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Zentalis(ZNTL) - 2023 Q2 - Quarterly Report
2023-08-09 11:06
Financial Performance - Total current assets increased to $563,929,000 as of June 30, 2023, compared to $451,933,000 at December 31, 2022, representing a 25% increase[21] - Operating expenses for the three months ended June 30, 2023, were $103,916,000, up 64% from $63,461,000 in the same period of 2022[24] - Net loss for the six months ended June 30, 2023, was $175,826,000, compared to a net loss of $127,629,000 for the same period in 2022, reflecting a 38% increase in losses[27] - Cash and cash equivalents at the end of the period were $266,558,000, significantly up from $43,069,000 at the end of 2022[21] - The company reported a net cash used in operating activities of $128,558,000 for the six months ended June 30, 2023, compared to $93,220,000 for the same period in 2022[30] - The net loss per common share for the three months ended June 30, 2023, was $1.85, compared to $1.34 for the same period in 2022[24] - The net loss attributable to the company for the three months ended June 30, 2023, was $112,527,000, compared to a net loss of $68,357,000 for the same period in 2022, indicating an increase of approximately 64.6%[92] - The company raised a total of $1.2 billion in gross proceeds from the sale of common stock and convertible preferred units since inception, including $250 million from a follow-on offering in June 2023[156] Research and Development - Research and development expenses for the six months ended June 30, 2023, totaled $91,268,000, slightly up from $89,937,000 in the prior year[24] - Research and development (R&D) expenses for Q2 2023 were $42.7 million, a decrease of $1.1 million from $43.8 million in Q2 2022[137] - Azenosertib development costs for the three months ended June 30, 2023, were $13.9 million, while ZN-d5 costs were $5.1 million[127] - Zentera Collaboration Products development costs incurred for the six months ended June 30, 2023, totaled $3.5 million, down from $5.1 million in the same period of 2022[98] - Azenosertib is currently being evaluated in multiple clinical trials, including monotherapy and combinations with chemotherapy and targeted agents[104] - ZN-d5 is being evaluated in multiple clinical trials, including a Phase 1/2 trial for relapsed or refractory light chain amyloidosis with an expected enrollment of approximately 140 patients[111] Equity and Financing - The total stockholders' equity increased to $523,282,000 as of June 30, 2023, from $434,024,000 at December 31, 2022, marking a 21% increase[21] - The company issued common stock resulting in net proceeds of $235,680,000 during the six months ended June 30, 2023[30] - The company completed a follow-on offering on June 15, 2023, issuing 11,032,656 shares at $22.66 per share, generating gross proceeds of approximately $250 million before expenses[78] - Cash, cash equivalents, and marketable securities totaled $553.0 million as of June 30, 2023, expected to fund operations into 2026[113] Collaboration and Licensing - Zentalis terminated its collaboration and license agreements with Zentera Therapeutics, regaining worldwide rights to azenosertib, ZN-d5, and ZN-c5[55] - A $30 million upfront payment was made to Zentera Therapeutics as part of the termination of collaboration agreements, regaining rights for azenosertib, ZN-d5, and ZN-c5 in Greater China[122] - The total consideration for reacquiring the licensed intellectual property from Zentera was $45.6 million, including a fixed payment of $30 million[57] Clinical Trials and Product Development - Azenosertib, a WEE1 inhibitor, has shown a confirmed objective response rate (ORR) of 50.0% in combination with paclitaxel and a median progression-free survival (mPFS) of 7.4 months in patients with Cyclin E1 positive tumors[105] - The company has initiated a Phase 3 study comparing azenosertib dosed intermittently with carboplatin or paclitaxel in patients with Cyclin E1 positive platinum-sensitive ovarian cancer[106] - Azenosertib has received Fast Track designation from the FDA for advanced or metastatic uterine serous carcinoma patients who have undergone prior platinum-based chemotherapy[105] - The company is conducting IND-enabling studies for its BCL-xL product candidate, which targets solid tumors and hematological malignancies[101] Future Outlook and Risks - The company expects to continue incurring significant expenses and operating losses for the foreseeable future[113] - The company currently has no products approved for commercial sale and does not expect to generate revenue from product sales for several years[181][186] - The company will require substantial additional capital to finance operations and may need to delay or reduce research and development programs if unable to raise funds[190] - Market conditions and external factors could adversely impact the company's ability to access capital when needed, potentially affecting its financial condition[193] - The lengthy approval process and unpredictability of clinical trial results may result in failure to obtain regulatory approval for product candidates, significantly harming the company's business and prospects[209]
