Zymeworks Provides Corporate Update and Reports Year-End 2021 Financial Results
Zymeworks Inc. (NYSE: ZYME) reports pivotal trial progress for zanidatamab in gastroesophageal adenocarcinoma and biliary tract cancer, with expected enrollment completion dates in 2023 and mid-2022, respectively. The company's financial position is enhanced by a successful equity offering in January 2022, extending its cash runway into the second half of 2023. A workforce reduction exceeding 25% is in progress, alongside the appointment of Chris Astle, PhD, as CFO. Zymeworks expects to provide significant data updates in 2022 and continues to focus on partnerships to strengthen its financial position.
- Successful completion of January 2022 equity offering strengthens financial position.
- Cash runway extended into the second half of 2023.
- Pivotal trials for zanidatamab are on track for enrollment completion.
- New partnerships and collaborations expected to drive revenue.
- 2021 revenue decreased to $26.7 million from $39.0 million in 2020.
- Net loss increased to $211.8 million in 2021 from $180.6 million in 2020.
- Research and development expenses rose to $199.8 million in 2021.
- Enrollment on track for both pivotal trials of zanidatamab in 1L gastroesophageal adenocarcinoma (GEA) and 2L biliary tract cancer (BTC).
-
Announced submission of abstracts for upcoming clinical data for the 2022
American Society for Clinical Oncology (ASCO) Annual Meeting. - Financial position strengthened and cash runway extended following successful completion of equity offering in January.
-
Announced
Chris Astle , PhD as new Chief Financial Officer, withNeil Klompas continuing as Chief Operating Officer. -
Expected to exceed the previously announced workforce reduction of at least
25% byMarch 1, 2022 , ahead of schedule. -
Will host conference call with management today at
4:30 p.m. ET .
“Since assuming my new role a month ago, I am pleased with our progress to focus on our key strategic priorities and improve our operational performance in order to deliver exceptional results for patients and our investors,” said
Business Highlights and Recent Developments
Clinical Program Highlights
“This year will be important for progressing our two clinical-stage product candidates, including the reporting of additional clinical data on both zanidatamab and ZW49,” said
-
Zanidatamab Advances with Two Pivotal Trials.
HERIZON-GEA-01, a pivotal study evaluating zanidatamab in 1L HER2-positive GEA, continues to enroll patients based on confirmatory data presented inSeptember 2021 at ESMO in the 1L GEA setting for zanidatamab in combination with chemotherapy. These data position zanidatamab as a potential new standard of care in the first-line setting, and enrollment for HERIZON-GEA-01 continues with plans to complete by the end of 2023. HERIZON-BTC-01, a pivotal study evaluating zanidatamab in previously-treated advanced HER2-amplified BTC, continues to enroll patients and we expect to complete enrollment by mid-2022.
-
Multiple data catalysts in 2022 to be presented at major medical meetings, including ASCO.
Zymeworks , along with our partner BeiGene, has submitted abstracts to be presented at the 2022 ASCO Annual Meeting in June. Subject to acceptance of these abstracts, we look forward to sharing important new data from the clinical development program for zanidatamab. In addition,Zymeworks will host a conference call discussing results of these studies after the completion of the 2022 ASCO Annual Meeting.
-
ZW49 Continues to Advance Towards Clinical Data Readout in H2 2022.
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. The weekly dosing regimen continues to progress with no dose-limiting toxicities observed to date. We plan to present the results and recommended development path forward at a major medical meeting in the second half of 2022.
Continued Focus on Partnerships and Collaboration
We remain focused on driving value through executing new partnerships and collaborations to support the development of our clinical-stage product candidates, zanidatamab and ZW49, and advancing new antibody-drug conjugate (ADC) or multispecific product candidates based on our novel, next-generation multifunctional therapeutic platforms. We continue to prioritize partnerships and collaborations to fund our operations and further strengthen our financial position.
