On August 2, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the second quarter ended June 30, 2019 (Press release, Zymeworks, AUG 2, 2019, View Source [SID1234538102]).

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"We had a notable second quarter that included significant activity from our pharmaceutical partners and was highlighted by a successful financing," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We are well capitalized to accelerate and expand the clinical development of both ZW25 and ZW49 and plan to provide updates in the near-term beginning with ZW25 single agent and chemo combination data this fall."

Second Quarter 2019 Business Highlights and Recent Developments

Raised Over $200 Million in Upsized Public Offering
Zymeworks completed a public offering of 7,013,892 common shares (including the exercise in full of the underwriters’ over-allotment to purchase 1,458,336 additional common shares) and, in lieu of common shares, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares, for aggregate gross proceeds of US$201.3 million.
First ZymeLink Platform Deal and Progress from Existing Partners
We granted Iconic Therapeutics a license to the ZymeLink Antibody Drug Conjugate (ADC) platform for its ICON-2 Tissue Factor ADC, marking our first collaboration leveraging the ZymeLink platform and our third technology platform licensed to a collaborator. In addition, we received milestone payments from Daiichi Sankyo, Merck, and Celgene as a result of advancements they made with their Azymetric bispecifics towards the clinic. Furthermore, GSK broadened its Azymetric platform license resulting in increased potential milestone payments and royalties to Zymeworks.

Received Fast Track Designation to Expedite ZW25’s Development
The FDA granted ZW25 Fast Track designation for frontline treatment of patients with advanced HER2-overexpressing gastroesophageal adenocarcinoma, an area of significant unmet medical need. Zymeworks is currently enrolling patients in a frontline Phase 2 clinical trial in combination with standard of care chemotherapy with plans to initiate a registrational trial in 2020.

Expanded Board of Directors Increases Commercial Expertise
As Zymeworks advances into late-stage clinical development, we added Dr. Sue Mahony and Troy Cox to our Board, two pharmaceutical executives with extensive global strategic development and therapeutic commercialization experience.

Financial Results for the Quarter Ended June 30, 2019

Revenue for the three months ended June 30, 2019 was $7.9 million as compared to $22.0 million in the same period of 2018. Revenue for the second quarter of 2019 includes a $2.0 million development milestone received from Merck on its completion of a GLP toxicology study for its first program, $3.5 million received upon Daiichi Sankyo’s exercise of a commercial license option, $1.0 million recognized in relation to milestone revenue from Iconic, as well as a total of $1.4 million in research support payments. Revenue in the same period in 2018 was due to an $18.0 million upfront technology access fee in relation to our second licensing agreement with Daiichi Sankyo and a $4.0 million collaboration expansion fee from Celgene.

For the three months ended June 30, 2019, research and development expenses were $23.8 million as compared to $15.4 million in the same period of the prior year. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing for ZW25, as well as an increase in other research and discovery activities compared to the same period in 2018. Research and development expenses included non-cash stock-based compensation expense of $1.5 million from equity-classified stock options and $1.6 million expense related to the non-cash mark-to-market revaluation of certain historical liability-classified stock options.

For the three months ended June 30, 2019, general and administrative expenses were $12.8 million as compared to $8.6 million in the same period in 2018, primarily due to an increase in employee compensation expense due to increased head count in 2019 over 2018, including non-cash stock-based compensation. General and administrative expenses in 2019 included non-cash stock-based compensation expense of $1.6 million from equity-classified stock options and $4.8 million related to the non-cash mark-to-market revaluation of certain historical liability-classified stock options.

The net loss for the three months ended June 30, 2019, was $29.1 million as compared to $5.9 million in the same period of 2018. This was primarily due to a decrease in revenue and an increase in research and development expenses associated with our lead therapeutic candidates and other programs, as well as increase in general and administrative expenses and the impairment expense recognized on our acquired IPR&D in 2019. This increase was partially offset by warrant valuation expenses recognized in 2018.

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

As of June 30, 2019, Zymeworks had $355.7 million in cash and cash equivalents and short-term investments.

On August 2, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported the closing of its previously announced underwritten public offering of 31,625,000 shares of its common stock to the public at $2.00 per share, which included the exercise in full by the underwriters of their option to purchase 4,125,000 additional shares of common stock (Press release, Exicure, AUG 2, 2019, View Source [SID1234538101]).

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In connection with the offering, Exicure’s common stock began trading on the Nasdaq Capital Market under the symbol "XCUR" at the opening of trading on July 31, 2019. Exicure expects to appoint to its board of directors an individual designated by Abingworth LLP and an individual designated by another investor in connection with their participation in the offering.

Exicure received gross proceeds of $63.25 million from the sale of common stock in the offering, prior to deducting the underwriting discounts and commissions and estimated offering expenses payable by it. Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to develop an SNA therapeutic candidate for a neurology condition and advance it into Phase 1 clinical trials; and for general corporate purposes.