Zentalis(ZNTL) - 2023 Q1 - Quarterly Report
2023-05-10 11:06
Financial Performance - Total assets decreased from $539,310,000 on December 31, 2022, to $489,342,000 on March 31, 2023, representing a decline of approximately 9.3%[22] - Cash and cash equivalents decreased from $43,069,000 to $36,280,000, a reduction of about 15.7%[22] - Total operating expenses increased from $57,879,000 in Q1 2022 to $64,953,000 in Q1 2023, marking an increase of approximately 12.0%[24] - Net loss attributable to Zentalis increased from $59,077,000 in Q1 2022 to $63,219,000 in Q1 2023, an increase of about 7.3%[24] - The company reported a total comprehensive loss of $62,465,000 for Q1 2023, compared to $60,221,000 in Q1 2022, an increase of about 3.7%[26] - The net loss attributable to the company for the three months ended March 31, 2023, was $63,219 thousand, compared to a net loss of $59,077 thousand for the same period in 2022, indicating an increase in loss of approximately 7.3%[79] - The company reported a net loss of $237.1 million for the year ended December 31, 2022, and an accumulated deficit of $659.6 million as of March 31, 2023[100] - The accumulated deficit as of March 31, 2023, was $659.6 million, indicating significant operating losses since inception[137] Cash Flow and Liquidity - Cash used in operating activities was $49,283,000 for Q1 2023, compared to $50,190,000 in Q1 2022, indicating a slight improvement of approximately 1.8%[29] - Net cash used in operating activities for the three months ended March 31, 2023 was $49.3 million, primarily due to a net loss of $63.3 million[141] - Net cash provided by investing activities for the same period was $42.1 million, resulting from proceeds of $106.0 million from maturities of marketable securities, offset by a net investment of $63.9 million[142] - Net cash provided by financing activities was $0.4 million from the issuance of common stock under equity incentive plans[143] - As of March 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $392.5 million, expected to fund operations into Q2 2025[100] - Existing cash, cash equivalents, and marketable securities as of March 31, 2023 are projected to fund operating expenses into the second quarter of 2025[146] - The company has raised a total of $975.9 million in gross proceeds from the sale of common stock and convertible preferred units since inception, with cash, cash equivalents, and marketable securities totaling $392.5 million as of March 31, 2023[137] Equity and Investments - Total stockholders' equity decreased from $434,024,000 at the end of 2022 to $385,665,000 by March 31, 2023, a decline of about 11.1%[22] - The company’s investment in Zentera Therapeutics decreased from $21,213,000 to $18,903,000, a decline of approximately 10.9%[22] - The company’s additional paid-in capital increased from $1,031,462,000 to $1,045,568,000, an increase of about 1.4%[32] - As of March 31, 2023, the equity method investment in Zentera is recorded at $18.9 million, representing the maximum exposure to loss from this involvement[47] Research and Development - Research and development expenses for Q1 2023 were $48.6 million, an increase of $2.5 million from $46.1 million in Q1 2022, primarily due to increased overhead allocations and personnel costs[130] - Azenosertib, a WEE1 inhibitor, is currently in multiple clinical trials, demonstrating monotherapy anti-tumor activity across various tumor types[87] - ZN-d5, a selective BCL-2 inhibitor, is being evaluated in clinical trials for hematological malignancies, showing promising tolerability[87] - Azenosertib has received FDA Fast Track Designation for patients with advanced or metastatic Uterine Serous Carcinoma who have undergone at least one prior platinum-based chemotherapy regimen[93] - Azenosertib is being evaluated in a Phase 2 trial for Cyclin E1 driven High-Grade Serous Ovarian Cancer, with a focus on patient enrichment strategies[93] - The company is conducting IND-enabling studies for its BCL-xL degrader program, which targets solid tumors and hematological malignancies[90] - Azenosertib demonstrated five confirmed partial responses (cPRs) in a Phase 1 trial for solid tumors, with ovarian cancer showing a cPR