Throughout 2021 our partnerships continued to advance into the clinical setting, reflected by the receipt of milestone payments in conjunction with Janssen initiating clinical studies with two bispecific antibodies using the Azymetric™ and EFECT™ platforms, and BeiGene initiating the pivotal study, HERIZON-GEA-01, in its territory. In tandem, we recognized partnership revenues from the amendment of the Iconic/Exelixis sub-licensing agreement for a ZymeLink™ ADC.
Corporate Updates
We continue to deliver upon our previously announced cost-efficiency measures and reduction in workforce and expect to exceed our target of reducing employee headcount by at least
With a more focused and efficient workforce, combined with a reduction in operational expenses and the proceeds from our public offering that closed on
In addition, we are pleased to announce that effective immediately,
Chris joined the finance group at
“I am thrilled to continue working with Chris in his new position as Senior Vice President and CFO,” said
Financial Results for the Year 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 was
We anticipate continuing to receive revenue from our existing and future strategic partnerships, including technology access fees and milestone-based payments. However, our ability to receive these payments is dependent upon either
Research and development expense was
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.
General and administrative expense was
In
Net loss was
As of
About
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the
|
||||||||||||||||
Consolidated Statements of Loss and Comprehensive Loss |
||||||||||||||||
(Expressed in thousands of |
||||||||||||||||
|
Three Months Ended |
|
Year Ended |
|||||||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|||||||||
|
(unaudited) |
|
(unaudited) |
|
|
|
|
|||||||||
Revenue |
|
|
|
|
|
|
|
|||||||||
Research and development collaborations |
$ |
19,870 |
|
|
$ |
15,680 |
|
|
$ |
26,680 |
|
|
$ |
38,951 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
|
54,865 |
|
|
|
40,075 |
|
|
|
199,752 |
|
|
|
171,203 |
|
|
General and administrative |
|
5,854 |
|
|
|
13,150 |
|
|
|
42,561 |
|
|
|
55,216 |
|
|
Impairment on acquired IPR&D |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Total operating expenses |
|
60,719 |
|
|
|
53,225 |
|
|
|
242,313 |
|
|
|
226,419 |
|
|
Loss from operations |
|
(40,849 |
) |
|
|
(37,545 |
) |
|
|
(215,633 |
) |
|
|
(187,468 |
) |
|
Other (expense) income, net |
|
326 |
|
|
|
(187 |
) |
|
|
3,274 |
|
|
|
7,345 |
|
|
Loss before income taxes |
|
(40,523 |
) |
|
|
(37,732 |
) |
|
|
(212,359 |
) |
|
|
(180,123 |
) |
|
Income tax (expense) recovery, net |
|
1,371 |
|
|
|
(161 |
) |
|
|
516 |
|
|
|
(429 |
) |
|
Net loss and comprehensive loss |
$ |
(39,152 |
) |
|
$ |
(37,893 |
) |
|
$ |
(211,843 |
) |
|
$ |
(180,552 |
) |
|
Net loss per common share: |
|
|
|
|
|
|
|
|||||||||
Basic |
|
(0.76 |
) |
|
|
(0.74 |
) |
|
|
(4.11 |
) |
|
|
(3.58 |
) |
|
Diluted |
|
(0.95 |
) |
|
|
(0.74 |
) |
|
|
(4.61 |
) |
|
|
(3.58 |
) |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|||||||||
Basic |
|
51,841,032 |
|
|
|
51,136,942 |
|
|
|
51,553,869 |
|
|
|
50,382,497 |
|
|
Diluted |
|
52,226,549 |
|
|
|
51,136,942 |
|
|
|
52,131,596 |
