitor of B-cell lymphoma 2 (BCL-2) initially in development for the treatment of hematologic malignancies.

    "The acceptance of this IND, our fourth cleared in only five years, highlights the capability and efficiency of our Integrated Discovery Engine in developing novel oncology therapies," commented Dr. Anthony Sun, Chairman…

    NEW YORK and SAN DIEGO, April 30, 2020 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ZN-d5, an oral selective inhibitor of B-cell lymphoma 2 (BCL-2) initially in development for the treatment of hematologic malignancies.

    "The acceptance of this IND, our fourth cleared in only five years, highlights the capability and efficiency of our Integrated Discovery Engine in developing novel oncology therapies," commented Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals. "BCL-2 is as an important mediator in restoring the normal apoptotic process in tumor cells, making this protein a vital target for the treatment of cancer. ZN-d5, a BCL-2 inhibitor, may offer patients with hematologic and epithelial malignancies a differentiated therapy option, both as a monotherapy and in combination with other agents including our oral selective estrogen receptor degrader (SERD), ZN-c5. We are thrilled to explore this candidate's full potential as we advance toward clinical development."

    About ZN-d5

    ZN-d5 is an oral selective inhibitor of B-cell lymphoma 2 (BCL-2). BCL-2 is a protein that plays a critical role in the regulation of cell death. The overexpression of BCL-2 is frequently detected in numerous cancer types, which prevent apoptosis of cancer cells. We believe a BCL-2 inhibitor will restore the normal apoptosis process, making it an important target for cancer treatments. ZN-d5 is designed to have optimized potency, selectively and pharmacokinetics.

    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. In addition to its lead program, ZN-c5, an oral selective estrogen receptor degrader (SERD) for estrogen-receptor-positive, HER2-negative breast cancer, the Company is developing a broad pipeline of oncology candidates, targeting areas of major unmet medical need. The Company has offices in New York and San Diego. For more information, please visit www.zentalis.com

    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, commercialization, potential, safety, efficacy, and regulatory and clinical progress of our product candidates. 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 outbreak of the novel strain of coronavirus disease, COVID-19, could 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 candidate; 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; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our final prospectus under Rule 424(b)(4) filed with the Securities and Exchange Commission on April 6, 2020 could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. 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:
    Thomas Hoffmann
    Solebury Trout
    1.646.378.2931

    Media Contact:
    Julia Deutsch
    Solebury Trout
    1.646.378.2967

    Primary Logo

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