Zymeworks Provides Corporate Update and Reports First Quarter 2022 Financial Results
- Last patient enrolled ahead of expectations in pivotal trial evaluating zanidatamab as monotherapy in 2L biliary tract cancers (BTC)
-
Two zanidatamab data presentations at ASCO in June: 1L breast cancer and 1L gastroesophageal adenocarcinoma (
GEA )
- Presented topoisomerase 1 inhibitor (TOPO1i) antibody-drug conjugate (ADC) platform at World ADC London highlighting next-generation ADC capabilities and potential ADC candidates
- Completed licensing agreement with Atreca utilizing ZymeLink's auristatin-based ADC platform
- ZW49 continues to progress towards anticipated data read-out in 2H22
-
Will host conference call with Management today at
4:30 PM ET
“We are incredibly excited to celebrate the milestone of the last patient enrolled for our pivotal study in second-line biliary tract cancers, as well as the continued progression of multiple zanidatamab clinical studies that we will be presenting over the course of the year starting at ASCO in June,” said
First Quarter 2022 Business Highlights and Recent Developments
-
Completed Enrollment in HERIZON-BTC-01 Pivotal Trial in 2L Biliary Tract Cancers (BTC)
Enrollment was completed ahead of schedule for the global, pivotal trial
(HERIZON-BTC-01) evaluating zanidatamab monotherapy in patients with previously-treated advanced HER2-amplified BTC. The primary endpoint of this pivotal trial is confirmed objective response rate as determined by independent central review and we expect to finalize and present top-line data by early 2023. We expect that full details of the study will be presented at a major medical meeting in 2023.
-
Unveiled Next-Generation TOPO1i ADC Platform Presentation
The presentation shown in March at World ADC London highlighted the development of our next-generation TOPO1i ADC payload technology. We anticipate sharing more information on potential therapeutic candidates leveraging this TOPO1i platform at our R&D day in the fourth quarter of this year as we advance towards our goal of submitting two new Investigational New Drug applications by the end of 2024.
-
Completed Licensing Agreement with Atreca Utilizing Auristatin-Based ADC Platform
The technology licensing agreement with Atreca provides further validation of our auristatin-based ADC and technology platforms and showcases our ability to generate continued non-dilutive funding opportunities.
-
ZW49 Enrollment Continues to Advance Toward Anticipated Data Readout in 2H22
Zymeworks’ second clinical-stage asset and first biparatopic HER2-targeting antibody-drug conjugate, ZW49, has completed enrollment of 30 patients in the expansion cohorts targeting 2.5 mg/kg every three weeks. Additionally, the weekly dosing regimen recently expanded enrollment in the 1.5 mg/kg cohort and, in parallel, is now enrolling patients in the 1.75 mg/kg escalation cohort. Enrollment continues to progress well and we remain on target to submit data for presentation at a major medical meeting expected to occur in the second half of this year.
Zanidatamab Update at 2022
Zymeworks’
“We look forward to discussing these two important datasets at the ASCO meeting, and how the results will help shape our future development plans for zanidatamab,” said
Financial Results for the Quarter Ended
Zymeworks’ revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as payments for research and development support. Revenue for the three months ended
Research and development expense increased by
We expect research and development expenditures to fluctuate over time in line with the advancement, expansion and completion of the clinical development of our product candidates, as well as our ongoing preclinical research activities.
