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This Day That Year: BioXcel Therapeutics

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Shares of BioXcel Therapeutics Inc. (BTAI) are down nearly 47% from their all-time high of $14.79 recorded on July 10, 2018.

It was on this day last year, i.e. on March 8, 2018, that BioXcel debuted on the NASDAQ Capital Market by setting a public offering at $11 per share.

BioXcel Therapeutics is a clinical-stage biopharmaceutical company focused on drug development that utilizes novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology.

The Company has two drug candidates in clinical development - BXCL501 and BXCL701.

BXCL501 is a first in class, sublingual film of Dexmedetomidine, a selective alpha 2a receptor agonist for the acute treatment of agitation in schizophrenia, bipolar disorder, and dementia, and it carries the FDA's Fast Track Designation.

This compound is under a phase I placebo-controlled, dose-escalation study in healthy adult volunteers across various dosing groups. The Company expects to report top-line data from this study in the second quarter of 2019.

BXCL501 also has potential application in opioid withdrawal symptoms. Last month, the Company announced proof-of-concept data from its phase Ib study of intravenously-administered Dexmedetomidine (IV Dex) in patients suffering from opioid withdrawal symptoms, providing evidence to expand the potential market for BXCL501 to treat symptoms associated with Opioid drug withdrawal.

Next in the pipeline is BXCL701.

BXCL701 is a first-in-class, clinically validated, oral, small molecule for the treatment of emergent neuroendocrine prostate cancer and pancreatic cancer.

A phase Ib trial of BXCL701 in combination with Merck's (MRK) Keytruda for the treatment of emergent neuroendocrine prostate cancer was initiated in late 2018. Data from this trial is expected throughout 2019.

The Company also has plans to initiate a clinical study to understand the underlying role of BXCL 701 and its mechanism of action in the treatment of pancreatic cancer.

Partnerships:

In November 2017, BioXcel and Nektar Therapeutics (NKTR) entered into a preclinical research collaboration, which focused on utilizing the complementary mechanisms of BXCL701 and NKTR-214 to stimulate the body's own immune system to overcome immunosuppressive mechanisms in the tumor microenvironment.

Last September, the two companies expanded their ongoing research collaboration to evaluate a triple combination of BioXcel Therapeutics' BXCL701, Nektar's NKTR-214 and a checkpoint inhibitor as a potential therapy for pancreatic cancer.

Early this month, BioXcel added Merck KGaA, Darmstadt, Germany, and Pfizer (PFE) to its Nektar Therapeutics clinical collaboration to evaluate a novel triple combination therapy in pancreatic cancer.

The triple combination now includes Bavencio (avelumab), BioXcel's BXCL701, and Nektar's NKTR-214 therapy for pancreatic cancer.

Avelumab, approved for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma, is co-developed and co-commercialized by Merck KGaA Darmstadt, Germany and Pfizer.

Balance Sheet:

The Company incurred a net loss of $19.3 million or $1.32 per share for the full year 2018, compared to a net loss of $4.5 million or $0.47 per share for the same period in 2017. No revenue has been generated to date.

The Company had an accumulated deficit of $23.72 million and cash of $42.6 million at year-end 2018.

BTAI has thus far hit a low of $2.41 and a high of $14.79. The stock closed Thursday's trading at $7.91, down 4.93%.

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