rate of 69%[24] Clinical Trials and Regulatory Risks - The company acknowledges that the regulatory approval process is lengthy and unpredictable, which could hinder its ability to generate product revenue[185] - The company has not yet submitted for regulatory approval for any product candidates, and there is a risk that none may ever receive approval[185] - Delays in clinical trials can arise from various factors, including regulatory disagreements, site issues, and patient enrollment challenges, potentially harming commercial prospects[196] - The approval process for product candidates may result in limitations on indications or require costly post-marketing trials, impacting commercialization[192] - The company may face challenges in establishing collaborations for diagnostic tool development, which could hinder the progress of product candidates[206] Future Funding and Financial Outlook - The company plans to finance operations through equity sales, debt financings, or collaborations, facing challenges due to economic downturns and uncertainties related to global events[135] - The company anticipates needing substantial additional capital to finance ongoing operations and product development, which may require public or private equity offerings, debt financing, or collaborations[173] - Future funding requirements will depend on various factors, including the progress of clinical trials and the ability to establish strategic collaborations[149] - The company does not expect to generate revenue from product sales in the foreseeable future, relying instead on collaboration agreements for potential revenue[116] Market and Competitive Landscape - The company emphasizes that even if product candidates receive regulatory approval, they may not achieve adequate market acceptance among physicians, patients, and healthcare payors, which is crucial for commercial success[213] - Factors influencing market acceptance include efficacy and safety profiles, timing of market introduction, and availability of coverage and reimbursement by third-party payors[216] - The effectiveness of sales and marketing efforts will play a critical role in the acceptance of approved product candidates[216] - The company is focused on ensuring that its product candidates demonstrate perceived advantages over alternative treatments to enhance market acceptance[216]
Zentalis(ZNTL) - 2022 Q4 - Annual Report
2023-03-01 12:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _________ TO _________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-3607803 ...
Zentalis Pharmaceuticals (ZNTL) Investor Presentation - Slideshow
2022-11-23 11:23
zentalis 1 CORPORATE PRESENTATION November 2022 Forward-Looking Statements and Disclaimer Zentalis Pharmaceuticals, Inc. ("we," "us," "our," "Zentalis" or the "Company") cautions that this presentation (including oral commentary that accompanies this presentation) contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-lookin ...
Zentalis Pharmaceuticals (ZNTL) Investor Presentation - Slideshow
2022-08-11 17:53
ZN-c3 (Wee1 Inhibitor) - ZN-c3 has shown partial responses in four tumor types and has potential accelerated approval paths for USC and biomarker-driven trials[8] - Zentalis' ZN-c3-002 trial showed an overall objective response rate (ORR) of 302% in evaluable ovarian cancer patients, with a disease control rate (DCR) of 860%[51] - In a ZN-c3-001 study of USC patients, the overall response rate was 273% (95% CI = 60%, 610%) and the disease control rate (DCR) was 909% (95% CI = 587%, 998%)[67] - Preclinical data indicates that ZN-c3, when combined with Sotorasib, induces regressions in a KRAS/TP53 mutant colorectal cancer model[115] - In preclinical models, ZN-c3 combined with Niraparib shows regressions and is well-tolerated in a TNBC PDX tumor model[118] ZN-d5 (BCL-2 Inhibitor) - ZN-d5 has >14x improved selectivity for BCL-2 vs BCL-xL and binds with higher affinity to BCL-2 mutants than Venetoclax[132] - In AL Amyloidosis, 63% of patients achieved VGPR/CR (very good partial response/complete response)[150] - Early data in NHL shows a favorable toxicity profile for ZN-d5 compared to published venetoclax data[144] ZN-c3 & ZN-d5 Combination - Preclinical data suggests that the combination of ZN-d5 and ZN-c3 has synergistic and additive activity across multiple indications in both solid and liquid tumors[141] - In preclinical AML models, the combination of ZN-d5 and ZN-c3 resulted in a 94% regression[172] - In preclinical models, the combination of ZN-c3 with Navitoclax resulted in a 96% tumor growth inhibition (TGI)[192]
Zentalis(ZNTL) - 2022 Q2 - Quarterly Report
2022-08-09 20:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter ...
