On August 5, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers reported financial results for the second quarter ended June 30, 2020, and recent corporate highlights (Press release, Checkpoint Therapeutics, AUG 5, 2020, View Source [SID1234562929]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to advance the development of cosibelimab, our potential best-in-class anti-PD-L1 antibody product candidate, towards the completion of its registration-enabling study in metastatic cutaneous squamous cell carcinoma ("mCSCC"). The trial is currently over 50% enrolled, with full enrollment anticipated around year-end. With a potential favorable safety profile and a plan to commercialize at a substantially lower price, we believe cosibelimab can be a market disruptive product in the $25 billion PD-(L)1 class." Mr. Oliviero continued, "We look forward to presenting updated interim safety and efficacy data from our ongoing mCSCC trial at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020 that will supplement the encouraging data previously reported, which included a 50% objective response rate for cosibelimab by investigator assessment in the first 14 mCSCC patients, including one complete response."

Recent Corporate Highlights:

•In July 2020, Checkpoint announced that an abstract highlighting updated interim safety and efficacy data from the ongoing registration-enabling clinical trial of cosibelimab in patients with mCSCC was accepted for e-poster presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020.
•In April 2020, Checkpoint announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.

Financial Results:

•Cash Position: As of June 30, 2020, Checkpoint’s cash and cash equivalents totaled $21.9 million, compared to $26.1 million as of December 31, 2019, a decrease of $4.2 million year-to-date. Cash and cash equivalents as of June 30, 2020 does not include approximately $5.0 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement during the third quarter of 2020.
•R&D Expenses: Research and development expenses for the second quarter of 2020 were $3.0 million, compared to $4.1 million for the second quarter of 2019, a decrease of $1.1 million. Research and development expenses for the second quarters of 2020 and 2019 each included $0.2 million of non-cash stock expenses.
•G&A Expenses: General and administrative expenses for the second quarter of 2020 were $1.7 million, compared to $1.8 million for the second quarter of 2019, a decrease of $0.1 million. General and administrative expenses for the second quarters of 2020 and 2019 each included $0.7 million of non-cash stock expenses.
•Net Loss: Net loss attributable to common stockholders for the second quarter of 2020 was $4.6 million, or $0.09 per share, compared to a net loss of $4.8 million, or $0.15 per share, in the second quarter of 2019.

On August 5, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in August (Press release, MacroGenics, AUG 5, 2020, View Source [SID1234562928]):

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BTIG Virtual Biotechnology Conference. MacroGenics’ management will participate in one-on-one meetings and a fire-side chat discussion hosted by the analyst on Monday, August 10, 2020 at 12:30 p.m. ET.
Wedbush PacGrow Healthcare Conference. MacroGenics’ management will participate in one-on-one meetings and provide a corporate overview on August 12, 2020, at 8:35 a.m. ET.
Webcasts of each presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

On August 5, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the quarter ended June 30, 2020 (Press release, Zymeworks, AUG 5, 2020, View Source [SID1234562927]).

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"Among many notable accomplishments in the past quarter, I am particularly excited about the transition of our lead therapeutic program, zanidatamab, into late stage clinical development, providing a clear path for Zymeworks to seek its first potential approval in biliary tract cancer in 2022," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Looking ahead, with zanidatamab in five active Phase 2 programs and ZW49 advancing in its dose-escalation study, we anticipate a number of important data readouts over the next six to twelve months. We are proud of everything that we have accomplished and are well positioned to strategically execute on our mission of sending patients home to their loved ones, disease free."

Second Quarter 2020 Business Highlights and Recent Developments

•Zanidatamab (ZW25) Advances into Global Registration-Enabling Study
Zymeworks initiated a global Phase 2 registration-enabling study of single agent zanidatamab in patients with previously-treated HER2 gene amplified biliary tract cancer (BTC). This study is designed to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety and may enable filing of a Biologics License Application (BLA) as early as 2022.

•Zanidatamab Data Updates Support Advancement in First Line Gastric Cancer
In addition to BTC, updated data were also presented from single agent zanidatamab and zanidatamab in combination with chemotherapy in patients with refractory HER2-expressing gastroesophageal adenocarcinomas (GEA). Zanidatamab continues to demonstrate promising single agent anti-tumor activity with response rates and durability that further improved when zanidatamab was combined with either paclitaxel or capecitabine. Zymeworks plans to initiate its second registration-enabling study for zanidatamab as first line treatment for advanced HER2+ GEA.
•ZW49 Continues Dose Escalation
Zymeworks’ second clinical candidate, ZW49, a bispecific antibody-drug conjugate targeting HER2, continues to be evaluated across multiple dosing regimens in the dose-escalation portion of a Phase 1 clinical trial. In the first half of the year, Zymeworks initiated recruitment at five additional clinical sites bringing the total to 11 across North America.

Merck Signs New Partnership to Develop Additional Azymetric Multispecific Antibodies
Long-term partner Merck signed a new licensing agreement to develop and commercialize up to three new multispecific antibodies toward Merck’s therapeutic targets in human health. Zymeworks is eligible to receive up to $411.0 million in option exercise fees and clinical development and regulatory approval milestone payments and up to $480.0 million in commercial milestone payments, as well as tiered royalties on worldwide sales.

•Bristol-Myers Squibb Expands Partnership and Adds EFECT Platform
BMS (formerly Celgene) expanded its Azymetric collaboration with Zymeworks, gaining access to the EFECT platform and extending its research term, resulting in a $12.0 million upfront payment to Zymeworks. Milestones remain at up to $1.7 billion plus tiered royalties on global sales.

•Strengthens Clinical Drug Development Expertise
Pamela Farmer, MD, joins Zymeworks as Vice President, Pharmacovigilance to provide medical oversight and ensure comprehensive and timely risk-benefit assessments of Zymeworks safety data. Dr. Farmer has held various leadership roles in drug safety and pharmacovigilance at major pharmaceutical companies including Prothena, Amgen, Genentech, and BioMarin, working on multiple regulatory submissions including Rituxan, Actemra and Vimizim.

Financial Results for the Quarter Ended June 30, 2020

Revenue for the three months ended June 30, 2020 was $12.4 million as compared to $7.9 million in the same period of 2019. Revenue for the three months ended June 30, 2020 included recognition of a $12.0 million expansion fee resulting from the BMS collaboration agreement expansion, as well as $0.4 million in research support and other payments from our partners. Revenue for the same period in 2019 included a $3.5 million commercial license option exercise fee from Daiichi Sankyo, $3.0 million in development milestone payments from our partners, as well as $1.4 million in research support and other payments from our partners.

For the three months ended June 30, 2020, research and development expenses were $39.2 million as compared to $23.8 million in the same period of 2019. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing costs for zanidatamab, an increase in development activity for ZW49, an increase in licensing fee expenses as well as an increase in salaries and benefits expense from additional research and development headcount in 2020 as compared to the same period in 2019. Research and development expenses also included non-cash stock-based compensation expense of $3.2 million comprised of $3.3 million from equity classified equity awards and a $0.1 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.
For the three months ended June 30, 2020, general and administrative expenses were $13.5 million as compared to $12.8 million in the same period in 2019. The change was primarily due to an increase in salaries and benefits expense resulting from an increase in headcount to support our expanding research and development activities and higher insurance expenses offset by lower non-cash stock-based compensation expense in 2020, compared to 2019. General and administrative expenses included non-cash stock-based compensation expense of $3.7 million comprised of $4.0 million from equity classified equity awards and a $0.3 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

Net loss for the three months ended June 30, 2020 was $39.0 million as compared to $29.1 million in the same period of 2019. This was primarily due to the increases in research and development expenses and general and administrative expenses referred to above, partially offset by an increase in revenue.
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 June 30, 2020, Zymeworks had $512.0 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

On August 5, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported second quarter 2020 financial results and recent business highlights (Press release, Sangamo Therapeutics, AUG 5, 2020, View Source [SID1234562926]).

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"We are very excited about our global collaboration agreement announced with Novartis last week. This is our second impactful partnership announced this year, and we believe it affirms the value our industry sees in our zinc finger technology," said Sandy Macrae, CEO of Sangamo. "By advancing our robust partnership strategy, we proactively expand our genomic medicines pipeline into potential additional new indications, create substantial value for shareholders, and advance our mission to bring our medicines to patients."

Recent Highlights

•Announced global collaboration agreement with Novartis to develop and commercialize gene regulation therapies to treat three neurodevelopmental targets, including genes linked to autism spectrum disorder and intellectual disability. Under the collaboration agreement, Sangamo expects to receive a $75 million upfront licensing fee from Novartis in the third quarter of 2020 and is eligible to earn up to $720 million in potential milestones, in addition to tiered high single-digit to sub-teen double-digit royalties on potential net commercial sales.
•In partnership with Pfizer, presented updated results from the Phase 1/2 Alta study evaluating giroctocogene fitelparvovec, or SB-525, gene therapy in patients with severe hemophilia A at the virtual World Federation of Hemophilia 2020 Congress. The results demonstrated sustained Factor VIII activity levels and no bleeding events or factor usage in the five patients who received the 3e13 vg/kg dose for up to 61 weeks, the extent of follow-up for the longest-treated patient in the cohort.
•Highlighted Sangamo’s zinc finger protein in vivo genome regulation programs and capabilities and research detailing Sangamo’s engineered adeno-associated virus (AAV) directed evolution platform in six abstracts presented at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper).
•Announced organizational changes in R&D designed to increase the speed and efficiency of clinical translation of Sangamo science, including separating the research and development organizations. Jason Fontenot, Senior Vice President and Head of Cell Therapy, was appointed Interim Head of Research, and a search for Head of Development is currently underway.

Second Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities were $664.9 million as of June 30, 2020, compared to $384.3 million as of December 31, 2019. The balance at the end of the second quarter reflects amounts received from our previously announced collaboration with Biogen for an upfront license fee and issuance of Sangamo common stock.

Consolidated net loss attributable to Sangamo for the second quarter ended June 30, 2020 was $35.9 million, or $0.26 per share, compared to a net loss of $30.3 million, or $0.26 per share, for the same period in 2019. Revenues for the second quarter ended June 30, 2020 were $21.6 million, compared to $17.5 million for the same period in 2019.

Total operating expenses were $59.4 million for the second quarter ended June 30, 2020, compared to $51.1 million for the same period in 2019. Non-GAAP operating expenses, which exclude stock-based compensation expense, were $52.7 million for the second quarter ended June 30, 2020, compared to $46.2 million for the same period in 2019. The increase in operating expenses reflects our headcount growth and facilities expansion to support the advancement of our therapeutic pipeline and manufacturing capabilities. These increases were partially offset by a decrease in clinical and manufacturing supply expenses.

Financial Guidance for 2020

•On a GAAP basis, we are revising our operating expense guidance. We expect operating expenses to be in the range of $235 million to $250 million (previously expected to be in the range of $270 million to $285 million). This includes estimated stock-based compensation expense of approximately $25 million.
•We expect non-GAAP operating expenses, which excludes stock-based compensation expense, to be in the range of $210 million to $225 million (previously expected to be in the range of $245 million to $260 million).
•The reduction in our operating expense guidance is primarily driven by the evolving COVID-19 pandemic and its anticipated impact on our clinical program timelines.

Conference Call

Sangamo will host a conference call today, August 5, 2020, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5667347. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5667347.

On August 5, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported it will be featured as a presenting company at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 (Press release, Sesen Bio, AUG 5, 2020, View Source [SID1234562925]). The Company will provide an update on the regulatory process in the US and Europe, and the BD process outside the US.

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Event: Canaccord Genuity 40th Annual Growth Conference
Date: August 13, 2020
Time: 11:00-11:25 AM ET

A live webcast of the Company’s presentation will be accessible from the Investors & Media section of Sesen Bio’s website, www.sesenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.