ZNTL Zentalis Pharmaceuticals Inc.

54.45
-4.37  -7%
Previous Close 58.82
Open 57.05
52 Week Low 25.41
52 Week High 62.79
Market Cap $2,249,448,528
Shares 41,312,186
Float 26,852,693
Enterprise Value $2,093,476,780
Volume 177,633
Av. Daily Volume 325,096
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Upcoming Catalysts

Drug Stage Catalyst Date
ZN-e4
Non-small cell lung cancer
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
ZN-c3 and Zejula (niraparib)
Ovarian cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial to commence 2H 2021.
ZN-c3 and chemotherapy
Osteosarcoma
Phase 1/2
Phase 1/2
Phase 1/2 trial to commence 3Q 2021.
ZN-c3
Uterine serous carcinoma
Phase 2
Phase 2
Phase 2 trial to commence 3Q 2021.
ZN-c5 and abemaciclib
ER+/HER2- advanced breast cancer
Phase 1b
Phase 1b
Phase 1b trial initiation announced January 6, 2021.
ZN-d5
Acute Myeloid Leukemia
Phase 1
Phase 1
Phase 1 trial initiation announced January 6, 2021.
ZN-c5
ER+/HER2- breast cancer
Phase 1/2
Phase 1/2
Phase 2 monotherapy trial to be initiated in the first half of 2021.

Latest News

  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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