Zentalis Pharmaceuticals (ZNTL) Investor Presentation - Slideshow
2022-06-13 18:18
zentalis C O R P O R AT E P R E S E N TAT I O N J u n e 2 0 2 2 Forward-Looking Statements and Disclaimer Zentalis Pharmaceuticals, Inc. ("we," "us," "our," "Zentalis" or the "Company") cautionsthat this presentation (including oral commentary that accompaniesthis presentation) containsforward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forwar ...
Zentalis(ZNTL) - 2022 Q1 - Quarterly Report
2022-05-05 11:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its charte ...
Zentalis(ZNTL) - 2021 Q4 - Annual Report
2022-02-24 12:11
Drug Development and Clinical Trials - The company is developing ZN-c3, a Wee1 inhibitor, and ZN-c5, an oral selective estrogen receptor degrader, with a focus on large patient populations in oncology [29]. - ZN-c3 is currently in multiple Phase 1/2 clinical trials for advanced solid tumors, including a Phase 2 trial for recurrent uterine serous carcinoma, with Fast Track designation granted by the FDA [36][56]. - ZN-c5 is being evaluated in combination with Pfizer's palbociclib and Lilly's abemaciclib, with initial results expected in the first half of 2022 [42]. - The company plans to initiate combination trials for ZN-d5 and ZN-c3 in acute myeloid leukemia and ZN-c5 and ZN-c3 for CDK4/6i resistant breast cancer in 2022 [31][39]. - ZN-d5 is in a Phase 1 trial for non-Hodgkin's lymphoma and acute myelogenous leukemia, with initial results reported in Q4 2021 [43]. - ZN-e4 is undergoing a Phase 1/2 trial for advanced non-small cell lung cancer, with results expected in 2022 [44]. - In Q4 2021, the company initiated a Phase 2 trial for ZN-c3 targeting solid tumors with a predictive biomarker, and a Phase 1/2 trial in combination with niraparib for ovarian cancer [59]. - The company plans to initiate a Phase 1b trial of ZN-c5 and ZN-c3 in CDK4/6i resistant breast cancer in 2022 [59]. - The company is conducting a Phase 1/2 clinical trial for ZN-c5 as monotherapy and in combination with palbociclib, with plans to initiate a Phase 1b trial in 2022 [133]. - The company plans to open enrollment for a Phase 1 study of ZN-d5 in patients with relapsed or refractory amyloidosis in Q1 2022 [165]. - A Phase 1/2 combination trial of ZN-d5 with ZN-c3 in AML is planned for 2022, aiming to enroll up to 100 subjects [186]. Efficacy and Safety of Drug Candidates - ZN-c3 demonstrated a solubility of 2,132,000 nM, approximately 35 times greater than adavosertib, which may reduce inter-patient drug exposure variability [82]. - In preclinical studies, ZN-c3 showed superior anti-tumor activity compared to adavosertib across various solid tumor cell lines [74]. - ZN-c3 exhibited a Cmax of 5,100 ng/mL at a dose of 80 mg/kg/day, significantly higher than adavosertib's Cmax of 4,703 ng/mL at the same dose [91]. - The combination of ZN-c3 and gemcitabine in preclinical osteosarcoma models resulted in better anti-tumor effects than either treatment alone [93]. - ZN-c3 was well tolerated across varying dosage levels in preclinical studies and clinical trials [80]. - The company believes ZN-c3's characteristics may allow for sequential therapy with PARP inhibitors, maintaining strong anti-tumor activity [72]. - Adavosertib demonstrated an overall response rate of 43% in a Phase 2 trial for relapsed ovarian cancer, indicating the potential efficacy of Wee1 inhibitors [66]. - ZN-c3 demonstrated better anti-tumor activity in combination with carboplatin compared to monotherapy treatments, with a dosing regimen of 60 mg/kg QD for ZN-c3 and 50 mg/kg QW for