Zymeworks Reports 2021 Second Quarter Financial Results
“The second half of 2021 is an exciting time at
Second Quarter 2021 Business Highlights and Recent Developments
- Zanidatamab in First-Line Gastroesophageal Adenocarcinoma (GEA) to be Presented at ESMO Annual Meeting
The presentation will feature new clinical data for our lead product candidate, zanidatamab, in combination with chemotherapy, as a first-line treatment for patients with HER2-positive GEA. The presentation will be available onThursday, September 16 at8:30 AM CEST (Central EuropeanSummer Time ) on both the ESMO andZymeworks websites. - Enrollment Initiated for First-Line Biliary Tract Cancer and Colorectal Cancer Cohorts in Zanidatamab Phase 2 Clinical Trial
The ongoing Phase 2 study is evaluating zanidatamab in combination with standard of care chemotherapy as a first-line treatment for patients with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastrointestinal cancers including biliary tract cancer, colorectal cancer, and GEA. Results from this study are expected to inform future potential pivotal trials. - First Patient Dosed with Zanidatamab in Combination with Tukysa® (Tucatinib) and Chemotherapy in Advanced HER2-Positive Breast Cancer
The first patient has been dosed in a new cohort of a Phase 1 trial investigating the safety, tolerability, and efficacy of zanidatamab in combination with tucatinib and capecitabine. This new cohort will evaluate HER2-positive breast cancer patients with locally advanced (unresectable) and/or metastatic disease that have received prior therapy with trastuzumab, pertuzumab and T-DM1. - First Patient Dosed for Janssen-Developed Bispecific Antibody Utilizing Zymeworks' Azymetric™ and EFECT™ Therapeutic Platforms
The new bispecific antibody developed by Janssen, JNJ-78278343, represents Zymeworks’ fourth pharmaceutical partnership with programs reaching clinical development.Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen. - ZW49 Cohort Expansion Study Opens New Sites in
South Korea andAustralia Zymeworks has opened new sites inSouth Korea andAustralia to accelerate the cohort expansion portion of the Phase 1 clinical trial for ZW49. This will supportZymeworks' goal of identifying the recommended Phase 2 dose and schedule by the end of this year. Dose escalation continues in weekly and once every three week schedules while three indication-specific expansion cohorts utilizing the 2.5 mg/kg once every three week regimen are ongoing.
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 research support and other payments. Revenue for the three months ended
For the three months ended
For the three months ended
Net loss for the three months ended
As of
About
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the
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Three Months Ended |
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Six Months Ended |
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2021 |
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2020 |
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2021 |
|
2020 |
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Revenue |
|
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|
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|
|
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Research and development collaborations |
$ |
1,771 |
|
|
|
$ |
12,359 |
|
|
|
$ |
2,415 |
|
|
|
$ |
20,628 |
|
|
Operating expenses: |
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|
|
|
|
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Research and development |
50,711 |
|
|
|
39,784 |
|
|
|
94,994 |
|
|
|
76,727 |
|
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General and administrative |
19,945 |
|
|
|
12,924 |
|
|
|
21,241 |
|
|
|
20,130 |
|
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Total operating expenses |
70,656 |
|
|
|
52,708 |
|
|
|
116,235 |
|
|
|
96,857 |
|
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Loss from operations |
(68,885 |
) |
|
|
(40,349 |
) |
|
|
(113,820 |
) |
|
|
(76,229 |
) |
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Other income, net |
929 |
|
|
|
1,324 |
|
|
|
1,799 |
|
|
|
6,443 |
