On May 12, 2020 BioXcel Therapeutics, Inc. ("BTI" or "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, reported its quarterly results for the first quarter ended March 31, 2020 and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, MAY 12, 2020, View Source [SID1234557588]).

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"BioXcel continued to advance on its key milestones for 2020," stated Vimal Mehta, Chief Executive Officer of BTAI. "Beginning with our neuroscience program, we have made significant progress advancing BXCL501, as evidenced by our three ongoing clinical trials, SERENITY I & II and TRANQUILITY, and our Phase 1b/2 RELEASE trial initiating shortly. In parallel, we are investigating biomarkers associated with agitation in hopes of expanding the potential market for BXCL501 to additional indications. These significant achievements showcase the versatility of this candidate and we believe provides the foundation for creating a highly valuable neuroscience franchise. In addition, we have made great strides with our immuno-oncology program, identifying the recommended dose of BXCL701 when used in combination with KEYTRUDA for our Phase 2 efficacy trial for treatment emergent Neuroendocrine Prostate Cancer. We believe this candidate has the potential to provide a treatment for this advanced prostate cancer that currently does not have an effective standard of care."

Dr. Mehta added, "In light of the COVID-19 pandemic, we are continuously monitoring the safety of our team, as well as its potential impact on our clinical and corporate plans. To date, we have not experienced any significant delays with our ongoing clinical trials and have developed a risk mitigation strategy to manage business operations."

First Quarter 2020 and Recent Highlights

BXCL501-Neuroscience Program

BXCL501 is an investigational sublingual thin film of dexmedetomidine, a selective alpha-2A adrenergic receptor agonist, designed for the treatment of acute agitation. The Company believes BXCL501 may directly target a causal agitation mechanism.

·The SERENITY program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder, is ongoing, with more than one-third of the patients enrolled and treated as of March 19, 2020. Enrollment is progressing as planned, and the Company is on track to report topline data from both Phase 3 trials in mid-2020.
In January 2020, the first patient was enrolled in the TRANQUILITY study, a Phase 1b/2 trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia. BTI is currently assessing safety and tolerability data in order to choose the next tested dose, and the Company expects to report topline results in mid-2020.

·Our Investigational New Drug application for the treatment of opioid withdrawal symptoms, a fourth indication for BXCL501, received clearance from the U.S. Food and Drug Administration in February 2020. The Company is planning to initiate the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms shortly.
·In February 2020, researchers at Yale University initiated a Phase 2 study designed to measure biomarkers associated with agitation in patients with schizophrenia and their response to treatment with BXCL501.
·The Company is currently completing the clinical planning stage for its fifth indication, agitation associated with hyperactive delirium, and is preparing to initiate a Phase 1b/2 trial of BXCL501 in the second half of 2020.

BXCL701-Immuno-Oncology Program

BXCL701 is an orally-delivered small molecule, innate immunity activator designed to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). It has shown single agent activity in melanoma and safety has been evaluated in more than 700 healthy subjects and cancer patients.

·After completing the Phase 1b safety lead-in, the Company has initiated the Phase 2 portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA) for treatment emergent Neuroendocrine Prostate Cancer (tNEPC). 0.3 mg of BXCL701 twice daily (BID) was found to be the recommended dose when used in combination with KEYTRUDA and this dose regime will be used for the efficacy assessment of the clinical program. The Company expects to report initial data from this trial in the fourth quarter of 2020.
·The open label Phase 2 basket trial evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid cancers has been initiated. This study, which is being conducted at the MD Anderson Cancer Center, is following the dosing schedule used in the Phase 1b/2 study for tNEPC.
·The BXCL701 phase of the triple combination study of BXCL701, bempegaldesleukin (NKTR-214, Nektar Therapeutics, Inc.) and BAVENCIO (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer is expected to begin following Nektar and Pfizer’s Phase 1b safety trial of a double combination of bempegaldesleukin and avelumab and the outcome of that trial.

Strengthened Balance Sheet

·In February 2020, the Company raised net proceeds of approximately $60 million in connection with its common stock offering. BTI believes that proceeds from this offering, together with current reserves, provide cash runway to fund key clinical, regulatory and operational milestones into 2021.

COVID-19

During the first quarter of 2020, the Company took steps in line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the State of Connecticut to protect the health and safety of its employees and the community. In particular, the Company implemented a work-from-home policy for all employees and has restricted on-site activities to certain chemical, manufacturing and control ("CMC") and clinical trial activities. To date, the Company has not experienced any significant delays to its ongoing or planned clinical trials; however, this could rapidly change.

First Quarter 2020 Financial Results

BTI reported a net loss of $14.9 million for the first quarter of 2020, compared to a net loss of $7.2 million for the same period in 2019. The first quarter 2020 results include approximately $0.8 million in non-cash stock-based compensation.

