Initiated a number of early-stage scientific trials evaluating its oral SERD, ZN-c5, WEE1 inhibitor, ZN-c3 and BCL-2 inhibitor, ZN-d5
Introduced strategic collaboration with Tempus to increase and strengthen the Firm’s analysis and growth capabilities
The Firm’s majority-owned three way partnership, Zentera Therapeutics, submitted two Investigational New Drug (IND) purposes in China forward of schedule
Presenting scientific information from the Section 1 monotherapy trial of ZN-c3 in a late-breaking session on the upcoming AACR 2021 Annual Assembly
NEW YORK and SAN DIEGO, March 25, 2021 (GLOBE NEWSWIRE) — Zentalis Prescribed drugs, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical firm centered on discovering and creating small molecule therapeutics concentrating on basic organic pathways of cancers, in the present day introduced monetary outcomes for the fourth quarter and full 12 months ended December 31, 2020 and highlighted current company accomplishments.
“2020 was a pivotal 12 months for Zentalis, marked by the development of our broad pipeline, a number of scientific and strategic collaborations, in addition to profitable public choices,” commented Dr. Anthony Solar, Chairman and Chief Govt Officer of Zentalis. “With the initiation of quite a few research on the finish of 2020, our internally found candidates at the moment are being investigated in a mixed whole of seven ongoing scientific trials, additional exploring their potential to deal with a spread of cancers. We consider our collaborations with world innovators within the biopharmaceutical and know-how industries present us with the sources wanted to judge the complete potential of our differentiated product candidates within the clinic as each monotherapies and in mixtures.”
Continued Dr. Solar, “Trying to the 12 months forward, we’re strongly positioned to succeed in our upcoming milestones, beginning with our late-breaker presentation discussing information from the Section 1 portion of the Section 1/2 monotherapy trial of ZN-c3 at AACR in April. This readout, together with outcomes from our different ongoing trials investigating ZN-c5, ZN-d5 and ZN-e4, is anticipated to ship essential insights into our scientific and regulatory methods as we advance our goal of bringing improved therapies to most cancers sufferers in want.”
- Zentalis initiated affected person dosing in three mixture and monotherapy scientific trials, which included a Section 1b mixture trial with ZN-c5 and abemaciclib (marketed as Verzenio ® by Eli Lilly) in ER+/HER2- superior breast most cancers, a Section 1 mixture dose escalation trial with ZN-c3 and chemotherapy in superior ovarian most cancers and a Section 1 trial with ZN-d5 in acute myeloid leukemia and Non-Hodgkin’s lymphoma. Every trial will assess the protection, tolerability and pharmacokinetics of the respective candidate.
- In February 2021, Zentalis entered right into a strategic collaboration with Tempus to leverage its patient-derived organoid organic modeling platform to assist Zentalis in discovering and creating novel oncology therapies. The collaboration will initially goal to validate Zentalis’ WEE1 inhibitor, ZN-c3, and its DNA harm response pathway in genetically distinct affected person populations.
- Three abstracts, together with a late-breaker oral presentation on ZN-c3, had been accepted for presentation on the upcoming American Affiliation for Most cancers Analysis (AACR) Annual Assembly 2021. Zentalis expects to report scientific information from the Section 1 portion of its Section 1/2 monotherapy trial of ZN-c3 in superior stable tumors.
- Zentera Therapeutics, Zentalis’ majority-owned three way partnership, submitted two IND purposes in China for ZN-c5 and ZN-c3 in December 2020 and February 2021, respectively. A 3rd IND utility for ZN-d5 is anticipated to be submitted in 2021.
- In February 2021, the Firm appointed Enoch Kariuki, Pharm.D., to the Board of Administrators. Dr. Kariuki most lately served as Chief Monetary Officer at VelosBio and has over a decade of expertise in life sciences funding banking, strategic advising and enterprise growth.
Fourth Quarter and Full Yr 2020 Monetary Outcomes
- Money and Marketable Securities Place: As of December 31, 2020, Zentalis had money, money equivalents and marketable securities of $338.5 million. Zentalis expects that its current money, money equivalents and marketable securities, which incorporates the web proceeds of roughly $155.2 million from the August 2020 follow-on providing, will allow the Firm to fund its working bills and capital expenditure necessities into 2023.
- Analysis and Growth Bills: Analysis and growth bills had been $29.5 million within the fourth quarter of 2020, in comparison with $11.9 million for a similar interval in 2019. This enhance of $17.6 million was primarily because of will increase in exterior analysis and growth bills associated to our lead product candidates, as we superior our Section 1/2 scientific trials investigating ZN-c5, ZN-c3 and ZN-d5 in 2020. As well as, in 2020 we carried out extra preclinical research, incurred extra manufacturing prices, and incurred elevated prices for research and lab supplies. Unallocated analysis and growth bills elevated by $10.2 million primarily because of $5.3 million of extra worker associated prices, of which $2.6 million was pushed by non-cash stock-based compensation from incentive grants and elevated headcount to help our platform growth, $1.6 million of services and different allotted overhead bills, $3.0 million of consulting, provides and outdoors companies, and decreased federal grant reimbursements of $0.3 million.
Analysis and growth bills for the complete 12 months had been $84.9 million, in contrast with $38.4 million in 2019.
- Common and Administrative Bills: Common and administrative bills for the fourth quarter had been $10.7 million, in comparison with $3.0 million for a similar interval in 2019. This enhance of $7.7 million was primarily attributable to a rise of $7.3 million in employee-related prices, of which $5.1 million was pushed by non-cash stock-based compensation from incentive grants issued through the 12 months and elevated headcount to help our development. The remaining enhance in spend was primarily pushed by skilled service charges for authorized companies of $0.6 million, consulting and different outdoors companies of $0.7 million, and insurance coverage prices of $0.6 million, which had been offset by allotted overhead bills.