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Loss before income taxes |
(67,956 |
) |
|
|
(39,025 |
) |
|
|
(112,021 |
) |
|
|
(69,786 |
) |
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||||
Income tax expense |
434 |
|
|
|
64 |
|
|
|
(91 |
) |
|
|
(311 |
) |
|
||||
Net loss and comprehensive loss |
$ |
(67,522 |
) |
|
|
$ |
(38,961 |
) |
|
|
$ |
(112,112 |
) |
|
|
$ |
(70,097 |
) |
|
Net loss per common share: |
|
|
|
|
|
|
|
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Basic |
$ |
(1.31 |
) |
|
|
$ |
(0.77 |
) |
|
|
$ |
(2.18 |
) |
|
|
$ |
(1.41 |
) |
|
Diluted |
$ |
(1.31 |
) |
|
|
$ |
(0.77 |
) |
|
|
$ |
(2.42 |
) |
|
|
$ |
(1.41 |
) |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
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Basic |
51,422,066 |
|
|
|
50,788,681 |
|
|
|
51,395,015 |
|
|
|
49,737,699 |
|
|
||||
Diluted |
51,422,066 |
|
|
|
50,788,681 |
|
|
|
52,068,506 |
|
|
|
49,737,699 |
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|
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(unaudited) |
|
|
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Cash, cash equivalents, short-term investments and certain long-term investments |
$ |
359,811 |
|
|
|
$ |
451,557 |
|
|
Working capital |
309,952 |
|
|
|
369,410 |
|
|
||
Total assets |
471,954 |
|
|
|
538,376 |
|
|
||
Accumulated deficit |
(583,373 |
) |
|
|
(471,261 |
) |
|
||
Total shareholders’ equity |
321,472 |
|
|
|
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 |
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Three Months Ended |
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Six Months Ended |
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|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||||||
|
|
|
|
|
|
|
|
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Research and development expenses |
$ |
50,711 |
|
|
|
$ |
39,784 |
|
|
|
$ |
94,994 |
|
|
|
$ |
76,727 |
|
|
Stock-based compensation for equity classified instruments |
(5,790 |
) |
|
|
(3,346 |
) |
|
|
(10,126 |
) |
|
|
(5,496 |
) |
|
||||
Stock-based compensation for liability classified instruments |
(245 |
) |
|
|
107 |
|
|
|
2,268 |
|
|
|
1,900 |
|
|
||||
Normalized research and development expenses (Non-GAAP basis) |
$ |
44,676 |
|
|
|
$ |
36,545 |
|
|
|
$ |
87,136 |
|
|
|
$ |
73,131 |
|
|
|
|
|
|
|
|
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|
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General and administrative expenses |
$ |
19,945 |
|
|
|
$ |
12,924 |
|
|
|
$ |
21,241 |
|
|
|
$ |
20,130 |
|
|
Stock-based compensation for equity classified instruments |
(5,296 |
) |
|
|
(4,046 |
) |
|
|
(9,488 |
) |
|
|
(6,497 |
) |
|
||||
Stock-based compensation for liability classified instruments |
(1,545 |
) |
|
|
310 |
|
|
|
11,406 |
|
|
|
5,799 |
|
|
||||
Normalized general and administrative expenses (Non-GAAP basis) |
$ |
13,104 |
|
|
|
$ |
9,188 |
|
|
|
$ |
23,159 |
|
|
|
$ |
19,432 |
|
|
|
|
|
|
|
|
|
|
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Net loss per common share – Basic |
$ |
(1.31 |
) |
|
|
$ |
(0.77 |
) |
|
|
$ |
(2.18 |
) |
|
|
$ |
(1.41 |
) |
|
Stock based compensation for equity classified instruments |
0.22 |
|
|
|
0.15 |
|
|
|
0.38 |
|
|
|
0.24 |
|
|
||||
Stock based compensation for liability classified instruments |
0.03 |
|
|
|
(0.01 |
) |
|
|
(0.27 |
) |
|
|
(0.15 |
) |
|
||||
Normalized net loss per common share – Basic (Non-GAAP basis) |
$ |
(1.06 |
) |
|
|
$ |
(0.63 |
) |
|
|
$ |
(2.07 |
) |
|
|
$ |
(1.32 |
) |
|
|
|
|
|
|
|
|
|
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Net loss per common share – Diluted |
$ |
(1.31 |
) |
|
|
$ |
(0.77 |
) |
|
|
$ |
(2.42 |
) |
|
|
$ |
(1.41 |
) |
|
Stock based compensation for equity classified instruments |
0.22 |
|
|
|
0.15 |
|
|
|
0.38 |
|
|
|
0.24 |
|
|
||||
Stock based compensation for liability classified instruments |
0.03 |
|
|
|
(0.01 |
) |
|
|
(0.26 |
) |
|
|
(0.15 |
) |
|
||||
Normalized net loss per common share – Diluted (Non-GAAP basis) |
$ |
(1.06 |
) |
|
|
$ |
(0.63 |
) |
|
|
$ |
(2.30 |
) |
|
|
$ |
(1.32 |
) |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210804006023/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: