On May 6, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion’s lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R) (Press release, Fusion Pharmaceuticals, MAY 6, 2021, View Source [SID1234579413]).

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"With our strong preclinical data demonstrating promising activity with FPI-1434 and immuno-oncology agents, we believe we have an opportunity to improve efficacy in tumor indications where KEYTRUDA is approved, and to potentially expand into new tumor indications," said Chief Executive Officer John Valliant, Ph.D. "This collaboration with Merck builds off our research on the mechanism of action of alpha radiation and aligns with our goal to expand the utility of radiopharmaceutical therapies, including advancing into earlier lines of cancer therapy."

The planned Phase 1/2 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

On May 6, 2021 Asieris Pharmaceuticals ("Asieris") and BeiGene, Ltd. ("BeiGene") reported that they have entered into a clinical collaboration agreement to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, MAY 6, 2021, View Source [SID1234579412]). Asieris plans to submit INDs in China and United States for an open-label, multi-center Phase I/II clinical study with primary objectives including: to evaluate the safety in MIBC patients; determine the RP2D (recommended phase 2 dose), and efficacy as neoadjuvant therapy for MIBC.

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APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It has been approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with high expression of PD-L1 who have failed to receive platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that has progressed within 12 months.

"We are excited to collaborate with BeiGene to further explore the potential of APL-1202," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "We found that synergistic effects of APL-1202 and immunotherapies have been shown in orthotopic prostate cancer and MIBC efficacy animal models. Based on these preclinical data, we hope that this clinical trial will prove the concept of APL-1202’s activity in modulating tumor microenvironment, and believe that APL-1202 in combination with tislelizumab could be an effective neoadjuvant therapy for patients with MIBC."

On May 6, 2021 HanAll Biopharma (KRX: 009420) (HanAll) reported that it achieved 27.8 billion won in sales, 5.4 billion won in operating profit and 4.5 billion won in net profit in the first quarter of this year (Press release, HanAll Biopharma, MAY 6, 2021, View Source [SID1234579411]).

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Sales and operating profit rose 26% and 80%, respectively, compared to the same period last year thanks to increased R&D revenue and increased product revenue. Operating margin increased to 19% from 14%, and net income for the period was estimated at 4.5 billion won, up 13 percent year-on-year.

The growth of R&D revenue including milestone payments from HL161 and HL036 licensed to Immunovant and Harbour BioMed was a main performance driver while domestic drug sales slightly increased year-on-year. HanAll remain committed to delivering innovative medicines for patients with its improved financial performance.

The company plans to start the second Phase 3 clinical trial in dry eye disease (DED) in the 2H of 2021, which is being co-developed with Daewoong Pharmaceutical.

Meanwhile, HanAll has recently appointed David Hernandez, former Head of Clinical Operations Japan at Merck Biopharma, as Vice President of Clinical Operations at HPI, a U.S. subsidiary of HanAll, to accelerate clinical trials of its current and future pipeline compounds.

On May 6, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the first quarter ended March 31, 2021 (Press release, ViewRay, MAY 6, 2021, View Source [SID1234579410]).

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First Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $40.9 million, compared to four new orders totaling $22.6 million in the first quarter of 2020.
Total backlog increased to $264.3 million as of March 31, 2021, compared to $230.8 million as of March 31, 2020.
Total revenue of $15.5 million primarily from two revenue units, compared to $14.3 million primarily from three revenue units, including one system upgrade, in the first quarter of 2020.
Cash burn in the first quarter of 2021 was approximately $28 million, excluding the net proceeds from the January 2021 public offering, compared to approximately $36 million in the first quarter of 2020.
Cash and cash equivalents were $182.0 million as of March 31, 2021.
2021 Public Offering of Common Stock

As previously disclosed, in January 2021, the Company raised aggregate net proceeds of approximately $53.5 million after deducting the underwriting discounts, commissions, and estimated offering expenses via a public offering in which 11,856,500 shares of our common stock were issued and sold, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $4.85 per share.
"Our performance in the first quarter 2021 represents a solid step forward and progress on our mission to improve the paradigm of care for cancer patients globally," said Scott Drake, President and CEO. "Our clinical and innovation pipelines are driving commercial traction. We look forward to upcoming clinical trial data and advancements in our product pipeline which we expect will fuel future growth."

Financial Results

Total revenue for the three months ended March 31, 2021 was $15.5 million compared to $14.3 million for the same period last year.

Total gross profit for the three months ended March 31, 2021 was $0.3 million, compared to ($2.1) million for the same period last year.

Total operating expenses for the three months ended March 31, 2021 were $25.0 million, compared to $27.9 million for the same period last year.

Net loss for the three months ended March 31, 2021 was $26.7 million, or $0.17 per share, compared to $27.5 million, or $0.19 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $182 million at March 31, 2021.

Financial Guidance

Due to the ongoing impact and uncertainty of the COVID-19 pandemic globally, the Company will not be providing financial guidance at this time.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, May 6, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (888) 771-4371 for domestic callers and (847) 585-4405 for international callers. The confirmation number is 50150605. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until May 13, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8484107.

On May 6, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, MAY 6, 2021, View Source [SID1234579409]):

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BofA Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 2:00 p.m. ET
RBC Capital Markets 2021 Global Health Care Conference on Wednesday, May 19, 2021 at 10:20 a.m. ET
The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.