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On May 5, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the first quarter ended March 31, 2021 (Press release, Zymeworks, MAY 5, 2021, View Source [SID1234579204]).

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"As we look ahead over the next 12 months, Zymeworks is focused on delivering several key clinical data presentations highlighting the significant potential of zanidatamab and ZW49, as well as driving continued value creation from our preclinical assets and partnerships," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Recently, the FDA cleared the IND for zanidatamab’s first randomized Phase 3 trial in first line HER2-positive gastric cancer, which represents a significant corporate milestone. This will also be the second pivotal trial for zanidatamab, in addition to our ongoing trial in refractory HER2-amplified biliary tract cancer. We look forward to presenting the supportive Phase 2 data at an upcoming medical meeting this year."

First Quarter 2021 Business Highlights and Recent Developments

Zanidatamab Advances in Pivotal Trial in Biliary Tract Cancer (BTC)
Enrollment continues at sites across North and South America, Europe, and Asia for the global, pivotal trial for zanidatamab (a HER2-targeted bispecific antibody) monotherapy in patients with previously treated HER2 gene-amplified BTC (HERIZON-BTC-01). This trial was initiated based on encouraging data, recently updated at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January, which highlighted a 40% confirmed objective response rate for zanidatamab monotherapy in BTC. Zanidatamab development is also supported by a number of special designations in the U.S. and European Union, including Breakthrough Therapy designation for BTC from the U.S. Food and Drug Administration (FDA).
FDA Clears Zanidatamab Phase 3 Pivotal Trial in First Line HER2-positive Gastroesophageal Adenocarcinoma (GEA)
Zymeworks recently received clearance from the FDA for its first randomized Phase 3 clinical trial for zanidatamab. HERIZON-GEA-01 is a randomized, multicenter study of zanidatamab in combination with chemotherapy with or without BeiGene’s PD-1-targeted antibody, tislelizumab, as a first line treatment for patients with HER2-positive unresectable locally advanced or metastatic GEA. Supportive clinical data from an ongoing Phase 2 clinical trial evaluating zanidatamab with chemotherapy in first line HER2-positive GEA are expected to be presented at a medical conference in the second half of the year.
ZW49 Continues Enrollment in Dose-Escalation and Expansion Cohorts
In January, interim data was presented for ZW49, a bispecific antibody-drug conjugate targeting HER2, which demonstrated antitumor activity and a differentiated safety profile. Specifically, there have been no dose limiting toxicities, no treatment-related hematologic, pulmonary, or liver toxicity, and no treatment-related deaths. Over 90% of treatment-related adverse events have been mild or moderate in severity, with the most common being keratitis, fatigue, and diarrhea, which have been reversible and manageable in an outpatient setting. ZW49 has demonstrated antitumor activity at all dose levels evaluated in the once every three week regimen, including confirmed partial responses and stable disease per RECIST 1.1. Dose escalation is continuing in both the weekly and once every three week schedules and three indication-specific expansion cohorts (HER2-positive breast cancer, HER2-positive GEA, and a basket cohort of other HER2-positive cancers) utilizing the 2.5 mg/kg once every three week regimen have also been initiated. The objective of these studies is to identify a recommended Phase 2 dose and schedule by the end of this year.
Preclinical Assets, Including New Therapeutic Platform, ProTECT, and Zanidatamab Mechanisms of Action Showcased at AACR (Free AACR Whitepaper) Annual Meeting
Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April highlighted preclinical data that reveal new insights into the unique mechanisms of action of lead clinical candidate, zanidatamab, introduce Zymeworks’ fourth therapeutic platform, ProTECT, and describe two new preclinical assets focused on both the cytokine, IL-12, and the immune-oncology target, 4-1BB.
Expanded Commercial and Clinical Leadership
As zanidatamab advances in late-stage clinical development, Zymeworks continues to build its clinical and commercial leadership team in preparation for potential commercial launch. In January, James Priour, former Senior Vice President, Commercial, was promoted to Chief Commercial Officer and named to the Company’s Executive Committee. The Commercial team also recruited Manny Duenas as Vice President, Global Value & Access. The clinical team was strengthened with the recent additions of Dr. Jonas Hylton as Vice President, Medical and Scientific Affairs and Dr. Kaycia Wilde as Vice President, Clinical Operations.
Financial Results for the Quarter Ended March 31, 2021

Revenue for the three months ended March 31, 2021 was $0.6 million compared to $8.3 million for the same period of 2020. Revenue for the first quarter of 2021 related to research support and other payments from our partners. Revenue for the same period in 2020 included $5.0 million from BeiGene for a development milestone and $3.3 million from our partners for research support, drug supply and other payments.