Common and administrative bills for the complete 12 months had been $33.9 million, in contrast with $8.5 million in 2019.
- Internet Loss: The Firm’s web loss for the fourth quarter of 2020 was $40.4 million, in comparison with a web lack of $14.5 million for a similar interval in 2019.
The Firm’s web loss for the complete 12 months 2020 was $118.5 million, in comparison with a web lack of $46.4 million for a similar interval in 2019.
- Affect from COVID-19 Pandemic: Although the impression of the COVID-19 pandemic to our enterprise and working outcomes presents extra uncertainty and can’t be predicted with confidence, we proceed to make use of one of the best data obtainable to tell our vital accounting estimates.
About Zentalis Prescribed drugs
Zentalis Prescribed drugs, Inc. is a clinical-stage biopharmaceutical firm centered on discovering and creating small molecule therapeutics concentrating on basic organic pathways of cancers. The Firm is creating a broad pipeline of doubtless best-in-class oncology candidates, all internally found, which embrace ZN-c5, an oral selective estrogen receptor degrader (SERD) for ER+/HER2- breast most cancers, ZN-c3, a WEE1 inhibitor for superior stable 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 three way partnership, Zentera Therapeutics, to develop and commercialize these candidates in China. Zentalis has operations in each New York and San Diego.
This press launch incorporates forward-looking statements inside the that means of the Non-public Securities Litigation Reform Act of 1995. All statements contained on this press launch that don’t relate to issues of historic truth must be thought-about forward-looking statements, together with with out limitation statements concerning our expectations surrounding the event, potential, security, efficacy, and regulatory and scientific progress of our product candidates within the Unites States and globally, plans and timing for the initiation of and the discharge of information from our scientific trials and our capability to satisfy different key milestones, actions in reference to our collaboration with Tempus, the anticipated impression of the COVID-19 pandemic on our enterprise and working outcomes, our participation in upcoming occasions and displays, and the sufficiency of our money and money equivalents. These statements are neither guarantees nor ensures, however contain identified and unknown dangers, uncertainties and different essential components that will trigger our precise outcomes, efficiency or achievements to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking statements, together with, however not restricted to, the next: the COVID-19 pandemic has adversely impacted and should proceed to adversely impression our enterprise, together with our preclinical research and scientific trials; our restricted working historical past, which can make it troublesome to judge our present enterprise and predict our future success and viability; we’ve got and count on to proceed to incur vital losses; our want for extra funding, which might not be obtainable; our substantial dependence on the success of our lead product candidate; failure to establish extra product candidates and develop or commercialize marketable merchandise; the early stage of our growth efforts; potential unexpected occasions throughout scientific trials might trigger delays or different hostile penalties; dangers referring to the regulatory approval course of or ongoing regulatory obligations; failure to acquire U.S. or worldwide advertising and marketing approval; our product candidates might trigger critical hostile negative effects; incapability to keep up our collaborations, or the failure of those collaborations; our reliance on third events; results of serious competitors; the opportunity of system failures or safety breaches; dangers referring to mental property; our capability to draw, retain and encourage certified personnel; and vital prices on account of working as a public firm. These and different essential components mentioned beneath the caption “Danger Elements” in our Annual Report on Kind 10-Ok for the 12 months ended December 31, 2020 filed with the U.S. Securities and Alternate Fee (SEC) and our different filings with the SEC might trigger precise outcomes to vary materially from these indicated by the forward-looking statements made on this press launch. Any such forward-looking statements characterize administration’s estimates as of the date of this press launch. Whereas we might elect to replace such forward-looking statements sooner or later sooner or later, we disclaim any obligation to take action, even when subsequent occasions trigger our views to alter.
Zentalis Prescribed drugs, Inc. (Successor to Zentalis Prescribed drugs, LLC)
Condensed Consolidated Statements of Operations
(In 1000’s, besides per unit and per share quantities)
|Three months ended December 31,||Yr ended December 31,|
|Analysis and growth||$||29,521||$||11,869||$||84,901||$||38,386|
|Common and administrative||10,724||3,036||33,886||8,459|
|Complete working bills||40,245||14,905||118,787||46,845|
|Different Earnings (Expense)|
|Funding and different earnings (expense), web||315||359||683||482|
|Internet loss earlier than earnings taxes||(39,930||)||(14,546||)||(118,104||)||(46,363||)|
|Earnings tax expense||426||—||444||15|
|Internet loss attributable to noncontrolling pursuits||(53||)||(40||)||(707||)||(715||)|
|Internet loss attributable to Zentalis||$||(40,303||)||$||(14,506||)||$||(117,841||)||$||(45,663||)|
|Internet loss per frequent share excellent, fundamental and diluted||$||(1.01||)||$||—||$||(4.19||)||$||—|
|Internet loss per Class A typical unit excellent, fundamental and diluted||$||—||$||(2.59||)||$||—||$||(8.16||)|
|Frequent shares/items utilized in computing web loss per share/Class A typical unit, fundamental and diluted||39,936||5,601||28,113||5,597|
Zentalis Prescribed drugs, Inc. (Successor to Zentalis Prescribed drugs, LLC)
Chosen Condensed Consolidated Stability Sheet Knowledge
|Money, money equivalents and marketable securities||$||338,505||$||67,246|
|Working capital (1)||316,503||53,994|
|Convertible most well-liked items||—||141,706|
|Complete Zentalis fairness (deficit)||333,377||(73,285||)|
|(1) The Firm defines working capital as present property much less present liabilities.|