Guggenheim Securities acted as sole book-running manager for the offering. Chardan acted as lead manager for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann acted as co-managers for the offering.

The securities described above were offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A final prospectus supplement and accompanying prospectus describing the terms of the offering was filed with the SEC on August 1, 2019 and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On August 2, 2019 Transgene (Paris:TNG), a biotech company designing and developing virus-based immunotherapies for the treatment of solid tumors, reported that the independent Data Monitoring Committee ("IDMC") of the PHOCUS study of Pexa-Vec in Liver Cancer has completed a planned interim futility analysis. Sillajen has informed Transgene of the IDMC’s recommendation to stop enrolment in the study, as the study is unlikely to meet its primary objective by the time of the final analysis (Press release, Transgene, AUG 2, 2019, View Source [SID1234538100]). SillaJen has not reported safety concerns. Transgene will provide an update in an upcoming conference call.

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The PHOCUS trial is a Phase 3 clinical trial evaluating the oncolytic immunotherapy Pexa-Vec for advanced liver cancer patients who have not received prior systemic treatment for their cancer. The study is being conducted by Transgene’s partner, SillaJen.

In the PHOCUS study, patients were randomized to one of two treatment groups: one receiving Pexa-Vec followed by sorafenib and one receiving sorafenib alone. The primary objective of the study was to determine the overall survival of patients treated with Pexa-Vec, followed by sorafenib versus sorafenib alone. Secondary objectives included safety as well as assessments for tumor responses between the two groups as measured by the following endpoints: time to progression, progression-free survival, overall response rate and disease control rate.

-Ends-

About Pexa-Vec
Pexa-Vec (JX-594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells through viral replication, reduce the blood supply to tumors through vascular disruption, and stimulate the body’s immune response against cancer cells.
In a Phase 2 study, results of patients with advanced liver cancer showed that patients receiving the high dose had a statistically significant clinical improvement in terms of overall survival compared to the group receiving the low dose. Median overall survival was respectively 14.1 months in the high-dose group and 6.7 months in the low-dose group, which compares favorably with current approved treatments. (Heo J. et al., Nature Medicine, March 2013, doi: 10.1038/nm.3089)
Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe. Its partner SillaJen, Inc. is focused on developing Pexa-Vec for the North American market and has also granted exclusive development and commercial rights to Pexa-Vec in Hong Kong and The People’s Republic of China to Lee’s Pharmaceutical.

On August 2, 2019 Biotechnology company Antikor Biopharma Ltd is reported that it has entered into an Investment Agreement for up to US$3,100,000 with Essex Bio-Investment, a wholly-owned subsidiary of Essex Bio-Technology Ltd ("EssexBio"), which will enable Antikor to consolidate and expand its position as a leading innovator in smaller-format conjugate therapies for solid tumours (Press release, Antikor Biopharma, AUG 2, 2019, View Source [SID1234538099]).

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Mahendra Deonarain, Antikor’s CEO and visiting Reader in Antibody Technology at Imperial College London where Antikor has its roots, commented: "We believe we have a platform that is tailored to make an impact in an area of major unmet medical need, and with EssexBio’s considerable commercial and clinical expertise, we now have the opportunity for translating the promised advantages of Antikor’s proprietary products into clinical benefit."

"We are excited to have established a strong alliance with Antikor", said Malcolm Ngiam, President of Essex Bio-Investment, "Fragment-Drug Conjugate is an innovative approach with the potential to overcome many of the challenges faced by current treatment methods. The research and commercial partnership with Antikor is an important step towards developing first-in-class treatment for cancer."

Antikor’s novel technology platform will enrich Essex’s research pipeline and is aligned with EssexBio’s long-term research and commercial strategy.

Antibody Fragment-Drug Conjugates (FDCs)

Antibody Fragment-Drug Conjugates (FDCs, also called immuno-conjugates) combine the pharmacological potency of highly cytotoxic drugs with the high specificity of an antibody against tumour-associated targets. FDCs comprise much smaller antibody fragments (single-chain scFvs) than ‘whole’ antibody drug conjugates (ADCs). FDCs are relatively easy to discover and can be bioengineered for multiple drug-molecule conjugation, leading to higher loadings than has so far been achieved with whole mAbs. FDCs demonstrate superior tumour penetration and rapid elimination from normal tissues, without running the risk of problems with product manufacturing or stability.1 As a next-generation cancer therapy that can overcome the many limitations of existing treatment options, FDCs have exciting market potential, with predicted sales of drug-conjugates of over $18 billion by 2022.2

On August 2, 2019 Allergan plc (NYSE: AGN) reported it will release second quarter 2019 financial results on Tuesday, August 6, 2019, prior to the open of U.S. financial markets (Press release, Allergan, AUG 2, 2019, View Source [SID1234538096]).

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For additional materials related to Allergan’s second quarter results, please visit Allergan’s Investor Relations website at View Source;.