|
|
|
50,382,497 |
|
|
||||||||
Selected Consolidated Balance Sheet Data |
||||||||
(Expressed in thousands of |
||||||||
|
|
|
|
|||||
|
|
|
|
|||||
Cash, cash equivalents, short-term investments and certain long-term investments |
$ |
252,608 |
|
|
$ |
451,557 |
|
|
Working capital |
|
216,367 |
|
|
|
369,410 |
|
|
Total assets |
|
389,132 |
|
|
|
538,376 |
|
|
Accumulated deficit |
|
(683,104 |
) |
|
|
(471,261 |
) |
|
Total shareholders’ equity |
|
249,094 |
|
|
|
409,922 |
|
NON-GAAP FINANCIAL MEASURES
In addition to reporting financial information in accordance with
Normalized expenses are a non-GAAP measure that
GAAP to Non-GAAP Reconciliations |
||||||||||||||||
(Expressed in thousands of |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
Three Months Ended |
|
Year Ended |
|||||||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|||||||||
Research and development expenses |
$ |
54,865 |
|
|
$ |
40,075 |
|
|
$ |
199,752 |
|
|
$ |
171,203 |
|
|
Stock based compensation for equity-classified instruments |
|
(4,401 |
) |
|
|
(3,619 |
) |
|
|
(20,090 |
) |
|
|
(12,299 |
) |
|
Stock based compensation for liability-classified instruments |
|
1,461 |
|
|
|
485 |
|
|
|
4,646 |
|
|
|
6 |
|
|
Normalized research and development expenses (Non-GAAP basis) |
$ |
51,925 |
|
|
$ |
36,941 |
|
|
$ |
184,308 |
|
|
$ |
158,910 |
|
|
|
|
|
|
|
|
|
|
|||||||||
General and administrative expenses |
$ |
5,854 |
|
|
$ |
13,150 |
|
|
$ |
42,561 |
|
|
$ |
55,216 |
|
|
Stock based compensation for equity-classified instruments |
|
(3,924 |
) |
|
|
(3,942 |
) |
|
|
(18,184 |
) |
|
|
(14,645 |
) |
|
Stock based compensation for liability-classified instruments |
|
8,753 |
|
|
|
980 |
|
|
|
23,758 |
|
|
|
(1,416 |
) |
|
Normalized general and administrative expenses (Non-GAAP basis) |
$ |
10,683 |
|
|
$ |
10,188 |
|
|
$ |
48,135 |
|
|
$ |
39,155 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Net loss per common share – Basic |
$ |
(0.76 |
) |
|
$ |
(0.74 |
) |
|
$ |
(4.11 |
) |
|
$ |
(3.58 |
) |
|
Stock based compensation for equity-classified instruments |
|
0.16 |
|
|
|
0.15 |
|
|
|
0.74 |
|
|
|
0.53 |
|
|
Stock based compensation for liability-classified instruments |
|
(0.20 |
) |
|
|
(0.03 |
) |
|
|
(0.55 |
) |
|
|
0.03 |
|
|
Normalized net loss per common share – Basic (Non-GAAP basis) |
$ |
(0.80 |
) |
|
$ |
(0.62 |
) |
|
$ |
(3.92 |
) |
|
$ |
(3.02 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Net loss per common share – Diluted |
$ |
(0.95 |
) |
|
$ |
(0.74 |
) |
|
$ |
(4.61 |
) |
|
$ |
(3.58 |
) |
|
Stock based compensation for equity-classified instruments |
|
0.16 |
|
|
|
0.15 |
|
|
|
0.73 |
|
|
|
0.53 |
|
|
Stock based compensation for liability-classified instruments |
|
(0.20 |
) |
|
|
(0.03 |
) |
|
|
(0.54 |
) |
|
|
0.03 |
|
|
Normalized net loss per common share – Diluted (Non-GAAP basis) |
$ |
(0.99 |
) |
|
$ |
(0.62 |
) |
|
$ |
(4.42 |
) |
|
$ |
(3.02 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220224006052/en/
Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com
(604) 678-1388
ir@zymeworks.com
Media Inquiries:
(604) 678-1388
media@zymeworks.com
Source:
FAQ
What are the enrollment updates for Zymeworks' pivotal trials in 2022?
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