Research and development expenses were $12.4 million for the first quarter of 2020, as compared to $5.7 million for the same period in 2019. The increase was primarily due to an increase in clinical trial expenses, salaries, bonus and related costs, professional research and project-related costs and chemical, manufacturing and controls costs related to our BXCL501 and BXCL701 product candidates.

General and administrative expenses were $2.6 million for the first quarter of 2020, as compared to $1.7 million for the same period in 2019. The increase was primarily due to professional fees for additional legal and patent services.

Total operating expenses for the first quarter of 2020 were approximately $15.0 million, as compared to total operating expenses of approximately $7.4 million for the same period in 2019.

As of March 31, 2020, cash and cash equivalents totaled approximately $80.1 million.

Conference Call:

BTI will host a conference call and webcast today at 8:30 a.m. ET. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors sections of the BTI website at www.bioxceltherapeutics.com. The replay will be available through May 26, 2020.

On May 12, 2020 Varian (NYSE: VAR) reported that Dow Wilson, Chief Executive Officer, J. Michael Bruff, Chief Financial Officer, and Anshul Maheshwari, Vice President, Investor Relations and Treasurer, will participate in a virtual fireside chat at the UBS Virtual Global Healthcare Conference at 1:20 p.m. EDT on Monday, May 18, 2020 (Press release, Varian Medical Systems, MAY 12, 2020, View Source [SID1234557604]).

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Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/investors.

On May 12, 2020 Frazier Healthcare Partners ("Frazier") reported the launch of Lengo Therapeutics, Inc. ("Lengo"), a biopharmaceutical company focused on the discovery and development of novel treatments targeting driver mutations in oncology (Press release, Frazier Healthcare, MAY 12, 2020, View Source [SID1234557620]).

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"Lengo emerged from discussions at Frazier and among a highly experienced group of oncology researchers, including Frazier Senior Advisors Roger Ulrich, Ph.D., Jim Bristol, Ph.D., Michael Gallatin, Ph.D. and Bruce Roth, Ph.D., who helped identify several mutations in cancers that we felt were not well addressed by existing therapeutics," said Tracy Saxton, Ph.D., CEO of Lengo. "We were fortunate to identify novel chemical matter discovered at Jubilant to address some of these mutations of interest."

Jubilant Life Sciences Ltd ("Jubilant") has granted an exclusive license to Lengo for the worldwide development and commercialization of a portfolio of novel chemistry against undisclosed oncology targets. In connection with the license, Lengo has completed a $15 million Series A financing round from Frazier.

Jubilant and Frazier have been working together on multiple discovery-stage companies since 2016, starting with Mavupharma which was acquired by AbbVie in 2019.

"Company formation is one of our core activities at Frazier, and Jubilant has been a key part of several of our early-stage companies," said Daniel Estes, Ph.D., General Partner on the Frazier Life Sciences team. "We are excited to advance the assets we have licensed at Lengo to the clinic as quickly as possible."

"We are pleased to be strengthening our ties with Frazier Healthcare Partners," said Shyam Bhartia and Hari Bhartia, founders of Jubilant. "We welcome the addition of Lengo to the pipeline of companies we are working on together in drug discovery."

On May 12, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported certain
differences between its financial forecast on November 6, 2019, for the fiscal year ended March 31, 2020 (April 1, 2019, to March 31, 2020) and the actual results announced today (Press release, Sysmex, MAY 12, 2020, View Source [SID1234557556]). Furthermore, at a meeting of the Managing Board on May 12, 2020, Sysmex resolved to award dividends from surplus as described below, with a record date of March 31, 2020.

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1. Change from Financial Forecasts

(1) Consolidated Financial Results for Fiscal Year from April 1, 2019, to March 31, 2020

(2) Reason

In addition to the impact of the spreading COVID-19 pandemic, major reasons for the change in consolidated net sales were lower-than-expected sales in the hemostasis and urinalysis fields in the United States and sales to distributors in Latin America and the EMEA region, which were lower than forecast. Despite efforts to reduce selling, general and administrative expenses, operating profit, profit before tax and profit attributable to owners of the parent were also below forecast, due to lower sales and a foreign exchange valuation loss.

2. Dividend from Surplus

(2) Reason

In terms of returns to shareholders, we intend to provide a stable dividend on a continuous basis and aim for a consolidated payout ratio of 30% under our basic policy of sharing the successes of our operations in line with business performance. In accordance with this policy, we have set the ordinary year-end dividend for the fiscal year ended March 31, 2020, at ¥36 per share. Accordingly, annual total dividends will be ¥72 and the consolidated payout ratio will be 43.1%. This amounts to an increase of ¥2 in the total dividend for the year, from ¥70 in the fiscal year ended March 31, 2019.

On May 12, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will present at the 2020 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19 at 4:15 p.m. ET (Press release, IGM Biosciences, MAY 12, 2020, View Source [SID1234557589]). The conference will be held in a virtual meeting format.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.