Excluding the impact of stock-based compensation and restructuring expenses, general and administrative expense increased on a Non-GAAP basis by
Net loss for the three months ended
"We continue to make progress upon our goal of improving our financial position and have successfully completed the first steps with the reduction in anticipated spending through prioritization of R&D programs and the previously announced new equity issuance closed in January," said
As of
About
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
(Expressed in thousands of |
|||||||
|
Three Months Ended |
||||||
|
|
2022 |
|
|
|
2021 |
|
Revenue |
|
|
|
||||
Research and development collaborations |
$ |
1,916 |
|
|
$ |
644 |
|
Operating expenses: |
|
|
|
||||
Research and development |
|
62,510 |
|
|
|
44,283 |
|
General and administrative |
|
12,092 |
|
|
|
1,296 |
|
Total operating expenses |
|
74,602 |
|
|
|
45,579 |
|
Loss from operations |
|
(72,686 |
) |
|
|
(44,935 |
) |
Other income (expense), net |
|
(13 |
) |
|
|
870 |
|
Loss before income taxes |
|
(72,699 |
) |
|
|
(44,065 |
) |
Income tax recovery (expense) |
|
74 |
|
|
|
(525 |
) |
Net loss and comprehensive loss |
$ |
(72,625 |
) |
|
$ |
(44,590 |
) |
Net loss per common share: |
|
|
|
||||
Basic |
$ |
(1.18 |
) |
|
$ |
(0.87 |
) |
Diluted |
$ |
(1.19 |
) |
|
$ |
(0.87 |
) |
Weighted-average common shares outstanding: |
|
|
|
||||
Basic |
|
61,367,368 |
|
|
|
51,367,663 |
|
Diluted |
|
61,378,170 |
|
|
|
51,367,663 |
|
Selected Condensed Consolidated Balance Sheet Data
(Expressed in thousands of |
|||||||
|
|
|
|
||||
|
(unaudited) |
|
|
||||
Cash, cash equivalents and short-term investments |
$ |
300,534 |
|
|
$ |
252,608 |
|
Working capital |
|
244,051 |
|
|
|
216,367 |
|
Total assets |
|
429,977 |
|
|
|
389,132 |
|
Accumulated deficit |
|
(755,729 |
) |
|
|
(683,104 |
) |
Total shareholders’ equity |
|
282,444 |
|
|
|
249,094 |
|
NON-GAAP FINANCIAL MEASURES
In addition to reporting financial information in accordance with
Adjusted expenses are a non-GAAP measure that
GAAP to Non-GAAP Reconciliations
(Expressed in thousands of (unaudited) |
|||||||
|
Three Months Ended |
||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
||||
Research and development expenses |
$ |
62,510 |
|
|
$ |
44,283 |
|
Stock-based compensation recovery / (expense) for equity classified instruments (*) |
|
2,747 |
|
|
|
(4,336 |
) |
Stock-based compensation recovery / (expense) for liability classified instruments (*) |
|
474 |
|
|
|
2,513 |
|
Restructuring expenses |
|
(5,542 |
) |
|
|
— |
|
Adjusted research and development expenses (Non-GAAP basis) |
$ |
60,189 |
|
|
$ |
42,460 |
|
|
|
|
|
||||
General and administrative expenses |
$ |
12,092 |
|
|
$ |
1,296 |
|
Stock-based compensation recovery / (expense) for equity classified instruments (*) |
|
2,232 |
|
|
|
(4,192 |
) |
Stock-based compensation recovery / (expense) for liability classified instruments (*) |
|
2,876 |
|
|
|
12,951 |
|
Restructuring expenses |
|
(3,935 |
) |
|
|
— |
|
Adjusted general and administrative expenses (Non-GAAP basis) |
$ |
13,265 |
|
|
$ |
10,055 |
|
|
|
|
|
||||
Net loss per common share – Basic |
$ |
(1.18 |
) |
|
$ |
(0.87 |
) |
Stock-based compensation recovery |
|
(0.13 |
) |
|
|
(0.13 |
) |
Restructuring expenses |
|
0.15 |
|
|
|
— |
|
Adjusted net loss per common share – Basic (Non-GAAP basis) |
$ |
(1.16 |
) |
|
$ |
(1.00 |
) |
|
|
|
|
||||
Net loss per common share – Diluted |
$ |
(1.19 |
) |
|
$ |
(0.87 |
) |
Stock-based compensation recovery |
|
(0.13 |
) |
|
|
(0.13 |
) |
Restructuring expenses |
|
0.15 |
|
|
|
— |
|
Adjusted net loss per common share – Diluted (Non-GAAP basis) |
$ |
(1.17 |
) |
|
$ |
(1.00 |
) |
(*): Research and development expenses and general and administrative expenses include stock-based compensation recovery related to the restructuring of
View source version on businesswire.com: https://www.businesswire.com/news/home/20220504005986/en/
Investor Inquiries:
(604) 678-1388
ir@zymeworks.com
Media Inquiries:
(604) 678-1388
media@zymeworks.com
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