carboplatin [96]. - In the Phase 1 clinical trial of ZN-c3, the overall objective response rate (ORR) increased from 40% to 43%, with five confirmed partial responses (PRs) reported [109]. - The maximum tolerated dose (MTD) for ZN-c3 was determined to be 350 mg QD, while the recommended Phase 2 dose (RP2D) was set at 300 mg QD [114]. - ZN-c5, an oral SERD, is being developed for ER+/HER2- breast cancer, which affects approximately 70% of breast cancer patients in the U.S. [120]. - As of September 15, 2021, the clinical benefit rate (CBR) for ZN-c5 was reported at 38% in the Phase 1 trial, with confirmed PRs at 150 mg/day and 300 mg/day [128]. - ZN-c5 is designed for once-daily oral administration, potentially improving patient convenience compared to existing treatments [132]. - ZN-c5 has demonstrated anti-tumor activity in preclinical studies, showing superior tumor growth inhibition compared to fulvestrant [127]. - The combination of ZN-c5 (20 mg/kg) and ZN-c3 (80 mg/kg) demonstrated greater anti-tumor activity than ZN-c5 alone in preclinical studies [135]. - ZN-c5 was well tolerated in the Phase 1 monotherapy trial, with 96% of patients experiencing treatment-emergent adverse events (TEAEs), primarily of Grade 1 or 2 severity [143][145]. - The pharmacokinetic analysis showed ZN-c5 had fast absorption with median Tmax values of 1 to 2 hours, and no significant accumulation was observed after 15 days of dosing [153]. - In the Phase 1 combination trial with palbociclib, ZN-c5 was also well tolerated, with no dose-limiting toxicities reported [147]. - ZN-d5 shows over 600 times greater selectivity for BCL-2 compared to BCL-xL, which may limit thrombocytopenia incidence [165]. - ZN-d5 demonstrated potent anti-tumor activity in a RS4;11 xenograft leukemia mouse model, with durable complete responses observed after treatment cessation [175]. - The combination of ZN-d5 and ZN-c3 resulted in 94% tumor regression in a preclinical study, indicating synergistic effects [178]. - ZN-d5 has been well-tolerated in clinical studies, with 74% of NHL subjects experiencing adverse events, primarily anemia (22%), diarrhea (13%), and nausea/vomiting (9%) [183]. Market Potential and Competitive Landscape - Sales of FDA-approved PARP inhibitors were approximately $1.6 billion in 2019, projected to grow to $6.9 billion by 2026 [64]. - Osimertinib, a third-generation EGFR inhibitor, reported sales of $4.3 billion in 2020, a 36% increase from 2019, with projections to grow to $9.5 billion by 2026 [192]. - The biotechnology and pharmaceutical industries are characterized by significant competition, with potential competitors having greater financial resources and expertise [226]. - Key competitive factors for the company's product candidates include efficacy, safety profile, convenience, and cost [227]. Manufacturing and Supply Chain - The company relies on third-party contract manufacturing organizations (CMOs) for the production of product candidates and does not own manufacturing facilities [222]. - The company has engaged CMOs to manufacture and package ZN-c3, ZN-c5, ZN-d5, and ZN-e4 for preclinical and clinical use [223]. - The company aims to identify and contract with at least two manufacturers for active pharmaceutical ingredients and drug products prior to seeking regulatory approval [223]. - The company does not currently have long-term supply arrangements in place with its CMOs, which may impact production stability [223].
Zentalis(ZNTL) - 2021 Q3 - Quarterly Report
2021-11-10 12:52
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its ch ...