UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
March 7, 2019
BioXcel Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-38410 |
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82-1386754 |
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(State or other jurisdiction of
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(Commission File Number) |
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(I. R. S. Employer
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555 Long Wharf Drive
New Haven, CT 06511
(Address of principal executive offices, including ZIP code)
(475) 238-6837
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements with Certain Officers
On March 7, 2019, based on the recommendation of the Nominating and Governance Committee, the board of directors (the “Board”) of BioXcel Therapeutics, Inc. (the “Company”) voted to increase the size of the Board from four directors to five directors and appointed Michal Votruba as a Class II member of the Board to fill the resulting vacancy. Concurrent with his election to the Board, Mr. Votruba was also elected as an independent member of the Audit Committee (the “Audit Committee”). Mr. Votruba does not have any family relationship with any director, executive officer or person nominated or chosen by us to become a director. There is no understanding or arrangement between Mr. Votruba and any other person pursuant to which Mr. Votruba was selected as a director. There are no transactions in which Mr. Votruba has an interest requiring disclosure under Item 404(a) of Regulation S-K.
Since 2013, Mr. Votruba has been the Director of the Gradus/RSJ Life Sciences Fund, the largest dedicated fund in Central Europe with a portfolio of companies in Europe and the United States. Mr. Votruba has served as a director of Mynd Anlaytics, Inc. (NASDAQ: MYND), a telebehavioral health services company, since July 2015. Since 2010, he has served as a member of the board of PrimeCell Therapeutics as the Director of Global Business Development overseeing the expansion of the largest regenerative medicine company operating in Central Europe. In 2009, the Czech Academy of Sciences solicited Mr. Votruba’s expertise for the first successful privatization project of the Institute of Experimental Medicine in Prague: the newly created protocol established a precedent for future privatization projects in the Czech Republic. Mr. Votruba graduated as a Clinical Psychiatrist from the Medical Faculty of Charles University in Prague in 1989. Shortly thereafter, he emigrated from Czechoslovakia and developed his professional career in Canada and the USA. Since 2005, Mr. Votruba combined his theoretical and clinical experience in the field of Competitive Intelligence serving the global pharmaceutical industry for eight years as an industry analyst advising senior leaders of companies including Amgen, Novartis, Eli Lilly, Allergan, EMD, Serono and Sanofi.
Pursuant to the Board’s standard compensation policy for non-employee directors, Mr. Votruba will receive an annual cash retainer of $35,000 for service as a Board member, an annual retainer of $7,500 for service as an Audit Committee member and was granted an option to purchase 10,000 shares of our common stock at the fair market value on the date of his appointment, which vests annually over a three year period. The options were issued under the Company’s 2017 Equity Incentive Plan.
In addition, Mr. Votruba and the Company will enter into the Company’s standard indemnification agreement, the terms of which are described in the Company’s Registration Statement on Form S-1 (File No. 333-222990) (the “Registration Statement”) and a form of such agreement was filed as Exhibit 10.6 to the Registration Statement.
Item 8.01 Other Events.
On March 11, 2019, the Company issued a press release announcing that it will present a late breaking poster featuring data from a preclinical study of the Company’s BXCL701 and an OX40-agonist antibody as a potential combination therapy for treatment of certain solid tumors at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2019 being held from March 29 to April 3, 2019 in Atlanta, Georgia. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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(d) |
Exhibits. |
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Exhibit
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Description |
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99.1 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: March 11, 2019 |
BIOXCEL THERAPEUTICS, INC. |
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/s/ Richard Steinhart |
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Richard Steinhart |
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Chief Financial Officer |
BioXcel Therapeutics Announces Late Breaking Data Presentation at AACR 2019 Annual Meeting
NEW HAVEN, Conn., March 11, 2019 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI”) (BTAI) today announced that it will present a late breaking poster featuring data from a preclinical study of the Company’s BXCL701 and an OX40-agonist antibody as a potential combination therapy for treatment of certain solid tumors at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2019 being held from March 29 to April 3, 2019 in Atlanta, Georgia.
Details of the accepted poster are below:
Abstract #077 / Poster #22 : Dipeptidyl Peptidase Inhibitor BXCL701 synergizes with an OX40-agonist antibody resulting in synergistic anti-tumor response and survival in an animal model of colorectal cancer by bridging the innate and adaptive arms of the immune system
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Date: |
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Monday, April 01, 2019 |
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Time: |
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8:00 AM-12:00 PM ET |
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Session: |
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Late Breaking Research - Immunotherapy 1 |
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Location: |
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Georgia World Congress Center, Exhibit Hall B, Section 41 |
Dr. Vince O’Neill, Chief Medical Officer of BTI commented, “The encouraging results from this preclinical study of BXCL701 and an OX40 agonist, an investigational monoclonal antibody immunotherapy, represent a potentially valuable therapeutic option for cancer patients. We believe that this immunotherapy combination can effectively activate both the innate and adaptive immune system to fight cancer. We are excited to showcase this compelling data set and its potential at the AACR annual meeting.”
About BXCL701
BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. It has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). Preclinical
combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701’s primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing an important validation of the scientific rationale behind BXCL701.
About BioXcel Therapeutics, Inc.:
BioXcel Therapeutics, Inc. 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. BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI’s two most advanced clinical development programs are BXCL501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neurological and psychiatric disorders, and BXCL701, an immuno-oncology agent designed for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer. For more information, please visit www.bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of BXCL501 and BXCL701, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon BioXcel’s current expectations and various assumptions. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.
BioXcel may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in BioXcel’s Form 10Q for the period ending September 30, 2018, and BioXcel’s other filings made with the Securities and Exchange
Commission. Consequently, forward-looking statements should be regarded solely as BioXcel’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. BioXcel cannot guarantee future results, events, levels of activity, performance or achievements. BioXcel does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contact Information:
BioXcel Therapeutics
The Ruth Group
Lee Roth/ Janhavi Mohite
646-536-7012/ 7026
lroth@theruthgroup.com/ jmohite@theruthgroup.com