For the three months ended March 31, 2021, research and development expenses were $44.3 million compared to $36.9 million for the same period of 2020. The increase was primarily due to higher salaries and benefits expense from additional headcount and an increase in lab and consulting expenses partly offset by slightly lower third-party research and development program expenses. For the three months ended March 31, 2021, research and development expenses included non-cash stock-based compensation expense of $4.3 million from equity-classified equity awards and a $2.5 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

For the three months ended March 31, 2021, general and administrative expenses were $1.3 million compared to $7.2 million for the same period in 2020. The decrease was primarily due to a $5.7 million increase in stock-based compensation recovery. For the three months ended March 31, 2021, general and administrative expenses included non-cash stock-based compensation expense of $4.2 million from equity-classified equity awards and a $13.0 million recovery related to the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation, general and administrative expense decreased by $0.2 million in the three months ended March 31, 2021 compared to the same period in 2020.

Net loss for the three months ended March 31, 2021 was $44.6 million compared to $31.1 million for the same period of 2020. This was primarily due to the decrease in revenue and interest income and increase in research and development expenses referred to above, partially offset by lower general and administrative expenses.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of March 31, 2021, Zymeworks had $411.5 million in cash resources consisting of cash, cash equivalents and short-term investments. We anticipate this will enable us to fund our planned operations into the second half of 2022 and potentially beyond.

On May 5, 2021 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, reported that it will report its first quarter 2021 financial results on Tuesday, May 11, 2021 after the close of the U.S. financial markets (Press release, Prothena, MAY 5, 2021, View Source [SID1234579220]).

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Consistent with past practice, the Company will not be conducting a conference call in conjunction with this financial results release on May 11.

On May 5, 2021 BridGene Biosciences, Inc., a biotechnology company using cutting-edge chemoproteomic technology to discover and develop small molecules for high value, yet traditionally undruggable targets, reported that it has raised $12 million in a Series A private financing round led by Wedo Venture Partners with additional participation by Kaitai Capital and Takeda Ventures, alongside existing investor Pangu Venture (Press release, Bridgene Biosciences, MAY 5, 2021, View Source [SID1234579237]).

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BridGene plans to use proceeds from the Series A financing to expand the company’s proprietary covalent library to discover small-molecule ligands for a broader range of targets, advance existing oncology programs and enhance operations.

The Company’s proprietary chemoproteomic platform, IMTAC (Isobaric Mass Tagged Affinity Characterization), addresses many of the challenges associated with small-molecule drug discovery. Many disease drivers have long been deemed undruggable because their functional pockets are either too shallow or formed transiently in live cells, making such conditions difficult for conventional small molecules to address. While phenotypic screening can be performed in live cells, it is extremely difficult to identify small-molecule hits’ cellular targets that are responsible for the phenotypic modulation. BridGene has the unique ability to meet these challenges as IMTAC screening not only enables the efficient discovery of novel hits for myriad proteins, including those deemed undruggable in live cells, but also allows target deconvolution for phenotypic screening hits.

"We are pleased to make this investment, as we believe BridGene plays an important role in discovering small molecules for traditionally undruggable targets, as well as rapidly identifying (deconvoluting) targets in phenotypic screening, and revolutionarily developing precision medicine for a wide range of unmet medical need," said Leilei Wang, managing partner of Wedo Venture Partners. "Medical advancement requires greater efficiency across the spectrum of development – from discovery through commercialization, and BridGene’s IMTAC platform has the potential to positively impact the earliest, and often most challenging, steps in this process."

"This financing, combined with our recently announced collaboration with Takeda, affirms the strong support among investors and pharmaceutical developers for our proprietary drug discovery and development platform and experienced management team," stated Ping Cao, Ph.D., Co-Founder and CEO of BridGene Biosciences. "Over the last few years, we have pursued pioneering work in covalent small molecules and chemoproteomic screening to identify small molecules for traditional undruggable targets and quickly move from hits to leads. Today, thanks to the help of our investors, we are in a strong financial position to continue building a unique chemoproteomic platform and advance the development of our internal pipeline with the goal of providing new therapies for unmet medical needs."

On May 5, 2021 MannKind Corporation (Nasdaq:MNKD) reported that it will release its 2021 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, May 12, 2021 (Press release, Mannkind, MAY 5, 2021, View Source [SID1234579152]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven B. Binder.

Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under Events & Presentations. A replay will also be available on MannKind’s website for 14 days.